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  1. Confidentiality Commitments

CSTD Canada - FDA, Confidentiality Commitment (English)

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STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE CONTROLLED SUBSTANCES AND TOBACCO DIRECTORATE OF THE HEALTHY ENVIRONMENTS AND CONSUMER SAFETY BRANCH OF HEALTH CANADA NOT TO PUBLICLY DISCLOSE INFORMATION SHARED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION

The Controlled Substances and Tobacco Directorate of the Healthy Environments and Consumer Safety Branch of Health Canada (CSTD) understands that the United States Food and Drug Administration (FDA), is authorized under 21 C.F.R. § 20.89 to disclose non-public information regarding tobacco product regulation activities as part of cooperative law enforcement or cooperative regulatory activities, including regulatory compliance activities.

CSTD understands that, unless otherwise specified, the information provided by FDA 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.

CSTD understands that some of the information may include non-public information that may be exempt from public disclosure under Canada’s laws and regulations, including, but not limited to, confidential business information; trade secret information; personal information as the term is defined in Canada’s Privacy Act; law enforcement information; or internal, pre-decisional information.

CSTD 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 CSTD and FDA 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, CSTD certifies that it:

  1. has the authority to protect from public disclosure such non-public information provided to it in confidence by FDA;
     
  2. will advise FDA of the non-public status of the information at the time that the information is shared;
     
  3. will protect such non-public information from public disclosure in accordance with its applicable laws and policies;
     
  4. will not publicly disclose any non-public information provided by FDA to third parties without the written authorization of FDA or, if FDA cannot provide that authorization, from the entity from which the information originally came or from the individual to whom the information relates; if applicable, FDA may also provide a written statement to CSTD that the information no longer has non-public status;
     
  5. 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;
     
  6. 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 that such recipients 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 FDA of any actual or potential occurrence of an event; and will prevent a recurrence of the event;
     
  7. will notify FDA 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 the FDA, CSTD will take all appropriate legal measures 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
     
  8. will promptly inform FDA of any changes to Canada’s legislation, regulation, policies, or procedures that could affect the CSTD’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 CSTD to carry out its responsibilities, nor does it create legally binding obligations on CSTD to share information with FDA.

Signed on behalf of CSTD:

---/s/---

________________________

January 13, 2012
Date

Hilary Geller
Assistant Deputy Minister
Healthy Environments and Consumer Safety Branch
Health, Canada
269 Laurier Avenue West
Ottawa, Ontario KIA OK9

Telephone: 613-957-2991
Facsimile: 613-941-5366

 
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