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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Gen IC Memo Quantitative data on Tobacco Products and Comminucations Gen IC Memo.doc	Supplementary Document	Uploaded 2015-05-27	Available
OMB_Generic Clearance Supporting Statement B _10-23.doc	Supporting Statement B	Uploaded 2015-10-23	Available
OMB_Generic Clearance Quantitative Supporting Statement 10-23-15.doc	Supporting Statement A	Uploaded 2015-10-23	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
229885	FDA CTP Public Education Materials Study	Other-INFORMED CONSENT	New
228226	FDA CTP E-Blast Survey Audience Analysis Study	Other-INFORMED CONSENT INFORMATION	New
225031	LGBT Campaign: Wave 1B Online Quantitative Study Designed to Prevent Young Adult Tobacco Use	Other-Social Media Ads	New
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	New
222137	Fresh Empire Campaign: Wave 2 Quantitative Study of Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use	Other-Parental Opt-Out (Social Media)	New
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	New
220770	Quantitative Study of Tobacco Facts Designed to Inform Youth Tobacco Prevention Messaging	Other-Attachment A - Invitation and Parental Permission Form	New

ICR Details

OMB Control No: 0910-0810	ICR Reference No: 201411-0910-008
Status: Historical Active	Previous ICR Reference No:
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: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/24/2016
	Date Received in OIRA: 12/03/2014
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

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2018	36 Months From Approved
Responses	21,600	0	0
Time Burden (Hours)	7,128	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 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): US Code: 21 USC 355 Name of Law: Federal Food, Drug, and Cosmetic Act
   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
  

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: 7

table that charts list of burden

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

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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	21,600	0	0	21,600	0	0
Annual Time Burden (Hours)	7,128	0	0	7,128	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: $525,238

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: 12/03/2014

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