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

Forms and Documents

Document Name	Status

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

IC Document Collections

IC ID	Document Title	Status
203555	Roll Your Own Tobacco Product - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms	Modified
203553	Smokeless - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms	Modified
203551	Cigarette - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms	Modified

ICR Details

OMB Control No: 0910-0732	ICR Reference No: 201909-0910-010
Status: Active	Previous ICR Reference No: 201904-0910-006
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: 10/07/2019
	Date Received in OIRA: 09/27/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	08/31/2022	08/31/2022
Responses	70	0	70
Time Burden (Hours)	2,516	0	2,516
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:
	84 FR 744	01/31/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 25812	06/04/2019
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Cigarette - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms	Form FDA 3787g, Form FDA 3787h, Form FDA 3787a, Form FDA 3787d , Form FDA 3787f, Form FDA 3787e
Smokeless - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms	Form FDA 3787b, Form FDA 3787i
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

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ICR Summary 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	70	70	0	0	0	0
Annual Time Burden (Hours)	2,516	2,516	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: Our estimated burden for the information collection reflects an overall decrease of 2,125 hours and a corresponding decrease of 142 responses. We attribute this decrease to updated information on the number of submissions we received over the last few years. We removed the additional HPHC reports IC as these are no longer being submitted to FDA because as of August 2016, a court decision ruled that name and label changes (under substantial equivalence) do not render a product new.

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Annual Cost to Federal Government: $376,000

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

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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: 09/27/2019

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