80_FR_48481 80 FR 48326 - Center for Scientific Review; Notice of Closed Meetings

80 FR 48326 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 155 (August 12, 2015)

Page Range48326-48327
FR Document2015-19802

Federal Register, Volume 80 Issue 155 (Wednesday, August 12, 2015)
[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48326-48327]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19802]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of the following 
meetings.
    The meetings will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, 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; Hypertension and Microcirculation.
    Date: September 15, 2015.
    Time: 10:00 a.m. to 12:00 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: 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: Digestive, Kidney and Urological Systems 
Integrated Review Group; Clinical, Integrative and Molecular 
Gastroenterology Study Section.
    Date: September 28, 2015.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.

[[Page 48327]]

    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military 
Road NW., Washington, DC 20015.
    Contact Person: Mushtaq A. Khan, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 2176, MSC 7818, Bethesda, MD 
20892, 301-435-1778, [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: August 7, 2015.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-19802 Filed 8-11-15; 8:45 am]
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                                                  48326                      Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices

                                                  (FDA). The meeting will be open to the                     11. RECOTHROM (thrombin, topical                     FDA is committed to the orderly
                                                  public.                                                 [recombinant]),                                       conduct of its advisory committee
                                                     Name of Committee: Pediatric                            12. PREVNAR 13 (Pneumococcal 13-valent             meetings. Please visit our Web site at
                                                                                                          Conjugate Vaccine [Diphtheria CRM197                  http://www.fda.gov/
                                                  Advisory Committee.                                     Protein]),
                                                     General Function of the Committee:                      13. PLEXIMMUNE,
                                                                                                                                                                AdvisoryCommittees/
                                                  To provide advice and                                      14. ELANA SURGICAL KIT (HUD),                      AboutAdvisoryCommittees/
                                                  recommendations to the Agency on                           15. BERLIN HEART EXCOR PEDIATRIC                   ucm111462.htm for procedures on
                                                  FDA’s regulatory issues.                                VENTRICULAR ASSIST DEVICE (VAD),                      public conduct during advisory
                                                     Date and Time: The meeting will be                      16. ENTERRA THERAPY SYSTEM, and                    committee meetings.
                                                  held on Wednesday, September 16,                           17. CONTEGRA Pulmonary Valved
                                                                                                                                                                  Notice of this meeting is given under
                                                  2015, from 8:30 a.m. to 5:30 p.m.                       Conduit.
                                                                                                                                                                the Federal Advisory Committee Act (5
                                                     Location: Double Tree by Hilton, 8727                   FDA intends to make background                     U.S.C. app. 2).
                                                  Colesville Rd., Silver Spring, MD 20910,                material available to the public no later                Dated: August 5, 2015.
                                                  301–589–5200. Answers to commonly                       than 2 business days before the meeting.
                                                                                                                                                                Jill Hartzler Warner,
                                                  asked questions including information                   If FDA is unable to post the background
                                                  regarding special accommodations due                    material on its Web site prior to the                 Associate Commissioner for Special Medical
                                                                                                                                                                Programs.
                                                  to a disability, visitor parking, and                   meeting, the background material will
                                                  transportation may be accessed at:                      be made publicly available at the                     [FR Doc. 2015–19729 Filed 8–11–15; 8:45 am]
                                                  http://doubletree3.hilton.com/en/hotels/                location of the advisory committee                    BILLING CODE 4164–01–P
                                                  maryland/doubletree-by-hilton-hotel-                    meeting, and the background material
                                                  washington-dc-silver-spring-DCASSDT/                    will be posted on FDA’s Web site after
                                                  index.html.                                             the meeting. Background material is                   DEPARTMENT OF HEALTH AND
                                                     Contact Person: Walter Ellenberg,                    available at http://www.fda.gov/                      HUMAN SERVICES
                                                  Office of the Commissioner, Food and                    AdvisoryCommittees/Calendar/
                                                                                                                                                                National Institutes of Health
                                                  Drug Administration, 10903 New                          default.htm. Scroll down to the
                                                  Hampshire Ave., Bldg. 32, Rm. 5154,                     appropriate advisory committee link.                  Center for Scientific Review; Notice of
                                                  Silver Spring, MD 20993, 301–796–                          Procedure: Interested persons may                  Closed Meetings
                                                  0885, email: walter.ellenberg@                          present data, information, or views,
                                                  fda.hhs.gov or FDA Advisory Committee                   orally or in writing, on issues pending                 Pursuant to section 10(d) of the
                                                  Information Line, 1–800–741–8138                        before the committee. Written                         Federal Advisory Committee Act, as
                                                  (301–443–0572 in the Washington, DC                     submissions may be made to the contact                amended (5 U.S.C. App.), notice is
                                                  area). A notice in the Federal Register                 person on or before September 8, 2015.                hereby given of the following meetings.
                                                  about last minute modifications that                    Oral presentations from the public will
                                                                                                                                                                  The meetings will be closed to the
                                                  impact a previously announced                           be scheduled between approximately 9
                                                                                                                                                                public in accordance with the
