80_FR_36950 80 FR 36827 - National Institute of General Medical Sciences; Notice of Closed Meetings

80 FR 36827 - National Institute of General Medical Sciences; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 123 (June 26, 2015)

Page Range36827-36828
FR Document2015-15659

Federal Register, Volume 80 Issue 123 (Friday, June 26, 2015)
[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36827-36828]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15659]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of General Medical Sciences; 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: National Institute of General Medical 
Sciences Special Emphasis Panel; Medical Scientist Training Program 
Grants.
    Date: July 14, 2015.
    Time: 1:00 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Natcher Building, 45 
Center Drive, Room 3An.12, Bethesda, MD 20892, (Telephone Conference 
Call).
    Contact Person: Rebecca H. Johnson, Ph.D., Scientific Review 
Officer, Office of Scientific Review, National Institute of General 
Medical Sciences, National Institutes of Health, 45 Center Drive, 
Room 3An.18C, Bethesda, MD 20892, 301-594-2771, 
[email protected].

    Name of Committee: National Institute of General Medical 
Sciences Special Emphasis

[[Page 36828]]

Panel Review of R25 Research Training Grant Applications.
    Date: July 17, 2015.
    Time: 8:30 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Courtyard by Marriott Chevy Chase, 5520 Wisconsin Avenue, 
Chevy Chase, MD 20815
    Contact Person: Lisa A. Dunbar, Ph.D., Scientific Review 
Officer, Office of Scientific Review, National Institute of General 
Medical Sciences, National Institutes of Health, 45 Center Drive, 
Room 3An.12F, Bethesda, MD 20892, 301-594-2849, 
[email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.375, 
Minority Biomedical Research Support; 93.821, Cell Biology and 
Biophysics Research; 93.859, Pharmacology, Physiology, and 
Biological Chemistry Research; 93.862, Genetics and Developmental 
Biology Research; 93.88, Minority Access to Research Careers; 93.96, 
Special Minority Initiatives, National Institutes of Health, HHS)

    Dated: June 22, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-15659 Filed 6-25-15; 8:45 am]
BILLING CODE 4140-01-P



                                                                              Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices                                                  36827

