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  1. Confidentiality Commitments

FDA - ANSES France, Confidentiality Commitment

 

United States Food and Drug Administration

French Agency for Food, Environmental and Occupational Health and Safety

 

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY AND BETWEEN THE UNITED STATES FOOD AND DRUG ADMINISTRATION AND THE AGENCY FOR FOOD, ENVIRONMENTAL AND OCCUPATIONAL HEALTH AND SAFETY OF FRANCE

The United States Food and Drug Administration (FDA) and the Agency for Food, Environmental and Occupational Health and Safety of France (ANSES) (hereinafter the Participants) are authorized to disclose non-public information regarding regulated products as part of cooperative law enforcement or cooperative regulatory activities.

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

Each Participant certifies that it:

  1. has the authority to protect from public disclosure such non-public information provided to it in confidence by the other Participant;
  2. will not publicly disclose such non-public information without the written authorization from 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 the other Participant that the information no longer has non-public status;
  3. will inform the other Participant promptly of any effort made by judicial or legislative mandate to obtain non-public information from the other Participant. If such judicial or legislative mandate orders disclosure of such non-public information, the Participant 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 the other of any changes to the Participant’s laws, or any relevant policies or procedures that would affect the Participant’s ability to honor the commitments in this document.

 

Signed on behalf of FDA:


____________/s/______________
Murray M. Lumpkin, M.D., M.Sc.
Deputy Commissioner
International Programs


Food and Drug Administration
10903 New Hampshire Avenue
Building 31
Silver Spring, MD 20993
UNITED STATES OF AMERICA


Telephone: +1 (301) 796 8400
Facsimile: +1 (301) 595 7937


Date: March 21, 2011

 

Signed on behalf of ANSES:


___________/s/____________
Marc Mortureux
Director General


Agency for Food, Environmental and
Occupational Health and Safety
27-31 Avenue du Général Leclerc
F-94701 Maisons-Alfort Cedex
FRANCE


Telephone: + 33 (0) 1 49 77 38 96
Facsimile : + 33 (0) 1 49 77 26 26



Date: March 21, 2011

 
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