Premarket Tobacco Product Applications and Recordkeeping Requirements
Revision of a currently approved collection
No
Regular
Approved with change
03/27/2025
11/27/2024
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
03/31/2028
36 Months From Approved
12/31/2025
1,493
0
191
383,262
0
13,707
0
0
0
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.
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
FDA 4057a, FDA 4057, FDA 4057b, FDA Web Form 4057, FDA Web Form 4057a
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,
,
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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
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
Yes
Miscellaneous Actions
No
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 the consolidation of the collection of PMTA submissions for ENDS products, previously collected under OMB Control Number 0910-0768. This has resulted in an increase in the submission of standard bundled PMTAs from 1 per year to 215 per year. Additionally, FDA expects submitters to implement the use of the validator tool in each submission.
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, consolidating the burden previously received under OMB Control Number 0910-0768, and reevaluating our current estimates.
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:
(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;
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.
Recordkeeping; Premarket Tobacco Product Applications