Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 54106-54107 [2018-23449]
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Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices
FEDERAL RESERVE SYSTEM
Government in the Sunshine Meeting
Notice
Board of
Governors of the Federal Reserve
System.
TIME AND DATE: 10:30 a.m. on
Wednesday, October 31, 2018.
PLACE: Marriner S. Eccles Federal
Reserve Board Building, 20th Street
entrance between Constitution Avenue
and C Streets, NW, Washington, DC
20551.
STATUS: Open.
On the day of the meeting, you will
be able to view the meeting via webcast
from a link available on the Board’s
public website. You do not need to
register to view the webcast of the
meeting. A link to the meeting
documentation will also be available
approximately 20 minutes before the
start of the meeting. Both links may be
accessed from the Board’s public
website at www.federalreserve.gov.
If you plan to attend the open meeting
in person, we ask that you notify us in
advance and provide your name, date of
birth, and social security number (SSN)
or passport number. You may provide
this information by calling 202–452–
2474 or you may register online. You
may pre-register until close of business
on Tuesday, October 30, 2018. You also
will be asked to provide identifying
information, including a photo ID,
before being admitted to the Board
meeting. The Public Affairs Office must
approve the use of cameras; please call
202–452–2955 for further information. If
you need an accommodation for a
disability, please contact Penelope
Beattie on 202–452–3982. For the
hearing impaired only, please use the
Telecommunication Device for the Deaf
(TDD) on 202–263–4869.
Privacy Act Notice: The information
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243 and 248, and Executive Order 9397.
In accordance with Executive Order
9397, we collect your SSN so that we
can keep accurate records, because other
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people may have the same name and
birth date. In addition, we use your SSN
when we make requests for information
about you from law enforcement and
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Furnishing the information requested is
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your request for access to the Board’s
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or imprisonment under 18 U.S.C 1001
for any false statements you make in
your request to enter the Board’s
premises.
Matters To Be Considered
Discussion Agenda:
1. Prudential Standards for Large
Bank Holding Companies, Savings and
Loan Holding Companies, and State
Member Banks.
Notes: 1. The staff memos to the
Board will be made available to
attendees on the day of the meeting in
paper and the background material will
be made available on a compact disc
(CD). If you require a paper copy of the
entire document, please call Penelope
Beattie on 202–452–3982. The
documentation will not be available to
the public until about 20 minutes before
the start of the meeting.
2. This meeting will be recorded for
the benefit of those unable to attend.
The webcast recording and a transcript
of the meeting will be available after the
meeting on the Board’s public website
https://www.federalreserve.gov/
aboutthefed/boardmeetings/ or if you
prefer, a CD recording of the meeting
will be available for listening in the
Board’s Freedom of Information Office,
and copies can be ordered for $4 per
disc by calling 202–452–3684 or by
writing to: Freedom of Information
Office, Board of Governors of the
Federal Reserve System, Washington,
DC 20551.
For more information please contact:
Michelle Smith, Director, or Dave
Skidmore, Assistant to the Board, Office
of Board Members at 202–452–2955.
You may
access the Board’s public website at
www.federalreserve.gov for an electronic
announcement. (The website also
includes procedural and other
information about the open meeting.)
SUPPLEMENTARY INFORMATION:
Dated: October 24, 2018
Ann E. Misback,
Secretary of the Board.
[FR Doc. 2018–23559 Filed 10–24–18; 4:15 pm]
BILLING CODE 6210–01–P
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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
November 13, 2018.
A. Federal Reserve Bank of
Minneapolis (Mark A. Rauzi, Vice
President), 90 Hennepin Avenue,
Minneapolis, Minnesota 55480–0291:
1. Lance E. Skov, Albert Lea,
Minnesota; to become trustee of the
Lake Bank Shares, Inc., Employee Stock
Ownership Plan, and thereby indirectly
acquire shares of Lake Bank Shares, Inc.,
which owns Security Bank Minnesota,
both of Albert Lea, Minnesota.
Board of Governors of the Federal Reserve
System, October 22, 2018.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2018–23385 Filed 10–25–18; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL RESERVE SYSTEM
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
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Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than November 23,
2018.
A. Federal Reserve Bank of Boston
(Prabal Chakrabarti, Senior Vice
President) 600 Atlantic Avenue, Boston,
Massachusetts 02210–2204. Comments
can also be sent electronically to
BOS.SRC.Applications.Comments@
bos.frb.org:
1. Hometown Financial Group, MHC
and Hometown Financial Group, Inc.,
both of Easthampton, Massachusetts; to
merge with Pilgrim Bancshares, Inc.,
and thereby acquire Pilgrim Bank, both
of Cohasset, Massachusetts.
Board of Governors of the Federal Reserve
System, October 23, 2018.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2018–23449 Filed 10–25–18; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3614]
Biopharmaceutics Classification
System-Based Biowaivers;
International Council for
Harmonisation; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Biopharmaceutics Classification
System-Based Biowaivers.’’ The draft
guidance was prepared under the
auspices of the International Council for
Harmonisation (ICH), formerly the
International Conference on
Harmonisation. The draft guidance will
provide recommendations to support
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the biopharmaceutics classification of
drug substances and the
Biopharmaceutics Classification System
(BCS)-based waiver of in vivo
bioequivalence (BE) studies for drug
products. In vivo BE studies are needed
to demonstrate lack of impact of
significant formulation changes on a
drug’s bioavailability during its
development, for post-approval line
extensions, and when developing a
generic product. Utilizing the critical
properties of the drug substance and the
drug product, and applying the BCS
framework, assurance of in vivo BE
findings can be obtained using extensive
in vitro studies. The draft guidance is
intended to avoid unnecessary human
BE trials based on extensive in vitro
characterization of the drug substance
and drug product properties.
DATES: Submit either electronic or
written comments on the draft guidance
by January 24, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
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54107
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–3614 for ‘‘Biopharmaceutics
Classification System-Based
Biowaivers.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
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Agencies
[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54106-54107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23449]
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FEDERAL RESERVE SYSTEM
Formations of, Acquisitions by, and Mergers of Bank Holding
Companies
The companies listed in this notice have applied to the Board for
approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C.
1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other
applicable statutes and regulations to become a bank holding company
and/or to acquire the assets or the ownership of, control of, or the
power to vote shares of a bank or bank holding company and all of the
banks and nonbanking companies owned by the bank holding company,
including the companies listed below.
The applications listed below, as well as other related filings
required by the Board, are available for immediate inspection at the
Federal Reserve Bank indicated. The applications will also be
[[Page 54107]]
available for inspection at the offices of the Board of Governors.
Interested persons may express their views in writing on the standards
enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also
involves the acquisition of a nonbanking company, the review also
includes whether the acquisition of the nonbanking company complies
with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless
otherwise noted, nonbanking activities will be conducted throughout the
United States.
Unless otherwise noted, comments regarding each of these
applications must be received at the Reserve Bank indicated or the
offices of the Board of Governors not later than November 23, 2018.
A. Federal Reserve Bank of Boston (Prabal Chakrabarti, Senior Vice
President) 600 Atlantic Avenue, Boston, Massachusetts 02210-2204.
Comments can also be sent electronically to
[email protected]:
1. Hometown Financial Group, MHC and Hometown Financial Group,
Inc., both of Easthampton, Massachusetts; to merge with Pilgrim
Bancshares, Inc., and thereby acquire Pilgrim Bank, both of Cohasset,
Massachusetts.
Board of Governors of the Federal Reserve System, October 23,
2018.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2018-23449 Filed 10-25-18; 8:45 am]
BILLING CODE P