Documents

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

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  • Approval of Respiratory Protective Devices

    Federal Register · Rule · Sep 27, 2021

    AND HUMAN SERVICES Public Health Service 42 CFR Part 84 Approval of Respiratory Protective Devices CFR Correction In Title 42 of the Code of Federal Regulations, Public Health, Parts 1 to 399 … [FR Doc. 2021-21061 Filed 9-24-21; 8:45 am] BILLING CODE 0099-10-P

    86 FR 53228Health and Human Services DepartmentPublic Health Service
  • AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New Drug Application for IRESSA

    Federal Register · Notice · Apr 25, 2012

    , Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and § 314.150(d), and under authority delegated by the Commissioner to the Director, Center for Drug Evaluation and Research, approval of NDA 21-399 … [FR Doc. 2012-9944 Filed 4-24-12; 8:45 am] BILLING CODE 4160-01-P

    77 FR 24723Health and Human Services DepartmentFood and Drug Administration
  • Medicare Program; Proposed Rate Year (RY) 2010 Medicare Severity-Long-Term Care Diagnosis-Related Group (MS-LTC-DRG) Relative Weights and High-Cost Outlier Fixed-Loss Amount

    Federal Register · Proposed Rule · Jun 3, 2009

    Bed Size LTCHs were grouped into six categories based on bed size: 0-24 beds; 25-49 beds; 50-74 beds; 75-124 beds; 125-199 beds; and greater than 200 beds. … LTCHs in the bed size category of 0-24 beds are projected to experience a higher than average increase (2.8 percent) in estimated payments per discharge from the 2009 LTCH PPS rate year to the 2010 LTCH

    74 FR 26600Health and Human Services DepartmentCenters for Medicare & Medicaid Services
  • Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register · Notice · Aug 27, 2002

    Agenda : On September 24, 2002, the committee will discuss new drug application (NDA) 21-399, IRESSAr (gefitinib), AstraZeneca Pharmaceuticals LP, indicated for the treatment of patients with locally … Oral presentations from the public will be scheduled between approximately 8:45 a.m. and 9:45 a.m. on September 24, 2002. Time allotted for each presentation may be limited.

    67 FR 55024Health and Human Services DepartmentFood and Drug Administration
  • Specifications for Medical Examinations of Coal Miners

    Federal Register · Rule · Apr 27, 2015

    DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 37 Specifications for Medical Examinations of Coal Miners CFR Correction In Title 42 of the Code of Federal Regulations, Parts 1 to 399, revised … [FR Doc. 2015-09757 Filed 4-24-15; 8:45 am] BILLING CODE 1505-01-D

    80 FR 23241Health and Human Services Department
  • Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability

    Federal Register · Notice · Aug 4, 2011

    Pending PMCs comprise 50 percent (201/399) of the on-schedule NDA/ANDA PMCs and 28 percent (66/236) of the on-schedule BLA PMCs. … ) Combined total 399 (84%) 236 (77%) 1  See note 1 for table 1 of this document.

    76 FR 47211Health and Human Services DepartmentFood and Drug Administration
  • Agency Information Collection Activities: Submission for OMB Review; Comment Request; Alzheimer's and Dementia Program Data Reporting Tool

    Federal Register · Notice · Aug 23, 2016

    DATES: Submit written comments on the collection of information by October 24, 2016. … SUPPLEMENTARY INFORMATION: The Alzheimer's Disease Supportive Services Program (ADSSP) is authorized through Sections 398, 399 and 399A of the Public Health Service (PHS) Act, as amended by Public Law

    81 FR 57591Health and Human Services DepartmentCommunity Living Administration
  • Office of Rural Health Policy; Notice of Meetings

    Federal Register · Notice · Apr 8, 2009

    Dates and Times: April 24, 2009, 8 a.m.—3 p.m. in Albuquerque, NM. May 18, 2009, 8 a.m.—3 p.m. in Seattle, WA. June 26, 2009, 8 a.m.—3 p.m. in Omaha, NE. … The Omaha Marriott, 10220 Regency Circle, Omaha, NE 68114, Phone: 402-399-9000. Status: The meetings will be open to the public.

    74 FR 15995Health and Human Services DepartmentHealth Resources and Services Administration
  • Meeting of the Advisory Committee on Minority Health

    Federal Register · Notice · Jan 13, 2020

    Preregistration by January 24, 2020, is required for the public to attend the meeting, provide comments, and/or distribute printed material(s) to ACMH members. … Any individual who wishes to attend the meeting in person or by webcast must register by sending an email to OMH-ACMH@hhs.gov by January 24, 2020.