                                                  advisory committee meeting cannot                       a.m. and 10 a.m. Those individuals
                                                                                                                                                                provisions set forth in sections
                                                  always be published quickly enough to                   interested in making formal oral
                                                                                                                                                                552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
                                                  provide timely notice. Therefore, you                   presentations should notify the contact
                                                                                                                                                                as amended. The grant applications and
                                                  should always check the Agency’s Web                    person and submit a brief statement of
                                                                                                                                                                the discussions could disclose
                                                  site at http://www.fda.gov/                             the general nature of the evidence or
                                                                                                                                                                confidential trade secrets or commercial
                                                  AdvisoryCommittees/default.htm and                      arguments they wish to present, the
                                                                                                                                                                property such as patentable material,
                                                  scroll down to the appropriate advisory                 names and addresses of proposed
                                                                                                                                                                and personal information concerning
                                                  committee meeting link, or call the                     participants, and an indication of the
                                                                                                                                                                individuals associated with the grant
                                                  advisory committee information line to                  approximate time requested to make
                                                                                                                                                                applications, the disclosure of which
                                                  learn about possible modifications                      their presentation on or before
                                                                                                                                                                would constitute a clearly unwarranted
                                                  before coming to the meeting.                           September 1, 2015. Time allotted for
                                                                                                                                                                invasion of personal privacy.
                                                     Agenda: On September 16, 2015, the                   each presentation may be limited. If the
                                                  Pediatric Advisory Committee (PAC)                      number of registrants requesting to                     Name of Committee: Center for Scientific
                                                  will meet to discuss pediatric-focused                  speak is greater than can be reasonably               Review Special Emphasis Panel;
                                                                                                          accommodated during the scheduled                     Hypertension and Microcirculation.
                                                  safety reviews, as mandated by the Best
                                                                                                          open public hearing session, FDA may                    Date: September 15, 2015.
                                                  Pharmaceuticals for Children Act (Pub.                                                                          Time: 10:00 a.m. to 12:00 p.m.
                                                  L. 107–109) and the Pediatric Research                  conduct a lottery to determine the                      Agenda: To review and evaluate grant
                                                  Equity Act (Pub. L. 108–155). The PAC                   speakers for the scheduled open public                applications.
                                                  will meet to discuss the following                      hearing session. The contact person will                Place: National Institutes of Health, 6701
                                                  products:                                               notify interested persons regarding their             Rockledge Drive, Bethesda, MD 20892,
                                                    1. DUREZOL (difluprednate ophthalmic
                                                                                                          request to speak by September 8, 2015.                (Telephone Conference Call).
                                                  emulsion) 0.05%, Phenylephrine                             Persons attending FDA’s advisory                     Contact Person: Katherine M. Malinda,
                                                  Hydrochloride Ophthalmic Solution,                      committee meetings are advised that the               Ph.D., Scientific Review Officer, Center for
                                                    2. ZYLET (loteprednol etabonate and                   Agency is not responsible for providing               Scientific Review, National Institutes of
                                                  tobramycin ophthalmic suspension),                      access to electrical outlets.                         Health, 6701 Rockledge Drive, Room 4140,
                                                    3. BETHKIS (tobramycin Inhalation                        FDA welcomes the attendance of the                 MSC 7814, Bethesda, MD 20892, 301–435–
                                                  Solution),                                                                                                    0912, Katherine_Malinda@csr.nih.gov.
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                                                                                                          public at its advisory committee
                                                    4. INTELENCE (etravirine),                            meetings and will make every effort to                  Name of Committee: Digestive, Kidney and
                                                    5. PREZISTA (darunavir),                                                                                    Urological Systems Integrated Review Group;
                                                                                                          accommodate persons with physical                     Clinical, Integrative and Molecular
                                                    6. VIRAMUNE XR (nevirapine),
                                                    7. EPIDUO (adapalene and benzoyl
                                                                                                          disabilities or special needs. If you                 Gastroenterology Study Section.
                                                  peroxide),                                              require special accommodations due to                   Date: September 28, 2015.
                                                    8. EXJADE (deferasirox),                              a disability, please contact Walter                     Time: 8:00 a.m. to 6:00 p.m.
                                                    9. DOTAREM (gadoterate meglumine),                    Ellenberg at least 7 days in advance of                 Agenda: To review and evaluate grant
                                                    10. FYCOMPA (perampanel),                             the meeting.                                          applications.



