Monthly Monitoring Study

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Monthly Monitoring Study SS part A 1-11-2023.docx	Supporting Statement A	Uploaded 2023-02-08	Repair queued
Monthly Monitoring Study SS part B 1-11-2023.docx	Supporting Statement B	Uploaded 2023-02-08	Repair queued
Attachment 6. Monthly Monitoring Study ENDS Ads.docx	Supplementary Document	Uploaded 2023-01-13	Repair queued
Attachment 4. Monthly Monitoring Study FAQs.docx	Supplementary Document	Uploaded 2023-01-13	Repair queued
Monthly Monitoring System (MMS) PIA Approval.pdf	Supplementary Document	Uploaded 2023-01-13	Repair queued
IRB Subject Facing Material Modification Approval Notice.pdf	Supplementary Document	Uploaded 2023-01-13	Repair queued
IRB Modification Approval Notice.pdf	Supplementary Document	Uploaded 2023-01-13	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
257909	Young Adult Consent and Online Survey	Other-Monthly Monitoring Study ENDS Screener/Survey	New
257908	Young Adult Screener	Other-Monthly Monitoring Study ENDS Screener/Survey	New
257907	Youth Assent and Online Survey	Other-Monthly Monitoring Study ENDS Screener/Survey	New
257905	Youth Screener	Other-Monthly Monitoring Study ENDS Screener/Survey	New

ICR Details

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:

table that charts list comparision

	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

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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.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
Young Adult Consent and Online Survey
Young Adult Screener
Youth Assent and Online Survey
Youth Screener

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ICR Summary of Burden

table that charts list 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

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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

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Common Form ICR:  No

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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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