Premarket Tobacco Product Applications and Recordkeeping Requirements

Forms and Documents

Document Name	Status
Form FDA 4057 Reporting: PMTA submission; amendment; unique identification for new products; validator spreadsheet; periodic reports; change in ownership; supplemental applications; resubmissions; waiver Form and Instruction	Modified
Change Request OMB Memo September 2023.docx Justification for No Material/Nonsubstantive Change	2023-09-08
0910-0879_SSA_2024._Final 11-21-24.docx Supporting Statement A	2024-11-21
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
267445	Recordkeeping; Premarket Tobacco Product Applications	New
237744	Reporting: PMTA submission; amendment; unique identification for new products; validator spreadsheet; periodic reports; change in ownership; supplemental applications; resubmissions; waiver Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0879	ICR Reference No: 202403-0910-005
Status: Received in OIRA	Previous ICR Reference No: 202309-0910-004
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: Regular	Date Submitted to OIRA: 11/27/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	1,493	191
Time Burden (Hours)	383,262	13,707
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports Food and Drug Administration requirements for the content and format of Premarket Tobacco Applications (PMTA) Reports which are utilized for the premarket review of new tobacco products. Section 910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387(j)), established requirements for premarket review of new tobacco products and the implementing regulations per the PMTA final rule (86 FR 55300, October 5, 2021) that are found in 21 CFR 1114. This information collection supports requirements for the content and format of Premarket Tobacco Applications (PMTA) Reports which are utilized for the premarket review of new tobacco products. The information collection contains 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 information collection also contains requirements related to 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. There are three FDA forms required for use under sections 1114.7(b) and 1114.9(a) when submitting PMTA information to the Agency. Forms FDA 4057 and 4057b are required when submitting PMTA single and bundled submissions. Form FDA 4057a is for use when firms are submitting amendments and other general correspondence. Form FDA 4057b assists industry and FDA in identifying the products that are the subject of a submission. The new CTP Portal NG application will provide web forms for PMTA applications and amendments, respectively, which will improve the submission preparation process for the tobacco industry.

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Authorizing Statute(s): US Code: 21 USC 387(j) Name of Law: Federal Food, Drug and Cosmetic Act
   US Code: 21 USC 201(rr) 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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 57907	07/16/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 93300	11/26/2024
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Recordkeeping; Premarket Tobacco Product Applications
Reporting: PMTA submission; amendment; unique identification for new products; validator spreadsheet; periodic reports; change in ownership; supplemental applications; resubmissions; waiver	FDA 4057a, FDA 4057, FDA 4057b, FDA Web Form 4057a, FDA Web Form 4057	Premarket Tobacco Product Application (PMTA) Submission ,   Premarket Tobacco Product Application (PMTA) Amendment and General Correspondence Submission ,   Unique Identifying Information for New Tobacco Products ,   Premarket Tobacco Product Application (PMTA) Submission (FDA Web Form 4057) ,   Premarket Tobacco Product Application (PMTA) Amendment and General Correspondence Submission (FDA Web Form 4057a)

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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	1,493	191	0	24	1,278	0
Annual Time Burden (Hours)	383,262	13,707	0	17	369,538	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: Program Change Burden The content in Form FDA 4057, 4057a and 4057b have not significantly changed and we do not attribute program change burden related to the form revisions. There is a program change increase in reporting burden hours related to use of the validator tool. Adjustments Burden The burden adjustment is related to an increase in respondents reporting information and an increase in periodic reporting responses. The increase is off-set by burden decreases in the number of responses associated with reporting under the Form FDA 4057 and waiver requests, as well as a decrease in the average response time associated with the Form FDA 4057b. Total Burden Our estimated burden for the information collection reflects an overall increase of 369,555 hours and a corresponding increase of 1,302 responses/records. We attribute this to providing the validator tool and reevaluating our current estimates.

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Annual Cost to Federal Government: $16,868,670

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: 11/27/2024

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