Tobacco Product Standard on Flavored Cigarettes

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
190703	Form FDA 3734: Reporting violations of section 907(a)(1)(A) of the FFDCA	New

ICR Details

OMB Control No: 0910-0647	ICR Reference No: 200909-0910-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Tobacco Product Standard on Flavored 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: 09/18/2009
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/18/2009
	Date Received in OIRA: 09/16/2009
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for 6 months. However, prior to launch of the system, FDA must submit final screenshots of the website where this information will be collected and a completed phone script. FDA may submit these documents as a non-substantive, non-material change to the collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2010	6 Months From Approved
Responses	1,700	0	0
Time Burden (Hours)	283	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA) (Public Law 111-31) into law. The FSPTCA amended the Federal Food, Drug, and Cosmetic Act (FFDCA) by adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. As part of our enforcement strategy, FDA is creating a Tobacco Call Center (with a toll-free number) to handle complaint investigations for violations of the cigarette flavor ban. Callers will be able to report violations of the flavor ban and FDA will conduct targeted follow-up investigation of complaints that are received. When callers report a violation, the caller will be asked for certain information: name, caller contact information, purchase date, description of the tobacco product, and address of the retail outlet or Internet address where the violative product was viewed.

Emergency Justfication: FDA is requesting emergency OMB approval of the information collection pertaining to section 907(a)(1)(A) of the FFDCA, as amended by FSPTCA, which provides a general tobacco standard special rule for cigarettes that becomes effective on September 22, 2009.

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Authorizing Statute(s): US Code: 21 USC 907(a)(1)(A) Name of Law: FSPTCA
  

Citations for New Statutory Requirements: US Code: 21 USC 907(a)(1)(A) Name of Law: FSPTCA

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking
	Other Documents for OIRA Review

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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
Form FDA 3734: Reporting violations of section 907(a)(1)(A) of the FFDCA	FDA 3734

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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	1,700	0	1,700	0	0	0
Annual Time Burden (Hours)	283	0	283	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection. On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA) (Public Law 111-31) into law. The FSPTCA amended the Federal Food, Drug, and Cosmetic Act (FFDCA) by adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. The ability to solicit complaint information regarding violations of the cigarette flavor ban is an important component of FDA's enforcement of the FSPTCA.

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Annual Cost to Federal Government: $32,300

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]? Uncollected

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: 09/16/2009

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