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4.1 Applicant Eligibility

Each person making application to import veterinary biologics shall reside, or operate a
business, in the United States. Under U.S. law, only domestically produced products may be
issued a license; therefore, foreign-produced product must be imported under a permit. The
holder of the permit is therefore a U.S. entity importing the foreign-produced biologic for
research and evaluation and is legally responsible for regulatory compliance.

Consider the affiliation and location of the applicant as part of the review. Specifically, CVB
will generally not issue a permit to a home address, a mobile address (e.g., a boat on Puget
Sound), or to someone with no affiliation to an established veterinary clinic, academic
institution, commercial manufacturer, animal producer, or diagnostic laboratory. If the
applicant uses their home address or a warehouse address, is not forthcoming about the
purpose of the import, and wants to import a large quantity of vaccines or diagnostic kits,
then they may intend to market them. Some importers think that importing “for research
purposes only” means that they can market or distribute products to research facilities.

It is acceptable for a broker or assistant to be involved in the import process but not as the
permit applicant/ holder. The applicant must be the end user of the product since the entity
named on the permit is responsible for adhering to the permit conditions. The only exception
is if the permit scenario includes a 9 CFR 103.3 restriction that, once fulfilled, allows the
product to be moved elsewhere. Sometimes the e-Authentication account associated with the
application is different than the applicant name. This may be acceptable if it means an
assistant submitted the permit on behalf of the applicant.

4.2 Reviewing Data Fields from APHIS Form 2005

Applicants for R & E and transit permits must use the NCAH Portal; do not accept paper
applications. Level 1 e-authorization is required for applicants to submit these permit
applications, which is less than the level-2 authorization required for other biologics
submissions. Review each entry on the Mail Log entry screen; these align with APHIS Form
2005. If any information is too vague, ask the applicant for more details. Specific details for
the reviewer to consider include:

e Previous Permit #: This information is only to aid the reviewer if similar
applications have been made in the past. Permits are valid for one year and cannot be
renewed. Applicants must re-apply yearly to receive a new permit.

e Name and Address of Applicant: See applicant eligibility criteria above.

Name and Address of Producer: This field refers to the producer of the product
being imported. The country of origin is the most important factor and will be further
discussed below. The producer organization is often the next most important thing to
consider; does it appear to be a legitimate institution versus someone’s home address?
Sometimes the applicant will identify the producer but indicate in another field of the
application that the material is being shipped from another location, such as a
distributor; this is acceptable.

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7.2 APPENDIX 2: Example R&E Permit

United States
Department of Agricultu re

UNITED STATES VETERINARY BIOLOGIGAL PRODUCT PERMIT
RESEARCH AND EVALUATION

No. VB-178485
as Issued at Washington, D.C. on 04/14/2019
Expires: 04/15/2020

This permit is issued pursuant to the tems of the Act of Comrass approved March 4, 1913 (37 State. 832),
govaming the preparation, sale, barter, exchanye, shipsent, and importation of veterinary biological products
So far as the jurisdiction of the U.S. Department of Agriculture is concemed,

John Doe

Super Laboratory

1234 Street, Ames, [A 50010

is authorized to isport

ABC Company Salmonella ELISA Plates

This product is 2 Diagnostic to be used In Vitro

Product is a diagnostic ELISA kit containing plates coated with Salmonella antigen and a positive control antiserum produced
in goats. No other ingredients of animal origin are included. The kit will be used to screen sheep samples for experimental
purposes, Samples and unused imported material will be autoclaved.

prepared by

ABC Company

Jane Doe

1234 Rue, Paris, France

into the United States throwh the port of Any US Port

Importation shell be made subject to the followiny special conditions:

This importation is authorized in accordance with Title 9, Code of Federal Regulations, Part 104 for evaluation at the
research/containment facility or diagnostic laboratory specified in the application filed with the Animal and Plant Health
Inspection Service. All unused portions of imported materials must be autoctaved or incinerated before disposal. Imported
materials have not been approved by the USDA for sale and distribution. Therefore any claims regarding the prevention,
diagnosis, management or cure of animal diseases have not been proven

A COPY OF THIS PERMIT MUST BE INCLUDED WITH THE SHIPMENT FOR PORT INSPECTION.

This permit aay be revoked if the permittee violates or fails to comply with said Act, the regulations
nade theramzler, or the conditions speci fied herein.

04142019

Date for Director, Canter for Veterinary Biologics Animal amd Plant
Health Inspection Service
‘APH FORM 2005 @R 2m)

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our extensive licensing process, the CVB allowed an unlicensed live vaccine to be
used under commercial/field conditions.

