Department of Health and Human Services July 20, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 22 of 22
Office of Biotechnology Activities; Recombinant DNA Research: Proposed Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
Under the NIH Guidelines, experiments involving the generation of transgenic rodents by recombinant DNA technology must be registered with the Institutional Biosafety Committee (IBC). Specifically, Section
Memorandum of Understanding: Food and Drug Administration and the National Institutes of Health, National Institutes of Environmental Health Sciences, National Toxicology Program; and the National Institutes of Health, National Human Genome Research Institute, National Institutes of Health, Chemical Genomics Center; and the Environmental Protection Agency, Office of Research and Development
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the National Institutes of Health (NIH), National Institutes of Environmental Health Sciences (NIEHS), National Toxicology Program (NTP); and the NIH, National Human Genome Research Institute (NHGRI), NIH Chemical Genomics Center (NCGC); and the Environmental Protection Agency, Office of Research and Development.
Advancing the Development of Medical Products Used In the Prevention, Diagnosis, and Treatment of Neglected Tropical Diseases; Public Hearing
The Food and Drug Administration (FDA) is announcing a public hearing to solicit general views and information from interested persons on issues related to advancing the development of medical products (drugs, biological products, and medical devices) used in the prevention, diagnosis, and treatment of neglected tropical diseases. In particular, FDA is seeking these views and information from interested persons on preclinical studies, trial design, regulatory approaches, and optimal solutions as they relate to the prevention, diagnosis, and treatment of neglected tropical diseases. To help solicit such views and information, FDA is seeking comments on specific issues (see section IV of this document).
International Conference on Harmonisation; Draft Recommendation for the Revision of the Permitted Daily Exposure for the Solvent Cumene According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled ``Q3C: Impurities: Residual Solvents.'' The draft recommendation was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure; Withdrawal
The Food and Drug Administration (FDA) published in the Federal Register of April 1, 2010, a direct final rule that was intended to make noncontroversial amendments to existing regulations which would require the submission of readily available pediatric medical device information as a part of premarket approval applications, requests for humanitarian use device exemptions, and any product development protocols. The comment period closed on June 15, 2010. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
Agency Information Collection Activities; Proposed Collection; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the paperwork associated with designation under the Minor Use and Minor Species (MUMS) Animal Health Act of 2004.
Agency Information Collection Activities; Proposed Collection; Comment Request; Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements contained in existing FDA regulations governing petitions to request an exemption from 100 percent identity testing of dietary ingredients.
Agency Information Collection Activities; Proposed Collection; Comment Request; Information Request Regarding Menthol in Cigarettes
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on an information request regarding the use of menthol in cigarettes.
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