February 18, 2022

Andrea Ammon
Director
European Centre for Disease Prevention and Control (ECDC)
Gustav den III:s Boulevard 40, 169 73
Solna, Sweden

Subject: Statement of Authority and Confidentiality Commitment from the United States Food and Drug Administration Not to Publicly Disclose Non-Public Information Shared by the European Centre for Disease Prevention and Control

Dear Dr. Ammon,

The United States Food and Drug Administration (FDA) acknowledges that the European Centre for Disease Prevention and Control (ECDC) is authorized to disclose non-public information to the FDA regarding surveillance of emerging infectious disease and public health threats, and adverse event reporting and response for products within ECDC’s jurisdiction.

FDA understands that some of the information it receives from ECDC may include non-public information exempt from public disclosure under the laws and regulations of the European Union, which is confidential commercial information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. FDA understands that this non-public information is shared in confidence and that ECDC considers it critical that FDA maintains the confidentiality of the information. Public disclosure of this information by FDA could seriously jeopardize any further scientific and regulatory interactions between ECDC and FDA. FDA understands that ECDC will advise FDA of the non-public status of the information at the time that the information is shared.

FDA has the authority to protect from public disclosure such non-public information provided to FDA in confidence by ECDC.

FDA will not publicly disclose such ECDC-provided non-public information without the written authorization of the owner of the information, the written authorization from the individual who is the subject of the personal privacy information, or a written statement from ECDC that the information no longer has non-public status;

FDA will inform ECDC promptly of any effort made by judicial or legislative mandate to obtain ECDC-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of ECDC-provided non-public information, FDA will take all appropriate legal measures in an effort to ensure that the information will be disclosed in a manner that protects the information from public disclosure.

FDA will promptly inform ECDC of any changes to the United States of America’s laws, or to any relevant policies or procedures, that would affect FDA’s abilities to honor the commitments in this document.

Yours sincerely,