OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Tobacco Health Document Submission

ICR 201308-0910-007 · OMB 0910-0654 · Historical Active

Forms and Documents
Document
Name
Status
Form and Instruction
 Removed
Form and Instruction
 Modified
Supplementary Document
2013-08-06
Supporting Statement A
2013-08-27
IC Document Collections
IC ID
Document
Title
Status
191699 Removed
191698 Modified
ICR Details
0910-0654 201308-0910-007
Historical Active 201007-0910-005
HHS/FDA 20268
Tobacco Health Document Submission
Extension without change of a currently approved collection   No
Regular
Approved without change 12/13/2013
Retrieve Notice of Action (NOA) 08/28/2013
  Inventory as of this Action Requested Previously Approved
12/31/2016 36 Months From Approved 12/31/2013
8 0 832
400 0 8,000
208 0 828
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
  78 FR 21379 04/10/2013
78 FR 49527 08/14/2013
Yes
  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 8 832 0 0 -824 0
Annual Time Burden (Hours) 400 8,000 0 0 -7,600 0
Annual Cost Burden (Dollars) 208 828 0 0 -620 0
No
No
FDA expects that this collection of information will experience a burden decrease of 7,600 hours because the number of documents received each year since the original collection period has fallen to less than 5 percent of what was received in the original collection period. FDA expects this is because most documents created within the specified period have already been submitted. Also, the number of respondents who might still have documents to submit has decreased.
$242,000
No
No
No
No
No
Uncollected
JonnaLynn Capezzuto 301 827-4659 jonnalynn.capezzuto@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.
08/28/2013