View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0879	ICR Reference No: 202203-0910-009
Status: Historical Inactive	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: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 04/13/2022
	Date Received in OIRA: 04/04/2022
Terms of Clearance: Should be submitted as an ICR Revision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2024	12/31/2024	12/31/2024
Responses	72	0	72
Time Burden (Hours)	13,592	0	13,592
Cost Burden (Dollars)	0	0	0

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

Agency Contact: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

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