Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 8871 

Washington, DC 20573, within twelve 

days of the date this notice appears in 

the Federal Register. Copies of the 

agreements are available through the 

Commission’s Web site (www.fmc.gov) 

or by contacting the Office of 

Agreements at (202)–523–5793 or 

tradeanalysis@fmc.gov. 

Agreement No.: 011488–005. 

Title: CSVV/Cool Carriers Space 

Charter Agreement. 

Parties: Cool Carriers AB and CSAV 

Sud Americana De Vapores S.A. 

Filing Party: David F. Smith, Esq.; 

Cozen O’Connor; 1627 I Street NW., 

Suite 1100; Washington, DC 20006. 

Synopsis: The Amendment changes 

the name of Agreement party NYKCool 

AB to Cool Carriers AB and makes 

related conforming changes. 

Agreement No.: 012287–001. 

Title: Siem Car Carriers AS/Mitsui 

O.S.K Lines Ltd. Space Charter 

Agreement. 

Parties: Siem Car Carriers AS and 

Mitsui O.S.K Lines, Ltd. 

Filing Party: Ashley W. Craig, Esq. 

and Elizabeth K. Lowe, Esq.; Venable 

LLP; 575 Seventh Street NW., 

Washington, DC 20004. 

Synopsis: The Amendment adds 

Germany and the U.S. Gulf Coast to the 

geographic scope of the Agreement. 

Agreement No.: 012317. 

Title: MOL/‘‘K’’ Line U.S. Atlantic 

and China Sailing Agreement. 

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

Kawasaki Kisen Kaisha, Ltd. 

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 coordinate their sailings 

and space requirements in the trade, 

and to discuss and agree upon the 

volumes, cargo characteristics, shipping 

requirements, and other transportation 

features of service for a specific shipper, 

when such shipper has given written 

authorization for such discussion and 

agreement. 

By Order of the Federal Maritime 

Commission. 

Dated: February 13, 2015. 

Rachel E. Dickon, 

Assistant Secretary. 

[FR Doc. 2015–03506 Filed 2–18–15; 8:45 am] 

BILLING CODE 6730–01–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 March 

5, 2015. 

A. Federal Reserve Bank of San 

Francisco (Gerald C. Tsai, Director, 

Applications and Enforcement) 101 

Market Street, San Francisco, California 

94105–1579: 

1. Bruce M. Williams and Joyce L. 

Williams, Anaheim, California; Brian 

Edward Williams, Yorba Linda, 

California; Ashley Maureen Williams, 

Orange, California; Brooke Ann 

Williams, Anaheim, California; Michael 

Robert Williams, Las Vegas, Nevada; 

Rebecca Kristy Williams, Fullerton, 

California; the Gladys M. Bryant Living 

Trust, Anaheim, California; and Bruce 

M. Williams as Trustee of the Gladys M. 

Bryant Living Trust, Anaheim, 

California; to acquire and retain 10 

percent or more of the shares of CalWest 

Bancorp and thereby indirectly South 

County Bank National Association, both 

of Rancho Santa Margarita, California. 

Board of Governors of the Federal Reserve 

System, February 13, 2015. 

Michael J. Lewandowski, 

Assistant Secretary of the Board. 

[FR Doc. 2015–03426 Filed 2–18–15; 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 March 16, 

2015. 

A. Federal Reserve Bank of Atlanta 

(Chapelle Davis, Assistant Vice 

President) 1000 Peachtree Street NE., 

Atlanta, Georgia 30309: 

1. First Mercantile Financial 

Corporation, to become a bank holding 

company by acquiring 100 percent of 

the outstanding shares of Putnam 1st 

Mercantile Bank, both of Cookeville, 

Tennessee. 

Board of Governors of the Federal Reserve 

System, February 13, 2015. 

Michael J. Lewandowski, 

Associate Secretary of the Board. 

[FR Doc. 2015–03427 Filed 2–18–15; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1399] 

Guidance for Entities Considering 

Whether To Register as Outsourcing 

Facilities Under Section 503B of the 

Federal Food, Drug, and Cosmetic Act; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Guidance for Entities Considering 

Whether to Register as Outsourcing 

Facilities Under Section 503B of the 

Federal Food, Drug, and Cosmetic Act.’’ 

