Abbreviated New Animal Drug Applications

ICR 201908-0910-009

OMB: 0910-0669

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Form and Instruction
Modified
Supporting Statement A
2019-08-14
ICR Details
0910-0669 201908-0910-009
Active 201608-0910-009
HHS/FDA CVM
Abbreviated New Animal Drug Applications
Revision of a currently approved collection   No
Regular
Approved without change 10/08/2019
Retrieve Notice of Action (NOA) 09/09/2019
  Inventory as of this Action Requested Previously Approved
10/31/2022 36 Months From Approved 10/31/2019
51 0 33
3,604 0 3,339
0 0 0

This ICR collects information from animal drug manufacturers who seek approval of a generic copy of an approved new animal drug. The information required to be submitted as part of an abbreviated new animal drug application.

US Code: 21 USC 360b(b)(2) Name of Law: FD&C Act
  
None

Not associated with rulemaking

  84 FR 16270 04/18/2019
84 FR 46543 09/04/2019
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 51 33 0 18 0 0
Annual Time Burden (Hours) 3,604 3,339 0 265 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our previous estimate of the number of respondents submitting generic drug applications. However, as discussed, the burden for this information collection (a program change) was increased by 265 hours and 18 responses since the last OMB approval. This is due to adding to this collection burden hours and responses for biowaiver requests. We have also added to this collection a discussion of the use of veterinary master files by the animal pharmaceutical industry in support of information being submitted for NADAs, ANADAs, INAD files, and JINAD files.

$4,995,680
No
    Yes
    No
No
No
No
Uncollected
Jonna Capezzuto 301 796-3794 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.
09/09/2019


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