Information Collection Request

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

ICR 201802-0910-015 · OMB 0910-0808 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
0_RESPECT_OMB_SS_PartA_Revised_FU4.docx Supporting Statement A Uploaded 2018-03-01 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 Repair queued
0_RESPECT_OMB_SS_PartB_Revised_FU4.docx Supporting Statement B Uploaded 2018-02-21 Repair queued
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 Repair queued
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 Repair queued
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 Repair queued
Attachment12_SocialMediaRecruitmentAdvertisement FU2.docx Supplementary Document Uploaded 2017-01-31 Repair queued
Attachment10_StudyInfoCards.docx Supplementary Document Uploaded 2016-02-24 Repair queued
Attachment9_IncentiveReceipt.docx Supplementary Document Uploaded 2016-01-13 Repair queued
Attachment4_Incentive Lit Review.doc Supplementary Document Uploaded 2016-01-13 Available
IC Document Collections
IC IDCollectionTypeStatusForm
218390 Venue Owners and Managers Other-Talking Points for Recruiting Venues Modified
218389 LGBT young adults Outcome follow-up questionnaire (in person) Other-Longitudinal Screener Inf Con Modified
218388 LGBT young adults outcome baseline (in person) Other-Web 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-CrossSectional Survey Informed Consent Modified
218385 LGBT young adults outcome baseline (social media) Other-Web Survey 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 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
0910-0808 201802-0910-015
Historical Active 201707-0910-017
HHS/FDA CTP
Food and Drug Administration's Research and Evaluation Survey for the Public Education Campaign on Tobacco among LGBT (RESPECT)
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 03/13/2018
Retrieve Notice of Action (NOA) 03/01/2018
  Inventory as of this Action Requested Previously Approved
01/31/2019 01/31/2019 01/31/2019
17,989 0 15,288
4,677 0 3,839
0 0 0

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.

PL: Pub.L. 111 - 31 Section 1003(d)(2)(D) Name of Law: Tobacco Control Act
  
None

Not associated with rulemaking

  80 FR 37270 06/30/2015
80 FR 83799 10/21/2015
Yes

  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 17,989 15,288 0 -3,153 5,854 0
Annual Time Burden (Hours) 4,677 3,839 0 -2,103 2,941 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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..

$8,037,087
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
03/01/2018