Appendix_B

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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

jlentini on DSKJ8SOYB1PROD with NOTICES

General
General
General
General
General

public
public
public
public
public

and
and
and
and
and

health
health
health
health
health

care
care
care
care
care

providers
providers
providers
providers
providers

Number of
respondents

Form name
.......................
.......................
.......................
.......................
.......................

Screener ............................
Consent Forms ..................
Individual interview ............
Group interview ..................
Individual Survey ...............

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]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

BILLING CODE 4163–18–P

[60–Day–09–0741]

Centers for Disease Control and
Prevention

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

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Number of
responses
per respondent

81,200
40,600
6,600
4,000
30,000

1
1
1
1
1

Average burden
per response
(in hours)
10/60
5/60
1
2
30/60

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

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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
Number of
respondents

Form

1.
2.
3.
4.
5.

Average
burden
per response
(in hours)

Total burden
(in hours)

Initial Contact by Mail ................................................................................
Invitation Telephone Contact .....................................................................
Self-administered Questionnaires and buccal sample ..............................
Caregiver Interview by telephone ..............................................................
Child Clinic Visit (Child Development Evaluation, physical exam, and
biosamples) ................................................................................................
Case .......................................................................................................
NIC ..........................................................................................................
Subcohort ...............................................................................................
6. Parent Child Development Interview (Case participants only) ..................
7. Parent biosamples .....................................................................................

9,252
3,886
1,749
1,434

1
1
1
1

10/60
20/60
3
1.5

1,542
1,295
5,247
2,151

1,329
443
443
443
414
1,242

1
1
1
1
1

2
2
2
3
15/60

886
886
886
1242
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

jlentini on DSKJ8SOYB1PROD with NOTICES

Number of
responses per
respondent

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:
ACTION:

Indian Health Service, HHS.

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

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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)

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