80_FR_29110 80 FR 29013 - Center for Scientific Review; Notice of Closed Meetings

80 FR 29013 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 97 (May 20, 2015)

Page Range29013-29014
FR Document2015-12242

Federal Register, Volume 80 Issue 97 (Wednesday, May 20, 2015)
[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Notices]
[Pages 29013-29014]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12242]


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

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: Oncology 2--Translational Clinical Integrated 
Review

[[Page 29014]]

Group; Radiation Therapeutics and Biology Study Section.
    Date: June 15-16, 2015.
    Time: 8:00 a.m. to 4:00 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: Bo Hong, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 6194, MSC 7804, Bethesda, MD 20892, 301-996-
6208, hongb@csr.nih.gov.

    Name of Committee: Biobehavioral and Behavioral Processes 
Integrated Review Group; Motor Function, Speech and Rehabilitation 
Study Section.
    Date: June 15, 2015.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: St. Gregory Hotel, 2033 M Street NW., Washington, DC 
20036.
    Contact Person: Biao Tian, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 3166, MSC 7848, Bethesda, MD 20892, 301-402-
4411, tianbi@csr.nih.gov.

    Name of Committee:Oncology 2--Translational Clinical Integrated 
Review Group; Cancer Biomarkers Study Section.
    Date: June 17, 2015.
    Time: 8:00 a.m. to 6:00 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: Lawrence Ka-Yun Ng, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 6152, MSC 7804, Bethesda, MD 
20892, 301-357-9318, ngkl@csr.nih.gov.

    Name of Committee: Endocrinology, Metabolism, Nutrition and 
Reproductive Sciences Integrated Review Group; Cellular Aspects of 
Diabetes and Obesity Study Section.
    Date: June 18, 2015.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Doubletree Hotel Bethesda (Formerly Holiday Inn Select), 
8120 Wisconsin Avenue, Bethesda, MD 20814.
    Contact Person: Alexander D Politis, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3210, MSC 7808, Bethesda, MD 
20892, (301) 435-1150, politisa@csr.nih.gov.

    Name of Committee: Endocrinology, Metabolism, Nutrition and 
Reproductive Sciences Integrated Review Group; Molecular and 
Cellular Endocrinology Study Section.
    Date: June 18, 2015.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, 
MD 20814.
    Contact Person: John Bleasdale, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 6170, MSC 7892, Bethesda, MD 
20892, 301-435-4514, bleasdaleje@csr.nih.gov.

    Name of Committee: Molecular, Cellular and Developmental 
Neuroscience Integrated Review Group; Synapses, Cytoskeleton and 
Trafficking Study Section.
    Date: June 18-19, 2015.
    Time: 8:30 a.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hotel Monaco Alexandria, 480 King Street, Alexandria, VA 
22314.
    Contact Person: Christine A Piggee, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4186, MSC 7850, Bethesda, MD 
20892, 301-435-0657, christine.piggee@nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Traumatic Brain Injury and Cerebrovascular Disorders.
    Date: June 19, 2015.
    Time: 1:00 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: Alexander Yakovlev, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5206, MSC 7846, Bethesda, MD 
20892-7846, 301-435-1254, yakovleva@csr.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.306, 
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, 
National Institutes of Health, HHS)

    Dated: May 15, 2015.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-12242 Filed 5-19-15; 8:45 am]
BILLING CODE 4140-01-P



                                                                                          Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices                                                            29013

