STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION NOT TO PUBLICLY DISCLOSE INFORMATION SHARED BY THE CONTROLLED SUBSTANCES AND TOBACCO DIRECTORATE OF THE HEALTHY ENVIRONMENTS AND CONSUMER SAFETY BRANCH OF HEALTH CANADA
The United States Food and Drug Administration (FDA) understands that the Controlled Substances and Tobacco Directorate of the Healthy Environments and Consumer Safety Branch of Health Canada (CSTD), as part of its mandate to regulate the manufacture, sale, labeling and promotion of tobacco products, may disclose non-public information regarding tobacco product regulation activities as part of cooperative law enforcement or cooperative regulatory activities, including regulatory compliance activities.
FDA understands that, unless otherwise specified, the information provided by CSTD is authorized for use only for cooperative law enforcement or cooperative regulatory activities related to the purposes for which it was originally collected, namely, tobacco product regulation activities.
FDA understands that some of the shared information may include non-public information that may be exempt from public disclosure under the United States of America’s laws and regulations, including, but not limited to, confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information.
FDA understands that the information is provided in confidence and understands that public disclosure of this information could seriously jeopardize any further scientific and regulatory interactions between FDA and CSTD as well as between the CSTD, FDA and third parties or individuals within their respective jurisdictions to whom the non-public information relates or concerns.
Therefore, FDA certifies that it:
- has the authority to protect from public disclosure such non-public information provided to it in confidence by CSTD;
- will advise CSTD of the non-public status of the information at the time that the information is shared;
- will protect such non-public information from public disclosure in accordance with its applicable laws and policies;
- will not publicly disclose such CSTD-provided non-public information without the written authorization of CSTD or, if CSTD cannot provide that authorization, from the entity from whom the information originally came or from the individual who is the subject of the personal privacy information, or a written statement from CSTD that the information no longer has non-public status;
- will ensure the security and integrity of the non-public information entrusted to it and safeguard the information against accidental or unauthorized access, disclosure, or use;
- in the event of accidental or unauthorized access, disclosure, or use of the shared non-public information, will promptly take all reasonable steps to minimize the extent of the unauthorized access, disclosure, or use; will notify the recipients of the aforesaid information of the accidental or unauthorized disclosure of information and request such recipients to destroy or return all aforesaid information in whatever form it exists, including copies and request written confirmation that the aforesaid information was not further distributed to other third parties; will promptly notify CSTD of the occurrence; and will prevent a recurrence of the event;
- will notify CSTD promptly of any decision made by a judicial body or pursuant to any legislative mandate to access or obtain non-public information. If a judicial body or a legislative mandate orders disclosure of non-public information provided by CSTD, FDA will take all appropriate legal measures in an effort to ensure that the aforesaid information is disclosed in a manner that minimizes any risks to third parties or individuals to whom the aforesaid information applies and who may be harmed by public disclosure of the information; and
- will promptly inform CSTD of any changes to the United States of America’s legislation, regulation, policies, or procedures that could affect the FDA’s ability to protect the non-public information.
Notwithstanding any other provision of this commitment, this Statement of Authority and Confidentiality Commitment does not compromise the regulatory authority of FDA to carry out its responsibilities, nor does it create legally binding obligations on FDA to share information with CSTD.
Signed of behalf of FDA:
January 26, 2012
Deborah M. Autor, Esq.Deputy Commissioner
Global Regulatory Operations and Policy
U. S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Tel. +1 301-796-4600
Fax. +1 301-595-7937