[Federal Register Volume 68, Number 133 (Friday, July 11, 2003)]
[Notices]
[Pages 41386-41387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17637]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0233]


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 over-the-counter (OTC) 
drug products: Amiloxate (isoamyl p-methoxycinnamate), up to 10 
percent, as a sunscreen single active ingredient and in combination 
with other sunscreen active ingredients; enzacamene (methyl benzylidene 
camphor), up to 4 percent, as a sunscreen single active ingredient and 
in combination with other sunscreen active ingredients; and octyl 
triazone, up to 5 percent, as a sunscreen single active ingredient and 
in combination with other sunscreen active ingredients. FDA has 
reviewed time and extent applications (TEAs) for these conditions and 
determined that they are eligible for consideration in it's 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 October 9, 
2003.

ADDRESSES: Submit written comments, data, and information to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments, data, and information to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Matthew R. Holman, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2222.

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 Sec.  
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 (Sec.  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 TEAs that the agency 
reviewed (Refs. 1, 2, and 3) and FDA's evaluation of the TEAs (Refs. 4, 
5, and 6) 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.

II. Request for Data and Information

    The conditions amiloxate, up to 10 percent; enzacamene, up to 4 
percent; and octyl triazone, up to 5 percent, as sunscreen single 
active ingredients and in combination with other existing monograph 
sunscreen active ingredients will be evaluated for inclusion in the 
monograph for OTC sunscreen drug products (21 CFR part 352). 
Accordingly, FDA invites all interested persons to submit data and 
information, as described in Sec.  330.14(f), on the safety and 
effectiveness of these single active ingredients for FDA to determine 
whether they can be GRAS/E and not misbranded under recommended 
conditions of OTC use. Additional data (from human clinical studies) 
should be included to establish the safety and effectiveness of 
combination sunscreen drug products containing amiloxate, enzacamene, 
or octyl triazone with other existing sunscreen monograph active 
ingredients.
    Interested persons should submit comments, data, and information to 
the Divison of Dockets Management (see ADDRESSES) by October 9, 2003. 
Three copies of all comments, data, and information are to be 
submitted. 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 
Sec.  10.30 (21 CFR 10.30).

III. Marketing Policy

    Under Sec.  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 amiloxate (isoamyl p-methoxycinnamate) submitted by 
Haarmann & Reimer Corp. dated August 14, 2002.
    2. TEA for enzacamene (methyl benzylidene camphor) submitted by

[[Page 41387]]

Buchanan Ingersoll on behalf of Merck KGaA dated August 21, 2002.
    3. TEA for octyl triazone submitted by Morgan, Lewis & Bockius 
LLP on behalf of BASF AG dated August 21, 2002.
    4. FDA's evaluation and comments on the TEA for amiloxate.
    5. FDA's evaluation and comments on the TEA for enzacamene.
    6. FDA's evaluation and comments on the TEA for octyl triazone.

    Dated: July 5, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-17637 Filed 7-10-03; 8:45 am]
BILLING CODE 4160-01-S