21 CFR 20.103 - Correspondence.
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 The direct final rule published at 77 FR 16923, March 23, 2012, is withdrawn, effective June 27, 2012. 21 CFR Part 20 The Food and Drug Administration (FDA) published in the Federal Register of March 23, 2012 (77 FR 16923), a direct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
§ 2575b - Subpart definitions
§ 2575a - Inquiry point
§ 2575 - General
§ 2576b - Subpart definitions
§ 2576a - Inquiry point
§ 2576 - General
§ 2577 - Definitions
§ 2578b - Definitions
§ 2578a - Equivalence determinations
§ 2578 - Notice of United States participation in international standard-setting activities
§ 2581 - Auction of import licenses
§ 2582 - Repealed.
§ 321d - Market names for catfish and ginseng
§ 321c - Nonfat dry milk; “milk” defined
§ 321b - “Package” defined
§ 321a - “Butter” defined
§ 321 - Definitions; generally
§ 331 - Prohibited acts
§ 332 - Injunction proceedings
§ 333a - Repealed.
§ 333 - Penalties
§ 334 - Seizure
§ 335b - Civil penalties
§ 335a - Debarment, temporary denial of approval, and suspension
§ 335 - Hearing before report of criminal violation
§ 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
§ 343a - Repealed.
21 USC § 343–3 - Disclosure
21 USC § 343–2 - Dietary supplement labeling exemptions
21 USC § 343–1 - National uniform nutrition labeling
§ 343 - Misbranded food
§ 344 - Emergency permit control
§ 345 - Regulations making exemptions
§ 346b - Authorization of appropriations
§ 346a - Tolerances and exemptions for pesticide chemical residues
§ 346 - Tolerances for poisonous or deleterious substances in food; regulations
§ 347b - Contravention of State laws
§ 347a - Congressional declaration of policy regarding oleomargarine sales
§ 347 - Intrastate sales of colored oleomargarine
§ 348 - Food additives
§ 349 - Bottled drinking water standards; publication in Federal Register
§ 350e - Sanitary transportation practices
§ 350d - Registration of food facilities
§ 350c - Maintenance and inspection of records
§ 350b - New dietary ingredients
§ 350a - Infant formulas
§ 350 - Vitamins and minerals
§ 350g - Hazard analysis and risk-based preventive controls
§ 350f - Reportable food registry
21 USC § -
21 USC § -
§ 350k - Laboratory accreditation for analyses of foods
§ 350j - Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
§ 350i - Protection against intentional adulteration
§ 350h - Standards for produce safety
§ 351 - Adulterated drugs and devices
§ 352 - Misbranded drugs and devices
§ 353b - Prereview of television advertisements
§ 353a - Pharmacy compounding
§ 353 - Exemptions and consideration for certain drugs, devices, and biological products
§ 354 - Veterinary feed directive drugs
§ 355e - Pharmaceutical security
§ 355d - Internal committee for review of pediatric plans, assessments, deferrals, and waivers
§ 355c - Research into pediatric uses for drugs and biological products
§ 355b - Adverse-event reporting
§ 355a - Pediatric studies of drugs
21 USC § 355–1 - Risk evaluation and mitigation strategies
§ 355 - New drugs
§ 356c - Discontinuance of life saving product
§ 356b - Reports of postmarketing studies
§ 356a - Manufacturing changes
21 USC § 356–1 - Accelerated approval of priority countermeasures
§ 356 - Fast track products
§ 357 - Repealed.
§ 358 - Authority to designate official names
§ 359 - Nonapplicability of subchapter to cosmetics
§ 360 - Registration of producers of drugs or devices
§ 360n - Priority review to encourage treatments for tropical diseases
§ 360m - Accredited persons
21 USC § -
§ 360k - State and local requirements respecting devices
§ 360j - General provisions respecting control of devices intended for human use
§ 360i - Records and reports on devices
§ 360h - Notification and other remedies
§ 360g - Judicial review
§ 360f - Banned devices
21 USC § 360e–1 - Pediatric uses of devices
§ 360e - Premarket approval
§ 360d - Performance standards
§ 360c - Classification of devices intended for human use
§ 360b - New animal drugs
§ 360a - Clinical trial guidance for antibiotic drugs
§ 360ee - Grants and contracts for development of drugs for rare diseases and conditions
§ 360dd - Open protocols for investigations of drugs for rare diseases or conditions
§ 360cc - Protection for drugs for rare diseases or conditions
§ 360bb - Designation of drugs for rare diseases or conditions
§ 360aa - Recommendations for investigations of drugs for rare diseases or conditions
21 USC § -
§ 360kk - Performance standards for electronic products
§ 360jj - Studies by Secretary
§ 360ii - Program of control
§ 360hh - Definitions
§ 360ss - State standards
§ 360rr - Federal-State cooperation
§ 360qq - Repealed.
