Guidance Document for the completion of APHIS/CDC Form 2

Form Approved
OMB Control No. 0920-0576
Exp. Date xx/xx/2020

Guidance Document for the Completion of APHIS/CDC Form 2
(Request to Transfer Select Agents and Toxins)
Completion of all fields on Request to Transfer Select Agents and Toxins (APHIS/CDC
Form 2) is required unless otherwise noted in this guidance document. Please note that
both pages of the form 2 are required in order to process the request. Prior to
completing APHIS/CDC Form 2 please ensure that you are using the current, Office of
Management and Budget (OMB) approved form and/or tables found at:
http://www.selectagents.gov/form2.html. Submissions using expired or unapproved
forms or tables will not be accepted.
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. To request approval, the recipient’s Responsible Official (RO)
[or the Alternate Responsible Official (ARO) if acting in the absence of the RO] must
submit APHIS/CDC Form 2 to either APHIS or CDC:
Animal and Plant Health Inspection Service
Agriculture Select Agent Services
4700 River Road Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737
301-851-3300 option 3
FAX: (301) 734-3652
Email: [email protected]

Centers for Disease Control and Prevention
Division of Select Agents and Toxins
1600 Clifton Road NE, Mailstop A-46
Atlanta, GA 30329
(404) 718-2000
FAX (404) 471-8468
Email: [email protected]

Upon receipt of the transfer authorization from APHIS or CDC, entities have 30 calendar
days to complete the approved transfer. If the transfer does not occur within the 30
calendar day authorization period, the recipient Responsible Official [or the Alternate
Responsible Official (ARO) if acting in the absence of the RO] must complete Block 42
of Section 3, sign and date below Section 3, and send the completed form to APHIS or
CDC.
***If any Blocks on APHIS/CDC Form 2 are incomplete, illegible, or contain
insufficient information we will be unable to process your transfer request.
APHIS or CDC will contact your entity to obtain the necessary information
before proceeding with the review of your request***

Updated: November 30, 2015

APHIS/CDC Form 2 Guidance

Page 1 of 12

Table of Contents
SECTION 1 – TO BE COMPLETED BY RECIPIENT...........................................................................................3
SECTION A – RECIPIENT INFORMATION ...................................................................................................................3
Block 1 – Recipient Entity Name: ....................................................................................................................3
Block 2 – Recipient Entity Registration Number: ..........................................................................................3
Block 3-6 – Recipient Entity Address: ............................................................................................................3
Block 7 – Recipient Principal Investigator Name: .........................................................................................3
Block 8 – Permit Number (if required): ...........................................................................................................4
Block 9 – Recipient Responsible Official Name:...........................................................................................4
Block 10 – Recipient Telephone #: .................................................................................................................4
Block 11 – Recipient FAX #: ............................................................................................................................4
Block 12 – Recipient E-Mail Address: ............................................................................................................4
SECTION B – SENDER INFORMATION.......................................................................................................................4
Block 13 – Sender Entity Name: .....................................................................................................................4
Block 14 – Sender Entity Type: .......................................................................................................................5
Block 15-19 – Sender Entity Address: ...........................................................................................................5
Block 20 – Sender Entity Responsible Official or Facility Director Name: ................................................5
Block 21 – Sender Telephone #: .....................................................................................................................5
Block 22 – Sender FAX #: ................................................................................................................................5
Block 23 – Sender E-mail Address: ................................................................................................................5
Block 24 – Identification of a Select Agent or Toxin in a Clinical/Diagnostic Sample: ............................6
Block 25 – A product of a restricted experiment: ..........................................................................................6
SECTION C – LIST OF SELECT AGENTS AND TOXINS REQUESTED ........................................................................6
Block 26 – Select Agents and Toxins Requested: .......................................................................................6
Signature: ...........................................................................................................................................................6
SECTION 2 – TO BE COMPLETED BY SENDER ...............................................................................................7
SECTION D – LIST OF SELECT AGENTS AND TOXINS SHIPPED ..............................................................................7
Block 27 – Select Agents and Toxins Shipped: ............................................................................................7
Block 28 – Characterization of Agents Shipped: ..........................................................................................7
Block 29 – Number of Items Shipped: ............................................................................................................7
Block 30 – Form of Agents Shipped: ..............................................................................................................7
Block 31 – Total Volume/Weight of Agents Shipped: ..................................................................................8
Example: .............................................................................................................................................................8
SECTION E – RECIPIENT NOTIFICATION INFORMATION ...........................................................................................8
Block 32 – Name of Individual at Recipient Entity Notified of Shipment Date: ........................................8
Block 33 – Date of Shipment Notification: .....................................................................................................8
Block 34 – Method of Shipment Notification (check all applicable boxes):...............................................8
SECTION F – SHIPPING INFORMATION .....................................................................................................................9
Block 35 – Name of Individual Who Packaged the Shipment: ...................................................................9
Block 36 – Number of Packages Shipped: ....................................................................................................9
Block 37 – Shipment Date: ..............................................................................................................................9
Block 38 – Package Description: ....................................................................................................................9
Block 39 – Name of Shipment Carrier:...........................................................................................................9
Block 40 – Shipment Tracking Number: ...................................................................................................... 10
Signature: ......................................................................................................................................................... 10
SECTION 3 – TO BE COMPLETED BY RECIPIENT......................................................................................... 10
DOCUMENT CHANGE HISTORY ......................................................................................................................... 12
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 30329; ATTN: PRA (0920-0576).

