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55144 Federal Register / Vol. 70, No.

181 / Tuesday, September 20, 2005 / Notices

Dated: September 12, 2005. Management (HFA–305), Food and Drug to bind FDA or the public. An
Jeffrey Shuren, Administration, 5630 Fishers Lane, rm. alternative approach may be used if
Assistant Commissioner for Policy. 1061, Rockville, MD 20852. Submit such approach satisfies the
[FR Doc. 05–18654 Filed 9–19–05; 8:45 am] electronic comments to http:// requirements of the applicable statute
www.fda.gov/dockets/ecomments. and regulations.
Identify comments with the docket III. Electronic Access
number found in brackets in the
DEPARTMENT OF HEALTH AND heading of this document. To receive ‘‘Class II Special Controls
HUMAN SERVICES Guidance Document: Oral Rinse to
Reduce the Adhesion of Dental Plaque’’
Robert Betz, Center for Devices and
Food and Drug Administration by fax, call the CDRH Facts-On-Demand
Radiological Health (HFZ–410), Food
system at 800–899–0381 or 301–827–
[Docket No. 2005D–0337] and Drug Administration, 9200
0111 from a touch-tone telephone. Press
Corporate Blvd., Rockville, MD 20850,
1 to enter the system. At the second
Guidance for Industry and Food and 301–827–5283, ext. 125.
voice prompt, press 1 to order a
Drug Administration Staff; Class II SUPPLEMENTARY INFORMATION: document. Enter the document number
Special Controls Guidance Document: (1559) followed by the pound sign (#).
Oral Rinse to Reduce the Adhesion of I. Background
Follow the remaining voice prompts to
Dental Plaque; Availability Elsewhere in this issue of the Federal complete your request.
Register, FDA is publishing a final rule Persons interested in obtaining a copy
AGENCY: Food and Drug Administration, classifying the oral rinse to reduce the
HHS. of the guidance may also do so by using
adhesion of dental plaque device into the Internet. The Center for Devices and
ACTION: Notice. class II (special controls) under section Radiological Health (CDRH) maintains
513(f)(2) of the Federal Food, Drug, and an entry on the Internet for easy access
SUMMARY: The Food and Drug
Cosmetic Act (the act) (21 U.S.C. to information including text, graphics,
Administration (FDA) is announcing the
360c(f)(2)). This guidance document and files that may be downloaded to a
availability of the guidance document
will serve as the special control for the personal computer with Internet access.
entitled ‘‘Class II Special Controls
generic device oral rinse to reduce the Updated on a regular basis, the CDRH
Guidance Document: Oral Rinse to
adhesion of dental plaque. Section home page includes device safety alerts,
Reduce the Adhesion of Dental Plaque.’’
513(f)(2) of the act provides that any Federal Register reprints, information
This guidance document describes a
person who submits a premarket on premarket submissions (including
means by which oral rinse to reduce the
notification under section 510(k) of the lists of approved applications and
adhesion of dental plaque may comply
act (21 U.S.C. 360(k)) for a device that manufacturers’ addresses), small
with the requirements of special
has not previously been classified may, manufacturer’s assistance, information
controls for class II devices. Elsewhere
within 30 days after receiving an order on video conferencing and electronic
in this issue of the Federal Register,
classifying the device in class III under submissions, Mammography Matters,
FDA is publishing a final rule to classify
