83 FR 50383 - Center for Scientific Review; Notice of Closed Meetings
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 194 (October 5, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 194 (October 5, 2018)
| Page Range | 50383-50384 | |
| FR Document | 2018-21645 |
[Federal Register Volume 83, Number 194 (Friday, October 5, 2018)] [Notices] [Pages 50383-50384] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices 50383
FDA to review and process a user fee FDA to review and process a user fee who submitted a duplicate payment or
payment refund. The information payment transfer request. The overpayment for a user fee cover sheet
collected includes the organization, information collected includes payment or invoice. Respondents may also
contact, and payment information. The and organization information. The include firms that withdrew an
information is used to determine the information is used to determine the application or submission. Transfer
reason for the refund, the refund reason for the transfer, how the transfer request forms target respondents who
amount, and who to contact if there are should be performed, and who to submitted payment for a user fee cover
any questions regarding the refund contact if there are any questions sheet or invoice and need that payment
request. A submission of the User Fee regarding the transfer request. A to be reapplied to another cover sheet or
Payment Refund Request form does not submission of the User Fee Payment invoice (transfer of funds).
guarantee that a refund will be issued. Transfer Request form does not The electronic user fee payment
FDA estimates an average of 0.40 hours guarantee that a transfer will be request forms will streamline the refund
per response, including the time to performed. FDA estimates an average of and transfer processes, facilitate
review instructions, search existing data 0.25 hours per response, including the processing, and improve the tracking of
sources, gather and maintain the data time to review instructions, search requests. The burden for this collection
needed, and complete and review the existing data sources, gather and of information is the same for all
collection of information. The estimated maintain the data needed, and complete customers (small and large
hours are based on past FDA experience and review the collection of organizations). The information being
with user fee payment refund requests. information. FDA estimated hours are requested or required has been held to
In fiscal year 2017, approximately based on past FDA experience with user the absolute minimum required for the
1,657 user fee refunds were processed fee payment transfer requests. intended use of the data. Customers will
for cover sheets and invoices including In fiscal year 2017, approximately 871 be able to request a user fee payment
12 for Animal Drug User Fee Act, 2 for user fee payment transfers were refund and transfer online at https://
Animal Generic Drug User Fee Act, 13 processed for cover sheets and invoices www.fda.gov/forindustry/userfees/
for Biosimilar Drug User Fee Act, 68 for including 8 for Animal Drug User Fee default.htm. This electronic submission
Export Certificate Program, 14 for Act, 1 for Animal Generic Drug User Fee is intended to reduce the burden for
Freedom of Information Act requests, Act, 1 for Biosimilar Drug User Fee Act, customers to submit user fee payment
227 for Generic Drug User Fee 163 for Generic Drug User Fee refund and transfer requests.
Amendments, 1,021 for Medical Device Amendments, 692 for Medical Device In the Federal Register of May 15,
User Fee Amendments, 227 for User Fee Amendments, and 6 for 2018 (83 FR 22493), FDA published a
mammography inspection fees, 67 for Prescription Drug User Fee Act. 60-day notice requesting public
Prescription Drug User Fee Act, and 6 Respondents for the electronic request comment on the proposed collection of
for tobacco product fees. forms include domestic and foreign information. No comments were
Form FDA 3914, User Fee Payment firms (including pharmaceutical, received.
Transfer Request, is designed to provide medical device, etc.). Specifically, FDA estimates the burden of this
the minimum information necessary for refund request forms target respondents collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
FDA Form responses per Total hours
respondents responses response
respondent
User Fee Payment Refund Request—Form FDA 3913 ........ 1,657 1 1,657 0.40 (24 minutes) .... 663
User Fee Payment Transfer Request—Form FDA 3914 ...... 871 1 871 0.25 (15 minutes) .... 218
Total ................................................................................ .................... ........................ .................... ................................. 881
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We have adjusted our burden DEPARTMENT OF HEALTH AND individuals associated with the grant
estimate, which has resulted in a HUMAN SERVICES applications, the disclosure of which
decrease to the currently approved would constitute a clearly unwarranted
burden. New information technology National Institutes of Health invasion of personal privacy.
applications have more accurately Name of Committee: Center for Scientific
Center for Scientific Review; Notice of
calculated the number of registrants of Review Special Emphasis Panel; Member
Closed Meetings
drug facilities/food facilities/medical Conflict: Applications in Lung Disease.
device facilities/medicated feed Pursuant to section 10(d) of the Date: October 30–31, 2018.
facilities, and we have therefore revised Federal Advisory Committee Act, as Time: 9:00 a.m. to 3:00 p.m.
the number of respondents to the amended, notice is hereby given of the Agenda: To review and evaluate grant
information collection. following meetings. applications.
