Source: https://www.law.cornell.edu/cfr/text/21/part-16/subpart-D?qt-cfr_tabs=1
Timestamp: 2016-02-06 07:39:12
Document Index: 508668835

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21 CFR Part 16, Subpart D - Procedures for Regulatory Hearing | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter A › Part 16 › Subpart D 21 CFR Part 16, Subpart D - Procedures for Regulatory Hearing
There are 7 Updates appearing in the Federal Register for 21 CFR Part 16. View below or at eCFR (GPOAccess)
§ 16.60 — Hearing procedure.
§ 16.62 — Right to counsel.
Title 21 published on 2015-04-01.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.2015-11-27; vol. 80 # 228 - Friday, November 27, 201580 FR 74354 - Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
typeregulations.gov FR Doc.2015-28159 RIN0910-AG35 Docket No.FDA-2011-N-0921 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective January 26, 2016. The effective date of §§ 117.5(k)(2), 117.8, 117.405(c), 117.410(d)(2)(ii), 117.430(d), and 117.475(c)(13) published September 17, 2015 (80 FR 55908), is January 26, 2016. The effective date of §§ 507.12(a)(1)(ii), 507.105(c), 507.110(d)(2)(ii), 507.130(d), and 507.175(c)(13) published September 17, 2015 (80 FR 56170), is January 26, 2016. See section XXIV of this document for the compliance dates. The incorporation by reference of certain publications listed in this rule is approved by the Director of the Federal Register as of January 26, 2016. 21 CFR Parts 11, 16, and 112 SummaryTo minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA or we) is establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is establishing these standards as part of our implementation of the FDA Food Safety and Modernization Act. These standards do not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect the rule to reduce foodborne illness associated with the consumption of contaminated produce.
2015-07-20; vol. 80 # 138 - Monday, July 20, 201580 FR 42723 - Regulatory Hearing Before the Food and Drug Administration; Technical Amendment
typeregulations.gov FR Doc.2015-17714 RIN Docket No.FDA-2015-N-0011 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective July 20, 2015. 21 CFR Part 16 SummaryThe Food and Drug Administration (FDA) is updating an authority citation for the Code of Federal Regulations. This action is technical in nature and is intended to provide accuracy of the Agency&apos;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.United States CodeU.S. Code: Title 15 - COMMERCE AND TRADE§ 1451 - Congressional declaration of policy§ 1452 - Unfair and deceptive packaging and labeling; scope of prohibition§ 1453 - Requirements of labeling; placement, form, and contents of statement of quantity; supplemental statement of quantity§ 1454 - Rules and regulations§ 1455 - Procedure for promulgation of regulations§ 1456 - Enforcement§ 1457 - Omitted§ 1458 - Cooperation with State authorities; transmittal of regulations to States; noninterference with existing programs§ 1459 - Definitions§ 1460 - Savings provisions§ 1461 - Effect upon State law
U.S. Code: Title 21 - FOOD AND DRUGS§ 141 - Prohibition of importation without permit§ 142 - Milk or cream when unfit for importation§ 143 - Inspection; certified statement in lieu thereof; waiver of requirements of section 142; regulations; suspension and revocation of permits§ 144 - Unlawful receiving of imported milk or cream§ 145 - Penalties§ 146 - Authorization of appropriations§ 147 - Repeal of inconsistent laws§ 148 - Powers of State with respect to milk or cream lawfully imported§ 149 - Definitions§ 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. Pub. L. 101–647, title XIX, § 1905, Nov. 29, 1990, 104 Stat. 4853§ 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. Pub. L. 106–554, § 1(a)(1) [title V, § 517], Dec. 21, 2000, 114 Stat. 2763, 2763A–73§ 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§ 350l - Mandatory recall authority§ 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. Pub. L. 105–115, title I, § 125(b)(1), Nov. 21, 1997, 111 Stat. 2325§ 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 devices§ 360l - Postmarket surveillance§ 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§ 360ll - Notification of defects in and repair or replacement of electronic products§ 360mm - Imports§ 360nn - Inspection, records, and reports§ 360oo - Prohibited acts§ 360pp - Enforcement§ 360qq - Repealed. Pub. L. 105–362, title VI, § 601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285§ 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. Pub. L. 86–618, title I, § 103(a)(3), July 12, 1960, 74 Stat. 398§ 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 system§ 379l - Education§ 379o - Environmental impact§ 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 products§ 387l - Judicial review§ 387m - Equal treatment of retail outlets§ 387n - Jurisdiction of and coordination with the Federal Trade Commission§ 387o - Regulation requirement§ 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§ 393a - Office of Pediatric Therapeutics§ 394 - Scientific review groups§ 467f - Federal Food, Drug, and Cosmetic Act applications§ 679 - Application of Federal Food, Drug, and Cosmetic Act§ 821 - Rules and regulations§ 1034 - Inspection of egg products
U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE§ 201 - Definitions§ 262 - Regulation of biological products§ 364
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 16 after this date.2015-11-27; vol. 80 # 228 - Friday, November 27, 201580 FR 74354 - Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption