[Federal Register: March 15, 2002 (Volume 67, Number 51)]
[Notices]
[Page 11704-11705]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15mr02-85]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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