Proposed Changes to the Application for Permit to Import Infectious Biological Agents into the US

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

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

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

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)
8. Permittee’s Telephone Number
101. Secondary Contact’s Name
134. Institutional Biosafety Officer’s Name

5. City

6. State

7. Zip Code

9. Permittee’s Email
10. Will the permittee be the courier of the imported biological agent?
a Yes
b No
112. Secondary Contact’s Telephone
123. Secondary Contact’s Email Name
Number
145. Institutional Biosafety Officer’s
Telephone Number

156. Institutional Biosafety Officer’s Email Name

CLICK HERE TO ADD ADDITIONAL ROWS (AUTHORIZED USERS OF THE PERMIT)
1. Sender’s Last Name

SECTION B - Sender of Imported Infectious Biological Agent(s) or Vector(s)
2. Sender’s First Name
3. Sender’s Organization

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

5. City

6. State/Providence

7. Country

box)

8. Postal Code

9. Telephone Number

10 Email

CLICK HERE TO ADD ADDITIONAL ROWS (ADDITIONAL SENDERS)
1. Method(s) of Shipment
a Commercial Carrier (e.g., FedEx)
b Hand-carried by individuals listed in Section A

SECTION C - Shipment Information
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):
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

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.)

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

Formatted Table

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)
2. Description of material(s) containing biological agent(s)
(Check all that apply and provide description below)
a Infected or suspected infected human
a Field-collected specimen
e Tissues
b Infected or suspected infected vector
b Laboratory derived isolate/culture
f Organs/Body parts
1 live
2 dead
c Blood/blood products
g Vector
c Environment (please describe):__________________________________
d Other body fluids
h Other
c Recombinant/synthetic (please describe):_________________________
d Other (please describe):_________________________________________
i Provide a detailed description of the material containing the biological agent:

SECTION F- Biosafety Measures
2. Personal Protective Measures to
3. Personnel Training provided (Check all
4. Has the permittee
that apply)
be used (Check all that apply)
implemented biosafety
a
Risk(s)
associated
with
the
imported
a Gloves
measures commensurate with
biological agent(s)
b Protective Clothing (e.g.,
the hazard posed by the
b Hazardous Material Packing/Shipping
laboratory coat)
infectious biological agent,
c Laboratory Standard Practices
c Goggles
infectious substance, and/or
d Hazardous Waste Handling/Disposal
X Face Shield
vector to be imported, and the
e Emergency Response Procedures
d Facemask
level of risk given its intended
g Spill Procedures
e N95 or N100 Respirator
use?
h Other (please describe):
X Powered Air Purifying Respirator
a No
b Yes (Plan may be
________________________
required to be submitted)
(PAPR)
f Immunizations
g Other (please describe):____________
5. Anticipated disposition of Infectious Biological Agent(s) (and
6. If Agent(s) will be destroyed, list expected method(s) of destruction
material containing it) when work is completed
a Thermal:
a Will be retained at address listed in SECTION A
X Onsite Autoclave
b Will be transferred to location listed in SECTION G
X Onsite Incineration
c Will be destroyed (please complete Block 6)
b Chemical (describe chemical):_____________________________________
c Irradiation (describe energy source):_________________________________
X Contracted hazardous waste disposal company (name of company):
__________________________
d Other (please describe): _________________________________________
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):

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

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):
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

8. Zip Code

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.)

X Face Shield
d Facemask
e N95 or N100 Respirator
X Powered Air Purifying
Respirator (PAPR)
f Immunizations
g Other (please

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
19.
20.
21. Safety Level
1 7.
18. Suite/Room
Laborat Storage
X BSL-1
Building
Location
ory
X BSL-2
Location
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
24. Personnel Training provided 25. Has the permittee implemented
(Check all that apply)
biosafety measures commensurate with the
a Risk(s) associated with the
hazard posed by the infectious biological
imported biological agent(s)
agent, infectious substance, and/or vector
b Hazardous Material
to be imported, and the level of risk given its
Packing/Shipping
intended use?
c Laboratory Standard Practices
a No
b Yes (Plan may be required to be
d Hazardous Waste
submitted)
Handling/Disposal
e Emergency Response
Procedures
g Spill Procedures
h Other (please describe):

describe):____________

________________________

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

16. Strain (if applicable)

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

+ 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.

1. Permittee’s Signature (REQUIRED)

SECTION H - Signature of Permittee
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)