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This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 321 - Definitions; generally
§ 341 - Definitions and standards for food
§ 342 - Adulterated food
§ 346 - Tolerances for poisonous or deleterious substances in food; regulations
§ 346a - Tolerances and exemptions for pesticide chemical residues
§ 348 - Food additives
§ 355 - New drugs
§ 355a - Pediatric studies of drugs
§ 355b - Adverse-event reporting
§ 355c - Research into pediatric uses for drugs and biological products
§ 355d - Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
§ 355e - Pharmaceutical security
§ 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions
§ 356a - Manufacturing changes
§ 356b - Reports of postmarketing studies
§ 356c - Discontinuance or interruption in the production of life-saving drugs
§ 357 - Qualification of drug development tools
§ 360b - New animal drugs
§ 360c - Classification of devices intended for human use
§ 360d - Performance standards
§ 360e - Premarket approval
§ 360f - Banned devices
§ 371 - Regulations and hearings
§ 216 - Regulations
§ 241 - Research and investigations generally
§ 262 - Regulation of biological products
§ 263b - Certification of mammography facilities
Title 21 published on 2015-12-03
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 570 after this date.
The Food and Drug Administration (FDA or we) is issuing a final rule that amends and clarifies the criteria in our regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of its intended use. We also are amending our regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use. The clarified criteria for GRAS status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act, and the notification procedure will enable stakeholders to be aware of whether we have questioned the basis of a conclusion of GRAS status.