[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
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Average
Type of Number of Number of burden per Total annual
Activity name respondent respondents responses per response (in burden hours
respondent hours)
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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