[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]
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