Department of Health and Human Services December 16, 2010 – Federal Register Recent Federal Regulation Documents

This notice announces the request for nominations for consideration for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other things, the MEDCAC advises the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS), as requested by the Secretary, whether medical items and services are ``reasonable and necessary'' and therefore eligible for coverage under Title XVIII of the Social Security Act. We are requesting nominations for both voting and nonvoting members to serve on the MEDCAC. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. We have a special interest in ensuring that the interests of both women and men, members of all racial and ethnic groups, and physically challenged individuals are adequately represented on the MEDCAC. Therefore, we encourage nominations of qualified candidates who can represent these interests. The MEDCAC reviews and evaluates medical literature, reviews technology assessments, and examines data and information on the effectiveness and appropriateness of medical items and services that are covered or eligible for coverage under Medicare.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary SupplementsSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is being issued for a final rule and an interim final rule published in the Federal Register of June 25, 2007, and is intended to set forth in plain language the requirements of that final rule and interim final rule and to help small businesses understand the regulations. In addition, the SECG includes several recommendations made by FDA in that final rule so that the guidance in those recommendations will be readily accessible to small businesses.

The Food and Drug Administration (FDA) has determined the regulatory review period for ANGIOMAX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

On November 5, 2009, President Obama signed the ``Memorandum for the Heads of Executive Departments and Agencies on Tribal Consultation.'' The President stated that his Administration is committed to regular and meaningful consultation and collaboration with tribal officials in policy decisions that have tribal implications, including, as an initial step, through complete and consistent implementation of Executive Order 13175. The United States has a unique legal and political relationship with Indian tribal governments, established through and confirmed by the Constitution of the United States, treaties, statutes, executive orders, and judicial decisions. In recognition of that special relationship, pursuant to Executive Order 13175 of November 6, 2000, executive departments and agencies are charged with engaging in regular and meaningful consultation and collaboration with tribal officials in the development of Federal policies that have tribal implications, and are responsible for strengthening the government-to-government relationship between the United States and Indian Tribes. The Department of Health and Human Services (HHS) has taken its responsibility to comply with Executive Order 13175 very seriously over the past decade, including the initial implementation of a Department- wide policy on tribal consultation and coordination in 1997, and through multiple evaluations and revisions of that policy, most recently in 2008. Many HHS agencies have already developed their own agency-specific consultation policies that complement the Department- wide efforts. Since 2005, the Administration for Children and Families (ACF) has been working under the guidance of the HHS policy issued in 2005, and updated in 2008. Due to the various programs administered by ACF and the many requests from Tribes for consultation for specific programs, as well as specific program mandates for tribal consultation, ACF has decided to create an ACF Tribal Consultation Policy to help ACF program and regional offices better engage Federally recognized Indian Tribes in the development or revision of policies, regulations, and proposed legislation that impact American Indians. ACF firmly believes that to create a good policy, ACF needs input from Tribes to ensure that ACF is meeting tribal needs and to establish a partnership that can carry into the future. ACF solicited membership for an ACF Tribal/Federal Workgroup to develop the initial draft policy. The Workgroup met August 23 and 24, 2010, in Washington, DC, and again in Minneapolis, Minnesota, on September 16 and 17, 2010. The draft was reviewed by tribal leaders attending the ACF Tribal Consultation Session held in Washington, DC on September 29, 2010, and the Workgroup met again to address the comments heard at the Tribal Consultation Session. ACF will convene the Tribal/Federal Workgroup again to review and address the comments received from this publication.