81_FR_7851 81 FR 7821 - Center for Scientific Review; Notice of Closed Meeting

81 FR 7821 - Center for Scientific Review; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 30 (February 16, 2016)

Page Range7821-7822
FR Document2016-02973

Federal Register, Volume 81 Issue 30 (Tuesday, February 16, 2016)
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7821-7822]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02973]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Notice of Closed Meeting

    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 
meeting.
    The meeting 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; Special Topic: Social Sciences and Population Studies.
    Date: February 23, 2016.
    Time: 12:00 p.m. to 12:30 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: Suzanne Ryan, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of

[[Page 7822]]

Health, 6701 Rockledge Drive, Room 3139, MSC 7770, Bethesda, MD 
20892, (301) 435-1712, ryansj@csr.nih.gov.

    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

(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 9, 2016.
Sylvia Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-02973 Filed 2-12-16; 8:45 am]
 BILLING CODE 4140-01-P



                                                                              Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices                                                  7821

                                                    Licensing Opportunity: Researchers at                    Title of invention: Modified griffithsin           —A. Chatterjee et al.,Griffithsin and
                                                  the NICHD seek licensing and/or co-                     tandemers for enhanced activity and                    Carrageenan Combination To Target
                                                  development research collaborations for                 reduced viral aggregation.                             Herpes Simplex Virus 2 and Human
                                                                                                             Description of Technology: Griffithsin              Papillomavirus, Antimicrob Agents
                                                  the therapeutic management of Menkes                                                                           Chemother. 2015 Dec; 59(12): 7290–7298.
                                                  Disease and related copper transport                    (GRFT) is a lectin with potent antiviral
                                                  disorders.                                              properties that is capable of preventing              Intellectual Property
                                                                                                          and treating infections caused by a                     HHS Reference No. E–034–2013/0–
                                                  Contact Information
                                                                                                          number of enveloped viruses (including                US–01.
                                                    Requests for copies of the patent                     HIV, SARS, HCV, HSV, and Japanese                       PCT Application No. PCT/US2014/
                                                  application or inquiries about licensing,               encephalitis) and is currently in clinical            040992 (HHS Reference No. E–034–
                                                  research collaborations, and co-                        development as an anti-HIV                            2013/0- US–01) filed June 5, 2013
                                                  development opportunities should be                     microbicide. In addition to its broad                 entitled ‘‘Modified griffithsin tandemers
                                                  sent to John D. Hewes, Ph.D., email:                    antiviral activity, GRFT is stable at high            for enhanced activity and reduced viral
                                                  john.hewes@nih.gov.                                     temperature and at a broad pH range,                  aggregation’’.
                                                    Dated: February 8, 2016.                              displays low toxicity and                               Licensing and Collaborative/Co-
                                                  John D. Hewes,                                          immunogenicity, and is amenable to                    Development Research Opportunity:
                                                  Technology Transfer Specialist, Technology              large-scale manufacturing. Native GRFT                Researchers at the NCI seek licensees
                                                  Transfer Center, National Cancer Institute.             is a domain-swapped homodimer that                    and/or co-development partners for the
                                                  [FR Doc. 2016–02970 Filed 2–12–16; 8:45 am]             binds to viral envelope glycoproteins                 commercialization of Griffithsin and
                                                  BILLING CODE 4140–01–P                                  and has displayed mid-picomolar                       Griffithsin tandemers, specifically,
                                                                                                          activity in cell-based anti-HIV assays.               additional studies on stability, toxicity,
                                                                                                          This invention is directed to synthetic               immunogenicity, and large-scale
                                                  DEPARTMENT OF HEALTH AND                                proteins that comprise two (or more)                  production.
                                                  HUMAN SERVICES                                          obligate monomers (‘‘mGRFT’’) joined                    Dated: February 1, 2016.
                                                                                                          by an amino acid linker to form
                                                  National Institutes of Health                                                                                 John D. Hewes,
                                                                                                          tandemers (‘‘mGRFT tandemers’’). Each
                                                                                                                                                                Technology Transfer Specialist, Technology
                                                                                                          obligate monomer is generated by the
                                                  Government-Owned Inventions;                                                                                  Transfer Center, National Cancer Institute.
                                                                                                          addition of Gly-Ser residues in the hinge
                                                  Availability for Licensing                              region of wild-type GRFT. Two or more                 [FR Doc. 2016–02971 Filed 2–12–16; 8:45 am]
                                                                                                                                                                BILLING CODE 4140–01–P
                                                  AGENCY:    National Institutes of Health,               obligate monomers are joined by an
                                                  HHS.                                                    amino acid linker to form the mGRFT
                                                  ACTION:   Notice.                                       tandamers. The properties of the
                                                                                                                                                                DEPARTMENT OF HEALTH AND
                                                                                                          mGRFT tandemers can be modulated by
                                                                                                                                                                HUMAN SERVICES
