[Federal Register Volume 77, Number 100 (Wednesday, May 23, 2012)]
[Notices]
[Page 30540]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12489]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Cognitive Testing of
Instrumentation and Materials for the Population Assessment of Tobacco
and Health (PATH) Study
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 Drug
Abuse (NIDA), 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: Cognitive Testing of Instrumentation
and Materials for Population Assessment of Tobacco and Health (PATH)
Study. Type of Information Collection Request: Generic Clearance. Need
and Use of Information Collection: The PATH study will establish a
population-based framework for monitoring and evaluating the behavioral
and health impacts of regulatory provisions implemented as part of the
Family Smoking Prevention and Tobacco Control Act (FSPTCA) by the Food
and Drug Administration (FDA). NIDA is requesting generic approval from
OMB for cognitive testing of the PATH study's instrumentation,
materials to support data collection (e.g., advance mailings, reminder
letters, etc.), consent forms, and methods of administration (e.g.,
computer assisted personal interviews [CAPI], audio computer assisted
self-interviews [ACASI], web-based interviews). Cognitive testing of
these materials and methods will help to ensure that their design and
content are valid and meet the PATH study's objectives. Additionally,
results from cognitive testing will inform the feasibility (scientific
robustness), acceptability (burden to participants and study logistics)
and cost of the information collection to help minimize its estimated
cost and public burden.
Frequency of Response: Annual [As needed on an on-going and
concurrent basis]. Affected Public: Members of the public. Type of
Respondents: Youth (ages 12-17) and Adults (ages 18+). Annual Reporting
Burden: See Table 1. The annualized cost to respondents is estimated
at: $11,861. There are no Capital Costs to report. There are no
Operating or Maintenance Costs to report.
Table 1--Estimated Annual Reporting Burden Summary--Cognitive Testing of Instrumentation and Materials for the PATH Study
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Estimated Estimated number Average burden Estimated total
Instruments/Documents to be tested Type of respondent number of of responses per hours per annual burden
respondents respondent response* hours requested
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Materials to Support Data Collection....... Adult.............................. 100 1 1\30/60\ 150
Assent Forms............................... Youth.............................. 98 1 2 196
Consent Forms.............................. Adult.............................. 98 1 2 196
PATH Study Questionnaires.................. Youth.............................. 40 1 2 80
Adult.............................. 130 1 2 260
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Total...................................... ................................... 466 ................ ................ 882
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* Calculations include one hour of travel time per respondent.
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 CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans
contact Kevin P. Conway, Ph.D., Deputy Director, Division of
Epidemiology, Services, and Prevention Research, National Institute on
Drug Abuse, 6001 Executive Blvd., Room 5185, Rockville, MD 20852, or
call non-toll free number 301-443-8755 or Email your request, including
your address to: PATHprojectofficer@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60-days
of the date of this publication.
Dated: May 17, 2012.
David Shurtleff,
Acting Deputy Director, NIDA.
[FR Doc. 2012-12489 Filed 5-22-12; 8:45 am]
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