30838 Federal Register / Vol. 75, No. 105 / Wednesday, June 2, 2010 / Notices 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, One Choke Cherry Road, 

Rockville, MD 20857. Written comments 

should be received within 60 days of 

this notice. 

Dated: May 25, 2010. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. 2010–13145 Filed 6–1–10; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2003–N–0196] (formerly 

Docket No. 2003N–0233) 

Drometrizole Trisiloxane Eligibility for 

Potential Inclusion in Sunscreen 

Monograph; Over-the-Counter 

Sunscreen Drug Products for Human 

Use; Request for Safety, Effectiveness, 

and Environmental Data 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of eligibility; request for 

data and information. 

SUMMARY: As part of our ongoing review 

of over-the-counter (OTC) drug 

products, we (Food and Drug 

Administration, FDA) are announcing a 

call-for-data for safety, effectiveness, 

and environmental information for 

drometrizole trisiloxane, in 

concentrations up to 15 percent, as a 

sunscreen single active ingredient and 

in combination with generally 

recognized as safe and effective 

(GRASE) sunscreen active ingredients 

found in the sunscreen monograph. We 

reviewed a time and extent application 

(TEA) for drometrizole trisiloxane and 

determined that it is eligible to be 

considered for inclusion in our OTC 

drug monograph system. We will 

evaluate the submitted safety and 

effectiveness data and information to 

determine whether drometrizole 

trisiloxane can be GRASE for its 

proposed OTC use. We also request data 

and information to assess the projected 

environmental effects of a potential 

GRASE determination in order to assist 

us in complying with the requirements 

of the National Environmental Policy 

Act of 1969 (NEPA). 

DATES: Submit data, information, and 

general comments by August 31, 2010. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2003–N– 

0196, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the agency name and 

docket number. All comments received 

may be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Anita Kumar, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5445, 

Silver Spring, MD 20993, 301–796– 

2090. 

SUPPLEMENTARY INFORMATION: 

I. Eligibility of Drometrizole Trisiloxane 

In January 2009, we received a TEA 

(Ref. 1) requesting that drometrizole 

trisiloxane be found eligible for review 

and potential inclusion in our OTC 

sunscreen drug monograph (part 352 (21 

CFR part 352)). After reviewing the 

TEA, we believe that it includes 

adequate data demonstrating that 

drometrizole trisiloxane has been 

marketed for the prevention of sunburn 

for a material time and to a material 

extent as required by § 330.14 (21 CFR 

330.14) (Ref. 2). Drometrizole 

trisiloxane-containing sunscreen 

products indicated for the prevention of 

sunburn have been marketed directly to 

consumers for over 5 continuous years 

in 40 countries, with over 177 million 

dosage units marketed in 54 countries. 

Therefore, we conclude that 

drometrizole trisiloxane, in 

concentrations up to 15 percent, is 

eligible to be considered for potential 

inclusion in the OTC sunscreen drug 

monograph as a single active ingredient 

and in combination with GRASE 

sunscreen active ingredients found in 

§ 352.10. 

II. Request for Data and Information 

We invite all interested persons to 

submit data and information, as 

described in § 330.14(f), on the safety 

and effectiveness of drometrizole 

trisiloxane for use as an active 

ingredient in OTC sunscreen products. 

The data should be sufficient so that we 

can determine whether the ingredient 

can be GRASE and not misbranded 

under recommended conditions of OTC 

use. Interested parties may refer to 21 

CFR 330.10(a)(4) regarding the evidence 

necessary for establishing general 

recognition of safety and effectiveness. 

Because the TEA that we reviewed 

did not include an official or proposed 

United States Pharmacopeia-National 

Formulary (USP–NF) drug monograph 

for drometrizole trisiloxane, we are 

asking interested parties to provide such 

a monograph to us. An active ingredient 

must be recognized in an official USP– 

NF drug monograph that sets forth its 

standards of identity, strength, quality, 

and purity in order to be included in a 

final OTC monograph (§ 330.14(i)). 