Updated: November 30, 2015

APHIS/CDC Form 2 Guidance

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Section 1 – To Be Completed By Recipient
Section A – Recipient Information
Block 1 – Recipient Entity Name:
 Please provide the name of the recipient entity exactly as it appears on the
current certificate of registration.
 If you do not know the recipient entity’s “registration name”, please contact
the Responsible Official.


Please do not abbreviate the entity name.

Block 2 – Recipient Entity Registration Number:
 Please enter the registration number of the recipient entity exactly as it appears
on the current certificate of registration. Please do not provide the entity’s
application number; provide only the thirteen digit registration number (e.g.
A00000000-0000 or C00000000-0000).
 If you do not know the recipient entity’s registration number, please
contact the Responsible Official.
Block 3-6 – Recipient Entity Address:
 Please provide the recipient entity’s complete address, exactly as it appears on
the current certificate of registration.
 If the recipient entity wishes to provide an address other than the address
that appears on the current certificate of registration, written verification of
the address being provided must be submitted along with the completed
APHIS/CDC Form 2.


Do not provide a P.O. Box address.



Zip Code – please provide only the five digit zip code

Block 7 – Recipient Principal Investigator Name:
 Print the full name of the recipient entity’s Principal Investigator (PI) who will be
responsible for the requested select agents and/or toxins.
 For the purposes of the APHIS/CDC Form 2, the term “PI” refers to the
one individual who supervises all activities associated with the select
agents and/or toxins being requested.
 The individual listed in Block 7 must be approved to work with the requested
select agents and/or toxins on the recipient entity’s current certificate of
registration.

Updated: November 30, 2015

APHIS/CDC Form 2 Guidance

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

The individual listed in Block 7 must have a current security risk assessment
(SRA) approval.
 Provide the individual’s full name, exactly as it appears on the current
certificate of registration.

Block 8 – Permit Number (if required):
 Please provide the APHIS Permit # if the importation was not authorized in
accordance with 42 CFR § 73.16 or 9 CFR § 121.16.
Block 9 – Recipient Responsible Official Name:
 Please provide the complete name of the recipient entity’s Responsible Official
(RO), exactly as it appears on the current certificate of registration.
 The recipient entity’s Responsible Official must be listed in Block 9 even if
the Alternate Responsible Official signs the APHIS/CDC Form 2 in the
absence of the Responsible Official.
Block 10 – Recipient Telephone #:
 Please provide the direct dial 10-digit telephone number for the Responsible
Official; including any extension.
Block 11 – Recipient FAX #:
 Please provide the 10-digit Fax number for the Responsible Official.
Block 12 – Recipient E-Mail Address:
 Please provide the email address for the Responsible Official.


Please print or type clearly and ensure the email domain (e.g., .org, .gov, .edu,
.com, .net) is included.

Section B – Sender Information
Note: If the recipient entity does not know the sender entity’s information they may
have the sender complete Section B.
Block 13 – Sender Entity Name:
 For entities registered with APHIS or CDC, please provide the name of the entity
exactly as it appears on the current certificate of registration.
 If you do not know the entity’s “registration name”, please contact the
Responsible Official.


For non-registered entities, please provide the complete name of the entity under
which the business conducts its operations (e.g. International Business Machine
Corporation instead of IBM).



Please do not abbreviate the entity name.

Updated: November 30, 2015

APHIS/CDC Form 2 Guidance

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Block 14 – Sender Entity Type:
 For senders that are registered with APHIS or CDC, please check the box titled
“Entity registration number” and enter the registration number exactly as it
appears on the current certificate of registration. Please do not provide the
entity’s application number; provide only the thirteen digit registration number
(e.g. A00000000-0000 or C00000000-0000).
 If you do not know the registration number, please contact the
Responsible Official.


