83_FR_26598 83 FR 26488 - National Institute of Nursing Research; Notice to Close Meeting

83 FR 26488 - National Institute of Nursing Research; Notice to Close Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 110 (June 7, 2018)

Page Range26488-26488
FR Document2018-12178

Federal Register, Volume 83 Issue 110 (Thursday, June 7, 2018)
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Page 26488]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12178]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Nursing Research; Notice to Close Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, 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: National Institute of Nursing Research 
Special Emphasis Panel; Multicenter Clinical Grants.
    Date: June 6, 2018.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, 
Bethesda, MD 20817.
    Contact Person: Tamizchelvi Thyagarajan, Ph.D., Scientific 
Review Officer, National Institute of Nursing Research, National 
Institutes of Health, 6701 Democracy Boulevard, Bethesda, MD 20892, 
(301) 594-0343, [email protected].

    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. 93.361, 
Nursing Research, National Institutes of Health, HHS)

    Dated: June 1, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-12178 Filed 6-6-18; 8:45 am]
BILLING CODE 4140-01-P



                                                26488                          Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices

                                                   U.S. Patent Application 60/703,798                     (2) a Pseudomonas Exotoxin A-based                   presumed to contain business
                                                (HHS reference E–262–2005–0–US–01),                     payload consisting of a PE25 variant with or           confidential information and any release
                                                PCT Application PCT/US2006/028986                       without alterations of one or more amino               of information in these license
                                                                                                        acids in one or more B cell and/or T cell
                                                (HHS reference E–262–2005–0–PCT–                                                                               applications will be made only as
                                                                                                        epitopes.
                                                02), Australian Patent 2006275865 (HHS                  for the treatment of hematological                     required and upon a request under the
                                                reference E–262–2005–0–AU–03),                          malignancies.’’                                        Freedom of Information Act, 5 U.S.C.
                                                Canadian Patent 2616987 (HHS                                                                                   552.
                                                reference E–262–2005–0–CA–04),                             The E–010–2016 technology discloses
                                                                                                        antibodies that recognize the BCMA (B                    Dated: June 1, 2018.
                                                European Patent 1910407 (HHS
                                                                                                        Cell Maturation Antigen) protein.                      Richard U. Rodriguez,
                                                reference E–262–2005–0–EP–05) as
                                                validated in Switzerland, Germany,                      BCMA is expressed on the cell surface                  Associate Director, Technology Transfer
                                                                                                        of several forms of cancer, most notably               Center, National Cancer Institute.
                                                Spain, France, the United Kingdom, and
                                                Italy, U.S. Patent 8,907,060 (HHS                       multiple myeloma. Although these                       [FR Doc. 2018–12179 Filed 6–6–18; 8:45 am]

                                                reference E–262–2005–0–US–06),                          BCMA antibodies can potentially be                     BILLING CODE 4140–01–P