4.3.8.4 Country of origin is free of FAD of concern to APHIS

At a minimum, request a subset of information from the Import SIF, including
ingredients of animal origin, sources and history of seeds/cells, and a list of other
organisms maintained in the facility. If this information and a study protocol raise no
undue concerns, safety testing is typically not necessary. For an inactivated product,
request and review detailed information about the inactivation method and
confirmatory testing.

4.4 Safety Testing

As indicated above, some applications can only be approved subject to satisfactory safety
testing by the National Veterinary Services Laboratories (NVSL). This typically occurs at
the Foreign Animal Disease Diagnostic Laboratory (FADDL) on Plum Island for non-poultry
FAD and in the Diagnostic Virology Laboratory (DVL) in Ames for poultry diseases.

Use the following procedure for NVSL-FADDL:

e Notify the applicant that, due to the risk factors or failure to provide satisfactory
information, safety testing by the USDA is required. Use the following language, or
equivalent applicable wording, in correspondence to the applicant: “This product
must be safety tested at the USDA’s Foreign Animal Disease Diagnostic Lab
(FADDL) as a condition of import. If you wish to proceed, the CVB will notify
FADDL, and a permit will be issued to allow importation to FADDL via John F
Kennedy International airport. The product will be released to you only after
satisfactory testing at FADDL. In most cases, transport and testing will cost $500 to
$1,000, depending on the number of samples and pathogens tested. The exact cost is
subject to project details.”

e Ifthe applicant agrees to proceed: Notify FADDL (FADDL Director, or currently Dr.
Ming Deng) via email of the need for safety testing. Include a completed copy of the

form found at K:\CVB PEL Shared\Risk Manager\CVB
Permits & Docs.

e Issue an R&E permit to the FADDL Director to import the product to FADDL only
via JFK airport.

e FADDL provides and instructs the applicant to complete the “PIADC Risk
Assessment Questionnaire.”

e Once safety testing has been completed, FADDL is authorized by this permit to
transfer the material to the permittee

Use the following procedure for NVSL-DVL:

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4.3.1 Import Summary Information Format (SIF)

Depending on the product being imported and the country where it is manufactured, an
applicant may need to submit a SIF for the Importation of Veterinary Biological Products
into the United States from Countries where Foreign Animal Diseases Exist and Other
Specified Countries prior to issuing a permit. This SIF identifies critical information
regarding the manufacturing facilities, reagents included in diagnostic kits, ingredients
used in production, production procedures, and testing procedures to be evaluated when
assessing the risk of importation. Key portions of the SIF may be required to evaluate the
application even when the foreign country is not known to have foreign animal diseases
of concern to APHIS. Required information typically includes inactivation procedures,
inactivation confirmation testing, origin of any ingredients of animal origin included in
the product or used in the manufacturing process, and a list of other organisms
maintained in the producer facility.

4.3.2 Product Labeling Insert

If available, a product insert should be submitted with every application. This is strongly
enforced with vaccines, but has become flexible for diagnostic kits due to the volume and
repeated requests for the same kits. If the insert is not provided because of repeated
applications, be sure a previous permit number, citing the location where an insert can be
found, is listed.

4.3.3 State Veterinarian Approval

This may be requested to support any permit request but is typically limited to unique
situations. Always ensure the applicant requests approval when an unlicensed biologic
will be used in client-owned animals or animals outside of containment. Common
examples include imported anti-venin or when an importer plans to share product with
another in the same local area (which may be reasonable in an outbreak scenario). From a
practical standpoint, the CVB never wants a State Veterinarian to be caught unaware if a
controversial event occurs from the use of an unlicensed veterinary biologic. For
example, repeat importation of a diagnostic test kit for an endemic disease for use in a
State Diagnostic laboratory may not need approval, but importation of a vaccine that has
the potential to trigger a program disease traceback into the State would need approval. If
a new State approval is not provided for a repeat application, ensure that the Mail Log
record links to the prior permit application where a State Vet approval is attached.

