Veterinary Feed Directive

ICR 202103-0910-012

OMB: 0910-0363

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2021-06-07
IC Document Collections
ICR Details
0910-0363 202103-0910-012
Received in OIRA 201804-0910-018
HHS/FDA CVM
Veterinary Feed Directive
Extension without change of a currently approved collection   No
Regular 06/08/2021
  Requested Previously Approved
36 Months From Approved 07/31/2021
7,507,340 3,005,311
201,138 131,990
0 0

A VFD drug is a drug intended for use in animal feeds and limited to use under the professional supervision of a licensed veterinarian. This information collection request supports the agency's regulations establishing the requirements for the distribution and use of VFD drugs and animal feeds containing VFD drugs. Respondents to the collection are VFD Feed distributors, veterinarians, and food animal producers.

PL: Pub.L. 104 - 250 5 Name of Law: Animal Drug Availability Act
  
None

Not associated with rulemaking

  85 FR 83968 12/23/2020
86 FR 26532 05/14/2021
No

  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 7,507,340 3,005,311 0 0 4,502,029 0
Annual Time Burden (Hours) 201,138 131,990 0 0 69,148 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This information collection reflects adjustments since last OMB approval. We attribute the increase in reporting, recordkeeping, and cost burden to the significant increase in the number of VFD distributors that have transitioned new animal drugs from over-the-counter to VFD marketing status. This is a result of VFD regulations that were implemented by a rule that published in 2015. Not all distributors transitioned right away. As a result, we believe that the numbers are now a better representation of the distributors. We have since decreased the number of new distributors required to submit first-time notifications. We have also since increased the number of respondents submitting updated notifications for business changes due to the higher number of VFD distributors subject to VFD reporting requirements since the previous collection. Because we attribute the increased number to the information collection, we have increased our estimate of the associated burden accordingly. The information collection, therefore, reflects a cumulative increase in burden by 4,502,029 annual responses and 69,148 burden hours.

$11,853
No
    No
    No
No
No
No
No
Amber Sanford 301 796-8867 [email protected]

  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.
06/08/2021


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