APHIS Form 2071 Application for Authorization to Ship Experimental Veter

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 Approved
0579-0013
Exp Date: XX/XXXX

This application may be submitted to request authorization to ship experimental biological product, as specified in 9CFR 103.3.
INSTRUCTIONS: See reverse side.
U.S. DEPARTMENT OF AGRICULTURE
1. NAME AND FULL MAILING ADDRESS OF APPLICANT
ANIMAL AND PLANT HEALTH INSPECTION SERVICE
VETERINARY SERVICES, CENTER FOR VETERINARY BIOLOGICS

APPLICATION FOR AUTHORIZATION TO SHIP EXPERIMENTAL
VETERINARY BIOLOGICAL PRODUCTS
2. U.S. VET. EST.
NO. (if applicable) 3. APPLICATION TYPE:

 NEW

 AMENDMENT
TO SUBMISSION DATED______________
AND/OR PRIOR CVB MAIL LOG ID______________
4. PRODUCT(S) TO BE SHIPPED

(CHECK HERE  IF ADDITIONAL PRODUCT INFO APPENDED)

A. BIOLOGICAL PRODUCT TRUE NAME OR DESCRIPTION (INCLUDING ANY INTERNAL IDENTIFIER IF THE PRODUCT
DOES NOT HAVE AN APHIS PRODUCT CODE)

B. APHIS PROD C. SERIAL/LOT ID(s)
CODE

D. MAX QTY
(DS OR ML)

UNL LIC
UNL LIC
(CHECK HERE  IF ADDITIONAL RECIPIENT INFO APPENDED)

5. RECIPIENT(S)

B. LOCATION OF PRODUCT USE (IF DIFFERS FROM 5A)

A. NAME AND SHIPPING ADDRESS

CHECKLIST FOR SUPPORTING MATERIAL
ITEM

A. WITH THIS
APPLICATION
("X")

DESCRIPTION

 OUTLINE OF PRODUCTION (9CFR 114.9)
 APHIS FORM 2008

6. METHOD OF PRODUCTION
7. PRODUCT TEST RESULTS
8. PERMIT OR LETTER OF PERMISSION FROM
AUTHORITIES IN EACH STATE/FOREIGN COUNTRY
9. STUDY PROTOCOL NO. _________________________

B. DATE OR
CVB MAIL LOG ID OF
PREV SUBMISSION

SIMILAR INFO
OTHER

LIST STATE(S) OR FOREIGN COUNTRY:

 PIVOTAL USDA LICENSING STUDY  EXPLORATORY
 FOR INTERNATIONAL REGISTRATION

10. DISTRIBUTION OF PRODUCT AMONG MULTIPLE
RECIPIENTS (if applicable)
11. EXPERIMENTAL LABELS
12. DATA TO DEMONSTRATE WHOLESOMENESS OF
MEAT (if applicable)
13. OTHER
14. BIOSECURITY OF STUDY FACLITY: :

 BSL 1

 BSL 2

 BSL 3

 FIELD STUDY/ UNSPECIFIED BIOCONTAINMENT

DESTROY ONSITE RETURN TO APPLICANT OTHER (describe)________________________________________________________
 ONSITE DISPOSAL RETURN TO OWNER  SLAUGHTER NO LESS THAN ______ DAYS AFTER FINAL PRODUCT USE
 OTHER (describe) __________________________________________________________________________________________________________________

15. DISPOSITION OF UNUSED PRODUCT:
16. DISPOSITION OF ANIMALS:

I agree to ship this experimental product in accordance with 9CFR 103.3 and conduct the study according to the filed protocol, also observing any additional
conditions imposed by the State or foreign country in which the study will be conducted. I agree to furnish, upon request, additional information concerning meat
animals prior to moving these animals from the test premises. Upon conclusion of the studies, I agree to summarize the results and submit them to APHIS.
17. PRINTED NAME AND TITLE OF APPLICANT

18. SIGNATURE OF APPLICANT (Paper Submissions Only)

19. DATE SUBMITTED

FOR VETERINARY BIOLOGICS USE ONLY

The applicant is authorized to ship the above experimental product to the designated recipients to conduct the specified study, with any Exceptions that may be
attached (i.e., if there is a check in the box in item 20). In the event the product is compromised prior to use, one repeat shipment may be made. This
authorization is effective for one year from the date in Item 21. If a pivotal USDA licensing study protocol was submitted with this application, comments on the
study may be returned under separate cover. Other protocols are filed for information only, unless CVB comments are explicitly requested.
20. APPLICATION APPROVED BY (Signature)

APHIS FORM 2071

OCT 2015

 CVB EXCEPTIONS ATTACHED
 DATE-STAMPED LABELS ENCLOSED

21. DATE APPROVED

22. CVB MAIL LOG NO.

INSTRUCTIONS FOR COMPLETING APHIS FORM 2071:
Submit one copy of the form. Enclose one copy of each supporting document,
except for labels (Line Item 12). If additional space is needed, attach additional
sheets and refer to Item No.

