[Federal Register Volume 78, Number 36 (Friday, February 22, 2013)]
[Pages 12335-12336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04128]



National Institutes of Health

Submission for OMB review; Comment Request: Methodological 
Studies for the Population Assessment of Tobacco and Health (PATH) 

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 November 
26, 2012, Vol. 77, No. 227, p. 70451 and allowed 60-days for public 
comment. Two comments were received in support of this request. 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 
    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 assessing 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 methodological studies to improve the PATH study instrumentation 
and data collection procedures. These methodological studies will 
support ongoing assessment and refinement of the PATH study's design, 
and highlight ways to improve study implementation, data collection 
procedures, and techniques for retention and followup. Data collection 
methods to be used in these methodological studies include: in-person 
and telephone surveys; web and smartphone/mobile phone surveys; and 
focus group and individual in-depth qualitative interviews. 
Biospecimens may also be collected from adults.
    Frequency of Response: Annual [As needed on an on-going and 
concurrent basis]. Affected Public: Individuals. 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: $371,284. 
There are no capital, operating or maintenance costs.

          Table 1--Estimated Annual Reporting Burden Summary--Methodological Studies for the PATH Study
                                     Type of         Number of     Responses per     Hours per      Annual hour
   Data collection activity        respondent       respondents     respondent       response         burden
In-person and telephone         Adults..........           5,000               1         \90/60\           7,500
                                Youth...........           3,500               1         \90/60\           5,250
Web and smartphone/mobile       Adults..........           5,000               1         \90/60\           7,500
 phone surveys.
                                Youth...........           3,500               1         \90/60\           5,250
Focus groups and individual in- Adults..........           1,000               1               2           2,000
 depth qualitative interviews.
                                Youth...........           1,000               1               2           2,000
Biospecimen collection........  Adults..........           1,000               1         \15/60\             250

[[Page 12336]]

    Total.....................  ................          20,000  ..............  ..............          29,750

    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; 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 30-days 
of the date of this publication.

    Dated: February 19, 2013.
Glenda J. Conroy,
Executive Officer (OM Director), National Institute on Drug Abuse 
[FR Doc. 2013-04128 Filed 2-21-13; 8:45 am]