Guidance Document for the Completion of APHIS/CDC Form 2
Completion of all fields on APHIS/CDC Form 2 is required unless otherwise noted in this guidance document. 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. Submissions using expired or unapproved forms or tables will not be accepted. The current, approved form and tables can be downloaded from http://www.selectagents.gov/TransferForm.html.
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 Agricultural Select Agent Program 4700 River Road Unit 2, Mailstop 22, Cubicle 1A07 Riverdale, MD 20737 (301) 734-5960 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 30333 (404) 718-2000 FAX (404) 718-2096 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] complete Block 40 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***
Table of Contents
Section 1 – To Be Completed By Recipient Error! Bookmark not defined.
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 12 – Recipient E-Mail Address: 4
Section B – Sender Information 5
Block 13 – Sender Entity Name: 5
Block 14 – Sender Entity Type: 5
Block 15-18 – Sender Entity Address: 5
Block 19 – Sender Entity Responsible Official or Facility Director Name: 6
Block 20 – Sender Telephone #: 6
Block 22 – Sender E-mail Address: 6
Block 23 – Identification of a Select Agent or Toxin in a Clinical/Diagnostic Sample: 6
Section C – List of Select Agents and Toxins Requested 6
Block 24 – Select Agents and Toxins Requested: 6
Section 2 – To Be Completed By Sender 7
Section D – List of Select Agents and Toxins Shipped 7
Block 25 – Select Agents and Toxins Shipped: 7
Block 26 – Characterization of Agents Shipped: 7
Block 27 – Number of Items Shipped: 8
Block 28 – Form of Agents Shipped: 8
Block 29 – Volume/Weight of Agents Shipped: 8
Section E – Recipient Notification Information 8
Block 30 – Name of Individual at Recipient Entity Notified of Shipment Date: 8
Block 31 – Date of Shipment Notification: 9
Block 32 – Method of Shipment Notification (check all applicable boxes): 9
Section F – Shipping Information 9
Block 33 – Name of Individual Who Packaged the Shipment: 9
Block 34 – Number of Packages Shipped: 9
Block 36 – Package Description: 9
Block 37 – Name of Shipment Carrier: 10
Block 38 – Shipment Tracking Number: 10
Section 3 – To Be Completed By Recipient 10
Block 39 – Name of Individual Who Received the Shipment: 10
Block 40 – Shipment Event Acknowledgement: 11
Block 41 – Agents/Toxins Receipt Acknowledgement: 11
Block 42 – Shipment/Packaging Regulatory Compliance Acknowledgement: 11
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 their current certificate of registration.
If you do not know the recipient entity’s “registration name”, please contact their 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 their 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 their Responsible Official.
Block 3-6 – Recipient Entity Address:
Please provide the recipient entity’s complete address, exactly as it appears on their current certificate of registration.
If the recipient entity wishes to provide an address other than the address that appears on their 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.
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):
If the select agent or toxin transfer involves importation of HHS only or Overlap agent(s)/toxin(s) into the United States, please enter the US PHS import permit number(s) in Block 8b. If the HHS only or Overlap agent(s)/toxin(s) transfer does not involve importation of the agent(s) into the United States, please leave Block 8b blank.
If the select agent or toxin transfer involves importation or interstate transfer of USDA only agent(s) into or within the United States, please enter the APHIS permit number(s) in Block 8a.
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.
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 their current certificate of registration.
If you do not know the entity’s “registration name”, please contact their 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.
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 their 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 their registration number, please contact their 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 15-18 – Sender Entity Address:
For sender entities registered with APHIS or CDC, please provide the sender entity’s complete address, exactly as it appears on their current certificate of registration.
If the sender entity wishes to provide an address other than the address that appears on their current certificate of registration, written verification of the address being provided must be submitted along with the completed APHIS/CDC Form 2.
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
Block 19 – 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 their 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 20 – Sender Telephone #:
Please provide the direct dial 10-digit telephone number for the individual listed in Block 19; including any extension.
Please provide the 10-digit Fax number for the individual listed in Block 19.
Block 22 – Sender E-mail Address:
Please provide the email address for the individual listed in Block 19.
Please print or type clearly and ensure the email domain (e.g., .org, .gov, .edu, .com, .net) is included.
Block 23 – 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.
For more information on the APHIS/CDC Form 4, please see http://www.selectagent.gov/CDForm.html.
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 24 prior to APHIS or CDC authorizing the requested transfer. If additional rows are needed to complete Section C, a Microsoft® Excel spreadsheet can be downloaded from: http://www.selectagents.gov/TransferForm.html.
