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
Federal Register / Vol. 80, No. 4 / Wednesday, January 7, 2015 / Notices 893 

Sponsors may submit a written 

request for a meeting with FDA to 

discuss any of these proposed sunscreen 

orders (see DATES). Submit meeting 

requests electronically to 

www.regulations.gov or in writing to the 

Division of Dockets Management (see 

ADDRESSES), identified with the active 

ingredient name(s), the corresponding 

docket number(s) shown in Table 1, and 

the heading ‘‘Sponsor Meeting 

Request.’’ To facilitate your request, 

please also send a copy to Kristen 

Hardin (see FOR FURTHER INFORMATION

CONTACT). 

III. Comments 

Interested persons may submit either 

electronic comments about the proposed 

orders discussed in 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 appropriate 

docket number(s) and active ingredient 

name(s) shown in Table 1 for the 

proposed order(s) that the comments 

address. Comments on this notice may 

be viewed in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday, and will be 

posted to the appropriate docket(s) at 

http://www.regulations.gov. 

Dated: December 31, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–00002 Filed 1–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

[CIS No. 2550–14; DHS Docket No. USCIS– 

2007–0028] 

RIN 1615–ZB36 

Extension of the Designation of El 

Salvador for Temporary Protected 

Status 

AGENCY: U.S. Citizenship and 

Immigration Services, Department of 

Homeland Security. 

ACTION: Notice. 

SUMMARY: Through this Notice, the 

Department of Homeland Security 

(DHS) announces that the Secretary of 

Homeland Security (Secretary) is 

extending the designation of El Salvador 

for Temporary Protected Status (TPS) 

for 18 months from March 10, 2015, 

through September 9, 2016. 

The extension allows currently 

eligible TPS beneficiaries to retain TPS 

through September 9, 2016, so long as 

they otherwise continue to meet the 

eligibility requirements for TPS. The 

Secretary has determined that an 

extension is warranted because the 

conditions in El Salvador that prompted 

the TPS designation continue to be met. 

There continues to be a substantial, but 

temporary, disruption of living 

conditions in El Salvador resulting from 

a series of earthquakes in 2001, and El 

Salvador remains unable, temporarily, 

to handle adequately the return of its 

nationals. 

Through this Notice, DHS also sets 

forth procedures necessary for nationals 

of El Salvador (or aliens having no 

nationality who last habitually resided 

in El Salvador) to re-register for TPS and 

to apply for renewal of their 

Employment Authorization Documents 

(EADs) with U.S. Citizenship and 

Immigration Services (USCIS). Reregistration is limited to persons who 

have previously registered for TPS 

under the designation of El Salvador 

and whose applications have been 

granted. Certain nationals of El Salvador 

(or aliens having no nationality who last 

habitually resided in El Salvador) who 

have not previously applied for TPS 

may be eligible to apply under the late 

initial registration provisions, if they 

meet: (1) At least one of the late initial 

filing criteria; and, (2) all TPS eligibility 

criteria (including continuous residence 

in the United States since February 13, 

2001, and continuous physical presence 

in the United States since March 9, 

2001). 

For individuals who have already 

been granted TPS under the El Salvador 

designation, the 60-day re-registration 

period runs from January 7, 2015 

through March 9, 2015. USCIS will 

issue new EADs with a September 9, 

2016 expiration date to eligible El 

Salvador TPS beneficiaries who timely 

re-register and apply for EADs under 

this extension. Given the timeframes 

involved with processing TPS reregistration applications, DHS 

recognizes that not all re-registrants will 

receive new EADs before their current 

EADs expire on March 9, 2015. 

Accordingly, through this Notice, DHS 

automatically extends the validity of 

EADs issued under the TPS designation 

of El Salvador for 6 months, through 

September 9, 2015, and explains how 

TPS beneficiaries and their employers 

may determine which EADs are 

automatically extended and their impact 

on Employment Eligibility Verification 

(Form I–9) and the E-Verify processes. 

DATES: The 18-month extension of the 

TPS designation of El Salvador is 

effective March 10, 2015, and will 

remain in effect through September 9, 

2016. The 60-day re-registration period 

runs from January 7, 2015 through 

March 9, 2015March 9, 2015. (Note: It 

is important for re-registrants to timely 

re-register during this 60-day reregistration period and not to wait until 

their EADs expire.) 

FOR FURTHER INFORMATION CONTACT: 

• For further information on TPS, 

including guidance on the application 

process and additional information on 

eligibility, please visit the USCIS TPS 

Web page at http://www.uscis.gov/tps. 

You can find specific information about 

this extension of El Salvador for TPS by 

selecting ‘‘TPS Designated Country: El 

Salvador’’ from the menu on the left of 

the TPS Web page. 

• You can also contact the TPS 

Operations Program Manager at the 

Family and Status Branch, Service 

Center Operations Directorate, U.S. 

Citizenship and Immigration Services, 

Department of Homeland Security, 20 

Massachusetts Avenue NW., 

Washington, DC 20529–2060; or by 

phone at (202) 272–1533 (this is not a 

toll-free number). Note: The phone 

number provided here is solely for 

questions regarding this TPS Notice. It 

is not for individual case status 

inquires. 

• Applicants seeking information 

about the status of their individual cases 

can check Case Status Online, available 

at the USCIS Web site at http://

www.uscis.gov, or call the USCIS 

National Customer Service Center at 

800–375–5283 (TTY 800–767–1833). 

Service is available in English and 

Spanish. 

• Further information will also be 

available at local USCIS offices upon 

publication of this Notice. 

SUPPLEMENTARY INFORMATION: 

Table of Abbreviations 

BIA—Board of Immigration Appeals 

DHS—Department of Homeland Security 

DOS—Department of State 

EAD—Employment Authorization Document 

FNC—Final Nonconfirmation 

Government—U.S. Government 

IJ—Immigration Judge 

INA—Immigration and Nationality Act 

OSC—U.S. Department of Justice, Office of 

Special Counsel for Immigration-Related 

Unfair Employment Practices 

SAVE—USCIS Systematic Alien Verification 

for Entitlements Program 

Secretary—Secretary of Homeland Security 

TNC—Tentative Nonconfirmation 

TPS—Temporary Protected Status 

TTY—Text Telephone 

USCIS—U.S. Citizenship and Immigration 

Services 


rljohnson on DSK3VPTVN1PROD with NOTICES