[Federal Register Volume 67, Number 51 (Friday, March 15, 2002)]
[Notices]
[Pages 11704-11705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6181]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 80N-0042]
RIN 0910-AA01


Anticaries Drug Products for Over-the-Counter Human Use; Use of 
Intraoral Appliance Models for Compliance With Biological Testing 
Requirements; Request for Information and Comments; Reopening of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until July 
12, 2002, the comment period on the notice requesting information and 
comments on the use of intraoral appliance (IOA) models as a substitute 
for the animal caries reduction biological test required by the 
monograph for over-the-counter (OTC) anticaries drug products to 
demonstrate the availability of fluoride in OTC dentifrice 
formulations. The notice was published in the Federal Register of 
October 15, 2001 (66 FR 52418). 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 use 
of IOA models. The comment period for this information closed on 
January 14, 2002.

DATES: Submit written or electronic comments by July 12, 2002.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(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 October 15, 2001 (66 FR 52418), FDA 
published a notice requesting information and comments regarding use of 
the IOA test in lieu of animal caries studies to demonstrate the 
effectiveness of new fluoride formulations. FDA issued this notice to 
gather information concerning IOA models and whether and how they can 
be used in lieu of the animal caries models in meeting the biological 
testing requirements for OTC anticaries drug products. The agency has 
determined that it is appropriate to address these issues in a public 
forum where experts can debate the usefulness and acceptability of 
alternate biological testing methods such as the IOA model. The agency 
anticipates that this information-gathering process will be followed by 
an advisory committee meeting at which the various models and the 
appropriate statistical analyses will be discussed.
    On November 14, 2001, the Joint Anticaries Task Group (the Task 
Group) of the Consumer Healthcare Products Association, a trade 
association of manufacturers of nonprescription drugs and dietary 
supplements, and the Cosmetic, Toiletry, and Fragrance Association, a 
trade association of manufacturers of personal care products, requested 
a 180-day extension in which to file comments and new information (Ref. 
1). The request stated that the closing date for the original comment 
period would not allow the Task Group to utilize the results of its 
ongoing research in its response to FDA, resulting in important 
information being omitted from the agency's consideration. In addition, 
the Task Group noted that the agency's request raises complicated 
questions concerning statistical approaches that could potentially 
impact statistical methodology utilized for current biological testing 
requirements for fluoride dentifrices. The Task Group also stated that 
manufacturers need sufficient time to assess the potential impact that 
the agency's statistical questions may have on manufacturing practices, 
as well as research and product development.
    FDA has carefully considered the request and acknowledges the 
complicated issues concerning statistical approaches used to evaluate 
IOA testing and their potential affect on current biological testing 
requirements of the anticaries monograph. Manufacturers and the Task 
Group may require additional time to obtain and review information to 
fully respond to the agency's request. FDA considers an extension of 
time for comments in this case to be in the public interest. 
Accordingly, the comment period is reopened to July 12, 2002.

II. Request for Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding this notice by 
July 12, 2002. Three copies of all written comments are to be 
submitted. Individuals submitting written comments or anyone submitting 
electronic comments may submit one 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 Dockets Management Branch between 
9 a.m. and 4 p.m., Monday through Friday.

III. Reference

    The following reference has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Comment No. EXT11, Docket No. 80N-0042.


[[Page 11705]]


    Dated: March 1, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-6181 Filed 3-14-02; 8:45 am]
BILLING CODE 4160-01-S