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21 CFR 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

Title 21 published on 2011-04-01

no entries appear in the Federal Register after this date.

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.


United States Code

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21 USC 333a - Repealed.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21 USC 343a - Repealed.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 262 - Regulation of biological products

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 11

  • 2011-05-24; vol. 76 # 100 - Tuesday, May 24, 2011
    1. 76 FR 30050 - Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Correction
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule; correction.
      21 CFR Parts 11 and 101