Tobacco Health Document Submission

ICR 201903-0910-024

OMB: 0910-0654

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2019-05-20
IC Document Collections
IC ID
Document
Title
Status
191698 Modified
ICR Details
0910-0654 201903-0910-024
Active 201710-0910-014
HHS/FDA CTP
Tobacco Health Document Submission
Extension without change of a currently approved collection   No
Regular
Approved without change 09/18/2019
Retrieve Notice of Action (NOA) 05/21/2019
  Inventory as of this Action Requested Previously Approved
09/30/2022 36 Months From Approved 09/30/2019
32 0 32
1,600 0 1,600
902 0 832

FDA guidance on this collection requested health documents that were created during the period of June 23, 2009, through December 31, 2009. FDA is in the process of revising the April 2010 guidance but will continue collecting documents created during the period of June 23, 2009 through December 31, 2009, from any manufacturers, importers, or their agents who still have documents to submit. The information collected will inform FDA's development of good manufacturing practices, review standards for new tobacco products, and regulation of modified risk tobacco products, among others. Respondents submit information through a facilitative electronic form or in paper form using Form FDA 3743. In both forms, FDA is requesting the following information: 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.

US Code: 21 USC 904(a)(4) Name of Law: FFDCA
  
None

Not associated with rulemaking

  83 FR 42664 08/23/2018
84 FR 22860 05/20/2019
Yes

1
IC Title Form No. Form Name
Tobacco Health Document Submission FDA Tobacco Health Document Submission

  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 32 32 0 0 0 0
Annual Time Burden (Hours) 1,600 1,600 0 0 0 0
Annual Cost Burden (Dollars) 902 832 0 0 70 0
No
No

$242,000
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  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.
05/21/2019


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