Department of Health and Human Services June 26, 2009 – Federal Register Recent Federal Regulation Documents

The President's Advisory Council for Faith-based and Neighborhood Partnerships will hold a Council meeting. Topics to be discussed include updates from Council subcommittees on Reform of the Office, Economic Recovery, Fatherhood and Healthy Families, Inter- religious Dialogue and Cooperation, Environment and Climate Change and Global Poverty and Development.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the supplemental approval of a new animal drug application (NADA) filed by Dechra, Ltd. The supplemental NADA provides for the addition of a 10-milligram capsule size of trilostane, used in dogs for treatment of hyperadrenocorticism.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Center for Complementary and Alternative Medicine (NCCAM), at the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA) is announcing an amendment to the Emergency Use Authorization (EUA) (the Authorization) for doxycycline hyclate tablet emergency kits for eligible U.S. Postal Service (USPS) participants in the Cities Readiness Initiative (CRI) and their household members issued on October 3, 2008, under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Health and Human Services (HHS). Following issuance of FDA's October 3, 2008, Authorization letter, on February 19, 2009, BARDA submitted a request on behalf of ASPR, to amend the Authorization. In response to BARDA's request, FDA amended the Authorization letter and reissued the Authorization letter in its entirety on February 25, 2009. The Authorization, as amended and reissued in its entirety, is reprinted in this document.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January 2009 through March 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 tomography for dementia, and a list of Medicare-approved bariatric surgery facilities.