H. Rept. 114-41 - IMPROVING REGULATORY TRANSPARENCY FOR NEW MEDICAL THERAPIES ACT114th Congress (2015-2016)
Committee Report
| Report Type: | House Report |
|---|---|
| Accompanies: | H.R.639 |
| Committees: |
H. Rept. 114-41 - 114th Congress (2015-2016)
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House Report 114-41 - IMPROVING REGULATORY TRANSPARENCY FOR NEW MEDICAL THERAPIES ACT
[House Report 114-41]
[From the U.S. Government Publishing Office]
114th Congress } { Rept. 114-41
HOUSE OF REPRESENTATIVES
1st Session } { Part 1
======================================================================
IMPROVING REGULATORY TRANSPARENCY FOR NEW MEDICAL THERAPIES ACT
_______
March 16, 2015.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Upton, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 639]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 639) to amend the Controlled Substances Act with
respect to drug scheduling recommendations by the Secretary of
Health and Human Services, and with respect to registration of
manufacturers and distributors seeking to conduct clinical
testing, having considered the same, report favorably thereon
with amendments and recommend that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 4
Background and Need for Legislation.............................. 5
Hearings......................................................... 6
Committee Consideration.......................................... 6
Committee Votes.................................................. 6
Committee Oversight Findings..................................... 6
Statement of General Performance Goals and Objectives............ 6
New Budget Authority, Entitlement Authority, and Tax Expenditures 7
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 7
Committee Cost Estimate.......................................... 7
Congressional Budget Office Estimate............................. 7
Federal Mandates Statement....................................... 7
Duplication of Federal Programs.................................. 7
Disclosure of Directed Rule Makings.............................. 7
Advisory Committee Statement..................................... 7
Applicability to Legislative Branch.............................. 7
Section-by-Section Analysis of the Legislation................... 8
Changes in Existing Law Made by the Bill, as Reported............ 8
Exchange of Letters with Additional Committees of Referral....... 132
The amendments are as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Improving Regulatory Transparency for
New Medical Therapies Act''.
SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW FDA-APPROVED DRUGS.
(a) Effective Date of Approval.--
(1) Effective date of drug approval.--Section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended
by adding at the end the following:
``(x) Date of Approval in the Case of Recommended Controls Under the
CSA.--
``(1) In general.--In the case of an application under
subsection (b) with respect to a drug for which the Secretary
provides notice to the sponsor that the Secretary intends to
recommend controls under the Controlled Substances Act,
approval of such application shall not take effect until the
interim final rule controlling the drug is issued in accordance
with section 201(j) of the Controlled Substances Act.
``(2) Date of approval.--For purposes of this section, with
respect to an application described in paragraph (1), the term
`date of approval' shall mean the later of--
``(A) the date an application under subsection (b) is
approved under subsection (c); or
``(B) the date of issuance of the interim final rule
controlling the drug.''.
(2) Effective date of approval of biological products.--
Section 351 of the Public Health Service Act (42 U.S.C. 262) is
amended by adding at the end the following:
``(n) Date of Approval in the Case of Recommended Controls Under the
CSA.--
``(1) In general.--In the case of an application under
subsection (a) with respect to a biological product for which
the Secretary provides notice to the sponsor that the Secretary
intends to recommend controls under the Controlled Substances
Act, approval of such application shall not take effect until
the interim final rule controlling the biological product is
issued in accordance with section 201(j) of the Controlled
Substances Act.
``(2) Date of approval.--For purposes of this section, with
respect to an application described in paragraph (1),
references to the date of approval of such application, or
licensure of the product subject to such application, shall
mean the later of--
``(A) the date an application is approved under
subsection (a); or
``(B) the date of issuance of the interim final rule
controlling the biological product.''.
(3) Effective date of approval of animal drugs.--
(A) In general.--Section 512 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b) is amended by
adding at the end the following:
``(q) Date of Approval in the Case of Recommended Controls Under the
CSA.--
``(1) In general.--In the case of an application under
subsection (b) with respect to a drug for which the Secretary
provides notice to the sponsor that the Secretary intends to
recommend controls under the Controlled Substances Act,
approval of such application shall not take effect until the
interim final rule controlling the drug is issued in accordance
with section 201(j) of the Controlled Substances Act.
``(2) Date of approval.--For purposes of this section, with
respect to an application described in paragraph (1), the term
`date of approval' shall mean the later of--
``(A) the date an application under subsection (b) is
approved under subsection (c); or
``(B) the date of issuance of the interim final rule
controlling the drug.''.
(B) Conditional approval.--Section 571(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360ccc(d)) is amended by adding at the end the
following:
``(4)(A) In the case of an application under subsection (a)
with respect to a drug for which the Secretary provides notice
to the sponsor that the Secretary intends to recommend controls
under the Controlled Substances Act, conditional approval of
such application shall not take effect until the interim final
rule controlling the drug is issued in accordance with section
201(j) of the Controlled Substances Act.
``(B) For purposes of this section, with respect to an
application described in subparagraph (A), the term `date of
approval' shall mean the later of--
``(i) the date an application under subsection (a) is
conditionally approved under subsection (b); or
``(ii) the date of issuance of the interim final rule
controlling the drug.''.
(C) Indexing of legally marketed unapproved new
animal drugs.--Section 572 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360ccc-1) is amended by
adding at the end the following:
``(k) In the case of a request under subsection (d) to add a drug to
the index under subsection (a) with respect to a drug for which the
Secretary provides notice to the person filing the request that the
Secretary intends to recommend controls under the Controlled Substances
Act, a determination to grant the request to add such drug to the index
shall not take effect, and the Secretary shall not list the drug on
such index, until the interim final rule controlling the drug is issued
in accordance with section 201(j) of the Controlled Substances Act.''.
(4) Date of approval for designated new animal drugs.--
Section 573(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360ccc-2(c)) is amended by adding at the end the
following:
``(3) For purposes of determining the 7-year period of
exclusivity under paragraph (1) for a drug for which the
Secretary intends to recommend controls under the Controlled
Substances Act, the drug shall not be considered approved or
conditionally approved until the date that the interim final
rule controlling the drug is issued in accordance with section
201(j) of the Controlled Substances Act.''.
(b) Scheduling of Newly Approved Drugs.--Section 201 of the
Controlled Substances Act (21 U.S.C. 811) is amended by inserting after
subsection (i) the following:
``(j)(1) With respect to a drug referred to in subsection (f), if the
Secretary of Health and Human Services recommends that the Attorney
General add the drug to schedule II, III, IV, or V pursuant to
subsections (a) and (b), the Attorney General shall, not later than 90
days after the date described in paragraph (2), issue an interim final
rule controlling the drug in accordance with such subsections and
section 202(b) using the procedures described in paragraph (3).
``(2) The date described in this paragraph shall be the later of--
``(A) the date on which the Attorney General receives the
scientific and medical evaluation and recommendations from the
Secretary of Health and Human Services in accordance with
subsection (b); or
``(B) the date on which the Attorney General receives
notification from the Secretary of Health and Human Services
that the Secretary has approved an application under section
505(c), 512, 571, or 572 of the Federal Food, Drug, and
Cosmetic Act or section 351(a) of the Public Health Service Act
with respect to the drug described in paragraph (1).
``(3) A rule issued by the Attorney General under paragraph (1) shall
be in accordance with the procedures provided in subsection (a), except
that the rule shall become immediately effective as an interim final
rule without requiring the Attorney General to demonstrate good cause
therefor. After publication of the interim final rule, the Attorney
General shall issue a final rule in accordance with the procedures
provided in subsection (a).''.
(c) Extension of Patent Term.--Section 156 of title 35, United States
Code, is amended--
(1) in subsection (d)(1), in the matter preceding
subparagraph (A), by inserting ``, or in the case of a drug
product described in subsection (i) within the sixty-day period
beginning on the covered date (as defined in subsection (i))''
after ``marketing or use''; and
(2) by adding at the end the following:
``(i)(1) For purposes of this section, if the Secretary of Health and
Human Services provides notice to the sponsor of an application or
request for approval, conditional approval, or indexing of a drug
product for which the Secretary intends to recommend controls under the
Controlled Substances Act, beginning on the covered date, the drug
product shall be considered to--
``(A) have been approved; and
``(B) have permission for commercial marketing or use.
``(2) In this subsection, the term `covered date' means the later
of--
``(A) the date an application is approved--
``(i) under section 351(a)(2)(C) of the Public Health
Service Act; or
``(ii) under section 505(b) or 512(c) of the Federal
Food, Drug, and Cosmetic Act;
``(B) the date an application is conditionally approved under
section 571(b) of the Federal Food, Drug, and Cosmetic Act;
``(C) the date a request for indexing is granted under
section 572(d) of the Federal Food, Drug, and Cosmetic Act; or
``(D) the date of issuance of the interim final rule
controlling the drug under section 201(j) of the Controlled
Substances Act.''.
SEC. 3. ENHANCING NEW DRUG DEVELOPMENT.
Section 303 of the Controlled Substances Act (21 U.S.C. 823) is
amended by adding at the end the following:
``(i)(1) For purposes of registration to manufacture a controlled
substance under subsection (d) for use only in a clinical trial, the
Attorney General shall register the applicant, or serve an order to
show cause upon the applicant in accordance with section 304(c), not
later than 180 days after the date on which the application is accepted
for filing.
``(2) For purposes of registration to manufacture a controlled
substance under subsection (a) for use only in a clinical trial, the
Attorney General shall, in accordance with the regulations issued by
the Attorney General, issue a notice of application not later than 90
days after the application is accepted for filing. Not later than 90
days after the date on which the period for comment pursuant to such
notice ends, the Attorney General shall register the applicant, or
serve an order to show cause upon the applicant in accordance with
section 304(c), unless the Attorney General has granted a hearing on
the application under section 1008(i) of the Controlled Substances
Import and Export Act.''.
Amend the title so as to read:
A bill to amend the Controlled Substances Act with respect
to drug scheduling recommendations by the Secretary of Health
and Human Services, and with respect to registration of
manufacturers and distributors seeking to conduct clinical
testing, and for other purposes.
Purpose and Summary
H.R. 639 would amend the Controlled Substances Act (CSA) to
require the Drug Enforcement Administration (DEA) to issue an
interim final rule to place a drug that has both not been
marketed previously in the United States and has abuse
potential in a CSA schedule within ninety days of when the drug
was approved by the Food and Drug Administration (FDA) or
within ninety days of when FDA, through the Assistant Secretary
of the Department of Health and Human Services (HHS), sends a
scheduling recommendation to the DEA, whichever comes later.
Because the Administrative Procedure Act provides that an
interim final rule is a final agency action, an interim final
rule scheduling a newly approved FDA product would constitute a
``final scheduling decision,'' allowing a manufacturer to begin
marketing the product upon its issuance.
FDA's recommendations on medical and scientific matters
would continue to be binding on the DEA, and, if FDA recommends
that a previously scheduled drug be decontrolled, the DEA would
no longer control the drug.
In addition, for purposes of calculating a new drug's
exclusivity and patent term restoration periods under the
Hatch-Waxman Act, H.R. 639 would clarify that for a new drug
that has been recommended to be scheduled by the FDA, the
effective date of approval would be the later of FDA approval
of the drug product or the issuance of an interim final rule by
DEA scheduling the new drug. H.R. 639 also would make similar
changes to treatment of animal drugs and biologics.
Finally, under 21 CFR 1301.14, the DEA must accept a
complete application for filing or, if the application is found
defective, the agency must notify the applicant within ten days
of receipt that the application is defective, including a
statement for the reason for not accepting the application for
filing. For registration applications related to Schedule III,
IV, and V drugs that will only be used in clinical trials, H.R.
639 would require the DEA to register the applicant or serve an
order to show cause why the applicant shall not be registered
within 180 days of the filing of the application. For drugs in
Schedule I or II that will only be used in clinical trials, the
DEA would be required to issue a notice of application not
later than ninety days after an application is accepted for
filing. Ninety days after the end of the comment period
pursuant to the notice, H.R. 639 would require the DEA to
register the applicant or serve an order to show cause on why
the registrant should not be registered.
Background and Need for Legislation
During the new drug approval process, FDA examines whether
the new drug has abuse potential and, if so, makes a scheduling
recommendation through the Assistant Secretary of HHS to the
DEA. In formulating its recommendation, the FDA uses an eight
part test outlined in section 201(c) of the CSA. Scientific and
medical matters related to the scheduling recommendation by the
FDA are binding on the DEA. The DEA uses the same eight part
test outlined in Section 201(c), but given the binding nature
of FDA's findings on scientific and medical matters, the DEA's
primary examination rests in three areas: the actual or
relative potential for abuse; its history or current patterns
of abuse; and the scope, duration, and significance of abuse.
Since 1996, the DEA has not made any scheduling decision for a
new drug that was contrary to the FDA recommendation.
When a new drug is approved by the FDA, a company can begin
marketing the product upon its approval. However, for the
subset of drugs that the FDA recommends to the DEA be
scheduled, the FDA requires a company attest that they will not
market the product until the DEA makes a ``final scheduling
decision.'' The attestation is found on HHS Form 356(h). There
is no schedule or deadline for the DEA to make a scheduling
decision. As such, the FDA can approve a new drug as safe and
effective, but patients and physicians must wait to access the
newly approved therapy with no expectation of a reasonable
timetable in which access will be granted. H.R. 639 would
continue to allow DEA to conduct its own analysis, but would
remove much of the uncertainty from the process.
The Hatch-Waxman Act of 1984 provided a new drug with five
years of data exclusivity after it has been approved as well as
eligibility for patent term restoration to compensate for the
time taken to receive regulatory approval. The exclusivity
starts and the patent term restoration is calculated based on
the date of approval for the product. H.R. 639 would clarify
that for a new drug that has been recommended to be scheduled
by the FDA, the effective date of approval would be the later
of the date of FDA approval of the drug product or the date of
issuance of an interim final rule by DEA scheduling the new
drug. H.R. 639 also would make similar changes to the treatment
of animal drugs and biologics. These changes would align the
exclusivity and patent term restoration periods with other
products that do not need to be scheduled prior to marketing.
Inconsistency and lengthy review times at DEA are not
limited to scheduling decisions for new drugs, but also apply
to the review of registration applications submitted by
companies in advance of conducting clinical trials. The DEA
registration does not distinguish between the manufacturing of
a controlled substance for marketing and the manufacturing of a
controlled substance for the use in clinical trials. There is
no timetable for the DEA to grant approval of registration
applications, and there is not a transparent process for the
applicant to determine the reasons for a delay in the
application. H.R. 639 would bring transparency and
predictability to the registration process so companies can
properly plan clinical trial schedules for new therapies.
Hearings
The Committee on Energy and Commerce held a hearing on
January 27, 2015.\1\ The Subcommittee received testimony from:
---------------------------------------------------------------------------
\1\H.R. 471 is a reintroduced version of H.R. 4069, the ``Ensuring
Patient Access and Effective Drug Enforcement of 2013.''
---------------------------------------------------------------------------
Mr. Ben D. Chlapek, Deputy Chief, Central Jackson
County Fire, Blue Springs, Missouri;
Mr. John L. Eadie, Director, Prescription Drug
Monitoring Program Center of Excellence, Brandeis University;
Dr. Blaine Enderson, Department of Surgery,
University of Tennessee Medical Center;
Dr. Nathan Fountain, Professor of Neurology,
University of Virginia; and,
Mr. Linden Barber, Partner and Director, DEA
Compliance Operations, Quarles & Brady.
Committee Consideration
On February 4, 2015, the Subcommittee on Health met in open
markup session to consider H.R. 639 and forwarded the bill to
the full Committee, as amended, by a voice vote. On February 11
and 12, 2015, the full Committee met in open markup session to
consider H.R. 639 and ordered the bill favorably reported to
the House, as amended, by a voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
H.R. 639. A motion by Mr. Upton to order H.R. 639 reported to
the House, as amended, was agreed to by a voice vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee held a hearing and made
findings that are reflected in this report.
Statement of General Performance Goals and Objectives
The objective of this legislation is to facilitate patient
access to new therapies in an efficient and transparent manner,
while ensuring appropriate controls are in place under the CSA.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
639 would result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
In compliance with clause 9(e), 9(f), and 9(g) of rule XXI
of the Rules of the House of Representatives, the Committee
finds that H.R. 639 contains no earmarks, limited tax benefits,
or limited tariff benefits.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974. At the
time this report was filed, the estimate was not available.
Congressional Budget Office Estimate
At the time this report was filed, the cost estimate
prepared by the Director of the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of 1974
was not available.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Duplication of Federal Programs
No provision of H.R. 639 establishes or reauthorizes a
program of the Federal Government known to be duplicative of
another Federal program, a program that was included in any
report from the Government Accountability Office to Congress
pursuant to section 21 of Public Law 111-139, or a program
related to a program identified in the most recent Catalog of
Federal Domestic Assistance.
Disclosure of Directed Rule Makings
The Committee estimates that enacting H.R. 639 specifically
directs to be completed zero specific rule makings within the
meaning of 5 U.S.C. 551.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1: Short title
Section 1 provides that the bill may be cited as the
``Improving Regulatory Transparency for New Medical Therapies
Act.''
Section 2: Scheduling of substances includes in new FDA-approved drugs
Paragraph (a) amends section 505 of the Federal Food, Drug,
and Cosmetic Act (FFDCA) to state that, for new drugs the
Assistant Secretary of Department of Health and Human Services
(HHS) recommends to be scheduled by the Drug Enforcement
Administration (DEA) under the Controlled Substances Act (CSA),
the effective date of approval of the drug shall be the later
of the date the application is approved by the Food and Drug
Administration (FDA) or the date of the issuance of an Interim
Final Rule (IFR) by the DEA controlling the drug. This would
align the effective date of approval of the application to when
the drug could be marketed.
Paragraph (a) makes similar changes related to biologic
license application under section 351 of the Public Health
Service Act, animal drugs under section 512 of the FFDCA, minor
use/minor species animal drugs under section 571 of the FFDCA,
indexed animal drugs under section 572 of the FFDCA. For each
of these sections, the effective date of approval of these
products would be the later of when the product is approved by
FDA or the issuance of an Interim Final Rule scheduling the
drug.
Paragraph (b) of section 2 amends the CSA to require the
DEA to issue an IFR scheduling a drug the FDA has recommended
to be scheduled not later than 90 days of the later of: 1) the
date on which DEA receives FDA recommendation or 2) the date on
which the FDA approves new drug application or biologic drug
application.
Paragraph (c) of section 2 amends 35 U.S.C. 156 to align a
company's patent term restoration to when the company can begin
marketing the product.
Section 3: Enhancing new drug development
Section 3 amends the CSA to provide more predictability for
when companies will receive a registration to manufacture a
drug that will be used in a clinical trial. For Schedule III,
IV, or V drugs, the DEA will be required to register an
applicant or serve an order to show cause on why they cannot
register an applicant within 180 days of the application being
accepted for filing. For Schedule I or II drugs, the DEA will
be required to issue a notice of application within 90 days
after the application is accepted for filing. Not later than 90
days after the comment period is closed, the DEA will be
required to register the applicant or serve an order to show
cause on why the applicant shall not be registered.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
* * * * * * *
new drugs
Sec. 505. (a) No person shall introduce or deliver for
introduction into interstate commerce any new drug, unless an
approval of an application filed pursuant to subsection (b) or
(j) is effective with respect to such drug.
(b)(1) Any person may file with the Secretary an application
with respect to any drug subject to the provisions of
subsection (a). Such persons shall submit to the Secretary as a
part of the application (A) full reports of investigations
which have been made to show whether or not such drug is safe
for use and whether such drug is effective in use; (B) a full
list of the articles used as components of such drug; (C) a
full statement of the composition of such drug; (D) a full
description of the methods used in, and the facilities and
controls used for, the manufacture, processing, and packing of
such drug; (E) such samples of such drug and of the articles
used as components thereof as the Secretary may require; (F)
specimens of the labeling proposed to be used for such drug,
and (G) any assessments required under section 505B. The
applicant shall file with the application the patent number and
the expiration date of any patent which claims the drug for
which the applicant submitted the application or which claims a
method of using such drug and with respect to which a claim of
patent infringement could reasonably be asserted if a person
not licensed by the owner engaged in the manufacture use, or
sale of the drug. If a application is filed under this
subsection for a drug and a patent which claims such drug or a
method of using such drug is issued after the filing date but
before approval of the application, the applicant shall amend
the application to include the information required by the
preceding sentence. Upon approval of the application, the
Secretary shall publish information submitted under the two
preceding sentences. The Secretary shall, in consultation with
the Director of the National Institutes of Health and with
representatives of the drug manufacturing industry, review and
develop guidance, as appropriate, on the inclusion of women and
minorities in clinical trials required by clause (A).
(2) An application submitted under paragraph (1) for a drug
for which the investigations described in clause (A) of such
paragraph and relied upon by the applicant for approval of the
application were not conducted by or for the applicant and for
which the applicant has not obtained a right of reference or
use from the person by or for whom the investigations were
conducted shall also include--
(A) a certification, in the opinion of the applicant
and to the best of his knowledge, with respect to each
patent which claims the drug for which such
investigations were conducted or which claims a use for
such drug for which the applicant is seeking approval
under this subsection and for which information is
required to be filed under paragraph (1) or subsection
(c)--
(i) that such patent information has not been
filed,
(ii) that such patent has expired,
(iii) of the date on which such patent will
expire, or
(iv) that such patent is invalid or will not
be infringed by the manufacture, use, or sale
of the new drug for which the application is
submitted; and
(B) if with respect to the drug for which
investigations described in paragraph (1)(A) were
conducted information was filed under paragraph (1) or
subsection (c) for a method of use patent which does
not claim a use for which the applicant is seeking
approval under this subsection, a statement that the
method of use patent does not claim such a use.
(3) Notice of opinion that patent is invalid or will not be
infringed.--
(A) Agreement to give notice.--An applicant that
makes a certification described in paragraph (2)(A)(iv)
shall include in the application a statement that the
applicant will give notice as required by this
paragraph.
(B) Timing of notice.--An applicant that makes a
certification described in paragraph (2)(A)(iv) shall
give notice as required under this paragraph--
(i) if the certification is in the
application, not later than 20 days after the
date of the postmark on the notice with which
the Secretary informs the applicant that the
application has been filed; or
(ii) if the certification is in an amendment
or supplement to the application, at the time
at which the applicant submits the amendment or
supplement, regardless of whether the applicant
has already given notice with respect to
another such certification contained in the
application or in an amendment or supplement to
the application.
(C) Recipients of notice.--An applicant required
under this paragraph to give notice shall give notice
to--
(i) each owner of the patent that is the
subject of the certification (or a
representative of the owner designated to
receive such a notice); and
(ii) the holder of the approved application
under this subsection for the drug that is
claimed by the patent or a use of which is
claimed by the patent (or a representative of
the holder designated to receive such a
notice).
(D) Contents of notice.--A notice required under this
paragraph shall--
(i) state that an application that contains
data from bioavailability or bioequivalence
studies has been submitted under this
subsection for the drug with respect to which
the certification is made to obtain approval to
engage in the commercial manufacture, use, or
sale of the drug before the expiration of the
patent referred to in the certification; and
(ii) include a detailed statement of the
factual and legal basis of the opinion of the
applicant that the patent is invalid or will
not be infringed.
(4)(A) An applicant may not amend or supplement an
application referred to in paragraph (2) to seek approval of a
drug that is a different drug than the drug identified in the
application as submitted to the Secretary.
(B) With respect to the drug for which such an application is
submitted, nothing in this subsection or subsection (c)(3)
prohibits an applicant from amending or supplementing the
application to seek approval of a different strength.
(5)(A) The Secretary shall issue guidance for the individuals
who review applications submitted under paragraph (1) or under
section 351 of the Public Health Service Act, which shall
relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and
knowledge of regulatory and scientific standards, and which
shall apply equally to all individuals who review such
applications.
(B) The Secretary shall meet with a sponsor of an
investigation or an applicant for approval for a drug under
this subsection or section 351 of the Public Health Service Act
if the sponsor or applicant makes a reasonable written request
for a meeting for the purpose of reaching agreement on the
design and size--
(i)(I) of clinical trials intended to form the
primary basis of an effectiveness claim; or
(II) in the case where human efficacy studies are not
ethical or feasible, of animal and any associated
clinical trials which, in combination, are intended to
form the primary basis of an effectiveness claim; or
(ii) with respect to an application for approval of a
biological product under section 351(k) of the Public
Health Service Act, of any necessary clinical study or
studies.
The sponsor or applicant shall provide information necessary
for discussion and agreement on the design and size of the
clinical trials. Minutes of any such meeting shall be prepared
by the Secretary and made available to the sponsor or applicant
upon request.
(C) Any agreement regarding the parameters of the design and
size of clinical trials of a new drug under this paragraph that
is reached between the Secretary and a sponsor or applicant
shall be reduced to writing and made part of the administrative
record by the Secretary. Such agreement shall not be changed
after the testing begins, except--
(i) with the written agreement of the sponsor or
applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing
division, that a substantial scientific issue essential
to determining the safety or effectiveness of the drug
has been identified after the testing has begun.
(D) A decision under subparagraph (C)(ii) by the director
shall be in writing and the Secretary shall provide to the
sponsor or applicant an opportunity for a meeting at which the
director and the sponsor or applicant will be present and at
which the director will document the scientific issue involved.
(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by,
the field or compliance division personnel unless such field or
compliance division personnel demonstrate to the reviewing
division why such decision should be modified.
(F) No action by the reviewing division may be delayed
because of the unavailability of information from or action by
field personnel unless the reviewing division determines that a
delay is necessary to assure the marketing of a safe and
effective drug.
(G) For purposes of this paragraph, the reviewing division is
the division responsible for the review of an application for
approval of a drug under this subsection or section 351 of the
Public Health Service Act (including all scientific and medical
matters, chemistry, manufacturing, and controls).
(6) An application submitted under this subsection
shall be accompanied by the certification required
under section 402(j)(5)(B) of the Public Health Service
Act. Such certification shall not be considered an
element of such application.
(c)(1) Within one hundred and eighty days after the filing of
an application under subsection (b), or such additional period
as may be agreed upon by the Secretary and the applicant, the
Secretary shall either--
(A) approve the application if he then finds that
none of the grounds for denying approval specified in
subsection (d) applies, or
(B) give the applicant notice of an opportunity for a
hearing before the Secretary under subsection (d) on
the question whether such application is approvable. If
the applicant elects to accept the opportunity for
hearing by written request within thirty days after
such notice, such hearing shall commence not more than
ninety days after the expiration of such thirty days
unless the Secretary and the applicant otherwise agree.
Any such hearing shall thereafter be conducted on an
expedited basis and the Secretary's order thereon shall
be issued within ninety days after the date fixed by
the Secretary for filing final briefs.
(2) If the patent information described in subsection (b)
could not be filed with the submission of an application under
subsection (b) because the application was filed before the
patent information was required under subsection (b) or a
patent was issued after the application was approved under such
subsection, the holder of an approved application shall file
with the Secretary, the patent number and the expiration date
of any patent which claims the drug for which the application
was submitted or which claims a method of using such drug and
with respect to which a claim of patent infringement could
reasonably be asserted if a person not licensed by the owner
engaged in the manufacture, use, or sale of the drug. If the
holder of an approved application could not file patent
information under subsection (b) because it was not required at
the time the application was approved, the holder shall file
such information under this subsection not later than thirty
days after the date of the enactment of this sentence, and if
the holder of an approved application could not file patent
information under subsection (b) because no patent had been
issued when an application was filed or approved, the holder
shall file such information under this subsection not later
than thirty days after after the date the patent involved is
issued. Upon the submission of patent information under this
subsection, the Secretary shall publish it.
(3) The approval of an application filed under subsection (b)
which contains a certification required by paragraph (2) of
such subsection shall be made effective on the last applicable
date determined by applying the following to each certification
made under subsection (b)(2)(A):
(A) If the applicant only made a certification
described in clause (i) or (ii) of subsection (b)(2)(A)
or in both such clauses, the approval may be made
effective immediately.
(B) If the applicant made a certification described
in clause (iii) of subsection (b)(2)(A), the approval
may be made effective on the date certified under
clause (iii).
(C) If the applicant made a certification described
in clause (iv) of subsection (b)(2)(A), the approval
shall be made effective immediately unless, before the
expiration of 45 days after the date on which the
notice described in subsection (b)(3) is received, an
action is brought for infringement of the patent that
is the subject of the certification and for which
information was submitted to the Secretary under
paragraph (2) or subsection (b)(1) before the date on
which the application (excluding an amendment or
supplement to the application) was submitted. If such
an action is brought before the expiration of such
days, the approval may be made effective upon the
expiration of the thirty-month period beginning on the
date of the receipt of the notice provided under
subsection (b)(3) or such shorter or longer period as
the court may order because either party to the action
failed to reasonably cooperate in expediting the
action, except that--
(i) if before the expiration of such period
the district court decides that the patent is
invalid or not infringed (including any
substantive determination that there is no
cause of action for patent infringement or
invalidity), the approval shall be made
effective on--
(I) the date on which the court
enters judgment reflecting the
decision; or
(II) the date of a settlement order
or consent decree signed and entered by
the court stating that the patent that
is the subject of the certification is
invalid or not infringed;
(ii) if before the expiration of such period
the district court decides that the patent has
been infringed--
(I) if the judgment of the district
court is appealed, the approval shall
be made effective on--
(aa) the date on which the
court of appeals decides that
the patent is invalid or not
infringed (including any
substantive determination that
there is no cause of action for
patent infringement or
invalidity); or
(bb) the date of a settlement
order or consent decree signed
and entered by the court of
appeals stating that the patent
that is the subject of the
certification is invalid or not
infringed; or
(II) if the judgment of the district
court is not appealed or is affirmed,
the approval shall be made effective on
the date specified by the district
court in a court order under section
271(e)(4)(A) of title 35, United States
Code;
(iii) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent is invalid or not
infringed, the approval shall be made effective
as provided in clause (i); or
(iv) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent has been infringed,
the approval shall be made effective as
provided in clause (ii).
In such an action, each of the parties shall reasonably
cooperate in expediting the action.
(D) Civil action to obtain patent certainty.--
(i) Declaratory judgment absent infringement
action.--
(I) In general.--No action may be
brought under section 2201 of title 28,
United States Code, by an applicant
referred to in subsection (b)(2) for a
declaratory judgment with respect to a
patent which is the subject of the
certification referred to in
subparagraph (C) unless--
(aa) the 45-day period
referred to in such
subparagraph has expired;
(bb) neither the owner of
such patent nor the holder of
the approved application under
subsection (b) for the drug
that is claimed by the patent
or a use of which is claimed by
the patent brought a civil
action against the applicant
for infringement of the patent
before the expiration of such
period; and
(cc) in any case in which the
notice provided under paragraph
(2)(B) relates to
noninfringement, the notice was
accompanied by a document
described in subclause (III).
(II) Filing of civil action.--If the
conditions described in items (aa),
(bb), and as applicable, (cc) of
subclause (I) have been met, the
applicant referred to in such subclause
may, in accordance with section 2201 of
title 28, United States Code, bring a
civil action under such section against
the owner or holder referred to in such
subclause (but not against any owner or
holder that has brought such a civil
action against the applicant, unless
that civil action was dismissed without
prejudice) for a declaratory judgment
that the patent is invalid or will not
be infringed by the drug for which the
applicant seeks approval, except that
such civil action may be brought for a
declaratory judgment that the patent
will not be infringed only in a case in
which the condition described in
subclause (I)(cc) is applicable. A
civil action referred to in this
subclause shall be brought in the
judicial district where the defendant
has its principal place of business or
a regular and established place of
business.
(III) Offer of confidential access to
application.--For purposes of subclause
(I)(cc), the document described in this
subclause is a document providing an
offer of confidential access to the
application that is in the custody of
the applicant referred to in subsection
(b)(2) for the purpose of determining
whether an action referred to in
subparagraph (C) should be brought. The
document providing the offer of
confidential access shall contain such
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, as would
apply had a protective order been
entered for the purpose of protecting
trade secrets and other confidential
business information. A request for
access to an application under an offer
of confidential access shall be
considered acceptance of the offer of
confidential access with the
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, contained
in the offer of confidential access,
and those restrictions and other terms
of the offer of confidential access
shall be considered terms of an
enforceable contract. Any person
provided an offer of confidential
access shall review the application for
the sole and limited purpose of
evaluating possible infringement of the
patent that is the subject of the
certification under subsection
(b)(2)(A)(iv) and for no other purpose,
and may not disclose information of no
relevance to any issue of patent
infringement to any person other than a
person provided an offer of
confidential access. Further, the
application may be redacted by the
applicant to remove any information of
no relevance to any issue of patent
infringement.
(ii) Counterclaim to infringement action.--
(I) In general.--If an owner of the
patent or the holder of the approved
application under subsection (b) for
the drug that is claimed by the patent
or a use of which is claimed by the
patent brings a patent infringement
action against the applicant, the
applicant may assert a counterclaim
seeking an order requiring the holder
to correct or delete the patent
information submitted by the holder
under subsection (b) or this subsection
on the ground that the patent does not
claim either--
(aa) the drug for which the
application was approved; or
(bb) an approved method of
using the drug.
(II) No independent cause of
action.--Subclause (I) does not
authorize the assertion of a claim
described in subclause (I) in any civil
action or proceeding other than a
counterclaim described in subclause
(I).
(iii) No damages.--An applicant shall not be
entitled to damages in a civil action under
clause (i) or a counterclaim under clause (ii).
(E)(i) If an application (other than an abbreviated
new drug application) submitted under subsection (b)
for a drug, no active ingredient (including any ester
or salt of the active ingredient) of which has been
approved in any other application under subsection (b),
was approved during the period beginning January 1,
1982, and ending on the date of the enactment of this
subsection, the Secretary may not make the approval of
another application for a drug for which the
investigations described in clause (A) of subsection
(b)(1) and relied upon by the applicant for approval of
the application were not conducted by or for the
applicant and for which the applicant has not obtained
a right of reference or use from the person by or for
whom the investigations were conducted effective before
the expiration of ten years from the date of the
approval of the application previously approved under
subsection (b).
(ii) If an application submitted under subsection (b)
for a drug, no active ingredient (including any ester
or salt of the active ingredient) of which has been
approved in any other application under subsection (b),
is approved after the date of the enactment of this
clause, no application which refers to the drug for
which the subsection (b) application was submitted and
for which the investigations described in clause (A) of
subsection (b)(1) and relied upon by the applicant for
approval of the application were not conducted by or
for the applicant and for which the applicant has not
obtained a right of reference or use from the person by
or for whom the investigations were conducted may be
submitted under subsection (b) before the expiration of
five years from the date of the approval of the
application under subsection (b), except that such an
application may be submitted under subsection (b) after
the expiration of four years from the date of the
approval of the subsection (b) application if it
contains a certification of patent invalidity or
noninfringement described in clause (iv) of subsection
(b)(2)(A). The approval of such an application shall be
made effective in accordance with this paragraph except
that, if an action for patent infringement is commenced
during the one-year period beginning forty-eight months
after the date of the approval of the subsection (b)
application, the thirty-month period referred to in
subparagraph (C) shall be extended by such amount of
time (if any) which is required for seven and one-half
years to have elapsed from the date of approval of the
subsection (b) application.
(iii) If an application submitted under subsection
(b) for a drug, which includes an active ingredient
(including any ester or salt of the active ingredient)
that has been approved in another application approved
under subsection (b), is approved after the date of the
enactment of this clause and if such application
contains reports of new clinical investigations (other
than bioavailability studies) essential to the approval
of the application and conducted or sponsored by the
applicant, the Secretary may not make the approval of
an application submitted under subsection (b) for the
conditions of approval of such drug in the approved
subsection (b) application effective before the
expiration of three years from the date of the approval
of the application under subsection (b) if the
investigations described in clause (A) of subsection
(b)(1) and relied upon by the applicant for approval of
the application were not conducted by or for the
applicant and if the applicant has not obtained a right
of reference or use from the person by or for whom the
investigations were conducted.
(iv) If a supplement to an application approved under
subsection (b) is approved after the date of enactment
of this clause and the supplement contains reports of
new clinical investigations (other than bioavailabilty
studies) essential to the approval of the supplement
and conducted or sponsored by the person submitting the
supplement, the Secretary may not make the approval of
an application submitted under subsection (b) for a
change approved in the supplement effective before the
expiration of three years from the date of the approval
of the supplement under subsection (b) if the
investigations described in clause (A) of subsection
(b)(1) and relied upon by the applicant for approval of
the application were not conducted by or for the
applicant and if the applicant has not obtained a right
of reference or use from the person by or for whom the
investigations were conducted.
