81_FR_14170 81 FR 14119 - National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting

81 FR 14119 - National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 51 (March 16, 2016)

Page Range14119-14119
FR Document2016-05967

Federal Register, Volume 81 Issue 51 (Wednesday, March 16, 2016)
[Federal Register Volume 81, Number 51 (Wednesday, March 16, 2016)]
[Notices]
[Page 14119]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05967]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Neurological Disorders and Stroke; Notice 
of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of a meeting of the 
Board of Scientific Counselors, National Institute of Neurological 
Disorders and Stroke.
    The meeting will be closed to the public as indicated below in 
accordance with the provisions set forth in sections 552b(c)(6), Title 
5 U.S.C., as amended for the review, discussion, and evaluation of 
individual intramural programs and projects conducted by the National 
Institute of Neurological Disorders and Stroke, including consideration 
of personnel qualifications and performance, and the competence of 
individual investigators, the disclosure of which would constitute a 
clearly unwarranted invasion of personal privacy.

    Name of Committee: Board of Scientific Counselors; National 
Institute of Neurological Disorders and Stroke.
    Date: April 24-26, 2016.
    Time: 6:00 p.m. to 11:30 a.m.
    Agenda: To review and evaluate personal qualifications and 
performance, and competence of individual investigators.
    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, 
MD 20814.
    Contact Person: Alan P. Koretsky, Ph.D., Scientific Director, 
Division of Intramural Research, National Institute of Neurological 
Disorders and Stroke, NIH, 35 Convent Drive, Room 6A 908, Bethesda, 
MD 20892, (301) 435-2232, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.853, 
Clinical Research Related to Neurological Disorders; 93.854, 
Biological Basis Research in the Neurosciences, National Institutes 
of Health, HHS).

    Dated: March 11, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-05967 Filed 3-15-16; 8:45 am]
 BILLING CODE 4140-01-P



                                                                                 Federal Register / Vol. 81, No. 51 / Wednesday, March 16, 2016 / Notices                                                                                   14119

                                                  opportunities to accelerate research                              part of the registration process,                                        a Data Use Certification agreement.
                                                  through the power of combining large                              investigators must provide basic study                                   Requests to renew data access and
                                                  and information-rich datasets. To                                 information such as the type of data that                                reports to close out data use are similar
                                                  promote robust sharing of human and                               will be submitted to dbGaP, a                                            to the initial data access request,
                                                  non-human data from a wide range of                               description of the study, and an                                         requiring sign-off by both the requestor
                                                  large-scale genomic research and                                  institutional assurance (i.e. Institutional                              and the institution, but also ask for
                                                  provide appropriate protections for                               Certification) of the data submission                                    information about how the data have
                                                  research involving human data, the NIH                            which delineates any limitations on the                                  been used, and about publications,
                                                  issued the NIH Genomic Data Sharing                               secondary use of the data (e.g., data                                    presentations, or intellectual property
                                                  Policy (GDS Policy). Human genomic                                cannot be shared with for-profit                                         based on the research conducted with
                                                  data submissions and controlled-access                            companies, data can be used only for                                     the accessed data as well as any data
                                                  are managed through a central data                                research of particular diseases).                                        security issues or other data
                                                  repository, the database of Genotypes                               Investigators interested in using                                      management incidents.
                                                  and Phenotypes (dbGaP) which is                                   controlled-access data for secondary                                       The NIH has developed online forms,
                                                  administered by the National Center for                           research must apply through dbGaP and                                    available through dbGaP, in an effort to
                                                  Biotechnology Information (NCBI), part                            be granted permission from the relevant                                  reduce the burden for researchers and
                                                  of the National Library of Medicine at                            NIH Data Access Committee(s). As part                                    their institutional officials to complete
                                                  the NIH.                                                          of the application process, investigators                                the study registration, data submission,
                                                     Under the GDS Policy, all                                      and their institutions must provide                                      data access, and renewal and closeout
                                                  investigators who receive NIH funding                             information such as a description of the                                 processes.
                                                  to conduct large-scale genomic research                           proposed research use of controlled-                                       OMB approval is requested for 3
                                                  are expected to register studies with                             access datasets that conforms to any                                     years. There are no costs to respondents
                                                  human genomic data in dbGaP, no                                   data use limitations, agree to the                                       other than their time. The total
                                                  matter which NIH-designated data                                  Genomic Data User Code of Conduct,                                       estimated annualized burden hours are
                                                  repository will maintain the data. As                             and agree to the terms of access through                                 2,505.

