APHIS Form 2072 Application for Authorization to Ship Biological Product

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 product samples for confirmatory testing by APHIS.
U.S. DEPARTMENT OF AGRICULTURE
ANIMAL AND PLANT HEALTH INSPECTION SERVICE
VETERINARY SERVICES, CENTER FOR VETERINARY BIOLOGICS (CVB)

OMB Approved
0579-0013
EXP: XX/XXXX

INSTRUCTIONS: See reverse side.

1. NAME AND FULL MAILING ADDRESS OF APPLICANT

APPLICATION FOR AUTHORIZATION TO SHIP BIOLOGICAL PRODUCT
SAMPLES FOR CONFIRMATORY TESTING BY APHIS
2. U.S. VET. EST.
NO.

 NEW

3. APPLICATION TYPE:

 AMENDMENT
TO SUBMISSION DATED

______________

AND/OR PRIOR CVB MAIL LOG NO. ______________
4. PURPOSE:

 PRE-LICENSE

 POST-LICENSE OUTLINE CHANGE

 OTHER (describe) ___________________________________________________
5. ITEM(S) TO BE SHIPPED

A. TRUE NAME OF PRODUCT

(CHECK HERE

 IF ADDITIONAL ITEM INFORMATION IS APPENDED)

B. PRODUCT CODE

C. SERIAL NUMBER

D. APHIS USE ONLY
APHIS TEST AUTH #

CHECKLIST FOR SUPPORTING MATERIAL FOR CONFIRMATORY TESTING
DESCRIPTION
(SEE INSTRUCTIONS ON REVERSE FOR DETAILS)

ITEM

6. ITEMIZATION OF SERIAL RELEASE TESTING,
VALIDITY CRITERIA, REQUIREMENTS FOR RELEASE

A. WITH THIS
APPLICATION
("X")

B. DATE AND/OR
CVB MAIL LOG NO OF
PRIOR SUBMISSION

SECTION V OF OUTLINE OF PRODUCTION (9 CFR 114.9)
IN FINAL FORMAT

7. STEPWISE PROTOCOLS FOR EACH ASSAY IN
SECTION V OF OUTLINE OF PRODUCTION

 OUTLINE OF PRODUCTION (9 CFR 114.9)  SPECIAL OUTLINE
TO BE SUBMITTED PRIOR TO REQUESTING AUTHORIZATION TO SUBMIT
SAMPLES

8. ASSAY VALIDATION REPORT(S)
9. DILUTION OF PRESERVATIVE STUDY

9 CFR 113.25(d)

10. RESULTS OF TESTING CONDUCTED BY APPLICANT

APHIS FORM 2008: SUBMIT TO CVB-IC PRIOR TO REQUESTING AUTHORIZATION TO
SUBMIT SAMPLES (DISPOSITION BY FIRM=OTHER-PRELICENSE, OTHER-OUTLINE CHANGE,
OR OTHER-TECH TRANSFER)

11. OTHER
12. 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 CONFIRMATORY TESTING, LIST THIS INDIVIDUAL BELOW.
A. CONTACT NAME

B. PHONE

C. EMAIL

I agree to ship this product in accordance with 9 CFR 113.3, under cover of APHIS Form 2020, and to provide any test reagents requested by the CVB. I agree to
provide the CVB with an anticipated shipping date for reagents. Once shipped, I will provide tracking information.
13. OTHER COMMENTS

14. PRINTED NAME AND TITLE OF APPLICANT

15. SIGNATURE OF APPLICANT

16. DATE SUBMITTED

FOR CENTER FOR VETERINARY BIOLOGICS USE ONLY

The applicant is authorized to ship the above product(s) to the CVB, with any exceptions that may be attached (i.e., if there is a check in the box in Item 20). Ship
the requested quantity of samples and/or reagents under cover of APHIS Form 2020, noting the test authorization (Item 5D) 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.
17. REQUESTED NUMBER OF SAMPLES PER SERIAL IF DIFFERS FROM 9CFR 113.3

18. CENTER FOR VETERINARY BIOLOGICS LABORATORY COORDINATOR

20. APPLICATION APPROVED BY (signature)

APHIS FORM 2072
NOV 2017

19. COORDINATOR’S EMAIL

 CVB EXCEPTIONS ATTACHED
 OTHER DOCUMENTS ATTACHED

21. DATE APPROVED

22. CVB MAIL LOG NO.

INSTRUCTIONS FOR COMPLETING APHIS FORM 2072:
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. PURPOSE
Indicate whether the confirmatory testing is for a prelicense product or a licensed
product with a proposed change in manufacture (Outline of Production change). If
testing is being conducted for another purpose, please describe.
5. ITEMS TO BE SHIPPED
Applicants should submit samples in accordance with 9 CFR 113.3. Indicate the
True Name, USDA Product Code, and serial number of the product(s) to be
shipped. APHIS will enter a test authorization number upon approval of the
request. This authorization number is valid for 90 days from the Date Approved
(Block 21).
CHECKLIST OF SUPPORTING MATERIAL
The checklist includes items that must be satisfactorily reviewed by the CVB prior
to authorizing submission of product 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.
6. Itemization of Serial Release Testing: Section V of the Outline of Production
(9 CFR 114.9) should be in its expected final format with regard to tests
conducted, validity criteria, and requirements for a satisfactory serial.
7. Stepwise Protocols for tests: Stepwise assay protocols, with sufficient detail
for the CVB laboratory to replicate the assay, should be provided either in
Section V of the Outline of Production or Special Outlines.
8. Assay validation reports: All non-codified assays must be validated for use in
serial release testing. Please submit validation reports prior to submitting an
application to ship product samples. Assays must be validated before the CVB
conducts confirmatory testing.
9. Dilution of preservative study: Testing per 9 CFR 113.25(d) must be
conducted to determine the appropriate volume of diluent for sterility and purity
testing (9 CFR 113.26 or 113.27).
10. Results of Testing Conducted by the Applicant: All Section V testing must
be conducted by, or under the oversight of, the applicant prior to requesting
confirmatory testing. Submit all results on APHIS Form 2008. See Veterinary
Services Memorandum 800.53 for additional guidance on completing APHIS
Form 2008.
11. 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.
12. 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
product. Provide the contact’s name, phone number, and email address. If all
communications should go through the APHIS liaison, enter NA (not applicable).
13. OTHER COMMENTS
Enter any other pertinent information here.
14. PRINTED NAME AND TITLE OF APPLICANT
The APHIS primary or alternate liaison for the establishment should serve as the
applicant.
15. SIGNATURE OF APPLICANT
Self-explanatory
16. 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
17. REQUESTED NUMBER OF SAMPLES PER SERIAL IF DIFFERENT
FROM 9 CFR 113.3
After the request to submit is approved, submit the requested number of samples
listed in this block. If this block is empty, follow the sampling guidance in 9 CFR
113.3.
18-19. CENTER FOR VETERINARY BIOLOGICS LABORATORY
COORDINATOR AND PHONE NUMBER
The CVB designates a Laboratory Coordinator for confirmatory testing. This
contact serves as the laboratory point of contact for interactions with the
applicant and the CVB licensing reviewer.
20. 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.
21. DATE APPROVED
Self-explanatory. Shipment of product should not occur prior to this date.
22. 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.