Department of Health and Human Services May 25, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
The Food and Drug Administration (FDA) is issuing an interim final rule to amend certain regulations regarding the screening and testing of donors of human cells, tissues, and cellular and tissue- based products (HCT/Ps), and related labeling. FDA is taking this action in response to comments from affected interested persons regarding the impracticability of complying with certain regulations as they affect particular HCT/Ps.
Solicitation of Public Review and Comment on Research Protocol: Precursor Preference in Surfactant Synthesis of Newborns
The Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA), are soliciting public review and comment on a proposed research protocol entitled ``Precursor Preference in Surfactant Synthesis of Newborns.'' The proposed research would be conducted at the St. Louis Children's Hospital and supported by the National Heart, Lung and Blood Institute. Public review and comment are solicited regarding the proposed research protocol under the requirements of HHS and FDA regulations.
Draft Guidance for Industry on Antiviral Drug Development-Conducting Virology Studies and Submitting the Data to the Agency; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Antiviral Drug DevelopmentConducting Virology Studies and Submitting the Data to the Agency.'' This guidance is being issued to assist sponsors in developing and submitting nonclinical and clinical virology data, which are important to support clinical trials of antiviral agents. Nonclinical and clinical virology reports are essential components in the review of investigational antiviral drugs. The information in this guidance will facilitate the development of antiviral drug products.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for FY 2006
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities for Federal fiscal year 2006 as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before August 1 before each fiscal year, the classification and weighting factors for the inpatient rehabilitation facilities case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year. In addition, we are proposing new policies and are proposing to change existing policies regarding the prospective payment system within the authority granted under section 1886(j) of the Act.
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