[Federal Register Volume 77, Number 100 (Wednesday, May 23, 2012)]
[Notices]
[Page 30540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12489]


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

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                            ------------------------------------------------------------------------------------------------------------
Total......................................  ...................................               466  ................  ................               882
--------------------------------------------------------------------------------------------------------------------------------------------------------
* 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: [email protected].
    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]
BILLING CODE 4140-01-P