This draft guidance is intended to 

inform entities that are considering 

registering as outsourcing facilities 

under section 503B of the Federal Food, 


emcdonald on DSK67QTVN1PROD with NOTICES
8872 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 

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

as added by the Drug Quality and 

Security Act (DQSA), of the regulatory 

implications of registration as an 

outsourcing facility. 

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 on 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 May 20, 2015. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

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. 

FOR FURTHER INFORMATION CONTACT: Sara 

Rothman, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–3110. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Guidance for Entities Considering 

Whether to Register as Outsourcing 

Facilities Under Section 503B of the 

Federal Food, Drug, and Cosmetic Act.’’ 

On November 27, 2013, President 

Obama signed the DQSA (Pub. L. 113– 

54) into law. The DQSA added a new 

section 503B to the FD&C Act that 

created a category of entities called 

‘‘outsourcing facilities.’’ Section 

503B(d)(4) of the FD&C Act (21 U.S.C. 

353b(d)(4)) defines an outsourcing 

facility, in part, as a facility that 

complies with all of the requirements of 

section 503B, including registering with 

FDA as an outsourcing facility and 

paying associated fees. If the conditions 

outlined in section 503B(a) of the FD&C 

Act are satisfied, a drug compounded by 

or under the direct supervision of a 

licensed pharmacist in an outsourcing 

facility is exempt from certain sections 

of the FD&C Act, including section 

502(f)(1) (21 U.S.C. 352(f)(1)) 

(concerning the labeling of drugs with 

adequate directions for use) and section 

505 (21 U.S.C. 355) (concerning the 

approval of human drug products under 

new drug applications (NDAs) or 

abbreviated new drug applications 

(ANDAs)). Drugs compounded in 

outsourcing facilities are not exempt 

from the requirements of section 

501(a)(2)(B) of the FD&C Act (21 U.S.C. 

351(a)(2)(B)) (concerning current good 

manufacturing practice for drugs). 

FDA has received questions about 

whether entities engaged in various 

types of activities (e.g., a facility that is 

compounding only non-sterile drugs or 

only repackaging biological products) 

should register as an outsourcing 

facility. Because entities that register as 

outsourcing facilities in fiscal year 2015 

(beginning October 1, 2014) must pay a 

registration fee and FDA has determined 

that fees paid pursuant to sections 503B 

and 744K of the FD&C Act will not be 

refunded, FDA is issuing this guidance 

to answer some of these questions and 

to provide potential registrants 

additional information about the 

regulatory impact of registering as an 

outsourcing facility. 

Elsewhere in this volume of the 

Federal Register, FDA is announcing 

the availability of separate FDA 

guidance documents on (1) mixing, 

diluting, or repackaging biological 

products outside the scope of an 

approved biologics license application, 

and (2) repackaging certain human drug 

products by pharmacies and 

outsourcing facilities. These guidance 

documents describe FDA’s compliance 

policies with respect to biological 

products that are mixed, diluted, or 

repackaged outside the scope of an 

approved biologics license application 

and repackaged human drugs. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on registering as an outsourcing facility 

under section 503B of the FD&C Act. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: February 11, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03416 Filed 2–18–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–2138] 

Adverse Event Reporting for 

Outsourcing Facilities Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Adverse 

Event Reporting for Outsourcing 

Facilities Under Section 503B of the 

Federal Food, Drug, and Cosmetic Act.’’ 

Under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act), an 

outsourcing facility must submit 

adverse event reports to FDA. This 

guidance explains FDA’s current 

thinking on adverse event reporting for 

outsourcing facilities. 

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 on this draft 

guidance before it begins work to 

finalize the guidance, submit either 

electronic or written comments on this 

draft guidance by May 20, 2015. Submit 

either electronic or written comments 

concerning the collection of information 

proposed in the draft guidance by May 

20, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 


emcdonald on DSK67QTVN1PROD with NOTICES