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

Non-Competitive One-Year Extension With Funds for Black Lung/Coal Miner Clinics Program (H37) Current Grantee
Document Number: 2013-10793
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration published a notice in the Federal Register FR 2013-08482 (April 12, 2013), announcing the issuing of a non-competitive one-year extension with funds for the Black Lung/Coal Miner Clinics Program awards to the current grantees (included in attached chart), in amounts between $299,000 and $1.5 million over the one-year extension project period.
Proposed Collection; 60-Day Comment Request: Financial Sustainability of Human Tissue Biobanking (NCI)
Document Number: 2013-10772
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
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.
Proposed Collection; 60-Day Comment Request: The Framingham Heart Study (FHS)
Document Number: 2013-10771
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
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 Heart, Lung, and Blood Institute (NHLBI), 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 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 request more information on the proposed project or to obtain a copy of data collection plans and instruments, contact Dr. Gina Wei, Division of Cardiovascular Sciences, NHLBI, NIH, Two Rockledge Center, 6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892-7936, or call non-toll- free number (301) 435-0456, or email your request, including your address to: weig@nhlbi.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: The Framingham Heart Study, 0925-0216, Extension, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). Need and Use of Information Collection: The Framingham Heart Study will continue to conduct morbidity and mortality follow-up, as well as examinations, for the purpose of studying the determinants of cardiovascular disease. Morbidity and mortality follow-up will continue to occur in all of the cohorts (Original, Offspring, Third Generation, Omni Group 1, and Omni Group 2). Examinations will continue to be conducted on the Original, Offspring, and Omni Group 1 Cohorts. OMB approval is requested for 3 years. There is no cost to the respondents other than their time. The total estimated annualized burden hours are 4264.
National Institute of Diabetes and Digestive and Kidney Diseases, Diabetes Mellitus Interagency Coordinating Committee Notice of Workshop
Document Number: 2013-10770
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
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.
Office of Health Assessment and Translation Evaluation of the State of the Science for Transgenerational Inheritance of Health Effects; Request for Information
Document Number: 2013-10726
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
The Office of Health Assessment and Translation (OHAT) of the Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), is initiating one or more systematic reviews to examine the state of the science for transgenerational inheritance of health effects. The specific scope of the evaluation will be determined following a phase of exploratory screening of the literature and consideration of responses to this request for information (RFI). OHAT requests information on the proposed approach for conducting the exploratory screening of the literature and the identification of scientists with knowledge or expertise relevant to this topic.
Prospective Grant of Start-Up Exclusive License: 1. Catalytic Domains of Beta (1,4)-Galactosyltransferase I Having Altered Donor and Acceptor Specificities Domains, That Promote in Vitro Protein Folding and Methods for Their Use; 2. Targeted Delivery System for Bioactive Agents
Document Number: 2013-10721
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
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:
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2013-10720
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2013-10719
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2013-10718
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-10716
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-10715
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members
Document Number: 2013-10714
Type: Notice
Date: 2013-05-07
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-10713
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2013-10712
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
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