Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
203555	Roll Your Own Tobacco Product - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms		Unchanged
203553	Smokeless - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms		Unchanged
203551	Cigarette - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms / Testing of HPHC		Unchanged

ICR Details

OMB Control No: 0910-0732	ICR Reference No: 202410-0910-007
Status: Active	Previous ICR Reference No: 202207-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
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: Approved without change	Conclusion Date: 01/03/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/25/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2025	08/31/2025	08/31/2025
Responses	424	0	424
Time Burden (Hours)	19,163	0	19,163
Cost Burden (Dollars)	0	0	0

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Abstract: This collection requires each tobacco product manufacturer or importer, or an agent, to report to FDA "all constituents, including smoke constituents, identified by [FDA] as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product." These entities must also provide similar information at least 90 days prior to introducing the product into interstate commerce.

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Authorizing Statute(s): PL: Pub.L. 111 - 111 31 Name of Law: The Family Smoking Prevention and Tobacco Control Act (the Tobacco Control 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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 6869	02/07/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 41730	07/13/2022
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
Cigarette - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms / Testing of HPHC	Form FDA 3787h, Form FDA 3787g, Form FDA 3787a, Form FDA 3787d , Form FDA 3787f, Form FDA 3787e
Roll Your Own Tobacco Product - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms	Form FDA 3787c, Form FDA 3787j
Smokeless - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms	Form FDA 3787b, Form FDA 3787i

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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	424	424	0	0	0	0
Annual Time Burden (Hours)	19,163	19,163	0	0	0	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: The total estimated burden for this information collection is expected to be 19,163 hours and 424 annual responses. Our estimated burden for the information collection reflects an overall increase of 354 annual responses and a corresponding increase of 16,647 hours. We attribute this adjustment to updated methodology in which the current estimates are derived from historical statutory tobacco product applications submitted and authorized by FDA in the past 4 years as (1) manufacturers and importers (or their agents) of authorized products are required to submit HPHC reports at least 90 days prior to delivery for introduction into interstate commerce for all new products and (2) initial reporting under section 904(a)(3) of the FD&C Act for statutory products was completed in 2012.

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Annual Cost to Federal Government: $352,515

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: 10/25/2024

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