Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway

ICR 201909-0910-003

OMB: 0910-0454

Federal Form Document

ICR Details
0910-0454 201909-0910-003
Active 201609-0910-002
HHS/FDA CVM
Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway
Extension without change of a currently approved collection   No
Regular
Approved without change 11/18/2019
Retrieve Notice of Action (NOA) 10/16/2019
  Inventory as of this Action Requested Previously Approved
11/30/2022 36 Months From Approved 11/30/2019
251 0 38
20 0 3
0 0 0

This information collection request collects information from sponsors of new animal drug applications who wish to submit pre-market information to Center for Veterinary Medicine (CVM) using the FDA Electronic Submissions Gateway (ESG). These types of documents are listed in public docket FDA-1992-S-0039 as required by 21 CFR 11.2. CVM's guidance # 108 entitled "Guidance for Industry: How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway," outlines general standards to be used for the submission of any electronic information to CVM using the FDA ESG, including how to register with CVM's Electronic Submission System (ESS).

None
None

Not associated with rulemaking

  84 FR 15621 04/16/2019
84 FR 55160 10/15/2019
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 251 38 0 0 213 0
Annual Time Burden (Hours) 20 3 0 0 17 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Our estimated burden for the information collection reflects an overall increase of 17 hours and a corresponding increase of 213 responses. We attribute this adjustment to the reauthorizations of both the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act, which require sponsors to submit information electronically to CVM’s Office of New Animal Drug Evaluation. Because of this requirement, sponsors are now registering to use the CVM ESS in greater numbers than in previous years.

$950
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.
10/16/2019


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