View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0808
ICR Reference No:
201810-0910-015
Status:
Historical 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
Retrieve Notice of Action (NOA)
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
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
Number of Information Collection (IC) in this ICR:
8
IC Title
Form No.
Form Name
General Population: Pilot test of Procedures in Bars
General population – outcome screener (in person)
General population – outcome screener (social media)
LGBT young adults Outcome follow-up questionnaire (in person)
LGBT young adults Outcome follow-up questionnaire (social media)
LGBT young adults media tracking questionnaire
LGBT young adults media tracking screener
LGBT young adults outcome baseline (in person)
LGBT young adults outcome baseline (social media)
Venue Owners and Managers
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.
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
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov
Common Form ICR:
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:
(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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