Veterinary Feed Directive (Proposed Rule)

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
5990	Veterinary Feed Directive (Proposed Rule)	Migrated

ICR Details

OMB Control No: 0910-0363	ICR Reference No: 199910-0910-011
Status: Historical Active	Previous ICR Reference No: 199907-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Veterinary Feed Directive (Proposed Rule)
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: 10/29/1999
	Date Received in OIRA: 10/29/1999
Terms of Clearance: Approval of this collection covers only the existing collection. FDA shall assess comments received regarding this collection in the final rule. We are taking this action because the agency requested public comment on this collection when the implementing regulations were proposed. However, FDA has previously extended this collection numerous times without seeking public comment. Approval is granted for only one year. To extend this collection prior to its expiration, FDA will have to submit a request to OMB formally. An additional emergency extension will not be granted.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2002	10/31/2002	10/31/1999
Responses	1,885,101	0	20,000
Time Burden (Hours)	121,329	0	5,000
Cost Burden (Dollars)	0	0	0

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Abstract: Under the Animal Drug Availability Act (ADAA), the Food and Drug Administration is proposing to amend the animal drug regulations to implement provisions for the Veterinary Feed Directives (VFD) Drugs. A VFD drug is a drug intended for use in animal feeds which is limited to use under the professional supervision of a licensed veterinarian. The proposed regulation would establish the requirements relating to the distribution and use of VFD drugs and animal feeds containing VFD drugs.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Veterinary Feed Directive (Proposed Rule)

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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	1,885,101	20,000	0	1,865,101	0	0
Annual Time Burden (Hours)	121,329	5,000	0	116,329	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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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: 10/29/1999

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