83_FR_30574 83 FR 30449 - Office of the Secretary; Amended Notice of Meeting

83 FR 30449 - Office of the Secretary; Amended Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 125 (June 28, 2018)

Page Range30449-30449
FR Document2018-13895

Federal Register, Volume 83 Issue 125 (Thursday, June 28, 2018)
[Federal Register Volume 83, Number 125 (Thursday, June 28, 2018)]
[Notices]
[Page 30449]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13895]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Secretary; Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the 
Interagency Pain Research Coordinating Committee, July 09, 2018, 02:00 
p.m. to July 09, 2018, 04:00 p.m., National Institutes of Health, 
Building 31, 31 Center Drive, Conference Room 6, Bethesda, MD, 20892 
which was published in the Federal Register on May 18, 2018, 83 FR 
23283.
    The meeting notice is amended to change the time of the meeting 
from 2-4 p.m. to 4-6 p.m. Date has not changed. The meeting is open to 
the public.

    Dated: June 22, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-13895 Filed 6-27-18; 8:45 am]
BILLING CODE 4140-01-P



                                                                            Federal Register / Vol. 83, No. 125 / Thursday, June 28, 2018 / Notices                                           30449

                                              Intellectual Property                                   Cancer Institute receives written                      for Disease Control and Prevention;
                                                 United States Provisional Patent                     evidence and argument that establishes                 Department of Health and Human
                                              Application No. 61/040,005, filed March                 that the grant of the license would not                Services.
                                              27, 2008 and entitled ‘‘Human                           be consistent with the requirements of                 ACTION: Notice of meetings.
                                              Monoclonal Antibodies Specific for                      35 U.S.C. 209 and 37 CFR part 404.
                                                                                                        In response to this Notice, the public               SUMMARY:   Notice is hereby given of the
                                              Mesothelin’’ [HHS Reference No.
                                                                                                      may file comments or objections.                       meetings on July 22–23, 2018, of the
                                              E–079–2008/0–US–01];
                                                                                                      Comments and objections, other than                    Substance Abuse and Mental Health
                                                 PCT Patent Application PCT/US2009/
                                                                                                      those in the form of a license                         Services Administration’s (SAMHSA)
                                              038228, filed March 25, 2009 and
                                                                                                      application, will not be treated                       Tribal Technical Advisory Committee
                                              entitled ‘‘Human Monoclonal Antibody
                                                                                                      confidentially, and may be made                        (TTAC); on July 23 and July 25, 2018,
                                              Against Mesothelin’’ [HHS Reference
                                                                                                      publicly available.                                    of the Centers for Disease Control and
                                              No. E–079–2008/0–PCT–02]; and US
                                                                                                        License applications submitted in                    Prevention (CDC)/Agency for Toxic
                                              Patent No. 8,357,783, filed September
                                                                                                      response to this Notice will be                        Substances and Disease Registry
                                              22, 2010, Issued January 22, 2013 and
                                                                                                      presumed to contain business                           (ATSDR) Tribal Advisory Committee
                                              entitled ‘‘Human Anti-Mesothelin
                                                                                                      confidential information and any release               (TAC); and on July 24, 2018, of the Joint
                                              Monoclonal Antibodies’’ [HHS
                                                                                                      of information in these license                        Tribal Advisory Committee (JTAC).
                                              Reference No. E–079–2008/0–US–06].
                                                 The patent rights in these inventions                applications will be made only as                      DATES:
                                              have been assigned and/or exclusively                   required and upon a request under the                  SAMHSA TTAC
                                              licensed to the government of the                       Freedom of Information Act, 5 U.S.C.                   July 22, 2018, 1:00 p.m. to 5:00 p.m.
                                              United States of America.                               552.                                                     EDT (OPEN)
                                                 The prospective exclusive license                      Dated: June 21, 2018                                 July 23, 2018, 9:00 a.m. to 5:00 p.m.
                                              territory may be worldwide and the                      Richard U. Rodriguez,
                                                                                                                                                               EDT (OPEN)
                                              field of use may be limited to: ‘‘The                                                                          • CDC/ATSDR TAC
                                                                                                      Associate Director, Technology Transfer
                                              development of a mesothelin chimeric                                                                           July 23, 2018, 8:00 a.m. to 6:00 p.m.
                                                                                                      Center, National Cancer Institute.
                                              antigen receptor (CAR)-based                                                                                     EDT (OPEN)
                                                                                                      [FR Doc. 2018–13893 Filed 6–27–18; 8:45 am]
                                              immunotherapy using autologous or                                                                              July 25, 2018, 8:00 a.m. to 12:00 p.m.
                                                                                                      BILLING CODE 4140–01–P                                   EDT (OPEN)
                                              allogeneic T cells either transduced
                                                                                                                                                             • JTAC
                                              with a retroviral vector (including
                                                                                                                                                             July 24, 2018, 1:00 p.m. to 5:00 p.m.
                                              lentiviral vectors) or modified using a                 DEPARTMENT OF HEALTH AND                                 EDT, (OPEN)
