Department of Health and Human Services March 17, 2015 – 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 Human Genome Research Institute (NHGRI), 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, submit comments in writing, or request more information on the proposed project, contact: Carla L. Easter, Ph.D., Chief, Education and Community Involvement Branch, NHGRI, Building 31, Room B1B55, 31 Center Drive, MSC 2070, Bethesda, MD 20892 or call non-toll-free number (301) 594-1364 or Email your request, including your address to: easterc@mail.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: Surveys to Support an Evaluation of the NHGRI Summer Workshop in Genomics (Short Course), 0925-NEW, National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of the proposed data collection activity is to complete a full-scale outcome evaluation of NHGRI's Summer Workshop in Genomics (a.k.a., the ``Short Course'') focusing on program participants between 2004 and 2012. This training program is an intensive multi-day course that updates instructors and researchers of biology and nursing (and other related disciplines) on the latest research trends and topics in genomic science. The course focuses on the continuing effort to find the genetic basis of various diseases and disorders, and current topics on the ethical, legal and social implications of genomics. The Education and Community Involvement Branch (ECIB) designed the program to accomplish the following goals, which align with elements of both the NIH and NHGRI missions: Expand NIH and NHGRI's professional network to reach out to diverse communities, and to create new partnership opportunities. Prepare the next generation of genomics professionals for an era of genomic medicine. Train and diversify the pipeline of genome professionals in alignment with the NIH and US Department of Health and Human Services diversity efforts. The ECIB has systematically collected feedback annually after the program from participants since inception of the Short Course in 2003, and then used the data to tweak the program, but it has not conducted a long-term, cumulative and substantive outcome evaluation. NHGRI and the ECIB propose to conduct such an outcome evaluation, focusing on three main objectives: (1) To understand the degree of genetic and genomic curriculum integration by faculty participants; (2) To explore the barriers and supports faculty experience and changes when integrating curriculum; and (3) To investigate the influence of the program on the participants' career path. Survey findings will provide valuable information about the various methods and pathways instructors use to disseminate new knowledge (and the associated timelines), the barriers and supports experienced by faculty as they integrate new knowledge into their teaching, and insights about additional avenues of support that NHGRI could provide teaching faculty from the types of institutions identified. Key indicators will also provide evidence about the degree to which the Short Course is meeting its goals. Collectively, the outcome evaluation will inform future program design and budget allocations. OMB approval is requested for 2 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 155.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Advancing Translational Sciences (NCATS), the National Institutes of Health, 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 November 21, 2014, page 69499 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 Center for Advancing Translational Sciences (NCATS), 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: NIH Desk Officer. 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.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Ebola Zaire virus in response to the 2014 Ebola virus outbreak in West Africa. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Roche Molecular Systems, Inc. (Roche). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

The Health Resources and Services Administration (HRSA) is updating income levels used to identify a ``low-income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. These various programs are authorized in Titles III, VII, and VIII of the Public Health Service Act. The Department periodically publishes in the Federal Register low- income levels to be used by institutions receiving grants and cooperative agreements in order to determine individual eligibility for programs providing training for (1) disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from low-income families.