                                                 for the prophylaxis and treatment of                   Complete applications for a license in                  Place: NIAAA, NIH, 5635 Fishers Lane,
                                              cancer.’’                                               an appropriate field of use that are filed             Room CR2098, Rockville, MD 20852,
                                                                                                      in response to this notice will be treated             (Telephone Conference Call).
                                              DATES: Only applications for a license
                                                                                                                                                                Contact Person: Ranga Srinivas, Ph.D.,
                                              which are received by the NIH Office of                 as objections to the grant of the                      Chief, Extramural Project Review Branch,
                                              Technology Transfer on or before July                   contemplated exclusive license.                        National Institute on Alcohol Abuse and
                                              27, 2015 will be considered.                            Comments and objections submitted to                   Alcoholism, NIH, 5635 Fishers Lane, Room
                                              ADDRESSES: Requests for copies of the                   this notice will not be made available                 2085, Rockville, MD 20852, (301) 451–2067,
                                              patent application, inquiries, comments,                for public inspection and, to the extent               srinivar@mail.nih.gov.
                                                                                                      permitted by law, will not be released                 (Catalogue of Federal Domestic Assistance
                                              and other materials relating to the
                                                                                                      under the Freedom of Information Act,                  Program Nos. 93.271, Alcohol Research
                                              contemplated exclusive license should                                                                          Career Development Awards for Scientists
                                              be directed to: David A. Lambertson,                    5 U.S.C. 552.
                                                                                                                                                             and Clinicians; 93.272, Alcohol National
                                              Ph.D., Senior Licensing and Patenting                     Dated: June 22, 2015.                                Research Service Awards for Research
                                              Manager, Office of Technology Transfer,                 Richard U. Rodriguez,                                  Training; 92.273, Alcohol Research Programs;
                                              National Institutes of Health, 6011                                                                            93.891, Alcohol Research Center Grants;
                                                                                                      Acting Director, Office of Technology
                                              Executive Boulevard, Suite 325,                                                                                93.701, ARRA Related Biomedical Research
                                                                                                      Transfer, National Institutes of Health.
                                              Rockville, MD 20852–3804; Telephone:                                                                           and Research Supports Awards, National
                                                                                                      [FR Doc. 2015–15656 Filed 6–25–15; 8:45 am]            Institutes of Health, HHS)
                                              (301) 435–4632; Facsimile: (301) 402–                   BILLING CODE 4140–01–P
                                              0220; Email: lambertsond@mail.nih.gov.                                                                           Dated: June 22, 2015.
                                              SUPPLEMENTARY INFORMATION: This                                                                                Melanie J. Gray,
                                              invention concerns an anti-TSLPR                        DEPARTMENT OF HEALTH AND                               Program Analyst, Office of Federal Advisory
                                              (Thymic Stromal Lymphopoietin                           HUMAN SERVICES                                         Committee Policy.
                                              Receptor) chimeric antigen receptor                                                                            [FR Doc. 2015–15658 Filed 6–25–15; 8:45 am]
                                              (CAR) and methods of using the CAR for                  National Institutes of Health                          BILLING CODE 4140–01–P
                                              the treatment of TSLPR-expressing
                                              cancers, including B cell malignancies.                 National Institute on Alcohol Abuse
                                                 TSLPR is a cell surface antigen that is              and Alcoholism; Notice of Closed                       DEPARTMENT OF HEALTH AND
                                              preferentially expressed on certain types               Meetings                                               HUMAN SERVICES
                                              of cancer cells, particularly rare cancers
                                              of B cell origin such as acute                            Pursuant to section 10(d) of the                     National Institutes of Health
                                              lymphoblastic leukemia (ALL). The                       Federal Advisory Committee Act, as
