21 CFR 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
- SUBPART A — General Provisions (§§ 16.1 - 16.5)
- SUBPART B — Initiation of Proceedings (§§ 16.22 - 16.26)
- SUBPART C — Commissioner and Presiding Officer (§§ 16.40 - 16.44)
- SUBPART D — Procedures for Regulatory Hearing (§§ 16.60 - 16.62)
- SUBPART E — Administrative Record and Decision (§§ 16.80 - 16.95)
- SUBPART F — Reconsideration and Stay (§§ 16.119 - 16.119)
- SUBPART G — Judicial Review (§§ 16.120 - 16.120)
Title 21 published on 2011-04-01
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.
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.
15 USC 1451 - Congressional declaration of policy
15 USC 1452 - Unfair and deceptive packaging and labeling; scope of prohibition
15 USC 1453 - Requirements of labeling; placement, form, and contents of statement of quantity; supplemental statement of quantity
15 USC 1454 - Rules and regulations
15 USC 1455 - Procedure for promulgation of regulations
15 USC 1456 - Enforcement
15 USC 1457 - Omitted
15 USC 1458 - Cooperation with State authorities; transmittal of regulations to States; noninterference with existing programs
15 USC 1459 - Definitions
15 USC 1460 - Savings provisions
15 USC 1461 - Effect upon State law
21 USC 1034 - Inspection of egg products
21 USC 141 - Prohibition of importation without permit
21 USC 142 - Milk or cream when unfit for importation
21 USC 143 - Inspection; certified statement in lieu thereof; waiver of requirements of
21 USC 144 - Unlawful receiving of imported milk or cream
21 USC 145 - Penalties
21 USC 146 - Authorization of appropriations
21 USC 147 - Repeal of inconsistent laws
21 USC 148 - Powers of State with respect to milk or cream lawfully imported
21 USC 149 - Definitions
21 USC 321 - Definitions; generally
21 USC 321a - “Butter” defined
21 USC 321b - “Package” defined
21 USC 321c - Nonfat dry milk; “milk” defined
21 USC 321d - Market names for catfish and ginseng
21 USC 331 - Prohibited acts
21 USC 332 - Injunction proceedings
21 USC 333 - Penalties
21 USC 333a - Repealed.
21 USC 334 - Seizure
21 USC 335 - Hearing before report of criminal violation
21 USC 335a - Debarment, temporary denial of approval, and suspension
21 USC 335b - Civil penalties
21 USC 335c - Authority to withdraw approval of abbreviated drug applications
21 USC 336 - Report of minor violations
21 USC 337 - Proceedings in name of United States; provision as to subpoenas
21 USC 341 - Definitions and standards for food
21 USC 342 - Adulterated food
21 USC 343 - Misbranded food
21 USC § 343–1 - National uniform nutrition labeling
21 USC § 343–2 - Dietary supplement labeling exemptions
21 USC § 343–3 - Disclosure
21 USC 343a - Repealed.
21 USC 344 - Emergency permit control
21 USC 345 - Regulations making exemptions
21 USC 346 - Tolerances for poisonous or deleterious substances in food; regulations
21 USC 346a - Tolerances and exemptions for pesticide chemical residues
21 USC 346b - Authorization of appropriations
21 USC 347 - Intrastate sales of colored oleomargarine
21 USC 347a - Congressional declaration of policy regarding oleomargarine sales
21 USC 347b - Contravention of State laws
21 USC 348 - Food additives
21 USC 349 - Bottled drinking water standards; publication in Federal Register
21 USC 350 - Vitamins and minerals
21 USC 350a - Infant formulas
21 USC 350b - New dietary ingredients
21 USC 350c - Maintenance and inspection of records
21 USC 350d - Registration of food facilities
21 USC 350e - Sanitary transportation practices
21 USC 350f - Reportable food registry
21 USC 350g - Hazard analysis and risk-based preventive controls
21 USC 350h - Standards for produce safety
21 USC 350i - Protection against intentional adulteration
21 USC 350j - Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
21 USC 350k - Laboratory accreditation for analyses of foods
21 USC § -
21 USC § -
21 USC 351 - Adulterated drugs and devices
21 USC 352 - Misbranded drugs and devices
21 USC 353 - Exemptions and consideration for certain drugs, devices, and biological products
21 USC 353a - Pharmacy compounding
21 USC 353b - Prereview of television advertisements
21 USC 354 - Veterinary feed directive drugs
21 USC 355 - New drugs
21 USC § 355–1 - Risk evaluation and mitigation strategies
21 USC 355a - Pediatric studies of drugs
21 USC 355b - Adverse-event reporting
21 USC 355c - Research into pediatric uses for drugs and biological products
21 USC 355d - Internal committee for review of pediatric plans, assessments, deferrals, and waivers
21 USC 355e - Pharmaceutical security
21 USC 356 - Fast track products
21 USC § 356–1 - Accelerated approval of priority countermeasures
21 USC 356a - Manufacturing changes
21 USC 356b - Reports of postmarketing studies
21 USC 356c - Discontinuance of life saving product
21 USC 357 - Repealed.
21 USC 358 - Authority to designate official names
21 USC 359 - Nonapplicability of subchapter to cosmetics
21 USC 360 - Registration of producers of drugs or devices
21 USC 360a - Clinical trial guidance for antibiotic drugs
21 USC 360aa - Recommendations for investigations of drugs for rare diseases or conditions
21 USC 360aaa to 360aaa–6 - Omitted
21 USC 360b - New animal drugs
21 USC 360bb - Designation of drugs for rare diseases or conditions
