[Federal Register Volume 65, Number 92 (Thursday, May 11, 2000)]
[Notices]
[Pages 30419-30420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11739]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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


                                                     Year 2
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated                       Estimated
                                                     Estimated       number of    Average burden   total annual
               Type of respondents                   number of     responses per     hours per     burden hours
                                                    respondents     respondent       response        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

[[Page 30420]]

7003, Bethesda, MD 20892-7003, or call (301) 443-0912 or E-mail your 
request, including your address to: [email protected].
    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.
[FR Doc. 00-11739 Filed 5-10-00; 8:45 am]
BILLING CODE 4140-10-M