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U.S. Department of Health and Human Services

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FSAI - FDA

FDA - FSAI

STATEMENT OF AUTHORITY
AND
CONFIDENTIALITY COMMITMENT
FROM
THE FOOD SAFETY AUTHORITY OF IRELAND
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 Food Safety Authority of Ireland (FSAI) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

FSAI 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, which is confidential commercial information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. FSAI understands that this non-public information is shared in confidence and that FDA considers it critical that FSAI maintain the confidentiality of the information. Public disclosure of this information by FSAI could seriously jeopardize any further scientific and regulatory interactions between FDA and FSAI. FDA will advise FSAI of the non-public status of the information at the time that the information is shared.

Therefore, FSAI certifies that it:

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

Signed on behalf of FSAI:

_____--/s/--______                        Date: January 10, 2013
Prof Alan Reilly
Chief Executivy

The Food Safety Authority of Ireland
Abbey Court
Lower abbey Street
Dublin 1

Telephone: 00 353 18171300
Facsimile: 00 353 1 8171250