21 USC 360bbb - Expanded access to unapproved therapies and diagnostics
21 USC § 360bbb–1 - Dispute resolution
21 USC § 360bbb–2 - Classification of products
21 USC § 360bbb–3 - Authorization for medical products for use in emergencies
21 USC § 360bbb–4 - Technical assistance
21 USC § 360bbb–5 - Critical Path Public-Private Partnerships
21 USC § 360bbb–6 - Risk communication
21 USC 360c - Classification of devices intended for human use
21 USC 360cc - Protection for drugs for rare diseases or conditions
21 USC 360ccc - Conditional approval of new animal drugs for minor use and minor species
21 USC § 360ccc–1 - Index of legally marketed unapproved new animal drugs for minor species
21 USC § 360ccc–2 - Designated new animal drugs for minor use or minor species
21 USC 360d - Performance standards
21 USC 360dd - Open protocols for investigations of drugs for rare diseases or conditions
21 USC 360e - Premarket approval
21 USC § 360e–1 - Pediatric uses of devices
21 USC 360ee - Grants and contracts for development of drugs for rare diseases and conditions
21 USC 360f - Banned devices
21 USC 360g - Judicial review
21 USC 360h - Notification and other remedies
21 USC 360hh - Definitions
21 USC 360i - Records and reports on devices
21 USC 360ii - Program of control
21 USC 360j - General provisions respecting control of devices intended for human use
21 USC 360jj - Studies by Secretary
21 USC 360k - State and local requirements respecting devices
21 USC 360kk - Performance standards for electronic products
21 USC § -
21 USC § -
21 USC 360m - Accredited persons
21 USC 360mm - Imports
21 USC 360n - Priority review to encourage treatments for tropical diseases
21 USC 360nn - Inspection, records, and reports
21 USC § -
21 USC 360pp - Enforcement
21 USC 360qq - Repealed.
21 USC 360rr - Federal-State cooperation
21 USC 360ss - State standards
21 USC 361 - Adulterated cosmetics
21 USC 362 - Misbranded cosmetics
21 USC 363 - Regulations making exemptions
21 USC 364 - Repealed.
21 USC 371 - Regulations and hearings
21 USC 372 - Examinations and investigations
21 USC 372a - Transferred
21 USC 373 - Records
21 USC 374 - Inspection
21 USC 374a - Inspections relating to food allergens
21 USC 375 - Publicity
21 USC 376 - Examination of sea food on request of packer; marking food with results; fees; penalties
21 USC 377 - Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
21 USC 378 - Advertising of foods
21 USC 379 - Confidential information
21 USC 379a - Presumption of existence of jurisdiction
21 USC 379aa - Serious adverse event reporting for nonprescription drugs
21 USC § 379aa–1 - Serious adverse event reporting for dietary supplements
21 USC 379b - Consolidated administrative and laboratory facility
21 USC 379c - Transferred
21 USC 379d - Automation of Food and Drug Administration
21 USC § 379d–1 - Conflicts of interest
21 USC § 379d–2 - Policy on the review and clearance of scientific articles published by FDA employees
21 USC 379dd - Establishment and functions of the Foundation
21 USC § 379dd–1 - Location of Foundation
21 USC § 379dd–2 - Activities of the Food and Drug Administration
21 USC 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics
21 USC 379f - Recovery and retention of fees for freedom of information requests
21 USC 379g - Definitions
21 USC 379h - Authority to assess and use drug fees
21 USC § 379h–1 - Fees relating to advisory review of prescription-drug television advertising
21 USC § 379h–2 - Reauthorization; reporting requirements
21 USC 379i - Definitions
21 USC 379j - Authority to assess and use device fees
21 USC § 379j–1 - Reauthorization; reporting requirements
21 USC § 379j–11 - Definitions
21 USC § 379j–12 - Authority to assess and use animal drug fees
21 USC § 379j–13 - Reauthorization; reporting requirements
21 USC § 379j–21 - Authority to assess and use generic new animal drug fees
21 USC § 379j–22 - Reauthorization; reporting requirements
21 USC § 379j–31 - Authority to collect and use fees
21 USC 379k - Information system
21 USC § -
21 USC § -
21 USC 379r - National uniformity for nonprescription drugs
21 USC 379s - Preemption for labeling or packaging of cosmetics
21 USC 379v - Safety report disclaimers
21 USC 381 - Imports and exports
21 USC 382 - Exports of certain unapproved products
21 USC 383 - Office of International Relations
21 USC 384 - Importation of prescription drugs
21 USC 384a - Foreign supplier verification program
21 USC 384b - Voluntary qualified importer program
21 USC 384c - Inspection of foreign food facilities
21 USC 384d - Accreditation of third-party auditors
21 USC 387 - Definitions
21 USC 387a - FDA authority over tobacco products
21 USC § 387a–1 - Final rule
21 USC 387b - Adulterated tobacco products
21 USC 387c - Misbranded tobacco products
21 USC 387d - Submission of health information to the Secretary
21 USC 387e - Annual registration
21 USC 387f - General provisions respecting control of tobacco products
21 USC § 387f–1 - Enforcement action plan for advertising and promotion restrictions
21 USC 387g - Tobacco product standards
21 USC 387h - Notification and other remedies
21 USC 387i - Records and reports on tobacco products
21 USC 387j - Application for review of certain tobacco products
21 USC 387k - Modified risk tobacco products
21 USC § -
21 USC 387m - Equal treatment of retail outlets
