BMG - FDA
STATEMENT OF LEGAL AUTHORITY
AND COMMITMENT FROM THE GERMAN FEDERAL MINISTRY OF HEALTH (BMG)
NOT TO PUBLICLY DISCLOSE NON-PUBLIC
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 the Federal Ministry of Health (BMG-Bundesministerium fuer Gesundheit) regarding USFDA regulated products as part of cooperative law enforcement or cooperative regulatory activities.
BMG 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, predecisional information. BMG understands that this non-public information is shared in confidence, and that USFDA considers it critical that BMG maintains the confidentiality of the information. Public disclosure of this information by BMG could seriously jeopardize any further scientific and regulatory interactions between USFDA and BMG. US FDA will advise BMG of the non-public status of the information at the time that the information is shared.
Therefore, BMG certifies that it:
- has the authority to protect the non-public information provided to BMG in confidence by the USFDA from public disclosure;
- will not publicly disclose USFDA-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;
- will inform USFDA within two working days of any effort made to obtain USFDA provided non-public information from BMG by judicial or legislative mandate. If such judicial or legislative mandate orders disclosure of US FDA-provided nonpublic information, BMG 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
- will promptly inform USFDA of any changes to laws, BMG policies or procedures that would affect BMG's ability to honor the agreements in this document.
------------/s/------------ January 25, 2008
Signature of foreign government official Date
Print or Type foreign government official
Under Secretary for Pharmaceuticals Medical Devices, Biotechnologies
Title of foreign government institution official
Federal Ministry of Health
Name of foreign government institution
Federal Ministry of Health
Under Secretary for Pharmaceuticals, Medical Devices and Biotechnologies
Friedrichstr. 108, D-10117 Berlin, Germany
Telephone: +49 (0)228 99 441-1050 / 4600
and facsimile: +49 (0)228 99 441-4910 / 4848