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OMB Control No: 0910-0650	ICR Reference No: 201904-0910-005
Status: Historical Active	Previous ICR Reference No: 201712-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Tobacco Product Establishment Registration and Submission of Certain Health Information
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: 09/16/2019
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/21/2019
Terms of Clearance: Previous terms continue: The data to be collected by CTP in this ICR (OMB Control No. 0910-0650) and Center for Disease Control (OMB Control No.’s: 0920-0210 and 0920-0338) overlap in terms of the similar tobacco product ingredient collections being conducted. However, at this time, the CTP data cannot currently be used by CDC due to both logistical reasons and restrictions on the use of information collected. OMB encourages the agencies to consider future efforts to eliminate duplication and reduce burden on respondents

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2022	36 Months From Approved	09/30/2019
Responses	3,858	0	85,494
Time Burden (Hours)	830	0	93,916
Cost Burden (Dollars)	21	0	44

Abstract: The Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by the Tobacco Control Act of 2009, grants FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Section 905 of the FD&C Act requires the annual registration of any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products. Section 904 of the FD&C Act requires that each tobacco product manufacturer or importer submit a listing of all ingredients and additives that are added by the manufacturer to each tobacco product by brand and by quantity in each brand and sub brand. Section 904 also requires that a tobacco product manufacturer advise the FDA in writing prior to adding any new tobacco additive or increasing in quantity an existing tobacco additive. It also requires that a tobacco product manufacturer advise the FDA in writing prior to eliminating or decreasing an existing additive, or adding or increasing an additive designated by the FDA as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use.

Authorizing Statute(s): PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
   US Code: 21 USC 905 Name of Law: FFDCA
   US Code: 21 USC 904 Name of Law: FFDCA

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 53478	10/23/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 21787	05/15/2019
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	3,858	85,494	0	-81,636
Annual Time Burden (Hours)	830	93,916	0	-93,086
Annual Cost Burden (Dollars)	21	44	20	-43

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 estimates the total burden for this collection is 830 hours. We have adjusted our burden estimate, which has resulted in a decrease of 93,086 hours and 81,636 annual responses to the currently approved burden. The IC referencing vape shops was deleted as these numbers have been incorporated into the appropriate places. Additionally, the IC titled Tobacco Product Ingredient Listing electronic and paper submission was deleted as it was a duplicate item intended to be removed previously. Based on data we reviewed from the past 3 years and projecting the number of remaining establishments that have not registered and submitted product ingredient listings, we revised the number of respondents and burden hours in this information collection.

Annual Cost to Federal Government: $928,000

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? Uncollected

Agency Contact: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

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