Department of Health and Human Services July 2010 – Federal Register Recent Federal Regulation Documents

HHS gives notice of a decision to designate a class of employees from the University of Rochester Atomic Energy Project in Rochester, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 13, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees from the Mound Plant in Miamisburg, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 14, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees from the Downey Facility in Los Angeles County, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 13, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees from BWX Technologies, Inc., in Lynchburg, Virginia, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 13, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is announcing the availability of a report entitled ``A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration: The Reportable Food Registry.'' The report presents FDA's experience with the Reportable Food Registry (RFR or the Registry) from the opening of the Reportable Food electronic portal on September 8, 2009, until March 31, 2010.

Section 1101 of Title I of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) requires that the Secretary establish, either directly or through contracts with States or nonprofit private entities, a temporary high risk health insurance pool program to provide affordable health insurance coverage to uninsured individuals with pre-existing conditions. This program will continue until January 1, 2014, when Exchanges established under sections 1311 and 1321 of the Affordable Care Act will be available for individuals to obtain health insurance coverage. This interim final rule implements requirements in section 1101 of the Affordable Care

This notice requests comments from the public for our consideration in developing the Secretary's recommendations for legislative changes to improve the quality of care provided to children under Medicaid and the Children's Health Insurance Program, including recommendations for quality reporting by the States. The Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) requires the Secretary of Health and Human Services to provide to Congress recommendations for legislative changes to improve the quality of care provided to children under Medicaid and the Children's Health Insurance Program.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Eisenberg Center Voluntary Customer Survey Generic Clearance for the Agency for Health Care Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of General Medical Sciences (NIGMS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 18, 2010, pages 27789-27790, and allowed 60 days for public comment. One comment was received on 6/25/2010. The public respondent requested that eligibility for this program be offered to American citizens only. As stated in A.1., Justification, of the Supporting Statement A, applicants for this program must be U.S. citizens or permanent residents of the United States who have been awarded a terminal degree, or who have been certified by a university as meeting all the requirements leading to a doctorate may be hired as PRAT Fellows. The purpose of this notice is to allow an additional 30 days for public comment. 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.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent Application No. 60/336,394, filed on October 22, 2001 (HHS Ref. No. E-064-2004/0-US-01); PCT Application No. PCT/US02/033875, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0-PCT-02); U.S. Patent Application No. 10/279,129, filed on October 22, 2002 (HHS Ref. No. E- 064-2004/0-US-03); Japanese Patent Application No. 2003-537565, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0-JP-04); Mexican Patent No. 250445, filed on October 22, 2002 and granted on October 16, 2007 (HHS Ref. No. E-064-2004/0-MX-05); Polish Patent Application No. P- 374301, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0-PL-6); Canadian Patent Application No. 2464277, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0-CA-07); European Patent Application No. 02793811.7, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0-EP- 08); U.S. Patent No. 7,183,254, filed on July 18, 2003 and granted on 2/27/2007 (HHS Ref. No. E-064-2004/0-US-09); U.S. Patent Application No. 11/606,805, filed on October 29, 2006 (HHS Ref. No. E-064-2004/0- US-10); Mexican Patent Application No. 2007/006095, filed on May 14, 2007 (HHS Ref. No. E-064-2004/0-MX-11); Australian Patent Application No. 2002359288, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0- AU-12); Hong Kong Patent Application No. 4106574.7, filed on September 1, 2004 (HHS Ref. No. E-064-2004/0-HK-13); European Patent Application No. 10165256.8, filed on June 8, 2010 (HHS Ref. No. E-064-2004/0-EP- 14); and Japanese Patent Application No. 2010-137501, filed on June 16, 2010 (HHS Ref. No. E-064-2004/0-JP-15), all entitled ``Use of Leptin for Treating Human Lipoatrophy and Method of Determining Predisposition to Said Treatment'', to Amylin Pharmaceuticals, Inc., having a place of business in San Diego, California, U.S.A. The patent rights in this invention have been assigned to the United States of America, the University of Texas Southwestern Medical Center at Dallas, and Amgen, Inc.

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 reopening until September 7, 2010, the comment period for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice, FDA requested comments on draft guidance documents for 11 neurological and physical medicine devices. FDA is reopening the comment period to allow further comment and to receive any new information.

The Department of Health and Human Services (HHS) is issuing this final rule to complete the adoption of an initial set of standards, implementation specifications, and certification criteria, and to more closely align such standards, implementation specifications, and certification criteria with final meaningful use Stage 1 objectives and measures. Adopted certification criteria establish the required capabilities and specify the related standards and implementation specifications that certified electronic health record (EHR) technology will need to include to, at a minimum, support the achievement of meaningful use Stage 1 by eligible professionals, eligible hospitals, and/or critical access hospitals (hereafter, references to ``eligible hospitals'' in this final rule shall mean ``eligible hospitals and/or critical access hospitals'') under the Medicare and Medicaid EHR Incentive Programs. Complete EHRs and EHR Modules will be tested and certified according to adopted certification criteria to ensure that they have properly implemented adopted standards and implementation specifications and otherwise comply with the adopted certification criteria.