section 513(f)(1) of the act, request FDA and other device-oriented information.
oral rinse to reduce the adhesion of
to classify the device under the criteria The CDRH Web site may be accessed at
dental plaque into class II (special
set forth in section 513(a)(1) of the act. http://www.fda.gov/cdrh. A search
controls). This guidance document is
FDA shall, within 60 days of receiving capability for all CDRH guidance
immediately in effect as the special
such a request, classify the device by documents is available at http://
control for the oral rinse to reduce the
written order. This classification shall www.fda.gov/cdrh/guidance.html.
adhesion of dental plaque, but it
be the initial classification of the device. Guidance documents are also available
remains subject to comment in
Within 30 days after the issuance of an on the Division of Dockets Management
accordance with the agency’s good
order classifying the device, FDA must Internet site at http://www.fda.gov/
guidance practices (GGPs). General
publish a notice in the Federal Register ohrms/dockets.
comments on agency guidance
announcing such classification. Because
documents are welcomed at any time. IV. Paperwork Reduction Act of 1995
of the timeframes established by section
DATES: Submit written or electronic 513(f)(2) of the act, FDA has This guidance contains information
comments on this guidance at any time. determined, under § 10.115(g)(2) (21 collection provisions that are subject to
ADDRESSES: Submit written requests for CFR 10.115(g)(2)), that it is not feasible review by the Office of Management and
single copies on a 3.5′′ diskette of the to allow for public participation before Budget (OMB) under the Paperwork
guidance document entitled ‘‘Class II issuing this guidance as a final guidance Reduction Act of 1995 (the PRA) (44
Special Controls Guidance Document: document. Therefore, FDA is issuing U.S.C. 3501–3520). The collections of
Oral Rinse to Reduce the Adhesion of this guidance document as a level 1 information addressed in the guidance
Dental Plaque’’ to the Division of Small guidance document that is immediately document have been approved by OMB
Manufacturers, International, and in effect. FDA will consider any in accordance with the PRA under the
Consumer Assistance (HFZ–220), Center comments that are received in response regulations governing premarket
for Devices and Radiological Health, to this notice to determine whether to notification submissions (21 CFR part
Food and Drug Administration, 1350 amend the guidance document. 807, subpart E, OMB control number
Piccard Dr., Rockville, MD 20850. Send 0910–0120). The labeling provisions
one self-addressed adhesive label to II. Significance of Guidance
addressed in the guidance have been
assist that office in processing your This guidance is being issued approved by OMB under OMB control
request or fax your request to 301–443– consistent with FDA’s GGPs regulation number 0910–0485.
8818. See the SUPPLEMENTARY (§ 10.115). The guidance represents the
INFORMATION section for information on agency’s current thinking on oral rinse V. Comments
electronic access to the guidance. to reduce the adhesion of dental plaque. Interested persons may submit to the
Submit written comments concerning It does not create or confer any rights for Division of Dockets Management (see
this guidance to the Division of Dockets or on any person and does not operate ADDRESSES), written or electronic

