NICNAS - FDA
STATEMENT OF AUTHORITY
AND CONFIDENTIALITY COMMITMENT
AUSTRALIAN GOVERNMENT NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
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 Australian Government National Industrial Chemicals Notification and Assessment Scheme (NICNAS) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
NICNAS 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, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. NICNAS understands that this non-public information is shared in confidence and that FDA considers it critical that NICNAS maintain the confidentiality of the information. Public disclosure of this information by NICNAS could seriously jeopardize any further scientific and regulatory interactions between FDA and NICNAS. FDA will advise NICNAS of the non-public status of the information at the time that the information is shared.
Therefore, NICNAS certifies that it:
- subject to judicial and legislative mandate, has the authority to protect from public disclosure such non-public information provided to NICNAS in confidence by FDA;
- 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;
- will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from NICNAS. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, NICNAS 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 FDA of any changes to Australia’s laws, or to any relevant policies or procedures, that would affect NICNAS’s ability to honor the commitments in this document.
__________/s/_______________ March 8, 2011
Marion J. Healy Date
Australian Government National Industrial
Chemicals Notification and Assessment Scheme
Level 7, 260 Elizabeth Street
Surry Hills NSW 2010
GPO Box 58
Sydney NSW 2001
Telephone: +61 (02) 8577 8800
Facsimile: +61 (02) 8577 8888