Department of Health and Human Services January 21, 2005 – Federal Register Recent Federal Regulation Documents
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Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.
Request for Public Comment on a Written Request Issued by the Food and Drug Administration on the Use of Meropenem for the Treatment of Complicated Intra-Abdominal Infections in Preterm and Term Newborn and Infant Patients Younger Than 91 Days of Age
The National Institutes of Health (NIH) is requesting public comment on the following Written Request issued by the Food and Drug Administration (FDA) for off-patent drugs as defined in the Best Pharmaceuticals for Children Act (BPCA). The Written Request was referred to the NIH by the FDA as required by the BPCA. The Written Request was developed following formulation of an NIH-generated priority list, which prioritizes certain drugs most in need of study for use by children. The priority list was produced in consultation with the FDA, other NIH Institutes and Centers, and pediatric experts, as mandated by the BPCA. The studies that are described in the Written Request are intended to characterize the safety, efficacy, and pharmacokinetics of the drug for optimum use in pediatric patients.
Availability of Final Toxicological Profiles
This notice announces the availability of the sixteenth set of final toxicological profiles of priority hazardous substances prepared by ATSDR. This set comprises two new and three updated profiles.
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