4.3.4 Study Protocol

Ensure that applications for all biologics other than diagnostic kits contain at least a brief
protocol describing the intended use. This should, at a minimum, include where product
will be stored, a description of any animals receiving the product, the location of the
study, biosafety level, waste handling, and disposal method of animals from the study.
As applicable, ensure there is assurance the animals given imported biologic will not

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e Product Name: There is no required convention; usually the applicant lists the Trade
Name. Only one product per permit is allowed. If the applicant wants to import
multiple different products, then they need to apply for multiple permits.

e Product Type: This interface is a picklist, currently limited to Vaccine, Diagnostic
kit, or Other.

e In Vitro/In Vivo: Clarifies whether the product will be administered to animals (in
vivo) or not (in vitro) or both.

e Product Description: A general description of the vaccine or kit. Ensure that the
description and/or Product Name includes, at a minimum, the information equivalent
to that included in the True Name of a USDA-regulated biologic such as which
antigens are in the product, whether its live or killed, recombinant or conventional,
etc.

e Product Use or Evaluation: A brief description of intended use. This field is often
enough to support approval of a diagnostic kit, but vaccines require additional
documentation discussed below.

e Estimated Arrival Date: This information is most significant for transit permits (to
arrange pick up) and to coordinate any pre-use safety testing of products under R&E
(see Section 4.5).

e Estimated Quantity: The NCAH Portal currently limits entries to mL (for vaccines)
and tests (for diagnostics). Consider the potential for illicit marketing if volumes
seem unreasonably high for single institution use. Note that the quantity is not
included in the final permit and is not tracked in any way once the permit is issued.

e Port of Entry: This defaults to “Any US Port” and currently can only be changed by
the CVB. The most common reasons to limit the port of entry are to allow safety
testing at the Foreign Animal Disease Diagnostic Laboratory (FADDL), Diagnostic
Virology Laboratory (DVL), or to control transit shipments. Note: Sometimes the
applicant may list a specific port e.g. FedEx hub in Memphis) and an arrival date that
is a few days away. This may mean that they shipped the product without a permit.
Since part 104.1(a) indicates that the shipment must have a permit before it enters the
US, the CVB is not obligated to cut corners with import requirements or “rush
through” an application if it is placed on hold by U.S. Customs.

e Institution Info: This will often be “same as applicant.” If another institution is
involved in the evaluation, such as a contract research organization, ensure it is listed
here. If the applicant intends to move the material to another institution, a 9 CFR
103.3 restriction likely applies as described in Section 4.6.

4.3 Supporting Documentation

Some or all of the following documents may be necessary to evaluate an application;
consider them on a case-by-case basis. These documents may be attached to the initial
application, but often the reviewer will need to request these via email and subsequently
upload them to the application. (The NCAH Portal functionality for R&E and transit permits
does not include the ability for submitters to upload their own supporting documents
subsequent to the initial submission.)

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Signature Manifest Title: Import Permits for Research and Evaluation or Transit Shipment Only

Release Date: 20 Jul 2020

Author:

Page 1 of 1

Document Number: CVB-SOP-5109.01

CONTROLLED//PROPIN//BASIC

Signature Manifest

Document Number: CVB-SOP-5109
Title: Import Permits for Research and Evaluation or Transit Shipment Only

Effective Date: 20 Jul 2020

Revision: 01

All dates and times are in Central Standard Time.

CVB-SOP-5109 01 Import Permits for Research and Evaluation or Transit Shipment Only

Review for Doc Format

Name/Signature
CROSLEY HERR (CRHERR)

Director Final Approval

Title
QM Program Asst

Date
11 May 2020, 01:48:27 PM

Meaning/Reason
Approved

Name/Signature Title Date Meaning/Reason
PAUL HAUER (PHAUER) CVB PEL DIRECTOR 09 Jun 2020, 01:15:06 PM Approved

Final Quality Check

Name/Signature Title Date Meaning/Reason
MARK PAGALA (MPAGALA) Assistant Director 20 Jul 2020, 03:27:24 PM Approved

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file:///E:/Mastercontrol/Pub/installedServices/publishingGL V T/adlib/work/mcjobs/all/6BD1E73C...

10/4/2022


Title: Import Permits for Research and Evaluation or Transit Shipment Only
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Veterinarian approval does not by itself supersede any requirements and does not mean
the application will be approved.

4.3.8 Country of Origin

Applications can generally be grouped into risk scenarios based on country of origin.
Consult the following sources to evaluate the FAD status of a particular country:
e — https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-
product-import-information/animal-health-status-of-regions
e — https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-
product-import-information
e — https://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/a
pm.pdf
e VS International Health also sends out real-time notifications from the World
Organization for Animal Health (OIE) on disease outbreaks.

4.3.8.1 Country of origin has foot and mouth disease (FMD) virus

By default, the CVB will not approve for import any kit or vaccine, whether live or
killed, from an FMD-positive country. Any consideration of unique circumstances
requires the items below for other FADs, and the proposed evaluation is typically
restricted to BSL-3 facilities.

