Center for Scientific Review; Notice of Closed Meeting, 30448 [2018-13894]
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30448
Federal Register / Vol. 83, No. 125 / Thursday, June 28, 2018 / Notices
State Enforcement Notifications
OMB Control Number 0910–0275—
Extension
This information collection supports
Agency regulations. Specifically, section
310(b) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
337(b)) authorizes a State to enforce
certain sections of the FD&C Act in its
own name and within its own
jurisdiction. However, before doing so,
a State must provide notice to FDA
according to § 100.2 (21 CFR 100.2). The
information required in a letter of
notification under § 100.2(d) enables us
to identify the food against which a
State intends to take action and to
advise that State whether Federal
enforcement action against the food has
been taken or is in process. With certain
narrow exceptions, Federal enforcement
action precludes State action under the
FD&C Act.
In the Federal Register of February 7,
2018 (83 FR 5438), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received one
comment in support of the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR part
Number of
respondents
Number of
responses per
respondents
Total annual
responses
Average
burden per
response
Total hours
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
information collection has not changed
since the last OMB approval. The
estimated reporting burden for
§ 100.2(d) is minimal because
enforcement notifications are seldom
used by States. During the last 3 years,
we have not received any new
enforcement notifications; therefore, we
estimate that one or fewer notifications
will be submitted annually. Although
we have not received any new
enforcement notifications in the last 3
years, we believe these information
collection provisions should be
extended to provide for the potential
future need of a State government to
submit enforcement notifications
informing us when it intends to take
enforcement action under the FD&C Act
against a particular food located in the
State.
Dated: June 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–13868 Filed 6–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
amozie on DSK3GDR082PROD with NOTICES1
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
VerDate Sep<11>2014
17:08 Jun 27, 2018
Jkt 244001
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, gubanics@csr.nih.gov.
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
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development of an
Anti-Mesothelin Chimeric Antigen
Receptor (CAR) for the Treatment of
Human Cancer
National Institutes of Health,
Department of Health and Human
Services.
AGENCY:
ACTION:
Notice.
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
U.S. Patents and Patent Applications
listed in the Supplementary Information
section of this notice to Atara
Biotherapeutics Inc. (‘‘Atara’’) located in
South San Francisco, CA.
SUMMARY:
Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before July 13, 2018 will be
considered.
DATES:
Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
an Exclusive Patent License should be
directed to: Rose M. Freel, Ph.D.,
Licensing and Patenting Manager, NCI
Technology Transfer Center, 8490
Progress Drive, Suite 400, Frederick, MD
21701; Telephone: (301)–624–8775;
Facsimile: (240)–276–5504; Email:
rose.freel@nih.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
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[Federal Register Volume 83, Number 125 (Thursday, June 28, 2018)]
[Notices]
[Page 30448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
