Department of Health and Human Services October 2008 – Federal Register Recent Federal Regulation Documents

The Secretary of the Department of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)(4), to justify the emergency use of doxycycline hyclate tablets accompanied by emergency use information, contained in emergency kits for eligible United States Postal Service (USPS) Cities Readiness Initiative (CRI) participants and their household members in advance of a potential attack involving Bacillus anthracis. Bacillus anthracis is a biological agent known to cause anthrax. The Secretary, HHS, provides notice of the determination of the Secretary of Homeland Security on September 23, 2008 that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agentsin this case, Bacillus anthracis, although there is no current domestic emergency involving anthrax, no current heightened risk of an anthrax attack, and no credible information indicating an imminent threat of an attack involving Bacillus anthracis. The Secretary also provides notice that, on the basis of such determination, he has declared an emergency justifying the authorization of emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued by the Food and Drug Commissioner under 21 U.S.C. 360bbb-3(a).

Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the third meeting of the Secretary's Advisory Committee on Re-designation of Head Start Grantees, Department of Health and Human Services (HHS). The meeting will be held on Tuesday, October 21, 2008, from 9 a.m. to 5:30 p.m., and on Wednesday, October 22, 2008, from 9 a.m. to 1 p.m. at the Hotel Palomar Arlington, 1121 North 19th Street, in Arlington, Virginia. The meeting will be open to the public; however, seating is limited and preregistration is encouraged (see below).

The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), herein announces the awarding of a Mentoring Children of Prisoners (MCP) replacement grant to Mother Seton House, Inc., in Virginia Beach, VA. A prior grantee recently relinquished their MCP grant. With the funds provided, Mother Seton House, Inc., will continue the provision of mentoring services for children of incarcerated parents in Hampton Roads, VA.

The purpose of the ORR award is to assist California in providing medical screenings in accordance with ORR guidance in State Letter 95-37, 11/21/95, and follow-up activities to newly arriving refugees for conditions of public health concern. California Senate Bill 162 established a new California Department of Public Health to take the place of the California Department of Health Services which ceased to exist. California requests that the funds be awarded to the new California Department of Public Health to carry out the remaining years of the project.

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 National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Hispanic Community Health Study (HCHS)/Study of Latinos (SOL). Type of Information Collection Request: Revision. OMB 0925-0584, exp. 2/28/2011. Need and Use of Information Collection: The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL) will identify risk factors for cardiovascular and lung disease in Hispanic populations and determine the role of acculturation in the prevalence and development of these diseases. Hispanics, now the largest minority population in the US, are influenced by factors associated with immigration from different cultural settings and environments, including changes in diet, activity, community support, working conditions, and health care access. This project is a multicenter, six-and-a-half year epidemiologic study and will recruit 16,000 Hispanic men and women aged 18-74 in four community-based cohorts in Chicago, Miami, San Diego, and the Bronx. The study will also examine measures of obesity, physical activity, nutritional habits, diabetes, lung and sleep function, cognitive function, hearing, and dental conditions. Closely integrated with the research component will be a community and professional education component, with the goals of bringing the research results back to the community, improving recognition and control of risk factors, and attracting and training Hispanic researchers in epidemiology and population-based research. Frequency of Response: The participants will be contacted annually. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 30,320; Estimated Number of Responses per Respondent: 2.238; Average Burden Hours Per Response: 0.7161; and Estimated Total Annual Burden Hours Requested: 48,583. The annualized cost to respondents is estimated at $753,285, assuming respondents time at the rate of $15 per hour and physician time at the rate of $55 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

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.

This notice contains tables listing the final wage indices, hospital reclassifications, payment rates, impacts, and other related tables effective for fiscal year (FY) 2009. The tables and impacts included in this notice reflect the extension of the expiration date for certain geographic reclassifications and special exception wage indices as required by section 124 of the Medicare Improvement for Patients and Providers Act of 2008 (MIPPA), Public Law 110-275. These geographic reclassifications and special exception wage indices were previously set to expire on September 30, 2008 and are now extended through September 30, 2009. (Additionally, the final rates, wage indices, budget neutrality factors and tables included in this notice also reflect a correction made to the wage data for one hospital, as discussed in the correction notice for the FY 2009 IPPS final rule published elsewhere within this Federal Register.)

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``National Study of the Hospital Adverse Event Reporting Follow-Up Survey.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506()(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 24th, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. Changes were made to this 30 day notice to account for the electronic patient records review which were not accounted for in the 60 day notice.

The CERHR plans to convene an expert panel to conduct updated evaluations of the scientific evidence regarding the potential reproductive and/or developmental toxicity associated with exposure to genistein and soy formula begun in 2006. The expert panel will consist of approximately 10-12 scientists selected for their scientific expertise in various aspects of reproductive and developmental toxicology and other relevant areas of science. CERHR invites the submission of information about ongoing studies or upcoming publications on these substances that might be considered for inclusion in the evaluations and the nomination of scientists to serve on the expert panel (see SUPPLEMENTARY INFORMATION below). This meeting is tentatively scheduled for spring or summer 2009, although the exact date and location are not yet set. As plans are finalized, they will be announced in the Federal Register and posted on the CERHR Web site (https://cerhr.niehs.nih.gov). CERHR expert panel meetings are open to the public with time scheduled for oral public comment.

This notice solicits nominations for individuals to serve on the Program Advisory and Oversight Committee (PAOC) that will advise the Secretary of Health and Human Services on the competitive acquisition of durable medical equipment and certain other items and services under the Medicare program. Section 1847(c) of the Social Security Act requires the Secretary of the Department of Health and Human Services (Secretary) to establish the PAOC. In addition, section 1847(c)(4) exempts the PAOC from the Federal Advisory Committee Act, 5 U.S.C., appendix 2.