2010-10585. 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 [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 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) 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

Type of respondent	Form name	Number of respondents	Responses per respondent	Avg. burden per response (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 packet	402	1	1.5
Parent	Follow-up telephone call packet	347	3	20/60
Parent and Child	Biosample packet	1,041	1	40/60
Parent and Child	Blood Draw	966	1	15/60
Child	Clinic Visit—control children packet	214	1	1
Parent	Clinic Visit—control parent	80	1	45/60
Parent	Control parent consent form	214	1	10/60
Child	Clinic Visit—Case children packet	107	1	1.5
Parent	Clinic Visit—Case parent packet	107	1	3.5
Parent	Medical Record Abstraction	347	5	3/60

Maryam I. Daneshvar,

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