This electronic document was downloaded from the GPO web site, August 2002,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated each year in early summer.
The most current version of the regulations may be found at the
GPO web site or from the current
printed version.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.1]
[Page 198]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart A--Official Testimony and Information
Sec. 20.1 Testimony by Food and Drug Administration employees.
(a) No officer or employee of the Food and Drug Administration or of
any other office or establishment in the Department of Health and Human
Services, except as authorized by the Commissioner of Food and Drugs
pursuant to this section or in the discharge of his official duties
under the laws administered by the Food and Drug Administration, shall
give any testimony before any tribunal pertaining to any function of the
Food and Drug Administration or with respect to any information acquired
in the discharge of his official duties.
(b) Whenever a subpoena, in appropriate form, has been lawfully
served upon an officer or employee of the Food and Drug Administration
commanding the giving of any testimony, such officer or employee shall,
unless otherwise authorized by the Commissioner, appear in response
thereto and respectfully decline to testify on the grounds that it is
prohibited by this section.
(c) A person who desires testimony from any employee may make
written request therefor, verified by oath, directed to the Commissioner
setting forth his interest in the matter sought to be disclosed and
designating the use to which such testimony will be put in the event of
compliance with such request: Provided, That a written request therefor
made by a health, food, or drug officer, prosecuting attorney, or member
of the judiciary of any State, Territory, or political subdivision
thereof, acting in his official capacity, need not be verified by oath.
If it is determined by the Commissioner, or any other officer or
employee of the Food and Drug Administration whom he may designate to
act on his behalf for the purpose, that such testimony will be in the
public interest and will promote the objectives of the act and the
agency, the request may be granted. Where a request for testimony is
granted, one or more employees of the Food and Drug Administration may
be designated to appear, in response to a subpoena, and testify with
respect thereto.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.2]
[Page 198]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart A--Official Testimony and Information
Sec. 20.2 Production of records by Food and Drug Administration employees.
(a) Any request for records of the Food and Drug Administration,
whether it be by letter or by a subpena duces tecum or by any other
writing, shall be handled pursuant to the procedures established in
subpart B of this part, and shall comply with the rules governing public
disclosure established in subparts C, D, E, and F of this part and in
other regulations cross-referenced in Sec. 20.100(c).
(b) Whenever a subpoena duces tecum, in appropriate form, has been
lawfully served upon an officer or employee of the Food and Drug
Administration commanding the production of any record, such officer or
employee shall appear in response thereto, respectfully decline to
produce the record on the ground that it is prohibited by this section,
and state that the production of the record(s) involved will be handled
by the procedures established in this part.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.3]
[Page 198]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart A--Official Testimony and Information
Sec. 20.3 Certification and authentication of Food and Drug Administration records.
(a) Upon request, the Food and Drug Administration will certify the
authenticity of copies of records that are requested to be disclosed
pursuant to this part or will authenticate copies of records previously
disclosed.
(b) A request for certified copies of records or for authentication
of records shall be sent in writing to the Freedom of Information Staff
(HFI-35), Food and Drug Administration, Room 12A-16, 5600 Fishers Lane,
Rockville, MD 20857.
[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981]
[[Page 199]]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.20]
[Page 199]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart B--General Policy
Sec. 20.20 Policy on disclosure of Food and Drug Administration records.
(a) The Food and Drug Administration will make the fullest possible
disclosure of records to the public, consistent with the rights of
individuals to privacy, the property rights of persons in trade secrets
and confidential commercial or financial information, and the need for
the agency to promote frank internal policy deliberations and to pursue
its regulatory activities without disruption.
(b) Except where specifically exempt pursuant to the provisions of
this part, all Food and Drug Administration records shall be made
available for public disclosure.
(c) Except as provided in paragraph (d) of this section, all
nonexempt records shall be made available for public disclosure upon
request regardless whether any justification or need for such records
have been shown.
(d) Under Sec. 21.71 of this chapter, a statement of the purposes to
which the record requested is to be put, and a certification that the
record will be so used, may be requested when:
(1) The requested record is contained in a Privacy Act Record System
as defined in Sec. 21.3(c) of this chapter;
(2) The requester is a person other than the individual who is the
subject of the record that is so retrieved or a person acting on his
behalf; and
(3) The disclosure is one that is discretionary, i.e., not required
under this part.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.21]
[Page 199]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart B--General Policy
Sec. 20.21 Uniform access to records.
Any record of the Food and Drug Administration that is disclosed in
an authorized manner to any member of the public is available for
disclosure to all members of the public, except that:
(a) Data and information subject to the exemptions established in
Sec. 20.61 for trade secrets and confidential commercial or financial
information, and in Sec. 20.63 for personal privacy, shall be disclosed
only to the persons for the protection of whom these exemptions exist.
(b) The limited disclosure of records permitted in Sec. 7.87(c) of
this chapter for section 305 hearing records, in Sec. 20.80(b) regarding
certain limitations on exemptions, in Sec. 20.103(b) for certain
correspondence, and in Sec. 20.104(b) for certain summaries of oral
discussions, shall be subject to the special rules stated therein.
(c) Disclosure of a record about an individual, as defined in
Sec. 21.3(a) of this chapter, that is retrieved by the individual's name
or other personal identifier and is contained in a Privacy Act Record
System, as defined in Sec. 21.3(c) of this chapter, shall be subject to
the special requirements of part 21 of this chapter. Disclosure of such
a record to an individual who is the subject of the record does not
invoke the rule established in this section that such records shall be
made available for disclosure to all members of the public.
[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9037, Mar. 3, 1989]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.22]
[Page 199]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart B--General Policy
Sec. 20.22 Partial disclosure of records.
If a record contains both disclosable and nondisclosable
information, the nondisclosable information will be deleted and the
remaining record will be disclosed unless the two are so inextricably
intertwined that it is not feasible to separate them or release of the
disclosable information would compromise or impinge upon the
nondisclosable portion of the record.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.23]
[Page 199-200]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart B--General Policy
Sec. 20.23 Request for existing records.
(a) Any written request to the Food and Drug Administration for
existing records not prepared for routine distribution to the public
shall be deemed to be a request for records pursuant to the Freedom of
Information Act, whether or not the Freedom of Information Act is
mentioned in the request, and shall be governed by the provisions of
this part.
(b) Records or documents prepared by the Food and Drug
Administration for routine public distribution, e.g., pamphlets,
speeches, and educational materials, shall be furnished free of charge
upon request as long as the supply lasts. The provisions of this part
shall not be applicable to such requests except when the supply of such
material is exhausted and it is necessary to reproduce individual copies
upon specific request.
[[Page 200]]
(c) All existing Food and Drug Administration records are subject to
routine destruction according to standard record retention schedules.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.24]
[Page 200]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart B--General Policy
Sec. 20.24 Preparation of new records.
(a) The Freedom of Information Act and the provisions of this part
apply only to existing records that are reasonably described in a
request filed with the Food and Drug Administration pursuant to the
procedures established in subpart C of this part.
(b) The Commissioner may, in his discretion, prepare new records in
order to respond adequately to a request for information when he
concludes that it is in the public interest and promotes the objectives
of the act and the agency.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.25]
[Page 200]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart B--General Policy
Sec. 20.25 Retroactive application of regulations.
The provisions of this part apply to all records in Food and Drug
Administration files.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.26]
[Page 200]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart B--General Policy
Sec. 20.26 Indexes of certain records.
(a) Indexes shall be maintained, and revised at least quarterly, for
the following Food and Drug Administration records:
(1) Final orders published in the Federal Register with respect to
every denial or withdrawal of approval of a new drug application or a
new animal drug application for which a public hearing has been
requested.
(2) Statements of policy and interpretation adopted by the agency
and still in force and not published in the Federal Register.
(3) Administrative staff manuals and instructions to staff that
affect a member of the public.
(b) A copy of each such index is available at cost from the Freedom
of Information Staff (HFI-35), Food and Drug Administration, Room 12A-
16, 5600 Fishers Lane, Rockville, MD 20857.
[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.27]
[Page 200]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart B--General Policy
Sec. 20.27 Submission of records marked as confidential.
Marking records submitted to the Food and Drug Administration as
confidential, or with any other similar term, raises no obligation by
the Food and Drug Administration to regard such records as confidential,
to return them to the person who has submitted them, to review them
pursuant to the procedures established in Sec. 20.44, to withhold them
from disclosure to the public, or to advise the person submitting them
when a request for their public disclosure is received or when they are
in fact disclosed.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.28]
[Page 200]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart B--General Policy
Sec. 20.28 Food and Drug Administration determinations of confidentiality.
A determination that data or information submitted to the Food and
Drug Administration will be held in confidence and will not be available
for public disclosure shall be made only in the form of a regulation
published or cross-referenced in this part or by a written determination
pursuant to the procedure established in Sec. 20.44.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.29]
[Page 200]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart B--General Policy
Sec. 20.29 Prohibition on withdrawal of records from Food and Drug Administration files.
Except pursuant to the procedure established in Sec. 20.44 for
presubmission review of records, no person may withdraw records
submitted to the Food and Drug Administration. All Food and Drug
Administration records shall be retained by the agency until disposed of
pursuant to routine record disposal procedures.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.30]
[Page 200]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart B--General Policy
Sec. 20.30 Food and Drug Administration Freedom of Information Staff.
(a) The Office responsible for agency compliance with the Freedom of
Information Act and this part is:
Freedom of Information Staff (HFI-35), Food and Drug Administration,
Room 12A-16, 5600 Fishers Lane, Rockville, MD 20857.
(b) All requests for agency records shall be sent in writing to this
office.
[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.31]
[Page 200-201]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart B--General Policy
Sec. 20.31 Retention schedule of requests for Food and Drug Administration records.
(a) Unless unusual circumstances dictate otherwise, the Food and
Drug Administration shall maintain and dispose of files of requests and
reponses furnished thereto within the time limits authorized by GSA
General Records
[[Page 201]]
Schedule 14, FPMR 101-11-4, January 10, 1977, as follows:
(1) Files created by the receipt of and response to freedom of
information requests, except denials and/or appeals, may be destroyed 2
years from date of final response.
(2) Files created by a freedom of information request which was
wholly or partially denied may be destroyed 5 years after the denial
letter was issued.
(3) Files created by a freedom of information request which was
wholly or partially denied and which denial was subsequently appealed to
the Department of Health and Human Services may be destroyed 4 years
after final determination by FDA or 3 years after final adjudication by
courts, whichever is later.
(b) This destruction schedule will automatically be revised whenever
the time limits pertaining to these records are revised by the GSA
General Records Schedule.
[47 FR 24277, June 4, 1982]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.32]
[Page 201]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart B--General Policy
Sec. 20.32 Disclosure of Food and Drug Administration employee names.
The names of Food and Drug Administration employees will not be
deleted from disclosable records except where such deletion is necessary
to prevent disclosure of an informant or danger to the life or physical
safety of the employee or under other extraordinary circumstances.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.40]
[Page 201]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart C--Procedures and Fees
Sec. 20.40 Filing a request for records.
(a) All requests for Food and Drug Administration records shall be
filed in writing by mailing the request or delivering it to the Freedom
of Information Staff (HFI-35), Food and Drug Administration, Room 12A-
16, 5600 Fishers Lane, Rockville, MD 20857.
