Energy Policy and New Uses Office, Agriculture Department 2015 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS or ``the Department'') is issuing this proposed rule on Section 1557 of the Affordable Care Act (ACA) (Section 1557). Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. Section 1557(c) of the ACA authorizes the Secretary of the Department to promulgate regulations to implement the nondiscrimination requirements of Section 1557. In addition, the Secretary is authorized to prescribe regulations for the Department's governance, conduct, and performance of its business, including, here, how HHS will apply the standards of Section 1557 to HHS-administered health programs and activities.

The National Institutes of Health (NIH), through the Department of Health and Human Services (HHS), is issuing regulations governing the National Institute on Minority Health and Health Disparities (NIMHD) endowment grants awarded to section 736 and section 464z-4 Centers of Excellence to facilitate minority health disparities research and other health disparities research.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May and June 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a nonsubstantive change. This technical amendment is being made to improve the accuracy of the regulations.

HRSA announces its intent to award a program expansion supplement in the amount of $118,700 for the National Center for Family/Professional Partnerships (NCFPP) cooperative agreement. The purpose of the NCFPP cooperative agreement, as stated in the funding opportunity announcement, is to improve the health delivery system and quality of life for children (and youth) with special health care needs (CSHCN) and their families. Strategies may include: (1) Family-centered care, (2) cultural and linguistic competence, and (3) shared decision- making for families of CSHCN at all levels of decision-making (individual, peer, community, etc.). Family/Professional Partnership program activities are primarily carried out through federal leadership strategies, the NCFPP cooperative agreement and state implementation grants in the form of Family-to-Family Health Information Centers. The purpose of this notice is to award supplemental funds to coordinate among leadership trainings for families partnering on state and national level system and service improvements by Family Voices, the cooperative agreement awardee who serves as the NCFPP, during the budget period of 6/1/2015- 5/31/2016.

This document corrects a technical error that appeared in the proposed rule published in the Federal Register on July 1, 2015, entitled ``Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program.''

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) reapprove the proposed information collection project: ``Medical Expenditure Panel SurveyInsurance Component.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on June 11th, 2015 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the National Health Interview Survey (NHIS). The annual National Health Interview Survey is a major source of general statistics on the health of the U.S. population.

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.

The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research, in cosponsorship with the Drug Information Association (DIA), is announcing a meeting entitled ``FDA/DIA Oligonucleotide-Based Therapeutics Conference 2015'' (FDA/DIA 2015 conference). The purpose of the meeting is to discuss advances, safety, and challenges in the field of oligonucleotide-based therapeutics.

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 Middle East Respiratory Syndrome Coronavirus (MERS-CoV). FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by altona Diagnostics GmbH. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the May 29, 2013, determination by the Department of Health and Human Services (HHS) Secretary that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves MERS-CoV. On the basis of such determination, the Secretary of HHS also declared on May 29, 2013, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic devices for detection of MERS-CoV 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 Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI #225) entitled ``Electronic Exchange of Documents: Electronic File Format'' (VICH GL53). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to cover the electronic file format specifications for individual documents and collections of multiple related documents that do not need subsequent modification during the regulatory procedure and are utilized for electronic exchange between industry and regulatory authorities in the context of regulatory approval of veterinary medicinal products.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.