Form 2 Guidance

Attachment 16 - APHIS-CDC_Form_2_Guidance_track.pdf

[CPR] Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)

Form 2 Guidance

OMB: 0920-0576

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Request to Transfer Select Agents and Toxins APHIS/CDC Form 2

Instructions
Answer all items completely and type or print in ink. Questions concerning the completion of this form can be directed to the respective
agency listed below:
Division of Agricultural Select Agents and Toxins
Telephone: (301) 851-2070
Email: [email protected]

Division of Regulatory Science and Compliance
Telephone: (404) 718-2000
Email: [email protected]

This form must be signed and submitted to either:
Division of Agricultural Select Agents and Toxins
4700 River Road Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737
FAX: (301) 734-3652
Email: [email protected]

Division of Regulatory Science and Compliance
1600 Clifton Road NE, Mailstop H21-4
Atlanta, GA 30329
FAX: (404) 471-8468
Email: [email protected]

Section 1 – To Be Completed By Recipient
Section A – Recipient Information
Blocks A1 – Recipient Entity Name:
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Print information as it appears on your entity’s current certificate of registration.

Block A2 – Recipient Principal Investigator Name:
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Print the full name of the Principal Investigator (PI) who will be responsible for the requested select
agents and/or toxins.

Section B – Sender Information
Note: The recipient entity should communicate with the sender to complete Section B.
Block B3-B11 – Sender Information:
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Provide complete and accurate information.
For an entity registered with APHIS or CDC, provide the entity’s information as it
appears on the current certificate of registration, if known.
For a non-registered entity, provide the complete name and address of the entity. (e.g.,
International Business Machine Corporation instead of IBM).
For non-registered entities, provide the full legal name of the entity’s Laboratory
Supervisor.

 Note: The term ‘Laboratory Supervisor’ refers to the person ultimately responsible

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for the overall operation and administration of the laboratory and who ensures that
quality standardized testing methods provide accurate and reliable results.
Provide the direct dial 10-digit telephone number including extension, and email address including the
domain (e.g., .org, .gov, .edu, .com, .net). for the individual listed in Block 6.

Block B12 – Identification of a Select Agent or Toxin in a Clinical/Diagnostic Sample:
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If ‘Yes’, provide the APHIS/CDC Form 4 ‘Reporting the Identification of a Select Agent or Toxin from a

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Request to Transfer Select Agents and Toxins APHIS/CDC Form 2

Instructions
Clinical/Diagnostic Specimen’ number. Contact APHIS or CDC for the number, if needed.
Block B13 – A Product of a Restricted Experiment:
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If ‘Yes’, provide the description used in the Federal Select Agent Program approval letter for the
restricted experiment that produced the agent.
Note: Refer to Section 13 of the regulations for information concerning a restricted experiment.

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 C14 prior to APHIS or CDC
authorizing the requested transfer.
Block C14 – Select Agents and Toxins Requested:
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List all select agents and/or toxins being requested by the recipient entity exactly
as it appears in the Select Agent regulations. (Select Agent/ToxinList)
List only one select agent or toxin per line.

Block C15 – Transfer Cancellation:
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If ‘Yes’, provide a reason for cancellation and resubmit the form.

Block C16 – Name of Carrier and DOT Registration Number:
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Signature:
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Provide the complete name of carrier and DOT number.
 If hand delivered, provide name of individual. The individual must have approval to access select
agents or toxins from APHIS or CDC.
The recipient Responsible Official [or the Alternate Responsible Official (ARO)] or Laboratory
Supervisor must print their name, title, sign, and date below Section C.

Section 2 – To Be Completed by Sender
Section D – List of Select Agents and Toxins Shipped
Block D17-D21 – Select Agents and Toxins Shipped. Complete All Blocks:
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List all select agents and/or toxins that will be transferred to the recipient entity exactly as they appear
in the Select Agent regulations (Select Agent/Toxin List). The select agents and/or toxins listed in this
section should be included in the list of requested select agents and toxins in Section C.
 Only those select agents and/or toxins listed in Block C14 are authorized for transfer
to the recipient entity.

