[Federal Register Volume 68, Number 164 (Monday, August 25, 2003)]
[Proposed Rules]
[Pages 50991-50992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21669]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 356

[Docket No. 81N-033P]
RIN 0910-AA01


Oral Health Care Drug Products for Over-the-Counter Human Use; 
Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; extension of comment 
period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending to 
November 25, 2003, the comment period for an advance notice of proposed 
rulemaking (ANPR) for over-the-counter (OTC) antigingivitis/antiplaque 
drug products. The ANPR was published in the Federal Register of May 
29, 2003. FDA is taking this action in response to a request for 
extension of the comment period to allow interested persons additional 
time to submit comments and information on the conditions under which 
OTC antigingivitis/antiplaque drug products are generally recognized as 
safe and effective and not misbranded. FDA is also extending the reply 
comment period to February 23, 2004.

DATES: Submit written or electronic comments by November 25, 2003.

[[Page 50992]]

 Submit reply comments by February 23, 2004.

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

FOR FURTHER INFORMATION CONTACT:  Robert L. Sherman, 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 May 29, 2003 (68 FR 32232), FDA 
published an ANPR based on the recommendations of the Dental Plaque 
Subcommittee (the Subcommittee) of the Nonprescription Drugs Advisory 
Committee (NDAC). FDA issued this notice to establish conditions under 
which OTC drug products for the reduction or prevention of dental 
plaque and gingivitis are generally recognized as safe and effective 
and not misbranded.

II. Request for Extension of Time

    On July 15, 2003, the Consumer Healthcare Products Association 
(CHPA), a trade association of manufacturers of nonprescription drugs 
and dietary supplements, and the Cosmetic, Toiletry, and Fragrance 
Association (CTFA), a trade association of manufacturers of personal 
care products, requested a 90-day extension in which to file comments 
and new information (Ref. 1). CHPA/CTFA also requested that FDA accept 
reply comments up to 180 days after the closing date for the comment 
period. The request stated that the closing date for the original 
comment period would not allow CHPA/CTFA time to adequately assess the 
implications of the Subcommittee's proposed rulemaking. The request 
noted that, because this is the first time FDA published the 
Subcommittee's recommendations, industry needs sufficient time to 
provide additional data and perspectives on inclusion of several of the 
Subcommittee's proposed Category III (insufficient data) active 
ingredients in a tentative final monograph, and to support a Category I 
(safe and effective) status for these ingredients. In addition, CHPA/
CTFA stated that because FDA specifically requested information on 
testing protocols, statistical methods, and effectiveness criteria, 
industry needs sufficient time to develop a set of common elements and 
basic criteria for performance testing.
    CHPA/CTFA stated that individual companies are likely to submit 
relevant data on antigingivitis/antiplaque active ingredients and on 
drug products in which antigingivitis/antiplaque active ingredients are 
combined with other oral health care active ingredients. Further, these 
companies are considering additional clinical studies that would 
involve time for FDA's review of submitted protocols and likely require 
12 to 18 months to complete.

III. FDA's Decision

    FDA has carefully considered the request and acknowledges its 
request for information on effectiveness criteria for antigingivitis/
antiplaque active ingredients, performance testing, and the statistical 
approaches used to evaluate these tests. Manufacturers and CTFA/CTFA 
may require additional time to develop and review information to fully 
respond to the agency's request. However, FDA believes that extension 
of the reply comment period from 60 to 90 days should be sufficient 
time for manufacturers to respond to comments submitted during the 
comment period. The reply comment period is not intended to remain open 
for new study results to be submitted. Accordingly, the comment period 
is extended to November 25, 2003, and the reply comment period is 
extended to February 23, 2004. FDA considers an extension of time for 
comments in this case to be in the public interest.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the ANPR. Submit a 
single paper copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document and may be accompanied by a supporting 
memorandum or brief. Received comments may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Reference

    The following reference has been placed 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. Comment No. EXT7.

    Dated: August 19, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-21669 Filed 8-22-03; 8:45 am]
BILLING CODE 4160-01-S