[Federal Register Volume 70, Number 181 (Tuesday, September 20, 2005)]
[Notices]
[Pages 55144-55145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18655]


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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://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 (<greek-i>). 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://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at 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