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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 AdministrationUse 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 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 AdministrationNational 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 DepartmentFederal 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 AdministrationMedical 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 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 AdministrationUpdated 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 PreventionStandards 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 DepartmentFederal 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 AdministrationUse 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 AdministrationUse 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 AdministrationFederal 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 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 AdministrationFederal Register · Notice · Feb 25, 2000
Clean Air Act (CAA). … —Maximum Penalties for Violation of Clean Air Act 42 U.S.C. § 7413 (b)-(d).
65 FR 10230Health and Human Services DepartmentApproval Tests and Standards for Air-Purifying Particulate Respirators
Federal Register · Rule · Apr 14, 2020
Issuance of an Interim Final Rule With Immediate Effective Date Rulemaking under the Administrative Procedure Act (APA) generally requires a public notice and comment period and consideration of the submitted … (1) Powered air-purifying particulate respirators utilize a blower to move the ambient air through the air-purifying filter elements (filters) to remove particulate contaminants and deliver clean air
85 FR 20598Health and Human Services DepartmentUse 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 · Notice · Jan 19, 2016
Is there an existing test protocol for evaluation of the protective efficacy of air-cleaning or filtration technologies CSTDs? … Are you interested in being a collaborative partner with NIOSH on the development of an air cleaning or filtration technologies CSTD test protocol?
81 FR 2863Health and Human Services DepartmentCenters for Disease Control and Prevention
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