[Federal Register Volume 77, Number 174 (Friday, September 7, 2012)]
[Notices]
[Pages 55217-55218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22107]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request: Cognitive Testing of
Instrumentation and Materials for the Population Assessment of Tobacco
and Health (PATH) Study
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the
National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request to review and approve the
information collection listed below. This proposed information
collection was previously published in the Federal Register on May 23,
2012, page 30540 and allowed 60-days for public comment. No public
comments were received. The purpose of this notice is to allow an
additional 30 days for public comment. The National Institutes of
Health may not conduct or sponsor, and the respondent is not required
to respond to, an information collection that has been extended,
revised, or implemented on or after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection: Title: Cognitive Testing of Instrumentation
and Materials for Population Assessment of Tobacco and Health (PATH)
Study. Type of Information Collection Request: New. 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, supporting
materials, 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: Individuals and Households. Type of Respondents:
Youth (ages 12-17) and Adults (ages 18+). The annual reporting burden
for the screening of respondents for the PATH study cognitive testing
is presented in Table 1, and the annual reporting burden for the PATH
study cognitive testing is presented in Table 2. The annualized cost to
respondents for participating in screening for PATH study cognitive
testing is estimated at: $6,632; and the annualized cost to respondents
for participating in PATH study cognitive testing is estimated at:
$20,346. There are no capital, operating or maintenance costs.
Table 1--Estimated Annual Reporting Burden for Screening of PATH Study Cognitive Testing Respondents
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Type of Number of Responses per Hours per Annual hour
Screening for respondents respondent respondents respondent response burden
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Screener...................... Youth........... 1000 1 \10/60\ 167
[[Page 55218]]
Adult........... 2000 1 \10/60\ 333
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Total..................... ................ 3000 .............. .............. 500
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Table 2--Estimated Annual Reporting Burden Summary--Cognitive Testing of Instrumentation and Forms for the PATH
Study
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Type of Number of Responses per Hours per Annual hour
Instrument/form to be tested respondent respondents respondent response burden
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Forms to support data Adult........... 200 1 1 \30/60\ 300
collection*.
Assent forms for participation Youth........... 200 1 1 \30/60\ 300
in PATH study.
Consent forms for Adult........... 200 1 1 \30/60\ 300
participation in PATH study.
PATH study questionnaires..... Youth........... 100 1 1 \30/60\ 150
Adult........... 300 1 1 \30/60\ 450
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Total..................... ................ 1000 .............. .............. 1500
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* For example, letters, mailing envelopes, PATH study brochures, instructions for collection of biospecimens.
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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, [email protected] or by fax to 202-395-6974,
Attention: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, 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; 301-443-8755; email
[email protected].
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
Dated: August 30, 2012.
Glenda P. Conroy,
Executive Officer (OM Director), NIDA.
[FR Doc. 2012-22107 Filed 9-6-12; 8:45 am]
BILLING CODE 4140-01-P