Tobacco Product Manufacturing Practice Requirements

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Part A Supporting Statement TPMP NPRM Final 3-13-2023.docx	Supporting Statement A	Uploaded 2023-03-13	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
257024	Manufacturing code		New
257023	Subpart H Recordkeeping and Document Controls Annual		New
257022	Subpart G Handling, Storage, and Distribution Annual Recordkeeping		New
257021	Subpart F Packaging and Labeling Controls Annual Recordkeeping		New
257020	Subpart E Process Controls Annual Recordkeeping		New
257019	Subpart D Design and Development Controls Annual Recordkeeping		New
257018	Subpart C Buildings, Facilities, and Equipment Annual Recordkeeping		New
257017	Subpart B Management System Requirements Annual Recordkeeping		New
257015	Subpart H Recordkeeping and Document Controls (One-Time)		New
257014	Subpart G Handling, Storage, and Distribution Recordkeeping (One-Time)		New
257012	Subpart F Packaging and Labeling Controls Recordkeeping (One-Time)		New
257004	Subpart E Process Controls Recordkeeping (One-Time)		New
257003	Subpart D Design and Development Controls Recordkeeping (One-Time)		New
256993	Subpart C Buildings, Facilities, and Equipment Recordkeeping (One-Time)		New
256992	Subpart B Management System Requirements Recordkeeping (One-Time)		New
256989	Petition for Exemption or Variance and Environmental Assessment		New

ICR Details

OMB Control No: 0910-0913	ICR Reference No: 202211-0910-006
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Tobacco Product Manufacturing Practice Requirements
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 04/18/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/13/2023
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration is proposing to establish tobacco product manufacturing practice requirements for manufacturers of finished and bulk tobacco products. The proposed rule, if finalized, would set forth the requirements with which finished and bulk tobacco product manufacturers must comply in the manufacture, preproduction design validation, packing, and storage of finished and bulk tobacco products. 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: 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:
0910-AH91	Proposed rulemaking	88 FR 15174	03/10/2023

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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: 16

table that charts list of burden

IC Title	Form No.	Form Name
Manufacturing code
Petition for Exemption or Variance and Environmental Assessment
Subpart B Management System Requirements Annual Recordkeeping
Subpart B Management System Requirements Recordkeeping (One-Time)
Subpart C Buildings, Facilities, and Equipment Annual Recordkeeping
Subpart C Buildings, Facilities, and Equipment Recordkeeping (One-Time)
Subpart D Design and Development Controls Annual Recordkeeping
Subpart D Design and Development Controls Recordkeeping (One-Time)
Subpart E Process Controls Annual Recordkeeping
Subpart E Process Controls Recordkeeping (One-Time)
Subpart F Packaging and Labeling Controls Annual Recordkeeping
Subpart F Packaging and Labeling Controls Recordkeeping (One-Time)
Subpart G Handling, Storage, and Distribution Annual Recordkeeping
Subpart G Handling, Storage, and Distribution Recordkeeping (One-Time)
Subpart H Recordkeeping and Document Controls (One-Time)
Subpart H Recordkeeping and Document Controls Annual

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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 proposed regulation--proposed part 1120 (21 CFR part 1120)--sets forth requirements for tobacco product manufacturing practice (TPMP) and provides a framework for manufacturers of finished or bulk tobacco products to follow.

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Annual Cost to Federal Government: $0

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.     No

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: 03/13/2023

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