81 FR 15322 - Center for Scientific Review, Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 55 (March 22, 2016)

Page Range		15322-15323
FR Document		2016-06334

Federal Register, Volume 81 Issue 55 (Tuesday, March 22, 2016)

[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Notices]
[Pages 15322-15323]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06334]


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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 
amended (5 U.S.C. App.), 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,

[[Page 15323]]

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; Member Conflict: Addictions, Depression, Bipolar Disorder, 
Schizophrenia.
    Date: April 1, 2016.
    Time: 9:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892, (Virtual Meeting).
    Contact Person: Samuel C Edwards, Ph.D., IRG CHIEF, Center for 
Scientific Review, National Institutes of Health, 6701 Rockledge 
Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435-1246, 
[email protected].

    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: Developmental Brain Disorders, Chronic and 
Clinical Neurodegeneration.
    Date: April 7, 2016.
    Time: 2:00 p.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Seetha Bhagavan, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5194, MSC 7846. Bethesda, MD 
20892, (301) 237-9838, [email protected].

    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

(Catalogue of Federal Domestic Assistance Program Nos. 93.306, 
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, 
National Institutes of Health, HHS)

    Dated: March 16, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-06334 Filed 3-21-16; 8:45 am]
 BILLING CODE 4140-01-P

15322 Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Notices

protocol registration process. Final IBC M–V, Special Issues will be deleted in 779–9040 and use Participant Passcode
approval may then be granted. their entirety, except for Appendix M– 5055308 for access to the meeting.
RAC meetings will be open to the III–B–2–b, Long Term Follow-Up which Individuals needing special assistance
public except where trade secrets or will be updated to include a reference should notify the Contact Person listed
confidential commercial information are to FDA’s current guidance on this issue below in advance of the meeting.
reviewed. To enable all aspects of the and will become Appendix M–II. Name of Committee: Advisory Committee
protocol review process to be open to Appendix M–II will be amended as to the Director, National Institutes of Health.
the public, information provided in follows: Date: April 21, 2016.
response to Appendix M–I–A should Time: 4:00 p.m. to 6:00 p.m. EDT.
Appendix M–II. Long Term Follow-Up Agenda: The HeLa Genome Data Access
not contain trade secrets or confidential
commercial or financial information. To permit evaluation of long-term safety working group will report on the evaluation
Documentation submitted to the NIH and efficacy of gene transfer, prospective of requests to access HeLa cell genome
subjects should be informed that they are sequence data. The Clinical Center working
OSP shall not be designated as group will present their final report to the
expected to cooperate in long-term follow-up
‘confidential’ in its entirety. In the event that extends beyond the active phase of the Advisory Committee to the Director, NIH.
that a determination has been made that study. A list of persons who can be contacted Place: National Institutes of Health,
a specific portion of a document in the event that questions arise during the (Telephone Conference Call), Dial In Number
submitted should be considered as follow-up period should be provided to the 800–779–9040, Participant Passcode:
proprietary or trade secret, each specific investigator. In addition, the investigator 5055308.
portion should be clearly identified as should request that subjects continue to Contact Person: Gretchen Wood, Staff
provide a current address and telephone Assistant, National Institutes of Health,
such. The cover letter (attached to the
number. Office of the Director, One Center Drive,
submitted material) shall: (1) Clearly The subjects should be informed of any Building 1, Room 126, Bethesda, MD 20892,
indicate what select portions contain significant findings resulting from the study Telephone: 301–496–4272, Email: woodgs@
information considered as proprietary or will be made known in a timely manner to od.nih.gov.
a trade secret; and (2) provide them and/or their parent or guardian Any interested person may file written
justification as to why this information including new information about the
comments with the committee by forwarding
