Extra Label Drug Use in Animals

ICR 201802-0910-009

OMB: 0910-0325

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-02-11
IC Document Collections
IC ID
Document
Title
Status
5906
Modified
ICR Details
0910-0325 201802-0910-009
Active 201501-0910-008
HHS/FDA CVM
Extra Label Drug Use in Animals
Extension without change of a currently approved collection   No
Regular
Approved without change 03/06/2018
Retrieve Notice of Action (NOA) 02/13/2018
  Inventory as of this Action Requested Previously Approved
03/31/2021 36 Months From Approved 03/31/2018
2 0 2
8,320 0 8,320
0 0 0

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.

PL: Pub.L. 103 - 396 2; Unapproved uses Name of Law: Animal Medicinal Drug Use Clarification Act
  
None

Not associated with rulemaking

  82 FR 28858 06/26/2017
83 FR 1262 01/10/2018
No

1
IC Title Form No. Form Name
Submission of Analytical Method

  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
No
No

$0
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
02/13/2018


© 2024 OMB.report | Privacy Policy