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 01/31/2017

Application Number: Permit # issued (For Program use ONLY)

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: 404-471-8333. 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 US (Permittee)

1. Permittee's Last Name

2. Permittee’s First Name

3. MI

4. Permittee’s Organization

5. Physical Address (NOT a post office box)

6. City

7. State

8. Zip Code

9. Permittee’s Telephone Number

10. Permittee’s Fax Number

11. Permittee’s Email

12. Secondary Contact’s Name

13. Secondary Contact’s Telephone Number

14. Secondary Contact’s Email Name

1 5. Will the permittee be the courier of the imported biological agent? a Yes b No

16. 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 7. Check here if you have included a Continuation Form to list others authorized to use this permit

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

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

SECTION D, Final Destination of Imported Infectious Biological Agent(s) or Vector(s)

1. Is final destination of biological agent(s) or vector(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

CDC Form 0.753, Revised January 2014 Page 1

APPLICATION FOR PERMIT TO IMPORT INFECTIOUS BIOLOGICAL AGENTS, INFECTIOUS SUBSTANCES, OR VECTORS OF HUMAN DISEASE INTO THE UNITED STATES FORM APPROVED (OMB NO. 0920-0199/EXP DATE 01/31/2017)

SECTION E, Description of Infectious Biological Agent(s)

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.)

3 . Check here if you included a Continuation Form to list additional agents to be imported with this Permit.

4. Scientific name of known/suspected biological agent(s) including Genus and species

5. Strain Designation (list “N/A” if not applicable)

6. Location

7. Laboratory or Storage (Select one or both)

8. Laboratory Safety Level (Leave blank if storage only)

9. Person Responsible for Laboratory

Bldg

Suite/Room

Lab

Storage

SECTION F, 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 (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)

SECTION G, 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 f Other (please describe):

2. 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):____________

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 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): _________________________________________

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) CDC Form 0.753, Revised January 2014 Page 2