Deeming Tobacco Products To Be Subject to the FD&C Act

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0768 Tobacco Products Subject to FFDCA SSA 2022.docx	Supporting Statement A	Uploaded 2022-10-25	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
210603	Exemptions From the Required Warning Statement Requirement		Removed
210600	Request for meeting with CTP's Office of Science to discuss Investigational Plan	Other-Agency Guidance	Modified
210599	Obtaining an FDA order authorizing marketing of tobacco product (the application)		Modified
210598	Small Scale Manufacturer Report		Removed
210597	Cigar Warning Plan Manufacturers, Importers and Retailers		Modified

ICR Details

OMB Control No: 0910-0768	ICR Reference No: 202210-0910-017
Status: Historical Active	Previous ICR Reference No: 201907-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Deeming Tobacco Products To Be Subject to the FD&C Act
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/02/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/25/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2025	36 Months From Approved	12/31/2022
Responses	849	0	1,040
Time Burden (Hours)	1,381,099	0	1,287,800
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports requirements applicable to the review of tobacco products by FDA. In addition, the information collection supports meeting request with FDA for persons who would like to study new tobacco products.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 101 Name of Law: The Family Smoking Prevention and Tobacco Control Act
   US Code: 21 USC 301 et seq Name of Law: The 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:
	87 FR 25280	04/28/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 62414	10/14/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
Cigar Warning Plan Manufacturers, Importers and Retailers
Exemptions From the Required Warning Statement Requirement
Obtaining an FDA order authorizing marketing of tobacco product (the application)
Request for meeting with CTP's Office of Science to discuss Investigational Plan
Small Scale Manufacturer Report

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ICR Summary of Burden

table that charts list of burden

	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	849	1,040	0	0	-191	0
Annual Time Burden (Hours)	1,381,099	1,287,800	0	0	93,299	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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: Although we have removed burden associated with cigar and pipe tobacco warnings (set forth in 21 CFR 1143.3 and 1143.5), we characterize this submission as an extension because the removals were made as a result of a September 2020 court order vacating these requirements and not through any agency action. We discuss this more fully in our supporting statement and in our 60- and 30-day Federal Register notices.

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Annual Cost to Federal Government: $6,462,775

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: 10/25/2022

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