The meetings will be closed to the Place: National Institutes of Health, 6701
Dated: October 1, 2018. public in accordance with the Rockledge Drive, Bethesda, MD 20892
daltland on DSKBBV9HB2PROD with NOTICES
Leslie Kux, provisions set forth in sections (Virtual Meeting).
Associate Commissioner for Policy. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Contact Person: George M. Barnas, Ph.D.,
[FR Doc. 2018–21682 Filed 10–4–18; 8:45 am] as amended. The grant applications and Scientific Review Officer, Center for
BILLING CODE 4164–01–P the discussions could disclose Scientific Review, National Institutes of
confidential trade secrets or commercial Health, 6701 Rockledge Drive, Room 4220,
property such as patentable material, MSC 7818, Bethesda, MD 20892, 301–435–
and personal information concerning 0696, barnasg@csr.nih.gov.
VerDate Sep<11>2014 17:11 Oct 04, 2018 Jkt 247001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1](https://thefederalregister.org/doc/83_FR_50577/page/1.svg)
![50384 Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices
Name of Committee: Center for Scientific Place: National Institutes of Health, 6701 Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member Rockledge Drive, Bethesda, MD 20892 Review Special Emphasis Panel; Member
Conflict: Child Psychopathology and (Virtual Meeting). Conflict: Skeletal Muscle Physiology.
Developmental Disabilities. Contact Person: Kate Fothergill, Ph.D., Date: November 2, 2018.
Date: October 31, 2018. Scientific Review Officer, Center for Time: 12:30 p.m. to 4:00 p.m.
Time: 1:00 p.m. to 5:00 p.m. Scientific Review, National Institutes of Agenda: To review and evaluate grant
Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 3142, applications.
applications. Bethesda, MD 20892, 301–435–2309, Place: National Institutes of Health, 6701
Place: National Institutes of Health, 6701 fothergillke@mail.nih.gov. Rockledge Drive, Bethesda, MD 20892,
Rockledge Drive, Bethesda, MD 20892 Name of Committee: Center for Scientific (Virtual Meeting).
(Virtual Meeting). Review Special Emphasis Panel; Accelerating Contact Person: Rajiv Kumar, Ph.D., Chief,
Contact Person: Andrea B. Kelly, Ph.D., the Pace of Drug Abuse Research Using MOSS IRG, Center for Scientific Review,
Scientific Review Officer, Center for Existing Data. National Institutes of Health, 6701 Rockledge
Scientific Review, National Institutes of Date: November 2, 2018. Drive, Room 4216, MSC 7802, Bethesda, MD
Health, 6701 Rockledge Drive, Room 3182, Time: 11:00 a.m. to 4:00 p.m. 20892, 301–435–1212, kumarra@csr.nih.gov.
MSC 7770, Bethesda, MD 20892, (301) 455– Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance
1761, kellya2@csr.nih.gov. applications. Program Nos. 93.306, Comparative Medicine;
Name of Committee: Center for Scientific Place: National Institutes of Health, 6701 93.333, Clinical Research, 93.306, 93.333,
Review Special Emphasis Panel; Rockledge Drive, Bethesda, MD 20892 93.337, 93.393–93.396, 93.837–93.844,
Fellowships: Cell Biology, Developmental (Virtual Meeting). 93.846–93.878, 93.892, 93.893, National
Biology, and Bioengineering. Contact Person: Delia Olufokunbi Sam, Institutes of Health, HHS)
Date: November 1–2, 2018. Ph.D., Scientific Review Officer, Center for
Time: 8:00 a.m. to 6:00 p.m. Dated: September 28, 2018.
Scientific Review, National Institutes of
Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 3158, Sylvia L. Neal,
applications. MSC 7770, Bethesda, MD 20892, 301–435– Program Analyst, Office of Federal Advisory
Place: Hotel Nikko San Francisco, 222 0684, olufokunbisamd@csr.nih.gov. Committee Policy.
Mason Street, San Francisco, CA 94102. Name of Committee: Center for Scientific [FR Doc. 2018–21645 Filed 10–4–18; 8:45 am]
Contact Person: Raj K. Krishnaraju, Ph.D., Review Special Emphasis Panel; PAR 17–199
Scientific Review Officer, Center for BILLING CODE 4140–01–P
and PAR 17–200: Development of Pediatric
Scientific Review, National Institutes of Formulations and Drug Delivery Systems.
Health, 6701 Rockledge Drive, Room 6190, Date: November 2, 2018.
Bethesda, MD 20892, 301–435–1047, Time: 11:00 a.m. to 2:00 p.m.
DEPARTMENT OF HEALTH AND
kkrishna@csr.nih.gov. Agenda: To review and evaluate grant HUMAN SERVICES
Name of Committee: Center for Scientific applications.
