Guidance for Industry on How to Use E-Mail Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway

ICR 201309-0910-004

OMB: 0910-0454

Federal Form Document

Forms and Documents
ICR Details
0910-0454 201309-0910-004
Historical Active 201005-0910-013
HHS/FDA 20469
Guidance for Industry on How to Use E-Mail Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway
Extension without change of a currently approved collection   No
Regular
Approved without change 11/21/2013
Retrieve Notice of Action (NOA) 09/13/2013
  Inventory as of this Action Requested Previously Approved
11/30/2016 36 Months From Approved 11/30/2013
156 0 16
12 0 1
0 0 0

This collection request covers certain electronic submissions with no requirements for a paper copy. These types of documents are listed in public docket 97S-0251 (subsequently changed to FDA-1992-S-0039) as required by 21 CFR 11.2. CVM's guidance entitled "Guidance for Industry: How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway," outlines how to register with CVM's Electronic Submission System (ESS). The likely respondents are sponsors of new animal drug applications who want to submit pre-market information to CVM using the FDA Electronic Submissions Gateway (ESG).

US Code: 21 USC 360b Name of Law: null
  
None

Not associated with rulemaking

  78 FR 28851 05/16/2013
78 FR 53772 08/30/2013
No

  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 156 16 0 0 140 0
Annual Time Burden (Hours) 12 1 0 0 11 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Extension of a currently approved collection.

$559
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@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.
09/13/2013


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