(b) A request for Food and Drug Administration records shall
reasonably describe the records being sought, in a way that they can be
identified and located. A request should include all pertinent details
that will help identify the records sought.
(1) If the description is insufficient to locate the records
requested, the Food and Drug Administration will so notify the person
making the request and indicate the additional information needed to
identify the records requested.
(2) Every reasonable effort shall be made by the Food and Drug
Administration to assist in the identification and location of the
records sought.
(c) Upon receipt of a request for records, the Freedom of
Information Staff shall enter it in a public log. The log shall state
the date received, the name of the person making the request, the nature
of the record requested, the action taken on the request, the date of
determination letter sent pursuant to Sec. 20.41(b), and the date(s) any
records are subsequently furnished.
(d) A request by an individual, as defined in Sec. 21.3(a) of this
chapter, for a record about himself shall be subject to:
(1) The special requirements of part 21 of this chapter (the privacy
regulations), and not to the provisions of this subpart, if the record
requested is retrieved by the individual's name or other personal
identifier and is contained in a Privacy Act Record System, as defined
in Sec. 21.3(c) of this chapter.
(2) The provisions of this subpart if the record requested is not
retrieved by the individual's name or other personal identifier, whether
or not the record is contained in a Privacy Act Record System.
[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.41]
[Page 201-202]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart C--Procedures and Fees
Sec. 20.41 Time limitations.
(a) All time limitations prescribed pursuant to this section shall
begin as of the time at which a request for records is logged in by the
Freedom of Information Staff pursuant to Sec. 20.40(c). An oral request
for records shall not begin any time requirement. A written request for
records sent elsewhere within the agency shall not begin any time
requirement until it is redirected to the Freedom of Information Staff
and is logged in there in accordance with Sec. 20.40(c).
(b) Within 10 working days (excepting Saturdays, Sundays, and legal
public holidays) after a request for records is logged in at the Freedom
of Information Staff, a letter shall be sent to the
[[Page 202]]
persons making the request determining whether, or to the extent which,
the agency will comply with the request, and, if any records are denied,
the reasons therefor.
(1) If all of the records requested have been located and a final
determination has been made with respect to disclosure of all of the
records requested, the letter shall so state.
(2) If all of the records have not been located or a final
determination has not yet been made with respect to disclosure of all of
the records requested, e.g., because it is necessary to consult the
person affected pursuant to Sec. 20.45, the letter shall state the
extent to which the records involved shall be disclosed pursuant to the
rules established in this part.
(3) In the following unusual circumstances, the time for sending
this letter may be extended for up to an additional 10 working days by
written notice to the person making the request setting forth the
reasons for such extension and the time within which a determination is
expected to be dispatched:
(i) The need to search for and collect the requested records from
field facilities or other establishments that are separate from the
Freedom of Information Staff.
(ii) The need to search for, collect, and appropriately examine a
voluminous amount of separate and distinct records which are demanded in
a single request.
(iii) The need for consultation, which shall be conducted with all
practicable speed, with another agency having a substantial interest in
the determination of the request or among two or more components of the
Food and Drug Administration having substantial subject-matter interest
therein.
(4) If any record is denied, the letter shall state the right of the
person requesting such records to appeal any adverse determination to
the Assistant Secretary for Health, Department of Health and Human
Services, in accordance with the provisions of 45 CFR 5.34.
[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 55
FR 1405, Jan. 16, 1990; 59 FR 533, Jan. 5, 1994]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.42]
[Page 202-204]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart C--Procedures and Fees
Sec. 20.42 Fees to be charged.
(a) Categories of requests. Paragraphs (a) (1) through (3) of this
section state, for each category of request, the type of fees that the
Food and Drug Administration will generally charge. However, for each of
these categories, the fees may be limited, waived, or reduced for the
reasons given in paragraphs (b) and (c) of this section and in
Sec. 20.43 or for other reasons.
(1) Commercial use request. If the request is for a commercial use,
the Food and Drug Administration will charge for the costs of search,
review, and duplication.
(2) Educational and scientific institutions and news media. If the
request is from an educational institution or a noncommercial scientific
institution, operated primarily for scholarly or scientific research, or
a representative of the news media, and the request is not for a
commercial use, the Food and Drug Administration will charge only for
the duplication of documents. Also, the Food and Drug Administration
will not charge the copying costs for the first 100 pages of
duplication.
(3) Other requests. If the request is not the kind described in
paragraph (a)(1) or (a)(2) of this section, then the Food and Drug
Administration will charge only for the search and the duplication.
Also, the Food and Drug Administration will not charge for the first 2
hours of search time or for the copying costs of the first 100 pages of
duplication.
(b) General provisions. (1) The Food and Drug Administration may
charge search fees even if the records found are exempt from disclosure
or if no records are found.
(2) If, under paragraph (a)(3) of this section, there is no charge
for the first 2 hours of search time, and those 2 hours are spent on a
computer search, then the 2 free hours are the first 2 hours of the
operator's own operation. If the operator spends less than 2 hours on
the search, the total search fees will be reduced by the average hourly
rate for the operator's time, multiplied by 2.
(3) If, under paragraph (a)(2) or (a)(3) of this section, there is
no charge for the first 100 pages of duplication, then those 100 pages
are the first 100 pages
[[Page 203]]
of photocopies of standard size pages, or the first 100 pages of
computer printout. If this method to calculate the fee reduction cannot
be used, then the total duplication fee will be reduced by the normal
charge for photocopying a standard size page, multiplied by 100.
(4) No charge will be made if the costs of routine collection and
processing of the fee are likely to equal or exceed the amount of the
fee.
(5) If it is determined that a requester (acting either alone or
together with others) is breaking down a single request into a series of
requests in order to avoid (or reduce) the fees charged, all these
requests may be aggregated for purposes of calculating the fees charged.
(6) Interest will be charged on unpaid bills beginning on the 31st
day following the day the bill was sent. Provisions in 45 CFR part 30,
the Department of Health and Human Services regulations governing claims
collection, will be used in assessing interest, administrative costs,
and penalties, and in taking actions to encourage payment.
(c) Fee schedule. The Food and Drug Administration charges the
following fees:
(1) Manual searching for or reviewing of records. When the search or
review is performed by employees at grade GS-1 through GS-8, an hourly
rate based on the salary of a GS-5, step 7, employee; when done by a GS-
9 through GS-14, an hourly rate based on the salary of a GS-12, step 4,
employee; and when done by a GS-15 or above, an hourly rate based on the
salary of a GS-15, step 7, employee. In each case, the hourly rate will
be computed by taking the current hourly rate for the specified grade
and step, adding 16 percent of that rate to cover benefits, and rounding
to the nearest whole dollar. As of January 1, 1993, these rates were
$12, $24, and $43 respectively. When a search involves employees at more
than one of these levels, the Food and Drug Administration will charge
the rate appropriate for each.
(2) Computer searching and printing. The actual cost of operating
the computer plus charges for the time spent by the operator, at the
rates given in paragraph (c)(1) of this section.
(3) Photocopying standard size pages. $0.10 per page. Freedom of
Information Officers may charge lower fees for particular documents
where:
(i) The document has already been printed in large numbers;
(ii) The program office determines that using existing stock to
answer this request, and any other anticipated Freedom of Information
requests, will not interfere with program requirements; and
(iii) The Freedom of Information Officer determines that the lower
fee is adequate to recover the prorated share of the original printing
costs.
(4) Photocopying odd-size documents (such as punchcards or
blueprints), or reproducing other records (such as tapes). The actual
costs of operating the machine, plus the actual cost of the materials
used, plus charges for the time spent by the operator, at the rates
given in paragraph (c)(1) of this section.
(5) Certifying that records are true copies. This service is not
required by the Freedom of Information Act. If the Food and Drug
Administration agrees to provide certification, there is a $10 charge
per certification.
(6) Sending records by express mail, certified mail, or other
special methods. This service is not required by the Freedom of
Information Act. If the Food and Drug Administration agrees to provide
this service, actual costs will be charged.
(7) Performing any other special service in connection with a
request to which the Food and Drug Administration has agreed. Actual
costs of operating any machinery, plus actual cost of any materials
used, plus charges for the time of the Food and Drug Administration's
employees, at the rates given in paragraph (c)(1) of this section.
(d) Procedures for assessing and collecting fees--(1) Agreement to
pay. The Food and Drug Administration generally assumes that a requester
is willing to pay the fees charged for services associated with the
request. The requester may specify a limit on the amount to be spent. If
it appears that the fees will exceed the limit, the Food and Drug
Administration will consult the requester to determine whether to
proceed with the search.
[[Page 204]]
(2) Advance payment. If a requester has failed to pay previous bills
in a timely fashion, or if the Food and Drug Administration's initial
review of the request indicates that the charges will exceed $250, the
requester will be required to pay past due fees and/or the estimated
fees, or a deposit, before the search for the requested records begins.
In such cases, the requester will be notified promptly upon receipt of
the request, and the administrative time limits prescribed in Sec. 20.41
will begin only after there is an agreement with the requester over
payment of fees, or a decision that fee waiver or reduction is
appropriate.
(3) Billing and payment. Ordinarily, the requester will be required
to pay all fees before the Food and Drug Administration will furnish the
records. At its discretion, the Food and Drug Administration may send
the requester a bill along with or following the records. For example,
the Food and Drug Administration may do this if the requester has a
history of prompt payment. The Food and Drug Administration may also, at
its discretion, aggregate the charges for certain time periods in order
to avoid sending numerous small bills to frequent requesters, or to
businesses or agents representing requesters. For example, the Food and
Drug Administration might send a bill to such a requester once a month.
Fees should be paid in accordance with the instructions furnished by the
person who responds to the request.
[59 FR 533, Jan. 5, 1994]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.43]
[Page 204-205]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart C--Procedures and Fees
Sec. 20.43 Waiver or reduction of fees.
(a) Standard. The Associate Commissioner for Public Affairs will
waive or reduce the fees that would otherwise be charged if disclosure
of the information meets both of the following tests:
(1) Is in the public interest because it is likely to contribute
significantly to public understanding of the operations or activities of
the Government; and
(2) It is not primarily in the commercial interest of the requester.
These two tests are explained in paragraphs (b) and (c) of this section.
(b) Public interest. Disclosure of information satisfies the first
test only if it furthers the specific public interest of being likely to
contribute significantly to public understanding of Government
operations or activities, regardless of any other public interest it may
further. In analyzing this question, the Food and Drug Administration
will consider the following factors:
(1) Whether the records to be disclosed pertain to the operations or
activities of the Federal Government;
(2) Whether disclosure of the records would reveal any meaningful
information about Government operations or activities that is not
already public knowledge;
(3) Whether disclosure will advance the understanding of the general
public as distinguished from a narrow segment of interested persons.
Under this factor, the Food and Drug Administration may consider whether
the requester is in a position to contribute to public understanding.
For example, the Food and Drug Administration may consider whether the
requester has such knowledge or expertise as may be necessary to
understand the information, and whether the requester's intended use of
the information would be likely to disseminate the information to the
public. An unsupported claim to be doing research for a book or article
does not demonstrate that likelihood, while such a claim by a
representative of the news media is better evidence; and
(4) Whether the contribution to public understanding will be a
significant one, i.e., will the public's understanding of the
Government's operations be substantially greater as a result of the
disclosure.
