Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices 14133 

Parties: Mitsui O.S.K. Lines, Ltd. and 

Wallenius Wilhelmsen Logistics AS. 

Filing Party: Eric. C. Jeffrey, Esq.; 

Nixon Peabody LLP; 401 9th Street NW., 

Suite 900, Washington, DC 20004. 

Synopsis: The Agreement authorizes 

the parties to charter space to/from one 

another for the transportation of 

vehicles or other Ro/Ro cargo in the 

trade between the United States and 

Europe. 

Agreement No.: 012320. 

Title: HLAG/CSAV Agreement. 

Parties: Hapag-Lloyd AG and 

Compania Sud Americana De Vapores, 

S.A. 

Filing Party: Wayne R. Rohde, Esq.; 

Cozen O’Connor, 1627 I Street NW., 

Washington, DC 20006. 

Synopsis: The Agreement would 

authorize certain on-going arrangements 

between the Parties that are ancillary to 

the acquisition of CSAV’s containerized 

ocean liner business by Hapag-Lloyd. 

More specifically, it would set forth the 

terms of a non-compete arrangement 

between the Parties, and authorize the 

exchange of information and agreement 

between the parties on matters 

necessary to complete the efficient 

transfer of the business. 

By Order of the Federal Maritime 

Commission. 

Karen V. Gregory, 

Secretary. 

[FR Doc. 2015–06202 Filed 3–17–15; 8:45 am] 

BILLING CODE 6730–01–P 

FEDERAL RESERVE SYSTEM 

Formations of, Acquisitions by, and 

Mergers of Savings and Loan Holding 

Companies 

The companies listed in this notice 

have applied to the Board for approval, 

pursuant to the Home Owners’ Loan Act 

(12 U.S.C. 1461 et seq.) (HOLA), 

Regulation LL (12 CFR part 238), and 

Regulation MM (12 CFR part 239), and 

all other applicable statutes and 

regulations to become a savings and 

loan holding company and/or to acquire 

the assets or the ownership of, control 

of, or the power to vote shares of a 

savings association and nonbanking 

companies owned by the savings and 

loan 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 application also will 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 HOLA (12 U.S.C. 1467a(e)). 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 10(c)(4)(B) of the 

HOLA (12 U.S.C. 1467a(c)(4)(B)). 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 April 13, 2015. 

A. Federal Reserve Bank of Cleveland 

(Nadine Wallman, Vice President) 1455 

East Sixth Street, Cleveland, Ohio 

44101–2566: 

1. CF Mutual Holding Company and 

CF Bancorp, Inc., both in Cincinnati, 

Ohio; to become a savings and loan 

holding companies upon the conversion 

of Cincinnati Federal Savings Loan 

Association, Cincinnati, Ohio, which is 

converting from mutual to stock form. 

Board of Governors of the Federal Reserve 

System, March 13, 2015. 

Michael J. Lewandowski, 

Associate Secretary of the Board. 

[FR Doc. 2015–06197 Filed 3–17–15; 8:45 am] 

BILLING CODE 6210–01–P 

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 April 2, 

2015. 

A. Federal Reserve Bank of Kansas 

City (Dennis Denney, Assistant Vice 

President) 1 Memorial Drive, Kansas 

City, Missouri 64198–0001: 

1. Georgia A. Gross, Roseburg, 

Oregon, acting in concert with the Gross 

Family; to acquire voting shares of 

Commercial Bancorp, and thereby 

indirectly acquire voting shares of 

Farmers State Bank, both in Pine Bluffs, 

Wyoming. 

Board of Governors of the Federal Reserve 

System, March 13, 2015. 

Michael J. Lewandowski, 

Associate Secretary of the Board. 

[FR Doc. 2015–06198 Filed 3–17–15; 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 April 13, 2025. 

A. Federal Reserve Bank of 

Minneapolis (Jacquelyn K. Brunmeier, 

Assistant Vice President) 90 Hennepin 

Avenue, Minneapolis, Minnesota 

55480–0291: 

1. Beartooth Financial Corporation, 

Billings, Montana; to become a bank 

holding company by acquiring 100 

percent of the voting shares of Beartooth 

Bank, Billings, Montana. 