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                                                                             Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices                                                 48327

                                                    Place: Embassy Suites at the Chevy Chase                Dated: August 7, 2015.                                Agenda: To review and evaluate grant
                                                  Pavilion, 4300 Military Road NW.,                       Melanie J. Gray,                                      applications.
                                                  Washington, DC 20015.                                   Program Analyst, Office of Federal Advisory             Place: The Embassy Suites DC Convention
                                                    Contact Person: Mushtaq A. Khan, Ph.D.,                                                                     Center, 900 10th Street NW., Washington, DC
                                                                                                          Committee Policy.
                                                  Scientific Review Officer, Center for                                                                         20001.
                                                                                                          [FR Doc. 2015–19784 Filed 8–11–15; 8:45 am]             Contact Person: John Bishop, Ph.D.,
                                                  Scientific Review, National Institutes of               BILLING CODE 4140–01–P                                Scientific Review Officer, Center for
                                                  Health, 6701 Rockledge Drive, Room 2176,                                                                      Scientific Review, National Institutes of
                                                  MSC 7818, Bethesda, MD 20892, 301–435–                                                                        Health, 6701 Rockledge Drive, Room 5182,
                                                  1778, khanm@csr.nih.gov.                                DEPARTMENT OF HEALTH AND                              MSC 7844, Bethesda, MD 20892, (301) 408–
                                                  (Catalogue of Federal Domestic Assistance               HUMAN SERVICES                                        9664, bishopj@csr.nih.gov.
                                                  Program Nos. 93.306, Comparative Medicine;                                                                      Name of Committee: Genes, Genomes, and
                                                  93.333, Clinical Research; 93.306, 93.333,              National Institutes of Health                         Genetics Integrated Review Group; Molecular
                                                  93.337, 93.393–93.396, 93.837–93.844,                                                                         Genetics B Study Section.
                                                  93.846–93.878, 93.892, 93.893, National                 Center for Scientific Review; Notice of                 Date: September 28–29, 2015.
                                                  Institutes of Health, HHS)                              Closed Meetings                                         Time: 8:00 a.m. to 6:00 p.m.
                                                                                                                                                                  Agenda: To review and evaluate grant
                                                    Dated: August 7, 2015.                                  Pursuant to section 10(d) of the                    applications.
                                                  Anna Snouffer,                                          Federal Advisory Committee Act, as                      Place: The Westin St. Francis, 335 Powell
                                                                                                          amended (5 U.S.C. App.), notice is                    Street, San Francisco, CA 94102.
                                                  Deputy Director, Office of Federal Advisory
                                                                                                          hereby given of the following meetings.                 Contact Person: Richard A Currie, Ph.D.,
                                                  Committee Policy.
                                                                                                            The meetings will be closed to the                  Scientific Review Officer, Center for
                                                  [FR Doc. 2015–19802 Filed 8–11–15; 8:45 am]                                                                   Scientific Review, National Institutes of
                                                                                                          public in accordance with the
                                                  BILLING CODE 4140–01–P                                  provisions set forth in sections                      Health, 6701 Rockledge Drive, Room 5128,
                                                                                                          552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,            MSC 7840, Bethesda, MD 20892, (301) 435–
                                                                                                                                                                1219, currieri@csr.nih.gov.
                                                                                                          as amended. The grant applications and
                                                  DEPARTMENT OF HEALTH AND                                the discussions could disclose                          Name of Committee: Vascular and
                                                  HUMAN SERVICES                                                                                                Hematology Integrated Review Group;
                                                                                                          confidential trade secrets or commercial
                                                                                                                                                                Atherosclerosis and Inflammation of the
                                                                                                          property such as patentable material,                 Cardiovascular System Study Section.
                                                  National Institutes of Health                           and personal information concerning                     Date: September 28–29, 2015.
                                                                                                          individuals associated with the grant                   Time: 8:00 a.m. to 6:00 p.m.
                                                  National Institute on Aging; Notice of
                                                                                                          applications, the disclosure of which                   Agenda: To review and evaluate grant
                                                  Closed Meeting
                                                                                                          would constitute a clearly unwarranted                applications.
                                                                                                          invasion of personal privacy.                           Place: Bolger Center, 9600 Newbridge
                                                    Pursuant to section 10(d) of the                                                                            Drive, Potomac, MD 20854.
                                                  Federal Advisory Committee Act, as                        Name of Committee: Vascular and                       Contact Person: Natalia Komissarova,
                                                  amended (5 U.S.C. App.), notice is                      Hematology Integrated Review Group;
                                                                                                                                                                Ph.D., Scientific Review Officer, Center for
                                                                                                          Hypertension and Microcirculation Study
