Attachment 3b - Original Request to Transfer Form

GUIDANCE DOCUMENT FOR REQUEST TO TRANSFER
SELECT AGENTS AND TOXINS
(APHIS/CDC FORM 2)

FORM APPROVED
OMB NO. 0579-0213
OMB NO. 0920-0576
EXP DATE 12/31/2008

INTRODUCTION
The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final rules (7 CFR 331, 9 CFR 121, and
42 CFR 73), which implement the provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
(Public Law 107-188) setting forth the requirements for possession, use, and transfer of select agents and toxins. The select agents
and toxins identified in the final rules have the potential to pose a severe threat to public health and safety, to animal and plant health,
or to animal and plant products. Responsibility for providing guidance on this form was designated to the Centers for Disease Control
and Prevention (CDC) by the HHS Secretary and to the Animal and Plant Health Inspection Service (APHIS) by the USDA Secretary. In
order to minimize the reporting burden to the public, APHIS and CDC have developed a common reporting form for this data collection.
A select agent or toxin may only be transferred under the conditions described in 7 CFR 331.16, 9 CFR 121.16, and 42 CFR 73.16 and
must be authorized by APHIS or CDC prior to transfer. Upon receipt of a transfer request (APHIS/CDC Form 2) from the intended
recipient, the sending entity’s Responsible Official (RO) or facility director must obtain approval from APHIS or CDC prior to transfer of
a select agent or toxin. To request approval, the sender must submit this form (APHIS/CDC Form 2) to either APHIS (facsimile: 301734-3652) or CDC (facsimile: 404-718-2096).
PURPOSE
The purpose of this form is to request prior authorization of a transfer of select agent(s) or toxin(s) and to provide a method for the
documentation of the transfer. The form must be completed for each transfer of select agents or toxins and maintained for three years.
INSTRUCTIONS
Prior to transferring a select agent or toxin:
(A) Recipient Responsibilities:
1. Completes Section A and blocks 30 (including strain designation if known) and 37 (information should match the information
submitted for the entity’s certificate of registration). The recipient’s RO then sends the form to the sender.
2. Transfer of select agents or toxins may require the intended recipient to obtain a valid USDA and/or PHS permit prior to the
transfer (See 7 CFR Part 330.200, 9 CFR Part 122.2, and 42 CFR Part 71.54) The application and instructions for obtaining
USDA transport or import permits are available through the APHIS website at: http://www.aphis.usda.gov/vs/ncie/ or the PPQ
website at: http://www.aphis.usda.gov/ppq/permits/ or by calling 301-734-5960. The application and instructions for obtaining
PHS import permits are available through the CDC website at: http://www.cdc.gov/od/ohs/biosfty/imprtper.htm or by calling
404-718-2077.
3. For importation of select agents, the recipient’s RO completes Sections A and B as instructed; completes Sections C and D for
sender, placing the “APHIS Permit Number or PHS Permit Number” in block 3 of the form; and transmits the form via facsimile
to APHIS (FAX: 301-734-3652) or CDC (FAX: 404-718-2096).
(B) Sender Responsibilities:
1. Completes Section B and blocks 31-36. If known, please provide characterization of agent (e.g., strain designation, GenBank
Accession number, publication citation, molecular characterization data, etc.). Provide additional information on attached
sheet if needed. The sender’s RO or facility director transmits the form via facsimile to APHIS (FAX: 301-734-3652) or CDC
(FAX: 404-718-2096).
2. Clinical and diagnostic laboratories that transfer select agents and toxins after identification (See 7 CFR 331, 9 CFR
121, and 42 CFR 73) are required to submit this form for approval prior to transferring the select agent or toxin to a registered
entity (see also APHIS/CDC Form 4, “Report of the Identification of a Select Agent or Toxin”).
(C) APHIS/CDC Responsibilities: APHIS or CDC will FAX the form back to the sender and/or recipient with an approval authorization
number after verification of the information on the form.
After authorization of transfer:
(A) Sender Responsibilities: Must ship the material to the recipient only after the sender has received the approval authorization
number from APHIS or CDC. The approval authorization number will be valid for only 30 days after issuance. If the sender has a
suspicion that the agent may not be used for the requested purpose, then the sender should consult with APHIS or CDC prior to the
transfer. The sender completes blocks 38-40. Select agents and toxins must be packaged, labeled, and shipped in accordance with all
federal and international regulations. It is highly recommended that the sender utilize a method for tracking the movement of the select
agents and toxins being shipped. A copy of the completed form must be maintained for 3 years.
(B) Recipient Responsibilities: Upon receipt of the shipment, the recipient’s RO must complete blocks 41 and 42 and FAX or mail the
form to both the sender’s RO and APHIS or CDC within 2 business days of receipt. The recipient’s RO must immediately report to
APHIS or CDC and complete APHIS/CDC Form 3, “Report of Theft, Loss, or Release of Select Agents and Toxins”, if the select agent
or toxin has not been received within 48 hours after the expected delivery time or the package received containing select agents or
toxins has been damaged to the extent that a release of the select agent or toxin may have occurred. A copy of the completed form
must be maintained for 3 years.
OBTAINING EXTRA COPIES OF THIS FORM
Additional copies of this form are available on APHIS website (http://www.aphis.usda.gov/programs/ag_selectagent/index.html) or the
CDC website (http://www.cdc.gov/od/sap) or by contacting APHIS at (301) 734-5960 or CDC at (404) 718-2000.

