Mark Abdoo
Associate Commissioner
Office of Global Policy and Strategy
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
United States of America

Stockholm, 2 February 2022

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

Dear Mr. Abdoo,

The European Centre for Disease Prevention and Control (ECDC) acknowledges that the United States Food and Drug Administration (FDA) is authorized under 21 C.F.R. § 20.89 to disclose non-public information to ECDC regarding surveillance of emerging infectious disease and public health threats, and adverse event reporting and response for products within FDA's jurisdiction.

ECDC acts under the framework established by Regulation (EC) No 851/2004 of the European Parliament and of the Council. Such Regulation foresees in art. 20 that Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents shall apply to documents held by ECDC.

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

ECDC has the legal means to protect the information received from FDA, in accordance with and within the limits of Regulation (EC) No 1049/2001. In the event ECDC receives a request for disclosure of information that FDA has identified as non-public, ECDC will in good faith rely on any appropriate exceptions provided for in Article 4 of Regulation (EC) No 1049/2001, to refuse disclosure of such non- public information.

ECDC will promptly inform FDA of any request made by any judicial or supervisory authority or auditing body to obtain FDA-provided non-public information from ECDC. In case ECDC is legally obliged to disclose the information, ECDC will take all appropriate measures to ensure that the information is disclosed in a manner that protects it from public disclosure.

ECDC will promptly inform FDA of any changes to the European Union’s laws, or other obligations that would affect ECDC’s abilities to honour the commitments in this document.

Yours sincerely,