Department of Health and Human Services July 2005 – Federal Register Recent Federal Regulation Documents

This notice requests nominations for individuals to serve on the Advisory Panel on Medicare Education (the Panel). The Panel advises and makes recommendations to the Secretary of the Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on opportunities for CMS to optimize the effectiveness of the National Medicare Education Program and other CMS programs that help Medicare beneficiaries understand the Medicare program and the range of health plan options available. Nominees must be knowledgeable in the field of labor and retirement benefits.

This notice requests nominations for consideration for membership on the Medicare Coverage Advisory Committee (MCAC).

The CERHR announces the availability of the expert panel report on styrene on July 18, 2005 from the CERHR Web site (https:// cerhr.niehs.nih.gov) or in print from the CERHR (see ADDRESSES below). The expert panel report is an evaluation of the reproductive and developmental toxicity of styrene conducted by a 13-member expert panel composed of scientists from the federal government, universities, and private organizations. The CERHR invites the submission of public comments on this expert panel report (see SUPPLEMENTARY INFORMATION below). The CERHR previously solicited public comment on the draft version of this expert panel report (Federal Register Vol. 70, No. 45 pp. 11680-11681). Public deliberations by the panel took place on June 1-3, 2005, at the Holiday Inn Old Town Select Alexandria, Virginia to review and revise the draft expert panel report and reach conclusions regarding whether exposure to styrene is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director, Office of Science Policy, Office of Science Education, National Institutes of Health 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 has not been previously published in the Federal Register. The purpose of this notice is to allow 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 number. Proposed Collection: Title: The Effectiveness of the NIH Curriculum Supplements and Workshops Survey. Information Collection Request: NEW. New and Use of Information Collection: The survey will attempt to assess the effectiveness of the NIH curriculum supplements in aiding teachers to teach science in a more engaging and interactive way. The supplements help k-12 educators teach science in more engaging and effective ways by featuring the latest NIH research. A typical supplement contains two weeks of student activities on the science behind a health topic, such as cancer, sleep or obesity. Web-based simulations, animations and experiments enhance the ``pencil and paper'' activities. In addition to developing and distributing the supplements, OSE conducts professional workshops to help teachers successfully implement these lessons with their students. Since January 2000, over 3,000 teachers have attended an OSE workshop. Assessing the effectiveness of the NIH Curriculum Supplements and teacher workshops is critical to determining if OSE is successfully fulfilling its mission. OSE has the database infrastructure in place to easily collect customer satisfaction data from supplement requests and workshops attendees. At present, we do not have clearance to contact our customers to determine how NIH resources are meeting their educational needs.

The Food and Drug Administration (FDA) is correcting the single-ingredient roxarsone Type A medicated article that may be used to formulate three-way, combination drug Type C medicated broiler chicken feeds containing semduramicin, virginiamycin, and roxarsone under a new animal drug application (NADA) recently approved for Phibro Animal Health. FDA is also amending the animal drug regulations to reflect two roxarsone Type A medicated articles approved under separate new animal drug applications (NADAs) for different conditions of use. This action is being taken to improve the accuracy of the agency's regulations.

The Food and Drug Administration (FDA) is announcing the availability of two draft manuals entitled ``Managing Food Safety: A Manual for the Voluntary Use of HACCP Principles for Operators of Food Service and Retail Establishments'' (the ``Operator's Manual'') and ``Managing Food Safety: A Regulator's Manual for Applying HACCP Principles to Risk-Based Retail and Food Service Inspections and Evaluating Voluntary Food Safety Management Systems'' (the ``Regulator's Manual''). The Operator's Manual presents FDA's best advice to retail and foodservice operators for voluntarily implementing food safety management systems based on hazard analysis and critical control point (HACCP) principles to reduce the occurrence of foodborne illness risk factors. The Regulator's Manual is intended to assist State, local, and tribal regulatory authorities in identifying and assessing control of foodborne illness risk factors during routine inspections of retail and foodservice establishments by providing a risk-based inspection methodology.

The Food and Drug Administration (FDA) is announcing a public meeting to obtain expert comment and consultation from stakeholders to help the agency to define and permit the voluntary use on food labeling of the term ``gluten-free''. The meeting will focus on food manufacturing, analytical methods, and consumer issues related to reduced levels of gluten in food. We request that those who wish to speak at the meeting, or otherwise provide FDA with their written or oral comments, focus on the questions set out in this document.

This notice is to inform the public of SAMHSA's anticipated grant funding opportunities for FY 2006, based on the President's FY 2006 budget request. All information provided is tentative and preliminary. These plans may change and final figures will not be available until after SAMHSA receives its 2006 appropriation. In January 2005, SAMHSA ceased publishing notices of grant funding opportunities in the Federal Register, consistent with the Department of Health and Human Services management objectives. Announcements are instead posted on https://www.Grants.gov and on SAMHSA's Web site at https://www.samhsa.gov. Interested applicants should visit these Web sites for specific information about these programs as it becomes available. Applicants should also be aware that all the necessary information to apply for grant funds will continue to be available at SAMHSA's two national clearinghouses: the National Clearinghouse for Alcohol and Drug Information (NCADI)-1-800-729-6686for substance abuse prevention or treatment grants; and the National Mental Health Information Center-1-800-789-CMHS (2647)for mental health grants.

The Administration for Native Americans (ANA) herein issues final interpretive rules, general statement of policy, and rules of agency procedure or practice in relation to the Social and Economic Development Strategies (SEDS) project SMART NA Communities (Strengthening Marriages and Relationships in Tribal and Native American Communities). For FY 2005, ANA reserved an amount of funding under the SEDS program to fund projects that are beneficial to the development of healthy Native American communities. ANA has decided to participate in ACF's Healthy Marriage Initiative, and intends to use the reserved SEDS funds to support projects that improve child well- being by removing barriers associated with forming and retaining healthy families and marriages in Native American communities. Under the statute, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, statements of general policy, and rules of agency procedure or practice, and to give notice of the final adoption of such changes at least 30 days before the changes become effective. The notice also provides additional information about ANA's plan for administering the programs.