04-2102. 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 the CDC Reports Clearance Officer on [phone].

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. Send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-E11, Atlanta, GA 30333. 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 for Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).

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, John Hopkins University, the University of Pennsylvania, and the University of North Carolina at Chapel Hill. CDC National Center for Birth Defect 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.

Data collection methods will consist of the following: (1) Medical and educational 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 interview (for case participants only) administered over the telephone or in-person; (6) a developmental and physical exam of the child participant; (7) biological sampling of the child participant (blood and hair); and, (8) biological sampling of the biological parents of the child participant (blood only). OMB clearance is requested for the self administered questionnaires and buccal swab kit, the primary caregiver interview, and the child development interview. There is no cost to respondents.

Survey	Number of respondents	Number of responses per respondent	Average burden per response (in hrs.)	Total burden (in hrs.)
Cases:
—Self administered questionnaires and buccal swab kit	644	1	3	1932
—Primary caregiver interview	644	1	40/60	429
—Child development interview	644	1	3	1932
Controls:
—Self administered questionnaires and buccal swab kit	1288	1	3	3864
—Primary caregiver interview	1288	1	40/60	859
—Child development interview	1288	1	1	1288
Total				10,304

Dated: January 27, 2004.

Alvin Hall,

Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.