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U.S. Department of Health and Human Services

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FSCAB and NVAL - FDA

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

The Food Safety and Consumer Affairs Bureau (FSCAB) and National Veterinary Assay Laboratory (NVAL), Ministry of Agriculture, Forestry and Fisheries of Japan, are authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding FSCAB and NVAL-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

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

Therefore, FSCAB and NVAL each certify that it:

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

Signed on behalf of FSCAB

_________/s/_________                Date: March 12, 2012
Hiroshi Takahashi
Director General

The Food Safety and Consumer Affairs Bureau,
Ministry of Agriculture, Forestry and Fisheries
1-2-1 Kasumigaseki, Chiyoda-ku, Tokyo 100-8950, Japan

Telephone: +81-3-3591-6870
Facsimile: +81-3-3501-8715


Signed on behalf of NVAL
_________/s/_________                Date: March 12, 2012
Masato Sakai
Director General

National Veterinary Assay Laboratory,
Ministry of Agriculture, Forestry and Fisheries
1-15-1 Tokura, Kokubunji, Tokyo 185-8511, JAPAN

Telephone: +81-42-323-1765
Facsimile: +81-42-329-4376