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Federal 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 · 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 · 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 AdministrationUse 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 AdministrationUse 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 AdministrationFederal Register · Proposed Rule · Dec 7, 2006
Background As described more fully in the related direct final rule, the Clean Air Act prohibits most uses of chlorofluorocarbons (CFCs) (a class of ODSs). … 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 70912Health and Human Services DepartmentFood and Drug AdministrationSalmonella Enteritidis in Eggs
Federal Register · Proposed Rule · May 19, 1998
FDA requests comments on the latter two practices described above could violate 403(a) or other provisions of the Act. … The comment period on this ANPR closed on February 20, 1997. Fifty-two comments have been received. (3) Risk Assessment. The agencies are conducting a quantitative risk assessment for shell eggs.
63 FR 27502Agriculture DepartmentFood Safety and Inspection ServiceUse of Ozone-Depleting Substances; Removal of Essential-Use Designations
Federal Register · Proposed Rule · Jun 16, 2004
Section 614(b) of the Clean Air Act provides that in the case of a conflict between any provision of the Clean Air Act and any provision of the Montreal Protocol, the more stringent provision will govern … Section 604 of the Clean Air Act requires the phaseout of the production of CFCs by 2000 (42 U.S.C. 7671c) 3 , while section 610 of the Clean Air Act (42 U.S.C. 7671i) required EPA to issue regulations
69 FR 33602Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 3, 1996
The Clean Air Act requires that the warning labels be on all products containing or manufactured with CFC's on or after May 15, 1993. … For this interim rule, FDA finds that notice and comment procedures would be impracticable for a CFC warning statement requirement because the Clean Air Act requires such warning statements to be placed
61 FR 20096Warning Statements for Products Containing or Manufactured WithHealth and Human Services DepartmentFederal Register · Proposed Rule · Mar 6, 1997
Section 601(8) of the Clean Air Act (42 U.S.C. 7671(8)) defines ``medical device'' as any device (as defined in the Federal Food, Drug, and Cosmetic Act), diagnostic product, drug (as defined in the Federal … Firms that wish to use CFC's manufactured after the phaseout date in medical devices (as [[Page 10243]] defined in section 601(8) of the Clean Air Act) covered under section 610 of the Clean Air Act
62 FR 10242Health and Human Services DepartmentFood and Drug AdministrationUse of Ozone-Depleting Substances; Removal of Essential-Use Designation (Flunisolide, etc.)
Federal Register · Rule · Apr 14, 2010
The 1990 Amendments to the Clean Air Act In 1990, Congress amended the Clean Air Act to, among other things, better protect stratospheric ozone (Public Law No. 101-549, November 15, 1990) (the 1990 … Section 614(b) of the Clean Air Act provides that, in the case of a conflict between any provision of the Clean Air Act and any provision of the Montreal Protocol, the more stringent provision will govern
75 FR 19213Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 23, 2022
The Agency has received comments recommending that it issue a separate warning statement requirement for medical air that states that medical air may be used without a prescription for breathing support … The Agency seeks comment on the appropriateness of the 3-day reporting period.
87 FR 31302Health and Human Services DepartmentFood and Drug Administration
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