Department of Health and Human Services October 17, 2007 – Federal Register Recent Federal Regulation Documents

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (NTP BSC). The NTP BSC is composed of scientists from the public and private sectors and provides primary scientific oversight to the NTP Director and evaluates the scientific merit of the NTP's intramural and collaborative programs.

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.

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.

This notice announces the first demonstration site for the Medicare Clinical Laboratory Services Competitive Bidding Demonstration project and the date for the Bidder's Conference. The Medicare Clinical Laboratory Competitive Bidding Demonstration was mandated by the Congress. Section 302(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) requires the Centers for Medicare & Medicaid Services (CMS) to conduct a demonstration project on the application of competitive acquisition for clinical laboratory services that would otherwise be paid under the Medicare Part B fee schedule. The objective of the demonstration is to determine whether competitive bidding can be used to provide Part B clinical laboratory services at fees below current Medicare payment rates while maintaining quality and access to care. The MMA specifically requires that the demonstration: (1) Includes tests paid under the Medicare Part B Clinical Laboratory Fee Schedule; (2) excludes entities that have a ``face-to-face encounter'' with the patient; (3) excludes Pap smears and colorectal cancer screening tests; and, (4) includes requirements under the Clinical Laboratory Improvement Amendments (CLIA) program. An initial Report to the Congress was submitted April 2006. Site(S): The fundamental criteria for selecting demonstration sites require that each Metropolitan Statistical Area (MSA) allows for potential Medicare program savings from the demonstration, is administratively feasible, represents the laboratory market, and will yield demonstration results that can be generalized to other MSAs. The first demonstration site will be the San Diego-Carlsbad-San Marcos, California MSA. A Bidders Conference is planned for October 31, 2007 in the San Diego-Carlsbad-San Marcos, California MSA. The demonstration covers tests provided to beneficiaries enrolled in the traditional fee-for-service (FFS) Medicare program who reside in the area of the demonstration site or competitive bid area (CBA) during the 3 year demonstration period. Beneficiaries who travel outside the CBA during the demonstration period and require laboratory services will be able to access services from most laboratories in the United States. We will not directly pay, however, for services furnished by a required bidder that did not bid or bid and did not win or a non- required bidder that bid and did not win. (The terms ``required bidder'' and ``non-required bidder'' are explained in section II below.) Laboratories may not bill beneficiaries for laboratory services covered under the Medicare program.

The Food and Drug Administration (FDA) is seeking comment on whether to withdraw its guidance document entitled ``FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues.'' FDA is considering withdrawing its guidance in response to the release by the Environmental Protection Agency (EPA) of a draft ``White Paper Concerning Dietary Exposure to Cry9C Protein Produced by STARLINK Corn and the Potential Risks Associated with Such Exposure,'' the availability of which is announced elsewhere in this issue of the Federal Register.