§ 360pp - Enforcement
21 USC § -
§ 360nn - Inspection, records, and reports
§ 360mm - Imports
§ 360aaa to 360aaa–6 - Omitted
21 USC § 360bbb–6 - Risk communication
21 USC § 360bbb–5 - Critical Path Public-Private Partnerships
21 USC § 360bbb–4 - Technical assistance
21 USC § 360bbb–3 - Authorization for medical products for use in emergencies
21 USC § 360bbb–2 - Classification of products
21 USC § 360bbb–1 - Dispute resolution
§ 360bbb - Expanded access to unapproved therapies and diagnostics
21 USC § 360ccc–2 - Designated new animal drugs for minor use or minor species
21 USC § 360ccc–1 - Index of legally marketed unapproved new animal drugs for minor species
§ 360ccc - Conditional approval of new animal drugs for minor use and minor species
§ 361 - Adulterated cosmetics
§ 362 - Misbranded cosmetics
§ 363 - Regulations making exemptions
§ 364 - Repealed.
§ 371 - Regulations and hearings
§ 372a - Transferred
§ 372 - Examinations and investigations
§ 373 - Records
§ 374a - Inspections relating to food allergens
§ 374 - Inspection
§ 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
21 USC § 379d–2 - Policy on the review and clearance of scientific articles published by FDA employees
21 USC § 379d–1 - Conflicts of interest
§ 379d - Automation of Food and Drug Administration
§ 379c - Transferred
§ 379b - Consolidated administrative and laboratory facility
§ 379a - Presumption of existence of jurisdiction
§ 379 - Confidential information
§ 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
21 USC § 379h–2 - Reauthorization; reporting requirements
21 USC § 379h–1 - Fees relating to advisory review of prescription-drug television advertising
§ 379h - Authority to assess and use drug fees
§ 379i - Definitions
21 USC § 379j–1 - Reauthorization; reporting requirements
§ 379j - Authority to assess and use device fees
21 USC § 379j–12 - Authority to assess and use animal drug fees
21 USC § 379j–11 - Definitions
21 USC § 379j–13 - Reauthorization; reporting requirements
21 USC § 379j–22 - Reauthorization; reporting requirements
21 USC § 379j–21 - Authority to assess and use generic new animal drug fees
21 USC § 379j–31 - Authority to collect and use fees
§ 379k - Information system
21 USC § -
21 USC § -
§ 379s - Preemption for labeling or packaging of cosmetics
§ 379r - National uniformity for nonprescription drugs
§ 379v - Safety report disclaimers
21 USC § 379aa–1 - Serious adverse event reporting for dietary supplements
§ 379aa - Serious adverse event reporting for nonprescription drugs
21 USC § 379dd–2 - Activities of the Food and Drug Administration
21 USC § 379dd–1 - Location of Foundation
§ 379dd - Establishment and functions of the Foundation
§ 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
§ 384d - Accreditation of third-party auditors
§ 384c - Inspection of foreign food facilities
§ 384b - Voluntary qualified importer program
§ 387a - FDA authority over tobacco products
§ 387 - Definitions
§ 387u - Studies of progress and effectiveness
§ 387t - Labeling, recordkeeping, records inspection
§ 387s - User fees
§ 387r - Drug products used to treat tobacco dependence
§ 387q - Tobacco Products Scientific Advisory Committee
§ 387p - Preservation of State and local authority
21 USC § -
§ 387n - Jurisdiction of and coordination with the Federal Trade Commission
§ 387m - Equal treatment of retail outlets
21 USC § -
§ 387k - Modified risk tobacco products
§ 387j - Application for review of certain tobacco products
§ 387i - Records and reports on tobacco products
§ 387h - Notification and other remedies
§ 387g - Tobacco product standards
21 USC § 387f–1 - Enforcement action plan for advertising and promotion restrictions
§ 387f - General provisions respecting control of tobacco products
§ 387e - Annual registration
§ 387d - Submission of health information to the Secretary
§ 387c - Misbranded tobacco products
§ 387b - Adulterated tobacco products
21 USC § 387a–1 - Final rule
§ 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–5 - Centers for research and demonstration of health promotion and disease prevention
42 USC § 300u–3 - Grants and contracts for information programs; authority of Secretary; particular activities
42 USC § 300u–2 - Grants and contracts for community health programs
42 USC § 300u–1 - Grants and contracts for research programs; authority of Secretary; review of applications; additional functions; periodic public survey
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 § 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.