THE PROPOSAL WOULD AMEND THE ANIMAL
DRUG REGULATIONS TO ESTABLISH CRITERIA AND PROCEDURES FOR APPROVAL
OF NEW ANIMAL DRUG APPLICATIONS FOR BULK NEW ANIMAL SUBSTANCES FOR
USE BY OR ON THE PRESCRIPTION OF LICENSED VETERINARIANS.
VETERINARIANS WILL BE ABLE TO OBTAIN APPROVED BULKN NEW ANIMAL DRUG
SUBSTANCES FOR COMPOUNDING DRUGS FOR USE IN THEI PRIVATE PRACTICES,
AND PHARMACISTS WILL BE ABLE TO COMPOUND SUCH SUBSTANCES ON THE
PRESCRIPTION OF A VETERINARIAN.
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.