[Federal Register Volume 73, Number 168 (Thursday, August 28, 2008)]
[Notices]
[Pages 50820-50821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-19968]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-08-08AL]
Proposed Data Collections Submitted for Public Comment and
Recommendations
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
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) 395-6974.
Written comments should be received within 30 days of this notice.
Proposed Project
The Natural History of Spina Bifida in Children Pilot Project-New-
National Center on Birth Defects and Developmental Disabilities
(NCBDDD), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Spina Bifida (SB) is one of the most common birth defects,
affecting approximately 2 per 10,000 live births in the United States
annually. To date, there are no U.S. population-based cohort studies or
programs on the natural history of SB. This is of importance because
persons with SB often experience condition-specific difficulties and
secondary conditions that detrimentally affect several aspects of their
lives. The long-term purpose of this project is to increase the
knowledge about the natural history of Spina Bifida by prospectively
studying children who were born with this potentially disabling
condition. We estimate to enroll approximately 40 parents with a child
with Spina Bifida ages 3-, 4-, or 5-years of age, and 20 of the
children of these forty parents. The data to be collected will relate
to medical concerns prevalent among individuals with Spina Bifida in
the areas of neurology/neurosurgery, urology, and orthopedics;
development and learning; nutrition and physical growth; mobility and
functioning; general health; and family demographics. Families
interested in participating can choose between participating in a phone
survey (no more than 45 minutes) or an in-person assessment (no more
than 3 hrs). For families who participate in the in-person assessment
(estimated to be twenty of the forty families), the child will also be
invited to participate in a child-appropriate assessment.
Data will also be collected on the actual recruitment process.
Results from the project will be evaluated and disseminated to provide
guidance for states that are interested in following children with
Spina Bifida prospectively. The proposed project is the initial step to
document the development, the health status, and the onset of
complications among children with SB in order that effective
interventions may be identified that will ameliorate the course of this
complex, multi-system condition. Long-term results will help determine
if it would be beneficial to systematically screen children with Spina
Bifida for certain health-related educational and developmental
problems that these children are at an increased risk of experiencing
and at what age such a screening should be performed.
There will be no cost to the respondents other than their time. The
total estimated annualized burden hours are 97.
Estimated Annualized Burden Hours
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Number of Average burden
Respondents Number of responses per per response
respondents respondent (in hours)
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Parents (phone survey).......................................... 20 1 45/60
Parents (in-person assessment).................................. 20 1 2.5
Child (in-person assessment).................................... 20 1 1.5
SB Clinic Coordinator (recruitment effort)...................... 1 1 2
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[[Page 50821]]
Dated: August 22, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E8-19968 Filed 8-27-08; 8:45 am]
BILLING CODE 4163-18-P