83_FR_46353 83 FR 46176 - Center for Scientific Review; Notice of Closed Meetings

83 FR 46176 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 177 (September 12, 2018)

Page Range46176-46177
FR Document2018-19796

Federal Register, Volume 83 Issue 177 (Wednesday, September 12, 2018)
[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Notices]
[Pages 46176-46177]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19796]


-----------------------------------------------------------------------

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: Healthcare Delivery and Methodologies 
Integrated Review Group; Clinical Management of Patients in 
Community-based Settings Study Section.
    Date: September 27-28, 2018.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Warwick Denver, 1776 Grant Street, Denver, CO 80203.
    Contact Person: Martha L Hare, Ph.D., RN, Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3154, MSC 7770, Bethesda, MD 
20892, (301) 451-8504, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Hypertension and Microcirculation.
    Date: October 2, 2018.
    Time: 8:00 a.m. to 2:00 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: Katherine M. Malinda, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4140, MSC 7814, Bethesda, MD 
20892, 301-435-0912, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: Dental, Microbiology and Oral Biology.
    Date: October 3, 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: Baljit S Moonga, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4214, MSC 7806, Bethesda, MD 
20892, 301-435-1777, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; PAR-17-094: Maximizing Investigators' Research Award (R35).
    Date: October 10-11, 2018.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.

[[Page 46177]]

    Place: Residence Inn Capital View, 2850 South Potomac Avenue, 
Arlington, VA 22202.
    Contact Person: Jonathan Arias, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5170, MSC 7840, Bethesda, MD 
20892, 301-435-2406, [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 6, 2018.
David D. Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-19796 Filed 9-11-18; 8:45 am]
 BILLING CODE 4140-01-P



                                               46176                           Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices

                                                 The purpose of the information                                          the Agency’s experience, reviewing                                          revised, as applicable, so that the
                                               package is to provide Agency staff the                                    such information is critical to achieving                                   information reflects the most current
                                               opportunity to adequately prepare for                                     a productive meeting. If the information                                    and accurate information available.
                                               the meeting, including the review of                                      package was previously submitted in                                           FDA estimates the burden of this
                                               relevant data concerning the product. In                                  the meeting request, it should be                                           collection of information as follows:

                                                                                                            TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                                        Number of                                                Average
                                                                                                                                             Number of                                            Total annual
                                                                                     Activity                                                                         responses per                                            burden per              Total hours
                                                                                                                                            respondents                                            responses
                                                                                                                                                                        respondent                                              response

                                                                                                                                              Meeting Requests

                                               Combining and Sending Meeting Request Letters for Man-
                                                 ufacturers, Importers, and Researchers ..........................                                             83                           1                        83                         10              830

                                                                                                                                    Meeting Information Packages

                                               Combining and Submitting Meeting Information Packages
                                                 for Manufacturers, Importers, and Researchers ..............                                                  83                           1                        83                         18            1,494

                                                    Total ..............................................................................   ........................   ........................   ........................   ........................          2,324
                                                  1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