Do not request HHS only and USDA only agents and/or toxins on a single transfer request application. Transfer requests for HHS only and USDA only agents and/or toxins must be submitted on separate applications.
Block 24 – 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 24.
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.
The recipient Responsible Official [or the Alternate Responsible Official (ARO) if acting in the absence of the RO] must print their 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
Note: If additional rows are needed to complete Section D, a Microsoft® Excel spreadsheet can be downloaded from: http://www.selectagents.gov/TransferForm.html.
Section D – List of Select Agents and Toxins Shipped
Block 25 – 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 24 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 26 – Characterization of Agents Shipped:
List the strain designation(s) for all select agents and toxins listed in Block 25 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 27 – Number of Items Shipped:
For each select agent or toxin listed in Block 25, list the total number of items (primary containers) to be transferred for the particular select agent or toxin.
Block 28 – 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 26-29 for each form. (See example below.)
Block 29 – Volume/Weight of Agents Shipped:
For each select agent or toxin listed in Block 25, 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 29.
If you are shipping agar slants or plates, please enter the total number of slants or plates to be shipped in Block 27 and leave Block 29 blank.
SECTION 2 – TO BE COMPLETED BY SENDER |
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SECTION D – LIST OF SELECT AGENTS AND TOXINS SHIPPED (attach additional sheets if necessary) |
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25. Select agents and/or toxins: |
26. Characterization of agent: |
27. Number of items (e.g. vial, slant, plant, etc.): |
28. Form (powder/liquid/ slant): |
29. Total volume or weight of item contents (e.g., mL, mg, ng): |
A |
Yersinia pestis |
CO92 |
1 |
Agar Slant |
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B |
Eastern Equine Encephalitis virus |
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18 |
Liquid |
36.0mL |
C |
Bacillus anthracis |
Ames |
3 |
Liquid |
2.5 mL |
D |
Bacillus anthracis |
Ames |
5 |
Powder |
5.0mg |
E |
Botulinum neurotoxins |
Type A |
2 |
Liquid |
2.0mL |
F |
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Section E – Recipient Notification Information
Note: 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 prior to sending the shipment.
Block 30 – 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 30 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 31 – Date of Shipment Notification:
Provide the exact date that the individual listed in Block 30 was notified of the expected (or actual) shipment.
Block 32 – Method of Shipment Notification (check all applicable boxes):
Indicate the method(s) used to notify the individual listed in Block 30 of the expected (or actual) shipment date.
Section F – Shipping Information
Block 33 – 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 33 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 34 – Number of Packages Shipped:
Enter the total number of packages to be shipped to the recipient entity.
Enter the exact date that all of the packages indicated in Block 34 will be shipped to the recipient entity.
Block 36 – 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 36, 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 37 – Name of Shipment Carrier:
Enter the name of the commercial carrier (e.g., FedEx, DHL, etc.) or individual hand-carrier that will deliver all packages indicated in Block 34.
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.
Block 38 – 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.
For sender entities registered with APHIS or CDC, the Responsible Official [or the Alternate Responsible Official (ARO) if acting in the absence of the RO] must print their name, sign, and date below Section E.
For non-registered sender entities, the Facility Director or the individual listed in Block 19 must print their name, sign, and date below Section E.
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 at: http://www.selectagents.gov/resources/CDC-APHIS_Theft_Loss_Release_Information_Document.pdf
Block 39 – 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:
All select agents and/or toxins listed in Section D were received,
No additional select agents and/or toxins not listed in Section D were received,
The shipment was packaged, labeled, and shipped in accordance with all federal and international regulations, and that
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 39 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 40 – Shipment Event Acknowledgement:
If the transfer occurred, check the “Transfer Occurred/Date of Receipt” box and provide the date that all packages listed in Block 34 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 41 – 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 42 – 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).
The recipient Responsible Official [or the Alternate Responsible Official (ARO) if acting in the absence of the RO] must print their name, sign, and date below Section 3.
Version |
Date |
Summary of Changes |
1.0 |
August 2009 |
Initial Release |
1.1 |
September 2010 |
Block 35 – Package Description: Added guidance regarding the submission of package photographs |
2.0 |
August 2011 |
Updated to reflect revisions to Form 2. |
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Updated:
08/23/2011 APHIS/CDC Form 2 Guidance Page
| File Type | application/msword |
| File Title | Guidance Document for the Completion of APHIS/CDC Form 1 |
| Author | Andrew Hammond |
| Last Modified By | cbsickles |
| File Modified | 2012-10-10 |
| File Created | 2012-10-10 |