Department of Health and Human Services September 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee, Center for Tobacco Products. 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.

This notice provides notice of CDC's intent to fund continuation cooperative agreement applications under the Nutrition, Physical Activity, and Obesity Program. These applications have been previously received and competed in response to CDC's Funding Opportunity CDC-RFA-DP08-805. It is the intent of CDC to provide continuation funding to sixteen (16) previously received and reviewed applications with the Patient Protection Affordable Care Act (PPACA), Section 4002, appropriations.

This notice provides notice of CDC's intent to fund continuation cooperative agreement applications under REACH US, Racial and Ethnic Approaches to Community Health Across the U.S. These applications have been previously received and competed in response to CDC Funding Opportunity CDC-RFA-DP07-707. It is the intent of CDC to provide continuation funding to thirty nine (39) previously received and reviewed applications with Patient Protection Affordable Care Act (PPACA), Section 4002, appropriations.

This notice provides notice of CDC's intent to fund continuation cooperative agreement applications under the Racial and Ethnic Approaches to Community Health National Organizations that Serve Minority Communities, REACH MNO. These applications have been previously received and competed in response to CDC Funding Opportunity CDC-RFA-DP09-905. It is the intent of CDC to provide continuation funding to three (3) previously received and reviewed applications with Patient Protection Affordable Care Act (PPACA), Section 4002, appropriations.

Under the provisions of Section (3507(a)(1)(D)) of the Paperwork Reduction Act of 1995, 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 April 27, 2011, pages 23609-23611, and allowed 60 days for public comment. Two written comments and two verbal comments were received. The verbal comments expressed support for the broad scope of the study. The written comments were identical and questioned the cost and utility of the study. 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: Biospecimen and Physical Measures Formative Research Methodology Studies for the National Children's Study (NCS). Type of Information Request: NEW. Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106- 310) states:

The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is extending the comment period for an advance notice of proposed rulemaking (ANPRM) requesting comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. That ANPRM was published in the Federal Register on July 26, 2011.

This final rule finalizes revisions to the regulations governing the Medicare Advantage (MA) program (Part C), prescription drug benefit program (Part D) and section 1876 cost plans including conforming changes to the MA regulations to implement statutory requirements regarding special needs plans (SNPs), private fee-for- service plans (PFFS), regional preferred provider organizations (RPPO) plans, and Medicare medical savings accounts (MSA) plans, cost-sharing for dual-eligible enrollees in the MA program and prescription drug pricing, coverage, and payment processes in the Part D program, and requirements governing the marketing of Part C and Part D plans.