Virus-Serum-Toxin Act and Regulations in 9 CFR Subchapter, Parts 101-124
Revision of a currently approved collection
No
Regular
Approved without change
02/28/2012
12/15/2011
In accordance with the terms of 5 CFR 1320, OMB approves this collction of information for a period of 18 months. During that time, APHIS should develop a plan by which the forms associated with this collection can be submitted electronically. During that period, APHIS should also take into consideration the public comment received on this collection and determine whether it is feasible to waive the requirements for minor changes to labels, as suggested.
When submitting this collection for reapproval, APHIS should also submit a written response to both of these issues.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
08/31/2013
36 Months From Approved
02/29/2012
19,304
0
21,726
74,386
0
80,937
0
0
0
The purpose of this collection is to verify that compliance requirements for biological products used in the United States are met (i.e., the products are pure, safe, potent, and effective).
In the previous information collection there were 500 total respondents and in the current collection there are 202 total respondents; a decrease of -298 total respondents from the previous collection due to fewer requests for licenses.
The Autogenous Biologics Labels were deleted from the collection causing a program change decrease of -30 respondents and -30 responses resulting in a decrease of -15 burden hours. However, with the addition of the Individual IC (Due diligence petition and certification statement of true and completed copy and Request for restriction on distribution and use of veterinary biological product) there is a program change increase of +1 respondent and +2 responses with an increase of +2 burden hours. The total program change is -29 respondents, -28 responses and -13 hours.
With fewer request for licenses there were adjustments to both the State and business ICs. There is an adjustment to the State IC with a decrease of -42 responses and -1 burden hour. Under the Business IC there was an adjustment of -2,352 responses and -6,537 burden hours to the various recordkeeping responses. The total adjustment is -2,394 responses and -6,538 total burden hours.
$451,034
No
No
No
No
No
Uncollected
Donna Malloy 301 734-3277
Reginfo record details
No
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.
Virus-Serum-Toxin Act and Regulations - Business