81_FR_31347 81 FR 31251 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

81 FR 31251 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 96 (May 18, 2016)

Page Range31251-31251
FR Document2016-11663

Federal Register, Volume 81 Issue 96 (Wednesday, May 18, 2016)
[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Notices]
[Page 31251]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-11663]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Dental & Craniofacial Research; 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 Dental and Craniofacial 
Research Special Emphasis Panel; NIDCR Data Analysis and Statistical 
Methodology PARs.
    Date: June 10, 2016.
    Time: 11:00 a.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, One Democracy Plaza, 6701 
Democracy Boulevard, Bethesda, MD 20892.
    Contact Person: Victor Henriquez, Ph.D., Scientific Review 
Officer DEA/SRB/NIDCR, 6701 Democracy Blvd., Room 668, Bethesda, MD 
20892-4878, 301-451-2405, henriquv@nidcr.nih.gov.

    Name of Committee: NIDCR Special Grants Review Committee.
    Date: June 16-17, 2016.
    Time: 8:00 a.m. to 12:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Wyndham San Antonio Riverwalk 111 East Pecan Street, San 
Antonio, TX 78205
    Contact Person: Marilyn Moore-Hoon, Ph.D., Scientific Review 
Officer, Scientific Review Branch, National Institute of Dental and 
Craniofacial Research, 6701 Democracy Blvd., Rm. 676, Bethesda, MD 
20892-4878, 301-594-4861, mooremar@nidcr.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral 
Diseases and Disorders Research, National Institutes of Health, HHS)

    Dated: May 12, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-11663 Filed 5-17-16; 8:45 am]
 BILLING CODE 4140-01-P



                                                                             Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices                                              31251

