[Federal Register Volume 74, Number 172 (Tuesday, September 8, 2009)]
[Notices]
[Pages 46200-46201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21675]
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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 [email protected].
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
[[Page 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
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Number of Average burden
Form Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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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 1,749 1 3 5,247
sample........................................
4. Caregiver Interview by telephone............ 1,434 1 1.5 2,151
5. Child Clinic Visit (Child Development 1,329
Evaluation, physical exam, and biosamples)....
Case....................................... 443 1 2 886
NIC........................................ 443 1 2 886
Subcohort.................................. 443 1 2 886
6. Parent Child Development Interview (Case 414 1 3 1242
participants only)............................
7. Parent biosamples........................... 1,242 1 15/60 311
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Total.................................. .............. ............... .............. 14,446
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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]
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