Previous Application for Permit to Import Infectious Agents

Attachment 5-Application for Permit to Import Biological Agents and Vectors of Human Disease into the United States.pdf

Import Permit Applications (42 CFR 71.54)

Previous Application for Permit to Import Infectious Agents

OMB: 0920-0199

Document [pdf]
Download: pdf | pdf
FORM APPROVED
OMB NO. 0920-0199
EXP DATE 01/31/2014

APPLICATION FOR PERMIT
TO IMPORT BIOLOGICAL AGENTS OR VECTORS OF
HUMAN DISEASE INTO THE UNITED STATES

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

Application Number:

Guidance for completing this form is available at www.cdc.gov/od/eaipp/ImportApplicationForms.htm. 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.

Permit # issued

Please submit completed form only once by either email, fax, or mail
(For Program use ONLY)

SECTION A, Person Requesting Permit in US (Permittee)
1. Permittee's Last Name

2. First Name

3. MI

5. Physical Address (NOT a post office box)

6. City

9. Telephone

7. State

10. Fax

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

1. Sender’s Last Name (

4. Permittee’s Organization
8. Zip Code

11. Email
13. 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

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

SECTION B, Sender of Imported Biological Agent(s)
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.

10. Telephone

11. Fax

1. Method(s) of Shipment
a Commercial Carrier (e.g., FedEx)
b Hand-carried by (provide name of
person):_____________________

SECTION C, Shipment Information
2. Number of Shipments
3. Shipment Temperature(s)
a Single Shipment
a Ambient
b Multiple Shipments
b Frozen/Refrigerated
i. Estimated # of shipments:____

8. Country

12. Email

9. Postal Code
13. Check here
if you
have included a Continuation
Form to list multiple senders

4. Anticipated U.S. Port(s) of Entry

SECTION D, Final Destination of Imported Biological Agent
1. Is final destination of biological agent(s) 2. Last Name of Recipient at Destination
3. First Name
different from address in Section A?
a No (skip to Section E) b Yes
5 .Destination Organization

10. Telephone

CDC Form 0.753, Revised January 2011

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

11. Fax

7. City

12. Email

4. MI

8. State

9. Zip Code

13. Check here
if you
have included a Continuation
Form to list multiple final
destinations
Page 1

APPLICATION FOR PERMIT TO IMPORT BIOLOGICAL AGENTS OR VECTOR OF HUMAN DISEASE INTO THE US

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

SECTION E, Description of Imported Biological Agent
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. Scientific name of known/suspected biological agent(s)
Genus

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

4. Type(s) of Biological Agent

Species

Bacteria

a

a

b

b

c

c

d

d

Virus

Fungi

Toxin

Parasite

Prion

Recombinant
Genetic Material

SECTION F, Description of Material(s) Containing the Biological Agent(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/organs
b Infected or suspected infected vector (APHIS permit may be
b Laboratory isolate/culture
f Body parts
required)
i (please describe) ______________________________________________
c Blood/blood products
g Vector
d Other body fluids
h Other
ii Vector viability:
1 live
2 dead
c Environment (please describe):__________________________________
i Provide a detailed description of the material containing the biological agent:
d

Other (please describe):_________________________________________

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)
1. Laboratory Biosafety Level
(Check all that apply)
ABSL-1
e
ABSL-2
f
ABSL-3
g
ABSL-4
h

BSL-1
BSL-2
BSL-3
BSL-4
i Other (please describe):

a
b
c
d

SECTION G, Receiving Laboratory Capabilities
2. Primary Containment to 3. Personal Protective Measures to 4. Personnel Training provided (Check all that
apply)
be used (Check all that apply) be used (Check all that apply)
a Risk(s) associated with the imported
a None (open bench)
a Gloves
biological agent(s)
b Class I
b Protective Clothing
b Hazardous Material Packing/Shipping
c Class II, Type _______
c Goggles and/or Face Shield
c Laboratory Standard Practices
d Class III
d Facemask
d Hazardous Waste Handling/Disposal
e Fume Hood
e Respirators:
e Emergency Response Procedures
f Other (please describe):
Type i N95/100 ii PAPR
g Spill Procedures
f Immunizations
g Other (please describe):____________ h Other (please describe): ________________________

5. Anticipated disposition of 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.

1. Requestor’s Signature (REQUIRED)

SECTION H, Signature of Permittee
2. Requestor’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 2011

Page 2


File Typeapplication/pdf
AuthorEd Gaunt
File Modified2011-02-18
File Created2011-02-01

© 2024 OMB.report | Privacy Policy