STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE AGENZIA ITALIANA DEL FARMACO

The Agenzia Italiana del Farmaco (AIFA) is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding AIFA-regulated products as part of cooperative law enforcement or cooperative regulatory activities. FDA understands that some of the information it receives from AIFA may include non-public information exempt from public disclosure under the laws and regulations of Italy, 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 AIFA 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 AIFA and FDA. AIFA will advise FDA of the non-public status of the information at the time that the information is shared. When documents are shared, AIFA will mark each document clearly with its non-public status.

Therefore, FDA certifies that it:

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

On behalf of the
United States Food and Drug Administration

__________/s/____________
Margaret A. Hamburg, M.D. 
Commissioner of Food and Drugs

10903 New Hampshire Avenue
Building 1, Room 2217
Silver Spring, MD 20993

Telephone: 301-796-5000
Facsimile: 301-847-3531

Date: December 4, 2009