21 CFR Part 20 - PUBLIC INFORMATION
- SUBPART A — Official Testimony and Information (§§ 20.1 - 20.3)
- SUBPART B — General Policy (§§ 20.20 - 20.34)
- SUBPART C — Procedures and Fees (§§ 20.40 - 20.55)
- SUBPART D — Exemptions (§§ 20.60 - 20.67)
- SUBPART E — Limitations on Exemptions (§§ 20.80 - 20.91)
- SUBPART F — Availability of Specific Categories of Records (§§ 20.100 - 20.120)
Title 21 published on 2012-04-01
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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-15713 RIN Docket No. FDA-2012-N-0205 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Direct final rule; withdrawal. The direct final rule published at 77 FR 16923, March 23, 2012, is withdrawn, effective June 27, 2012. 21 CFR Part 20 The Food and Drug Administration (FDA) published in the Federal Register of March 23, 2012 (77 FR 16923), a direct final rule making technical changes to update a requirement that many of its written agreements and memoranda of understanding with other departments, Agencies, and organizations be published in the Federal Register. The comment period closed June 6, 2012. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.
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.
§ 552 - Public information; agency rules, opinions, orders, records, and proceedings
§ 1905 - Disclosure of confidential information generally
§ 2531 - Certain standards-related activities
§ 2532 - Federal standards-related activities
§ 2533 - State and private standards-related activities
§ 2541 - Functions of Trade Representative
§ 2542 - Establishment and operation of technical offices
§ 2543 - Representation of United States interests before international standards organizations
§ 2544 - Standards information center
§ 2545 - Contracts and grants
§ 2546 - Technical assistance
§ 2547 - Consultations with representatives of domestic interests
§ 2551 - Right of action
§ 2552 - Representations
§ 2553 - Action after receipt of representations
§ 2554 - Procedure after finding by international forum
§ 2561 - Findings of reciprocity required in administrative proceedings
§ 2562 - Consideration of standards-related activities by an international forum
§ 2571 - Definitions
§ 2572 - Exemptions
§ 2573 - Reports to Congress on operation of agreement
§ 2575 - General
§ 2575a - Inquiry point
§ 2575b - Subpart definitions
§ 2576 - General
§ 2576a - Inquiry point
§ 2576b - Subpart definitions
§ 2577 - Definitions
§ 2578 - Notice of United States participation in international standard-setting activities
§ 2578a - Equivalence determinations
§ 2578b - Definitions
§ 2581 - Auction of import licenses
§ 2582 - Repealed.
§ 321 - Definitions; generally
§ 321a - “Butter” defined
§ 321b - “Package” defined
§ 321c - Nonfat dry milk; “milk” defined
§ 321d - Market names for catfish and ginseng
§ 331 - Prohibited acts
§ 332 - Injunction proceedings
§ 333 - Penalties
§ 333a - Repealed.
§ 334 - Seizure
§ 335 - Hearing before report of criminal violation
§ 335a - Debarment, temporary denial of approval, and suspension
§ 335b - Civil penalties
§ 335c - Authority to withdraw approval of abbreviated drug applications
§ 336 - Report of minor violations
§ 337 - Proceedings in name of United States; provision as to subpoenas
§ 341 - Definitions and standards for food
§ 342 - Adulterated food
§ 343 - Misbranded food
21 USC § 343–1 - National uniform nutrition labeling
21 USC § 343–2 - Dietary supplement labeling exemptions
21 USC § 343–3 - Disclosure
§ 343a - Repealed.
