Center for Scientific Review; Notice of Closed Meetings, 50383-50384 [2018-21645]
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Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices
FDA to review and process a user fee
payment refund. The information
collected includes the organization,
contact, and payment information. The
information is used to determine the
reason for the refund, the refund
amount, and who to contact if there are
any questions regarding the refund
request. A submission of the User Fee
Payment Refund Request form does not
guarantee that a refund will be issued.
FDA estimates an average of 0.40 hours
per response, including the time to
review instructions, search existing data
sources, gather and maintain the data
needed, and complete and review the
collection of information. The estimated
hours are based on past FDA experience
with user fee payment refund requests.
In fiscal year 2017, approximately
1,657 user fee refunds were processed
for cover sheets and invoices including
12 for Animal Drug User Fee Act, 2 for
Animal Generic Drug User Fee Act, 13
for Biosimilar Drug User Fee Act, 68 for
Export Certificate Program, 14 for
Freedom of Information Act requests,
227 for Generic Drug User Fee
Amendments, 1,021 for Medical Device
User Fee Amendments, 227 for
mammography inspection fees, 67 for
Prescription Drug User Fee Act, and 6
for tobacco product fees.
Form FDA 3914, User Fee Payment
Transfer Request, is designed to provide
the minimum information necessary for
FDA to review and process a user fee
payment transfer request. The
information collected includes payment
and organization information. The
information is used to determine the
reason for the transfer, how the transfer
should be performed, and who to
contact if there are any questions
regarding the transfer request. A
submission of the User Fee Payment
Transfer Request form does not
guarantee that a transfer will be
performed. FDA estimates an average of
0.25 hours per response, including the
time to review instructions, search
existing data sources, gather and
maintain the data needed, and complete
and review the collection of
information. FDA estimated hours are
based on past FDA experience with user
fee payment transfer requests.
In fiscal year 2017, approximately 871
user fee payment transfers were
processed for cover sheets and invoices
including 8 for Animal Drug User Fee
Act, 1 for Animal Generic Drug User Fee
Act, 1 for Biosimilar Drug User Fee Act,
163 for Generic Drug User Fee
Amendments, 692 for Medical Device
User Fee Amendments, and 6 for
Prescription Drug User Fee Act.
Respondents for the electronic request
forms include domestic and foreign
firms (including pharmaceutical,
medical device, etc.). Specifically,
refund request forms target respondents
50383
who submitted a duplicate payment or
overpayment for a user fee cover sheet
or invoice. Respondents may also
include firms that withdrew an
application or submission. Transfer
request forms target respondents who
submitted payment for a user fee cover
sheet or invoice and need that payment
to be reapplied to another cover sheet or
invoice (transfer of funds).
The electronic user fee payment
request forms will streamline the refund
and transfer processes, facilitate
processing, and improve the tracking of
requests. The burden for this collection
of information is the same for all
customers (small and large
organizations). The information being
requested or required has been held to
the absolute minimum required for the
intended use of the data. Customers will
be able to request a user fee payment
refund and transfer online at https://
www.fda.gov/forindustry/userfees/
default.htm. This electronic submission
is intended to reduce the burden for
customers to submit user fee payment
refund and transfer requests.
In the Federal Register of May 15,
2018 (83 FR 22493), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA Form
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
User Fee Payment Refund Request—Form FDA 3913 ........
User Fee Payment Transfer Request—Form FDA 3914 ......
Total ................................................................................
1,657
871
....................
1
1
........................
1,657
871
....................
0.40 (24 minutes) ....
0.25 (15 minutes) ....
.................................
663
218
881
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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We have adjusted our burden
estimate, which has resulted in a
decrease to the currently approved
burden. New information technology
applications have more accurately
calculated the number of registrants of
drug facilities/food facilities/medical
device facilities/medicated feed
facilities, and we have therefore revised
the number of respondents to the
information collection.
Dated: October 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21682 Filed 10–4–18; 8:45 am]
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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, 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
PO 00000
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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: Applications in Lung Disease.
Date: October 30–31, 2018.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: George M. Barnas, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4220,
MSC 7818, Bethesda, MD 20892, 301–435–
0696, barnasg@csr.nih.gov.
E:\FR\FM\05OCN1.SGM
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50384
Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Child Psychopathology and
Developmental Disabilities.
Date: October 31, 2018.
Time: 1:00 p.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: Andrea B. Kelly, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3182,
MSC 7770, Bethesda, MD 20892, (301) 455–
1761, kellya2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Cell Biology, Developmental
Biology, and Bioengineering.
Date: November 1–2, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Nikko San Francisco, 222
Mason Street, San Francisco, CA 94102.
Contact Person: Raj K. Krishnaraju, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6190,
Bethesda, MD 20892, 301–435–1047,
kkrishna@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Neural Basis
of Psychopathology, Addictions and Sleep
Disorders.
Date: November 1, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn, Washington, DC
Downtown, 1199 Vermont Ave., Washington,
DC 20005.
Contact Person: Samuel C. Edwards, Ph.D.,
Chief, BDCN IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 5210, MSC 7846,
Bethesda, MD 20892, (301) 435–1246,
edwardss@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Neural Basis of Psychopathology,
Addictions and Sleep Disorders Study
Section.
Date: November 1–2, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Washington, DC
Downtown, 1199 Vermont Avenue NW,
Washington, DC 20005.
