Tobacco Health Document Submission

ICR 202201-0910-006

OMB: 0910-0654

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2022-08-03
ICR Details
0910-0654 202201-0910-006
Received in OIRA 201903-0910-024
HHS/FDA CTP
Tobacco Health Document Submission
Revision of a currently approved collection   No
Regular 08/03/2022
  Requested Previously Approved
36 Months From Approved 09/30/2022
132 32
1,800 1,600
0 902

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.

US Code: 21 USC 904(a)(4) Name of Law: FFDCA
  
PL: Pub.L. 117 - 103 111 Name of Law: The Consolidated Appropriations Act of 2022

Not associated with rulemaking

  87 FR 10800 02/25/2022
87 FR 43875 07/22/2022
No

  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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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.

$117,505
No
    Yes
    No
No
No
No
No
Rachel Showalter 202 693-2146 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/03/2022


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