80_FR_10167 80 FR 10130 - Center for Scientific Review; Notice of Closed Meetings

80 FR 10130 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 37 (February 25, 2015)

Page Range10130-10131
FR Document2015-03778

Federal Register, Volume 80 Issue 37 (Wednesday, February 25, 2015)
[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10130-10131]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03778]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (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; Member Conflict: Autoimmunity Transplantation Intolerance.
    Date: March 11, 2015.
    Time: 3:00 p.m. to 7:00 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: Betty Hayden, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 4206, MSC 7812, Bethesda, MD 20892, 301-435-
1223, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Topics in Drug Discovery and Mechanisms of Antimicrobial 
Resistance.
    Date: March 13, 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: Guangyong Ji, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 3211, MSC 7808, Bethesda, MD 20892, 301-435-
1146, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Skeletal Muscle related SBIR/STTR.
    Date: March 17, 2015.
    Time: 1:00 p.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892, (Telephone Conference Call).
    Contact Person: Richard Ingraham, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4116, MSC 7814, Bethesda, MD 
20892, 301-496-8551, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Program Project: Regulation of Cell Survival and Death 
Pathways by Fe-S Proteins.
    Date: March 19-20, 2015.
    Time: 11:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892, (Virtual Meeting).

[[Page 10131]]

    Contact Person: William A. Greenberg, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4168, MSC 7806, Bethesda, MD 
20892, (301) 435-1726, [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: February 19, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-03778 Filed 2-24-15; 8:45 am]
BILLING CODE 4140-01-P



                                                    10130                     Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices

                                                    progressive multifocal                                  cell division. 89Zr-oxine labeled cells                 The meetings will be closed to the
                                                    leukoencephalopathy (PML), and                          can also be easily cross labeled (for                 public in accordance with the
                                                    trichodysplasia spinulosa (TS). The                     example, optically or magnetically) for               provisions set forth in sections
                                                    methods could also be used to restore                   multi-modality imaging and analysis.                  552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                    polyomavirus-specific immunity in                       Labeled cell migration and kinetics can               as amended. The grant applications and
                                                    immunocompromised individuals.                          be analyzed and quantified in vivo over               the discussions could disclose
                                                       Potential Commercial Applications:                   a week, improving research strategies                 confidential trade secrets or commercial
                                                    Immunotherapy for immunosuppressed                      and ability to develop and improve cell               property such as patentable material,
                                                    individuals with polyomavirus-                          therapies and diagnostics.                            and personal information concerning
                                                    associated pathologies.                                    Potential Commercial Applications:                 individuals associated with the grant
                                                       Competitive Advantages: Methods                      Cell therapies and diagnostics.                       applications, the disclosure of which
                                                    allow development of polyomavirus                          Competitive Advantages: Simple                     would constitute a clearly unwarranted
                                                    antigen-specific T cells.                               preparation, broadly applicable cell                  invasion of personal privacy.
                                                       Development Stage:                                   label, high resolution imaging and                      Name of Committee: Center for Scientific
                                                       • Early-stage                                        monitoring over period of a week, low                 Review Special Emphasis Panel; Member
                                                       • In vitro data available                            toxicity, easily combined with labeling               Conflict: Autoimmunity Transplantation
                                                       Inventors: John A. Barrett (NHLBI),                  technologies and cell therapies.                      Intolerance.
                                                    Dhanalakshmi Chinnasamy (NHLBI),                           Development Stage: In vivo data                      Date: March 11, 2015.
                                                    Pawel J. Muranski (NHLBI), Christopher                  available (animal).                                     Time: 3:00 p.m. to 7:00 p.m.
                                                    B. Buck (NCI)                                              Inventors: Noriko Sato (NCI), Haitao                 Agenda: To review and evaluate grant
                                                       Intellectual Property: HHS Reference                 Wu (NHLBI), Gary L. Griffiths (NCI),                  applications.
                                                    No. E–166–2014/0—US Application No.                     Peter L. Choyke (NCI)                                   Place: National Institutes of Health, 6701
                                                    62/075,726 filed November 5, 2014                          Publications:                                      Rockledge Drive, Bethesda, MD 20892,
                                                       Related Technologies:                                   1. Sato N, et al. Generation and use of            (Telephone Conference Call).
                                                       • HHS Reference No. E–168–2011                       long-lasting cell labeling agent for                    Contact Person: Betty Hayden, Ph.D.,
                                                                                                                                                                  Scientific Review Officer, Center for
                                                       • HHS Reference No. E–549–2013                       positron emission tomography (PET)
                                                                                                            imaging. J Nucl Med. May 2014; 55                     Scientific Review, National Institutes of
                                                       Licensing Contact: Patrick McCue,                                                                          Health, 6701 Rockledge Drive, Room 4206,
                                                    Ph.D.; 301–435–5560; mccuepat@                          (Supplement 1):273.                                   MSC 7812, Bethesda, MD 20892, 301–435–
                                                    od.nih.gov                                                 2. Sato N, et al. 89Zr-oxine complex               1223, haydenb@csr.nih.gov.
                                                       Collaborative Research Opportunity:                  positron emission tomography (PET)
                                                                                                                                                                    Name of Committee: Center for Scientific
                                                    The National Heart, Lung, and Blood                     cell imaging for monitoring cell-based
                                                                                                                                                                  Review Special Emphasis Panel; Topics in
                                                    Institute is seeking statements of                      therapies. Radiology, 2015, In press.                 Drug Discovery and Mechanisms of
                                                    capability or interest from parties                        Intellectual Property: HHS Reference               Antimicrobial Resistance.
                                                    interested in collaborative research to                 No. E–080–2014/0—US Patent                              Date: March 13, 2015.
                                                    further develop, evaluate or                            Application No. 61/973,706 filed April                  Time: 8:00 a.m. to 6:00 p.m.
                                                    commercialize methods to generate T                     1, 2014                                                 Agenda: To review and evaluate grant
                                                    cells responsive to multiple                               Licensing Contact: Edward (Tedd)                   applications
