Source: https://www.law.cornell.edu/cfr/text/21/20.48
Timestamp: 2015-10-10 16:44:11
Document Index: 284136173

Matched Legal Cases: ['art 20', '§ 20', '§ 20', '§ 20', '§ 321', '§ 321', '§ 321', '§ 321', '§ 321', '§ 331', '§ 332', '§ 333', '§ 333', '§ 334', '§ 335', '§ 335', '§ 335', '§ 335', '§ 336', '§ 337', '§ 341', '§ 342', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 344', '§ 345', '§ 346', '§ 346', '§ 346', '§ 347', '§ 347', '§ 347', '§ 348', '§ 349', '§ 350', '§ 350', '§ 350', '§ 350', '§ 350', '§ 350', '§ 350', '§ 350', '§ 350', '§ 350', '§ 350', '§ 350', '§ 350', '§ 351', '§ 352', '§ 353', '§ 353', '§ 353', '§ 354', '§ 355', '§ 355', '§ 355', '§ 355', '§ 355', '§ 355', '§ 355', '§ 356', '§ 356', '§ 356', '§ 356', '§ 356', '§ 357', '§ 358', '§ 359', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 361', '§ 362', '§ 363', '§ 364', '§ 371', '§ 372', '§ 372', '§ 373', '§ 374', '§ 374', '§ 375', '§ 376', '§ 377', '§ 378', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 379', '§ 381', '§ 382', '§ 383', '§ 384', '§ 384', '§ 384', '§ 384', '§ 384', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 391', '§ 392', '§ 393', '§ 1401', '§ 1402', '§ 1403', 'art 20']

21 CFR 20.48 - Judicial review of proposed disclosure. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter A › Part 20 › Subpart C › Section 20.48 21 CFR 20.48 - Judicial review of proposed disclosure.
§ 20.48
Judicial review of proposed disclosure.
Where the Food and Drug Administration consults with a person who will be affected by a proposed disclosure of data or information contained in Food and Drug Administration records pursuant to § 20.47, and rejects the person's request that part or all of the records not be made available for public disclosure, the decision constitutes final agency action that is subject to judicial review pursuant to 5 U.S.C. chapter 7. The person affected will be permitted 5 days after receipt of notification of such decision within which to institute suit in a United States District Court to enjoin release of the records involved. If suit is brought, the Food and Drug Administration will not disclose the records involved until the matter and all related appeals have been concluded.
§ 20.48 Judicial review of proposed disclosure.
U.S. Code: Title 21 - FOOD AND DRUGS§ 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§ 343-1§ 343-2§ 343-3§ 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 foods21 U.S. Code § -§ 350l-1§ 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 - Outsourcing facilities§ 354 - Veterinary feed directive drugs§ 355 - New drugs§ 355-1§ 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, deferral extensions, and waivers§ 355e - Pharmaceutical security§ 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions§ 356-1§ 356a - Manufacturing changes§ 356b - Reports of postmarketing studies§ 356c - Discontinuance or interruption in the production of life-saving drugs§ 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§ 360e-1§ 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 devices21 U.S. Code § -§ 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 products21 U.S. Code § -§ 360mm - Imports§ 360nn - Inspection, records, and reports21 U.S. Code § -§ 360pp - Enforcement§ 360qq - Repealed.§ 360rr - Federal-State cooperation§ 360ss - State standards§ 360aaa to 360aaa–6 - Omitted§ 360bbb - Expanded access to unapproved therapies and diagnostics§ 360bbb-1§ 360bbb-2§ 360bbb-3§ 360bbb-4§ 360bbb-5§ 360bbb-6§ 360ccc - Conditional approval of new animal drugs for minor use and minor species§ 360ccc-1§ 360ccc-2§ 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§ 379d-1§ 379d-2§ 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§ 379h-1§ 379h-2§ 379i - Definitions§ 379j - Authority to assess and use device fees§ 379j-1§ 379j-11§ 379j-12§ 379j-13§ 379j-21§ 379j-22§ 379j-31§ 379k - Information system21 U.S. Code § -21 U.S. Code § -§ 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§ 379aa-1§ 379dd - Establishment and functions of the Foundation§ 379dd-1§ 379dd-2§ 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§ 387a-1§ 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§ 387f-1§ 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 products21 U.S. Code § -§ 387m - Equal treatment of retail outlets§ 387n - Jurisdiction of and coordination with the Federal Trade Commission21 U.S. Code § -§ 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
Title 21 published on 2015-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 20 after this date.2015-07-08; vol. 80 # 130 - Wednesday, July 8, 201580 FR 38915 - Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products