                                                 FDA’s estimate of the number of                                         application compliance deadlines will                                         Contact Person: Martha L Hare, Ph.D., RN,
                                               respondents for meeting requests in                                       come due in the next 3 years.                                               Scientific Review Officer, Center for
                                               table 1 is based on the number of                                                                                                                     Scientific Review, National Institutes of
                                                                                                                           Dated: September 4, 2018.                                                 Health, 6701 Rockledge Drive, Room 3154,
                                               meeting requests received and projected
                                                                                                                         Leslie Kux,                                                                 MSC 7770, Bethesda, MD 20892, (301) 451–
                                               over the next 3 years. FDA estimates
                                                                                                                         Associate Commissioner for Policy.                                          8504, harem@mail.nih.gov.
                                               that 83 preapplication meetings will be
                                               requested.                                                                [FR Doc. 2018–19743 Filed 9–11–18; 8:45 am]                                   Name of Committee: Center for Scientific
                                                                                                                                                                                                     Review Special Emphasis Panel;
                                                 The hours per response for combining                                    BILLING CODE 4164–01–P
                                                                                                                                                                                                     Hypertension and Microcirculation.
                                               and sending meeting request letters are                                                                                                                 Date: October 2, 2018.
                                               estimated at 10 hours each, and the total                                                                                                               Time: 8:00 a.m. to 2:00 p.m.
                                               burden hours for meeting requests are                                     DEPARTMENT OF HEALTH AND
                                                                                                                         HUMAN SERVICES                                                                Agenda: To review and evaluate grant
                                               expected to be 830 hours. Based on                                                                                                                    applications.
                                               FDA’s experience, the Agency expects it                                                                                                                 Place: Embassy Suites at the Chevy Chase
                                                                                                                         National Institutes of Health
                                               will take respondents this amount of                                                                                                                  Pavilion, 4300 Military Road NW,
                                               time to prepare, gather, copy, and                                        Center for Scientific Review; Notice of                                     Washington, DC 20015.
                                               submit brief statements about the                                         Closed Meetings                                                               Contact Person: Katherine M. Malinda,
                                               product and a description of the                                                                                                                      Ph.D., Scientific Review Officer, Center for
                                               purpose and details of the meeting.                                                                                                                   Scientific Review, National Institutes of
                                                                                                                           Pursuant to section 10(d) of the
                                                 FDA’s estimates that 83 respondents                                                                                                                 Health, 6701 Rockledge Drive, Room 4140,
                                                                                                                         Federal Advisory Committee Act, as
                                               will compile meeting information                                                                                                                      MSC 7814, Bethesda, MD 20892, 301–435–
                                                                                                                         amended, notice is hereby given of the                                      0912, Katherine_Malinda@csr.nih.gov.
                                               packages and submit to FDA at 18 hours                                    following meetings.
                                               per response. Based on FDA’s                                                                                                                            Name of Committee: Center for Scientific
                                                                                                                           The meetings will be closed to the                                        Review Special Emphasis Panel; Member
                                               experience, the Agency expects that it
                                                                                                                         public in accordance with the                                               Conflict: Dental, Microbiology and Oral
                                               will take respondents 1,494 hours (83
                                                                                                                         provisions set forth in sections                                            Biology.
                                               respondents × 18 hours) to gather, copy,                                                                                                                Date: October 3, 2018.
                                                                                                                         552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                               and submit brief statements about the                                                                                                                   Time: 12:00 p.m. to 3:00 p.m.
                                                                                                                         as amended. The grant applications and
                                               product, a description of the details of                                                                                                                Agenda: To review and evaluate grant
                                                                                                                         the discussions could disclose
                                               the anticipated meeting, and data and                                                                                                                 applications.
                                                                                                                         confidential trade secrets or commercial
                                               information that generally would                                                                                                                        Place: National Institutes of Health, 6701
                                                                                                                         property such as patentable material,
                                               already have been generated for the                                                                                                                   Rockledge Drive, Bethesda, MD 20892
                                                                                                                         and personal information concerning
                                               planned research and/or product                                                                                                                       (Telephone Conference Call).
                                                                                                                         individuals associated with the grant                                         Contact Person: Baljit S Moonga, Ph.D.,
                                               development.
                                                                                                                         applications, the disclosure of which                                       Scientific Review Officer, Center for
                                                 The total number of burden hours for                                    would constitute a clearly unwarranted
                                               this collection of information is                                                                                                                     Scientific Review, National Institutes of
                                                                                                                         invasion of personal privacy.                                               Health, 6701 Rockledge Drive, Room 4214,
                                               estimated to be 2,324 hours (830 hours
                                                                                                                           Name of Committee: Healthcare Delivery                                    MSC 7806, Bethesda, MD 20892, 301–435–
                                               to prepare and submit meeting requests
                                                                                                                         and Methodologies Integrated Review Group;                                  1777, moongabs@mail.nih.gov.
                                               and 1,494 hours to prepare and submit
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                                               information packages).                                                    Clinical Management of Patients in                                            Name of Committee: Center for Scientific
                                                                                                                         Community-based Settings Study Section.                                     Review Special Emphasis Panel; PAR–17–
                                                 Our estimated burden for the                                              Date: September 27–28, 2018.                                              094: Maximizing Investigators’ Research
                                               information collection reflects an                                          Time: 8:00 a.m. to 5:00 p.m.                                              Award (R35).
                                               overall increase of 16 respondents and                                      Agenda: To review and evaluate grant                                        Date: October 10–11, 2018.
                                               448 hours. We attribute this adjustment                                   applications.                                                                 Time: 8:00 a.m. to 6:00 p.m.
                                               to an increase in the number of industry                                    Place: Warwick Denver, 1776 Grant Street,                                   Agenda: To review and evaluate grant
                                               meetings as the premarket tobacco                                         Denver, CO 80203.                                                           applications.



