Attachment 3-General Application 2003

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

APPLICATION FOR PERMIT TO IMPORT OR TRANSPORT
ETIOLOGIC AGENTS, HOSTS, OR VECTORS
OF HUMAN DISEASE

FORM APPROVED
OMB NO. 0920-0199
EXP DATE 08/31/2006

Read instructions before completing. Answer all items completely and type or print in ink. Let us know if you have
already faxed your application. Use additional sheets if necessary. Complete and submit original signed
application to: Centers for Disease Control and Prevention, Etiologic Agent Import Permit Program, 1600 Clifton
Road NE, Mailstop E-79, Atlanta, GA 30333; Telephone: 404-498-2260; FAX: 404-498-2275.
SECTION A – PERSON REQUESTING PERMIT IN U.S.A.
1.Last Name of Permittee (Applicant)
2. First
3. MI
4. Organization
5. Address (NOT a post office box)
9. Telephone

6. City
10. FAX

8. Zip Code

11. E-mail

SECTION B – SENDER OF MATERIAL
2. First
3. MI
4. Organization

1. Last Name of Sender
5. Address (NOT a post office box)
10. Telephone

7. State

6. City
11. FAX

7.State/Prov

8. Postal Code

9. Country

12. E-mail

SECTION C – DESCRIPTION OF MATERIAL
1. Provide a detailed description of the material ( Check here if additional sheets are attached):

2. Country of origin of the material:
3. Address where the human pathogen is to be used if different
from Section A (NOT a post office box):

4. City

5. State

6. Zip Code

7. Is the material known or suspected to contain human or animal pathogens?
Yes
No (If no, then see instructions: an import
permit may not be required)
8. If yes, give the name of the etiologic agent(s) known or suspected to be present:
9. Natural host(s) for this etiologic agent(s):
10. Type of material:

Fluids or tissues (List species samples are from: ________________________________________________)
Isolate(s)
Bacterial toxin(s)
Host or vector
Other (Describe):________________________________________________________________________
11. Does this material contain a select agent (specified in 42 C.F.R. Part 73)?
Yes
No
If yes, provide your CDC or APHIS facility registration number:___________________ Expiration date of registration: ____________

APPLICATION FOR PERMIT TO IMPORT OR TRANSPORT AGENTS OR VECTORS OF HUMAN DISEASE
Page 2 of 2
12 Are these materials for laboratory use only?
Yes
No
If no, will the materials be used for the production of biologics for humans or animals?
Yes
No
13. Estimated completion date of work:
14. Proposed use of material:
15. Describe objectives of work (

Research

Diagnostics

Production

Other (Describe:______________________________)

Additional sheets attached):

16. Final disposition of material(s) after completion of work:
Long-term storage onsite
Transfer to another location (Describe:________________________________________________________________________)
Destroyed on site (Method of destruction: ______________________________________________________________________)
Other (Describe:__________________________________________________________________________________________)
1. Importation into U.S.:

SECTION D – TYPE OF PERMIT AND SHIPMENT INFORMATION
Single
Multiple No. of shipments expected to be made within the next 12 months:_________________

2. Transfer within the U.S.:
Single Multiple
None
No. of shipments expected to be made within the next 12 months:______________
3. U.S. port(s) of entry (if known):
4. Total volume (indicate units, ml, mg, liter):
SECTION E – ISOLATION AND CONTAINMENT FACILITIES AND TECHNICAL PERSONNEL
1. Description of applicant laboratory facilities and equipment (

2. Biosafety level (See instructions):

Biosafety level 1

Check here if additional sheets are attached):

Biosafety level 2

Biosafety level 3

3. Describe the qualifications and experience of technical personnel handling the material (

Biosafety level 4

Additional sheets attached):

I hereby certify that the information submitted in this application is complete and accurate to the best of my knowledge and belief. I agree to comply with
the conditions listed in the application and all restrictions and precautions that may be specified in the permit, in addition to all applicable regulations which
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 F – SIGNATURE OF PERMITTEE
1. APPLICANT (Print Name)

2. SIGNATURE:

3. TITLE:

4. DEGREE(S)

5. DATE SIGNED
(dd/mm/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/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS E-11, Atlanta, Georgia
30333; ATTN: PRA (0920-0199)
CDC 0.753
REV. 02/04

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

GUIDANCE DOCUMENT FOR THE APPLICATION FOR PERMIT
TO IMPORT OR TRANSPORT ETIOLOGIC AGENTS, HOSTS, OR
VECTORS OF HUMAN DISEASE

