Department of Health and Human Services May 28, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 22 of 22
NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2016; Request for Comment
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document for public comment entitled ``NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2016.'' The document and instructions for submitting comments can be found at www.regulations.gov. This guidance document does not have the force and effect of law.
Radiation Biodosimetry Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for an additional 30 days, for the notice of availability entitled ``Radiation Biodosimetry Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability'', published in the Federal Register of December 30, 2014. In that document, FDA announced the availability of a draft guidance for industry and FDA staff and requested comments. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Integrated Food Safety System Online Collaboration Development
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the National Center for Food Protection and Defense (NCFPD). The goal of the NCFPD is to provide well-established and high-level access to Food/Agriculture Sector Organizations and coordination of electronic collaborative tools; collaborative support from the Department of Health and Human Services (HHS), the Department of Homeland Security (DHS), and the U.S. Department of Agriculture (USDA). NCFPD also has past experience directly supporting the President's Food Safety Working Group Objectives to integrate the food safety system at all levels.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation
The Food and Drug Administration (FDA) is classifying the vibrator for climax control of premature ejaculation into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the classification of the vibrator for climax control of premature ejaculation. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Pediatric Studies of Meropenem Conducted in Accordance With the Public Health Service Act; Availability of Summary Report and Requested Labeling Changes
The Food and Drug Administration (FDA) is publishing a summary report of the pediatric studies of meropenem conducted in accordance with the Public Health Service Act (the PHS Act) and is making available requested labeling changes for meropenem. The Agency is making this information available consistent with the PHS Act.
M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; International Conference on Harmonisation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.
Molecular Characterization of Multiple Myeloma Black/African Ancestry Disparity
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the efforts of the Center for Drug Evaluation and Research (CDER). FDA is announcing its intent to accept and consider a single-source application for the award of a grant to the Multiple Myeloma Service of Memorial Sloan Kettering Cancer Institute. The goal of the cooperative agreement between CDER and the Multiple Myeloma Service of Memorial Sloan Kettering Cancer Institute is to support the development of appropriate methodologies to conduct clinical trial design evaluation and determine extrapolation of findings from the general population to the U.S. Black population.
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