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

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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.
Submission for OMB Review; Comment Request
Document Number: 2015-21625
Type: Notice
Date: 2015-09-01
Agency: Energy Policy and New Uses Office, Agriculture Department, Executive Office of the President
Submission for OMB Review; Comment Request
Document Number: 2015-21619
Type: Notice
Date: 2015-09-01
Agency: Energy Policy and New Uses Office, Agriculture Department, Executive Office of the President
Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Middle East Respiratory Syndrome Coronavirus; Availability
Document Number: 2015-21585
Type: Notice
Date: 2015-09-01
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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.
Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Guidance for Industry; Availability
Document Number: 2015-21583
Type: Notice
Date: 2015-09-01
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #227 entitled ``Two- Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections.'' The guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions to the Center of Veterinary Medicine (CVM) to support approval of a new animal drug or abbreviated new animal drug.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Electronic Exchange of Documents: Electronic File Format; Guidance for Industry; Availability
Document Number: 2015-21582
Type: Notice
Date: 2015-09-01
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2015-21581
Type: Notice
Date: 2015-09-01
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Modernization Commission
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.samhsa.gov/workplace.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2015-21576
Type: Notice
Date: 2015-09-01
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Logistics Agency
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.
Substance Abuse and Mental Health Services Administration
Document Number: 2015-21547
Type: Notice
Date: 2015-09-01
Agency: Energy Policy and New Uses Office, Agriculture Department
National Institute of Nursing Research; Notice of Closed Meetings
Document Number: 2015-21530
Type: Notice
Date: 2015-09-01
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Fogarty International Center; Amended Notice of Meeting
Document Number: 2015-21529
Type: Notice
Date: 2015-09-01
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2015-21528
Type: Notice
Date: 2015-09-01
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute On Aging; Notice of Closed Meeting
Document Number: 2015-21482
Type: Notice
Date: 2015-08-31
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2015-21481
Type: Notice
Date: 2015-08-31
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-21480
Type: Notice
Date: 2015-08-31
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Cancer Institute; Notice of Meeting
Document Number: 2015-21479
Type: Notice
Date: 2015-08-31
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2015-21478
Type: Notice
Date: 2015-08-31
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 2015-21476
Type: Notice
Date: 2015-08-31
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol and Tobacco Tax and Trade Bureau
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. 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. We are, however, requesting an emergency review of the information collection referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. This is necessary to ensure compliance with an initiative of the Administration. We are requesting an emergency review under 5 CFR 1320.13(a)(2)(i) because public harm is reasonably likely to result if the normal clearance procedures are followed. We are seeking emergency approval for modifications to the information collection request (ICR) currently approved under Office of Management and Budget (OMB) control number 0938-1155. CMS seeks an emergency revision to the ICR approved under 0938-1155 to collect additional information from health insurance companies as part of the MLR and risk corridors programs. This ICR is necessary to validate data that issuers have previously submitted to CMS in more detail than CMS has previously anticipated. While conducting program integrity reviews of submitted data, CMS has identified a number of significant discrepancies in the 2014 benefit year submissions that issuers made for MLR and risk corridors on July 31, 2015. CMS also identified a number of common errors that may lead to submissions that do not comply with CMS regulations and guidance. In order to resolve these potential discrepancies, ensure all submissions comply with applicable guidance, and operate the MLR and risk corridors program accurately and effectively, CMS needs additional information to explain the data found in issuers' underlying MLR and risk corridors submissions. Without this additional information, CMS will be unable to verify the accuracy of the submission and validate the data needed to operate the MLR or risk corridors programs.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2015-21467
Type: Notice
Date: 2015-08-31
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2015-21437
Type: Notice
Date: 2015-08-31
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Findings of Research Misconduct
Document Number: 2015-21421
Type: Notice
Date: 2015-08-31
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Logistics Agency
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Peter Littlefield, University of California, San Francisco: Based on an assessment conducted by the University of California, San Francisco (UCSF), the Respondent's admission, and analysis conducted by ORI, ORI and UCSF found that Mr. Peter Littlefield, Graduate Student on a leave of absence from the Tetrad Graduate Program, UCSF, engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), training grant T32 GM007810 and grant R01 GM109176. ORI found that the Respondent engaged in research misconduct by falsifying and/or fabricating data in the following two (2) publications:
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2015-21397
Type: Notice
Date: 2015-08-31
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-21396
Type: Notice
Date: 2015-08-31
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2015-21395
Type: Notice
Date: 2015-08-31
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Medicare Program; Solicitation of Nominations to the Advisory Panel on Hospital Outpatient Payment
Document Number: 2015-21419
Type: Notice
Date: 2015-08-28
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol and Tobacco Tax and Trade Bureau
This notice solicits nominations for up to seven new members to the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel). There will be vacancies on the Panel for four-year terms that begin during Calendar Year 2016. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (Secretary) and the Administrator of the Centers for Medicare & Medicaid Services on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services. The Secretary re-chartered the Panel in 2014 for a 2-year period effective through November 6, 2016.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Protection and Advocacy for Assistive Technology (PAAT) Program Performance Report
Document Number: 2015-21409
Type: Notice
Date: 2015-08-28
Agency: Energy Policy and New Uses Office, Agriculture Department, Denali Commission
The Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL) is announcing an opportunity to comment on the proposed collection of 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 30 days for public comment in response to the notice. This notice collects comments on the information collection requirements relating to an existing collection: Protection and Advocacy for Assistive Technology (PAAT) Program Performance Report (0985-0046).
Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability
Document Number: 2015-21383
Type: Notice
Date: 2015-08-28
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled ``Nonproprietary Naming of Biological Products.'' The draft guidance describes our current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix. Our current thinking is that shared nonproprietary names are not appropriate for all biological products. There is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable. Accordingly, for biological products, we intend to designate a nonproprietary name that includes a suffix composed of four lowercase letters. Each suffix will be incorporated in the nonproprietary name of the product. This naming convention is applicable to biological products previously licensed and newly licensed under the PHS Act. The nonproprietary name designated for originator biological products, related biological products, and biosimilars will include a unique suffix. However, FDA is considering whether the nonproprietary name for an interchangeable product should include a unique suffix, or should share the same suffix as its reference product. FDA invites comment on the draft guidance and solicits comments on ways to improve active pharmacovigilance systems for the purposes of monitoring the safety of biological products.
Designation of Official Names and Proper Names for Certain Biological Products
Document Number: 2015-21382
Type: Proposed Rule
Date: 2015-08-28
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is proposing a regulation to designate official names and proper names for certain biological products. These products are filgrastim-sndz (Biologics License Application (BLA) 125553), filgrastim (BLA 103353), tbo- filgrastim (BLA 125294), pegfilgrastim (BLA 125031), epoetin alfa (BLA 103234), and infliximab (BLA 103772). The official names and proper names of these products would include distinguishing suffixes composed of four lowercase letters and would be designated as filgrastim-bflm (BLA 125553), filgrastim-jcwp (BLA 103353), filgrastim-vkzt (BLA 125294), pegfilgrastim-ljfd (BLA 125031), epoetin alfa-cgkn (BLA 103234), and infliximab-hjmt (BLA 103772). Although FDA is continuing to consider the appropriate naming convention for biological products, including how such a convention would be applied retrospectively to currently licensed products, FDA is proposing to take action with respect to these six products because of the need to encourage routine usage of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices for the biological products subject to this rulemaking, and to avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2015-21378
Type: Notice
Date: 2015-08-28
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2015-21377
Type: Notice
Date: 2015-08-28
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Findings of Research Misconduct
Document Number: 2015-21354
Type: Notice
Date: 2015-08-28
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Logistics Agency
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Brandi Blaylock, Wake Forest School of Medicine: Based on an investigation conducted by Wake Forest School of Medicine (WFSOM) and additional analysis conducted by ORI, ORI found that Ms. Brandi Blaylock, former Graduate Student, WFSOM, engaged in research misconduct in research supported by National Institute of Drug Abuse (NIDA), National Institutes of Health (NIH), grant R01 DA012460 and Ruth L. Kirschstein National Research Service Award (NRSA) K31 DA033106. ORI found that Respondent engaged in research misconduct by falsifying and/or fabricating data reported in two poster presentations, several laboratory meetings, and progress reports associated with NIDA, NIH, grant R01 DA012460. Specifically, ORI found that the Respondent knowingly presented falsified and/or fabricated data indicating that twelve non-human primates (either rhesus or cynomolgus monkeys) responded to anti-abuse nicotinic acetylcholine and/or dopamine receptor selective compounds in self-selectivity assays for cocaine, methamphetamines, or nicotine when the compounds were never given to the monkeys per protocol. Respondent has not applied for or engaged in U.S. Public Health Service (PHS)-supported research within the last three (3) years and has stated that she has no intention of engaging in PHS-supported research in the future. Ms. Blaylock has entered into a Voluntary Settlement Agreement and has voluntarily agreed: (1) That if within three (3) years from the effective date of the Agreement, Respondent receives or applies for PHS support, Respondent agreed to have her research supervised for a period of three (3) years beginning on the date of her employment in a position in which she receives or applies for PHS support and to notify her employer(s)/ institution(s) of the terms of this supervision; Respondent agreed that prior to the submission of an application for PHS support for a research project on which her participation is proposed and prior to her participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of her duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of her research contribution; Respondent agreed that she shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; (2) that if within three (3) years from the effective date of the Agreement, Respondent receives or applies for PHS support, Respondent agreed that for a period of three (3) years beginning on the data of her employment in a position in which she receives or applies for PHS support, any institution employing her shall submit in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived, and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; and (3) to exclude herself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of three (3) years, beginning on August 4, 2015.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-21346
Type: Notice
Date: 2015-08-28
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 Epidemiologic Study of Health Effects Associated With Low Pressure Events in Drinking Water Distribution Systems.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2015-21345
Type: Notice
Date: 2015-08-28
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 effort 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 extension of the information collection entitled The Gonococcal Isolate Surveillance Project (GISP), which is the only source in the United States of national, regional, and site-specific gonococcal antibiotic resistance information that provides information to support informed and scientifically-based treatment recommendations. To request more information on the below proposed project or to obtain a copy of the information collection plan and instruments, call 404-639-7570 or send comments to Leroy A. Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to omb@cdc.gov.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-21344
Type: Notice
Date: 2015-08-28
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 a proposed information collect project entitled Balance After Baby Intervention: Phase 2 (BABI2.) A three-year clearance is requested to conduct a randomized controlled trial of a Web site-based lifestyle program with a racially diverse population of postpartum women who had recent Gestational diabetes mellitus (GDM).
