Respondents to this information
collection are sponsors of abbreviated animal drug applications
(ANADA) seeking approval of a generic copy of an approved new
animal drug. These applications are required to contain information
to demonstrate that the proposed generic drug is bioequivalent to,
and has the same labeling as, the approved drug referenced in the
application. Form FDA 356V must also be completed and accompamy
each submission.
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.