                                                                                                      amended (5 U.S.C. App.), notice is                     National Institute of General Medical
                                              anti-TSLPR CARs of this technology                                                                             Sciences; Notice of Closed Meetings
                                              contain (1) antigen recognition                         hereby given of the following meetings.
                                              sequences that bind specifically to                       The meetings will be closed to the                     Pursuant to section 10(d) of the
                                              TSLPR and (2) signaling domains that                    public in accordance with the                          Federal Advisory Committee Act, as
                                              can activate the cytotoxic functions of a               provisions set forth in sections                       amended (5 U.S.C. App.), notice is
                                              T cell. The anti-TSLPR CAR can be                       552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,             hereby given of the following meetings.
                                              transduced into T cells that are                        as amended. The grant applications and                   The meetings will be closed to the
                                              harvested from a cancer patient; from                   the discussions could disclose                         public in accordance with the
                                              there, T cells expressing the anti-TSLPR                confidential trade secrets or commercial               provisions set forth in sections
                                              CAR are selected, expanded and then be                  property such as patentable material,                  552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                              reintroduced into the patient. Once the                 and personal information concerning                    as amended. The grant applications and
                                              anti-TSLPR CAR-expressing T cells are                   individuals associated with the grant                  the discussions could disclose
                                              reintroduced into the patient, the T cells              applications the disclosure of which                   confidential trade secrets or commercial
                                              can selectively bind to TSLPR-                          would constitute a clearly unwarranted                 property such as patentable material,
                                              expressing cancer cells through its                     invasion of personal privacy.                          and personal information concerning
                                              antigen recognition sequences, thereby                     Name of Committee: National Institute on            individuals associated with the grant
                                              activating the T cell through its                       Alcohol Abuse and Alcoholism Special                   applications, the disclosure of which
                                              signaling domains to selectively kill the               Emphasis Panel; NIAAA Review of Member                 would constitute a clearly unwarranted
                                              cancer cells. Through this mechanism of                 Conflict Applications (AA2).                           invasion of personal privacy.
                                              action, the selectivity of the a CAR                       Date: July 24, 2015.                                  Name of Committee: National Institute of
                                              allows the T cells to kill cancer cells                    Time: 1:00 a.m. to 4:00 p.m.                        General Medical Sciences Special Emphasis
                                                                                                         Agenda: To review and evaluate grant                Panel; Medical Scientist Training Program
                                              while leaving healthy, essential cells                  applications.
                                              unharmed. This can result in an                                                                                Grants.
                                                                                                         Place: NIAAA, NIH, 5635 Fishers Lane,                 Date: July 14, 2015.
                                              effective therapeutic strategy with fewer               Room CR2098, Rockville, MD 20852,                        Time: 1:00 p.m. to 5:00 p.m.
                                              side effects due to less non-specific                   (Telephone Conference Call).                             Agenda: To review and evaluate grant
                                              killing of cells.                                          Contact Person: Ranga Srinivas, Ph.D.,              applications.
                                                 The prospective exclusive license will               Chief, Extramural Project Review Branch,                 Place: National Institutes of Health,
                                              be royalty bearing and will comply with                 National Institute on Alcohol Abuse and                Natcher Building, 45 Center Drive, Room
                                              the terms and conditions of 35 U.S.C.                   Alcoholism, NIH, 5635 Fishers Lane, Room               3An.12, Bethesda, MD 20892, (Telephone
                                              209 and 37 CFR part 404. The                            2085, Rockville, MD 20852, (301) 451–2067,             Conference Call).
                                              prospective exclusive license may be                    srinivar@mail.nih.gov.                                   Contact Person: Rebecca H. Johnson, Ph.D.,
                                                                                                         Name of Committee: National Institute on            Scientific Review Officer, Office of Scientific
tkelley on DSK3SPTVN1PROD with NOTICES