                                                    polyomaviruses. For collaboration                       Fenn; 424–297–0336; Tedd.fenn@                          Place: Residence Inn Bethesda, 7335
                                                    opportunities, please contact Dr.                       nih.gov                                               Wisconsin Avenue, Bethesda, MD 20814.
                                                    Vincent Kolesnitchenko at kolesniv@                        Collaborative Research Opportunity:                  Contact Person: Guangyong Ji, Ph.D.,
                                                                                                            The National Cancer Institute is seeking              Scientific Review Officer, Center for
                                                    nhlbi.nih.gov.                                                                                                Scientific Review, National Institutes of
                                                                                                            statements of capability or interest from
                                                    89Zr-Oxine   Complex for In Vivo PET                    parties interested in collaborative                   Health, 6701 Rockledge Drive, Room 3211,
                                                    Imaging of Labelled Cells and                           research to further develop, evaluate or              MSC 7808, Bethesda, MD 20892, 301–435–
                                                                                                                                                                  1146, jig@csr.nih.gov.
                                                    Associated Methods                                      commercialize cell labeling, cell
                                                                                                            tracking, cell trafficking, cell-based                  Name of Committee: Center for Scientific
                                                       Description of Technology: This                                                                            Review Special Emphasis Panel; Skeletal
                                                    technology relates to a Zirconium-89                    therapy, PET imaging. For collaboration
                                                                                                                                                                  Muscle related SBIR/STTR.
                                                    (89Zr)-oxine complex for cell labeling,                 opportunities, please contact John D.                   Date: March 17, 2015.
                                                    tracking of labeled cells by whole-body                 Hewes, Ph.D. at john.hewes@nih.gov or                   Time: 1:00 p.m. to 4:00 p.m.
                                                    positron emission tomography/                           240–276–5515.                                           Agenda: To review and evaluate grant
                                                    computed tomography (PET/CT)                              Dated: February 18, 2015.                           applications.
                                                    imaging, and associated methods. A                      Richard U. Rodriguez,                                   Place: National Institutes of Health, 6701
                                                                                                                                                                  Rockledge Drive, Bethesda, MD 20892,
                                                    long half-life of 89Zr (78.4 hours), high               Acting Director, Office of Technology
                                                                                                                                                                  (Telephone Conference Call).
                                                    sensitivity of PET and absence of                       Transfer, National Institutes of Health.
                                                                                                                                                                    Contact Person: Richard Ingraham, Ph.D.,
                                                    background signal in the recipient                      [FR Doc. 2015–03779 Filed 2–24–15; 8:45 am]           Scientific Review Officer, Center for
                                                    enable tracking cells over a week using                 BILLING CODE 4140–01–P                                Scientific Review, National Institutes of
                                                    low levels of labeling radioactivity,                                                                         Health, 6701 Rockledge Drive, Room 4116,
                                                    without causing cellular toxicity. The                                                                        MSC 7814, Bethesda, MD 20892, 301–496–
                                                    89Zr-oxine complex is synthesized                       DEPARTMENT OF HEALTH AND                              8551, ingrahamrh@mail.nih.gov.
                                                    quickly by mixing components at room                    HUMAN SERVICES                                          Name of Committee: Center for Scientific
                                                    temperature and produces high yields.                                                                         Review Special Emphasis Panel; Program
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    Cell labeling is achieved by a short,                   National Institutes of Health                         Project: Regulation of Cell Survival and
                                                    room temperature incubation. The 89Zr-                                                                        Death Pathways by Fe-S Proteins.
                                                                                                            Center for Scientific Review; Notice of                 Date: March 19–20, 2015.
                                                    oxine complex is capable of labeling a
                                                                                                            Closed Meetings                                         Time: 11:00 a.m. to 5:00 p.m.
                                                    wide range of cell types of therapeutic                                                                         Agenda: To review and evaluate grant
                                                    or pathogenic relevance (natural,                         Pursuant to section 10(d) of the                    applications.
                                                    disease, engineered cells), independent                 Federal Advisory Committee Act, as                      Place: National Institutes of Health, 6701
                                                    of factors such as cell cycle or receptor               amended (5 U.S.C. App.), notice is                    Rockledge Drive, Bethesda, MD 20892,
                                                    expression. The label is retained during                hereby given of the following meetings.               (Virtual Meeting).



