
[Federal Register: September 12, 2008 (Volume 73, Number 178)]
[Notices]               
[Page 53029-53030]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12se08-69]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0474]

 
Ecamsule Eligibility for Inclusion in Monograph; Over-the-Counter 
Sunscreen Drug Products for Human Use; Request for Safety and 
Effectiveness Data

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of eligibility; request for data and information.

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SUMMARY: The Food and Drug Administration 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: 
Ecamsule (terephthalylidene dicamphor sulfonic acid), in concentrations 
of up to 10 percent, as a sunscreen single active ingredient and in 
combination with other sunscreen active ingredients that are generally 
recognized as safe and effective (GRASE) and are found in the sunscreen 
monograph regulations. FDA reviewed a time and extent application (TEA) 
for ecamsule 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 ecamsule can be generally recognized 
as safe and effective (GRASE) for its proposed OTC use.

DATES: Submit data, information, and general comments by December 11, 
2008.

ADDRESSES: You may submit comments, identified by docket number FDA-
2008-N-0474, 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.
    To ensure more timely processing of comments, we are 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, as described previously, in the ADDRESSES portion 
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://www.regulations.gov, including 
any personal information provided. For additional information on 
submitting comments, see the ``Comments'' 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.regulations.gov and insert the 
docket number(s), 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. Chasey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, MS 5411, Silver Spring, MD 20993, 301-796-
2090.

SUPPLEMENTARY INFORMATION:

I. Eligibility of Ecamsule

    In September 2007, FDA received a TEA (Ref. 1) requesting that 
ecamsule be eligible for review under our OTC sunscreen drug monograph 
(part 352 (21 CFR part 352)). After reviewing the TEA, the agency 
believes that it

[[Page 53030]]

includes adequate data demonstrating that ecamsule has been marketed 
for a material time and to a material extent as required by Sec.  
330.14 (21 CFR 330.14) (Ref. 2). Ecamsule-containing sunscreen products 
have been marketed directly to consumers for over 5 continuous years in 
48 countries, with an estimated 472 million dosage units marketed in 55 
countries. Therefore, ecamsule, in concentrations of up to 10 percent, 
is eligible for inclusion in the OTC sunscreen drug monograph as a 
single active ingredient and in combination with GRASE sunscreen active 
ingredients found in Sec.  352.10.

II. Request for Data and Information

    FDA invites all interested persons to submit data and information 
on the safety and effectiveness of this single active ingredient in 
order for us to determine whether it is GRASE and not misbranded under 
recommended conditions of OTC use (see Sec.  330.14(f)). FDA is also 
seeking data to establish the safety and effectiveness of ecamsule for 
use as a sunscreen active ingredient when combined with GRASE sunscreen 
active ingredients found in Sec.  352.10. The effectiveness data should 
include studies conducted according to the testing procedures in the 
sunscreen monograph (i.e., part 352, subpart D). Such data for 
combinations should meet both criteria described in the sunscreen 
monograph (Sec.  352.20):
     The ingredient contributes a Sun Protection Factor (SPF) 
of at least 2 to the final formulation;
     The SPF of the final formulation equals at least two times 
the number of active ingredients
The safety data should include animal and human studies that meet 
current scientific standards (see Sec.  330.14(f)(1) and 21 CFR 
330.10(a)(2)).

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 Ecamsule (Terephthalylidene Dicamphor Sulfonic Acid) 
Submitted by L'Oreal USA Products, Inc., dated September 18, 2007.
    2. FDA's evaluation of the TEA for ecamsule.

    Dated: September 4, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21291 Filed 9-11-08; 8:45 am]

BILLING CODE 4160-01-S
