Tecovirimat (TPOXX) IND Registry for Providers/Facilities

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An online registry has been available since October 28, 2022 for healthcare providers and their affiliated medical facilities providing TPOXX under the CDC-held expanded access Investigational New Drug (IND) protocol to register as participating providers and sites. The online registry is to:

Assist providers and facilities providing TPOXX under the EA-IND protocol to be in compliance with U.S. Food and Drug Administration (FDA) IND regulations.

Allow providers' access to electronic TPOXX IND forms for completing and returning to CDC in more convenient, time-efficient, and secure manner.

Please be informed that system-generated emails containing tokenized links to electronic TPOXX IND forms (Patient Intake Form and Clinical Outcome Form) are sent to individual providers' email addresses. Therefore, providers must provide valid business emails to receive the tokenized links to these electronic forms. This public-facing online registry, which requires providers to enter their email addresses, bridges the providers' access to secure the electronic TPOXX IND forms.

For questions on TPOXX IND registry or electronic forms, please email regaffairs@cdc.gov.

Please read completely and follow the instructions below.

The registration must be completed by licensed providers whose scope of professional practice per licensing state laws and regulations and/or applicable governing authority permits them to prescribe medication and provide medical care, such as diagnosing, treating, and clinically managing patients with orthopoxvirus infections.

New providers who have not previously submitted any TPOXX IND forms (Form FDA 1572, Patient Intake, and/or Clinical Outcome) to CDC must register as a participating provider with their facility information under the CDC-held EA-IND protocol to provide TPOXX treatment. Please follow the instructions below to complete the Full Registry.

Providers and affiliated staff who have been providing TPOXX treatment under one umbrella 1572 submitted to CDC prior to the online registry, but whose individual email addresses were not included in the TPOXX IND forms (Patient Intake and/or Clinical Outcome) submitted to CDC prior to this online registry, will need to register online to gain access to the electronic TPOXX IND forms. Please follow the instructions below to complete the Abbreviated Registry.

Those providers and affiliated facilities that received an email from "DCIPHER (CDC)" on October 25, 2022 with instructions to access secure links to the Patient Intake and Clinical Outcome forms without having completed an online registry (referred to as grandfathered), these links have expired. Providers need to register online to obtain access to the electronic TPOXX IND forms.

The tokenized links to these electronic forms expire 180 days from issuance. If you have links that are expired or are not working, please re-register online to obtain new tokenized links to the electronic TPOXX IND forms.

For questions on TPOXX IND registry or electronic forms, please email regaffairs@cdc.gov.

Choose a statement that applies to you. The appropriate section will display on your screen based on your response. I am a licensed provider qualified to diagnose and clinically manage orthopoxvirus infected patients and....

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have not previously submitted any TPOXX IND forms to CDC or completed this online registry.

have previously submitted Form FDA 1572 and TPOXX IND forms prior to this online registry, but I did not receive an email to gain access to electronic TPOXX IND forms.

have been providing TPOXX treatment but need to register with my own email address to gain access to the electronic TPOXX IND forms.

have received an email to access the electronic TPOXX IND forms but need to add additional staff members under my registry.

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Abbreviated Registry

The abbreviated registry is for providers whose affiliated facilities is already a registered site. Select your facility from the registered facilities in the drop down.

Full Registry

All new providers to TPOXX IND program as well as providers and their affiliated facilities that have not previously submitted any TPOXX IND forms to CDC prior to the online registry must complete a full registry. Follow the instruction below.

Licensed provider's name

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Please select and provide information for one of the following:

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Provider license #

National provider identifier #

DEA #

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Number

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To which jurisdiction is the license associated with?

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Licensed provider's work email address

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Facility name

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Your affiliated facility is not registered. Please complete the Full Registry.

Facility name

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Alternative facility name (if applicable)

Name of the health system (if applicable)

Indicate if facility is a federal entity

If other, please specify

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Facility address

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10)

City where the facility is located

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11)

U.S. state or territory where the facility is located

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12)

Facility zip code

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13)

How many additional staff's work email addresses would you like to add? (Optional)

Additional staff contacts included will receive a registry confirmation email for a verification step to gain access to the electronic TPOXX IND forms (e.g., required Patient Intake and Clinical Outcome forms).

14)

Does your facility have an institutional or designated pharmacy managing TPOXX dispensing ?

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Yes

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15)

Pharmacy contact name

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16)

Pharmacy contact email address

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