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Title: Requesting International Inspections
Release Date: 14 Dec 2018 Author: SKARLI Document Number: CVB-WI-0080.02

Nb
Veterinary Services
FA

facthieceacn _- Requesting International Inspections

Service

Veterinary Services

Center for Veterinary

Biologics

1920 Dayton Avenue

PO Box 844

Ames, IA 50010

(51) 337-6100
Document Number: CVB-WI-0080 Revision: 02
Previous Number: ICWI0045.01
Author: SKARLI
Section/Area: CVB-WI-IC
Release Date: 14 Dec 2018
Notes:

Printed by: LSNAVELY on 18 Dec 2018, 12:37:12 pm.
For Official Use Only


Title: Requesting International Inspections
Release Date: 14 Dec 2018 Author: SKARLI Document Number: CVB-WI-0080.02

Requesting International Inspections

Source Document: Title 9, Code of Federal Regulations, part 104.5(a)(2)

Under normal circumstances, international inspections are conducted as a special inspection (i.e.,
pre-permitting inspection) or an in-depth (on-going compliance) inspection. Follow-up
inspections are generally not conducted on foreign locations. If necessary, discuss the need with
the Section Leader — Inspection and the Inspection and Compliance (IC) Director for
concurrence.

The process described involves multiple parties and will be followed for scheduling, establishing
cooperative agreements, funding, and international notification for all international inspections.
For pre-permitting inspections, please allow approximately 6 months for approvals. In-depth
inspections can be scheduled approximately 3 months out.

The International Inspection Checklist attached as an appendix to this document describes each
of the steps and responsible parties to conduct the steps. CVB-SOP-0024, Delegation of
Authority for Center for Veterinary Biologics-Inspection and Compliance, should also be
consulted for delegation of authority, if necessary, for approvals.

To use the checklist, follow the order of steps and activities. Each step identifies the
“Responsible Party” that is to initiate each step and who they are to “Inform” based on position
titles. Please make sure that every position identified in the “Inform” box is notified as
instructed. Additionally, information is included regarding “Timeframe” on the checklist for
each step.

The CSA Information Document prepared by the IC DO details the expected itinerary for the trip
from departure to arrival back in Ames, Iowa. Please pay particular attention to the draft CSA
Information Document when you receive it for review and make sure the expected time
allocations are appropriate for the inspection/travel. Once approved, the Information Document
forms the basis for the budget preparation and eventual funding by the U.S. Permittee of the
inspection, including your salary and benefits, all travel expenses, and any travel compensation
time. Any deviations from the expected itinerary require approval by the IC DO, MPA, and the
U.S. Permittee, and may require additional funds be deposited in advance of the trip.

Additional details for Specialist are as follows when using the International Inspection Checklist
— numbering follows the numbering listed on the Checklist.

1. Schedule Inspection

a. International inspections are conducted every 2 years, unless otherwise noted.

b.
HE At that time, the Specialist assigned to the firm should contact the
permittee and set up an inspection date that is acceptable to the Permittee, foreign
manufacturer, and the CVB.
Please be aware of multiple sites that may need to be inspected and account for
appropriate time and methods of travel.

c. Once a date has been agreed on, request the inspection for all the appropriate sites in
LSRTIS. This should be completed no later than 6 months prior to the inspection.

Page | of 5

Printed by: LSNAVELY on 18 Dec 2018, 12:37:12 pm.
For Official Use Only


10.

14.

15.

Title: Requesting International Inspections
Release Date: 14 Dec 2018 Author: SKARLI Document Number: CVB-WI-0080.02

Requesting International Inspections

d. The Section Leader for Inspection will approve the inspection (all international
inspections are approved within 1 week of the LSRTIS request).
This will generate an email notification, including the IC Director. This is the flag to draft
the international travel notification, Step 2.

Prepare the Pre-Travel Worksheet and submit the travel request in accordance with CVB-

WI-0010, Requesting to Attend Training or Travel for CVB

a. In some cases, the foreign site or permittee may make lodging reservations for you.
While this is acceptable, the Specialist is responsible for the expense. The lodging and
any taxes must be within the lodging per diem for that area. If not, actual subsistence may
be requested. If the lodging reservations are made for you, please email the following to

i. Name, address and phone number of the hotel

ii. Copy of the reservations, including confirmation number

iii. Rate quoted, including all taxes (can be in foreign currency — so remember to include
the unit of measure)

iv. Cancellation policy

Provide travel info (cost and flight schedule)
The flights (cost and schedule) may change when ticketed as there are no guarantees until the
ticket is issued, but this estimate provides a basis for the expenses listed on the CSA.

Review travel information and confirm
If there are questions concerning time needed for the actual inspection based on the travel
information, please consult with a Section Leader or the IC Director.

Draft CSA Information Document

Many times LSRTIS does not have all the information required for the CSA. The IC Director
will ask the Specialist for the site contact at the foreign facility. The information required is
name, phone number, and email. The site contact should have an APHIS Form 2007 on file
with CVB.

Confirm CSA Information

Please pay particular attention to the DRAFT CSA Information Document when you receive
it for review and make sure the expected time allocations are appropriate for the
inspection/travel.

Prepare Excel T&A Worksheet

The IC Director will provide a Time & Attendance worksheet in Excel that will form the
basis for the inspection. You should follow this very closely and not deviate unless travel
conditions cause delays. Inspection days are capped at 8 hours. You will be compensated for
actual travel time.

Request Travel Comp in WebTA
Once you are provided this shell, you should request the appropriate amount of travel comp

in WebTA and make note of the CSA # in the WebTA remarks.
Page 2 of 5

Printed by: LSNAVELY on 18 Dec 2018, 12:37:12 pm.
For Official Use Only