Contact Person: Julius Cinque, MS,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5186,
MSC 7846, Bethesda, MD 20892, cinquej@
csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Accelerating
the Pace of Drug Abuse Research Using
Existing Data.
Date: November 2, 2018.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Kate Fothergill, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3142,
Bethesda, MD 20892, 301–435–2309,
fothergillke@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Accelerating
the Pace of Drug Abuse Research Using
Existing Data.
Date: November 2, 2018.
Time: 11:00 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: Delia Olufokunbi Sam,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
MSC 7770, Bethesda, MD 20892, 301–435–
0684, olufokunbisamd@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR 17–199
and PAR 17–200: Development of Pediatric
Formulations and Drug Delivery Systems.
Date: November 2, 2018.
Time: 11:00 a.m. to 2:00 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: Sharon S. Low, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5104,
MSC 5104, Bethesda, MD 20892, 301–237–
1487, lowss@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Immunology
AREA Review.
Date: November 2, 2018.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Liying Guo, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4016F,
Bethesda, MD 20892, 301–435–0908, lguo@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–18–
133: Strategies to Increase Delivery of
Guideline-Based Care to Populations with
Health Disparities.
Date: November 2, 2018.
Time: 12:00 p.m. to 5:00 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: Jessica Bellinger, Ph.D.,
Scientific Review Administrator, Center for
Scientific of Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
Bethesda, Md 20892, 301–827–4446,
bellingerjd@csr.nih.gov.
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Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Skeletal Muscle Physiology.
Date: November 2, 2018.
Time: 12:30 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,
(Virtual Meeting).
Contact Person: Rajiv Kumar, Ph.D., Chief,
MOSS IRG, 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.
(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 28, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–21645 Filed 10–4–18; 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: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Cardiovascular Differentiation and
Development Study Section.
Date: October 24, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Sara Ahlgren, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, RM 4136,
Bethesda, MD 20892, 301–435–0904,
sara.ahlgren@nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
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]]>Agencies
[Federal Register Volume 83, Number 194 (Friday, October 5, 2018)]
[Notices]
[Pages 50383-50384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21645]
-----------------------------------------------------------------------
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; Member Conflict: Applications in Lung Disease.
Date: October 30-31, 2018.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: George M. Barnas, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4220, MSC 7818, Bethesda, MD
20892, 301-435-0696, [email protected].
[[Page 50384]]
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Child Psychopathology and Developmental
Disabilities.
Date: October 31, 2018.
Time: 1:00 p.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: Andrea B. Kelly, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3182, MSC 7770, Bethesda, MD
20892, (301) 455-1761, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Fellowships: Cell Biology, Developmental Biology, and
Bioengineering.
Date: November 1-2, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hotel Nikko San Francisco, 222 Mason Street, San
Francisco, CA 94102.
Contact Person: Raj K. Krishnaraju, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6190, Bethesda, MD 20892, 301-
435-1047, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Neural Basis of Psychopathology, Addictions and Sleep
Disorders.
Date: November 1, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn, Washington, DC Downtown, 1199 Vermont
Ave., Washington, DC 20005.
Contact Person: Samuel C. Edwards, Ph.D., Chief, BDCN IRG,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435-
1246, [email protected].
Name of Committee: Brain Disorders and Clinical Neuroscience
Integrated Review Group; Neural Basis of Psychopathology, Addictions
and Sleep Disorders Study Section.
Date: November 1-2, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Washington, DC Downtown, 1199 Vermont
Avenue NW, Washington, DC 20005.
Contact Person: Julius Cinque, MS, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5186, MSC 7846, Bethesda, MD 20892,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Accelerating the Pace of Drug Abuse Research Using Existing
Data.
Date: November 2, 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: Kate Fothergill, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3142, Bethesda, MD 20892, 301-
435-2309, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Accelerating the Pace of Drug Abuse Research Using Existing
Data.
Date: November 2, 2018.
Time: 11:00 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: Delia Olufokunbi Sam, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD
20892, 301-435-0684, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR 17-199 and PAR 17-200: Development of Pediatric
Formulations and Drug Delivery Systems.
Date: November 2, 2018.
Time: 11:00 a.m. to 2:00 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: Sharon S. Low, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5104, MSC 5104, Bethesda, MD 20892, 301-237-
1487, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Immunology AREA Review.
Date: November 2, 2018.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda,
MD 20814.
Contact Person: Liying Guo, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4016F, Bethesda, MD 20892, 301-435-0908,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR-18-133: Strategies to Increase Delivery of Guideline-
Based Care to Populations with Health Disparities.
Date: November 2, 2018.
Time: 12:00 p.m. to 5:00 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: Jessica Bellinger, Ph.D., Scientific Review
Administrator, Center for Scientific of Review, National Institutes
of Health, 6701 Rockledge Drive, Room 3158, Bethesda, Md 20892, 301-
827-4446, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Skeletal Muscle Physiology.
Date: November 2, 2018.
Time: 12:30 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, (Virtual Meeting).
Contact Person: Rajiv Kumar, Ph.D., Chief, MOSS IRG, Center for
Scientific Review, National Institutes of Health, 6701 Rockledge
Drive, Room 4216, MSC 7802, Bethesda, MD 20892, 301-435-1212,
[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 28, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-21645 Filed 10-4-18; 8:45 am]
BILLING CODE 4140-01-P