Review Special Emphasis Panel; Neural Basis Place: National Institutes of Health, 6701 National Institutes of Health
of Psychopathology, Addictions and Sleep Rockledge Drive, Bethesda, MD 20892
Disorders. (Telephone Conference Call). Center for Scientific Review; Notice of
Date: November 1, 2018. Contact Person: Sharon S. Low, Ph.D., Closed Meetings
Time: 8:30 a.m. to 5:00 p.m. Scientific Review Officer, Center for
Agenda: To review and evaluate grant Scientific Review, National Institutes of
Pursuant to section 10(d) of the
applications. Health, 6701 Rockledge Drive, Room 5104, Federal Advisory Committee Act, as
Place: Residence Inn, Washington, DC MSC 5104, Bethesda, MD 20892, 301–237– amended, notice is hereby given of the
Downtown, 1199 Vermont Ave., Washington, 1487, lowss@csr.nih.gov. following meetings.
DC 20005. Name of Committee: Center for Scientific The meetings will be closed to the
Contact Person: Samuel C. Edwards, Ph.D., Review Special Emphasis Panel; Immunology public in accordance with the
Chief, BDCN IRG, Center for Scientific AREA Review. provisions set forth in sections
Review, National Institutes of Health, 6701 Date: November 2, 2018. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Rockledge Drive, Room 5210, MSC 7846, Time: 11:00 a.m. to 5:00 p.m.
Bethesda, MD 20892, (301) 435–1246, as amended. The grant applications and
Agenda: To review and evaluate grant the discussions could disclose
edwardss@csr.nih.gov. applications.
Name of Committee: Brain Disorders and confidential trade secrets or commercial
Place: Residence Inn Bethesda, 7335
Clinical Neuroscience Integrated Review Wisconsin Avenue, Bethesda, MD 20814.
property such as patentable material,
Group; Neural Basis of Psychopathology, Contact Person: Liying Guo, Ph.D., and personal information concerning
Addictions and Sleep Disorders Study Scientific Review Officer, Center for individuals associated with the grant
Section. Scientific Review, National Institutes of applications, the disclosure of which
Date: November 1–2, 2018. Health, 6701 Rockledge Drive, Room 4016F, would constitute a clearly unwarranted
Time: 8:30 a.m. to 5:00 p.m. Bethesda, MD 20892, 301–435–0908, lguo@ invasion of personal privacy.
Agenda: To review and evaluate grant mail.nih.gov.
applications. Name of Committee: Center for Scientific Name of Committee: Cardiovascular and
Place: Residence Inn Washington, DC Review Special Emphasis Panel; PAR–18– Respiratory Sciences Integrated Review
Downtown, 1199 Vermont Avenue NW, 133: Strategies to Increase Delivery of Group; Cardiovascular Differentiation and
Washington, DC 20005. Guideline-Based Care to Populations with Development Study Section.
Contact Person: Julius Cinque, MS, Health Disparities. Date: October 24, 2018.
Scientific Review Officer, Center for Date: November 2, 2018. Time: 8:00 a.m. to 6:00 p.m.
Scientific Review, National Institutes of Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant
Health, 6701 Rockledge Drive, Room 5186, Agenda: To review and evaluate grant applications.
MSC 7846, Bethesda, MD 20892, cinquej@ applications. Place: Hilton Garden Inn Bethesda, 7301
csr.nih.gov. Place: National Institutes of Health, 6701 Waverly Street, Bethesda, MD 20814.
daltland on DSKBBV9HB2PROD with NOTICES
Name of Committee: Center for Scientific Rockledge Drive, Bethesda, MD 20892, Contact Person: Sara Ahlgren, Ph.D.,
Review Special Emphasis Panel; Accelerating (Telephone Conference Call). Scientific Review Officer, Center for
the Pace of Drug Abuse Research Using Contact Person: Jessica Bellinger, Ph.D., Scientific Review, National Institutes of
Existing Data. Scientific Review Administrator, Center for Health, 6701 Rockledge Drive, RM 4136,
Date: November 2, 2018. Scientific of Review, National Institutes of Bethesda, MD 20892, 301–435–0904,
Time: 11:00 a.m. to 5:00 p.m. Health, 6701 Rockledge Drive, Room 3158, sara.ahlgren@nih.gov.
Agenda: To review and evaluate grant Bethesda, Md 20892, 301–827–4446, Name of Committee: Biobehavioral and
applications. bellingerjd@csr.nih.gov. Behavioral Processes Integrated Review
VerDate Sep<11>2014 17:11 Oct 04, 2018 Jkt 247001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1](https://thefederalregister.org/doc/83_FR_50577/page/2.svg)
Document Created: 2018-10-05 01:52:22
Document Modified: 2018-10-05 01:52:22
| 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 | October 30-31, 2018. | |
| FR Citation | 83 FR 50383 |
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