Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product

Forms and Documents

Document Name	Status
Form FDA 3964 Tobacco Amendment and General Correspondence Report Form and Instruction	New
Form FDA 3965 Tobacco Substantial Equivalence Report Submission Form and Instruction	New
0673 final rule ss 9-15-2021.docx Supporting Statement A	2021-09-15
FDA CTP Electronic Submissions (eSub) PIA 1.15.2021.pdf Supplementary Document	2021-01-15
Substantial Equivalence (SE) eSubmitter Screenshots.docx Supplementary Document	2021-01-12

IC Document Collections

IC ID	Document Title	Status
245290	Recordkeeping SE Report under 1107.18-1107.58	New
245289	Waiver from Electronic submission	New
245288	Tobacco Amendment and General Correspondence Report Form and Instruction	New
245286	Tobacco Substantial Equivalence Report Submission Form and Instruction	New
221154	Identical Characteristics (Bundled) Other-Guidance	Modified
221153	Bundled Reports	Modified
215515	Identical Characteristics Reports Other-Guidance	Modified
195793	(Full SE) Reports Demonstrating Substantial Equivalence for Tobacco Products (Sections 905(j) and 910(a)) Instruction	Modified

ICR Details

OMB Control No: 0910-0673	ICR Reference No: 202101-0910-003
Status: Received in OIRA	Previous ICR Reference No: 201904-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/05/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2022
Responses	4,479	1,570
Time Burden (Hours)	282,330	278,637
Cost Burden (Dollars)	0	0

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Abstract: The FD&C Act requires FDA to issue an order under section 910(c)(1)(A)(i) (order after review of a premarket application, see section 910(b) of the FD&C Act) before a new tobacco product may be commercially marketed. An order under section 910(c)(1)(A)(i) is not required, however, if a manufacturer submits a report under section 905(j)(1)(A)(i) for the new tobacco product and FDA issues an order finding that the tobacco product is (1) substantially equivalent to a tobacco product commercially marketed in the United States as of February 15, 2007, and (2) in compliance with the requirements of the FD&C Act. Manufacturers of these tobacco products may submit a report under section 905(j)(1)(A)(i) demonstrating that a new tobacco product is “substantially equivalent, within the meaning of section 910, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 910, is substantially equivalent and that it is in compliance with the requirements of this Act” (section 905(j)(1)(A)(i) of the FD&C Act). The comparison product chosen by the tobacco product manufacturer is referred to by FDA as the predicate tobacco product. (In addition to the premarket application under section 910(b) and a report under 905(j)(1)(A)(i), certain new tobacco products may use the exemption premarket pathway, see 21 CFR 1107.1.) The Food and Drug Administration (FDA) is now issuing a rule that establishes requirements for the content and format of SE Reports intended to establish the substantial equivalence of a tobacco product. The rule establishes the information an SE Report must include so that FDA may make a substantial equivalence determination. In addition, the rule establishes the general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications with the applicant and the confidentiality of data in an SE Report.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 905 Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG89	Final or interim final rulemaking	86 FR 55224	10/05/2021

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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: 8

IC Title	Form No.	Form Name
(Full SE) Reports Demonstrating Substantial Equivalence for Tobacco Products (Sections 905(j) and 910(a))
Bundled Reports
Identical Characteristics (Bundled)
Identical Characteristics Reports
Recordkeeping SE Report under 1107.18-1107.58
Tobacco Amendment and General Correspondence Report	FDA 3964	Tobacco Amendment and General Correspondence
Tobacco Substantial Equivalence Report Submission	FDA 3965	Tobacco Substantial Equivalence Report Submission
Waiver from Electronic submission

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ICR Summary of Burden

	Total Request	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	4,479	1,570	0	2,909	0	0
Annual Time Burden (Hours)	282,330	278,637	0	3,693	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: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new final rule. FDA estimates that the burden for new requirements will increase this collection by 3,693 hours (1,338 reporting + 2,355 recordkeeping) and 2,909 responses. The burden for the submission of substantial equivalence information is estimated to total 282,330 hours (279,975 reporting and 2,355 recordkeeping). In this submission, the burden increased from the proposed rule ICR submission by 1,618 hours. This change was based on the increased burden per response for the associated forms.

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Annual Cost to Federal Government: $2,320,000

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 10/05/2021

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