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The import permit forms used to collect data through the electronic Import Permit Program system (eIPP) are set to expire on 08/31/2024. These expired forms can continue to be used because the revision package is currently under review by the Office of Management and Budget. When there are any relevant changes in the status of the forms, we will follow up with updates.

If you have any questions, please contact ÐÇ¿ÕÓéÀÖ¹ÙÍø/DRSC at 404-718-2077 or [email protected].

The Import Permit Program wishes to announce a change in leadership at the Centers for Disease Control and Prevention (ÐÇ¿ÕÓéÀÖ¹ÙÍø)'s Division of Regulatory Science and Compliance (DRSC). Dr. Samuel Edwin, previous DRSC director, now holds the position of Senior Scientist within DRSC's Office of the Director. In this position, Dr. Edwin will continue to support ÐÇ¿ÕÓéÀÖ¹ÙÍø's Import Permit Program and support the transition to a new director. Effective July 1, 2024, Dr. Daniel Singer has taken over the position of acting DRSC division director.

Dr. Daniel Singer most recently served as the Director for Countering Biological Threats on the National Security Council at the White House. He is an internal medicine physician with expertise in infectious disease outbreak response and health policy who has worked in multiple countries on five continents.

Dr. Singer began his public health career at ÐÇ¿ÕÓéÀÖ¹ÙÍø as an Epidemic Intelligence Service Officer in 1999. He left the agency for a series of distinguished federal positions focusing on global health and the integration of science and policy (including at HHS, the Department of State, and the National Institutes of Health). He returned to ÐÇ¿ÕÓéÀÖ¹ÙÍø in 2012, first to the ÐÇ¿ÕÓéÀÖ¹ÙÍø programs in Malawi and Mozambique and then as the Regional Director for Central Asia where he managed four ÐÇ¿ÕÓéÀÖ¹ÙÍø offices in Kazakhstan, Kyrgyzstan, Tajikistan, and Uzbekistan.

Dr. Singer received his B.A. from the University of Pennsylvania and his M.D. from the University of Pittsburgh. He did his internal medicine residency at the University of Maryland and completed his Masters in Public Health in International Health at Johns Hopkins University.

Please be assured that while this leadership change is underway, our steadfast commitment to the program's mission remains unchanged.

More information will be shared regarding the appointment of a permanent DRSC division director as it is available.

If you have any questions, please contact ÐÇ¿ÕÓéÀÖ¹ÙÍø/DRSC at 404-718-2077 or [email protected].

Respectfully,
Daniel Singer, MD
Acting Director
Division of Regulatory Science and Compliance

Yesterday, June 6, 2024, the Federal Select Agent Program announced a . The Administrator of the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) has utilized his exemption authority under 9 C.F.R. 121.5(f) in the select agent and toxin regulations to temporarily exempt H5 avian influenza viruses from the requirements of the regulations listed in 9 C.F.R. Part 121 for a period of three years.

For the duration of the H5 Avian Influenza Virus exemption, APHIS, Veterinary Services (VS), Organisms and Vectors (OV) Permitting Unit will issue permits for importation and interstate transportation of all H5 avian influenza viruses pursuant to 9 C.F.R. Part 122. The APHIS, VS, OV Permitting Unit can be contacted by email at: [email protected].

An import permit from the Centers for Disease Control and Prevention's Import Permit Program will be required for all H5 Avian Influenza variants that are known or suspected to cause human disease. If any imported agent is determined to not cause disease in humans (e.g., attenuated strains that are no longer infectious), then an importer certification statement should be included to avoid potential shipping delays. The Import Permit Program can be contacted by email at: [email protected].

If you have any questions, please contact [email protected].

On December 7, 2023, the Centers for Disease Control and Prevention (ÐÇ¿ÕÓéÀÖ¹ÙÍø) issued a . Clade I (Congo Basin Clade) Mpox virus has not been reported in the United States at this time; however, clinicians should be aware of the possibility of Clade I Mpox virus in travelers who have been in the Democratic Republic of Congo.

As a reminder, orthopoxvirus and non-variola orthopoxvirus are infectious to humans and a ÐÇ¿ÕÓéÀÖ¹ÙÍø import permit must be issued prior to importing material that is known or reasonably expected to contain these infectious biological agents into the U.S.[42 CFR 71.54]. Only if the material has not been identified and is reasonably expected to contain an infectious biological agent would an import permit need to be obtained.

Per the HHS select agent and toxin regulations, each identification of Mpox virus, clade undetermined, or Clade I (Congo Basin Clade) Mpox virus must be reported to the ÐÇ¿ÕÓéÀÖ¹ÙÍø Division of Regulatory Science and Compliance (DRSC) using an [42 CFR 73.5 (a-b) and 73.9 (c-d)]. Prior to importing or subsequently transferring material identified as a select agent, an must be submitted and approved. See 42 CFR 73.5 (a-b), 73.9 (c-d), and 73.16.

DRSC will continue to review the status of the Democratic Republic of Congo Mpox Clade I Outbreak and communicate information to permittees as needed.

If you have any questions, please contact [email protected].

In order to provide more clarity on which imported agents require an additional permit for all subsequent distribution, ÐÇ¿ÕÓéÀÖ¹ÙÍø's Import Permit Program has posted a list to its website. The agents include:

• Mycobacterium tuberculosis
• Coronaviruses (SARS-CoV-2, MERS-CoV)
• Influenza viruses (H2N2, H6N1, low pathogenic avian H7N9)
• Viral hemorrhagic fevers (e.g., Tick-borne encephalitis viruses – Central European subtypes, Old World hantaviruses that cause hemorrhagic fever with renal syndrome (HFRS))
• Mpox (clade II) (formerly known as: Monkeypox – West African clade)
• Poliovirus (serotypes 1, 2, 3)

This process is effective as of December 14, 2023. For more information, please visit the IPP website.

If you have any questions, please contact [email protected] or 404-781-2077.

The Centers for Disease Control and Prevention's Import Permit Program (IPP) may inspect an entity to verify the importer has 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.

IPP inspectors have the authority to perform these inspections in accordance with the Import Permit Regulations (42 CFR Part 71.54).

All IPP inspectors have undergone appropriate Federal background investigations and obtained the necessary medical clearance to conduct IPP inspections. Each inspector also maintains a copy of his/her immunization records and his/her respirator fit testing card.

An IPP inspector may show an entity his/her official government badge to identify themselves prior to performing an inspection. The official government badge consists of the employee's name, picture of the employee, the individual's personal identifier number, and the government agency with which the employee is affiliated. In addition, the facility may request IPP to provide the entity with an "Inspector Verification" letter prior to the arrival of the inspectors that includes information on the individual's current health status.

The IPP inspector is not allowed to:

• Give the entity his/her official government badge in exchange for the entity's identification badge. In addition, the entity is not allowed to copy the badge.
• Sign a confidentiality agreement.
• Sign any type of document releasing the entity from liability.

Therefore, doing so may not be required as a condition for entry to conduct an IPP inspection.

In addition, the entity to be inspected may not require the inspector to do any of the following as a condition of entry:

• Provide the entity with any personal identification such as driver's license, social security card, etc.
• Participate in any entity medical surveillance program.

Failure to grant an IPP inspector access to the locations necessary to conduct an inspection may result in denial or revocation of an IPP import permit.