Department of Health and Human Services March 22, 2007 – Federal Register Recent Federal Regulation Documents

NIOSH is implementing a new record schedule governing the retention of records transferred to the agency by employers pursuant to the regulations of the Occupational Safety and Health Administration (OSHA). Pursuant to this schedule, NIOSH will review these records to determine if they document exposures or medical conditions as required under the OSHA regulations and have research value. Those records that NIOSH determines meet the OSHA regulations and have a research value will be retained for 30 years. Those records that do not document exposure or medical condition and treatment or have no research value will not be retained.

The National Institute for Occupational Safety and Health (NIOSH) announces the availability of opportunity for the public to provide input regarding the draft document, ``Long-Term Field Evaluation (LTFE) Program Concept.'' The public meeting will be held on March 22, 2007 at the DoubleTree Pittsburgh Airport Hotel, 8402 University Blvd., Moon Township, PA 15108. NIOSH is the Federal agency responsible for conducting research and making recommendations for the approval for self-contained, self- rescuer (SCSR) closed circuit escape respirators, Title 42, Code of Federal Regulations (CFR), Part 84. The LTFE program for self-contained self-rescuers (SCSRs) for miners was initiated more than 20 years ago by the U.S. Bureau of Mines. The objective for the LTFE program is to obtain data to determine the expected performance characteristics of SCSRs used in the mining industry. LTFE program results based on scientific principles can provide useful information to monitor expected SCSR performance and assess possible degradation due to the physical stresses of in-mine use. Of utmost concern is the successful performance of any SCSR that passes its inspection criteria specified by the manufacturer. It is such an apparatus that must be relied upon in an emergency. A copy of the draft document can be found at: https://www.cdc.gov/ niosh/review/public/NPPTL-LTFE/.

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 use of rapid response surveys to obtain data on safety information to support quick- turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals and other user-facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Allergenic Products Advisory Committee, Blood Products Advisory Committee, Cellular, Tissue and Gene Therapies Advisory Committee, Transmissible Spongiform Encephalopathies Advisory Committee, and the Vaccines and Related Biological Products Advisory Committee in the Center for Biologics Evaluation and Research (CBER). Nominations will be accepted for vacancies that will or may occur through January 31, 2008. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees, and therefore, encourages nominations of qualified candidates from these groups.