This ICR is
approved, consistent with the reporting and record keeping
requirements promulgated at 40 CFR Part 451 (FR Vol 69, No 162, Aug
23, 2004). Note that the brief characterization of the requirements
contained in Section 1 and 2 of the ICR supporting statement is
incomplete and does not include a number of important caveats and
exceptions that were included in the final rule to reduce burden.
For example, reporting on extra label and INAD use of drugs is not
required when the drug has been previously approved by FDA for a
different species or disease if the INAD or extra label use is at
or below the approved dosage and involves similar conditions of use
(40 CFR 451.3(a)). A more complete characterization of the
requirements is included in the ICR supporting statement in Section
4b. In any event, in case of ambiguity, this approval applies to
the reporting and recordkeeping requirements as promulgated in the
final rule and spelled out in 40 CFR Part 451.
Inventory as of this Action
Requested
Previously Approved
09/30/2007
09/30/2007
88
0
0
45,000
0
0
0
0
0
This data collection request is
required through an effluent guidelines regulation which controls
is the discharge of pollutions from concerntrated aquatic animal
production (CAAPs).
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.