(c) Not primarily in the requester's commercial interest. If
disclosure passes the test of furthering the specific public interest
described in paragraph (b) of this section, the Food and Drug
Administration will determine whether disclosure also furthers the
requester's commercial interest and, if so, whether this effect
outweighs the advancement of that public interest. In applying this
second test, the Food and Drug Administration will consider the
following factors:
(1) Whether disclosure would further a commercial interest of the
requester, or of someone on whose behalf the requester is acting.
Commercial interests include interests relating to business,
[[Page 205]]
trade, and profit. Both profit and nonprofit-making corporations have
commercial interests, as well as individuals, unions, and other
associations. The interest of a representative of the news media in
using the information for news dissemination purposes will not be
considered a commercial interest.
(2) If disclosure would further a commercial interest of the
requester, whether that effect outweighs the advancement of the public
interest as defined in paragraph (b) of this section.
(d) Deciding between waiver and reduction. If the disclosure of the
information requested passes both tests described in paragraphs (b) and
(c) of this section, the Food and Drug Administration will normally
waive fees. However, in some cases the Food and Drug Administration may
decide only to reduce the fees. For example, the Food and Drug
Administration may do this when disclosure of some but not all of the
requested records passes the tests.
(e) Procedure for requesting a waiver or reduction. A requester must
request a waiver or reduction of fees at the same time as the request
for records. The requester should explain why a waiver or reduction is
proper under the factors set forth in paragraphs (a) through (d) of this
section. Only the Associate Commissioner for Public Affairs may make the
decision whether to waive or reduce the fees. If the Food and Drug
Administration does not completely grant the request for a waiver or
reduction, the denial letter will designate a review official. The
requester may appeal the denial to that official. The appeal letter
should address reasons for the Associate Commissioner's decision that
are set forth in the denial letter.
[59 FR 534, Jan. 5, 1994]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.44]
[Page 205-206]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart C--Procedures and Fees
Sec. 20.44 Presubmission review of request for confidentiality of voluntarily
submitted data or information.
(a) Any person who is considering submission of data or information
voluntarily to the Food and Drug Administration may forward to the
Director of the Center involved, or to the Associate Commissioner for
Regulatory Affairs, a request for presubmission review of the records
involved to determine whether the Food and Drug Administration will or
will not make part or all of them available for public disclosure upon
request if they are submitted. Any such request shall state why the data
or information involved fall within an exemption from public disclosure
set out in subpart D of this part and shall enclose the records
involved.
(b) Pending a determination upon such request, the records involved
shall be held confidentially and separately by the Food and Drug
Administration and shall not be received as part of Food and Drug
Administration files.
(c) Pursuant to such a request, the Food and Drug Administration
shall make a determination whether part or all of the records involved
will be made available for public disclosure upon request if they are
submitted. A determination of confidentiality will be made only if it is
concluded that the data or information involved fall within an exemption
from public disclosure set out in subpart D of this part and are
relevant to and important for agency activity.
(d) After a determination is made pursuant to this section, the Food
and Drug Administration shall receive as part of its files the records
for which a request for confidentiality has been granted and shall so
mark or designate those records. The person requesting the presubmission
review shall have the option of submitting or withdrawing the records
for which a request for confidentiality has been denied. No copy or
summary of records withdrawn pursuant to this section, or any
correspondence or memoranda or records relating thereto, shall be
retained in Food and Drug Administration files.
(e) A determination of confidentiality pursuant to this section is
subject to the limitations established in subpart E of this part except
that the data or information involved shall not be subject to
discretionary release pursuant to Sec. 20.82. Such a determination of
confidentiality by the Food and Drug Administration means that the Food
and Drug Administration will not make the data or information involved
available for public disclosure unless ordered to do so by a court.
[[Page 206]]
(f) A determination based upon a presubmission review pursuant to
this section shall be made in writing and shall be signed only by the
Associate Commissioner for Public Affairs.
(g) Data and information that may be required to be submitted to the
Food and Drug Administration but that are submitted voluntarily instead
are not subject to the provisions of this section and will be handled as
if they had been required to be submitted.
(h) No request under this section shall be accepted if the status of
the records involved is already determined by Sec. 20.111 or by any
other regulation published or cross-referenced in this part.
[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 50
FR 8995, Mar. 6, 1985]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.45]
[Page 206]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart C--Procedures and Fees
Sec. 20.45 Situations in which confidentiality is uncertain.
In situations where the confidentiality of data or information is
uncertain and there is a request for public disclosure, the Food and
Drug Administration will consult with the person who has submitted or
divulged the data or information or who would be affected by disclosure
before determining whether or not such data or information is available
for public disclosure.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.46]
[Page 206]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart C--Procedures and Fees
Sec. 20.46 Judicial review of proposed disclosure.
Where the Food and Drug Administration consults with a person who
will be affected by a proposed disclosure of data or information
contained in Food and Drug Administration records pursuant to
Sec. 20.45, and rejects the person's request that part or all of the
records not be made available for public disclosure, the decision
constitutes final agency action that is subject to judicial review
pursuant to 5 U.S.C. chapter 7. The person affected will be permitted 5
days after receipt of notification of such decision within which to
institute suit in a United States District Court to enjoin release of
the records involved. If suit is brought, the Food and Drug
Administration will not disclose the records involved until the matter
and all related appeals have been concluded.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.47]
[Page 206]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart C--Procedures and Fees
Sec. 20.47 Denial of a request for records.
(a) A denial of a request for records, in whole or in part, shall be
signed by the Associate Commissioner for Public Affairs.
(b) The name and title or position of each person who participated
in the denial of a request for records shall be set forth in the letter
denying the request. This requirement may be met by attaching a list of
such individuals to the letter.
(c) A letter denying a request for records, in whole or in part,
shall state the reasons for the denial and shall state that an appeal
may be made to the Assistant Secretary for Health, Department of Health
and Human Services, pursuant to the provisions of 45 CFR 5.34.
(d) Minor deletions of nondisclosable data and information from
disclosable records shall not be deemed to be a denial of a request for
records.
[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 55
FR 1405, Jan. 16, 1990]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.48]
[Page 206-207]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart C--Procedures and Fees
Sec. 20.48 Nonspecific and overly burdensome requests.
The Food and Drug Administration will make every reasonable effort
to comply fully with all requests for disclosure of nonexempt records.
Nonspecific requests or requests for a large number of documents that
require the deployment of a substantial amount of agency man-hours to
search for and compile will be processed taking into account the staff-
hours required, the tasks from which these resources must be diverted,
the impact that this diversion will have upon the agency's consumer
protection activities, and the public policy reasons justifying the
requests. A decision on the processing of such a request for information
shall be made after balancing the public benefit to be gained by the
disclosure against the public loss that will result from diverting
agency personnel from their other responsibilities. In any situation in
which it is determined that a request for voluminous records would
unduly burden and interfere with the operations of the Food and Drug
Administration, the person making the request will be asked to be more
specific and to narrow the request, and to agree
[[Page 207]]
on an orderly procedure for the production of the requested records, in
order to satisfy the request without disproportionate adverse effects on
agency operations.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.49]
[Page 207]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart C--Procedures and Fees
Sec. 20.49 Referral to primary source of records.
Upon receipt of a request for a record or document which is
contained in Food and Drug Administration files but which is available
elsewhere at a lower cost, the person requesting the record or document
shall be referred to the primary source of the record or document.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.50]
[Page 207]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart C--Procedures and Fees
Sec. 20.50 Availability of records at National Technical Information Service.
The Food and Drug Administration is furnishing a number of records
to the National Technical Information Service (NTIS), 5285 Port Royal
Rd., Springfield, VA 22162, which reproduces and distributes such
information to the public at cost. A single copy of each such record
shall be available for public review at the Food and Drug
Administration. All persons requesting copies of such records shall be
answered by referring the person requesting the records to NTIS.
[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.51]
[Page 207]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart C--Procedures and Fees
Sec. 20.51 Use of private contractor for copying.
The Food and Drug Administration may furnish requested records to a
private contractor for copying after deletion of all nondisclosable data
and information. Under these circumstances, the Food and Drug
Administration will charge the person requesting the records for all of
the fees involved pursuant to Sec. 20.42.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.52]
[Page 207]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart C--Procedures and Fees
Sec. 20.52 Request for review without copying.
(a) A person requesting disclosure of records shall be permitted an
opportunity to review them without the necessity for copying them where
the records involved contain only disclosable data and information.
Under these circumstances, the Food and Drug Administration will charge
only for the costs of searching for the records.
(b) Where a request is made for review of records without copying,
and the records involved contain both disclosable and nondisclosable
information, the records containing nondisclosable information shall
first be copied with the nondisclosable information blocked out and the
Food and Drug Administration will charge for the costs of searching and
copying.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.53]
[Page 207]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart C--Procedures and Fees
Sec. 20.53 Indexing trade secrets and confidential commercial or financial information.
Whenever the Food and Drug Administration denies a request for a
record or portion thereof on the grounds that the record or portion
thereof is exempt from public disclosure as trade secret or confidential
commercial or financial data and information under Sec. 20.61, and the
person requesting the record subsequently contests the denial in the
courts, the Food and Drug Administration will so inform the person
affected, i.e., the person who submitted the record, and will require
that such person intervene to defend the exempt status of the record. If
a court requires the Food and Drug Administration to itemize and index
such records, the Food and Drug Administration will so inform the person
affected and will require that such person undertake the itemization and
indexing of the records. If the affected person fails to intervene to
defend the exempt status of the records and to itemize and index the
disputed records, the Food and Drug Administration will take this
failure into consideration in deciding whether that person has waived
such exemption so as to require the Food and Drug Administration to
promptly make the records available for public disclosure.
[42 FR 15616, Mar. 22, 1977, as amended at 59 FR 535, Jan. 5, 1994]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.60]
[Page 207-208]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart D--Exemptions
Sec. 20.60 Applicability of exemptions.
(a) The exemptions established in this subpart shall apply to all
Food and Drug Administration records, except as provided in subpart E of
this part. Accordingly, a record that is ordinarily
[[Page 208]]
available for public disclosure in accordance with the provisions in
subpart F of this part or of another regulation cross-referenced in
Sec. 20.100(c) is not available for such disclosure to the extent that
it falls within an exemption contained in this subpart, except as
provided by the limitations on exemptions specified in subpart E of this
part. For example, correspondence that is ordinarily disclosable under
Sec. 20.103 is not disclosable to the extent that it contains trade
secrets exempt from disclosure under Sec. 20.61 and is not subject to
discretionary release under Sec. 20.82.
(b) Where application of one or more exemptions results in a record
being disclosable in part and nondisclosable in part, the rule
established in Sec. 20.22 shall apply.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.61]
[Page 208-209]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart D--Exemptions
Sec. 20.61 Trade secrets and commercial or financial information which is
privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan,
formula, process, or device that is used for the making, preparing,
compounding, or processing of trade commodities and that can be said to
be the end product of either innovation or substantial effort. There
must be a direct relationship between the trade secret and the
productive process.
(b) Commercial or financial information that is privileged or
confidential means valuable data or information which is used in one's
business and is of a type customarily held in strict confidence or
regarded as privileged and not disclosed to any member of the public by
the person to whom it belongs.
