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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0910-0808 Change Request Memo FU5.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2018-07-19	Available
0_RESPECT_OMB_SS_PartA FU5.docx	Supporting Statement A	Uploaded 2018-07-19	Available
0910-0808 Change Request FU4 Memo.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2018-03-01	Available
Attachment 15_ Social Media FAQs.docx	Supplementary Document	Uploaded 2018-02-21	Available
0_RESPECT_OMB_SS_PartB FU5.docx	Supporting Statement B	Uploaded 2018-07-19	Available
0910-0808 Change Request Memo.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2017-07-31	Available
0910-0808 RESPECT Non-substantive Change Request Memo 01-2017.docx	Supplementary Document	Uploaded 2017-01-31	Available
Attachment 2a_Rationale for Item Changes to Followup Instrument FU4.docx	Supplementary Document	Uploaded 2018-02-21	Available
0910-0808 change request justification memo Aug 2016.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2016-08-02	Available
0910-0808 change request justification memo July 2016.doc	Justification for No Material/Nonsubstantive Change	Uploaded 2016-07-05	Available
Attachment 11 EmailToRespondents_FU4.docx	Supplementary Document	Uploaded 2018-02-21	Available
0910-0808 RESPECT Non-substantive Change Request 02-2016.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2016-02-24	Available
0910-0808 RESPECT Non-substantive Change Request 01-2016.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2016-01-26	Available
Attachment12_SocialMediaRecruitmentAdvertisement FU2.docx	Supplementary Document	Uploaded 2017-01-31	Available
Attachment10_StudyInfoCards.docx	Supplementary Document	Uploaded 2016-02-24	Available
Attachment9_IncentiveReceipt.docx	Supplementary Document	Uploaded 2016-01-13	Available
Attachment4_Incentive Lit Review.doc	Supplementary Document	Uploaded 2016-01-13	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
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-Web Survey Informed Consent	Unchanged
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-Web Survey Informed Consent	Unchanged
218384	General population – outcome screener (social media)	Other-Screener Informed Consent	Modified
218383	LGBT young adults media tracking questionnaire	Other-Follow up	Modified
218382	LGBT young adults media tracking screener	Other-Screener Informed Consent	Modified
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: 201807-0910-007
Status: Historical Active	Previous ICR Reference No: 201802-0910-015
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/01/2018
	Date Received in OIRA: 07/26/2018
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2019	01/31/2019	01/31/2019
Responses	21,902	0	17,989
Time Burden (Hours)	5,856	0	4,677
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

table that charts list of burden

IC Title	Form No.	Form Name
Venue Owners and Managers
General Population: Pilot test of Procedures in Bars
LGBT young adults media tracking screener
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 questionnaire

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ICR Summary of Burden

table that charts list 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	21,902	17,989	0	0	3,913	0
Annual Time Burden (Hours)	5,856	4,677	0	0	1,179	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 nonmaterial/non-substantive change request to add a Follow-up 4 to our data collection schedule and refine the data collection documents for Follow-up 4. Follow-Up 4 is scheduled for May through July 2018. During this follow-up data collection effort, we will continue to re-contact participants and recruit new respondents to offset attrition. OMB previously concurred with the submission of this change request. The addition of Follow up 4 increases respondents by 2,701 and burden hours by 838. Also, 3,153 responses and 2,103 hours that were misallocated in ROCIS during the original submission have been reallocated to the correct IC, resulting in a total change due to agency adjustment of 5,854 annualized responses and 2,941 burden hours..

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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

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: 07/26/2018

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