Tobacco Health Document Submission

Forms and Documents

Document Name	Status
Form FDA 3743 Tobacco Health Document Submission Form and Instruction	Modified
0654SupportingStatementFinal 08-03-22.docx Supporting Statement A	2022-08-03

IC Document Collections

IC ID	Document Title	Status
254991	Health Document Submission Requirements for Tobacco Products; Guidance for Industry Other-Guidance: Health Document Submission Requirements for Toba	New
191698	Tobacco Health Document Submission Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0654	ICR Reference No: 202201-0910-006
Status: Received in OIRA	Previous ICR Reference No: 201903-0910-024
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Tobacco Health Document Submission
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/03/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2022
Responses	132	32
Time Burden (Hours)	1,800	1,600
Cost Burden (Dollars)	0	902

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Abstract: In the guidance document, FDA requests tobacco health document submissions from manufacturers and importers of tobacco products based on the statutory requirements and compliance dates. As indicated in the guidance, all manufacturers and importers of tobacco products are required to provide immediate and ongoing submission of health documents developed after June 22, 2009. However, FDA generally does not intend to enforce the requirement at this time with respect to all such health documents, so long as a specified set of documents, those developed between June 23, 2009, and December 31, 2009, are provided at least 90 days prior to the delivery for introduction of tobacco products into interstate commerce. Thereafter, manufacturers should preserve all health documents, including those that relate to products for further manufacturing and those developed after December 31, 2009, for future submission to FDA. Respondents submit information through a facilitative electronic form or in paper form using Form FDA 3743. In both forms, FDA requests information including: submitter identification, submitter point of contact, submission format and contents (as applicable), confirmation statement, document categorization (as applicable), document readability and accessibility, and document metadata. The information collected will inform FDA's regulatory processes and decision making such as, development of good manufacturing practices, review standards for new tobacco products, and regulation of modified risk tobacco products, among others.

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Authorizing Statute(s): US Code: 21 USC 904(a)(4) Name of Law: FFDCA
  

Citations for New Statutory Requirements: PL: Pub.L. 117 - 103 111 Name of Law: The Consolidated Appropriations Act of 2022

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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 10800	02/25/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 43875	07/22/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Health Document Submission Requirements for Tobacco Products; Guidance for Industry
Tobacco Health Document Submission	FDA 3743	Tobacco Health Document Submission

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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	132	32	100	-110	110	0
Annual Time Burden (Hours)	1,800	1,600	200	0	0	0
Annual Cost Burden (Dollars)	0	902	0	0	-902	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: We have added 200 hours based on new authority provided by the Consolidated Appropriations Act, 2022. Additionally, we have removed the mailing costs that were assumed as capital costs as we no longer believe this is a capital cost. We now estimate the burden for this collection to be 1,800 hours.

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Annual Cost to Federal Government: $117,505

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: 08/03/2022

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