Department of Health and Human Services June 2006 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Los Alamos National Laboratory, Los Alamos, New Mexico, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Los Alamos National Laboratory. Location: Los Alamos, New Mexico. Job Titles and/or Job Duties: All workers potentially exposed to radioactive lanthanum at the Technical Area 10 Bayo Canyon facility, TA-35 (Ten Site), or TA-1, buildings Sigma, H, and U. Period of Employment: September 1, 1944 through July 18, 1963.

In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the second biannual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2006. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the clinical integrity of the APC groups and their associated weights. The advice provided by the Panel will be considered as we prepare the final rule that updates the hospital Outpatient Prospective Payment System (OPPS) for CY 2007.

This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC) (``Committee''). Among other things, the Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting will discuss the following issues: (1) Glycemic control and the use of glucose monitors by which sensors automatically monitor glucose levels in body fluids; and (2) whether and how the frequency of outpatient glucose monitoring is related to glycemic control and clinical outcomes in the various Medicare populations. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January 2006 through March 2006, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations. Finally, this notice includes a list of Medicare-approved carotid stent facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.

The Food and Drug Administration (FDA) has determined the regulatory review period for CIALIS 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 that claims that human drug product.

The Food and Drug Administration (FDA) is announcing a call- for-data for safety and effectiveness information on the following condition as part of FDA's ongoing review of over-the-counter (OTC) drug products: Sodium picosulfate, up to 10 milligrams (mg), as a laxative single active ingredient. FDA reviewed a time and extent application (TEA) for this condition and determined that it is eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether this condition can be generally recognized as safe and effective (GRAS/E) for its proposed OTC use.

The Office of Public Health and Science, HHS, is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides science-based advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on a broad range of issues and topics pertaining to chronic fatigue syndrome (CFS). CFSAC, which was formerly known as the Chronic Fatigue Syndrome Coordinating Committee, was established by the Secretary of Health and Human Services on September 5, 2002. The appointments of five Committee members are scheduled to end on September 30, 2006. Nominations of qualified candidates are being sought to fill these scheduled vacancies.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Substances Generally Recognized as Safe: Notification Procedure'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006,'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled ``PHS Guideline on Infectious Disease Issues in Xenotransplantation'' dated January 19, 2001.

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.