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Federal Register · Notice · May 30, 2013
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.
78 FR 32400Health and Human Services DepartmentFood and Drug AdministrationPremarket Tobacco Product Applications and Recordkeeping Requirements
Federal Register · Rule · Oct 5, 2021
the comment is suggesting go to TPSAC within the 180-day review period required by section 910(c) of the FD&C Act. … • Pressure drop through air valve (mm H 2 O). • Air flow through air valve (cc/min).
86 FR 55300Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 29, 2015
DATES: Fax written comments on the collection of information by March 2, 2015. … 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.
80 FR 4928Health and Human Services DepartmentFood and Drug AdministrationFluorinated Polyethylene Containers for Food Contact Use; Request for Information
Federal Register · Notice · Jul 20, 2022
Current data and information on these topics will help us advance our public health mission and further support the current Administration's comprehensive approach to addressing PFAS and advancing clean … air, water, and food (Ref. 4).
87 FR 43274Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 19, 1999
CGMP Regulations for Finished Pharmaceuticals--21 CFR Parts 210 and 211 (OMB Control Number 0910-0139)--Reinstatement 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
64 FR 19180Health and Human Services DepartmentFood and Drug AdministrationRevision of the Requirements For Spore-Forming Microorganisms; Companion to Direct Final Rule
Federal Register · Proposed Rule · Dec 30, 2003
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).
68 FR 75179Health and Human Services DepartmentFood and Drug AdministrationSterility Requirements for Inhalation Solution Products
Federal Register · Proposed Rule · Sep 23, 1997
DATES: Written comments by December 22, 1997. Submit written comments on the information collection requirements by October 23, 1997. … FDA finds that the cost of building a new clean room may amount to almost $600 per square foot. The size of pharmaceutical clean rooms is reported to vary widely, from 200 to 2,500 square feet.
62 FR 49638Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 4, 2018
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk … 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.
83 FR 44884Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 16, 2012
L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). … It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document.
77 FR 15765Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 7, 2022
(FD&C Act) regarding safety, identity, strength, quality, and purity and are issued under the provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. … Five comments were received and are summarized here.
87 FR 61070Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 27, 2013
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.
78 FR 18605Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 7, 2022
(FD&C Act) regarding safety, identity, strength, quality, and purity and are issued under the provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. … Annual Recordkeeping Incoming Acceptance Tests Records (§§ 212.20(c), 212.40(a) and (b)) 23 24 552 0.5 276 Annual Recordkeeping Batch Testing (creating testing records for sterility, periodic
87 FR 20420Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 1, 2014
Medical Device Labeling Regulations—21 CFR 800, 801, and 809 (OMB Control Number 0910-0485)—Extension Section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352), among other … 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.
79 FR 44782Health and Human Services DepartmentFood and Drug AdministrationPremarket Tobacco Product Applications and Recordkeeping Requirements
Federal Register · Proposed Rule · Sep 25, 2019
and the opportunity to submit comments. … FDA requests public comments on its interpretation of 910(d)(1)(A) of the FD&C Act.
84 FR 50566Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 22, 2018
Medical Device Labeling Regulations—21 CFR parts 800, 801, and 809 OMB Control Number 0910-0485—Extension Section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352), among other … 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.
83 FR 7728Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 27, 2010
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk … DSHEA, among other things, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)).
75 FR 59266Health and Human Services DepartmentFood and Drug AdministrationElectronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components
Federal Register · Rule · Jun 10, 2005
Act (PHS Act) (42 U.S.C. 201 et seq. ) to chapter V of the act (21 U.S.C. 301 et seq. ). … No additional information was received on this topic during the comment period.
70 FR 33998Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 29, 2023
and corrective actions; removing language on voluntary periodic sampling and testing of sprouts, and clarifying our expectations for corrective actions after an operation detects Listeria spp. or … 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 of 1995
88 FR 67157Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 17, 2015
out the provisions of the FD&C Act. … the same ad airs three to six times.
80 FR 34672Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 24, 1998
One comment requested a 2-year grace period for small businesses before implementation if pasteurization were to be required. … The agency disagrees with the comments that stated that it should require that apple juice be pasteurized because apples can be difficult to clean.
63 FR 20450Health and Human Services DepartmentFood and Drug Administration
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