[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Pages 61829-61830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26100]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request Population 
Assessment of Tobacco and Health (PATH) Study (NIDA)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health (NIH) has 
submitted to the Office of Management and Budget (OMB) a request for 
review and approval of the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on June 30, 2015, pages 37276-37277 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.
    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: NIH Desk Officer.
    Comment 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.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments or request more information on the 
proposed project, contact: Dr. Kevin P. Conway, Deputy Director, 
Division of Epidemiology, Services, and Prevention Research, NIDA, NIH, 
6001 Executive Boulevard, Room 5185, Rockville, MD 20852; or call non-
toll-free number (301) 443-8755 or Email your request, including your 
address to: [email protected]. Formal requests for 
additional plans and instruments must be requested in writing.
    Proposed Collection: Cognitive Interviews and Focus Groups for the 
Population Assessment of Tobacco and Health (PATH) Study (NIDA), 0925-
0663, Expiration Date 11/30/2015, Revision, National Institute on Drug 
Abuse, National Institutes of Health (NIH), in partnership with the 
Food and Drug Administration (FDA).
    Need and Use of Information Collection: This is a revision request 
for the Population Assessment of Tobacco and Health (PATH) Study to 
conduct cognitive interviews and focus groups, to support the 
development of the Study's questionnaires and other materials. The PATH 
Study is a national longitudinal cohort study of tobacco use behavior 
and health among the U.S. household population of adults age 18 and 
older and youth ages 12 to 17; the Study conducts annual interviews and 
collects biospecimens from adults to inform FDA's regulatory actions 
under the Family Smoking Prevention and

[[Page 61830]]

Control Act. Cognitive interviews and focus groups are qualitative 
methods to assess how people interpret, process, retrieve, and respond 
to phrases, questions, response options, and product images that may be 
used in the development of the PATH Study's questionnaires and other 
materials. These methods have previously been used to help the PATH 
Study improve the comprehensibility of its materials for Study 
participants, and to increase efficiencies in data collection and 
reduce duplication and its associated burden on participants and the 
public.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total annualized burden hours 
are 2,617.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                      Type of        Number of       Number of      burden per     Total annual
          Activity name             respondent      respondents    responses per   response  (in   burden hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Completing eligibility screener.           Youth           1,600               1           10/60             267
                                          Adults           2,400               1           10/60             400
Examining concepts to be                   Youth             100               1           90/60             150
 measured in PATH Study.........
                                          Adults             200               1           90/60             300
Examining assent forms for                 Youth             200               1           90/60             300
 participation in PATH Study....
Examining consent forms for               Adults             200               1           90/60             300
 participation in PATH Study....
Examining other forms and                 Adults             200               1           90/60             300
 materials to support PATH Study
 data collection................
Examining PATH Study                       Youth             100               1           90/60             150
 questionnaires.................
                                          Adults             300               1           90/60             450
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    Dated: October 7, 2015.
Genevieve deAlmeida-Morris,
Project Clearance Liaison, NIDA, NIH.
[FR Doc. 2015-26100 Filed 10-13-15; 8:45 am]
BILLING CODE 4140-01-P