(c) Data and information submitted or divulged to the Food and Drug
Administration which fall within the definitions of a trade secret or
confidential commercial or financial information are not available for
public disclosure.
(d) A person who submits records to the Government may designate
part or all of the information in such records as exempt from disclosure
under exemption 4 of the Freedom of Information Act. The person may make
this designation either at the time the records are submitted to the
Government or within a reasonable time thereafter. The designation must
be in writing. Where a legend is required by a request for proposals or
request for quotations, pursuant to 48 CFR 352.215-12, then that legend
is necessary for this purpose. Any such designation will expire 10 years
after the records were submitted to the Government.
(e) The procedures in this paragraph apply to records on which the
submitter has designated information as provided in paragraph (d) of
this section. These procedures also apply to records that were submitted
to the Food and Drug Administration when the agency has substantial
reason to believe that information in the records could reasonably be
considered exempt under exemption 4 of the Freedom of Information Act.
Certain exceptions to these procedures are set forth in paragraph (f) of
this section.
(1) When the Food and Drug Administration receives a request for
such records and determines that disclosure may be required, the Food
and Drug Administration will make reasonable efforts to notify the
submitter about these facts. The notice will include a copy of the
request, and it will inform the submitter about the procedures and time
limits for submission and consideration of objections to disclosure. If
the Food and Drug Administration must notify a large number of
submitters, notification may be done by posting or publishing a notice
in a place where the submitters are reasonably likely to become aware of
it.
(2) The submitter has 5 working days from receipt of the notice to
object to disclosure of any part of the records and to state all bases
for its objections.
(3) The Food and Drug Administration will give consideration to all
bases that have been stated in a timely manner by the submitter. If the
Food and Drug Administration decides to disclose the records, the Food
and Drug Administration will notify the submitter in writing. This
notice will briefly explain why the agency did not sustain the
submitter's objections. The Food and Drug Administration will include
with the notice a copy of the records about which the submitter
objected, as the agency proposes to disclose them. The notice will state
that the Food and Drug Administration intends to disclose the records 5
working
[[Page 209]]
days after the submitter receives the notice unless a U.S. District
Court orders the agency not to release them.
(4) If a requester files suit under the Freedom of Information Act
to obtain records covered by this paragraph, the Food and Drug
Administration will promptly notify the submitter.
(5) Whenever the Food and Drug Administration sends a notice to a
submitter under paragraph (e)(1) of this section, the Food and Drug
Administration will notify the requester that the Food and Drug
Administration is giving the submitter a notice and an opportunity to
object. Whenever the Food and Drug Administration sends a notice to a
submitter under paragraph (e)(3) of this section, the Food and Drug
Administration will notify the requester of this fact.
(f) The notice requirements in paragraph (e) of this section do not
apply in the following situations:
(1) The Food and Drug Administration decided not to disclose the
records;
(2) The information has previously been published or made generally
available;
(3) Disclosure is required by a regulation issued after notice and
opportunity for public comment, that specifies narrow categories of
records that are to be disclosed under the Freedom of Information Act,
but in this case a submitter may still designate records as described in
paragraph (d) of this section, and in exceptional cases, the Food and
Drug Administration may, at its discretion, follow the notice procedures
in paragraph (e) of this section;
(4) The information requested has not been designated by the
submitter as exempt from disclosure when the submitter had an
opportunity to do so at the time of submission of the information or
within a reasonable time thereafter, unless the Food and Drug
Administration has substantial reason to believe that disclosure of the
information would result in competitive harm; or
(5) The designation appears to be obviously frivolous, but in this
case the Food and Drug Administration will still give the submitter the
written notice required by paragraph (e)(3) of this section (although
this notice need not explain our decision or include a copy of the
records), and the Food and Drug Administration will notify the requester
as described in paragraph (e)(5) of this section.
[42 FR 15616, Mar. 22, 1977, as amended at 59 FR 535, Jan. 5, 1994]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.62]
[Page 209]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart D--Exemptions
Sec. 20.62 Inter- or intra-agency memoranda or letters.
All communications within the Executive Branch of the Federal
government which are in written form or which are subsequently reduced
to writing may be withheld from public disclosure except that factual
information which is reasonably segregable in accordance with the rule
established in Sec. 20.22 is available for public disclosure.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.63]
[Page 209-210]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart D--Exemptions
Sec. 20.63 Personnel, medical, and similar files, disclosure of which
constitutes a clearly unwarranted invasion of personal privacy.
(a) The names or other information which would identify patients or
research subjects in any medical or similar report, test, study, or
other research project shall be deleted before the record is made
available for public disclosure.
(b) The names and other information which would identify patients or
research subjects should be deleted from any record before it is
submitted to the Food and Drug Administration. If the Food and Drug
Administration subsequently needs the names of such individuals, a
separate request will be made.
(c) Requests for deletion of business or product names prior to
disclosure of any record to the public shall not be granted on the
ground of privacy, but such deletion may be justified under another
exemption established in this subpart, e.g., the exemption for trade
secrets and confidential commercial or financial information under
Sec. 20.61.
(d) Names of individuals conducting investigations, studies, or
tests on products or ingredients shall not be deleted prior to
disclosure of any record to the public unless extraordinary
circumstances are shown.
(e) A request for all records relating to a specific individual will
be denied as a clearly unwarranted invasion of personal privacy unless
accompanied
[[Page 210]]
by the written consent of the individual named.
(f) The names and any information that would identify the voluntary
reporter or any other person associated with an adverse event involving
a human drug, biologic, or medical device product shall not be disclosed
by the Food and Drug Administration or by a manufacturer in possession
of such reports in response to a request, demand, or order. Information
that would identify the voluntary reporter or persons identified in the
report includes, but is not limited to, the name, address, institution,
or any other information that would lead to the identities of the
reporter or persons identified in a report. This provision does not
affect disclosure of the identities of reporters required by a Federal
statute or regulation to make adverse event reports. Disclosure of the
identities of such reporters is governed by the applicable Federal
statutes and regulations.
(1) Exceptions. (i) Identities may be disclosed if both the
voluntary reporter and the person identified in an adverse event report
or that person's legal representative consent in writing to disclosure,
but neither FDA nor any manufacturer in possession of such reports shall
be required to seek consent for disclosure from the voluntary reporter
or the person identified in the adverse event report or that person's
legal representative; or
(ii) Identities of the voluntary reporter and the person who
experienced the reported adverse event may be disclosed pursuant to a
court order in the course of medical malpractice litigation involving
both parties; or (iii) The report, excluding the identities of any other
individuals, shall be disclosed to the person who is the subject of the
report upon request.
(2) Preemption. No State or local governing entity shall establish
or continue in effect any law, rule, regulation, or other requirement
that permits or requires disclosure of the identities of the voluntary
reporter or other person identified in an adverse event report except as
provided in this section.
[42 FR 15616, Mar. 22, 1977, as amended at 60 FR 16968, Apr. 3, 1995]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.64]
[Page 210-211]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart D--Exemptions
Sec. 20.64 Records or information compiled for law enforcement purposes.
(a) Records or information compiled for law enforcement purposes may
be withheld from public disclosure pursuant to the provisions of this
section to the extent that disclosure of such records or information:
(1) Could reasonably be expected to interfere with enforcement
proceedings;
(2) Would deprive a person to a right to a fair trial or an
impartial adjudication;
(3) Could reasonably be expected to constitute an unwarranted
invasion of personal privacy;
(4) Could reasonably be expected to disclose the identity of a
confidential source, including a State, local, or foreign agency or
authority or any private institution which furnished information on a
confidential basis; and information furnished by a confidential source
in the case of a record compiled by the Food and Drug Administration or
any other criminal law enforcement authority in the course of a criminal
investigation or by an agency conducting a lawful national security
intelligence investigation;
(5) Would disclose techniques and procedures for law enforcement
investigations or prosecutions or would disclose guidelines for law
enforcement investigations or prosecutions, if such disclosure could
reasonably be expected to risk circumvention of the law; or
(6) Could reasonably be expected to endanger the life or physical
safety of any individual.
(b) Records include all records relating to regulatory enforcement
action, including both administrative and court action, which have not
been disclosed to any member of the public, including any person who is
the subject of the investigation.
(c) Any record which is disclosed to any person, including any
person who is the subject of a Food and Drug Administration
investigation, and any data or information received from any person who
is the subject of a Food and Drug Administration investigation relating
to such investigation, is available for public disclosure at that time
[[Page 211]]
in accordance with the rule established in Sec. 20.21, except that:
(1) Disclosure of such records shall be subject to the other
exemptions established in this subpart and to the limitations on
exemptions established in subpart E of this part.
(2) The record of a section 305 hearing shall be available for
public disclosure only in accordance with the provisions of Sec. 7.87 of
this chapter.
(d) Records for law enforcement purposes shall be subject to the
following rules:
(1) No such record is available for public disclosure prior to the
consideration of regulatory enforcement action based upon that record's
being closed, except as provided in Sec. 20.82. The Commissioner will
exercise his discretion to disclose records relating to possible
criminal prosecution pursuant to Sec. 20.82 prior to consideration of
criminal prosecution being closed only very rarely and only under
circumstances that demonstrate a compelling public interest.
(2) After the consideration of regulatory enforcement action is
closed, such records shall be made available for public disclosure
except to the extent that other exemptions from disclosure in this
subpart are applicable. No statements of witnesses obtained through
promises of confidentiality are available for public disclosure.
(3) The consideration of regulatory enforcement action based upon a
particular record shall be deemed to be closed within the meaning of
this section:
(i) If it relates to administrative action, when a final decision
has been made not to take such action or such action has been taken and
the matter has been concluded.
(ii) If it relates to court action, when a final decision has been
made not to recommend such action to a United States attorney based upon
that record, or a recommendation has been finally refused by a United
States attorney, or court action has been instituted and the matter and
all related appeals have been concluded, or the statute of limitations
runs.
(iii) If it relates to both administrative and court action, when
the events described in both paragraph (d)(3) (i) and (ii) of this
section have occurred.
(4) Prior to disclosure of any record specifically reflecting
consideration of possible criminal prosecution of any individual, all
names and other information that would identify an individual who was
considered for criminal prosecution but who was not prosecuted shall be
deleted unless the Commissioner concludes that there is a compelling
public interest in the disclosure of such names.
(e) Names and other information that would identify a Food and Drug
Administration employee shall be deleted from records prior to public
disclosure only pursuant to Sec. 20.32.
[42 FR 15616, Mar. 22, 1977, as amended at 59 FR 536, Jan. 5, 1994]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.80]
[Page 211-212]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart E--Limitations on Exemptions
Sec. 20.80 Applicability of limitations on exemptions.
(a) The limitations on exemptions established in this subpart shall
apply to all Food and Drug Administration records, except as
specifically provided herein. Accordingly, a record that is ordinarily
exempt from public disclosure in accordance with the provisions in
subpart D of this part is available for such disclosure to the extent
that it falls within a limitation on the exemption contained in this
subpart. For example, an investigatory record that is ordinarily exempt
from disclosure under Sec. 20.64 is disclosable to Congress in
accordance with the provisions of Sec. 20.87.
