72448 Federal Register / Vol. 70, No. 232 / Monday, December 5, 2005 / Notices 

(section 301(j) of the Federal Food, 

Drug, and Cosmetic Act) was deleted 

from the TEA before it was placed on 

public display. 

II. Request for Comments, Data, and 

Information 

FDA has determined that the 

information submitted in this TEA 

satisfies the criteria of § 330.14(b). FDA 

will evaluate both leave-on formulations 

containing 0.2 to 0.5 percent triclosan 

and rinse-off formulations containing 

0.3 to 1.0 percent triclosan for inclusion 

in the monograph for OTC topical acne 

drug products (21 CFR part 333, subpart 

D). Accordingly, FDA invites all 

interested persons to submit data and 

information, as described in § 330.14(f), 

on the safety and effectiveness of this 

active ingredient for this use, so that 

FDA can determine whether it can be 

GRAS/E and not misbranded under 

recommended conditions of OTC use. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments, data, and information. 

Submit three copies of all comments, 

data, and information. Individuals 

submitting written information or 

anyone submitting electronic comments 

may submit one copy. Submissions are 

to be identified with the docket number 

found in brackets in the heading of this 

document and may be accompanied by 

supporting information. Received 

submissions may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Information submitted after the closing 

date will not be considered except by 

petition under 21 CFR 10.30. 

III. Marketing Policy 

Under § 330.14(h), any product 

containing the conditions for which 

data and information are requested 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) and may 

be seen by interested persons between 9 

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

Friday. 

1. Amended TEA for triclosan as an acne 

active ingredient submitted by CIBA 

Specialty Chemicals Corp., on April 22, 2004. 

2. FDA’s evaluation and comments on the 

TEA for triclosan. 

Dated: November 22, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–23570 Filed 12–2–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0444] 

Over-the-Counter Drug Products; 

Safety and Efficacy Review; Additional 

Dandruff Control Ingredient 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of eligibility; request for 

data and information. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

call-for-data for safety and effectiveness 

information on the following conditions 

as part of FDA’s ongoing review of overthe-counter (OTC) drug products: 

Climbazole, 0.1 to 0.5 percent and 0.5 to 

2.0 percent, as a dandruff control active 

ingredient in leave-on and rinse-off 

dosage forms, respectively. FDA has 

reviewed a time and extent application 

(TEA) for these conditions and 

determined that they are eligible for 

consideration in its OTC drug 

monograph system. FDA will evaluate 

the submitted data and information to 

determine whether these conditions can 

be generally recognized as safe and 

effective (GRASE) for their proposed 

OTC use. 

DATES: Submit data, information, and 

general comments by March 6, 2006. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2005N–0444, 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

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. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

docket number. All comments received 

may be posted without change to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, including any personal 

information provided. For additional 

information on submitting comments, 

see the ‘‘Request for Comments, Data, 

and Information’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm 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: 

Michael L. Koenig, Center for Drug 

Evaluation and Research (mail stop 

5411), Food and Drug Administration, 

10903 New Hampshire Ave., bldg. 22, 

Silver Spring, MD 20993, 301–796–

2090. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 23, 

2002 (67 FR 3060), FDA published a 

final rule establishing criteria and 

procedures for additional conditions to 

become eligible for consideration in the 

OTC drug monograph system. These 

criteria and procedures, codified in 

§ 330.14 (21 CFR 330.14), permit OTC 

drugs initially marketed in the United 

States after the OTC drug review began 

in 1972 and OTC drugs without any 

marketing experience in the United 

States to become eligible for FDA’s OTC 

drug monograph system. The term 

‘‘condition’’ means an active ingredient 

or botanical drug substance (or a 

combination of active ingredients or 

botanical drug substances), dosage form, 

dosage strength, or route of 

administration, marketed for a specific 

OTC use (§ 330.14(a)). The criteria and 

procedures also permit conditions that 

are regulated as cosmetics or dietary 

supplements in foreign countries but 

that would be regulated as OTC drugs in 

Federal Register / Vol. 70, No. 232 / Monday, December 5, 2005 / Notices 72449 

the United States to become eligible for 

the OTC drug monograph system. 

