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Federal Register · Notice · Sep 24, 1998
The comments in the docket will be periodically reviewed, and, where appropriate, the guidance will be amended. … These would include diet, cleaning and feeding schedules, provisions for periodic veterinary care if applicable, and details of special handling that the animals may require once inoculated.
63 FR 51074Health and Human Services DepartmentFood and Drug AdministrationDraft Revised Compliance Policy Guide; Male Condom Defects; Availability
Federal Register · Notice · Mar 29, 2002
In accordance with section 514(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d(c)), as amended by the FDA Modernization Act of 1997, the agency now recognizes some voluntary industrial … standards for purposes of meeting the act's requirements.
67 FR 15213Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 2, 2004
Arsenic is an element that occurs naturally in rocks, soil, water, air, plants, and animals. … Because arsenic is naturally occurring, the entire population is exposed to low levels of arsenic through food, water, air, and contact with soil.
69 FR 70082Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 31, 2019
control environmental conditions and inspection result records; (4) requirements for personnel hygiene; (5) procedures for preventing contamination of equipment and products; (6) equipment adjustment, cleaning … 27,074 6 162,444 Distribution procedures and records—820.160(a) and (b) 27,074 1 27,074 1 27,074 Installation—820.170 27,074 1 27,074 2 54,148 Record retention period
84 FR 37317Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 10, 2013
control environmental conditions and inspection result records; (4) requirements for personnel hygiene; (5) procedures for preventing contamination of equipment and products; (6) equipment adjustment, cleaning … 25,986 6 155,916 Distribution procedures and records—820.160(a) and (b) 25,986 1 25,986 1 25,986 Installation—820.170 25,986 1 25,986 2 51,972 Record retention period
78 FR 74146Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 8, 1996
The directions are for a product that must deliver 0.04 to 0.150 milligram of l-desoxyephedrine in each 800 milliliters of air. … (1) Comment No. CP1, Docket No. 95P-0245, Dockets Management Branch. (2) Draft Compendial Monograph, in Comment No. CP1, Docket No. 95P-0245, Dockets Management Branch.
61 FR 9570Health and Human Services DepartmentFood and Drug AdministrationLatex Condoms; User Labeling; Expiration Dating
Federal Register · Proposed Rule · May 24, 1996
FDA invites advance comments on these issues. … Section 510(h) of the act (21 U.S.C. 360(h)) requires that condom manufacturers as device manufacturers be inspected at least once in a 2-year period.
61 FR 26140Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 8, 2016
control environmental conditions and inspection result records; (4) requirements for personnel hygiene; (5) procedures for preventing contamination of equipment and products; (6) equipment adjustment, cleaning … 24,738 6 148,428 Distribution procedures and records—820.160(a) and (b) 24,738 1 24,738 1 24,738 Installation—820.170 24,738 1 24,738 2 49,476 Record retention period
81 FR 62144Health and Human Services DepartmentFood and Drug AdministrationRevocation of Certain Regulations; Opportunity for Public Comment
Federal Register · Proposed Rule · Oct 13, 1995
DATES: Submit comments by January 11, 1996. … Chlorofluorocarbons are prohibited by the Clean Air Act Amendments of 1990 (42 U.S.C. 7671) and can no longer be marketed for this use.
60 FR 53480Health and Human Services DepartmentFood and Drug AdministrationAnimal Drugs, Feeds, and Related Products; Chlortetracycline
Federal Register · Rule · Jul 9, 1996
The authority citation for 21 CFR part 558 continues to read as follows: Authority: Secs. 512, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b, 371). 4. … Beaulieau, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 96-17169 Filed 7-8-96; 8:45 am] BILLING CODE 4160-01-F
61 FR 35949Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 6, 2016
Paperwork Reduction Act of 1995 VIII. Environmental Impact IX. Federalism X. … (Response 1) The purpose of an ANPR is to allow the public a period of time to comment on regulations that the FDA may pursue as part of a future rulemaking.
81 FR 61106Health and Human Services DepartmentFood and Drug AdministrationIndirect Food Additives: Paper and Paperboard Components
Federal Register · Rule · Jan 4, 2016
Comments on the Filing Notice We received very few comments on the petition. These comments stated that the use of the three FCSs as listed in § 176.170 has been abandoned. … We have not received any new information or comments that would affect our previous determination. VII. Paperwork Reduction Act of 1995 This final rule contains no collection of information.
81 FR 5Health and Human Services DepartmentFood and Drug AdministrationGood Laboratory Practice for Nonclinical Laboratory Studies
Federal Register · Proposed Rule · Aug 24, 2016
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 23, 2016 see section IX). … (a) Equipment must be adequately inspected, cleaned, and maintained.
81 FR 58342Health and Human Services DepartmentFood and Drug AdministrationSkin Protectant Drug Products for Over-the-Counter Human Use; Final Monograph
Federal Register · Rule · Jun 4, 2003
section 505(a) of the act … section 505(a) of the act
68 FR 33362Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 22, 2001
DATES: Submit written comments by April 9, 2001. … FDA invites comment on this point.
66 FR 6502Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 24, 2022
Section 801.410(f) requires that the results of impact tests and description of the test method and apparatus be retained for a period of 3 years. … Total annual disclosures Average burden per disclosure Total hours Part 800 and Part 801, subparts A, C, D, and E: General Labeling; OTC Devices; Exemptions Contact lens cleaning
87 FR 51989Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 8, 2011
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule to require premarket … The FD&C Act does not permit an extension of the 90-day period after issuance of a final rule within which an application or a notice is required to be filed.
76 FR 48058Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 8, 2015
Thus, for these devices, the later of these two time periods is the 90-day period. … FDA disagrees with this comment.
80 FR 32307Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Radiology Devices; Classification of Blood Irradiators
Federal Register · Proposed Rule · Mar 18, 2026
DATES: Either electronic or written comments on the proposed rule must be submitted by May 18, 2026. ADDRESSES: You may submit comments as follows. … ” to the Federal Food, Drug, and Cosmetic Act (FD&C Act).
91 FR 12951Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 1, 2003
FDA agrees and will replace the term “state-of-the-art” with “appropriately fit conventional air conduction hearing aids.” … Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act
68 FR 45256Health and Human Services DepartmentFood and Drug Administration
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