HSA - FDA
STATEMENT OF LEGAL AUTHORITY AND COMMITMENT
HEALTH SCIENCES AUTHORITY, REPUBLIC OF SINGAPORE (HSA),
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
THE U. S. FOOD AND DRUG ADMINISTRATION (USFDA),
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
The United States Food and Drug Administration (USFDA), a part of the United States Department of Health and Human Services, is authorized under 21 C.F.R. § 20.89 ("Communications with Foreign Government Officials") to disclose non-public information to Health Sciences Authority, Republic of Singapore (HSA) regarding USFDA regulated products as part of cooperative law enforcement or cooperative regulatory activities.
HSA understands that some of the information it receives from USFDA 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. HSA understands that this non-public information is shared in confidence, and that USFDA considers it critical that HSA maintains the confidentiality of the information. Public disclosure of this information by HSA could seriously jeopardize any further scientific and regulatory interactions between USFDA and HSA. US FDA will advise HSA of the non-public status of the information at the time that the information is shared.
Therefore, HSA certifies that it:
- has the authority to protect the non-public information provided to HSA in confidence by the USFDA from public disclosure;
- will not publicly disclose the USFDA-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 USFDA that the information no longer has non-public status;
- will inform USFDA within two working days of any effort made to obtain USFDA-provided non-public information from HSA by judicial or legislative mandate. If such judicial or legislative mandate orders disclosure of USFDA-provided non-public information, HSA will take all 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 USFDA of any changes to the Singapore laws, HSA policies or procedures that would affect HAS’s ability to honor the agreements in this document.
___________/s/_____________ Date: Aug 25, 2004
Dr. Tan Chor Hiang
Chief Executive Officer
Health Science Authority
Republic of Singapore
11 Outram Road