(b) Disclosure of a record to any member of the public pursuant to
the provisions in Sec. 20.81, data and information previously disclosed
to the public, in Sec. 20.82, discretionary disclosure by the
Commissioner, and in Sec. 20.83, disclosure pursuant to a court order,
shall involve the rule established in Sec. 20.21 that the record shall
be made available for disclosure to all members of the public who
request it. Disclosure of a record only to the limited categories of
persons and under the conditions specified in Sec. 20.84, special
government employees, in Sec. 20.85, other Federal government
departments and agencies, in
[[Page 212]]
Sec. 20.86, in camera disclosure in administrative or court proceedings,
in Sec. 20.87(b), Congress, in Sec. 20.88, State and local government
officials, in Sec. 20.89, foreign government officials, and in
Sec. 20.90, contractors, which does not result in disclosure of the
record to any member of the public in an authorized manner, shall not
invoke the rule established in Sec. 20.21.
(c) Disclosure to government employees and special government
employees of records exempt from public disclosure shall subject those
persons to the same restrictions with respect to the disclosure of such
records as any Food and Drug Administration employee.
(d) In the case of a record in a Privacy Act Record System, as
defined in Sec. 21.3(c) of this chapter:
(1) The availability to an individual, as defined in Sec. 21.3(a),
of a record about himself that is retrieved by the individual's name or
other personal identifier and is contained in a Privacy Act Record
System shall be subject to the special requirements of part 21 of this
chapter (the privacy regulations) and shall not be subject to the
exemptions in subpart D of this part except that where the system is
exempt and the requested record is not available under Sec. 21.61 of
this chapter, the provisions of this part shall apply.
(2) The availability of a record about an individual to persons
other than the individual who is the subject of the record shall be
subject to the special requirements of part 21, subpart G, of this
chapter (restrictions on disclosure in the privacy regulations), and
shall not be subject to the limitations on exemptions in this subpart
except as provided in part 21, subpart G, of this chapter.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.81]
[Page 212]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart E--Limitations on Exemptions
Sec. 20.81 Data and information previously disclosed to the public.
(a) Any Food and Drug Administration record that is otherwise exempt
from public disclosure pursuant to subpart D of this part is available
for public disclosure to the extent that it contains data or information
that have previously been disclosed in a lawful manner to any member of
the public, other than an employee or consultant or pursuant to other
commerical arrangements with appropriate safeguards for secrecy.
(1) For purposes of this section, an individual shall be deemed to
be a consultant only if disclosure of the information was necessary in
order to perform that specific consulting service and the purpose of the
disclosure was solely to obtain that service. The number of consultants
who have received such information shall have been limited to the number
reasonably needed to perform that particular consulting service.
(2) For purposes of this section, other commercial arrangements
shall include licenses, contracts, and similar legal relationships
between business associates.
(3) For purposes of this section, data and information disclosed to
clinical investigators or members of institutional review committees,
whether required by regulations of the Food and Drug Administration, or
made voluntarily, if accompanied by appropriate safeguards to assure
secrecy and otherwise in accordance with this section, are not deemed to
have been previously disclosed to any member of the public within the
meaning of paragraph (a) of this section.
(b) Any data or information furnished to the Food and Drug
Administration for a presubmission review pursuant to the procedure
established in Sec. 20.44 shall be accompanied by a statement that the
information has not previously been published or disclosed to anyone
other than as provided in paragraph (a) of this section.
(c) Any statement relating to prior public disclosure is subject to
the False Reports to the Government Act, 18 U.S.C. 1001.
[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989; 59
FR 536, Jan. 5, 1994]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.82]
[Page 212-213]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart E--Limitations on Exemptions
Sec. 20.82 Discretionary disclosure by the Commissioner.
(a) Except as provided in paragraph (b) of this section, the
Commissioner may, in his discretion, disclose part or all of any Food
and Drug Administration record that is otherwise exempt from disclosure
pursuant to subpart D of this part. The Commissioner shall exercise his
discretion to disclose such records whenever he determines that
[[Page 213]]
such disclosure is in the public interest, will promote the objectives
of the act and the agency, and is consistent with the rights of
individuals to privacy, the property rights of persons in trade secrets,
and the need for the agency to promote frank internal policy
deliberations and to pursue its regulatory activities without
disruption.
(b) The Commissioner shall not make available for public disclosure
any record that is:
(1) Exempt from public disclosure pursuant to Sec. 20.61.
(2) Exempt from public disclosure pursuant to Sec. 20.63.
(3) Prohibited from public disclosure pursuant to 21 U.S.C. 331(j),
42 U.S.C. 263g(d), 42 U.S.C. 263i, or 18 U.S.C. 1905.
(4) Contained in a Privacy Act Record System where disclosure would
constitute a clearly unwarranted invasion of personal privacy or is
otherwise in violation of 5 U.S.C. 552a(b), as applied in part 21,
subpart G, of this chapter (restrictions on disclosure in the privacy
regulations).
(c) Discretionary disclosure of a record pursuant to this section
shall invoke the requirement that the record shall be disclosed to any
person who requests it pursuant to Sec. 20.21, but shall not set a
precedent for discretionary disclosure of any similar or related record
and shall not obligate the Commissioner to exercise his discretion to
disclose any other record that is exempt from disclosure.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.83]
[Page 213]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart E--Limitations on Exemptions
Sec. 20.83 Disclosure required by court order.
(a) Records of the Food and Drug Administration which the
Commissioner has determined are not available for public disclosure,
either in the form of a regulation published or cross-referenced in this
part or by a written determination pursuant to the procedure established
in Sec. 20.44, shall nevertheless be made available for public
disclosure in compliance with a final court order requiring such
disclosure.
(b) Where the Food and Drug Administration record ordered disclosed
under paragraph (a) of this section is a record about an individual that
is not available for public disclosure under Sec. 20.63, the Food and
Drug Administration shall attempt to notify the individual who is the
subject of the record of the disclosure, by sending a notice to the
individual's last known address.
(c) Paragraph (b) of this section shall not apply where the name or
other personal identifying information is deleted prior to disclosure.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.84]
[Page 213]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart E--Limitations on Exemptions
Sec. 20.84 Disclosure to consultants, advisory committees, State and local
government officials commissioned pursuant to 21 U.S.C. 372(a), and other special
government employees.
Data and information otherwise exempt from public disclosure may be
disclosed to Food and Drug Administration consultants, advisory
committees, State and local government officials commissioned pursuant
to 21 U.S.C. 372(a), and other special government employees for use only
in their work with the Food and Drug Administration. Such persons are
thereafter subject to the same restrictions with respect to the
disclosure of such data and information as any other Food and Drug
Administration employee.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.85]
[Page 213]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart E--Limitations on Exemptions
Sec. 20.85 Disclosure to other Federal government departments and agencies.
Any Food and Drug Administration record otherwise exempt from public
disclosure may be disclosed to other Federal government departments and
agencies, except that trade secrets and confidential commercial or
financial information prohibited from disclosure by 21 U.S.C. 331(j), 21
U.S.C. 360(j)(c), 42 U.S.C. 263g(d) and 42 U.S.C. 263i(e) may be
released only as provided by those sections. Any disclosure under this
section shall be pursuant to a written agreement that the record shall
not be further disclosed by the other department or agency except with
the written permission of the Food and Drug Administration.
[47 FR 10804, Mar. 12, 1982, as amended at 59 FR 536, Jan. 5, 1994]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.86]
[Page 213-214]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart E--Limitations on Exemptions
Sec. 20.86 Disclosure in administrative or court proceedings.
Data and information otherwise exempt from public disclosure may be
revealed in Food and Drug Administration administrative proceedings
pursuant to parts 10, 12, 13, 14, 15, 17, and 19
[[Page 214]]
of this chapter or court proceedings, where data or information are
relevant. The Food and Drug Administration will take appropriate
measures, or request that appropriate measures be taken, to reduce
disclosure to the minimum necessary under the circumstances.
[42 FR 15616, Mar. 22, 1977, as amended at 60 FR 38633, July 27, 1995]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.87]
[Page 214]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart E--Limitations on Exemptions
Sec. 20.87 Disclosure to Congress.
(a) All records of the Food and Drug Administration shall be
disclosed to Congress upon an authorized request.
(b) An authorized request for Food and Drug Administration records
by Congress shall be made by the chairman of a committee or subcommittee
of Congress acting pursuant to committee business.
(c) An individual member of Congress who requests a record for his
own use or on behalf of any constituent shall be subject to the same
rules in this part that apply to any other member of the public.
[42 FR 15616, Mar. 22, 1977, as amended at 59 FR 536, Jan. 5, 1994]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.88]
[Page 214-216]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart E--Limitations on Exemptions
Sec. 20.88 Communications with State and local government officials.
(a) A State or local government official commissioned by the Food
and Drug Administration pursuant to 21 U.S.C. 372(a) shall have the same
status with respect to disclosure of Food and Drug Administration
records as any special government employee.
(b) Communications with State and local government officials with
respect to law enforcement activities undertaken pursuant to a contract
between the Food and Drug Administration and such officials shall be
subject to the rules for public disclosure established in Sec. 20.64.
(c) Communications with State and local government officials who are
not commissioned pursuant to 21 U.S.C. 372(a) or under a contract to
perform law enforcement activities shall have the same status as
communications with any member of the public, except that:
(1) Investigatory records compiled for law enforcement purposes by
State and local government officials who perform counterpart functions
to the Food and Drug Administration at the State and local level, and
trade secrets and confidential commercial or financial information
obtained by such officials, which are voluntarily disclosed to the Food
and Drug Administration as part of cooperative law enforcement and
regulatory efforts, shall be exempt from public disclosure to the same
extent to which the records would be so exempt pursuant to Secs. 20.61
and 20.64, as if they had been prepared by or submitted directly to Food
and Drug Administration employees, except that investigatory records
shall be exempt from disclosure for a longer period of time if the State
or local government officials so require as a condition of their
furnishing the information to the Food and Drug Administration.
(2) Disclosure of investigatory records compiled for law enforcement
purposes by the Food and Drug Administration to State and local
government officials who perform counterpart functions to the Food and
Drug Administratrion at the State and local level as part of cooperative
law enforcement efforts does not invoke the rule established in
Sec. 20.21 that such records shall be made available for disclosure to
all members of the public.
(d)(1) The Commissioner of Food and Drugs, or any other officer or
employee of the Food and Drug Administration whom the Commissioner may
designate to act on his or her behalf for the purpose, may authorize the
disclosure of confidential commercial information submitted to the Food
and Drug Administration, or incorporated into agency-prepared records,
to State government officials as part of cooperative law enforcement or
regulatory efforts, provided that:
(i) The State government agency has provided both a written
statement establishing its authority to protect confidential commercial
information from public disclosure and a written commitment not to
disclose any such information provided without the written permission of
the sponsor or written confirmation by the Food and Drug Administration
that the information no longer has confidential status; and
(ii) The Commissioner of Food and Drugs or the Commissioner's
designee
[[Page 215]]
makes one or more of the following determinations:
(A) The sponsor of the product application has provided written
authorization for the disclosure;
(B) Disclosure would be in the interest of public health by reason
of the State government's possessing information concerning the safety,
effectiveness, or quality of a product or information concerning an
investigation, or by reason of the State government being able to
exercise its regulatory authority more expeditiously than the Food and
Drug Administration; or
(C) The disclosure is to a State government scientist visiting the
Food and Drug Administration on the agency's premises as part of a joint
review or long-term cooperative training effort authorized under section
708 of the Federal Food, Drug, and Cosmetic Act (the act), the review is
in the interest of public health, the Food and Drug Administration
retains physical control over the information, the Food and Drug
Administration requires the visiting State government scientist to sign
a written commitment to protect the confidentiality of the information,
and the visiting State government scientist provides a written assurance
that he or she has no financial interest in the regulated industry of
the type that would preclude participation in the review of the matter
if the individual were subject to the conflict of interest rules
applicable to the Food and Drug Administration advisory committee
members under Sec. 14.80(b)(1) of this chapter. Subject to all the
foregoing conditions, a visiting State government scientist may have
access to trade secret information, entitled to protection under section
301(j) of the act, in those cases where such disclosures would be a
necessary part of the joint review or training.
