IP Grams

The Import Permit Program wishes to announce a change in leadership at the Centers for Disease Control and Prevention (CDC)’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 CDC’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 CDC 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 CDC in 2012, first to the CDC programs in Malawi and Mozambique and then as the Regional Director for Central Asia where he managed four CDC 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 CDC/DRSC at 404-718-2077 or importpermit@cdc.gov.

Respectfully,

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

Yesterday, June 6, 2024, the Federal Select Agent Program announced a new H5 Avian Influenza Virus Exemption. 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: apie@usda.gov.

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: importpermit@cdc.gov.

If you have any questions, please contact importpermit@cdc.gov.

On December 7, 2023, the Centers for Disease Control and Prevention (CDC) issued a Health Alert regarding Mpox Caused by Human-to-Human Transmission of Monkeypox Virus with Geographic Spread in the Democratic Republic of the Congo. 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 CDC 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 CDC Division of Regulatory Science and Compliance (DRSC) using an APHIS/CDC Form 4 Report of the Identification of Select Agent [42 CFR 73.5 (a-b) and 73.9 (c-d)]. Prior to importing or subsequently transferring material identified as a select agent, an APHIS/CDC Form 2 Request to Transfer a select agent 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 importpermit@cdc.gov.

In order to provide more clarity on which imported agents require an additional permit for all subsequent distribution, CDC’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 importpermit@cdc.gov or 404-781-2077.

CDC’s Import Permit Program wishes to inform users of new enhancements that will be made to the electronic Import Permit Program (eIPP) information system on Wednesday, October 18, from 9PM -11PM ET. During this time, eIPP will be unavailable; however, release updates will be available to users beginning on Thursday morning, October 19.

The new updates include the following:

• Agents Application Guidance – Throughout ‘Agents Application’, there are now ‘?’ boxes and boxes labeled ‘Section X Guidance’ that include guidance for the corresponding section or field.
• Warning Messages – When attempting to submit an application with incomplete required fields, specific warning messages will appear at the bottom of the application noting what information is missing.
• SMART Materials – Sections D and E within ‘Agents Application’ have been reformatted to allow for clarity regarding infectious biological agents and associated material descriptions.
  • Some fields from Section E are now integrated into the ‘Add Infectious Biological Agent’ pop-up modal.
  • Non-human primate and bat species are included in dropdown menus when selecting material type.
  • Note that all previously saved ‘Agent Templates’ have been removed to ensure that no issues arise with the new features implemented.
• SMART Description of Materials – The Description of Material section on ‘Agent Permits’ has been reformatted for better visualization and data standardization.
• Draft Application Removals – This feature removes all draft applications after 30 days and allows for the user to remove their own drafts from the corresponding table at any point.
  • Note that all draft applications have been removed to ensure that no issues arise with the new features implemented.

Please note the Guidance on Completing Applications to Import Infectious Biological Agents, Infectious Substances, and Vectors is being updated to reflect the above changes. An IP Gram will be sent when the updates are complete, and the new version has been posted on the IPP website.

If you have any questions, please contact importpermit@cdc.gov.

Effective October 1, the CDC’s Division of Select Agents and Toxins (DSAT) will be known as the Division of Regulatory Science and Compliance (DRSC).

While the Division’s name is changing, its regulatory authority has not.  DRSC will continue to implement the same regulatory programs – including the Federal Select Agent Program and the Import Permit Program.

The Division will continue to develop and implement U.S. Federal regulations for compliance to help enhance biosafety and security in laboratory science that can lead to improved detection, prevention, diagnostic, and treatment options for some of the most deadly diseases impacting public health.

We would like to make the regulated community aware of this change and assure you that this organizational change will not affect the division’s regulatory oversight.

Please note that our materials and website are currently in the process of being updated to reflect these changes.

If you have any questions, please feel free to contact us at LRSAT@cdc.gov or 404-718-2000.

It has recently come to the Import Permit Program’s attention that issues have arisen surrounding user accounts and associated emails. As a reminder, eIPP information system is built specifically for a one-to-one relationship between a permittee and their individual associated permits. The account holder and named permittee is the responsible party for all actions on their account, applications, and permits. There should be no sharing of accounts across multiple people or alternate delegates for accounts. This is a security risk, and violation of both SAMS and eIPP information system user terms agreements.

Please review the Guidance on SAMS Accounts and eIPP Information System Email to ensure that you are in compliance or follow the provided steps to help you get in compliance.

If you have any questions, please contact eIPPSupport@cdc.gov.

The Centers for Disease Control and Prevention’s Import Permit Program (IPP) e-tool, which helps potential applicants determine if an import permit for infectious biological materials is needed, has been updated to a new and improved version and is now available here.

The IPP e-tool is a user resource structured as a series of questions and answers to assist potential applicants determine whether a permit is needed for human, animal, lab-derived, and environmental materials.

The improved version of the e-tool will enhance the user experience by:

• Including more examples of source materials
• Providing direct links to supplemental guidance
• Working on mobile devices

The CDC Import Permit Program (IPP) is pleased to announce the publication of a new guidance document entitled Guidance on Completing Applications to Import Infectious Biological Agents, Infectious Substances, and Vectors [PDF – 1 MB].