                                              granted unless the NIH receives written
                                                                                                      Alcohol Abuse and Alcoholism Special                   Review, National Institute of General Medical
                                              evidence and argument that establishes                                                                         Sciences, National Institutes of Health, 45
                                                                                                      Emphasis Panel; NIAAA Neuroscience
                                              that the grant of the license would not                 Member Conflict Applications.                          Center Drive, Room 3An.18C, Bethesda, MD
                                              be consistent with the requirements of                     Date: July 29, 2015.                                20892, 301–594–2771, johnsonrh@
                                              35 U.S.C. 209 and 37 CFR part 404                          Time: 1:00 p.m. to 4:00 p.m.                        nigms.nih.gov.
                                              within thirty (30) days from the date of                   Agenda: To review and evaluate grant                  Name of Committee: National Institute of
                                              this published notice.                                  applications.                                          General Medical Sciences Special Emphasis



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                                              36828                           Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices

                                              Panel Review of R25 Research Training Grant             [HHS Ref. E–039–2011/0–CA–04];                         cells. Moreover, as these antibodies
                                              Applications.                                           European Patent Application No.                        selectively target ROR1, they can also be
                                                Date: July 17, 2015.                                  11791733.6 entitled, ‘‘Chimeric rabbit/                used to diagnose B-cell malignancies.
                                                Time: 8:30 a.m. to 5:00 p.m.                          human ROR1 antibodies’’ filed                             The prospective exclusive license will
                                                Agenda: To review and evaluate grant
                                                                                                      November 30, 2011 [HHS Ref. E–039–                     comply with the terms and conditions
                                              applications.
                                                Place: Courtyard by Marriott Chevy Chase,             2011/0–EP–05]; and U.S. Patent                         of 35 U.S.C. 209 and 37 CFR part 404.
                                              5520 Wisconsin Avenue, Chevy Chase, MD                  Application No. 13/990,977 entitled,                   The exclusive license may be granted
                                              20815                                                   ‘‘Chimeric rabbit/human ROR1                           unless within thirty (30) days from the
                                                Contact Person: Lisa A. Dunbar, Ph.D.,                antibodies’’ filed May 31, 2013 [HHS                   date of this published notice, the NIH
                                              Scientific Review Officer, Office of Scientific         Ref. E–039–2011/0–US–06] and all                       receives written evidence and argument
                                              Review, National Institute of General Medical           related continuing and foreign patents/                that establishes that the grant of the
                                              Sciences, National Institutes of Health, 45             patent applications for the technology                 license would not be consistent with the
                                              Center Drive, Room 3An.12F, Bethesda, MD                family to Emergent BioSolutions. The                   requirements of 35 U.S.C. 209 and 37
                                              20892, 301–594–2849, dunbarl@mail.nih.gov.
                                                                                                      patent rights in these inventions have                 CFR part 404.
                                              (Catalogue of Federal Domestic Assistance               been assigned to the Government of the                    Any additional, properly filed, and
                                              Program Nos. 93.375, Minority Biomedical                                                                       complete applications for a license in
                                                                                                      United States of America.
                                              Research Support; 93.821, Cell Biology and
                                                                                                         The prospective exclusive license                   the field of use filed in response to this
                                              Biophysics Research; 93.859, Pharmacology,
                                              Physiology, and Biological Chemistry                    territory may be worldwide and the                     notice will be treated as objections to
                                              Research; 93.862, Genetics and                          field of use may be limited to the use                 the grant of the contemplated exclusive
                                              Developmental Biology Research; 93.88,                  of the Licensed Patent Rights to                       license. Comments and objections
                                              Minority Access to Research Careers; 93.96,             develop, make, have made, sell, have                   submitted to this notice will not be
                                              Special Minority Initiatives, National                  sold, import and export bi-specific and                made available for public inspection
                                              Institutes of Health, HHS)                              multi-specific fusion proteins that are                and, to the extent permitted by law, will
                                                Dated: June 22, 2015.                                 capable of eliciting redirected T-cell                 not be released under the Freedom of
                                              Melanie J. Gray,                                        cytotoxicity for the treatment of human                Information Act, 5 U.S.C. 552.
                                              Program Analyst, Office of Federal Advisory             receptor tyrosine kinase-like orphan                     Dated: June 22, 2015.
                                              Committee Policy.                                       receptor 1 (ROR1) expressing cancers,                  Richard U. Rodriguez,
                                              [FR Doc. 2015–15659 Filed 6–25–15; 8:45 am]
                                                                                                      wherein said fusion proteins comprise
                                                                                                                                                             Acting Director, Office of Technology
                                                                                                      one or more single-chain variable                      Transfer, National Institutes of Health.
                                              BILLING CODE 4140–01–P
