APHIS Form 2070 Application for Authorization to Ship Master Seed or Cel

According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it
displays a valid OMB control number. The valid OMB control number for this information collection is 0579-0013. The time required to complete this information collection is
estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information.
This application may be submitted to request authorization to ship biological samples for confirmatory testing by APHIS.
U.S. DEPARTMENT OF AGRICULTURE
ANIMAL AND PLANT HEALTH INSPECTION SERVICE
VETERINARY SERVICES, CENTER FOR VETERINARY BIOLOGICS (CVB)
1920 DAYTON AVE, AMES, IA 50010

OMB Approval
0579-0013
EXP: XX/XXXX

INSTRUCTIONS: See reverse side.
1. NAME AND FULL MAILING ADDRESS OF APPLICANT

APPLICATION FOR AUTHORIZATION TO SHIP MASTER SEED OR CELL
SAMPLES FOR CONFIRMATORY TESTING BY APHIS
2. U.S. VET. EST.
3. APPLICATION TYPE:
NO.

 NEW

 AMENDMENT
TO SUBMISSION DATED______________
AND/OR PRIOR CVB MAIL LOG NO______________

CVB USE ONLY

4. ITEM(S) TO BE SHIPPED (USE SEPARATE FORM FOR EACH SEED OR CELL)
A. COMPLETE IDENTIFICATION OF SEED/CELL, EXACTLY AS IT APPEARS ON CONTAINERS
(INCLUDING LOT NO.)
BASELINE PASSAGE

B. PASSAGE

X

C. HOW TO BE
SHIPPED

D. BIOTECH- E. QUANTITY
DERIVED
REQUESTED BY APHIS

 DRY ICE
 LIQUID
NITROGEN

HIGH PASSAGE (CELLS AND BIOTECHNOLOGY-DERIVED SEEDS ONLY)

X+______

 OTHER (describe)

 YES
 NO

PARENTAL CONSTRUCT (BIOTECHNOLOGY-DERIVED ONLY)

CHECKLIST OF SUPPORTING MATERIAL
ITEM

5. MASTER SEED OR CELL REPORT

DESCRIPTION
(SEE INSTRUCTIONS ON REVERSE SIDE FOR ADDITIONAL GUIDANCE)

B. DATE AND/OR
CVB MAIL LOG ID OF
PRIOR SUBMISSION

HISTORY, PREPARATION, AND TESTING OF SEED OR CELL
STEPWISE PROCEDURES FOR NON-CODIFIED ASSAYS
USED TO TEST SEED/CELL

6. ASSAY PROTOCOLS
7. SUMMARY OF INFORMATION FORMAT

A. WITH THIS
APPLICATION
("X")

FOR BIOTECHNOLOGY-DERIVED OR IMPORTED SEEDS/CELLS

8. ELECTRONIC FILES CONTAINING
GENETIC SEQUENCE DATA

BIOTECHNOLOGY-DERIVED SEEDS/CELLS
OR AS REQUESTED BY APHIS

9. OTHER
10. BY DEFAULT, ALL CVB COMMUNICATIONS ARE DIRECTED TO THE APHIS LIAISON FOR THE ESTABLISHMENT. IF YOU WISH TO DESIGNATE A LABORATORY CONTACT TO HANDLE
COMMUNICATIONS FOR THIS SEED/CELL, LIST THIS INDIVIDUAL BELOW.
A. CONTACT NAME
B. PHONE
C. EMAIL

11. OTHER COMMENTS

I agree to ship samples in accordance with applicable USDA and hazardous shipping regulations and to provide any reagents requested by the CVB. I agree to
provide the CVB with an anticipated shipping date, ideally 2 weeks beforehand. Once shipped, I will provide tracking information.
12. PRINTED NAME AND TITLE OF APPLICANT

