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  • National 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 Service
  • Use 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
  • Salmonella 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 Service
  • Use of Ozone-Depleting Substances; Removal of Essential Use Designations; Companion Document to Direct Final Rule

    Federal 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 Administration
  • Use 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 Administration
  • Warning Statements for Products Containing or Manufactured With Chlorofluorocarbons and Other Ozone-Depleting Substances

    Federal 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 Department
  • Chlorofluorocarbon Propellants in Self-Pressurized Containers; Determinations That Uses Are No Longer Essential; Request for Comments

    Federal 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 Administration
  • Use 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 Administration
  • Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases

    Federal 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
  • Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements

    Federal Register · Rule · Nov 18, 2016

    (Comment 5) Some comments express concerns with FDA's proposal to add medical air to the list of gases at § 201.161(a) without providing a warning statement specific to medical air. … (Comment 25) FDA received several comments that the 60-day time period proposed for implementation of the proposed rule is insufficient.

    81 FR 81685Health and Human Services DepartmentFood and Drug Administration
  • Use 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 Administration
  • National Institutes of Health Training Grants

    Federal Register · Rule · Oct 24, 1996

    , as amended, and section 103(h)(2) of the 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.

    61 FR 55110Health and Human Services Department
  • Use of Ozone-Depleting Substances; Removal of Essential-Use Designations; Extension of Comment Period

    Federal 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 Administration
  • Current 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 Department
  • Updated Guidance: Prevention Strategies for Seasonal Influenza in Healthcare Settings

    Federal Register · Notice · Jun 22, 2010

    ACTION: Notice with comment period. … Information on air flow/air entrainment performance should be evaluated for such devices.

    75 FR 35497Health and Human Services DepartmentCenters for Disease Control and Prevention
  • Standards of Care for Chimpanzees Held in the Federally Supported Chimpanzee Sanctuary System

    Federal Register · Rule · Oct 10, 2008

    The NPRM provided for a 60-day public comment period. In December 2007, the CHIMP Act was amended by the “Chimp Haven is Home Act” (Pub. … (Comments) Three commenters suggested (1) the reference to a cleaning schedule for indoor enclosures be changed to read “Indoor primary enclosures must be cleaned as often as required to maintain a clean

    73 FR 60410Health and Human Services Department
  • Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases

    Federal Register · Rule · Jun 18, 2024

    (Comment 36) One comment suggests revising § 213.182 to state that cleaning and maintenance is performed on a periodic basis or when there is suspected contamination and is not associated with a batch … (Comment 63) One comment maintains that entering a specific percentage of oxygen in the distribution records for each medical air cylinder is not necessary, because medical air contains a range of oxygen

    89 FR 51738Health and Human Services DepartmentFood and Drug Administration
  • Proposal To Establish Procedures for the Safe Processing and Importing of Fish and Fishery Products

    Federal Register · Uncategorized Document · Jan 28, 1994

    Air-packaged. … Air-packaged products.

    Proposal To Establish Procedures for the Safe Processing and ImportingHealth and Human Services Department
  • Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)

    Federal Register · Rule · Nov 19, 2008

    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

    73 FR 69532Health and Human Services DepartmentFood and Drug Administration
  • Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers

    Federal Register · Rule · Mar 3, 2011

    (Comment 28) One comment suggested that the statement that air-operated temperature controllers should have adequate filter systems to ensure a supply of clean, dry air is misplaced in the regulations … Air-operated temperature controllers should have adequate filter systems to ensure a supply of clean, dry air.

    76 FR 11892Health and Human Services DepartmentFood and Drug Administration

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