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                                                                        Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices                                            46177

                                                 Place: Residence Inn Capital View, 2850                 Place: Kinzie Hotel, 20 West Kinzie Street,            Date: October 11–12, 2018.
                                               South Potomac Avenue, Arlington, VA                     Chicago, IL 60654.                                       Time: 8:00 a.m. to 5:00 p.m.
                                               22202.                                                    Contact Person: Luis Dettin, Ph.D.,                    Agenda: To review and evaluate grant
                                                 Contact Person: Jonathan Arias, Ph.D.,                Scientific Review Officer, Center for                 applications.
                                               Scientific Review Officer, Center for                   Scientific Review, National Institutes of                Place: Baltimore Marriott Waterfront, 700
                                               Scientific Review, National Institutes of               Health, 6701 Rockledge Drive, Room 2208,              Aliceanna Street, Baltimore, MD 21202.
                                               Health, 6701 Rockledge Drive, Room 5170,                Bethesda, MD 20892, 301–451–1327,                        Contact Person: Lee S. Mann, Ph.D.,
                                               MSC 7840, Bethesda, MD 20892, 301–435–                  dettinle@csr.nih.gov.                                 Scientific Review Officer, Center for
                                               2406, ariasj@csr.nih.gov.                                 Name of Committee: Biobehavioral and                Scientific Review, National Institutes of
                                               (Catalogue of Federal Domestic Assistance               Behavioral Processes Integrated Review                Health, 6701 Rockledge Drive, Room 3224,
                                               Program Nos. 93.306, Comparative Medicine;              Group; Motor Function, Speech and                     MSC 7808, Bethesda, MD 20892, 301–435–
                                               93.333, Clinical Research, 93.306, 93.333,              Rehabilitation Study Section.                         0677, mannl@csr.nih.gov.
                                               93.337, 93.393–93.396, 93.837–93.844,                     Date: October 4, 2018.                                 Name of Committee: Digestive, Kidney and
                                               93.846–93.878, 93.892, 93.893, National                   Time: 8:00 a.m. to 7:00 p.m.                        Urological Systems Integrated Review Group;
                                               Institutes of Health, HHS)                                Agenda: To review and evaluate grant                Hepatobiliary Pathophysiology Study
                                                                                                       applications.                                         Section.
                                                 Dated: September 6, 2018.                               Place: Westin Georgetown, 2350 M Street                Date: October 11–12, 2018.
                                                                                                       NW, Washington, DC 20037.                                Time: 8:00 a.m. to 6:00 p.m.
                                               David D. Clary,
                                                                                                         Contact Person: Biao Tian, Ph.D., Scientific           Agenda: To review and evaluate grant
                                               Program Analyst, Office of Federal Advisory             Review Officer, Center for Scientific Review,         applications.
                                               Committee Policy.                                       National Institutes of Health, 6701 Rockledge            Place: Hyatt Regency Bethesda, One
                                               [FR Doc. 2018–19796 Filed 9–11–18; 8:45 am]             Drive, Room 3166, MSC 7848, Bethesda, MD              Bethesda Metro Center, 7400 Wisconsin
                                               BILLING CODE 4140–01–P                                  20892, 301–402–4411, tianbi@csr.nih.gov.              Avenue, Bethesda, MD 20814.
                                                                                                         Name of Committee: Vascular and                        Contact Person: Jianxin Hu, Ph.D.,
                                                                                                       Hematology Integrated Review Group;                   Scientific Review Officer, Center for
                                               DEPARTMENT OF HEALTH AND                                Atherosclerosis and Inflammation of the               Scientific Review, National Institutes of
                                               HUMAN SERVICES                                          Cardiovascular System Study Section.                  Health, 6701 Rockledge Drive, Room 2156,
                                                                                                         Date: October 11–12, 2018.                          Bethesda, MD 20892, 301–827–4417,
                                               National Institutes of Health                             Time: 8:00 a.m. to 5:00 p.m.                        jianxinh@csr.nih.gov.
                                                                                                         Agenda: To review and evaluate grant
                                                                                                                                                                Name of Committee: Molecular, Cellular
                                                                                                       applications.
                                               Center for Scientific Review; Notice of                                                                       and Developmental Neuroscience Integrated
                                                                                                         Place: The William F. Bolger Center, 9600
                                               Closed Meetings                                         Newbridge Drive, Potomac, MD 20854.                   Review Group; Neural Oxidative Metabolism
                                                                                                         Contact Person: Natalia Komissarova,                and Death Study Section.
                                                 Pursuant to section 10(d) of the                      Ph.D., Scientific Review Officer, Center for             Date: October 11–12, 2018.
                                               Federal Advisory Committee Act, as                      Scientific Review, National Institutes of                Time: 8:00 a.m. to 2:30 p.m.
                                               amended, notice is hereby given of the                  Health, 6701 Rockledge Drive, Room 5207,                 Agenda: To review and evaluate grant
                                               following meetings.                                     MSC 7846, Bethesda, MD 20892, 301–435–                applications.
                                                                                                       1206, komissar@mail.nih.gov.                             Place: Crystal Gateway Marriott, 1700