                                                  SUMMARY:    The invention listed below is               the length of the amino acid linker and
                                                  owned by an agency of the U.S.                          the number of obligate monomers co-                   National Institutes of Health
                                                  Government and is available for                         joined. mGRFT tandemers exhibit gore
                                                  licensing and/or co-development in the                  potent anti-viral properties when                     Center for Scientific Review; Notice of
                                                  U.S. in accordance with 35 U.S.C. 209                   compared against native GRFT and are                  Closed Meeting
                                                  and 37 CFR part 404 to achieve                          equipotent against viruses that are both
                                                  expeditious commercialization of                        sensitive and resistant to naive GRFT.                  Pursuant to section 10(d) of the
                                                  results of federally-funded research and                As such, potential uses of the invention              Federal Advisory Committee Act, as
                                                  development. Foreign patent                             tandemers include topical and                         amended (5 U.S.C. App.), notice is
                                                  applications are filed on selected                      intravenous therapy to treat HIV                      hereby given of the following meeting.
                                                  inventions to extend market coverage                                                                            The meeting will be closed to the
                                                                                                          infection, particularly to treat HIV
                                                  for companies and may also be available                                                                       public in accordance with the
                                                                                                          infections that are resistant to native
                                                  for licensing and/or co-development.                                                                          provisions set forth in sections
                                                                                                          GRFT.
                                                                                                                                                                552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                  ADDRESSES: Information on licensing,
                                                                                                          Potential Commercial Applications                     as amended. The grant applications and
                                                  co-development research collaborations,                                                                       the discussions could disclose
                                                  and/or copies of the U.S. patent                        • Broad-spectrum antiviral agent
                                                                                                            similar to wild type GRFT                           confidential trade secrets or commercial
                                                  applications listed below may be                                                                              property such as patentable material,
                                                  obtained by contacting: Attn. Invention                 • Potential activity against SARS CoV,
                                                                                                            MERS, Ebola, HCV and influenza                      and personal information concerning
                                                  Development and Marketing Unit,                                                                               individuals associated with the grant
                                                  Technology Transfer Center, National                    Value Proposition                                     applications, the disclosure of which
                                                  Cancer Institute, 9609 Medical Center
                                                                                                          • Broad antiviral activity                            would constitute a clearly unwarranted
                                                  Drive, Mail Stop 9702, Rockville, MD,                   • Stable at high temperature and at a                 invasion of personal privacy.
                                                  20850–9702, Tel. 240–276–5515 or                          broad pH range
                                                  email ncitechtransfer@mail.nih.gov. A                                                                           Name of Committee: Center for Scientific
                                                                                                          • Displays low toxicity and                           Review Special Emphasis Panel; Special
                                                  signed Confidential Disclosure                            immunogenicity.                                     Topic: Social Sciences and Population
                                                  Agreement may be required to receive                                                                          Studies.
                                                  copies of the patent applications.                        Development Stage: In vivo/Lead
                                                                                                                                                                  Date: February 23, 2016.
                                                  FOR FURTHER INFORMATION CONTACT:
                                                                                                          Validation.
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                                                                                                                                                                  Time: 12:00 p.m. to 12:30 p.m.
                                                                                                            Inventor(s): Barry R. O’Keefe (NCI), A.               Agenda: To review and evaluate grant
                                                  Requests for copies of the patent
                                                                                                          Wlodawer (NCI), T. Moulaei (NCI).                     applications.
                                                  application or inquiries about licensing
                                                  and/or co-development should be sent                    Publication(s)                                          Place: National Institutes of Health, 6701
                                                                                                                                                                Rockledge Drive, Bethesda, MD 20892
                                                  to John D. Hewes, Ph.D., email:                         —Moulaei T. et al., Griffithsin tandemers:            (Telephone Conference Call).
                                                  john.hewes@nih.gov.                                      flexible and potent lectin inhibitors of the           Contact Person: Suzanne Ryan, Ph.D.,
                                                  SUPPLEMENTARY INFORMATION:                               human immunodeficiency virus.                        Scientific Review Officer, Center for
                                                  Technology description follows.                          Retrovirology. 2015 Jan 23;12:6.                     Scientific Review, National Institutes of



