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

OMB Approval #
EXP DATE mm/dd/yyy

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 (No acronyms unless part of the legal name)

4. Physical Address (NOT a post office box)

5. City

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

13. Institutional Biosafety Officer’s Name (Or other qualified party. If

14. Institutional Biosafety
Officer’s Telephone Number (Or

15. Institutional Biosafety
Officer’s Email (Or equivalent

no BSO, enter permittee contact info)

6. State

equivalent party)

7. Zip Code

party)

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 (Full name of organization preferred)

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

5. City

6. State/Province

8. Postal Code

9. Telephone Number

7. Country

10. Email

CLICK HERE TO ADD ADDITIONAL ROWS (ADDITIONAL SENDERS)

SECTION C-Shipment Information
1. Method(s) of Shipment
☐Commercial Carrier (e.g., FedEx)
☐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)

2. Provide a detailed description of the work to be accomplished with the
imported agent(s) (Describe your work clearly & simply. Include background, purpose,

☐Diagnostic
☐Research
☐Clinical trials
☐Education
☐Production
☐Other (please describe):

objectives, methods, etc.)

3. Will the agent(s) be propagated or cultured?
☐Yes
☐No

4. Will the agent(s) be used to inoculate animals or arthropods?
☐The agent will NOT be used to inoculate animals or arthropods
☐Nonhuman primates (NHPs)
☐Rodent species
☐Arthropods
☐Other animal species (please list species):

If yes, will the total culture volume exceed 10 liters
at any point?
☐Yes
☐No

If yes, what route(s) will inoculation occur?
☐Aerosol (NOT intranasal)
☐ Other (please describe):

☐Intranasal
☐Subcutaneous (SQ)
☐Intramuscular (IM)

Will necropsies be performed?
☐Yes
☐No
5. Scientific name of
known/suspected
biological agent(s)

6. Strain (If
applicable)

7. Building
Location

8. Suite/Room
Location

9. Laboratory

10. Storage

11. Biosafety
Level

(Include Genus and species)

CLICK HERE TO ADD ADDITIONAL ROWS (ADDITIONAL LOCATIONS FOR INFECTIOUS BIOLOGICIAL
AGENT)
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. Description of material(s) containing the biological agent(s) (Check all

2. Original source of material(s) being imported (Check all

☐Blood/blood products
☐Tissues
☐Organs/body parts
☐Urine
☐Feces
☐Sputum/Saliva
☐Environmental field-collected
specimen

☐Human
☐Animal
☐Arthropod vector
☐Live
☐Dead
☐Eggs/larvae
☐Recombinant/Synthetic
☐Environment
☐Other (please describe):

that apply)

☐Soil
☐Water
☐Sewage
☐Isolate/Culture

☐Isolate/Culture
☐Infectious clones
☐Purified Nucleic acids
☐Other (please describe):

that apply)

☐Food
products
☐Surface
swab

i. Provide a detailed description of the material containing the biologic agent(s) in the following format:
(Options selected in E1) from (Options selected in E2) that may contain (Infectious Biological Agent)

SECTION F-Biosafety Measures
1. Primary Containment to be
used (Check all that apply)

2. Personal Protective Measures to be used (Check

☐None/Open bench
☐Downdraft table
☐Backdraft table
☐Fume Hood
☐Biosafety cabinet
☐Class I
☐Class II
☐Class III
☐Flexible film isolator with
HEPA filtration
☐Animal caging with HEPA
filtration
☐Other (please describe):

☐Gloves
☐Laboratory coat
☐Sleeves
☐Booties/Shoe covers
☐Aprons
☐Smocks
☐Coveralls
☐Scrubs
☐Olefin suits
☐Positive Pressure
Encapsulating Unit
(PPES)

all that apply)

4. Anticipated disposition of Infectious 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 G
Will be destroyed (complete Block 5)

