Federal Register / Vol. 74, No. 62 / Thursday, April 2, 2009 / Notices 14991 

the institution; the Respondent agrees 

that he will not participate in any PHSsupported research until such a 

supervisory plan is submitted to ORI; 

and 

(3) To ensure that any institution 

employing him submits, in conjunction 

with each application for PHS funds or 

report, manuscript, or abstract of PHSfunded research in which the 

Respondent is involved, a certification 

that the data provided by the 

Respondent are based on actual 

experiments or are otherwise 

legitimately derived and that the data, 

procedures, and methodology are 

accurately reported in the application or 

report. The Respondent must ensure 

that the institution sends the 

certification to ORI. 

FOR FURTHER INFORMATION CONTACT: 

Director, Division of Investigative 

Oversight, Office of Research Integrity, 

1101 Wootton Parkway, Suite 750, 

Rockville, MD 20852, (240) 453–8800. 

John Dahlberg, 

Director, Division of Investigative Oversight, 

Office of Research Integrity. 

[FR Doc. E9–7411 Filed 4–1–09; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day-09–08BI] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–6974. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Evaluation of the National Youth 

Violence Prevention Resource Center 

(NYVPRC)—New—National Center for 

Injury Prevention and Control (NCIPC), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

The origin of the National Youth 

Violence Prevention Resource Center 

(NYVPRC) is woven into the federal 

response to the Columbine High School 

shootings in 1999. As the Nation took a 

broad look at the issue of violence 

occurring in school settings, it became 

clear that violence among adolescents 

stretched far beyond the walls of 

educational institutions and presented a 

complex threatening public health 

concern requiring a comprehensive 

response. To that end, the White House 

established the Council on Youth 

Violence in October 1999 to coordinate 

youth violence prevention activities of 

all federal agencies. The Council, in 

collaboration with CDC and other 

federal agencies, directed the 

development of NYVPRC to serve as a 

user-friendly, single point of entry to 

potentially life-saving information about 

youth violence prevention. 

Since 1999, a substantial body of 

evidence has evolved to support the 

belief that youth violence can be 

prevented through the comprehensive, 

systematic application of effective 

approaches. A better understanding of 

the key influencers on the prevention of 

youth violence has emerged. Armed 

with this greater understanding, the 

NYVPRC’s role has been refocused to 

better position it to respond to emerging 

needs. 

This project will evaluate a pilot 

implementation of the revised NYVPRC 

Web site. The revised Web site will 

target local government and community 

leaders with youth violence-related 

online training, information resources 

and community workspace to build and 

sustain comprehensive, communitywide prevention efforts. The objectives 

of the NYVPRC pilot project are to 

determine (1) The usefulness and 

favorability of the online training, 

information resources and community 

workspaces, (2) the reach of targeted 

promotional efforts, and (3) progress 

made on short term outcomes. Four data 

collection tools will be used to measure 

these objectives: (1) user feedback 

surveys, (2) training surveys, (3) 

implementation interviews and (4) 

coalition capacity surveys. 

The user feedback surveys will elicit 

feedback from users at various points on 

the NYVPRC Web site. The training 

surveys will be conducted during the 

online training available through the 

Web site. The implementation 

interviews and coalition capacity 

surveys will be conducted at the 

beginning of the pilot period as a 

baseline measure and again at the end 

of the 12-month pilot period. The 

baseline information will assist CDC in 

tailoring technical assistance that might 

be required by the pilot communities. 

The evaluation will then utilize these 

baseline measures along with the 

information collected following the 

pilot to assess the Web site’s success at 

supporting the development of 

community-wide youth violence 

prevention coalitions and subsequent 

strategic planning. 

The pre-post research design of the 

evaluation will aid CDC in assessing the 

changes in knowledge, attitudes, and 

resource capacity associated with the 

NYVPRC Web site and will inform 

revision of the Web site materials for a 

future nationwide launch. There is no 

cost to respondents for participation. 

The total estimated annualized 

burden hours are 353. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses/ 

respondent 

Avg. burden/ 

response 

(in hrs.) 

General Public, coalition members, coalition leaders ..................................... Online 

Training 

Survey 

400 1 15/60 

General Public, coalition members, coalition leaders ..................................... User 

Feedback 

Survey 

1000 1 5/60 

Coalition Members ........................................................................................... Coalition 

Member 

Survey 

120 2 30/60 

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14992 Federal Register / Vol. 74, No. 62 / Thursday, April 2, 2009 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent Form name Number of 

respondents 

Number of 

responses/ 

respondent 

Avg. burden/ 

response 

(in hrs.) 

Coalition Leaders ............................................................................................. Coalition 

Leader 

Interviews 

50 2 30/60 

Dated: March 27, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–7413 Filed 4–1–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0132] 

Draft Guidance for Industry: Somatic 

Cell Therapy for Cardiac Disease; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry: Somatic Cell 

Therapy for Cardiac Disease’’ dated 

March 2009. The draft guidance 

document provides sponsors of cellular 

therapies for the treatment of cardiac 

disease with recommendations on the 

design of preclinical and clinical 

studies, and information that should be 

submitted about the product delivery 

system. This guidance also provides 

recommendations on the chemistry, 

manufacturing and controls information 

to include in an investigational new 

drug application (IND) for cardiac 

cellular therapy. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115 (g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by July 1, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448; 

or the Division of Small Manufacturers, 

International, and Consumer Assistance 

(DSMICA), Center for Devices and 

Radiological Health (CDRH), Food and 

Drug Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist the 

office in processing your requests. The 

draft guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

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.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Brenda R. Friend, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448, 301– 

827–6210; or 

Sabina Reilly, Center for Devices and 

Radiological Health (HFZ–450), 

Food and Drug Administration, 

9200 Corporate Blvd., Rockville, 

MD 20850, 240–276–4095. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for 

Industry: Somatic Cell Therapy for 

Cardiac Disease’’ dated March 2009. 

This guidance provides to sponsors 

developing cellular therapies for the 

treatment of cardiac disease with 

recommendations including, but not 

limited to, the following: (1) Design of 

preclinical and clinical studies; (2) 

information to submit on the product 

delivery system; and (3) the chemistry, 

manufacturing and controls information 

to include in an IND for cardiac cellular 

therapy. This guidance also includes 

regulatory considerations for the use of 

intravascular catheter delivery systems. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. 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 requirement 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

the IND regulations (21 CFR part 312) 

have been approved under OMB control 

number 0910–0014, and the Good 

Laboratory Practice regulations (21 CFR 

part 58) have been approved under 

OMB control number 0910–0119. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the draft 

guidance. 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 the 

brackets in the heading of this 

document. A copy of 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cber/guidelines.htm 

or http://www.regulations.gov. 

Dated: March 27, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–7350 Filed 4–1–09; 8:45 am] 

BILLING CODE 4160–01–S 

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