Attachment 5 Summary of Changes

Attachment 5: Revisions to the Application for Permit to Import or Transport Etiologic Agents, Hosts, or Vectors of Human Disease

Old Form Section A:

SECTION A – PERSON REQUESTING PERMIT IN U.S.A.
1.Last Name of Permittee (Applicant)		2. First	3. MI	4. Organization
5. Address (NOT a post office box)				6. City	7. State	8. Zip Code
9. Telephone	10. FAX			11. E-mail

New Form Section A:

SECTION A, Person Requesting Permit in US (Permittee)
1. Permittee's Last Name	2. First Name			3. MI		4. Permittee’s Organization
5. Physical Address (NOT a post office box)					6. City				7. State	8. Zip Code
9. Telephone		10. Fax					11. Email
1 2. Will the permittee be the courier of the imported biological agent? a Yes b No			13. Will other members of the organization listed above, in Section A Block 4, be authorized to use the approved permit? a No b Yes if Yes					1 4. Check here if you have included a Continuation Form to list others authorized to use this permit

• Added item 12 to the new form: Will the permittee be the courier of the imported biological agent?

• Added item 13 to the new form: Will other members of the organization listed above, in Section A Block 4, be authorized to use the approved permit?

• Added item 14 to the new form: Check here if you have included a Continuation Form to list others authorized to use this permit.

Old Form Section B:

SECTION B – SENDER OF MATERIAL
1. Last Name of Sender		2. First		3. MI		4. Organization ( Check here if additional sheets are attached for multiple senders)
5. Address (NOT a post office box)			6. City		7.State/Prov		8. Postal Code	9. Country
10. Telephone	11. FAX					12. E-mail

New form Section B:

SECTION B, Sender of Imported Biological Agent(s)
1 . Sender’s Last Name ( Check if same as Sec A)		2. First Name			3. MI		4. Sender’s Organization
5. Physical Address Outside of the US (NOT a post office box)			6. City			7. State/Prov.		8. Country		9. Postal Code
10. Telephone	11. Fax			12. Email					1 3. Check here if you have included a Continuation Form to list multiple senders

• Added item 13 to the new form: Check here if you have included a Continuation Form to list multiple senders.

Old form Section C:

SECTION C – DESCRIPTION OF MATERIAL
1. Provide a detailed description of the material ( Check here if additional sheets are attached):
2. Country of origin of the material:
3. Address where the human pathogen is to be used if different from Section A (NOT a post office box):	4. City	5. State	6. Zip Code
7. Is the material known or suspected to contain human pathogens?  Yes  No (If no, then see instructions: an import permit may not be required) 8. If yes, give the name of the etiologic agent(s) known or suspected to be present:
9. Natural host(s) for this etiologic agent(s):
10. Type of material:  Fluids or tissues (List species samples are from: ________________________________________________)  Isolate(s)  Bacterial toxin(s)  Host or vector  Other (Describe):________________________________________________________________________
11. Does this material contain a select agent (specified in 42 C.F.R. Part 73)?  Yes  No If yes, provide your CDC or APHIS facility registration number:______________________ Expiration date of registration:____________
12 Are these materials for laboratory use only?  Yes  No If no, will the materials be used for the production of biologics for humans or animals?  Yes  No
13. Estimated completion date of work:
14. Proposed use of material:  Research  Diagnostics  Production Other (Describe:______________________________)
15. Describe objective of work (Additional sheets attached):
16. Final disposition of material(s) after completion of work:  Long-term storage onsite Transfer to another location (Describe:________________________________________________________________________)  Destroyed on site (Method of destruction: ______________________________________________________________________)  Other (Describe:__________________________________________________________________________________________)

New form Section C:

SECTION C, Shipment Information
1. Method(s) of Shipment a Commercial Carrier (e.g., FedEx) b Hand-carried by (provide name of person):_____________________	2. Number of Shipments a Single Shipment b Multiple Shipments i. Estimated # of shipments:____	3. Shipment Temperature(s) a Ambient b Frozen/Refrigerated	4. Anticipated U.S. Port(s) of Entry