☐Eye protection
☐Face shield
☐N95 or N100
Respirator
☐Powered Air
Purifying Respirator
(PAPR)/Controlled Air
Purifying Respirator
(CAPR)
☐Half-face respirator
☐Full-face respirator
☐Immunizations

3. Personnel Training provided (Check all that apply)
☐Risk(s) associated with manipulating/storing
the imported biological agent(s)
☐Laboratory Standard Practices
☐Hazardous Waste Handling/Disposal
☐Emergency Response Procedures
☐Spill Procedures
☐Visitor Training
☐Other (please describe):

5. If Agent(s) will be destroyed, list the expected primary method of
destruction
☐Thermal:
☐Onsite Autoclave
☐Onsite Incineration
☐Chemical (describe chemical):
☐Effluent Decontamination System (EDS)
☐Contracted hazardous waste disposal company
☐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?
☐Yes (complete items 2-24)
☐No (go to end of application)
2. Last Name of Recipient at
3. First Name
4. Destination Organization (No acronyms unless part of the legal name)
Destination
5. Final Destination Address (NOT a post office box)

6. City

7. State

8. Zip Code

9. Final Destination Telephone Number

10. Final Destination Email

11. Intended use(s) of imported agent(s)

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.)

☐Diagnostic
☐Research and development
☐Clinical trials
☐Education
☐Production
☐Other (please describe):
13. Will the agent(s) be propagated or cultured?
☐Yes
☐No
If yes, will the total culture volume exceed 10 liters at
any point?
☐Yes
☐No

14. Will the agent(s) be used to inoculate animals or arthropods?
☐The agent will NOT be used to inoculate animals or arthropods
☐Nonhuman primates (NHPs)
☐Rodent species
☐Arthropods
☐Other animal species (please list species):
If yes, what route(s) will inoculation occur?
☐Aerosol (NOT intranasal)
☐ Other (please describe):

☐Intranasal
☐Subcutaneous (SQ)
☐Intramuscular (IM)

15. Scientific name of
known/suspected
biological agent(s)

16. Strain (If
applicable)

17. Building
Location

18. Suite/Room
Location

Will necropsies be performed?
☐Yes
☐No
19. Laboratory
20. Storage

21. Biosafety
Level

(Include Genus and species)

CLICK HERE TO ADD ADDITIONAL ROWS (ADDITIONAL LOCATIONS FOR INFECTIOUS BIOLOGICIAL AGENT)
CLICK HERE TO ADD ADDITIONAL ROWS (ADDITIONAL INFECTIOUS BIOLOGICIAL AGENTS)

22. Primary Containment to
be used (Check all that apply)
☐None/Open bench
☐Downdraft table
☐Backdraft table
☐Fume Hood
☐Biosafety cabinet
☐Class I
☐Class II
☐Class III
☐Flexible film isolator with
HEPA filtration
☐Animal caging with HEPA
filtration
☐Other (please describe):

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

☐Gloves
☐Laboratory coat
☐Sleeves
☐Booties/Shoe covers
☐Aprons
☐Smocks
☐Coveralls
☐Scrubs
☐Olefin suits
☐Positive Pressure
Encapsulating Unit
(PPES)

☐Eye protection
☐Face shield
☐N95 or N100
Respirator
☐Powered Air
Purifying Respirator
(PAPR)/Controlled Air
Purifying Respirator

24. Personnel Training provided (Check all that
apply)

☐Risk(s) associated with manipulating/storing
the imported biological agent(s)
☐Laboratory Standard Practices
☐Hazardous Waste Handling/Disposal
☐Emergency Response Procedures
☐Spill Procedures
☐Visitor Training
☐Other (please describe):

(CAPR)

☐Half-face respirator
☐Full-face respirator
☐Immunizations

CLICK HERE TO ADD ADDITIONAL ROWS (Final Destination(s) 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)

4. I attest that the permittee has implemented and will continue to implement 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. ☐Accept and Submit

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)