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  1. Confidentiality Commitments

FDA - FSCAB and NVAL Japan, Confidentiality Commitment

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY FOOD SAFETY AND CONSUMER AFFAIRS BUREAU AND NATIONAL VETERINARY ASSAY LABORATORY, MINISTRY OF AGRICULTURE, FORESTRY AND FISHERIES OF JAPAN

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 and Consumer Affairs Bureau (FSCAB) and National Veterinary Assay Laboratory (NVAL), Ministry of Agriculture, Forestry and Fisheries of Japan regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

FDA understands that some of the information it receives from the FSCAB and NVAL may include non-public information exempt from public disclosure under the laws and regulations of Japan, 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 FSCAB and NVAL 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 FSCAB and NVAL and FDA. FDA will advise FSCAB and NVAL 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 FSCAB and NVAL;
     
  2. will not publicly disclose such FSCAB and NVAL-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 FSCAB and NVAL that the information no longer has non-public status;
     
  3. will inform FSCAB and NVAL promptly of any effort made by judicial or legislative mandate to obtain FSCAB and NVAL provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of FSCAB and NVAL 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 FSCAB and NVAL 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.

Signed on behalf of FDA:

__________/s/__________
Deborah M. Autor, Esq.
Deputy Commissioner for
Global Regulatory Operations and Policy

United States Food and Drug Administration
10903 New Hampshire Avenue
Building 31
Silver Spring, MD 20993
United States of America

Telephone: +1 (301) 796 8400
Facsimile: +1 (301) 595 7937

Date: March 16, 2012

 
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