Meeting of the National Vaccine Advisory Committee, 3395-3396 [2020-00882]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 13 / Tuesday, January 21, 2020 / Notices Integrity (ORI) has taken final action in the following case: Ozgur Tataroglu, Ph.D., University of Massachusetts Medical School: Based on the report of an investigation conducted by UMMS and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Ozgur Tataroglu, former postdoctoral fellow, Department of Neurobiology, UMMS, engaged in research misconduct in research supported by PHS funds, specifically NIGMS, NIH, grants R01 GM066777 and R01 GM079182. Respondent neither admits nor denies ORI’s findings of research misconduct. The settlement is not an admission of liability on the part of the Respondent. The parties entered into a Voluntary Settlement Agreement (Agreement) to conclude this matter without further expenditure of time, finances, or other resources. ORI found that Respondent engaged in research misconduct by knowingly, intentionally, and/or recklessly falsifying data included in the following one (1) paper and two (2) grant applications submitted to NIGMS, NIH: • Calcium and SOL Protease Mediate Temperature Resetting of Circadian Clocks. Cell 2015 Nov 19;163(5):1214– 1224 (hereafter referred to as ‘‘Cell 2015’’). Retracted in: Cell 2017 Sep 21;171(1):256. • R01 GM079182–05A1, ‘‘Synchronization of Drosophila Circadian Rhythms by Temperature Cycles,’’ submitted to NIGMS, NIH, on July 18, 2014. • R35 GM118087–01, ‘‘Molecular and neural mechanisms generating and synchronizing circadian rhythms,’’ submitted to NIGMS, NIH, on May 19, 2015. Specifically, ORI found that Respondent engaged in research misconduct by knowingly, intentionally, and/or recklessly falsifying data in bar graphs representing phase shift of circadian clock activity between Drosophila without and with heat pulse (HP) treatment in: Figures 1G, 2F, 3C, and 4C of Cell 2015; Figures 7D, 8G, and 9C in grant application R01 GM079182–05A1; Figures 3C and 4 in grant application R35 GM118087–01; and two (2) figures recorded in his unpublished data files, by selectively altering the original Drosophila behavior locomotor data in his primary data files. The data manipulations resulted in the creation or exaggeration of phase shifts caused by either HP treatment or overexpression of the calpain protease SOL, to support the hypothesis that temperature phase shifts the Drosophila circadian clock through the regulated VerDate Sep<11>2014 18:20 Jan 17, 2020 Jkt 250001 degradation of the pacemaker protein TIMELESS mediated by SOL. Dr. Tataroglu entered into an Agreement and voluntarily agreed: (1) To have his research supervised for a period of three (3) years beginning on December 30, 2019; Respondent agreed that prior to the submission of an application for PHS support for a research project on which Respondent’s participation is proposed and prior to Respondent’s participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent’s duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent’s research contribution; Respondent agreed that he 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 supervision plan; (2) that the requirements for Respondent’s supervision plan are as follows: i. A committee of 2–3 senior faculty members at the institution who are familiar with Respondent’s field of research, but not including Respondent’s supervisor or collaborators, will provide oversight and guidance for three (3) years beginning on December 30, 2019; the committee will review primary data from Respondent’s laboratory on a quarterly basis and submit a report to ORI at six (6) month intervals setting forth the committee meeting dates, Respondent’s compliance with appropriate research standards, and confirming the integrity of Respondent’s research; and ii. the committee will conduct an advance review of any PHS grant applications (including supplements, resubmissions, etc.), manuscripts reporting PHS-funded research submitted for publication, and abstracts; the review will include a discussion with Respondent of the primary data represented in those documents and will include a certification to ORI that the data presented in the proposed application/publication is supported by the research record; (3) that for a period of three (3) years beginning on December 30, 2019, any institution employing him 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, PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 3395 procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; (4) that if no supervisory plan is provided to ORI, Respondent shall provide certification to ORI at the conclusion of the supervision period that he has not engaged in, applied for, or had his name included on any application, proposal, or other request for PHS funds without prior notification to ORI; and (5) to exclude himself 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 December 30, 2019. Elisabeth A. Handley, Interim Director, Office of Research Integrity. [FR Doc. 2020–00874 Filed 1–17–20; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a two-day meeting in-person meeting. The meeting will be open to the public and public comment sessions will be held during the meeting. DATES: The meeting will be held on Tuesday and Wednesday, February 13– 14, 2020. The confirmed meeting times and agenda will be posted on the NVAC website at http://www.hhs.gov/nvpo/ nvac/meetings/index.html as soon as they become available. ADDRESSES: Instructions regarding attending this meeting will be posted online at: http://www.hhs.gov/nvpo/ nvac/meetings/index.html at least one week prior to the meeting. Preregistration is required for those who wish to attend the meeting