§ 344 - Emergency permit control
§ 345 - Regulations making exemptions
§ 346 - Tolerances for poisonous or deleterious substances in food; regulations
§ 346a - Tolerances and exemptions for pesticide chemical residues
§ 346b - Authorization of appropriations
§ 347 - Intrastate sales of colored oleomargarine
§ 347a - Congressional declaration of policy regarding oleomargarine sales
§ 347b - Contravention of State laws
§ 348 - Food additives
§ 349 - Bottled drinking water standards; publication in Federal Register
§ 350 - Vitamins and minerals
§ 350a - Infant formulas
§ 350b - New dietary ingredients
§ 350c - Maintenance and inspection of records
§ 350d - Registration of food facilities
§ 350e - Sanitary transportation practices
§ 350f - Reportable food registry
§ 350g - Hazard analysis and risk-based preventive controls
§ 350h - Standards for produce safety
§ 350i - Protection against intentional adulteration
§ 350j - Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
§ 350k - Laboratory accreditation for analyses of foods
21 USC § -
21 USC § -
§ 351 - Adulterated drugs and devices
§ 352 - Misbranded drugs and devices
§ 353 - Exemptions and consideration for certain drugs, devices, and biological products
§ 353a - Pharmacy compounding
§ 353b - Prereview of television advertisements
§ 354 - Veterinary feed directive drugs
§ 355 - New drugs
21 USC § 355–1 - Risk evaluation and mitigation strategies
§ 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, and waivers
§ 355e - Pharmaceutical security
§ 356 - Fast track products
21 USC § 356–1 - Accelerated approval of priority countermeasures
§ 356a - Manufacturing changes
§ 356b - Reports of postmarketing studies
§ 356c - Discontinuance of life saving product
§ 357 - Repealed.
§ 358 - Authority to designate official names
§ 359 - Nonapplicability of subchapter to cosmetics
§ 360 - Registration of producers of drugs or devices
§ 360a - Clinical trial guidance for antibiotic drugs
§ 360b - New animal drugs
§ 360c - Classification of devices intended for human use
§ 360d - Performance standards
§ 360e - Premarket approval
21 USC § 360e–1 - Pediatric uses of devices
§ 360f - Banned devices
§ 360g - Judicial review
§ 360h - Notification and other remedies
§ 360i - Records and reports on devices
§ 360j - General provisions respecting control of devices intended for human use
§ 360k - State and local requirements respecting devices
21 USC § -
§ 360m - Accredited persons
§ 360n - Priority review to encourage treatments for tropical diseases
§ 360aa - Recommendations for investigations of drugs for rare diseases or conditions
§ 360bb - Designation of drugs for rare diseases or conditions
§ 360cc - Protection for drugs for rare diseases or conditions
§ 360dd - Open protocols for investigations of drugs for rare diseases or conditions
§ 360ee - Grants and contracts for development of drugs for rare diseases and conditions
§ 360hh - Definitions
§ 360ii - Program of control
§ 360jj - Studies by Secretary
§ 360kk - Performance standards for electronic products
21 USC § -
§ 360mm - Imports
§ 360nn - Inspection, records, and reports
21 USC § -
§ 360pp - Enforcement
§ 360qq - Repealed.
§ 360rr - Federal-State cooperation
§ 360ss - State standards
§ 360aaa to 360aaa–6 - Omitted
§ 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
§ 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
§ 361 - Adulterated cosmetics
§ 362 - Misbranded cosmetics
§ 363 - Regulations making exemptions
§ 364 - Repealed.