For non-registered senders, please check the box titled “Clinical/diagnostic
laboratory” or “Other”.
 If you select “Other”, please provide a detailed description of the entity
type. (Example: non-US based entity)

Block 15-19 – Sender Entity Address:
 For sender entities registered with APHIS or CDC, please provide the sender
entity’s complete address, exactly as it appears on the current certificate of
registration.


For non-registered entities, please provide the complete address of the entity.



Do not provide a P.O. Box address.



Zip Code – please provide only the five digit zip code



Country – please provide the unabbreviated country name

Block 20 – Sender Entity Responsible Official or Facility Director Name:
 For sender entities registered with APHIS or CDC, please provide the complete
name of the sender entity’s Responsible Official (RO), exactly as it appears on
the current certificate of registration.


For non-registered entities, please provide the full legal name of the entity’s
Facility Director.
 For the purposes of the APHIS/CDC Form 2, the term “Facility Director”
refers to the person ultimately responsible for the overall operation and
administration of the laboratory and who ensures that quality standardized
testing methods provide accurate and reliable results.

Block 21 – Sender Telephone #:
 Please provide the direct dial 10-digit telephone number for the individual listed in
Block 20; including any extension.
Block 22 – Sender FAX #:
 Please provide the 10-digit Fax number for the individual listed in Block 20.
Block 23 – Sender E-mail Address:

Updated: November 30, 2015

APHIS/CDC Form 2 Guidance

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

Please provide the email address for the individual listed in Block 20.



Please print or type clearly and ensure the email domain (e.g., .org, .gov, .edu,
.com, .net) is included.

Block 24 – Identification of a Select Agent or Toxin in a Clinical/Diagnostic Sample:
 Please identify whether the sample being transferred was identified in a clinical
or diagnostic sample.


If yes, please ensure that an APHIS/CDC Form 4 “Report of the Identification or a
Select Agent or Toxin” is submitted to APHIS or CDC within 7 calendar days after
identification. After identification, all entities that are not registered to possess the
select agent or toxin must transfer or destroy the select agent or toxin on site by a
recognized sterilization or inactivation process within seven calendar days.

Block 25 – A product of a restricted experiment:
 Please identify whether the sample being transferred represents the product of a
restricted experiment. Products from the following restricted experiments need to be
reported in block 25: (1) Experiments that involve the deliberate transfer of, or
selection for, a drug resistance trait to select agents that are not known to acquire
the trait naturally, if such acquisition could compromise the control of disease agents
in humans, veterinary medicine, or agriculture. (2) Experiments involving the
deliberate formation of synthetic or recombinant DNA containing genes for the
biosynthesis of select toxins lethal for vertebrates at an LD[50] < 100 ng/kg body
weight.
 If yes, please provide the description used in the Federal Select Agent Program
approval letter for the restricted experiment that produced the agent.

Section C – List of Select Agents and Toxins Requested
Note: The recipient entity must be registered for all select agents and/or toxins listed in
Block 26 prior to APHIS or CDC authorizing the requested transfer.
Block 26 – Select Agents and Toxins Requested:
 List all select agents and/or toxins being requested by the recipient entity.
 Do not list strain designations in Block 26.





List only one select agent or toxin per line.
Do not abbreviate the name of a select agent or toxin.
Use the name of the select agent or toxin exactly as it appears in the Select
Agent regulations (Select Agent/Toxin List).
Do not list an agent or toxin that is not a select agent.

Signature:

Updated: November 30, 2015

APHIS/CDC Form 2 Guidance

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

The recipient Responsible Official [or the Alternate Responsible Official (ARO) if
acting in the absence of the RO] must print the name, sign, and date below
Section C.
 If the Alternate Responsible Official is signing in the absence of the
Responsible Official, the Responsible Official still must be listed in Block 9.

Section 2 – To Be Completed By Sender
Section D – List of Select Agents and Toxins Shipped
Block 27 – Select Agents and Toxins Shipped:
 List all select agents and/or toxins that will be transferred to the recipient entity
listed in Section A.
 Only those select agents and/or toxins listed in Block 26 are authorized for
transfer to the recipient entity.





List only one select agent or toxin per line.
Do not abbreviate the name of a select agent or toxin.
Use the name of the select agent or toxin exactly as it appears in the Select
Agent regulations (Select Agent/Toxin List).
Do not list an agent or toxin that is not a select agent.

