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FDA - EE SAM Estonia, Confidentiality Commitment

EE SAM - FDA

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE ESTONIAN STATE AGENCY OF MEDICINES

The Estonian State Agency of Medicines (EE SAM) is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding EE SAM-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

FDA understands that some of the information it receives from EE SAM may include non-public information exempt from public disclosure under the laws and regulations of Estonia, 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 EE SAM considers it critical that FDA maintain the confidentiality of the information. Public disclosure of this information by FDA could seriously jeopardize any further scientific and regulatory interactions between EE SAM and FDA. EE SAM will advise FDA of the non-public status of the information at the time that the information is shared.

Therefore, FDA certifies that it:

  1. has the authority to protect from public disclosure such non-public information provided to FDA in confidence by EE SAM;
     
  2. will not publicly disclose such EE SAM-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 EE SAM that the information no longer has non-public status;
     
  3. will inform EE SAM promptly of any effort made by judicial or legislative mandate to obtain EE SAM-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of EE SAM-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; and
     
  4. will promptly inform EE SAM of any changes to the United States of America's laws, or to any relevant policies or procedures, that would affect FDA's ability to honor the commitments in this document.

Signed on behalf of FDA:

_______/s/_________
John M. Taylor III
Acting Deputy Commissioner
Global Regulatory Operations and Policy
 

Date: December 2, 2013


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