[Federal Register Volume 78, Number 62 (Monday, April 1, 2013)]
[Notices]
[Pages 19496-19497]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07551]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-day Comment Request; The National 
Cancer Institute (NCI) SmokefreeTXT Program Evaluation

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

[[Page 19497]]

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 January 14, 2013 (Volume 78, Page 2678) and allowed 60-days for 
public comment. Shortly after the publication, two public comments were 
received requesting a copy of the data collection plans and instruments 
and one public comment was received in regards to the funding of the 
study. The comments were responded to with the requested information. 
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, OIRA_submission@omb.eop.gov 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, contact Erik Augustson, Ph.D., MPH, 
Behavioral Scientist/Health Science Administrator, Division of Cancer 
Control and Population Sciences, 6130 Executive Blvd., EPN-4034, 
Bethesda, MD 20892-7337 or call non-toll-free number 301-435-7610 or 
Email your request, including your address to: augustse@mail.nih.gov. 
Formal requests for additional plans and instruments must be requested 
in writing.
    Proposed Collection: The National Cancer Institute (NCI) 
SmokefreeTXT Program Evaluation, 0925-NEW, NEW, National Cancer 
Institute (NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: This study seeks to assess 
the efficacy of the SmokefreeTXT program, a text message smoking 
cessation intervention designed for young adult smokers ages 18 to 29. 
The SmokefreeTXT program is a component of a larger series of eHealth/
mHealth tobacco cessation intervention programs. SmokefreeTXT has been 
developed (and is managed) by the National Cancer Institute (NCI) 
Tobacco Control Research Branch (TCRB) at the request of the Office of 
the Assistant Secretary for Health (OASH) at the Department of Health 
and Human Services (DHHS). The study seeks to recruit a large sample of 
adult smokers to examine how exposure to the SmokefreeTXT intervention 
affects participants' success at quitting smoking. There will be 3-arms 
to the study; participants will be enrolled for a maximum of 8 weeks of 
treatment in the SmokefreeTXT program, with frequency and duration of 
the treatment varying by study arm. The SmokefreeTXT Study will collect 
self-reported cessation data using the bidirectional aspect of text-
messaging service and a series of web-based surveys. All web-based 
survey data will be collected and stored by a third-party, Research 
Triangle Institute International (RTI). Respondents will complete a 
screener, 5 web-based surveys, and an exit survey for a total of 8,353 
annual burden hours. The five surveys include: (1) Pre-treatment 
baseline survey; (2) one week post quit date questionnaire; (3) end of 
active cessation treatment questionnaire; (4) 12-week post-treatment 
questionnaire; (5) 24-weeks post-treatment questionnaire.
    OMB approval is requested for 2 years. There are no costs to 
respondents other than their time. The estimated annualized burden 
hours are 4,250.

                                        Estimated Annualized Burden Hours
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                                                                     Number of     Average time
      Type of respondents            Survey          Number of     responses per   per response    Total burden
                                   instrument       respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Adults Aged 18 to 29..........  Screener/                 10,620               1            5/60             885
                                 recruitment.
                                Baseline........           2,124               1           30/60           1,062
                                1 week post-quit           1,700               1           15/60             425
                                 date.
                                6 weeks post               1,360               1           30/60             680
                                 quit date.
                                12 weeks post-             1,088               1           15/60             272
                                 treatment.
                                24 weeks post                870               1           15/60             218
                                 treatment.
                                Ineligible                 8,496               1            5/60             708
                                 Script.
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    Dated: March 19, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, NCI, NIH.
[FR Doc. 2013-07551 Filed 3-29-13; 8:45 am]
BILLING CODE 4140-01-P