[Federal Register: September 20, 2005 (Volume 70, Number 181)]
[Notices]
[Page 55144-55145]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se05-68]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0337]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Oral Rinse to Reduce the
Adhesion of Dental Plaque; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance document entitled ``Class II Special
Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental
Plaque.'' This guidance document describes a means by which oral rinse
to reduce the adhesion of dental plaque may comply with the
requirements of special controls for class II devices. Elsewhere in
this issue of the Federal Register, FDA is publishing a final rule to
classify oral rinse to reduce the adhesion of dental plaque into class
II (special controls). This guidance document is immediately in effect
as the special control for the oral rinse to reduce the adhesion of
dental plaque, but it remains subject to comment in accordance with the
agency's good guidance practices (GGPs). General comments on agency
guidance documents are welcomed at any time.
DATES: Submit written or electronic comments on this guidance at any
time.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Class II Special Controls
Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque''
to the Division of Small Manufacturers, International, and Consumer
Assistance (HFZ-220), Center for Devices and Radiological Health, Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send
one self-addressed adhesive label to assist that office in processing
your request or fax your request to 301-443-8818. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
Submit written comments concerning this guidance 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Robert Betz, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-827-5283, ext. 125.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying the oral rinse to reduce the adhesion of
dental plaque device into class II (special controls) under section
513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 360c(f)(2)). This guidance document will serve as the special
control for the generic device oral rinse to reduce the adhesion of
dental plaque. Section 513(f)(2) of the act provides that any person
who submits a premarket notification under section 510(k) of the act
(21 U.S.C. 360(k)) for a device that has not previously been classified
may, within 30 days after receiving an order classifying the device in
class III under section 513(f)(1) of the act, request FDA to classify
the device under the criteria set forth in section 513(a)(1) of the
act. FDA shall, within 60 days of receiving such a request, classify
the device by written order. This classification shall be the initial
classification of the device. Within 30 days after the issuance of an
order classifying the device, FDA must publish a notice in the Federal
Register announcing such classification. Because of the timeframes
established by section 513(f)(2) of the act, FDA has determined, under
Sec. 10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to
allow for public participation before issuing this guidance as a final
guidance document. Therefore, FDA is issuing this guidance document as
a level 1 guidance document that is immediately in effect. FDA will
consider any comments that are received in response to this notice to
determine whether to amend the guidance document.
II. Significance of Guidance
This guidance is being issued consistent with FDA's GGPs regulation
(Sec. 10.115). The guidance represents the agency's current thinking
on oral rinse to reduce the adhesion of dental plaque. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute and
regulations.
III. Electronic Access
To receive ``Class II Special Controls Guidance Document: Oral
Rinse to Reduce the Adhesion of Dental Plaque'' by fax, call the CDRH
Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-
tone telephone. Press 1 to enter the system. At the second voice
prompt, press 1 to order a document. Enter the document number (1559)
followed by the pound sign (). Follow the remaining voice
prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so by using the Internet. The Center for Devices and Radiological
Health (CDRH) maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh.
A search capability for all CDRH guidance documents is available
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets
.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
The collections of information addressed in the guidance document have
been approved by OMB in accordance with the PRA under the regulations
governing premarket notification submissions (21 CFR part 807, subpart
E, OMB control number 0910-0120). The labeling provisions addressed in
the guidance have been approved by OMB under OMB control number 0910-
0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic
[[Page 55145]]
comments regarding this document. Submit a single 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. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: September 9, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-18655 Filed 9-19-05; 8:45 am]
BILLING CODE 4160-01-S