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

This proposed notice acknowledges the receipt of a deeming application from the Community Health Accreditation Program (CHAP) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the University of Rochester in Rochester, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:

In FY 2007, ORR awarded a competitive service grant for the Microenterprise Development Program grant to New York Association for New Americans, Inc. (NYANA) in New York, New York. The original project was from September 29, 2007, through September 30, 2012. NYANA served as the fiscal sponsor and legal entity of the approved project. As of February 1, 2009, NYANA has ceased operations of the Microenterprise Development Program. NYANA has requested ORR permission for the Center for Community Development for New Americans (CCDNA) to assume the grant. CCDNA has agreed to this request. The effect of this deviation request is to transfer the grant from the initial grantee to a new grantee with all the responsibilities of managing and implementing the project for the remainder of the grant period.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Biomedical Advanced Development Authority (BARDA), Chemical Biological, Radiological & Nuclear (CBRN) Medical Countermeasures and Acquisitions Management Systems (AMS) will be holding a public workshop. The workshop is open to the public.

In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to alter the system of records for the C.W. Bill Young Cell Transplantation Program. This system of records is required to comply with the implementation directives of Public Law 109-129. Records are used for the C.W. Bill Young Cell Transplantation Program's planning, implementation, evaluation, monitoring, and document storage purposes.

In accordance with the memorandum of January 20, 2009, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Review,'' this action delays until December 30, 2010, the effective date of the final rule entitled ``State Parent Locator Service; Safeguarding Child Support Information,'' published in the Federal Register on September 26, 2008 (73 FR 56422). The delay in effective date is necessary to give Department officials the opportunity for further review of the issues of law and policy raised by this rule.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill three vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by Title XXI of the Public Health Service Act (the Act), as enacted by Public Law (Pub. L.) 99-660 and as subsequently amended, and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director, National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 20, 2009, pages 7908-7909 and allowed 60 days for public comment. No public comments were received. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

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.

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).

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in US Patent Application 60/792,098 entitled ``Tetrahalogenated Compounds Useful as Inhibitors'' [HHS Ref. E-080-2006/0-US-01], PCT Application PCT/US2007/008849 entitled ``Tetrahalogenated Compounds Useful as Inhibitors'' [HHS Ref. E-080-2006/0-PCT-02], Australian Patent Application 2007238785 entitled ``A New Series Of Thalidomide Analogs That Have Potent Anti-angiogenic Properties'' [HHS Ref. E-080-2006/0- AU-03], Canadian Patent Application 2,648,216 entitled ``A New Series Of Thalidomide Analogs That Have Potent Anti-angiogenic Properties'' [HHS Ref. E-080-2006/0-CA-04], European Patent Application 07755201.6 entitled ``A New Series Of Thalidomide Analogs That Have Potent Anti- angiogenic Properties'' [HHS Ref. E-080-2006/0-EP-05], US Patent Application 12/287,597 entitled ``A New Series Of Thalidomide Analogs That Have Potent Anti-angiogenic Properties'' [HHS Ref. E-080-2006/0- US-06], and all continuing patents, patent applications, and foreign counterparts thereto, to CuriRx, Inc., which has offices in Andover, Massachusetts. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America.

The Office of Public Health and Science (OPHS) is seeking nominations of qualified individuals to be considered for appointment as members of the Advisory Committee on Blood Safety and Availability (ACBSA). ACBSA is a Federal advisory committee in the Department of Health and Human Services. Management support for the activities of this Committee is the responsibility of the OPHS.

The Food and Drug Administration (FDA) is withdrawing approval of 92 new drug applications (NDAs) and 49 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.