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

Forms and Documents

Document Name	Status
Gen IC Memo Qualitative data on Tobacco Products and Comminucations Gen IC Memo.doc Supplementary Document	2015-05-27
Generic Clearance_SS B_qualitative 11.14.14.doc Supporting Statement B	2014-11-17
Generic Clearance_SS_ A_qualitative 6 18 OMB.docx Supporting Statement A	2015-06-18

IC Document Collections

IC ID	Document Title	Status
229710	Qualitative Study on Acute Nicotine Toxicity Warnings for E-Liquids: Knowledge, Beliefs, and Perceptions Other-Moderator Guide	New
229494	Qualitative Study on Consumer perceptions of Cigarettes Health Warning Images Other-Contact sheet Adolescent	New
229407	The Real Cost Smokeless: Wave 2 In-depth Interviews Designed to Prevent Rural Youth Tobacco Use Other-Screener	New
229406	The Real Cost Smokeless: Wave 2 Focus Group Study of Reactions to Creative Advertising Concepts Designed to Prevent Rural Youth Tobacco Use Other-Screener	New
229054	The Real Cost General Market: Wave 4 Creative Concept Testing Designed to Prevent Youth ENDS Use Other-Parental Permission Form	New
224800	Multicultural Campaign: Wave 3 focus group study of reactions to creative advertising concepts designed to prevent multicultural youth tobacco use Other-Check-In Survey	New
224759	Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products Other-Screener HPHC Phase 1 IDIs	New
223841	2017 FDA Tobacco Retail Compliance Check Inspection Program Coordinators' Training Other-2017 PC Training Survey	New
221172	American Indian/Alaska Native Campaign: Focus Group Study of Reactions to Strategic Concepts Designed to Prevent Youth Tobacco Use Other-Adult Recruit Script Screener	New
220637	Point-of-Sale Creative Concept Testing – Focus Groups with Current Adult Smokers Other-Screener	New
219930	Focus Groups on ENDS: Device Types, User Experiences, and Product Appeal Other-Background Assessment	New
218581	Focus Group Study of Youth Reactions to Creative Advertising Concepts Designed to Prevent Youth Tobacco Use among Multicultural Youth Other-Instrument Pictures	New
218142	Qualitative Study of Perceptions and Knowledge of Visually Depicted Health Conditions Other-Stimuli	New

ICR Details

OMB Control No: 0910-0796	ICR Reference No: 201411-0910-007
Status: Historical Active	Previous ICR Reference No:
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: 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: 06/26/2015
	Date Received in OIRA: 12/10/2014
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	06/30/2018	36 Months From Approved
Responses	24,050	0	0
Time Burden (Hours)	29,059	0	0
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:
	79 FR 44779	08/01/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 72685	12/08/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
American Indian/Alaska Native Campaign: Focus Group Study of Reactions to Strategic Concepts Designed to Prevent Youth Tobacco Use
Focus Groups on ENDS: Device Types, User Experiences, and Product Appeal
Focus Group Study of Youth Reactions to Creative Advertising Concepts Designed to Prevent Youth Tobacco Use among Multicultural Youth
Multicultural Campaign: Wave 3 focus group study of reactions to creative advertising concepts designed to prevent multicultural youth tobacco use
Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products
Point-of-Sale Creative Concept Testing – Focus Groups with Current Adult Smokers
Qualitative Study on Acute Nicotine Toxicity Warnings for E-Liquids: Knowledge, Beliefs, and Perceptions
The Real Cost General Market: Wave 4 Creative Concept Testing Designed to Prevent Youth ENDS Use
The Real Cost Smokeless: Wave 2 In-depth Interviews Designed to Prevent Rural Youth Tobacco Use
Qualitative Study of Perceptions and Knowledge of Visually Depicted Health Conditions
The Real Cost Smokeless: Wave 2 Focus Group Study of Reactions to Creative Advertising Concepts Designed to Prevent Rural Youth Tobacco Use
Qualitative Study on Consumer perceptions of Cigarettes Health Warning Images
2017 FDA Tobacco Retail Compliance Check Inspection Program Coordinators' Training

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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	24,050	0	0	24,050	0	0
Annual Time Burden (Hours)	29,059	0	0	29,059	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: New collection

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Annual Cost to Federal Government: $1,025,238

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 12/10/2014

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