                                                  OMB, Attn: FDA Desk Officer, FAX:                                         has submitted the following proposed                    notification under § 100.2(d) enables us
                                                  202–395–7285, or emailed to oira_                                         collection of information to OMB for                    to identify the food against which a
                                                  submission@omb.eop.gov. All                                               review and clearance.                                   State intends to take action and to
                                                  comments should be identified with the                                                                                            advise that State whether Federal
                                                                                                                            State Enforcement Notifications—21
                                                  OMB control number 0910–0275. Also                                                                                                enforcement action against the food has
                                                                                                                            CFR 100.2(d)
                                                  include the FDA docket number found                                                                                               been taken or is in process. With certain
                                                  in brackets in the heading of this                                        OMB Control Number 0910–0275—                           narrow exceptions, Federal enforcement
                                                  document.                                                                 Extension                                               action precludes State action under the
                                                                                                                              Section 310(b) of the Federal Food,                   FD&C Act.
                                                  FOR FURTHER INFORMATION CONTACT:    FDA
                                                                                                                            Drug, and Cosmetic Act (the FD&C Act)                     In the Federal Register of March 13,
                                                  PRA Staff, Office of Operations, Food
                                                                                                                            (21 U.S.C. 337(b)) authorizes a State to                2015 (80 FR 13392), FDA published a
                                                  and Drug Administration, 8455
                                                                                                                            enforce certain sections of the FD&C Act                60-day notice requesting public
                                                  Colesville Rd.; COLE–14526, Silver
                                                                                                                            in their own name and within their own                  comment on the proposed collection of
                                                  Spring, MD 20993–0002 PRAStaff@
                                                                                                                            jurisdiction. However, before doing so,                 information. No comments were
                                                  fda.hhs.gov.
                                                                                                                            a State must provide notice to FDA                      received.
                                                  SUPPLEMENTARY INFORMATION:  In                                            according to 21 CFR 100.2. The                            We estimate the burden of this
                                                  compliance with 44 U.S.C. 3507, FDA                                       information required in a letter of                     collection of information as follows:

                                                                                                                TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                                 Number of                              Average
                                                                                                                                               Number of                          Total annual
                                                                                  21 CFR section                                                               responses per                          burden per       Total hours
                                                                                                                                              respondents                          responses
                                                                                                                                                                respondents                            response

                                                  100.2(d) ................................................................................        1                   1                1                10                10
                                                     1 There     are no capital costs or operating and maintenance costs associated with this collection of information.


