This ICR collects information from
animal drug manufacturers who seek approval of a generic copy of an
approved new animal drug. The information required to be submitted
as part of an abbreviated new animal drug application.
Based on a review of the
information collection since our last request for OMB approval, we
have made no adjustments to our previous estimate of the number of
respondents submitting generic drug applications. However, as
discussed, the burden for this information collection (a program
change) was increased by 265 hours and 18 responses since the last
OMB approval. This is due to adding to this collection burden hours
and responses for biowaiver requests. We have also added to this
collection a discussion of the use of veterinary master files by
the animal pharmaceutical industry in support of information being
submitted for NADAs, ANADAs, INAD files, and JINAD files.
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.