(v) If an application (or supplement to an
application) submitted under subsection (b) for a drug,
which includes an active ingredient (including any
ester or salt of the active ingredient) that has been
approved in another application under subsection (b),
was approved during the period beginning January 1,
1982, and ending on the date of the enactment of this
clause, the Secretary may not make the approval of an
application submitted under this subsection and for
which the investigations described in clause (A) of
subsection (b)(1) and relied upon by the applicant for
approval of the application were not conducted by or
for the applicant and for which the applicant has not
obtained a right of reference or use from the person by
or for whom the investigations were conducted and which
refers to the drug for which the subsection (b)
application was submitted effective before the
expiration of two years from the date of enactment of
this clause.
(4) A drug manufactured in a pilot or other small facility
may be used to demonstrate the safety and effectiveness of the
drug and to obtain approval for the drug prior to manufacture
of the drug in a larger facility, unless the Secretary makes a
determination that a full scale production facility is
necessary to ensure the safety or effectiveness of the drug.
(d) If the Secretary finds, after due notice to the applicant
in accordance with subsection (c) and giving him an opportunity
for a hearing, in accordance with said subsection, that (1) the
investigations, reports of which are required to be submitted
to the Secretary pursuant to subsection (b), do not include
adequate tests by all methods reasonably applicable to show
whether or not such drug is safe for use under the conditions
prescribed, recommended, or suggested in the proposed labeling
thereof; (2) the results of such tests show that such drug is
unsafe for use under such conditions or do not show that such
drug is safe for use under such conditions; (3) the methods
used in, and the facilities and controls used for, the
manufacture, processing, and packing of such drug are
inadequate to preserve its identity, strength, quality, and
purity; (4) upon the basis of the information submitted to him
as part of the application, or upon the basis of any other
information before him with respect to such drug, he has
insufficient information to determine whether such drug is safe
for use under such conditions; or (5) evaluated on the basis of
the information submitted to him as part of the application and
any other information before him with respect to such drug,
there is a lack of substantial evidence that the drug will have
the effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the
proposed labeling thereof; or (6) the application failed to
contain the patent information prescribed by subsection (b); or
(7) based on a fair evaluation of all material facts, such
labeling is false or misleading in any particular; he shall
issue an order refusing to approve the application. If, after
such notice and opportunity for hearing, the Secretary finds
that clauses (1) through (6) do not apply, he shall issue an
order approving the application. As used in this subsection and
subsection (e), the term ``substantial evidence'' means
evidence consisting of adequate and well-controlled
investigations, including clinical investigations, by experts
qualified by scientific training and experience to evaluate the
effectiveness of the drug involved, on the basis of which it
could fairly and responsibly be concluded by such experts that
the drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof. If the
Secretary determines, based on relevant science, that data from
one adequate and well-controlled clinical investigation and
confirmatory evidence (obtained prior to or after such
investigation) are sufficient to establish effectiveness, the
Secretary may consider such data and evidence to constitute
substantial evidence for purposes of the preceding sentence.
The Secretary shall implement a structured risk-benefit
assessment framework in the new drug approval process to
facilitate the balanced consideration of benefits and risks, a
consistent and systematic approach to the discussion and
regulatory decisionmaking, and the communication of the
benefits and risks of new drugs. Nothing in the preceding
sentence shall alter the criteria for evaluating an application
for premarket approval of a drug.
(e) The Secretary shall, after due notice and opportunity for
hearing to the applicant, withdraw approval of an application
with respect to any drug under this section if the Secretary
finds (1) that clinical or other experience, tests, or other
scientific data show that such drug is unsafe for use under the
conditions of use upon the basis of which the application was
approved; (2) that new evidence of clinical experience, not
contained in such application or not available to the Secretary
until after such application was approved, or tests by new
methods, or tests by methods not deemed reasonably applicable
when such application was approved, evaluated together with the
evidence available to the Secretary when the application was
approved, shows that such drug is not shown to be safe for use
under the conditions of use upon the basis of which the
application was approved; or (3) on the basis of new
information before him with respect to such drug, evaluated
together with the evidence available to him when the
application was approved, that there is a lack of substantial
evidence that the drug will have the effect it purports or is
represented to have under the conditions of use prescribed,
recommended, or suggested in the labeling thereof; or (4) the
patent information prescribed by subsection (c) was not filed
within thirty days after the receipt of written notice from the
Secretary specifying the failure to file such information; or
(5) that the application contains any untrue statement of a
material fact: Provided, That if the Secretary (or in his
absence the officer acting as Secretary) finds that there is an
imminent hazard to the public health, he may suspend the
approval of such application immediately, and give the
applicant prompt notice of his action and afford the applicant
the opportunity for an expedited hearing under this subsection;
but the authority conferred by this proviso to suspend the
approval of an application shall not be delegated. The
Secretary may also, after due notice and opportunity for
hearing to the applicant, withdraw the approval of an
application submitted under subsection (b) or (j) with respect
to any drug under this section if the Secretary finds (1) that
the applicant has failed to establish a system for maintaining
required records, or has repeatedly or deliberately failed to
maintain such records or to make required reports, in
accordance with a regulation or order under subsection (k) or
to comply with the notice requirements of section 510(k)(2), or
the applicant has refused to permit access to, or copying or
verification of, such records as required by paragraph (2) of
such subsection; or (2) that on the basis of new information
before him, evaluated together with the evidence before him
when the application was approved, the methods used in, or the
facilities and controls used for, the manufacture, processing,
and packing of such drug are inadequate to assure and preserve
its identity, strength, quality, and purity and were not made
adequate within a reasonable time after receipt of written
notice from the Secretary specifying the matter complained of;
or (3) that on the basis of new information before him,
evaluated together with the evidence before him when the
application was approved, the labeling of such drug, based on a
fair evaluation of all material facts, is false or misleading
in any particular and was not corrected within a reasonable
time after receipt of written notice from the Secretary
specifying the matter complained of. Any order under this
subsection shall state the findings upon which it is based. The
Secretary may withdraw the approval of an application submitted
under this section, or suspend the approval of such an
application, as provided under this subsection, without first
ordering the applicant to submit an assessment of the approved
risk evaluation and mitigation strategy for the drug under
section 505-1(g)(2)(D).
(f) Whenever the Secretary finds that the facts so require,
he shall revoke any previous order under subsection (d) or (e)
refusing, withdrawing, or suspending approval of an application
and shall approve such application or reinstate such approval,
as may be appropriate.
(g) Orders of the Secretary issued under this section shall
be served (1) in person by any officer or employee of the
Department designated by the Secretary or (2) by mailing the
order by registered mail or by certified mail addressed to the
applicant or respondent at his last-known address in the
records of the Secretary.
(h) An appeal may be taken by the applicant from an order of
the Secretary refusing or withdrawing approval of an
application under this section. Such appeal shall be taken by
filing in the United States court of appeals for the circuit
wherein such applicant resides or has his principal place of
business, or in the United States Court of Appeals for the
District of Columbia Circuit, within sixty days after the entry
of such order, a written petition praying that the order of the
Secretary be set aside. A copy of such petition shall be
forthwith transmitted by the clerk of the court to the
Secretary, or any officer designated by him for that purpose,
and thereupon the Secretary shall certify and file in the court
the record upon which the order complained of was entered, as
provided in section 2112 of title 28, United States Code. Upon
the filing of such petition such court shall have exclusive
jurisdiction to affirm or set aside such order, except that
until the filing of the record the Secretary may modify or set
aside his order. No objection to the order of the Secretary
shall be considered by the court unless such objection shall
have been urged before the Secretary or unless there were
reasonable grounds for failure so to do. The finding of the
Secretary as to the facts, if supported by substantial
evidence, shall be conclusive. If any person shall apply to the
court for leave to adduce additional evidence, and shall show
to the satisfaction of the court that such additional evidence
is material and that there were reasonable grounds for failure
to adduce such evidence in the proceeding before the Secretary,
the court may order such additional evidence to be taken before
the Secretary and to be adduced upon the hearing in such manner
and upon such terms and conditions as to the court may seem
proper. The Secretary may modify his findings as to the facts
by reason of the additional evidence so taken, and he shall
file with the court such modified findings which, if supported
by substantial evidence, shall be conclusive, and his
recommendation, if any, for the setting aside of the original
order. The judgment of the court affirming or setting aside any
such order of the Secretary shall be final, subject to review
by the Supreme Court of the United States upon certiorari or
certification as provided in section 1254 of title 28 of the
United States Code. The commencement of proceedings under this
subsection shall not, unless specifically ordered by the court
to the contrary, operate as a stay of the Secretary's order.
(i)(1) The Secretary shall promulgate regulations for
exempting from the operation of the foregoing subsections of
this section drugs intended solely for investigational use by
experts qualified by scientific training and experience to
investigate the safety and effectiveness of drugs. Such
regulations may, within the discretion of the Secretary, among
other conditions relating to the protection of the public
health, provide for conditioning such exemption upon--
(A) the submission to the Secretary, before any
clinical testing of a new drug is undertaken, of
reports, by the manufacturer or the sponsor of the
investigation of such drug, or preclinical tests
(including tests on animals) of such drug adequate to
justify the proposed clinical testing;
(B) the manufacturer or the sponsor of the
investigation of a new drug proposed to be distributed
to investigators for clinical testing obtaining a
signed agreement from each of such investigators that
patients to whom the drug is administered will be under
his personal supervision, or under the supervision of
investigators responsible to him, and that he will not
supply such drug to any other investigator, or to
clinics, for administration to human beings;
(C) the establishment and maintenance of such
records, and the making of such reports to the
Secretary, by the manufacturer or the sponsor of the
investigation of such drug, of data (including but not
limited to analytical reports by investigators)
obtained as the result of such investigational use of
such drug, as the Secretary finds will enable him to
evaluate the safety and effectiveness of such drug in
the event of the filing of an application pursuant to
subsection (b); and
(D) the submission to the Secretary by the
manufacturer or the sponsor of the
investigation of a new drug of a statement of
intent regarding whether the manufacturer or
sponsor has plans for assessing pediatric
safety and efficacy.
(2) Subject to paragraph (3), a clinical investigation of a
new drug may begin 30 days after the Secretary has received
from the manufacturer or sponsor of the investigation a
submission containing such information about the drug and the
clinical investigation, including--
(A) information on design of the investigation and
adequate reports of basic information, certified by the
applicant to be accurate reports, necessary to assess
the safety of the drug for use in clinical
investigation; and
(B) adequate information on the chemistry and
manufacturing of the drug, controls available for the
drug, and primary data tabulations from animal or human
studies.
(3)(A) At any time, the Secretary may prohibit the sponsor of
an investigation from conducting the investigation (referred to
in this paragraph as a ``clinical hold'') if the Secretary
makes a determination described in subparagraph (B). The
Secretary shall specify the basis for the clinical hold,
including the specific information available to the Secretary
which served as the basis for such clinical hold, and confirm
such determination in writing.
(B) For purposes of subparagraph (A), a determination
described in this subparagraph with respect to a clinical hold
is that--
(i) the drug involved represents an unreasonable risk
to the safety of the persons who are the subjects of
the clinical investigation, taking into account the
qualifications of the clinical investigators,
information about the drug, the design of the clinical
investigation, the condition for which the drug is to
be investigated, and the health status of the subjects
involved; or
(ii) the clinical hold should be issued for such
other reasons as the Secretary may by regulation
establish (including reasons established by regulation
before the date of the enactment of the Food and Drug
Administration Modernization Act of 1997).
(C) Any written request to the Secretary from the sponsor of
an investigation that a clinical hold be removed shall receive
a decision, in writing and specifying the reasons therefor,
within 30 days after receipt of such request. Any such request
shall include sufficient information to support the removal of
such clinical hold.
(4) Regulations under paragraph (1) shall provide that such
exemption shall be conditioned upon the manufacturer, or the
sponsor of the investigation, requiring that experts using such
drugs for investigational purposes certify to such manufacturer
or sponsor that they will inform any human beings to whom such
drugs, or any controls used in connection therewith, are being
administered, or their representatives, that such drugs are
being used for investigational purposes and will obtain the
consent of such human beings or their representatives, except
where it is not feasible or it is contrary to the best
interests of such human beings. Nothing in this subsection
shall be construed to require any clinical investigator to
submit directly to the Secretary reports on the investigational
use of drugs. The Secretary shall update such regulations to
require inclusion in the informed consent documents and process
a statement that clinical trial information for such clinical
investigation has been or will be submitted for inclusion in
the registry data bank pursuant to subsection (j) of section
402 of the Public Health Service Act.
(j)(1) Any person may file with the Secretary an abbreviated
application for the approval of a new drug.
(2)(A) An abbreviated application for a new drug shall
contain--
(i) information to show that the conditions of use
prescribed, recommended, or suggested in the labeling
proposed for the new drug have been previously approved
for a drug listed under paragraph (7) (hereinafter in
this subsection referred to as a ``listed drug'');
(ii)(I) if the listed drug referred to in clause (i)
has only one active ingredient, information to show
that the active ingredient of the new drug is the same
as that of the listed drug;
(II) if the listed drug referred to in clause (i) has
more than one active ingredient, information to show
that the active ingredients of the new drug are the
same as those of the listed drug, or
(III) if the listed drug referred to in clause (i)
has more than one active ingredient and if one of the
active ingredients of the new drug is different and the
application is filed pursuant to the approval of a
petition filed under subparagraph (C), information to
show that the other active ingredients of the new drug
are the same as the active ingredients of the listed
drug, information to show that the different active
ingredient is an active ingredient of a listed drug or
of a drug which does not meet the requirements of
section 201(p), and such other information respecting
the different active ingredient with respect to which
the petition was filed as the Secretary may require;
(iii) information to show that the route of
administration, the dosage form, and the strength of
the new drug are the same as those of the listed drug
referred to in clause (i) or, if the route of
administration, the dosage form, or the strength of the
new drug is different and the application is filed
pursuant to the approval of a petition filed under
subparagraph (C), such information respecting the route
of administration, dosage form, or strength with
respect to which the petition was filed as the
Secretary may require;
(iv) information to show that the new drug is
bioequivalent to the listed drug referred to in clause
(i), except that if the application is filed pursuant
to the approval of a petition filed under subparagraph
(C), information to show that the active ingredients of
the new drug are of the same pharmacological or
therapeutic class as those of the listed drug referred
to in clause (i) and the new drug can be expected to
have the same therapeutic effect as the listed drug
when administered to patients for a condition of use
referred to in clause (i);
(v) information to show that the labeling proposed
for the new drug is the same as the labeling approved
for the listed drug referred to in clause (i) except
for changes required because of differences approved
under a petition filed under subparagraph (C) or
because the new drug and the listed drug are produced
or distributed by different manufacturers;
(vi) the items specified in clauses (B) through (F)
of subsection (b)(1);
(vii) a certification, in the opinion of the
applicant and to the best of his knowledge, with
respect to each patent which claims the listed drug
referred to in clause (i) or which claims a use for
such listed drug for which the applicant is seeking
approval under this subsection and for which
information is required to be filed under subsection
(b) or (c)--
(I) that such patent information has not been
filed,
(II) that such patent has expired,
(III) of the date on which such patent will
expire, or
(IV) that such patent is invalid or will not
be infringed by the manufacture, use, or sale
of the new drug for which the application is
submitted; and
(viii) if with respect to the listed drug referred to
in clause (i) information was filed under subsection
(b) or (c) for a method of use patent which does not
claim a use for which the applicant is seeking approval
under this subsection, a statement that the method of
use patent does not claim such a use.
The Secretary may not require that an abbreviated application
contain information in addition to that required by clauses (i)
through (viii).
(B) Notice of opinion that patent is invalid or will not be
infringed.--
(i) Agreement to give notice.--An applicant that
makes a certification described in subparagraph
(A)(vii)(IV) shall include in the application a
statement that the applicant will give notice as
required by this subparagraph.
(ii) Timing of notice.--An applicant that makes a
certification described in subparagraph (A)(vii)(IV)
shall give notice as required under this subparagraph--
(I) if the certification is in the
application, not later than 20 days after the
date of the postmark on the notice with which
the Secretary informs the applicant that the
application has been filed; or
(II) if the certification is in an amendment
or supplement to the application, at the time
at which the applicant submits the amendment or
supplement, regardless of whether the applicant
has already given notice with respect to
another such certification contained in the
application or in an amendment or supplement to
the application.
(iii) Recipients of notice.--An applicant required
under this subparagraph to give notice shall give
notice to--
(I) each owner of the patent that is the
subject of the certification (or a
representative of the owner designated to
receive such a notice); and
(II) the holder of the approved application
under subsection (b) for the drug that is
claimed by the patent or a use of which is
claimed by the patent (or a representative of
the holder designated to receive such a
notice).
(iv) Contents of notice.--A notice required under
this subparagraph shall--
(I) state that an application that contains
data from bioavailability or bioequivalence
studies has been submitted under this
subsection for the drug with respect to which
the certification is made to obtain approval to
engage in the commercial manufacture, use, or
sale of the drug before the expiration of the
patent referred to in the certification; and
(II) include a detailed statement of the
factual and legal basis of the opinion of the
applicant that the patent is invalid or will
not be infringed.
(C) If a person wants to submit an abbreviated application
for a new drug which has a different active ingredient or whose
route of administration, dosage form, or strength differ from
that of a listed drug, such person shall submit a petition to
the Secretary seeking permission to file such an application.
The Secretary shall approve or disapprove a petition submitted
under this subparagraph within ninety days of the date the
petition is submitted. The Secretary shall approve such a
petition unless the Secretary finds--
(i) that investigations must be conducted to show the
safety and effectiveness of the drug or of any of its
active ingredients, the route of administration, the
dosage form, or strength which differ from the listed
drug; or
(ii) that any drug with a different active ingredient
may not be adequately evaluated for approval as safe
and effective on the basis of the information required
to be submitted in an abbreviated application.
(D)(i) An applicant may not amend or supplement an
application to seek approval of a drug referring to a different
listed drug from the listed drug identified in the application
as submitted to the Secretary.
(ii) With respect to the drug for which an application is
submitted, nothing in this subsection prohibits an applicant
from amending or supplementing the application to seek approval
of a different strength.
(iii) Within 60 days after the date of the enactment of the
Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, the Secretary shall issue guidance defining the term
``listed drug'' for purposes of this subparagraph.
(3)(A) The Secretary shall issue guidance for the individuals
who review applications submitted under paragraph (1), which
shall relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and
knowledge of regulatory and scientific standards, and which
shall apply equally to all individuals who review such
applications.
(B) The Secretary shall meet with a sponsor of an
investigation or an applicant for approval for a drug under
this subsection if the sponsor or applicant makes a reasonable
written request for a meeting for the purpose of reaching
agreement on the design and size of bioavailability and
bioequivalence studies needed for approval of such application.
The sponsor or applicant shall provide information necessary
for discussion and agreement on the design and size of such
studies. Minutes of any such meeting shall be prepared by the
Secretary and made available to the sponsor or applicant.
(C) Any agreement regarding the parameters of design and size
of bioavailability and bioequivalence studies of a drug under
this paragraph that is reached between the Secretary and a
sponsor or applicant shall be reduced to writing and made part
of the administrative record by the Secretary. Such agreement
shall not be changed after the testing begins, except--
(i) with the written agreement of the sponsor or
applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing
division, that a substantial scientific issue essential
to determining the safety or effectiveness of the drug
has been identified after the testing has begun.
(D) A decision under subparagraph (C)(ii) by the director
shall be in writing and the Secretary shall provide to the
sponsor or applicant an opportunity for a meeting at which the
director and the sponsor or applicant will be present and at
which the director will document the scientific issue involved.
(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by,
the field or compliance office personnel unless such field or
compliance office personnel demonstrate to the reviewing
division why such decision should be modified.
(F) No action by the reviewing division may be delayed
because of the unavailability of information from or action by
field personnel unless the reviewing division determines that a
delay is necessary to assure the marketing of a safe and
effective drug.
(G) For purposes of this paragraph, the reviewing division is
the division responsible for the review of an application for
approval of a drug under this subsection (including scientific
matters, chemistry, manufacturing, and controls).
(4) Subject to paragraph (5), the Secretary shall approve an
application for a drug unless the Secretary finds--
(A) the methods used in, or the facilities and
controls used for, the manufacture, processing, and
packing of the drug are inadequate to assure and
preserve its identity, strength, quality, and purity;
(B) information submitted with the application is
insufficient show that each of the proposed conditions
of use have been previously approved for the listed
drug referred to in the application;
(C)(i) if the listed drug has only one active
ingredient, information submitted with the application
is insufficient to show that the active ingredient is
the same as that of the listed drug;
(ii) if the listed drug has more than one active
ingredient, information submitted with the application
is insufficient to show that the active ingredients are
the same as the active ingredients of the listed drug,
or
(iii) if the listed drug has more than one active
ingredient and if the application is for a drug which
has an active ingredient different from the listed
drug, information submitted with the application is
insufficient to show--
(I) that the other active ingredients are the
same as the active ingredients of the listed
drug, or
(II) that the different active ingredient is
an active ingredient of a listed drug or a drug
which does not meet the requirements of section
201(p),
or no petition to file an application for the drug with
the different ingredient was approved under paragraph
(2)(C);
(D)(i) if the application is for a drug whose route
of administration, dosage form, or strength of the drug
is the same as the route of administration, dosage
form, or strength of the listed drug referred to in the
application, information submitted in the application
is insufficient to show that the route of
administration, dosage form, or strength is the same as
that of the listed drug, or
(ii) if the application is for a drug whose route of
administration, dosage form, or strength of the drug is
different from that of the listed drug referred to in
the application, no petition to file an application for
the drug with the different route of administration,
dosage form, or strength was approved under paragraph
(2)(C);
(E) if the application was filed pursuant to the
approval of a petition under paragraph (2)(C), the
application did not contain the information required by
the Secretary respecting the active ingredient, route
of administration, dosage form, or strength which is
not the same;
(F) information submitted in the application is
insufficient to show that the drug is bioequivalent to
the listed drug referred to in the application or, if
the application was filed pursuant to a petition
approved under paragraph (2)(C), information submitted
in the application is insufficient to show that the
active ingredients of the new drug are of the same
pharmacological or therapeutic class as those of the
listed drug referred to in paragraph (2)(A)(i) and that
the new drug can be expected to have the same
therapeutic effect as the listed drug when administered
to patients for a condition of use referred to in such
paragraph;
(G) information submitted in the application is
insufficient to show that the labeling proposed for the
drug is the same as the labeling approved for the
listed drug referred to in the application except for
changes required because of differences approved under
a petition filed under paragraph (2)(C) or because the
drug and the listed drug are produced or distributed by
different manufacturers;
(H) information submitted in the application or any
other information available to the Secretary shows that
(i) the inactive ingredients of the drug are unsafe for
use under the conditions prescribed, recommended, or
suggested in the labeling proposed for the drug, or
(ii) the composition of the drug is unsafe under such
conditions because of the type or quantity of inactive
ingredients included or the manner in which the
inactive ingredients are included;
(I) the approval under subsection (c) of the listed
drug referred to in the application under this
subsection has been withdrawn or suspended for grounds
described in the first sentence of subsection (e), the
Secretary has published a notice of opportunity for
hearing to withdraw approval of the listed drug under
subsection (c) for grounds described in the first
sentence of subsection (e), the approval under this
subsection of the listed drug referred to in the
application under this subsection has been withdrawn or
suspended under paragraph (6), or the Secretary has
determined that the listed drug has been withdrawn from
sale for safety or effectiveness reasons;
(J) the application does not meet any other
requirement of paragraph (2)(A); or
(K) the application contains an untrue statement of
material fact.
(5)(A) Within one hundred and eighty days of the initial
receipt of an application under paragraph (2) or within such
additional period as may be agreed upon by the Secretary and
the applicant, the Secretary shall approve or disapprove the
application.
(B) The approval of an application submitted under paragraph
(2) shall be made effective on the last applicable date
determined by applying the following to each certification made
under paragraph (2)(A)(vii):
(i) If the applicant only made a certification
described in subclause (I) or (II) of paragraph
(2)(A)(vii) or in both such subclauses, the approval
may be made effective immediately.
(ii) If the applicant made a certification described
in subclause (III) of paragraph (2)(A)(vii), the
approval may be made effective on the date certified
under subclause (III).
(iii) If the applicant made a certification described
in subclause (IV) of paragraph (2)(A)(vii), the
approval shall be made effective immediately unless,
before the expiration of 45 days after the date on
which the notice described in paragraph (2)(B) is
received, an action is brought for infringement of the
patent that is the subject of the certification and for
which information was submitted to the Secretary under
subsection (b)(1) or (c)(2) before the date on which
the application (excluding an amendment or supplement
to the application), which the Secretary later
determines to be substantially complete, was submitted.
If such an action is brought before the expiration of
such days, the approval shall be made effective upon
the expiration of the thirty-month period beginning on
the date of the receipt of the notice provided under
paragraph (2)(B)(i) or such shorter or longer period as
the court may order because either party to the action
failed to reasonably cooperate in expediting the
action, except that--
(I) if before the expiration of such period
the district court decides that the patent is
invalid or not infringed (including any
substantive determination that there is no
cause of action for patent infringement or
invalidity), the approval shall be made
effective on--
(aa) the date on which the court
enters judgment reflecting the
decision; or
(bb) the date of a settlement order
or consent decree signed and entered by
the court stating that the patent that
is the subject of the certification is
invalid or not infringed;
(II) if before the expiration of such period
the district court decides that the patent has
been infringed--
(aa) if the judgment of the district
court is appealed, the approval shall
be made effective on--
(AA) the date on which the
court of appeals decides that
the patent is invalid or not
infringed (including any
substantive determination that
there is no cause of action for
patent infringement or
invalidity); or
(BB) the date of a settlement
order or consent decree signed
and entered by the court of
appeals stating that the patent
that is the subject of the
certification is invalid or not
infringed; or
(bb) if the judgment of the district
court is not appealed or is affirmed,
the approval shall be made effective on
the date specified by the district
court in a court order under section
271(e)(4)(A) of title 35, United States
Code;
(III) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent is invalid or not
infringed, the approval shall be made effective
as provided in subclause (I); or
(IV) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent has been infringed,
the approval shall be made effective as
provided in subclause (II).
In such an action, each of the parties shall reasonably
cooperate in expediting the action.
(iv) 180-day exclusivity period.--
(I) Effectiveness of application.--Subject to
subparagraph (D), if the application contains a
certification described in paragraph
(2)(A)(vii)(IV) and is for a drug for which a
first applicant has submitted an application
containing such a certification, the
application shall be made effective on the date
that is 180 days after the date of the first
commercial marketing of the drug (including the
commercial marketing of the listed drug) by any
first applicant.
(II) Definitions.--In this paragraph:
(aa) 180-day exclusivity period.--
The term ``180-day exclusivity period''
means the 180-day period ending on the
day before the date on which an
application submitted by an applicant
other than a first applicant could
become effective under this clause.
(bb) First applicant.--As used in
this subsection, the term ``first
applicant'' means an applicant that, on
the first day on which a substantially
complete application containing a
certification described in paragraph
(2)(A)(vii)(IV) is submitted for
approval of a drug, submits a
substantially complete application that
contains and lawfully maintains a
certification described in paragraph
(2)(A)(vii)(IV) for the drug.
(cc) Substantially complete
application.--As used in this
subsection, the term ``substantially
complete application'' means an
application under this subsection that
on its face is sufficiently complete to
permit a substantive review and
contains all the information required
by paragraph (2)(A).
(dd) Tentative approval.--
(AA) In general.--The term
``tentative approval'' means
notification to an applicant by
the Secretary that an
application under this
subsection meets the
requirements of paragraph
(2)(A), but cannot receive
effective approval because the
application does not meet the
requirements of this
subparagraph, there is a period
of exclusivity for the listed
drug under subparagraph (F) or
section 505A, or there is a 7-
year period of exclusivity for
the listed drug under section
527.
(BB) Limitation.--A drug that
is granted tentative approval
by the Secretary is not an
approved drug and shall not
have an effective approval
until the Secretary issues an
approval after any necessary
additional review of the
application.
(C) Civil action to obtain patent certainty.--
(i) Declaratory judgment absent infringement
action.--
(I) In general.--No action may be
brought under section 2201 of title 28,
United States Code, by an applicant
under paragraph (2) for a declaratory
judgment with respect to a patent which
is the subject of the certification
referred to in subparagraph (B)(iii)
unless--
(aa) the 45-day period
referred to in such
subparagraph has expired;
(bb) neither the owner of
such patent nor the holder of
the approved application under
subsection (b) for the drug
that is claimed by the patent
or a use of which is claimed by
the patent brought a civil
action against the applicant
for infringement of the patent
before the expiration of such
period; and
(cc) in any case in which the
notice provided under paragraph
(2)(B) relates to
noninfringement, the notice was
accompanied by a document
described in subclause (III).
(II) Filing of civil action.--If the
conditions described in items (aa),
(bb), and as applicable, (cc) of
subclause (I) have been met, the
applicant referred to in such subclause
may, in accordance with section 2201 of
title 28, United States Code, bring a
civil action under such section against
the owner or holder referred to in such
subclause (but not against any owner or
holder that has brought such a civil
action against the applicant, unless
that civil action was dismissed without
prejudice) for a declaratory judgment
that the patent is invalid or will not
be infringed by the drug for which the
applicant seeks approval, except that
such civil action may be brought for a
declaratory judgment that the patent
will not be infringed only in a case in
which the condition described in
subclause (I)(cc) is applicable. A
civil action referred to in this
subclause shall be brought in the
judicial district where the defendant
has its principal place of business or
a regular and established place of
business.
(III) Offer of confidential access to
application.--For purposes of subclause
(I)(cc), the document described in this
subclause is a document providing an
offer of confidential access to the
application that is in the custody of
the applicant under paragraph (2) for
the purpose of determining whether an
action referred to in subparagraph
(B)(iii) should be brought. The
document providing the offer of
confidential access shall contain such
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, as would
apply had a protective order been
entered for the purpose of protecting
trade secrets and other confidential
business information. A request for
access to an application under an offer
of confidential access shall be
considered acceptance of the offer of
confidential access with the
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, contained
in the offer of confidential access,
and those restrictions and other terms
of the offer of confidential access
shall be considered terms of an
enforceable contract. Any person
provided an offer of confidential
access shall review the application for
the sole and limited purpose of
evaluating possible infringement of the
patent that is the subject of the
certification under paragraph
(2)(A)(vii)(IV) and for no other
purpose, and may not disclose
information of no relevance to any
issue of patent infringement to any
person other than a person provided an
offer of confidential access. Further,
the application may be redacted by the
applicant to remove any information of
no relevance to any issue of patent
infringement.
(ii) Counterclaim to infringement action.--
(I) In general.--If an owner of the
patent or the holder of the approved
application under subsection (b) for
the drug that is claimed by the patent
or a use of which is claimed by the
patent brings a patent infringement
action against the applicant, the
applicant may assert a counterclaim
seeking an order requiring the holder
to correct or delete the patent
information submitted by the holder
under subsection (b) or (c) on the
ground that the patent does not claim
either--
(aa) the drug for which the
application was approved; or
(bb) an approved method of
using the drug.
(II) No independent cause of
action.--Subclause (I) does not
authorize the assertion of a claim
described in subclause (I) in any civil
action or proceeding other than a
counterclaim described in subclause
(I).
(iii) No damages.--An applicant shall not be
entitled to damages in a civil action under
clause (i) or a counterclaim under clause (ii).
(D) Forfeiture of 180-day exclusivity period.--
(i) Definition of forfeiture event.--In this
subparagraph, the term ``forfeiture event'',
with respect to an application under this
subsection, means the occurrence of any of the
following:
(I) Failure to market.--The first
applicant fails to market the drug by
the later of--
(aa) the earlier of the date
that is--
(AA) 75 days after
the date on which the
approval of the
application of the
first applicant is made
effective under
subparagraph (B)(iii);
or
(BB) 30 months after
the date of submission
of the application of
the first applicant; or
(bb) with respect to the
first applicant or any other
applicant (which other
applicant has received
tentative approval), the date
that is 75 days after the date
as of which, as to each of the
patents with respect to which
the first applicant submitted
and lawfully maintained a
certification qualifying the
first applicant for the 180-day
exclusivity period under
subparagraph (B)(iv), at least
1 of the following has
occurred:
(AA) In an
infringement action
brought against that
applicant with respect
to the patent or in a
declaratory judgment
action brought by that
applicant with respect
to the patent, a court
enters a final decision
from which no appeal
(other than a petition
to the Supreme Court
for a writ of
certiorari) has been or
can be taken that the
patent is invalid or
not infringed.
(BB) In an
infringement action or
a declaratory judgment
action described in
subitem (AA), a court
signs a settlement
order or consent decree
that enters a final
judgment that includes
a finding that the
patent is invalid or
not infringed.
(CC) The patent
information submitted
under subsection (b) or
(c) is withdrawn by the
holder of the
application approved
under subsection (b).
(II) Withdrawal of application.--The
first applicant withdraws the
application or the Secretary considers
the application to have been withdrawn
as a result of a determination by the
Secretary that the application does not
meet the requirements for approval
under paragraph (4).
(III) Amendment of certification.--
The first applicant amends or withdraws
the certification for all of the
patents with respect to which that
applicant submitted a certification
qualifying the applicant for the 180-
day exclusivity period.
(IV) Failure to obtain tentative
approval.--The first applicant fails to
obtain tentative approval of the
application within 30 months after the
date on which the application is filed,
unless the failure is caused by a
change in or a review of the
requirements for approval of the
application imposed after the date on
which the application is filed.
(V) Agreement with another applicant,
the listed drug application holder, or
a patent owner.--The first applicant
enters into an agreement with another
applicant under this subsection for the
drug, the holder of the application for
the listed drug, or an owner of the
patent that is the subject of the
certification under paragraph
(2)(A)(vii)(IV), the Federal Trade
Commission or the Attorney General
files a complaint, and there is a final
decision of the Federal Trade
Commission or the court with regard to
the complaint from which no appeal
(other than a petition to the Supreme
Court for a writ of certiorari) has
been or can be taken that the agreement
has violated the antitrust laws (as
defined in section 1 of the Clayton Act
(15 U.S.C. 12), except that the term
includes section 5 of the Federal Trade
Commission Act (15 U.S.C. 45) to the
extent that that section applies to
unfair methods of competition).
(VI) Expiration of all patents.--All
of the patents as to which the
applicant submitted a certification
qualifying it for the 180-day
exclusivity period have expired.
(ii) Forfeiture.--The 180-day exclusivity
period described in subparagraph (B)(iv) shall
be forfeited by a first applicant if a
forfeiture event occurs with respect to that
first applicant.
(iii) Subsequent applicant.--If all first
applicants forfeit the 180-day exclusivity
period under clause (ii)--
(I) approval of any application
containing a certification described in
paragraph (2)(A)(vii)(IV) shall be made
effective in accordance with
subparagraph (B)(iii); and
(II) no applicant shall be eligible
for a 180-day exclusivity period.
(E) If the Secretary decides to disapprove an application,
the Secretary shall give the applicant notice of an opportunity
for a hearing before the Secretary on the question of whether
such application is approvable. If the applicant elects to
accept the opportunity for hearing by written request within
thirty days after such notice, such hearing shall commence not
more than ninety days after the expiration of such thirty days
unless the Secretary and the applicant otherwise agree. Any
such hearing shall thereafter be conducted on an expedited
basis and the Secretary's order thereon shall be issued within
ninety days after the date fixed by the Secretary for filing
final briefs.
(F)(i) If an application (other than an abbreviated new drug
application) submitted under subsection (b) for a drug, no
active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other application
under subsection (b), was approved during the period beginning
January 1, 1982, and ending on the date of the enactment of
this subsection, the Secretary may not make the approval of an
application submitted under this subsection which refers to the
drug for which the subsection (b) application was submitted
effective before the expiration of ten years from the date of
the approval of the application under subsection (b).
(ii) If an application submitted under subsection (b) for a
drug, no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other
application under subsection (b), is approved after the date of
the enactment of this subsection, no application may be
submitted under this subsection which refers to the drug for
which the subsection (b) application was submitted before the
expiration of five years from the date of the approval of the
application under subsection (b), except that such an
application may be submitted under this subsection after the
expiration of four years from the date of the approval of the
subsection (b) application if it contains a certification of
patent invalidity or noninfringement described in subclause
(IV) of paragraph (2)(A)(vii). The approval of such an
application shall be made effective in accordance with
subparagraph (B) except that, if an action for patent
infringement is commenced during the one-year period beginning
forty-eight months after the date of the approval of the
subsection (b) application, the thirty-month period referred to
in subparagraph (B)(iii) shall be extended by such amount of
time (if any) which is required for seven and one-half years to
have elapsed from the date of approval of the subsection (b)
application.
