[Federal Register: August 25, 2003 (Volume 68, Number 164)]
[Proposed Rules]
[Page 50991-50992]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au03-12]
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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.
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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