Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications, 30447-30448 [2018-13868]
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Federal Register / Vol. 83, No. 125 / Thursday, June 28, 2018 / Notices
required to respond to a collection of
information unless it displays a
currently valid OMB control number.
Additional comments may be
submitted on or before July 30, 2018.
DATES:
Submit your comments,
referencing Docket ID Number EPA–
HQ–OARM–2018–0028, to (1) EPA
online using www.regulations.gov (our
preferred method), oei.docket@epa.gov,
or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave.
NW, Washington, DC 20460, and (2)
OMB via email to oira_submission@
omb.eop.gov. Address comments to
OMB Desk Officer for EPA.
EPA’s policy is that all comments
received will be included in the public
docket without change including any
personal information provided, unless
the comment includes profanity, threats,
information claimed to be Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Pamela Leftrict, Policy, Training, and
Oversight Division, Acquisition Policy
and Training Service Center (3802R),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460; telephone number: 202–564–
9463; email address: leftrict.pamela@
epa.gov.
amozie on DSK3GDR082PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
Supporting documents, which explain
in detail the information that the EPA
will be collecting, are available in the
public docket for this ICR. The docket
can be viewed online at
www.regulations.gov or in person at the
EPA Docket Center, WJC West, Room
3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number
for the Docket Center is 202–566–1744.
For additional information about EPA’s
public docket, visit https://www.epa.gov/
dockets.
Abstract: EPA contractors are required
to disclose business relationships and
corporate affiliations to determine
whether EPA’s interests are jeopardized
by such relationships. Because EPA has
the dual responsibility of cleanup and
enforcement and because its contractors
are often involved in both activities, it
is imperative that contractors are free
from conflicts of interest so as not to
prejudice response and enforcement
actions. Contractors are required to
maintain a database of business
relationships and report information to
EPA on either an annual basis or when
each work order is issued.
Form numbers: None.
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Respondents/affected entities:
Businesses or organizations performing
contracts for the EPA.
Respondent’s obligation to respond:
Required to obtain or retain benefits.
Estimated number of respondents: 45.
Frequency of response: Annually and
on occasion.
Total estimated burden: 56,055 hours
(per year). Burden is defined at 5 CFR
1320.03(b).
Total estimated cost: $4,139,627 (per
year), which includes $0 annualized
capital or operation & maintenance
costs.
Changes in estimates: There is a
significant reduction in expected
respondents (135 to 45), burden hours
(164,525 to 50,055), and costs associated
with this proposed renewal package
compared to the ICR currently approved
by OMB. These reductions are solely a
result of corrections to the ICR’s burden
calculations; they are not a product of
modifications to the collection
methodology or the actual respondent
universe.
Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2018–13921 Filed 6–27–18; 8:45 am]
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30447
members of the previously approved
Mullins Family Control Group which
controls FCB Bancshares, Inc., Cullman,
Alabama, and thereby indirectly
controls Premier Bank of the South,
Good Hope, Alabama.
Board of Governors of the Federal Reserve
System, June 25, 2018.
Ann Misback,
Secretary of the Board.
[FR Doc. 2018–13914 Filed 6–27–18; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0074]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; State Enforcement
Notifications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 30,
2018.
SUMMARY:
FEDERAL RESERVE SYSTEM
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
The notificants listed below have
applied under the Change in Bank
Control Act (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire shares of a bank
or bank holding company. The factors
that are considered in acting on the
notices are set forth in paragraph 7 of
the Act (12 U.S.C. 1817(j)(7)).
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
the offices of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices
of the Board of Governors. Comments
must be received not later than July 13,
2018.
A. Federal Reserve Bank of Atlanta
(Kathryn Haney, Director of
Applications) 1000 Peachtree Street NE,
Atlanta, Georgia 30309. Comments can
also be sent electronically to
Applications.Comments@atl.frb.org:
1. Robert Ward Mullins II, Huntsville,
Alabama, and Holly S. Mullins,
Vinemont, Alabama; to become
PO 00000
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To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0275. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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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
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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
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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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]]>Agencies
[Federal Register Volume 83, Number 125 (Thursday, June 28, 2018)]
[Notices]
[Pages 30447-30448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13868]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0074]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; State Enforcement
Notifications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July
30, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0275.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
[[Page 30448]]
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 Sec. 100.2 (21 CFR 100.2). The information required
in a letter of notification under Sec. 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 60-day 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part Number of responses per Total annual Average burden Total hours
respondents respondents responses per 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 information collection has not
changed since the last OMB approval. The estimated reporting burden for
Sec. 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