(iii) If an application submitted under subsection (b) for a
drug, which includes an active ingredient (including any ester
or salt of the active ingredient) that has been approved in
another application approved under subsection (b), is approved
after the date of enactment of this subsection and if such
application contains reports of new clinical investigations
(other than bioavailability studies) essential to the approval
of the application and conducted or sponsored by the applicant,
the Secretary may not make the approval of an application
submitted under this subsection for the conditions of approval
of such drug in the subsection (b) application effective before
the expiration of three years from the date of the approval of
the application under subsection (b) for such drug.
(iv) If a supplement to an application approved under
subsection (b) is approved after the date of enactment of this
subsection and the supplement contains reports of new clinical
investigations (other than bioavailability studies) essential
to the approval of the supplement and conducted or sponsored by
the person submitting the supplement, the Secretary may not
make the approval of an application submitted under this
subsection for a change approved in the supplement effective
before the expiration of three years from the date of the
approval of the supplement under subsection (b).
(v) If an application (or supplement to an application)
submitted under subsection (b) for a drug, which includes an
active ingredient (including any ester or salt of the active
ingredient) that has been approved in another application under
subsection (b), was approved during the period beginning
January 1, 1982, and ending on the date of the enactment of
this subsection, the Secretary may not make the approval of an
application submitted under this subsection which refers to the
drug for which the subsection (b) application was submitted or
which refers to a change approved in a supplement to the
subsection (b) application effective before the expiration of
two years from the date of enactment of this subsection.
(6) If a drug approved under this subsection refers in its
approved application to a drug the approval of which was
withdrawn or suspended for grounds described in the first
sentence of subsection (e) or was withdrawn or suspended under
this paragraph or which, as determined by the Secretary, has
been withdrawn from sale for safety or effectiveness reasons,
the approval of the drug under this subsection shall be
withdrawn or suspended--
(A) for the same period as the withdrawal or
suspension under subsection (e) or this paragraph, or
(B) if the listed drug has been withdrawn from sale,
for the period of withdrawal from sale or, if earlier,
the period ending on the date the Secretary determines
that the withdrawal from sale is not for safety or
effectiveness reasons.
(7)(A)(i) Within sixty days of the date of the enactment of
this subsection, the Secretary shall publish and make available
to the public--
(I) a list in alphabetical order of the official and
proprietary name of each drug which has been approved
for safety and effectiveness under subsection (c)
before the date of the enactment of this subsection;
(II) the date of approval if the drug is approved
after 1981 and the number of the application which was
approved; and
(III) whether in vitro or in vivo bioequivalence
studies, or both such studies, are required for
applications filed under this subsection which will
refer to the drug published.
(ii) Every thirty days after the publication of the first
list under clause (i) the Secretary shall revise the list to
include each drug which has been approved for safety and
effectiveness under subsection (c) or approved under this
subsection during the thirty-day period.
(iii) When patent information submitted under subsection (b)
or (c) respecting a drug included on the list is to be
published by the Secretary, the Secretary shall, in revisions
made under clause (ii), include such information for such drug.
(B) A drug approved for safety and effectiveness under
subsection (c) or approved under this subsection shall, for
purposes of this subsection, be considered to have been
published under subparagraph (A) on the date of its approval or
the date of enactment, whichever is later.
(C) If the approval of a drug was withdrawn or suspended for
grounds described in the first sentence of subsection (e) or
was withdrawn or suspended under paragraph (6) or if the
Secretary determines that a drug has been withdrawn from sale
for safety or effectiveness reasons, it may not be published in
the list under subparagraph (A) or, if the withdrawal or
suspension occurred after its publication in such list, it
shall be immediately removed from such list--
(i) for the same period as the withdrawal or
suspension under subsection (e) or paragraph (6), or
(ii) if the listed drug has been withdrawn from sale,
for the period of withdrawal from sale or, if earlier,
the period ending on the date the Secretary determines
that the withdrawal from sale is not for safety or
effectiveness reasons.
A notice of the removal shall be published in the Federal
Register.
(8) For purposes of this subsection:
(A)(i) The term ``bioavailability'' means the rate
and extent to which the active ingredient or
therapeutic ingredient is absorbed from a drug and
becomes available at the site of drug action.
(ii) For a drug that is not intended to be absorbed
into the bloodstream, the Secretary may assess
bioavailability by scientifically valid measurements
intended to reflect the rate and extent to which the
active ingredient or therapeutic ingredient becomes
available at the site of drug action.
(B) A drug shall be considered to be bioequivalent to
a listed drug if--
(i) the rate and extent of absorption of the
drug do not show a significant difference from
the rate and extent of absorption of the listed
drug when administered at the same molar dose
of the therapeutic ingredient under similar
experimental conditions in either a single dose
or multiple doses; or
(ii) the extent of absorption of the drug
does not show a significant difference from the
extent of absorption of the listed drug when
administered at the same molar dose of the
therapeutic ingredient under similar
experimental conditions in either a single dose
or multiple doses and the difference from the
listed drug in the rate of absorption of the
drug is intentional, is reflected in its
proposed labeling, is not essential to the
attainment of effective body drug
concentrations on chronic use, and is
considered medically insignificant for the
drug.
(C) For a drug that is not intended to be absorbed
into the bloodstream, the Secretary may establish
alternative, scientifically valid methods to show
bioequivalence if the alternative methods are expected
to detect a significant difference between the drug and
the listed drug in safety and therapeutic effect.
(9) The Secretary shall, with respect to each application
submitted under this subsection, maintain a record of--
(A) the name of the applicant,
(B) the name of the drug covered by the application,
(C) the name of each person to whom the review of the
chemistry of the application was assigned and the date
of such assignment, and
(D) the name of each person to whom the
bioequivalence review for such application was assigned
and the date of such assignment.
The information the Secretary is required to maintain under
this paragraph with respect to an application submitted under
this subsection shall be made available to the public after the
approval of such application.
(10)(A) If the proposed labeling of a drug that is the
subject of an application under this subsection differs from
the listed drug due to a labeling revision described under
clause (i), the drug that is the subject of such application
shall, notwithstanding any other provision of this Act, be
eligible for approval and shall not be considered misbranded
under section 502 if--
(i) the application is otherwise eligible for
approval under this subsection but for expiration of
patent, an exclusivity period, or of a delay in
approval described in paragraph (5)(B)(iii), and a
revision to the labeling of the listed drug has been
approved by the Secretary within 60 days of such
expiration;
(ii) the labeling revision described under clause (i)
does not include a change to the ``Warnings'' section
of the labeling;
(iii) the sponsor of the application under this
subsection agrees to submit revised labeling of the
drug that is the subject of such application not later
than 60 days after the notification of any changes to
such labeling required by the Secretary; and
(iv) such application otherwise meets the applicable
requirements for approval under this subsection.
(B) If, after a labeling revision described in subparagraph
(A)(i), the Secretary determines that the continued presence in
interstate commerce of the labeling of the listed drug (as in
effect before the revision described in subparagraph (A)(i))
adversely impacts the safe use of the drug, no application
under this subsection shall be eligible for approval with such
labeling.
(k)(1) In the case of any drug for which an approval of an
application filed under subsection (b) or (j) is in effect, the
applicant shall establish and maintain such records, and make
such reports to the Secretary, of data relating to clinical
experience and other data or information, received or otherwise
obtained by such applicant with respect to such drug, as the
Secretary may by general regulation, or by order with respect
to such application, prescribe on the basis of a finding that
such records and reports are necessary in order to enable the
Secretary to determine, or facilitate a determination, whether
there is or may be ground for invoking subsection (e) of this
section. Regulations and orders issued under this subsection
and under subsection (i) shall have due regard for the
professional ethics of the medical profession and the interests
of patients and shall provide, where the Secretary deems it to
be appropriate, for the examination, upon request, by the
persons to whom such regulations or orders are applicable, of
similar information received or otherwise obtained by the
Secretary.
(2) Every person required under this section to maintain
records, and every person in charge or custody thereof, shall,
upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable
times to have access to and copy and verify such records.
(3) Active postmarket risk identification.--
(A) Definition.--In this paragraph, the term
``data'' refers to information with respect to
a drug approved under this section or under
section 351 of the Public Health Service Act,
including claims data, patient survey data,
standardized analytic files that allow for the
pooling and analysis of data from disparate
data environments, and any other data deemed
appropriate by the Secretary.
(B) Development of postmarket risk
identification and analysis methods.--The
Secretary shall, not later than 2 years after
the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, in
collaboration with public, academic, and
private entities--
(i) develop methods to obtain access
to disparate data sources including the
data sources specified in subparagraph
(C);
(ii) develop validated methods for
the establishment of a postmarket risk
identification and analysis system to
link and analyze safety data from
multiple sources, with the goals of
including, in aggregate--
(I) at least 25,000,000
patients by July 1, 2010; and
(II) at least 100,000,000
patients by July 1, 2012; and
(iii) convene a committee of experts,
including individuals who are
recognized in the field of protecting
data privacy and security, to make
recommendations to the Secretary on the
development of tools and methods for
the ethical and scientific uses for,
and communication of, postmarketing
data specified under subparagraph (C),
including recommendations on the
development of effective research
methods for the study of drug safety
questions.
(C) Establishment of the postmarket risk
identification and analysis system.--
(i) In general.--The Secretary shall,
not later than 1 year after the
development of the risk identification
and analysis methods under subparagraph
(B), establish and maintain
procedures--
(I) for risk identification
and analysis based on
electronic health data, in
compliance with the regulations
promulgated under section
264(c) of the Health Insurance
Portability and Accountability
Act of 1996, and in a manner
that does not disclose
individually identifiable
health information in violation
of paragraph (4)(B);
(II) for the reporting (in a
standardized form) of data on
all serious adverse drug
experiences (as defined in
section 505-1(b)) submitted to
the Secretary under paragraph
(1), and those adverse events
submitted by patients,
providers, and drug sponsors,
when appropriate;
(III) to provide for active
adverse event surveillance
using the following data
sources, as available:
(aa) Federal health-
related electronic data
(such as data from the
Medicare program and
the health systems of
the Department of
Veterans Affairs);
(bb) private sector
health-related
electronic data (such
as pharmaceutical
purchase data and
health insurance claims
data); and
(cc) other data as
the Secretary deems
necessary to create a
robust system to
identify adverse events
and potential drug
safety signals;
(IV) to identify certain
trends and patterns with
respect to data accessed by the
system;
(V) to provide regular
reports to the Secretary
concerning adverse event
trends, adverse event patterns,
incidence and prevalence of
adverse events, and other
information the Secretary
determines appropriate, which
may include data on comparative
national adverse event trends;
and
(VI) to enable the program to
export data in a form
appropriate for further
aggregation, statistical
analysis, and reporting.
(ii) Timeliness of reporting.--The
procedures established under clause (i)
shall ensure that such data are
accessed, analyzed, and reported in a
timely, routine, and systematic manner,
taking into consideration the need for
data completeness, coding, cleansing,
and standardized analysis and
transmission.
(iii) Private sector resources.--To
ensure the establishment of the active
postmarket risk identification and
analysis system under this subsection
not later than 1 year after the
development of the risk identification
and analysis methods under subparagraph
(B), as required under clause (i), the
Secretary may, on a temporary or
permanent basis, implement systems or
products developed by private entities.
(iv) Complementary approaches.--To
the extent the active postmarket risk
identification and analysis system
under this subsection is not sufficient
to gather data and information relevant
to a priority drug safety question, the
Secretary shall develop, support, and
participate in complementary approaches
to gather and analyze such data and
information, including--
(I) approaches that are
complementary with respect to
assessing the safety of use of
a drug in domestic populations
not included, or
underrepresented, in the trials
used to approve the drug (such
as older people, people with
comorbidities, pregnant women,
or children); and
(II) existing approaches such
as the Vaccine Adverse Event
Reporting System and the
Vaccine Safety Datalink or
successor databases.
(v) Authority for contracts.--The
Secretary may enter into contracts with
public and private entities to fulfill
the requirements of this subparagraph.
(4) Advanced analysis of drug safety data.--
(A) Purpose.--The Secretary shall establish
collaborations with public, academic, and
private entities, which may include the Centers
for Education and Research on Therapeutics
under section 912 of the Public Health Service
Act, to provide for advanced analysis of drug
safety data described in paragraph (3)(C) and
other information that is publicly available or
is provided by the Secretary, in order to--
(i) improve the quality and
efficiency of postmarket drug safety
risk-benefit analysis;
(ii) provide the Secretary with
routine access to outside expertise to
study advanced drug safety questions;
and
(iii) enhance the ability of the
Secretary to make timely assessments
based on drug safety data.
(B) Privacy.--Such analysis shall not
disclose individually identifiable health
information when presenting such drug safety
signals and trends or when responding to
inquiries regarding such drug safety signals
and trends.
(C) Public process for priority questions.--
At least biannually, the Secretary shall seek
recommendations from the Drug Safety and Risk
Management Advisory Committee (or any successor
committee) and from other advisory committees,
as appropriate, to the Food and Drug
Administration on--
(i) priority drug safety questions;
and
(ii) mechanisms for answering such
questions, including through--
(I) active risk
identification under paragraph
(3); and
(II) when such risk
identification is not
sufficient, postapproval
studies and clinical trials
under subsection (o)(3).
(D) Procedures for the development of drug
safety collaborations.--
(i) In general.--Not later than 180
days after the date of the
establishment of the active postmarket
risk identification and analysis system
under this subsection, the Secretary
shall establish and implement
procedures under which the Secretary
may routinely contract with one or more
qualified entities to--
(I) classify, analyze, or
aggregate data described in
paragraph (3)(C) and
information that is publicly
available or is provided by the
Secretary;
(II) allow for prompt
investigation of priority drug
safety questions, including--
(aa) unresolved
safety questions for
drugs or classes of
drugs; and
(bb) for a newly-
approved drugs, safety
signals from clinical
trials used to approve
the drug and other
preapproval trials;
rare, serious drug side
effects; and the safety
of use in domestic
populations not
included, or
underrepresented, in
the trials used to
approve the drug (such
as older people, people
with comorbidities,
pregnant women, or
children);
(III) perform advanced
research and analysis on
identified drug safety risks;
(IV) focus postapproval
studies and clinical trials
under subsection (o)(3) more
effectively on cases for which
reports under paragraph (1) and
other safety signal detection
is not sufficient to resolve
whether there is an elevated
risk of a serious adverse event
associated with the use of a
drug; and
(V) carry out other
activities as the Secretary
deems necessary to carry out
the purposes of this paragraph.
(ii) Request for specific
methodology.--The procedures described
in clause (i) shall permit the
Secretary to request that a specific
methodology be used by the qualified
entity. The qualified entity shall work
with the Secretary to finalize the
methodology to be used.
(E) Use of analyses.--The Secretary shall
provide the analyses described in this
paragraph, including the methods and results of
such analyses, about a drug to the sponsor or
sponsors of such drug.
(F) Qualified entities.--
(i) In general.--The Secretary shall
enter into contracts with a sufficient
number of qualified entities to develop
and provide information to the
Secretary in a timely manner.
(ii) Qualification.--The Secretary
shall enter into a contract with an
entity under clause (i) only if the
Secretary determines that the entity
has a significant presence in the
United States and has one or more of
the following qualifications:
(I) The research,
statistical, epidemiologic, or
clinical capability and
expertise to conduct and
complete the activities under
this paragraph, including the
capability and expertise to
provide the Secretary de-
identified data consistent with
the requirements of this
subsection.
(II) An information
technology infrastructure in
place to support electronic
data and operational standards
to provide security for such
data.
(III) Experience with, and
expertise on, the development
of drug safety and
effectiveness research using
electronic population data.
(IV) An understanding of drug
development or risk/benefit
balancing in a clinical
setting.
(V) Other expertise which the
Secretary deems necessary to
fulfill the activities under
this paragraph.
(G) Contract requirements.--Each contract
with a qualified entity under subparagraph
(F)(i) shall contain the following
requirements:
(i) Ensuring privacy.--The qualified
entity shall ensure that the entity
will not use data under this subsection
in a manner that--
(I) violates the regulations
promulgated under section
264(c) of the Health Insurance
Portability and Accountability
Act of 1996;
(II) violates sections 552 or
552a of title 5, United States
Code, with regard to the
privacy of individually-
identifiable beneficiary health
information; or
(III) discloses individually
identifiable health information
when presenting drug safety
signals and trends or when
responding to inquiries
regarding drug safety signals
and trends.
Nothing in this clause prohibits lawful
disclosure for other purposes.
(ii) Component of another
organization.--If a qualified entity is
a component of another organization--
(I) the qualified entity
shall establish appropriate
security measures to maintain
the confidentiality and privacy
of such data; and
(II) the entity shall not
make an unauthorized disclosure
of such data to the other
components of the organization
in breach of such
confidentiality and privacy
requirement.
(iii) Termination or nonrenewal.--If
a contract with a qualified entity
under this subparagraph is terminated
or not renewed, the following
requirements shall apply:
(I) Confidentiality and
privacy protections.--The
entity shall continue to comply
with the confidentiality and
privacy requirements under this
paragraph with respect to all
data disclosed to the entity.
(II) Disposition of data.--
The entity shall return any
data disclosed to such entity
under this subsection to which
it would not otherwise have
access or, if returning the
data is not practicable,
destroy the data.
(H) Competitive procedures.--The Secretary
shall use competitive procedures (as defined in
section 4(5) of the Federal Procurement Policy
Act) to enter into contracts under subparagraph
(G).
(I) Review of contract in the event of a
merger or acquisition.--The Secretary shall
review the contract with a qualified entity
under this paragraph in the event of a merger
or acquisition of the entity in order to ensure
that the requirements under this paragraph will
continue to be met.
(J) Coordination.--In carrying out this
paragraph, the Secretary shall provide for
appropriate communications to the public,
scientific, public health, and medical
communities, and other key stakeholders, and to
the extent practicable shall coordinate with
the activities of private entities,
professional associations, or other entities
that may have sources of drug safety data.
(5) The Secretary shall--
(A) conduct regular, bi-weekly screening of
the Adverse Event Reporting System database and
post a quarterly report on the Adverse Event
Reporting System Web site of any new safety
information or potential signal of a serious
risk identified by Adverse Event Reporting
System within the last quarter;
(B) report to Congress not later than 2 year
after the date of the enactment of the Food and
Drug Administration Amendments Act of 2007 on
procedures and processes of the Food and Drug
Administration for addressing ongoing post
market safety issues identified by the Office
of Surveillance and Epidemiology and how
recommendations of the Office of Surveillance
and Epidemiology are handled within the agency;
and
(C) on an annual basis, review the entire
backlog of postmarket safety commitments to
determine which commitments require revision or
should be eliminated, report to the Congress on
these determinations, and assign start dates
and estimated completion dates for such
commitments.
(l)(1) Safety and effectiveness data and information which
has been submitted in an application under subsection (b) for a
drug and which has not previously been disclosed to the public
shall be made available to the public, upon request, unless
extraordinary circumstances are shown--
(A) if no work is being or will be undertaken to have
the application approved,
(B) if the Secretary has determined that the
application is not approvable and all legal appeals
have been exhausted,
(C) if approval of the application under subsection
(c) is withdrawn and all legal appeals have been
exhausted,
(D) if the Secretary has determined that such drug is
not a new drug, or
(E) upon the effective date of the approval of the
first application under subsection (j) which refers to
such drug or upon the date upon which the approval of
an application under subsection (j) which refers to
such drug could be made effective if such an
application had been submitted.
(2) Action Package for Approval.--
(A) Action package.--The Secretary shall publish the
action package for approval of an application under
subsection (b) or section 351 of the Public Health
Service Act on the Internet Web site of the Food and
Drug Administration--
(i) not later than 30 days after the date of
approval of such application for a drug no
active ingredient (including any ester or salt
of the active ingredient) of which has been
approved in any other application under this
section or section 351 of the Public Health
Service Act; and
(ii) not later than 30 days after the third
request for such action package for approval
received under section 552 of title 5, United
States Code, for any other drug.
(B) Immediate publication of summary review.--
Notwithstanding subparagraph (A), the Secretary shall
publish, on the Internet Web site of the Food and Drug
Administration, the materials described in subparagraph
(C)(iv) not later than 48 hours after the date of
approval of the drug, except where such materials
require redaction by the Secretary.
(C) Contents.--An action package for approval of an
application under subparagraph (A) shall be dated and
shall include the following:
(i) Documents generated by the Food and Drug
Administration related to review of the
application.
(ii) Documents pertaining to the format and
content of the application generated during
drug development.
(iii) Labeling submitted by the applicant.
(iv) A summary review that documents
conclusions from all reviewing disciplines
about the drug, noting any critical issues and
disagreements with the applicant and within the
review team and how they were resolved,
recommendations for action, and an explanation
of any nonconcurrence with review conclusions.
(v) The Division Director and Office
Director's decision document which includes--
(I) a brief statement of concurrence
with the summary review;
(II) a separate review or addendum to
the review if disagreeing with the
summary review; and
(III) a separate review or addendum
to the review to add further analysis.
(vi) Identification by name of each officer
or employee of the Food and Drug Administration
who--
(I) participated in the decision to
approve the application; and
(II) consents to have his or her name
included in the package.
(D) Review.--A scientific review of an application is
considered the work of the reviewer and shall not be
altered by management or the reviewer once final.
(E) Confidential information.--This paragraph does
not authorize the disclosure of any trade secret,
confidential commercial or financial information, or
other matter listed in section 552(b) of title 5,
United States Code.
(m) For purposes of this section, the term ``patent'' means a
patent issued by the United States Patent and Trademark Office.
(n)(1) For the purpose of providing expert scientific advice
and recommendations to the Secretary regarding a clinical
investigation of a drug or the approval for marketing of a drug
under section 505 or section 351 of the Public Health Service
Act, the Secretary shall establish panels of experts or use
panels of experts established before the date of enactment of
the Food and Drug Administration Modernization Act of 1997, or
both.
(2) The Secretary may delegate the appointment and oversight
authority granted under section 1004 to a director of a center
or successor entity within the Food and Drug Administration.
(3) The Secretary shall make appointments to each panel
established under paragraph (1) so that each panel shall
consist of--
(A) members who are qualified by training and
experience to evaluate the safety and effectiveness of
the drugs to be referred to the panel and who, to the
extent feasible, possess skill and experience in the
development, manufacture, or utilization of such drugs;
(B) members with diverse expertise in such fields as
clinical and administrative medicine, pharmacy,
pharmacology, pharmacoeconomics, biological and
physical sciences, and other related professions;
(C) a representative of consumer interests, and a
representative of interests of the drug manufacturing
industry not directly affected by the matter to be
brought before the panel; and
(D) two or more members who are specialists or have
other expertise in the particular disease or condition
for which the drug under review is proposed to be
indicated.
Scientific, trade, and consumer organizations shall be afforded
an opportunity to nominate individuals for appointment to the
panels. No individual who is in the regular full-time employ of
the United States and engaged in the administration of this Act
may be a voting member of any panel. The Secretary shall
designate one of the members of each panel to serve as chairman
thereof.
(4) The Secretary shall, as appropriate, provide education
and training to each new panel member before such member
participates in a panel's activities, including education
regarding requirements under this Act and related regulations
of the Secretary, and the administrative processes and
procedures related to panel meetings.
(5) Panel members (other than officers or employees of the
United States), while attending meetings or conferences of a
panel or otherwise engaged in its business, shall be entitled
to receive compensation for each day so engaged, including
traveltime, at rates to be fixed by the Secretary, but not to
exceed the daily equivalent of the rate in effect for positions
classified above grade GS-15 of the General Schedule. While
serving away from their homes or regular places of business,
panel members may be allowed travel expenses (including per
diem in lieu of subsistence) as authorized by section 5703 of
title 5, United States Code, for persons in the Government
service employed intermittently.
(6) The Secretary shall ensure that scientific advisory
panels meet regularly and at appropriate intervals so that any
matter to be reviewed by such a panel can be presented to the
panel not more than 60 days after the matter is ready for such
review. Meetings of the panel may be held using electronic
communication to convene the meetings.
(7) Within 90 days after a scientific advisory panel makes
recommendations on any matter under its review, the Food and
Drug Administration official responsible for the matter shall
review the conclusions and recommendations of the panel, and
notify the affected persons of the final decision on the
matter, or of the reasons that no such decision has been
reached. Each such final decision shall be documented including
the rationale for the decision.
(o) Postmarket Studies and Clinical Trials; Labeling.--
(1) In general.--A responsible person may not
introduce or deliver for introduction into interstate
commerce the new drug involved if the person is in
violation of a requirement established under paragraph
(3) or (4) with respect to the drug.
(2) Definitions.--For purposes of this subsection:
(A) Responsible person.--The term
``responsible person'' means a person who--
(i) has submitted to the Secretary a
covered application that is pending; or
(ii) is the holder of an approved
covered application.
(B) Covered application.--The term ``covered
application'' means--
(i) an application under subsection
(b) for a drug that is subject to
section 503(b); and
(ii) an application under section 351
of the Public Health Service Act.
(C) New safety information; serious risk.--
The terms ``new safety information'', ``serious
risk'', and ``signal of a serious risk'' have
the meanings given such terms in section 505-
1(b).
(3) Studies and clinical trials.--
(A) In general.--For any or all of the
purposes specified in subparagraph (B), the
Secretary may, subject to subparagraph (D),
require a responsible person for a drug to
conduct a postapproval study or studies of the
drug, or a postapproval clinical trial or
trials of the drug, on the basis of scientific
data deemed appropriate by the Secretary,
including information regarding chemically-
related or pharmacologically-related drugs.
(B) Purposes of study or clinical trial.--The
purposes referred to in this subparagraph with
respect to a postapproval study or postapproval
clinical trial are the following:
(i) To assess a known serious risk
related to the use of the drug
involved.
(ii) To assess signals of serious
risk related to the use of the drug.
(iii) To identify an unexpected
serious risk when available data
indicates the potential for a serious
risk.
(C) Establishment of requirement after
approval of covered application.--The Secretary
may require a postapproval study or studies or
postapproval clinical trial or trials for a
drug for which an approved covered application
is in effect as of the date on which the
Secretary seeks to establish such requirement
only if the Secretary becomes aware of new
safety information.
(D) Determination by secretary.--
(i) Postapproval studies.--The
Secretary may not require the
responsible person to conduct a study
under this paragraph, unless the
Secretary makes a determination that
the reports under subsection (k)(1) and
the active postmarket risk
identification and analysis system as
available under subsection (k)(3) will
not be sufficient to meet the purposes
set forth in subparagraph (B).
(ii) Postapproval clinical trials.--
The Secretary may not require the
responsible person to conduct a
clinical trial under this paragraph,
unless the Secretary makes a
determination that a postapproval study
or studies will not be sufficient to
meet the purposes set forth in
subparagraph (B).
(E) Notification; timetables; periodic
reports.--
(i) Notification.--The Secretary
shall notify the responsible person
regarding a requirement under this
paragraph to conduct a postapproval
study or clinical trial by the target
dates for communication of feedback
from the review team to the responsible
person regarding proposed labeling and
postmarketing study commitments as set
forth in the letters described in
section 101(c) of the Food and Drug
Administration Amendments Act of 2007.
(ii) Timetable; periodic reports.--
For each study or clinical trial
required to be conducted under this
paragraph, the Secretary shall require
that the responsible person submit a
timetable for completion of the study
or clinical trial. With respect to each
study required to be conducted under
this paragraph or otherwise undertaken
by the responsible person to
investigate a safety issue, the
Secretary shall require the responsible
person to periodically report to the
Secretary on the status of such study
including whether any difficulties in
completing the study have been
encountered. With respect to each
clinical trial required to be conducted
under this paragraph or otherwise
undertaken by the responsible person to
investigate a safety issue, the
Secretary shall require the responsible
person to periodically report to the
Secretary on the status of such
clinical trial including whether
enrollment has begun, the number of
participants enrolled, the expected
completion date, whether any
difficulties completing the clinical
trial have been encountered, and
registration information with respect
to the requirements under section
402(j) of the Public Health Service
Act. If the responsible person fails to
comply with such timetable or violates
any other requirement of this
subparagraph, the responsible person
shall be considered in violation of
this subsection, unless the responsible
person demonstrates good cause for such
noncompliance or such other violation.
The Secretary shall determine what
constitutes good cause under the
preceding sentence.
(F) Dispute resolution.--The responsible
person may appeal a requirement to conduct a
study or clinical trial under this paragraph
using dispute resolution procedures established
by the Secretary in regulation and guidance.
(4) Safety labeling changes requested by secretary.--
(A) New safety information.--If the Secretary
becomes aware of new safety information that
the Secretary believes should be included in
the labeling of the drug, the Secretary shall
promptly notify the responsible person or, if
the same drug approved under section 505(b) is
not currently marketed, the holder of an
approved application under 505(j).
(B) Response to notification.--Following
notification pursuant to subparagraph (A), the
responsible person or the holder of the
approved application under section 505(j) shall
within 30 days--
(i) submit a supplement proposing
changes to the approved labeling to
reflect the new safety information,
including changes to boxed warnings,
contraindications, warnings,
precautions, or adverse reactions; or
(ii) notify the Secretary that the
responsible person or the holder of the
approved application under section
505(j) does not believe a labeling
change is warranted and submit a
statement detailing the reasons why
such a change is not warranted.
(C) Review.--Upon receipt of such supplement,
the Secretary shall promptly review and act
upon such supplement. If the Secretary
disagrees with the proposed changes in the
supplement or with the statement setting forth
the reasons why no labeling change is
necessary, the Secretary shall initiate
discussions to reach agreement on whether the
labeling for the drug should be modified to
reflect the new safety information, and if so,
the contents of such labeling changes.
(D) Discussions.--Such discussions shall not
extend for more than 30 days after the response
to the notification under subparagraph (B),
unless the Secretary determines an extension of
such discussion period is warranted.
(E) Order.--Within 15 days of the conclusion
of the discussions under subparagraph (D), the
Secretary may issue an order directing the
responsible person or the holder of the
approved application under section 505(j) to
make such a labeling change as the Secretary
deems appropriate to address the new safety
information. Within 15 days of such an order,
the responsible person or the holder of the
approved application under section 505(j) shall
submit a supplement containing the labeling
change.
(F) Dispute resolution.--Within 5 days of
receiving an order under subparagraph (E), the
responsible person or the holder of the
approved application under section 505(j) may
appeal using dispute resolution procedures
established by the Secretary in regulation and
guidance.
(G) Violation.--If the responsible person or
the holder of the approved application under
section 505(j) has not submitted a supplement
within 15 days of the date of such order under
subparagraph (E), and there is no appeal or
dispute resolution proceeding pending, the
responsible person or holder shall be
considered to be in violation of this
subsection. If at the conclusion of any dispute
resolution procedures the Secretary determines
that a supplement must be submitted and such a
supplement is not submitted within 15 days of
the date of that determination, the responsible
person or holder shall be in violation of this
subsection.
(H) Public health threat.--Notwithstanding
subparagraphs (A) through (F), if the Secretary
concludes that such a labeling change is
necessary to protect the public health, the
Secretary may accelerate the timelines in such
subparagraphs.
(I) Rule of construction.--This paragraph
shall not be construed to affect the
responsibility of the responsible person or the
holder of the approved application under
section 505(j) to maintain its label in
accordance with existing requirements,
including subpart B of part 201 and sections
314.70 and 601.12 of title 21, Code of Federal
Regulations (or any successor regulations).
(5) Non-delegation.--Determinations by the Secretary
under this subsection for a drug shall be made by
individuals at or above the level of individuals
empowered to approve a drug (such as division directors
within the Center for Drug Evaluation and Research).
(p) Risk Evaluation and Mitigation Strategy.--
(1) In general.--A person may not introduce or
deliver for introduction into interstate commerce a new
drug if--
(A)(i) the application for such drug is
approved under subsection (b) or (j) and is
subject to section 503(b); or
(ii) the application for such drug is
approved under section 351 of the Public Health
Service Act; and
(B) a risk evaluation and mitigation strategy
is required under section 505-1 with respect to
the drug and the person fails to maintain
compliance with the requirements of the
approved strategy or with other requirements
under section 505-1, including requirements
regarding assessments of approved strategies.
(2) Certain postmarket studies.--The failure to
conduct a postmarket study under section 506, subpart H
of part 314, or subpart E of part 601 of title 21, Code
of Federal Regulations (or any successor regulations),
is deemed to be a violation of paragraph (1).
(q) Petitions and Civil Actions Regarding Approval of Certain
Applications.--
(1) In general.--
(A) Determination.--The Secretary shall not
delay approval of a pending application
submitted under subsection (b)(2) or (j) of
this section or section 351(k) of the Public
Health Service Act because of any request to
take any form of action relating to the
application, either before or during
consideration of the request, unless--
(i) the request is in writing and is
a petition submitted to the Secretary
pursuant to section 10.30 or 10.35 of
title 21, Code of Federal Regulations
(or any successor regulations); and
(ii) the Secretary determines, upon
reviewing the petition, that a delay is
necessary to protect the public health.
Consideration of the petition shall be separate
and apart from review and approval of any
application.
(B) Notification.--If the Secretary
determines under subparagraph (A) that a delay
is necessary with respect to an application,
the Secretary shall provide to the applicant,
not later than 30 days after making such
determination, the following information:
(i) Notification of the fact that a
determination under subparagraph (A)
has been made.
(ii) If applicable, any clarification
or additional data that the applicant
should submit to the docket on the
petition to allow the Secretary to
review the petition promptly.
(iii) A brief summary of the specific
substantive issues raised in the
petition which form the basis of the
determination.
(C) Format.--The information described in
subparagraph (B) shall be conveyed via either,
at the discretion of the Secretary--
(i) a document; or
(ii) a meeting with the applicant
involved.
(D) Public disclosure.--Any information
conveyed by the Secretary under subparagraph
(C) shall be considered part of the application
and shall be subject to the disclosure
requirements applicable to information in such
application.
(E) Denial based on intent to delay.--If the
Secretary determines that a petition or a
supplement to the petition was submitted with
the primary purpose of delaying the approval of
an application and the petition does not on its
face raise valid scientific or regulatory
issues, the Secretary may deny the petition at
any point based on such determination. The
Secretary may issue guidance to describe the
factors that will be used to determine under
this subparagraph whether a petition is
submitted with the primary purpose of delaying
the approval of an application.
(F) Final agency action.--The Secretary shall
take final agency action on a petition not
later than 150 days after the date on which the
petition is submitted. The Secretary shall not
extend such period for any reason, including--
(i) any determination made under
subparagraph (A);
(ii) the submission of comments
relating to the petition or
supplemental information supplied by
the petitioner; or
(iii) the consent of the petitioner.
(G) Extension of 30-month period.--If the
filing of an application resulted in first-
applicant status under subsection
(j)(5)(D)(i)(IV) and approval of the
application was delayed because of a petition,
the 30-month period under such subsection is
deemed to be extended by a period of time equal
to the period beginning on the date on which
the Secretary received the petition and ending
on the date of final agency action on the
petition (inclusive of such beginning and
ending dates), without regard to whether the
Secretary grants, in whole or in part, or
denies, in whole or in part, the petition.
(H) Certification.--The Secretary shall not
consider a petition for review unless the party
submitting such petition does so in written
form and the subject document is signed and
contains the following certification: ``I
certify that, to my best knowledge and belief:
(a) this petition includes all information and
views upon which the petition relies; (b) this
petition includes representative data and/or
information known to the petitioner which are
unfavorable to the petition; and (c) I have
taken reasonable steps to ensure that any
representative data and/or information which
are unfavorable to the petition were disclosed
to me. I further certify that the information
upon which I have based the action requested
herein first became known to the party on whose
behalf this petition is submitted on or about
the following date: __________. If I received
or expect to receive payments, including cash
and other forms of consideration, to file this
information or its contents, I received or
expect to receive those payments from the
following persons or organizations:
_____________. I verify under penalty of
perjury that the foregoing is true and correct
as of the date of the submission of this
petition.'', with the date on which such
information first became known to such party
and the names of such persons or organizations
inserted in the first and second blank space,
respectively.
