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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Aug 3, 2021
FDA-2020-D-2024] Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Extension of Comment Period AGENCY: … ACTION: Notice of availability; extension of comment period.
86 FR 41853Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 27, 2011
FDA-2011-N-0528] Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012; Extension of Comment Period AGENCY … ACTION: Notice; extension of comment period.
76 FR 66723Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 4, 2025
ACTION: Notice of availability; reopening of comment period. … SUMMARY: The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability entitled “Prescription Drug User Fee Act VII; Independent Assessment of Communication
90 FR 36443Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 26, 2026
FDA-2018-N-3240] List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period AGENCY: Food and Drug … ACTION: Notice; extension of comment period.
91 FR 38719Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 30, 2011
ACTION: Proposed rule; extension of comment period. SUMMARY: This document extends the comment period for two proposed rules published in the Federal Register on July 15, 2011. … Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail.
76 FR 60788Health and Human Services DepartmentFederal Register · Notice · Jan 8, 2021
FDA-2018-N-3240] List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Reopening of the Comment Period AGENCY: Food and … ACTION: Notice; reopening of the comment period.
86 FR 1515Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 23, 2011
The public comment period was scheduled to end on June 20, 2011. We have received a request asking to extend the public comment period. … HHS received a request to extend the comment period.
76 FR 36891Health and Human Services DepartmentFederal Register · Notice · Jun 12, 2024
and Comments; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. … (FD&C Act).
89 FR 49884Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 2, 2013
ACTION: Notice; extension of comment period. … SUMMARY: The Food and Drug Administration (FDA) is extending the comment period for the notice entitled “Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish
78 FR 19715Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 24, 2014
FDA-2014-N-0189] RIN 0910-AG38 Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on … ACTION: Proposed rule; extension of comment period.
79 FR 35711Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 8, 2016
ACTION: Notice of petition; reopening of comment period. … FDA has considered the request; however, because the request was submitted too late to allow us to extend the comment period, we are, instead, reopening the comment period until September 19, 2016.
81 FR 52370Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 7, 2022
ACTION: Notice of availability; extension of comment period. … The Agency has received a request for an extension of the comment period.
87 FR 6875Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 23, 2019
ACTION: Proposed rule; supplement and extension of comment period. … SUMMARY: This document extends the comment period for the proposed rule entitled “Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for
84 FR 16834Health and Human Services DepartmentCenters for Medicare & Medicaid ServicesUse of Ozone-Depleting Substances
Federal Register · Rule · Oct 26, 2016
Air Act. … under the Clean Air Act.
81 FR 74298Health and Human Services DepartmentFood and Drug AdministrationUse of Ozone-Depleting Substances
Federal Register · Proposed Rule · Oct 26, 2016
Air Act. … under the Clean Air Act.
81 FR 74364Health and Human Services DepartmentFood and Drug AdministrationUse of Ozone-Depleting Substances; Essential-Use Determinations
Federal Register · Rule · Jul 24, 2002
However, FDA is changing the regulation to conform to the authority delegated to it under the Clean Air Act. FDA notes that EPA is responsible for enforcement of the Clean Air Act. … The Clean Air Act then prevents marketing of those ODS-containing products. The use of stockpiled CFCs is governed by the Clean Air Act.
67 FR 48370Health and Human Services DepartmentFood and Drug AdministrationUse of Ozone-Depleting Substances; Essential Use Determinations
Federal Register · Proposed Rule · Sep 1, 1999
Air Act. … essential under the Clean Air Act (42 U.S.C. 7671(8)).
64 FR 47719Health and Human Services DepartmentFood and Drug AdministrationUse of Ozone-Depleting Substances; Removal of Essential Use Designations
Federal Register · Rule · Dec 7, 2006
Air Act. … Therefore, under the Federal Food, Drug, and Cosmetic Act, the Clean Air Act, and under authority delegated to the Commissioner of Food and Drugs, after consultation with the Administrator of the Environmental
71 FR 70870Health and Human Services DepartmentFood and Drug AdministrationNational Institutes of Health Training Grants
Federal Register · Proposed Rule · Jan 24, 1995
Clean Air Act, as amended. … NIH also needs to provide regulations for training grants authorized by section 901 of the Clean Air Act Amendments of 1990, Public Law 101-549, which amended section 103(h)(2) of the Clean Air Act.
60 FR 4742Health and Human Services DepartmentPublic Health ServiceUse of Ozone-Depleting Substances; Removal of Essential-Use Designations
Federal Register · Rule · Apr 4, 2005
Under the Clean Air Act, a use of an ODS is either essential or it is not. … Air Act.
70 FR 17168Health and Human Services DepartmentFood and Drug Administration
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