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  1. Confidentiality Commitments

FDA - IPMA Portugal, Confidentiality Commitment

Information Sharing (Information from IPMA to FDA only; FDA employees are not authorized to share non-public information with IPMA).

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE PORTUGUESE INSTITUTE OF SEA AND ATMOSPHERE, I.P. (IPMA)

The Portuguese Institute of Sea and Atmosphere, I.P. (IPMA) is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding IPMA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

FDA understands that some of the information it receives from IPMA may include non-public information exempt from public disclosure under the laws and regulations of Portugal, 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 IPMA 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 IPMA and FDA. IPMA 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 IPMA;
     
  2. will not publicly disclose such IPMA-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 IPMA that the information no longer has non-public status;
     
  3. will inform IPMA promptly of any effort made by judicial or legislative mandate to obtain IPMA-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of IPMA-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 IPMA 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
Counselor to the Commissioner
Acting Deputy Commissioner for
Global Regulatory Operations and Policy
Food and Drug Administration

10903 New Hampshire Avenue
Building One
Silver Spring, MD 20993
United States of America

Telephone: +1 (301) 796-8400
Facsimile: +1 (301) 595-7937

Date: 11 September 2013

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