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Briefs, oral arguments, agency decisions and the Federal Register.

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  • Dental Devices; Effective Date of Requirement for Premarket Approval of Endodontic Dry Heat Sterilizer

    Federal Register · Proposed Rule · Jun 7, 1995

    If FDA does not initiate such a proceeding, section 515(b)(3) of the act provides that FDA shall, after the close of the [[Page 30033]] comment period on the proposed rule and consideration of any comments … The difficulty was attributed to two factors: the large mass of the file, and the air trapped in the deep trough since air is a poor heat conductor (Ref. 5).

    60 FR 30032Health and Human Services DepartmentFood and Drug Administration
  • Respiratory Protective Devices

    Federal Register · Rule · Jun 8, 1995

    The commenter suggested a thirty-day preconditioning period. … The Regulatory Flexibility Act (the Act) also requires that the agency periodically review existing regulations and consider reforming those that burden small entities, taking into account the degree to

    60 FR 30336Health and Human Services DepartmentPublic Health Service
  • Sanitary Transportation of Human and Animal Food

    Federal Register · Rule · Apr 6, 2016

    The commenter observes that railroads do not generally clean rail cars and do not track the cleaning of railcars. … period beyond the latest requirement.

    81 FR 20092Health and Human Services DepartmentFood and Drug Administration
  • Educating the Public About Removal of Essential-Use Designation for Epinephrine; Public Workshop; Request for Comments

    Federal Register · Notice · Aug 20, 2009

    Air Act, Public Law No. 101-549 (November 15, 1990). … At the public workshop, FDA will provide relevant background information, including a brief summary of the Montreal Protocol, the Clean Air Act, and the epinephrine final rule.

    74 FR 42080Health and Human Services DepartmentFood and Drug Administration
  • Changes To Be Reported for Product and Establishment License Applications; Guidance

    Federal Register · Notice · Apr 6, 1995

    DATES: Written comments may be submitted at any time. … Comments should be identified with the docket number found in brackets in the heading of this document. Two copies of any comments are to be submitted except that individuals may submit one copy.

    60 FR 17535Health and Human Services Department
  • Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements

    Federal Register · Proposed Rule · Apr 10, 2006

    Paperwork Reduction Act of 1995 VI. Environmental Impact VII. Effective Date VIII. Federalism IX. Request for Comments I. Background A. … b)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(g)(1) and 353(b)(1)).

    71 FR 18039Health and Human Services DepartmentFood and Drug Administration
  • Proposed Data Collections Submitted for Public Comment and Recommendations

    Federal Register · Notice · Jun 13, 2012

    requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC … products, latex, indoor air pollution, volatile organic compounds (VOCs) and bioaerosols.

    77 FR 35405Health and Human Services DepartmentCenters for Disease Control and Prevention
  • Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-The-Counter Human Use; Proposed Amendment of Monograph for OTC Bronchodilator Drug Products

    Federal Register · Proposed Rule · Mar 9, 1995

    Proposed Replacement of CFC Propellants The Clean Air Act Amendments of 1990, Title VI (Pub. … Ozone-depleting substances covered by the Clean Air Act Amendments of 1990 include CFC's and hydrochlorofluorocarbons.

    60 FR 13014Health and Human Services DepartmentFood and Drug Administration
  • Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

    Federal Register · Rule · Jun 25, 2007

    Although the proposed rule's comment period was scheduled to end on June 11, 2003, in the Federal Register of May 19, 2003 (68 FR 27008), we extended the comment period to August 11, 2003. … (Comment 103) Several comments interpret proposed § 111.20(d)(4) as requiring fans and air-blowing equipment.

    72 FR 34752Health and Human Services DepartmentFood and Drug Administration
  • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

    Federal Register · Rule · Sep 17, 2015

    Some comments agree that it is important that these food-contact surfaces are clean and sanitary when used, but because storage of equipment and utensils could be for an extended period of time, the comments … Proposed § 117.40(g)—Compressed Air or Other Gases We proposed no revisions to the requirement that compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces

    80 FR 55908Health and Human Services DepartmentFood and Drug Administration
  • Interstate Shipment of Etiologic Agents

    Federal Register · Rule · Jan 23, 2008

    The comment period for the proposed rule closed on March 5, 2007. HHS received no comments on the proposed rule. … (IATA), for air, and the U.S.

    73 FR 3874Health and Human Services Department
  • Agency Forms Undergoing Paperwork Reduction Act Review

    Federal Register · Notice · Apr 9, 2013

    Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice. … products, latex, indoor air pollution, volatile organic compounds (VOCs) and bioaerosols.

    78 FR 21126Health and Human Services DepartmentCenters for Disease Control and Prevention
  • Preliminary Finding of No Significant Impact

    Federal Register · Notice · Mar 26, 2001

    Water Act, or interfere with State water quality standards. … the Clean Air Act, or interfere with state ambient air quality standards.

    66 FR 16478Health and Human Services DepartmentChildren and Families Administration
  • Head Start and Early Head Start Grantees; Preliminary Finding of No Significant Impact

    Federal Register · Notice · Jan 25, 2001

    Water Act, or interfere with state water quality standards. … the Clean Air Act, or interfere with state ambient air quality standards.

    66 FR 7768Health and Human Services DepartmentChildren and Families Administration
  • Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine); Public Meeting; Extension of Comment Period

    Federal Register · Proposed Rule · Nov 8, 2007

    Background Under the Clean Air Act, FDA, in consultation with the Environmental Protection Agency, is required to determine whether an FDA-regulated product that releases an ODS is an essential use … Extension of the Comment Period for the Proposed Rule FDA is extending the comment period for the proposed rule to December 19, 2007.

    72 FR 63141Health and Human Services DepartmentFood and Drug Administration
  • Performance Standard for the Infant Apnea Monitor

    Federal Register · Proposed Rule · Feb 21, 1995

    comments regarding this proposal. … Sec. 896.57 Air mattress warning. Air mattresses shall be permanently labeled with the warning: ``Inflate only with room air, do NOT use pure oxygen''.

    60 FR 9762Health and Human Services DepartmentFood and Drug Administration
  • Request for Information (RFI): 2022 HHS Environmental Justice Strategy and Implementation Plan Draft Outline

    Federal Register · Notice · Apr 8, 2022

    Fund and implement training and workforce development programs that build skills and careers related to climate, natural disasters, environment, clean energy, clean transportation, housing, water and wastewater … Performance Measures (Evaluation) ○ Priority Action(s) Develop milestones and provide periodic progress to demonstrate accountability and progress.

    87 FR 20876Health and Human Services Department
  • Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016

    Federal Register · Proposed Rule · Jul 15, 2015

    comment period. … — ++ Fixed Wing Air Ambulance (FW) ++ Rotary Wing Air Ambulance (RW) b.

    80 FR 41686Health and Human Services DepartmentCenters for Medicare & Medicaid Services
  • Control of Communicable Disease; Foreign-Requirements for Importers of Nonhuman Primates (NHP)

    Federal Register · Rule · Feb 15, 2013

    life of an NHP and a period after death, as some commenters suggested. … -based animal acts to the same requirements for entry as foreign-based animal acts; all such NHPs will be subject to a quarantine period regardless of where the animals are based. M.

    78 FR 11522Health and Human Services Department
  • Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

    Federal Register · Proposed Rule · Jan 16, 2013

    We seek comment on these proposed implementation periods. … We seek comment on the proposed waiting period.

    78 FR 3504Health and Human Services DepartmentFood and Drug Administration

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