View Information Collection Request (ICR) Package
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View Information Collection (IC) List
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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 Generic ICR - OIRA Conclusion
OMB Control No:
0910-0796
ICR Reference No:
201411-0910-007
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CTP
Title:
Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
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:
06/26/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/10/2014
Terms of Clearance:
FDA will submit a mini-supporting statement for each individual Gen IC submission. The mini-supporting statement must describe the specific purpose of the collection, including the way that the resulting data will be used (i.e., identify the activity that the developmental work will inform, and broader purpose of the activity that is being informed by the developmental work being conducted in the particular Gen IC). When incentives are used, FDA will provide a justification.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2018
36 Months From Approved
Responses
24,050
0
0
Time Burden (Hours)
29,059
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
The Food and Drug Administration (FDA) is requesting approval of a new generic for collecting information through the use of qualitative methods for studies about tobacco products. FDA will employ qualitative research, including individual in-depth interviews (IDIs), small group discussions, and focus groups to explore knowledge and perceptions about tobacco-related topics with specific target audiences. FDA will only submit an individual generic collection for approval under this generic clearance if the individual collection meets the outlined conditions.
Authorizing Statute(s):
US Code:
21 USC 355
Name of Law: Family Smoking Prevention And Tobacco Control Act
US Code:
21 USC 393
Name of Law: FFDCA
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:
79 FR 44779
08/01/2014
30-day Notice:
Federal Register Citation:
Citation Date:
79 FR 72685
12/08/2014
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
13
IC Title
Form No.
Form Name
2017 FDA Tobacco Retail Compliance Check Inspection Program Coordinators' Training
American Indian/Alaska Native Campaign: Focus Group Study of Reactions to Strategic Concepts Designed to Prevent Youth Tobacco Use
Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products
Focus Group Study of Youth Reactions to Creative Advertising Concepts Designed to Prevent Youth Tobacco Use among Multicultural Youth
Focus Groups on ENDS: Device Types, User Experiences, and Product Appeal
Multicultural Campaign: Wave 3 focus group study of reactions to creative advertising concepts designed to prevent multicultural youth tobacco use
Point-of-Sale Creative Concept Testing – Focus Groups with Current Adult Smokers
Qualitative Study of Perceptions and Knowledge of Visually Depicted Health Conditions
Qualitative Study on Acute Nicotine Toxicity Warnings for E-Liquids: Knowledge, Beliefs, and Perceptions
Qualitative Study on Consumer perceptions of Cigarettes Health Warning Images
The Real Cost General Market: Wave 4 Creative Concept Testing Designed to Prevent Youth ENDS Use
The Real Cost Smokeless: Wave 2 Focus Group Study of Reactions to Creative Advertising Concepts Designed to Prevent Rural Youth Tobacco Use
The Real Cost Smokeless: Wave 2 In-depth Interviews Designed to Prevent Rural Youth Tobacco Use
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
24,050
0
0
24,050
0
0
Annual Time Burden (Hours)
29,059
0
0
29,059
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
Annual Cost to Federal Government:
$1,025,238
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
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:
12/10/2014
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