Sponsors must provide specific data 

and information in a TEA to 

demonstrate that the condition has been 

marketed for a material time and to a 

material extent to become eligible for 

consideration in the OTC drug 

monograph system. When the condition 

is found eligible, FDA publishes a 

notice of eligibility and request for 

safety and effectiveness data for the 

proposed OTC use. The TEA that FDA 

reviewed (Ref. 1) and the FDA’s 

evaluation of the TEA (Ref. 2) have been 

placed on public display in the Division 

of Dockets Management (see ADDRESSES) 

under the docket number found in 

brackets in the heading of this 

document. Information deemed 

confidential under 18 U.S.C. 1905, 5 

U.S.C. 552(b), or 21 U.S.C. 331(j) 

(section 301(j) of the Federal Food, 

Drug, and Cosmetic Act) was deleted 

from the TEA before it was placed on 

public display. 

II. Request for Comments, Data, and 

Information 

FDA has determined that the 

information submitted in this TEA 

satisfies the criteria of § 330.14(b). FDA 

will evaluate both leave-on formulations 

containing 0.1 to 0.5 percent climbazole 

and rinse-off formulations containing 

0.5 to 2.0 percent climbazole for 

inclusion in the monograph for OTC 

drug products for the control of 

dandruff, seborrheic dermatitis, and 

psoriasis (21 CFR part 358, subpart H). 

Accordingly, FDA invites all interested 

persons to submit data and information, 

as described in § 330.14(f), on the safety 

and effectiveness of this active 

ingredient for this use, so that FDA can 

determine whether it can be GRAS/E 

and not misbranded under 

recommended conditions of OTC use. 

The TEA did not include an official or 

proposed United States PharmacopeiaNational Formulary (USP–NF) drug 

monograph for climbazole. According to 

§ 330.14(i), an official or proposed USP–

NF monograph for climbazole must be 

included as part of the safety and 

effectiveness data for this ingredient. 

Interested parties should provide an 

official or proposed USP–NF 

monograph. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments, data, and information. 

Submit three copies of all comments, 

data, and information. Individuals 

submitting written information or 

anyone submitting electronic comments 

may submit one copy. Submissions are 

to be identified with the docket number 

found in brackets in the heading of this 

document and may be accompanied by 

supporting information. Received 

submissions may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Information submitted after the closing 

date will not be considered except by 

petition under 21 CFR 10.30. 

III. Marketing Policy 

Under § 330.14(h), any product 

containing the conditions for which 

data and information are requested 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) and may 

be seen by interested persons between 9 

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

Friday. 

1. TEA for climbazole as a dandruff control 

active ingredient submitted by Steinberg & 

Associates on behalf of Symrise, Inc., on 

December 15, 2004. 

2. FDA’s evaluation and comments on the 

TEA for climbazole. 

Dated: November 22, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–23569 Filed 12–2–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0446] 

Over-the-Counter Drug Products; 

Safety and Efficacy Review; Additional 

Sunscreen Ingredients 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of eligibility; request for 

data and information. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

call-for-data for safety and effectiveness 

information on the following conditions 

as part of FDA’s ongoing review of overthe-counter (OTC) drug products: 

Bisoctrizole, up to 10 percent, as a 

sunscreen single active ingredient and 

in combination with other sunscreen 

active ingredients; and bemotrizinol, up 

to 10 percent, as a sunscreen single 

active ingredient and in combination 

with other sunscreen active ingredients. 

FDA reviewed time and extent 

applications (TEAs) for these conditions 

and determined that they are eligible for 

consideration in our OTC drug 

monograph system. FDA will evaluate 

the submitted data and information to 

determine whether these conditions can 

be generally recognized as safe and 

effective (GRAS/E) for their proposed 

OTC use. 

DATES: Submit data, information, and 

general comments by March 6, 2006. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2005N–0446, 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

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. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

docket number. All comments received 

may be posted without change to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, including any personal 

information provided. For additional 

information on submitting comments, 

see the ‘‘Request for Comments, Data 

and Information’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm 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: 

Michael L. Koenig, Center for Drug