Documents
Briefs, oral arguments, agency decisions and the Federal Register.
750 results
1.06s
Federal Register · Proposed Rule · May 18, 2010
FDA-2010-N-0136] RIN 0910-AG33 Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act; Extension of Comment Period AGENCY: Food and Drug Administration, … ACTION: Advance notice of proposed rulemaking; extension of comment period.
75 FR 27672Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 22, 1996
of Comment Period as to Specific Documents AGENCY: Food and Drug Administration, HHS. … , 1996, the comment period on specific information that supports certain categorical exclusions proposed by FDA in the proposed rule entitled ``National Environmental Policy Act; Proposed Revision of Policies
61 FR 54746Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 18, 2014
Cosmetic Act; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. … ACTION: Advance notice of proposed rulemaking; reopening of comment period.
79 FR 34668Health 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 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 · 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 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 · 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 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 AdministrationUse of Ozone-Depleting Substances; Removal of Essential-Use Designations
Federal Register · Proposed Rule · Jun 11, 2007
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
72 FR 32030Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 7, 2007
Government to meet their obligations under the Clean Air Act (42 U.S.C. 7401 et seq. ) and the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol) (September 16, 1987, … Air Act (42 U.S.C. 7671c).
72 FR 44037Health and Human Services DepartmentFood and Drug AdministrationCurrent Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements
Federal Register · Proposed Rule · Feb 6, 1997
(2) Effective hand-cleaning and sanitizing preparations. (3) Air driers, sanitary towel service or suitable drying devices. … Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning.
62 FR 5700Current Good Manufacturing Practice in Manufacturing, Packing, orHealth and Human Services DepartmentUse of Ozone-Depleting Substances
Federal Register · Proposed Rule · Oct 26, 2016
Air Act. … The social benefits of the proposed rule derive from greater compliance with the Clean Air Act.
81 FR 74368Health and Human Services DepartmentFood and Drug AdministrationUse of Ozone-Depleting Substances; Request for Comment Concerning Essential-Use Designations
Federal Register · Proposed Rule · Jun 29, 2015
FDA is seeking public comment because it is responsible for determining which FDA-regulated products that release CFCs or other ODSs are essential uses under the Clean Air Act. … Firms that wish to use CFCs manufactured after the phase-out date in medical devices (as defined in section 601(8) of the Clean Air Act) covered under section 610 of the Clean Air Act must receive exemptions
80 FR 36937Health and Human Services DepartmentFood and Drug AdministrationUse of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
Federal Register · Proposed Rule · Sep 20, 2007
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
72 FR 53711Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 9, 1996
gross particulates in the intake air. … (g) Compressed air or other gases that are mechanically introduced into infant formula, that are used to clean any equipment, or that come into contact with any other surface that contacts ingredients,
61 FR 36154Current Good Manufacturing Practice, Quality Control Procedures,Quality Factors, Notification Requirements, and Records and Reports,Federal Register · Proposed Rule · Mar 14, 2007
Paperwork Reduction Act VII. Federalism VIII. Comments IX. References I. … Air-operated temperature controllers should have adequate filter systems to ensure a supply of clean, dry air.
72 FR 11990Health and Human Services DepartmentFood and Drug Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.