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  1. Confidentiality Commitments

The Health, Technology Assessment and Access Division of the Australia Department of Health – FDA Confidentiality Commitment

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE HEALTH, TECHNOLOGY ASSESSMENT AND ACCESS DIVISON OF THE AUSTRALIA DEPARTMENT OF HEALTH 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 Health, Technology Assessment and Access Division of the Australia Department of Health (TAAD) regarding FDA­ regulated products as part of cooperative law enforcement or cooperative regulatory activities.

TAAD 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. TAAD understands that this non-public information is shared in confidence and that FDA considers it critical that TAAD maintain the confidentiality of the information. Public disclosure of this information by TAAD could seriously jeopardize any further scientific and regulatory interactions between FDA and TAAD. FDA will advise TAAD of the non-public status of the information at the time that the information is shared.

Therefore, TAAD certifies that it:

  1. has the authority to protect from public disclosure such non-public information provided to TAAD in confidence by FDA;
     
  2. will not publicly disclose such FDA-provided non-public information without the written authorization of the owner of the information, the written authorization from the individual who is the subject of the personal privacy information, or a written statement from FDA that the information no longer has non-public status;
     
  3. will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from TAAD. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, TAAD 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. will promptly inform FDA of any changes to Australia's laws, or to any relevant policies or procedures, that would affect TAAD's ability to honor the commitments in this document.
     

Signature of foreign agency official

 

----------------/s/--------------------

Adriana Platona PSM                                                                Date:   20 August, 2020
First Assistant Secretary
Technology Assessment and Access Division
Health Resourcing
Department of Health

Address:   23 Furzer Street, Woden ACT 2606
Telephone:   (02) 6289 7085
Email:   adrian.platona@health.gov.au

 
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