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View ICR - OIRA Conclusion

OMB Control No: 0910-0879	ICR Reference No: 202403-0910-005
Status: Active	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
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/27/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/27/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2028	36 Months From Approved	12/31/2025
Responses	1,493	0	191
Time Burden (Hours)	383,262	0	13,707
Cost Burden (Dollars)	0	0	0

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.

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	1,493	191	24	1,278
Annual Time Burden (Hours)	383,262	13,707	17	369,538
Annual Cost Burden (Dollars)	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 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.

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

Agency Contact: Rachel Showalter 202 693-2146 Showalter.Rachel@dol.gov