[Federal Register Volume 77, Number 174 (Friday, September 7, 2012)]
[Notices]
[Pages 55217-55218]
From the Federal Register Online via the Government Printing 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
----------------------------------------------------------------------------------------------------------------
Screener......................  Youth...........            1000               1         \10/60\             167

[[Page 55218]]

 
                                Adult...........            2000               1         \10/60\             333
                                                 ---------------------------------------------------------------
    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
----------------------------------------------------------------------------------------------------------------
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
                                                 ---------------------------------------------------------------
    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, OIRA_submission@omb.eop.gov 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 
PATHprojectofficer@mail.nih.gov.
    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