                                                    The estimated reporting burden for                                      provisions set forth in sections                        (Catalogue of Federal Domestic Assistance
                                                  § 100.2(d) is minimal because                                             552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              Program Nos. 93.853, Clinical Research
                                                  enforcement notifications are seldom                                      as amended. The grant applications and                  Related to Neurological Disorders; 93.854,
                                                  used by States. During the last 3 years,                                  the discussions could disclose                          Biological Basis Research in the
                                                                                                                                                                                    Neurosciences, National Institutes of Health,
                                                  we have not received any new                                              confidential trade secrets or commercial                HHS)
                                                  enforcement notifications; therefore, we                                  property such as patentable material,
                                                  estimate that one or fewer notifications                                  and personal information concerning                       Dated: May 14, 2015.
                                                  will be submitted annually. Although                                      individuals associated with the grant                   Carolyn Baum,
                                                  we have not received any new                                              applications, the disclosure of which                   Program Analyst, Office of Federal Advisory
                                                  enforcement notifications in the last 3                                   would constitute a clearly unwarranted                  Committee Policy.
                                                  years, we believe these information                                       invasion of personal privacy.                           [FR Doc. 2015–12125 Filed 5–19–15; 8:45 am]
                                                  collection provisions should be                                             Name of Committee: National Institute of              BILLING CODE 4140–01–P
                                                  extended to provide for the potential                                     Neurological Disorders and Stroke, Initial
                                                  future need of a State government to                                      Review Group, Neurological Sciences and
                                                  submit enforcement notifications                                          Disorders B.                                            DEPARTMENT OF HEALTH AND
                                                  informing us when it intends to take                                        Date: June 25–26, 2015.                               HUMAN SERVICES
                                                  enforcement action under the FD&C Act                                       Time: 8:00 a.m. to 6:00 p.m.
                                                  against a particular food located in the                                    Agenda: To review and evaluate grant                  National Institutes of Health
                                                                                                                            applications.
                                                  State.                                                                      Place: Wyndam Grand Chicago Riverfront                Center for Scientific Review; Notice of
                                                    Dated: May 15, 2015.                                                    Hotel, 71 E. Wacker Drive, Chicago, IL 60601.           Closed Meetings
                                                  Leslie Kux,                                                                 Contact Person: Birgit Neuhuber, Ph.D.,
                                                                                                                            Scientific Review Officer, Scientific Review              Pursuant to section 10(d) of the
                                                  Associate Commissioner for Policy.
                                                                                                                            Branch, Division of Extramural Research,
                                                  [FR Doc. 2015–12236 Filed 5–19–15; 8:45 am]                               NINDS/NIH/DHHS/Neuroscience Center,
                                                                                                                                                                                    Federal Advisory Committee Act, as
                                                  BILLING CODE 4164–01–P                                                    6001 Executive Boulevard, Suite 3208, MSC               amended (5 U.S.C. App.), notice is
                                                                                                                            9529, Bethesda, MD 20892–9529, 301–496–                 hereby given of the following meetings.
                                                                                                                            3562, neuhuber@ninds.nih.gov.                             The meetings will be closed to the
                                                  DEPARTMENT OF HEALTH AND                                                    Name of Committee: Neurological Sciences              public in accordance with the
                                                  HUMAN SERVICES                                                            Training Initial Review Group, NST–2                    provisions set forth in sections
                                                                                                                            Subcommittee.                                           552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                  National Institutes of Health                                               Date: June 29–30, 2015.
                                                                                                                              Time: 8:00 a.m. to 4:00 p.m.
                                                                                                                                                                                    as amended. The grant applications and
                                                  National Institute of Neurological                                          Agenda: To review and evaluate grant                  the discussions could disclose
                                                  Disorders and Stroke; Notice of Closed                                    applications.                                           confidential trade secrets or commercial
                                                                                                                              Place: The Fairmont Washington, DC, 2401              property such as patentable material,
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  Meetings
                                                                                                                            M Street NW., Washington, DC 20037.                     and personal information concerning
                                                    Pursuant to section 10(d) of the                                          Contact Person: Elizabeth A. Webber,                  individuals associated with the grant
                                                  Federal Advisory Committee Act, as                                        Ph.D., Scientific Review Officer, Scientific            applications, the disclosure of which
                                                                                                                            Review Branch, Division of Extramural                   would constitute a clearly unwarranted
                                                  amended (5 U.S.C. App.), notice is                                        Research, NINDS/NIH/DHHS/Neuroscience
                                                  hereby given of the following meetings.                                   Center, 6001 Executive Boulevard, Suite
                                                                                                                                                                                    invasion of personal privacy.
                                                    The meetings will be closed to the                                      3208, MSC 9529, Bethesda, MD 20892–9529,                  Name of Committee: Oncology 2—
                                                  public in accordance with the                                             301–496–1917, webbere@mail.nih.gov.                     Translational Clinical Integrated Review



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                                                  29014                        Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices

                                                  Group; Radiation Therapeutics and Biology               Scientific Review, National Institutes of             for companies and may also be available
                                                  Study Section.                                          Health, 6701 Rockledge Drive, Room 6170,              for licensing.
                                                    Date: June 15–16, 2015.                               MSC 7892, Bethesda, MD 20892, 301–435–
                                                                                                                                                                FOR FURTHER INFORMATION CONTACT:
                                                    Time: 8:00 a.m. to 4:00 p.m.                          4514, bleasdaleje@csr.nih.gov.
                                                    Agenda: To review and evaluate grant                                                                        Licensing information and copies of the
                                                                                                            Name of Committee: Molecular, Cellular
                                                  applications.                                                                                                 U.S. patent applications listed below
                                                                                                          and Developmental Neuroscience Integrated
                                                    Place: Embassy Suites at the Chevy Chase              Review Group; Synapses, Cytoskeleton and              may be obtained by writing to the
                                                  Pavilion, 4300 Military Road NW.,                       Trafficking Study Section.                            indicated licensing contact at the Office
                                                  Washington, DC 20015.                                     Date: June 18–19, 2015.                             of Technology Transfer, National
                                                    Contact Person: Bo Hong, Ph.D., Scientific              Time: 8:30 a.m. to 4:00 p.m.                        Institutes of Health, 6011 Executive
                                                  Review Officer, Center for Scientific Review,             Agenda: To review and evaluate grant                Boulevard, Suite 325, Rockville,
                                                  National Institutes of Health, 6701 Rockledge           applications.                                         Maryland 20852–3804; telephone: 301–
                                                  Drive, Room 6194, MSC 7804, Bethesda, MD                  Place: Hotel Monaco Alexandria, 480 King
                                                  20892, 301–996–6208, hongb@csr.nih.gov.                                                                       496–7057; fax: 301–402–0220. A signed
                                                                                                          Street, Alexandria, VA 22314.                         Confidential Disclosure Agreement will
                                                    Name of Committee: Biobehavioral and                    Contact Person: Christine A Piggee, Ph.D.,
                                                  Behavioral Processes Integrated Review                                                                        be required to receive copies of the
                                                                                                          Scientific Review Officer, Center for
                                                  Group; Motor Function, Speech and                       Scientific Review, National Institutes of             patent applications.
                                                  Rehabilitation Study Section.                           Health, 6701 Rockledge Drive, Room 4186,              SUPPLEMENTARY INFORMATION:
                                                    Date: June 15, 2015.                                  MSC 7850, Bethesda, MD 20892, 301–435–                Technology descriptions follow.
                                                    Time: 8:00 a.m. to 6:00 p.m.                          0657, christine.piggee@nih.gov.
                                                    Agenda: To review and evaluate grant                                                                        A Novel Therapeutic Vector for
                                                                                                            Name of Committee: Center for Scientific
                                                  applications.                                           Review Special Emphasis Panel, Traumatic
                                                                                                                                                                Hemoglobin Disorders
                                                    Place: St. Gregory Hotel, 2033 M Street               Brain Injury and Cerebrovascular Disorders.              Description of Technology:
                                                  NW., Washington, DC 20036.                                Date: June 19, 2015.                                Investigators at the National Heart,
                                                    Contact Person: Biao Tian, Ph.D., Scientific            Time: 1:00 p.m. to 3:00 p.m.
                                                  Review Officer, Center for Scientific Review,
                                                                                                                                                                Lung, and Blood Institute have designed
                                                                                                            Agenda: To review and evaluate grant                a novel lentiviral vector as a potential
                                                  National Institutes of Health, 6701 Rockledge           applications.
                                                  Drive, Room 3166, MSC 7848, Bethesda, MD                                                                      gene therapy for sickle cell anemia and
                                                                                                            Place: National Institutes of Health, 6701
                                                  20892, 301–402–4411, tianbi@csr.nih.gov.                Rockledge Drive, Bethesda, MD 20892
                                                                                                                                                                beta-thalassemia. The novel lentiviral
                                                    Name of Committee:Oncology 2—                         (Telephone Conference Call).                          vector encodes the beta-globin gene in a
                                                  Translational Clinical Integrated Review                  Contact Person: Alexander Yakovlev,                 forward orientation and can produce 5–
                                                  Group; Cancer Biomarkers Study Section.                 Ph.D., Scientific Review Officer, Center for          10 fold higher viral titer and 4–10 fold
                                                    Date: June 17, 2015.                                  Scientific Review, National Institutes of             higher gene transfer efficiency to
                                                    Time: 8:00 a.m. to 6:00 p.m.                          Health, 6701 Rockledge Drive, Room 5206,              hematopoietic stem cells than reverse-
                                                    Agenda: To review and evaluate grant                  MSC 7846, Bethesda, MD 20892–7846, 301–               oriented lentiviral vectors. In vivo
                                                  applications.                                           435–1254, yakovleva@csr.nih.gov.                      studies conducted in rhesus macaques
                                                    Place: Embassy Suites at the Chevy Chase              (Catalogue of Federal Domestic Assistance