    85 FR 1813Health and Human Services Department
  • Findings of Research Misconduct

    Federal Register · Notice · Nov 25, 2014

    Physiol. 545(2):399-406, 2002 • J. … [FR Doc. 2014-27813 Filed 11-24-14; 8:45 am] BILLING CODE P

    79 FR 70187Health and Human Services DepartmentOffice of the Secretary
  • Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Federal Register · Notice · Mar 5, 2024

    Form Number: CMS-10383 (OMB Control Number 0938-1389; Frequency: Occasionally; Affected Public: State Governments; Number of Respondents: 19; Total Annual Responses: 399; Total Annual … [FR Doc. 2024-04591 Filed 3-4-24; 8:45 am] BILLING CODE 4120-01-P

    89 FR 15874Health and Human Services DepartmentCenters for Medicare & Medicaid Services
  • New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection

    Federal Register · Rule · Jul 24, 2013

    DATES: This rule is effective July 24, 2013. FOR FURTHER INFORMATION CONTACT: Steven D. … Mowbray, Leicestershire, England LE13 0PB has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 099-667 for IMPOSIL (iron dextran complex) Injection and NADA 110-399

    78 FR 44432Health and Human Services DepartmentFood and Drug Administration
  • Agency Information Collection Activities; Proposed Collection; Comment Request

    Federal Register · Notice · Apr 12, 2012

    The length of time that individual families will participate in the study is up to 24 months. … The core of service system data will be collected every 18-24 months throughout the 5-year evaluation period.

    77 FR 21986Health and Human Services DepartmentSubstance Abuse and Mental Health Services Administration
  • Notification of Interpretation and Enforcement of Section 1557 of the Affordable Care Act and Title IX of the Education Amendments of 1972

    Federal Register · Rule · May 25, 2021

    Bd., 972 F.3d 586, 616 (4th Cir. 2020), as amended (Aug. 28, 2020), 5 reh'g en banc denied, 976 F.3d 399 (4th Cir. 2020), petition for cert. filed, No. 20-1163 (Feb. 24, 2021); Adams … [FR Doc. 2021-10477 Filed 5-24-21; 8:45 am] BILLING CODE 4153-01-P

    86 FR 27984Health and Human Services Department
  • Determination of Regulatory Review Period for Purposes of Patent Extension; XOFLUZA

    Federal Register · Notice · Aug 8, 2024

    The date the application was approved: October 24, 2018. FDA has verified the applicant's claim that NDA 210854 was approved on October 24, 2018. … In its application for patent extension, this applicant seeks 399 days of patent term extension. III.

    89 FR 64920Health and Human Services DepartmentFood and Drug Administration
  • Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule; Withdrawal of Guidance

    Federal Register · Notice · Apr 30, 2020

    Food and Drug Administration, et al., 399 F.Supp.3d 479 (D. Md. 2019). … Dated: April 24, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020-09163 Filed 4-29-20; 8:45 am] BILLING CODE 4164-01-P

    85 FR 23968Health and Human Services DepartmentFood and Drug Administration
  • Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Federal Register · Notice · Jun 12, 2012

    The length of time that individual families will participate in the study is up to 24 months. … The core of service system data will be collected every 18-24 months throughout the 5-year evaluation period.

    77 FR 34961Health and Human Services DepartmentSubstance Abuse and Mental Health Services Administration
  • Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register · Notice · Oct 17, 2023

    On October 24, 2018, the Departments published guidance (86 FR 53575) that provided supplementary information about the requirements that must be met for the approval of a section 1332 waiver, the Secretaries … Form Number: CMS-10383 (OMB Control Number 0938-1389; Frequency: Occasionally; Affected Public: State Governments; Number of Respondents: 19; Total Annual Responses: 399; Total Annual

    88 FR 71573Health and Human Services DepartmentCenters for Medicare & Medicaid Services
  • State Children's Health Insurance Program; Reserved Allotments to States for Fiscal Year 1999 and Revised Reserved Allotments to States for Fiscal Year 1998

    Federal Register · Notice · Feb 8, 1999

    150.62 2.09 88,417,899 NEW MEXICO............................... 117 0.9169 107.28 1.49 62,972,705 NEW YORK................................. 399 … 88,000,326 [[Page 6108]] NEW MEXICO............................... 117 0.9169 107.28 1.49 62,675,303 NEW YORK................................. 399

    64 FR 6102Health and Human Services DepartmentHealth Care Finance Administration
  • New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address

    Federal Register · Rule · Feb 24, 2017

    DATES: This rule is effective February 24, 2017, except for the amendment to 21 CFR 524.1465, which is effective March 6, 2017. FOR FURTHER INFORMATION CONTACT: George K. … Product name 21 CFR section 099-667 IMPOSIL (iron heptomer) Injection 522.1182 110-399 GLEPTOSIL (gleptoferron) Injection 522.1055 Following these changes of sponsorship, Sogeval

    82 FR 11506Health and Human Services DepartmentFood and Drug Administration

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