FDA – The Regulatory Operations and Regions Branch (RORB), Confidentiality Commitment
STATEMENT OF AUTHORITY
CONFIDENTIALITY COMMITMENT FROM
THE UNITED STATES FOOD AND DRUG ADMINISTRATION
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
THE REGULATORY OPERATIONS AND REGIONS BRANCH OF
THE DEPARTMENT OF HEALTH OF CANADA
The Regulatory Operations and Regions Branch (RORB) of the Department of Health of Canada is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding RORB-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
FDA understands that some of the information it receives from RORB may include non-public information exempt from public disclosure under the laws and regulations of Canada and its provinces and territories, which is confidential commercial information; trade secret information; 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 RORB considers it critical that FDA maintain the confidentiality of the information. Public disclosure of this information by FDA may seriously jeopardize any further scientific and regulatory interactions between RORB and FDA. RORB intends to advise FDA of the non-public status of the information at the time that the information is shared.
Therefore, FDA certifies that it:
- has the authority to protect from public disclosure such non-public information provided to FDA in confidence by RORB;
- will not publicly disclose such RORB provided non-public information without: (a) the written authorization of RORB, or if RORB cannot provide that authorization, from the individual or entity that can provide such authorization, as determined by RORB and FDA on a case-by-case basis; or (b) a written statement from RORB that the non-public information has become publicly available;
- will inform RORB promptly of any effort made by judicial or legislative authorities to obtain RORB-provided non-public information from FDA. If such judicial or legislative authorities orders disclosure of RORB-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
- will promptly inform RORB 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.
This text does not create rights and obligations under international or national law.
This document is also intended to cover RORB-provided non-public information in FDA’s possession that FDA obtained prior to the signing date of this document.
Signed on behalf of FDA:
Acting Deputy Commissioner
Office of Global Regulatory Operations and Policy
The United States Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
United States of America