80 FR 34909 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies

FEDERAL RESERVE SYSTEM

Federal Register Volume 80, Issue 117 (June 18, 2015)

Page Range		34909-34909
FR Document		2015-14985

Federal Register, Volume 80 Issue 117 (Thursday, June 18, 2015)

[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Notices]
[Page 34909]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14985]



[[Page 34909]]

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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 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 July 13, 2015.
    A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant 
Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:
    1. Southwest Bancorp, Inc., Stillwater, Oklahoma; to acquire 100 
percent of the voting shares of First Commercial Bancshares, Inc., and 
thereby indirectly acquire voting shares of First Commercial Bank, both 
in Edmond, Oklahoma.

    Board of Governors of the Federal Reserve System, June 15, 2015.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2015-14985 Filed 6-17-15; 8:45 am]
BILLING CODE 6210-01-P

Federal Register / Vol. 80, No. 117 / Thursday, June 18, 2015 / Notices 34909

FEDERAL RESERVE SYSTEM DEPARTMENT OF HEALTH AND Development, Center for Biologics
HUMAN SERVICES Evaluation and Research, Food and
Formations of, Acquisitions by, and Drug Administration, 10903 New
Mergers of Bank Holding Companies Food and Drug Administration Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
[Docket No. FDA–2015–D–1777]
The companies listed in this notice one self-addressed adhesive label to
have applied to the Board for approval, Factors To Consider When Making assist that office in processing your
pursuant to the Bank Holding Company Benefit-Risk Determinations for request.
Act of 1956 (12 U.S.C. 1841 et seq.) Medical Device Investigational Device Submit electronic comments on the
(BHC Act), Regulation Y (12 CFR part Exemptions; Draft Guidance for draft guidance to http://
225), and all other applicable statutes Investigational Device Exemption www.regulations.gov. Submit written
and regulations to become a bank Sponsors, Sponsor-Investigators, and comments to the Division of Dockets
holding company and/or to acquire the Food and Drug Administration Staff; Management (HFA–305), Food and Drug
assets or the ownership of, control of, or Availability Administration, 5630 Fishers Lane, Rm.
the power to vote shares of a bank or 1061, Rockville, MD 20852. Identify
AGENCY: Food and Drug Administration, comments with the docket number
bank holding company and all of the
HHS. found in brackets in the heading of this
banks and nonbanking companies
ACTION: Notice. document.
owned by the bank holding company,
FOR FURTHER INFORMATION CONTACT:
including the companies listed below. SUMMARY: The Food and Drug Sugato De, Center for Devices and
The applications listed below, as well Administration (FDA) is announcing the Radiological Health, Food and Drug
as other related filings required by the availability of the draft guidance Administration, 10903 New Hampshire
Board, are available for immediate entitled ‘‘Factors to Consider When Ave., Bldg. 66, Rm. 5435, Silver Spring,
inspection at the Federal Reserve Bank Making Benefit-Risk Determinations for MD 20993–0002, 301–796–6270; or
indicated. The applications will also be Medical Device Investigational Device Stephen Ripley, Center for Biologics
available for inspection at the offices of Exemptions (IDEs).’’ The purpose of this Evaluation and Research, Food and
the Board of Governors. Interested draft guidance is to provide greater Drug Administration, 10903 New
persons may express their views in clarity for FDA staff and IDE sponsors Hampshire Ave., Bldg. 71, Rm. 7301,
writing on the standards enumerated in and sponsor-investigators regarding the Silver Spring, MD 20993, 240–402–
the BHC Act (12 U.S.C. 1842(c)). If the principal factors that FDA considers 7911.
proposal also involves the acquisition of when assessing the benefits and risks of
SUPPLEMENTARY INFORMATION:
a nonbanking company, the review also IDE applications for human clinical
study. The draft guidance also I. Background
includes whether the acquisition of the
characterizes benefits in the context of
nonbanking company complies with the A primary goal of this guidance is to
investigational research, which includes
standards in section 4 of the BHC Act clarify the factors that FDA considers
direct benefits to the subjects and
(12 U.S.C. 1843). Unless otherwise when assessing risks and anticipated
benefits to others (to the extent they are
noted, nonbanking activities will be benefits for IDE studies, and how
indirect benefits to subjects or reflect
conducted throughout the United States. uncertainty may be offset by a variety of
the importance of knowledge to be
risk mitigation measures that can assure
Unless otherwise noted, comments gained). This draft guidance is not final
appropriate patient and participant
regarding each of these applications nor is it in effect at this time.
protections in investigational research
must be received at the Reserve Bank DATES: Although you can comment on settings. At earlier stages of device
indicated or the offices of the Board of any guidance at any time (see 21 CFR development, FDA considers
Governors not later than July 13, 2015. 10.115(g)(5)), to ensure that the Agency appropriate mitigation measures for
A. Federal Reserve Bank of Kansas considers your comment of this draft anticipated possible risks and
City (Dennis Denney, Assistant Vice guidance before it begins work on the unanticipated risks, whereas in later
President) 1 Memorial Drive, Kansas final version of the guidance, submit stages, risk mitigation focuses
City, Missouri 64198–0001: either electronic or written comments increasingly on the most probable risks.
on the draft guidance by September 16, Another important goal of this guidance
1. Southwest Bancorp, Inc., Stillwater, 2015. is to characterize benefits in the context
Oklahoma; to acquire 100 percent of the
ADDRESSES: An electronic copy of the of investigational research, which
voting shares of First Commercial guidance document is available for includes direct benefits to the subjects
Bancshares, Inc., and thereby indirectly download from the Internet. See the and benefits to others (to the extent they
acquire voting shares of First SUPPLEMENTARY INFORMATION section for are indirect benefits to subjects or reflect
Commercial Bank, both in Edmond, information on electronic access to the the importance of knowledge to be
Oklahoma. guidance. Submit written requests for a gained).
Board of Governors of the Federal Reserve single hard copy of the draft guidance As with the benefit-risk framework for
System, June 15, 2015. entitled ‘‘Factors to Consider When evaluating marketing applications, FDA
Michael J. Lewandowski, Making Benefit-Risk Determinations for assessment of benefits and risks for an
Medical Device Investigational Device IDE application takes into account the
Associate Secretary of the Board.
Exemptions (IDEs)’’ to the Office of the contextual setting in which the study is
[FR Doc. 2015–14985 Filed 6–17–15; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES

Center Director, Guidance and Policy being proposed, including but not
BILLING CODE 6210–01–P Development, Center for Devices and limited to characterization of the disease
Radiological Health, Food and Drug or condition being treated or diagnosed,
Administration, 10903 New Hampshire the availability of alternative treatments
Ave., Bldg. 66, Rm. 5431, Silver Spring, or diagnostics, and the risks associated
MD 20993–0002; or the Office of with them. When available, information
Communication, Outreach, and characterizing subject tolerance for risk

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Document Created: 2018-02-22 11:12:19
Document Modified: 2018-02-22 11:12:19

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		80 FR 34909