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U.S. Department of Health and Human Services

International Programs

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FDA-DMA

STATEMENT OF AUTHORITY
AND
CONFIDENTIALITY COMMITMENT
FROM
THE UNITED STATES FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
BY
THE DANISH MEDICINES AGENCY

The Danish Medicines Agency (DMA) is authorized to disclose non-public information to the United States Food and Drug Administration, an agency within the Department of Health and Human Services (HHS/FDA), regarding DMA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

HHS/FDA understands that some of the information it receives from DMA may include non-public information exempt from public disclosure such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. HHS/FDA understands that this non-public information is shared in confidence, and that DMA considers it critical that HHS/FDA maintain the confidentiality of the information. Public disclosure of this information by HHS/FDA could seriously jeopardize any further scientific and regulatory interactions between USFDA and DMA. DMA will advise HHS/FDA of the non-public status of the information at the time that the information is shared.

Therefore, HHS/FDA certifies that it:

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

This commitment will become effective upon DMA’s signing of a similar commitment and will remain in effect until cancelled by DMA or HHS/FDA upon 30 days written notice. However, even following such cancellation, DMA will continue to protect from public disclosure all nonpublic information that was shared by HHS/FDA with DMA while the commitment was in effect.

 

___________/s/_____________               Date: 14 November 2007
Murray M. Lumpkin, M.D., M.Sc.

Deputy Commissioner
International and Special Programs
Food and Drug Administration
Department of Health and Human Services
UNITED STATES OF AMERICA

5600 Fishers Lane
Rockville, MD 20857

(301) 827-2410 (ph)
(301) 443-3100 (fax)