E6-22579. 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 the CDC Reports Clearance Officer at [phone] or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

The National Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) Study—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

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 CADDRE centers: 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 will participate as the 6th site.

The purpose of this program is to establish a multi-site, collaborative epidemiological investigation of possible causes of autism spectrum disorders. Children with autism spectrum disorders will be 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 will consist of the following: (1) Medical record review of the child participant and biological mother; (2) self-administered Questionnaires; (3) buccal cell collection; (4) a telephone interview of the biological mother and/or primary caregiver; (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); (7) a physical exam of the child; (8) biological sampling of the child (blood and hair); and (9) biological sampling of the biological parents (blood only).

There are no costs to respondents other than their time. The total estimated annualized burden is 30,103 hours.

Estimated Annualized Burden Hours

Respondents	Number of respondents	Number of responses per respondent	Average burden per response (In hrs)	Total burden hours
Contact by Mail	17,610	1	10/60	2,935
Telephone Contact	8,922	1	20/60	2,974
Parent Questionnaires and biologic sample	3,456	1	235/60 (3h 55m)	13,548
Caregiver Interview	3,282	1	30/60	1,641
Clinic Visit (Child Development Evaluation, physical exam, and biosamples):
• Case	810	1	355/60 (5h 55m)	4,793
• NIC	1,170	1	110/60 (1h 50m)	2,145
• Subcohort	1,134	1	110/60 (1h 50m)	2,079
TOTAL				30,103

Dated: December 26, 2006.

Joan F. Karr,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.