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U.S. Department of Health and Human Services

International Programs

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FDA - BASG

STATEMENT OF AUTHORITY
AND
CONFIDENTIALITY COMMITMENT
FROM
THE UNITED STATES FOOD AND DRUG ADMINISTRATION
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
BY
THE AUSTRIAN FEDERAL OFFICE FOR SAFETY IN HEALTH CARE

The Austrian Federal Office for Safety in Health Care (BASG) is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding BASG-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

FDA understands that some of the information it receives from BASG may include non-public information exempt from public disclosure under the laws and regulations of the Austria, 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 BASG 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 BASG and FDA. BASG will advise FDA of the non-public status of the information at the time that the information is shared.

Therefore, FDA certifies that it:

  1. has the authority to protect from public disclosure such non-public information provided to FDA in confidence by BASG; 
  2. will not publicly disclose such BASG-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 BASG that the information no longer has non-public status; 
  3. will inform BASG promptly of any effort made by judicial or legislative mandate to obtain BASG-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of BASG-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 BASG 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/____________                            08/18/2009
Murray M. Lumpkin, M.D., M.Sc.                           Date:

Deputy Commissioner
International Programs
Office of the Commissioner

5600 Fishers Lane (HF-3)
Rockville, MD 20857

Telephone: 301-827-5709
Facsimile: 301-443-3100