U.S. flag An official website of the United States government
  1. Home
  2. International Programs
  3. International Arrangements
  4. Confidentiality Commitments
  5. The Regulatory Operations and Regions Branch (RORB) – FDA, Confidentiality Commitment
  1. International Arrangements

The Regulatory Operations and Regions Branch (RORB) – FDA, Confidentiality Commitment

STATEMENT OF AUTHORITY
AND
CONFIDENTIALITY COMMITMENT FROM
THE REGULATORY OPERATIONS AND REGIONS BRANCH OF
THE DEPARTMENT OF HEALTH OF CANADA
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 Regulatory Operations and Regions Branch (RORB) of the Department of Health of Canada regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

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

Therefore, RORB certifies that it:

  1. has the authority, as a Branch within the Department of Health of Canada, to protect from public disclosure such non-public information provided to RORB in confidence by FDA;
     
  2. will not publicly disclose such FDA provided non-public information without: (a) the written authorization of FDA, or if FDA cannot provide that authorization, from the individual or entity that can provide such authorization, as determined by FDA and RORB on a case-by-case basis; or (b) a written statement from FDA that the non-public information has become publicly available;
     
  3. will inform FDA promptly of any effort made by judicial or legislative authorities to obtain FDA-provided non-public information from RORB. If such judicial or legislative authorities order disclosure of FDA-provided non-public information, RORB 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 in accordance with applicable laws; and
     
  4. will promptly inform FDA of any changes to Canada’s laws, or to any relevant policies or procedures, that would affect RORB’s ability to honor the commitments in this document.

 

This text does not create rights and obligations under international or national law.

This document is also intended to cover FDA-provided non-public information in RORB’s possession that RORB obtained prior to the signing date of this document.

Signed on behalf of RORB:

______________/S/_______________
02/26/2018

Tina Green
Assistant Deputy Minister

Regulatory Operations and Regions Branch
Health Canada
200 Eglantine Driveway
Ottawa, Ontario K1A 0K9
CANADA

Telephone: 613-954-0690

Date