Department of Health and Human Services January 8, 2016 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table
This document announces a public hearing to receive information and views on the Notice of Proposed Rulemaking (NPRM) entitled ``National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table.''
Use of Nucleic Acid Tests To Reduce the Risk of Transmission of Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry.'' The draft guidance document provides establishments that make donor eligibility determinations for donors of human cells, tissues, and tissue-based products (HCT/Ps), with recommendations concerning the use of FDA-licensed nucleic acid tests (NAT) in donor testing for hepatitis B virus (HBV) deoxyribonucleic acid (DNA). The draft guidance, when finalized, is intended to supplement previous FDA recommendations to HCT/P establishments concerning donor testing for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc), in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps)'' dated August 2007 (2007 Donor Eligibility Guidance).
Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Extension of Comment Period
The Food and Drug Administration (FDA or Agency) is extending the comment period provided in the notice entitled ``Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability'' that appeared in the Federal Register on November 23, 2015 (80 FR 72975). That notice announced the availability of a draft guidance for industry and requested comments to that draft guidance by January 22, 2016. FDA is extending the draft guidance's comment period by 30 days (to February 22, 2016) in response to a request for an extension to allow interested persons additional time to submit comments.
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