Department of Health and Human Services August 28, 2013 – 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 Nursing Research (NINR), the 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 June, 14, 2013, page 35942 and allowed 60-days for public comment. No public comments were received. 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. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_ submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Adrienne Burroughs, Health Communications Specialist, Office of Communications and Public Liaison, NINR, NIH, Building 31, Room 5B10, 31 Center Drive, Bethesda, MD 20892, or call non-toll-free number (301) 496-0256, or Email your request, including your address to: adrienne.burroughs@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Palliative Care: Conversations Matter Evaluation, -0925-NewNational Institute of Nursing Research (NINR), National Institutes of Health (NIH). Need and Use of Information Collection: NINR developed Palliative Care: Conversations Matter, a pediatric palliative care campaign to address the communications challenges faced by health care providers who recommend and provide palliative care to pediatric populations. NINR is launching this effort to increase the use of palliative care for children living with serious illness or life-limiting conditions. The Palliative Care: Conversations Matter evaluation will assess the information and materials being disseminated as part of the official campaign. Survey findings will help (1) Determine if the campaign is effective, relevant, and useful to health care providers who recommend and provide palliative care to pediatric populations; (2) to better understand the information needs of health care providers to inform future campaign efforts; and (3) examine how effective the campaign materials are in starting and continuing a pediatric palliative care conversation and addressing the communications needs of health care providers around this topic. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 200.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0317, which expires on October 31, 2013. Prior to submitting ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Peptron, Inc., a company having a place of business in Daejeon, South Korea, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/309,076, filed July 31, 2001, entitled ``Long-Acting Insulinotropic Peptides and Uses Thereof'' (HHS Ref. No. E-049-2001/0-US-01); U.S. Patent No. 7,576,050, issued August 18, 2009, entitled ``GLP-1 Exendin-4 Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-US-03); U.S. Patent No. 8,278,272, issued October 2, 2012, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-US-14); U.S. Patent Application No. 13/594,313, filed August 24, 2012, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-US-21); PCT Patent Application No. PCT/US2002/024141, filed July 30, 2002, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-PCT-02); Australian Patent No. 2002317599, issued July 17, 2008, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-AU-04); Australian Patent No. 2008202893, issued April 26, 2012, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-AU-10); Australian Patent Application No. 2012202081, filed April 11, 2012, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-AU-20); Canadian Patent Application No. 2455963, filed January 29, 2004, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-CA-05); European Patent No. 1411968, issued September 17, 2008, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-EP-06) and validated in Germany (HHS Ref. No. E-049-2001/0-DE-11), France (HHS Ref. No. E-049-2001/0-FR-12), and Great Britain (HHS Ref. No. E-049- 2001/0-GB-13); European Patent No. 2022505, issued December 14, 2011, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-EP-09) and validated in Germany (HHS Ref. No. E- 049-2001/0-DE-17), France (HHS Ref. No. E-049-2001/0-FR-18), and Great Britain (HHS Ref. No. E-049-2001/0-GB-19); European Patent Application No. 10177860.3, filed September 21, 2010, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-EP-16); Indian Patent Application No. 0488/DELNP/2004, filed February 27, 2004, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-IN-07); Japanese Patent Application No. 2003- 517083, filed February 2, 2004, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-JP-08); Japanese Patent Application No. 2009-262568, filed November 18, 2009, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E- 049-2001/0-JP-15; and Japanese Patent Application No. 2013-007743, filed January 18, 2013, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-JP-22). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Exclusive Patent License may be worldwide, and the field of use may be limited to ``Methods of using exenatide for the treatment of neurodegenerative disease in humans.''

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions & Answers.'' This draft guidance answers commonly asked questions about the applicability of good laboratory practice (GLP) to nonclinical laboratory studies conducted in support of research and marketing applications for medical devices. This draft guidance is not final nor is it in effect at this time.