Department of Health and Human Services July 28, 2010 – Federal Register Recent Federal Regulation Documents

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.