Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0796 Summaries of Generic Submissions 2021.docx	Supplementary Document	Uploaded 2021-06-14	Repair queued
0796 Supporting Statement Part B - Generic Clearance of Qualitative Data on Tobacco Products 2021.docx	Supporting Statement B	Uploaded 2021-06-14	Repair queued
0796 Supporting Statement Part A - Generic Clearance of Qualitative Data on Tobacco Products 2021.docx	Supporting Statement A	Uploaded 2021-06-14	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
254369	Menthol User Audience Research	Other-Appendix A - Study Invitation	New

ICR Details

OMB Control No: 0910-0796	ICR Reference No: 202105-0910-001
Status: Historical Active	Previous ICR Reference No: 202007-0910-005
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/29/2021
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/16/2021
Terms of Clearance: Previous terms continue: 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. Feedback collected under this generic clearance will not yield data that can be generalized to the overall population. Findings will be used to only to inform experimental research, public education, or communication activities.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2024	36 Months From Approved	07/31/2021
Responses	28,174	0	11,589
Time Burden (Hours)	14,934	0	9,293
Cost Burden (Dollars)	0	0	0

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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.

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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

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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:
	85 FR 60999	09/29/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 31328	06/11/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Menthol User Audience Research

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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	28,174	11,589	0	16,585	0	0
Annual Time Burden (Hours)	14,934	9,293	0	5,641	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: Our estimated burden for the information collection reflects an overall increase of 5,641 hours and a corresponding increase of 16,585 responses The burden is now estimated to be 14,934 hours.

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Annual Cost to Federal Government: $1,026,460

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

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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: 06/16/2021

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