Information Request Regarding Menthol in Cigarettes

Forms and Documents

Document Name	Status
Emergency request for menthol.doc Supplementary Document	2010-05-18
Supporting statement TPSAC Menthol 05212010_final.doc Supporting Statement A	2010-05-21

IC Document Collections

IC ID	Document Title	Status
192893	Submission of menthol-related documents Other-Letter to industry	New

ICR Details

OMB Control No: 0910-0662	ICR Reference No: 201005-0910-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Information Request Regarding Menthol in Cigarettes
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 05/17/2010
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/24/2010
	Date Received in OIRA: 05/14/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2010	6 Months From Approved
Responses	116	0	0
Time Burden (Hours)	16,240	0	0
Cost Burden (Dollars)	1,940	0	0

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Abstract: To report accurately on the impact of the use of menthol in cigarettes on the public health, TPSAC requires information from cigarette 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).

Emergency Justfication: We are requesting emergency processing of this information collection regarding the public health impact of menthol in cigarettes. As described above, section 907(e) of the act requires TPSAC to study "the issue of the impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities," and to provide CTP with a report and recommendations. To ensure a comprehensive review of this issue, CTP is requesting tobacco industry data and information to support the work of TPSAC. Pursuant to section 907(e), TPSAC must submit its report and recommendations to the Secretary of Health and Human Services within one year of its formation, or March 23, 2011. We are requesting emergency processing and clearance of this information collection by May 17, 2010, so that FDA can issue the letter to industry requesting this information soon thereafter. This timeframe will enable FDA to receive information by July, 2010 in order for TPSAC to have this information for its analysis and review for developing its report and recommendations.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 101 Name of Law: Tobacco Control Act
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 31 101 Name of Law: Tobacco Control Act

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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

Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Submission of menthol-related documents

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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	116	0	0	116	0	0
Annual Time Burden (Hours)	16,240	0	0	16,240	0	0
Annual Cost Burden (Dollars)	1,940	0	0	1,940	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 information collection.

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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]? Uncollected

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: 05/14/2010

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