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

Forms and Documents

Document Name	Status
0796 Generic Clearance_SS B_qualitative Clean.docx Supporting Statement B	2018-07-31
0796_Supporting Statement_Part A_2018 Clean.docx Supporting Statement A	2018-07-31
0796 Summaries of Generic Submissions 2018.docx Supplementary Document	2018-05-16

IC Document Collections

IC ID	Document Title	Status
238368	Creative Concept Testing Designed to Prevent Youth ENDS, Cigarette ad Other Tobacco Product Other-Parental Permission Form	New
237278	Nicotine Education Project: Qualitative Study to Gain Insights from Adult Current and Former Smokers to Educate the General Public about Changing Nicotine Standards Other-Screener	New
236942	Developing Brand & Creative Concepts Designed to Prevent AI/AN Youth Tobacco Use Other-Information Packet Materials	New
236392	Creative Concept Testing Designed to Prevent Youth ENDS Use in General and Hip Hop Audiences Other-Screener Contact Sheet	New
232660	5-day turnaround Gen IC: Rapid Message Testing with Consumer Panel-Nicotine Dialogue Campaign Branding Other-interview screener	New

ICR Details

OMB Control No: 0910-0796	ICR Reference No: 201805-0910-001
Status: Historical Active	Previous ICR Reference No: 201411-0910-007
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 with change	Conclusion Date: 07/31/2018
	Date Received in OIRA: 05/17/2018
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	07/31/2021	36 Months From Approved	07/31/2018
Responses	11,589	0	24,050
Time Burden (Hours)	9,293	0	29,059
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:
	82 FR 54351	11/17/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 22690	05/16/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Creative Concept Testing Designed to Prevent Youth ENDS, Cigarette ad Other Tobacco Product
Nicotine Education Project: Qualitative Study to Gain Insights from Adult Current and Former Smokers to Educate the General Public about Changing Nicotine Standards
Creative Concept Testing Designed to Prevent Youth ENDS Use in General and Hip Hop Audiences
Developing Brand & Creative Concepts Designed to Prevent AI/AN Youth Tobacco Use
5-day turnaround Gen IC: Rapid Message Testing with Consumer Panel-Nicotine Dialogue Campaign Branding

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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	11,589	24,050	0	0	-12,461	0
Annual Time Burden (Hours)	9,293	29,059	0	0	-19,766	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: FDA has updated the existing burden from 6,184 to an estimated 9,293 hours. This is based on our experience the last three years and forecasting the generics to be submitted during the next approval. Additionally, we have also updated the cost burden estimate and the cost to the Federal government based on current salary figures. FDA is also noting that the burden figures in ROCIS (24,050 responses and 29,059 hours) are incorrect. An error was made after approval and the updated burden was not entered into ROCIS. The burden should have been updated to 14,800 responses and 6,184 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? Uncollected

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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: 05/17/2018

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