Approved
consistent with clarifications in FDA memos of 8-29-02 and
9-12-02.
Inventory as of this Action
Requested
Previously Approved
11/30/2005
11/30/2005
09/30/2002
2
0
2
8,320
0
8,320
0
0
0
The Animal Medicinal Drug Use
Clarification Act of 1994 amended the FD&C Act to allow
licensed veterinarians to prescribe extra label 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.
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.