Department of Health and Human Services 2009 – Federal Register Recent Federal Regulation Documents

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July 2009 through September 2009, 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. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomogrogphy for dementia, and a list of Medicare-approved bariatric surgery facilities.

The Food and Drug Administration (FDA) Florida District, in cosponsorship with The Society of Clinical Research Associates, Inc. (SoCRA), is announcing a public workshop entitled ``FDA Clinical Trial Requirements, Regulations, Compliance and GCP.'' This 2-day public workshop is intended to provide information about FDA clinical trial requirements to the regulated industry.

The Health Resources and Services Administration (HRSA) will be transferring Health Center Program (section 330 of the Public Health Service Act) New Access Point (NAP) and Increased Demand for Service (IDS) funds originally awarded to Trover Health System to Regional Health Care Affiliates to ensure the provision of critical primary health care services to underserved populations in Webster and McLean Counties, Kentucky.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for use of two-way combination Type B and C medicated swine feeds formulated with ractopamine hydrochloride and tylosin phosphate following use of tylosin tartrate medicated drinking water consistent with the sequential use approved for single-ingredient tylosin medicated swine feed.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 11: Capillary Electrophoresis General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Capillary Electrophoresis General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This draft guidance is the 11th annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 12: Analytical Sieving General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Analytical Sieving General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This draft guidance is the 12th annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).

The Centers for Disease Control and Prevention (CDC) is extending to March 29, 2010, the comment period for the notice of proposed rulemaking by the National Institute for Occupational Safety and Health (NIOSH) of CDC, entitled ``Total Inward Leakage Requirements for Respirators,'' published in the Federal Register on Friday, October 30, 2009 (74 FR 56141). In the notice of proposed rulemaking, CDC requested comments by December 29, 2009. The Agency is taking this action in response to requests for an extension to allow interested parties additional time to submit comments.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet, Inc. The supplemental NADA adds Mycoplasma bovis to the bovine respiratory disease pathogens for which florfenicol injectable solution is approved as a treatment.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) debarring Peter Xuong Lam for a period of 20 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Lam was convicted of four felonies under Federal law for conduct relating to the importation into the United States of an article of food. After being given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Mr. Lam failed to request a hearing. Mr. Lam's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.