Department of Health and Human Services September 29, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for TARCEVA 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.

This document corrects technical errors that appeared in the final rule published in the Federal Register on August 18, 2006, titled ``Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers'' (71 FR 48354).

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research is announcing the withdrawal of three guidances for industry: ``Providing Submissions in Electronic FormatNDAs,'' ``Providing Regulatory Submissions in Electronic FormatANDAs,'' and ``Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs.'' These guidances are being withdrawn because they are no longer consistent with more recent guidance and no longer reflect the agency's preferred format for receiving electronic submissions.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases,'' dated September 2006. This guidance provides recommendations to manufacturers of viral vaccines for the characterization and qualification of cell substrates and viral seeds used in the production of viral vaccines for human use. This draft guidance, when finalized, will replace the information specific to viral vaccines contained in the 1993 document, entitled ``Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.''

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April 2006 through June 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. In addition, for the first time, we are also including 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.