Extension without change of a currently approved collection
No
Regular
09/27/2022
Requested
Previously Approved
36 Months From Approved
10/31/2022
63
51
4,299
3,604
0
0
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 (ANADA) is
described in section 512(n)(1) of the FD&C Act (21 U.S.C.
360b(n)(1)). Among other things, an ANADA is required to contain
information to show that the proposed generic drug is bioequivalent
to, and has the same labeling as, the approved new animal drug. We
allow applicants to submit a complete ANADA or to submit
information in support of an ANADA for phased review. Form FDA 356v
facilitates a complete ANADA or a phased review submission to
ensure efficient and accurate processing of information.
Our estimated burden for the
information collection reflects an overall adjustment increase of
695 hours and a corresponding increase of 12 responses, based on an
increase in the number of respondents submitting generic drug
applications.
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.