[Federal Register: July 11, 2003 (Volume 68, Number 133)]
[Notices]
[Page 41386-41387]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy03-71]
-----------------------------------------------------------------------
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