Center for Scientific Review; Notice of Closed Meetings, 47927-47929 [2018-20520]
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Federal Register / Vol. 83, No. 184 / Friday, September 21, 2018 / Notices
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Patrick McNeilly, Office of Good
Clinical Practice, Food and Drug
Administration, 10903 New Hampshire
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Avenue, Bldg. 32, Rm. 5172, Silver
Spring, MD 20993–0002, 301–796–2941.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Civil Money Penalties Relating to the
ClinicalTrials.gov Data Bank; Draft
Guidance for FDA Staff, Responsible
Parties, and Submitters of Certain
Applications and Submissions to FDA.’’
The draft guidance provides the current
thinking of FDA’s CDER, CBER, and
CDRH (Center, or collectively Centers),
regarding civil money penalties for
responsible parties and/or submitters of
certain applications and submissions to
FDA regarding drug products, biological
products, or device products
(submitters) who violate applicable
FD&C Act (21 U.S.C. 301 et seq.)
prohibitions relating to requirements
under section 402(j) of the Public Health
Service Act (PHS Act) (42 U.S.C. 282(j)),
including its implementing regulations
in 42 CFR part 11, to submit registration
and/or results information to the
ClinicalTrials.gov data bank and/or
certain certifications to FDA. The draft
guidance is intended to address several
questions. First, how the Centers
identify whether responsible parties
have failed to submit required clinical
trial registration and/or results
information to the ClinicalTrials.gov
data bank or submitted false or
misleading information to the data bank,
and whether submitters have failed to
submit the certification required by
section 402(j)(5)(B) of the PHS Act (42
U.S.C. 282(j)(5)(B)) to FDA or knowingly
submitted a false certification to FDA.
Second, under what circumstances a
Center may decide to seek civil money
penalties against a responsible party or
submitter. Third, what procedures apply
when a Center seeks civil money
penalties; and finally, what civil money
penalty amounts may be assessed for:
(1) Failing to submit required clinical
trial registration and/or results
information to the ClinicalTrials.gov
data bank, (2) knowingly submitting
false or misleading clinical trial
information to the data bank, (3) failing
to submit the required certification to
FDA, or (4) knowingly submitting a false
certification to FDA.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on civil money penalties relating to the
ClinicalTrials.gov data bank. It does not
establish any rights for any person and
is not binding on FDA or the public.
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You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: September 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20560 Filed 9–20–18; 8:45 am]
BILLING CODE 4164–01–P
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, 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; Evaluation
and Implementation of Patient Care.
Date: October 11, 2018.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Capital Skyline Hotel, 10 I Street
SW, Washington, DC 20024.
Contact Person: Gabriel B. Fosu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3108,
MSC 7808, Bethesda, MD 20892, (301) 435–
3562, fosug@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Academic-Industrial Partnerships Research
for Cancer Diagnosis and Treatment.
Date: October 15–16, 2018.
Time: 8:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
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Contact Person: Guo Feng Xu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5122,
MSC 7854, Bethesda, MD 20892, 301–237–
9870, xuguofen@csr.nih.gov.
Name of Committee: Genes, Genomes, and
Genetics Integrated Review Group; Genetic
Variation and Evolution Study Section.
Date: October 15–16, 2018.
Time: 8:30 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn San Diego Downtown
Bayfront, 900 Bayfront Court, San Diego, CA
92104.
Contact Person: Cheryl M. Corsaro, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2204,
MSC 7890, Bethesda, MD 20892, (301) 435–
1045, corsaroc@csr.nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Child Psychopathology and
Developmental Disabilities Study Section.
Date: October 18–19, 2018.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz-Carlton Hotel, 1700 Tysons
Boulevard, McLean, VA 22102.
Contact Person: Katherine Colona Morasch,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3170,
Bethesda, MD 20892, moraschkc@
csr.nih.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group;
Integrative and Clinical Endocrinology and
Reproduction Study Section.
Date: October 18, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott Silver Spring,
8506 Fenton Street, Silver Spring, MD 20910.
Contact Person: Dianne Hardy, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6175,
MSC 7892, Bethesda, MD 20892, 301–435–
1154, dianne.hardy@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Surgical Disparities Research.
Date: October 19, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Palomar, 2121 P Street NW,
Washington, DC 20037.
Contact Person: Yvonne Owens Ferguson,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
Bethesda, MD 20892, 301–827–3689,
fergusonyo@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR18–721:
Counter Act Exploratory Grants.
Date: October 19, 2018.
Time: 8:00 a.m. to 6:00 p.m.