(2) Except as provided under paragraph (d)(1)(ii)(C) of this
section, this provision does not authorize the disclosure to State
government officials of trade secret information concerning
manufacturing methods and processes prohibited from disclosure by
section 301(j) of the act, unless pursuant to an express written
authorization provided by the submitter of the information.
(3) Any disclosure under this section of information submitted to
the Food and Drug Administration or incorporated into agency-prepared
records does not invoke the rule established in Sec. 20.21 that such
records shall be made available to all members of the public.
(e)(1) The Senior Associate Commissioner for Policy, Planning, and
Legislation, or the Deputy Commissioner for International and
Constituent Relations, or any other officer or employee of the Food and
Drug Administration whom the Senior Associate Commissioner for Policy,
Planning, and Legislation or the Deputy Commissioner for International
and Constituent Relations may designate to act on their behalf for the
purpose, may authorize the disclosure to, or receipt from, an official
of a State government agency of nonpublic, predecisional documents
concerning the Food and Drug Administration's or the other government
agency's regulations or other regulatory requirements, or other
nonpublic information relevant to either agency's activities, as part of
efforts to improve Federal-State uniformity, cooperative regulatory
activities, or implementation of Federal-State agreements, provided
that:
(i) The State government agency has the authority to protect such
nonpublic documents from public disclosure and will not disclose any
such documents provided without the written confirmation by the Food and
Drug Administration that the documents no longer have nonpublic status;
and
(ii) The Senior Associate Commissioner for Policy, Planning, and
Legislation or the Deputy Commissioner for International and Constituent
Relations or their designee makes the determination that the exchange is
reasonably necessary to improve Federal-State uniformity, cooperative
regulatory activities, or implementation of Federal-State agreements.
(2) Any exchange under this section of nonpublic documents does not
invoke the rule established at Sec. 20.21 that such records shall be
made available to all members of the public.
(3) For purposes of this paragraph, the term official of a State
government agency includes, but is not limited to,
[[Page 216]]
an agent contracted by the State government, and an employee of an
organization of State officials having responsibility to facilitate
harmonization of State standards and requirements in FDA's areas of
responsibility. For such officials, the statement and commitment
required by paragraph (e)(1)(i) of this section shall be provided by
both the organization and the individual.
[42 FR 15616, Mar. 22, 1977, as amended at 60 FR 63381, Dec. 8, 1995; 65
FR 11887, Mar. 7, 2000]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.89]
[Page 216-217]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart E--Limitations on Exemptions
Sec. 20.89 Communications with foreign government officials.
Communications with foreign government officials shall have the same
status as communications with any member of the public, except that:
(a) Investigatory records compiled for law enforcement purposes by
foreign government officials who perform counterpart functions to the
Food and Drug Administration in a foreign country, and trade secrets and
confidential commercial or financial information obtained by such
officials, which are voluntarily disclosed to the Food and Drug
Administration as part of cooperative law enforcement and regulatory
efforts, shall be exempt from public disclosure to the same extent to
which the records would be so exempt pursuant to Secs. 20.61 and 20.64,
as if they had been prepared by or submitted directly to Food and Drug
Administration employees, except that investigatory records shall be
exempt from disclosure for a longer period of time if the foreign
government officials so require as a condition of their furnishing the
information to the Food and Drug Administration.
(b) Disclosure of investigatory records compiled for law enforcement
purposes by the Food and Drug Administration to foreign government
officials who perform counterpart functions to the Food and Drug
Administration in a foreign country as part of cooperative law
enforcement efforts does not invoke the rule established in Sec. 20.21
that such records shall be made available for disclosure to all members
of the public.
(c)(1) The Commissioner of Food and Drugs, or any other officer or
employee of the Food and Drug Administration whom the Commissioner may
designate to act on his or her behalf for the purpose, may authorize the
disclosure of confidential commercial information submitted to the Food
and Drug Administration, or incorporated into agency-prepared records,
to foreign government officials who perform counterpart functions to the
Food and Drug Administration as part of cooperative law enforcement or
regulatory efforts, provided that:
(i) The foreign government agency has provided both a written
statement establishing its authority to protect confidential commercial
information from public disclosure and a written commitment not to
disclose any such information provided without the written permission of
the sponsor or written confirmation by the Food and Drug Administration
that the information no longer has confidential status; and
(ii) The Commissioner of Food and Drugs or the Commissioner's
designee makes one or more of the following determinations:
(A) The sponsor of the product application has provided written
authorization for the disclosure;
(B) Disclosure would be in the interest of public health by reason
of the foreign government's possessing information concerning the
safety, efficacy, or quality of a product or information concerning an
investigation; or
(C) The disclosure is to a foreign scientist visiting the Food and
Drug Administration on the agency's premises as part of a joint review
or long-term cooperative training effort authorized under section 708 of
the act, the review is in the interest of public health, the Food and
Drug Administration retains physical control over the information, the
Food and Drug Administration requires the visiting foreign scientist to
sign a written commitment to protect the confidentiality of the
information, and the scientist provides a written assurance that he or
she has no financial interest in the regulated industry of the type that
would preclude participation in the review of the matter if the
individual were subject to the conflict of interest rules applicable to
the Food and Drug Administration advisory committee members under
Sec. 14.80(b)(1)
[[Page 217]]
of this chapter. Subject to all of the foregoing conditions, visiting
foreign scientists may have access to trade secret information, entitled
to protection under section 301(j) of the Federal Food, Drug, and
Cosmetic Act (the act), in those cases where such disclosures would be a
necessary part of the joint review or training.
(2) Except as provided under paragraph (c)(1)(ii)(C) of this
section, this provision does not authorize the disclosure to foreign
government officials of other countries of trade secret information
concerning manufacturing methods and processes prohibited from
disclosure by section 301(j) of the act, unless pursuant to an express
written authorization provided by the submitter of the information.
(3) Any disclosure under this section of information submitted to
the Food and Drug Administration or incorporated into agency-prepared
records does not invoke the rule established in Sec. 20.21 that such
records shall be made available to all members of the public.
(d)(1) The Senior Associate Commissioner for Policy, Planning, and
Legislation, or the Deputy Commissioner for International and
Constituent Relations, or any other officer or employee of the Food and
Drug Administration whom the Senior Associate Commissioner for Policy,
Planning, and Legislation or the Deputy Commissioner for International
and Constituent Relations may designate to act on their behalf for the
purpose, may authorize the disclosure to, or receipt from, an official
of a foreign government agency of nonpublic, predecisional documents
concerning the Food and Drug Administration's or the other government
agency's regulations or other regulatory requirements, or other
nonpublic information relevant to either agency's activities, as part of
cooperative efforts to facilitate global harmonization of regulatory
requirements, cooperative regulatory activities, or implementation of
international agreements, provided that:
(i) The foreign government agency has the authority to protect such
nonpublic documents from public disclosure and will not disclose any
such documents provided without the written confirmation by the Food and
Drug Administration that the documents no longer have nonpublic status;
and
(ii) The Senior Associate Commissioner for Policy, Planning, and
Legislation or the Deputy Commissioner for International and Constituent
Relations or their designee makes the determination that the exchange is
reasonably necessary to facilitate global harmonization of regulatory
requirements, cooperative regulatory activities, or implementation of
international agreements.
(2) Any exchange under this section of nonpublic documents does not
invoke the rule established in Sec. 20.21 that such records shall be
made available to all members of the public.
(e) For purposes of this section, the term ``official of a foreign
government agency'' includes, but is not limited to, employees (whether
temporary or permanent) of and agents contracted by the foreign
government, or by an international organization established by law,
treaty, or other governmental action and having responsibility to
facilitate global or regional harmonization of standards and
requirements in FDA's areas of responsibility or to promote and
coordinate public health efforts. For such officials, the statement and
commitment required by paragraph (c)(1)(i) of this section shall be
provided on behalf of both the organization and the individual.
[42 FR 15616, Mar. 22, 1977, as amended at 58 FR 61603, Nov. 19, 1993;
60 FR 63382, Dec. 8, 1995; 65 FR 11888, Mar. 7, 2000]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.90]
[Page 217-218]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart E--Limitations on Exemptions
Sec. 20.90 Disclosure to contractors.
(a) Data and information otherwise exempt from public disclosure may
be disclosed to contractors with the Food and Drug Administration and
their employees for use only in their work for the Food and Drug
Administration. Contractors and their employees are thereafter subject
to the same legal restrictions and penalties with respect to the
disclosure of such data and information as Food and Drug Administration
employees.
(b) A written agreement between the Food and Drug Administration and
any contractor shall be entered into before data and information
otherwise exempt from public disclosure may be disclosed to the
contractor. The contractor shall
[[Page 218]]
agree to establish and follow security precautions considered by the
Food and Drug Administration to be necessary to ensure proper and
confidential handling of the data and information. The written agreement
shall include, where appropriate, provisions establishing:
(1) Restrictions on access to the data and information by the
contractor, its employees, or other persons;
(2) Physical storage requirements;
(3) Requirements for the handling and accountability of the data and
information by the contractor and its employees;
(4) Limitations on reproduction, transmission, and disclosure of the
data and information;
(5) A requirement of advance approval by the Food and Drug
Administration of the use by the contractor of subcontractors, vendors,
or suppliers;
(6) Procedures to be followed when the contractor employs time-
shared computer operations;
(7) Methods of destroying source documents or related waste
material; and
(8) The period during which the contractor may retain such data and
information.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.91]
[Page 218]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart E--Limitations on Exemptions
Sec. 20.91 Use of data or information for administrative or court enforcement action.
Nothing in this part or this chapter shall prevent the Food and Drug
Administration from using any data or information, whether obtained
voluntarily or involuntarily and whether or not it is available for
public disclosure, as the basis for taking any administrative or court
enforcement action within its jurisdiction. Data and information
otherwise exempt from public disclosure are nevertheless available for
public disclosure to the extent necessary to effectuate such action,
e.g., the brand name, code designation, and distribution information are
released when a product is recalled.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.100]
[Page 218-219]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.100 Applicability; cross-reference to other regulations.