§ 371 - Regulations and hearings
§ 372 - Examinations and investigations
§ 372a - Transferred
§ 373 - Records
§ 374 - Inspection
§ 374a - Inspections relating to food allergens
§ 375 - Publicity
§ 376 - Examination of sea food on request of packer; marking food with results; fees; penalties
§ 377 - Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
§ 378 - Advertising of foods
§ 379 - Confidential information
§ 379a - Presumption of existence of jurisdiction
§ 379b - Consolidated administrative and laboratory facility
§ 379c - Transferred
§ 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
§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics
§ 379f - Recovery and retention of fees for freedom of information requests
§ 379g - Definitions
§ 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
§ 379i - Definitions
§ 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
§ 379k - Information system
21 USC § -
21 USC § -
§ 379r - National uniformity for nonprescription drugs
§ 379s - Preemption for labeling or packaging of cosmetics
§ 379v - Safety report disclaimers
§ 379aa - Serious adverse event reporting for nonprescription drugs
21 USC § 379aa–1 - Serious adverse event reporting for dietary supplements
§ 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
§ 381 - Imports and exports
§ 382 - Exports of certain unapproved products
§ 383 - Office of International Relations
§ 384 - Importation of prescription drugs
§ 384a - Foreign supplier verification program
§ 384b - Voluntary qualified importer program
§ 384c - Inspection of foreign food facilities
§ 384d - Accreditation of third-party auditors
§ 387 - Definitions
§ 387a - FDA authority over tobacco products
21 USC § 387a–1 - Final rule
§ 387b - Adulterated tobacco products
§ 387c - Misbranded tobacco products
§ 387d - Submission of health information to the Secretary
§ 387e - Annual registration
§ 387f - General provisions respecting control of tobacco products
21 USC § 387f–1 - Enforcement action plan for advertising and promotion restrictions
§ 387g - Tobacco product standards
§ 387h - Notification and other remedies
§ 387i - Records and reports on tobacco products
§ 387j - Application for review of certain tobacco products
§ 387k - Modified risk tobacco products
21 USC § -
§ 387m - Equal treatment of retail outlets
§ 387n - Jurisdiction of and coordination with the Federal Trade Commission
21 USC § -
§ 387p - Preservation of State and local authority
§ 387q - Tobacco Products Scientific Advisory Committee
§ 387r - Drug products used to treat tobacco dependence
§ 387s - User fees
§ 387t - Labeling, recordkeeping, records inspection
§ 387u - Studies of progress and effectiveness
§ 391 - Separability clause
§ 392 - Exemption of meats and meat food products
§ 393 - Food and Drug Administration
§ 1401 - Pesticide monitoring and enforcement information
§ 1402 - Foreign pesticide information
§ 1403 - Pesticide analytical methods
§ 241 - Research and investigations generally
§ 242 - Studies and investigations on use and misuse of narcotic drugs and other drugs; annual report to Attorney General; cooperation with States
§ 242a - Repealed.
42 USC § -
§ 242n - Repealed.
§ 243 - General grant of authority for cooperation
§ 262 - Regulation of biological products
§ 263 - Preparation of biological products by Service
§ 263b - Certification of mammography facilities
42 USC § 259 to 261a - Repealed.
§ 264 - Regulations to control communicable diseases
§ 265 - Suspension of entries and imports from designated places to prevent spread of communicable diseases
§ 300u - General authority of Secretary
42 USC § 300u–1 - Grants and contracts for research programs; authority of Secretary; review of applications; additional functions; periodic public survey
42 USC § 300u–2 - Grants and contracts for community health programs
42 USC § 300u–3 - Grants and contracts for information programs; authority of Secretary; particular activities
42 USC § 300u–4 - Status reports to President and Congress; study of health education and preventive health services with respect to insurance coverage
42 USC § 300u–5 - Centers for research and demonstration of health promotion and disease prevention
42 USC § 300aa–1 - Establishment
Title 21 published on 2012-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 20 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20610 RIN Docket No. FDA-2012-N-0205 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 22, 2012. 21 CFR Part 20 This final rule makes technical changes that will update a requirement that many of the written agreements and memoranda of understanding (MOUs) between the Food and Drug Administration (FDA) and other departments, Agencies, and organizations be published in the Federal Register . Because we already post and will continue to post our ongoing agreements and MOUs with other departments, Agencies, and organizations on our Web site upon their completion, this requirement is no longer necessary. This final rule, accordingly, eliminates it. We are making these technical changes to conserve Agency time and resources, reduce government paperwork, and eliminate unnecessary Federal Register printing costs while continuing to afford public access to these documents.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-15713 RIN Docket No. FDA-2012-N-0205 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Direct final rule; withdrawal. The direct final rule published at 77 FR 16923, March 23, 2012, is withdrawn, effective June 27, 2012. 21 CFR Part 20 The Food and Drug Administration (FDA) published in the Federal Register of March 23, 2012 (77 FR 16923), a direct final rule making technical changes to update a requirement that many of its written agreements and memoranda of understanding with other departments, Agencies, and organizations be published in the Federal Register. The comment period closed June 6, 2012. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.