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  1. Confidentiality Commitments

FDA - CSCB Canada, Confidentiality Commitment

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATIONNOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHAREDBY THE CONTROLLED SUBSTANCES AND CANNABIS BRANCH OF THE DEPARTMENT OF HEALTH OF CANADA

The Controlled Substances and Cannabis Branch (CSCB) of the Department of Health of Canada, as part of its mandate to legalize and strictly regulate the production, distribution, sale, possession, and promotion of cannabis and cannabis products, is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding CSCB-quality standards, supporting methodologies, and clinical research safety standards for regulated cannabis products, health products containing cannabis and drugs containing cannabis.

Recognizing the differing legal status of the possession, production and distribution of certain cannabis related products at the federal level in Canada and the United States, FDA understands that information exchanged under this Statement of Authority and Confidentiality Commitment is exclusively for the purposes of supporting cooperative regulatory activities, and where appropriate, cooperative law enforcement activities.

I. UNDERSTANDINGS WITH RESPECT TO SHARED INFORMATION

FDA understands that some of the information it receives from CSCB may include non-public information exempt from public disclosure under the laws and regulations of Canada. Canadian information, including personal information, will only be shared by Canada in accordance with the laws and regulations of Canada. Non-public information may include confidential commercial information; trade secret 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 CSCB 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 CSCB and FDA. CSCB will advise FDA of the non-public status of the information at the time that the information is shared.

Therefore, FDA certifies the following:

  1. FDA has the authority to protect from public disclosure such non-public information provided to FDA in confidence by CSCB;
  2. FDA will not publicly disclose or share with other government entities or third parties such CSCB-provided non-public information without the written authorization of the owner or subject of the information, or a written statement from CSCB that the information no longer has non-public status;
  3. FDA will inform CSCB promptly of any effort made by judicial or legislative mandate to obtain CSCB-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of CSCB-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. FDA will promptly inform CSCB 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 Statement of Authority and Confidentiality Commitment.

This Statement of Authority and Confidentiality Commitment does not compromise the regulatory authority of FDA to carry out its responsibilities.

This Statement of Authority and Confidentiality Commitment is not legally binding. FDA understands that CSCB may choose to refuse to share information.

Signed on behalf of FDA:

______________/S/_______________

March 18, 2021

Mark Abdoo
Associate Commissioner
Office of Global Policy and Strategy

U.S. Food & Drug Administration
10903 New Hampshire Avenue,
Silver Spring, Maryland 20993
United States of America

Date

 
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