[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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