Department of Health and Human Services September 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 These guidances are being withdrawn because they are no longer consistent with more recent guidance and no longer reflect the agency's preferred format for receiving electronic submissions.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 This draft guidance, when finalized, will replace the information specific to viral vaccines contained in the 1993 document, entitled ``Points to Consider in the Characterization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.

NICEATM announces the availability of an addendum to the report, ``Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Evaluation of In Vitro Test Methods for Detecting Potential Endocrine Disruptors: Estrogen Receptor and Androgen Receptor Binding and Transcriptional Activation Assays'' [NIH Publication 03-4503]. The addendum describes the rationale for revisions to the original list of recommended reference substances for validation of in vitro estrogen receptor (ER) and androgen receptor (AR) binding and transcriptional activation (TA) assays.

This notice announces the availability of two interaction profiles prepared by ATSDR [final documents].

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA provides for use of neomycin sulfate soluble powder in livestock for the treatment and control of bacterial enteritis.

The Food and Drug Administration (FDA) has determined the regulatory review period for LYRICA (new drug application (NDA) 21-446) 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 notice announces an administrative hearing to be held on November 15, 2006, at the Richard Bolling Federal Building, 601 E. 12th Street, Kansas City, MO 64106-2898, the Kansas City Room, to reconsider CMS' decision to disapprove Missouri State plan amendment 05-11. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by October 12, 2006.

This notice announces the tenth meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).