63188 Federal Register / Vol. 75, No. 198 / Thursday, October 14, 2010 / Notices 

ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN—Continued 

Section and activity Number of 

respondents 

Responses per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

121.9(b) Designated Transplant Program Requirements ............................................................................ 10 1 10 5 .0 50 

121.9(d) Appeal for designation .................................... 2 1 2 6 12 

Total .......................................................................... 3,014 .......................... 36,524 .......................... 20,063 

E-mail comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–33, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, MD 20857. Written comments 

should be received within 60 days of 

this notice. 

Dated: October 7, 2010. 

Wendy Ponton, 

Director, Office of Management. 

[FR Doc. 2010–25843 Filed 10–13–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office at (301) 443– 

1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project Title: Evaluation of 

the National Healthy Start Program— 

[NEW] 

Background: The National Healthy 

Start Program, funded through the 

Health Resources and Services 

Administration’s (HRSA) Maternal and 

Child Health Bureau (MCHB), was 

developed in 1991 with the goal of 

reducing infant mortality disparities in 

high-risk populations through 

community-based interventions. The 

program originally began as a five-year 

demonstration project within 15 

communities that had infant mortality 

rates 1.5 to 2.5 times above the national 

average. 

The National Healthy Start Program 

has since expanded in size and mission 

to include 102 grantees across the 

nation, emphasizing a communitybased, culturally competent approach to 

the delivery of care for women and their 

babies. MCHB seeks to conduct a crosssite evaluation of all Healthy Start 

grantees to document the 

accomplishments made by the National 

Healthy Start Program. 

Purpose: The purpose of the survey is 

to collect consistent data on the services 

and activities of all 102 Healthy Start 

grantees. The data collected though this 

survey will be used to: 

• Evaluate the grantees’ performance 

and progress toward achieving shortterm and long-term goals; 

• Evaluate the relationship of 

performance and progress to 

implementation features of Healthy 

Start Program components; 

• Assist MCHB in determining on a 

national level where technical 

assistance may be needed to improve 

program performance, set future 

priorities for program activities, and 

contribute to the overall strategic 

planning activities of MCHB; and 

• Provide foundation data for future 

measurement of the initiative’s longterm impact. 

Respondents: The project directors of 

Healthy Start grants funded by HRSA 

will be the respondents for this data 

collection activity. The estimated 

response burden is as follows: 

No. of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Average 

hours per 

respondent 

Total burden 

hours 

Healthy Start Grantee Web Survey ..................................... 102 1 102 4.0 408 

Total .............................................................................. 102 1 102 4.0 408 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to 

the desk officer for HRSA, either by 

email to 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974. Please direct all 

correspondence to the ‘‘attention of the 

desk officer for HRSA.’’ 

Dated: October 7, 2010. 

Wendy Ponton, 

Director, Office of Management. 

[FR Doc. 2010–25841 Filed 10–13–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0500] 

Draft Guidance for Industry: Early 

Clinical Trials With Live Biotherapeutic 

Products: Chemistry, Manufacturing, 

and Control Information; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


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