46200 Federal Register / Vol. 74, No. 172 / Tuesday, September 8, 2009 / Notices 

communication channels, for 

influencing behavior change. It helps 

researchers identify and understand the 

characteristics—interests, behaviors and 

needs—of target populations that 

influence their decisions and actions. 

Formative research is integral in 

developing programs as well as 

improving existing and ongoing 

programs. Formative research also looks 

at the community in which an 

intervention is being or planning to be 

implemented and helps the project staff 

understand the interests, attributes and 

needs of different populations and 

persons in their community. Formative 

research is research that occurs before a 

program is designed and implemented, 

or while a program is being conducted. 

Formative research is an integral part of 

developing programs or adapting 

programs that deal with the complexity 

of behaviors, social context, cultural 

identities, and health care that underlie 

the epidemiology of HIV/AIDS, viral 

hepatitis, STDs, and TB in the U.S. 

CDC conducts formative research to 

develop public-sensitive 

communication messages and userfriendly tools prior to developing or 

recommending interventions, or care. 

Sometimes these studies are entirely 

behavioral but most often they are 

cycles of interviews and focus groups 

designed to inform the formation of a 

product. Short term qualitative 

interviewing and cognitive research 

techniques have previously proven 

invaluable in the development of 

scientifically valid and populationappropriate methods, interventions, and 

instruments. Products from the 

proposed studies will be used for 

sustainable projects for HIV/AIDS, 

Sexually Transmitted Infections (STI), 

viral Hepatitis, and Tuberculosis 

prevention that are presented as 

evidence to disease specific National 

Advisory Committees, in order to 

support revisions to existing prevention 

and intervention methods, and provide 

new recommendations which cannot be 

developed without formative research. 

This request includes studies 

investigating the utility and 

acceptability of proposed recruitment 

methods, intervention contents and 

delivery, questionnaire domains, 

individual questions, and interactions 

with project staff or electronic data 

collection equipment. These activities 

will also provide information about how 

respondents answer questions and ways 

in which question response bias and 

error can be reduced. Overall, these 

development activities are intended to 

provide information that will increase 

the success of the surveillance or 

research project through increasing 

response rates and decreasing response 

error thereby decreasing future data 

collection burden to the public. The 

studies that will be covered under this 

request will include one or more of the 

following investigational modalities: (1) 

Focus group and individual interviews; 

(2) Cognitive interviews for 

development and testing of specific data 

collection instruments; (3) Component 

testing of instruments developed from 

qualitative research or communication 

methods; (4) testing of behavioral 

interventions; (5) public acceptance of 

intervention and prevention methods; 

(6) utilizing computer-assisted 

instruments (including web-based 

technology). The implementors may be 

health jurisdictions, non-governmental 

organizations including academia, forprofit contractors, private health care 

facilities, pharmacies, or a combination 

of these agencies. 

Respondents who will participate in 

individual and group interviews 

(qualitative, cognitive, and computerassisted development activities) are 

selected purposely from those who 

respond to recruitment advertisements. 

In addition to utilizing advertisements 

for recruitment, respondents who will 

participate in research on survey 

methods may be selected purposively or 

systematically from within an ongoing 

surveillance or research project. 

Participants may be offered cash or gift 

certificates as tokens of appreciation for 

participating. 

CDC estimates that the public will 

participate in 10 different information 

collection activities, each lasting 

between 6–12 months. Participation of 

respondents is always voluntary and 

there is no cost to the respondents other 

than their time. The estimated annual 

burden hours requested is 46,516 hours. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses 

per respondent 

Average burden 

per response 

(in hours) 

General public and health care providers ....................... Screener ............................ 81,200 1 10/60 

General public and health care providers ....................... Consent Forms .................. 40,600 1 5/60 

General public and health care providers ....................... Individual interview ............ 6,600 1 1 

General public and health care providers ....................... Group interview .................. 4,000 1 2 

General public and health care providers ....................... Individual Survey ............... 30,000 1 30/60 

Dated: September 2, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–21676 Filed 9–4–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60–Day–09–0741] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Maryam I. Daneshvar, 

CDC Acting Reports Clearance Officer, 

1600 Clifton Road, MS–D74, Atlanta, 

GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited 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 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 172 / Tuesday, September 8, 2009 / Notices 46201 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance 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. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

The Study to Explore Early 

Development, [OMB# 0920–0741 Exp. 

