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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0363
ICR Reference No:
202103-0910-012
Status:
Active
Previous ICR Reference No:
201804-0910-018
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CVM
Title:
Veterinary Feed Directive
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/13/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/08/2021
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2024
36 Months From Approved
07/31/2021
Responses
7,507,340
0
3,005,311
Time Burden (Hours)
201,138
0
131,990
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
PL:
Pub.L. 104 - 250 5
Name of Law: Animal Drug Availability Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
85 FR 83968
12/23/2020
30-day Notice:
Federal Register Citation:
Citation Date:
86 FR 26532
05/14/2021
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Veterinary Feed Directive (Recordkeeping)
Veterinary Feed Directive (Reporting)
Veterinary Feed Directive (Third-Party Disclosures)
ICR Summary of Burden
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
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
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
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.
Annual Cost to Federal Government:
$11,853
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
06/08/2021
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