Block 28 – Characterization of Agents Shipped:
 List the strain designation(s) for all select agents and toxins listed in Block 27
only if known, otherwise leave blank.
Note: For the purposes of the APHIS/CDC Form 2, the term “strain” refers to a
group of organisms of the same species, sharing certain hereditary
characteristics not typical of the entire species but minor enough not to
warrant classification as a separate breed or variety. Resistance to
specific antibiotics is a feature of certain strains of bacteria. For select
agents that have been genetically modified such as introduction of an
antibiotic resistant gene, you would note that in the characterization of
agent column.
Block 29 – Number of Items Shipped:
 For each select agent or toxin listed in Block 27, list the total number of items
(primary containers) to be transferred for the particular select agent or toxin.
Block 30 – Form of Agents Shipped:
 Enter the form of each select agent or toxin that is to be transferred. (e.g.,
powder, liquid, agar slant, agar plate, etc.).
 If a select agent or toxin is to be transferred in more than one form, please list the
select agent or toxin on two or more rows in the Section D table and complete
Blocks 27-31 for each form. (See example below.)
Updated: November 30, 2015

APHIS/CDC Form 2 Guidance

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Block 31 – Total Volume/Weight of Agents Shipped:
 For each select agent or toxin listed in Block 27, enter the total volume or weight
of all item contents to be transferred.
Example: If you are shipping six vials with individual volumes of 50 µL, 100 µL,
500 µL, 125 µL, 250 µL, and 600 µL you would enter 1.625 mL in Block 31.
 If you are shipping agar slants or plates, please enter the total number of slants
or plates to be shipped in Block 29 and leave Block 31 blank.
Example:
SECTION 2 – TO BE COMPLETED BY SENDER
SECTION D – LIST OF SELECT AGENTS AND TOXINS SHIPPED (attach additional sheets if necessary)
27. Select agents and/or toxins:

28. Characterization of agent:

29. Number
of items (e.g.
vial, slant,
plant, etc.):

30. Form
(powder/liquid/ slant):

A

Yersinia pestis

CO92

1

Agar Slant

B

Eastern Equine Encephalitis virus

18

Liquid

36.0 mL

C

Bacillus anthracis

Ames

3

Liquid

2.5 mL

D

Bacillus anthracis

Ames

5

Powder

5.0 mg

E

Botulinum neurotoxins

Type A

2

Liquid

2.0 mL

31. Total volume or
weight of item contents
(e.g., mL, mg, ng):

F

Section E – Recipient Notification Information
Note: After approved by CDC or APHIS and prior to sending the shipment, the sender
must place one copy of the completed and signed page 2 of APHIS/CDC Form 2
in the shipment and send one copy of the completed and signed page 2 of the
form to CDC or APHIS.
Block 32 – Name of Individual at Recipient Entity Notified of Shipment Date:
 Print the name of the individual at the recipient entity who was notified of the
expected (or actual) shipment date.
 The individual listed in Block 32 must have a current security risk assessment
(SRA) approval.
 Provide the individual’s complete name, exactly as it appears on the
entity’s current certificate of registration.
Block 33 – Date of Shipment Notification:
 Provide the exact date that the individual listed in Block 32 was notified of the
expected (or actual) shipment.
Block 34 – Method of Shipment Notification (check all applicable boxes):

Updated: November 30, 2015

APHIS/CDC Form 2 Guidance

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

Indicate the method(s) used to notify the individual listed in Block 32 of the
expected (or actual) shipment date.

Section F – Shipping Information
Block 35 – Name of Individual Who Packaged the Shipment:
 Print the name of the individual at the sender entity who packaged the select
agents and/or toxins for shipment.
 The individual listed in Block 35 must have a current security risk assessment
(SRA) approval (For select agent registered entities only)
Block 36 – Number of Packages Shipped:
 Enter the total number of packages to be shipped to the recipient entity.
Block 37 – Shipment Date:
 Enter the exact date that all of the packages indicated in Block 36 will be shipped
to the recipient entity.
Block 38 – Package Description:
 Provide a detailed description of how the select agents and/or toxins were
packaged for shipment. The description should include items such as the size,
shape, and a description of the packaging and the number and type of inner
packages.
 In addition to the written package description in Block 38, you may also
submit a photograph(s) of the package(s) to APHIS or CDC prior to
sending the shipment. Please note that the photograph(s) does not
replace the written package description requirement.
Note: All select agent and/or toxin transfers must be packaged, labeled, and
shipped in accordance with all federal and international regulations.
Block 39 – Name of Shipment Carrier:
 Enter the name of the commercial carrier (e.g., FedEx, DHL, UPS, etc.) or
individual hand-carrier that will deliver all packages indicated in Block 36. For
hand-carried packages, the entity remains responsible for ensuring that all local,
state or federal transportation requirements for the transportation of hazardous
materials are followed.
 If all packages are to be hand-delivered, print the full name of the individual who
will deliver the package(s).
 The individual who will hand-carry the packages must have a current
security risk assessment (SRA) approval.
 Provide the individual’s complete name, exactly as it appears on the
entity’s current certificate of registration.

