Department of Health and Human Services December 22, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending a medical device regulation to include references to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). This regulation pertains to the disqualification of a clinical investigator. Currently, only a reference to the Center for Devices and Radiological Health is listed in this regulation. This action is being taken to ensure the accuracy of FDA's regulations.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Referrals to FDA Under 21 CFR 50.54: Additional Safeguards for Children in Clinical Investigations.'' This guidance is intended to assist clinical investigators, Institutional Review Boards (IRBs), sponsors, and other interested parties in understanding FDA's process for handling clinical investigations that include children as subjects and that have been referred to FDA for review under FDA regulations on additional safeguards for children in clinical investigations. The guidance describes the procedures FDA generally intends to follow in handling clinical investigations referred for review under Sec. 50.54 (21 CFR 50.54) and in reaching final determinations in accordance with these regulations. The guidance announced in this notice finalizes the draft guidance of the same title dated May 2006.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Provisional Patent Application No. 60/718,172, filed September 16, 2005, entitled ``Method of Treating or Preventing Cancer Using Pyridine Carboxaldehyde Pyridine Thiosemicarbazone Radiosensitizing Agents'' [E- 319-2005/0-US-01; E-319-2005/0-PCT-02], to Vion Pharmaceuticals, Inc., having a place of business in New Haven, Connecticut. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of the Triapine as a radiosensitizer as claimed in the licensed patent rights for the treatment of cancer and other tumors.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July 2006 through September 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 and a list of Medicare-approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. 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.

This notice announces a Town Hall Meeting to discuss fiscal year (FY) 2008 applications for add-on payments for new medical services and technologies under the Inpatient Prospective Payment System (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2008 new medical services and technologies applications meet the substantial clinical improvement criteria. Additionally, we will hold an Informational Workshop for all interested parties on the application process and criteria for new medical services and technologies add-on payments under the IPPS, the transitional pass-through payment and new technology ambulatory payment classification (APC) assignment application processes under the Outpatient Prospective Payment System (OPPS) and the processes of Diagnosis-Related Group (DRG) assignment and requesting new ICD-9 codes under the IPPS.