Premarket Tobacco Product Applications and Recordkeeping Requirements

Forms and Documents

Document Name	Status
Form Form FDA 4057 PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers Form and Instruction	Modified
0879 supporting statement A FINAL 4.13.22.pdf Supporting Statement A	2022-04-13
FDA CTP Electronic Submissions (eSub) PIA 1.15.2021.pdf Supplementary Document	2021-01-15

IC Document Collections

IC ID	Document Title	Status
237744	PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0879	ICR Reference No: 202204-0910-012
Status: Received in OIRA	Previous ICR Reference No: 202101-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Premarket Tobacco Product Applications and Recordkeeping Requirements
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 04/14/2022
Date Submitted to OIRA: 04/13/2022

	Requested	Previously Approved
Expiration Date	6 Months From Approved	12/31/2024
Responses	72	72
Time Burden (Hours)	13,740	13,592
Cost Burden (Dollars)	0	0

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Abstract: The Tobacco Control Act was enacted on June 22, 2009, amending the Federal Food, Drug, and Cosmetic Act (FD&C Act) and providing FDA with the authority to regulate tobacco products (Pub. L. 111-31; 123 Stat. 1776). Section 910(a) established requirements for premarket review of new tobacco products. FDA is finalizing requirements for the content, format, submission, and review of PMTAs, as well as other requirements related to PMTAs, including recordkeeping requirements, and postmarket reporting. FDA will also require recordkeeping regarding the legal marketing of Pre-Existing Tobacco Products (i.e., those products that were commercially marketed as of February 15, 2007) and products that are exempt from the requirements of demonstrating substantial equivalence.

Emergency Justfication: If certain conditions are met, an agency head or designee may request expedited OMB review of an information collection request (ICR), also known as an "emergency" review. OMB may grant expedited review if the collection is essential to the mission of the agency, clearance is needed sooner than the normal timeframe, and the agency cannot reasonably comply with the normal clearance procedures of the Paperwork Reduction Act of 1995 (the PRA) because: "(i) public harm is reasonably likely to result if normal clearance procedures are followed; (ii) an unanticipated event has occurred; or (iii) the use of normal clearance procedures is reasonably likely to prevent or disrupt the collection of information or is reasonably likely to cause a statutory or court ordered deadline to be missed" (5 CFR § 1320.13(a)(2)). When OMB expedites review, OMB acts promptly to review the ICR through a suitably streamlined process, consistent with the purposes of the PRA. For example, OMB may modify—or, if necessary, waive—the public comment requirements. Emergency clearance may be granted for a maximum of six months. We are seeking emergency processing for the following reasons: (1) The revision of the collection of information (form FDA 4057b) is needed prior to the expiration of normal clearance time periods and is essential to the mission of the FDA; and (2) FDA cannot reasonably comply with normal clearance procedures because use of normal clearance procedures is reasonably likely to cause a statutory deadline to be missed and to prevent or disrupt the required collection of information. The enactment of the Appropriations Act on March 15, 2022, with an effective date of April 14, 2022, does not allow us sufficient time to comply with the normal clearance procedures. The expectation that companies will submit PMTAs on or before May 14, 2022, underscores the need for this revision to be approved expeditiously. This revision will ensure applicants are able to submit, and FDA is able to efficiently process, identifying information about NTN products. Being able to quickly review this identifying information will help FDA determine whether the products that are subject to the application qualify for 60 days of continued marketing. In addition, without emergency clearance and the accompanying revisions to form FDA 4057b, FDA will be unable to ensure that interested stakeholders will provide complete requests, which include the information necessary to submit premarket tobacco product applications (PMTAs). Furthermore, without the ability to receive information from industry in a standardized format, FDA will be unable to allow for applicants to identify products containing non-tobacco derived nicotine. FDA is requesting that OMB allow use of its emergency clearance process to immediately approve the revision of OMB Control No. 0910-0879, so that FDA may immediately collect the information necessary to be in alignment with the changes to the definition of “tobacco product” in section 201(rr) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(rr)).

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Authorizing Statute(s): US Code: 21 USC 201(rr) Name of Law: FFDCA
   US Code: 21 USC 387j Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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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
PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers	Form FDA 4057a, Form FDA 4057, Form FDA 4057b, FDA 4057b, FDA 4057b	Premarket Tobacco Product Application (PMTA) Submission ,   Premarket Tobacco Product Application Amendment and General Correspondence Submission ,   Unique Identifying Information for New Tobacco Products ,   Premarket Tobacco Product Application Grouping Submission ,   Premarket Tobacco Product Application Grouping Submission (detailed changes)

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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	72	72	0	0	0	0
Annual Time Burden (Hours)	13,740	13,592	0	148	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: The Food and Drug Administration is submitting this revision under emergency clearance procedures to revise Form FDA 4057b to account for products containing non-tobacco derived nicotine through PMTA applications. Effective April 14, 2022, Section 201(rr) of the FD&C Act now applies to “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption”. Form FDA 4057b has been modified to be in alignment with the changes to the definition of “tobacco product” in section 201(rr) of the FD&C Act. Currently, we do not have an accurate assessment of how this will affect our burden estimates. For this emergency clearance request, FDA has added burden to account for products containing non-tobacco derived nicotine. This resulted in an increase of 45 responses and 148 hours. The new estimated burden for this collection is 13,740 hours.

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Annual Cost to Federal Government: $7,150,000

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: 04/13/2022

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