Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 55143 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per respondent 

Average burden hours per response Total burden hours 

Baseline Survey ..................................................... 1,750 1 .33 hours (approx. 20 minutes) ............................. 577.5 

Follow-up Survey ................................................... 1,750 1 .42 hours (approx. 25 minutes) ............................. 735 

Estimated Total Annual Burden Hours .................. 3,500 .................... ................................................................................ 1,312.5 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

grjohnson@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Attn: Desk Officer for 

ACF, E-mail address: 

Katherine_T._Astrich@omb.eop.gov. 

Dated: September 13, 2005. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 05–18735 Filed 9–19–05; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Industry Exchange Workshop on Food 

and Drug Administration Clinical Trials 

Statutory and Regulatory 

Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) Cincinnati 

District, in cooperation with the Society 

of Clinical Research Associates 

(SoCRA), is announcing a workshop on 

FDA clinical trial statutory and 

regulatory requirements. This 2-day 

workshop for the clinical research 

community targets sponsors, monitors, 

clinical investigators, institutional 

review boards, and those who interact 

with them for the purpose of conducting 

FDA-regulated clinical research. The 

workshop will include both industry 

and FDA perspectives on proper 

conduct of clinical trials regulated by 

FDA. 

Date and Time: The public workshop 

will be held on Wednesday, December 

7, 2005, from 8:15 a.m. to 5 p.m. and 

Thursday, December 8, 2005, from 8:15 

a.m. to 4 p.m. 

Location: The public workshop will 

be held at The Westin Cincinnati, 21 

East 5th St., Cincinnati, OH 45202–

3160, 513–621–7700, FAX: 513–852–

5670. 

Contact: Marie Falcone, Food and 

Drug Administration, rm. 900, U.S. 

Customhouse, 200 Chestnut St., 

Philadelphia, PA 19106, 215–717–3703, 

FAX: 215–597–5798, e-mail: 

mfalcone@ora.fda.gov. 

Registration: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), and the registration fee of $485 

(member), $560 (nonmember), or $460 

(government employee nonmember) 

(includes a 1-year membership). The 

registration fee for FDA employees is 

waived. Make the registration fee 

payable to SoCRA, P.O. Box 101, 

Furlong, PA 18925. To register via the 

Internet go to http://www.socra.org/ 

FDA_Conference.htm. (FDA has verified 

the Web site address, but is not 

responsible for subsequent changes to 

the Web site after this document 

publishes in the Federal Register.) 

The registrar will also accept payment 

by major credit cards. For more 

information on the meeting, or for 

questions on registration, contact 800–

SoCRA92 (800–762–7292), or 215–345–

7749, or FAX: 215–345–7369, or e-mail: 

socramail@aol.com. Attendees are 

responsible for their own 

accommodations. To make reservations 

at The Westin Cincinnati at the reduced 

conference rate, contact The Westin 

Cincinnati see Location) through 

November 7, 2005, or until the SoCRA 

room block is full. 

The registration fee will be used to 

offset the expenses of hosting the 

conference, including meals, 

refreshments, meeting rooms, and 

materials. Space is limited, therefore 

interested parties are encouraged to 

register early. Limited onsite registration 

may be available. Please arrive early to 

ensure prompt registration. 

If you need special accommodations 

due to a disability, please contact Marie 

Falcone at least 7 days in advance of the 

workshop. 

SUPPLEMENTARY INFORMATION: The ‘‘FDA 

Clinical Trials Statutory and Regulatory 

Requirements’’ workshop helps fulfill 

the Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health by educating 

researchers on proper conduct of 

clinical trials. FDA has made education 

of the research community a high 

priority to assure the quality of clinical 

data and protect research subjects. 

The workshop helps to implement the 

objectives of section 903 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

393) and the FDA Plan for Statutory 

Compliance, which includes working 

more closely with stakeholders and 

ensuring access to needed scientific and 

technical expertise. The workshop also 

furthers the goals of the Small Business 

Regulatory Enforcement Fairness Act 

(Public Law 104–121) by providing 

outreach activities by Government 

agencies directed to small businesses. 

The following topics will be 

discussed at the workshop: 

• FDA and confidence in the conduct 

of clinical research; 

• Medical device, drug, and 

biological product aspects of clinical 

research; 

• Investigator initiated research; 

• Pre-investigational new drug 

application (IND) meetings and FDA 

meeting process; 

• Informed consent requirements; 

• Ethics in subject enrollment; 

• FDA regulation of Institutional 

Review Boards; 

• Electronic records requirements; 

• Adverse event reporting; 

• How FDA conducts bioresearch 

inspections; and 

• What happens after the FDA 

inspection. 

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