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                                                  7822                        Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices

                                                  Health, 6701 Rockledge Drive, Room 3139,                Background                                            participants in NEXUS and certain
                                                  MSC 7770, Bethesda, MD 20892, (301) 435–                                                                      participants in SENTRI would still be
                                                  1712, ryansj@csr.nih.gov.                               Global Entry Program
                                                                                                                                                                allowed to use the Global Entry kiosks.
                                                    This notice is being published less than 15                                                                    In a notice published in the Federal
                                                                                                             Global Entry is a voluntary program
                                                  days prior to the meeting due to the timing                                                                   Register (78 FR 48706) on August 9,
                                                  limitations imposed by the review and
                                                                                                          that allows for dedicated CBP
                                                                                                          processing of pre-approved travelers                  2013, CBP expanded Global Entry
                                                  funding cycle.
                                                                                                          arriving in the United States at Global               eligibility to include citizens of the
                                                  (Catalogue of Federal Domestic Assistance                                                                     Republic of Korea who are participants
                                                  Program Nos. 93.306, Comparative Medicine;              Entry kiosks located at designated
                                                                                                          airports. On February 6, 2012, CBP                    in the Smart Entry System (SES), a
                                                  93.333, Clinical Research, 93.306, 93.333,
                                                  93.337, 93.393–93.396, 93.837–93.844,                   issued the final rule that promulgated                trusted traveler program for pre-
                                                  93.846–93.878, 93.892, 93.893, National                 the regulation (8 CFR 235.12) to                      approved, low-risk travelers at
                                                  Institutes of Health, HHS)                              establish Global Entry as an ongoing                  designated airports in the Republic of
                                                                                                          voluntary regulatory program in the                   Korea via the use of e-gates; a limited
                                                    Dated: February 9, 2016.
                                                                                                          Federal Register (77 FR 5681). The final              number of citizens of the State of Qatar;
                                                  Sylvia Neal,
                                                                                                          rule contains a detailed description of               and a limited number of citizens of the
                                                  Program Analyst, Office of Federal Advisory                                                                   United Kingdom who frequently travel
                                                  Committee Policy.                                       the program, the eligibility criteria, the
                                                                                                          application and selection process, and                to the United States.
                                                  [FR Doc. 2016–02973 Filed 2–12–16; 8:45 am]                                                                      In a notice published in the Federal
                                                                                                          the initial airport locations. Travelers
                                                  BILLING CODE 4140–01–P
                                                                                                          who wish to participate in Global Entry               Register (80 FR 1509) on January 12,
                                                                                                          must apply via the Global On-Line                     2015, CBP expanded Global Entry
                                                                                                          Enrollment System (GOES) Web site,                    eligibility to include citizens of the
                                                                                                          https://goes-app.cbp.dhs.gov, and pay                 Republic of Panama. Additionally, this
                                                  DEPARTMENT OF HOMELAND
                                                                                                          the applicable fee. Applications for                  document announced that U.S. citizens
                                                  SECURITY
                                                                                                          Global Entry must be completed and                    who participate in Global Entry or U.S.
                                                  U.S. Customs and Border Protection                      submitted electronically.                             citizens who can utilize Global Entry
                                                                                                                                                                kiosks as NEXUS or SENTRI
                                                                                                             Eligibility for participation in Global            participants have the option to apply for
                                                  [CBP Dec. No. 16–04]                                    Entry is limited to U.S. citizens, U.S.               membership in Panama Global Pass, the
                                                                                                          nationals, U.S. lawful permanent                      Republic of Panama’s trusted traveler
                                                  Expansion of Global Entry Eligibility to                residents, and certain nonimmigrant
                                                  All Citizens of the Federal Republic of                                                                       program.
                                                                                                          aliens from countries that have entered
                                                  Germany                                                 into arrangements with CBP regarding                  Limited Global Entry Pilot for Certain