                                                  Dated: May 12, 2016.                                    Dated: May 12, 2016.                                exclusively licensed to the Government
                                                Richard U. Rodriguez,                                   Natasha M. Copeland,                                  of the United States of America.
                                                Associate Director, Technology Transfer                 Program Analyst, Office of Federal Advisory              The prospective exclusive licensed
                                                Center, National Cancer Institute.                      Committee Policy.                                     territory may be the United States,
                                                [FR Doc. 2016–11661 Filed 5–17–16; 8:45 am]             [FR Doc. 2016–11663 Filed 5–17–16; 8:45 am]           Australia, Canada, the European Union,
                                                                                                        BILLING CODE 4140–01–P                                Russia, China, Hong Kong, Japan,
                                                BILLING CODE 4140–01–P
                                                                                                                                                              Taiwan, South Korea and Singapore,
                                                                                                                                                              and the field of use may be limited to:
                                                DEPARTMENT OF HEALTH AND                                DEPARTMENT OF HEALTH AND                              ‘‘The development of a glypican-3
                                                HUMAN SERVICES                                          HUMAN SERVICES                                        (GPC3) chimeric antigen receptor (CAR)-
                                                                                                                                                              based immunotherapy using autologous
                                                National Institutes of Health                           National Institutes of Health                         (meaning one individual is both the
                                                                                                                                                              donor and the recipient) primary human
                                                National Institute of Dental &                          Prospective Grant of an Exclusive                     lymphocytes (T cells or NK cells)
                                                                                                        License: The Development of an Anti-                  transfected with a lentiviral or retroviral
                                                Craniofacial Research; Notice of
                                                                                                        GPC3 Chimeric Antigen Receptor                        vector, wherein the vector expresses a
                                                Closed Meetings
                                                                                                        (CAR) Based on YP7 for the Treatment                  CAR having (1) a single antigen
                                                  Pursuant to section 10(d) of the                      of Human Cancers                                      specificity and (2) comprising at least:
                                                Federal Advisory Committee Act, as                      AGENCY:  Public Health Service, National              (a) The complementary determining
                                                amended (5 U.S.C. App.), notice is                      Institutes of Health, HHS.                            region (CDR) sequences of the anti-GPC3
                                                hereby given of the following meetings.                 ACTION: Notice.                                       antibody known as YP7; and (b) a T cell
                                                                                                                                                              signaling domain; for the prophylaxis
                                                  The meetings will be closed to the
                                                                                                        SUMMARY:   This notice, in accordance                 and treatment of GPC3-expressing
                                                public in accordance with the
                                                                                                        with 35 U.S.C. 209(c)(1) and 37 CFR                   cancers.’’
                                                provisions set forth in sections
                                                                                                        Part 404.7(a)(1)(i), that the National                DATES: Only written comments and/or
                                                552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                                                                        Institutes of Health, Department of                   applications for a license which are
                                                as amended. The grant applications and
                                                                                                        Health and Human Services, is                         received by the NCI Technology
                                                the discussions could disclose
                                                                                                        contemplating the grant of an exclusive               Transfer Center on or before June 2,
                                                confidential trade secrets or commercial
                                                                                                        license to practice the inventions                    2016 will be considered.
                                                property such as patentable material,
                                                                                                        embodied in:
                                                and personal information concerning                                                                           ADDRESSEES: Requests for copies of the
                                                individuals associated with the grant                   Intellectual Property                                 patent application, inquiries, comments,
                                                applications, the disclosure of which                      U.S. Provisional Patent Application                and other materials relating to the
                                                would constitute a clearly unwarranted                  61/654,232 entitled ‘‘High-affinity                   contemplated exclusive license should
                                                invasion of personal privacy.                           Monoclonal Antibodies To Glypican-3                   be directed to: David A. Lambertson,
                                                  Name of Committee: National Institute of              And Use Thereof’’ [HHS Ref. E–136–                    Ph.D., Senior Licensing and Patenting
                                                Dental and Craniofacial Research Special                2012/0–US–01]; PCT Patent Application                 Manager, National Cancer Institute,
                                                Emphasis Panel; NIDCR Data Analysis and                 PCT/US2013/043633 entitled ‘‘High-                    9609 Medical Center Drive, Rm 1–E530
                                                Statistical Methodology PARs.                           affinity Monoclonal Antibodies To                     MSC9702, Rockville, MD 20850–9702,
                                                  Date: June 10, 2016.                                  Glypican-3 And Use Thereof’’ [HHS Ref.                Email: david.lambertson@nih.gov.
                                                  Time: 11:00 a.m. to 4:00 p.m.                         E–136–2012/0–PCT–02]; Chinese Patent                  SUPPLEMENTARY INFORMATION: This
                                                  Agenda: To review and evaluate grant                  Application 201380039993.7 entitled                   invention concerns an anti-GPC3
                                                applications.                                           ‘‘High-affinity Monoclonal Antibodies                 (Glypican-3) chimeric antigen receptor
                                                  Place: National Institutes of Health, One             To Glypican-3 And Use Thereof’’ [HHS                  (CAR) and methods of using the CAR for
                                                Democracy Plaza, 6701 Democracy                         Ref. E–136–2012/0–CN–03]; Japanese                    the treatment of GPC3-expressing
                                                Boulevard, Bethesda, MD 20892.                          Patent Application 2015–515243                        cancers. GPC3 is a cell surface antigen
                                                  Contact Person: Victor Henriquez, Ph.D.,              entitled ‘‘High-affinity Monoclonal                   that is preferentially expressed on
                                                Scientific Review Officer DEA/SRB/NIDCR,                Antibodies To Glypican-3 And Use                      certain types of cancer cells, particularly
                                                6701 Democracy Blvd., Room 668, Bethesda,                                                                     liver cancers such as hepatocellular
                                                                                                        Thereof’’ [HHS Ref. E–136–2012/0–JP–
                                                MD 20892–4878, 301–451–2405, henriquv@                                                                        carcinoma (HCC). The anti-GPC3 CARs
                                                                                                        04]; South Korea Patent Application 10–
                                                nidcr.nih.gov.
                                                                                                        2014–7037046 entitled ‘‘High-affinity                 of this technology contain (1) antigen
                                                  Name of Committee: NIDCR Special Grants               Monoclonal Antibodies To Glypican-3                   recognition sequences that bind
                                                Review Committee.                                       And Use Thereof’’ [HHS Ref. E–136–                    specifically to GPC3 and (2) signaling
                                                  Date: June 16–17, 2016.                                                                                     domains that can activate the cytotoxic
                                                                                                        2012/0–KR–05]; Singapore Patent
                                                  Time: 8:00 a.m. to 12:00 p.m.
                                                                                                        Application 11201407972R entitled                     functions of a T cell. The anti-GPC3
                                                  Agenda: To review and evaluate grant
                                                                                                        ‘‘High-affinity Monoclonal Antibodies                 CAR can be transduced into T cells that
                                                applications.
                                                  Place: Wyndham San Antonio Riverwalk
                                                                                                        To Glypican-3 And Use Thereof’’ [HHS                  are harvested from a donor, followed by
                                                111 East Pecan Street, San Antonio, TX                  Ref. E–136–2012/0–SG–06]; United                      (a) selection and expansion of the T
                                                78205                                                   States Patent Application 14/403,896                  cells expressing the anti-GPC3 CAR, and
                                                  Contact Person: Marilyn Moore-Hoon,                   entitled ‘‘High-affinity Monoclonal                   (b) reintroduction of the T cells into the
                                                Ph.D., Scientific Review Officer, Scientific            Antibodies To Glypican-3 And Use                      patient. Once the anti-GPC3 CAR-
                                                                                                        Thereof’’ [HHS Ref. E–136–2012/0–US–                  expressing T cells are reintroduced into
sradovich on DSK3TPTVN1PROD with NOTICES




                                                Review Branch, National Institute of Dental
                                                and Craniofacial Research, 6701 Democracy               07];                                                  the patient, the T cells can selectively
                                                Blvd., Rm. 676, Bethesda, MD 20892–4878,                and all continuing U.S. and foreign                   bind to GPC3-expressing cancer cells
                                                301–594–4861, mooremar@nidcr.nih.gov.                   patents/patent applications for the                   through its antigen recognition
                                                (Catalogue of Federal Domestic Assistance               technology family, to Lentigen                        sequences, thereby activating the T cell
                                                Program Nos. 93.121, Oral Diseases and                  Technology, Inc.                                      through its signaling domains to
                                                Disorders Research, National Institutes of                 The patent rights to these inventions              selectively kill the cancer cells. Through
                                                Health, HHS)                                            have been assigned to and/or                          this mechanism of action, the selectivity


                                           VerDate Sep<11>2014   17:10 May 17, 2016   Jkt 238001   PO 00000   Frm 00028   Fmt 4703   Sfmt 4703   E:\FR\FM\18MYN1.SGM   18MYN1



Document Created: 2016-05-18 00:06:11
Document Modified: 2016-05-18 00:06:11
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesJune 10, 2016.
FR Citation81 FR 31251 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR