[Federal Register: July 26, 2005 (Volume 70, Number 142)]
[Notices]               
[Page 43151]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jy05-89]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-05-0466X]

 
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) 371-5983 or send an email to 
omb@cdc.gov. Send written comments to CDC Desk Officer, Human Resources 

and Housing Branch, New Executive Office Building, Room 10235, 
Washington, DC 20503 or by fax to (202) 395-6974. Written comments 
should be received within 30 days of this notice.

Proposed Project

    Validating Autism Surveillance Methodology in Metropolitan Atlanta 
Developmental Disabilities Surveillance Program (MADDSP)--New--National 
Center on Birth Defects and Developmental Disabilities (NCBDDD), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    MADDSP was established in 1991 as an ongoing active surveillance 
system for select developmental disabilities (mental retardation, 
cerebral palsy, vision impairment, and hearing loss) in 3 to 10 year 
old children. In 1996, autism spectrum disorders (ASD) was added to 
MADDSP due to growing concern about the prevalence of the condition. 
MADDSP defines ASD as a constellation of social, communicative, and 
behavioral impairments consistent with the DSM-IV-TR diagnostic 
criteria for Autistic Disorder, Asperger's Disorder, and Pervasive 
Developmental Disorders not otherwise specified.
    MADDSP relies on an extensive review of records to identify 
children with an ASD. Potential case records are identified from 
multiple sources which are likely to maintain evaluation or treatment 
records for children with ASD. Pertinent ICD-9, DSM-IV codes and 
predetermined behavioral descriptions are used to trigger records for 
abstraction. Clinical experts then review the abstracted data and 
determine case status based on a behavioral coding scheme that is in 
accordance with the DSM-IV-TR definition for Pervasive Developmental 
Disorders.
    This record review methodology for ASD surveillance has been 
executed and is being used; however, the method is not currently 
validated by a clinical sample which is considered the gold standard 
for identifying ASD. For this reason, it is important to validate 
surveillance methods in a clinical sample in order to determine whether 
current surveillance methodology accurately captures prevalence 
estimates for this developmental outcome. The sensitivity and 
specificity of MADDSP will be measured using judgments from the 
clinical exam as the gold standard. The results from this study will 
provide important implications for how ASD surveillance is maintained.
    Primary caregivers of children already identified through 
surveillance methods will be contacted, informed of the study, and 
asked to participate through telephone contact. Clinic visits will be 
scheduled for all children whose primary caregiver agrees to take part 
in the study and who signs a written informed consent; child assent 
will be obtained at the time of the clinic visit. Data collection 
methods will consist of: (1) Parental questionnaires, which will focus 
on questions about their child's behavior and developmental history; 
and, (2) a developmental evaluation for the child participant, which 
includes a play based assessment specific to ASD and a measure of 
cognitive development. There is no cost to respondents other than their 
time. The total estimated annualized burden hours are 646.

                                        Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of      Avg. burden
                       Survey instruments                            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Telephone Contact...............................................             500               1           10/60
Parental Interviews and Questionnaires..........................             125           1*2.5
Developmental Evaluation of the Child...........................             125               1               2
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\*\ One response per hour for an estimated 2.5 hours of clinic time; estimation of clinic time takes into
  consideration that parents and children will be encouraged to complete assessment simultaneously and that
  additional clinic time may be required due to individual differences.


    Dated: July 20, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 05-14681 Filed 7-25-05; 8:45 am]

BILLING CODE 4163-18-P