6/30/2010]—Revision—National Center 

on Birth Defects and Developmental 

Disabilities (NCBDDD), Centers for 

Disease Control and Prevention (CDC). 

The Children’s Health Act of 2000 

mandated CDC to establish autism 

surveillance and research programs to 

address the number, incidence, 

correlates, and causes of autism and 

related disabilities. Under the 

provisions of this act, CDC funded 5 

Centers for Autism and Developmental 

Disabilities Research and Epidemiology 

(CADDRE) including the California 

Department of Health and Human 

Services, Colorado Department of Public 

Health and Environment, Johns Hopkins 

University, the University of 

Pennsylvania, and the University of 

North Carolina at Chapel Hill. CDC 

National Center on Birth Defects and 

Developmental Disabilities participates 

as the 6th CADDRE site. The SEED 

multi-site, collaborative project is an 

epidemiological investigation of 

possible causes for the autism spectrum 

disorders. 

Study participants are to be selected 

from children born in and residing in 

the following six areas: Atlanta 

metropolitan area, San Francisco Bay 

area, Denver metropolitan area, 

Baltimore metropolitan area, 

Philadelphia metropolitan area, and 

Central North Carolina. Children with 

autism spectrum disorders are 

compared to children with other 

developmental problems, referred to as 

the neurodevelopmentally impaired 

group (NIC), as well as children who do 

not have developmental problems, 

referred to as the subcohort. 

Data collection methods consist of the 

following: (1) Medical record review of 

the child participant; (2) medical record 

review of the biological mother of the 

child participant; (3) packets sent to the 

participants with self-administered 

questionnaires and a buccal swab kit; (4) 

a telephone interview focusing on 

pregnancy-related events and early life 

history (biological mother and/or 

primary caregiver interview); (5) a child 

development evaluation (more 

comprehensive for case participants 

than for the control group participants); 

(6) parent child development interview 

(for case participants only) administered 

over the telephone or in-person; (7) a 

physical exam of the child participant; 

(8) biological sampling of the child 

participant (blood and hair); and, (9) 

biological sampling of the biological 

parents of the child participant (blood 

only). Minor changes to some of the self 

administered questionnaires and the 

telephone interview include 

clarification of instructions to the 

respondent and clarifying specific 

questions to make the instruments 

easier to complete and further improve 

data quality. 

There is no cost to respondents other 

than their time. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Form Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Total burden 

(in hours) 

1. Initial Contact by Mail ................................................................................ 9,252 1 10/60 1,542 

2. Invitation Telephone Contact ..................................................................... 3,886 1 20/60 1,295 

3. Self-administered Questionnaires and buccal sample .............................. 1,749 1 3 5,247 

4. Caregiver Interview by telephone .............................................................. 1,434 1 1.5 2,151 

5. Child Clinic Visit (Child Development Evaluation, physical exam, and 

biosamples) ................................................................................................ 1,329 

Case ....................................................................................................... 443 1 2 886 

NIC .......................................................................................................... 443 1 2 886 

Subcohort ............................................................................................... 443 1 2 886 

6. Parent Child Development Interview (Case participants only) .................. 414 1 3 1242 

7. Parent biosamples ..................................................................................... 1,242 1 15/60 311 

Total ................................................................................................. ........................ .......................... ........................ 14,446 

Dated: September 2, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–21675 Filed 9–4–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Request for Public Comment: 60-Day 

Proposed Information Collection: 

Indian Health Service Customer 

Satisfaction Survey 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 which requires 

60-day advance opportunity for public 

comment on proposed information 

collection projects, the Indian Health 

Service (IHS) is publishing for comment 

a summary of a proposed information 

collection to be submitted to the Office 

of Management and Budget (OMB) for 

review. 

Proposed Collection: Title: 0917– 

NEW, ‘‘Indian Health Service Customer 

Satisfaction Survey.’’ Type of 

Information Collection Request: Threeyear approval of this new information 

collection, 0917–NEW, ‘‘Indian Health 

Service Customer Satisfaction Survey.’’ 

Form(s): Tribal Homeowner Survey, 

Tribal Partner Survey, Annual Operator 

Operation and Maintenance (O&M) 


jlentini on DSKJ8SOYB1PROD with NOTICES