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List only one select agent or toxin per line.

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List the strain designation(s) for all select agents and toxins listed in Block D17 if known, otherwise
leave blank.
For each select agent or toxin listed in Block D17, list the total number of items
(primary containers or plants) to be transferred.
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 D17-21 for
each form. (See example below)
For each select agent or toxin listed in Block D17, enter the total volume or weight of all
item contents to be transferred.

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Request to Transfer Select Agents and Toxins APHIS/CDC Form 2

Instructions
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 D21.
Note: If you are shipping agar slants or plates, please enter the total number of slants or
plates to be shipped in Block D19 and leave Block D21 blank.

Section E – Recipient Notification Information
Blocks E22-E24 – Contact Information for Individual Notified of Expected Shipment:
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Provide complete name of individual notified, date of notification and method used to notify the
individual at recipient entity.

Section F – Shipping Information
Blocks F25-F29 – Packaging and Shipping Information:
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Print the name of the individual at the sender entity who packaged the select agents
and/or toxins for shipment.
Note: For a registered entity, the individual must have approval to access select agents
or toxins from APHIS or CDC.
Enter the total number of packages to be shipped to the recipient entity.
Enter the date that all packages indicated in Block F27 will be shipped to the recipient
entity.
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.
Note: All select agent and/or toxin transfers must be packaged, labeled, and shipped in
accordance with all federal and international regulations. FSAP transfer approval does
not indicate compliance.
Enter the shipment tracking number(s) (e.g., airway bill number, bill of lading number,
tracking number, etc.) for all packages being shipped.
Note: After approval by APHIS or CDC and prior to sending the shipment, the sender
must place one copy of the completed and signed Section 2 of APHIS/CDC Form 2 in
the shipment and send one copy of the completed and signed Section 2 of the form to
APHIS or CDC.

Signature:
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The sending Responsible Official [or the Alternate Responsible Official (ARO)] or Laboratory
Supervisor must print their name, title, sign, and date below Section F.

Section 3 – To Be Completed by Recipient
Note: 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

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Request to Transfer Select Agents and Toxins APHIS/CDC Form 2

Instructions
Toxins’ to APHIS or CDC. Additional guidance for submitting an APHIS/CDC Form 3 is available at
https://www.selectagents.gov/. Provisions for unexpected shipments of select agents or toxins must be
described in the entity’s security plan that includes securing containers on site.
Blocks 30-33 –Shipment Receipt and Condition:
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Print the complete name of the individual who received the shipment.
Note: The individual must have approval to access select agents or toxins from APHIS or CDC.
 For the purposes of the APHIS/CDC Form 2, ‘received’ refers to the individual who
opens the package under appropriate biocontainment conditions and verifies the
contents.
 If an individual not approved to access select agents or toxins from APHIS or CDC
opens the package or the package is not handled under appropriate biocontainment
conditions, the entity should contact APHIS or CDC immediately. An APHIS/CDC
Form 3 may be required.
Enter the date of receipt.
Note: This section must be completed and submitted within 2 days of receipt.
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), select ‘No’ and fully
describe the discrepancy in a separate attachment.
Note: The entity must immediately notify APHIS or CDC and submit a completed APHIS/CDC Form
3.
If the package(s) received by the recipient entity were not packaged, labeled, and
shipped in accordance with all federal and international regulations, select ‘No’ and
fully describe the discrepancy in a separate attachment.

Signature:
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The recipient Responsible Official [or the Alternate Responsible Official (ARO)] or Laboratory
Supervisor must print their name, title, sign, and date below Section 3.

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File Typeapplication/pdf
File TitleRequest to Transfer Select Agents and Toxins APHIS/CDC Form 2
AuthorJoshi, Nina (CDC/DDPHSIS/CPR/DSAT) (CTR)
File Modified2023-11-14
File Created2022-04-11

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