B. Federal Reserve Bank of Dallas 

(Robert L. Triplett III, Senior Vice 

President) 2200 North Pearl Street, 

Dallas, Texas 75201–2272: 

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14134 Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices 

1. FNBK Holdings, Inc., Dallas, Texas; 

to become a bank holding company by 

acquiring 100 percent of the voting 

shares of The First National Bank of 

Kemp, Kemp, Texas. 

Board of Governors of the Federal Reserve 

System, March 13, 2015. 

Michael J. Lewandowski, 

Associate Secretary of the Board. 

[FR Doc. 2015–06196 Filed 3–17–15; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0044] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Recommended 

Recordkeeping for Exempt Infant 

Formula Production 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing an opportunity for public 

comment on our proposed collection of 

certain information. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice invites comments on 

the information collection provisions of 

the draft guidance entitled ‘‘Draft 

Guidance for Industry: Exempt Infant 

Formula Production: Current Good 

Manufacturing Practices (CGMPs), 

Quality Control Procedures, Conduct of 

Audits, and Records and Reports.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 18, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Recommended Recordkeeping for 

Exempt Infant Formula Production— 

OMB Control Number 0910—NEW 

I. Background 

Section 412(h)(1) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 350a(h)(1)) exempts an infant 

formula which is represented and 

labeled for use by an infant with an 

inborn error of metabolism, low birth 

weight, or who otherwise has an 

unusual medical or dietary problem 

from the requirements of section 412(a), 

(b), and (c) of the FD&C Act. These 

formulas are customarily referred to as 

‘‘exempt infant formulas.’’ In the 

Federal Register of June 10, 2014 (79 FR 

33057), we published a final rule that 

adopted, with some modifications, an 

interim final rule published on February 

10, 2014 (79 FR 7933), that established 

requirements for quality factors for 

infant formulas and current good 

manufacturing practices (CGMPs), 

including quality control procedures, 

under section 412 of the FD&C Act. The 

final rule will help prevent the 

manufacture of adulterated infant 

formula, ensure the safety of infant 

formula, and ensure that the nutrients in 

infant formula are present in a form that 

is bioavailable. 

In the Federal Register of February 

10, 2014 (79 FR 7610), we published a 

notice of availability of the draft 

guidance document entitled ‘‘Guidance 

for Industry: Exempt Infant Formula 

Production: Current Good 

Manufacturing Practices (CGMPs), 

Quality Control Procedures, Conduct of 

Audits, and Records and Reports’’ (the 

draft guidance). The draft guidance, 

when finalized, will describe our 

current thinking on the manufacturing 

of exempt infant formula in relation to 

the requirements in part 106 (21 CFR 

part 106) for CGMPs, quality control 

procedures, conduct of audits, and 

records and reports that apply to 

nonexempt infant formulas. Persons 

with access to the Internet may obtain 

the draft guidance at http://

www.fda.gov/FoodGuidances. 

II. Analysis of the Proposed 

Information Collection 

The proposed information collection 

seeks OMB approval of the 

recordkeeping recommendations of the 

draft guidance. Our estimate of the 

burden of the recordkeeping 

recommendations includes the one-time 

burden of developing production and 

in-process control systems and the 

annual burdens of developing and 

maintaining production aggregate 

production and control records, records 

pertaining to the distribution of infant 

formula, and records pertaining to 

regularly scheduled audits. Included in 

the burden estimate is the time for 

reviewing instructions, searching 

existing data sources, gathering and 

maintaining the data needed, and 

completing and reviewing each 

collection of information. 

Description of Respondents: The 

respondent recordkeepers are 

manufacturers of exempt infant formula. 

Description: The records 

recommended, to the extent practicable, 

in the draft guidance include records 

required by part 106, subparts A, B, C, 

D, and F for non-exempt infant 

formulas. Because the records and 

reporting requirements related to part 

106 subparts E and G are not generally 

applicable to exempt infant formula 

manufacturers, FDA is not 

recommending in the draft guidance 

that exempt infant formula 

manufacturers follow these 

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