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 

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 § 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 

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://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 

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

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. 

SUMMARY: 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 

electronic comments to http:// 

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 

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 

http://www.fda.gov/cder/guidance/ 

index.htm, http://www.fda.gov/ohrms/ 

dockets/default.htm, or http:// 

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 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice to supplement the singlesource cooperative agreement with the 

National Indian Health Board. 

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