In accordance
with 5 CFR 1320, OMB is withholding approval for the collection at
this time. Prior to publication of the final rule, the agency must
provide to OMB all comments related to the new reporting comments
and associated burden. They should also provide a summary of their
responses and any changes made to the final rule as a result of
these comments.
Inventory as of this Action
Requested
Previously Approved
02/28/2006
09/30/2008
02/28/2006
1,000
0
1,000
1,000
0
0
0
0
0
We are amending the Virus-Serum-Toxin
Act regulations for records and reports. First, we are requiring
veterinary biologics licensees are permittees to record and submit
reports to APHIS concerning adverse events associated with the use
of biological products that they produce or distribute. Second, we
are requiring veterinary biologics licensees and permittees to
report to APHIS the number of doses of each licensed product that
they distribute. Third, we are allowing reports to be
electronically submitted to APHIS.
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.