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Agenda: To review and evaluate grant
applications.
Place: Lord Baltimore Hotel, 20 West
Baltimore Street, Baltimore, MD 21201.
Contact Person: Geoffrey G. Schofield,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040–A,
MSC 7850, Bethesda, MD 20892, 301–435–
1235, geoffreys@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Medical Imaging Investigations.
Date: October 19, 2018.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Guo Feng Xu, Ph.D.,
Scientific Review Office, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 5122, MSC 7854,
Bethesda, MD 20892, 301–237–9870,
xuguofen@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR 18–
039: Intellectual and Developmental
Disabilities Outcomes.
Date: October 19, 2018.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz-Carlton Hotel, 1700 Tysons
Boulevard, McLean, VA 22102.
Contact Person: Katherine Colona Morasch,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3170,
Bethesda, Md 20892, moraschkc@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Ocular
Surface, Cornea, Anterior Segment Glaucoma
and Refractive Error.
Date: October 22–23, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Beacon Hotel and Corporate
Quarters, 1615 Rhode Island Avenue NW,
Washington, DC 20036.
Contact Person: Kristin Kramer, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5205,
MSC 7846, Bethesda, MD 20892, (301) 437–
0911, kramerkm@csr.nih.gov.
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group;
Virology—A Study Section,
Date: October 22–23, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Westin Crystal City, 1800 Jefferson
Davis Highway, Arlington, VA 22202.
Contact Person: Kenneth M Izumi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3204,
MSC 7808, Bethesda, MD 20892, 301–496–
6980, izumikm@csr.nih.gov.
Name of Committee: Oncology 1—Basic
Translational Integrated Review Group;
Tumor Microenvironment Study Section.
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Date: October 22–23, 2018.
Time: 8:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz-Carlton Hotel, 1700 Tysons
Boulevard, McLean, VA 22102.
Contact Person: Angela Y. Ng, Ph.D., MBA,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6200,
MSC 7804, Bethesda, MD 20892, 301–435–
1715, ngan@mail.nih.gov.
Name of Committee: Cell Biology
Integrated Review Group; Membrane Biology
and Protein Processing Study Section.
Date: October 22–23, 2018.
Time: 8:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Janet M. Larkin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5142,
MSC 7840, Bethesda, MD 20892, 301–806–
2765, larkinja@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Aging Systems and Geriatrics Study
Section.
Date: October 22–23, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Inese Z. Beitins, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6152,
MSC 7892, Bethesda, MD 20892, 301–435–
1034, beitinsi@csr.nih.gov.
Name of Committee: Oncology 1—Basic
Translational Integrated Review Group;
Cancer Genetics Study Section.
Date: October 22–23, 2018.
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: Juraj Bies, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 4158, MSC 7806, Bethesda, MD
20892, 301–435–1256, biesj@mail.nih.gov.
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group;
Virology—B Study Section.
Date: October 22–23, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Alexandrian, 480 King Street,
Alexandria, VA 22314.
Contact Person: John C. Pugh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1206,
MSC 7808, Bethesda, MD 20892, (301) 435–
2398, pughjohn@csr.nih.gov.
Name of Committee: Vascular and
Hematology Integrated Review Group;
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Vascular Cell and Molecular Biology Study
Section.
Date: October 22–23, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Larry Pinkus, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4132,
MSC 7802, Bethesda, MD 20892, (301) 435–
1214, pinkusl@csr.nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Adult Psychopathology and Disorders
of Aging Study Section.
Date: October 22–23, 2018.
Time: 8:30 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz-Carlton Hotel at Pentagon City,
1250 South Hayes Street, Arlington, VA
22202.
Contact Person: Serena Chu, Ph.D.,
Scientific Review Officer, BBBP IRG, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3178,
MSC 7848, Bethesda, MD 20892, (301) 500–
5829, sechu@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Risk
Prevention and Health Behavior AREA
Review.
Date: October 22, 2018.
Time: 11:00 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: John H. Newman, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3222,
MSC 7808, Bethesda, MD 20892, (301) 435–
0628, newmanjh@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Psychosocial Risks and Disease
Prevention.
Date: October 22, 2018.
Time: 12:00 p.m. to 3:00 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: Weijia Ni, Ph.D., Chief/
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3100,
MSC 7808, Bethesda, MD 20892, 301–594–
3292, niw@csr.nih.gov.
(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)
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Dated: September 17, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–20520 Filed 9–20–18; 8:45 am]
BILLING CODE 4140–01–P
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, 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: Bioengineering
Sciences & Technologies Integrated Review
Group; Modeling and Analysis of Biological
Systems Study Section.
