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U.S. Department of Health and Human Services

International Programs

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BASG - FDA

Murray M. Lumpkin, M.D., M.SC                                  Datum: 18 August 2009
Deputy COmmissioner for International Programs            Kontakt: Dr. Marcus Müllner
United States Food and Drug Administration                 Tel: 00435055536000
5600 Fishers Lane (HF-3)                                          Email: marcus.muellner@ages.at
Rockville, MD 20857

 

 

STATEMENT OF AUTHORITY
AND
CONFIDENTIALITY COMMITMENT FROM
THE AUSTRIAN FEDERAL OFFICE FOR SAFETY IN HEALTH CARE
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 the Austrian Federal Office for Safety in Health Care (BASG) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

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

Therefore, BASG certifies that it:

  1. has the authority to protect from public disclosure such non-public information provided to BASG 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 BASG. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, BASG 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 BASG’s laws, or to any relevant policies or procedures, that would affect BASG’s ability to honor the commitments in this document.

On behalf of the
Austrian Federal Office for Safety in Health Care

__________/s/____________                                            18.8.2009
Ao. Univ. Prof. Dr. Marcus Müllner                                      Date: