CDC_IPP_FAQ.pdf

Frequently Asked Questions

For answers to frequently asked questions about the importation of etiologic agents, please refer to the document below. For detailed information and direction on how to complete all sections of the

Application for Permit to Import or Transport Etiologic Agents Hosts or Vectors of Human Disease form, please refer to the guidance document available on the Import Permit Applications webpage.

Should you have any further questions, please contact us at importpermit@cdc.gov

(mailto:importpermit@cdc.gov).

Application Questions

Where can I find the import permit application?∠

How do I submit the import permit application?∠

I have an existing import permit that is about to expire. How do I request a renewal?∠

How do permittees complete the port of entry question (Question #4 (Anticipated U.S. Port(s) of Entry in Section C (Shipment Information) when unsure of the port of entry for the import material?

How do I ensure a complete application is submitted to CDC Import Permit Program by responding to all the required questions?

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General Questions

To facilitate clearance of materials that do not require a U.S. PHS Import Permit, each shipment must be accompanied by a certification statement, on an official letterhead, from the sender or the recipient of this material.

The certification statement must include:

• A detailed description of the material.

• Statements affirming:

1. The material is not known or suspected to contain an infectious biological agent, and

2. One of the following:

◾ How the person knows that the material does not contain an infectious biological agent, or

◾ Why there is no reason to suspect that the material contains an infectious biological agent, or

◾ A detailed description of how the material was rendered noninfectious.

If my information does not change on my import permit, do I need to still complete an application to renew it?

How do I account for multiple senders that our facility will be receive imported material?∠

How do I account for multiple agents that our facility will receive?∠

Am I able to amend (e.g., add/remove permittees, senders, or infectious biological agents) a current import permit?

According to the import permit regulations, an import permit is not required for a diagnostic specimen

(with the exception of bat or nonhuman primate specimens) not known by the importer to contain, or suspected by the importer of containing, an infectious biological agent and accompanied by a certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent, or has been rendered noninfectious. What needs to be included in the certification statement?

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Is there a fee for obtaining a CDC import permit?∠

Is a CDC import permit required for the interstate transfer of an etiologic agent?∠

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

Are there any restrictions on material that can be imported into the United States?∠

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?

Where can I find information on CDC Division of Global Migration and Quarantine’s Recommended

Methods for “Rendering Animal Products to be Used as Hunting Trophies Noninfectious”?

Do I need an import permit?∠

Is a USDA/APHIS and HHS/CDC import permit required for the novel H7N9 influenza virus strains?∠

What type of material requires a CDC Import Permit?∠

Which types of materials do NOT require an import permit?∠

Is a USDA permit also required for pandemic novel H1N1 influenza virus strains?∠

Is an import permit required for a human urine sample being imported for drug testing purposes?∠

Is an import permit required to import unregulated amount of a select toxin? Note: An “unregulated amount” of a select toxin would be those amounts listed in 42 CFR § 73.3(d)(3).

Is an import permit required for a diagnostic specimen that is suspected to contain a select agent?∠

Is an import permit required to import dead animals not known to be infectious to humans?∠

Is an import permit required to import adult worms which cannot infect humans?∠

Is an import permit required to import adult worms which cannot infect humans?∠

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Is an import permit required to import material that has received approval from U.S. Food and Drug

Administration?

Is an import permit required to import genomic material?∠

Is an import permit required for infectious biological agent after dosing the infectious biological agent with an investigational new drug product under review by U.S. Food and Drug Administration?

What if my facility receives an infectious biological agent, infectious substance, or vector that is not listed on my CDC import permit?

Does the CDC Import Permit Program regulate the exportation of infectious biological agents, infectious substances, and vectors of human disease outside the United States?

Where can I find the “Guidance for Importation of Human Remains into the United States for Interment or Subsequent Cremation?”

How would an importer know if authorization for subsequent transfers of imported materials within the

United States is needed?

Does a recipient within the United States need a CDC Import Permit to receive an infectious biological agent, infectious substance or vector from a facility that imported the material if the condition was indicated on the issued permit for the importer?

Besides a CDC Import Permit, when would a United States Department of Agriculture (USDA) permit be needed for importing an infectious biological agent, infectious substance or vector?

How long is an import permit valid to import infectious biological agent, infectious substance or vector into the United States?

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

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?

Does the issuance of CDC import permit allow the importee to “hand carry” the imported material into

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Inspection Questions

Bat Questions the United States?∠

How does my facility find methods for rendering agents non-infectious?∠

Where can I find information on Middle East Respiratory Syndrome (MERS), the viral respiratory illness first reported in Saudi Arabia in 2012, including recommendations for safety working with the virus?

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

Is a CDC import permit need to import human breast milk?∠

Will my facility be inspected prior to issuance of an import permit?∠

What areas will CDC inspect as it relates to my import permit application?∠

How will my facility be notified if an inspection is required?∠

Is our facility allowed to reuse shipping and packaging material?∠

According to the import permit regulations, an import permit is not required for a diagnostic specimen

(with the exception of bat or nonhuman primate specimens) not known by the importer to contain, or suspected by the importer of containing, an infectious biological agent and accompanied by a certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent, or has been rendered noninfectious. What needs to be included in the certification statement?

What are the requirements for importation of live bats into the U.S.?∠

Is there a fee for obtaining a CDC import permit?∠

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Transport Questions

Get Email Updates

To receive email updates from the Import Permit Program, enter your email address:

What's this? (http://www.cdc.gov/emailupdates/)

Is a CDC import permit required for the interstate transfer of an etiologic agent?

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

Are there any restrictions on material that can be imported into the United States?

Is an import permit required for importation and transfer of live bats?

What application do I need to complete if I wish to import live bats or transfer live bats within the

United States?

What are some of the specific measures required to ensure that infectious biological agents, infectious substances, and vectors are shipped safely?

What areas will CDC inspect as it relates to my import permit application?

What are the specific regulations that govern the shipment of infectious substances?

Is our facility allowed to reuse shipping and packaging material?

According to the import permit regulations, an import permit is not required for a diagnostic specimen

(with the exception of bat or nonhuman primate specimens) not known by the importer to contain, or suspected by the importer of containing, an infectious biological agent and accompanied by a certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent, or has been rendered noninfectious. What needs to be included in the certification statement?

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Page last reviewed: March 13, 2018

Page last updated: March 13, 2018

Content source: Office of Public Health Preparedness and Response (http://www.cdc.gov/phpr)

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