Date: October 18–19, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The William F. Bolger Center, 9600
Newbridge Drive, Potomac, MD 20854.
Contact Person: Craig Giroux, Ph.D.,
Scientific Review Officer, BST IRG, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5150,
Bethesda, MD 20892, 301–435–2204,
girouxcn@csr.nih.gov.
Name of Committee: Vascular and
Hematology Integrated Review Group;
Hemostasis and Thrombosis Study Section.
Date: October 18, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Bukhtiar H. Shah, DVM,
Ph.D., Scientific Review Officer, Vascular
and Hematology IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 4120, MSC 7802,
Bethesda, MD 20892, (301) 806–7314,
shahb@csr.nih.gov.
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group;
Host Interactions with Bacterial Pathogens
Study Section.
Date: October 18–19, 2018.
Time: 8:00 a.m. to 3:00 p.m.
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Agenda: To review and evaluate grant
applications.
Place: Warwick Denver, 1776 Grant Street,
Denver, CO 80203.
Contact Person: Fouad A. El-Zaatari, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3186,
MSC 7808, Bethesda, MD 20892, (301) 435–
1149, elzaataf@csr.nih.gov.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Oral, Dental and Craniofacial Sciences Study
Section.
Date: October 18–19, 2018.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Capital View, 2850
South Potomac Avenue, Arlington, VA
22202.
Contact Person: Yi-Hsin Liu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214,
MSC 7814, Bethesda, MD 20892, 301–435–
1781, liuyh@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Neurodevelopment, Synaptic
Plasticity and Neurodegeneration.
Date: October 18–19, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda
(Formerly Holiday Inn Select), 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Mary Schueler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5214,
MSC 7846, Bethesda, MD 20892, 301–451–
0996, marygs@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Fellowship:
Behavioral Neuroscience.
Date: October 18–19, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites DC Convention
Center, 900 10th Street NW, Washington, DC
20001.
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: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Biophysical, Physiological,
Pharmacological and Bioengineering
Neuroscience.
Date: October 18–19, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda
(Formerly Holiday Inn Select), 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Sussan Paydar, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
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[Federal Register Volume 83, Number 184 (Friday, September 21, 2018)]
[Notices]
[Pages 47927-47929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20520]
-----------------------------------------------------------------------
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, 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; Evaluation and Implementation of Patient Care.
Date: October 11, 2018.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Capital Skyline Hotel, 10 I Street SW, Washington, DC
20024.
Contact Person: Gabriel B. Fosu, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3108, MSC 7808, Bethesda, MD
20892, (301) 435-3562, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR Panel: Academic-Industrial Partnerships Research for
Cancer Diagnosis and Treatment.
Date: October 15-16, 2018.
Time: 8:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
[[Page 47928]]
Contact Person: Guo Feng Xu, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5122, MSC 7854, Bethesda, MD 20892, 301-237-
9870, [email protected].
Name of Committee: Genes, Genomes, and Genetics Integrated
Review Group; Genetic Variation and Evolution Study Section.
Date: October 15-16, 2018.
Time: 8:30 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn San Diego Downtown Bayfront, 900 Bayfront
Court, San Diego, CA 92104.
Contact Person: Cheryl M. Corsaro, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2204, MSC 7890, Bethesda, MD
20892, (301) 435-1045, [email protected].
Name of Committee: Biobehavioral and Behavioral Processes
Integrated Review Group; Child Psychopathology and Developmental
Disabilities Study Section.
Date: October 18-19, 2018.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Ritz-Carlton Hotel, 1700 Tysons Boulevard, McLean, VA
22102.
Contact Person: Katherine Colona Morasch, Ph.D., Scientific
Review Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3170, Bethesda, MD 20892,
[email protected].
Name of Committee: Endocrinology, Metabolism, Nutrition and
Reproductive Sciences Integrated Review Group; Integrative and
Clinical Endocrinology and Reproduction Study Section.
Date: October 18, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Courtyard by Marriott Silver Spring, 8506 Fenton Street,
Silver Spring, MD 20910.
Contact Person: Dianne Hardy, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6175, MSC 7892, Bethesda, MD 20892, 301-435-
1154, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR Panel: Surgical Disparities Research.
Date: October 19, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hotel Palomar, 2121 P Street NW, Washington, DC 20037.
Contact Person: Yvonne Owens Ferguson, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139, Bethesda, MD 20892, 301-
827-3689, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR18-721: Counter Act Exploratory Grants.
