SS viruses, serums, toxins, new

SUPPORTING STATEMENT
VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; SUSPENSION,
REVOCATION, OR TERMINATION OF BIOLOGICAL LICENSES OR PERM;
INSPECTIONS
OMB NUMBER 0579-xxxx
February 27, 2006
A. Justification
1. Explain the circumstances that make the collection of information necessary. Identify
any legal or administrative requirements that necessitate the collection. Attach a copy of
the appropriate section of each statute and regulation mandating or authorizing the
collection of information.
The Virus-Serum-Toxin Act (37 Stat. 832-833, 21 U.S.C. 151-159) gives the United States
Department of Agriculture (USDA) the authority to promulgate regulations designed to prevent
the importation, preparation, sale, or shipment of harmful veterinary biological products. These
regulations are contained in Title 9, Code of Federal Regulations, Subchapter E, Parts 102 to
124.
A veterinary biological product is defined as all viruses, serums, toxins, and analogous products
of natural or synthetic origin (such as vaccines, antitoxins, or the immunizing components of
microorganisms intended for the diagnosis, treatment, or prevention of diseases in domestic
animals).
Under APHIS’ regulations in section 105.3(a), the Center for Veterinary Biologics, Animal and
Plant Health Inspection Service (APHIS), USDA, may notify a licensee or permittee to stop the
preparation, sale, barter, exchange, shipment, or importation of any biological product if, at any
time, it appears that such product may be dangerous in the treatment of domestic animals.
APHIS believes it is imperative to use the most expeditious means available to notify anyone
who may be in possession of such products that a stop distribution and sale action has occurred.
Any delay in this notification process increases the risk that these products could cause harm to
animals, the public health, or to the environment.
On April 9, 2003 APHIS published in the Federal Register (68 FR 17327-17330, Docket
Number 02-107-1) a proposed rule specifying actions that veterinary biologics licensees and
permittees must take when APHIS issues a stop distribution and sale notice concerning a
veterinary biological product. This process entails the use of two information collection
activities.
First, licensees and permittees must notify their wholesalers, jobbers, dealers, consignees, or
other persons in their respective distribution systems that a stop distribution and sale order has
been issued by APHIS.

Second, licensees and permittees must obtain a complete accounting of the inventory of the
product in the possession of wholesalers, jobbers, dealers, consignees, or other persons in their
respective distribution systems.
APHIS is asking the Office of Management and Budget (OMB) to approve for 3 years, the
information collection activities associated with this proposed rule. This information is needed in
connection with APHIS’ efforts to prevent biological products from harming animals, the public
health, or the environment.

2. Indicate how, by whom, how frequently, and for what purpose the information is to be
used. Except for a new collection, indicate the actual use the agency has made of the
information received from the current collection.
Notification Process
After being contacted by APHIS, veterinary biologics licensees or permittees must immediately
provide stop distribution and sale notification to wholesalers, jobbers, dealers, consignees, or
other persons in their respective distribution systems known to be in possession of serials or
subserials of veterinary biologics that are involved in the APHIS stop distribution and sale
action. This notification must be documented, in writing, and submitted to APHIS as
verification that the notification process has been promptly implemented. In addition to
notification information, licensees and permittees must document – and submit to APHIS – any
other communications they have with wholesalers, jobbers, dealers, consignees, or others
concerning the stop distribution and sale action.
Accounting of Inventory
Veterinary biologics licensees or permittees must provide APHIS with a complete accounting of
the inventory in the current possession of each wholesaler, jobber, dealer, consignee, or other
person engaged in the distribution and sale of the serials or subserials subject to the APHIS stop
distribution and sale action. These inventories can be transmitted electronically by these
individuals to the licensee or permittees, who can then electronically transmit this information to
APHIS. APHIS must have this information in order to successfully monitor the whereabouts of
the biologics while they are being removed from distribution channels. In addition to inventory
information, licensees and permittees must document – and submit to APHIS – any other
communications they have with wholesalers, jobbers, dealers, consignees, or others concerning
the stop distribution and sale action.

3. Describe whether, and to what extent, the collection of information involves the use of
automated, electronic, mechanical, or other technological collection techniques or other
forms of information technology, e.g., permitting electronic submission of responses, and
the basis for the decision for adopting this means of collection. Also describe any
consideration of using information technology to reduce burden.

The information collected in connection with this program may be submitted to APHIS via fax,
or via e-mail. No official VS forms are used in the collection of this information.

4. Describe efforts to identify duplication. Show specifically why any similar information
already available cannot be used or modified for use for the purpose described in item 2
above.
The information that APHIS is requesting is exclusive to mission of preventing continued use of
veterinary biological products that are ineffective or harmful. No other Federal agency is
responsible for regulating veterinary biological products.

5. If the collection of information impacts small businesses or other small entities, describe
any methods used to minimize burden.
The information APHIS is requiring is the absolute minimum needed to ensure that potentially
harmful veterinary biologics do not cause harm to animals, the public health, or the environment.
Electronic submission of this information should make this reporting task even less timeconsuming.