4.3.8.2 Country of origin has other FADs of interest to APHIS

Whether the product is live or inactivated, err toward the conservative side on import
decisions. Use the full Import SIF and study protocol as the basis for the risk
analysis. For vaccines, a safety test is typically required. State Vet approval and
facility restrictions (e.g. BSL-3) also may be warranted.

4.3.8.3 Country of origin is low FAD risk with caveats

In some cases, the APHIS Disease Status notes that a country, while free of a
particular FAD, is in proximity, or has trade practices, with countries that are
affected. Many EU countries fall into this category. For a live product, treat the
product the same as if it were from a country with FADs and request additional
information. For an inactivated product, request and review detailed information
about the inactivation method and confirmatory testing. If satisfactory, safety testing
may not be required.

APHIS-level risk assessments are performed for the import of certain commodities,
e.g. meat, live animals, semen/embryos. Since these risk assessments do not address
vaccine safety, the CVB is justified in requiring, for example, a safety test for CSF
and/or FMD for the import of a live swine vaccine from the EU. Even with a safety
test, the CVB would likely restrict the vaccine to use in containment under laboratory
conditions, not in commercial herds/flocks. It would set a difficult precedent if, with

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Title: Import Permits for Research and Evaluation or Transit Shipment Only

Release Date: 20 Jul 2020 Author: ay Document Number: CVB-SOP-5109.01

Health Inspection
Service

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

CONTROLLED//PROPIN//BASIC

Import Permits for Research and Evaluation or Transit Shipment
Only

Document Number: CVB-SOP-5109 Revision: 01
Previous Number:

Vault: CVB-Released

Section/Area: CVB-SOP-PEL

Effective Date: 20 Jul 2020

Notes:

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4.5.5 Prelicense Serials

Applicants pursuing a permit for General Sale and Distribution (S&D) must import pre-
licensing serials for confirmatory testing, but they may not always identify the shipment
as part of the pre-licensing process on their R&E permit application. Contact the CVB
reviewer assigned to the applicant firm if there are questions and to ensure the
importation is not premature. Occasionally applicants want to import a large quantity of
product as soon as they apply for the S&D permit, before they have submitted an Outline
of Production or any other preliminary information. Unless there are extenuating
circumstances, decline such requests and instruct the applicant to reapply for the R&E
permit once the reviewer has accepted supporting information.

4.5.6 Disease Emergency or Outbreak

In the case of a state or federal disease outbreak for which no USDA-licensed product
exists, an R&E permit may be used to import product for use in the field. This typically is
limited to inactivated products, preferably licensed in a country with proper regulatory
oversight, and is subject to a CVB risk analysis. State Veterinarian approval is required,
as well as approval by any relevant USDA programs.

4.5.7 FAD or USDA Program Diseases

Do not allow importation of vaccines against FADs or USDA Program diseases unless
there is USDA approval from the appropriate program. Kits for USDA Program
diseases, such as tuberculosis and brucellosis, are usually imported by State veterinary
diagnostic labs. Do not allow importation of FAD diagnostic kits unless explicitly
approved by the Director of the National Animal Health Laboratory Network (NAHLN).
Historically specific applications have been approved after consultation with the
NAHLN, NVSL, and upper management. Research use by reputable institutions may be
approved with specific restrictions. Obtain State Veterinarian approval for the initial
permit for kits for USDA Program diseases or FADs.

4.5.8 Select Agents

Do not allow vaccines for protection against Select Agents without additional federal
approval. Safety testing would likely be required. Some diagnostic kits, such as those
for brucellosis, may be approved if they do not contain live organisms or toxins. If there
are questions, consult Program staff.

4.5.9 Product Manufactured in the US, Exported, and Re-Imported

Requests to re-import finished product are subject to restrictions in 9 CFR 104.2(d) and
104.4(d). Re-imported product may not be used in animals in the US. Small quantities
may be re-imported under an R&E permit for in vitro testing only.

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e Imported material mu:
Services Laboratories,
The permittee should contact NVSL for packing and shipping instructions.

e Prior to shipment, provide with the
following information: flight number, waybill number, date and time of arrival, and a
copy of this permit. This information should also be sent via email to

e Once safety testing has been completed, DVL is authorized by this permit to transfer
the material to the permittee

4.5 Specific Application Scenarios

4.5.1 Diagnostic Kits

This is the most common permit request, often associated with biologics firms or
university/commercial diagnostic laboratories. Often the target diseases are endemic, and
seemingly similar alternatives may be licensed in the US. To date, applications have not
been denied based on possible alternatives. Although kits imported under an R&E permit
are not to be sold or distributed, the CVB recognizes that some laboratories may use these
kits in fee-for-service testing.