                                                                                                                   ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                 Average
                                                                                                                                                                                             Number of         burden per              Total annual
                                                            Form name                            Type of respondent                             Number of respondents                      responses per        response               burden hour
                                                                                                                                                                                             respondent         (in hours)

                                                  Study Registration and Data             Investigator Submitting Data                      150 ........................................                1                        1              150
                                                    Submission.
                                                                                          Institutional Official to Certify                 150 ........................................                1                 30/60                  75
                                                                                            Submission.
                                                  Requesting Access to Data ...           Investigator Requesting Data                      633 ........................................                2                 45/60                 950
                                                                                          Signing Official to Certify Re-                   633 ........................................                2                 30/60                 633
                                                                                            quest.
                                                  Renewal/project Close-out               Investigator Requesting Data                      633 (same individuals as list-                              2                 15/60                 317
                                                   Process.                                                                                   ed above).
                                                                                          Signing Official to Certify Re-                   633 (same individuals as list-                              2                 18/60                 380
                                                                                            quest.                                            ed above).

                                                       Grand Total ....................   ...............................................   1,566 .....................................            5,064    ........................          2,505



                                                    Dated: March 10, 2016.                                            The meeting will be closed to the                                        Place: Residence Inn Bethesda, 7335
                                                  Lawrence A. Tabak,                                                public as indicated below in accordance                                  Wisconsin Avenue, Bethesda, MD 20814.
                                                  Deputy Director, National Institutes of Health.                   with the provisions set forth in sections                                  Contact Person: Alan P. Koretsky, Ph.D.,
                                                  [FR Doc. 2016–05910 Filed 3–15–16; 8:45 am]                       552b(c)(6), Title 5 U.S.C., as amended                                   Scientific Director, Division of Intramural
                                                                                                                    for the review, discussion, and                                          Research, National Institute of Neurological
                                                  BILLING CODE 4140–01–P
                                                                                                                    evaluation of individual intramural                                      Disorders and Stroke, NIH, 35 Convent Drive,
                                                                                                                    programs and projects conducted by the                                   Room 6A 908, Bethesda, MD 20892, (301)
                                                  DEPARTMENT OF HEALTH AND                                          National Institute of Neurological                                       435–2232, koretskya@ninds.nih.gov.
                                                  HUMAN SERVICES                                                    Disorders and Stroke, including                                          (Catalogue of Federal Domestic Assistance
                                                                                                                    consideration of personnel                                               Program Nos. 93.853, Clinical Research
                                                  National Institutes of Health                                     qualifications and performance, and the                                  Related to Neurological Disorders; 93.854,
                                                                                                                    competence of individual investigators,                                  Biological Basis Research in the
                                                  National Institute of Neurological                                the disclosure of which would                                            Neurosciences, National Institutes of Health,
                                                  Disorders and Stroke; Notice of Closed                            constitute a clearly unwarranted                                         HHS).
                                                  Meeting                                                           invasion of personal privacy.
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                                                                                                                                                               Dated: March 11, 2016.
                                                    Pursuant to section 10(d) of the                                  Name of Committee: Board of Scientific                                 Sylvia L. Neal,
                                                  Federal Advisory Committee Act, as                                Counselors; National Institute of
                                                                                                                    Neurological Disorders and Stroke.                                       Program Analyst, Office of Federal Advisory
                                                  amended (5 U.S.C. App.), notice is                                                                                                         Committee Policy.
                                                                                                                      Date: April 24–26, 2016.
                                                  hereby given of a meeting of the Board                              Time: 6:00 p.m. to 11:30 a.m.                                          [FR Doc. 2016–05967 Filed 3–15–16; 8:45 am]
                                                  of Scientific Counselors, National                                  Agenda: To review and evaluate personal                                BILLING CODE 4140–01–P
                                                  Institute of Neurological Disorders and                           qualifications and performance, and
                                                  Stroke.                                                           competence of individual investigators.



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Document Created: 2016-03-15 23:43:48
Document Modified: 2016-03-15 23:43:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesApril 24-26, 2016.
FR Citation81 FR 14119 

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