[Federal Register Volume 69, Number 128 (Tuesday, July 6, 2004)]
[Notices]
[Pages 40640-40641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15136]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1981N-0033P]


Over-the-Counter Drug Products; Safety and Efficacy Review; 
Additional Antigingivitis/Antiplaque Ingredient

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 (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: Triclosan, 0.3 percent maximum, as an antigingivitis 
ingredient in dental pastes and oral rinses. FDA has reviewed a time 
and extent application (TEA) for this condition and determined that it 
is eligible for consideration in its 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 (GRAS/
E) for its proposed OTC use.

DATES: Submit data, information, and general comments by October 4, 
2004.

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:  Michael L. Koenig, 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 TEA that the agency 
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) was deleted from the TEA before it 
was placed on public display.

II. Request for Data and Information

    The condition triclosan, 0.3 percent maximum, as an antigingivitis 
ingredient in dental pastes and oral rinses will be evaluated for 
inclusion in the monograph being developed for OTC oral health care 
drug products (21 CFR part 356). FDA will include this condition in its 
review of antigingivitis/antiplaque drug products. FDA published the 
advance notice of proposed rulemaking for these products in the Federal 
Register of May 29, 2003 (68 FR 32232). FDA invites all interested 
persons to submit data and information, as described in Sec.  
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 should, on or before 90 days after the date of 
publication in the Federal Register, submit comments, data, and 
information to the Division of Dockets Management (see ADDRESSES). 
Three copies of all comments, data, and information are to

[[Page 40641]]

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 
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 triclosan as an antigingivitis active ingredient 
submitted by CIBA Specialty Chemicals Corp. on November 25, 2003.
    2. FDA's evaluation and comments on the TEA for triclosan.

    Dated: June 24, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15136 Filed 7-2-04; 8:45 am]
BILLING CODE 4160-01-S