83_FR_30573 83 FR 30448 - Center for Scientific Review; Notice of Closed Meeting

83 FR 30448 - Center for Scientific Review; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

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

Page Range30448-30448
FR Document2018-13894

Federal Register, Volume 83 Issue 125 (Thursday, June 28, 2018)
[Federal Register Volume 83, Number 125 (Thursday, June 28, 2018)]
[Notices]
[Page 30448]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13894]


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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, 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; Developmental Therapeutics.
    Date: July 9, 2018.
    Time: 12:00 p.m. to 3:00 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: Sharon K. Gubanich, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 6195D, MSC 7804, Bethesda, MD 
20892, (301) 408-9512, [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. 93.306, 
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: June 22, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-13894 Filed 6-27-18; 8:45 am]
 BILLING CODE 4140-01-P



                                              30448                              Federal Register / Vol. 83, No. 125 / Thursday, June 28, 2018 / Notices

                                              State Enforcement Notifications                                 jurisdiction. However, before doing so,                action precludes State action under the
                                                                                                              a State must provide notice to FDA                     FD&C Act.
                                              OMB Control Number 0910–0275—
                                                                                                              according to § 100.2 (21 CFR 100.2). The                 In the Federal Register of February 7,
                                              Extension
                                                                                                              information required in a letter of                    2018 (83 FR 5438), FDA published a 60-
                                                This information collection supports                          notification under § 100.2(d) enables us               day notice requesting public comment
                                              Agency regulations. Specifically, section                       to identify the food against which a                   on the proposed collection of
                                              310(b) of the Federal Food, Drug, and                           State intends to take action and to                    information. FDA received one
                                              Cosmetic Act (FD&C Act) (21 U.S.C.                              advise that State whether Federal                      comment in support of the information
                                              337(b)) authorizes a State to enforce                           enforcement action against the food has                collection.
                                              certain sections of the FD&C Act in its                         been taken or is in process. With certain                FDA estimates the burden of this
                                              own name and within its own                                     narrow exceptions, Federal enforcement                 collection of information as follows:

                                                                                                   TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                  Number of                             Average
                                                                                                                               Number of                           Total annual
                                                                            21 CFR part                                                         responses per                         burden per     Total hours
                                                                                                                              respondents                           responses
                                                                                                                                                 respondents                           response

                                              21 CFR Section 100.2(d) .....................................................        1                    1               1                10              10
                                                 1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


                                                The estimated burden for this                                 confidential trade secrets or commercial               DEPARTMENT OF HEALTH AND
                                              information collection has not changed                          property such as patentable material,                  HUMAN SERVICES
                                              since the last OMB approval. The                                and personal information concerning
                                              estimated reporting burden for                                  individuals associated with the grant                  National Institutes of Health
                                              § 100.2(d) is minimal because                                   applications, the disclosure of which
                                              enforcement notifications are seldom                                                                                   Prospective Grant of an Exclusive
                                                                                                              would constitute a clearly unwarranted
                                              used by States. During the last 3 years,                                                                               Patent License: Development of an
                                                                                                              invasion of personal privacy.
                                              we have not received any new                                                                                           Anti-Mesothelin Chimeric Antigen
                                              enforcement notifications; therefore, we                          Name of Committee: Center for Scientific             Receptor (CAR) for the Treatment of
                                              estimate that one or fewer notifications                        Review Special Emphasis Panel;                         Human Cancer
                                                                                                              Developmental Therapeutics.
                                              will be submitted annually. Although
                                              we have not received any new                                      Date: July 9, 2018.                                  AGENCY:  National Institutes of Health,
                                                                                                                Time: 12:00 p.m. to 3:00 p.m.                        Department of Health and Human
                                              enforcement notifications in the last 3
                                                                                                                Agenda: To review and evaluate grant                 Services.
                                              years, we believe these information
                                                                                                              applications.
                                              collection provisions should be                                                                                        ACTION:   Notice.
                                                                                                                Place: National Institutes of Health, 6701
                                              extended to provide for the potential
                                                                                                              Rockledge Drive, Bethesda, MD 20892
                                              future need of a State government to                            (Telephone Conference Call).                           SUMMARY:    The National Cancer Institute,
                                              submit enforcement notifications                                  Contact Person: Sharon K. Gubanich,                  an institute of the National Institutes of
                                              informing us when it intends to take                            Ph.D., Scientific Review Officer, Center for           Health, Department of Health and
                                              enforcement action under the FD&C Act                           Scientific Review, National Institutes of              Human Services, is contemplating the
                                              against a particular food located in the                        Health, 6701 Rockledge Drive, Room 6195D,              grant of an Exclusive Patent License to
                                              State.                                                          MSC 7804, Bethesda, MD 20892, (301) 408–               practice the inventions embodied in the
                                                Dated: June 21, 2018.                                         9512, gubanics@csr.nih.gov.                            U.S. Patents and Patent Applications
                                              Leslie Kux,                                                       This notice is being published less than 15          listed in the Supplementary Information
                                              Associate Commissioner for Policy.                              days prior to the meeting due to the timing            section of this notice to Atara
                                              [FR Doc. 2018–13868 Filed 6–27–18; 8:45 am]                     limitations imposed by the review and                  Biotherapeutics Inc. (‘‘Atara’’) located in
                                                                                                              funding cycle.                                         South San Francisco, CA.
                                              BILLING CODE 4164–01–P
                                                                                                              (Catalogue of Federal Domestic Assistance              DATES:  Only written comments and/or
                                                                                                              Program Nos. 93.306, Comparative Medicine;             applications for a license which are
                                              DEPARTMENT OF HEALTH AND                                        93.333, Clinical Research, 93.306, 93.333,             received by the National Cancer
                                              HUMAN SERVICES                                                  93.337, 93.393–93.396, 93.837–93.844,                  Institute’s Technology Transfer Center
                                                                                                              93.846–93.878, 93.892, 93.893, National                on or before July 13, 2018 will be
                                              National Institutes of Health                                   Institutes of Health, HHS)                             considered.
                                              Center for Scientific Review; Notice of                           Dated: June 22, 2018.
                                                                                                                                                                     ADDRESSES:   Requests for copies of the
                                              Closed Meeting                                                  Sylvia L. Neal,                                        patent application, inquiries, and
                                                                                                              Program Analyst, Office of Federal Advisory            comments relating to the contemplated
                                                Pursuant to section 10(d) of the                              Committee Policy.
                                              Federal Advisory Committee Act, as                                                                                     an Exclusive Patent License should be
                                              amended, notice is hereby given of the
                                                                                                              [FR Doc. 2018–13894 Filed 6–27–18; 8:45 am]            directed to: Rose M. Freel, Ph.D.,
amozie on DSK3GDR082PROD with NOTICES1




                                              following meeting.                                              BILLING CODE 4140–01–P                                 Licensing and Patenting Manager, NCI
                                                                                                                                                                     Technology Transfer Center, 8490
                                                The meeting will be closed to the
                                                                                                                                                                     Progress Drive, Suite 400, Frederick, MD
                                              public in accordance with the
                                                                                                                                                                     21701; Telephone: (301)–624–8775;
                                              provisions set forth in sections
                                                                                                                                                                     Facsimile: (240)–276–5504; Email:
                                              552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                                                                                                                                     rose.freel@nih.gov.
                                              as amended. The grant applications and
                                              the discussions could disclose                                                                                         SUPPLEMENTARY INFORMATION:



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Document Created: 2018-11-06 09:55:27
Document Modified: 2018-11-06 09:55:27
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 9, 2018.
FR Citation83 FR 30448 

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