Department of Health and Human Services October 16, 2015 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee and is seeking nominations for this committee.

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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), will issue a funding announcement for the Media-Smart Youth Leaders Program 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: Whether the proposed collection of information is necessary for the proper selection of facilitators to serve as local health educators, using the Media-Smart Youth curriculum; the accuracy of the agency's estimate of the burden of the proposed collection of information; ways to enhance the quality, utility, and clarity of the information to be collected; and 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: Dr. Sarah Glavin, Acting Director, Office of Science Policy, Analysis, and Communications, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Dr., Bldg. 31, Rm. 2A28, Bethesda, MD 20892, or call non-toll-free number (301) 496-7898, or email your request, including your address to: glavins@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: Application for Consideration for the Media- Smart Youth Leaders Program (A Local Health Education Program and Leadership Opportunity): 0925New, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). Need and Use of Information Collection: Media-Smart Youth: Eat, Think, and Be Active![supreg] is an interactive program designed to teach youth ages 11-13 about how media can affect their health. Developed by the NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the program includes 10 lessons on media analysis, nutrition, and physical activity, plus a final capstone project. The Media-Smart Youth[supreg] Leaders Program is designed for teens and adults, ages 15 years and up, who are interested in bringing the Media-Smart Youth program to their community. In return for recruiting youth participants, teaching the 10 lessons, and leading the final project, Media-Smart Youth Leaders will receive leadership experience, community service hours, and recognition from the NICHD. To help Leaders succeed, the NICHD will provide training, ongoing assistance, and a small funding amount for program expenses. The purpose of this information collection is to solicit information from applicants about their qualifications that would make them effective Leaders, their reason for wanting to pursue this opportunity, and the details of their proposed program (including, but not limited to, location, community partner(s), and proposed budget). This information will help NICHD staff select the candidates for the program who are most likely to succeed in implementing the full curriculum and teaching youth effective lessons about nutrition, physical activity, and media. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 800.

The Food and Drug Administration (FDA or Agency) is announcing the availability of draft recommendations for a new permitted daily exposure (PDE) for the residual solvent triethylamine and a revised PDE for the residual solvent methylisobutylketone, according to the maintenance procedures for the guidance for industry entitled ``Q3C Impurities: Residual Solvents.'' The draft recommendations were prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The document is intended to recommend acceptable amounts for the listed residual solvents in pharmaceuticals for the safety of the patient.

The Agency for Toxic Substances and Disease Registry (ATSDR), located within the Department of Health and Human Services (HHS) announces the availability of Set 27 Toxicological Profiles for review and comment. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Sec. 104(i)(3), (42 U.S.C. 9604(i)(3)), directs the ATSDR Administrator to prepare Toxicological Profiles of Priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile. Comments can include additional information or reports on studies about the health effects of Set 27 substances. Although ATSDR considered key studies for each of these substances during the profile development process, the Federal Register notice solicits any relevant, additional studies, particularly unpublished data. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile. ATSDR remains committed to providing a public comment period for this document as a means to best serve public health and our clients.

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

This final rule finalizes a new edition of certification criteria (the 2015 Edition health IT certification criteria or ``2015 Edition'') and a new 2015 Edition Base Electronic Health Record (EHR) definition, while also modifying the ONC Health IT Certification Program to make it open and accessible to more types of health IT and health IT that supports various care and practice settings. The 2015 Edition establishes the capabilities and specifies the related standards and implementation specifications that Certified Electronic Health Record Technology (CEHRT) would need to include to, at a minimum, support the achievement of meaningful use by eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) under the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) when such edition is required for use under these programs.