13. SIGNATURE OF APPLICANT (Paper Submissions Only)

14. DATE SUBMITTED

FOR CENTER FOR VETERINARY BIOLOGICS USE ONLY

The applicant is authorized to ship the above Seed/Cell to the CVB, with any Exceptions that may be attached (i.e., if there is a check in the box in item 19). Ship
the requested quantity of samples and reagents under cover of APHIS Form 2020, noting the test authorization and, if applicable, institutional biosafety committee
numbers in the Remarks section. Ship to the CVB address listed above, addressed to the attention of the CVB Laboratory Coordinator. This authorization is valid
for 90 days, after which a new authorization number must be requested. Samples without a valid authorization may be destroyed.
15. TEST AUTHORIZATION NO

16. INSTITUTIONAL BIOSAFETY COMMITTEE NO (genetically modified Seed/Cell only)

17. CENTER FOR VETERINARY BIOLOGICS LABORATORY COORDINATOR

18. COORDINATOR’S EMAIL

19. APPLICATION APPROVED BY (Signature)

APHIS FORM 2070
OCT 2017

 CVB EXCEPTIONS ATTACHED
 OTHER DOCUMENTS ATTACHED

20. DATE APPROVED

21. CVB MAIL LOG NO.

INSTRUCTIONS FOR COMPLETING APHIS FORM 2070:
Submit one copy of the form. Enclose two copies of each supporting document,
except for electronic files. If additional space is needed, attach additional sheets
and refer to Item No.
If APHIS’s Center for Veterinary Biologics (CVB) approves the request, the CVB
will complete items 4E and 14-21 and return the form to the applicant.
1. NAME AND FULL MAILING ADDRESS OF APPLICANT
Enter the establishment name and complete mailing address (street, city, state,
ZIP) of the applicant. The processed form will be returned to this address.
2. U.S. VETERINARY ESTABLISHMENT NUMBER
Enter the veterinary biologics establishment number assigned by APHIS.
3. APPLICATION TYPE
Indicate whether this is a new request or an amendment to a prior authorization.
If it is an amendment, enter the submission date and, if known, the CVB mail log
number of the prior submission. The CVB mail log number appears in Item 21 of
processed forms.
4. ITEMS TO BE SHIPPED
Applicants should prepare to ship a baseline passage (x) of conventional Master
Seeds. Master Cells and biotechnology-derived Master Seeds require a baseline
passage and the highest passage to be used in production (typically X+20 for
cells and X+5 for Seeds). Parental constructs also may be required for Seeds
with defined gene insertions or deletions.
A. Complete Identification: Enter the complete identification of the Seed/Cell,
including lot number, exactly as it appears on Seed/Cell container labels. If the
identifier on the container contains only acronyms or abbreviations and does not
clearly state the agent or cell type, add this information in parentheses at the
end.
B. Passage: All baseline passages are considered passage X. Specify the
passage beyond X for the high passage item.
C. How to be shiped: Specify whether the samples will be shipped to the CVB
on dry ice, liquid nitrogen, or some other defined environmental condition.
E. Biotech-derived: Indicate whether the Seed/Cell is derived from
biotechnological methods.
D. Quantity Requested by APHIS: This item will be completed by the CVB upon
review of the application. The amount will typically be in accordance with 9CFR
113.3(c)(1 through 4), unless extra samples are needed for testing specific to an
individual Seed or Cell.
CHECKLIST OF SUPPORTING MATERIAL
The checklist includes items that must be satisfactorily reviewed by the CVB prior
to authorizing shipment of Seed/Cell samples for confirmatory testing. If
supporting information is attached to, or provided concurrently with, the
application, place an X in column A of the corresponding item. If the information
was provided previously, it is permissible to cite the submission date and/or CVB
Mail Log Number of the prior submission in lieu of providing another copy.
5. MASTER SEED OR CELL REPORT
This is a comprehensive report detailing the history, preparation, and testing of the
Master Seed/Cell candidate. See Veterinary Services Memorandum 800.109 for
guidance on preparing this report. All Master Seed/Cell testing required by 9CFR,
as well as any other testing conducted, should be included in this report. The CVB
typically does not accept samples for confirmatory testing until the applicant has
satisfactorily completed required testing.
6. ASSAY PROTOCOLS
Applicants frequently use custom testing protocols to demonstrate specific
characteristics of an individual Master Seed or Cell. Applicants need to provide
stepwise instructions for any assays that are not codified. The protocols should
have sufficient detail to allow the CVB to replicate the assay.
7. SUMMARY INFORMATION FORMAT
The Summary Information Format (SIF) is a standardized document that assists
in risk evaluations for biotechnology-derived and imported Seeds and Cells. There
are several categories, depending on the nature of the Seed and the product in
which it will be used. Templates are available on the Biologics Regulations &
Guidance page of the CVB Website. For Category I, submit the complete SIF.
For Category II, Sections I and II should be complete; Section III may be
preliminary. For the Importation SIF, Sections I and II should be complete.
8. ELECTRONIC FILES CONTAINING GENETIC SEQUENCE DATA
Genetic sequence data should be provided electronically for Seeds/Cells that have
specific gene modifications (insertions/deletions). The CVB may request
sequence data on conventional Seeds as well if product labeling or promotional
materials will describe a Seed to a high degree of specificity.
9. OTHER
The CVB may request other data to support an application to submit samples for
confirmatory testing. Any such requirements will be communicated by the CVB
licensing reviewer for the applicant.
10.
APPLICANT’S LABORATORY CONTACT
By default, the CVB communicates through the APHIS liaison for the applicant
establishment. The applicant, however, may designate a Laboratory Contact to

