Department of Health and Human Services April 17, 2008 – Federal Register Recent Federal Regulation Documents
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Notice of Draft Document Available for Public 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 available for public comment entitled ``Preventing Occupational Exposures to Lead and Noise at Indoor Firing Ranges.'' The draft document and instructions for submitting comments can be found at https:// www.cdc.gov/niosh/review/public/-128/. Comments should be provided to the NIOSH Docket Number above. Public Comment Period: April 17, 2008 through June 30, 2008. Status: Written comments may be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, Mailstop C- 34, Cincinnati, Ohio 45226. All material submitted to the Agency should reference NIOSH Docket number 128 and must be submitted by June 30, 2008, to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226. After the comment period has closed, comments may be accessed electronically at https://www.cdc.gov/NIOSH under the link to the NIOSH docket. As appropriate, NIOSH will post comments with the commenters' names, affiliations, and other information, on the Internet. Background: This Alert is intended to address the concerns of Federal, State, and local law enforcement agencies about occupational exposures of their officers to lead and noise during firearms training and qualifications. The Alert describes the health effects that can occur from occupational exposures to lead and noise at indoor firing ranges and recommends steps that firing range operators, employers, and workers should take to minimize the health risk to workers and shooters. This guidance document does not have the force and effect of law. Contact Person for Technical Information: Chucri (Chuck) A. Kardous, Commander, U.S. Public Health Service, Senior Research Engineer, Division of Applied Research and Technology, CDC/NIOSH, 4676 Columbia Parkway, C27, Cincinnati, Ohio 45225, Phone: 513-533-8146, E-mail: ckardous@cdc.gov. Reference: Web address for this document: https://www.cdc.gov/niosh/ review/public/128/.
Proposed Collection; Comment Request; Reinstatement of Generic Clearance for Partners and Customers Satisfaction Surveys
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Center for Scientific Review (CSR), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects. To request more information or to obtain a copy of the information collection plans, call the CSR Director of Planning, Analysis, and Evaluation on 301-435- 1133. Proposed Collection: Title: Reinstatement of Generic Clearance for Voluntary Partners and Customers Satisfaction Surveys: Reinstatement: The information collected in these surveys will be used by the Center for Scientific Review management and personnel: (1) To assess the quality of the modified operations and processes now used by CSR to review grant applications; (2) To assess the quality of service provided by CSR to our customers; (3) To enable identification of the most promising biomedical research that will have the greatest impact on improving public health by using a peer review process that is fair, unbiased from outside influence, timely, and (4) To develop new modes of operation based on customer need and customer feedback about the efficacy of implemented modifications. These surveys, which will be both quantitative and qualitative, are designed to assess the quality of services we provide to our major external customers. Customers include the research scientists who submit applications for grant funding to NIH. Those grant applications are reviewed and ranked by the grant scientific peer review study groups' members and chairs. These surveys will almost certainly lead to quality improvement activities that will enhance and/or streamline CSR's operations. Our partners include current grant scientific peer review study groups' members and chairs. Frequency of Response: On occasion. Affected Public: Scientific peer review study groups' members and chairs, grant applicants, other members of the research community. Type of Respondents: Adult scientific professionals.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Secretary's Advisory Committee on Genetics, Health, and Society
The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is updating its study priorities. SACGHS requests suggestions on possible new topics for the Committee to address.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Office of Global Health Affairs; Regulation on the Organizational Integrity of Entities Implementing Leadership Act Programs and Activities
The Office of Global Health Affairs within the U.S. Department of Health and Human Services (HHS) is issuing this Notice of Proposed Rulemaking (NPRM) to obtain input from stakeholders and other interested parties regarding the separation that must exist between a recipient of HHS funds to implement HIV/AIDS programs and activities under the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003 (the ``Leadership Act''), Public Law No. 108-25 (May 27, 2003), and an affiliate organization that engages in activities that are not consistent with a policy opposing prostitution and sex trafficking, as required under Section 301(f) of the Leadership Act. The proposed rule provides additional information on the policy requirement expressed in this law for entities that receive grants, contracts, or cooperative agreements from the U.S. Department of Health and Human Services (``HHS'') to implement programs or projects under the authority of the Leadership Act. Specifically, it describes the legal, financial, and organizational separation that must exist between these recipients of HHS HIV/AIDS funds and an affiliate organization that engages in activities that are not consistent with a policy opposing prostitution and sex trafficking.
Use of Materials Derived From Cattle in Human Food and Cosmetics
The Food and Drug Administration (FDA) is amending its regulations on the use of materials derived from cattle in human food and cosmetics. In these regulations, FDA has designated certain materials from cattle as ``prohibited cattle materials'' and has banned the use of such materials in human food, including dietary supplements, and in cosmetics. Prohibited cattle materials include specified risk materials (SRMs), the small intestine of all cattle unless the distal ileum is removed, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, or mechanically separated (MS) (Beef). Specified risk materials include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine of all cattle. FDA is amending its regulations so that FDA may designate a country as not subject to certain bovine spongiform encephalopathy (BSE)-related restrictions applicable to FDA regulated human food and cosmetics. A country seeking to be so designated must send a written request to the Director of FDA's Center for Food Safety and Applied Nutrition, including information about the country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other relevant information.
Medicare Program; Modification to the Weighting Methodology Used To Calculate the Low-Income Benchmark Amount; Correction
This document corrects mathematical errors that appeared in the impact analysis accompanying the final rule that appeared in the Federal Register on April 3, 2008 entitled, ``Modification to the Weighting Methodology Used to Calculate the Low-Income Benchmark Amount.''
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