Antimicrobial Animal Drug Sales and Distribution

ICR 202409-0910-001

OMB: 0910-0659

Federal Form Document

ICR Details
0910-0659 202409-0910-001
Received in OIRA 202205-0910-009
HHS/FDA CVM
Antimicrobial Animal Drug Sales and Distribution
Extension without change of a currently approved collection   No
Regular 05/12/2025
  Requested Previously Approved
36 Months From Approved 06/30/2025
362 389
8,384 8,438
0 505,773

This information collection requires that sponsors of each new animal drug that contains an antimicrobial agent submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. Its purpose is to ensure that the FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals.

US Code: 21 USC 360b Name of Law: FFDCA
  
PL: Pub.L. 110 - 316 105 Name of Law: Animal Drug User Fee Amendments

Not associated with rulemaking

  89 FR 84887 10/24/2024
90 FR 18662 05/01/2025
Yes

  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 362 389 0 0 -27 0
Annual Time Burden (Hours) 8,384 8,438 0 0 -54 0
Annual Cost Burden (Dollars) 0 505,773 0 0 -505,773 0
No
No
We have adjusted our burden estimate downward by which has resulted in a decrease to the currently approved burden. We attribute this to respondents who submitted by paper in previous years are now reporting electronically. We also note a decrease in recordkeeping respondents. We attribute this to the mergers of sponsors over the years.

$568,891
No
    No
    No
No
No
No
No
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.
05/12/2025


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