Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Attachment 1.pdf	Supplementary Document	Uploaded 2012-09-18	Available
Pierce et al.pdf	Supplementary Document	Uploaded 2012-09-18	Available
Attachment 2.pdf	Supplementary Document	Uploaded 2012-09-18	Available
Attachment 3.pdf	Supplementary Document	Uploaded 2012-09-18	Available
Part B Supporting Statement Experimenatal Study Consumer HPHC list-091812.doc	Supporting Statement B	Uploaded 2012-09-18	Available
Altria1.pdf	Supplementary Document	Uploaded 2012-05-07	Available
Legacy1.pdf	Supplementary Document	Uploaded 2012-05-07	Available
World Lung Foundation reduced size .pdf	Supplementary Document	Uploaded 2012-05-07	Available
Global Dialogue.pdf	Supplementary Document	Uploaded 2012-05-07	Available
Cohen.pdf	Supplementary Document	Uploaded 2012-05-07	Available
CanadianCancer.pdf	Supplementary Document	Uploaded 2012-05-07	Available
Star Scientific1.pdf	Supplementary Document	Uploaded 2012-05-07	Available
JT internationa reduced sizel.pdf	Supplementary Document	Uploaded 2012-05-07	Available
Part A Supporting Statment Experimental Study Consumer HPHC list-091812.doc	Supporting Statement A	Uploaded 2012-09-18	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
202182	Experimental Survey	Other-Appendix B - Stimuli	New
202181	Screener	Other-Survey Questions	New
202180	Pre Test	Other-HPHC Prototype1 Roll Your Own10	New

ICR Details

OMB Control No: 0910-0736	ICR Reference No: 201205-0910-004
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents
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OIRA Conclusion Action: Withdrawn	Conclusion Date: 01/14/2013
	Date Received in OIRA: 05/08/2012
Terms of Clearance: In accordance with 5 CFR 1320, this collection has been withdrawn at the request of the Agency.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		18 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Tobacco Control Act (Public Law 111-31) amends the FD&C Act to grant FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Section 904(d)(1) of the FD&C Act states, "Not later than 3 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, and annually thereafter, the Secretary shall publish in a format that is understandable and not misleading to a lay person, and place on public display (in a manner determined by the Secretary) the list [of harmful or potentially harmful constituents] established under [section 904(e)]" of the Act. Section 904(e) of the FD&C Act directs FDA to establish "a list of harmful and potentially harmful constituents, including smoke constituents, to health in each tobacco product by brand, and by quantity in each brand and subbrand." On January 31, 2011, FDA announced the availability of a final guidance representing the Agency's current thinking on the meaning of the term "harmful and potentially harmful constituent" (see 76 FR 5387). On April 3, 2012, FDA published a notice in the Federal Register establishing a list of the harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke (see 77 FR 20034). FDA's Center for Tobacco Products requires data on how consumers may respond to information about HPHCs in order to determine the appropriate format of the HPHC list provided to the public.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 1 Name of Law: Family Smoking Prevention and Tobacco Control 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:
	76 FR 77837	12/14/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 26284	05/03/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
Pre Test
Screener
Experimental Survey

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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.

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Annual Cost to Federal Government: $302,949

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: 05/08/2012

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