• Removed item 1 from old form: Provide a detailed description of the material (check here if additional sheets are attached):

• Removed item 2 from old form: Country of origin of the material

• Removed item 3 from old form: Address where the human pathogen is to be used if different from Section A (NOT a post office box)

• Removed item 4 from old form: City

• Removed item 5 from old form: State

• Removed item 6 from old form: Zip Code

• Removed item 7 from old form: Is the material known or suspected to contain human pathogens?  Yes  No (If no, then see instructions: an import permit may not be required)

• Removed item 8 from old form: If yes, give the name of the etiologic agent(s) known or suspected to be present:

• Removed item 9 from old form: Natural host(s) for this etiologic agent(s):

• Removed item 10 from old form: Type of material

 Fluids or tissues (List species samples are from: ____________________________)

 Isolate(s)  Bacterial toxin(s)  Host or vector  Other (Describe):______________________________________________________

• Removed item 11 from old form: Does this material contain a select agent (specified in 42 C.F.R. Part 73)?  Yes  No

If yes, provide your CDC or APHIS facility registration number:____ _______ Expiration date of registration:____________

• Removed item 12 from old form: Are these materials for laboratory use only?Yes  No

If no, will the materials be used for the production of biologics for humans or animals?  Yes  No

• Removed item 13 from old form: Estimated completion date of work:

• Removed item 14 from old form: Proposed use of material:  Research  Diagnostics  Production Other (Describe:______________________________)

• Removed item 15 from old form: Describe objectives of work ( Additional sheets attached):

• Removed item 16: from old form Final disposition of material(s) after completion of work:

 Long-term storage onsite

 Transfer to another location (Describe:_______________________________________________________________)

 Destroyed on site (Method of destruction: ________________________________)

 Other (Describe:___________ ____________________)

• Added item 1 to the new form: Method(s) of Shipment

 Commercial Carrier (e.g., FedEx)

 Hand-carried by (provide name of person):_______________

• Added item 2 to the new form: Number of Shipments

 Single Shipment

 Multiple Shipments

1. Estimated # of shipments:___

• Added item 3 to the new form: Shipment Temperature(s)

 Ambient

 Frozen/Refrigerated

• Added item 4 to the new form: Anticipated U.S. Port(s) of Entry

Old form Section D:

SECTION D – TYPE OF PERMIT AND SHIPMENT INFORMATION
1. Importation into U.S.: Single  Multiple No. of shipments expected to be made within the next 12 months:_________________
2. Transfer within the U.S.:  Single  Multiple  None No. of shipments expected to be made within the next 12 months:______________
3. U.S. port(s) of entry (if known):	4. Total volume (indicate units, ml, mg, liter):

New form Section D:

SECTION D, Final Destination of Imported Biological Agent
1. Is final destination of biological agent(s) different from address in Section A? a No (skip to Section E) b Yes			2. Last Name of Recipient at Destination			3. First Name				4. MI
5 .Destination Organization	6. Final Destination Address (NOT a post office box)				7. City			8. State	9. Zip Code
10. Telephone		11. Fax		12. Email			1 3. Check here if you have included a Continuation Form to list multiple final destinations

• Removed item 1 from old form: Importation into U.S.: Single  Multiple No. of shipments expected to be made within the next 12 months:_________________

• Removed item 2 from old form: Transfer within the U.S.:  Single  Multiple  None

No. of shipments expected to be made within the next 12 months:______________

• Removed item 3 from old form: U.S. port(s) of entry (if known):

• Removed item 4 from old form: Total volume (indicate units, ml, mg, liter):

• Added item 1 to new form: Is final destination of biological agent(s) different from address in Section A?  No (skip to Section E)  Yes

• Added item 2 to new form: Last Name of Recipient at Destination

• Added item 3 to new form: First Name

• Added item 4 to new form: MI

• Added item 5 to new form: Destination Organization

• Added item 6 to new form: Final Destination Address (NOT a post office box)

