Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Notices 58969 

grant application derived from those 

figures were also false. 

5. Two figures in NIAID, NIH, grant 

application P01 AI44236–05 contained 

falsified data: In Figure 1b, panels of 

confocal microscopy images of 

intestinal biopsies from four patients 

were falsified by duplication; and in 

Figure 3, one panel of PCR data was 

duplicated and similarly misrepresented 

as data from the same four biopsy 

specimens. 

Dr. Sperber has entered into a 

Voluntary Exclusion Agreement in 

which he neither admitted or denied 

HHS’ findings of scientific misconduct. 

However, he recognized that if this 

matter were to proceed to an 

administrative hearing, there is 

sufficient evidence upon which an 

Administrative Law Judge could make 

findings of scientific misconduct against 

him. Dr. Sperber agreed not to contest 

or appeal the jurisdiction of the PHS or 

HHS findings of scientific misconduct 

as set forth above and in the MSSM 

Report. Dr. Sperber has voluntarily 

agreed, for a period of four (4) years, 

beginning on September 12, 2008: 

(1) To exclude himself from any 

contracting or subcontracting with any 

agency of the United States Government 

and from eligibility or involvement in 

nonprocurement programs of the United 

States pursuant to HHS’ Implementation 

(2 CFR Part 376 et seq.) of OMB 

Guidelines to Agencies on Government 

wide Debarment and Suspension (2 

C.F.R., Part 180); and 

(2) To exclude himself from serving in 

any advisory capacity to PHS, including 

but not limited to service on any PHS 

advisory committee, board, and/or peer 

review committee, or as a consultant or 

contractor to PHS. 

FOR FURTHER INFORMATION CONTACT: 

Director, Division of Investigative 

Oversight, Office of Research Integrity, 

1101 Wootton Parkway, Suite 750, 

Rockville, MD 20852, (240) 453–8800. 

Chris B. Pascal, 

Director, Office of Research Integrity. 

[FR Doc. E8–23820 Filed 10–7–08; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Breast and Cervical Cancer Early 

Detection and Control Advisory 

Committee: Notice of Charter Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that the Breast 

and Cervical Cancer Early Detection and 

Control Advisory Committee, 

Department of Health and Human 

Services, has been renewed for a 2-year 

period through September 12, 2010. 

For information, contact Debra 

Younginer, Executive Secretary, Breast 

and Cervical Cancer Early Detection and 

Control Advisory Committee, 

Department of Health and Human 

Services, 4770 Buford Highway, NE., 

Mailstop K57, Chamblee, Georgia 30341, 

telephone (770) 488–1074; fax (770) 

488–3230. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: October 1, 2008. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E8–23815 Filed 10–7–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Task Force on Community Preventive 

Services 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following meeting: 

Name: Task Force on Community 

Preventive Services. 

Times and Dates: 8 a.m.–6 p.m. EST, 

October 22, 2008; 8 a.m.–1 p.m. EST, October 

23, 2008. 

Place: Centers for Disease Control and 

Prevention, 2500 Century Parkway, Atlanta, 

Georgia 30345. 

Status: Open to the public, limited only by 

the space available. 

Purpose: The mission of the Task Force is 

to develop and publish the Guide to 

Community Preventive Services (Community 

Guide), which consists of systematic reviews 

of the best available scientific evidence and 

associated recommendations regarding what 

works in the delivery of essential public 

health services. 

Topics include: 

• Sexual Behavior: Group-based 

interventions to reduce adolescent 

pregnancy, HIV, and other Sexually 

Transmitted Diseases. 

• Vaccine Preventable Diseases: 

Interventions to reduce out-of-pocket costs. 

• Vaccine Preventable Diseases: 

Immunization Information Systems. 

• Physical Activity Updates. 

Agenda items are subject to change as 

priorities dictate. 

Persons interested in reserving a space for 

this meeting should call Charmen Crawford 

at 404. 498.2498 by close of business on 

October 17, 2008. 

Contact person for additional information: 

Charmen Crawford, Coordinating Center for 

Health Information and Services, National 

Center for Health Marketing, Office of the 

Director, Centers for Disease Control and 

Prevention, 1600 Clifton Road, M/S E–69, 

Atlanta, GA 30329, phone: 404.4982498. 

Dated: September 30, 2008. 

James D. Seligman, 

Chief Information Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E8–23814 Filed 10–7–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Head Start Grants 

Administration (45 CFR Part 1301). 

OMB No.: 0980–0243. 

Description: 45 CFR contains 

provisions applicable to program 

administration and grants 

administration under the Head Start 

Act, as amended. The provisions specify 

the requirements for grantee agencies for 

insurance, bonding, the submission of 

audits, matching of federal funds, 

accounting systems certifications and 

other provisions applicable to personnel 

administration. 

Respondents: Head Start and Early 

Start grantees. 


jlentini on PROD1PC65 with NOTICES
58970 Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

45 CFR Part 1301 ........................................................................... 2,500 2 2 10,000 

Estimated Total Annual Burden 

Hours: 10,000. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded 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. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: October 3, 2008. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E8–23798 Filed 10–7–08; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0521] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Clinical Trial Sponsors: Establishment 

and Operation of Clinical Trial Data 

Monitoring Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the collection of information concerning 

the establishment and operation of 

clinical trial data monitoring 

committees. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 8, 2008. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance for Clinical Trial Sponsors: 

Establishment and Operation of 

Clinical Trial Data Monitoring 

Committees—(OMB Control Number 

0910–0581)—Extension 

Sponsors are required to monitor 

studies evaluating new drugs, biologics, 

and devices (21 CFR 312.50 and 312.56 

for drugs and biologics, and 21 CFR 

812.40 and 812.46 for devices). Various 

individuals and groups play different 

roles in clinical trial monitoring. One 

such group is a Data Monitoring 

Committee (DMC), appointed by a 

sponsor to evaluate the accumulating 

outcome data in some trials. A clinical 

trial DMC is a group of individuals with 

pertinent expertise that reviews on a 

regular basis accumulating data from an 


jlentini on PROD1PC65 with NOTICES