(I) Verification.--The Secretary shall not
accept for review any supplemental information
or comments on a petition unless the party
submitting such information or comments does so
in written form and the subject document is
signed and contains the following verification:
``I certify that, to my best knowledge and
belief: (a) I have not intentionally delayed
submission of this document or its contents;
and (b) the information upon which I have based
the action requested herein first became known
to me on or about __________. If I received or
expect to receive payments, including cash and
other forms of consideration, to file this
information or its contents, I received or
expect to receive those payments from the
following persons or organizations: _____. I
verify under penalty of perjury that the
foregoing is true and correct as of the date of
the submission of this petition.'', with the
date on which such information first became
known to the party and the names of such
persons or organizations inserted in the first
and second blank space, respectively.
(2) Exhaustion of administrative remedies.--
(A) Final agency action within 150 days.--The
Secretary shall be considered to have taken
final agency action on a petition if--
(i) during the 150-day period
referred to in paragraph (1)(F), the
Secretary makes a final decision within
the meaning of section 10.45(d) of
title 21, Code of Federal Regulations
(or any successor regulation); or
(ii) such period expires without the
Secretary having made such a final
decision.
(B) Dismissal of certain civil actions.--If a
civil action is filed against the Secretary
with respect to any issue raised in the
petition before the Secretary has taken final
agency action on the petition within the
meaning of subparagraph (A), the court shall
dismiss without prejudice the action for
failure to exhaust administrative remedies.
(C) Administrative record.--For purposes of
judicial review related to the approval of an
application for which a petition under
paragraph (1) was submitted, the administrative
record regarding any issue raised by the
petition shall include--
(i) the petition filed under
paragraph (1) and any supplements and
comments thereto;
(ii) the Secretary's response to such
petition, if issued; and
(iii) other information, as
designated by the Secretary, related to
the Secretary's determinations
regarding the issues raised in such
petition, as long as the information
was considered by the agency no later
than the date of final agency action as
defined under subparagraph (2)(A), and
regardless of whether the Secretary
responded to the petition at or before
the approval of the application at
issue in the petition.
(3) Annual report on delays in approvals per
petitions.--The Secretary shall annually submit to the
Congress a report that specifies--
(A) the number of applications that were
approved during the preceding 12-month period;
(B) the number of such applications whose
effective dates were delayed by petitions
referred to in paragraph (1) during such
period;
(C) the number of days by which such
applications were so delayed; and
(D) the number of such petitions that were
submitted during such period.
(4) Exceptions.--
(A) This subsection does not apply to--
(i) a petition that relates solely to
the timing of the approval of an
application pursuant to subsection
(j)(5)(B)(iv); or
(ii) a petition that is made by the
sponsor of an application and that
seeks only to have the Secretary take
or refrain from taking any form of
action with respect to that
application.
(B) Paragraph (2) does not apply to a
petition addressing issues concerning an
application submitted pursuant to section
351(k) of the Public Health Service Act.
(5) Definitions.--
(A) Application.--For purposes of this
subsection, the term ``application'' means an
application submitted under subsection (b)(2)
or (j) of the Act or 351(k) of the Public
Health Service Act.
(B) Petition.--For purposes of this
subsection, other than paragraph (1)(A)(i), the
term ``petition'' means a request described in
paragraph (1)(A)(i).
(r) Postmarket Drug Safety Information for Patients and
Providers.--
(1) Establishment.--Not later than 1 year after the
date of the enactment of the Food and Drug
Administration Amendments Act of 2007, the Secretary
shall improve the transparency of information about
drugs and allow patients and health care providers
better access to information about drugs by developing
and maintaining an Internet Web site that--
(A) provides links to drug safety information
listed in paragraph (2) for prescription drugs
that are approved under this section or
licensed under section 351 of the Public Health
Service Act; and
(B) improves communication of drug safety
information to patients and providers.
(2) Internet web site.--The Secretary shall carry out
paragraph (1) by--
(A) developing and maintaining an accessible,
consolidated Internet Web site with easily
searchable drug safety information, including
the information found on United States
Government Internet Web sites, such as the
United States National Library of Medicine's
Daily Med and Medline Plus Web sites, in
addition to other such Web sites maintained by
the Secretary;
(B) ensuring that the information provided on
the Internet Web site is comprehensive and
includes, when available and appropriate--
(i) patient labeling and patient
packaging inserts;
(ii) a link to a list of each drug,
whether approved under this section or
licensed under such section 351, for
which a Medication Guide, as provided
for under part 208 of title 21, Code of
Federal Regulations (or any successor
regulations), is required;
(iii) a link to the registry and
results data bank provided for under
subsections (i) and (j) of section 402
of the Public Health Service Act;
(iv) the most recent safety
information and alerts issued by the
Food and Drug Administration for drugs
approved by the Secretary under this
section, such as product recalls,
warning letters, and import alerts;
(v) publicly available information
about implemented RiskMAPs and risk
evaluation and mitigation strategies
under subsection (o);
(vi) guidance documents and
regulations related to drug safety; and
(vii) other material determined
appropriate by the Secretary;
(C) providing access to summaries of the
assessed and aggregated data collected from the
active surveillance infrastructure under
subsection (k)(3) to provide information of
known and serious side-effects for drugs
approved under this section or licensed under
such section 351;
(D) preparing, by 18 months after approval of
a drug or after use of the drug by 10,000
individuals, whichever is later, a summary
analysis of the adverse drug reaction reports
received for the drug, including identification
of any new risks not previously identified,
potential new risks, or known risks reported in
unusual number;
(E) enabling patients, providers, and drug
sponsors to submit adverse event reports
through the Internet Web site;
(F) providing educational materials for
patients and providers about the appropriate
means of disposing of expired, damaged, or
unusable medications; and
(G) supporting initiatives that the Secretary
determines to be useful to fulfill the purposes
of the Internet Web site.
(3) Posting of drug labeling.--The Secretary shall
post on the Internet Web site established under
paragraph (1) the approved professional labeling and
any required patient labeling of a drug approved under
this section or licensed under such section 351 not
later than 21 days after the date the drug is approved
or licensed, including in a supplemental application
with respect to a labeling change.
(4) Private sector resources.--To ensure development
of the Internet Web site by the date described in
paragraph (1), the Secretary may, on a temporary or
permanent basis, implement systems or products
developed by private entities.
(5) Authority for contracts.--The Secretary may enter
into contracts with public and private entities to
fulfill the requirements of this subsection.
(6) Review.--The Advisory Committee on Risk
Communication under section 567 shall, on a regular
basis, perform a comprehensive review and evaluation of
the types of risk communication information provided on
the Internet Web site established under paragraph (1)
and, through other means, shall identify, clarify, and
define the purposes and types of information available
to facilitate the efficient flow of information to
patients and providers, and shall recommend ways for
the Food and Drug Administration to work with outside
entities to help facilitate the dispensing of risk
communication information to patients and providers.
(s) Referral to Advisory Committee.--Prior to the approval of
a drug no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other
application under this section or section 351 of the Public
Health Service Act, the Secretary shall--
(1) refer such drug to a Food and Drug Administration
advisory committee for review at a meeting of such
advisory committee; or
(2) if the Secretary does not refer such a drug to a
Food and Drug Administration advisory committee prior
to the approval of the drug, provide in the action
letter on the application for the drug a summary of the
reasons why the Secretary did not refer the drug to an
advisory committee prior to approval.
(t) Database for Authorized Generic Drugs.--
(1) In general.--
(A) Publication.--The Commissioner shall--
(i) not later than 9 months after the
date of the enactment of the Food and
Drug Administration Amendments Act of
2007, publish a complete list on the
Internet Web site of the Food and Drug
Administration of all authorized
generic drugs (including drug trade
name, brand company manufacturer, and
the date the authorized generic drug
entered the market); and
(ii) update the list quarterly to
include each authorized generic drug
included in an annual report submitted
to the Secretary by the sponsor of a
listed drug during the preceding 3-
month period.
(B) Notification.--The Commissioner shall
notify relevant Federal agencies, including the
Centers for Medicare & Medicaid Services and
the Federal Trade Commission, when the
Commissioner first publishes the information
described in subparagraph (A) that the
information has been published and that the
information will be updated quarterly.
(2) Inclusion.--The Commissioner shall include in the
list described in paragraph (1) each authorized generic
drug included in an annual report submitted to the
Secretary by the sponsor of a listed drug after January
1, 1999.
(3) Authorized generic drug.--In this section, the
term ``authorized generic drug'' means a listed drug
(as that term is used in subsection (j)) that--
(A) has been approved under subsection (c);
and
(B) is marketed, sold, or distributed
directly or indirectly to retail class of trade
under a different labeling, packaging (other
than repackaging as the listed drug in blister
packs, unit doses, or similar packaging for use
in institutions), product code, labeler code,
trade name, or trade mark than the listed drug.
(u) Certain Drugs Containing Single Enantiomers.--
(1) In general.--For purposes of subsections
(c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is
submitted under subsection (b) for a non-racemic drug
containing as an active ingredient (including any ester
or salt of the active ingredient) a single enantiomer
that is contained in a racemic drug approved in another
application under subsection (b), the applicant may, in
the application for such non-racemic drug, elect to
have the single enantiomer not be considered the same
active ingredient as that contained in the approved
racemic drug, if--
(A)(i) the single enantiomer has not been
previously approved except in the approved
racemic drug; and
(ii) the application submitted under
subsection (b) for such non-racemic drug--
(I) includes full reports of new
clinical investigations (other than
bioavailability studies)--
(aa) necessary for the
approval of the application
under subsections (c) and (d);
and
(bb) conducted or sponsored
by the applicant; and
(II) does not rely on any clinical
investigations that are part of an
application submitted under subsection
(b) for approval of the approved
racemic drug; and
(B) the application submitted under
subsection (b) for such non-racemic drug is not
submitted for approval of a condition of use--
(i) in a therapeutic category in
which the approved racemic drug has
been approved; or
(ii) for which any other enantiomer
of the racemic drug has been approved.
(2) Limitation.--
(A) No approval in certain therapeutic
categories.--Until the date that is 10 years
after the date of approval of a non-racemic
drug described in paragraph (1) and with
respect to which the applicant has made the
election provided for by such paragraph, the
Secretary shall not approve such non-racemic
drug for any condition of use in the
therapeutic category in which the racemic drug
has been approved.
(B) Labeling.--If applicable, the labeling of
a non-racemic drug described in paragraph (1)
and with respect to which the applicant has
made the election provided for by such
paragraph shall include a statement that the
non-racemic drug is not approved, and has not
been shown to be safe and effective, for any
condition of use of the racemic drug.
(3) Definition.--
(A) In general.--For purposes of this
subsection, the term ``therapeutic category''
means a therapeutic category identified in the
list developed by the United States
Pharmacopeia pursuant to section 1860D-
4(b)(3)(C)(ii) of the Social Security Act and
as in effect on the date of the enactment of
this subsection.
(B) Publication by secretary.--The Secretary
shall publish the list described in
subparagraph (A) and may amend such list by
regulation.
(4) Availability.--The election referred to in
paragraph (1) may be made only in an application that
is submitted to the Secretary after the date of the
enactment of this subsection and before October 1,
2017.
(v) Antibiotic Drugs Submitted Before November 21, 1997.--
(1) Antibiotic drugs approved before november 21,
1997.--
(A) In general.--Notwithstanding any
provision of the Food and Drug Administration
Modernization Act of 1997 or any other
provision of law, a sponsor of a drug that is
the subject of an application described in
subparagraph (B)(i) shall be eligible for, with
respect to the drug, the 3-year exclusivity
period referred to under clauses (iii) and (iv)
of subsection (c)(3)(E) and under clauses (iii)
and (iv) of subsection (j)(5)(F), subject to
the requirements of such clauses, as
applicable.
(B) Application; antibiotic drug described.--
(i) Application.--An application
described in this clause is an
application for marketing submitted
under this section after the date of
the enactment of this subsection in
which the drug that is the subject of
the application contains an antibiotic
drug described in clause (ii).
(ii) Antibiotic drug.--An antibiotic
drug described in this clause is an
antibiotic drug that was the subject of
an application approved by the
Secretary under section 507 of this Act
(as in effect before November 21,
1997).
(2) Antibiotic drugs submitted before november 21,
1997, but not approved.--
(A) In general.--Notwithstanding any
provision of the Food and Drug Administration
Modernization Act of 1997 or any other
provision of law, a sponsor of a drug that is
the subject of an application described in
subparagraph (B)(i) may elect to be eligible
for, with respect to the drug--
(i)(I) the 3-year exclusivity period
referred to under clauses (iii) and
(iv) of subsection (c)(3)(E) and under
clauses (iii) and (iv) of subsection
(j)(5)(F), subject to the requirements
of such clauses, as applicable; and
(II) the 5-year exclusivity period
referred to under clause (ii) of
subsection (c)(3)(E) and under clause
(ii) of subsection (j)(5)(F), subject
to the requirements of such clauses, as
applicable; or
(ii) a patent term extension under
section 156 of title 35, United States
Code, subject to the requirements of
such section.
(B) Application; antibiotic drug described.--
(i) Application.--An application
described in this clause is an
application for marketing submitted
under this section after the date of
the enactment of this subsection in
which the drug that is the subject of
the application contains an antibiotic
drug described in clause (ii).
(ii) Antibiotic drug.--An antibiotic
drug described in this clause is an
antibiotic drug that was the subject of
1 or more applications received by the
Secretary under section 507 of this Act
(as in effect before November 21,
1997), none of which was approved by
the Secretary under such section.
(3) Limitations.--
(A) Exclusivities and extensions.--Paragraphs
(1)(A) and (2)(A) shall not be construed to
entitle a drug that is the subject of an
approved application described in subparagraphs
(1)(B)(i) or (2)(B)(i), as applicable, to any
market exclusivities or patent extensions other
than those exclusivities or extensions
described in paragraph (1)(A) or (2)(A).
(B) Conditions of use.--Paragraphs (1)(A) and
(2)(A)(i) shall not apply to any condition of
use for which the drug referred to in
subparagraph (1)(B)(i) or (2)(B)(i), as
applicable, was approved before the date of the
enactment of this subsection.
(4) Application of certain provisions.--
Notwithstanding section 125, or any other provision, of
the Food and Drug Administration Modernization Act of
1997, or any other provision of law, and subject to the
limitations in paragraphs (1), (2), and (3), the
provisions of the Drug Price Competition and Patent
Term Restoration Act of 1984 shall apply to any drug
subject to paragraph (1) or any drug with respect to
which an election is made under paragraph (2)(A).
(w) Deadline for Determination on Certain Petitions.--The
Secretary shall issue a final, substantive determination on a
petition submitted pursuant to subsection (b) of section
314.161 of title 21, Code of Federal Regulations (or any
successor regulations), no later than 270 days after the date
the petition is submitted.
(x) Date of Approval in the Case of Recommended Controls
Under the CSA.--
(1) In general.--In the case of an application under
subsection (b) with respect to a drug for which the
Secretary provides notice to the sponsor that the
Secretary intends to recommend controls under the
Controlled Substances Act, approval of such application
shall not take effect until the interim final rule
controlling the drug is issued in accordance with
section 201(j) of the Controlled Substances Act.
(2) Date of approval.--For purposes of this section,
with respect to an application described in paragraph
(1), the term ``date of approval'' shall mean the later
of--
(A) the date an application under subsection
(b) is approved under subsection (c); or
(B) the date of issuance of the interim final
rule controlling the drug.
* * * * * * *
new animal drugs
Sec. 512. (a)
(1) A new animal drug shall, with respect to any particular
use or intended use of such drug, be deemed unsafe for purposes
of section 501(a)(5) and section 402(a)(2)(C)(ii) unless--
(A) there is in effect an approval of an application
filed pursuant to subsection (b) with respect to such
use or intended use of such drug, and such drug, its
labeling, and such use conform to such approved
application;
(B) there is in effect a conditional approval of an
application filed pursuant to section 571 with respect
to such use or intended use of such drug, and such
drug, its labeling, and such use conform to such
conditionally approved application; or
(C) there is in effect an index listing pursuant to
section 572 with respect to such use or intended use of
such drug in a minor species, and such drug, its
labeling, and such use conform to such index listing.
A new animal drug shall also be deemed unsafe for such purposes
in the event of removal from the establishment of a
manufacturer, packer, or distributor of such drug for use in
the manufacture of animal feed in any State unless at the time
of such removal such manufacturer, packer, or distributor has
an unrevoked written statement from the consignee of such drug,
or notice from the Secretary, to the effect that, with respect
to the use of such drug in animal feed, such consignee (i)
holds a license issued under subsection (m) and has in its
possession current approved labeling for such drug in animal
feed; or (ii) will, if the consignee is not a user of the drug,
ship such drug only to a holder of a license issued under
subsection (m).
(2) An animal feed bearing or containing a new animal drug
shall, with respect to any particular use or intended use of
such animal feed be deemed unsafe for purposes of section
501(a)(6) unless--
(A) there is in effect--
(i) an approval of an application filed
pursuant to subsection (b) with respect to such
drug, as used in such animal feed, and such
animal feed and its labeling, distribution,
holding, and use conform to such approved
application;
(ii) a conditional approval of an application
filed pursuant to section 571 with respect to
such drug, as used in such animal feed, and
such animal feed and its labeling,
distribution, holding, and use conform to such
conditionally approved application; or
(iii) an index listing pursuant to section
572 with respect to such drug, as used in such
animal feed, and such animal feed and its
labeling, distribution, holding, and use
conform to such index listing; and
(B) such animal feed is manufactured at a site for
which there is in effect a license issued pursuant to
subsection (m)(1) to manufacture such animal feed.
(3) A new animal drug or an animal feed bearing or containing
a new animal drug shall not be deemed unsafe for the purposes
of section 501(a)(5) or (6) if such article is for
investigational use and conforms to the terms of an exemption
in effect with respect thereto under section 512(j).
(4)(A) Except as provided in subparagraph (B), if an approval
of an application filed under subsection (b) is in effect with
respect to a particular use or intended use of a new animal
drug, the drug shall not be deemed unsafe for the purposes of
paragraph (1) and shall be exempt from the requirements of
section 502(f) with respect to a different use or intended use
of the drug, other than a use in or on animal feed, if such use
or intended use--
(i) is by or on the lawful written or oral order of a
licensed veterinarian within the context of a
veterinarian-client-patient relationship, as defined by
the Secretary; and
(ii) is in compliance with regulations promulgated by
the Secretary that establish the conditions for such
different use or intended use.
The regulations promulgated by the Secretary under clause (ii)
may prohibit particular uses of an animal drug and shall not
permit such different use of an animal drug if the labeling of
another animal drug that contains the same active ingredient
and which is in the same dosage form and concentration provides
for such different use.
(B) If the Secretary finds that there is a reasonable
probability that a use of an animal drug authorized under
subparagraph (A) may present a risk to the public health, the
Secretary may--
(i) establish a safe level for a residue of an animal
drug when it is used for such different use authorized
by subparagraph (A); and
(ii) require the development of a practical,
analytical method for the detection of residues of such
drug above the safe level established under clause (i).
The use of an animal drug that results in residues exceeding a
safe level established under clause (i) shall be considered an
unsafe use of such drug under paragraph (1). Safe levels may be
established under clause (i) either by regulation or order.
(C) The Secretary may by general regulation provide access to
the records of veterinarians to ascertain any use or intended
use authorized under subparagraph (A) that the Secretary has
determined may present a risk to the public health.
(D) If the Secretary finds, after affording an opportunity
for public comment, that a use of an animal drug authorized
under subparagraph (A) presents a risk to the public health or
that an analytical method required under subparagraph (B) has
not been developed and submitted to the Secretary, the
Secretary may, by order, prohibit any such use.
(5) If the approval of an application filed under section 505
is in effect, the drug under such application shall not be
deemed unsafe for purposes of paragraph (1) and shall be exempt
from the requirements of section 502(f) with respect to a use
or intended use of the drug in animals if such use or intended
use--
(A) is by or on the lawful written or oral order of a
licensed veterinarian within the context of a
veterinarian-client-patient relationship, as defined by
the Secretary; and
(B) is in compliance with regulations promulgated by
the Secretary that establish the conditions for the use
or intended use of the drug in animals.
(6) For purposes of section 402(a)(2)(D), a use or intended
use of a new animal drug shall not be deemed unsafe under this
section if the Secretary establishes a tolerance for such drug
and any edible portion of any animal imported into the United
States does not contain residues exceeding such tolerance. In
establishing such tolerance, the Secretary shall rely on data
sufficient to
demonstrate that a proposed tolerance is safe based on similar
food safety criteria used by the Secretary to establish
tolerances for applications for new animal drugs filed under
subsection (b)(1). The Secretary may consider and rely on data
submitted by the drug manufacturer, including data submitted to
appropriate regulatory authorities in any country where the new
animal drug is lawfully used or data available from a relevant
international organization, to the extent such data are not
inconsistent with the criteria used by the Secretary to
establish a tolerance for applications for new animal drugs
filed under subsection (b)(1). For purposes of this paragraph,
``relevant international organization'' means the Codex
Alimenterius Commission or other international organization
deemed appropriate by the Secretary. The Secretary may, under
procedures specified by regulation, revoke a tolerance
established under this paragraph if information demonstrates
that the use of the new animal drug under actual use conditions
results in food being imported into the United States with
residues exceeding the tolerance or if scientific evidence
shows the tolerance to be unsafe.
(b)(1) Any person may file with the Secretary an application
with respect to any intended use or uses of a new animal drug.
Such person shall submit to the Secretary as a part of the
application (A) full reports of investigations which have been
made to show whether or not such drug is safe and effective for
use; (B) a full list of the articles used as components of such
drug; (C) a full statement of the composition of such drug; (D)
a full description of the methods used in, and the facilities
and controls used for, the manufacture, processing, and packing
of such drug; (E) such samples of such drug and of the articles
used as components thereof, of any animal feed for use in or on
which such drug is intended, and of the edible portions or
products (before or after slaughter) of animals to which such
drug (directly or in or on animal feed) is intended to be
administered, as the Secretary may require; (F) specimens of
the labeling proposed to be used for such drug, or in case such
drug is intended for use in animal feed, proposed labeling
appropriate for such use, and specimens of the labeling for the
drug to be manufactured, packed, or distributed by the
applicant; (G) a description of practicable methods for
determining the quantity, if any, of such drug in or on food,
and any substance formed in or on food, because of its use; and
(H) the proposed tolerance or withdrawal period or other use
restrictions for such drug if any tolerance or withdrawal
period or other use restrictions are required in order to
assure that the proposed use of such drug will be safe. The
applicant shall file with the application the patent number and
the expiration date of any patent which claims the new animal
drug for which the applicant filed the application or which
claims a method of using such drug and with respect to which a
claim of patent infringement could reasonably be asserted if a
person not licensed by the owner engaged in the manufacture,
use, or sale of the drug. If an application is filed under this
subsection for a drug and a patent which claims such drug or a
method of using such drug is issued after the filing date but
before approval of the application, the applicant shall amend
the application to include the information required by the
preceding sentence. Upon approval of the application, the
Secretary shall publish information submitted under the two
preceding sentences.
(2) Any person may file with the Secretary an abbreviated
application for the approval of a new animal drug. An
abbreviated application shall contain the information required
by subsection (n).
(3) Any person intending to file an application under
paragraph (1), section 571, or a request for an investigational
exemption under subsection (j) shall be entitled to one or more
conferences prior to such submission to reach an agreement
acceptable to the Secretary establishing a submission or an
investigational requirement, which may include a requirement
for a field investigation. A decision establishing a submission
or an investigational requirement shall bind the Secretary and
the applicant or requestor unless (A) the Secretary and the
applicant or requestor mutually agree to modify the
requirement, or (B) the Secretary by written order determines
that a substantiated scientific requirement essential to the
determination of safety or effectiveness of the animal drug
involved has appeared after the conference. No later than 25
calendar days after each such conference, the Secretary shall
provide a written order setting forth a scientific
justification specific to the animal drug and intended uses
under consideration if the agreement referred to in the first
sentence requires more than one field investigation as being
essential to provide substantial evidence of effectiveness for
the intended uses of the drug. Nothing in this paragraph shall
be construed as compelling the Secretary to require a field
investigation.
(c)(1) Within one hundred and eighty days after the filing of
an application pursuant to subsection (b), or such additional
period as may be agreed upon by the Secretary and the
applicant, the Secretary shall either (A) issue an order
approving the application if he then finds that none of the
grounds for denying approval specified in subsection (d)
applies, or (B) give the applicant notice of an opportunity for
a hearing before the Secretary under subsection (d) on the
question whether such application is approvable. If the
applicant elects to accept the opportunity for a hearing by
written request within thirty days after such notice, such
hearing shall commence not more than ninety days after the
expiration of such thirty days unless the Secretary and the
applicant otherwise agree. Any such hearing shall thereafter be
conducted on an expedited basis and the Secretary's order
thereon shall be issued within ninety days after the date fixed
by the Secretary for filing final briefs.
(2)(A) Subject to subparagraph (C), the Secretary shall
approve an abbreviated application for a drug unless the
Secretary finds--
(i) the methods used in, or the facilities and
controls used for, the manufacture, processing, and
packing of the drug are inadequate to assure and
preserve its identity, strength, quality, and purity;
(ii) the conditions of use prescribed, recommended,
or suggested in the proposed labeling are not
reasonably certain to be followed in practice or,
except as provided in subparagraph (B), information
submitted with the application is insufficient to show
that each of the proposed conditions of use or similar
limitations (whether in the labeling or published
pursuant to subsection (i)) have been previously
approved for the approved new animal drug referred to
in the application;
(iii) information submitted with the application is
insufficient to show that the active ingredients are
the same as those of the approved new animal drug
referred to in the application;
(iv)(I) if the application is for a drug whose active
ingredients, route of administration, dosage form,
strength, or use with other animal drugs in animal feed
is the same as the active ingredients, route of
administration, dosage form, strength, or use with
other animal drugs in animal feed of the approved new
animal drug referred to in the application, information
submitted in the application is insufficient to show
that the active ingredients, route of administration,
dosage form, strength, or use with other animal drugs
in animal feed is the same as that of the approved new
animal drug, or
(II) if the application is for a drug whose active
ingredients, route of administration, dosage form,
strength, or use with other animal drugs in animal feed
is different from that of the approved new animal drug
referred to in the application, no petition to file an
application for the drug with the different active
ingredients, route of administration, dosage form,
strength, or use with other animal drugs in animal feed
was approved under subsection (n)(3);
(v) if the application was filed pursuant to the
approval of a petition under subsection (n)(3), the
application did not contain the information required by
the Secretary respecting the active ingredients, route
of administration, dosage form, strength, or use with
other animal drugs in animal feed which is not the
same;
(vi) information submitted in the application is
insufficient to show that the drug is bioequivalent to
the approved new animal drug referred to in the
application, or if the application is filed under a
petition approved pursuant to subsection (n)(3),
information submitted in the application is
insufficient to show that the active ingredients of the
new animal drug are of the same pharmacological or
therapeutic class as the pharmacological or therapeutic
class of the approved new animal drug and that the new
animal drug can be expected to have the same
therapeutic effect as the approved new animal drug when
used in accordance with the labeling;
(vii) information submitted in the application is
insufficient to show that the labeling proposed for the
drug is the same as the labeling approved for the
approved new animal drug referred to in the application
except for changes required because of differences
approved under a petition filed under subsection
(n)(3), because of a different withdrawal period, or
because the drug and the approved new animal drug are
produced or distributed by different manufacturers;
(viii) information submitted in the application or
any other information available to the Secretary shows
that (I) the inactive ingredients of the drug are
unsafe for use under the conditions prescribed,
recommended, or suggested in the labeling proposed for
the drug, (II) the composition of the drug is unsafe
under such conditions because of the type or quantity
of inactive ingredients included or the manner in which
the inactive ingredients are included, or (III) in the
case of a drug for food producing animals, the inactive
ingredients of the drug or its composition may be
unsafe with respect to human food safety;
(ix) the approval under subsection (b)(1) of the
approved new animal drug referred to in the application
filed under subsection (b)(2) has been withdrawn or
suspended for grounds described in paragraph (1) of
subsection (e), the Secretary has published a notice of
a hearing to withdraw approval of the approved new
animal drug for such grounds, the approval under this
paragraph of the new animal drug for which the
application under subsection (b)(2) was filed has been
withdrawn or suspended under subparagraph (G) for such
grounds, or the Secretary has determined that the
approved new animal drug has been withdrawn from sale
for safety or effectiveness reasons;
(x) the application does not meet any other
requirement of subsection (n); or
(xi) the application contains an untrue statement of
material fact.
(B) If the Secretary finds that a new animal drug for which
an application is submitted under subsection (b)(2) is
bioequivalent to the approved new animal drug referred to in
such application and that residues of the new animal drug are
consistent with the tolerances established for such approved
new animal drug but at a withdrawal period which is different
than the withdrawal period approved for such approved new
animal drug, the Secretary may establish, on the basis of
information submitted, such different withdrawal period as the
withdrawal period for the new animal drug for purposes of the
approval of such application for such drug.
(C) Within 180 days of the initial receipt of an application
under subsection (b)(2) or within such additional period as may
be agreed upon by the Secretary and the applicant, the
Secretary shall approve or disapprove the application.
(D) The approval of an application filed under subsection
(b)(2) shall be made effective on the last applicable date
determined under the following:
(i) If the applicant only made a certification
described in clause (i) or (ii) of subsection (n)(1)(G)
or in both such clauses, the approval may be made
effective immediately.
(ii) If the applicant made a certification described
in clause (iii) of subsection (n)(1)(G), the approval
may be made effective on the date certified under
clause (iii).
(iii) If the applicant made a certification described
in clause (iv) of subsection (n)(1)(G), the approval
shall be made effective immediately unless an action is
brought for infringement of a patent which is the
subject of the certification before the expiration of
45 days from the date the notice provided under
subsection (n)(2)(B)(i) is received. If such an action
is brought before the expiration of such days, the
approval shall be made effective upon the expiration of
the 30 month period beginning on the date of the
receipt of the notice provided under subsection
(n)(2)(B) or such shorter or longer period as the court
may order because either party to the action failed to
reasonably cooperate in expediting the action, except
that if before the expiration of such period--
(I) the court decides that such patent is
invalid or not infringed, the approval shall be
made effective on the date of the court
decision,
(II) the court decides that such patent has
been infringed, the approval shall be made
effective on such date as the court orders
under section 271(e)(4)(A) of title 35, United
States Code, or
(III) the court grants a preliminary
injunction prohibiting the applicant from
engaging in the commercial manufacture or sale
of the drug until the court decides the issues
of patent validity and infringement and if the
court decides that such patent is invalid or
not infringed, the approval shall be made
effective on the date of such court decision.
In such an action, each of the parties shall reasonably
cooperate in expediting the action. Until the
expiration of 45 days from the date the notice made
under subsection (n)(2)(B) is received, no action may
be brought under section 2201 of title 28, United
States Code, for a declaratory judgment with respect to
the patent. Any action brought under section 2201 shall
be brought in the judicial district where the defendant
has its principal place of business or a regular and
established place of business.
(iv) If the application contains a certification
described in clause (iv) of subsection (n)(1)(G) and is
for a drug for which a previous application has been
filed under this subsection containing such a
certification, the application shall be made effective
not earlier than 180 days after--
(I) the date the Secretary receives notice
from the applicant under the previous
application of the first commercial marketing
of the drug under the previous application, or
(II) the date of a decision of a court in an
action described in subclause (III) holding the
patent which is the subject of the
certification to be invalid or not infringed,
whichever is earlier.
(E) If the Secretary decides to disapprove an application,
the Secretary shall give the applicant notice of an opportunity
for a hearing before the Secretary on the question of whether
such application is approvable. If the applicant elects to
accept the opportunity for hearing by written request within 30
days after such notice, such hearing shall commence not more
than 90 days after the expiration of such 30 days unless the
Secretary and the applicant otherwise agree. Any such hearing
shall thereafter be conducted on an expedited basis and the
Secretary's order thereon shall be issued within 90 days after
the date fixed by the Secretary for filing final briefs.
(F)(i) If an application submitted under subsection (b)(1)
for a drug, no active ingredient (including any ester or salt
of the active ingredient) of which has been approved in any
other application under subsection (b)(1), is approved after
the date of the enactment of this paragraph, no application may
be submitted under subsection (b)(2) which refers to the drug
for which the subsection (b)(1) application was submitted
before the expiration of 5 years from the date of the approval
of the application under subsection (b)(1), except that such an
application may be submitted under subsection (b)(2) after the
expiration of 4 years from the date of the approval of the
subsection (b)(1) application if it contains a certification of
patent invalidity or noninfringement described in clause (iv)
of subsection (n)(1)(G). The approval of such an application
shall be made effective in accordance with subparagraph (B)
except that, if an action for patent infringement is commenced
during the one-year period beginning 48 months after the date
of the approval of the subsection (b) application, the 30 month
period referred to in subparagraph (D)(iii) shall be extended
by such amount of time (if any) which is required for seven and
one-half years to have elapsed from the date of approval of the
subsection (b) application.
(ii) If an application submitted under subsection (b)(1) for
a drug, which includes an active ingredient (including any
ester or salt of the active ingredient) that has been approved
in another application approved under such subsection, is
approved after the date of enactment of this paragraph and if
such application contains substantial evidence of the
effectiveness of the drug involved, any studies of animal
safety, or, in the case of food producing animals, human food
safety studies (other than bioequivalence studies or residue
depletion studies, except residue depletion studies for minor
uses or minor species) required for the approval of the
application and conducted or sponsored by the applicant, the
Secretary may not make the approval of an application submitted
under subsection (b)(2) for the conditions of approval of such
drug in the subsection (b)(1) application effective before the
expiration of 3 years from the date of the approval of the
application under subsection (b)(1) for such drug.
(iii) If a supplement to an application approved under
subsection (b)(1) is approved after the date of enactment of
this paragraph and the supplement contains substantial evidence
of the effectiveness of the drug involved, any studies of
animal safety, or, in the case of food producing animals, human
food safety studies (other than bioequivalence studies or
residue depletion studies, except residue depletion studies for
minor uses or minor species) required for the approval of the
supplement and conducted or sponsored by the person submitting
the supplement, the Secretary may not make the approval of an
application submitted under subsection (b)(2) for a change
approved in the supplement effective before the expiration of 3
years from the date of the approval of the supplement.
(iv) An applicant under subsection (b)(1) who comes within
the provisions of clause (i) of this subparagraph as a result
of an application which seeks approval for a use solely in non-
food producing animals, may elect, within 10 days of receiving
such approval, to waive clause (i) of this subparagraph, in
which event the limitation on approval of applications
submitted under subsection (b)(2) set forth in clause (ii) of
this subparagraph shall be applicable to the subsection (b)(1)
application.
(v) If an application (including any supplement to a new
animal drug application) submitted under subsection (b)(1) for
a new animal drug for a food-producing animal use, which
includes an active ingredient (including any ester or salt of
the active ingredient) which has been the subject of a waiver
under clause (iv) is approved after the date of enactment of
this paragraph, and if the application contains substantial
evidence of the effectiveness of the drug involved, any studies
of animal safety, or human food safety studies (other than
bioequivalence studies or residue depletion studies, except
residue depletion studies for minor uses or minor species)
required for the new approval of the application and conducted
or sponsored by the applicant, the Secretary may not make the
approval of an application (including any supplement to such
application) submitted under subsection (b)(2) for the new
conditions of approval of such drug in the subsection (b)(1)
application effective before the expiration of five years from
the date of approval of the application under subsection (b)(1)
for such drug. The provisions of this paragraph shall apply
only to the first approval for a food-producing animal use for
the same applicant after the waiver under clause (iv).
(G) If an approved application submitted under subsection
(b)(2) for a new animal drug refers to a drug the approval of
which was withdrawn or suspended for grounds described in
paragraph (1) or (2) of subsection (e) or was withdrawn or
suspended under this subparagraph or which, as determined by
the Secretary, has been withdrawn from sale for safety or
effectiveness reasons, the approval of the drug under this
paragraph shall be withdrawn or suspended--
(i) for the same period as the withdrawal or
suspension under subsection (e) or this subparagraph,
or
(ii) if the approved new animal drug has been
withdrawn from sale, for the period of withdrawal from
sale or, if earlier, the period ending on the date the
Secretary determines that the withdrawal from sale is
not for safety or effectiveness reasons.
(H) For purposes of this paragraph:
(i) The term ``bioequivalence'' means the rate and
extent to which the active ingredient or therapeutic
ingredient is absorbed from a new animal drug and
becomes available at the site of drug action.