• Added item 7 to new form: City

• Added item 8 to new form: State

• Added item 9 to new form: Zip Code

• Added item 10 to new form: Telephone

• Added item 11 to new form: Fax

• Added item 12 to new form: Email

• Added item 13 to new form: Check here  if you have included a Continuation Form to list multiple final destination

Old form Section E:

SECTION E – Isolation and containment facilities and technical personnel

1. Description of applicant laboratory facilities, containment equipment, and personal protective equipment ( Additional sheets attached):

2. Biosafety level (See instructions):  Biosafety level 1  Biosafety level 2  Biosafety level 3  Biosafety level 4

3. Describe the qualifications, experience, and training of technical personnel handling the material ( Additional sheets attached):

New form section E:

SECTION E, Description of Imported Biological Agent
1. Intended use(s) of imported agent(s) a Diagnostic b Research c Clinical trials d Education e Production f Other (please describe):		2. Provide a detailed description of the work to be accomplished with the imported agent(s) (Describe your work clearly & simply. Include background, purpose, objectives, methods, etc.)								5 . Check here if you included a Continuation Form to list additional agents to be imported with this Permit.
3. Scientific name of known/suspected biological agent(s)			4. Type(s) of Biological Agent
Genus	Species			Bacteria	Virus	Fungi	Toxin	Parasite	Prion		Recombinant Genetic Material
a			a
b			b
c			c
d			d

• Removed item 1 from old form: Description of applicant laboratory facilities, containment equipment, and personal protective equipment ( Additional sheets attached):

• Removed item 2 from old form: Biosafety level (See instructions):  Biosafety level 1  Biosafety level 2  Biosafety level 3  Biosafety level 4

• Removed item 3 from old form: Describe the qualifications, experience, and training of technical personnel handling the material ( Additional sheets attached):

• Added item 1 to new form: Intended use(s) of imported agent(s)

 Diagnostic

 Research

 Clinical trials

 Education

 Production

 Other (please describe):

• Added item 2 to new form: Provide a detailed description of the work to be accomplished with the imported agent(s) (Describe your work clearly & simply. Include background, purpose, objectives, methods, etc.)

• Added item 3 to new form: Scientific name of known/suspected biological agent(s)

Genus	Species
a
b
c
d

• Added item 4 to new form: Type(s) of Biological Agent

Bacteria	Virus	Fungi	Toxin	Parasite	Prion	Recombinant Genetic Material

• Added item 5 to the new form: Check here  if you included a Continuation Form to list additional agents to be imported with this Permit.

Old form section F:

SECTION F – signature of permittee
	1. APPLICANT (Print Name)	2. SIGNATURE:	3. TITLE:	4. DEGREE(S)	5. DATE SIGNED (MM/DD/YYYY)

New form section F:

SECTION F, Description of Material(s) Containing the Biological Agent(s) to be Imported
1. Source of material(s) being imported (Check all that apply) a Infected or suspected infected human b Infected or suspected infected vector (APHIS permit may be required) i (please describe) ______________________________________________ ii Vector viability: 1 live 2 dead c Environment (please describe):__________________________________ d Other (please describe):_________________________________________ ­	2. Description of material(s) containing biological agent(s) (Check all that apply and provide description below) a Field-collected specimen e Tissues/organs b Laboratory isolate/culture f Body parts c Blood/blood products g Vector d Other body fluids h Other i Provide a detailed description of the material containing the biological agent:
3. Does the material contain animal products or byproducts (e.g., Fetal Calf Serum or Bovine Serum Albumin)? a No b Yes (APHIS Import Permit may also be required)

• Removed item 1 from old form: APPLICANT (Print Name)

• Removed item 2 from old form: SIGNATURE

• Removed item 3 from old form: TITLE

• Removed item 4 from old form: DEGREE(S)

• Removed item 5 from old form: 5. DATE SIGNED (MM/DD/YYYY)

• Added item 1 to new form: Source of material(s) being imported (Check all that apply)

Infected or suspected infected human

 Infected or suspected infected vector (APHIS permit may be required)

i (please describe) ______________________________________________

ii Vector viability:  live dead

 Environment (please describe):__________________________________

 Other (please describe):_________________________________________

• Added item 2 to new form: Description of material(s) containing biological agent(s)

(Check all that apply and provide description below)

Field-collected specimen Tissues/organs

Laboratory isolate/culture Body parts

Blood/blood products Vector

Other body fluids Other

1. Provide a detailed description of the material containing the biological agent:

• Added item 3 to new form: Does the material contain animal products or byproducts (e.g., Fetal Calf Serum or Bovine Serum Albumin)?

