Department of Health and Human Services December 2010 – Federal Register Recent Federal Regulation Documents

This notice identifies an initial core set of health quality measures recommended for Medicaid-eligible adults, as required by section 2701 of the Affordable Care Act, for voluntary use by State programs administered under title XIX of the Social Security Act (the Act), health insurance issuers and managed care entities that enter into contracts with Medicaid, and providers of items and services under these programs. This notice also solicits comments on these initial measures, on facilitating the use of these measures by States and on identifying priority areas for measure enhancement and development.

The National Institute for Occupational Safety and Health (NIOSH), Personal Protective Technology (PPT) Program and National Personal Protective Technology Laboratory (NPPTL) will conduct a stakeholders meeting to provide updates on NIOSH-funded research, certification and standards, educate participants on resources to reinforce the proper use of NIOSH-certified respirators, and explore personal protective technology use in industry sectors. In addition, conformity assessment (certification and standards) needs and gaps relative to the personal protective technology will be discussed at this meeting.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Aging, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on 09-27-2010 at 08:45:00 (https://federalregister.gov/a/2010-24277, Vol. 75, No. 187, Page: 59723-59724 (2 pages); Document Citation: 75 FR 59723; Document Number: 2010-24277) and allowed 60-days for public comment. One comment was received from an organization who requested to be considered as a contractor for NIA's project. No other public comments were received. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Testing successful health communications surrounding aging-related issues from the National Institute on Aging (NIA). Type of Information Collection Request: New. Need and Use of Information Collection: This study will support NIA's mission ``to communicate information about aging and advances in research on aging to the scientific community, health care providers, and the public.'' The primary objectives of this study are to: Assess audiences' trusted/preferred sources for information, knowledge, attitudes, behaviors, and other characteristics for the planning/development of health messages and communications strategies; Pre-test health messages and outreach strategies while they are in developmental form to assess audience response, including their likes and dislikes.

This document corrects typographical and technical errors identified in the final rule entitled ``Medicare and Medicaid Programs; Electronic Health Record Incentive Program'' that appeared in the July 28, 2010 Federal Register.

The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) created and expanded State and Federal Child Support Enforcement databases under title IV-D of the Social Security Act (the Act) and significantly enhanced access to information for title IV-D child support purposes. States are moving toward a more integrated service delivery to better serve families and further the mission of the Child Support Enforcement program, while protecting confidential data. This final rule specifies requirements for: State Parent Locator Service responses to authorized location requests; and State Child Support Enforcement program safeguards for confidential information and authorized disclosures of this information. This final rule revises certain aspects of the State Parent Locator Service; Safeguarding Child Support Information final rule published on September 26, 2008 with an effective date delayed until December 30, 2010. This final rule will prohibit the disclosure of confidential and personally identifiable information to private collection agencies and expand disclosure to child welfare programs and the Supplemental Nutrition Assistance Program (SNAP).

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.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Research Resources, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on October 12, 2010, pages 62543-62544, 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. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: The National Evaluation of the Clinical and Translational Science Awards (CTSA) Initiative. Type of Information Collection Request: New. Need and Use of Information Collection: The CTSA Initiative is directed at transforming the way biomedical research is conducted nationwide by reducing the time it takes for basic science or laboratory discoveries to become treatments for patients, and for those treatments in turn to be incorporated and disseminated throughout community practice. The primary purpose of this data collection is to provide information about the process and early outcomes associated with 46 awardees participating in the first four cohorts of CTSA awards, in order to fulfill the congressional expectations for external program evaluation. NIH will use the results to understand the extent to which the CTSA Initiative is bringing about transformational changes in clinical and translational science among academic medical centers and their research partners, increasing the efficiency of the research process, and enhancing the capacity of the field to conduct clinical and translational research. All information collected will be used to provide analytical and policy support to NCRR, assisting NIH in making decisions about current CTSA programming, future funding, and other initiatives to improve clinical and translational science. It may also provide information for NIH's Government Performance and Results Act (GPRA) report. Frequency of Response: Biennial. Affected Public: Individuals. Type of Respondents: Scientific researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 3,563; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.13; Estimated Total Annual Burden Hours Requested: 451.5. The annualized cost to respondents is estimated at $14,056. There are no capital or start-up costs, and no maintenance or service cost components to report.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through December 2011.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Thorn Bioscience LLC. The NADA provides for the use of deslorelin acetate injectable suspension in mares for inducing ovulation.