Department of Health and Human Services August 4, 2008 – Federal Register Recent Federal Regulation Documents

This 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 U.S. Patent Application 11/137,114 entitled ``Scopolamine For The Treatment Of Depression And Anxiety'' [HHS Ref. E-175-2004/0-US-01], PCT Application PCT/US2006/019335 [HHS Ref. E-175-2004/0-PCT-02] and all continuing applications and foreign counterparts (Europe, Australia and Canada), to Transcept Pharmaceuticals, Inc., which has offices in Pt. Richmond, CA. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to:

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director (OD), Office of Extramural Research (OER), 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 March 12, 2008, Volume 73, No. 49, page 13242 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. Proposed Collection: Title: Individual Ruth L. Kirschstein National Research Service Award Applications and Related Forms; Type of Information Collection Request: Revision, OMB 0925-0002, Expiration Date 10/31/08. Form Numbers: PHS 416-1, 416-9, 416-5, 416-7, 6031, 6031-1. Need and Use of Information Collection: The 416-1 and 416-9 are used by individuals to apply for direct research training support. Awards are made to individual applicants for specified training proposals in biomedical and behavioral research, selected as a result of a national competition. The other related forms (PHS 416-5, 416-7, 6031, 6031-1) are used by these individuals to activate, terminate, and provide for payback of a National Research Service Award. Frequency of response: Applicants may submit applications for published receipt dates. If awarded, annual progress is reported and trainees may be appointed or reappointed. Affected Public: Individuals or Households; Business or other for-profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. Type of Respondents: Adult scientific trainees and professionals. The annual reporting burden is as follows: Estimated Number of Respondents: 34,454; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 4.1; and Estimated Total Annual Burden Hours Requested: 142,301. The annualized cost to respondents is estimated at: $4,980,535. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: 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 sent via e-mail to OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Ms. Mikia Currie, Project Clearance Branch, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Suite 350, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number (301) 435-0941, or e-mail your request, including your address to: curriem@od.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.