serve as the point of contact for all communications regarding the testing of this
Seed/Cell. Provide the contact’s name, phone number, and email address. If all
communications should go through the APHIS liaison, enter NA (not applicable).
11. OTHER COMMENTS
Enter any other pertinent information here.
12. PRINTED NAME AND TITLE OF APPLICANT
The APHIS primary or alternate liaison for the establishment should serve as the
applicant.
13. SIGNATURE OF APPLICANT
Self-explanatory
14. DATE SUBMITTED
This date should correspond to the date the application is mailed. This will be
the submission date cited in all return correspondence.
THE FOLLOWING ITEMS ARE FOR CENTER FOR VETERINARY BIOLOGICS
USE ONLY
15. TEST AUTHORIZATION NO
The CVB will issue a Test Authorization Number for the Seed/Cell. Include this
number in the Remarks section of the APHIS Form 2020 that accompanies the
samples, as well as any other communications regarding the testing. This
authorization number is valid for 90 days from the Date Approved (Block 20).
16. INSTITUTIONAL BIOSAFETY COMMITTEE NO
The CVB follows the guidelines of the National Institutes of Health (NIH) when
working with biotechnology-derived samples. An Institutional Biosafety
Committee (IBC) reviews all testing proposals prior to biotechnology-derived
sample submission. The IBC issues a number to all approved proposals. If a
number is provided, include it in the Remarks section of the APHIS Form 2020
that accompanies sample shipment.
17-18. CENTER FOR VETERINARY BIOLOGICS LABORATORY
COORDINATOR AND PHONE NUMBER
The CVB designates a Laboratory Coordinator for each Seed/Cell. This contact
serves as the laboratory point of contact for interactions with the applicant and
the CVB licensing reviewer.
19. APPLICATION APPROVED BY
Signature of CVB official approving the application. If APHIS identifies any
exceptions or special circumstances regarding the authorization to ship samples,
they will be noted on an attached document. If the application is not approved,
the form will not bear a signature in this item and reasons for denial will be
attached. If APHIS attaches documents to the return form, a check will appear in
the box in this item.
20. DATE APPROVED
Self-explanatory. Shipment of Seed/Cells or reagents should not occur prior to
this date.
21. CVB MAIL LOG NUMBER
The application is assigned a unique tracking number when received by the CVB.
For improved efficiency, cite this number in future communications regarding this
application.