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  1. Confidentiality Commitments

INDIA-MPEDA to FDA Confidentiality Commitment

STATEMENT OF AUTHORITY
AND
CONFIDENTIALITY COMMITMENT FROM
MARINE PRODUCTS EXPORT DEVELOPMENT AUTHORITY
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 Marine Products Export Development Authority of the Government of the Republic of India (MPEDA) regarding FDA-regulated human foods as part of cooperative law enforcement or cooperative regulatory activities. For purposes of this Statement of Authority and Confidentiality Commitment, non-public information references all written and unwritten information that is not publicly available.

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

Therefore, MPEDA certifies that it:

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

 

Signature of foreign agency official

 

 

___________/s/_____________

 

 

 

Mr. K S Pradeep IFS
MPEDA House
P.B. No. 4272
Panampilly Avenue, Panampilly
Kochi – 682 036

 

 

 

 

12/27/2021
Date

 

 

 

 

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