CITIZEN PETITION

[U.S. Food and Drug Administration]

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).

A. ACTION REQUESTED

  1. . 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.

  2. . 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.

  3. . 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.

B. STATEMENT OF GROUNDS
Include a well organized statement of the factual and legal grounds upon which the petition is based. Opposing views known to the petitioner should be presented.

C. ENVIRONMENTAL IMPACT STATEMENT
Give an environmental impact analysis report in the form specified in 21 CFR, Part 25.1(g), except for the types of actions specified in 21 CFR, Part 25.1(d).

D. 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.

The undersigned certifies that, to the best of his/her knowledge and belief, 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)

[FDA HOME PAGE]

Last revised August 1996