(a) The provisions set forth in this subpart or cross-referenced in
paragraph (c) of this section state the way in which specific categories
of Food and Drug Administration records are handled upon a request for
public disclosure. The exemptions established in subpart D of this part
and the limitations on exemptions established in subpart E of this part
shall be applicable to all Food and Drug Administration records, as
provided in Secs. 20.60 and 20.80. Accordingly, a record that is
ordinarily available for public disclosure in accordance with this part
or under other regulations is not available for such disclosure to the
extent that it falls within an exemption contained in subpart D of this
part except as provided by the limitations on exemptions specified in
subpart E of this part.
(b) The Commissioner, on his own initiative or on the petition of
any interested person, may amend this subpart or promulgate and cross-
reference additional regulations to state the status of additional
categories of documents to settle pending questions or to reflect court
decisions.
(c) In addition to the provisions of this part, rules on the
availability of the following specific categories of Food and Drug
Administration records are established by regulations in this chapter:
(1) Section 305 hearing records, in Sec. 7.87(c) of this chapter.
(2) Flavor ingredient records and notes, in Sec. 101.22(i)(4)(iv) of
this chapter.
(3) Environmental assessments; finding of no significant impact, in
Sec. 25.51 of this chapter, or draft and final environmental impact
statements, in Sec. 25.52 of this chapter.
(4) Color additive petitions, in Sec. 71.15 of this chapter.
(5) Food standard temporary permits, in Sec. 130.17(k) of this
chapter.
(6) Information on thermal processing of low-acid foods packaged in
hermetically sealed containers, in Sec. 108.35(l) of this chapter.
(7) Food additive petitions, in Secs. 171.1(h) and 571.1(h) of this
chapter.
(8) Action levels for natural and unavoidable defects in food for
human use, in Sec. 110.110(e) of this chapter.
(9) Drug establishment registrations and drug listings, in
Sec. 207.37 of this chapter.
[[Page 219]]
(10) Investigational new animal drug notices, in Sec. 514.12 of this
chapter.
(11) New animal drug application files, in Sec. 514.11 of this
chapter.
(12) Investigational new animal drug notice and a new animal drug
application file for an antibiotic drug, in Sec. 514.10 of this chapter.
(13) Methadone patient records, in Sec. 291.505(g) of this chapter.
(14) Investigational new drug notice, in Sec. 312.130 of this
chapter.
(15) Labeling for and lists of approved new drug applications, in
Sec. 314.430 of this chapter.
(16) Master file for a new drug application, in Sec. 312.420 of this
chapter.
(17) New drug application file, in Sec. 314.430 of this chapter.
(18) Data and information submitted for in vitro diagnostic
products, in Sec. 809.4 of this chapter.
(19) Data and information submitted for OTC drug review, in
Sec. 330.10(a)(2) of this chapter.
(20) Investigational new drug notice for an antibiotic drug, in
Sec. 431.70 of this chapter.
(21) Antibiotic drug file, in Sec. 314.430 of this chapter.
(22) Data and information submitted for biologics review, in
Sec. 601.25(b)(2) of this chapter.
(23) Investigational new drug notice for a biological product, in
Sec. 601.50 of this chapter.
(24) Applications for biologics licenses for biological products, in
Sec. 601.51 of this chapter.
(25) Cosmetic establishment registrations, in Sec. 710.7 of this
chapter.
(26) Cosmetic product ingredient and cosmetic raw material
composition statements, Sec. 720.8 of this chapter.
(27) Cosmetic product experience reports, in Sec. 730.7 of this
chapter.
(28) Device premarket notification submissions, in Sec. 807.95 of
this chapter.
(29) Electronic product information, in Secs. 1002.4 and 1002.42 of
this chapter.
(30) Data and information submitted to the Commissioner or to
classification panels in connection with the classification or
reclassification of devices intended for human use, in Sec. 860.5 of
this chapter.
(31) Data and information submitted in offers to develop a proposed
performance standard for medical devices, in Sec. 861.26 of this
chapter.
(32) Investigational device exemptions in Sec. 812.38 of this
chapter.
(33) Health claims petitions, in Sec. 101.70 of this chapter.
(34) Premarket approval application, in Sec. 814.9 of this chapter.
(35) Report of certain adverse experiences with a medical device, in
Sec. 803.9 of this chapter.
(36) Disqualification determination of an institutional review
board, in Sec. 56.122 of this chapter.
(37) Disqualification determination of a nonclinical laboratory, in
Sec. 58.213 of this chapter.
(38) Minutes or records regarding a public advisory committee, in
Sec. 14.65(c) of this chapter.
(39) Data submitted regarding persons receiving an implanted
pacemaker device or lead, in Sec. 805.25 of this chapter.
(40) Humanitarian device exemption application, in Sec. 814.122 of
this chapter.
[42 FR 15616, Mar. 22, 1977, as amended at 42 FR 19989, Apr. 15, 1977;
42 FR 42526, Aug. 28, 1977; 42 FR 58889, Nov. 11, 1977; 43 FR 32993,
July 28, 1978; 51 FR 22475, June 19, 1986; 54 FR 9038, Mar. 3, 1989; 58
FR 2533, Jan. 6, 1993; 59 FR 536, Jan. 5, 1994; 61 FR 33244, June 26,
1996; 62 FR 40592, July 29, 1997; 64 FR 56448, Oct. 20, 1999; 67 FR
13717, Mar. 26, 2002]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.101]
[Page 219-220]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.101 Administrative enforcement records.
(a) All Food and Drug Administration records relating to
administrative enforcement action disclosed to any member of the public,
including the person who is the subject of such action, are available
for public disclosure at the time such disclosure is first made. Such
records include correspondence with companies following factory
inspection, recall or detention requests, notice of refusal of admission
of an imported product, regulatory letters, information letters, Forms
FD-483 and FD-2275 furnished to companies after factory inspection, and
similar records.
(b) To the extent that any of such records fall within the exemption
for investigatory records established in Sec. 20.64, the Commissioner
determines that they are subject to discretionary release pursuant to
Sec. 20.82.
[[Page 220]]
(c) Records relating to administrative enforcement action that are
not disclosed to any member of the public constitute investigatory
records that are subject to the rules for disclosure established in
Sec. 20.64. For example, an establishment inspection report is an
investigatory record and thus subject to Sec. 20.64 except insofar as
the Commissioner exercises his discretion to release it pursuant to
Sec. 20.82.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.102]
[Page 220]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.102 Court enforcement records.
(a) All records and documents filed in the courts are available for
public disclosure unless the court orders otherwise. The Food and Drug
Administration will make available for public disclosure such records or
documents if the agency can determine that it has an accurate copy of
the actual record or document filed in the court. If the Food and Drug
Administration cannot determine whether it has an accurate copy of such
a record or document, the person requesting a copy shall be referred to
the court involved.
(b) After a recommendation for court action has been finally refused
by a United States attorney, the correspondence with the United States
attorney and the Department of Justice with respect to that
recommendation, including the pleadings recommended for filing with the
court, is available for public disclosure. Prior to disclosure of any
record specifically reflecting consideration of possible criminal
prosecution of any individual, all names and other information that
would identify an individual who was considered for criminal prosecution
but who was not prosecuted shall be deleted unless the Commissioner
concludes that there is a compelling public interest in the disclosure
of such names.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.103]
[Page 220]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.103 Correspondence.
(a) All correspondence to and from members of the public, members of
Congress, organization or company officials, or other persons, except
members of the Executive Branch of the Federal Government and special
government employees, is available for public disclosure.
(b) Any such correspondence is available for public disclosure at
the time that it is sent or received by the Food and Drug Administration
unless a different time for such disclosure is specified in other rules
established or cross-referenced in this part, e.g., correspondence
relating to an IND notice or an NDA in Sec. 314.430 of this chapter.
[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.104]
[Page 220]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.104 Summaries of oral discussions.
(a) All written summaries of oral discussions, whether in person or
by telephone, with members of the public, members of Congress,
organization or company officials, or other persons, except members of
the Executive Branch of the Federal government or special government
employees, are available for public disclosure.
(b) Any such summary is available for public disclosure at the time
that it is prepared by the Food and Drug Administration unless a
different time for such disclosure is specified in other rules
established or cross-referenced in this part, e.g., summaries of oral
discussions relating to a food additive petition in Sec. 171.1(h)(3) of
this chapter.
(c) If more than one summary of an oral discussion exists in a Food
and Drug Administration file, all such summaries shall be disclosed in
response to any request for such summary.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.105]
[Page 220-221]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.105 Testing and research conducted by or with funds provided by the
Food and Drug Administration.
(a) Any list that may be prepared by the Food and Drug
Administration of testing and research being conducted by or with funds
provided by the Food and Drug Administration is available for public
disclosure.
(b) Any contract relating to agency testing and research, and any
progress report relating thereto, is available for public disclosure.
(c) The results of all testing or research conducted by or with
funds provided by the Food and Drug Administration, such as
toxicological testing, compliance assays, methodology studies, and
product testing, are available for public disclosure when the final
report is complete and accepted by the
[[Page 221]]
responsible Food and Drug Administration official, after deletion of any
information that would reveal confidential investigative techniques and
procedures, e.g., the use of ``markers'' to document adulteration of a
product. If such results are disclosed in an authorized manner to any
member of the public before the final report is available, they are
immediately available for public disclosure to any member of the public
who requests them.
(d) Access to all raw data, slides, worksheets, and other similar
working materials shall be provided at the same time that the final
report is disclosed.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.106]
[Page 221]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.106 Studies and reports prepared by or with funds provided by the
Food and Drug Administration.
(a) The following types of reports and studies prepared by or with
funds provided by the Food and Drug Administration are available for
public disclosure upon their acceptance by the responsible agency
official:
(1) Quarterly and annual reports of the agency.
(2) External investigations or review of agency needs and
performance.
(3) Surveys, compilations, and summaries of data and information.
(4) Consumer surveys.
(5) Compliance surveys.
(6) Compliance programs, except that names of specific firms, the
location of specific activities, and details about sampling numbers or
sizes shall be deleted until implementation of the program is completed.
(7) Work plans prepared by Food and Drug Administration centers,
field offices, and other components, except that names of specific
firms, the location of specific activities, and details about sampling
numbers or sizes shall be deleted until implementation of the plan is
completed.
(b) The following types of reports and studies prepared by or with
funds provided by the Food and Drug Administration are not available for
public disclosure:
(1) Internal audits of agency needs and performance.
(2) Records relating to the internal planning and budget process.
(3) Legislative proposals or comments prior to submission to
Congress.
[42 FR FR 15616, Mar. 22, 1977, as amended at 50 FR 8995, Mar. 6, 1985]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.107]
[Page 221]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.107 Food and Drug Administration manuals.
(a) All Food and Drug Administration Staff Manuals and instructions
to staff that affect a member of the public are available for public
disclosure. An index of all such manuals is available at the Food and
Drug Administration's Freedom of Information Public Room in accordance
with Sec. 20.26.
(b) Manuals relating solely to internal personnel rules and
practices are not available for public disclosure except to the extent
that the Commissioner determines that they should be disclosed pursuant
to Sec. 20.82.
(c) All Food and Drug Administration action levels which are used to
determine when the agency will take regulatory action against a
violative product, limits of sensitivity and variability of analytical
methods which are used in determining whether a product violates the
law, and direct reference levels above which Food and Drug
Administration field offices may request legal action directly to the
office of the General Counsel, are available for public disclosure.
