Department of Health and Human Services March 26, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Change of Addresses and Names; Technical Amendment
The Food and Drug Administration (FDA) is amending its
Agency Emergency Processing Under Office of Management and Budget Review; Guidance for Industry: Animal Generic Drug User Fees and Fee Waivers and Reductions
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the burden hours required to implement the new statutory requirements for the user fees and fee waivers reductions provisions of the Animal Generic Drug User Fee Act of 2008 (AGDUFA) (Federal Food, Drug, and Cosmetic Act (the act)).
Developing a Consolidated Pediatric Rheumatology Observational Registry; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Developing a Consolidated Pediatric Rheumatology Observational Registry.'' This 2-day public workshop is intended to seek constructive input from key stakeholders in the pediatric rheumatology community, the pharmaceutical industry and the public to explore the value and feasibility of developing a consolidated pediatric rheumatology observational registry.
Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Source Plasma Establishments
The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation to participate in a pilot evaluation program for CBER's eSubmitter Program (eSubmitter). CBER's eSubmitter has been customized as an automated biologics license application (BLA) and BLA supplement (BLS) submission system for blood and blood components. Participation in the pilot program is open to blood establishments that collect Source Plasma. The pilot program is intended to provide industry and CBER regulatory review staff the opportunity to evaluate the eSubmitter system and determine if it facilitates the BLA/BLS submission process. The purpose of this notice is to invite blood establishments that collect Source Plasma to submit a request to CBER if they are interested in participating in this pilot program.
Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated March 2009. The draft guidance document notifies establishments that manufacture Whole Blood and blood components intended for use in transfusion, and establishments that make eligibility determinations for donors of HCT/Ps about FDA approval of a biologics license application for an enzyme-linked immunosorbent assay (ELISA) test system for the detection of antibodies to Trypanosoma cruzi (T. cruzi). The draft guidance also notifies establishments that make donor eligibility determinations for HCT/P donors that FDA has determined T. cruzi to be a relevant communicable disease under current regulations. In addition, the guidance provides recommendations for using a licensed test for antibodies to T. cruzi to test individual human donors, including donors of Whole Blood and blood components for transfusion and HCT/P donors (living and cadaveric (non-heart beating)), for antibodies to T. cruzi in plasma and serum samples. The guidance document does not apply to Source Plasma.
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