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Small Business Guide to FDA
(last revised on 03/31/04)
HOW TO PETITION THE FDA
Anyone may request or petition FDA to change or create an Agency policy
or regulation under 21 CFR Part 10.30. If you believe this type of action
is necessary, direct your request to FDA's Dockets Management Branch
http://www.fda.gov/ohrms/dockets/. When submitting a petition, keep
these points in mind:
FDA carefully considers every petition and must respond within 180
days by either approving or denying it (in whole or in part), or providing
a tentative response indicating why FDA has been unable to reach a
decision. All petitions will be subject to public examination and
copying as governed by the rules in 21 CFR 10.20(j). If FDA approves
the petition, it may be published in the Federal Register. Your petition
could eventually be incorporated into Agency policy. An example showing
how to prepare a citizen's petition follows:
Petition Content and Format
(Date) _______________________________________
Dockets Management Branch, Food and Drug Administration, Department
of Health and Human Services, Room 1-23, 12420 Parklawn Dr., Rockville,
MD 20857.
CITIZEN PETITION
The undersigned submits this petition under _______________________
(relevant statutory sections, if known) of the ____________________
Federal Food, Drug, and Cosmetic Act, the Public Health Service Act,
or any other statutory provision for which authority has been delegated
to the Commissioner of Food and Drugs (under 21 CFR, Part 5.10) to
request the Commissioner of Food and Drugs to __________________(issue,
amend, or revoke a regulation or order to take or refrain from taking
any other form of administrative action).
- ACTION REQUESTED
- If the petition requests the Commissioner to issue, amend or revoke
a regulation, give the exact wording of the existing regulation
(if any) and the proposed regulation or amendment requested.
- If the petition requests the Commissioner to issue, amend or revoke
an order, include a copy of the exact wording of the citation to the
existing order (if any) and the exact wording requested for the proposed
order.
- If the petition requests the Commissioner to take or refrain from
taking any other form of administrative action, state the specific
action or relief requested.
- STATEMENT OF GROUNDS
A full statement, in a well organized format, of the factual and legal
grounds on which the petitioner relies, including all relevant information
and views on which the petitioner relies, as well as representative
information known to the petitioner which is unfavorable to the
petitioner's position.
-
ENVIRONMENTAL IMPACT STATEMENT
Give an environmental impact analysis report in the manner specified
in 21 CFR 25.42. (Claim for categorical exclusion under 21 CFR 25.30,
25.31, 25.32, 25.33, or 25.34 or an environmental assessment under
Sec. 25.40 of this chapter.)
- ECONOMIC IMPACT STATEMENT
The following information is to be submitted only when requested by
the Commissioner following review of the petition: a statement of
the effect of the requested action on 1) cost (and price) increases
to industry, government, and consumers; 2) productivity of wage
earners, businesses, or government; 3) competition; 4) supplies
of important materials, products, or services; 5) employment; and
6) energy supply or demand.
- CERTIFICATION
The undersigned certifies that, to the best knowledge and belief of
the undersigned, this petition includes all information and views
on which the petition relies, and that it includes representative
data and information known to the petitioner which are unfavorable
to the petition.
___________________________
(Signature)
_______________________________
Name of Petitioner
_______________________________
(Mailing Address)
_______________________________
(Phone)
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