Application for Permit to Import Infectious Biological A

U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

APPLICATION FOR PERMIT TO IMPORT INFECTIOUS BIOLOGICAL AGENTS INTO THE UNITED STATES

FORM APPROVED OMB NO. 0920-0199 EXP DATE 12/31/2019

Guidance for completing this form is available at http://www.cdc.gov/od/eaipp/importApplication/. This form may be submitted by mail, fax, or email attachment to the Centers for Disease Control and Prevention, Import Permit Program. Mailing Address: 1600 Clifton Road NE, Mailstop A-46, Atlanta, GA 30333. Fax: 404-718-2093. E-mail: [email protected]. Telephone: 404-718-2077. Please submit completed form only once by either email, fax, or mail

SECTION A - Person Requesting Permit in U.S. (Permittee)

1. Permittee's Last Name

2. Permittee’s First Name

3. Permittee’s Organization

4. Physical Address (NOT a post office box)

5. City

6. State

7. Zip Code

8. Permittee’s Telephone Number

9. Permittee’s Email

10. Secondary Contact’s Name

11. Secondary Contact’s Telephone Number

12. Secondary Contact’s Email Name

13. Institutional Biosafety Officer’s Name

14. Institutional Biosafety Officer’s Telephone Number

15. Institutional Biosafety Officer’s Email Name

CLICK HERE TO ADD ADDITIONAL ROWS (AUTHORIZED USERS OF THE PERMIT)

SECTION B - Sender of Imported Infectious Biological Agent(s) or Vector(s)

1. Sender’s Last Name

2. Sender’s First Name

3. Sender’s Organization

4. Physical Address Outside of the U.S. (NOT a post office box)

5. City

6. State/Providence

7. Country

8. Postal Code

9. Telephone Number

10 Email

CLICK HERE TO ADD ADDITIONAL ROWS (ADDITIONAL SENDERS)

SECTION C - Shipment Information

1. Method(s) of Shipment a Commercial Carrier (e.g., FedEx) b Hand-carried by individuals listed in Section A

2. Estimated Number of Shipments [Enter numeric value]

SECTION D - Description of Infectious Biological Agent(s) and Permittee’s Laboratory

1. Intended use(s) of imported agent(s) a Diagnostic b Research c Clinical trials d Education e Production ff 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.)

3. Will the agent(s) be propagated or cultured? X Yes X No If yes, will the total culture volume exceed 10 liters at any point? X Yes X No

4. Will the agent(s) be used to inoculate animals or arthropods? X Yes X No If yes, will this be by the aerosol route? X Yes X No

5. Scientific name of known/suspected biological agents(s) include Genus and species

6. Strain (if applicable)

7. Building Location

8. Suite/Room Location

9. Laboratory

10. Storage

11. Safety Level X BSL-1 X BSL-2 X BSL-3 X BSL-4 X ABSL-1 X ABSL-2 X ABSL-3 X ABSL-4 X ACL-1 X ACL-2 X ACL-3 X ACL-4 X BSL-3 Ag

CLICK HERE TO ADD ADDITIONAL ROWS (Infectious Biological Agent(s))

SECTION E - Description of Material(s) Containing the Infectious Biological Agent(s) or Vector(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 1 live 2 dead c Environment (please describe):__________________________________ c Recombinant/synthetic (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 b Laboratory derived isolate/culture f Organs/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:
SECTION F- Biosafety Measures
1. 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 Negative pressure ventilated enclosure with HEPA filtration f Other (please describe):	2. Personal Protective Measures to be used (Check all that apply) a Gloves b Protective Clothing (e.g., laboratory coat) c Goggles X Face Shield d Facemask e N95 or N100 Respirator X Powered Air Purifying Respirator (PAPR) f Immunizations g Other (please describe):____________			3. 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): ________________________	4. Has the permittee implemented biosafety measures commensurate with the hazard posed by the infectious biological agent, infectious substance, and/or vector to be imported, and the level of risk given its intended use? a No b Yes (Plan may be required to be submitted)
5. Anticipated disposition of Infectious 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 G c Will be destroyed (please complete Block 6)			6. If Agent(s) will be destroyed, list expected method(s) of destruction a Thermal: X Onsite Autoclave X Onsite Incineration b Chemical (describe chemical):_____________________________________ c Irradiation (describe energy source):_________________________________ X Contracted hazardous waste disposal company (name of company): __________________________ d Other (please describe): _________________________________________

SECTION G – Final Destination(s) of Imported Biological Agent(s) or Vector(s)

1. Will the permittee transfer the imported materials to locations not listed in Section D above. X Yes (complete items 2-25) X No

2. Last Name of Recipient at Destination

3. First Name

4. Destination Organization

5. Final Destination Address (NOT a post office box)

6. City

7. State

8. Zip Code

9. Telephone Number

10. Email:

11. Intended use(s) of imported agent(s) a Diagnostic b Research c Clinical trials d Education e Production ff Other (please describe):

12. 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.)

13. Will the agent(s) be propagated or cultured? X Yes X No If yes, will the total culture volume exceed 10 liters at any point? X Yes X No

14. Will the agent(s) be used to inoculate animals or arthropods? X Yes X No If yes, will this be by the aerosol route? X Yes X No

15. Scientific name of known/suspected biological agents(s) include Genus and species

16. Strain (if applicable)

1 7. Building Location

18. Suite/Room Location

19. Laboratory

20. Storage

21. Safety Level X BSL-1 X BSL-2 X BSL-3 X BSL-4 X ABSL-1 X ABSL-2 X ABSL-3 X ABSL-4 X ACL-1 X ACL-2 X ACL-3 X ACL-4 X BSL-3 Ag

22. 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 Negative pressure ventilated enclosure with HEPA filtration f Other (please describe):

23. Personal Protective Measures to be used (Check all that apply) a Gloves b Protective Clothing c Goggles X Face Shield d Facemask e N95 or N100 Respirator X Powered Air Purifying Respirator (PAPR) f Immunizations g Other (please describe):____________

24. 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): ________________________

25. Has the permittee implemented biosafety measures commensurate with the hazard posed by the infectious biological agent, infectious substance, and/or vector to be imported, and the level of risk given its intended use? a No b Yes (Plan may be required to be submitted)

+ CLICK HERE TO ADD ADDITIONAL ROWS (Final Destinations of Imported Biological Agent(s) or Vector(s))

I hereby certify that all individuals listed in this application have the appropriate qualifications, experience and training to safely handle the agents being imported and that the information submitted in this application is complete and accurate to the best of my knowledge and belief. I agree to comply with all conditions, restrictions and precautions that may be specified in any permit that may be issued. Additionally, I agree to comply with all applicable regulations and guidelines that govern this transfer. I understand that failure to comply with the importation requirements may subject me to criminal penalties pursuant to 42 U.S.C. 271. I understand that any false statement made in this application may subject me to criminal penalties pursuant to 18 U.S.C. 1001.

SECTION H - Signature of Permittee

1. Permittee’s Signature (REQUIRED)

2. Permittee’s Printed Name (Print name)

3. Date Signed (mm/dd/yyyy)

Public recording burden of this collection of information is estimated to average 20 minutes 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 Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-0199)