National Institute of Dental & Craniofacial Research; Notice of Closed Meeting, 724 [2019-28512]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 724 Federal Register / Vol. 85, No. 4 / Tuesday, January 7, 2020 / Notices Nov;71(11):1262–70. Erratum in: JAMA Psychiatry 2014 Nov 7;71(11):1301. • Cannabinoid type 1 receptor availability in the amygdala mediates threat processing in trauma survivors. Neuropsychopharmacology 39(11):2519–28, 2014 Oct. • Linking plasma cortisol levels to phenotypic heterogeneity of posttraumatic stress symptomatology. Psychoneuroendocrinology 2014 Jan;39:88–93. • Association of posttraumatic stress disorder with reduced in vivo norepinephrine transporter availability in the locus coeruleus. JAMA Psychiatry 2013 Nov;70(11):1199–205. Specifically, the Respondent misrepresented the characteristics of the subjects entered in the research record by: • Combining data from multiple subjects to represent single subjects to justify financial payments • changing and/or instructing his staff to change, omit, or ignore clinical and psychiatric assessment data contained in the electronic and/or written research records • failing to conduct and/or document screening tests (i.e., pregnancy tests, urine toxicology, electrocardiograms, blood alcohol levels) to determine eligibility for each protocol • using outdated clinical and/or psychiatric assessments to determine eligibility for experimental and control groups • reporting the utilization of trained and/or licensed personnel to perform clinical and psychiatric assessments, when the specific training, certification, and/or licensing had not been obtained • including in subsequent clinical research trials and their associated publications, human research subjects’ data that were previously reported in: —Positron emission tomography shows elevated cannabinoid CB1 receptor binding in men with alcohol dependence. Alcohol Clin. Exp. Res. 2012 Dec;36(12):2104–9 This resulted in the inclusion of subjects in experimental and control groups who did not meet the criteria for entry, as specified in the protocols of the Respondent’s funded grants, rendering the data and/or published results invalid in the four (4) papers. The grants are: • R01 MH096876, ‘‘CB1 Receptor PET Imaging Reveals Gender Differences in PTSD,’’ project dates July 1, 2012– June 30, 2015 • R01 MH102566, ‘‘KOR Depression,’’ project dates June 1, 2014–June 30, 2015 VerDate Sep<11>2014 16:15 Jan 06, 2020 Jkt 250001 • R21 MH094763, ‘‘CB1 Receptor Imaging in Anorexia,’’ project dates April 1, 2012–March 31, 2014 • R21 MH096105, ‘‘Kappa Opioid Receptor Imaging in PTSD,’’ project dates April 1, 2012–March 31, 2015 • R21 MH102035, ‘‘Kappa Opioid Receptor Imaging in Anorexia,’’ project dates August 20, 2013–June 30, 2015 • R34 MH102871, ‘‘A mGlu2/3 agonist in the treatment of PTSD,’’ project dates July 9, 2014–June 30, 2015 Dr. Neumeister entered into an Agreement and agreed: (1) To exclude himself voluntarily for a period of two (2) years, beginning on December 13, 2019, from any contracting or subcontracting with any agency of the United States Government and from eligibility for or involvement in nonprocurement programs of the United States Government referred to as ‘‘covered transactions’’ pursuant to HHS’ Implementation (2 CFR part 376) of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively the ‘‘Debarment Regulations’’); at the conclusion of the period of voluntary exclusion, Respondent agreed to have his research supervised for a period of two (2) years; Respondent agreed that prior to submission of an application for U.S. Public Health Service (PHS) support for a research project on which the Respondent’s participation is proposed and prior to Respondent’s participation in any capacity on PHSsupported 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 PHSsupported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed supervision plan; (2) 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 four (4) years, beginning on December 13, 2019. (3) as a condition of the Agreement, Respondent will utilize information provided by ORI to request that the following papers be corrected or retracted in accordance with 42 CFR 93.407(a)(1): • JAMA Psychiatry 2014 Nov;71(11):1262–70. • Neuropsychopharmacology 2014 Oct;39(11):2519–38. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 • Psychoneuroendocrinology 2014 Jan;39:88–93. • JAMA Psychiatry 2013 Nov;70(11):1199–205. Respondent will copy ORI and the Research Integrity Officers at NYUSOM and Yale University on the correspondence. Elisabeth A. Handley, Interim Director, Office of Research Integrity. [FR Doc. 2020–00036 Filed 1–6–20; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental & Craniofacial Research; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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: National Institute of Dental and Craniofacial Research Special Emphasis Panel; NIDCR Clinical Research SEP. Date: February 12, 2020. Time: 8:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Garden Inn Bethesda, 7301 Waverly Street, Bethesda, MD 20814. Contact Person: Yun Mei, MD, Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, 6701 Democracy Boulevard, Suite #672, Bethesda, Maryland 20892, 301–827–4639, yun.mei@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) Dated: December 31, 2019. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–28512 Filed 1–6–20; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\07JAN1.SGM 07JAN1

Agencies

[Federal Register Volume 85, Number 4 (Tuesday, January 7, 2020)]
[Notices]
[Page 724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28512]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Dental & Craniofacial Research; Notice of 
Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of the following meeting.
    The meeting 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: National Institute of Dental and Craniofacial 
Research Special Emphasis Panel; NIDCR Clinical Research SEP.
    Date: February 12, 2020.
    Time: 8:00 a.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hilton Garden Inn Bethesda, 7301 Waverly Street, 
Bethesda, MD 20814.
    Contact Person: Yun Mei, MD, Scientific Review Officer, 
Scientific Review Branch, National Institute of Dental and 
Craniofacial Research, National Institutes of Health, 6701 Democracy 
Boulevard, Suite #672, Bethesda, Maryland 20892, 301-827-4639, 
[email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral 
Diseases and Disorders Research, National Institutes of Health, HHS)

    Dated: December 31, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-28512 Filed 1-6-20; 8:45 am]
 BILLING CODE 4140-01-P
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