Tobacco Products, Exemptions From Substantial Equivalence Requirements

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0910-0684_SS Tobacco Products Exemption from SE Requirements Final.docx	Supporting Statement A	Uploaded 2016-05-12	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
197951	Report Demonstrating Tobacco Product Mod under 905(j)(3), Commercially Mkted and Compliant, and Modifications covered under 905(j)(3)	Instruction	Modified
197950	Environmental Assessment Preparation under 25.40		Removed
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: 201601-0910-016
Status: Historical Active	Previous ICR Reference No: 201406-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Tobacco Products, Exemptions From Substantial Equivalence Requirements
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/27/2016
	Date Received in OIRA: 05/12/2016
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	09/30/2017
Responses	2,273	0	1,900
Time Burden (Hours)	23,871	0	14,700
Cost Burden (Dollars)	0	0	0

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Abstract: FDA has established in its regulations a pathway for manufacturers to request exemptions from the substantial equivalence requirements of the FD&C Act. An exemption request must be submitted with supporting documentation, the manufacturer's contact information, and a detailed explanation of the modification and its purpose. This information is submitted to FDA so FDA can determine whether an exemption from substantial equivalence to the predicate product is appropriate for the protection of the public health. FDA determines whether to grant or deny the request for an exemption based on whether the criteria in the statute have been satisfied. If FDA determines that the information is insufficient, FDA may request additional information from the manufacturer. If the manufacturer fails to respond within the timeframe requested, FDA will consider the exemption request withdrawn. FDA may rescind an exemption where necessary to protect the public health. 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) the modification would be a minor modification of a tobacco product, (2) a report demonstrating substantial equivalence is not necessary for the protection of public health, and (3) an exemption is otherwise appropriate.

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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-AG38	Final or interim final rulemaking	81 FR 28973	05/10/2016

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 23141	04/25/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 28973	05/10/2016
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
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)
Report Demonstrating Tobacco Product Mod under 905(j)(3), Commercially Mkted and Compliant, and Modifications covered under 905(j)(3)
Environmental Assessment Preparation under 25.40

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ICR Summary of Burden

table that charts list 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	2,273	1,900	0	873	-500	0
Annual Time Burden (Hours)	23,871	14,700	0	15,171	-6,000	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: The Food and Drug Administration (FDA) issued a final rule to deem products meeting the statutory definition of “tobacco product” to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. This final rule extends the Agency’s “tobacco product” authorities to all other categories of products that meet the statutory definition of “tobacco product” in the FD&C Act, except accessories of such newly deemed tobacco products.

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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: 05/12/2016

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