Food and Drug Administration's Research and Evaluation Survey for the Public Education Campaign on Tobacco among LGBT (RESPECT)

Forms and Documents

Document Name	Status
Attachment12_SocialMediaRecruitmentAdvertisement.docx Supplementary Document	2016-01-13
Attachment11_EmailsandTextMessagesToRespondents.docx Supplementary Document	2016-01-13
Attachment10_StudyInfoCards.docx Supplementary Document	2016-01-13
Attachment9_IncentiveReceipt.docx Supplementary Document	2016-01-13
Attachment4_Incentive Lit Review.doc Supplementary Document	2016-01-13
0_RESPECT_OMB_SS_Part A Final.docx Supporting Statement A	2016-01-13
0_RESPECT_OMB_SS_PartB Final.docx Supporting Statement B	2016-01-13

IC Document Collections

IC ID	Document Title	Status
218390	Venue Owners – Venue Recruitment Other-Script for Recruiting Intercept Participants	New
218389	Outcome Follow-up Questionnaire in Person Other-Follow Up	New
218388	Outcome Baseline in Person Other-Web Survey Informed Consent	New
218387	Outcome Screener in Person Other-Script for Recruiting Intercept Participants	New
218386	Outcome Follow-up Questionnaire via Social Media Other-Follow Up	New
218385	Outcome Baseline via Social Media Other-Baseline Web Survey	New
218384	Outcome Screener via Social Media Other-Screener Informed Consent	New
218383	Media Tracking Questionnaire Other-Follow up	New
218382	Media Tracking Screener Other-Screener Informed Consent	New
218381	Pilot of in-person Recruitment Other-Screener Informed Consent	New

ICR Details

OMB Control No: 0910-0808	ICR Reference No: 201509-0910-011
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Food and Drug Administration's Research and Evaluation Survey for the Public Education Campaign on Tobacco among LGBT (RESPECT)
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: 01/22/2016
	Date Received in OIRA: 10/28/2015
Terms of Clearance: Information collected in this campaign evaluation will not be generalized to broader or national LGBT populations.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2019	36 Months From Approved
Responses	15,288	0	0
Time Burden (Hours)	3,839	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration (FDA) requests Office of Management and Budget (OMB) approval to conduct in-person and Web-based surveys of lesbian, gay, bisexual, and transgender (LGBT) young adults 18 to 24 years old in the United States, as the Research and Evaluation Survey for the Public Education Campaign on Tobacco among LGBT (RESPECT). These surveys will be fielded for purposes of evaluating FDA’s [LGBT Campaign] public education campaign for LGBT young adults. The primary outcome evaluation will consist of a baseline survey and cross-sectional surveys at six-month intervals following the campaign launch in campaign and control cities. In addition, the cross-sectional surveys will include an embedded longitudinal cohort. Data from this evaluation will be used to gauge campaign awareness and examine the statistical relationships between exposure to the campaign and changes in outcome variables of interest.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 Section 1003(d)(2)(D) Name of Law: Tobacco Control 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:
	80 FR 37270	06/30/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 83799	10/21/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Outcome Follow-up Questionnaire via Social Media
Outcome Screener in Person
Outcome Baseline in Person
Outcome Follow-up Questionnaire in Person
Outcome Screener via Social Media
Media Tracking Questionnaire
Venue Owners – Venue Recruitment
Pilot of in-person Recruitment
Media Tracking Screener
Outcome Baseline via Social Media

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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	15,288	0	0	15,288	0	0
Annual Time Burden (Hours)	3,839	0	0	3,839	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: New collection

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Annual Cost to Federal Government: $8,037,087

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: 10/28/2015

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