Information Request Regarding Dissolvable Tobacco Products

Forms and Documents

Document Name	Status
Dissolvables 30-day draft.doc Supplementary Document	2011-02-25
dissolvables ss 3-2-11.doc Supporting Statement A	2011-03-02

IC Document Collections

IC ID	Document Title	Status
196906	Dissolvable Tobacco Products Information Request Instruction	New

ICR Details

OMB Control No: 0910-0685	ICR Reference No: 201103-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Information Request Regarding Dissolvable Tobacco Products
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: 05/31/2011
	Date Received in OIRA: 03/10/2011
Terms of Clearance: In accordance with 5 CFR 1320, OMB approves this collection for a period of three years. Before resubmitting this collection for an extension, the agency should determine whether it is duplicative of other information being collected by FDA or CDC.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2014	36 Months From Approved
Responses	120	0	0
Time Burden (Hours)	24,220	0	0
Cost Burden (Dollars)	924	0	0

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Abstract: FDA is requesting OMB approval of an information collection pursuant to subsections 904(b)(1) and 904(b)(3) an of the FFDCA, as amended by the Tobacco Control Act. To report accurately on the impact of the use of dissolvable tobacco products on the public health, TPSAC requires information from the tobacco industry manufacturers. FDA will be requesting this information through a letter sent to all manufacturers of tobacco products. This information will include information requests about research pursuant to sections 904(b)(1) and 904(b)(3) of the Tobacco Control Act as well as voluntary information requests beyond the inquiries described in section 904(b). To report accurately on the impact of the use of dissolvable tobacco products on the public health, FDA's Tobacco Product Scientific Advisory Committee (TPSAC) requires information from the tobacco industry manufacturers. FDA will be requesting this information through a letter sent to all manufacturers of tobacco products. This information will include information requests about research pursuant to sections 904(b)(1) and 904(b)(3) of the Tobacco Control Act as well as voluntary information requests beyond the inquiries described in section 904(b).

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Authorizing Statute(s): PL: Pub.L. 111 - 111 31 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:
	75 FR 65490	10/25/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 11485	03/02/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Dissolvable Tobacco Products Information Request

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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	120	0	0	120	0	0
Annual Time Burden (Hours)	24,220	0	0	24,220	0	0
Annual Cost Burden (Dollars)	924	0	0	924	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.

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Annual Cost to Federal Government: $387,000

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 03/10/2011

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