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
0808_Supporting Statement_2018.docx Supporting Statement A	2018-12-11
0_RESPECT_OMB_SS_PartB FU6.docx Supporting Statement B	2018-11-14
Attachment 15_ Social Media FAQs.docx Supplementary Document	2018-02-21
Attachment 11 EmailToRespondents_FU6.docx Supplementary Document	2018-11-14
Attachment 12 SocialMediaRecruitmentAdvertisement_FU6.docx Supplementary Document	2018-11-14
Attachment 10 StudyInfoCards_FU6.docx Supplementary Document	2018-11-14
Attachment 09 IncentiveReceipt_FU6.docx Supplementary Document	2018-11-14
Attachment 04 Incentive Lit Review_FU6.docx Supplementary Document	2018-11-14

IC Document Collections

IC ID	Document Title	Status
218390	Venue Owners and Managers Other-Talking Points for Recruiting Venues	Modified
218389	LGBT young adults Outcome follow-up questionnaire (in person) Other-Follow Up	Modified
218388	LGBT young adults outcome baseline (in person) Other-New Participant Survey Informed Consent	Modified
218387	General population – outcome screener (in person) Other-Script for Recruiting Intercept Participants	Modified
218386	LGBT young adults Outcome follow-up questionnaire (social media) Other-Follow Up	Modified
218385	LGBT young adults outcome baseline (social media) Other-New Participant Informed Consent	Modified
218384	General population – outcome screener (social media) Other-Screener Informed Consent	Modified
218383	LGBT young adults media tracking questionnaire Other-Follow up	Removed
218382	LGBT young adults media tracking screener Other-Screener Informed Consent	Removed
218381	General Population: Pilot test of Procedures in Bars Other-Script for Recruiting Participants	Modified

ICR Details

OMB Control No: 0910-0808	ICR Reference No: 201810-0910-015
Status: Active	Previous ICR Reference No: 201807-0910-007
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/22/2019
	Date Received in OIRA: 12/12/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2022	36 Months From Approved	03/31/2019
Responses	23,646	0	21,902
Time Burden (Hours)	6,566	0	5,856
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:
	83 FR 37817	08/02/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 63176	12/07/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Venue Owners and Managers
General Population: Pilot test of Procedures in Bars
LGBT young adults outcome baseline (social media)
LGBT young adults Outcome follow-up questionnaire (social media)
General population – outcome screener (in person)
LGBT young adults outcome baseline (in person)
LGBT young adults Outcome follow-up questionnaire (in person)
General population – outcome screener (social media)
LGBT young adults media tracking screener
LGBT young adults media tracking questionnaire

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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	23,646	21,902	0	0	1,744	0
Annual Time Burden (Hours)	6,566	5,856	0	0	710	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: The Food and Drug Administration is submitting this extension request to add a Follow-up 6 to our data collection schedule and refine the data collection documents for Follow-up 6. Follow-Up 6 is scheduled for May 2019 through August 2019. During this follow-up data collection effort, we will continue to re-contact participants and recruit new respondents to offset attrition. The media tracking ICs were removed because they were not needed for the information collection. This led to a decrease in 2,169 responses and 471 hours. The addition of Follow-up 6 increases respondents by 3,913 and burden hours by 1,180.

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Annual Cost to Federal Government: $8,039,606

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 12/12/2018

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