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INDIA-FDA to MPEDA 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
MARINE PRODUCTS EXPORT DEVELOPMENT AUTHORITY

The Marine Products Export Development Authority of the Government of the Republic of India (MPEDA) is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding MPEDA-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.

FDA understands that some of the information it receives from MPEDA may include non-public information exempt from public disclosure under the laws and regulations of India which is confidential commercial information; trade secrets; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. FDA understands that this non-public information is shared in confidence and that MPEDA 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 MPEDA and FDA. MPEDA will advise FDA of 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 MPEDA;
  2. will not publicly disclose such MPEDA-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 MPEDA that the information no longer has non-public status;
  3. will inform MPEDA promptly of any effort made by judicial or legislative mandate to obtain MPEDA-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of MPEDA-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 MPEDA 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/______________

 

 

 

Mark Abdoo
Associate Commissioner
Office of Global Policy and Strategy

 

 

01/19/2022
Date

 

 

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

 

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