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  1. Confidentiality Commitments

FDA to SENASICA, Confidentiality Commitment

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
BY Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria of Mexico

The National Agro-Alimentary Health, Safety and Quality Service (SENASICA) of the United Mexican States, an agency within the Secretariat of Agriculture, Livestock, Rural

Development, Fisheries and Food (SAGARPA), is authorized to disclose non-public information to the United States Food and Drug Administration (FDA)regarding SENASICA - regulated products as part of cooperative law enforcement or cooperative regulatory activities.

FDAunderstands that some of the information it receives from SENASICA may include non-public information exempt from public disclosure under the laws and regulations of the United Mexican States (Estados Unidos Mexicanos), which is confidential commercial information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information.  FDAunderstands that this non-public information is shared in confidence and that SENASICA 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 SENASICA and FDA.  SENASICA will advise FDAof the non-public status of the information at the time that the information is shared.

Therefore, FDAcertifies that it:

  1. has the authority to protect from public disclosure such non-public information provided to FDAin confidence by SENASICA;
     
  2. will not publicly disclose such SENASICA-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 SENASICA that the information no longer has non-public status;
     
  3. will inform SENASICA promptly of any effort made by judicial or legislative mandate to obtain SENASICA-provided non-public information from FDA.  If such judicial or legislative mandate orders disclosure of SENASICA-provided non-public information, FDAwill 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 SENASICA 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/_______________
___________________________

Dara A. Corrigan
Acting Deputy Commissioner
Office of Global Regulatory Operations and Policy

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

Date

 

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