[Federal Register Volume 75, Number 86 (Wednesday, May 5, 2010)]
[Notices]
[Pages 24706-24707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10585]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-10-0741]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
Maryam I. Daneshvar, the CDC Reports Clearance Officer, at (404) 639-
5960 or send an e-mail to [email protected]. Send written comments to CDC 
Desk Officer, Office of Management and Budget, Washington, DC or by fax 
to (202) 395-5806. Written comments should be received within 30 days 
of this notice.

Proposed Project

    The Study to Explore Early Development (SEED) (OMB No. 0920-0741 
exp. 6/30/2010)--Revision--National Center on Birth Defects and 
Developmental Disabilities (NCBDDD), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    This data collection is based on the following components of the 
Public Health Service Act: (1) Act 42 U.S.C. 241, Section 301, which 
authorizes ``research, investigations, experiments, demonstrations, and 
studies relating to the causes, diagnosis, treatment, control, and 
prevention of physical and mental diseases and impairments of man.'' 
(2) 42 U.S.C. 247b-4, Section 317 C, which authorizes the activities of 
the National Center on Birth Defects and Developmental Disabilities. 
This section was created by Public Law 106-310, also known as ``the 
Children's Health Act of 2000.'' This portion of the code has also been 
amended by Public Law 108-154, which is also known as the ``Birth 
Defects and Developmental Disabilities Prevention Act of 2003.''
    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 five 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 sixth 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 sub-cohort.
    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)

[[Page 24707]]

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. The only study design change that is being proposed is to 
expand the eligible study participant birth date range from September 
1, 2003-August 31, 2005 to September 1, 2003-August 31, 2006.
    There is no cost to respondents other than their time. The total 
estimated annualized burden is 4,948 hours.

                                       Estimate of Annualized Burden Hours
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                                                                                                    Avg. burden
          Type of respondent                    Form name            Number of     Responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Parent................................  Response Card...........           2,458               1           10/60
Parent................................  Invitation packet.......           1,008               1           30/60
Parent................................  Questionnaire packet....             347               1             3.5
Parent................................  Caregiver Interview                  402               1             1.5
                                         packet.
Parent................................  Follow-up telephone call             347               3           20/60
                                         packet.
Parent and Child......................  Biosample packet........           1,041               1           40/60
Parent and Child......................  Blood Draw..............             966               1           15/60
Child.................................  Clinic Visit--control                214               1               1
                                         children packet.
Parent................................  Clinic Visit--control                 80               1           45/60
                                         parent.
Parent................................  Control parent consent               214               1           10/60
                                         form.
Child.................................  Clinic Visit--Case                   107               1             1.5
                                         children packet.
Parent................................  Clinic Visit--Case                   107               1             3.5
                                         parent packet.
Parent................................  Medical Record                       347               5            3/60
                                         Abstraction.
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Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 2010-10585 Filed 5-4-10; 8:45 am]
BILLING CODE 4163-18-P