Purpose of Guidance Documents
Guidance documents are intended to:
provide information to the public and assistance to the regulated
industry by clarifying requirements that have been imposed
by Congress or issued by FDA in regulations, by explaining
how to comply with statutory and regulatory requirements,
and provide specific review and enforcement approaches to
help ensure that FDA employees implement the agency's mandate
in an effective, fair, and consistent manner.
Certain guidance documents provide information on important
characteristics of pre-clinical and clinical test procedures,
manufacturing practices, and scientific protocols. Others
provide information on how to comply with the relevant statutes
and regulations, avoid enforcement actions, or evaluate a
submission.
Legal Effect of Guidance Documents
Guidance documents are not legally binding on the public
or the agency. They represent the agency's current thinking
on the subject. While we will take steps to ensure that CVM
staff do not deviate from the guidance without appropriate
justification and appropriate supervisory concurrence, it
is acceptable for the regulated industry to use alternative
methods that comply with the relevant statute or regulations.
If a regulated company or person wishes to use an approach
that is different from that described in a guidance document,
FDA is willing to discuss the alternative methods of complying
with the applicable statutes or regulations. FDA encourages
the industry to discuss alternative methods before implementing
them to avoid unnecessary or wasteful expenditures of resources.
CVM develops and issues its guidance documents (guidances)
in accordance with FDA's good guidance practices (GGP) regulations
(21 CFR 10.115) published in the Federal Register on September
19, 2000 (65 FR 5646). The procedures differ for developing
and issuing Level 1 and Level 2 guidances. Usually, the agency
must request public comment before implementing Level 1 guidances,
while it may implement Level 2 guidances without prior comment.
Thus, CVM usually publishes Level 1 guidances in draft form
with a request for comments and, after it reviews comments,
publishes the guidance in final form. The criteria for determining
whether a guidance is Level 1 or 2 are found at 21 CFR 10.115(c).
(See Code of Federal Register Citations at the end of this
document.)
The GGP regulations encourage public participation in the
development and issuance of guidances. For example, the public
may comment at any time on a draft or final guidance that
the agency has issued. Anyone may suggest that the agency
revise or withdraw an existing guidance, and anyone may submit
a draft of a proposed guidance. The GGP regulations at 21
CFR 10.115 (f) describe how the public may participate. (See
Code of Federal Register Citations at the end of this document.)
To Comment on CVM Published Guidance
The agency welcomes comments on current guidance documents
at any time. Comments should be sent to the location provided
on the cover sheet of the guidance or to the Dockets Management
Branch (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. For directions on how to comment on guidance documents
under development, see CVM Guidance Documents Under Development.
Federal Register Notices
Docket No. 2004D-0160, CVM 200454. Withdrawal of Guidance Document on Use of Unapproved Hormone Implants in Veal Calves. Pages 42443 -42444 [FR Doc. 04-16036] July 15, 2004 [TXT] [PDF]
Docket No. 2004N-0234, OC 2004131. Annual Guidance Agenda. Pages 41510-41540 [FR Doc. 04-15660] July 9, 2004 [TXT] [PDF] Comments by July 9, 2006
To Obtain Copies of Published Guidance
To make the development and issuance of guidance documents
transparent, the agency uses the Internet and other means
to make documents accessible to the public. Electronic versions
of CVM's guidance documents are found on CVM's website and
on FDA's website . Notification of publication of CVM's recently
issued guidance documents can be found on CVM's website .
The public may search for notices of availability of guidance
documents at on the Federal Register's website. Paper copies
of CVM guidance documents can be obtained by writing to: Food
and Drug Administration, Center for Veterinary Medicine HFV-12,
Communications Staff, 7519 Standish Place, Rockville, Maryland
20855, or by calling 301-827-3800. A question on a published
guidance should be sent to the person listed in the guidance
document as the person to contact.
Additional Information
Additional information can be found in the FDA Compliance
Policy Guides and the CVM Program Policy and Procedures Manual.
For information on special symbols and other issues, see the
Conventions used in FDA CVM hypertext documents CVM Guidance
for Industry.
Code of Federal Regulations Citations
21 CFR 10.115(c)
Sec. 10.115(c) Good guidance practices.
* * * * *
(c) What other terms have a special meaning?
(1) ``Level 1 guidance documents'' include guidance documents
that:
(i) Set forth initial interpretations of statutory or regulatory
requirements;
(ii) Set forth changes in interpretation or policy that are
of more than a minor nature;
(iii) Include complex scientific issues; or
(iv) Cover highly controversial issues.
(2) ``Level 2 guidance documents'' are guidance documents
that set forth existing practices or minor changes in interpretation
or policy. Level 2 guidance documents include all guidance
documents that are not classified as Level 1.
(3) ``You'' refers to all affected parties outside of FDA.
21 CFR 10.115(f)
Sec. 10.115(f) Good guidance practices.
* * * * *
(f) How can you participate in the development and issuance
of guidance documents?
(1) You can provide input on guidance documents that FDA
is developing under the procedures described in paragraph
(g) of this section.
(2) You can suggest areas for guidance document development.
Your suggestions should address why a guidance document is
necessary.
(3) You can submit drafts of proposed guidance documents
for FDA to consider. When you do so, you should mark the document
``Guidance Document Submission'' and submit it to Dockets
Management Branch (HFA- 305), 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
(4) You can, at any time, suggest that FDA revise or withdraw
an already existing guidance document. Your suggestion should
address why the guidance document should be revised or withdrawn
and, if applicable, how it should be revised.
(5) Once a year, FDA will publish, both in the Federal Register
and on the Internet, a list of possible topics for future
guidance document development or revision during the next
year. You can comment on this list (e.g., by suggesting alternatives
or making recommendations on the topics that FDA is considering).
(6) To participate in the development and issuance of guidance
documents through one of the mechanisms described in paragraphs
(f)(1), (f)(2), or (f)(4) of this section, you should contact
the center or office that is responsible for the regulatory
activity covered by the guidance document.
(7) If FDA agrees to draft or revise a guidance document,
under a suggestion made under paragraphs (f)(1), (f)(2),
(f)(3) or (f)(4) of this section, you can participate in
the development of that guidance document under the procedures
described in paragraph (g) of this section.
Updated Thursday, July 15, 2004 @ 3:17 PM BY hd
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