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Federal Register · Notice · Nov 10, 2014
The FDA has the authority under section 701(a) of the FD&C Act (21 U.S.C. 371(a)) to issue regulations for the efficient enforcement of the FD&C Act regarding CGMP procedures for manufacturing, processing … Thereafter, SOPs need to be periodically updated. A combined estimate for routine maintenance of SOPs is provided in table 1.
79 FR 66724Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 27, 2015
L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). … Submission of Comments and Effective Date Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
80 FR 4274Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 11, 2012
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … FDA has determined that the applicable regulatory review period for Progel Pleural Air Leak Sealant is 3,854 days.
77 FR 34389Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 25, 2015
The FDA has the authority under section 701(a) of the FD&C Act (21 U.S.C. 371(a)) to issue regulations for the efficient enforcement of the FD&C Act regarding CGMP procedures for manufacturing, processing … Thereafter, SOPs need to be periodically updated. A combined estimate for routine maintenance of SOPs is provided in table 1.
80 FR 10117Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 6, 1999
Paperwork Reduction Act of 1995 IX. Comments X. References I. Background A. … After the eggs are washed, they are dried with forced ambient air and then packed.
64 FR 36492Proposed RulePreliminary Regulatory Impact Analysis and Initial RegulatoryFederal Register · Proposed Rule · Dec 12, 2000
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … Flexibility Act (5 U.S.C. 601-612) and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
65 FR 77532Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 14, 2017
Specifically, under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the methods used in or the facilities or controls … Thereafter, SOPs need to be periodically updated. A combined estimate for routine maintenance of SOPs is provided in table 1.
82 FR 58811Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 6, 2018
Thereafter, SOPs need to be periodically updated. A combined estimate for routine maintenance of SOPs is provided in table 1. … This notice is intended to solicit such public comment.
83 FR 14861Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 24, 2008
Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (OMB Control Number 0910-0139)—Extension Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the act) ( … FDA has the authority under section 701(a) of the act (21 U.S.C. 371(a)) to issue regulations for the efficient enforcement of the act regarding CGMP procedures for manufacturing, processing, and holding
73 FR 55108Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 10, 1998
Section 4 of Executive Order 12889 states that any agency subject to the Administrative Procedure Act shall provide a 75-day comment period for any proposed technical regulation. … As a result, a 75-day comment period is not required for this proposed rule. VII. References 1.
63 FR 17744Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 28, 2011
The FDA has the authority under Section 701(a) of the FD&C Act (21 U.S.C. 371(a)) to issue regulations for the efficient enforcement of the FD&C Act regarding CGMP procedures for manufacturing, processing … Thereafter, SOPs need to be periodically updated. A combined estimate for routine maintenance of SOPs is provided in table 1 of this document.
76 FR 60052Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 28, 2008
CGMP Regulations for Finished Pharmaceuticals—21 CFR Parts 210 and 211 (OMB Control Number 0910-0139)—Extension Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C … FDA has the authority under section 701(a) of the act (21 U.S.C. 371(a)) to issue regulations for the efficient enforcement of the act regarding CGMP procedures for manufacturing, processing, and holding
73 FR 22951Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 7, 2002
CGMP Regulations for Finished Pharmaceuticals—21 CFR Parts 210 and 211 (OMB Control No. 0910-0139)—Extension Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. … Section 211.56(c)—Use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents; 4. Section 211.67(b)—Cleaning and maintenance of equipment; 5.
67 FR 5825Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 25, 2005
• Section 211.182—Specifies requirements for equipment cleaning records and the use log. … Thereafter, SOPs need to be periodically updated. A combined estimate is provided in table 1 of this document.
70 FR 42579Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 31, 2011
FDA has the authority under section 701(a) of the FD&C Act (21 U.S.C. 371(a)) to issue regulations for the efficient enforcement of the FD&C Act regarding CGMP procedures for manufacturing, processing, … Thereafter, SOPs need to be periodically updated. A combined estimate for routine maintenance of SOPs is provided in table 1 of this document.
76 FR 31342Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 16, 2002
DATES: Submit written comments on the collection of information by June 17, 2002. … In the Federal Register of February 7, 2002 (67 FR 5825), the agency requested comments on the proposed collection of information. There were no comments received.
67 FR 34939Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 28, 2005
CGMP Regulations for Finished Pharmaceuticals—21 CFR Parts 210 and 211 (OMB Control Number 0910-0139)—Extension Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the act) (21 … • Section 211.182—Specifies requirements for equipment cleaning records and the use log.
70 FR 15628Health and Human Services DepartmentFood and Drug AdministrationFederal Measures To Mitigate BSE Risks: Considerations for Further Action
Federal Register · Proposed Rule · Jul 14, 2004
FSIS also issued a press release during the comment period for its SRM rule to specifically solicit public comment on methods used to prevent cross contamination of carcasses with SRMs. … To facilitate FDA's consideration of those comments in developing the proposed rule, please submit comments specific to the FDA issues and questions to FDA prior to close of the 30-day comment period listed
69 FR 42288Agriculture DepartmentAnimal and Plant Health Inspection ServiceFederal Register · Notice · Jun 6, 1997
However, as permitted by section 520(l)(5)(C) of the act, in the Federal Register of November 30, 1992 (57 FR 56586), the agency published a notice extending the period for issuing such regulations until … aids and accessory cleaning pads).
62 FR 31118Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 17, 2019
Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. … Records are maintained on file at each farm site and examined there periodically by FDA inspectors.
84 FR 34191Health and Human Services DepartmentFood and Drug Administration
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