or participate in one of the public comment sessions. Please register at http://www.hhs.gov/ nvpo/nvac/meetings/index.html. FOR FURTHER INFORMATION CONTACT: Ann Aikin, Acting Designated Federal Officer, at the Office of Infectious SUMMARY: E:\FR\FM\21JAN1.SGM 21JAN1 3396 Federal Register / Vol. 85, No. 13 / Tuesday, January 21, 2020 / Notices Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services, Mary E. Switzer Building, Room L618, 330 C Street SW, Washington, DC 20024. Phone: (202) 795–7611; email: nvac@hhs.gov. SUPPLEMENTARY INFORMATION: Pursuant to Section 2101 of the Public Health Service Act (42 U.S.C. 300aa–1), the Secretary of HHS was mandated to establish the National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The NVAC was established to provide advice and make recommendations to the Director of the National Vaccine Program on matters related to the Program’s responsibilities. The Assistant Secretary for Health serves as Director of the National Vaccine Program. During the February 2020 NVAC meeting, sessions will focus on vaccine innovation and vaccine confidence with updates from subcommittees and members. Please note that agenda items are related to charges of the committee and are subject to change, as priorities dictate. Information on the final meeting agenda will be posted prior to the meeting on the NVAC website: http:// www.hhs.gov/nvpo/nvac/index.html. Members of the public will have the opportunity to provide comments at the NVAC meeting during the public comment periods designated on the agenda. Public comments made during the meeting will be limited to three minutes per person to ensure time is allotted for all those wishing to speak. Individuals are also welcome to submit written comments. Written comments should not exceed three pages in length. Individuals submitting written comments should email their comments to the National Vaccine Program Office (nvac@hhs.gov) at least five business days prior to the meeting. Dated: January 3, 2020. Ann Aikin, Acting Designated Federal Official, Office of Infectious Disease and HIV/AIDS Policy. [FR Doc. 2020–00882 Filed 1–17–20; 8:45 am] BILLING CODE 4150–44–P jbell on DSKJLSW7X2PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Sep<11>2014 18:20 Jan 17, 2020 Jkt 250001 amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel Arthritis Connective Tissue and Skin Sciences. Date: February 12, 2020. Time: 10:30 a.m. to 11:30 a.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Pentagon City, 550 Army Navy Drive, Arlington, VA 22202. Contact Person: Rajiv Kumar, Ph.D., IRG Chief, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4216, MSC 7802, Bethesda, MD 20892, (301) 435–1212, kumarra@csr.nih.gov. Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group Skeletal Biology Development and Disease Study Section. Date: February 18–19, 2020. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Washington Marriott at Metro Center, 775 12th Street NW, Washington, DC 20005. Contact Person: Aruna K Behera, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4211, MSC 7814, Bethesda, MD 20892, (301) 435– 6809, beheraak@csr.nih.gov. Name of Committee: Biological Chemistry and Macromolecular Biophysics Integrated Review Group Macromolecular Structure and Function A Study Section. Date: February 18–19, 2020. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hotel Spero, 405 Taylor Street, San Francisco, CA 94102. Contact Person: David R Jollie, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4166, MSC 7806, Bethesda, MD 20892, (301) 408– 9072, jollieda@csr.nih.gov. Name of Committee: Infectious Diseases and Microbiology Integrated Review Group Vector Biology Study Section. Date: February 18–19, 2020. Time: 8:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: Catamaran Resort, 3999 Mission Boulevard, San Diego, CA 92109. Contact Person: Liangbiao Zheng, Ph.D., Scientific Review Officer, Center for PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD 20892, (301) 402– 5671, zhengli@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel PAR17–190: Maximizing Investigators’ Research Award for Early Stage Investigators (R35). Date: February 18–19, 2020. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, MD 20814. Contact Person: Jonathan Arias, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5170, MSC 7840, Bethesda, MD 20892, (301) 435– 2406, ariasj@csr.nih.gov. Name of Committee: Genes, Genomes, and Genetics Integrated Review Group Prokaryotic Cell and Molecular Biology Study Section. Date: February 18–19, 2020. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Renaissance Washington, DC Downtown Hotel, 999 Ninth Street NW, Washington, DC 20001–4427. Contact Person: Luis Dettin, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2208, Bethesda, MD 20892, (301) 451–1327, dettinle@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel Fellowships: Behavioral Neuroscience. Date: February 18–19, 2020. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bahia Resort Hotel, 998 West Mission Bay Drive, San Diego, CA 92109. Contact Person: Mei Qin, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5213, Bethesda, MD 20892, (301) 875–2215, qinmei@csr.nih.gov. Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group Chemosensory Systems Study Section. Date: February 18, 2020. Time: 10:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: John Bishop, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5182, MSC 7844, Bethesda, MD 20892, (301) 408– 9664, bishopj@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel Macromolecular Structure and Function A Study Section. Date: February 18, 2020. Time: 12:00 p.m. to 5:00 p.m. E:\FR\FM\21JAN1.SGM 21JAN1

