Department of Health and Human Services May 18, 2011 – Federal Register Recent Federal Regulation Documents
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Meeting of the National Toxicology Program (NTP) Board of Scientific Counselors
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC). The BSC is a federally chartered, external advisory group composed of scientists from the public and private sectors that provides primary scientific oversight to the NTP and evaluates the scientific merit of the NTP's intramural and collaborative programs.
Independent Scientific Peer Review Panel Report: Evaluation of the Validation Status of an In Vitro Estrogen Receptor Transcriptional Activation Test Method for Endocrine Disruptor Chemical Screening: Notice of Availability and Request for Public Comments
The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), on behalf of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), convened an independent international scientific peer review panel (hereafter, Panel) on March 29-30, 2011, to evaluate the validation status of the LUMI-CELL[supreg] (BG1Luc ER TA) test method, an in vitro transcriptional activation (TA) assay used to identify chemicals that can interact with human estrogen receptors (ERs). The Panel report is now available on the NICEATM-ICCVAM Web site at: http:/ / iccvam.niehs.nih.gov/docs/endodocs/EDPRPRept2011.pdf or by contacting NICEATM (see ADDRESSES). The report contains (1) the Panel's evaluation of the validation status of the test method and (2) the Panel's comments on the draft ICCVAM test method recommendations. NICEATM invites public comment on the Panel report.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial review.
Strategy To Address Recommendations Issued by the Institute of Medicine in November 2010 Report; Comment Request
The National Institute for Occupational Safety and Health (NIOSH), National Personal Protective Technology Laboratory (NPPTL), requests input on the NIOSH, NPPTL strategy to address the recommendations issued by the Institute of Medicine (IOM) in the November 2010 report Certifying Personal Protective Technologies: Improving Worker Safety. The report focuses on the need for a consistent and risk-based approach to Personal Protective Technology (PPT) conformity assessment.
Draft Alert Entitled “Preventing Occupational Respiratory Disease From Dampness in Office Buildings, Schools, and Other Nonindustrial Buildings”
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of a draft Alert entitled ``Preventing Occupational Respiratory Disease from Dampness in Office Buildings, Schools, and other Nonindustrial Buildings'' now available for public comment. The draft document and instructions for submitting comments can be found at: https://nioshdev.cdc.gov/niosh/docket/review/docket238/ default.html. The purpose of this Alert is to provide workers and employers with information necessary for prevention of respiratory disease and proper response to damp building conditions. This guidance does not have the force and effect of the law. Public Comment Period: Comments must be received by July 12, 2011.
Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection
The Food and Drug Administration (FDA) is proposing to classify in vitro diagnostic devices for Bacillus species (spp). detection into class II (special controls), in accordance with the recommendation of the Microbiology Devices Advisory Panel (the Panel). In addition, the proposed rule would establish as a special control limitations on the distribution of this device. FDA is publishing in this document the recommendations of the Panel regarding the classification of this device. After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability for comment of the draft guidance document that FDA proposes to designate as a special control for this device.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to classify in vitro diagnostic devices for Bacillus spp. detection into class II, subject to special controls. This draft guidance is not final nor is it in effect at this time.
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