Source: http://www.law.cornell.edu/cfr/text/21/16.26
Timestamp: 2014-04-20 18:34:13
Document Index: 387778879

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21 CFR 16.26 - Denial of hearing and summary decision. | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter A › Part 16 › Subpart B › Section 16.26 21 CFR 16.26 - Denial of hearing and summary decision.
§ 16.26
Denial of hearing and summary decision.
A request for a hearing may be denied, in whole or in part, if the Commissioner or the FDA official to whom authority is delegated to make the final decision on the matter determines that no genuine and substantial issue of fact has been raised by the material submitted. If the Commissioner or his or her delegate determines that a hearing is not justified, written notice of the determination will be given to the parties explaining the reason for denial.
After a hearing commences, the presiding officer may issue a summary decision on any issue in the hearing if the presiding officer determines from the material submitted in connection with the hearing, or from matters officially noticed, that there is no genuine and substantial issue of fact respecting that issue. For the purpose of this paragraph, a hearing commences upon the receipt by FDA of a request for hearing submitted under § 16.22(b).
The Commissioner or his or her delegate may review any summary decision of the presiding officer issued under paragraph (b) of this section at the request of a party or on the Commissioner's or his or her delegate's own initiative.
[53 FR 4615, Feb. 17, 1988, as amended at 69 FR 17290, Apr. 2, 2004]
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§ 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- Market names for catfish and ginseng§ 331 - Prohibited acts§ 332 - Injunction proceedings§ 333 - Penalties§ 333a - Repealed.§ 334 - Seizure§ 335 - Hearing before report of criminal violation§ 335a - Debarment, temporary denial of approval, and suspension§ 335b - Civil penalties§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 food21 U.S. Code § 343–1 - National uniform nutrition labeling21 U.S. Code § 343–2 - Dietary supplement labeling exemptions21 U.S. Code § 343–3 - Disclosure§ 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 § -21 U.S. Code § -§ 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 drugs21 U.S. Code § 355–1 - Risk evaluation and mitigation strategies§ 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 conditions21 U.S. Code § 356–1 - Accelerated approval of priority countermeasures§ 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 approval21 U.S. Code § 360e–1 - Pediatric uses of devices§ 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 diagnostics21 U.S. Code § 360bbb–1 - Dispute resolution21 U.S. Code § 360bbb–2 - Classification of products21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies21 U.S. Code § 360bbb–4 - Countermeasure development, review, and technical assistance21 U.S. Code § 360bbb–5 - Critical Path Public-Private Partnerships21 U.S. Code § 360bbb–6 - Risk communication§ 360ccc - Conditional approval of new animal drugs for minor use and minor species21 U.S. Code § 360ccc–1 - Index of legally marketed unapproved new animal drugs for minor species21 U.S. Code § 360ccc–2 - Designated new animal drugs for minor use or minor species§ 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 Administration21 U.S. Code § 379d–1 - Conflicts of interest21 U.S. Code § 379d–2 - Policy on the review and clearance of scientific articles published by FDA employees§ 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 fees21 U.S. Code § 379h–1 - Fees relating to advisory review of prescription-drug television advertising21 U.S. Code § 379h–2 - Reauthorization; reporting requirements§ 379i - Definitions§ 379j - Authority to assess and use device fees21 U.S. Code § 379j–1 - Reauthorization; reporting requirements21 U.S. Code § 379j–11 - Definitions21 U.S. Code § 379j–12 - Authority to assess and use animal drug fees21 U.S. Code § 379j–13 - Reauthorization; reporting requirements21 U.S. Code § 379j–21 - Authority to assess and use generic new animal drug fees21 U.S. Code § 379j–22 - Reauthorization; reporting requirements21 U.S. Code § 379j–31 - Authority to collect and use fees§ 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 drugs21 U.S. Code § 379aa–1 - Serious adverse event reporting for dietary supplements§ 379dd - Establishment and functions of the Foundation21 U.S. Code § 379dd–1 - Location of Foundation21 U.S. Code § 379dd–2 - Activities of the Food and Drug Administration§ 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 products21 U.S. Code § 387a–1 - Final rule§ 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 products21 U.S. Code § 387f–1 - Enforcement action plan for advertising and promotion restrictions§ 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§ 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
Title 21 published on 2013-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 16 after this date.2014-03-11; vol. 79 # 47 - Tuesday, March 11, 201479 FR 13593 - Environmental Impact Statement for the Proposed Rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Public Meeting on Scoping of Environmental Impact Statement and Extension of Comment Period for Environmental Impact Statement