4.5.2 Master Seeds and Cells

A common jurisdiction issue is whether the organism is currently an approved master
seed/cell (regulated by the CVB) or an unapproved “master seed/cell” (regulated by
APIE). An organism/cell is not truly a master seed/cell until it has been approved as such
by the CVB. APIE might not know if something described by the applicant as a master
seed/cell is currently approved or if the applicant is using the term because they want to
get it approved someday. APIE might check with the CVB whenever they see the
“master” terminology. A firm must have the necessary APIE permits to import an
unapproved seed/cell into the US for confirmatory testing. Even with an APIE permit,
these items may not be moved into a biologics production area without CVB approval.
The CVB may require additional information and testing for such movement.

4.5.3 Live Vaccines

The CVB typically limits live vaccines to facilities where biocontainment can be assured.
Additional risk analysis and scrutiny are needed prior to allowing outside of
biocontainment.

4.5.4 Recombinant Vaccines

Recombinant vaccines or Master Seeds are acceptable only for use in a proper
biocontainment facility or as part of an in vitro diagnostic kit. Do not approve live
recombinants for use outside of containment due to NEPA requirements.

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enter the food chain. If there have been previous studies, reviewers may request a
summary of those studies.

4.3.5 Experimental Labels

In some cases an experimental label should be submitted for the file. The label must
include an accurate description of the product, any warnings, and the statement
"Unlicensed veterinary biological product for experimental use only, not for sale."

4.3.6 Client Consent Forms

Applicants must provide a copy of the client consent form they will use when
administering product imported under an R&E permit in client-owned animals. The
consent form, at a minimum, must include information similar to an experimental label
(section 4.3.5) and a place for the client to confirm an understanding of this information.
In an outbreak situation, the form might also instruct the client to keep proof of
vaccination, especially if treatment might impact diagnostic testing.

4.3.7 Risk Analysis

The primary concern for evaluating CVB permits is the risk of introducing a foreign
animal disease (FAD) into the US. In general, the CVB has an extremely low risk
tolerance related to FADs. This is especially true for any product that contains ingredients
of animal origin or is proposed for use in animals. For vaccines, the following
information is minimally required and assessed for each situation. A description of the
product and ingredients of animal origin including source, a product insert, a study
protocol describing any animals being used, a description of vaccine storage facilities and
animal study facilities including biosafety level, proposed treatment of lab waste, and
treatment of animal waste and carcasses.

Diagnostic kits are generally given more flexibility, primarily because most kits are
utilized by trained laboratories and not in contact with animals. However, some kits are
not considered zero risk, so scrutinize diagnostic kits applications in regard to use (e.g.,
pen-side), country of origin, live components, and ingredients of animal origin.

Other factors may be relevant to the risk review. Are there alternative products available
in the US? Does the country of origin have a recognized competent regulatory authority
with oversight of the product? Does the foreign producer have a CVB permit for
distribution and sale for other products? What is the quantity being requested? Is there a
history of approvals for this applicant/producer? Is the applicant at a University with an
Institutional Biosafety Committee (IBC) approval of the project?

Some items may not be relevant. For example, a request to import a live vaccine for dogs
from a country with an FAD of concern to APHIS is not exempt from any requirements
just because the dog is not known to be susceptible to the FAD. Likewise, a State

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3. Regulatory Jurisdiction of Imports

The first step in the import permit process is often determining the appropriate jurisdiction. The
CVB only provides permits for veterinary biologics as defined in 9 CFR part 102. Veterinary
biologics include vaccines, bacterins, toxoids, antiserum, antitoxins, diagnostic kits, and
immunomodulators for the prevention, diagnosis, or treatment of animal diseases. Conversely,
Veterinary Services, Animal Product Import and Export (APIE) provides permits for bacteria,
viruses, toxins, et al (Organisms and Vectors) and cells, serum, antibodies, et al (Animal
Products) that do not meet the specific criteria of a biological product. The APIE is granted an
overarching authority under the Animal Health Protection Act that is not afforded to the CVB
under the Virus-Serum-Toxin Act. Therefore, APIE regulates the import and interstate
movement of material unless it is clearly identified by the permit applicant as a veterinary
biologic. The permittee is responsible for submitting accurate information and understanding the
nature of the material that they want to import.