(ii) A new animal drug shall be considered to be
bioequivalent to the approved new animal drug referred
to in its application under subsection (n) if--
(I) the rate and extent of absorption of the
drug do not show a significant difference from
the rate and extent of absorption of the
approved new animal drug referred to in the
application when administered at the same dose
of the active ingredient under similar
experimental conditions in either a single dose
or multiple doses;
(II) the extent of absorption of the drug
does not show a significant difference from the
extent of absorption of the approved new animal
drug referred to in the application when
administered at the same dose of the active
ingredient under similar experimental
conditions in either a single dose or multiple
doses and the difference from the approved new
animal drug in the rate of absorption of the
drug is intentional, is reflected in its
proposed labeling, is not essential to the
attainment of effective drug concentrations in
use, and is considered scientifically
insignificant for the drug in attaining the
intended purposes of its use and preserving
human food safety; or
(III) in any case in which the Secretary
determines that the measurement of the rate and
extent of absorption or excretion of the new
animal drug in biological fluids is
inappropriate or impractical, an appropriate
acute pharmacological effects test or other
test of the new animal drug and, when deemed
scientifically necessary, of the approved new
animal drug referred to in the application in
the species to be tested or in an appropriate
animal model does not show a significant
difference between the new animal drug and such
approved new animal drug when administered at
the same dose under similar experimental
conditions.
If the approved new animal drug referred to in the
application for a new animal drug under subsection (n)
is approved for use in more than one animal species,
the bioequivalency information described in subclauses
(I), (II), and (III) shall be obtained for one species,
or if the Secretary deems appropriate based on
scientific principles, shall be obtained for more than
one species. The Secretary may prescribe the dose to be
used in determining bioequivalency under subclause (I),
(II), or (III). To assure that the residues of the new
animal drug will be consistent with the established
tolerances for the approved new animal drug referred to
in the application under subsection (b)(2) upon the
expiration of the withdrawal period contained in the
application for the new animal drug, the Secretary
shall require bioequivalency data or residue depletion
studies of the new animal drug or such other data or
studies as the Secretary considers appropriate based on
scientific principles. If the Secretary requires one or
more residue studies under the preceding sentence, the
Secretary may not require that the assay methodology
used to determine the withdrawal period of the new
animal drug be more rigorous than the methodology used
to determine the withdrawal period for the approved new
animal drug referred to in the application. If such
studies are required and if the approved new animal
drug, referred to in the application for the new animal
drug for which such studies are required, is approved
for use in more than one animal species, such studies
shall be conducted for one species, or if the Secretary
deems appropriate based on scientific principles, shall
be conducted for more than one species.
(3) If the patent information described in subsection (b)(1)
could not be filed with the submission of an application under
subsection (b)(1) because the application was filed before the
patent information was required under subsection (b)(1) or a
patent was issued after the application was approved under such
subsection, the holder of an approved application shall file
with the Secretary the patent number and the expiration date of
any patent which claims the new animal drug for which the
application was filed or which claims a method of using such
drug and with respect to which a claim of patent infringement
could reasonably be asserted if a person not licensed by the
owner engaged in the manufacture, use, or sale of the drug. If
the holder of an approved application could not file patent
information under subsection (b)(1) because it was not required
at the time the application was approved, the holder shall file
such information under this subsection not later than 30 days
after the date of the enactment of this sentence, and if the
holder of an approved application could not file patent
information under subsection (b)(1) because no patent had been
issued when an application was filed or approved, the holder
shall file such information under this subsection not later
than 30 days after the date the patent involved is issued. Upon
the submission of patent information under this subsection, the
Secretary shall publish it.
(4) A drug manufactured in a pilot or other small facility
may be used to demonstrate the safety and effectiveness of the
drug and to obtain approval for the drug prior to manufacture
of the drug in a larger facility, unless the Secretary makes a
determination that a full scale production facility is
necessary to ensure the safety or effectiveness of the drug.
(d)(1) If the Secretary finds, after due notice to the
applicant in accordance with subsection (c) and giving him an
opportunity for a hearing, in accordance with said subsection,
that--
(A) the investigations, reports of which are required
to be submitted to the Secretary pursuant to subsection
(b), do not include adequate tests by all methods
reasonably applicable to show whether or not such drug
is safe for use under the conditions prescribed,
recommended, or suggested in the proposed labeling
thereof;
(B) the results of such tests show that such drug is
unsafe for use under such conditions or do not show
that such drug is safe for use under such conditions;
(C) the methods used in, and the facilities and
controls used for, the manufacture, processing, and
packing of such drug are inadequate to preserve its
identity, strength, quality, and purity;
(D) upon the basis of the information submitted to
him as part of the application, or upon the basis of
any other information before him with respect to such
drug, he has insufficient information to determine
whether such drug is safe for use under such
conditions;
(E) evaluated on the basis of the information
submitted to him as part of the application and any
other information before him with respect to such drug,
there is a lack of substantial evidence that the drug
will have the effect it purports or is represented to
have under the conditions of use prescribed,
recommended, or suggested in the proposed labeling
thereof;
(F) upon the basis of information submitted to the
Secretary as part of the application or any other
information before the Secretary with respect to such
drug, any use prescribed, recommended, or suggested in
labeling proposed for such drug will result in a
residue of such drug in excess of a tolerance found by
the Secretary to be safe for such drug;
(G) the application failed to contain the patent
information prescribed by subsection (b)(1);
(H) based on a fair evaluation of all material facts,
such labeling is false or misleading in any particular;
or
(I) such drug induces cancer when ingested by man or
animal or, after tests which are appropriate for the
evaluation of the safety of such drug, induces cancer
in man or animal, except that the foregoing provisions
of this subparagraph shall not apply with respect to
such drug if the Secretary finds that, under the
conditions of use specified in proposed labeling and
reasonably certain to be followed in practice (i) such
drug will not adversely affect the animals for which it
is intended, and (ii) no residue of such drug will be
found (by methods of examination prescribed or approved
by the Secretary by regulations, which regulations
shall not be subject to subsections (c), (d), and (h)),
in any edible portion of such animals after slaughter
or in any food yielded by or derived from the living
animals;
he shall issue an order refusing to approve the application.
If, after such notice and opportunity for hearing, the
Secretary finds that subparagraphs (A) through (I) do not
apply, he shall issue an order approving the application.
(2) In determining whether such drug is safe for use under
the conditions prescribed, recommended, or suggested in the
proposed labeling thereof, the Secretary shall consider, among
other relevant factors, (A) the probable consumption of such
drug and of any substance formed in or on food because of the
use of such drug, (B) the cumulative effect on man or animal of
such drug, taking into account any chemically or
pharmacologically related substance, (C) safety factors which
in the opinion of experts, qualified by scientific training and
experience to evaluate the safety of such drugs, are
appropriate for the use of animal experimentation data, and (D)
whether the conditions of use prescribed, recommended, or
suggested in the proposed labeling are reasonably certain to be
followed in practice. Any order issued under this subsection
refusing to approve an application shall state the findings
upon which it is based.
(3) As used in this section, the term ``substantial
evidence'' means evidence consisting of one or more adequate
and well controlled investigations, such as--
(A) a study in a target species;
(B) a study in laboratory animals;
(C) any field investigation that may be required
under this section and that meets the requirements of
subsection (b)(3) if a presubmission conference is
requested by the applicant;
(D) a bioequivalence study; or
(E) an in vitro study;
by experts qualified by scientific training and experience to
evaluate the effectiveness of the drug involved, on the basis
of which it could fairly and reasonably be concluded by such
experts that the drug will have the effect it purports or is
represented to have under the conditions of use prescribed,
recommended, or suggested in the labeling or proposed labeling
thereof.
(4) In a case in which an animal drug contains more than one
active ingredient, or the labeling of the drug prescribes,
recommends, or suggests use of the drug in combination with one
or more other animal drugs, and the active ingredients or drugs
intended for use in the combination have previously been
separately approved pursuant to an application submitted under
section 512(b)(1) for particular uses and conditions of use for
which they are intended for use in the combination--
(A) the Secretary shall not issue an order under
paragraph (1)(A), (1)(B), or (1)(D) refusing to approve
the application for such combination on human food
safety grounds unless the Secretary finds that the
application fails to establish that--
(i) none of the active ingredients or drugs
intended for use in the combination,
respectively, at the longest withdrawal time of
any of the active ingredients or drugs in the
combination, respectively, exceeds its
established tolerance; or
(ii) none of the active ingredients or drugs
in the combination interferes with the methods
of analysis for another of the active
ingredients or drugs in the combination,
respectively;
(B) the Secretary shall not issue an order under
paragraph (1)(A), (1)(B), or (1)(D) refusing to approve
the application for such combination on target animal
safety grounds unless the Secretary finds that--
(i)(I) there is a substantiated scientific
issue, specific to one or more of the active
ingredients or animal drugs in the combination,
that cannot adequately be evaluated based on
information contained in the application for
the combination (including any investigations,
studies, or tests for which the applicant has a
right of reference or use from the person by or
for whom the investigations, studies, or tests
were conducted); or
(II) there is a scientific issue raised by
target animal observations contained in studies
submitted to the
Secretary as part of the application; and
(ii) based on the Secretary's evaluation of
the information contained in the application
with respect to the issues identified in
clauses (i) (I) and (II), paragraph (1) (A),
(B), or (D) apply;
(C) except in the case of a combination that contains
a nontopical antibacterial ingredient or animal drug,
the
Secretary shall not issue an order under paragraph
(1)(E) refusing to approve an application for a
combination animal drug intended for use other than in
animal feed or drinking water unless the Secretary
finds that the application fails to demonstrate that--
(i) there is substantial evidence that any
active ingredient or animal drug intended only
for the same use as another active ingredient
or animal drug in the combination makes a
contribution to labeled effectiveness;
(ii) each active ingredient or animal drug
intended for at least one use that is different
from all other active ingredients or animal
drugs used in the combination
provides appropriate concurrent use for the
intended target population; or
(iii) where based on scientific information
the
Secretary has reason to believe the active
ingredients or animal drugs may be physically
incompatible or have disparate dosing regimens,
such active ingredients or
animal drugs are physically compatible or do
not have disparate dosing regimens; and
(D) the Secretary shall not issue an order under
paragraph (1)(E) refusing to approve an application for
a combination animal drug intended for use in animal
feed or drinking water unless the Secretary finds that
the application fails to demonstrate that--
(i) there is substantial evidence that any
active ingredient or animal drug intended only
for the same use as another active ingredient
or animal drug in the combination makes a
contribution to the labeled effectiveness;
(ii) each of the active ingredients or animal
drugs intended for at least one use that is
different from all other active ingredients or
animal drugs used in the combination provides
appropriate concurrent use for the intended
target population;
(iii) where a combination contains more than
one nontopical antibacterial ingredient or
animal drug, there is substantial evidence that
each of the nontopical antibacterial
ingredients or animal drugs makes a
contribution to the labeled effectiveness,
except that for purposes of this clause,
antibacterial ingredient or animal drug does
not include the ionophore or arsenical classes
of animal drugs; or
(iv) where based on scientific information
the Secretary has reason to believe the active
ingredients or animal drugs intended for use in
drinking water may be physically incompatible,
such active ingredients or animal drugs
intended for use in drinking water are
physically compatible.
(5) In reviewing an application that proposes a
change to add an intended use for a minor use or a
minor species to an approved new animal drug
application, the Secretary shall reevaluate only the
relevant information in the approved application to
determine whether the application for the minor use or
minor species can be approved. A decision to approve
the application for the minor use or minor species is
not, implicitly or explicitly, a reaffirmation of the
approval of the original application.
(e)(1) The Secretary shall, after due notice and opportunity
for hearing to the applicant, issue an order withdrawing
approval of an application filed pursuant to subsection (b)
with respect to any new animal drug if the Secretary finds--
(A) that experience or scientific data show that such
drug is unsafe for use under the conditions of use upon
the basis of which the application was approved or the
condition of use authorized under subsection (a)(4)(A);
(B) that new evidence not contained in such
application or not available to the Secretary until
after such application was approved, or tests by new
methods, or tests by methods not deemed reasonably
applicable when such application was approved,
evaluated together with the evidence available to the
Secretary when the application was approved, shows that
such drug is not shown to be safe for use under the
conditions of use upon the basis of which the
application was approved or that subparagraph (I) of
paragraph (1) of subsection (d) applies to such drug;
(C) on the basis of new information before him with
respect to such drug, evaluated together with the
evidence available to him when the application was
approved, that there is a lack of substantial evidence
that such drug will have the effect it purports or is
represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling
thereof;
(D) the patent information prescribed by subsection
(c)(3) was not filed within 30 days after the receipt
of written notice from the Secretary specifying the
failure to file such information;
(E) that the application contains any untrue
statement of a material fact; or
(F) that the applicant has made any changes from the
standpoint of safety or effectiveness beyond the
variations provided for in the application unless he
has supplemented the application by filing with the
Secretary adequate information respecting all such
changes and unless there is in effect an approval of
the supplemental application. The supplemental
application shall be treated in the same manner as the
original application.
If the Secretary (or in his absence the officer acting as
Secretary) finds that there is an imminent hazard to the health
of man or of the animals for which such drug is intended, he
may suspend the approval of such application immediately, and
give the applicant prompt notice of his action and afford the
applicant the opportunity for an expedited hearing under this
subsection; but the authority conferred by this sentence to
suspend the approval of an application shall not be delegated.
(2) The Secretary may also, after due notice and opportunity
for hearing to the applicant, issue an order withdrawing the
approval of an application with respect to any new animal drug
under this section if the Secretary finds--
(A) that the applicant has failed to establish a
system for maintaining required records, or has
repeatedly or deliberately failed to maintain such
records or to make required reports in accordance with
a regulation or order under subsection (l), or the
applicant has refused to permit access to, or copying
or verification of, such records as required by
paragraph (2) of such subsection;
(B) that on the basis of new information before him,
evaluated together with the evidence before him when
the application was approved, the methods used in, or
the facilities and controls used for, the manufacture,
processing, and packing of such drug are inadequate to
assure and preserve its identity, strength, quality,
and purity and were not made adequate within a
reasonable time after receipt of written notice from
the Secretary specifying the matter complained of; or
(C) that on the basis of new information before him,
evaluated together with the evidence before him when
the application was approved, the labeling of such
drug, based on a fair evaluation of all material facts,
is false or misleading in any particular and was not
corrected within a reasonable time after receipt of
written notice from the Secretary specifying the matter
complained of.
(3) Any order under this subsection shall state the findings
upon which it is based.
(f) Whenever the Secretary finds that the facts so require,
he shall revoke any previous order under subsection (d), (e),
or (m), or section 571 (c), (d), or (e) refusing, withdrawing,
or suspending approval of an application and shall approve such
application or reinstate such approval, as may be appropriate.
(g) Orders of the Secretary issued under this section, or
section 571 (other than orders issuing, amending, or repealing
regulations) shall be served (1) in person by any officer or
employee of the department designated by the Secretary or (2)
by mailing the order by registered mail or by certified mail
addressed to the applicant or respondent at his last known
address in the records of the Secretary.
(h) An appeal may be taken by the applicant from an order of
the Secretary refusing or withdrawing approval of an
application filed under subsection (b) or (m) of this section.
The provisions of subsection (h) of section 505 of this Act
shall govern any such appeal.
(i) When a new animal drug application filed pursuant to
subsection (b) or section 571 is approved, the Secretary shall
by notice, which upon publication shall be effective as a
regulation, publish in the Federal Register the name and
address of the applicant and the conditions and indications of
use of the new animal drug covered by such application,
including any tolerance and withdrawal period or other use
restrictions and, if such new animal drug is intended for use
in animal feed, appropriate purposes and conditions of use
(including special labeling requirements and any requirement
that an animal feed bearing or containing the new animal drug
be limited to use under the professional supervision of a
licensed veterinarian) applicable to any animal feed for use in
which such drug is approved, and such other information, upon
the basis of which such application was approved, as the
Secretary deems necessary to assure the safe and effective use
of such drug. Upon withdrawal of approval of such new animal
drug application or upon its suspension or upon failure to
renew a conditional approval under section 571, the Secretary
shall forthwith revoke or suspend, as the case may be, the
regulation published pursuant to this subsection (i) insofar as
it is based on the approval of such application.
(j) To the extent consistent with the public health, the
Secretary shall promulgate regulations for exempting from the
operation of this section new animal drugs, and animal feeds
bearing or containing new animal drugs, intended solely for
investigational use by experts qualified by scientific training
and experience to investigate the safety and effectiveness of
animal drugs. Such regulations may, in the discretion of the
Secretary, among other conditions relating to the protection of
the public health, provide for conditioning such exemption upon
the establishment and maintenance of such records, and the
making of such reports to the Secretary, by the manufacturer or
the sponsor of the investigation of such article, of data
(including but not limited to analytical reports by
investigators) obtained as a result of such investigational use
of such article, as the Secretary finds will enable him to
evaluate the safety and effectiveness of such article in the
event of the filing of an application pursuant to this section.
Such regulations, among other things, shall set forth the
conditions (if any) upon which animals treated with such
articles, and any products of such animals (before or after
slaughter), may be marketed for food use.
(k) While approval of an application for a new animal drug is
effective, a food shall not, by reason of bearing or containing
such drug or any substance formed in or on the food because of
its use in accordance with such application (including the
conditions and indications of use prescribed pursuant to
subsection (i)), be considered adulterated within the meaning
of clause (1) of section 402(a).
(l)(1) In the case of any new animal drug for which an
approval of an application filed pursuant to subsection (b) or
section 571 is in effect, the applicant shall establish and
maintain such records, and make such reports to the Secretary,
of data relating to experience, including experience with uses
authorized under subsection (a)(4)(A), and other data or
information, received or otherwise obtained by such applicant
with respect to such drug, or with respect to animal feeds
bearing or containing such drug, as the Secretary may by
general regulation, or by order with respect to such
application, prescribe on the basis of a finding that such
records and reports are necessary in order to enable the
Secretary to determine, or facilitate a determination, whether
there is or may be ground for invoking subsection (e) or
subsection (m)(4) of this section. Such regulation or order
shall provide, where the Secretary deems it to be appropriate,
for the examination, upon request, by the persons to whom such
regulation or order is applicable, of similar information
received or otherwise obtained by the Secretary.
(2) Every person required under this subsection to maintain
records, and every person in charge or custody thereof, shall,
upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable
times to have access to and copy and verify such records.
(3)(A) In the case of each new animal drug described in
paragraph (1) that contains an antimicrobial active ingredient,
the sponsor of the drug shall submit an annual report to the
Secretary on the amount of each antimicrobial active ingredient
in the drug that is sold or distributed for use in food-
producing animals, including information on any distributor-
labeled product.
(B) Each report under this paragraph shall specify the amount
of each antimicrobial active ingredient--
(i) by container size, strength, and dosage form;
(ii) by quantities distributed domestically and
quantities exported; and
(iii) by dosage form, including, for each such dosage
form, a listing of the target animals, indications, and
production classes that are specified on the approved
label of the product.
(C) Each report under this paragraph shall--
(i) be submitted not later than March 31 each year;
(ii) cover the period of the preceding calendar year;
and
(iii) include separate information for each month of
such calendar year.
(D) The Secretary may share information reported under this
paragraph with the Antimicrobial Resistance Task Force
established under section 319E of the Public Health Service
Act.
(E) The Secretary shall make summaries of the information
reported under this paragraph publicly available, except that--
(i) the summary data shall be reported by
antimicrobial class, and no class with fewer than 3
distinct sponsors of approved applications shall be
independently reported; and
(ii) the data shall be reported in a manner
consistent with protecting both national security and
confidential business information.
(m)(1) Any person may file with the Secretary an application
for a license to manufacture animal feeds bearing or containing
new animal drugs. Such person shall submit to the Secretary as
part of the application (A) a full statement of the business
name and address of the specific facility at which the
manufacturing is to take place and the facility's registration
number, (B) the name and signature of the responsible
individual or individuals for that facility, (C) a
certification that the animal feeds bearing or containing new
animal drugs are manufactured and labeled in accordance with
the applicable regulations published pursuant to subsection (i)
or for indexed new animal drugs in accordance with the index
listing published pursuant to section 572(e)(2) and the
labeling requirements set forth in section 572(h), and (D) a
certification that the methods used in, and the facilities and
controls used for, manufacturing, processing, packaging, and
holding such animal feeds are in conformity with current good
manufacturing practice as described in section 501(a)(2)(B).
(2) Within 90 days after the filing of an application
pursuant to paragraph (1), or such additional period as may be
agreed upon by the Secretary and the applicant, the Secretary
shall (A) issue an order approving the application if the
Secretary then finds that none of the grounds for denying
approval specified in paragraph (3) applies, or (B) give the
applicant notice of an opportunity for a hearing before the
Secretary under paragraph (3) on the question whether such
application is approvable. The procedure governing such a
hearing shall be the procedure set forth in the last two
sentences of subsection (c)(1).
(3) If the Secretary, after due notice to the applicant in
accordance with paragraph (2) and giving the applicant an
opportunity for a hearing in accordance with such paragraph,
finds, on the basis of information submitted to the Secretary
as part of the application, on the basis of a preapproval
inspection, or on the basis of any other information before the
Secretary--
(A) that the application is incomplete, false, or
misleading in any particular;
(B) that the methods used in, and the facilities and
controls used for, the manufacture, processing, and
packing of such animal feed are inadequate to preserve
the identity, strength, quality, and purity of the new
animal drug therein; or
(C) that the facility manufactures animal feeds
bearing or containing new animal drugs in a manner that
does not accord with the specifications for manufacture
or labels animal feeds bearing or containing new animal
drugs in a manner that does not accord with the
conditions or indications of use that are published
pursuant to subsection (i) or an index listing pursuant
to section 572(e),
the Secretary shall issue an order refusing to approve the
application. If, after such notice and opportunity for hearing,
the Secretary finds that subparagraphs (A) through (C) do not
apply, the Secretary shall issue an order approving the
application. An order under this subsection approving an
application for a license to manufacture animal feeds bearing
or containing new animal drugs shall permit a facility to
manufacture only those animal feeds bearing or containing new
animal drugs for which there are in effect regulations pursuant
to subsection (i) or an index listing pursuant to section
572(e) relating to the use of such drugs in or on such animal
feed.
(4)(A) The Secretary shall, after due notice and opportunity
for hearing to the applicant, revoke a license to manufacture
animal feeds bearing or containing new animal drugs under this
subsection if the Secretary finds--
(i) that the application for such license contains
any untrue statement of a material fact; or
(ii) that the applicant has made changes that would
cause the application to contain any untrue statements
of material fact or that would affect the safety or
effectiveness of the animal feeds manufactured at the
facility unless the applicant has supplemented the
application by filing with the Secretary adequate
information respecting all such changes and unless
there is in effect an approval of the supplemental
application.
If the Secretary (or in the Secretary's absence the officer
acting as the Secretary) finds that there is an imminent hazard
to the health of humans or of the animals for which such animal
feed is intended, the Secretary may suspend the license
immediately, and give the applicant prompt notice of the action
and afford the applicant the opportunity for an expedited
hearing under this subsection; but the authority conferred by
this sentence shall not be delegated.
(B) The Secretary may also, after due notice and opportunity
for hearing to the applicant, revoke a license to manufacture
animal feed under this subsection if the Secretary finds--
(i) that the applicant has failed to establish a
system for maintaining required records, or has
repeatedly or deliberately failed to maintain such
records or to make required reports in accordance with
a regulation or order under paragraph (5)(A) of this
subsection or section 504(a)(3)(A), or the applicant
has refused to permit access to, or copying or
verification of, such records as required by
subparagraph (B) of such paragraph or section
504(a)(3)(B);
(ii) that on the basis of new information before the
Secretary, evaluated together with the evidence before
the Secretary when such license was issued, the methods
used in, or the facilities and controls used for, the
manufacture, processing, packing, and holding of such
animal feed are inadequate to assure and preserve the
identity, strength, quality, and purity of the new
animal drug therein, and were not made adequate within
a reasonable time after receipt of written notice from
the Secretary, specifying the matter complained of;
(iii) that on the basis of new information before the
Secretary, evaluated together with the evidence before
the Secretary when such license was issued, the
labeling of any animal feeds, based on a fair
evaluation of all material facts, is false or
misleading in any particular and was not corrected
within a reasonable time after receipt of written
notice from the Secretary specifying the matter
complained of; or
(iv) that on the basis of new information before the
Secretary, evaluated together with the evidence before
the Secretary when such license was issued, the
facility has manufactured, processed, packed, or held
animal feed bearing or containing a new animal drug
adulterated under section 501(a)(6) and the facility
did not discontinue the manufacture, processing,
packing, or holding of such animal feed within a
reasonable time after receipt of written notice from
the
Secretary specifying the matter complained of.
(C) The Secretary may also revoke a license to manufacture
animal feeds under this subsection if an applicant gives notice
to the Secretary of intention to discontinue the manufacture of
all animal feed covered under this subsection and waives an
opportunity for a hearing on the matter.
(D) Any order under this paragraph shall state the findings
upon which it is based.
(5) When a license to manufacture animal feeds bearing or
containing new animal drugs has been issued--
(A) the applicant shall establish and maintain such
records, and make such reports to the Secretary, or (at
the option of the Secretary) to the appropriate person
or persons holding an approved application filed under
subsection (b), as the Secretary may by general
regulation, or by order with respect to such
application, prescribe on the basis of a finding that
such records and reports are necessary in order to
enable the Secretary to determine, or facilitate a
determination, whether there is or may be ground for
invoking subsection (e) or paragraph (4); and
(B) every person required under this subsection to
maintain records, and every person in charge or custody
thereof, shall, upon request of an officer or employee
designated by the Secretary, permit such officer or
employee at all reasonable times to have access to and
copy and verify such records.
(6) To the extent consistent with the public health, the
Secretary may promulgate regulations for exempting from the
operation of this subsection facilities that manufacture,
process, pack, or hold animal feeds bearing or containing new
animal drugs.
(n)(1) An abbreviated application for a new animal drug shall
contain--
(A)(i) except as provided in clause (ii), information
to show that the conditions of use or similar
limitations (whether in the labeling or published
pursuant to subsection (i)) prescribed, recommended, or
suggested in the labeling proposed for the new animal
drug have been previously approved for a new animal
drug listed under paragraph (4) (hereinafter in this
subsection referred to as an ``approved new animal
drug''), and
(ii) information to show that the withdrawal period
at which residues of the new animal drug will be
consistent with the tolerances established for the
approved new animal drug is the same as the withdrawal
period previously established for the approved new
animal drug or, if the withdrawal period is proposed to
be different, information showing that the residues of
the new animal drug at the proposed different
withdrawal period will be consistent with the
tolerances established for the approved new animal
drug;
(B)(i) information to show that the active
ingredients of the new animal drug are the same as
those of the approved new animal drug, and
(ii) if the approved new animal drug has more than
one active ingredient, and if one of the active
ingredients of the new animal drug is different from
one of the active ingredients of the approved new
animal drug and the application is filed pursuant to
the approval of a petition filed under paragraph (3)--
(I) information to show that the other active
ingredients of the new animal drug are the same
as the active ingredients of the approved new
animal drug,
(II) information to show either that the
different active ingredient is an active
ingredient of another approved new animal drug
or of an animal drug which does not meet the
requirements of section 201(v), and
(III) such other information respecting the
different active ingredients as the Secretary
may require;
(C)(i) if the approved new animal drug is permitted
to be used with one or more animal drugs in animal
feed, information to show that the proposed uses of the
new animal drug with other animal drugs in animal feed
are the same as the uses of the approved new animal
drug, and
(ii) if the approved new animal drug is permitted to
be used with one or more other animal drugs in animal
feed, and one of the other animal drugs proposed for
use with the new animal drug in animal feed is
different from one of the other animal drugs permitted
to be used in animal feed with the approved new animal
drug, and the application is filed pursuant to the
approval of a petition filed under paragraph (3)--
(I) information to show either that the
different animal drug proposed for use with the
approved new animal drug in animal feed is an
approved new animal drug permitted to be used
in animal feed or does not meet the
requirements of section 201(v) when used with
another animal drug in animal feed,
(II) information to show that other animal
drugs proposed for use with the new animal drug
in animal feed are the same as the other animal
drugs permitted to be used with the approved
new animal drug, and
(III) such other information respecting the
different animal drug or combination with
respect to which the petition was filed as the
Secretary may require,
(D) information to show that the route of
administration, the dosage form, and the strength of
the new animal drug are the same as those of the
approved new animal drug or, if the route of
administration, the dosage form, or the strength of the
new animal drug is different and the application is
filed pursuant to the approval of a petition filed
under paragraph (3), such information respecting the
route of administration, dosage form, or strength with
respect to which the petition was filed as the
Secretary may require;
(E) information to show that the new animal drug is
bioequivalent to the approved new animal drug, except
that if the application is filed pursuant to the
approval of a petition filed under paragraph (3) for
the purposes described in subparagraph (B) or (C),
information to show that the active ingredients of the
new animal drug are of the same pharmacological or
therapeutic class as the pharmacological or therapeutic
class of the approved new animal drug and that the new
animal drug can be expected to have the same
therapeutic effect as the approved new animal drug when
used in accordance with the labeling;
(F) information to show that the labeling proposed
for the new animal drug is the same as the labeling
approved for the approved new animal drug except for
changes required because of differences approved under
a petition filed under paragraph (3), because of a
different withdrawal period, or because the new animal
drug and the approved new animal drug are produced or
distributed by different manufacturers;
(G) the items specified in clauses (B) through (F) of
subsection (b)(1);
(H) a certification, in the opinion of the applicant
and to the best of his knowledge, with respect to each
patent which claims the approved new animal drug or
which claims a use for such approved new animal drug
for which the applicant is seeking approval under this
subsection and for which information is required to be
filed under subsection (b)(1) or (c)(3)--
(i) that such patent information has not been
filed,
(ii) that such patent has expired,
(iii) of the date on which such patent will
expire, or
(iv) that such patent is invalid or will not
be infringed by the manufacture, use, or sale
of the new animal drug for which the
application is filed; and
(I) if with respect to the approved new animal drug
information was filed under subsection (b)(1) or (c)(3)
for a method of use patent which does not claim a use
for which the applicant is seeking approval of an
application under subsection (c)(2), a statement that
the method of use patent does not claim such a use.
The Secretary may not require that an abbreviated application
contain information in addition to that required by
subparagraphs (A) through (I).
(2)(A) An applicant who makes a certification described in
paragraph (1)(G)(iv) shall include in the application a
statement that the applicant will give the notice required by
subparagraph (B) to--
(i) each owner of the patent which is the subject of
the certification or the representative of such owner
designated to receive such notice, and
(ii) the holder of the approved application under
subsection (c)(1) for the drug which is claimed by the
patent or a use of which is claimed by the patent or
the representative of such holder designated to receive
such notice.
(B) The notice referred to in subparagraph (A) shall state
that an application, which contains data from bioequivalence
studies, has been filed under this subsection for the drug with
respect to which the certification is made to obtain approval
to engage in the commercial manufacture, use, or sale of such
drug before the expiration of the patent referred to in the
certification. Such notice shall include a detailed statement
of the factual and legal basis of the applicant's opinion that
the patent is not valid or will not be infringed.
(C) If an application is amended to include a certification
described in paragraph (1)(G)(iv), the notice required by
subparagraph (B) shall be given when the amended application is
filed.
(3) If a person wants to submit an abbreviated application
for a new animal drug--
(A) whose active ingredients, route of
administration, dosage form, or strength differ from
that of an approved new animal drug, or
(B) whose use with other animal drugs in animal feed
differs from that of an approved new animal drug,
such person shall submit a petition to the Secretary seeking
permission to file such an application. The Secretary shall
approve a petition for a new animal drug unless the Secretary
finds that--
(C) investigations must be conducted to show the
safety and effectiveness, in animals to be treated with
the drug, of the active ingredients, route of
administration, dosage form, strength, or use with
other animal drugs in animal feed which differ from the
approved new animal drug, or
(D) investigations must be conducted to show the
safety for human consumption of any residues in food
resulting from the proposed active ingredients, route
of administration, dosage form, strength, or use with
other animal drugs in animal feed for the new animal
drug which is different from the active ingredients,
route of administration, dosage form, strength, or use
with other animal drugs in animal feed of the approved
new animal drug.
The Secretary shall approve or disapprove a petition submitted
under this paragraph within 90 days of the date the petition is
submitted.
(4)(A)(i) Within 60 days of the date of the enactment of this
subsection, the Secretary shall publish and make available to
the public a list in alphabetical order of the official and
proprietary name of each new animal drug which has been
approved for safety and effectiveness before the date of the
enactment of this subsection.
(ii) Every 30 days after the publication of the first list
under clause (i) the Secretary shall revise the list to include
each new animal drug which has been approved for safety and
effectiveness under subsection (c) during the 30 day period.
(iii) When patent information submitted under subsection
(b)(1) or (c)(3) respecting a new animal drug included on the
list is to be published by the Secretary, the Secretary shall,
in revisions made under clause (ii), include such information
for such drug.
(B) A new animal drug approved for safety and effectiveness
before the date of the enactment of this subsection or approved
for safety and effectiveness under subsection (c) shall, for
purposes of this subsection, be considered to have been
published under subparagraph (A) on the date of its approval or
the date of enactment, whichever is later.
(C) If the approval of a new animal drug was withdrawn or
suspended under subsection (c)(2)(G) or for grounds described
in subsection (e) or if the Secretary determines that a drug
has been withdrawn from sale for safety or effectiveness
reasons, it may not be published in the list under subparagraph
(A) or, if the withdrawal or suspension occurred after its
publication in such list, it shall be immediately removed from
such list--
(i) for the same period as the withdrawal or
suspension under subsection (c)(2)(G) or (e), or
(ii) if the listed drug has been withdrawn from sale,
for the period of withdrawal from sale or, if earlier,
the period ending on the date the Secretary determines
that the withdrawal from sale is not for safety or
effectiveness reasons.
A notice of the removal shall be published in the Federal
Register.
(5) If an application contains the information required by
clauses (A), (G), and (H) of subsection (b)(1) and such
information--
(A) is relied on by the applicant for the approval of
the application, and
(B) is not information derived either from
investigations, studies, or tests conducted by or for
the applicant or for which the applicant had obtained a
right of reference or use from the person by or for
whom the investigations, studies, or tests were
conducted,
such application shall be considered to be an application filed
under subsection (b)(2).
(o) For purposes of this section, the term ``patent'' means a
patent issued by the United States Patent and Trademark Office.
(p)(1) Safety and effectiveness data and information which
has been submitted in an application filed under subsection
(b)(1) or section 571(a) for a drug and which has not
previously been disclosed to the public shall be made available
to the public, upon request, unless extraordinary circumstances
are shown--
(A) if no work is being or will be undertaken to have
the application approved,
(B) if the Secretary has determined that the
application is not approvable and all legal appeals
have been exhausted,
(C) if approval of the application under subsection
(c) is withdrawn and all legal appeals have been
exhausted,
(D) if the Secretary has determined that such drug is
not a new drug, or
(E) upon the effective date of the approval of the
first application filed under subsection (b)(2) which
refers to such drug or upon the date upon which the
approval of an application filed under subsection
(b)(2) which refers to such drug could be made
effective if such an application had been filed.
(2) Any request for data and information pursuant to
paragraph (1) shall include a verified statement by the person
making the request that any data or information received under
such paragraph shall not be disclosed by such person to any
other person--
(A) for the purpose of, or as part of a plan, scheme,
or device for, obtaining the right to make, use, or
market, or making, using, or marketing, outside the
United States, the drug identified in the application
filed under subsection (b)(1) or section 571(a), and
(B) without obtaining from any person to whom the
data and information are disclosed an identical
verified statement, a copy of which is to be provided
by such person to the Secretary, which meets the
requirements of this paragraph.
(q) Date of Approval in the Case of Recommended Controls
Under the CSA.--
(1) In general.--In the case of an application under
subsection (b) with respect to a drug for which the
Secretary provides notice to the sponsor that the
Secretary intends to recommend controls under the
Controlled Substances Act, approval of such application
shall not take effect until the interim final rule
controlling the drug is issued in accordance with
section 201(j) of the Controlled Substances Act.
(2) Date of approval.--For purposes of this section,
with respect to an application described in paragraph
(1), the term ``date of approval'' shall mean the later
of--
(A) the date an application under subsection
(b) is approved under subsection (c); or
(B) the date of issuance of the interim final
rule controlling the drug.
* * * * * * *
Subchapter F--New Animal Drugs for Minor Use and Minor Species
SEC. 571. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS FOR MINOR USE AND
MINOR SPECIES.
