00-11739. Proposed Collection; Comment Request; Miniaturized Wearable Transdermal Alcohol Monitor

SUMMARY:

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 National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Proposed Collection:

Title: Miniaturized Wearable Transdermal Alcohol Monitor. Type of Information Collection Request: New. Need and Use of Information Collection: This Small Business Innovation Research two-year study is designed to complete the development and clinical testing of a miniaturized wearable Transdermal Alcohol Sensor/Recorder (TAS) that is ready for evaluation in various medical and forensic markets. The overall goal of the project is to refine the specifications of Giner, Inc.'s prototype TAS for miniaturization and to improve wearability for extended periods of time on the wrist or upper arm, maintaining all of the functionality of the current device. Testing on adult volunteers while they are consuming alcohol will determine wearability, performance, reliability, and reproducibility of the TAS in both clinical and normal living/working conditions. The subjects in two small clinical studies will be asked to keep a daily log of activities, including eating and drinking, while they are wearing the TAS for up 14 days. At the conclusion of the experiment, they will be interviewed about their drinking during the test period using the Time Line Followback (TLFB), a standard clinical interview instrument. A relative of each subject (collateral) will also be interviewed to corroborate the subjects' drinking record. A small sample of alcoholics will wear the TAS for 24 hours, while undergoing detoxification treatment under a physician's care, to evaluate the TAS response to high blood alcohol levels. They will be interviewed about their drinking in the past week using the TLFB. The findings of the studies will be used by the contractor to validate the performance of the re-designed TAS in different settings where monitoring of alcohol ingestion is desirable. Frequency of Response: Once, twice, or daily for 14 days. Affected Public: Individuals. Type of Respondents: Alcoholics, social drinkers, collaterals (ages 21-65). The annual reporting burden is as follows:

Year 1

Type of respondents	Estimated number of respondents	Estimated number of responses per respondent	Average burden hours per response	Estimated total annual burden hours requested
Alcoholics	6	1	0.1667	1
Social Drinkers	12	16	0.1667	32
Collaterals	12	2	0.1667	4
Total				37

Year 2

Type of respondents	Estimated number of respondents	Estimated number of responses per respondent	Average burden hours per response	Estimated total annual burden hours requested
Social Drinkers	42	15	0.1667	105
Collaterals	42	1	0.1667	7
Total				112

There are no costs to Respondents to report. Social drinker respondents who consume alcohol in controlled settings, wear the TAS, and keep daily log are paid $100-$150 for their participation. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

For Further Information: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Laurie Foudin, Program Administrator, Biomedical Research Branch, Division of Basic Research, NIAAA, 6000 Executive Blvd., MSC 7003, Bethesda, MD 20892-7003, or call [phone] or E-mail your request, including your address to: [e-mail].

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received on or before July 10, 2000.

Dated: May 2, 2000.

Stephen Long,

Executive Officer, NIAAA.