21 USC 387n - Jurisdiction of and coordination with the Federal Trade Commission
21 USC § -
21 USC 387p - Preservation of State and local authority
21 USC 387q - Tobacco Products Scientific Advisory Committee
21 USC 387r - Drug products used to treat tobacco dependence
21 USC 387s - User fees
21 USC 387t - Labeling, recordkeeping, records inspection
21 USC 387u - Studies of progress and effectiveness
21 USC 391 - Separability clause
21 USC 392 - Exemption of meats and meat food products
21 USC 393 - Food and Drug Administration
21 USC 393a - Office of Pediatric Therapeutics
21 USC 394 - Scientific review groups
21 USC 467f - Federal Food, Drug, and Cosmetic Act applications
21 USC 679 - Application of Federal Food, Drug, and Cosmetic Act
21 USC 821 - Rules and regulations
28 USC 2112 - Record on review and enforcement of agency orders
42 USC 201 - Definitions
42 USC 262 - Regulation of biological products
42 USC § 300ff–41 to 300ff–50 - Repealed.
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 16
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-2289 RIN 0910-AG60 Docket No. FDA-2011-N-0121 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective April 2, 2012. 21 CFR Parts 1, 7, and 16 The Food and Drug Administration (FDA) is amending certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products are subject to the same general requirements that apply to other FDA-regulated products.
GPO FDSys XML | Text type regulations.gov FR Doc. 2011-17457 RIN Docket No. FDA-2011-D-0398 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of availability. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on the draft guidance before it begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by September 12, 2011. 21 CFR Parts 16 and 118 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” (the draft guidance). The draft guidance provides guidance to egg producers and other persons who are covered by FDA's final rule entitled “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” (the final rule). The draft guidance contains questions FDA has received on the final rule since its publication and responses to those questions.
GPO FDSys XML | Text type regulations.gov FR Doc. 2011-9044 RIN 0910-AG60 Docket No. FDA-2011-N-0121 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by June 13, 2011. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by May 16, 2011, (see the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 1, 7, and 16 The Food and Drug Administration (FDA) is proposing to amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products.
GPO FDSys XML | Text type regulations.gov FR Doc. 2011-8786 RIN 0910-AG49 Docket No. FDA-2011-N-0079 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by July 12, 2011. See section VII of this document for the proposed effective date of a final rule based on this document. 21 CFR Parts 16, 312, 511, and 812 The Food and Drug Administration (FDA) is proposing to amend the regulations to expand the scope of clinical investigator disqualification. Under this proposal, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive certain test articles (drugs, devices, or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. This proposal is based in part upon recommendations from the Government Accountability Office, and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
GPO FDSys XML | Text type regulations.gov FR Doc. 2011-34 RIN 0910-AG39 Docket No. FDA-2010-N-0646 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by March 22, 2011. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 7, 2011, ( see the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 16 and 1107 The Food and Drug Administration (FDA) is issuing this proposed rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The proposed rule would describe the process and statutory criteria for requesting an exemption and explain how FDA would review requests for exemptions. Once finalized, this regulation will satisfy the requirement in the Tobacco Control Act that FDA issue regulations implementing the exemption provision.
GPO FDSys XML | Text type regulations.gov FR Doc. 2011-3 RIN 0910-AG39 Docket No. FDA-2010-N-0646 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Department of the Army, Food and Drug Administration, Corps of Engineers Proposed rule. Written comments must be submitted on or before March 7, 2011. The National Wetland Plant List (NWPL) is used to delineate wetlands for purposes of the Clean Water Act and the Wetland Conservation Provisions of the Food Security Act. Other applications of the list include wetland restoration, establishment, and enhancement projects. To update the NWPL, the U.S. Army Corps of Engineers (Corps), as part of an interagency effort with the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS) and the U.S. Department of Agriculture, Natural Resources Conservation Service (NRCS), is announcing the availability of the draft National Wetland Plant List (NWPL) and its web address to solicit public comments. The public will now be provided the opportunity to comment and vote on the wetland indicator status ratings of the plants, species nomenclature changes and the revisions to the definition of indicator status ratings contained in the NWPL.