(a)(1) Except as provided in paragraph (3) of this section,
any person may file with the Secretary an application for
conditional approval of a new animal drug intended for a minor
use or a minor species. Such an application may not be a
supplement to an application approved under section 512. Such
application must comply in all respects with the provisions of
section 512 of this Act except sections 512(a)(4), 512(b)(2),
512(c)(1), 512(c)(2), 512(c)(3), 512(d)(1), 512(e), 512(h), and
512(n) unless otherwise stated in this section, and any
additional provisions of this section. New animal drugs are
subject to application of the same safety standards that would
be applied to such drugs under section 512(d) (including, for
antimicrobial new animal drugs, with respect to antimicrobial
resistance).
(2) The applicant shall submit to the Secretary as part of an
application for the conditional approval of a new animal drug--
(A) all information necessary to meet the
requirements of section 512(b)(1) except section
512(b)(1)(A);
(B) full reports of investigations which have been
made to show whether or not such drug is safe under
section 512(d) (including, for an antimicrobial new
animal drug, with respect to antimicrobial resistance)
and there is a reasonable expectation of effectiveness
for use;
(C) data for establishing a conditional dose;
(D) projections of expected need and the
justification for that expectation based on the best
information available;
(E) information regarding the quantity of drug
expected to be distributed on an annual basis to meet
the expected need; and
(F) a commitment that the applicant will conduct
additional investigations to meet the requirements for
the full demonstration of effectiveness under section
512(d)(1)(E) within 5 years.
(3) A person may not file an application under paragraph (1)
if--
(A) the application seeks conditional approval of a
new animal drug that is contained in, or is a product
of, a transgenic animal.
(B) the person has previously filed an application
for conditional approval under paragraph (1) for the
same drug in the same dosage form for the same intended
use whether or not subsequently conditionally approved
by the Secretary under subsection (b), or
(C) the person obtained the application, or data or
other information contained therein, directly or
indirectly from the person who filed for conditional
approval under paragraph (1) for the same drug in the
same dosage form for the same intended use whether or
not subsequently conditionally approved by the
Secretary under subsection (b).
(b) Within 180 days after the filing of an application
pursuant to subsection (a), or such additional period as may be
agreed upon by the Secretary and the applicant, the Secretary
shall either--
(1) issue an order, effective for one year,
conditionally approving the application if the
Secretary finds that none of the grounds for denying
conditional approval, specified in subsection (c) of
this section applies and publish a Federal Register
notice of the conditional approval, or
(2) give the applicant notice of an opportunity for
an informal hearing on the question whether such
application can be conditionally approved.
(c) If the Secretary finds, after giving the applicant notice
and an opportunity for an informal hearing, that--
(1) any of the provisions of section 512(d)(1) (A)
through (D) or (F) through (I) are applicable;
(2) the information submitted to the Secretary as
part of the application and any other information
before the Secretary with respect to such drug, is
insufficient to show that there is a reasonable
expectation that the drug will have the effect it
purports or is represented to have under the conditions
of use prescribed, recommended, or suggested in the
proposed labeling thereof; or
(3) another person has received approval under
section 512 for the same drug in the same dosage form
for the same intended use, and that person is able to
assure the availability of sufficient quantities of the
drug to meet the needs for which the drug is intended;
the Secretary shall issue an order refusing to conditionally
approve the application. If, after such notice and opportunity
for an informal hearing, the Secretary finds that paragraphs
(1) through (3) do not apply, the Secretary shall issue an
order conditionally approving the application effective for one
year and publish a Federal Register notice of the conditional
approval. Any order issued under this subsection refusing to
conditionally approve an application shall state the findings
upon which it is based.
(d) A conditional approval under this section is effective
for a 1-year period and is thereafter renewable by the
Secretary annually for up to 4 additional 1-year terms. A
conditional approval shall be in effect for no more than 5
years from the date of approval under subsection (b)(1) or (c)
of this section unless extended as provided for in subsection
(h) of this section. The following shall also apply:
(1) No later than 90 days from the end of the 1-year
period for which the original or renewed conditional
approval is effective, the applicant may submit a
request to renew a conditional approval for an
additional 1-year term.
(2) A conditional approval shall be deemed renewed at
the end of the 1-year period, or at the end of a 90-day
extension that the Secretary may, at the Secretary's
discretion, grant by letter in order to complete review
of the renewal request, unless the Secretary determines
before the expiration of the 1-year period or the 90-
day extension that--
(A) the applicant failed to submit a timely
renewal request;
(B) the request fails to contain sufficient
information to show that--
(i) the applicant is making
sufficient progress toward meeting
approval requirements under section
512(d)(1)(E), and is likely to be able
to fulfill those requirements and
obtain an approval under section 512
before the expiration of the 5-year
maximum term of the conditional
approval;
(ii) the quantity of the drug that
has been distributed is consistent with
the conditionally approved intended use
and conditions of use, unless there is
adequate explanation that ensures that
the drug is only used for its intended
purpose; or
(iii) the same drug in the same
dosage form for the same intended use
has not received approval under section
512, or if such a drug has been
approved, that the holder of the
approved application is unable to
assure the availability of sufficient
quantities of the drug to meet the
needs for which the drug is intended;
or
(C) any of the provisions of section
512(e)(1) (A) through (B) or (D) through (F)
are applicable.
(3) If the Secretary determines before the end of the
1-year period or the 90-day extension, if granted, that
a conditional approval should not be renewed, the
Secretary shall issue an order refusing to renew the
conditional approval, and such conditional approval
shall be deemed withdrawn and no longer in effect. The
Secretary shall thereafter provide an opportunity for
an informal hearing to the applicant on the issue
whether the conditional approval shall be reinstated.
(4)(A) In the case of an application under subsection
(a) with respect to a drug for which the Secretary
provides notice to the sponsor that the Secretary
intends to recommend controls under the Controlled
Substances Act, conditional approval of such
application shall not take effect until the interim
final rule controlling the drug is issued in accordance
with section 201(j) of the Controlled Substances Act.
(B) For purposes of this section, with respect to an
application described in subparagraph (A), the term
``date of approval'' shall mean the later of--
(i) the date an application under subsection
(a) is conditionally approved under subsection
(b); or
(ii) the date of issuance of the interim
final rule controlling the drug.
(e)(1) The Secretary shall issue an order withdrawing
conditional approval of an application filed pursuant to
subsection (a) if the Secretary finds that another person has
received approval under section 512 for the same drug in the
same dosage form for the same intended use and that person is
able to assure the availability of sufficient quantities of the
drug to meet the needs for which the drug is intended.
(2) The Secretary shall, after due notice and opportunity for
an informal hearing to the applicant, issue an order
withdrawing conditional approval of an application filed
pursuant to subsection (a) if the Secretary finds that--
(A) any of the provisions of section 512(e)(1) (A)
through (B) or (D) through (F) are applicable; or
(B) on the basis of new information before the
Secretary with respect to such drug, evaluated together
with the evidence available to the Secretary when the
application was conditionally approved, that there is
not a reasonable expectation that such drug will have
the effect it purports or is represented to have under
the conditions of use prescribed, recommended, or
suggested in the labeling thereof.
(3) The Secretary may also, after due notice and opportunity
for an informal hearing to the applicant, issue an order
withdrawing conditional approval of an application filed
pursuant to subsection (a) if the Secretary finds that any of
the provisions of section 512(e)(2) are applicable.
(f)(1) The label and labeling of a new animal drug with a
conditional approval under this section shall--
(A) bear the statement, ``conditionally approved by
FDA pending a full demonstration of effectiveness under
application number''; and
(B) contain such other information as prescribed by
the Secretary.
(2) An intended use that is the subject of a conditional
approval under this section shall not be included in the same
product label with any intended use approved under section 512.
(g) A conditionally approved new animal drug application may
not be amended or supplemented to add indications for use.
(h) 180 days prior to the termination date established under
subsection (d) of this section, an applicant shall have
submitted all the information necessary to support a complete
new animal drug application in accordance with section
512(b)(1) or the conditional approval issued under this section
is no longer in effect. Following review of this information,
the Secretary shall either--
(1) issue an order approving the application under
section 512(c) if the Secretary finds that none of the
grounds for denying approval specified in section
512(d)(1) applies, or
(2) give the applicant an opportunity for a hearing
before the Secretary under section 512(d) on the
question whether such application can be approved.
Upon issuance of an order approving the application, product
labeling and administrative records of approval shall be
modified accordingly. If the Secretary has not issued an order
under section 512(c) approving such application prior to the
termination date established under subsection (d) of this
section, the conditional approval issued under this section is
no longer in effect unless the Secretary grants an extension of
an additional 180-day period so that the Secretary can complete
review of the application. The decision to grant an extension
is committed to the discretion of the Secretary and not subject
to judicial review.
(i) The decision of the Secretary under subsection (c), (d),
or (e) of this section refusing or withdrawing conditional
approval of an application shall constitute final agency action
subject to judicial review.
(j) In this section and section 572, the term ``transgenic
animal'' means an animal whose genome contains a nucleotide
sequence that has been intentionally modified in vitro, and the
progeny of such an animal; Provided that the term ``transgenic
animal'' does not include an animal of which the nucleotide
sequence of the genome has been modified solely by selective
breeding.
SEC. 572. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR
MINOR SPECIES.
(a)(1) The Secretary shall establish an index limited to--
(A) new animal drugs intended for use in a minor
species for which there is a reasonable certainty that
the animal or edible products from the animal will not
be consumed by humans or food-producing animals; and
(B) new animal drugs intended for use only in a
hatchery, tank, pond, or other similar contained man-
made structure in an early, non-food life stage of a
food-producing minor species, where safety for humans
is demonstrated in accordance with the standard of
section 512(d) (including, for an antimicrobial new
animal drug, with respect to antimicrobial resistance).
(2) The index shall not include a new animal drug that is
contained in or a product of a transgenic animal.
(b) Any person intending to file a request under this section
shall be entitled to one or more conferences to discuss the
requirements for indexing a new animal drug.
(c)(1) Any person may submit a request to the Secretary for a
determination whether a new animal drug may be eligible for
inclusion in the index. Such a request shall include--
(A) information regarding the need for the new animal
drug, the species for which the new animal drug is
intended, the proposed intended use and conditions of
use, and anticipated annual distribution;
(B) information to support the conclusion that the
proposed use meets the conditions of subparagraph (A)
or (B) of subsection (a)(1) of this section;
(C) information regarding the components and
composition of the new animal drug;
(D) a description of the methods used in, and the
facilities and controls used for, the manufacture,
processing, and packing of such new animal drug;
(E) an environmental assessment that meets the
requirements of the National Environmental Policy Act
of 1969, as amended, and as defined in 21 CFR Part 25,
as it appears on the date of enactment of this
provision and amended thereafter or information to
support a categorical exclusion from the requirement to
prepare an environmental assessment;
(F) information sufficient to support the conclusion
that the proposed use of the new animal drug is safe
under section 512(d) with respect to individuals
exposed to the new animal drug through its manufacture
or use; and
(G) such other information as the Secretary may deem
necessary to make this eligibility determination.
(2) Within 90 days after the submission of a request for a
determination of eligibility for indexing based on subsection
(a)(1)(A) of this section, or 180 days for a request submitted
based on subsection (a)(1)(B) of this section, the Secretary
shall grant or deny the request, and notify the person who
requested such determination of the Secretary's decision. The
Secretary shall grant the request if the Secretary finds that--
(A) the same drug in the same dosage form for the
same intended use is not approved or conditionally
approved;
(B) the proposed use of the drug meets the conditions
of subparagraph (A) or (B) of subsection (a)(1), as
appropriate;
(C) the person requesting the determination has
established appropriate specifications for the
manufacture and control of the new animal drug and has
demonstrated an understanding of the requirements of
current good manufacturing practices;
(D) the new animal drug will not significantly affect
the human environment; and
(E) the new animal drug is safe with respect to
individuals exposed to the new animal drug through its
manufacture or use.
If the Secretary denies the request, the Secretary shall
thereafter provide due notice and an opportunity for an
informal conference. A decision of the Secretary to deny an
eligibility request following an informal conference shall
constitute final agency action subject to judicial review.
(d)(1) With respect to a new animal drug for which the
Secretary has made a determination of eligibility under
subsection (c), the person who made such a request may ask that
the Secretary add the new animal drug to the index established
under subsection (a). The request for addition to the index
shall include--
(A) a copy of the Secretary's determination of
eligibility issued under subsection (c);
(B) a written report that meets the requirements in
subsection (d)(2) of this section;
(C) a proposed index entry;
(D) facsimile labeling;
(E) anticipated annual distribution of the new animal
drug;
(F) a written commitment to manufacture the new
animal drug and animal feeds bearing or containing such
new animal drug according to current good manufacturing
practices;
(G) a written commitment to label, distribute, and
promote the new animal drug only in accordance with the
index entry;
(H) upon specific request of the Secretary,
information submitted to the expert panel described in
paragraph (3); and
(I) any additional requirements that the Secretary
may prescribe by general regulation or specific order.
(2) The report required in paragraph (1) shall--
(A) be authored by a qualified expert panel;
(B) include an evaluation of all available target
animal safety and effectiveness information, including
anecdotal information;
(C) state the expert panel's opinion regarding
whether the benefits of using the new animal drug for
the proposed use in a minor species outweigh its risks
to the target animal, taking into account the harm
being caused by the absence of an approved or
conditionally approved new animal drug for the minor
species in question;
(D) include information from which labeling can be
written; and
(E) include a recommendation regarding whether the
new animal drug should be limited to use under the
professional supervision of a licensed veterinarian.
(3) A qualified expert panel, as used in this section, is a
panel that--
(A) is composed of experts qualified by scientific
training and experience to evaluate the target animal
safety and effectiveness of the new animal drug under
consideration;
(B) operates external to FDA; and
(C) is not subject to the Federal Advisory Committee
Act, 5 U.S.C. App. 2.
The Secretary shall define the criteria for selection of a
qualified expert panel and the procedures for the operation of
the panel by regulation.
(4) Within 180 days after the receipt of a request for
listing a new animal drug in the index, the Secretary shall
grant or deny the request. The Secretary shall grant the
request if the request for indexing continues to meet the
eligibility criteria in subsection (a) and the Secretary finds,
on the basis of the report of the qualified expert panel and
other information available to the Secretary, that the benefits
of using the new animal drug for the proposed use in a minor
species outweigh its risks to the target animal, taking into
account the harm caused by the absence of an approved or
conditionally-approved new animal drug for the minor species in
question. If the Secretary denies the request, the Secretary
shall thereafter provide due notice and the opportunity for an
informal conference. The decision of the Secretary following an
informal conference shall constitute final agency action
subject to judicial review.
(e)(1) The index established under subsection (a) shall
include the following information for each listed drug--
(A) the name and address of the person who holds the
index listing;
(B) the name of the drug and the intended use and
conditions of use for which it is being indexed;
(C) product labeling; and
(D) conditions and any limitations that the Secretary
deems necessary regarding use of the drug.
(2) The Secretary shall publish the index, and revise it
periodically.
(3) The Secretary may establish by regulation a process for
reporting changes in the conditions of manufacturing or
labeling of indexed products.
(f)(1) If the Secretary finds, after due notice to the person
who requested the index listing and an opportunity for an
informal conference, that--
(A) the expert panel failed to meet the requirements
as set forth by the Secretary by regulation;
(B) on the basis of new information before the
Secretary, evaluated together with the evidence
available to the Secretary when the new animal drug was
listed in the index, the benefits of using the new
animal drug for the indexed use do not outweigh its
risks to the target animal;
(C) the conditions of subsection (c)(2) of this
section are no longer satisfied;
(D) the manufacture of the new animal drug is not in
accordance with current good manufacturing practices;
(E) the labeling, distribution, or promotion of the
new animal drug is not in accordance with the index
entry;
(F) the conditions and limitations of use associated
with the index listing have not been followed; or
(G) the request for indexing contains any untrue
statement of material fact,
the Secretary shall remove the new animal drug from the index.
The decision of the Secretary following an informal conference
shall constitute final agency action subject to judicial
review.
(2) If the Secretary finds that there is a reasonable
probability that the use of the drug would present a risk to
the health of humans or other animals, the Secretary may--
(A) suspend the listing of such drug immediately;
(B) give the person listed in the index prompt notice
of the Secretary's action; and
(C) afford that person the opportunity for an
informal conference.
The decision of the Secretary following an informal conference
shall constitute final agency action subject to judicial
review.
(g) For purposes of indexing new animal drugs under this
section, to the extent consistent with the public health, the
Secretary shall promulgate regulations for exempting from the
operation of section 512 minor species new animal drugs and
animal feeds bearing or containing new animal drugs intended
solely for investigational use by experts qualified by
scientific training and experience to investigate the safety
and effectiveness of minor species animal drugs. Such
regulations may, at the discretion of the Secretary, among
other conditions relating to the protection of the public
health, provide for conditioning such exemption upon the
establishment and maintenance of such records, and the making
of such reports to the Secretary, by the manufacturer or the
sponsor of the investigation of such article, of data
(including but not limited to analytical reports by
investigators) obtained as a result of such investigational use
of such article, as the Secretary finds will enable the
Secretary to evaluate the safety and effectiveness of such
article in the event of the filing of a request for an index
listing pursuant to this section.
(h) The labeling of a new animal drug that is the subject of
an index listing shall state, prominently and conspicuously--
(1) ``Not approved by fda.--Legally marketed as an
FDA indexed product. Extra-label use is prohibited.'';
(2) except in the case of new animal drugs indexed
for use in an early life stage of a food-producing
animal, ``This product is not to be used in animals
intended for use as food for humans or other
animals.''; and
(3) such other information as may be prescribed by
the Secretary in the index listing.
(i)(1) In the case of any new animal drug for which an index
listing pursuant to subsection (a) is in effect, the person who
has an index listing shall establish and maintain such records,
and make such reports to the Secretary, of data relating to
experience, and other data or information, received or
otherwise obtained by such person with respect to such drug, or
with respect to animal feeds bearing or containing such drug,
as the Secretary may by general regulation, or by order with
respect to such listing, prescribe on the basis of a finding
that such records and reports are necessary in order to enable
the Secretary to determine, or facilitate a determination,
whether there is or may be ground for invoking subsection (f).
Such regulation or order shall provide, where the Secretary
deems it to be appropriate, for the examination, upon request,
by the persons to whom such regulation or order is applicable,
of similar information received or otherwise obtained by the
Secretary.
(2) Every person required under this subsection to maintain
records, and every person in charge or custody thereof, shall,
upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable
times to have access to and copy and verify such records.
(j)(1) Safety and effectiveness data and information which
has been submitted in support of a request for a new animal
drug to be indexed under this section and which has not been
previously disclosed to the public shall be made available to
the public, upon request, unless extraordinary circumstances
are shown--
(A) if no work is being or will be undertaken to have
the drug indexed in accordance with the request,
(B) if the Secretary has determined that such drug
cannot be indexed and all legal appeals have been
exhausted,
(C) if the indexing of such drug is terminated and
all legal appeals have been exhausted, or
(D) if the Secretary has determined that such drug is
not a new animal drug.
(2) Any request for data and information pursuant to
paragraph (1) shall include a verified statement by the person
making the request that any data or information received under
such paragraph shall not be disclosed by such person to any
other person--
(A) for the purpose of, or as part of a plan, scheme,
or device for, obtaining the right to make, use, or
market, or making, using, or marketing, outside the
United States, the drug identified in the request for
indexing; and
(B) without obtaining from any person to whom the
data and information are disclosed an identical
verified statement, a copy of which is to be provided
by such person to the Secretary, which meets the
requirements of this paragraph.
(k) In the case of a request under subsection (d) to add a
drug to the index under subsection (a) with respect to a drug
for which the Secretary provides notice to the person filing
the request that the Secretary intends to recommend controls
under the Controlled Substances Act, a determination to grant
the request to add such drug to the index shall not take
effect, and the Secretary shall not list the drug on such
index, until the interim final rule controlling the drug is
issued in accordance with section 201(j) of the Controlled
Substances Act.
SEC. 573. DESIGNATED NEW ANIMAL DRUGS FOR MINOR USE OR MINOR SPECIES.
(a) Designation.--
(1) The manufacturer or the sponsor of a new animal
drug for a minor use or use in a minor species may
request that the Secretary declare that drug a
``designated new animal drug''. A request for
designation of a new animal drug shall be made before
the submission of an application under section 512(b)
or section 571 for the new animal drug.
(2) The Secretary may declare a new animal drug a
``designated new animal drug'' if--
(A) it is intended for a minor use or use in
a minor species; and
(B) the same drug in the same dosage form for
the same intended use is not approved under
section 512 or 571 or designated under this
section at the time the request is made.
(3) Regarding the termination of a designation--
(A) the sponsor of a new animal drug shall
notify the Secretary of any decision to
discontinue active pursuit of approval under
section 512 or 571 of an application for a
designated new animal drug. The Secretary shall
terminate the designation upon such
notification;
(B) the Secretary may also terminate
designation if the Secretary independently
determines that the sponsor is not actively
pursuing approval under section 512 or 571 with
due diligence;
(C) the sponsor of an approved designated new
animal drug shall notify the Secretary of any
discontinuance of the manufacture of such new
animal drug at least one year before
discontinuance. The Secretary shall terminate
the designation upon such notification; and
(D) the designation shall terminate upon the
expiration of any applicable exclusivity period
under subsection (c).
(4) Notice respecting the designation or termination
of designation of a new animal drug shall be made
available to the public.
(b) Grants and Contracts for Development of Designated New
Animal Drugs.--
(1) The Secretary may make grants to and enter into
contracts with public and private entities and
individuals to assist in defraying the costs of
qualified safety and effectiveness testing expenses and
manufacturing expenses incurred in connection with the
development of designated new animal drugs.
(2) For purposes of paragraph (1) of this section--
(A) The term ``qualified safety and
effectiveness testing'' means testing--
(i) which occurs after the date such
new animal drug is designated under
this section and before the date on
which an application with respect to
such drug is submitted under section
512; and
(ii) which is carried out under an
investigational exemption under section
512(j).
(B) The term ``manufacturing expenses'' means
expenses incurred in developing processes and
procedures associated with manufacture of the
designated new animal drug which occur after
the new animal drug is designated under this
section and before the date on which an
application with respect to such new animal
drug is submitted under section 512 or 571.
(c) Exclusivity for Designated New Animal Drugs.--
(1) Except as provided in subsection (c)(2), if the
Secretary approves or conditionally approves an
application for a designated new animal drug, the
Secretary may not approve or conditionally approve
another application submitted for such new animal drug
with the same intended use as the designated new animal
drug for another applicant before the expiration of
seven years from the date of approval or conditional
approval of the application.
(2) If an application filed pursuant to section 512
or section 571 is approved for a designated new animal
drug, the Secretary may, during the 7-year exclusivity
period beginning on the date of the application
approval or conditional approval, approve or
conditionally approve another application under section
512 or section 571 for such drug for such minor use or
minor species for another applicant if--
(A) the Secretary finds, after providing the
holder of such an approved application notice
and opportunity for the submission of views,
that in the granted exclusivity period the
holder of the approved application cannot
assure the availability of sufficient
quantities of the drug to meet the needs for
which the drug was designated; or
(B) such holder provides written consent to
the Secretary for the approval or conditional
approval of other applications before the
expiration of such exclusivity period.
(3) For purposes of determining the 7-year period of
exclusivity under paragraph (1) for a drug for which
the Secretary intends to recommend controls under the
Controlled Substances Act, the drug shall not be
considered approved or conditionally approved until the
date that the interim final rule controlling the drug
is issued in accordance with section 201(j) of the
Controlled Substances Act.
* * * * * * *
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PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
Part F--Licensing--Biological Products and Clinical Laboratories
Subpart 1--Biological Products
regulation of biological products
Sec. 351. (a)(1) No person shall introduce or deliver for
introduction into interstate commerce any biological product
unless--
(A) a biologics license under this subsection or
subsection (k) is in effect for the biological product;
and
(B) each package of the biological product is plainly
marked with--
(i) the proper name of the biological product
contained in the package;
(ii) the name, address, and applicable
license number of the manufacturer of the
biological product; and
(iii) the expiration date of the biological
product.
(2)(A) The Secretary shall establish, by regulation,
requirements for the approval, suspension, and revocation of
biologics licenses.
(B) Pediatric studies.--A person that submits an
application for a license under this paragraph shall
submit to the Secretary as part of the application any
assessments required under section 505B of the Federal
Food, Drug, and Cosmetic Act.
(C) The Secretary shall approve a biologics license
application--
(i) on the basis of a demonstration that--
(I) the biological product that is the
subject of the application is safe, pure, and
potent; and
(II) the facility in which the biological
product is manufactured, processed, packed, or
held meets standards designed to assure that
the biological product continues to be safe,
pure, and potent; and
(ii) if the applicant (or other appropriate person)
consents to the inspection of the facility that is the
subject of the application, in accordance with
subsection (c).
(D) Postmarket Studies and Clinical Trials; Labeling; Risk
Evaluation and Mitigation Strategy.--A person that submits an
application for a license under this paragraph is subject to
sections 505(o), 505(p), and 505-1 of the Federal Food, Drug,
and Cosmetic Act.
(3) The Secretary shall prescribe requirements under which a
biological product undergoing investigation shall be exempt
from the requirements of paragraph (1).
(b) No person shall falsely label or mark any package or
container of any biological product or alter any label or mark
on the package or container of the biological product so as to
falsify the label or mark.
(c) Any officer, agent, or employee of the Department of
Health and Human Services, authorized by the Secretary for the
purpose, may during all reasonable hours enter and inspect any
establishment for the propagation or manufacture and
preparation of any biological product.
(d)(1) Upon a determination that a batch, lot, or other
quantity of a product licensed under this section presents an
imminent or substantial hazard to the public health, the
Secretary shall issue an order immediately ordering the recall
of such batch, lot, or other quantity of such product. An order
under this paragraph shall be issued in accordance with section
554 of title 5, United States Code.
(2) Any violation of paragraph (1) shall subject the violator
to a civil penalty of up to $100,000 per day of violation. The
amount of a civil penalty under this paragraph shall, effective
December 1 of each year beginning 1 year after the effective
date of this paragraph, be increased by the percent change in
the Consumer Price Index for the base quarter of such year over
the Consumer Price Index for the base quarter of the preceding
year, adjusted to the nearest \1/10\ of 1 percent. For purposes
of this paragraph, the term ``base quarter'', as used with
respect to a year, means the calendar quarter ending on
September 30 of such year and the price index for a base
quarter is the arithmetical mean of such index for the 3 months
comprising such quarter.
(e) No person shall interfere with any officer, agent, or
employee of the Service in the performance of any duty imposed
upon him by this section or by regulations made by authority
thereof.
(f) Any person who shall violate, or aid or abet in
violating, any of the provisions of this section shall be
punished upon conviction by a fine not exceeding $500 or by
imprisonment not exceeding one year, or by both such fine and
imprisonment, in the discretion of the court.
(g) Nothing contained in this Act shall be construed as in
any way affecting, modifying, repealing, or superseding the
provisions of the Federal Food, Drug, and Cosmetic Act (U.S.C.,
1940 edition, title 21, ch. 9).
(h) A partially processed biological product which--
(1) is not in a form applicable to the prevention,
treatment, or cure of diseases or injuries of man;
(2) is not intended for sale in the United States;
and
(3) is intended for further manufacture into final
dosage form outside the United States,
shall be subject to no restriction on the export of the product
under this Act or the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et. seq.) if the product is manufactured, processed,
packaged, and held in conformity with current good
manufacturing practice requirements or meets international
manufacturing standards as certified by an international
standards organization recognized by the Secretary and meets
the requirements of section 801(e)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(e)).
(i) In this section:
(1) The term ``biological product'' means a virus,
therapeutic serum, toxin, antitoxin, vaccine, blood,
blood component or derivative, allergenic product,
protein (except any chemically synthesized
polypeptide), or analogous product, or arsphenamine or
derivative of arsphenamine (or any other trivalent
organic arsenic compound), applicable to the
prevention, treatment, or cure of a disease or
condition of human beings.
(2) The term ``biosimilar'' or ``biosimilarity'', in
reference to a biological product that is the subject
of an application under subsection (k), means--
(A) that the biological product is highly
similar to the reference product
notwithstanding minor differences in clinically
inactive components; and
(B) there are no clinically meaningful
differences between the biological product and
the reference product in terms of the safety,
purity, and potency of the product.
(3) The term ``interchangeable'' or
``interchangeability'', in reference to a biological
product that is shown to meet the standards described
in subsection (k)(4), means that the biological product
may be substituted for the reference product without
the intervention of the health care provider who
prescribed the reference product.
(4) The term ``reference product'' means the single
biological product licensed under subsection (a)
against which a biological product is evaluated in an
application submitted under subsection (k).
(j) The Federal Food, Drug, and Cosmetic Act, including the
requirements under sections 505(o), 505(p), and 505-1 of such
Act, applies to a biological product subject to regulation
under this section, except that a product for which a license
has been approved under subsection (a) shall not be required to
have an approved application under section 505 of such Act.
(k) Licensure of Biological Products as Biosimilar or
Interchangeable.--
(1) In general.--Any person may submit an application
for licensure of a biological product under this
subsection.
(2) Content.--
(A) In general.--
(i) Required information.--An
application submitted under this
subsection shall include information
demonstrating that--
(I) the biological product is
biosimilar to a reference
product based upon data derived
from--
(aa) analytical
studies that
demonstrate that the
biological product is
highly similar to the
reference product
notwithstanding minor
differences in
clinically inactive
components;
(bb) animal studies
(including the
assessment of
toxicity); and
(cc) a clinical study
or studies (including
the assessment of
immunogenicity and
pharmacokinetics or
pharmacodynamics) that
are sufficient to
demonstrate safety,
purity, and potency in
1 or more appropriate
conditions of use for
which the reference
product is licensed and
intended to be used and
for which licensure is
sought for the
biological product;
(II) the biological product
and reference product utilize
the same mechanism or
mechanisms of action for the
condition or conditions of use
prescribed, recommended, or
suggested in the proposed
labeling, but only to the
extent the mechanism or
mechanisms of action are known
for the reference product;
(III) the condition or
conditions of use prescribed,
recommended, or suggested in
the labeling proposed for the
biological product have been
previously approved for the
reference product;
(IV) the route of
administration, the dosage
form, and the strength of the
biological product are the same
as those of the reference
product; and
(V) the facility in which the
biological product is
manufactured, processed,
packed, or held meets standards
designed to assure that the
biological product continues to
be safe, pure, and potent.
(ii) Determination by secretary.--The
Secretary may determine, in the
Secretary's discretion, that an element
described in clause (i)(I) is
unnecessary in an application submitted
under this subsection.
(iii) Additional information.--An
application submitted under this
subsection--
(I) shall include publicly-
available information regarding
the Secretary's previous
determination that the
reference product is safe,
pure, and potent; and
(II) may include any
additional information in
support of the application,
including publicly-available
information with respect to the
reference product or another
biological product.
(B) Interchangeability.--An application (or a
supplement to an application) submitted under
this subsection may include information
demonstrating that the biological product meets
the standards described in paragraph (4).
(3) Evaluation by secretary.--Upon review of an
application (or a supplement to an application)
submitted under this subsection, the Secretary shall
license the biological product under this subsection
if--
(A) the Secretary determines that the
information submitted in the application (or
the supplement) is sufficient to show that the
biological product--
(i) is biosimilar to the reference
product; or
(ii) meets the standards described in
paragraph (4), and therefore is
interchangeable with the reference
product; and
(B) the applicant (or other appropriate
person) consents to the inspection of the
facility that is the subject of the
application, in accordance with subsection (c).
(4) Safety standards for determining
interchangeability.--Upon review of an application
submitted under this subsection or any supplement to
such application, the Secretary shall determine the
biological product to be interchangeable with the
reference product if the Secretary determines that the
information submitted in the application (or a
supplement to such application) is sufficient to show
that--
(A) the biological product--
(i) is biosimilar to the reference
product; and
(ii) can be expected to produce the
same clinical result as the reference
product in any given patient; and
(B) for a biological product that is
administered more than once to an individual,
the risk in terms of safety or diminished
efficacy of alternating or switching between
use of the biological product and the reference
product is not greater than the risk of using
the reference product without such alternation
or switch.
(5) General rules.--
(A) One reference product per application.--A
biological product, in an application submitted
under this subsection, may not be evaluated
against more than 1 reference product.
(B) Review.--An application submitted under
this subsection shall be reviewed by the
division within the Food and Drug
Administration that is responsible for the
review and approval of the application under
which the reference product is licensed.
(C) Risk evaluation and mitigation
strategies.--The authority of the Secretary
with respect to risk evaluation and mitigation
strategies under the Federal Food, Drug, and
Cosmetic Act shall apply to biological products
licensed under this subsection in the same
manner as such authority applies to biological
products licensed under subsection (a).
(6) Exclusivity for first interchangeable biological
product.--Upon review of an application submitted under
this subsection relying on the same reference product
for which a prior biological product has received a
determination of interchangeability for any condition
of use, the Secretary shall not make a determination
under paragraph (4) that the second or subsequent
biological product is interchangeable for any condition
of use until the earlier of--
(A) 1 year after the first commercial
marketing of the first interchangeable
biosimilar biological product to be approved as
interchangeable for that reference product;
(B) 18 months after--
(i) a final court decision on all
patents in suit in an action instituted
under subsection (l)(6) against the
applicant that submitted the
application for the first approved
interchangeable biosimilar biological
product; or
(ii) the dismissal with or without
prejudice of an action instituted under
subsection (l)(6) against the applicant
that submitted the application for the
first approved interchangeable
biosimilar biological product; or
(C)(i) 42 months after approval of the first
interchangeable biosimilar biological product
if the applicant that submitted such
application has been sued under subsection
(l)(6) and such litigation is still ongoing
within such 42-month period; or
(ii) 18 months after approval of the first
interchangeable biosimilar biological product
if the applicant that submitted such
application has not been sued under subsection
(l)(6).
For purposes of this paragraph, the term ``final court
decision'' means a final decision of a court from which
no appeal (other than a petition to the United States
Supreme Court for a writ of certiorari) has been or can
be taken.
(7) Exclusivity for reference product.--
(A) Effective date of biosimilar application
approval.--Approval of an application under
this subsection may not be made effective by
the Secretary until the date that is 12 years
after the date on which the reference product
was first licensed under subsection (a).
(B) Filing period.--An application under this
subsection may not be submitted to the
Secretary until the date that is 4 years after
the date on which the reference product was
first licensed under subsection (a).
(C) First licensure.--Subparagraphs (A) and
(B) shall not apply to a license for or
approval of--
(i) a supplement for the biological
product that is the reference product;
or
(ii) a subsequent application filed
by the same sponsor or manufacturer of
the biological product that is the
reference product (or a licensor,
predecessor in interest, or other
related entity) for--
(I) a change (not including a
modification to the structure
of the biological product) that
results in a new indication,
route of administration, dosing
schedule, dosage form, delivery
system, delivery device, or
strength; or
(II) a modification to the
structure of the biological
product that does not result in
a change in safety, purity, or
potency.
(8) Guidance documents.--
(A) In general.--The Secretary may, after
opportunity for public comment, issue guidance
in accordance, except as provided in
subparagraph (B)(i), with section 701(h) of the
Federal Food, Drug, and Cosmetic Act with
respect to the licensure of a biological
product under this subsection. Any such
guidance may be general or specific.
(B) Public comment.--
(i) In general.--The Secretary shall
provide the public an opportunity to
comment on any proposed guidance issued
under subparagraph (A) before issuing
final guidance.
(ii) Input regarding most valuable
guidance.--The Secretary shall
establish a process through which the
public may provide the Secretary with
input regarding priorities for issuing
guidance.
(C) No requirement for application
consideration.--The issuance (or non-issuance)
of guidance under subparagraph (A) shall not
preclude the review of, or action on, an
application submitted under this subsection.
(D) Requirement for product class-specific
guidance.--If the Secretary issues product
class-specific guidance under subparagraph (A),
such guidance shall include a description of--
(i) the criteria that the Secretary
will use to determine whether a
biological product is highly similar to
a reference product in such product
class; and
(ii) the criteria, if available, that
the Secretary will use to determine
whether a biological product meets the
standards described in paragraph (4).
(E) Certain product classes.--
(i) Guidance.--The Secretary may
indicate in a guidance document that
the science and experience, as of the
date of such guidance, with respect to
a product or product class (not
including any recombinant protein) does
not allow approval of an application
for a license as provided under this
subsection for such product or product
class.
(ii) Modification or reversal.--The
Secretary may issue a subsequent
guidance document under subparagraph
(A) to modify or reverse a guidance
document under clause (i).
(iii) No effect on ability to deny
license.--Clause (i) shall not be
construed to require the Secretary to
approve a product with respect to which
the Secretary has not indicated in a
guidance document that the science and
experience, as described in clause (i),
does not allow approval of such an
application.
