Application for Permit to Import Infectious Biological A

Import Permit Applications (42 CFR 71.54)

Att 4a2-Application for Permit IBA_revised clean

Application for Permit to Import Infectious Biological Agents into the United States

OMB: 0920-0199

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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

Shape1 a Commercial Carrier (e.g., FedEx)

Shape2 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)

Shape3 a Diagnostic

Shape4 b Research

Shape5 c Clinical trials

Shape6 d Education

Shape7 e Production

Shape8 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)

Shape9 Shape10 a Infected or suspected infected human

Shape11

b Infected or suspected infected vector

Shape12 Shape13 1 live 2 dead

Shape14 c Environment (please describe):__________________________________

c Recombinant/synthetic (please describe):_________________________

Shape15 d Other (please describe):_________________________________________ ­

2. Description of material(s) containing biological agent(s)
(Check all that apply and provide description below)

Shape17 Shape16 a Field-collected specimen e Tissues

Shape19 Shape18 b Laboratory derived isolate/culture f Organs/Body parts

Shape21 Shape20 c Blood/blood products g Vector

Shape23 Shape22 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)

Shape24 a None (open bench)

Shape25 b Class I

Shape26 c Class II, Type _______

Shape27 d Class III

Shape28 e Fume Hood

Negative pressure ventilated enclosure with HEPA filtration

Shape29 f Other (please describe):

2. Personal Protective Measures to be used (Check all that apply)

Shape30 a Gloves

Shape31 b Protective Clothing (e.g., laboratory coat)

Shape32 c Goggles

X Face Shield

Shape33 d Facemask

Shape34 e N95 or N100 Respirator

X Powered Air Purifying Respirator (PAPR)

Shape35 f Immunizations

Shape36 g Other (please describe):____________

3. Personnel Training provided (Check all that apply)

Shape37

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

Shape38 b Hazardous Material Packing/Shipping

Shape39 c Laboratory Standard Practices

Shape40 d Hazardous Waste Handling/Disposal

Shape41

e Emergency Response Procedures

Shape42

g Spill Procedures

Shape43 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?

Shape45 Shape44 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

Shape46 a Will be retained at address listed in SECTION A

Shape47 b Will be transferred to location listed in SECTION G

Shape49 Shape48 c Will be destroyed (please complete Block 6)

6. If Agent(s) will be destroyed, list expected method(s) of destruction

Shape50 a Thermal:

X Onsite Autoclave

X Onsite Incineration

Shape51 b Chemical (describe chemical):_____________________________________

Shape52 c Irradiation (describe energy source):_________________________________

X Contracted hazardous waste disposal company (name of company): __________________________

Shape53 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)

Shape54 a Diagnostic

Shape55 b Research

Shape56 c Clinical trials

Shape57 d Education

Shape58 e Production

Shape59 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)

Shape60 a None (open bench)

Shape61 b Class I

Shape62 c Class II, Type _______

Shape63 d Class III

Shape64 e Fume Hood

Negative pressure ventilated enclosure with HEPA filtration

Shape65 f Other (please describe):

23. Personal Protective Measures to be used (Check all that apply)

Shape66 a Gloves

Shape67 b Protective Clothing

Shape68 c Goggles

X Face Shield

Shape69 d Facemask

Shape70 e N95 or N100 Respirator

X Powered Air Purifying Respirator (PAPR)

Shape71 f Immunizations

Shape72 g Other (please describe):____________

24. Personnel Training provided (Check all that apply)

Shape73

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

Shape74 b Hazardous Material Packing/Shipping

Shape75 c Laboratory Standard Practices

Shape76 d Hazardous Waste Handling/Disposal

Shape77

e Emergency Response Procedures

Shape78

g Spill Procedures

Shape79 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?

Shape81 Shape80 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)





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