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Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 55145

comments regarding this document. electronic comments to http:// regulations should they be published in
Submit a single copy of electronic www.fda.gov/dockets/ecomments. See final form.
comments or two paper copies of any the SUPPLEMENTARY INFORMATION section Elsewhere in this issue of the Federal
mailed comments, except that for electronic access to the draft Register, we are publishing a proposed
individuals may submit one paper copy. guidance. rule on CGMP for PET drug products.
Comments are to be identified with the We are making this draft guidance
FOR FURTHER INFORMATION CONTACT: available so that PET drug producers
docket number found in brackets in the
heading of this document. Received Brenda Uratani, Center for Drug can better understand FDA’s thinking
comments may be seen in the Division Evaluation and Research (HFD–320), on compliance with the proposed CGMP
of Dockets Management between 9 a.m. Food and Drug Administration, 11919 regulations if they become final after
and 4 p.m., Monday through Friday. Rockville Pike, Rockville, MD 20852, notice-and-comment rulemaking. We
301–827–8941. invite comments on whether the draft
Dated: September 9, 2005.
SUPPLEMENTARY INFORMATION: guidance would be a useful
Linda S. Kahan,
accompaniment to the proposed rule.
Deputy Director, Center for Devices and I. Background
Radiological Health. II. Comments
On November 21, 1997, the President
[FR Doc. 05–18655 Filed 9–19–05; 8:45 am] Interested persons may submit to the
signed the Food and Drug
Administration Modernization Act of Division of Dockets Management (see
1997 (Modernization Act) (Public Law ADDRESSES) written or electronic
105–115) into law. Section 121(c)(1)(A) comments on the draft guidance. Two
DEPARTMENT OF HEALTH AND paper copies of mailed comments are to
HUMAN SERVICES of the Modernization Act directs us to
establish appropriate approval be submitted, except that individuals
Food and Drug Administration procedures and CGMP requirements for may submit one paper copy. Comments
PET drugs. Section 121(c)(1)(B) states are to be identified with the docket
[Docket No. 1998D–0266] that, in adopting such requirements, we number found in brackets in the
must take due account of any relevant heading of this document. The draft
Draft Guidance on Current Good guidance and received comments are
Manufacturing Practice for Positron differences between not-for-profit
institutions that compound PET drugs available for public examination in the
Emission Tomography Drug Products; Division of Dockets Management
Availability for their patients and commercial
manufacturers of the drugs. Section between 9 a.m. and 4 p.m., Monday
AGENCY: Food and Drug Administration, 121(c)(1)(B) also directs us to consult through Friday.
HHS. with patient advocacy groups, III. Electronic Access
ACTION: Notice. professional associations,
manufacturers, and physicians and Persons with access to the Internet
SUMMARY: The Food and Drug scientists who make or use PET drugs as may obtain the document at either
Administration (FDA) is announcing the we develop PET drug CGMP http://www.fda.gov/cder/guidance/
availability of a draft guidance entitled requirements and approval procedures. index.htm, http://www.fda.gov/ohrms/
‘‘PET Drug Products—Current Good dockets/default.htm, or http://
We presented our initial tentative
Manufacturing Practice (CGMP).’’ www.fda.gov/cder/fdama under
approach to PET drug CGMP
Elsewhere in this issue of the Federal ‘‘Section 121—PET (Positron Emission
requirements and responded to
Register, we are issuing proposed Tomography).’’
numerous questions and comments
regulations on CGMPs for positron about that approach at a public meeting Dated: September 1, 2005.
emission tomography (PET) drug on February 19, 1999. In the Federal Jeffrey Shuren,
products. We are making the draft Register of September 22, 1999 (64 FR Assistant Commissioner for Policy.
guidance available so that producers of 51274), FDA published preliminary [FR Doc. 05–18509 Filed 9–15–05; 8:45 am]
PET drugs can better understand FDA’s draft regulations on CGMP for PET drug BILLING CODE 4160–01–S
thinking on CGMP compliance if the products. FDA received comments on
proposed regulations become final after the preliminary draft regulations at
notice-and-comment rulemaking. another public meeting on the same DEPARTMENT OF HEALTH AND
DATES: Submit written or electronic subject on September 28, 1999. FDA HUMAN SERVICES
comments on the draft guidance by made changes in the working draft in
December 19, 2005. General comments response to the public comments. In the Indian Health Service
on agency guidance documents are Federal Register of April 1, 2002 (67 FR
welcome at any time. 15344), FDA published a preliminary National Indian Health Board
ADDRESSES: Submit written requests for draft proposed rule, in conjunction with AGENCY: Indian Health Service, HHS.
single copies of the draft guidance to the the first draft guidance (67 FR 15404, ACTION: Notice to supplement the single-
Division of Drug Information (HFD– April 1, 2002). FDA received written source cooperative agreement with the
240), Center for Drug Evaluation and and oral comments on the preliminary National Indian Health Board.
Research, Food and Drug draft proposed rule and the first draft
Administration, 5600 Fishers Lane, guidance at a public meeting on May 21, SUMMARY: The Indian Health Service
Rockville, MD 20857. Send one self- 2002, and written comments after the (IHS) announces a supplement to the
addressed adhesive label to assist that May 2002 meeting, FDA has taken all single-source cooperative agreement
office in processing your requests. comments into consideration in revising award to the National Indian Health
Submit written comments on the draft the preliminary draft proposed rule and Board (NIHB) for costs in providing
guidance to the Division of Dockets the draft guidance. The draft guidance advice and technical assistance to the
Management (HFA–305), Food and Drug provides more details for discussion IHS on behalf of federally recognized
Administration, 5630 Fishers Lane, rm. purposes on acceptable approaches to Tribes in the area of health care policy
1061, Rockville, MD 20852. Submit complying with the proposed analysis and program development. The

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