E6-16455. Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to [e-mail].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 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 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 will participate as the 6th site. The multi-site, collaborative study will be an epidemiological investigation of possible causes for the autism spectrum disorders.

Study participants will 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 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; (2) medical record review of the biological mother of the child participant; (3) a packet 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). There is no cost to respondents other than their time.

Estimated Annualized Burden Hours

Form	Number of respondents	Number of responses per respondent	Avg. burden per response (in hours)	Total burden hours
1. Initial Contact by Mail	17,610	1	0.17	2,994
2. Invitation Telephone Contact	8,922	1	0.33	2,944
3. Self-administered Questionnaires and buccal sample	3,456	1	3.17	10,955
4. Caregiver Interview by telephone	3,282	1	0.83	2,724
5. Child Clinic Visit (Child Development Evaluation, physical exam, and biosamples)	3,114
Case	810	1	2.0	1,620
NIC	1,170	1	1.33	1,556
Subcohort	1,134	1	1.33	1,508
6. Parent-Child Development Interview (Case participants only)	810	1	3.17	2,568
7. Parent biosamples	3,114	1	0.25	779
Total				27,648

Dated: September 29, 2006.

Joan F. Karr,

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