Department of Health and Human Services May 7, 2013 – Federal Register Recent Federal Regulation Documents

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 Cancer Institute (NCI), 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 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. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Chana Rabiner, Ph.D., Biorepositories and Biospecimen Research Branch, Cancer Diagnosis Program, 9609 Medical Center Drive, Rockville, MD 20892 or call non-toll-free number 240-276- 5715 or Email your request, including your address to: chana.rabiner@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: Financial Sustainability of Human Tissue Biobanking, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this web- based survey is to collect information regarding the challenges that human tissue biobanks encounter in achieving financially sustainable operations. The information will be used to assist the National Cancer Institute (NCI) in strategizing program plans to provide increased and tailored support for national and international biobanks. The survey will collect a combination of structured, quantitative, and free-text descriptive data that characterize the type and maturity of respondent biobanks, their sources of funding, and their usage of funding in conducting operations. The survey will also collect information describing the difficulties in maintaining funding sources and establishing new ones. Finally, the survey will elicit descriptions of techniques used to overcome the difficulties. It is expected that the information generated by this survey will be used to inform published guidance to biobanks regarding the financial hazards to sustained operations and the means by which these hazards can be avoided or overcome. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 822.

The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a 2-day workshop on June 6-7, 2013. The workshop will be open to the public, with attendance limited to space available.

This is 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 a start-up exclusive patent license to practice the inventions embodied in:

42 U.S.C. 299c establishes a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Seven current members' terms will expire in November 2013. To fill these positions, we are seeking individuals who are distinguished: (1) In the conduct of research, demonstration projects, and evaluations with respect to health care; (2) in the fields of health care quality research or health care improvement; (3) in the practice of medicine; (4) in other health professions; (5) in representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) in the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) in representing the interests of patients and consumers of health care. 42 U.S.C. 299c(c)(2). Individuals are particularly sought with experience and success in activities specified in the summary above.