There may be gray areas between the CVB and APIE. The CVB only has the authority to
regulate veterinary biological products and cannot regulate the components of veterinary
biological products, which may include potential master seeds, potential master cell lines,
reagents, or manufacturing components. Thus, the CVB typically draws the line at “complete” or
“final form” products. For example, a vaccine in a bottle that is ready to give to an animal is a
final product and under CVB jurisdiction, but an attenuated or recombinant virus that might
someday be a vaccine is an organism/vector under APIE jurisdiction. A complete diagnostic kit
is under CVB jurisdiction, but an antigen or antibody to be used in an in-house diagnostic assay
is under APIE jurisdiction. Although a diagnostic proficiency panel is used to support diagnostic
testing, it is ultimately a collection of organisms or antibodies and therefore regulated by APIE.
In cases where a jurisdiction case can be made for either the CVB or APIE, the most important
consideration is that ultimately one of the units reviews the application and determines whether a
permit should be granted.

Appendix 7.1 contains an example letter of no jurisdiction; this same language is often used in
response to email inquiries as well. APIE applicants must use VS Forms 16-3 and 16-7 and
submit via the APHIS e-permit system. Contact information for APIE is (301) 851-3300 or

APIE@usda.gov.

Examples of requested materials that have received no jurisdiction responses from CVB include:
bacterial/viral cultures, pig serum, human Zika virus kit, sheep bones, skin biopsies, human
antibodies, archeological materials, gel capsules, pregnancy tests, milk powder, lung samples,
pancreatic islets, pet treats, food, proficiency panels, and PCR primers.

4, Evaluating Import Applications for Research and Evaluation Permits

Consider the following areas when reviewing the permit applications. This SOP, however, may
not account for every situation or detail. Apply and weigh the principles on a case-by-case basis.

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Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Import Permits for Research and Evaluation or Transit Shipment Only
Release Date: 20 Jul 2020 Author: a Document Number: CVB-SOP-5109.01
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5. Evaluating Import Applications for Transit Only Permits

Requests for transit permits are uncommon. When requested, require a sound justification for
why a product needs to go through the US even though it can’t be used here. These permits
typically have a short expiration period (a couple months) to cover the anticipated transit
timeline. Common application scenarios include:

5.1 Shipped through a US port

This is the most common reason for a transit permit. Even though the product will not be
unpackaged or used in the US, Customs needs this permit to move the product through the

port.
5.2 Research in another country

Occasionally an applicant will try to use a transit permit to bring product into the US with an
explanation that they intend to take the product with them to another country for use. The
CVB prefers these products be sent directly to the country where they will be used.

5.3 Vaccination of animals in transit

A transit permit is appropriate since the product is not unpackaged or used on US soil. The
product is administered on a shipping boat departing the US for another country. The shipper
must be working with a USDA VMO for this scenario. The VMO is the permit applicant and
holder. Place a restriction on the permit similar to the one titled “Transit Shipment Specific
for Inactivated FMD”.

6. Processing Permit Applications in the Mail Log

Process all permits through the NCAH Portal. Instruct applicants who attempt to submit hard
copy to resubmit via the Portal. Applicants for R&E or transit permits need only a Level 1 e-
Authentication, less than that required for other submissions to the CVB.

e R&E and Transit applications will go to the Permit Pool tab in the mail log. From here,
anyone with access to the pool can self-assign the ML to their own Active queue.

e The application should be reviewed based on the criteria discussed elsewhere in this SOP.

e Ifadditional information is needed to make a decision, the ML item can be child looped
to “request info from submitter.” However, a request can’t actually be sent this way, the
information will need to be requested via another route such as email and then added to
the ML.

e All fields should be checked for accuracy, the fields below require action. Click Edit Mail
Item to start processing the application.

e The submitter frequently leaves the “Brief Submission Description” box blank. To

Printed by: ANONYMOUS on 17 Oct 2023, 03:06:06 pm.
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Title: Import Permits for Research and Evaluation or Transit Shipment Only
Release Date: 20 Jul 2020 Author: Document Number: CVB-SOP-5109.01
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7. Appendices
7.1 APPENDIX I: Example No Jurisdiction Letter
<date>
<applicant address>
Dear <name of applicant>:

Importation of a mammalian cell line is not regulated by the Center for Veterinary Biologics
because it is not a veterinary biological product. Veterinary biologics include vaccines,
bacterins, antitoxins, and diagnostic kits for the prevention, diagnosis, or treatment of animal
diseases.

