Federal Register / Vol. 80, No. 4 / Wednesday, January 7, 2015 / Notices 891 

fcc504@fcc.gov or by calling the 

Consumer & Governmental Affairs at 

(202) 418–0432 (TTY). Such requests 

should include a detailed description of 

the accommodation requested. In 

addition, please include a way the FCC 

may contact you if it needs more 

information. Please allow at least five 

days’ advance notice; last minute 

requests will be accepted, but may be 

impossible to fill. 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary. 

[FR Doc. 2015–00004 Filed 1–6–15; 8:45 am] 

BILLING CODE 6712–01–P 

FEDERAL MINE SAFETY AND HEALTH 

REVIEW COMMISSION 

[BAC 6735–01] 

Sunshine Act Notice 

January 5, 2015. 

TIME AND DATE: 11:00 a.m., Thursday, 

January 15, 2015. 

PLACE: The Richard V. Backley Hearing 

Room, Room 511N, 1331 Pennsylvania 

Avenue NW., Washington, DC 20004 

(enter from F Street entrance). 

STATUS: Open. 

MATTERS TO BE CONSIDERED: The 

Commission will hear oral argument in 

the matter Secretary of Labor v. Jim 

Walter Resources, Inc., Docket No. SE 

2012–681–R (Issues include whether the 

Administrative Law Judge erred in 

upholding an imminent danger order.) 

Any person attending this oral 

argument who requires special 

accessibility features and/or auxiliary 

aids, such as sign language interpreters, 

must inform the Commission in advance 

of those needs. Subject to 29 CFR 

2706.150(a)(3) and 2706.160(d). 

CONTACT PERSON FOR MORE INFO: 

Emogene Johnson (202) 434–9935/(202) 

708–9300 for TDD Relay/1–800–877– 

8339 for toll free. 

Sarah L. Stewart, 

Deputy General Counsel. 

[FR Doc. 2015–00086 Filed 1–5–15; 4:15 pm] 

BILLING CODE P 

FEDERAL MINE SAFETY AND HEALTH 

REVIEW COMMISSION 

[BAC 6735–01] 

Sunshine Act Notice 

January 5, 2015. 

TIME AND DATE: 10:00 a.m., Thursday, 

January 15, 2015. 

PLACE: The Richard V. Backley Hearing 

Room, Room 511N, 1331 Pennsylvania 

Avenue NW., Washington, DC 20004 

(enter from F Street entrance). 

STATUS: Open. 

MATTERS TO BE CONSIDERED: The 

Commission will hear oral argument in 

the matter Secretary of Labor v. Jim 

Walter Resources, Inc., Docket No. SE 

2011–407–R (Issues include whether the 

Administrative Law Judge erred in 

upholding an imminent danger order.) 

Any person attending this oral 

argument who requires special 

accessibility features and/or auxiliary 

aids, such as sign language interpreters, 

must inform the Commission in advance 

of those needs. Subject to 29 CFR 

2706.150(a)(3) and 2706.160(d). 

CONTACT PERSON FOR MORE INFO: 

Emogene Johnson (202) 434–9935/(202) 

708–9300 for TDD Relay/1–800–877– 

8339 for toll free. 

Sarah L. Stewart, 

Deputy General Counsel. 

[FR Doc. 2015–00084 Filed 1–5–15; 4:15 pm] 

BILLING CODE 6735–01–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 February 2, 

2015. 

A. Federal Reserve Bank of St. Louis 

(Yvonne Sparks, Community 

Development Officer) P.O. Box 442, St. 

Louis, Missouri 63166–2034: 

1. First Horizon National Corporation, 

Memphis, Tennessee; to merge with 

TrustAtlantic Financial Corporation, 

and thereby indirectly acquire 

TrustAtlantic Bank, both in Raleigh, 

North Carolina. 

Board of Governors of the Federal Reserve 

System, January 2, 2015. 

Michael J. Lewandowski, 

Associate Secretary of the Board. 

[FR Doc. 2015–00033 Filed 1–6–15; 8:45 am] 

BILLING CODE 6210–01–P 

FEDERAL RESERVE SYSTEM 

Notice of Proposals To Engage in or 

To Acquire Companies Engaged in 

Permissible Nonbanking Activities 

The companies listed in this notice 

have given notice under section 4 of the 

Bank Holding Company Act (12 U.S.C. 

1843) (BHC Act) and Regulation Y, (12 

CFR part 225) to engage de novo, or to 

acquire or control voting securities or 

assets of a company, including the 

companies listed below, that engages 

either directly or through a subsidiary or 

other company, in a nonbanking activity 

that is listed in § 225.28 of Regulation Y 

(12 CFR 225.28) or that the Board has 

determined by Order to be closely 

related to banking and permissible for 

bank holding companies. Unless 

otherwise noted, these activities will be 

conducted throughout the United States. 

Each notice is available for inspection 

at the Federal Reserve Bank indicated. 

The notice also will be available for 

inspection at the offices of the Board of 

Governors. Interested persons may 

express their views in writing on the 

question whether the proposal complies 

with the standards of section 4 of the 

BHC Act. 

Unless otherwise noted, comments 

regarding the applications must be 

received at the Reserve Bank indicated 

or the offices of the Board of Governors 

not later than January 22, 2015. 

A. Federal Reserve Bank of San 

Francisco (Gerald C. Tsai, Director, 

Applications and Enforcement) 101 

Market Street, San Francisco, California 

94105–1579: 

1. CITIC Group Corporation, Beijing, 

China; to retain CLSA Americas, LLC, 

New York, New York, and to continue 

to engage in certain permissible 

nonbanking activities. 


rljohnson on DSK3VPTVN1PROD with NOTICES
892 Federal Register / Vol. 80, No. 4 / Wednesday, January 7, 2015 / Notices 

Board of Governors of the Federal Reserve 

System, January 2, 2015. 

