Veterinary Feed Directive

Forms and Documents

Document Name	Status
0363_Supporting Statement_2021.pdf Supporting Statement A	2021-06-07

IC Document Collections

IC ID	Document Title	Status
216539	Veterinary Feed Directive (Third-Party Disclosures)	Modified
216535	Veterinary Feed Directive (Recordkeeping)	Modified
216533	Veterinary Feed Directive (Reporting)	Modified

ICR Details

OMB Control No: 0910-0363	ICR Reference No: 202103-0910-012
Status: Received in OIRA	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	Date Submitted to OIRA: 06/08/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2021
Responses	7,507,340	3,005,311
Time Burden (Hours)	201,138	131,990
Cost Burden (Dollars)	0	0

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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.

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Authorizing Statute(s): PL: Pub.L. 104 - 250 5 Name of Law: Animal Drug Availability Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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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)

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ICR Summary of Burden

	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

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.

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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

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Common Form ICR:  No

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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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