Please review the Import Guidelines on the following web page to determine if your item fits
in one of these categories and therefore would not need an import permit:
https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-
information/import-live-animals/no-import-permit-req

If these Guidelines are not applicable to your item, submit an import permit application using
Veterinary Services (VS) Form 16-3, Application for Permit to Import or Transport
Controlled Material or Organisms or Vectors, through the ePermits portal.

https://www.aphis.usda.gov/aphis/resources/sa_epermits/eauth-epermits

Please contact Animal Product Import and Export at (301) 851-3300 or at APIE@usda.gov
for more information.

Sincerely,

<reviewer name>
Risk Manager
Center for Veterinary Biologics

ML xxxxx

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Title: Import Permits for Research and Evaluation or Transit Shipment Only
Release Date: 20 Jul 2020 Author: Document Number: CVB-SOP-5109.01
CONTROLLED//PROPIN//BASIC

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1. Purpose and Scope

This chapter covers requirements and activities for the issuance of Center for Veterinary
Biologics (CVB) import permits. As indicated in title 9, Code of Federal Regulations (9 CFR),
part 104.1, “No biological product shall be brought into the United States unless a permit has
been issued for such product.” The CVB issues 3 kinds of import permits for veterinary
biologics. Only permits for Research and Evaluation or for Transit Shipment Only are discussed
in this document. Permits for Distribution and Sale are covered in CVB-SOP-0084.

The Research and Evaluation (R&E) Permit is for importation and use of an unlicensed.
veterinary biologic in the United States. These requests are common, and the material is
generally either a vaccine or a diagnostic kit. The material is typically limited to in vitro or
contained in vivo use, although this permit can also be used for field use of an imported
unlicensed product in special situations. This chapter covers jurisdiction determination,
application review, and processing of R&E permit applications. Note that material imported on
an R&E permit may still require further authorizations. This includes permission to move
anything into a licensed production area, or permission to ship the biologic elsewhere in the
United States as described in 9 CFR 103.3.

The Transit Only permit is for transport of unlicensed material that would normally be under
CVB jurisdiction from one foreign country to another by way of the United States. These
requests are rare and generally fall into two categories. First, the product may go through a US
port on the way to another country. Second, the product may be imported for use in animals
being shipped from the US, but not while in the US. For example, foot and mouth disease (FMD)
vaccine has been imported under the control of a Veterinary Services veterinarian to vaccinate
cattle on a ship headed to another country. Both cases are considered transit since the product is
not unpackaged or used within the US.

2. Related Documents

Regulations:
Title 9, Code of Federal Regulations (9 CFR), parts 104.1 — 104.7

Policy:

e NCAH Portal: https://ncahappspub.aphis.usda.gov/NCAHPortal/public/

e Portal permit application user guides:
https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-
biologics/sa_ncah_portal_guidance/ct_vb_ncah_portal_user_guides
APHIS Form 2005: https://www.aphis.usda.gov/library/forms/pdf/APH1S2005.pdf
SIF for Importation:
https://www.aphis.usda.gov/animal_health/vet_biologics/publications/SIF_import.pdf

e LSRTIS User Guide

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Title: Import Permits for Research and Evaluation or Transit Shipment Only
Release Date: 20 Jul 2020 Author: Document Number: CVB-SOP-5109.01
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Import Permits for Research and Evaluation or Transit Shipment Only

Mention of trademark or proprietary product does not constitute a guarantee or warranty of the product by USDA

and does not imply its approval to the exclusion of other products that may be suitable.

Table of Contents

1.
2.
3.
4.

w

. Evaluating Import Applications for Transit Only Permits

. Appendices...

Purpose and Scope..
Related Documents.
Regulatory Jurisdiction of Imports
Evaluating Import Applications for Research and Evaluation Permits.
4.1 Applicant Eligibility...
4.2 Reviewing Data Fields from APHIS Form 2005
4.3 Supporting Documentation...
4.3.1 Import Summary Information Format (SIF)
4.3.2 Product Labeling Insert ...
4.3.3 State Veterinarian Approval.
4.3.4 Study Protocol......
4.3.5 Experimental Labels.
4.3.6 Client Consent Form:
4.3.7 Risk Analysis

4.5 Specific Application Scenario:
4.5.1 Diagnostic Kits.....
4.5.2 Master Seeds and Cells.
4.5.3 Live Vaccines .......
4.5.4 Recombinant Vaccines
4.5.5 Prelicense Serials ....
4.5.6 Disease Emergency or Outbreak
4.5.7 FAD or USDA Program Diseases .
4.5.8 Select Agents.......
4.5.9 Product Manufactured in the US, Exported, and Re-Imported.
4.5.10 Antivenin/Antivenom