                                                European Patent 2311854 (HHS                            used in many therapeutic formats (e.g.,
                                                reference E–262–2005–0–EP–07) as                        unconjugated antibodies, bispecific
                                                validated in Switzerland, Germany,                      antibodies (and variants thereof),                     DEPARTMENT OF HEALTH AND
                                                Spain, France, the United Kingdom, and                  antibody-drug conjugates (ADCs),                       HUMAN SERVICES
                                                Italy, European Patent 2332970 (HHS                     chimeric antigen receptors (CARs), etc.,
                                                                                                        to target cancer cells for destruction, the            National Institutes of Health
                                                reference E–262–2005–0–EP–08) as
                                                validated in Germany, Spain, France,                    contemplated field of use only concerns
                                                                                                        the development of one specific format                 National Institute of Nursing Research;
                                                the United Kingdom, and Italy,                                                                                 Notice to Close Meeting
                                                Australian Patent 2012216642 (HHS                       (recombinant immunotoxins) using one
                                                reference E–262–2005–0–AU–15),                          type of toxin variant (Pseudomonas
                                                                                                        Exotoxin A variants). Many other                         Pursuant to section 10(d) of the
                                                Australian Patent 2014208269 (HHS                                                                              Federal Advisory Committee Act, as
                                                reference E–262–2005–0–AU–22),                          formats, and therefore fields of use,
                                                                                                        remain available for licensing and                     amended, notice is hereby given of the
                                                European Patent Application                                                                                    following meeting.
                                                15191388.6 (HHS reference E–262–                        development.
                                                                                                           The E–263–2011–0, E–174–2011–0,                       The meeting will be closed to the
                                                2005–0–EP–28), European Patent
                                                                                                        E–269–2009–0, E–292–2007, E–262–                       public in accordance with the
                                                3006457 (HHS reference E–262–2005/0–
                                                                                                        2005–0 and E–771–2013–0–5                              provisions set forth in sections
                                                EP–29) as validated in Austria, Belgium,
                                                                                                        technologies (i.e., ‘‘non-E–010–2016–0                 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                Germany, Spain, France, the United
                                                                                                        technologies’’) all concern distinct                   as amended. The grant applications and
                                                Kingdom, Ireland, Italy, the
                                                                                                        variants of Pseudomonas Exotoxin A                     the discussions could disclose
                                                Netherlands, and Poland, European
                                                                                                        which can be used in the BCMA-                         confidential trade secrets or commercial
                                                Patent 3006458 (HHS reference E–262–
                                                                                                        targeted immunotoxin. The                              property such as patentable material,
                                                2005–0–EP–30) as validated in Austria,
                                                                                                        Pseudomonas Exotoxin A variants                        and personal information concerning
                                                Belgium, Germany, Spain, France, the
                                                                                                        represent the ‘‘payload’’ portion of the               individuals associated with the grant
                                                United Kingdom, Ireland, Italy, the
                                                                                                        immunotoxin, which is the portion that                 applications, the disclosure of which
                                                Netherlands, and Poland, Australian
                                                                                                        instigates the destruction of the cancer               would constitute a clearly unwarranted
                                                Patent 2016202754 (HHS reference E–
                                                                                                        cells that are targeted by the                         invasion of personal privacy.
                                                262–2005–0–AU–31), and Canadian
                                                                                                        aforementioned BCMA antibodies.                          Name of Committee: National Institute of
                                                Patent Application 2941466 (HHS                            The development of a new
                                                reference E–262–2005/0–CA–32);                                                                                 Nursing Research Special Emphasis Panel;
                                                                                                        therapeutic targeting BCMA will benefit                Multicenter Clinical Grants.
                                                and all continuing applications and                     public health by offering up a treatment                 Date: June 6, 2018.
                                                foreign counterparts to the patents and                 for these cancers in instances when                      Time: 8:00 a.m. to 5:00 p.m.
                                                applications listed above for each                      conventional first line therapies are                    Agenda: To review and evaluate grant
                                                technology.                                             ineffective.                                           applications.
                                                   With respect to persons who have an                     This notice is made in accordance                     Place: Bethesda Marriott Suites, 6711
                                                                                                        with 35 U.S.C. 209 and 37 CFR part 404.                Democracy Boulevard, Bethesda, MD 20817.
                                                obligation to assign their right, title and
                                                                                                        The prospective exclusive license will                   Contact Person: Tamizchelvi Thyagarajan,
                                                interest to the Government of the United                                                                       Ph.D., Scientific Review Officer, National
                                                States of America, the patent rights in                 be royalty bearing, and the prospective
                                                                                                                                                               Institute of Nursing Research, National
                                                these inventions have been assigned to                  exclusive license may be granted unless
                                                                                                                                                               Institutes of Health, 6701 Democracy
                                                the Government of the United States of                  within fifteen (15) days from the date of              Boulevard, Bethesda, MD 20892, (301) 594–
                                                America.                                                this published notice, the National                    0343, Tamizchelvi.thagarajan@nih.gov.
                                                   The prospective exclusive license                    Cancer Institute receives written                        This notice is being published less than 15
                                                territory may be worldwide and the                      evidence and argument that establishes                 days prior to the meeting due to the timing
                                                field of use may be limited to the                      that the grant of the license would not                limitations imposed by the review and
                                                following:                                              be consistent with the requirements of                 funding cycle.
                                                                                                        35 U.S.C. 209 and 37 CFR part 404.                     (Catalogue of Federal Domestic Assistance
                                                  ‘‘The development and commercialization                  In response to this Notice, the public              Program Nos. 93.361, Nursing Research,
                                                of a monospecific BCMA-targeted
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                        may file comments or objections.                       National Institutes of Health, HHS)
                                                immunotoxin, whereby the immunotoxin is                 Comments and objections, other than
                                                comprised of:                                                                                                    Dated: June 1, 2018.
                                                  (1) the complementary determining region
                                                                                                        those in the form of a completed license
                                                                                                        application, will not be treated                       Sylvia L. Neal,
                                                (CDR) sequences of either
                                                                                                        confidentially, and may be made                        Program Analyst, Office of Federal Advisory
                                                  i. the anti-BCMA antibody known as
                                                                                                        publicly available.                                    Committee Policy.
                                                BM24; or
                                                  ii. the anti-BCMA antibody known as                      License applications submitted in                   [FR Doc. 2018–12178 Filed 6–6–18; 8:45 am]
                                                BM306; and                                              response to this Notice will be                        BILLING CODE 4140–01–P




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Document Created: 2018-06-07 00:50:03
Document Modified: 2018-06-07 00:50:03
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 6, 2018.
FR Citation83 FR 26488 

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