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2015-21343
Type: Notice
Date: 2015-08-28
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 effort 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 National Ambulatory Medical Care Survey (NAMCS) on Culturally and Linguistically Appropriate Services (CLAS) Survey. The purpose of the NAMCS CLAS survey is to describe the awareness, training, adoption, and implementation of the Enhanced Standards for CLAS in Health and Health Care among office-based physicians.
National Committee on Vital and Health Statistics: Meeting
Document Number: 2015-21328
Type: Notice
Date: 2015-08-28
Agency: Energy Policy and New Uses Office, Agriculture Department
Submission for OMB Review; Comment Request
Document Number: 2015-21304
Type: Notice
Date: 2015-08-28
Agency: Energy Policy and New Uses Office, Agriculture Department, Executive Office of the President
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
Document Number: 2015-21291
Type: Notice
Date: 2015-08-28
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on September 28, 2015. The topic for this meeting will be ``New Opportunities for Clinical Research on Type 2 Diabetes.'' The meeting is open to the public.
Proposed Collection; 60-day Comment Request: A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI)
Document Number: 2015-21273
Type: Notice
Date: 2015-08-28
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 Cancer Institute, 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: Nathaniel Rothman, Senior Investigator, Division of Cancer Epidemiology and Genetics, 9609 Medical Center Drive, MSC 9776, Room 6E134, Bethesda, Maryland 20892 or call non-toll-free number (240) 276-7169 or Email your request, including your address to: rothmann@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: A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI), 0925-0654, Expiration Date 10/31/2015-REVISION, National Institutes of Health (NIH). Need and Use of Information Collection: Incidence rates of certain lymphomas have increased in the United States and in many other parts of the world. The contribution of environmental, occupational, and genetic factors to the cause of lymphoma and leukemia has generated a series of novel findings from epidemiological studies conducted in the United States that have attempted to explain this increase. However, none of the chemical associations have been conclusively established and the identification of the key, functional alleles in gene regions associated with risk of lymphoma requires further elucidation. Further, the ability to follow-up, confirm, and extend these observations in the United States is limited by the low prevalence and limited range of several important chemical and viral exposures and the high to complete linkage disequilibrium among key candidate genetic loci in Western populations. To optimize the ability to build on and clarify these findings, it is necessary to investigate populations that differ from those in the West in both exposure patterns and underlying genetic structure. A multidisciplinary case-control study of lymphoma in Asia, where lymphoma rates have also risen, provides an opportunity to replicate and extend recent and novel observations made in studies in the West in a population that is distinctly different with regard to patterns of key risk factors, including range of exposures, prevalence of exposures, correlations between exposures, and variation in gene regions of particular interest. It will also improve the ability to understand the causes of certain types of rare lymphoma tumors in the United States that occur at much higher rates in Asia. As such, AsiaLymph will confirm and extend previous findings and yield novel insights into the causes of lymphoma and leukemia in both Asia and in the United States. The major postulated risk factors for evaluation in this study are chemical exposures (i.e., organochlorines, trichloroethylene, and benzene) and genetic susceptibility. Other factors potentially related to lymphoma, such as viral infections, ultraviolet radiation exposure, medical conditions, and other lifestyle factors will also be studied. Patients from 11 participating hospitals will be screened and enrolled. There will be a one-time computer-administered interview, and patients will also be asked to provide a one-time blood and buccal cell mouth wash sample and lymphoma cases will be asked to make available a portion of their pathology sample. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 3,086.
Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order; Guidance for Tobacco Retailers; Availability
Document Number: 2015-21271
Type: Notice
Date: 2015-08-28
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the availability of a guidance for tobacco retailers entitled ``Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order.'' The guidance represents FDA's current thinking with respect to imposing no-tobacco-sale orders (NTSOs) on retailers who have committed repeated violations of certain restrictions on the sale and distribution of tobacco products. This guidance discusses, among other things, the period of time covered by an NTSO and a retailer's compliance with an NTSO.
340B Drug Pricing Program Omnibus Guidance
Document Number: 2015-21246
Type: Notice
Date: 2015-08-28
Agency: Energy Policy and New Uses Office, Agriculture Department, Management and Budget Office
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This notice proposes guidance for covered entities enrolled in the 340B Program and drug manufacturers that are required by section 340B of the PHSA to make their drugs available to covered entities under the 340B Program. When finalized after consideration of public comments solicited by this notice, the guidance is intended to assist 340B covered entities and drug manufacturers in complying with the statute.