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:
0910-0914
ICR Reference No:
202301-0910-009
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CTP
Title:
Monthly Monitoring Study
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:
04/25/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/10/2023
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
04/30/2026
36 Months From Approved
Responses
324,000
0
0
Time Burden (Hours)
31,500
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
This Information Collection Request collects information from youth and young adults, ages 15 to 24 years old, for FDA research designated as the Monthly Monitoring Study (MMS). The purpose of the MMS is to monitor perceptions and use of emerging and novel tobacco products, brands, and devices. Respondents will be asked to provide feedback on tobacco use and quitting behavior, as well as tobacco brand and device preferences, tobacco information sources, peer influence, and perceptions about tobacco via web-based surveys that are self-administered on personal computers or web-enabled mobile devices.
Authorizing Statute(s):
None
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:
87 FR 44405
07/26/2022
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 6261
01/31/2023
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
Young Adult Consent and Online Survey
Young Adult Screener
Youth Assent and Online Survey
Youth Screener
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
324,000
0
0
0
324,000
0
Annual Time Burden (Hours)
31,500
0
0
0
31,500
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:
New collection
Annual Cost to Federal Government:
$420,090
Does this IC contain surveys, censuses, or employ statistical methods?
No
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.
No
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.
Yes
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:
02/10/2023
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