Source: https://www.law.cornell.edu/cfr/text/21/100.1
Timestamp: 2017-01-22 23:07:45
Document Index: 225999544

Matched Legal Cases: ['art 100', 'art 100', '§ 10', '§ 10', 'art 10', '§ 10', 'art 100']

21 CFR 100.1 - Petitions requesting exemption from preemption for State or local requirements. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter B › Part 100 › Subpart A › Section 100.1 21 CFR 100.1 - Petitions requesting exemption from preemption for State or local requirements.
There is 1 Update appearing in the Federal Register for 21 CFR Part 100. View below or at eCFR (GPOAccess)
(a)Scope and purpose.
(1) This subpart applies to the submission and consideration of petitions under section 403A(b) of the Federal Food, Drug, and Cosmetic Act (the act), by a State or a political subdivision of a State, requesting exemption of a State requirement from preemption under section 403A(a) of the act.
(1)Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321et seq.).
(2)Agency means the Food and DrugAdministration.
(3)Commissioner means the Commissioner of Food and Drugs.
(4)State means a State as defined in section 201(a)(1) of the act (which includes a territory of the United States, the District of Columbia, and Puerto Rico) or any political subdivision of a State having authority to issue food standards and food labeling regulations having force of law.
(5)State requirement means any statute, standard, regulation, or other requirement that is issued by a State.
(c)Prerequisites for petitions for exemption from preemption. The Food and DrugAdministration will consider a petition for exemption from preemption on its merits only if the petition demonstrates that:
(4) The State requirement is subject to preemption under section 403A(a) of the act because it is not identical to the requirement of the preemptive Federal statutory provision or regulation including a standard of identity, quality, and fill. “Not identical to” does not refer to the specific words in the requirement but instead means that the State requirement directly or indirectly imposes obligations or contains provisions concerning the composition or labeling of food, or concerning a food container, that:
(d)Form of petition.
(1) All information included in the petition should meet the general requirements of § 10.20(c) of this chapter.
The undersigned submits this petition under section 403A(b)of the Federal Food, Drug, and Cosmetic Act to request that the Food and DrugAdministration 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).
(e)Submission of petition for exemption; public disclosure. The availability for public disclosure of a petition for exemption will be governed by the rules specified in § 10.20(j) of this chapter.
(f)Agency consideration of petitions.
(1) Unless otherwise specified in this section, all relevant provisions and requirements of subpart B of part 10 of this chapter, are applicable to State petitions requesting exemption from Federal preemption under section 403A(b) of the act.
(4) Any interested person may submit written comments to the Division of Dockets Management on a filed petition as provided in § 10.30(d) of this chapter.
Title 21 published on 2015-12-03The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 100 after this date.2016-08-29; vol. 81 # 167 - Monday, August 29, 201681 FR 59129 - Food Labeling; Technical Amendments
Title 21 published on 2015-12-03.The following are only the Rules published in the Federal Register after the published date of Title 21.For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.2016-08-29; vol. 81 # 167 - Monday, August 29, 201681 FR 59129 - Food Labeling; Technical Amendments