                                                  hereby given of the following meeting.                  Section.
                                                                                                                                                                Scientific Review, National Institutes of
                                                                                                                                                                Health, 6701 Rockledge Drive, Room 5207,
                                                    The meeting will be closed to the                       Date: September 14–15, 2015.
                                                                                                                                                                MSC 7846, Bethesda, MD 20892, 301–435–
                                                  public in accordance with the                             Time: 8:00 a.m. to 5:00 p.m.
                                                                                                            Agenda: To review and evaluate grant                1206, komissar@mail.nih.gov.
                                                  provisions set forth in sections                                                                              (Catalogue of Federal Domestic Assistance
                                                                                                          applications.
                                                  552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                Place: Marriott Wardman Park Washington             Program Nos. 93.306, Comparative Medicine;
                                                  as amended. The grant applications and                  DC Hotel, 2660 Woodley Road NW.,                      93.333, Clinical Research, 93.306, 93.333,
                                                  the discussions could disclose                          Washington, DC 20008                                  93.337, 93.393–93.396, 93.837–93.844,
                                                  confidential trade secrets or commercial                  Contact Person: Ai-Ping Zou, MD, Ph.D.,             93.846–93.878, 93.892, 93.893, National
                                                  property such as patentable material,                   Scientific Review Officer, Center for                 Institutes of Health, HHS)
                                                  and personal information concerning                     Scientific Review, National Institutes of               Dated: August 6, 2015.
                                                  individuals associated with the grant                   Health, 6701 Rockledge Drive, Room 4118,
                                                                                                          MSC 7814, Bethesda, MD 20892, 301–408–                Carolyn Baum,
                                                  applications, the disclosure of which                   9497, zouai@csr.nih.gov.                              Program Analyst, Office of Federal Advisory
                                                  would constitute a clearly unwarranted                                                                        Committee Policy.
                                                                                                            Name of Committee: Cardiovascular and
                                                  invasion of personal privacy.                           Respiratory Sciences Integrated Review                [FR Doc. 2015–19735 Filed 8–11–15; 8:45 am]
                                                    Name of Committee: National Institute on              Group; Lung Injury, Repair, and Remodeling            BILLING CODE 4140–01–P
                                                  Aging Special Emphasis Panel; Male                      Study Section.
                                                  Osteoporosis.                                             Date: September 21–22, 2015.
                                                                                                            Time: 8:00 a.m. to 5:00 p.m.                        DEPARTMENT OF HEALTH AND
                                                    Date: September 9, 2015.
                                                                                                            Agenda: To review and evaluate grant
                                                    Time: 1:00 p.m. to 4:00 p.m.                                                                                HUMAN SERVICES
                                                                                                          applications.
                                                    Agenda: To review and evaluate grant                    Place: Embassy Suites at the Chevy Chase
                                                  applications.                                                                                                 National Institutes of Health
                                                                                                          Pavilion, 4300 Military Road NW.,
                                                    Place: National Institute on Aging,                   Washington, DC 20015.
                                                  Gateway Building, Suite 2C212, 7201                       Contact Person: Ghenima Dirami, Ph.D.,
                                                                                                                                                                National Cancer Institute; Notice of
                                                  Wisconsin Ave., Bethesda, MD 20892,                     Scientific Review Officer, Center for                 Closed Meetings
                                                  (Telephone Conference Call).                            Scientific Review, National Institutes of               Pursuant to section 10(d) of the
                                                                                                          Health, 6701 Rockledge Drive, Room 4122,
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                                                    Contact Person: Alicja L. Markowska,                                                                        Federal Advisory Committee Act, as
                                                  Ph.D., DSC, Scientific Review Branch,                   MSC 7814, Bethesda, MD 20892, 240–498–
                                                                                                          7546, diramig@csr.nih.gov.                            amended (5 U.S.C. App.), notice is
                                                  National Institute On Aging, 7201 Wisconsin                                                                   hereby given of the following meetings.
                                                  Avenue, Suite 2c212, Bethesda, MD 20892,                  Name of Committee: Integrative,
                                                                                                          Functional and Cognitive Neuroscience
                                                                                                                                                                  The meetings will be closed to the
                                                  301–496–9666, markowsa@nia.nih.gov.                                                                           public in accordance with the
                                                                                                          Integrated Review Group; Sensorimotor
                                                  (Catalogue of Federal Domestic Assistance               Integration Study Section.                            provisions set forth in sections
                                                  Program Nos. 93.866, Aging Research,                      Date: September 22, 2015.                           552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                  National Institutes of Health, HHS)                       Time: 8:00 a.m. to 6:00 p.m.                        as amended. The grant applications and


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Document Created: 2016-09-27 22:27:00
Document Modified: 2016-09-27 22:27:00
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 15, 2015.
FR Citation80 FR 48326 

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