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

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  • Effective Date of Requirement for Premarket Approval for Blood Lancets

    Federal Register · Rule · Nov 22, 2021

    Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification … The comments and FDA responses to the comments are summarized in this section.

    86 FR 66177Health and Human Services DepartmentFood and Drug Administration
  • Proposed Data Collections Submitted for Public Comment and Recommendations

    Federal Register · Notice · Mar 4, 2010

    the 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) will publish periodic summaries of proposed projects.

    75 FR 9901Health and Human Services DepartmentCenters for Disease Control and Prevention
  • General Hospital and Personal Use Devices: Proposed Classification of Liquid Chemical Sterilants and General Purpose Disinfectants

    Federal Register · Proposed Rule · Nov 6, 1998

    DATES: Written comments by February 4, 1999. … In the Federal Register of May 22, 1997 (62 FR 28055), FDA extended the period to comment on the draft guidance until August 20, 1997.

    63 FR 59917Health and Human Services DepartmentFood and Drug Administration
  • Record of Decision-Construction and Operation of an Integrated Research Facility by the National Institutes of Health at Fort Detrick, MD

    Federal Register · Notice · Jan 29, 2004

    filters to capture small particles in laboratory exhaust air before venting the air to the outside; and • Requiring that IRF activities comply with the NIH waste management policies, which emphasize … received throughout the National Environmental Policy Act process, including comments on the Draft EIS and those provided during the required 30-day waiting period for the Final EIS; and other relevant

    69 FR 4307Health and Human Services DepartmentNational Institutes of Health
  • Final NIH Genomic Data Sharing Policy

    Federal Register · Notice · Aug 28, 2014

    Lauderdale agreements. 5 Some commenters were concerned that the elimination of the embargo period (i.e., the period between when a study is released for secondary research and when the submitting investigator … Several commenters were concerned that de-identified genotype data could be re-identified, even if these data are de-identified according to Health Insurance Portability and Accountability Act (HIPAA)

    79 FR 51345Health and Human Services DepartmentNational Institutes of Health
  • Agency Forms Undergoing Paperwork Reduction Act Review

    Federal Register · Notice · Dec 26, 2018

    CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. … The Camino Verde approach utilizes community mobilization to motivate clean-up campaigns to reduce rates of dengue virus infections in Nicaragua and Mexico.

    83 FR 66267Health and Human Services DepartmentCenters for Disease Control and Prevention
  • Proposed Data Collection Submitted for Public Comment and Recommendations

    Federal Register · Notice · Aug 27, 2018

    ACTION: Notice with comment period. … From approximately 1970 until 1991, the Air Force used AFFF for firefighting and training at Pease Air Force Base.

    83 FR 43685Health and Human Services DepartmentAgency for Toxic Substances and Disease Registry
  • NIH Bethesda Surgery, Radiology and Laboratory Medicine Record of Decision

    Federal Register · Notice · Aug 28, 2020

    This analysis conservatively estimates the emissions of nonattainment criteria pollutants during construction of the proposed facilities for the entire 6-year construction period. … Air Quality Standards.

    85 FR 53386Health and Human Services DepartmentNational Institutes of Health
  • Proposed Data Collection Submitted for Public Comment and Recommendations

    Federal Register · Notice · Dec 20, 2022

    ACTION: Notice with comment period. … on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995.

    87 FR 77840Health and Human Services DepartmentCenters for Disease Control and Prevention
  • Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register · Notice · Jun 9, 2010

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection. … In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection

    75 FR 32783Health and Human Services DepartmentAgency for Healthcare Research and Quality
  • Proposed Data Collection Submitted for Public Comment and Recommendations

    Federal Register · Notice · Dec 17, 2015

    ACTION: Notice with comment period. … on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

    80 FR 78738Health and Human Services DepartmentCenters for Disease Control and Prevention
  • Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device

    Federal Register · Proposed Rule · Sep 25, 2018

    ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 26, 2018. … If the device contains reusable eye-contact components, the validation tests must demonstrate adequate cleaning/reprocessing of these components.

    83 FR 48403Health and Human Services DepartmentFood and Drug Administration
  • Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 049

    Federal Register · Notice · Jun 7, 2018

    Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. … L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d).

    83 FR 26465Health and Human Services DepartmentFood and Drug Administration
  • Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System

    Federal Register · Rule · Sep 16, 2024

    (FD&C Act). … use with the delivery system; (B) Description of the safety-related components included in the system; (C) Identification of operational parameters; (D) Alarms and troubleshooting information; (E) Cleaning

    89 FR 75493Health and Human Services DepartmentFood and Drug Administration
  • Airborne Exposure Limits for Chemical Warfare Agents GA (Tabun), GB (Sarin), and VX

    Federal Register · Notice · Jan 8, 2002

    Submit your comments to Dr. Paul Joe, CDC, 4770 Buford Highway, Mail Stop F-16, Atlanta, Georgia 30341. 2. In person or by courier. Deliver your comments to Dr. … The analytical limitations are reflected further in the 72-hour averaging period rather than a more conventional 24-hour period.

    67 FR 894Health and Human Services DepartmentCenters for Disease Control and Prevention
  • General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products and Ultraviolet Lamps Intended for Use in Sunlamp Products

    Federal Register · Rule · Jun 2, 2014

    The proposed order also called for comments from any interested stakeholders. The comment period on the proposed order closed on August 7, 2013. … (B) Manufacturers shall provide validated instructions on cleaning and disinfection of sunlamp products between uses in the user instructions.

    79 FR 31205Health and Human Services DepartmentFood and Drug Administration
  • Mandatory Guidelines for Federal Workplace Drug Testing Programs

    Federal Register · Proposed Rule · Sep 10, 2020

    Please allow sufficient time for mailed comments to be received before the close of the comment period. • By express or overnight mail. … All comments received before the close of the comment period will be available for viewing by the public.

    85 FR 56108Health and Human Services Department
  • Record of Decision for the Final Supplemental Environmental Impact Statement for the Roybal Campus 2025 Master Plan

    Federal Register · Notice · Nov 17, 2022

    CDC announced a Notice of Availability (NOA) of the Draft SEIS on July 8, 2022 (87 FR 40844) and the public comment period ended August 22, 2022. … During the public comment period, a virtual public meeting was held on July 27, 2022. Two participants attended the meeting. CDC received five public comments.

    87 FR 69023Health and Human Services DepartmentCenters for Disease Control and Prevention
  • Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Federal Register · Notice · Mar 4, 2022

    ambulance services furnished by nonparticipating providers of air ambulance services. … (the Act) authorizes the Secretary to develop and periodically update a list of DMEPOS that the Secretary determines, on the basis of prior payment experience, are frequently subject to unnecessary utilization

    87 FR 12456Health and Human Services DepartmentCenters for Medicare & Medicaid Services
  • National Institutes of Health Contraception and Infertility Research Loan Repayment Program

    Federal Register · Proposed Rule · Dec 10, 1999

    DATES: Comments must be received on or before February 8, 2000 in order to assure that NIH will be able to consider the comments in preparing the final rule. … Comments may also be sent electronically by FAX (301-402-0169) or email ([email protected]).

    64 FR 69213Health and Human Services Department

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