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

Forms and Documents

Document Name	Status
0910-0810 change request Feb 18.docx Justification for No Material/Nonsubstantive Change	2018-02-15
Generic Clearance SS A 0810 Change request Clean Feb 18.docx Supporting Statement A	2018-02-15
Gen IC Memo Quantitative data on Tobacco Products and Comminucations Gen IC Memo.doc Supplementary Document	2015-05-27
OMB_Generic Clearance Supporting Statement B _10-23.doc Supporting Statement B	2015-10-23

IC Document Collections

IC ID	Document Title	Status
231334	The Real Cost Campaign: Online Quantitative Study of Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use Other-TRC Copy Testing Youth Screener	New
230877	Wave 3 Online Quantitative Study of Reactions to Rough-Cut Advertising Designed to Prevent Multicultural Youth Tobacco Use Other-Screener	New
229885	FDA CTP Public Education Materials Study Other-INFORMED CONSENT	Unchanged
228226	FDA CTP E-Blast Survey Audience Analysis Study Other-INFORMED CONSENT INFORMATION	Unchanged
225031	LGBT Campaign: Wave 1B Online Quantitative Study Designed to Prevent Young Adult Tobacco Use Other-Reminder Emails	Unchanged
223487	Point-of-Sale Campaign: Online Quantitative Study of Reactions to Rough-Cut Advertising Designed to Encourage Adult Smokers to Quit Smoking Other-Informed Consent Form	Unchanged
222137	Fresh Empire Campaign: Wave 2 Quantitative Study of Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use Other-Screener (In-Person Electronic)	Unchanged
222129	General Market Campaign: Wave 3 Online Quantitative Study of Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use Other-Parental Consent Opt-Out Form	Unchanged
220770	Quantitative Study of Tobacco Facts Designed to Inform Youth Tobacco Prevention Messaging Other-Attachment A - Invitation and Parental Permission Form	Unchanged

ICR Details

OMB Control No: 0910-0810	ICR Reference No: 201802-0910-012
Status: Historical Active	Previous ICR Reference No: 201411-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/20/2018
	Date Received in OIRA: 02/15/2018
Terms of Clearance: FDA will submit full Supporting Statements A and B for each individual Gen IC submission. The supporting statements must describe the specific purpose of the collection, including the way that the resulting data will be analyzed and 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 thorough justification. Information gathered will not be used for the purpose of substantially informing influential policy decisions, are intended to inform pretesting of tobacco communication messages and other materials directed at consumers, and are not intended to yield results that are statistically projectable, nationally representative, or precise estimates of population parameters

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2018	11/30/2018	11/30/2018
Responses	83,063	0	21,600
Time Burden (Hours)	9,430	0	7,128
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 quantitative methods for studies about tobacco products. FDA will need to employ quantitative research, including surveys and experimental studies to assess 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): PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
   US Code: 21 USC 372 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 393(d)(2)(D) Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 42 USC 241(a) Name of Law: Public Health Service Act
   US Code: 21 USC 355 Name of Law: Federal Food, Drug, and Cosmetic Act
  

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 41696	07/17/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 70873	11/28/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Wave 3 Online Quantitative Study of Reactions to Rough-Cut Advertising Designed to Prevent Multicultural Youth Tobacco Use
Fresh Empire Campaign: Wave 2 Quantitative Study of Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use
Quantitative Study of Tobacco Facts Designed to Inform Youth Tobacco Prevention Messaging
Point-of-Sale Campaign: Online Quantitative Study of Reactions to Rough-Cut Advertising Designed to Encourage Adult Smokers to Quit Smoking
The Real Cost Campaign: Online Quantitative Study of Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use
General Market Campaign: Wave 3 Online Quantitative Study of Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use
LGBT Campaign: Wave 1B Online Quantitative Study Designed to Prevent Young Adult Tobacco Use
FDA CTP E-Blast Survey Audience Analysis Study
FDA CTP Public Education Materials Study

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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	83,063	21,600	0	0	61,463	0
Annual Time Burden (Hours)	9,430	7,128	0	0	2,302	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:

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Annual Cost to Federal Government: $525,238

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.     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? 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: 02/15/2018

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