Updated: November 30, 2015

APHIS/CDC Form 2 Guidance

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Block 40 – Shipment Tracking Number:
 Enter the shipment tracking number(s) (e.g., airway bill number, bill of lading
number, tracking number, etc.) for all packages being shipped.
Signature:
 For sender entities registered with APHIS or CDC, the Responsible Official must
print the name, sign, and date below Section E.
 For non-registered sender entities, the Facility Director or the individual listed in
Block 20 must print the name, sign, and date below Section E.
 The entity provides the completed paperwork to CDC or APHIS.

Section 3 – To Be Completed By Recipient
Note: Upon receipt of the shipment, the recipient’s RO [or the Alternate Responsible
Official (ARO) if acting in the absence of the RO] must complete and sign Section
3 of APHIS/CDC Form 2 and send one copy of page 2 to the sender and one
copy to APHIS or CDC within 2 business days of receipt of the shipment. If the
select agents or toxins are not received within 48 hours after the expected
delivery time or if the package(s) received containing select agents or toxins
has/have been damaged to the extent that a release of the select agents or
toxins may have occurred, the recipient’s RO must immediately report this to
APHIS or CDC and submit a completed APHIS/CDC Form 3, “Report of Theft,
Loss, or Release of Select Agents and Toxins” to APHIS or CDC. Additional
guidance for submitting an APHIS/CDC Form 3 is available.
Block 41 – Name of Individual Who Received the Shipment:
 Print the name of the individual who received the shipment upon delivery.
 For the purposes of the APHIS/CDC Form 2, the individual who “received”
the shipment refers to the individual that opened the package under
appropriate biocontainment conditions and verified that:
1) all select agents and/or toxins listed in Section D were received,
2) no additional select agents and/or toxins not listed in Section D were
received,
3) the shipment was packaged, labeled, and shipped in accordance with
all federal and international regulations, and that
4) the package received containing select agents and/or toxins was not
damaged to the extent that a release of the select agents and/or toxins
may have occurred.
 The individual listed in Block 41 must have a current security risk assessment
(SRA) approval.
 Provide the individual’s complete name, exactly as it appears on the
entity’s current certificate of registration.
Block 42 – Shipment Event Acknowledgement:

Updated: November 30, 2015

APHIS/CDC Form 2 Guidance

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


If the transfer occurred, check the “Transfer Occurred/Date of Receipt” box and
provide the date that all packages listed in Block 36 were received.
If the transfer did not occur, check the “Transfer Did Not Occur” box.
 The recipient Responsible Official [or the Alternate Responsible Official
(ARO) if acting in the absence of the RO] must sign/date below Section 3,
and send the completed page 2 of APHIS/CDC Form 2 to APHIS or CDC.

Block 43 – Agents/Toxins Receipt Acknowledgement:
 If all of the select agents and/or toxins listed in Section D of APHIS/CDC Form 2
were received, check the “Yes” box.
 If all of the select agents and/or toxins listed in Section D of APHIS/CDC Form 2
were not received (or if additional select agents and/or toxins not listed in Section
D were received), check the “If no” box and explain any discrepancies in a
separate attachment (e.g., Microsoft® Word document).
Block 44 – Shipment/Packaging Regulatory Compliance Acknowledgement:
 If the package(s) received by the recipient entity were packaged, labeled, and
shipped in accordance with all federal and international regulations, check the
“Yes” box.
 If the package(s) received by the recipient entity were not packaged, labeled, and
shipped in accordance with all federal and international regulations, check the “If
no” box and explain any discrepancies in a separate attachment (e.g., Microsoft®
Word document).
Signature:
 The recipient Responsible Official [or the Alternate Responsible Official (ARO) if
acting in the absence of the RO] must print the name, sign, and date below
Section 3.

Updated: November 30, 2015

APHIS/CDC Form 2 Guidance

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Document Change History
Version
1.0
1.1
2.0
3.0
4.0

Date
August 2009
September
2010
August 2011
May 2014
November 2015

Updated: November 30, 2015

Summary of Changes
Initial Release
Block 35 – Package Description: Added guidance
regarding the submission of package photographs
Updated to reflect revisions to Form 2.
Updated to reflect information not required in block #8
Updated to reflect revisions to Form 2

APHIS/CDC Form 2 Guidance

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