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                                                                              Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices                                          10131

                                                      Contact Person: William A. Greenberg,                 in this notice, Policy Letter 01–14                      On February 7, 2014, the Coast Guard
                                                    Ph.D., Scientific Review Officer, Center for            became Policy Letter 01–15 and Policy                 published two draft policy letters (CG–
                                                    Scientific Review, National Institutes of               Letter 02–14 became Policy Letter 02–                 OES 01–14 and CG–OES 02–14),
                                                    Health, 6701 Rockledge Drive, Room 4168,                15.                                                   requesting comments, that
                                                    MSC 7806, Bethesda, MD 20892, (301) 435–
                                                    1726, greenbergwa@csr.nih.gov.                          FOR FURTHER INFORMATION CONTACT: If                   recommended the transfer procedures
                                                                                                            you have questions on this notice, call               and other operating guidelines for
                                                    (Catalogue of Federal Domestic Assistance
                                                    Program Nos. 93.306, Comparative Medicine;              or email Ken Smith, Vessel and Facility               vessels and waterfront facilities
                                                    93.333, Clinical Research, 93.306, 93.333,              Operating Standards Division (CG–                     providing LNG to vessels for use as fuel
                                                    93.337, 93.393–93.396, 93.837–93.844,                   OES–2), U.S. Coast Guard; telephone                   and for vessels operating in U.S. waters
                                                    93.846–93.878, 93.892, 93.893, National                 202–372–1413, email Ken.A.Smith@                      that will be fueled with natural gas that
                                                    Institutes of Health, HHS)                              uscg.mil. If you have questions on                    will be stored onboard as LNG. The
                                                                                                            viewing or submitting material to the                 Coast Guard has revised these policy
                                                      Dated: February 19, 2015.
                                                                                                            docket, call Cheryl Collins, Program                  letters based on comments received and
                                                    Carolyn Baum,                                                                                                 now makes the final policy letters
                                                                                                            Manager, Docket Operations, telephone
                                                    Program Analyst, Office of Federal Advisory                                                                   available to the public.
                                                    Committee Policy.                                       202–366–9826.
                                                                                                                                                                     The policy letters and voluntary
                                                                                                            SUPPLEMENTARY INFORMATION:
                                                    [FR Doc. 2015–03778 Filed 2–24–15; 8:45 am]                                                                   guidance do not apply to vessels
                                                                                                               Viewing material in the docket: To
                                                    BILLING CODE 4140–01–P                                                                                        regulated as LNG carriers that utilize
                                                                                                            view the policy letters and related
                                                                                                                                                                  their boil-off gas as fuel. They also do
                                                                                                            material, go to http://
                                                                                                                                                                  not provide guidance on vessel design
                                                                                                            www.regulations.gov, type the docket
                                                    DEPARTMENT OF HOMELAND                                                                                        criteria for natural gas fuel systems or
                                                                                                            number (USCG–2013–1084) in the
                                                    SECURITY                                                                                                      design of vessels providing LNG for use
                                                                                                            ‘‘SEARCH’’ box and click ‘‘SEARCH.’’
                                                                                                                                                                  as fuel. If you have questions about the
                                                                                                            Click on ‘‘Open Docket Folder’’ on the
                                                    Coast Guard                                                                                                   design of these systems, please contact
                                                                                                            line associated with this notice. If you
                                                                                                                                                                  the Coast Guard’s Office of Design and
                                                    [Docket No. USCG–2013–1084]                             do not have access to the Internet, you
                                                                                                                                                                  Engineering Standards (CG–ENG,
                                                                                                            may view the docket online by visiting
                                                    Policy Letters: Guidance for the Use of                                                                       formerly CG–521). See FOR FURTHER
                                                                                                            the Docket Management facility in
                                                    Liquefied Natural Gas as a Marine Fuel                                                                        INFORMATION CONTACT section for contact
                                                                                                            Room W12–140 on the ground floor of
                                                                                                                                                                  information.
                                                    AGENCY:   Coast Guard, DHS.                             the Department of Transportation West
                                                                                                            Building, 1200 New Jersey Avenue SE.,                 Discussion
                                                    ACTION:   Notice of availability.
                                                                                                            Washington, DC 20590, between 9 a.m.                     The Coast Guard received 27 letters
                                                    SUMMARY:    On February 7, 2014, the                    and 5 p.m., Monday through Friday,                    from the public containing a combined
                                                    Coast Guard announced the availability,                 except Federal holidays. We have an                   total of 185 individual comments which
                                                    in the docket, of two draft policy letters              agreement with the Department of                      are discussed below. We discuss more
                                                    for which it sought public comment.                     Transportation to use the Docket                      fully the changes we made to the policy
                                                    This notice announces the availability                  Management Facility.                                  letters in response to comments.
                                                    of the finalized Coast Guard policy                        Privacy Act: Anyone can search the                    All letters received were generally
                                                    letters, including explanations of                      electronic form of comments received                  supportive of the Coast Guard’s effort to
                                                    changes made to the policy letters and                  into any of our dockets by the name of                provide guidance on the use and
                                                    enclosures based on the public                          the individual submitting the comment                 transfer of LNG as a marine fuel and the
                                                    comments received. The first policy                     (or signing the comment, if submitted                 Coast Guard appreciates this important
                                                    letter provides voluntary guidance for                  on behalf of an association, business,                feedback.
                                                    liquefied natural gas (LNG) fuel transfer               labor union, etc.). You may review a                     We also received various comments
                                                    operations on vessels using natural gas                 Privacy Act, system of records notice                 recommending changes that cannot be
                                                    as fuel in U.S. waters, and training of                 regarding our public dockets in the                   made in a policy document because the
                                                    personnel on those vessels. It                          January 17, 2008, issue of the Federal                Coast Guard would need to undergo
                                                    recommends transfer and personnel                       Register (73 FR 3316).                                rulemaking to make these recommended
                                                    training measures that we believe will                  Background and Purpose                                changes enforceable. For example, one
                                                    achieve a level of safety that is at least                                                                    submitter suggested that we provide
                                                                                                               The shipping industry is exploring
                                                    equivalent to that provided for                                                                               specific details concerning the
                                                                                                            conversion from oil-based fuel to
                                                    traditional fueled vessels. It applies to               cleaner burning natural gas, because the              information that risk assessments
                                                    vessels equipped to receive LNG for use                 use of natural gas as fuel would                      should contain. Another submitter
                                                    as fuel, but not to vessels regulated as                substantially reduce carbon emissions,                suggested that we provide common
                                                    LNG carriers that utilize boil-off gas as               sulfur emissions, and nitrogen oxide                  checklists for industry to follow when
                                                    fuel. The second policy letter discusses                emissions. This natural gas fuel would                conducting bunkering operations. The
                                                    voluntary guidance and existing                         be stored on and transferred to vessels               Coast Guard will consider these
                                                    regulations applicable to vessels and                   in the form of liquefied natural gas                  comments and determine whether any
                                                    waterfront facilities conducting LNG                    (LNG). Existing regulations cover                     further action is necessary.
                                                    marine fuel transfer (bunkering)                        design, equipment, operations, and                    Additionally, the Coast Guard received
                                                    operations. The second policy letter                                                                          comments on matters unrelated to the
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                                                                            training of personnel on vessels that
                                                    provides voluntary guidance on safety,                  carry LNG as cargo and at waterfront                  two policy letters discussed in this
                                                    security, and risk assessment measures                  facilities that handle LNG in bulk. They              notice. Those comments have been
                                                    we believe will enhance safe LNG                        also cover conventional oil fuel transfer             reviewed but did not effect any changes
                                                    bunkering operations. Both policy                       operations, but do not address LNG                    to these policy letters. Examples of some
                                                    letters are available on the public                     transferred as fuel.1                                 of the comments we received pertaining
                                                    docket. They have been updated to                                                                             to design were related to venting
                                                    reflect publication numbers of the                        1 33 CFR parts 127, 155 and 156; 46 CFR parts 10–   arrangements, LNG tank design, and gas
                                                    current year. Accordingly, as discussed                 15, 30–39, and 154.                                   detection.


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Document Created: 2015-12-18 13:08:46
Document Modified: 2015-12-18 13:08:46
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
DatesMarch 11, 2015.
FR Citation80 FR 10130 

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