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STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY INSTITUTO DE SALUD PÚBLICA DE CHILE

The Instituto de Salud Pública de Chile (ISP) under the framework of Act. 20,285 on principles of transparency of the public function and access to the information of the organs of the administration of the State is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding ISP-regulated products as part of cooperative law enforcement or cooperative regulatory activities. FDA understands that some of the information it receives from ISP may include non-public information exempt from public disclosure under the laws and regulations of the Republic of Chile, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. FDA understands that this non-public information is shared in confidence and that ISP 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 ISP and FDA. ISP 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 ISP;
    
2. will not publicly disclose such ISP-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 ISP that the information no longer has non-public status;
    
3. will inform ISP promptly of any effort made by judicial or legislative mandate to obtain ISP-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of ISP-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 ISP of any changes to the United States of America’s laws, or to any relevant policies or procedures, which would affect FDA’s ability to honor the commitments in this document.

This Commitment will take effect when signed by FDA and will continue to be in effect until terminated by FDA on 30 days written notice to the ISP except that all non-public information received by FDA from the ISP will continue to be covered by this Commitment.

Signed on behalf of FDA:

__________/s/__________

Deborah M. Autor, Esq.
Deputy Commissioner
Global Regulatory Operations and Policy

Date: March 16, 2012
 

United States Food and Drug Administration
10903 New Hampshire Avenue
Building 31
Silver Spring, MD 20993

UNITED STATES OF AMERICA

Tel. +1.301.796.4600
Facsimile: +1.301.595.7937