Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 34909 [2015-14985]

Download as PDF Federal Register / Vol. 80, No. 117 / Thursday, June 18, 2015 / Notices FEDERAL RESERVE SYSTEM DEPARTMENT OF HEALTH AND HUMAN SERVICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies Food and Drug Administration 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. tkelley on DSK3SPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 16:53 Jun 17, 2015 Jkt 235001 [Docket No. FDA–2015–D–1777] Factors To Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions; Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs).’’ The purpose of this draft guidance is to provide greater clarity for FDA staff and IDE sponsors and sponsor-investigators regarding the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical study. The draft guidance also characterizes benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others (to the extent they are indirect benefits to subjects or reflect the importance of knowledge to be gained). This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 16, 2015. ADDRESSES: An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance entitled ‘‘Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs)’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002; or the Office of Communication, Outreach, and SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 34909 Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request. Submit electronic comments on the draft guidance to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Sugato De, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5435, Silver Spring, MD 20993–0002, 301–796–6270; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240–402– 7911. SUPPLEMENTARY INFORMATION: I. Background A primary goal of this guidance is to clarify the factors that FDA considers when assessing risks and anticipated benefits for IDE studies, and how uncertainty may be offset by a variety of risk mitigation measures that can assure appropriate patient and participant protections in investigational research settings. At earlier stages of device development, FDA considers appropriate mitigation measures for anticipated possible risks and unanticipated risks, whereas in later stages, risk mitigation focuses increasingly on the most probable risks. Another important goal of this guidance is to characterize benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others (to the extent they are indirect benefits to subjects or reflect the importance of knowledge to be gained). As with the benefit-risk framework for evaluating marketing applications, FDA assessment of benefits and risks for an IDE application takes into account the contextual setting in which the study is being proposed, including but not limited to characterization of the disease or condition being treated or diagnosed, the availability of alternative treatments or diagnostics, and the risks associated with them. When available, information characterizing subject tolerance for risk E:\FR\FM\18JNN1.SGM 18JNN1

Agencies

[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Notices]
[Page 34909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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