                                                 The meetings will be closed to the
                                                                                                                                                             Jefferson Davis Highway, Arlington, VA
                                               public in accordance with the                             Name of Committee: Risk, Prevention and
                                                                                                                                                             22202.
                                               provisions set forth in sections                        Health Behavior Integrated Review Group;
                                                                                                       Psychosocial Development, Risk and                       Contact Person: Carol Hamelink, Ph.D.,
                                               552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                                                                    Scientific Review Officer, Center for
                                                                                                       Prevention Study Section.
                                               as amended. The grant applications and                    Date: October 11–12, 2018.                          Scientific Review, National Institutes of
                                               the discussions could disclose                            Time: 8:00 a.m. to 5:00 p.m.                        Health, 6701 Rockledge Drive, Room 4192,
                                               confidential trade secrets or commercial                  Agenda: To review and evaluate grant                MSC 7850, Bethesda, MD 20892, (301) 213–
                                               property such as patentable material,                   applications.                                         9887, hamelinc@csr.nih.gov.
                                               and personal information concerning                       Place: The Fairmont Washington, DC, 2401               Name of Committee: Immunology
                                               individuals associated with the grant                   M Street NW, Washington, DC 20037.                    Integrated Review Group; Innate Immunity
                                               applications, the disclosure of which                     Contact Person: Anna L. Riley, Ph.D.,               and Inflammation Study Section.
                                                                                                       Scientific Review Officer, Center for                    Date: October 11–12, 2018.
                                               would constitute a clearly unwarranted
                                                                                                       Scientific Review, National Institutes of                Time: 8:00 a.m. to 5:00 p.m.
                                               invasion of personal privacy.                           Health, 6701 Rockledge Drive, Room 3114,                 Agenda: To review and evaluate grant
                                                 Name of Committee: Biobehavioral and                  MSC 7759, Bethesda, MD 20892, 301–435–                applications.
                                               Behavioral Processes Integrated Review                  2889, rileyann@csr.nih.gov.                              Place: Sheraton Grand at Wild Horse Pass,
                                               Group; Biobehavioral Regulation, Learning                 Name of Committee: Immunology                       5594 W Wild Horse Pass Boulevard, Phoenix,
                                               and Ethology Study Section.                             Integrated Review Group; Hypersensitivity,            AZ 85226.
                                                 Date: October 4–5, 2018.                              Autoimmune, and Immune-mediated                          Contact Person: Tina McIntyre, Ph.D.,
                                                 Time: 8:00 a.m. to 3:00 p.m.                          Diseases Study Section.                               Scientific Review Officer, Center for
                                                 Agenda: To review and evaluate grant                    Date: October 11–12, 2018.                          Scientific Review, National Institutes of
                                               applications.                                             Time: 8:00 a.m. to 5:00 p.m.                        Health, 6701 Rockledge Drive, Room 4202,
                                                 Place: Hotel Zoe, Fisherman’s Wharf, 425                Agenda: To review and evaluate grant                MSC 7812, Bethesda, MD 20892, 301–594–
                                               North Point Street, San Francisco, CA 94133.            applications.                                         6375, mcintyrt@csr.nih.gov.
                                                 Contact Person: Unja Hayes, Ph.D.,                      Place: Embassy Suites Alexandria Old                   Name of Committee: Digestive, Kidney and
                                               Scientific Review Officer, National Institutes          Town, 1900 Diagonal Road, Alexandria, VA              Urological Systems Integrated Review Group;
                                               of Health, Center for Scientific Review, 6701           22314.                                                Xenobiotic and Nutrient Disposition and
                                               Rockledge Drive, Bethesda, MD 20892, 301–                 Contact Person: Deborah Hodge, Ph.D.,               Action Study Section.
                                               827–6830, unja.hayes@nih.gov.                           Scientific Review Officer, Center for                    Date: October 11, 2018.
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                                                 Name of Committee: Genes, Genomes, and                Scientific Review, National Institutes of                Time: 8:00 a.m. to 8:00 p.m.
                                               Genetics Integrated Review Group;                       Health, 6701 Rockledge Drive, Room 4207                  Agenda: To review and evaluate grant
                                               Prokaryotic Cell and Molecular Biology                  MSC 7812, Bethesda, MD 20892, 301–435–                applications.
                                               Study Section.                                          1238, hodged@mail.nih.gov.                               Place: Bethesda North Marriott Hotel &
                                                 Date: October 4–5, 2018.                                Name of Committee: Risk, Prevention and             Conference Center, 5701 Marinelli Road,
                                                 Time: 8:00 a.m. to 6:00 p.m.                          Health Behavior Integrated Review Group;              Bethesda, MD 20852.
                                                 Agenda: To review and evaluate grant                  Behavioral Medicine, Interventions and                   Contact Person: Martha Garcia, Ph.D.,
                                               applications.                                           Outcomes Study Section.                               Scientific Reviewer Officer, Center for



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Document Created: 2018-09-12 02:06:29
Document Modified: 2018-09-12 02:06:29
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
DatesSeptember 27-28, 2018.
FR Citation83 FR 46176 

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