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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:
0910-0810
ICR Reference No:
202412-0910-014
Status:
Active
Previous ICR Reference No:
202308-0910-006
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CTP
Title:
Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
04/18/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/27/2024
Terms of Clearance:
Previous terms continue: Approved consistent with the understanding that FDA will submit individual collections under this generic clearance to OMB. These submissions will include the actual study instruments along with a memo describing the specific study goal, the study design, any incentives to be used, and the sampling and analysis plans. Each IC request should include a justification for the chosen incentive (unless it is equivalent to or less than the pre-approved "standard" for focus groups ($75) and cognitive interviews ($40)). Further, FDA will send OMB an annual report summarizing the number of hours used, as well as the nature and results of the activities completed under this clearance.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
04/30/2028
36 Months From Approved
04/30/2025
Responses
1,768,000
0
661,308
Time Burden (Hours)
188,534
0
91,865
Cost Burden (Dollars)
0
0
0
Abstract:
The Food and Drug Administration (FDA) is requesting extension of approval of a generic for collecting information through the use of quantitative methods for studies about tobacco products. FDA will need to employ quantitative research, including surveys and experimental studies to assess 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):
PL:
Pub.L. 111 - 111 31
Name of Law: Family Smoking Prevention and Tobacco Control Act
US Code:
21 USC 372
Name of Law: Federal Food, Drug, and Cosmetic Act
US Code:
21 USC 393(d)(2)(D)
Name of Law: Federal Food, Drug, and Cosmetic Act
US Code:
42 USC 241(a)
Name of Law: Public Health Service Act
US Code:
21 USC 355
Name of Law: Federal Food, Drug, and Cosmetic 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:
89 FR 52055
06/21/2024
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 92943
11/25/2024
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
0
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
1,768,000
661,308
0
0
1,106,692
0
Annual Time Burden (Hours)
188,534
91,865
0
0
96,669
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:
Our estimated burden for the information collection reflects an overall increase of 96,269 hours and a corresponding increase of 1,106,692 responses. We attribute this adjustment to the number of study responses used during the current approval and now estimated for the next 3 years. A greater number of quantitative studies will be conducted over the next 3 years due to the need to develop new creative messages and content. Recent years have seen a dramatic change in media. With the shift to digital media, FDA must adapt to communicate effectively in a digital environment. As digital tobacco use prevention/interventions are still in their infancy, we must better understand the types of digital channels available. To impact public health outcomes, we need to understand how to reach our intended audience. New foundational studies are needed (including those on digital metrics, measurement, and implementation) to support activities and initiatives that will enable the public to receive evidence-based, timely, and clear health communication and education. As a result, we have adjusted our burden estimate and revised the number of respondents to the information collection.
Annual Cost to Federal Government:
$1,029,503
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?
No
Agency Contact:
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@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:
12/27/2024
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