01-17535. Agency Information Collection Activities: Proposed Collection; Comment Request

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on [phone].

Comments are invited on: (a) Whether the proposed collections of information are 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.

Proposed Project: National Survey on Drug Use and Health Clinical Validation Study of the Substance Dependence and Abuse Measures— (New)—The Substance Abuse and Mental Health Services Administration's (SAMHSA) National Survey on Drug Use and Health (NSDUH), formerly the National Household Survey on Drug Abuse, is a survey of the civilian, noninstitutionalized population of the United States 12 years old and older. The data are used to determine the prevalence of use of tobacco products, alcohol, illicit substances, and illicit use of prescription drugs. The results are used by SAMHSA, the Office of National Drug Control Policy, other Federal government agencies, and other organizations and researchers to establish policy, direct program activities, and better allocate resources.

From 2001-2003, the NSDUH plans a two or three-phase Clinical Validation Study of Substance Dependence and Abuse Measures. Specific aims are to achieve the best overarching format, and the best wording and ordering for the assessment questions. The goal is quicker administration time, improved validity, and reduced respondent burden.

Half of all subject will be between 12 and 17, and half 18 years of age or older; subjects will be recruited from the Research Triangle and the Triad areas of North Carolina. In Phase 1, subjects, recruited through fliers and newspaper ads, will be asked (1) demographic information and (2) questions from two self-administered sections of the NSDUH questionnaire: Questions about the quantity and frequency of use of drugs and alcohol, and questions about symptoms of substance dependence and abuse.

A semi-structured clinical interview will then be administered to these same subjects by a trained clinician to determine the presence or absence of substance dependence and abuse. The clinical instruments used to assess subjects will be the substance abuse modules from the Structured Clinical Interview for DSM-IV (SCID) (for adults) and the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS ) (for those between 12 and 17 years of age). The correspondence of the diagnosis of substance dependence and abuse between the clinical and survey interview will then be compared.

Information from Phase 1 will then be used to assess if a lack of correspondence exists between the clinical and survey measures. If there is a lack of sufficient correspondence, we will then examine reasons for any lack of correspondence, and make decisions about how to modify the NSDUH questions on substance dependence and abuse to achieve better correspondence. This information will then be used to develop a revised NSDUH substance dependence and abuse module.

In Phase 2, a second clinical validation study will be conducted using the same procedures as Phase 1. This will allow a determination of the correspondence (kappa) between the revised diagnosis obtained from the NSDUH substance dependence and abuse module and the diagnosis from the structured clinical interviews. Final revisions to the survey instrument will be made based on findings from Phase 2.

Finally, if the revised NSDUH survey assessment of substance dependence and abuse still does not have sufficient correspondence with a structured clinical interview, overall, or for certain groups (for example, youth or marijuana users) or for certain criteria (withdrawal symptoms or substance abuse without dependence), then an additional phase of the study will be undertaken. Even if the overall correspondence from Phase 2 is good, for example, additional small validation studies might be conducted for specific groups (e.g., adolescent females, Hispanics) for whom there was not good correspondence as a result of small sample sizes or real differences in interpretation of the questionnaire items. All decisions about final revisions to the module will balance the need for correspondence across different groups.

	Number of respondents	Responses per respondent	Hours per response	Total burden hours
Phase I
Screener only	60	1	.08	5
Screener and Interview	270	1	1.5	405
Phase II
Screener only	100	1	.08	8
Screener and Interview	455	1	1.5	683
Phase III
Screener only	100	1	.08	8
Screener and Interview	455	1	1.5	683
Total	1,440			1,792

Send comments to Nancy Pearce, SAMHSA Reports Clearance Officer, Room 16-105, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice.

Dated: July 9, 2001.

Richard Kopanda,

Executive Officer, SAMHSA.