is considered to be proprietary or trade experimental procedure, the harms and
their statement electronically to the Contact
secret. This justification must be able to benefits experienced by other individuals
Person at woodgs@od.nih.gov. The statement
involved in the study, and any long-term
demonstrate with specificity how release effects that have been observed.
should include the name, address, telephone
of that information will reveal a trade number and when applicable, the business or
Additional guidance is available in the
secret or will result in substantial professional affiliation of the interested of the
FDA Guidance for Industry: Gene Therapy
competitive harm. interested person.
Clinical Trials—Observing Subjects for
Appendix M–I–C–2 currently states: Additional information for this meeting
Delayed Adverse Events (available at the
including both working group reports will be
following URL: http://www.fda.gov/
Appendix M–I–C–2. Additional Clinical posted, when available, on the Advisory
BiologicsBloodVaccines/
Trial Sites Committee to the Director, NIH, Web site
GuidanceComplianceRegulatoryInformation/
(http://acd.od.nih.gov). Additional
No research participant shall be enrolled Guidances/CellularandGeneTherapy/
information about the HeLA Genome Data
(see definition of enrollment in Section I–E– default.htm).
Access working group is available at http://
7) at a clinical trial site until the following Appendix M–VI Footnotes of Appendix acd.od.nih.gov/hlgda.htm and additional
documentation has been submitted to NIH M will be renumbered to Appendix M– information about the Clinical Center
OBA: (1) Institutional Biosafety Committee III. Footnotes of Appendix M. There will working group is available at http://
approval (from the clinical trial site); (2) acd.od.nih.gov/redteam.htm.
be no amendment to the language.
Institutional Review Board approval; (3)
Institutional Review Board-approved Dated: March 15, 2016. Dated: March 15, 2016.
informed consent document; (4) curriculum Francis S. Collins, Anna Snouffer,
vitae of the Principal Investigator(s) (no more Director, National Institutes of Health. Deputy Director, Office of Federal Advisory
than two pages in biographical sketch Committee Policy.
[FR Doc. 2016–06448 Filed 3–21–16; 8:45 am]
format); and (5) NIH grant number(s) if
applicable. BILLING CODE 4140–01–P [FR Doc. 2016–06333 Filed 3–21–16; 8:45 am]
BILLING CODE 4140–01–P
Appendix M–1–C–2 will be amended as
follows: DEPARTMENT OF HEALTH AND
Appendix M–I–C–2. Additional Clinical HUMAN SERVICES DEPARTMENT OF HEALTH AND
Trial Sites HUMAN SERVICES
National Institutes of Health
Within 30 days of enrollment (see National Institutes of Health
definition of enrollment in Section I–E–7) at Office of the Director, National
a clinical trial site, the following Institutes of Health Notice of Meeting Center for Scientific Review, Notice of
documentation shall be submitted to NIH Closed Meetings
OSP: (1) Institutional Biosafety Committee Pursuant to section 10(a) of the
approval (from the clinical trial site); (2) Federal Advisory Committee Act, as Pursuant to section 10(d) of the
Institutional Review Board approval; (3) amended (5 U.S.C. App.), notice is Federal Advisory Committee Act, as
Institutional Review Board-approved hereby given of a meeting of the amended (5 U.S.C. App.), notice is
informed consent document; and (4) NIH Advisory Committee to the Director, hereby given of the following meetings.
asabaliauskas on DSK3SPTVN1PROD with NOTICES

grant number(s) if applicable. National Institutes of Health. The meetings will be closed to the
There are no amendments to Appendix This meeting is open to the public but public in accordance with the
M–I–D, Safety Assessments in Human is being held by teleconference only. No provisions set forth in sections
Gene Transfer Research. physical meeting location is provided 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
The current appendices Appendix M– for any interested individuals to listen as amended. The grant applications and
II, Description of the Proposal; to and/or participate in the meeting. the discussions could disclose
Appendix M–III, Informed Consent; Any individual interested in listening to confidential trade secrets or commercial
Appendix M–IV, Privacy; and Appendix the meeting discussions must call 800– property such as patentable material,

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Document Created: 2018-02-02 15:15:26
Document Modified: 2018-02-02 15:15:26

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		April 1, 2016.
FR Citation		81 FR 15322

81 FR 15322 - Center for Scientific Review, Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 55 (March 22, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health