Source: https://www.law.cornell.edu/cfr/text/21/10.35
Timestamp: 2016-10-23 12:52:35
Document Index: 160704716

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21 CFR 10.35 - Administrative stay of action. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter A › Part 10 › Subpart B › Section 10.35 21 CFR 10.35 - Administrative stay of action.
§ 10.35 Administrative stay of action.
(b) An interested person may request the Commissioner to stay the effective date of any administrative action. A stay may be requested for a specific time period or for an indefinite time period. A request for stay must be submitted in accordance with § 10.20 and in the following form no later than 30 days after the date of the decision involved. The Commissioner may, for good cause, permit a petition to be filed after 30 days. In the case of a decision published in the Federal Register, the day of publication is the date of decision.
(c) A petition for stay of action relating to a petition submitted under § 10.25(a)(2) is subject to the requirements of § 10.30 (c) and (d), except that it will be filed in the same docket file as the petition to which it relates.
(d) Neither the filing of a petition for a stay of action nor action taken by an interested person in accordance with any other administrative procedure in this part or in any other section of this chapter, e.g., the filing of a citizen petition under § 10.30 or a petition for reconsideration under § 10.33 or a request for an advisory opinion under § 10.85, will stay or otherwise delay any administrative action by the Commissioner, including enforcement action of any kind, unless one of the following applies:
(e) The Commissioner
shall promptly review a petition for stay of action. The Commissioner may grant or deny a petition, in whole or in part; and may grant such other relief or take such other action as is warranted by the petition. The Commissioner may grant a stay in any proceeding if it is in the public interest and in the interest of justice. The Commissioner
shall grant a stay in any proceeding if all of the following apply:
(6) All documents filed with the Division of Dockets Management under § 10.65(h).
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 54 FR 9034, Mar. 3, 1989; 59 FR 14364, Mar. 28, 1994; 66 FR 6468, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001]
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§ 395 - Loan repayment program§ 396 - Practice of medicine§ 397 - Contracts for expert review§ 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
21 CFR 601.43 — Withdrawal Procedures.
21 CFR 601.92 — Withdrawal Procedures.
21 CFR 314.530 — Withdrawal Procedures.
21 CFR 17.51 — Judicial Review.
21 CFR 314.620 — Withdrawal Procedures.