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HOW TO PETITION THE FDA
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Author:  Scientist [ Sun Jul 15, 2007 3:16 pm ]
Post subject:  HOW TO PETITION THE FDA

From: http://www.fda.gov/ora/fed_state/Small_ ... petit.html

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:

Clearly state what problem you think the Agency needs to address.
Propose specifically what the Agency's action should be. Your proposal should be based on sound, supportable facts.
Submit the petition, an original and three (3) copies, unless otherwise stipulated in the Federal Register announcement, to:
Food and Drug Administration
Dockets Management Branch
Room 1-23
12420 Parklawn Drive
Rockville, MD 20857
(301) 827-6860

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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