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  1. Confidentiality Commitments

FDA - AESAN Spain, Confidentiality Commitment

FDA: Español      AESAN: English | Español

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

The Spanish Food Safety and Nutrition Agency (AESAN) is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding AESAN-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

FDA understands that some of the information it receives from AESAN may include non-public information exempt from public disclosure under the laws and regulations of Spain, 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 AESAN 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 AESAN and FDA. AESAN will advise FDA of the non-public status of the information at the time that the information is shared.

Therefore, FDA certifies that:

  1. it has the authority to protect from public disclosure such non-public information provided to FDA in confidence by AESAN;
     
  2. it will not publicly disclose such AESAN-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 AESAN that the information no longer has non-public status;
     
  3. it will inform AESAN promptly of any effort made by judicial or legislative mandate to obtain AESAN-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of AESAN-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;
     
  4. it will promptly inform AESAN 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; and
     
  5. this Confidentiality Commitment does not create binding obligations under international or domestic laws.

Signed on behalf of FDA:

____---/s/---___________
Michael R. Taylor
Deputy Commissioner of Food and Veterinary Medicine

The United States Food and Drug Administration
10903 New Hampshire Avenue
Building 1, Room 3240
Silver Spring, MD 20993
United States of America

Telephone: +1 (301) 796 4500
Facsimile: +1 (301) 847 3535

7th of March, 2013

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