11. EXPERIMENTAL LABELS
Submit each of the labels that will be affixed to the experimental product.
Format the labels according to 9CFR 103.3(d). Avoid acronyms and
abbreviations in the product name.

If APHIS’s Center for Veterinary Biologics (CVB) approves the request, the CVB
will complete items 20-22 and return the form to the applicant.

12. DATA TO DEMONSTRATE WHOLESOMENESS OF MEAT
If the study is being conducted in meat animals and the study animals will be
sent to slaughter for human consumption after participating in the study, attach
information (such as residue clearance data) to demonstrate that the meat from
the study animals should be wholesome.

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, if one
has been assigned.
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 22 of
all processed forms.
4. PRODUCT TO BE SHIPPED
A. True Name or Description: Enter the True Name designated by APHIS, if
applicable. Otherwise provide a clear description of the product; avoid
acronyms. Specify any in-house codes that may assist in identifying this product.
B. APHIS Product Code: Enter the Product Code assigned by APHIS, if
applicable. Otherwise, enter NA. (Enter internal working codes in item 4A.)
Check whether the product is currently licensed by the USDA (LIC). Select UNL
if the product is currently in the USDA licensing process, is not yet under
consideration for licensure, or is not intended for licensure.
C. Serial or Lot Number: Enter the unique lot identification for the product batch
being shipped. If more than one lot of the same product is being shipped, it is
permissible to enter more than one identification per line.
D. Maximum Quantity to be Shipped: Enter the maximum quantity of each serial
to be shipped. Indicate whether the quantity is expressed in mL or doses.
5. RECIPIENT
A. Name and Shipping Address: Enter the name, affiliation, and complete
shipping address of each recipient of the experimental product.
B. Location of Product Use: If the study location differs from the shipping
address, specify the study location(s). Otherwise, enter NA.

13. OTHER
APHIS may request additional information to support applications for certain
products or to conduct certain types of studies. If applicable, briefly describe the
purpose of the additional information in the line provided and attach supporting
documentation.
14. BIOSAFETY OF STUDY FACILITY
Indicate whether the facility meets the requirements of a biosafety level (BSL)
described in Biosafety in Microbiological and Biomedical Laboratories
published by, and available from, the Centers for Disease Control
(www.cdc.gov). Otherwise, describe the biocontainment features the facility has.
15. DISPOSITION OF UNUSED PRODUCT
Specify how the recipient will dispose of unused product when the study is
completed.
16. DISPOSITION OF STUDY ANIMALS
Specify how surviving study animals will be handled at the conclusion of the
study.
17. PRINTED NAME AND TITLE OF APPLICANT
If the applicant has been assigned a U.S. veterinary biologics establishment
number, the APHIS primary or alternate liaison should serve as the applicant.
18. SIGNATURE OF APPLICANT
Self-explanatory
19. 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 VETERINARY BIOLOGICS USE ONLY

CHECKLIST OF SUPPORTING MATERIAL
Items 6-11 and 14-16 in the checklist should be addressed for every application.
Items 12-13 should be provided as applicable. 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
previous submission in lieu of providing another copy.
6. METHOD OF PRODUCTION
Clearly explain how the experimental product was made. The most efficient
means is to provide an Outline of Production, formatted according to
9CFR 114.9. If an Outline is not available, ensure that the document provided
covers the same general production points found in Outline sections I-IV.
7. PRODUCT TEST RESULTS
The minimum testing required is sterility or purity testing; additional tests may be
required by APHIS depending on the nature of the product and the study
purpose. If the product is licensed or in the USDA licensing process, provide the
results of tests described in Section V of the Outline of Production. Ideally
submit these results on APHIS Form 2008, but an alternative document is
acceptable. For exploratory studies unrelated to product licensing, provide a
summary of preliminary research work.
8. PERMIT OR LETTER OF PERMISSION FROM AUTHORITIES IN EACH
STATE/FOREIGN COUNTRY
Authorization must be obtained from each state and foreign country described in
Items 5A and 5B. Attach a copy of each State authorization or acknowledgement
letter. Attach a copy of the import permit for each foreign country. If no import
permit is required, attach a document stating this.
9. STUDY PROTOCOL
Attach a study design/protocol for the in vivo work to be performed with the
experimental product.
If the protocol has a unique study identifier, enter it in the blank indicated. Check
whether the study is a pivotal USDA licensing study, an exploratory (non-pivotal)
study, or is being conducted solely to support international registration. The CVB
conducts in-depth reviews and provides comments on pivotal USDA licensing
study protocols. Unless otherwise requested, exploratory and international
registration study protocols are filed for information without return comments.
10. DISTRIBUTION OF PRODUCT AMONG MULTIPLE RECIPIENTS
If the experimental product is to be distributed among multiple recipients, attach a
document listing the quantity of each serial(s) to be provided to each recipient.

20. APPLICATION APPROVED BY
Signature of the APHIS-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 appropriate box(es) in this item.
21. DATE APPROVED
Self-explanatory. Shipment of experimental product should not occur prior to this
date.
22. CVB MAIL LOG NUMBER
The application is assigned a unique tracking number when received by APHIS.
For improved efficiency, cite this number in future communications regarding this
application.