Michael J. Lewandowski, 

Associate Secretary of the Board. 

[FR Doc. 2015–00032 Filed 1–6–15; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2005–N–0453, FDA– 

2003–N–0196, and FDA–2006–O–0314] 

Sunscreen Feedback Letters; Notice of 

Availability Under the Sunscreen 

Innovation Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of letters 

containing FDA’s initial determinations 

and feedback on safety and effectiveness 

data submitted to demonstrate that 

certain active ingredients are generally 

recognized as safe and effective 

(GRASE) and not misbranded for use in 

over-the-counter (OTC) sunscreen drug 

products (sunscreen feedback letters). 

We are taking this action under the 

Sunscreen Innovation Act (SIA). 

DATES: Submit either electronic or 

written comments by February 23, 2015. 

Sponsors may submit written requests 

for a meeting with FDA to discuss these 

proposed sunscreen orders by February 

6, 2015. 

ADDRESSES: Submit electronic 

comments 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. All 

comments should clearly identify the 

specific active ingredient(s) and docket 

number(s) to which the comments 

apply. 

FOR FURTHER INFORMATION CONTACT: 

Kristen Hardin, Division of 

Nonprescription Drug Products, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 5491, 

Silver Spring, MD 20993–0002, 240– 

402–4246. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

six sunscreen feedback letters on its 

Web site that contain the Agency’s 

tentative determinations and feedback 

on safety and effectiveness data 

submitted to demonstrate that certain 

active ingredients are GRASE and not 

misbranded for use in OTC sunscreen 

drug products. We are taking this action 

under the SIA (Pub. L. 113–195), 

enacted November 26, 2014. Before the 

SIA was enacted, these sunscreen 

feedback letters were issued to persons 

seeking OTC monograph status for 

nonprescription sunscreen active 

ingredients using the Time and Extent 

Application (TEA) process under FDA 

regulations in 21 CFR 330.14, and were 

also previously made available to the 

public in the docket. 

The SIA amended the Federal Food, 

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

among other things, provide an 

alternative process for FDA to review 

the safety and effectiveness of 

nonprescription sunscreen active 

ingredients. The SIA establishes new 

procedures for establishing the 

conditions under which sunscreens 

containing active ingredients that have 

been reviewed through the SIA process 

and found in a final sunscreen order to 

be GRASE and not misbranded may be 

marketed in the United States. 

Section 586C(b)(3) of the FD&C Act, 

as added by the SIA, provides that 

sunscreen feedback letters issued before 

the SIA was enacted are deemed to be 

proposed sunscreen orders. Proposed 

sunscreen orders contain FDA’s 

tentative determination that a 

nonprescription sunscreen active 

ingredient or combination of 

nonprescription sunscreen active 

ingredients: (A) Is GRASE and not 

misbranded if marketed in accordance 

with such order; (B) is not GRASE and 

is misbranded; or (C) is not GRASE and 

is misbranded because the data are 

insufficient to classify the active 

ingredient or combination of ingredients 

as GRASE and not misbranded, and 

additional data are necessary to allow 

FDA to determine otherwise. All of the 

proposed sunscreen orders addressed in 

this notice have been tentatively 

classified under category (C), as 

described in the previous sentence. 

Accordingly, additional data will be 

needed to support a determination that 

any or all of the active ingredients they 

address are GRASE and not misbranded. 

II. Sunscreen Feedback Letters Deemed 

To Be SIA Proposed Orders 

The six feedback letters that are 

deemed to be proposed orders under the 

SIA are identified in Table 1. They can 

be viewed electronically on FDA’s Web 

site at http://www.fda.gov/Drugs/

ResourcesForYou/Consumers/

BuyingUsingMedicineSafely/

UnderstandingOver-theCounterMedicines/ucm239463.htm, 

under the heading ‘‘FDA Regulatory 

Action on Sunscreen.’’ Related 

documents, including safety and 

efficacy data submissions, can be 

accessed in the corresponding dockets, 

identified in Table 1, at http://

www.regulations.gov. The letters and 

associated information may also be 

viewed by visiting FDA’s Division of 

Dockets Management (see ADDRESSES). 

TABLE 1—OTC SUNSCREEN FEEDBACK LETTERS DEEMED TO BE SIA PROPOSED ORDERS

Active ingredient Sponsor Date issued Docket 

No. 1

Bemotrizinol ............................................................ Ciba Specialty Chemicals Corp ............................. 11/13/2014 FDA–2005–N– 

0453 

Bisoctrizole .............................................................. Ciba Specialty Chemicals Corp ............................. 9/3/2014 FDA–2005–N– 

0453 

Drometrizole Trisiloxane ......................................... L’Oreal USA Products, Inc. .................................... 8/29/2014 FDA–2003–N– 

0196 

Octyl Triazone ......................................................... BASF AG ................................................................ 6/23/2014 FDA–2003–N– 

0196 

Amiloxate ................................................................ Symrise, Inc. ..........................................................

Ego Pharmaceuticals Pty. Ltd. ...............................

2/25/2014 FDA–2003–N– 

0196 

Diethylhexyl Butamido Triazone ............................. 3V Inc. .................................................................... 2/21/2014 FDA–2006–O– 

0314 

1Each letter was previously posted in the docket shown in Table 1 on the date that it was issued. 


rljohnson on DSK3VPTVN1PROD with NOTICES