 No  Yes (APHIS Import Permit may also be required)

New form section G:

SECTION G, Receiving Laboratory Capabilities
1. Laboratory Biosafety Level (Check all that apply) a ABSL-1 e BSL-1 b ABSL-2 f BSL-2 c ABSL-3 g BSL-3 d ABSL-4 h BSL-4 i Other (please describe):	2. Primary Containment to be used (Check all that apply) a None (open bench) b Class I c Class II, Type _______ d Class III e Fume Hood f Other (please describe):	3. Personal Protective Measures to be used (Check all that apply) a Gloves b Protective Clothing c Goggles and/or Face Shield d Facemask e Respirators: Type i N95/100 ii PAPR f Immunizations g Other (please describe):____________		4. Personnel Training provided (Check all that apply) a Risk(s) associated with the imported biological agent(s) b Hazardous Material Packing/Shipping c Laboratory Standard Practices d Hazardous Waste Handling/Disposal e Emergency Response Procedures g Spill Procedures h Other (please describe): ________________________
5. Anticipated disposition of Biological Agent(s) (and material containing it) when work is completed a Will be retained at address listed in SECTION A b Will be transferred to location listed in SECTION D c Will be destroyed (please complete Block 6)			6 . If Agent(s) will be destroyed, list expected method(s) of destruction a Thermal: (describe method):______________________________________ b Chemical (describe chemical):_____________________________________ c Irradiation (describe energy source):_________________________________ d Other (please describe): _________________________________________

• Section G did not exist on the old form

• Added item 1 to new form: Laboratory Biosafety Level

(Check all that apply)

 ABSL-1  BSL-1

 ABSL-2 f BSL-2

 ABSL-3  BSL-3

 ABSL-4  BSL-4

 Other (please describe):

• Added item 2 to new form: Primary Containment to be used (Check all that apply)

 None (open bench)

 Class I

 Class II, Type _______

 Class III

Fume Hood

 Other (please describe):

• Added item 3 to new form: Personal Protective Measures to be used (Check all that apply)

 Gloves

 Protective Clothing

 Goggles and/or Face Shield

 Facemask

 Respirators:

Type i N95/100 ii PAPR

 Immunizations

 Other (please describe):____________

• Added item 4 to new form: Personnel Training provided (Check all that apply)

Risk(s) associated with the imported biological agent(s)

Hazardous Material Packing/Shipping

Laboratory Standard Practices

Hazardous Waste Handling/Disposal

Emergency Response Procedures

Spill Procedures

Other (please describe): ________________________

• Added item 5 to new form: Anticipated disposition of Biological Agent(s) (and material containing it) when work is completed

Will be retained at address listed in SECTION A

Will be transferred to location listed in SECTION D

Will be destroyed (please complete Block 6)

• Added item 6 to new form: If Agent(s) will be destroyed, list expected method(s) of destruction

 Thermal: (describe method):______________________________________

 Chemical (describe chemical):_____________________________________

 Irradiation (describe energy source):_________________________________

 Other (please describe): _________________________________________

New form section H:

SECTION H, Signature of Permittee
1. Requestor’s Signature (REQUIRED)	2. Requestor’s Printed Name (Print name)	3. Date Signed (mm/dd/yyyy)

• Section H did not exist on the old form

• Added item 1 to new form: Requestor’s Signature (REQUIRED)

• Added item 2 to new form: Requestor’s Printed Name (Print name)

• Added item 3 to new form: Date Signed (mm/dd/yyyy)

08/27/2010 Application for Permit to Import Biological Agents or Vectors of Human Disease Page 11 of 11

Guidance Document