Department of Health and Human Services May 2011 – Federal Register Recent Federal Regulation Documents

This notice announces the closure of St. Vincent's Medical Center and the initiation of an application process for hospitals to apply to the Centers for Medicare & Medicaid Services (CMS) to receive St. Vincent's Medical Center's full time equivalent (FTE) resident cap slots.

The Food and Drug Administration (FDA) is providing notice of a cooperative arrangement between FDA and the Inter-American Institute for Cooperation in Agriculture. The purpose of the arrangement is to provide a framework between the two Agencies to facilitate the exchange of information and the development of projects of mutual interest.

The Food and Drug Administration (FDA) has determined the regulatory review period for ACTEMRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product.

The Department of Health and Human Services (HHS) proposes to alter System of Records, 09-20-0147, ``Occupational Health Epidemiological Studies and EEOICPA Program Records, HHS/CDC/NIOSH'' In accordance with the requirements of the Privacy Act, the Centers for Disease Control and Prevention (CDC) is publishing notice of the amendment of the categories of individuals covered by the system of records; the categories of records; the authorities; and the purposes for maintenance of the system of records. In addition, we are proposing to add new routine uses. The purpose of these modifications is to provide notice that the National Institute for Occupational Safety and Health (NIOSH) is complying with the Privacy Act in executing its responsibilities under the James Zadroga 9/11 Health and Compensation Act of 2010 found at Title XXXIII of the Public Health Service Act, 42 U.S.C. 300mm300mm-61 (Title XXXIII). To reflect these changes, NIOSH is also revising the name of the system of records to ``Occupational Health Epidemiological Studies, EEOICPA Program Records and WTC Health Program Records, HHS/CDC/NIOSH.'' The entire resulting system of records notice, as amended, appears below.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Stephen Lee Seldon, M.D. from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Seldon was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Seldon was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Seldon failed to respond. Dr. Seldon's failure to respond constitutes a waiver of his right to a hearing concerning this action.

HRSA will award non-competitively Ryan White HIV/AIDS Program, Part C funds to the Tutwiler Clinic, Tutwiler, Mississippi, to support comprehensive primary care services for persons living with HIV/AIDS, including primary medical care, laboratory testing, oral health care, outpatient mental health and substance abuse treatment, specialty and subspecialty care, referrals for health and support services and adherence monitoring/education services in order to ensure continuity of critical HIV medical care and treatment services, and to avoid a disruption of HIV clinical care to clients in Marks, Mississippi, and the surrounding counties.

The Department of Health and Human Services published a notice in the Federal Register of May 11, 2011 to announce a meeting of the Presidential Advisory Council on HIV/AIDS that will be held on Thursday, May 26, 2011, and Friday, May 27, 2011. The meeting is to be held from 10 a.m. to approximately 5 p.m. on May 26, 2011, and from 9 a.m. to approximately 3 p.m. on May 27, 2011. The meeting is scheduled to be held in the Department of Health and Human Services; Room 705A Hubert H. Humphrey Building; 200 Independence Avenue, SW.; Washington, DC 20201. The meeting dates have been changed.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Vaccine Safety Working Group (VSWG) of the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for public attendance. Individuals who wish to attend the meeting should register at https:// www.hhs.gov/nvpo/nvac, e- mail nvpo@hhs.gov or call 202-690-5566 and provide name, organization and e-mail address.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a study entitled: ``Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages.''

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).