Pretesting of Tobacco Communications

Forms and Documents

Document Name	Status
PartB_Tobacco_Generic_Clearance_ICR_20101104[1].doc Supporting Statement B	2010-11-10
PartA_Tobacco_Generic_Clearance_ICR_20101104.doc Supporting Statement A	2010-11-10

IC Document Collections

IC ID	Document Title	Status
202772	Focus Group Study of Adolescent and Young Adult Perceptions Related to Cigarette Smoking Other-Consent Form	New
200903	Stakeholder Interviews for Break the Chain Retailer Education Campaign Other-Appendix B with Survey	New
200081	FDA Consumer Perception Research on New and Emerging Tobacco Products Instruction	New
196026	"Consumer Perceptions Related to Harmful and Potentially Harmful Constituents in Tobacco Products"; OMB Control No. 0910-0674 Other-Cover memo and Survey Instruments	New

ICR Details

OMB Control No: 0910-0674	ICR Reference No: 201009-0910-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Pretesting of Tobacco 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: 01/06/2011
	Date Received in OIRA: 09/10/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2013	36 Months From Approved
Responses	16,448	0	0
Time Burden (Hours)	2,860	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: FDA's Center for Tobacco Products will conduct educational and public information programs relating to tobacco use, as authorized by Section 1003(d)(2)(D) of the Federal Food Drug and Cosmetic Act (21 U.S.C. Section 393(d)(2)(D)) (Attachment 2). The Center for Tobacco Products will create and use a variety of media, including print (e.g., brochures, posters, fact sheets, information kits), broadcast (e.g., Public Service Announcements, video news releases), and electronic formats (e.g., Internet, listservs, CD-roms) to inform and educate the public, tobacco retailers, and health professionals about the risks of tobacco use, how to quit using tobacco products, and FDA's role in regulating tobacco. Production of these materials will be the major way that FDA relays messages to its audiences.

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Authorizing Statute(s): 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:
	75 FR 9225	03/01/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 47600	08/06/2010
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
"Consumer Perceptions Related to Harmful and Potentially Harmful Constituents in Tobacco Products"; OMB Control No. 0910-0674
Focus Group Study of Adolescent and Young Adult Perceptions Related to Cigarette Smoking
FDA Consumer Perception Research on New and Emerging Tobacco Products
Stakeholder Interviews for Break the Chain Retailer Education Campaign

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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	16,448	0	0	16,448	0	0
Annual Time Burden (Hours)	2,860	0	0	2,860	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: This is a new collection of information to set up a new generic request.

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Annual Cost to Federal Government: $225,239

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: 09/10/2010

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