(l) Patents.--
(1) Confidential access to subsection (k)
application.--
(A) Application of paragraph.--Unless
otherwise agreed to by a person that submits an
application under subsection (k) (referred to
in this subsection as the ``subsection (k)
applicant'') and the sponsor of the application
for the reference product (referred to in this
subsection as the ``reference product
sponsor''), the provisions of this paragraph
shall apply to the exchange of information
described in this subsection.
(B) In general.--
(i) Provision of confidential
information.--When a subsection (k)
applicant submits an application under
subsection (k), such applicant shall
provide to the persons described in
clause (ii), subject to the terms of
this paragraph, confidential access to
the information required to be produced
pursuant to paragraph (2) and any other
information that the subsection (k)
applicant determines, in its sole
discretion, to be appropriate (referred
to in this subsection as the
``confidential information'').
(ii) Recipients of information.--The
persons described in this clause are
the following:
(I) Outside counsel.--One or
more attorneys designated by
the reference product sponsor
who are employees of an entity
other than the reference
product sponsor (referred to in
this paragraph as the ``outside
counsel''), provided that such
attorneys do not engage,
formally or informally, in
patent prosecution relevant or
related to the reference
product.
(II) In-house counsel.--One
attorney that represents the
reference product sponsor who
is an employee of the reference
product sponsor, provided that
such attorney does not engage,
formally or informally, in
patent prosecution relevant or
related to the reference
product.
(iii) Patent owner access.--A
representative of the owner of a patent
exclusively licensed to a reference
product sponsor with respect to the
reference product and who has retained
a right to assert the patent or
participate in litigation concerning
the patent may be provided the
confidential information, provided that
the representative informs the
reference product sponsor and the
subsection (k) applicant of his or her
agreement to be subject to the
confidentiality provisions set forth in
this paragraph, including those under
clause (ii).
(C) Limitation on disclosure.--No person that
receives confidential information pursuant to
subparagraph (B) shall disclose any
confidential information to any other person or
entity, including the reference product sponsor
employees, outside scientific consultants, or
other outside counsel retained by the reference
product sponsor, without the prior written
consent of the subsection (k) applicant, which
shall not be unreasonably withheld.
(D) Use of confidential information.--
Confidential information shall be used for the
sole and exclusive purpose of determining, with
respect to each patent assigned to or
exclusively licensed by the reference product
sponsor, whether a claim of patent infringement
could reasonably be asserted if the subsection
(k) applicant engaged in the manufacture, use,
offering for sale, sale, or importation into
the United States of the biological product
that is the subject of the application under
subsection (k).
(E) Ownership of confidential information.--
The confidential information disclosed under
this paragraph is, and shall remain, the
property of the subsection (k) applicant. By
providing the confidential information pursuant
to this paragraph, the subsection (k) applicant
does not provide the reference product sponsor
or the outside counsel any interest in or
license to use the confidential information,
for purposes other than those specified in
subparagraph (D).
(F) Effect of infringement action.--In the
event that the reference product sponsor files
a patent infringement suit, the use of
confidential information shall continue to be
governed by the terms of this paragraph until
such time as a court enters a protective order
regarding the information. Upon entry of such
order, the subsection (k) applicant may
redesignate confidential information in
accordance with the terms of that order. No
confidential information shall be included in
any publicly-available complaint or other
pleading. In the event that the reference
product sponsor does not file an infringement
action by the date specified in paragraph (6),
the reference product sponsor shall return or
destroy all confidential information received
under this paragraph, provided that if the
reference product sponsor opts to destroy such
information, it will confirm destruction in
writing to the subsection (k) applicant.
(G) Rule of construction.--Nothing in this
paragraph shall be construed--
(i) as an admission by the subsection
(k) applicant regarding the validity,
enforceability, or infringement of any
patent; or
(ii) as an agreement or admission by
the subsection (k) applicant with
respect to the competency, relevance,
or materiality of any confidential
information.
(H) Effect of violation.--The disclosure of
any confidential information in violation of
this paragraph shall be deemed to cause the
subsection (k) applicant to suffer irreparable
harm for which there is no adequate legal
remedy and the court shall consider immediate
injunctive relief to be an appropriate and
necessary remedy for any violation or
threatened violation of this paragraph.
(2) Subsection (k) application information.--Not
later than 20 days after the Secretary notifies the
subsection (k) applicant that the application has been
accepted for review, the subsection (k) applicant--
(A) shall provide to the reference product
sponsor a copy of the application submitted to
the Secretary under subsection (k), and such
other information that describes the process or
processes used to manufacture the biological
product that is the subject of such
application; and
(B) may provide to the reference product
sponsor additional information requested by or
on behalf of the reference product sponsor.
(3) List and description of patents.--
(A) List by reference product sponsor.--Not
later than 60 days after the receipt of the
application and information under paragraph
(2), the reference product sponsor shall
provide to the subsection (k) applicant--
(i) a list of patents for which the
reference product sponsor believes a
claim of patent infringement could
reasonably be asserted by the reference
product sponsor, or by a patent owner
that has granted an exclusive license
to the reference product sponsor with
respect to the reference product, if a
person not licensed by the reference
product sponsor engaged in the making,
using, offering to sell, selling, or
importing into the United States of the
biological product that is the subject
of the subsection (k) application; and
(ii) an identification of the patents
on such list that the reference product
sponsor would be prepared to license to
the subsection (k) applicant.
(B) List and description by subsection (k)
applicant.--Not later than 60 days after
receipt of the list under subparagraph (A), the
subsection (k) applicant--
(i) may provide to the reference
product sponsor a list of patents to
which the subsection (k) applicant
believes a claim of patent infringement
could reasonably be asserted by the
reference product sponsor if a person
not licensed by the reference product
sponsor engaged in the making, using,
offering to sell, selling, or importing
into the United States of the
biological product that is the subject
of the subsection (k) application;
(ii) shall provide to the reference
product sponsor, with respect to each
patent listed by the reference product
sponsor under subparagraph (A) or
listed by the subsection (k) applicant
under clause (i)--
(I) a detailed statement that
describes, on a claim by claim
basis, the factual and legal
basis of the opinion of the
subsection (k) applicant that
such patent is invalid,
unenforceable, or will not be
infringed by the commercial
marketing of the biological
product that is the subject of
the subsection (k) application;
or
(II) a statement that the
subsection (k) applicant does
not intend to begin commercial
marketing of the biological
product before the date that
such patent expires; and
(iii) shall provide to the reference
product sponsor a response regarding
each patent identified by the reference
product sponsor under subparagraph
(A)(ii).
(C) Description by reference product
sponsor.--Not later than 60 days after receipt
of the list and statement under subparagraph
(B), the reference product sponsor shall
provide to the subsection (k) applicant a
detailed statement that describes, with respect
to each patent described in subparagraph
(B)(ii)(I), on a claim by claim basis, the
factual and legal basis of the opinion of the
reference product sponsor that such patent will
be infringed by the commercial marketing of the
biological product that is the subject of the
subsection (k) application and a response to
the statement concerning validity and
enforceability provided under subparagraph
(B)(ii)(I).
(4) Patent resolution negotiations.--
(A) In general.--After receipt by the
subsection (k) applicant of the statement under
paragraph (3)(C), the reference product sponsor
and the subsection (k) applicant shall engage
in good faith negotiations to agree on which,
if any, patents listed under paragraph (3) by
the subsection (k) applicant or the reference
product sponsor shall be the subject of an
action for patent infringement under paragraph
(6).
(B) Failure to reach agreement.--If, within
15 days of beginning negotiations under
subparagraph (A), the subsection (k) applicant
and the reference product sponsor fail to agree
on a final and complete list of which, if any,
patents listed under paragraph (3) by the
subsection (k) applicant or the reference
product sponsor shall be the subject of an
action for patent infringement under paragraph
(6), the provisions of paragraph (5) shall
apply to the parties.
(5) Patent resolution if no agreement.--
(A) Number of patents.--The subsection (k)
applicant shall notify the reference product
sponsor of the number of patents that such
applicant will provide to the reference product
sponsor under subparagraph (B)(i)(I).
(B) Exchange of patent lists.--
(i) In general.--On a date agreed to
by the subsection (k) applicant and the
reference product sponsor, but in no
case later than 5 days after the
subsection (k) applicant notifies the
reference product sponsor under
subparagraph (A), the subsection (k)
applicant and the reference product
sponsor shall simultaneously exchange--
(I) the list of patents that
the subsection (k) applicant
believes should be the subject
of an action for patent
infringement under paragraph
(6); and
(II) the list of patents, in
accordance with clause (ii),
that the reference product
sponsor believes should be the
subject of an action for patent
infringement under paragraph
(6).
(ii) Number of patents listed by
reference product sponsor.--
(I) In general.--Subject to
subclause (II), the number of
patents listed by the reference
product sponsor under clause
(i)(II) may not exceed the
number of patents listed by the
subsection (k) applicant under
clause (i)(I).
(II) Exception.--If a
subsection (k) applicant does
not list any patent under
clause (i)(I), the reference
product sponsor may list 1
patent under clause (i)(II).
(6) Immediate patent infringement action.--
(A) Action if agreement on patent list.--If
the subsection (k) applicant and the reference
product sponsor agree on patents as described
in paragraph (4), not later than 30 days after
such agreement, the reference product sponsor
shall bring an action for patent infringement
with respect to each such patent.
(B) Action if no agreement on patent list.--
If the provisions of paragraph (5) apply to the
parties as described in paragraph (4)(B), not
later than 30 days after the exchange of lists
under paragraph (5)(B), the reference product
sponsor shall bring an action for patent
infringement with respect to each patent that
is included on such lists.
(C) Notification and publication of
complaint.--
(i) Notification to secretary.--Not
later than 30 days after a complaint is
served to a subsection (k) applicant in
an action for patent infringement
described under this paragraph, the
subsection (k) applicant shall provide
the Secretary with notice and a copy of
such complaint.
(ii) Publication by secretary.--The
Secretary shall publish in the Federal
Register notice of a complaint received
under clause (i).
(7) Newly issued or licensed patents.--In the case of
a patent that--
(A) is issued to, or exclusively licensed by,
the reference product sponsor after the date
that the reference product sponsor provided the
list to the subsection (k) applicant under
paragraph (3)(A); and
(B) the reference product sponsor reasonably
believes that, due to the issuance of such
patent, a claim of patent infringement could
reasonably be asserted by the reference product
sponsor if a person not licensed by the
reference product sponsor engaged in the
making, using, offering to sell, selling, or
importing into the United States of the
biological product that is the subject of the
subsection (k) application,
not later than 30 days after such issuance or
licensing, the reference product sponsor shall provide
to the subsection (k) applicant a supplement to the
list provided by the reference product sponsor under
paragraph (3)(A) that includes such patent, not later
than 30 days after such supplement is provided, the
subsection (k) applicant shall provide a statement to
the reference product sponsor in accordance with
paragraph (3)(B), and such patent shall be subject to
paragraph (8).
(8) Notice of commercial marketing and preliminary
injunction.--
(A) Notice of commercial marketing.--The
subsection (k) applicant shall provide notice
to the reference product sponsor not later than
180 days before the date of the first
commercial marketing of the biological product
licensed under subsection (k).
(B) Preliminary injunction.--After receiving
the notice under subparagraph (A) and before
such date of the first commercial marketing of
such biological product, the reference product
sponsor may seek a preliminary injunction
prohibiting the subsection (k) applicant from
engaging in the commercial manufacture or sale
of such biological product until the court
decides the issue of patent validity,
enforcement, and infringement with respect to
any patent that is--
(i) included in the list provided by
the reference product sponsor under
paragraph (3)(A) or in the list
provided by the subsection (k)
applicant under paragraph (3)(B); and
(ii) not included, as applicable,
on--
(I) the list of patents
described in paragraph (4); or
(II) the lists of patents
described in paragraph (5)(B).
(C) Reasonable cooperation.--If the reference
product sponsor has sought a preliminary
injunction under subparagraph (B), the
reference product sponsor and the subsection
(k) applicant shall reasonably cooperate to
expedite such further discovery as is needed in
connection with the preliminary injunction
motion.
(9) Limitation on declaratory judgment action.--
(A) Subsection (k) application provided.--If
a subsection (k) applicant provides the
application and information required under
paragraph (2)(A), neither the reference product
sponsor nor the subsection (k) applicant may,
prior to the date notice is received under
paragraph (8)(A), bring any action under
section 2201 of title 28, United States Code,
for a declaration of infringement, validity, or
enforceability of any patent that is described
in clauses (i) and (ii) of paragraph (8)(B).
(B) Subsequent failure to act by subsection
(k) applicant.--If a subsection (k) applicant
fails to complete an action required of the
subsection (k) applicant under paragraph
(3)(B)(ii), paragraph (5), paragraph (6)(C)(i),
paragraph (7), or paragraph (8)(A), the
reference product sponsor, but not the
subsection (k) applicant, may bring an action
under section 2201 of title 28, United States
Code, for a declaration of infringement,
validity, or enforceability of any patent
included in the list described in paragraph
(3)(A), including as provided under paragraph
(7).
(C) Subsection (k) application not
provided.--If a subsection (k) applicant fails
to provide the application and information
required under paragraph (2)(A), the reference
product sponsor, but not the subsection (k)
applicant, may bring an action under section
2201 of title 28, United States Code, for a
declaration of infringement, validity, or
enforceability of any patent that claims the
biological product or a use of the biological
product.
(m) Pediatric Studies.--
(1) Application of certain provisions.--The
provisions of subsections (a), (d), (e), (f), (h), (i),
(j), (k), (l), (n), and (p) of section 505A of the
Federal Food, Drug, and Cosmetic Act shall apply with
respect to the extension of a period under paragraphs
(2) and (3) to the same extent and in the same manner
as such provisions apply with respect to the extension
of a period under subsection (b) or (c) of section 505A
of the Federal Food, Drug, and Cosmetic Act.
(2) Market exclusivity for new biological products.--
If, prior to approval of an application that is
submitted under subsection (a), the Secretary
determines that information relating to the use of a
new biological product in the pediatric population may
produce health benefits in that population, the
Secretary makes a written request for pediatric studies
(which shall include a timeframe for completing such
studies), the applicant agrees to the request, such
studies are completed using appropriate formulations
for each age group for which the study is requested
within any such timeframe, and the reports thereof are
submitted and accepted in accordance with section
505A(d)(3) of the Federal Food, Drug, and Cosmetic
Act--
(A) the periods for such biological product
referred to in subsection (k)(7) are deemed to
be 4 years and 6 months rather than 4 years and
12 years and 6 months rather than 12 years; and
(B) if the biological product is designated
under section 526 for a rare disease or
condition, the period for such biological
product referred to in section 527(a) is deemed
to be 7 years and 6 months rather than 7 years.
(3) Market exclusivity for already-marketed
biological products.--If the Secretary determines that
information relating to the use of a licensed
biological product in the pediatric population may
produce health benefits in that population and makes a
written request to the holder of an approved
application under subsection (a) for pediatric studies
(which shall include a timeframe for completing such
studies), the holder agrees to the request, such
studies are completed using appropriate formulations
for each age group for which the study is requested
within any such timeframe, and the reports thereof are
submitted and accepted in accordance with section
505A(d)(3) of the Federal Food, Drug, and Cosmetic
Act--
(A) the periods for such biological product
referred to in subsection (k)(7) are deemed to
be 4 years and 6 months rather than 4 years and
12 years and 6 months rather than 12 years; and
(B) if the biological product is designated
under section 526 for a rare disease or
condition, the period for such biological
product referred to in section 527(a) is deemed
to be 7 years and 6 months rather than 7 years.
(4) Exception.--The Secretary shall not extend a
period referred to in paragraph (2)(A), (2)(B), (3)(A),
or (3)(B) if the determination under section 505A(d)(3)
is made later than 9 months prior to the expiration of
such period.
(n) Date of Approval in the Case of Recommended Controls
Under the CSA.--
(1) In general.--In the case of an application under
subsection (a) with respect to a biological product for
which the Secretary provides notice to the sponsor that
the Secretary intends to recommend controls under the
Controlled Substances Act, approval of such application
shall not take effect until the interim final rule
controlling the biological product is issued in
accordance with section 201(j) of the Controlled
Substances Act.
(2) Date of approval.--For purposes of this section,
with respect to an application described in paragraph
(1), references to the date of approval of such
application, or licensure of the product subject to
such application, shall mean the later of--
(A) the date an application is approved under
subsection (a); or
(B) the date of issuance of the interim final
rule controlling the biological product.
* * * * * * *
----------
CONTROLLED SUBSTANCES ACT
TITLE II--CONTROL AND ENFORCEMENT
* * * * * * *
Part B--Authority To Control; Standards and Schedules
authority and criteria for classification of substances
Sec. 201. (a) The Attorney General shall apply the provisions
of this title to the controlled substances listed in the
schedules established by section 202 of this title and to any
other drug or other substance added to such schedules under
this title. Except as provided in subsections (d) and (e), the
Attorney General may by rule--
(1) add to such a schedule or transfer between such
schedules any drug or other substance if he--
(A) finds that such drug or other substance
has a potential for abuse, and
(B) makes with respect to such drug or other
substance the findings prescribed by subsection
(b) of section 202 for the schedule in which
such drug is to be placed; or
(2) remove any drug or other substance from the
schedules if he finds that the drug or other substance
does not meet the requirements for inclusion in any
schedule.
Rules of the Attorney General under this subsection shall be
made on the record after opportunity for a hearing pursuant to
the rulemaking procedures prescribed by subchapter II of
chapter 5 of title 5 of the United States Code. Proceedings for
the issuance, amendment, or repeal of such rules may be
initiated by the Attorney General (1) on his own motion, (2) at
the request of the Secretary, or (3) on the petition of any
interested party.
(b) The Attorney General shall, before initiating proceedings
under subsection (a) to control a drug or other substance or to
remove a drug or other substance entirely from the schedules,
and after gathering the necessary data, request from the
Secretary a scientific and medical evaluation, and his
recommendations, as to whether such drug or other substance
should be so controlled or removed as a controlled substance.
In making such evaluation and recommendations, the Secretary
shall consider the factors listed in paragraphs (2), (3), (6),
(7), and (8) of subsection (c) and any scientific or medical
considerations involved in paragraphs (1), (4), and (5) of such
subsection. The recommendations of the Secretary shall include
recommendations with respect to the appropriate schedule, if
any, under which such drug or other substance should be listed.
The evaluation and the recommendations of the Secretary shall
be made in writing and submitted to the Attorney General within
a reasonable time. The recommendations of the Secretary to the
Attorney General shall be binding on the Attorney General as to
such scientific and medical matters, and if the Secretary
recommends that a drug or other substance not be controlled,
the Attorney General shall not control the drug or other
substance. If the Attorney General determines that these facts
and all other relevant data constitute substantial evidence of
potential for abuse such as to warrant control or substantial
evidence that the drug or other substance should be removed
entirely from the schedules, he shall initiate proceedings for
control or removal, as the case may be, under subsection (a).
(c) In making any finding under subsection (a) of this
section or under subsection (b) of section 202, the Attorney
General shall consider the following factors with respect to
each drug or other substance proposed to be controlled or
removed from the schedules:
(1) Its actual or relative potential for abuse.
(2) Scientific evidence of its pharmacological
effect, if known.
(3) The state of current scientific knowledge
regarding the drug or other substance.
(4) Its history and current pattern of abuse.
(5) The scope, duration, and significance of abuse.
(6) What, if any, risk there is to the public health.
(7) Its psychic or physiological dependence
liability.
(8) Whether the substance is an immediate precursor
of a substance already controlled under this title.
(d)(1) If control is required by United States obligations
under international treaties, conventions, or protocols in
effect on the effective date of this part, the Attorney General
shall issue an order controlling such drug under the schedule
he deems most appropriate to carry out such obligations,
without regard to the findings required by subsection (a) of
this section or section 202(b) and without regard to the
procedures prescribed by subsections (a) and (b) of this
section.
(2) (A) Whenever the Secretary of State receives notification
from the Secretary-General of the United Nations that
information has been transmitted by or to the World Health
Organization, pursuant to article 2 of the Convention on
Psychotropic Substances, which may justify adding a drug or
other substance to one of the schedules of the Convention,
transferring a drug or substance from one schedule to another,
or deleting it from the schedules, the Secretary of State shall
immediately transmit the notice to the Secretary of Health,
Education, and Welfare who shall publish it in the Federal
Register and provide opportunity to interested persons to
submit to him comments respecting the scientific and medical
evaluations which he is to prepare respecting such drug or
substance. The Secretary of Health, Education, and Welfare
shall prepare for transmission through the Secretary of State
to the World Health Organization such medical and scientific
evaluations as may be appropriate regarding the possible action
that could be proposed by the World Health Organization
respecting the drug or substance with respect to which a notice
was transmitted under this subparagraph.
(B) Whenever the Secretary of State receives information that
the Commission on Narcotic Drugs of the United Nations proposes
to decide whether to add a drug or other substance to one of
the schedules of the Convention, transfer a drug or substance
from one schedule to another, or delete it from the schedules,
the Secretary of State shall transmit timely notice to the
Secretary of Health, Education, and Welfare of such information
who shall publish a summary of such information in the Federal
Register and provide opportunity to interested persons to
submit to him comments respecting the recommendation which he
is to furnish, pursuant to this subparagraph, respecting such
proposal. The Secretary of Health, Education, and Welfare shall
evaluate the proposal and furnish a recommendation to the
Secretary of State which shall be binding on the representative
of the United States in discussions and negotiations relating
to the proposal.
(3) When the United States receives notification of a
scheduling decision pursuant to article 2 of the Convention on
Psychotropic Substances that a drug or other substance has been
added or transferred to a schedule specified in the
notification or receives notification (referred to in this
subsection as a ``schedule notice'') that existing legal
controls applicable under this title to a drug or substance and
the controls required by the Federal Food, Drug, and Cosmetic
Act do not meet the requirements of the schedule of the
Convention in which such drug or substance has been placed, the
Secretary of Health, Education, and Welfare, after consultation
with the Attorney General, shall first determine whether
existing legal controls under this title applicable to the drug
or substance and the controls required by the Federal Food,
Drug, and Cosmetic Act, meet the requirements of the schedule
specified in the notification or schedule notice and shall take
the following action:
(A) If such requirements are met by such existing
controls but the Secretary of Health, Education, and
Welfare nonetheless believes that more stringent
controls should be applied to the drug or substance,
the Secretary shall recommend to the Attorney General
that he initiate proceedings for scheduling the drug or
substance, pursuant to subsections (a) and (b) of this
section, to apply to such controls.
(B) If such requirements are not met by such existing
controls and the Secretary of Health, Education, and
Welfare concurs in the scheduling decision or schedule
notice transmitted by the notification, the Secretary
shall recommend to the Attorney General that he
initiate proceedings for scheduling the drug or
substance under the appropriate schedule pursuant to
subsections (a) and (b) of this section.
(C) If such requirements are not met by such existing
controls and the Secretary of Health, Education, and
Welfare does not concur in the scheduling decision or
schedule notice transmitted by the notification, the
Secretary shall--
(i) if he deems that additional controls are
necessary to protect the public health and
safety, recommend to the Attorney General that
he initiate proceedings for scheduling the drug
or substance pursuant to subsections (a) and
(b) of this section, to apply such additional
controls;
(ii) request the Secretary of State to
transmit a notice of qualified acceptance,
within the period specified in the Convention,
pursuant to paragraph 7 of article 2 of the
Convention, to the Secretary-General of the
United Nations;
(iii) request the Secretary of State to
transmit a notice of qualified acceptance as
prescribed in clause (ii) and request the
Secretary of State to ask for a review by the
Economic and Social Council of the United
Nations, in accordance with paragraph 8 of
article 2 of the Convention, of the scheduling
decision; or
(iv) in the case of a schedule notice,
request the Secretary of State to take
appropriate action under the Convention to
initiate proceedings to remove the drug or
substance from the schedules under the
Convention or to transfer the drug or substance
to a schedule under the Convention different
from the one specified in the schedule notice.
(4)(A) If the Attorney General determines, after consultation
with the Secretary of Health, Education, and Welfare, that
proceedings initiated under recommendations made under
paragraph (B) or (C)(i) of paragraph (3) will not be completed
within the time period required by paragraph 7 of article 2 of
the Convention, the Attorney General, after consultation with
the Secretary and after providing interested persons
opportunity to submit comments respecting the requirements of
the temporary order to be issued under this sentence, shall
issue a temporary order controlling the drug or substance under
schedule IV or V, whichever is most appropriate to carry out
the minimum United States obligations under paragraph 7 of
article 2 of the Convention. As a part of such order, the
Attorney General shall, after consultation with the Secretary,
except such drug or substance from the application of any
provision of part C of this title which he finds is not
required to carry out the United States obligations under
paragraph 7 of article 2 of the Convention. In the case of
proceedings initiated under subparagraph (B) of paragraph (3),
the Attorney General, concurrently with the issuance of such
order, shall request the Secretary of State to transmit a
notice of qualified acceptance to the Secretary-General of the
United Nations pursuant to paragraph 7 of article 2 of the
Convention. A temporary order issued under this subparagraph
controlling a drug or other substance subject to proceedings
initiated under subsections (a) and (b) of this section shall
expire upon the effective date of the application to the drug
or substance of the controls resulting from such proceedings.
(B) After a notice of qualified acceptance of a scheduling
decision with respect to a drug or other substance is
transmitted to the Secretary-General of the United Nations in
accordance with clause (ii) or (iii) of paragraph (3)(C) or
after a request has been made under clause (iv) of such
paragraph with respect to a drug or substance described in a
schedule notice, the Attorney General, after consultation with
the Secretary of Health, Education, and Welfare and after
providing interested persons opportunity to submit comments
respecting the requirements of the order to be issued under
this sentence, shall issue an order controlling the drug or
substance under schedule IV or V, whichever is most appropriate
to carry out the minimum United States obligations under
paragraph 7 of article 2 of the Convention in the case of a
drug or substance for which a notice of qualified acceptance
was transmitted or whichever the Attorney General determines is
appropriate in the case of a drug or substance described in a
schedule notice. As a part of such order, the Attorney General
shall, after consultation with the Secretary, except such drug
or substance from the application of any provision of part C of
this title which he finds is not required to carry out the
United States obligations under paragraph 7 of article 2 of the
Convention. If, as a result of a review under paragraph 8 of
article 2 of the Convention of the scheduling decision with
respect to which a notice of qualified acceptance was
transmitted in accordance with clause (ii) or (iii) of
paragraph (3)(C)--
(i) the decision is reversed, and
(ii) the drug or substance subject to such decision
is not required to be controlled under schedule IV or V
to carry out the minimum United States obligations
under paragraph 7 of article 2 of the Convention,
the order issued under this subparagraph with respect to such
drug or substance shall expire upon receipt by the United
States of the review decision. If, as a result of action taken
pursuant to action initiated under a request transmitted under
clause (iv) of paragraph (3)(C), the drug or substance with
respect to which such action was taken is not required to be
controlled under schedule IV or V, the order issued under this
paragraph with respect to such drug or substance shall expire
upon receipt by the United States of a notice of the action
taken with respect to such drug or substance under the
Convention.
(C) An order issued under subparagraph (A) or (B) may be
issued without regard to the findings required by subsection
(a) of this section or by section 202(b) and without regard to
the procedures prescribed by subsection (a) or (b) of this
section.
(5) Nothing in the amendments made by the Psychotropic
Substances Act of 1978 or the regulations or orders promulgated
thereunder shall be construed to preclude requests by the
Secretary of Health, Education, and Welfare or the Attorney
General through the Secretary of State, pursuant to article 2
or other applicable provisions of the Convention, for review of
scheduling decisions under such Convention, based on new or
additional information.
(e) The Attorney General may, without regard to the findings
required by subsection (a) of this section or section 202(b)
and without regard to the procedures prescribed by subsections
(a) and (b) of this section, place an immediate precursor in
the same schedule in which the controlled substance of which it
is an immediate precursor is placed or in any other schedule
with a higher numerical designation. If the Attorney General
designates a substance as an immediate precursor and places it
in a schedule, other substances shall not be placed in a
schedule solely because they are its precursors.
(f) If, at the time a new-drug application is submitted to
the Secretary for any drug having a stimulant, depressant, or
hallucinogenic effect on the central nervous system, it appears
that such drug has an abuse potential, such information shall
be forwarded by the Secretary to the Attorney General.
(g)(1) The Attorney General shall by regulation exclude any
nonnarcotic drug which contains a controlled substance from the
application of titles II and III of the Comprehensive Drug
Abuse Prevention and Control Act (21 U.S.C. 802 et seq.) if
such drug may, under the Federal Food, Drug, and Cosmetic Act,
be lawfully sold over the counter without a prescription.
(2) Dextromethorphan shall not be deemed to be included in
any schedule by reason of enactment of this title unless
controlled after the date of such enactment pursuant to the
foregoing provisions of this section.
(3) The Attorney General may, by regulation, exempt any
compound, mixture, or preparation containing a controlled
substance from the application of all or any part of this title
if he finds such compound, mixture, or preparation meets the
requirements of one of the following categories:
(A) A mixture, or preparation containing a
nonnarcotic controlled substance, which mixture or
preparation is approved for prescription use, and which
contains one or more other active ingredients which are
not listed in any schedule and which are included there
in such combinations, quantity, proportion, or
concentration as to vitiate the potential for abuse.
(B) A compound, mixture, or preparation which
contains any controlled substance, which is not for
administration to a human being or animal, and which is
packaged in such form or concentration, or with
adulterants or denaturants, so that as packaged it does
not present any significant potential for abuse.
(C) Upon the recommendation of the Secretary of
Health and Human Services, a compound, mixture, or
preparation which contains any anabolic steroid, which
is intended for administration to a human being or an
animal, and which, because of its concentration,
preparation, formulation or delivery system, does not
present any significant potential for abuse.
(h)(1) If the Attorney General finds that the scheduling of a
substance in schedule I on a temporary basis is necessary to
avoid an imminent hazard to the public safety, he may, by order
and without regard to the requirements of subsection (b)
relating to the Secretary of Health and Human Services,
schedule such substance in schedule I if the substance is not
listed in any other schedule in section 202 or if no exemption
or approval is in effect for the substance under section 505 of
the Federal Food, Drug, and Cosmetic Act. Such an order may not
be issued before the expiration of thirty days from--
(A) the date of the publication by the Attorney
General of a notice in the Federal Register of the
intention to issue such order and the grounds upon
which such order is to be issued, and
(B) the date the Attorney General has transmitted the
notice required by paragraph (4).
(2) The scheduling of a substance under this subsection shall
expire at the end of 2 years from the date of the issuance of
the order scheduling such substance, except that the Attorney
General may, during the pendency of proceedings under
subsection (a)(1) with respect to the substance, extend the
temporary scheduling for up to 1 year.
(3) When issuing an order under paragraph (1), the Attorney
General shall be required to consider, with respect to the
finding of an imminent hazard to the public safety, only those
factors set forth in paragraphs (4), (5), and (6) of subsection
(c), including actual abuse, diversion from legitimate
channels, and clandestine importation, manufacture, or
distribution.
(4) The Attorney General shall transmit notice of an order
proposed to be issued under paragraph (1) to the Secretary of
Health and Human Services. In issuing an order under paragraph
(1), the Attorney General shall take into consideration any
comments submitted by the Secretary in response to a notice
transmitted pursuant to this paragraph.
(5) An order issued under paragraph (1) with respect to a
substance shall be vacated upon the conclusion of a subsequent
rulemaking proceeding initiated under subsection (a) with
respect to such substance.
(6) An order issued under paragraph (1) is not subject to
judicial review.
(i) Temporary and Permanent Scheduling of Recently Emerged
Anabolic Steroids.--
(1) The Attorney General may issue a temporary order
adding a drug or other substance to the definition of
anabolic steroids if the Attorney General finds that--
(A) the drug or other substance satisfies the
criteria for being considered an anabolic
steroid under section 102(41) but is not listed
in that section or by regulation of the
Attorney General as being an anabolic steroid;
and
(B) adding such drug or other substance to
the definition of anabolic steroids will assist
in preventing abuse or misuse of the drug or
other substance.
(2) An order issued under paragraph (1) shall not
take effect until 30 days after the date of the
publication by the Attorney General of a notice in the
Federal Register of the intention to issue such order
and the grounds upon which such order is to be issued.
The order shall expire not later than 24 months after
the date it becomes effective, except that the Attorney
General may, during the pendency of proceedings under
paragraph (6), extend the temporary scheduling order
for up to 6 months.
(3) The Attorney General shall transmit notice of an
order proposed to be issued under paragraph (1) to the
Secretary of Health and Human Services. In issuing an
order under paragraph (1), the Attorney General shall
take into consideration any comments submitted by the
Secretary in response to a notice transmitted pursuant
to this paragraph.
(4) A temporary scheduling order issued under
paragraph (1) shall be vacated upon the issuance of a
permanent scheduling order under paragraph (6).
(5) An order issued under paragraph (1) is not
subject to judicial review.
(6) The Attorney General may, by rule, issue a
permanent order adding a drug or other substance to the
definition of anabolic steroids if such drug or other
substance satisfies the criteria for being considered
an anabolic steroid under section 102(41). Such
rulemaking may be commenced simultaneously with the
issuance of the temporary order issued under paragraph
(1).
(j)(1) With respect to a drug referred to in subsection (f),
if the Secretary of Health and Human Services recommends that
the Attorney General add the drug to schedule II, III, IV, or V
pursuant to subsections (a) and (b), the Attorney General
shall, not later than 90 days after the date described in
paragraph (2), issue an interim final rule controlling the drug
in accordance with such subsections and section 202(b) using
the procedures described in paragraph (3).
(2) The date described in this paragraph shall be the later
of--
(A) the date on which the Attorney General receives
the scientific and medical evaluation and
recommendations from the Secretary of Health and Human
Services in accordance with subsection (b); or
(B) the date on which the Attorney General receives
notification from the Secretary of Health and Human
Services that the Secretary has approved an application
under section 505(c), 512, 571, or 572 of the Federal
Food, Drug, and Cosmetic Act or section 351(a) of the
Public Health Service Act with respect to the drug
described in paragraph (1).
(3) A rule issued by the Attorney General under paragraph (1)
shall be in accordance with the procedures provided in
subsection (a), except that the rule shall become immediately
effective as an interim final rule without requiring the
Attorney General to demonstrate good cause therefor. After
publication of the interim final rule, the Attorney General
shall issue a final rule in accordance with the procedures
provided in subsection (a).
* * * * * * *
Part C--Registration of Manufacturers, Distributors, and Dispensers of
Controlled Substances; Piperidine Reporting
* * * * * * *
registration requirements
Sec. 303. (a) The Attorney General shall register an
applicant to manufacture controlled substances in schedule I or
II if he determines that such registration is consistent with
the public interest and with United States obligations under
international treaties, conventions, or protocols in effect on
the effective date of this part. In determining the public
interest, the following factors shall be considered:
(1) maintenance of effective controls against
diversion of particular controlled substances and any
controlled substance in schedule I or II compounded
therefrom into other than legitimate medical,
scientific, research, or industrial channels, by
limiting the importation and bulk manufacture of such
controlled substances to a number of establishments
which can produce an adequate and uninterrupted supply
of these substances under adequately competitive
conditions for legitimate medical, scientific,
research, and industrial purposes;
(2) compliance with applicable State and local law;
(3) promotion of technical advances in the art of
manufacturing these substances and the development of
new substances;
(4) prior conviction record of applicant under
Federal and State laws relating to the manufacture,
distribution, or dispensing of such substances;
(5) past experience in the manufacture of controlled
substances, and the existence in the establishment of
effective control against diversion; and
(6) such other factors as may be relevant to and
consistent with the public health and safety.
(b) The Attorney General shall register an applicant to
distribute a controlled substance in schedule I or II unless he
determines that the issuance of such registration is
inconsistent with the public interest. In determining the
public interest, the following factors shall be considered:
(1) maintenance of effective controls against
diversion of particular controlled substances into
other than legitimate medical, scientific, and
industrial channels;
(2) compliance with applicable State and local law;
(3) prior conviction record of applicant under
Federal or State laws relating to the manufacture,
distribution, or dispensing of such substances;
(4) past experience in the distribution of controlled
substances; and
(5) such other factors as may be relevant to and
consistent with the public health and safety.
(c) Registration granted under subsections (a) and (b) of
this section shall not entitle a registrant to (1) manufacture
or distribute controlled substances in schedule I or II other
than those specified in the registration, or (2) manufacture
any quantity of those controlled substances in excess of the
quota assigned pursuant to section 306.