6. Describe the consequence to Federal program or policy activities if the collection is not
conducted or is conducted less frequently, as well as any technical or legal obstacles to
reducing burden.
Failing to require this information from licensees and permittees could result in the continued
use of veterinary biologics products that are ineffective or harmful to animals.

7. Explain any special circumstances that require the collection to be conducted in a
manner inconsistent with the general information collection guidelines in 5 CFR 1320.5.
This project would be conducted in a manner consistent with the general information collection
guidelines established in 5 CFR 1320.5.

8. Describe efforts to consult with persons outside the agency to obtain their views on the
availability of data, frequency of collection, the clarity of instructions and recordkeeping,
disclosure, or reporting form, and on the data elements to be recorded, disclosed, or
reported. If applicable, provide a copy and identify the date and page number of
publication in the Federal Register of the agency's notice, soliciting comments on the
information collection prior to submission to OMB.

In 2007, APHIS has held productive consultations with the following individuals in connection
with its proposed system for promptly notifying wholesalers, dealers, jobbers, consignees, and
other persons that a stop distribution and sale order has occurred:
Dr. Norman Habermehl
Merial, Inc.
115 Transtech Drive
Athens, GA 30601
706-548-9292
[email protected]
Mary Anne Williams
Synbiotics Corporation
16420 Via Esprillo
San Diego, CA 92127
858-451-3770 (Ext 1502)
[email protected]
Dr. Garris Harris
Boehringer Ingelheim Vetmedica, Inc.
2621 North Belt Highway
St. Joseph, MO 64506
800-821-7467
[email protected]
The proposed rule, Docket Number 02-107-1, was published in the Federal Register on
Wednesday, April 9, 2003, with a 60-day comment period. During this time, interested members
of the public had the opportunity to provide their input concerning the usefulness, legitimacy,
and merit of the information collection activities APHIS was proposing.
9. Explain any decision to provide any payment or gift to respondents, other than
reenumeration of contractors or grantees.
This information collection activity involves no payments or gifts to respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for the
assurance in statute, regulation, or agency policy.
No additional assurance of confidentiality is provided with this information collection.
However, the confidentiality of information is protected under 5 U.S.C. 552a.

11. Provide additional justification for any questions of a sensitive nature, such as sexual
behavior or attitudes, religious beliefs, and other matters that are commonly considered
4

private. This justification should include the reasons why the agency considers the
questions necessary, the specific uses to be made of the information, the explanation to be
given to persons from whom the information is requested, and any steps to be taken to
obtain their consent.
This information collection activity will ask no questions of a personal or sensitive nature.

12. Provide estimates of the hour burden of the collection of information. Indicate the
number of respondents, frequency of response, annual hits burden, and an explanation of
how the burden was estimated.
•Indicate the number of respondents, frequency of response, annual hits burden, and an
explanation of how the burden was estimated. If this request for approval covers more than
one form, provide separate hits burden estimates for each form and aggregate the hits
burdens in Item 13 of OMB Form 83-I.
See APHIS Form 71 for burden hour estimates. Burden estimates were developed from
discussions with veterinary biologics licensees and permittees, with wholesalers, jobbers,
dealers, consignees, and other persons; and with State and Federal personnel engaged in the
regulation of veterinary biologics.
•Provide estimates of annualized cost to respondents for the hits burdens for collections of
information, identifying and using appropriate wage rate categories.
Respondents are veterinary biologics licensees and permittees, as well as certain wholesalers,
jobbers, dealers, consignees, or other persons who must provide inventory data to licensees or
permittees in the event of a stop distribution and sale order. APHIS estimates the total
annualized cost to these respondents at $5,300. APHIS arrived at this figure by multiplying the
hours of estimated response time (106) by the estimated average hourly wage of the above
respondents ($50.00).

13. Provide estimates of the total annual cost burden to respondents or recordkeepers
resulting from the collection of information (do not include the cost of any hits burden
shown in items 12 and 14). The cost estimates should be split into two components: (a) a
total capital and start-up cost component annualized over expected useful life; and (b) a
total operation and maintenance and purchase of services component.
There is zero annual cost burden associated with capital and start-up costs, operation and
maintenance expenditures, and purchase of services.

14. Provide estimates of annualized cost to the Federal government. Provide a description
of the method used to estimate cost and any other expense that would not have been
incurred without this collection of information.

The annualized cost to the Federal Government is estimated at $5,632.36.
(See APHIS Form 79.)
15. Explain the reasons for any program changes or adjustments reported in Items 13 or
14 of the OMB Form 83-1.
This is a new collection that will collect information about stop distribution and sale notification
to wholesalers, jobbers, dealers, consignees, or other persons totaling 106 hours of burden.

16. For collections of information whose results are planned to be published, outline plans
for tabulation and publication.
APHIS has no plans to publish information it collects in connection with this program.

17. If seeking approval to not display the expiration date for OMB approval of the
information collection, explain the reasons that display would be inappropriate.
There are no forms associated with this collection.

18. Explain each exception to the certification statement identified in "Certification for
Paperwork Reduction Act."
APHIS can certify compliance with all provisions under the Act.
B. Collections of Information Employing Statistical Methods
Statistical methods will not be used in connection with this project.