Extra Label Drug Use in Animals

Forms and Documents

Document Name	Status
0325 CVM Extra Label Use SSA 2018 Ext.pdf Supporting Statement A	2018-02-11

IC Document Collections

IC ID	Document Title	Status
5906	Submission of Analytical Method	Modified

ICR Details

OMB Control No: 0910-0325	ICR Reference No: 201802-0910-009
Status: Active	Previous ICR Reference No: 201501-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Extra Label Drug Use in Animals
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: 03/06/2018
	Date Received in OIRA: 02/13/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2021	36 Months From Approved	03/31/2018
Responses	2	0	2
Time Burden (Hours)	8,320	0	8,320
Cost Burden (Dollars)	0	0	0

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Abstract: The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), amended the FD&C Act to allow licensed veterinarians to prescribe extralabel uses in animals of approved drugs. Under AMDUCA, FDA may establish by regulation or order a safe residue level for an extralabel use and may require development of an analytical method for residue detection if it finds there is a reasonable probability of a risk to public health. Respondents to the collection, therefore, are private drug sponsors, veterinarian associations, veterinarians, or individuals submitting an analytical method for the quantification of residues for consideration by the agency.

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Authorizing Statute(s): PL: Pub.L. 103 - 396 2; Unapproved uses Name of Law: Animal Medicinal Drug Use Clarification 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:
	82 FR 28858	06/26/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 1262	01/10/2018
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
Submission of Analytical Method

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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	2	2	0	0	0	0
Annual Time Burden (Hours)	8,320	8,320	0	0	0	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:

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Annual Cost to Federal Government: $0

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? 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: 02/13/2018

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