Antitrust Division September 2015 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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 April 22, 2015, Vol. 80, No. 77 and allowed 60 days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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. 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 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: Desk Officer for NIH. Comment 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.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a worldwide exclusive license to practice the inventions embodied in: HHS Ref. No. E-553- 2013/0, U.S. Provisional Patent Application No. 61/863,071, filed August 7, 2013; International Patent Application PCT/US2013/072344 filed November 27, 2013 entitled ``Transvascular and Transcameral Device Access And Closure,'' to Transmural Systems, LLC, a limited liability company incorporated under the laws of the State of Massachusetts and having its principle place of business in Andover, Massachusetts. The contemplated exclusive license may be limited to caval-aortic devices for aortic valve replacement.

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. 209 and 37 CFR part 404 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.

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 a co-exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 13/580,571 filed 22 August, 2012 and entitled ``Biomarkers for Acute Ischemic Stroke'' [HHS Ref. No. E-023-2010/0-US-03] to CereDx, Inc., which is located in West Virginia. The patent rights in this invention have been assigned to the United States of America. The prospective co-exclusive license territory may be worldwide and the field of use may be limited to the use of the diagnostics of ischemic stroke.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Drug Abuse, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Albert Avila, Ph.D., Director, Office of Diversity and Health Disparities, NIDA, NIH, 6001 Executive Blvd., Room 3106, Rockville, MD 20852, or call non-toll-free number (301) 443-0441 or Email your request, including your address to: aavila@nida.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: NIDA Summer Research Internship Program, 0925- NEW, National Institute on Drug Abuse, NIDA, National Institutes of Health (NIH). Need and Use of Information Collection: The NIDA Summer Research Internship program introduces high school and undergraduate students of underrepresented populations to substance abuse research through internships with NIDA grantees at universities across the United States and Puerto Rico. Students intern with NIDA principal investigators for 8-10 weeks during the summer. The internship experience may include laboratory experiments, formal courses, data collection, data analysis, patient recruitment, manuscript preparation, literature reviews and library research. This outreach and pipeline program exposes students interested in biomedical and behavioral research careers to cutting edge substance abuse research. This program fills a significant unmet need to encourage and support individuals from underrepresented groups to pursue careers in substance abuse research. The NIDA Summer Research Internship program offers a unique opportunity to increase the diversity and creativity of the biomedical research workforce by fostering the development of young talent through the creation of mentorship and training opportunities with premier substance abuse research laboratories around the country. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 350.