                                              gene-editing technology, wherein the                    HUMAN SERVICES
                                              vector expresses a CAR comprising:                                                                             ADDRESSES:
                                                 (1) Single antigen specificity for                   National Institutes of Health                          • SAMHSA TTAC
                                              binding to mesothelin, and                                                                                       Marriott Wardman Park Hotel, 2660
                                                 (2) at least (a) the complementary                   Office of the Secretary; Amended                            Woodley Road NW, Washington,
                                              determining region (CDR) sequences of                   Notice of Meeting                                           DC 20008
                                              the anti-mesothelin antibody known as                                                                          • CDC/ATSDR TAC
                                                                                                        Notice is hereby given of a change in                  HHS Headquarters, Hubert H.
                                              m912, and (b) a T cell signaling domain;                the meeting of the Interagency Pain
                                              for the prophylaxis and treatment of                                                                                Humphrey Building, 200
                                                                                                      Research Coordinating Committee, July                       Independence Avenue SW,
                                              mesothelin-expressing human cancers.’’                  09, 2018, 02:00 p.m. to July 09, 2018,
                                                 This technology discloses a                                                                                      Washington, DC 20201
                                                                                                      04:00 p.m., National Institutes of Health,             • JTAC
                                              monoclonal antibody and methods of                      Building 31, 31 Center Drive,
                                              using the antibody for the treatment of                                                                          HHS Headquarters, Hubert H.
                                                                                                      Conference Room 6, Bethesda, MD,                            Humphrey Building, 200
                                              mesothelin-expressing cancers,                          20892 which was published in the
                                              including mesothelioma, lung cancer,                                                                                Independence Avenue SW,
                                                                                                      Federal Register on May 18, 2018, 83                        Washington, DC 20201.
                                              stomach/gastric cancer, ovarian cancer,                 FR 23283.
                                              and pancreatic cancer. The specific                                                                            FOR FURTHER INFORMATION CONTACT:
                                                                                                        The meeting notice is amended to
                                              antibody covered by this technology is                                                                         TTAC and JTAC, Mirtha Beadle, MPA,
                                                                                                      change the time of the meeting from 2–
                                              designated as m912, which is a fully                                                                             Director, Office of Tribal Affairs and
                                                                                                      4 p.m. to 4–6 p.m. Date has not changed.
                                              human monoclonal antibody against                                                                                Policy, Substance Abuse and Mental
                                                                                                      The meeting is open to the public.
                                              mesothelin.                                                                                                      Health Services Administration, 5600
                                                 Mesothelin is a cell surface antigen                   Dated: June 22, 2018.                                  Fishers Lane, Rockville, Maryland
                                              that is preferentially expressed on                     Sylvia L. Neal,                                          20857, Telephone: (240) 276–0641,
                                              certain types of cancer. The m912                       Program Analyst, Office of Federal Advisory              Email: otap@samhsa.hhs.gov.
                                              antibody selectively binds to the                       Committee Policy.                                      CDC/ATSDR/TAC, Carmen Clelland,
                                              mesothelin on the surface of cancer cells               [FR Doc. 2018–13895 Filed 6–27–18; 8:45 am]              PharmD, MPA, MPH, Associate
                                              and induces cell death of those cancer                  BILLING CODE 4140–01–P                                   Director for Tribal Support, Office for
                                              cells while leaving healthy cells                                                                                State, Tribal, Local and Territorial
                                              unharmed. This selectivity may lead to                                                                           Support, Centers for Disease Control
                                              fewer side effects due to decreased non-                DEPARTMENT OF HEALTH AND                                 and Prevention, 4770 Buford
                                              specific killing of cells.                              HUMAN SERVICES                                           Highway, Mailstop E–70, Atlanta, GA
amozie on DSK3GDR082PROD with NOTICES1




                                                 This notice is made in accordance                                                                             30341–3717, Telephone: (404) 498–
                                              with 35 U.S.C. 209 and 37 CFR part 404.                 Substance Abuse and Mental Health                        2205, Email: cclelland@cdc.gov.
                                              The prospective exclusive license will                  Services Administration                                SUPPLEMENTARY INFORMATION: Pursuant
                                              be royalty bearing, and the prospective                 Notice of Meetings                                     to Presidential Executive Order 13175
                                              exclusive license may be granted unless                                                                        signed on November 6, 2000 and the
                                              within fifteen (15) days from the date of               AGENCY: Substance Abuse and Mental                     Presidential Memorandum of September
                                              this published notice, the National                     Health Services Administration; Centers                23, 2004, SAMHSA established the


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Document Created: 2018-11-06 09:55:13
Document Modified: 2018-11-06 09:55:13
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
FR Citation83 FR 30449 

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