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BVL Germany - FDA, Confidentiality Commitment

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM BUNDESAMT FUR VERBRAUCHERSCHUTZ UND LEBENSMITTELSICHERHEIT NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION

The United States Food and Drug Administration (FDA), is authorized under 21 C.F.R. §20.89 to disclose non-public information to Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

BVL understands that some of the information it receives from FDA may include nonpublic 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, predecisional information. BVL understands that this non-public information is shared in confidence and that FDA considers it critical that BVL maintain the confidentiality of the information. Public disclosure of this information by BVL could seriously jeopardize any further scientific and regulatory interactions between FDA and BVL. FDA will advise BVL of the non-public status of the information at the time that the information is shared.

Therefore, BVL certifies that it:

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

Signature of foreign agency official

---/s/--- 
Dr. Helmut Tschiersky-Schöneburg
President
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
German Federal Office of Consumer Protection and Food Safety

Address: Bundesallee 50, Gebäude 247, 38116 Braunschweig, Germany
Telephone: +49-531-21497-0 Facsimile: +49-531-21497-299

 Date: 02/12/2010

Page Last Updated: 09/11/2015
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