Agencies

[Federal Register Volume 85, Number 13 (Tuesday, January 21, 2020)]
[Notices]
[Pages 3395-3396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00882]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the National Vaccine Advisory Committee

AGENCY: Office of Infectious Disease and HIV/AIDS Policy, Office of the 
Assistant Secretary for Health, Office of the Secretary, Department of 
Health and Human Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: As stipulated by the Federal Advisory Committee Act, the 
Department of Health and Human Services (HHS) is hereby giving notice 
that the National Vaccine Advisory Committee (NVAC) will hold a two-day 
meeting in-person meeting. The meeting will be open to the public and 
public comment sessions will be held during the meeting.

DATES: The meeting will be held on Tuesday and Wednesday, February 13-
14, 2020. The confirmed meeting times and agenda will be posted on the 
NVAC website at http://www.hhs.gov/nvpo/nvac/meetings/index.html as 
soon as they become available.

ADDRESSES: Instructions regarding attending this meeting will be posted 
online at: http://www.hhs.gov/nvpo/nvac/meetings/index.html at least 
one week prior to the meeting. Pre-registration is required for those 
who wish to attend the meeting or participate in one of the public 
comment sessions. Please register at http://www.hhs.gov/nvpo/nvac/meetings/index.html.

FOR FURTHER INFORMATION CONTACT: Ann Aikin, Acting Designated Federal 
Officer, at the Office of Infectious

[[Page 3396]]

Disease and HIV/AIDS Policy, U.S. Department of Health and Human 
Services, Mary E. Switzer Building, Room L618, 330 C Street SW, 
Washington, DC 20024. Phone: (202) 795-7611; email: [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to Section 2101 of the Public 
Health Service Act (42 U.S.C. 300aa-1), the Secretary of HHS was 
mandated to establish the National Vaccine Program to achieve optimal 
prevention of human infectious diseases through immunization and to 
achieve optimal prevention against adverse reactions to vaccines. The 
NVAC was established to provide advice and make recommendations to the 
Director of the National Vaccine Program on matters related to the 
Program's responsibilities. The Assistant Secretary for Health serves 
as Director of the National Vaccine Program.
    During the February 2020 NVAC meeting, sessions will focus on 
vaccine innovation and vaccine confidence with updates from 
subcommittees and members. Please note that agenda items are related to 
charges of the committee and are subject to change, as priorities 
dictate. Information on the final meeting agenda will be posted prior 
to the meeting on the NVAC website: http://www.hhs.gov/nvpo/nvac/index.html.
    Members of the public will have the opportunity to provide comments 
at the NVAC meeting during the public comment periods designated on the 
agenda. Public comments made during the meeting will be limited to 
three minutes per person to ensure time is allotted for all those 
wishing to speak. Individuals are also welcome to submit written 
comments. Written comments should not exceed three pages in length. 
Individuals submitting written comments should email their comments to 
the National Vaccine Program Office ([email protected]) at least five 
business days prior to the meeting.

    Dated: January 3, 2020.
Ann Aikin,
Acting Designated Federal Official, Office of Infectious Disease and 
HIV/AIDS Policy.
[FR Doc. 2020-00882 Filed 1-17-20; 8:45 am]
 BILLING CODE 4150-44-P