                                                  AGENCY:  U.S. Customs and Border                        international trusted traveler programs.              German Citizens
                                                  Protection; Department of Homeland                      Specifically, the regulation provides                    In the August 9, 2013 notice
                                                  Security.                                               that certain nonimmigrant aliens from                 referenced in the previous section, CBP
                                                  ACTION: General notice.
                                                                                                          countries that have entered into                      also announced a limited Global Entry
                                                                                                          arrangements with CBP concerning                      pilot program allowing certain German
                                                  SUMMARY:    U.S. Customs and Border                     international trusted traveler programs               citizens to apply for Global Entry. This
                                                  Protection (CBP) has established the                    may be eligible to apply for                          pilot program allowed certain German
                                                  Global Entry international trusted                      participation in Global Entry after CBP               citizens who participated in ABG Plus,
                                                  traveler program at most major U.S.                     announces the arrangement by                          Germany’s former trusted traveler
                                                  airports. Global Entry allows pre-                      publication of a notice in the Federal                program, to apply for participation in
                                                  approved participants dedicated CBP                     Register. The notice will include the                 Global Entry.2 During this limited pilot,
                                                  processing into the United States using                 country, the scope of eligibility of                  German citizens who were identified as
                                                  Global Entry kiosks located at                          nonimmigrant aliens from that country                 potentially being eligible for
                                                  designated airports. In 2013, CBP                       (e.g., whether only citizens of the                   participation in the pilot program
                                                  announced a limited pilot program                       foreign country or citizens and non-                  received a promotional code and
                                                  through which certain citizens of the                   citizens are eligible) and other                      information about the program from the
                                                  Federal Republic of Germany (Germany)                   conditions that may apply based on the                German government. The United States
                                                  were eligible to apply for participation                terms of the arrangement. See 8 CFR                   and Germany limited the number of
                                                  in the Global Entry program. This                       235.12(b)(1)(ii). In the preamble of the              citizens who could apply for Global
                                                  document announces that CBP is                          Global Entry final rule, CBP recognized               Entry to allow for the development of
                                                  concluding the pilot and expanding                      the existence of previous arrangements                the program’s infrastructure. The notice
                                                  eligibility in the Global Entry program                 it had with Mexico and the Netherlands                stated that CBP expected to be able to
                                                  to include all German citizens.                         regarding the international trusted                   expand eligiblility to include all
                                                  Additionally, this document announces                   traveler programs and announced that                  German citizens in the near future and
                                                  that certain U.S. citizens may apply for                Mexican nationals and certain citizens                that such an expansion would be
                                                  membership in EasyPASS, Germany’s                       of the Netherlands were eligible to                   announced by notice in the Federal
                                                  registered traveler program.                            apply for the Global Entry program. CBP               Register and on http://
                                                  DATES: Global Entry eligibility will be                 further specified that Mexican nationals              www.globalentry.gov.
                                                  expanded to German citizens on                          and citizens of the Netherlands who
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                                                                                                          were existing participants in the Global              Expansion of Global Entry Program to
                                                  February 16, 2016. Applications will be                                                                       Include All Citizens of Germany
                                                  accepted beginning February 16, 2016.                   Entry pilot would be automatically
                                                                                                          enrolled in the ongoing Global Entry                    This document announces that
                                                  FOR FURTHER INFORMATION CONTACT:
                                                                                                          program. CBP also stated that pursuant                pursuant to the Joint Declaration signed
                                                  Larry Panetta, Office of Field
                                                                                                          to a previous Federal Register notice,1
                                                  Operations, (202) 344–1253,
                                                                                                                                                                notice, December 29, 2010 (75 FR 82202) for further
                                                  Larry.A.Panetta@cbp.dhs.gov.                              1 See
                                                                                                               the Utilization of Global Entry Kiosks by        information.
                                                  SUPPLEMENTARY INFORMATION:                              NEXUS and SENTRI Participants Federal Register          2 ABG Plus has since been discontinued.




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Document Created: 2016-02-13 03:13:35
Document Modified: 2016-02-13 03:13:35
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
DatesFebruary 23, 2016.
FR Citation81 FR 7821 

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