76330 Federal Register / Vol. 79, No. 245 / Monday, December 22, 2014 / Notices 

Holding Company, Denton, Montana, 

and thereby indirectly acquire Farmers 

State Bank, Denton, Montana. 

Board of Governors of the Federal Reserve 

System, December 17, 2014. 

Michael J. Lewandowski, 

Associate Secretary of the Board. 

[FR Doc. 2014–29894 Filed 12–19–14; 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 

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 January 15, 

2015. 

A. Federal Reserve Bank of Chicago 

(Colette A. Fried, Assistant Vice 

President) 230 South LaSalle Street, 

Chicago, Illinois 60690–1414: 

1. Level One Bancorp, Inc., 

Farmington Hills, Michigan; to merge 

with Lotus Bancorp, Inc., Novi, 

Michigan; and thereby indirectly 

acquire Lotus Bank, Novi, Michigan. 

Board of Governors of the Federal Reserve 

System, December 16, 2014. 

Michael J. Lewandowski, 

Associate Secretary of the Board. 

[FR Doc. 2014–29771 Filed 12–19–14; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Draft Guidance on Disclosing 

Reasonably Foreseeable Risks in 

Research Evaluating Standards of 

Care 

AGENCY: Department of Health and 

Human Services (HHS), Office of the 

Secretary, Office of the Assistant 

Secretary for Health, Office for Human 

Research Protections; Extension of 

Comment Period. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS), through the 

Office for Human Research Protections 

(OHRP) is extending the public 

comment period for a draft guidance 

document for the research community 

entitled ‘‘Draft Guidance on Disclosing 

Reasonably Foreseeable Risks in 

Research Evaluating Standards of Care.’’ 

The availability of that draft document 

was published in the Federal Register 

on October 24, 2014, Volume 79, 

Number 206, page 63629. 

DATES: The comment period is extended 

by 30 days and thus will end on January 

22, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Draft Guidance on 

Disclosing Reasonably Foreseeable Risks 

in Research Evaluating Standards of 

Care’’ to the Division of Policy and 

Assurances, Office for Human Research 

Protections, 1101 Wootton Parkway, 

Suite 200, Rockville, MD 20852. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 301–402– 

2071. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the draft guidance 

document. 

You may submit comments identified 

by docket ID number HHS–OPHS– 

2014–0005 by one of the following 

methods: 

Federal eRulemaking Portal: http://

www.regulations.gov. Enter the above 

docket ID number in the Enter Keyword 

or ID field and click on ‘‘Search.’’ On 

the next page, click the ‘‘Submit a 

Comment’’ action and follow the 

instructions. 

Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions] 

to: Irene Stith-Coleman, Ph.D., Office for 

Human Research Protections, 1101 

Wootton Parkway, Suite 200, Rockville, 

MD 20852. 

Comments received, including any 

personal information, will be posted 

without change to http://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Irene Stith-Coleman, Ph.D., Office for 

Human Research Protections, 

Department of Health and Human 

Services, 1101 Wootton Parkway, Suite 

200, Rockville, MD 20852; phone 240– 

453–6900; email Irene.Stith-Coleman@

hhs.gov 

SUPPLEMENTARY INFORMATION: The notice 

of availability of the draft guidance 

document was published in the Federal 

Register on October 24, 2014, Volume 

79, Number 206, page 63629, with a 

deadline for comments of December 23, 

2014. OHRP is specifically addressing 

what risks to subjects are presented by 

research evaluating or comparing risks 

associated with standards of care, and 

which of these risks are reasonably 

foreseeable and should be disclosed to 

prospective research subjects as part of 

their informed consent. OHRP is 

soliciting written comments from all 

interested parties, including, but not 

limited to, IRB members, IRB staff, 

institutional officials, research 

institutions, investigators, research 

subject advocacy groups, ethicists, the 

regulated community, and the public at 

large. Since the notice of availability 

and draft guidance documents were 

published, the Department has received 

requests to extend the comment period 

to allow sufficient time for a full review 

of the draft guidance document. OHRP 

is committed to affording the public a 

meaningful opportunity to comment on 

the draft guidance document and 

welcomes comments. 

Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance document 

on OHRP’s Web site at http://

www.hhs.gov/ohrp/newsroom/rfc/

index.html or on the Federal 

Rulemaking Portal at http://

www.regulations.gov/. 

Dated: December 17, 2014. 

Jerry Menikoff, 

Director, Office for Human Research 

Protections. 

[FR Doc. 2014–29915 Filed 12–19–14; 8:45 am] 

BILLING CODE 4150–36–P 


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