FDA - AFSSA

CONFIDENTIALITY COMMITMENT
STATEMENT OF LEGAL AUTHORITY
AND COMMITMENT FROM
AGENCE NATIONALE DU MÉDICAMENT VÉTÉRINAIRE
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION
SHARED BY THE U. S. FOOD AND DRUG ADMINISTRATION (USFDA),
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

The United States Food and Drug Administration (USFDA), a part of the United States Department of Health and Human Services, is authorized under 21 C.F.R. § 20.89 ("Communications with Foreign Government Officials") to disclose non-public information to Agence Nationale Du Médicament Vétérinaire (AFSSA) regarding USFDA regulated products as part of cooperative law enforcement or cooperative regulatory activities. This sharing is in the interest of public health as it relates to the monitoring of non clinical laboratories and nonclinical laboratory studies.

AFSSA understands that some of the information it receives from USFDA may include non-public information exempt from public disclosure under the laws and regulations of the United States of America, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre- decisional information. AFSSA understands that this non-public information is shared in confidence, and that USFDA considers it critical that AFSSA maintain the confidentiality of the information. Public disclosure of this information by AFSSA could seriously jeopardize any further scientific and regulatory interactions between USFDA and AFSSA. US FDA will advise AFSSA of the non-public status of the information at the time that the information is shared.

Therefore, the AFSSA certifies that it:

1. has the authority to protect the non-public information provided to AFSSA in confidence by the USFDA from public disclosure; 
2. will not publicly disclose the US FDA-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 USFDA that the information no longer has non-public status; 
3. will inform USFDA within two working days of any effort made to obtain USFDA- provided non-public information from AFSSA by judicial or legislative mandate. If such judicial or legislative mandate orders disclosure of USFDA-provided non- public information, AFSSA will take all 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 USFDA of any changes to French laws, AFSSA policies or procedures that would affect AFSSA ability to honor the agreements in this document.

___________/s/_____________                                Date: 07 June 2005
Signature of AFSSA official

D. MOUROT
______________________________
Print or Type Name of AFSSA official

DEPUTY DIRECTOR OF THE NATIONAL AGENCY FOR VETERINARY MEDICINAL PRODUCTS
___________________
Title of AFSSA official

AGENCE NATIONALE DU MÉDICAMENT VÉTÉRINAIRE
La Haute Marche
JAVENE
35300 FOUGERES
FRANCE

Telephone and facsimile: Tel. 33 2 99 9466 65                Fax. 33 2 99 94 66 71