                                                                                                      fragment (scFv) ROR1 binding domains
                                                                                                                                                             [FR Doc. 2015–15655 Filed 6–25–15; 8:45 am]
                                                                                                      from the anti-ROR1 antibodies
                                                                                                                                                             BILLING CODE 4140–01–P
                                              DEPARTMENT OF HEALTH AND                                designated as R11 or R12, one or more
                                              HUMAN SERVICES                                          of Licensee’s proprietary scFv CD3
                                                                                                      binding domains, and optionally a
                                                                                                                                                             DEPARTMENT OF HEALTH AND
                                              National Institutes of Health                           fragment crystallizable (Fc) domain.
                                                                                                                                                             HUMAN SERVICES
                                                                                                      DATES: Only written comments and/or
                                              Prospective Grant of an Exclusive                       applications for a license which are                   National Institutes of Health
                                              License Agreement: Development of                       received by the NIH Office of
                                              Bispecific and Multi-Specific Fusion                    Technology Transfer on or before July                  Prospective Grant of Exclusive
                                              Proteins for the Treatment of ROR1                      27, 2015 will be considered.                           License: The Development of an Anti-
                                              Expressing Human Cancers                                ADDRESSES: Requests for copies of the                  CD19 Chimeric Antigen Receptor
                                              AGENCY:    National Institutes of Health,               patent applications, inquiries,                        (CAR) for the Treatment of Human
                                              HHS.                                                    comments, and other materials relating                 Cancers
                                              ACTION:   Notice.                                       to the contemplated exclusive                          AGENCY:   National Institutes of Health,
                                                                                                      evaluation option license should be                    HHS.
                                              SUMMARY:    This is notice, in accordance               directed to: Jennifer Wong, M.S., Senior
                                                                                                                                                             ACTION:   Notice.
                                              with 35 U.S.C. 209 and 37 CFR part 404,                 Licensing and Patenting Manager, Office
                                              that the National Institutes of Health,                 of Technology Transfer, National                       SUMMARY:   This is notice, in accordance
                                              Department of Health and Human                          Institutes of Health, 6011 Executive                   with 35 U.S.C. 209 and 37 CFR part 404,
                                              Services, is contemplating the grant of                 Boulevard, Suite 325, Rockville, MD                    that the National Institutes of Health,
                                              an exclusive license agreement to                       20852–3804; Telephone: (301) 435–                      Department of Health and Human
                                              practice the inventions embodied in US                  4633; Facsimile: (301) 402–0220; Email:                Services, is contemplating the grant of
                                              Provisional Application No. 61/418,550                  wongje@od.nih.gov.                                     an exclusive license to practice the
                                              entitled, ‘‘Chimeric rabbit/human ROR1                  SUPPLEMENTARY INFORMATION: Tyrosine                    inventions embodied in U.S. Provisional
                                              antibodies’’ filed December 1, 2010                     kinase-like orphan receptor 1 (ROR1) is                Patent Application 62/006,313 entitled
                                              [HHS Ref. E–039–2011/0–US–01]; PCT                      a signature cell surface antigen for B-cell            ‘‘Chimeric Antigen Receptors Targeting
                                              Application No. PCT/US2011/062670                       malignancies, most notably, B-cell                     CD–19’’ [HHS Ref. E–042–2014/0–US–
                                              entitled, ‘‘Chimeric rabbit/human ROR1                  chronic lymphocytic leukemia (B–CLL)                   01], and all related continuing and
                                              antibodies’’ filed November 30, 2011                    and mantle cell lymphoma (MCL) cells,                  foreign patents/patent applications for
                                              [HHS Ref. E–039–2011/0–PCT–02];                         two incurable diseases. The                            the technology family, to Kite Pharma,
                                              Australian Patent Application No.                       investigators have developed a portfolio               Inc. The patent rights in these
tkelley on DSK3SPTVN1PROD with NOTICES




                                              2011336650 entitled, ‘‘Chimeric rabbit/                 of chimeric anti-ROR1 monoclonal                       inventions have been assigned to and/or
                                              human ROR1 antibodies’’ filed                           antibodies that selectively target ROR1                exclusively licensed to the Government
                                              November 30, 2011 [HHS Ref. E–039–                      malignant B-cells but not normal B-                    of the United States of America.
                                              2011/0–AU–03]; Canadian Patent                          cells. These antibodies may be linked to                  The prospective exclusive licensed
                                              Application No. 2818992 entitled,                       chemical drugs or biological toxins thus               territory may be worldwide, and the
                                              ‘‘Chimeric rabbit/human ROR1                            providing targeted cytotoxic delivery to               field of use may be limited to: ‘‘All
                                              antibodies’’ filed November 30, 2011                    malignant B-cells while sparing normal                 prophylactic and therapeutic uses for


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Document Created: 2015-12-15 14:14:35
Document Modified: 2015-12-15 14:14:35
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
DatesJuly 14, 2015.
FR Citation80 FR 36827 

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