General Questions

How will I receive my permit once it has been approved?

Once approved, a downloadable PDF of the permit will be available in eIPP (the electronic application system for import permits). Since eIPP currently does not have an email alert feature to notify account holders of status changes or to automatically email the approved permit, it is recommended that account holders check the status of their application daily.

Do I need an import permit?

The e-Tool will assist you in determining if an import permit is needed to import infectious biological agents, infectious substances, and vectors into the United States.

Is there a fee for obtaining a CDC import permit?

No. Currently, there is no fee for processing a CDC import permit.

What are the responsibilities of the importer once an import permit has been issued?

The CDC import permit is issued only to the importer located in the United States. The importer must take measures to help ensure that the shipper complies with all applicable legal requirements concerning the packaging, labeling, and shipment of infectious substances.

What type of material requires a CDC import permit?

Infectious biological agent: A microorganism [including, but not limited to, bacteria (including rickettsiae), viruses, fungi, or protozoa] or prion, whether naturally occurring, bioengineered, or artificial, or a component of such microorganism or prion that is capable of causing communicable disease in a human.

Infectious substance: Any material that is known or reasonably expected to contain an infectious biological agent.

Vector: Any animals (vertebrate or invertebrate) including arthropods or any noninfectious self-replicating system (e.g., plasmids or other molecular vector) or animal products (e.g., a mount, rug, or other display item composed of the hide, hair, skull, teeth, bones, or claws of an animal) that are known to transfer or are capable of transferring an infectious biological agent to a human.

Which types of materials do NOT require an import permit?

• Select agents listed in 42 CFR Part 73 if importation has been authorized in accordance with 42 CFR 73.16 or 9 CFR 121.16.
• With the exception of bat or nonhuman primate specimens, diagnostic specimens not known by the importer to contain, or suspected by the importer of containing, an infectious biological agent if accompanied by an importer certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent, or has been rendered noninfectious.
• With the exception of live bats or bat or nonhuman primate products, animal or animal products being imported for educational, exhibition, or scientific purposes if accompanied by documentation confirming that the animal or animal product is not known to contain (or suspected of containing) an infectious biological agent or has been rendered noninfectious.
• Nucleic acids that cannot produce infectious forms of any infectious biological agent if the specimen is accompanied by an importer certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent.
• Animal or animal product listed in 42 CFR Part 71 if importation has been authorized in accordance with 42 CFR §§ 71.52, 71.53, or 71.56.
• Product that is cleared, approved, licensed, or otherwise authorized under any of the following laws:
  • The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
  • Section 351 of the Public Health Service Act pertaining to biological products (42 U.S.C. 262).
  • The Virus-Serum-Toxin Act (21 U.S.C. 151-159).

What type of animal vectors would require an import permit?

Animals: Any member of the animal kingdom except a human, including an animal product (e.g., a mount, rug, or other display item composed of the hide, hair, skull, teeth, bones, or claws).

Arthropods: Any living insect including crustaceans, spiders, scorpions, etc., capable of being a host or vector of human disease.

Snails: Any freshwater snails (phylum Mollusca, class Gastropoda) capable of transmitting schistosomiasis.

Bats: All live bats. See Importation of Bats Questions for further information on obtaining an import permit for live bats. Bats may also require a permit from the U.S. Department of Interior, Fish and Wildlife Service.

Non-human primate material: All non-human primate material (e.g. blood, plasma, tissue, urine, feces) requires an import permit, unless it has been specifically treated and rendered non-infectious.

Please note that the described material may require a permit from the United States Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS) or be prohibited from importation under the USDA regulations.

Do the issuance and expiration dates located on the import permit affect the permit conditions for importation and continued possession listed on the import permit?

The issuance and expiration dates located on the import permit pertain only to the dates that the importer is allowed to import into the United States the infectious biological agents, infectious substances, and vectors listed on the import permit. The conditions for importation and continued possession listed on the permit remain in effect until the importer is no longer in possession of the imported material.

How would an importer know if authorization for subsequent transfers of imported materials within the United States is needed?

If the CDC Import Permit Program requires an additional permit for subsequent transfers of any infectious biological agent, infectious substance, or vector within the United States, the requirement will be listed as a condition of issuance on the import permit.

To initiate the process for an additional permit, the recipient must submit an application through eIPP.

Is there a requirement for maintaining records of imported shipments for a specific amount of time?

There is no regulatory requirement in the import permit regulations for maintaining records of shipments for a specific amount of time. However, the CDC Import Permit Program recommends that the permittee maintain records of shipments for at least 3 years.

If our facility does not plan to receive any more imported material from outside the United States, does our facility have to renew our permit?

If your facility will no longer be importing infectious biological agents, infectious substances, or vectors of human disease into the United States, your facility should not complete an application to renew your facility’s import permit. However, the conditions specified on the permit apply until you no longer possess the material.

Does the issuance of a CDC import permit allow the importer to “hand carry” the imported material into the United States?

No. The issuance of an import permit is not an authorization to hand carry the imported material into the United States. The shipment of infectious biological agents, infectious substances, or vectors of human disease into the United States must be packaged, labeled, and shipped in accordance with all federal and international regulations. When traveling by air, the biological materials must be declared to the airline and cannot be concealed in checked luggage. Contact the airline and U.S. Customs in advance to ensure compliance with their policies and procedures.

No person may carry a hazardous material in the cabin of a passenger-carrying aircraft or on the flight deck of any aircraft, and the hazardous material must be located in a place that is inaccessible to persons other than crew members. Hazardous materials may be carried in a main deck cargo compartment of a passenger aircraft provided that the compartment is inaccessible to passengers and that it meets all certification requirements for a Class B aircraft cargo compartment in 14 CFR 25.857(b) or for a Class C aircraft cargo compartment in 14 CFR 25.857(c).

What is the process if my permit request gets denied, suspended, or revoked?

An applicant who wishes to make an appeal would have 30 calendar days after receiving the denial to submit the appeal in writing to the CDC Director. The appeal must state the factual basis for the appeal and provide any supporting documentations to justify the appeal (e.g., documents that demonstrate the facility has the appropriate biosafety measures in place for working safely with the requested imported material). CDC will issue a written response, which would constitute final agency action.

The applicant can submit the appeal to the CDC Director through the CDC Import Permit Program by email (importpermit@cdc.gov), fax [(404) 718-2093] or mail:

CDC Import Permit Program
1600 Clifton Rd, Mailstop A-46
Atlanta, GA 30329