(d) The Attorney General shall register an applicant to
manufacture controlled substances in schedule III, IV, or V,
unless he determines that the issuance of such registration is
inconsistent with the public interest. In determining the
public interest, the following factors shall be considered:
(1) maintenance of effective controls against
diversion of particular controlled substances and any
controlled substance in schedule III, IV, or V
compounded therefrom into other than legitimate
medical, scientific, or industrial channels;
(2) compliance with applicable State and local law;
(3) promotion of technical advances in the art of
manufacturing these substances and the development of
new substances;
(4) prior conviction record of applicant under
Federal or State laws relating to the manufacture,
distribution, or dispensing of such substances;
(5) past experience in the manufacture, distribution,
and dispensing of controlled substances, and the
existence in the establishment of effective controls
against diversion; and
(6) such other factors as may be relevant to and
consistent with the public health and safety.
(e) The Attorney General shall register an applicant to
distribute controlled substances in schedule III, IV, or V,
unless he determines that the issuance of such registration is
inconsistent with the public interest. In determining the
public interest, the following factors shall be considered:
(1) maintenance of effective controls against
diversion of particular controlled substances into
other than legitimate medical, scientific, and
industrial channels;
(2) compliance with applicable State and local law;
(3) prior conviction record of applicant under
Federal or State laws relating to the manufacture,
distribution, or dispensing of such substances;
(4) past experience in the distribution of controlled
substances; and
(5) such other factors as may be relevant to and
consistent with the public health and safety.
(f) The Attorney General shall register practitioners
(including pharmacies, as distinguished from pharmacists) to
dispense, or conduct research with, controlled substances in
schedule II, III, IV, or V and shall modify the registrations
of pharmacies so registered to authorize them to dispense
controlled substances by means of the Internet, if the
applicant is authorized to dispense, or conduct research with
respect to, controlled substances under the laws of the State
in which he practices. The Attorney General may deny an
application for such registration or such modification of
registration if the Attorney General determines that the
issuance of such registration or modification would be
inconsistent with the public interest. In determining the
public interest, the following factors shall be considered:
(1) The recommendation of the appropriate State
licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing, or
conducting research with respect to controlled
substances.
(3) The applicant's conviction record under Federal
or State laws relating to the manufacture,
distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or
local laws relating to controlled substances.
(5) Such other conduct which may threaten the public
health and safety.
Separate registration under this part for practitioners
engaging in research with controlled substances in schedule II,
III, IV, or V, who are already registered under this part in
another capacity, shall not be required. Registration
applications by practitioners wishing to conduct research with
controlled substances in schedule I shall be referred to the
Seretary, who shall determine the qualifications and competency
of each practitioner requesting registration, as well as the
merits of the research protocol. The Secretary, in determining
the merits of each research protocol, shall consult with the
Attorney General as to effective procedures to adequately
safeguard against diversion of such controlled substances from
legitimate medical or scientific use. Registration for the
purpose of bona fide research with controlled substances in
schedule I by a practitioner deemed qualified by the Secretary
may be denied by the Attorney General only on a ground
specified in section 304(a). Article 7 of the Convention on
Psychotrophic Substances shall not be construed to prohibit, or
impose additional restrictions upon, research involving drugs
or other substances scheduled under the convention which is
conducted in conformity with this subsection and other
applicable provisions of this title.
(g)(1) Except as provided in paragraph (2), practitioners who
dispense narcotic drugs to individuals for maintenance
treatment or detoxification treatment shall obtain annually a
separate registration for that purpose. The Attorney General
shall register an applicant to dispense narcotic drugs to
individuals for maintenance treatment or detoxification
treatment (or both)--
(A) if the applicant is a practitioner who is
determined by the Secretary to be qualified (under
standards established by the Secretary) to engage in
the treatment with respect to which registration is
sought;
(B) if the Attorney General determines that the
applicant will comply with standards established by the
Attorney General respecting (i) security of stocks of
narcotic drugs for such treatment, and (ii) the
maintenance of records (in accordance with section 307)
on such drugs; and
(C) if the Secretary determines that the applicant
will comply with standards established by the Secretary
(after consultation with the Attorney General)
respecting the quantities of narcotic drugs which may
be provided for unsupervised use by individuals in such
treatment.
(2)(A) Subject to subparagraphs (D) and (J), the requirements
of paragraph (1) are waived in the case of the dispensing
(including the prescribing), by a practitioner, of narcotic
drugs in schedule III, IV, or V or combinations of such drugs
if the practitioner meets the conditions specified in
subparagraph (B) and the narcotic drugs or combinations of such
drugs meet the conditions specified in subparagraph (C).
(B) For purposes of subparagraph (A), the conditions
specified in this subparagraph with respect to a practitioner
are that, before the initial dispensing of narcotic drugs in
schedule III, IV, or V or combinations of such drugs to
patients for maintenance or detoxification treatment, the
practitioner submit to the Secretary a notification of the
intent of the practitioner to begin dispensing the drugs or
combinations for such purpose, and that the notification
contain the following certifications by the practitioner:
(i) The practitioner is a qualifying physician (as
defined in subparagraph (G)).
(ii) With respect to patients to whom the
practitioner will provide such drugs or combinations of
drugs, the practitioner has the capacity to refer the
patients for appropriate counseling and other
appropriate ancillary services.
(iii) The total number of such patients of the
practitioner at any one time will not exceed the
applicable number. For purposes of this clause, the
applicable number is 30, unless, not sooner than 1 year
after the date on which the practitioner submitted the
initial notification, the practitioner submits a second
notification to the Secretary of the need and intent of
the practitioner to treat up to 100 patients. A second
notification under this clause shall contain the
certifications required by clauses (i) and (ii) of this
subparagraph. The Secretary may by regulation change
such total number.
(C) For purposes of subparagraph (A), the conditions
specified in this subparagraph with respect to narcotic drugs
in schedule III, IV, or V or combinations of such drugs are as
follows:
(i) The drugs or combinations of drugs have, under
the Federal Food, Drug, and Cosmetic Act or section 351
of the Public Health Service Act, been approved for use
in maintenance or detoxification treatment.
(ii) The drugs or combinations of drugs have not been
the subject of an adverse determination. For purposes
of this clause, an adverse determination is a
determination published in the Federal Register and
made by the Secretary, after consultation with the
Attorney General, that the use of the drugs or
combinations of drugs for maintenance or detoxification
treatment requires additional standards respecting the
qualifications of practitioners to provide such
treatment, or requires standards respecting the
quantities of the drugs that may be provided for
unsupervised use.
(D)(i) A waiver under subparagraph (A) with respect to a
practitioner is not in effect unless (in addition to conditions
under subparagraphs (B) and (C)) the following conditions are
met:
(I) The notification under subparagraph (B) is in
writing and states the name of the practitioner.
(II) The notification identifies the registration
issued for the practitioner pursuant to subsection (f).
(III) If the practitioner is a member of a group
practice, the notification states the names of the
other practitioners in the practice and identifies the
registrations issued for the other practitioners
pursuant to subsection (f).
(ii) Upon receiving a notification under subparagraph (B),
the Attorney General shall assign the practitioner involved an
identification number under this paragraph for inclusion with
the registration issued for the practitioner pursuant to
subsection (f). The identification number so assigned shall be
appropriate to preserve the confidentiality of patients for
whom the practitioner has dispensed narcotic drugs under a
waiver under subparagraph (A).
(iii) Not later than 45 days after the date on which the
Secretary receives a notification under subparagraph (B), the
Secretary shall make a determination of whether the
practitioner involved meets all requirements for a waiver under
subparagraph (B). If the Secretary fails to make such
determination by the end of the such 45-day period, the
Attorney General shall assign the physician an identification
number described in clause (ii) at the end of such period.
(E)(i) If a practitioner is not registered under paragraph
(1) and, in violation of the conditions specified in
subparagraphs (B) through (D), dispenses narcotic drugs in
schedule III, IV, or V or combinations of such drugs for
maintenance treatment or detoxification treatment, the Attorney
General may, for purposes of section 304(a)(4), consider the
practitioner to have committed an act that renders the
registration of the practitioner pursuant to subsection (f) to
be inconsistent with the public interest.
(ii)(I) Upon the expiration of 45 days from the date on which
the Secretary receives a notification under subparagraph (B), a
practitioner who in good faith submits a notification under
subparagraph (B) and reasonably believes that the conditions
specified in subparagraphs (B) through (D) have been met shall,
in dispensing narcotic drugs in schedule III, IV, or V or
combinations of such drugs for maintenance treatment or
detoxification treatment, be considered to have a waiver under
subparagraph (A) until notified otherwise by the Secretary,
except that such a practitioner may commence to prescribe or
dispense such narcotic drugs for such purposes prior to the
expiration of such 45-day period if it facilitates the
treatment of an individual patient and both the Secretary and
the Attorney General are notified by the practitioner of the
intent to commence prescribing or dispensing such narcotic
drugs.
(II) For purposes of subclause (I), the publication in the
Federal Register of an adverse determination by the Secretary
pursuant to subparagraph (C)(ii) shall (with respect to the
narcotic drug or combination involved) be considered to be a
notification provided by the Secretary to practitioners,
effective upon the expiration of the 30-day period beginning on
the date on which the adverse determination is so published.
(F)(i) With respect to the dispensing of narcotic drugs in
schedule III, IV, or V or combinations of such drugs to
patients for maintenance or detoxification treatment, a
practitioner may, in his or her discretion, dispense such drugs
or combinations for such treatment under a registration under
paragraph (1) or a waiver under subparagraph (A) (subject to
meeting the applicable conditions).
(ii) This paragraph may not be construed as having any legal
effect on the conditions for obtaining a registration under
paragraph (1), including with respect to the number of patients
who may be served under such a registration.
(G) For purposes of this paragraph:
(i) The term ``group practice'' has the meaning given
such term in section 1877(h)(4) of the Social Security
Act.
(ii) The term ``qualifying physician'' means a
physician who is licensed under State law and who meets
one or more of the following conditions:
(I) The physician holds a subspecialty board
certification in addiction psychiatry from the
American Board of Medical Specialties.
(II) The physician holds an addiction
certification from the American Society of
Addiction Medicine.
(III) The physician holds a subspecialty
board certification in addiction medicine from
the American Osteopathic Association.
(IV) The physician has, with respect to the
treatment and management of opiate-dependent
patients, completed not less than eight hours
of training (through classroom situations,
seminars at professional society meetings,
electronic communications, or otherwise) that
is provided by the American Society of
Addiction Medicine, the American Academy of
Addiction Psychiatry, the American Medical
Association, the American Osteopathic
Association, the American Psychiatric
Association, or any other organization that the
Secretary determines is appropriate for
purposes of this subclause.
(V) The physician has participated as an
investigator in one or more clinical trials
leading to the approval of a narcotic drug in
schedule III, IV, or V for maintenance or
detoxification treatment, as demonstrated by a
statement submitted to the Secretary by the
sponsor of such approved drug.
(VI) The physician has such other training or
experience as the State medical licensing board
(of the State in which the physician will
provide maintenance or detoxification
treatment) considers to demonstrate the ability
of the physician to treat and manage opiate-
dependent patients.
(VII) The physician has such other training
or experience as the Secretary considers to
demonstrate the ability of the physician to
treat and manage opiate-dependent patients. Any
criteria of the Secretary under this subclause
shall be established by regulation. Any such
criteria are effective only for 3 years after
the date on which the criteria are promulgated,
but may be extended for such additional
discrete 3-year periods as the Secretary
considers appropriate for purposes of this
subclause. Such an extension of criteria may
only be effectuated through a statement
published in the Federal Register by the
Secretary during the 30-day period preceding
the end of the 3-year period involved.
(H)(i) In consultation with the Administrator of the Drug
Enforcement Administration, the Administrator of the Substance
Abuse and Mental Health Services Administration, the Director
of the National Institute on Drug Abuse, and the Commissioner
of Food and Drugs, the Secretary shall issue regulations
(through notice and comment rulemaking) or issue practice
guidelines to address the following:
(I) Approval of additional credentialing bodies and
the responsibilities of additional credentialing
bodies.
(II) Additional exemptions from the requirements of
this paragraph and any regulations under this
paragraph.
Nothing in such regulations or practice guidelines may
authorize any Federal official or employee to exercise
supervision or control over the practice of medicine or the
manner in which medical services are provided.
(ii) Not later than 120 days after the date of the enactment
of the Drug Addiction Treatment Act of 2000, the Secretary
shall issue a treatment improvement protocol containing best
practice guidelines for the treatment and maintenance of
opiate-dependent patients. The Secretary shall develop the
protocol in consultation with the Director of the National
Institute on Drug Abuse, the Administrator of the Drug
Enforcement Administration, the Commissioner of Food and Drugs,
the Administrator of the Substance Abuse and Mental Health
Services Administration and other substance abuse disorder
professionals. The protocol shall be guided by science.
(I) During the 3-year period beginning on the date of the
enactment of the Drug Addiction Treatment Act of 2000, a State
may not preclude a practitioner from dispensing or prescribing
drugs in schedule III, IV, or V, or combinations of such drugs,
to patients for maintenance or detoxification treatment in
accordance with this paragraph unless, before the expiration of
that 3-year period, the State enacts a law prohibiting a
practitioner from dispensing such drugs or combinations of
drug.
(J)(i) This paragraph takes effect on the date of the
enactment of the Drug Addiction Treatment Act of 2000, and
remains in effect thereafter.
(ii) For purposes relating to clause (iii), the Secretary and
the Attorney General may, during the 3-year period beginning on
the date of the enactment of the Office of National Drug
Control Policy Reauthorization Act of 2006, make determinations
in accordance with the following:
(I) The Secretary may make a determination of whether
treatments provided under waivers under subparagraph
(A) have been effective forms of maintenance treatment
and detoxification treatment in clinical settings; may
make a determination of whether such waivers have
significantly increased (relative to the beginning of
such period) the availability of maintenance treatment
and detoxification treatment; and may make a
determination of whether such waivers have adverse
consequences for the public health.
(II) The Attorney General may make a determination of
the extent to which there have been violations of the
numerical limitations established under subparagraph
(B) for the number of individuals to whom a
practitioner may provide treatment; may make a
determination of whether waivers under subparagraph (A)
have increased (relative to the beginning of such
period) the extent to which narcotic drugs in schedule
III, IV, or V or combinations of such drugs are being
dispensed or possessed in violation of this Act; and
may make a determination of whether such waivers have
adverse consequences for the public health.
(iii) If, before the expiration of the period specified in
clause (ii), the Secretary or the Attorney General publishes in
the Federal Register a decision, made on the basis of
determinations under such clause, that subparagraph (B)(iii)
should be applied by limiting the total number of patients a
practitioner may treat to 30, then the provisions in such
subparagraph (B)(iii) permitting more than 30 patients shall
not apply, effective 60 days after the date on which the
decision is so published. The Secretary shall in making any
such decision consult with the Attorney General, and shall in
publishing the decision in the Federal Register include any
comments received from the Attorney General for inclusion in
the publication. The Attorney General shall in making any such
decision consult with the Secretary, and shall in publishing
the decision in the Federal Register include any comments
received from the Secretary for inclusion in the publication.
(h) The Attorney General shall register an applicant to
distribute a list I chemical unless the Attorney General
determines that registration of the applicant is inconsistent
with the public interest. Registration under this subsection
shall not be required for the distribution of a drug product
that is exempted under clause (iv) or (v) of section
102(39)(A). In determining the public interest for the purposes
of this subsection, the Attorney General shall consider--
(1) maintenance by the applicant of effective
controls against diversion of listed chemicals into
other than legitimate channels;
(2) compliance by the applicant with applicable
Federal, State, and local law;
(3) any prior conviction record of the applicant
under Federal or State laws relating to controlled
substances or to chemicals controlled under Federal or
State law;
(4) any past experience of the applicant in the
manufacture and distribution of chemicals; and
(5) such other factors as are relevant to and
consistent with the public health and safety.
(i)(1) For purposes of registration to manufacture a
controlled substance under subsection (d) for use only in a
clinical trial, the Attorney General shall register the
applicant, or serve an order to show cause upon the applicant
in accordance with section 304(c), not later than 180 days
after the date on which the application is accepted for filing.
(2) For purposes of registration to manufacture a controlled
substance under subsection (a) for use only in a clinical
trial, the Attorney General shall, in accordance with the
regulations issued by the Attorney General, issue a notice of
application not later than 90 days after the application is
accepted for filing. Not later than 90 days after the date on
which the period for comment pursuant to such notice ends, the
Attorney General shall register the applicant, or serve an
order to show cause upon the applicant in accordance with
section 304(c), unless the Attorney General has granted a
hearing on the application under section 1008(i) of the
Controlled Substances Import and Export Act.
* * * * * * *
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TITLE 35, UNITED STATES CODE
* * * * * * *
PART II--PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS
* * * * * * *
CHAPTER 14--ISSUE OF PATENT
* * * * * * *
Sec. 156. Extension of patent term
(a) The term of a patent which claims a product, a method of
using a product, or a method of manufacturing a product shall
be extended in accordance with this section from the original
expiration date of the patent, which shall include any patent
term adjustment granted under section 154(b), if--
(1) the term of the patent has not expired before an
application is submitted under subsection (d)(1) for
its extension;
(2) the term of the patent has never been extended
under subsection (e)(1) of this section;
(3) an application for extension is submitted by the
owner of record of the patent or its agent and in
accordance with the requirements of paragraphs (1)
through (4) of subsection (d);
(4) the product has been subject to a regulatory
review period before its commercial marketing or use;
(5)(A) except as provided in subparagraph (B) or (C),
the permission for the commercial marketing or use of
the product after such regulatory review period is the
first permitted commercial marketing or use of the
product under the provision of law under which such
regulatory review period occurred;
(B) in the case of a patent which claims a method of
manufacturing the product which primarily uses
recombinant DNA technology in the manufacture of the
product, the permission for the commercial marketing or
use of the product after such regulatory review period
is the first permitted commercial marketing or use of a
product manufactured under the process claimed in the
patent; or
(C) for purposes of subparagraph (A), in the case of
a patent which--
(i) claims a new animal drug or a veterinary
biological product which (I) is not covered by
the claims in any other patent which has been
extended, and (II) has received permission for
the commercial marketing or use in non-food-
producing animals and in food-producing
animals, and
(ii) was not extended on the basis of the
regulatory review period for use in non-food-
producing animals,
the permission for the commercial marketing or use of
the drug or product after the regulatory review period
for use in food-producing animals is the first
permitted commercial marketing or use of the drug or
product for administration to a food-producing animal.
The product referred to in paragraphs (4) and (5) is
hereinafter in this section referred to as the ``approved
product''.
(b) Except as provided in subsection (d)(5)(F), the rights
derived from any patent the term of which is extended under
this section shall during the period during which the term of
the patent is extended--
(1) in the case of a patent which claims a product,
be limited to any use approved for the product--
(A) before the expiration of the term of the
patent--
(i) under the provision of law under
which the applicable regulatory review
occurred, or
(ii) under the provision of law under
which any regulatory review described
in paragraph (1), (4), or (5) of
subsection (g) occurred, and
(B) on or after the expiration of the
regulatory review period upon which the
extension of the patent was based;
(2) in the case of a patent which claims a method of
using a product, be limited to any use claimed by the
patent and approved for the product--
(A) before the expiration of the term of the
patent--
(i) under any provision of law under
which an applicable regulatory review
occurred, and
(ii) under the provision of law under
which any regulatory review described
in paragraph (1), (4), or (5) of
subsection (g) occurred, and
(B) on or after the expiration of the
regulatory review period upon which the
extension of the patent was based; and
(3) in the case of a patent which claims a method of
manufacturing a product, be limited to the method of
manufacturing as used to make--
(A) the approved product, or
(B) the product if it has been subject to a
regulatory review period described in paragraph
(1), (4), or (5) of subsection (g).
As used in this subsection, the term ``product'' includes an
approved product.
(c) The term of a patent eligible for extension under
subsection (a) shall be extended by the time equal to the
regulatory review period for the approved product which period
occurs after the date the patent is issued, except that--
(1) each period of the regulatory review period shall
be reduced by any period determined under subsection
(d)(2)(B) during which the applicant for the patent
extension did not act with due diligence during such
period of the regulatory review period;
(2) after any reduction required by paragraph (1),
the period of extension shall include only one-half of
the time remaining in the periods described in
paragraphs (1)(B)(i), (2)(B)(i), (3)(B)(i), (4)(B)(i),
and (5)(B)(i) of subsection (g);
(3) if the period remaining in the term of a patent
after the date of the approval of the approved product
under the provision of law under which such regulatory
review occurred when added to the regulatory review
period as revised under paragraphs (1) and (2) exceeds
fourteen years, the period of extension shall be
reduced so that the total of both such periods does not
exceed fourteen years; and
(4) in no event shall more than one patent be
extended under subsection (e)(1) for the same
regulatory review period for any product.
(d)(1) To obtain an extension of the term of a patent under
this section, the owner of record of the patent or its agent
shall submit an application to the Director. Except as provided
in paragraph (5), such an application may only be submitted
within the sixty-day period beginning on the date the product
received permission under the provision of law under which the
applicable regulatory review period occurred for commercial
marketing or use, or in the case of a drug product described in
subsection (i) within the sixty-day period beginning on the
covered date (as defined in subsection (i)). The application
shall contain--
(A) the identity of the approved product and the
Federal statute under which regulatory review occurred;
(B) the identity of the patent for which an extension
is being sought and the identity of each claim of such
patent which claims the approved product or a method of
using or manufacturing the approved product;
(C) information to enable the Director to determine
under subsections (a) and (b) the eligibility of a
patent for extension and the rights that will be
derived from the extension and information to enable
the Director and the Secretary of Health and Human
Services or the Secretary of Agriculture to determine
the period of the extension under subsection (g);
(D) a brief description of the activities undertaken
by the applicant during the applicable regulatory
review period with respect to the approved product and
the significant dates applicable to such activities;
and
(E) such patent or other information as the Director
may require.
For purposes of determining the date on which a product
receives permission under the second sentence of this
paragraph, if such permission is transmitted after 4:30 P.M.,
Eastern Time, on a business day, or is transmitted on a day
that is not a business day, the product shall be deemed to
receive such permission on the next business day. For purposes
of the preceding sentence, the term ``business day'' means any
Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any
legal holiday under section 6103 of title 5.
(2)(A) Within 60 days of the submittal of an application for
extension of the term of a patent under paragraph (1), the
Director shall notify--
(i) the Secretary of Agriculture if the patent claims
a drug product or a method of using or manufacturing a
drug product and the drug product is subject to the
Virus-Serum-Toxin Act, and
(ii) the Secretary of Health and Human Services if
the patent claims any other drug product, a medical
device, or a food additive or color additive or a
method of using or manufacturing such a product,
device, or additive and if the product, device, and
additive are subject to the Federal Food, Drug, and
Cosmetic Act,
of the extension application and shall submit to the Secretary
who is so notified a copy of the application. Not later than 30
days after the receipt of an application from the Director, the
Secretary receiving the application shall review the dates
contained in the application pursuant to paragraph (1)(C) and
determine the applicable regulatory review period, shall notify
the Director of the determination, and shall publish in the
Federal Register a notice of such determination.
(B)(i) If a petition is submitted to the Secretary making the
determination under subparagraph (A), not later than 180 days
after the publication of the determination under subparagraph
(A), upon which it may reasonably be determined that the
applicant did not act with due diligence during the applicable
regulatory review period, the Secretary making the
determination shall, in accordance with regulations promulgated
by such Secretary, determine if the applicant acted with due
diligence during the applicable regulatory review period. The
Secretary making the determination shall make such
determination not later than 90 days after the receipt of such
a petition. For a drug product, device, or additive subject to
the Federal Food, Drug, and Cosmetic Act or the Public Health
Service Act, the Secretary may not delegate the authority to
make the determination prescribed by this clause to an office
below the Office of the Director of Food and Drugs. For a
product subject to the Virus-Serum-Toxin Act, the Secretary of
Agriculture may not delegate the authority to make the
determination prescribed by this clause to an office below the
Office of the Assistant Secretary for Marketing and Inspection
Services.
(ii) The Secretary making a determination under clause (i)
shall notify the Director of the determination and shall
publish in the Federal Register a notice of such determination
together with the factual and legal basis for such
determination. Any interested person may request, within the
60-day period beginning on the publication of a determination,
the Secretary making the determination to hold an informal
hearing on the determination. If such a request is made within
such period, such Secretary shall hold such hearing not later
than 30 days after the date of the request, or at the request
of the person making the request, not later than 60 days after
such date. The Secretary who is holding the hearing shall
provide notice of the hearing to the owner of the patent
involved and to any interested person and provide the owner and
any interested person an opportunity to participate in the
hearing. Within 30 days after the completion of the hearing,
such Secretary shall affirm or revise the determination which
was the subject of the hearing and shall notify the Director of
any revision of the determination and shall publish any such
revision in the Federal Register.
(3) For the purposes of paragraph (2)(B), the term ``due
diligence'' means that degree of attention, continuous directed
effort, and timeliness as may reasonably be expected from, and
are ordinarily exercised by, a person during a regulatory
review period.
(4) An application for the extension of the term of a patent
is subject to the disclosure requirements prescribed by the
Director.
(5)(A) If the owner of record of the patent or its agent
reasonably expects that the applicable regulatory review period
described in paragraph (1)(B)(ii), (2)(B)(ii), (3)(B)(ii),
(4)(B)(ii), or (5)(B)(ii) of subsection (g) that began for a
product that is the subject of such patent may extend beyond
the expiration of the patent term in effect, the owner or its
agent may submit an application to the Director for an interim
extension during the period beginning 6 months, and ending 15
days, before such term is due to expire. The application shall
contain--
(i) the identity of the product subject to regulatory
review and the Federal statute under which such review
is occurring;
(ii) the identity of the patent for which interim
extension is being sought and the identity of each
claim of such patent which claims the product under
regulatory review or a method of using or manufacturing
the product;
(iii) information to enable the Director to determine
under subsection (a)(1), (2), and (3) the eligibility
of a patent for extension;
(iv) a brief description of the activities undertaken
by the applicant during the applicable regulatory
review period to date with respect to the product under
review and the significant dates applicable to such
activities; and
(v) such patent or other information as the Director
may require.
(B) If the Director determines that, except for permission to
market or use the product commercially, the patent would be
eligible for an extension of the patent term under this
section, the Director shall publish in the Federal Register a
notice of such determination, including the identity of the
product under regulatory review, and shall issue to the
applicant a certificate of interim extension for a period of
not more than 1 year.
(C) The owner of record of a patent, or its agent, for which
an interim extension has been granted under subparagraph (B),
may apply for not more than 4 subsequent interim extensions
under this paragraph, except that, in the case of a patent
subject to subsection (g)(6)(C), the owner of record of the
patent, or its agent, may apply for only 1 subsequent interim
extension under this paragraph. Each such subsequent
application shall be made during the period beginning 60 days
before, and ending 30 days before, the expiration of the
preceding interim extension.
(D) Each certificate of interim extension under this
paragraph shall be recorded in the official file of the patent
and shall be considered part of the original patent.
(E) Any interim extension granted under this paragraph shall
terminate at the end of the 60-day period beginning on the date
on which the product involved receives permission for
commercial marketing or use, except that, if within that 60-day
period the applicant notifies the Director of such permission
and submits any additional information under paragraph (1) of
this subsection not previously contained in the application for
interim extension, the patent shall be further extended, in
accordance with the provisions of this section--
(i) for not to exceed 5 years from the date of
expiration of the original patent term; or
(ii) if the patent is subject to subsection
(g)(6)(C), from the date on which the product involved
receives approval for commercial marketing or use.
(F) The rights derived from any patent the term of which is
extended under this paragraph shall, during the period of
interim extension--
(i) in the case of a patent which claims a product,
be limited to any use then under regulatory review;
(ii) in the case of a patent which claims a method of
using a product, be limited to any use claimed by the
patent then under regulatory review; and
(iii) in the case of a patent which claims a method
of manufacturing a product, be limited to the method of
manufacturing as used to make the product then under
regulatory review.
(e)(1) A determination that a patent is eligible for
extension may be made by the Director solely on the basis of
the representations contained in the application for the
extension. If the Director determines that a patent is eligible
for extension under subsection (a) and that the requirements of
paragraphs (1) through (4) of subsection (d) have been complied
with, the Director shall issue to the applicant for the
extension of the term of the patent a certificate of extension,
under seal, for the period prescribed by subsection (c). Such
certificate shall be recorded in the official file of the
patent and shall be considered as part of the original patent.
(2) If the term of a patent for which an application has been
submitted under subsection (d)(1) would expire before a
certificate of extension is issued or denied under paragraph
(1) respecting the application, the Director shall extend,
until such determination is made, the term of the patent for
periods of up to one year if he determines that the patent is
eligible for extension.
(f) For purposes of this section:
(1) The term ``product'' means:
(A) A drug product.
(B) Any medical device, food additive, or
color additive subject to regulation under the
Federal Food, Drug, and Cosmetic Act.
(2) The term ``drug product'' means the active
ingredient of--
(A) a new drug, antibiotic drug, or human
biological product (as those terms are used in
the Federal Food, Drug, and Cosmetic Act and
the Public Health Service Act), or
(B) a new animal drug or veterinary
biological product (as those terms are used in
the Federal Food, Drug, and Cosmetic Act and
the Virus-Serum-Toxin Act) which is not
primarily manufactured using recombinant DNA,
recombinant RNA, hybridoma technology, or other
processes involving site specific genetic
manipulation techniques,
including any salt or ester of the active ingredient,
as a single entity or in combination with another
active ingredient.
(3) The term ``major health or environmental effects
test'' means a test which is reasonably related to the
evaluation of the health or environmental effects of a
product, which requires at least six months to conduct,
and the data from which is submitted to receive
permission for commercial marketing or use. Periods of
analysis or evaluation of test results are not to be
included in determining if the conduct of a test
required at least six months.
(4)(A) Any reference to section 351 is a reference to
section 351 of the Public Health Service Act.
(B) Any reference to section 503, 505, 512, or 515 is
a reference to section 503, 505, 512, or 515 of the
Federal Food, Drug, and Cosmetic Act.
(C) Any reference to the Virus-Serum-Toxin Act is a
reference to the Act of March 4, 1913 (21 U.S.C. 151-
158).
(5) The term ``informal hearing'' has the meaning
prescribed for such term by section 201(y) of the
Federal Food, Drug, and Cosmetic Act.
(6) The term ``patent'' means a patent issued by the
United States Patent and Trademark Office.
(7) The term ``date of enactment'' as used in this
section means September 24, 1984, for a human drug
product, a medical device, food additive, or color
additive.
(8) The term ``date of enactment'' as used in this
section means the date of enactment of the Generic
Animal Drug and Patent Term Restoration Act for an
animal drug or a veterinary biological product.
(g) For purposes of this section, the term ``regulatory
review period'' has the following meanings:
(1)(A) In the case of a product which is a new drug,
antibiotic drug, or human biological product, the term
means the period described in subparagraph (B) to which
the limitation described in paragraph (6) applies.
(B) The regulatory review period for a new drug,
antibiotic drug, or human biological product is the sum
of--
(i) the period beginning on the date an
exemption under subsection (i) of section 505
or subsection (d) of section 507 became
effective for the approved product and ending
on the date an application was initially
submitted for such drug product under section
351, 505, or 507, and
(ii) the period beginning on the date the
application was initially submitted for the
approved product under section 351, subsection
(b) of section 505, or section 507 and ending
on the date such application was approved under
such section.
(2)(A) In the case of a product which is a food
additive or color additive, the term means the period
described in subparagraph (B) to which the limitation
described in paragraph (6) applies.
(B) The regulatory review period for a food or color
additive is the sum of--
(i) the period beginning on the date a major
health or environmental effects test on the
additive was initiated and ending on the date a
petition was initially submitted with respect
to the product under the Federal Food, Drug,
and Cosmetic Act requesting the issuance of a
regulation for use of the product, and
(ii) the period beginning on the date a
petition was initially submitted with respect
to the product under the Federal Food, Drug,
and Cosmetic Act requesting the issuance of a
regulation for use of the product, and ending
on the date such regulation became effective
or, if objections were filed to such
regulation, ending on the date such objections
were resolved and commercial marketing was
permitted or, if commercial marketing was
permitted and later revoked pending further
proceedings as a result of such objections,
ending on the date such proceedings were
finally resolved and commercial marketing was
permitted.
(3)(A) In the case of a product which is a medical
device, the term means the period described in
subparagraph (B) to which the limitation described in
paragraph (6) applies.
(B) The regulatory review period for a medical device
is the sum of--
(i) the period beginning on the date a
clinical investigation on humans involving the
device was begun and ending on the date an
application was initially submitted with
respect to the device under section 515, and
(ii) the period beginning on the date an
application was initially submitted with
respect to the device under section 515 and
ending on the date such application was
approved under such Act or the period beginning
on the date a notice of completion of a product
development protocol was initially submitted
under section 515(f)(5) and ending on the date
the protocol was declared completed under
section 515(f)(6).
(4)(A) In the case of a product which is a new animal
drug, the term means the period described in
subparagraph (B) to which the limitation described in
paragraph (6) applies.
(B) The regulatory review period for a new animal
drug product is the sum of--
(i) the period beginning on the earlier of
the date a major health or environmental
effects test on the drug was initiated or the
date an exemption under subsection (j) of
section 512 became effective for the approved
new animal drug product and ending on the date
an application was initially submitted for such
animal drug product under section 512, and
(ii) the period beginning on the date the
application was initially submitted for the
approved animal drug product under subsection
(b) of section 512 and ending on the date such
application was approved under such section.
(5)(A) In the case of a product which is a veterinary
biological product, the term means the period described
in subparagraph (B) to which the limitation described
in paragraph (6) applies.
(B) The regulatory period for a veterinary biological
product is the sum of--
(i) the period beginning on the date the
authority to prepare an experimental biological
product under the Virus-Serum-Toxin Act became
effective and ending on the date an application
for a license was submitted under the Virus-
Serum-Toxin Act, and
(ii) the period beginning on the date an
application for a license was initially
submitted for approval under the Virus-Serum-
Toxin Act and ending on the date such license
was issued.
(6) A period determined under any of the preceding
paragraphs is subject to the following limitations:
(A) If the patent involved was issued after
the date of the enactment of this section, the
period of extension determined on the basis of
the regulatory review period determined under
any such paragraph may not exceed five years.
(B) If the patent involved was issued before
the date of the enactment of this section and--
(i) no request for an exemption
described in paragraph (1)(B) or (4)(B)
was submitted and no request for the
authority described in paragraph (5)(B)
was submitted,
(ii) no major health or environmental
effects test described in paragraph
(2)(B) or (4)(B) was initiated and no
petition for a regulation or
application for registration described
in such paragraph was submitted, or
(iii) no clinical investigation
described in paragraph (3) was begun or
product development protocol described
in such paragraph was submitted,
before such date for the approved product the
period of extension determined on the basis of
the regulatory review period determined under
any such paragraph may not exceed five years.
(C) If the patent involved was issued before
the date of the enactment of this section and
if an action described in subparagraph (B) was
taken before the date of the enactment of this
section with respect to the approved product
and the commercial marketing or use of the
product has not been approved before such date,
the period of extension determined on the basis
of the regulatory review period determined
under such paragraph may not exceed two years
or in the case of an approved product which is
a new animal drug or veterinary biological
product (as those terms are used in the Federal
Food, Drug, and Cosmetic Act or the Virus-
Serum-Toxin Act), three years.
(h) The Director may establish such fees as the Director
determines appropriate to cover the costs to the Office of
receiving and acting upon applications under this section.
(i)(1) For purposes of this section, if the Secretary of
Health and Human Services provides notice to the sponsor of an
application or request for approval, conditional approval, or
indexing of a drug product for which the Secretary intends to
recommend controls under the Controlled Substances Act,
beginning on the covered date, the drug product shall be
considered to--
(A) have been approved; and
(B) have permission for commercial marketing or use.
(2) In this subsection, the term ``covered date'' means the
later of--
(A) the date an application is approved--
(i) under section 351(a)(2)(C) of the Public
Health Service Act; or
(ii) under section 505(b) or 512(c) of the
Federal Food, Drug, and Cosmetic Act;
(B) the date an application is conditionally approved
under section 571(b) of the Federal Food, Drug, and
Cosmetic Act;
(C) the date a request for indexing is granted under
section 572(d) of the Federal Food, Drug, and Cosmetic
Act; or
(D) the date of issuance of the interim final rule
controlling the drug under section 201(j) of the
Controlled Substances Act.
* * * * * * *