21 CFR 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 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2011-13488 RIN Docket No. FDA-2011-N-0318 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective June 1, 2011. 21 CFR Parts 5, 10, 14, 19, 20, 21, 314, 350, 516, and 814 The Food and Drug Administration (FDA) is amending the Agency's regulations to reflect changes to the Division of Freedom of Information's office name, address, telephone number, and fax number and the Division of Freedom of Information Public Reading room's fax and room number. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
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.
18 USC 1905 - Disclosure of confidential information generally
19 USC 2531 - Certain standards-related activities
19 USC 2532 - Federal standards-related activities
19 USC 2533 - State and private standards-related activities
19 USC 2541 - Functions of Trade Representative
19 USC 2542 - Establishment and operation of technical offices
19 USC 2543 - Representation of United States interests before international standards organizations
19 USC 2544 - Standards information center
19 USC 2545 - Contracts and grants
19 USC 2546 - Technical assistance
19 USC 2547 - Consultations with representatives of domestic interests
19 USC 2551 - Right of action
19 USC 2552 - Representations
19 USC 2553 - Action after receipt of representations
19 USC 2554 - Procedure after finding by international forum
19 USC 2561 - Findings of reciprocity required in administrative proceedings
19 USC 2562 - Consideration of standards-related activities by an international forum
19 USC 2571 - Definitions
19 USC 2572 - Exemptions
19 USC 2573 - Reports to Congress on operation of agreement
19 USC 2575 - General
19 USC 2575a - Inquiry point
19 USC 2575b - Subpart definitions
19 USC 2576 - General
19 USC 2576a - Inquiry point
19 USC 2576b - Subpart definitions
19 USC 2577 - Definitions
19 USC 2578 - Notice of United States participation in international standard-setting activities
19 USC 2578a - Equivalence determinations
19 USC 2578b - Definitions
19 USC 2581 - Auction of import licenses
19 USC 2582 - Repealed.
21 USC 1401 - Pesticide monitoring and enforcement information
21 USC 1402 - Foreign pesticide information
21 USC 1403 - Pesticide analytical methods
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
42 USC 241 - Research and investigations generally
42 USC 242 - Studies and investigations on use and misuse of narcotic drugs and other drugs; annual report to Attorney General; cooperation with States
42 USC 242a - Repealed.
42 USC § -
42 USC 242n - Repealed.
42 USC 243 - General grant of authority for cooperation
42 USC 262 - Regulation of biological products
42 USC 263 - Preparation of biological products by Service
42 USC 263b - Certification of mammography facilities
42 USC § 259 to 261a - Repealed.
42 USC 264 - Regulations to control communicable diseases
42 USC 265 - Suspension of entries and imports from designated places to prevent spread of communicable diseases
42 USC § 300aa–1 - Establishment
42 USC 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
5 USC 552 - Public information; agency rules, opinions, orders, records, and proceedings
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 20
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6967 RIN Docket No. FDA-2012-N-0205 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Direct final rule. This rule is effective August 6, 2012. Submit either electronic or written comments on or before June 6, 2012. If we receive no significant adverse comments within the specified comment period, we will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date. 21 CFR Part 20 This direct final rule makes technical changes that will update a requirement that many of our written agreements and memoranda of understanding (MOUs) with 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 direct 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. We are proceeding in accordance with our direct final rule procedures. We are publishing a companion proposed rule under our usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event we receive any significant adverse comments and withdraw this direct final rule. The companion proposed rule and this direct final rule are substantively identical.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6969 RIN Docket No. FDA-2012-N-0205 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on or before June 6, 2012. If we receive any significant adverse comments, we will publish a document withdrawing the direct final rule within 30 days after the comment period ends. We will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures. 21 CFR Part 20 We are publishing this companion proposed rule to the direct final rule on “Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agencies, and Organizations,” which makes technical changes intended to update a requirement that many of these agreements and memoranda of understanding (MOUs) 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 proposed rule, accordingly, would eliminate it. We are proposing 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. 2012-1430 RIN 0910-AF78 Docket No. 2001N-0284) DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by April 24, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 24, 2012, (see the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 10, 20, 25, and 510 The Food and Drug Administration (FDA) is proposing to establish procedures by which a person may request that the Agency establish or amend tolerances for unapproved new animal drugs where edible portions of animals imported into the United States may contain residues of such drugs (import tolerances), as well as procedures to revoke an existing import tolerance. Such import tolerances provide a basis for legally marketing food of animal origin that is imported into the United States and contains residues of unapproved new animal drugs.
GPO FDSys XML | Text type regulations.gov FR Doc. 2011-13488 RIN Docket No. FDA-2011-N-0318 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective June 1, 2011. 21 CFR Parts 5, 10, 14, 19, 20, 21, 314, 350, 516, and 814 The Food and Drug Administration (FDA) is amending the Agency's regulations to reflect changes to the Division of Freedom of Information's office name, address, telephone number, and fax number and the Division of Freedom of Information Public Reading room's fax and room number. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.