This document is intended to assist electronic IPP (eIPP) information system users when completing applications for permits to import infectious biological agents, infectious substances, and vectors into the United States.

You can find the new guidance in the eIPP Resource Center.

If you have any questions, please contact importpermit@cdc.gov.

This is a notification that the IT Call Center will no longer be functional, including the current phone number (833-271-8310).

Any future requests for IT support regarding the eIPP Information System, can now be made by:

• Phone: 404-718-2000
• Online: By completing a Customer Support Request Form
• E-mail: eIPPSupport@cdc.gov

If you have any questions, please contact importpermit@cdc.gov.

As of September 2, 2022, the eIPP portal includes the following enhancements: Smart Agents, Expanded File Uploads, Permit Expiration Notifications, and Application Updates.

• Smart Agents – Section D, entry 5, is replaced with a dropdown list of standardized human infectious biological agents.
  • Note that applications in progress or in draft status, any infectious biological agent templates that existed prior to the above updates, have the Scientific Name entries cleared.
  • Please be sure to update any applications in progress or in draft status to include agents from the standardized list prior to submission.
  • If you plan to submit an application that was in draft form on September 2, 2022 or cannot see the agent type when you attempt to renew an approved application, you may need to clear your cache for the feature to work properly.
• Expanded File Uploads – The upload feature in the Inspection Module and Application system accepts files of the following formats:
  • Adobe Acrobat:  .pdf
  • Microsoft Office formats: .docx, .doc, .xls, .xlsx, .ppt, .pptx, .msg (Outlook emails)
  • Plain text files: .txt, .csv
  • Image Files: .jpg, .jpeg, .png, .tiff
  • Video Files: .mov, .avi, .mpg, .mpeg, .mp4
• Permit Expiration Notifications – Permittees receive a system generated notification in the General Discussion 30 days prior to permit expiration.
• Application Updates – The IPP Phone number and mailstop are updated. The “BSL-3 Ag” Lab Safety Level option in Section D, entry 10 are updated to ABSL-3Ag, as per the BMBL6 guidance.

If you have any questions, please contact importpermit@cdc.gov.

On December 2, 2021, the Centers for Disease Control and Prevention’s Import Permit Program (IPP) hosted a public webinar to address import permit regulations for bringing infectious biological agents, infectious substances, and vectors of human disease into the U.S.  In addition to the Centers for Disease Control and Prevention, additional presenters included representatives from the U.S. Department of Transportation, U.S. Department of Agriculture, U.S. National Authority for Containment of Poliovirus, U.S. Customs and Border Protection, and the U.S. Department of Commerce.

The presentations from the webinar have been posted to the IPP website and are now available at here.

If you have any questions regarding this email, please contact CDC’s Division of Select Agents and Toxins at 404-718-2077 or importpermit@cdc.gov.

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.

As someone who has received an import permit from the Centers for Disease Control and Prevention (CDC)’s Import Permit Program (IPP), we wanted to let you know that the program is hosting a public webinar on December 2, 2021 from 11 a.m. to 4 p.m. EST to address import permit regulations for bringing infectious biological agents, infectious substances, and vectors of human disease into the U.S.  While the agenda is still being finalized, additional presenters for this webinar will include representatives from the Department of Transportation, Animal and Plant Health Inspection Service, U.S. National Authority for Containment of Poliovirus, Customs and Border Protection, and the Department of Commerce.

Registration instructions are available on the CDC Import Permit Program website.  The webinar agenda will also be posted to this page once finalized.   All registration requests should be submitted by Friday, November 26, 2021.  The webinar link and supporting information will be sent to registered participants prior to the workshop.

The CDC Import Permit Program (IPP) inspects entities using standardized checklists to verify that facilities have implemented the appropriate biosafety measures for the infectious biological agent, infectious substance, or vector to be imported.

IPP has updated its inspection checklists to reflect the changes in the recently published 6th edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL). The updated inspection checklists are available for reference on the IPP website.

The Centers for Disease Control and Prevention, Import Permit Program (IPP) has posted the webcast presentations held on December 3, 2020, on the IPP website.

The Centers for Disease Control and Prevention (CDC) has published a Federal Register Notice seeking public comment on the request for continued approval by the Office of Budget and Management to collect information through use of the CDC’s Import Permit Program’s key reporting forms, including:

• Application for Permit to Import Biological Agents and Vectors of Human Disease into the United States
• Application for Permit to Import or Transport Live Bats
• Application for Permit to Import Infectious Human Remains into the United States

The Federal Register notice and information on how to submit public comments can be found here.  The public comment period ends on December 21, 2020.

The CDC Import Permit Program (IPP) wishes to make its stakeholders aware of a new resource that has been posted to its webpage, the Department of Transportation’s Guidance for Completing the Shipper’s Declaration for Dangerous Goods.

This Department of Transportation (DOT) guidance document provides step-by-step instructions for correctly filling out the DOT Shipper’s Declaration for Dangerous Goods to avoid delay in the importation into the U.S. and subsequent transfers within the U.S. of infectious biological materials that could cause disease in humans.

The DOT guidance and additional resources are available here.