Date: October 19, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Lord Baltimore Hotel, 20 West Baltimore Street,
Baltimore, MD 21201.
Contact Person: Geoffrey G. Schofield, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040-A, MSC 7850, Bethesda, MD
20892, 301-435-1235, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Medical Imaging Investigations.
Date: October 19, 2018.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Guo Feng Xu, Ph.D., Scientific Review Office,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5122, MSC 7854, Bethesda, MD 20892, 301-237-
9870, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR 18-039: Intellectual and Developmental Disabilities
Outcomes.
Date: October 19, 2018.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Ritz-Carlton Hotel, 1700 Tysons Boulevard, McLean, VA
22102.
Contact Person: Katherine Colona Morasch, Ph.D., Scientific
Review Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3170, Bethesda, Md 20892,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Ocular Surface, Cornea, Anterior Segment Glaucoma and
Refractive Error.
Date: October 22-23, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Beacon Hotel and Corporate Quarters, 1615 Rhode Island
Avenue NW, Washington, DC 20036.
Contact Person: Kristin Kramer, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5205, MSC 7846, Bethesda, MD
20892, (301) 437-0911, [email protected].
Name of Committee: Infectious Diseases and Microbiology
Integrated Review Group; Virology--A Study Section,
Date: October 22-23, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Westin Crystal City, 1800 Jefferson Davis Highway,
Arlington, VA 22202.
Contact Person: Kenneth M Izumi, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3204, MSC 7808, Bethesda, MD
20892, 301-496-6980, [email protected].
Name of Committee: Oncology 1--Basic Translational Integrated
Review Group; Tumor Microenvironment Study Section.
Date: October 22-23, 2018.
Time: 8:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Ritz-Carlton Hotel, 1700 Tysons Boulevard, McLean, VA
22102.
Contact Person: Angela Y. Ng, Ph.D., MBA, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6200, MSC 7804, Bethesda, MD
20892, 301-435-1715, [email protected].
Name of Committee: Cell Biology Integrated Review Group;
Membrane Biology and Protein Processing Study Section.
Date: October 22-23, 2018.
Time: 8:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda,
MD 20814.
Contact Person: Janet M. Larkin, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5142, MSC 7840, Bethesda, MD
20892, 301-806-2765, [email protected].
Name of Committee: Brain Disorders and Clinical Neuroscience
Integrated Review Group; Aging Systems and Geriatrics Study Section.
Date: October 22-23, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military
Road NW, Washington, DC 20015.
Contact Person: Inese Z. Beitins, MD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6152, MSC 7892, Bethesda, MD 20892, 301-435-
1034, [email protected].
Name of Committee: Oncology 1--Basic Translational Integrated
Review Group; Cancer Genetics Study Section.
Date: October 22-23, 2018.
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: Juraj Bies, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4158, MSC 7806, Bethesda, MD 20892, 301-435-
1256, [email protected].
Name of Committee: Infectious Diseases and Microbiology
Integrated Review Group; Virology--B Study Section.
Date: October 22-23, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: The Alexandrian, 480 King Street, Alexandria, VA 22314.
Contact Person: John C. Pugh, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 1206, MSC 7808, Bethesda, MD 20892, (301) 435-
2398, [email protected].
Name of Committee: Vascular and Hematology Integrated Review
Group;
[[Page 47929]]
Vascular Cell and Molecular Biology Study Section.
Date: October 22-23, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Larry Pinkus, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4132, MSC 7802, Bethesda, MD 20892, (301) 435-
1214, [email protected].
Name of Committee: Biobehavioral and Behavioral Processes
Integrated Review Group; Adult Psychopathology and Disorders of
Aging Study Section.
Date: October 22-23, 2018.
Time: 8:30 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Ritz-Carlton Hotel at Pentagon City, 1250 South Hayes
Street, Arlington, VA 22202.
Contact Person: Serena Chu, Ph.D., Scientific Review Officer,
BBBP IRG, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3178, MSC 7848, Bethesda, MD
20892, (301) 500-5829, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Risk Prevention and Health Behavior AREA Review.
Date: October 22, 2018.
Time: 11:00 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: John H. Newman, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3222, MSC 7808, Bethesda, MD
20892, (301) 435-0628, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Psychosocial Risks and Disease Prevention.
Date: October 22, 2018.
Time: 12:00 p.m. to 3:00 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: Weijia Ni, Ph.D., Chief/Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3100, MSC 7808, Bethesda, MD
20892, 301-594-3292, [email protected].
(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: September 17, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-20520 Filed 9-20-18; 8:45 am]
BILLING CODE 4140-01-P