REQUEST TO TRANSFER
SELECT AGENTS AND TOXINS
(APHIS/CDC FORM 2)

FORM APPROVED
OMB NO. 0579-0213
OMB NO. 0920-0576
EXP DATE 12/31/2008

Read all instructions carefully before completing the report. Answer all items completely and type or print in ink. This report must be
signed and submitted to either APHIS or CDC:
Animal and Plant Health Inspection Service
Agricultural Select Agent Program
4700 River Road Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737
FAX: 301-734-3652

Centers for Disease Control and Prevention
Division of Select Agents and Toxins
1600 Clifton Road NE, Mailstop A-46
Atlanta, GA 30333
FAX: 404-718-2096

FOR APHIS/CDC USE ONLY
APHIS/CDC AUTHORIZATION NUMBER: ________________________________________________________________
DATE: ____________________

INI:___________________

EXP DATE: ___________________________

SECTION A – RECIPIENT (REQUESTOR) INFORMATION
2. Entity registration number:
3. a. APHIS Permit #:
b. US PHS#:

1. Entity name:
4. Recipient name (authorized personnel)
First:
MI:
Last:

5. Date:

6. Phone:

7. FAX:

Signature:
8. Principal investigator name (if different from line above)
First:
MI:
Last:

9. Date:

10. Phone:

11. FAX:

Signature:
12. Responsible Official name
First:
MI:

13. Date:

14. Phone:

15. FAX:

Last:

Signature:
SECTION B – SENDER (TRANSFEROR) INFORMATION
17.
Entity registration number: __________________________
Clinical/diagnostic laboratory
Other: _______________________________________
19. Date:
20. Phone:
21. FAX:

16. Entity name:
18. Sender name
First:

MI:

Last:

Signature:
22. Principal investigator name (if different from line above)
First:
MI:
Last:

23. Date:

24. Phone:

25. FAX:

Signature:
26. Responsible Official name
First:
MI:

27. Date:

28. Phone:

29. FAX:

Signature:

Last:

FOR APHIS/CDC USE ONLY
APHIS/CDC AUTHORIZATION NUMBER: ________________________________________________________________
DATE: ____________________

INI:___________________

EXP DATE: ___________________________

SECTION C – LIST OF SELECT AGENTS AND TOXINS SHIPPED (attach additional sheets if necessary)
RECIPIENT

30. Select agent or toxin:

SENDER

31. Characterization of agent or toxin (see
instructions):

32.
Number
of vials:

33. Form (e.g.,
powder/liquid/
slant):

34. Vol
or wt
per vial
(e.g.,
ml, mg):

35. Total
quantity:

36. Concentration/
vial
(e.g., 108 cfu/ml):

a
b
c
d
e
f
g
h
i
j
k
l
m
37. Proposed Use:

Research

Diagnostics

Production

Storage Only

Other (explain):

SECTION D – SHIPPING INFORMATION (attach additional sheets if necessary)
38. Number of primary receptacles per outer package:____ Number of outer packages: ______

Carrier waybill (tracking) #(s):

39. Sender (Responsible Official or Facility Director) ensures select agents or toxins listed in section C were shipped
First:
MI:
Last:
Signature:
41. Recipient (Responsible Official) ensures select agents or toxins listed in section C were received
First:
MI:
Last:

40. Date shipped:
42. Date received:

Signature:
Public reporting burden: Public reporting burden of this collection of information is estimated to average 1.5 hours 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. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information
unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to
CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-0576).
Penalties: Knowingly providing false statements on any part of this form or its attachments will subject the offender to fines of up to $250,000 ($500,000 for organizations), imprisonment for up to 5 years or both
(18 USC Section 1001). Failure to maintain records constitutes a 1 year misdemeanor (42 USC Section 271).
APHIS/CDC FORM 2 (12/31/2008)