Premarket Tobacco Product Applications and Recordkeeping Requirements

Forms and Documents

Document Name	Status
Form FDA 4057 PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers Form and Instruction	Modified
Change Request OMB Memo September 2023.docx Justification for No Material/Nonsubstantive Change	2023-09-08
0910-0879 SSA AMENDED FINAL 9.2023.docx Supporting Statement A	2023-09-08
0910-0879 OMB Change Request Memo 6.2023.docx Justification for No Material/Nonsubstantive Change	2023-06-21
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: 202309-0910-004
Status: Received in OIRA	Previous ICR Reference No: 202306-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Premarket Tobacco Product Applications and Recordkeeping Requirements
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/08/2023

	Requested	Previously Approved
Expiration Date	12/31/2025	12/31/2025
Responses	191	191
Time Burden (Hours)	13,707	13,740
Cost Burden (Dollars)	0	0

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Abstract: This information collection interprets and establishes requirements related to the basic content and format of premarket tobacco product applications (PMTAs), the procedure by which FDA would review PMTAs, and the maintenance of records regarding the legal marketing of certain tobacco products without PMTAs. The regulation also addresses issues such as the procedures of retention of records related to the PMTA, confidentiality of application information, electronic submission of the PMTA and amendments, and postmarket reporting requirements.

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

Citations for New Statutory Requirements: US Code: 21 USC 201(rr) Name of Law: FFDCA

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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
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 29749	05/16/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 63502	10/19/2022
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	FDA 4057a, FDA 4057, FDA 4057b	Premarket Tobacco Product Application (PMTA) Submission ,   Premarket Tobacco Product Application Amendment and General Correspondence Submission ,   Unique Identifying Information for New Tobacco Products

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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	191	191	0	0	0	0
Annual Time Burden (Hours)	13,707	13,740	0	0	-33	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: FDA is submitting this non substantive change request for updates to FDA Forms 4057, 4057b, and a voluntary spreadsheet validation tool to assist industry users to complete the form efficiently and correctly.

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Annual Cost to Federal Government: $6,462,775

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: 09/08/2023

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