E6-11874. Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen 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 condition as part of FDA's ongoing review of over-the-counter (OTC) drug products: Diethylhexyl butamido triazone, up to 3 percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients. FDA reviewed a time and extent application (TEA) for this condition and determined that it is eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether this condition can be generally recognized as safe and effective (GRASE) for its proposed OTC use.

DATES:

Submit data, information, and general comments by October 24, 2006.

ADDRESSES:

You may submit comments, identified by Docket No. 2006O-0231, 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: [phone].
• 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 e-mail. 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 for this rulemaking. 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, bldg. 22, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 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 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 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 determined that the information submitted in this TEA satisfies the criteria of § 330.14(b). FDA will evaluate diethylhexyl butamido triazone, up to 3 percent, as a sunscreen single active ingredient and in combination with other existing monograph sunscreen active ingredients, for inclusion in the monograph for OTC sunscreen drug products (part 352 (21 CFR part 352)). 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 GRASE and not misbranded under recommended conditions of OTC use. Additional data should be included to establish the safety and effectiveness of sunscreen drug products containing a combination of diethylhexyl butamido triazone with other existing sunscreen monograph active ingredients in § 352.10.

The TEA did not include an official or proposed United States Pharmacopeia-National Formulary (USP-NF) drug monograph for diethylhexyl butamido triazone. According to § 330.14(i), sponsors must include an official or proposed USP-NF monograph as part of the safety and effectiveness data for this ingredient.

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 condition 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 diethylhexyl butamido triazone submitted by 3V, Inc., on September 16, 2005.

2. FDA's evaluation and comments on the TEA for diethylhexyl butamido triazone.

Dated: July 14, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.