FORM APPROVED
OMB NO. 0920-0199
EXP DATE 08/31/2006

Importation permits are issued by the Etiologic Agent Import Permit Program at the Centers for Disease Control
and Prevention (CDC) after review of a completed application form. The regulation, application, and instructions
can be found at the CDC website (http://www.cdc.gov/od/ohs/biosfty/imprtper.htm) or by calling the CDC fax
information service at 1-888-232-3299 and requesting document number 101000. Completed application forms
may be returned to the CDC, Etiologic Agent Import Permit Program by FAX (FAX: 404-498-2275) or by mail to:
Centers for Disease Control and Prevention
Etiologic Agent Import Permit Program
1600 Clifton Road, N.E. Mailstop E-79
Atlanta, GA 30333
Please note the following:
• Currently there is no fee for processing a U.S. Public Health Service import permit.
• At least 15 working days are required to process import permit applications, renewals and modifications.
Please allow 15 working days before inquiring about the status of your permit.
• Import permit applications, renewals and modifications are processed in the order they are received.
Requests for expediting permits will be handled on a case-by-case basis and only for documented
emergencies.
• Requests for renewal of an existing permit and modifications will require the completion of a new
application and current signature of the permittee. To prevent lapses in import permit status, please submit
renewal applications at least 30 days prior to expiration date of current permit.
• Incomplete or illegible applications will result in significant delays or denial of a permit. Applications may be
typed or handwritten. However, if handwritten, applications must be legible. Applications will be returned
without action if incomplete or illegible.
• Use additional sheet(s), noting the section number, if more space is needed.
Section A. The person requesting the permit (permittee or applicant) should be: (1) Knowledgeable and skilled in
the handling of the infectious agent or biological material (in general, regulatory affairs officers or other
administrative personnel are not acceptable as permittees), (2) Be directly responsible for work with the infectious
material, and (3) Should be located at the address within the U.S. where work with the infectious material will be
performed. Enter your complete name, address, telephone, and FAX number. Failure to include the telephone
and FAX numbers where you can be reached during the day will result in prolonged delays. The name appearing
in this section and in Section F should be the same. Only one name may be used.
Section B. Enter complete name, address, telephone and FAX number of the sender. Multiple sources may be
listed on an attached sheet as needed. List the corresponding infectious material that will be shipped for each
source.
Section C. Describe the type of material and answer “yes” or “no” to the questions given. If the material being
imported has been rendered sterile (e.g., radiation or chemical treatment) and is known not to contain infectious
agents for humans, then a permit is not required for importation. If the material is suspected or known to contain
an etiologic agent, then please indicate what the agent is and give a description of the material being imported
(e.g., tissue and blood containing Hepatitis A virus). Indicate the natural host for the agent (e.g., human, mouse,
insect, etc.). Note that incomplete information may result in significant delays or denial of your permit request.
Importers of select agents and toxins (as specified in 42 C.F.R. Part 73) must be registered with CDC in
accordance with 42 C.F.R. Part 73 (Possession, use and transfer of select agents and toxins). The 42 C.F.R. Part
73 and registration application package is available through the CDC Select Agent Program website at:
http://www.cdc.gov/od/sap. The transfer of select agents and toxins require prior authorization by CDC on a CDC
Form EA-101 in accordance with § 73.14.

Indicate if the material will be for laboratory use only or if it will be used in the production of biological products for
subsequent human or animal use. When describing the objectives of the work, please state the intended use(s)
(for example, infectious disease research or diagnosis, assay development, commercial production, etc.)
Section D. Importation into the U.S. refers to the package as it passes through the port of entry to the applicant's
address. Moving imported material from one air carrier to another at the port of entry on the way to its domestic
destination is not considered a transfer for the purposes of this permit. A transfer within the U.S. refers to shipping
from one address within the U.S. to another address within the U.S.
Permits for single importations are valid for six months. Permits for multiple importations are valid for one year.
For multiple shipments, enter the number of shipments you expect to receive in the next 12 months and number
of transfers you expect to make in the next 12 months.
Section E. Indicate the biosafety level of the laboratory where the work will occur and any other information
pertinent to available facilities. Definitions of biosafety levels follow that published in “Biosafety in Microbiological
and Biomedical Laboratories” (BMBL). The BMBL is available on the internet at
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm. Describe the qualifications and technical experience of
personnel that will be handling this material. A C.V. and a list of publications may be requested from CDC.
Section F. Type or print your name legibly in the appropriate space and sign name in the indicated space. The
application must be signed by the same person listed in Section A, or the permit application will not be processed.
Type or print the title and degree of the applicant and the date that the application is signed.