Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products

Forms and Documents

Document Name	Status
Nicotine PRIA.pdf Supplementary Document	2025-01-16
NPRM SSA Nicotine Product Standard FINAL.docx Supporting Statement A	2025-01-16

IC Document Collections

IC ID	Document Title	Status
273738	Review and familiarization with the rule - one time burden Other-proposed rule	New
273734	Package label requirements (manufacturing code)	New
273733	Procedures: products and related investigations of; control and disposition for nonconforming tobacco products	New
273732	Analytical test method, Sampling plan	New
273526	Product testing and batch testing	New

ICR Details

OMB Control No:	ICR Reference No: 202501-0910-002
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/16/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	10,022	0
Time Burden (Hours)	121,083	0
Cost Burden (Dollars)	0	0

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Abstract: The Food and Drug Administration is proposing to establish tobacco product standards, including product standards that include provisions for nicotine yields and for the reduction or elimination of other constituents (including smoke constituents) or harmful components. The proposed rule, if finalized, would set forth the requirements to limit nicotine yield by setting a maximum nicotine content level for finished cigarettes and certain other finished combusted tobacco products not to exceed 0.70 mg of nicotine per gram of total tobacco. The information collection requirements support the need for the FDA to assure that the public health is protected, and tobacco products are in compliance with the requirements of the FD&C Act.

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Authorizing Statute(s): US Code: 21 USC 387f Name of Law: FFDCA
   US Code: 21 USC 387i Name of Law: FFDCA
   US Code: 21 USC 387b-c Name of Law: FFDCA
   US Code: 21 USC 387j Name of Law: FFDCA
   US Code: 21 USC 331 Name of Law: FFDCA
   US Code: 21 USC 371 Name of Law: FFDCA
   US Code: 21 USC 374
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AI76	Proposed rulemaking	90 FR 5032	01/16/2025

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Analytical test method, Sampling plan
Package label requirements (manufacturing code)
Procedures: products and related investigations of; control and disposition for nonconforming tobacco products
Product testing and batch testing
Review and familiarization with the rule - one time burden

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ICR Summary of Burden

	Total Request	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	10,022	0	0	10,022	0	0
Annual Time Burden (Hours)	121,083	0	0	121,083	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $16,804

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: 01/16/2025

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