In addition, as stated in 21 CFR 25.1, 

FDA regulations must comply with 

NEPA. To comply with NEPA, an 

environmental assessment (EA) of 

agency actions is required unless we 

determine that a categorical exclusion is 

warranted. Therefore, we also invite all 

interested persons to either submit data 

and information that would support a 

determination that the potential 

inclusion of drometrizole trisiloxane in 

the OTC monograph for sunscreen 

meets the requirements for any 

categorical exclusion found in 21 CFR 

25.31, or to prepare an EA, if necessary. 

For additional information on the types 

of information that would support our 

environmental assessment, please refer 

to section IV (pages 9 through 27) of the 

Center for Drug Evaluation and Research 

Guidance on Environmental Assessment 

of Human Drug and Biologic 

Applications. The guidance document 

can be viewed at http://www.fda.gov/ 

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/ 

ucm070561.pdf. 

For all data and information 

submitted, we request that a submitter 

segregate any data or information that 

the submitter believes is protected from 

disclosure by 5 U.S.C. 552(b), 18 U.S.C. 

1905, or 21 U.S.C. 331(j) or 360j(c). If 

such data or information is included in 

the submission, we request that the 

submitter summarize the confidential 

information, to the extent possible, so 

that the summary can be publicly 

disclosed (see 21 CFR 25.50 and 

25.51(a); § 330.14(f)). 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 75, No. 105 / Wednesday, June 2, 2010 / Notices 30839 

III. Marketing Policy 

Under § 330.14(h), any sunscreen 

product containing drometrizole 

trisiloxane may not be marketed as an 

OTC drug in the United States at this 

time unless it is the subject of an 

approved new drug application or 

abbreviated new drug application. 

IV. References 

The following references are on 

display in the Division of Dockets 

Management (see ADDRESSES) under 

Docket No. FDA–2003–N–0196 and may 

be seen by interested persons between 9 

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

Friday. 

1. Redacted TEA for drometrizole 

trisiloxane submitted by L’Oreal USA 

Products, Inc., dated January 21, 2009. 

2. FDA’s evaluation of the TEA for 

drometrizole trisiloxane. 

Dated: May 25, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13001 Filed 6–1–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Cardiovascular and Renal Drugs 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Cardiovascular 

and Renal Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on July 28, 2010, from 8 a.m. to 5 

p.m. 

Location: The Marriott Inn and 

Conference Center, University of 

Maryland University College, 3501 

University Blvd. East, Adelphi, MD. The 

conference center telephone number is 

301–985–7300. 

Contact Person: Elaine Ferguson, c/o 

Christine Shipe, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, rm. 2419, Silver Spring, 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8532, e-mail: 

elaine.ferguson@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512533. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On July 28, 2010, the 

committee will discuss new drug 

application (NDA) 22–433, ticagrelor 

tablets, 90 milligrams, manufactured by 

AstraZeneca LP, for the proposed 

indication for use in acute coronary 

syndrome (including heart attacks and 

any of a group of signs and symptoms, 

such as chest pain or shortness of 

breath, that are consistent with 

blockages in the blood vessels that 

supply the heart). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before July 14, 2010. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before July 6, 2010. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by July 7, 2010. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Elaine 

Ferguson at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: May 27, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–13141 Filed 6–1–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Privacy Act of 1974; CMS Computer 

Match No. 2010–03, HHS Computer 

Match No. 1003, SSA Computer Match 

No. 1048, IRS Project No. 241 

AGENCY: Department of Health and 

Human Services (HHS), Centers for 

Medicare & Medicaid Services (CMS). 

ACTION: Notice of renewal of an existing 

computer matching program (CMP) that 

has an expiration date of June 30, 2010. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

as amended, this notice announces the 

renewal of an existing CMP between 

CMS, the Internal Revenue Service 

(IRS), and the Social Security 

Administration (SSA). We have 

provided information about the 

matching program in the 

SUPPLEMENTARY INFORMATION section 

below. The Privacy Act provides an 

opportunity for interested persons to 

comment on the matching program. We 

may defer implementation of this 

matching program if we receive 

comments that persuade us to defer 


sroberts on DSKD5P82C1PROD with NOTICES