                                                  Pavilion, 4300 Military Road NW.,
                                                                                                                                                                show beta-globin production after
                                                                                                          Program Nos. 93.306, Comparative Medicine;            transplantation with this novel
                                                  Washington, DC 20015.                                   93.333, Clinical Research, 93.306, 93.333,
                                                    Contact Person: Lawrence Ka-Yun Ng,                                                                         lentiviral vector. This technology could
                                                                                                          93.337, 93.393–93.396, 93.837–93.844,
                                                  Ph.D., Scientific Review Officer, Center for            93.846–93.878, 93.892, 93.893, National
                                                                                                                                                                provide an alternative therapy for
                                                  Scientific Review, National Institutes of               Institutes of Health, HHS)                            patients suffering from blood disorders
                                                  Health, 6701 Rockledge Drive, Room 6152,                                                                      associated with beta-globin gene
                                                  MSC 7804, Bethesda, MD 20892, 301–357–                    Dated: May 15, 2015.                                mutations.
                                                  9318, ngkl@csr.nih.gov.                                 Anna Snouffer,                                           Potential Commercial Applications:
                                                    Name of Committee: Endocrinology,                     Deputy Director, Office of Federal Advisory           Gene therapy.
                                                  Metabolism, Nutrition and Reproductive                  Committee Policy.                                        Competitive Advantages:
                                                  Sciences Integrated Review Group; Cellular              [FR Doc. 2015–12242 Filed 5–19–15; 8:45 am]              • Increased viral titers
                                                  Aspects of Diabetes and Obesity Study
                                                                                                          BILLING CODE 4140–01–P                                   • Increased transduction efficiency
                                                  Section.                                                                                                         • Large scale vector production
                                                    Date: June 18, 2015.                                                                                           Development Stage:
                                                    Time: 8:00 a.m. to 6:00 p.m.
                                                                                                          DEPARTMENT OF HEALTH AND                                 • Early-stage
                                                    Agenda: To review and evaluate grant                                                                           • In vitro data available
                                                  applications.                                           HUMAN SERVICES
                                                                                                                                                                   • In vivo data available (animal)
                                                    Place: Doubletree Hotel Bethesda                                                                               Inventors: Naoya Uchida and John F.
                                                  (Formerly Holiday Inn Select), 8120                     National Institutes of Health
                                                  Wisconsin Avenue, Bethesda, MD 20814.
                                                                                                                                                                Tisdale (NHLBI).
                                                    Contact Person: Alexander D Politis, Ph.D.,           Government-Owned Inventions;                             Intellectual Property: HHS Reference
                                                  Scientific Review Officer, Center for                   Availability for Licensing                            No. E–165–2014/0—U.S. Provisional
                                                  Scientific Review, National Institutes of                                                                     Application No. 62/048,881 filed
                                                  Health, 6701 Rockledge Drive, Room 3210,                AGENCY:    National Institutes of Health,             September 11, 2014.
                                                  MSC 7808, Bethesda, MD 20892, (301) 435–                HHS.                                                     Licensing Contact: Cristina
                                                  1150, politisa@csr.nih.gov.                             ACTION:   Notice.                                     Thalhammer-Reyero, Ph.D.; 301–495–
                                                    Name of Committee: Endocrinology,                                                                           4507; thalhamc@mail.nih.gov.
                                                  Metabolism, Nutrition and Reproductive                  SUMMARY:   The inventions listed below                   Collaborative Research Opportunity:
                                                  Sciences Integrated Review Group; Molecular             are owned by an agency of the U.S.                    The National Heart, Lung and Blood
                                                  and Cellular Endocrinology Study Section.
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                                                                          Government and are available for                      Institute is seeking statements of
                                                    Date: June 18, 2015.                                  licensing in the U.S. in accordance with              capability or interest from parties
                                                    Time: 8:00 a.m. to 6:00 p.m.                                                                                interested in collaborative research to
                                                                                                          35 U.S.C. 209 and 37 CFR part 404 to
                                                    Agenda: To review and evaluate grant
                                                  applications.                                           achieve expeditious commercialization                 further develop, evaluate or
                                                    Place: Residence Inn Bethesda, 7335                   of results of federally-funded research               commercialize this technology. For
                                                  Wisconsin Avenue, Bethesda, MD 20814.                   and development. Foreign patent                       collaboration opportunities, please
                                                    Contact Person: John Bleasdale, Ph.D.,                applications are filed on selected                    contact Denise Crooks at crooksd@
                                                  Scientific Review Officer, Center for                   inventions to extend market coverage                  mail.nih.gov.


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Document Created: 2018-02-21 10:29:39
Document Modified: 2018-02-21 10:29:39
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
DatesJune 15-16, 2015.
FR Citation80 FR 29013 

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