Energy Policy and New Uses Office, Agriculture Department September 2, 2015 – Federal Register Recent Federal Regulation Documents

Medicare Program; End-Stage Renal Disease Prospective Payment System; Correction
Document Number: 2015-21783
Type: Proposed Rule
Date: 2015-09-02
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol and Tobacco Tax and Trade Bureau
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.''
Submission for OMB Review; Comment Request
Document Number: 2015-21728
Type: Notice
Date: 2015-09-02
Agency: Energy Policy and New Uses Office, Agriculture Department, Executive Office of the President
Submission for OMB Review; Comment Request
Document Number: 2015-21727
Type: Notice
Date: 2015-09-02
Agency: Energy Policy and New Uses Office, Agriculture Department, Executive Office of the President
Patient Safety Organizations: Voluntary Relinquishment From Safe Pediatric Healthcare PSO
Document Number: 2015-21720
Type: Notice
Date: 2015-09-02
Agency: Energy Policy and New Uses Office, Agriculture Department, Federal Reserve System
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, (73 FR 70732-70814), provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from Safe Pediatric Healthcare PSO of its status as a PSO, and has delisted the PSO accordingly.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-21719
Type: Notice
Date: 2015-09-02
Agency: Energy Policy and New Uses Office, Agriculture Department, Federal Reserve System
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.
Prospective Grant of Co-Exclusive License: Biomarkers for Acute Ischemic Stroke
Document Number: 2015-21718
Type: Notice
Date: 2015-09-02
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a co-exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 13/580,571 filed 22 August, 2012 and entitled ``Biomarkers for Acute Ischemic Stroke'' [HHS Ref. No. E-023-2010/0-US-03] to CereDx, Inc., which is located in West Virginia. The patent rights in this invention have been assigned to the United States of America. The prospective co-exclusive license territory may be worldwide and the field of use may be limited to the use of the diagnostics of ischemic stroke.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-21708
Type: Notice
Date: 2015-09-02
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Nuclear Facilities Safety Board
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-21705
Type: Notice
Date: 2015-09-02
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2015-21704
Type: Notice
Date: 2015-09-02
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2015-21703
Type: Notice
Date: 2015-09-02
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Proposed Collection; 60-Day Comment Request; Application Forms for the NIDA Summer Research Internship Program (NIDA)
Document Number: 2015-21702
Type: Notice
Date: 2015-09-02
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act
Document Number: 2015-21645
Type: Notice
Date: 2015-09-02
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the requirement to make safety related labeling changes based upon new safety information that becomes available after the drug or biological product is approved under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) or the Public Health Service Act (PHS Act.)
Food and Drug Administration/Drug Information Association Oligonucleotide-Based Therapeutics Conference 2015
Document Number: 2015-21639
Type: Notice
Date: 2015-09-02
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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.
Availability of Draft Toxicological Profile; Perfluoroalkyls
Document Number: 2015-21544
Type: Notice
Date: 2015-09-02
Agency: Energy Policy and New Uses Office, Agriculture Department, Federal Retirement Thrift Investment Board
The Agency for Toxic Substances and Disease Registry (ATSDR) located in the Department of Health and Human Services (HHS) announces the availability of the Toxicological Profile for Perfluoroalkyls for review and comment. Comments can include additional information or reports on studies about the health effects of perfluoroalkyls. Although ATSDR considered key studies for this substance during the profile development process, this 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.
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