(3) Petitions for exemption from preemption for a State requirement shall be submitted to the Dockets Management Staff in the following form: (Date) ________________
Dockets Management Staff,
Food and Drug Administration,
Department of Health and Human Services,
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Petition Requesting Exemption from Preemption for State Requirement
The undersigned submits this petition under section 403A(b)of the Federal Food, Drug, and Cosmetic Act to request that the Food and Drug Administration exempt a State requirement from preemption.
The undersigned has authority to act for, or on behalf of, the (identify State or political subdivision of the State) because (document petitioner's authority to submit petition on behalf of the State).
A. Action Requested1. Identify and give the exact wording of the State requirement and give date it was enacted or issued in final form.2. Identify the specific standard or regulation that is believed to preempt the State requirement and the section and paragraph of the act that the standard or regulation implements.B. Documentation of State Requirement Provide a copy of the State requirement that is the subject of the application. Where available, the application should also include copies of any legislative history or background materials used in issuing the requirement, including hearing reports or studies concerning the development or consideration of the requirement.
C. Statement of Grounds A petition for an exemption from preemption should contain the following:1. An explanation of the State requirement and its rationale, and a comparison of State and Federal requirements to show differences.2. An explanation of why compliance with the State requirement would not cause a food to be in violation of any applicable requirement under Federal law.3. Information on the effect that granting the State petition will have on interstate commerce. The petition should contain information on economic feasibility, i.e., whether the State and Federal requirements have significantly different effects on the production and distribution of the food product; comparison of the costs of compliance as shown by data or information on the actual or anticipated effect of the State and Federal requirements on the sale and price of the food product in interstate commerce; and the effect of the State requirement on the availability of the food product to consumers. To the extent possible, the petition should include information showing that it is practical and feasible for producers of food products to comply with the State requirement. Such information may be submitted in the form of statements from affected persons indicating their ability to comply.4. Identification of a particular need for information that the State requirement is designed to meet, which need is not met by Federal law. The petition should describe the conditions that require the State to petition for an exemption, the information need that the State requirement fulfills, the inadequacy of the Federal requirement in addressing this need, and the geographical area or political subdivision in which such need exists.D. Environmental Impact The petition shall contain a claim for categorical exclusion under 21 CFR 25.24 or an environmental assessment under 21 CFR 25.31 .
E. Notification Provide name and address of person, branch, department, or other instrumentality of the State government that should be notified of the Commissioner's action concerning the petition.
F. 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.
(Signature) ________________________
(Name of petitioner) ________________
(Mailing address) __________________
(Telephone number) ________________
(Information collection requirements in this section were approved by the Office of Management and Budget (OMB) and assigned OMB number 0910-0277)