Extralabel Drug Use in Animals -- Proposed Rule

ICR 199605-0910-002

OMB: 0910-0325

Federal Form Document

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
5903
Migrated
ICR Details
0910-0325 199605-0910-002
Historical Active
HHS/FDA
Extralabel Drug Use in Animals -- Proposed Rule
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 07/12/1996
Retrieve Notice of Action (NOA) 05/31/1996
  Inventory as of this Action Requested Previously Approved
07/31/1999 07/31/1999
2 0 0
8,320 0 0
0 0 0

The Animal Medicinal Drug Use Clarification Act of 1994 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.

None
None


No

1
IC Title Form No. Form Name
Extralabel Drug Use in Animals -- Proposed Rule

  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 0 0 2 0 0
Annual Time Burden (Hours) 8,320 0 0 8,320 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
05/31/1996


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