4.6 Permit Conditions (Restrictions

5.1 Shipped through a US port....
5.2 Research in another country ..
5.3 Vaccination of animals in transit
Processing Permit Applications in the Mail Log

7.1 APPENDIX I: Example No Jurisdiction Letter
7.2. APPENDIX 2: Example R&E Permit

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Title: Import Permits for Research and Evaluation or Transit Shipment Only
Release Date: 20 Jul 2020 Author: Document Number: CVB-SOP-5109.01
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Re-importation of approved master seeds or cells originally prepared in the US may
happen when a global company shuts down a facility. This situation may be approved,
subject to a thorough history of the materials and a risk review. Ideally the vials have not
been opened or manipulated in any way.

4.5.10 Antivenin/Antivenom

These products are frequently requested by southern US states and imported from Mexico
or South America, based on justifications of why US products are not sufficient. Ensure
that applications include a product description, justification, plan of use, client consent
form, and State Vet approval.

4.6 Permit Conditions (Restrictions)

Reviewers must select the appropriate conditions to print on the permit. One or more of the
following conditions is required on each permit. See LSRTIS LOV Report for APHIS
2005 Conditions to see full text of each currently used restriction. Reviewers may
modify the syntax of each condition as applicable. The permit automatically includes, “A
copy of this permit must be included with the shipment for port inspection.”

Condition Title in LSRTIS Use on Permits For

Antivenom Product Antivenins, antivenoms

Diagnostic Test Kits All diagnostic kits

Disclaimer only All biological products other than kits,
approved seeds/cells

Experimental Label Required For products requiring an experimental

label, usually those used outside of
containment.

FADDL Safety Test For non-poultry products requiring APHIS
safety testing prior to being shipped to the
permit applicant

NVSL Safety Test For poultry products requiring APHIS safety
testing prior to being shipped to the permit
applicant

Product Evaluation Under 103.3 For products for which a Permit for General

Sale and Distribution is being pursued. To
import such products for “pre-license”
evaluation before issuing the S&D permit.

Product Under Veterinary-Client-Patient For products to be used in client-owned
Relationship animals
Vaccine 104.4(d) Restriction For product originally manufactured in the

US, which was exported and is now to be
re-imported in small quantities for in vitro
research & evaluation

Vaccine Import Under Specific Conditions _| For in vivo use specified in application.

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Release Date: 20 Jul 2020 Author: Document Number: CVB-SOP-5109.01
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benefit future internal searches, a few words describing the product should be inserted by
the reviewer. These can often be copy and pasted from the Product Name box further
down the page.

e Select and add the appropriate Agents.

Choose the Final Disposition:

o Approved: a permit will be granted

o Canceled: application is a mistake, duplicate or per request from submitter

o Denied: application is appropriate but request not approved

o No Jurisdiction: product is not a biologic regulated by CVB

e Ifthe permit is approved, one or more Conditions (restrictions) must be selected and
added. Note these can be edited as needed.

e Click Update

e Ifthe application is approved, scroll down and click “Generate Report” to create the
permit.

o Review the permit wording for accuracy.

o Permits should be limited to one page. If longer, the text should be edited or
condensed to make the permit one page only.

o The default expiration date is one year, this can be edited on the permit as needed.

o Electronically sign the permit and check the “lock document after signing” box

o Save the permit PDF to K:\CVB PEL Shared\Risk Manager\CVB Permits &
Docs. The file name should be the same as the Permit No.

o Inthe ML, click the documents tab and upload the signed permit as outgoing
correspondence.

o After uploading, return to the documents tab and confirm the correct and signed
permit was added. There are no other internal checks before the permit is pushed
to the portal.

o Move the ML forward and choose Workflow completed-no records management.

e Ifthe application is canceled, denied, or no jurisdiction

o The appropriate template letter should be used and modified as needed for the
applications. These letters are composed outside of the ML.

o Templates are found at K:\CVB PEL Shared\Risk Manager\CVB Permits & Docs

o. The final letter should be converted to a PDF, and electronically signed.

o Save the letter PDF to K:\CVB PEL Shared\Risk Manager\CVB Permits & Docs.
The file name should be the same as the ML No.

o Inthe ML, click the documents tab and upload the signed letter as outgoing
correspondence.

o After uploading, return to the documents tab and confirm the correct and signed
letter was added. There are no other internal checks before the letter is pushed to
the portal.

e Move the ML forward and choose Workflow completed-no records management.

Printed by: ANONYMOUS on 17 Oct 2023, 03:06:06 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100