APHIS 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.

OMB Approval 0579-0013 EXP DATE: XX/XXXX

This application may be submitted to request authorization to ship biological samples for confirmatory testing by APHIS. INSTRUCTIONS: See reverse side.

U.S. DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE VETERINARY SERVICES, CENTER FOR VETERINARY BIOLOGICS (CVB) 1920 DAYTON AVE, AMES, IA 50010 APPLICATION FOR AUTHORIZATION TO SHIP MASTER SEED OR CELL SAMPLES FOR CONFIRMATORY TESTING BY APHIS

1. NAME AND FULL MAILING ADDRESS OF APPLICANT

2. U.S. VET. EST. NO.

3. APPLICATION TYPE:  NEW  AMENDMENT TO SUBMISSION DATED______________ AND/OR PRIOR CVB MAIL LOG NO______________

4. ITEM(S) TO BE SHIPPED (USE SEPARATE FORM FOR EACH SEED OR CELL)

CVB USE ONLY

A. COMPLETE IDENTIFICATION OF SEED/CELL, EXACTLY AS IT APPEARS ON CONTAINERS (INCLUDING LOT NO.)

B. PASSAGE

C. HOW TO BE SHIPPED

D. BIOTECH-DERIVED

E. QUANTITY REQUESTED BY APHIS

BASELINE PASSAGE

X

 DRY ICE  LIQUID NITROGEN  OTHER (describe)

 YES  NO

HIGH PASSAGE (CELLS AND BIOTECHNOLOGY-DERIVED SEEDS ONLY)

X+______

PARENTAL CONSTRUCT (BIOTECHNOLOGY-DERIVED ONLY)

CHECKLIST OF SUPPORTING MATERIAL

ITEM

DESCRIPTION (SEE INSTRUCTIONS ON REVERSE SIDE FOR ADDITIONAL GUIDANCE)

A. WITH THIS APPLICATION ("X")

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

5. MASTER SEED OR CELL REPORT

HISTORY, PREPARATION, AND TESTING OF SEED OR CELL

6. ASSAY PROTOCOLS

STEPWISE PROCEDURES FOR NON-CODIFIED ASSAYS USED TO TEST SEED/CELL

7. SUMMARY OF INFORMATION FORMAT

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

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). The CVB Laboratory Coordinator (item 17) will contact the APHIS liaison or, if applicable, the designated Contact (item 10) to discuss needed reagents. 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.

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)  CVB EXCEPTIONS ATTACHED

20. DATE APPROVED

21. CVB MAIL LOG NO.

APHIS FORM 2070

SEPT 2012

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 at http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sifs.shtml. 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.

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.