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, 55144-55145 [05-18655]

Download as PDF 55144 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices Dated: September 12, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–18654 Filed 9–19–05; 8:45 am] BILLING CODE 4160–01–S 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. 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 VerDate Aug<31>2005 14:53 Sep 19, 2005 Jkt 205001 Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// 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 § 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 (§ 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 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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 https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://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 E:\FR\FM\20SEN1.SGM 20SEN1 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1998D–0266] Draft Guidance on Current Good Manufacturing Practice for Positron Emission Tomography Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘PET Drug Products—Current Good Manufacturing Practice (CGMP).’’ Elsewhere in this issue of the Federal Register, we are issuing proposed regulations on CGMPs for positron emission tomography (PET) drug products. We are making the draft guidance available so that producers of PET drugs can better understand FDA’s thinking on CGMP compliance if the proposed regulations become final after notice-and-comment rulemaking. DATES: Submit written or electronic comments on the draft guidance by December 19, 2005. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit SUMMARY: VerDate Aug<31>2005 14:53 Sep 19, 2005 Jkt 205001 electronic comments to https:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Brenda Uratani, Center for Drug Evaluation and Research (HFD–320), Food and Drug Administration, 11919 Rockville Pike, Rockville, MD 20852, 301–827–8941. SUPPLEMENTARY INFORMATION: I. Background On November 21, 1997, the President signed the Food and Drug Administration Modernization Act of 1997 (Modernization Act) (Public Law 105–115) into law. Section 121(c)(1)(A) of the Modernization Act directs us to establish appropriate approval procedures and CGMP requirements for PET drugs. Section 121(c)(1)(B) states that, in adopting such requirements, we must take due account of any relevant differences between not-for-profit institutions that compound PET drugs for their patients and commercial manufacturers of the drugs. Section 121(c)(1)(B) also directs us to consult with patient advocacy groups, professional associations, manufacturers, and physicians and scientists who make or use PET drugs as we develop PET drug CGMP requirements and approval procedures. We presented our initial tentative approach to PET drug CGMP requirements and responded to numerous questions and comments about that approach at a public meeting on February 19, 1999. In the Federal Register of September 22, 1999 (64 FR 51274), FDA published preliminary draft regulations on CGMP for PET drug products. FDA received comments on the preliminary draft regulations at another public meeting on the same subject on September 28, 1999. FDA made changes in the working draft in response to the public comments. In the Federal Register of April 1, 2002 (67 FR 15344), FDA published a preliminary draft proposed rule, in conjunction with the first draft guidance (67 FR 15404, April 1, 2002). FDA received written and oral comments on the preliminary draft proposed rule and the first draft guidance at a public meeting on May 21, 2002, and written comments after the May 2002 meeting, FDA has taken all comments into consideration in revising the preliminary draft proposed rule and the draft guidance. The draft guidance provides more details for discussion purposes on acceptable approaches to complying with the proposed PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 55145 regulations should they be published in final form. Elsewhere in this issue of the Federal Register, we are publishing a proposed rule on CGMP for PET drug products. We are making this draft guidance available so that PET drug producers can better understand FDA’s thinking on compliance with the proposed CGMP regulations if they become final after notice-and-comment rulemaking. We invite comments on whether the draft guidance would be a useful accompaniment to the proposed rule. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the draft guidance. Two paper copies of mailed comments are to be submitted, 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. The draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/cder/guidance/ index.htm, https://www.fda.gov/ohrms/ dockets/default.htm, or https:// www.fda.gov/cder/fdama under ‘‘Section 121—PET (Positron Emission Tomography).’’ Dated: September 1, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–18509 Filed 9–15–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service National Indian Health Board Indian Health Service, HHS. Notice to supplement the singlesource cooperative agreement with the National Indian Health Board. AGENCY: ACTION: SUMMARY: The Indian Health Service (IHS) announces a supplement to the single-source cooperative agreement award to the National Indian Health Board (NIHB) for costs in providing advice and technical assistance to the IHS on behalf of federally recognized Tribes in the area of health care policy analysis and program development. The E:\FR\FM\20SEN1.SGM 20SEN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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 https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at https://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

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