[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 46
FR 14340, Feb. 27, 1981]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.108]
[Page 221-222]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.108 Agreements between the Food and Drug Administration and other departments,
agencies, and organizations.
(a) All written agreements and understandings signed by the Food and
Drug Administration and other departments, agencies, and organizations
are available for public disclosure.
(b) A permanent file of all such agreements and understandings is
available for public review during working hours in the Food and Drug
Administration's Freedom of Information Public Room.
(c) All such agreements and understandings shall be published in the
Federal Register, except those agreements and memoranda of understanding
between FDA and State or
[[Page 222]]
local government agencies that are cooperative work-sharing agreements.
In lieu of publication of the complete text of these agreements and
understandings, FDA will publish in the Federal Register periodically,
but not less than once every 2 years, a notice listing all such
agreements and memoranda of understanding currently in effect between
FDA and State or local government agencies.
(d) Agreements and understandings signed by officials of FDA with
respect to activities of the Office of Criminal Investigations are
exempt from the requirements set forth in paragraphs (b) and (c) of this
section. Although such agreements and understandings will not be put on
display in FDA's Freedom of Information Public Room or published in the
Federal Register, these agreements will be available for disclosure in
response to a request from the public after deletion of information that
would disclose confidential investigative techniques or procedures, or
information that would disclose guidelines for law enforcement
investigations if such disclosure could reasonably be expected to risk
circumvention of the law.
[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 58
FR 48794, 48796, Sept. 20, 1993]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.109]
[Page 222]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.109 Data and information obtained by contract.
(a) All data and information obtained by the Food and Drug
Administration by contract, including all progress reports pursuant to a
contract, are available for public disclosure when accepted by the
responsible agency official except to the extent that they remain
subject to an exemption established in subpart D of this part, e.g.,
they relate to law enforcement matters as provided in Sec. 20.88(b).
(b) Upon the awarding of a contract by the Food and Drug
Administration, the technical proposal submitted by the successful
offeror will be available for public disclosure. All cost proposals and
the technical proposals of unsuccessful offerors submitted in response
to a request for proposals are exempt from disclosure as confidential
commercial or financial information pursuant to Sec. 20.61.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.110]
[Page 222]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.110 Data and information about Food and Drug Administration employees.
(a) The name, title, grade, position description, salary, work
address, and work telephone number for every Food and Drug
Administration employee are available for public disclosure. The home
address and home telephone number of any such employee are not available
for public disclosure.
(b) Statistics on the prior employment experience of present agency
employees, and subsequent employment of past agency employees, are
available for public disclosure.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.111]
[Page 222-224]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.111 Data and information submitted voluntarily to the Food and Drug Administration.
(a) The provisions of this section shall apply only to data and
information submitted voluntarily to the Food and Drug Administration,
whether in the course of a factory inspection or at any other time, and
not as a part of any petition, application, master file, or other
required submission or request for action. Data and information that may
be required to be submitted to the Food and Drug Administration but that
are submitted voluntarily instead are not subject to the provisions of
this section and will be handled as if they had been required to be
submitted.
(b) A determination that data or information submitted voluntarily
will be held in confidence and will not be available for public
disclosure shall be made only in the form of a regulation published or
cross-referenced in this part or by a written determination pursuant to
the procedure established in Sec. 20.44.
(c) The following data and information submitted voluntarily to the
Food and Drug Administration are available for public disclosure unless
extraordinary circumstances are shown:
(1) All safety, effectiveness, and functionality data and
information for a marketed ingredient or product, except as provided in
Sec. 330.10(a)(2) of this chapter for OTC drugs.
(2) A protocol for a test or study, unless it is shown to fall
within the exemption established in Sec. 20.61 for trade secrets and
confidential commercial or financial information.
[[Page 223]]
(3) Adverse reaction reports, product experience reports, consumer
complaints, and other similar data and information shall be disclosed as
follows:
(i) If submitted by a consumer or user of the product, the record is
available for public disclosure after deletion of names and other
information that would identify the person submitting the information.
(ii) If submitted by the manufacturer of the product, the record is
available for public disclosure after deletion of:
(a) Names and any information that would identify the person using
the product.
(b) Names and any information that would identify any third party
involved with the report, such as a physician or hospital or other
institution.
(c) Names and any other information that would identify the
manufacturer or the brand designation of the product, but not the type
of product or its ingredients.
(iii) If submitted by a third party, such as a physician or hospital
or other institution, the record is available for public disclosure
after deletion of:
(a) Names and any information that would identify the person using
the product.
(b) Names and any information that would identify any third party
involved with the report, such as a physician or hospital or other
institution.
(iv) If obtained through a Food and Drug Administration
investigation, the record shall have the same status as the initial
report which led to the investigation, i.e., it shall be disclosed in
accordance with paragraph (c)(3)(i) through (iii) of this section.
(v) Any compilation of data, information, and reports prepared in a
way that does not reveal data or information which is not available for
public disclosure under this section is available for public disclosure.
(vi) If a person requests a copy of any such record relating to a
specific individual or a specific incident, such request will be denied
unless accompanied by the written consent to such disclosure of the
person who submitted the report to the Food and Drug Administration and
the individual who is the subject of the report. The record will be
disclosed to the individual who is the subject of the report upon
request.
(4) A list of all ingredients contained in a food or cosmetic,
whether or not it is in descending order of predominance, or a list of
all active ingredients and any inactive ingredients previously disclosed
to the public as defined in Sec. 20.81 contained in a drug, or a list of
all ingredients or components in a device. A particular ingredient or
component or group of ingredients or components shall be deleted from
any such list for a cosmetic or device prior to public disclosure upon a
determination made pursuant to Sec. 20.44 that the ingredient or
ingredients fall within the exemption established in Sec. 20.61 for
trade secrets and confidential commercial information, and a notation
shall be made that any such ingredient list is incomplete.
(5) An assay method or other analytical method, unless it serves no
regulatory or compliance purpose and is shown to fall within the
exemption established in Sec. 20.61.
(d) The following data and information submitted voluntarily to the
Food and Drug Administration are not available for public disclosure
unless they have been previously disclosed to the public as defined in
Sec. 20.81 or they relate to a product or ingredient that has been
abandoned and they no longer represent a trade secret or confidential
commercial or financial information as defined in Sec. 20.61:
(1) All safety, effectiveness, and functionality data and
information for a developmental ingredient or product that has not
previously been disclosed to the public as defined in Sec. 20.81.
(2) Manufacturing methods or processes, including quality control
procedures.
(3) Production, sales, distribution, and similar data and
information, except that any compilation of such data and information
aggregated and prepared in a way that does not reveal data or
information which is not available for public disclosure under this
provision is available for public disclosure.
(4) Quantitative or semiquantitative formulas.
(e) For purposes of this regulation, safety, effectiveness, and
functionality
[[Page 224]]
data include all studies and tests of an ingredient or a product on
animals and humans and all studies and tests on the ingredient or
product for identity, stability, purity, potency, bioavailability,
performance, and usefulness.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.112]
[Page 224]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.112 Voluntary drug experience reports submitted by physicians and hospitals.
(a) A voluntary drug experience report to the Food and Drug
Administration on FDA Form 3500 shall be handled in accordance with the
rules established in Sec. 20.111(c)(3)(iii).
(b) If a person requests a copy of any such record relating to a
specific individual or a specific incident, such request will be denied
unless accompanied by the written consent to such disclosure of the
person who submitted the report to the Food and Drug Administration and
the individual who is the subject of the report.
[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989; 62
FR 52249, Oct. 7, 1997]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.113]
[Page 224]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.113 Voluntary product defect reports.
Voluntary reports of defects in products subject to the jurisdiction
of the Food and Drug Administration are available for public disclosure:
(a) If the report is submitted by the manufacturer, after deletion
of data and information falling within the exemptions established in
Sec. 20.61 for trade secrets and confidential commercial or financial
information and in Sec. 20.63 for personal privacy.
(b) If the report is submitted by any person other than the
manufacturer, after deletion of names and other information that would
identify the person submitting the report and any data or information
falling within the exemption established in Sec. 20.63 for personal
privacy.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.114]
[Page 224]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.114 Data and information submitted pursuant to cooperative quality assurance
agreements.
Data and information submitted to the Food and Drug Administration
pursuant to a cooperative quality assurance agreement shall be handled
in accordance with the rules established in Sec. 20.111.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.115]
[Page 224]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.115 Product codes for manufacturing or sales dates.
Data or information in Food and Drug Administration files which
provide a means for deciphering or decoding a manufacturing date or
sales date or use date contained on the label or in labeling or
otherwise used in connection with a product subject to the jurisdiction
of the Food and Drug Administration are available for public disclosure.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.116]
[Page 224]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.116 Drug and device listing information.
Information submitted to the Food and Drug Administration pursuant
to section 510 (a)-(j) of the act shall be subject only to the special
disclosure provisions established in Secs. 207.37 and 807.37 of this
chapter.
[42 FR 42526, Aug. 23, 1977]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.117]
[Page 224-225]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.117 New drug information.
(a) The following computer printouts are available for public
inspection in the Food and Drug Administration's Freedom of Information
Public Room:
(1) A numerical listing of all new drug applications and abbreviated
new drug applications approved since 1938, showing the NDA number, the
trade name, the applicant, the approval date, and, where applicable, the
date the approval was withdrawn and the date the Food and Drug
Administration was notified that marketing of the product was
discontinued.
(2) A numerical listing of all new drug applications and abbreviated
new drug applications approved since 1938 which are still approved,
showing the same information as is specified in paragraph (a)(1) of this
section except that it does not show a withdrawal date.
(3) A listing of new drug applications, abbreviated new drug
applications, which were approved since 1938 and which are still
approved, covering marketed prescription drug products except
prescription drug products covered by applications deemed approved under
the Drug Amendments of 1962 and not yet determined to be effective in
the Drug Efficacy Study Implementation program. The listing includes the
name of the active ingredient, the type of
[[Page 225]]
dosage form, the route of administration, the trade name of the product,
the name of the application holder, and the strength or potency of the
product. The listing also includes, for each active ingredient in a
particular dosage form for which there is more than one approved
application, an evaluation of the therapeutic equivalence of the drug
products covered by such applications.
(b) Other computer printouts containing IND and NDA information are
available to the extent that they do not reveal data or information
prohibited from disclosure under Secs. 20.61, 312.130, and 314.430 of
this chapter.
[42 FR 15616, Mar. 22, 1977, as amended at 45 FR 72608, Oct. 31, 1980;
46 FR 8457, Jan. 27, 1981; 54 FR 9038, Mar. 3, 1989; 64 FR 399, Jan. 5,
1999]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.118]
[Page 225]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.118 Advisory committee records.
All advisory committee records shall be handled in accordance with
the rules established in parts 10, 12, 13, 14, 15, 16, and 19 of this
chapter.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.119]
[Page 225]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20--PUBLIC INFORMATION--Table of Contents
Subpart F--Availability of Specific Categories of Records
Sec. 20.119 Lists of names and addresses.
Names and addresses of individuals in Food and Drug Administration
records shall not be sold or rented. Names and addresses shall not be
disclosed if disclosure is prohibited as a clearly unwarranted invasion
of personal privacy, e.g., lists of names and home addresses of Food and
Drug Administration employees, which shall not be disclosed under
Sec. 20.110.