Department of Health and Human Services March 2006 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 332
Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines,'' dated March 2006. The draft guidance document is intended to provide to sponsors of trivalent inactivated influenza vaccines guidance on the clinical data needed to support a Biologics License Application (BLA). The draft guidance summarizes clinical development approaches to facilitate and expedite the licensure of new trivalent inactivated influenza vaccines and addresses both traditional and accelerated approval.
Guidance for Industry and Food and Drug Administration; Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.'' This guidance provides recommendations intended to reduce life-threatening entrapments associated with hospital bed systems. It characterizes the body parts at risk for entrapment, identifies the locations of hospital bed openings that are potential entrapment areas, recommends dimensional criteria for bed systems, provides information about legacy beds including information to include when reporting entrapment adverse events, and provides the Hospital Bed Safety Workgroup (HBSW) test methods for assessing gaps.
National Practitioner Data Bank: Change in User Fees
The Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS), is announcing a fifty cent increase in the fee charged to entities authorized to request information from the National Practitioner Data Bank (NPDB) for all queries. The new fee will be $4.75. There will be no change to the $8.00 self-query fee.
National Toxicology Program (NTP); Liaison and Scientific Review Office; Meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee (TRR Subcommittee). The primary agenda topic is the peer review of the findings and conclusions presented in four draft NTP Technical Reports of rodent toxicology and carcinogenicity studies conducted by the NTP (see Preliminary Agenda below). The TRR Subcommittee meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on any draft technical report discussed at the meeting. The TRR Subcommittee deliberations on the draft technical reports will be reported to the NTP Board of Scientific Counselors (NTP Board) at a future date.
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