Tobacco Products, Exemptions From Substantial Equivalence Requirements

Forms and Documents

Document Name	Status
Tobacco Products Exemption from SE Requirements FR SS.doc Supporting Statement A	2011-05-20

IC Document Collections

IC ID	Document Title	Status
197951	Report Demonstrating Tobacco Product Mod under 905(j)(3), Commercially Mkted and Compliant, and Modifications covered under 905(j)(3) Instruction	New
197950	Environmental Assessment Preparation under 25.40	New
196723	Additional Information for Tobacco Product Exemption from Substantial Equivalence Request 21 CFR 1107.1(c)	Modified
196722	Tobacco Product Exemption from Substantial Equivalence Request 21 CFR 1107.1(b)	Modified

ICR Details

OMB Control No: 0910-0684	ICR Reference No: 201106-0910-002
Status: Historical Active	Previous ICR Reference No: 201103-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Tobacco Products, Exemptions From Substantial Equivalence Requirements
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: 08/03/2011
	Date Received in OIRA: 06/01/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2014	36 Months From Approved
Responses	1,900	0	0
Time Burden (Hours)	14,700	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 (Tobacco Control Act) (Public Law 111-31) into law. The Act amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding a chapter granting FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. The Tobacco Control Act requires that before a new tobacco product may be introduced or delivered for introduction into interstate commerce, one of the following must occur: 1) a premarket application under section 910(b) of the FD&C Act must be submitted to FDA, and FDA must issue an order finding that the new product may be introduced or delivered for introduction into interstate commerce under section 910(c) of the FD&C Act; or 2) a report under section 905(j) of the FD&C Act demonstrating the new tobacco product's substantial equivalence to an appropriate predicate product must be submitted and FDA must issue an order finding the new product to be substantially equivalent to the predicate product and in compliance with the requirements of the Tobacco Control Act. This rule implements section 905(j)(3) of the FD&C Act, as amended, which states that FDA may exempt tobacco products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, from the requirement of demonstrating substantial equivalence if the agency determines that (1) such modification would be a minor modification of a tobacco product that can be sold under the FD&C Act, (2) a report demonstrating substantial equivalence is not necessary to ensure that permitting the product to be marketed would be appropriate for the protection of public health, and (3) an exemption is otherwise appropriate. Section 905(j)(3)(B) of the FD&C Act requires FDA to issue regulations implementing this provision by July 1, 2011.

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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: PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG39	Final or interim final rulemaking	76 FR 38961	07/05/2011

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Federal Register Notices & Comments

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
Tobacco Product Exemption from Substantial Equivalence Request 21 CFR 1107.1(b)
Additional Information for Tobacco Product Exemption from Substantial Equivalence Request 21 CFR 1107.1(c)
Environmental Assessment Preparation under 25.40
Report Demonstrating Tobacco Product Mod under 905(j)(3), Commercially Mkted and Compliant, and Modifications covered under 905(j)(3)

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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	1,900	0	750	1,150	0	0
Annual Time Burden (Hours)	14,700	0	2,250	12,450	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: Changing Regulations

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: $580,000

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: 06/01/2011

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