The Saudi Food and Drug Authority, Kingdom of Saudi Arabia (SFDA) is authorized to disclose non-public information to the U.S. Food and Drug Administration (USFDA) regarding medical products used, or proposed to be used, for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) purposes as part of cooperative law enforcement or cooperative regulatory activities.

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

Therefore, USFDA certifies that it:

1. has the authority to protect from public disclosure such non-public information provided to USFDA in confidence by the SFDA;
2. will not publicly disclose such non-public information provided by the SFDA 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 SFDA that the information no longer has non-public status;
3. will inform the SFDA promptly of any effort made by judicial or legislative mandate to obtain non-public information provided by the SFDA from USFDA. If such judicial or legislative mandate orders disclosure of non-public information provided by the SFDA, USFDA will take all appropriate legal measures in an eff01i to ensure that the information will be disclosed in a manner that protects the information from public disclosure; and
4. will promptly inform SFDA of any changes to the United States laws, or to any relevant policies or procedures, that would affect USFDA's ability to honor the commitments in this document.

 

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Howard R. Sklamberg, J.D.                                           Date  10/20/2015
Deputy Commissioner for Global Regulatory
Operations and Policy
United States Food and Drug Administration
WO 1 RM2326
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Telephone: + 1 301 796 7460