Abbreviated New Animal Drug Applications

ICR 202202-0910-008

OMB: 0910-0669

Federal Form Document

Forms and Documents
Form and Instruction
Form and Instruction
Supporting Statement A
ICR Details
0910-0669 202202-0910-008
Received in OIRA 201908-0910-009
Abbreviated New Animal Drug Applications
Extension without change of a currently approved collection   No
Regular 09/27/2022
  Requested Previously Approved
36 Months From Approved 10/31/2022
63 51
4,299 3,604
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 (ANADA) is described in section 512(n)(1) of the FD&C Act (21 U.S.C. 360b(n)(1)). Among other things, an ANADA is required to contain information to show that the proposed generic drug is bioequivalent to, and has the same labeling as, the approved new animal drug. We allow applicants to submit a complete ANADA or to submit information in support of an ANADA for phased review. Form FDA 356v facilitates a complete ANADA or a phased review submission to ensure efficient and accurate processing of information.

US Code: 21 USC 360b(b)(2) Name of Law: FD&C Act
   US Code: 21 USC 512(n)(1) Name of Law: FD&C Act

Not associated with rulemaking

  87 FR 15436 03/18/2022
87 FR 57905 09/22/2022

  Total Request 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 63 51 0 0 12 0
Annual Time Burden (Hours) 4,299 3,604 0 0 695 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Our estimated burden for the information collection reflects an overall adjustment increase of 695 hours and a corresponding increase of 12 responses, based on an increase in the number of respondents submitting generic drug applications.

Rachel Showalter 202 693-2146 [email protected]


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.

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