The National Cancer Institute (NCI) SmokefreeTXT (Text Message) Program Evaluation

Forms and Documents

Document Name	Status
Form 7 Exit Scripts and Survey for Ineligibles (Attachment 13) Form and Instruction	New
Form 6 24 Week Post Quit Date Questionnaire (Attachment 20) Form and Instruction	New
Form 5 12 Week Post Quit Date Questionnaire (Attachment 19) Form and Instruction	New
Form 4 6 Weeks Post Quit Date Questionnaire (Attachment 15) Form and Instruction	New
Form 3 1 Week Post Quit Date Questionnaire (Attachment 14) Form and Instruction	New
Form 2 Baseline Questionnaire (Attachment 10) Form and Instruction	New
Form 1 Screener Questionnaire (Attachment 9) Form and Instruction	New
SSB SFTXT_3-21-2013.doc Supporting Statement B	2013-03-28
Attach18_PrivacyActMemo.pdf Supplementary Document	2013-03-28
Attach17_PIA.pdf Supplementary Document	2013-03-28
Attach16_SFTXT_Verification_12-06_2012.docx Supplementary Document	2013-03-28
Attach12_SFTXT_HonestPledge.docx Supplementary Document	2013-03-28
Attach11_SFTXT_RecruitPlan.pdf Supplementary Document	2013-03-28
Attach8_SFTXT_IRB Approval.docx Supplementary Document	2013-03-28
Attach7_SFTXT_REVISED_Consent Form_v2 5222013.docx Supplementary Document	2013-05-23
Attach6_SFTXT_Collaborators_11192012.docx Supplementary Document	2013-03-28
Attach5_SFTXT_Data Collection_12062012.docx Supplementary Document	2013-03-28
Attach4_SFTXT_Lit Review_11192012.docx Supplementary Document	2013-03-28
Attach3_SFTXT_Antifraud_11192012.docx Supplementary Document	2013-03-28
Attach2_SFTXT_Framework_11192012.docx Supplementary Document	2013-03-28
Attach1_SFTXT Planning Matrix_12062012.docx Supplementary Document	2013-03-28
Cover Memo_SFTXT_03122013.doc Supplementary Document	2013-03-28
SSA_SFTXT_REVISED_5222013.doc Supporting Statement A	2013-05-23

IC Document Collections

IC ID	Document Title	Status
206360	Exit Scripts and Survey for Ineligibles (Attachment 13) Form and Instruction	New
206359	24 Week Post Quit Date Questionnaire (Attachment 20) Form and Instruction	New
206358	12 Week Post Quit Date Questionnaire (Attachment 19) Form and Instruction	New
206357	6 Weeks Post Quit Date Questionnaire (Attachment 15) Form and Instruction	New
206356	1 Week Post Quit Date Questionnaire (Attachment 14) Form and Instruction	New
206355	Baseline Questionnaire (Attachment 10) Form and Instruction	New
206354	Screener Questionnaire (Attachment 9) Form and Instruction	New

ICR Details

OMB Control No: 0925-0676	ICR Reference No: 201304-0925-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No: 19204
Title: The National Cancer Institute (NCI) SmokefreeTXT (Text Message) Program Evaluation
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/30/2013
	Date Received in OIRA: 04/04/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2015	24 Months From Approved
Responses	26,258	0	0
Time Burden (Hours)	4,250	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This is a request for OMB to approve the new submission titled, "The National Cancer Institute (NCI) SmokefreeTXT Program Evaluation" for two years. The Office of the Assistant Secretary for Health (OASH) at the Department of Health and Human Services (DHHS) has requested the National Cancer Institute (NCI) Tobacco Control Research Branch (TCRB) develop and manage the SmokefreeTXT evaluation program, as part of a larger series of eHealth/mHealth tobacco cessation intervention programs. This evaluation has implications for international work that HHS deems crucial in designing and implementing similar programs in a variety of other countries. In addition, HHS is interested in increasing the visibility of the SmokefreeTXT domestic program as part of the resources it promotes via large scale promotional campaigns. This study seeks to assess the efficacy of a text message smoking cessation intervention designed for young adult smokers ages 18 to 29. Study plans include examining 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. Self-reported cessation data will be collected using the text-messaging service and web-based surveys. Respondents will complete 5 web-based surveys for: pre-treatment/baseline, 1 week post quit, 6 weeks post quit, 12 week and 24 week post-treatment questionnaires.

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Authorizing Statute(s): US Code: 42 USC 412(285a-1) Name of Law: Public Health Service Act
   US Code: 42 USC 410 (285) Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 2678	01/14/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 19496	04/01/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Screener Questionnaire (Attachment 9)	1	Screener
Baseline Questionnaire (Attachment 10)	2	Baseline
1 Week Post Quit Date Questionnaire (Attachment 14)	3	1 Week Post Quit Date Questionnaire
6 Weeks Post Quit Date Questionnaire (Attachment 15)	4	6 Weeks Post Quit Date Questionnaire
12 Week Post Quit Date Questionnaire (Attachment 19)	5	12 Week Post Quit Date Questionnaire
24 Week Post Quit Date Questionnaire (Attachment 20)	6	24 Week Post Quit Date Questionnaire
Exit Scripts and Survey for Ineligibles (Attachment 13)	7	Exit Scripts and Survey for Ineligibles

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	26,258	0	0	26,258	0	0
Annual Time Burden (Hours)	4,250	0	0	4,250	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $905,289

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 04/04/2013

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