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  1. Confidentiality Commitments

FDA to DG GROWTH, Confidentiality Commitments

STATEMENT OF AUTHORITY
AND
CONFIDENTIALITY COMMITMENT FROM
 THE UNITED STATES FOOD AND DRUG ADMINISTRATION
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
BY
THE EUROPEAN COMMISSION’S DIRECTORATE GENERAL FOR
INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP AND SMEs

The European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROWTH) is authorized to disclose non-public information to the United States Food and Drug Administration (FDA)regarding DG GROWTH - regulated health technology and cosmetics as part of cooperative law enforcement or cooperative regulatory activities.

FDAunderstands that some of the information it receives from DG GROWTH may include non-public information exempt from public disclosure under the laws and regulations of the European Union, which is confidential commercial information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. FDAunderstands that this non-public information is shared in confidence and that DG GROWTH 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 DG GROWTH and FDA. DG GROWTH will advise FDAof the non-public status of the information at the time that the information is shared.

Therefore, FDAcertifies that it:

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

This text is not intended to create rights and obligations under international or other law.

Signed on behalf of FDA:

 

__________/s/____________
Howard R. Sklamberg, J.D.
Deputy Commissioner
Office of Global Regulatory Operations and Policy

The United States Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
United States of America

[FDA to DG Growth PDF]