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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. ยง 20.89 ("Communications with Foreign Government Officials") to disclose non-public information to the Australian Therapeutic Goods Administration regarding USFDA regulated products as part of cooperative law enforcement or cooperative regulatory activities.
The Australian Therapeutic Goods Administration 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. The Australian Therapeutic Goods Administration understands that this non-public information is shared in confidence, and that USFDA considers it critical that the Australian Therapeutic Goods Administration maintains the confidentiality of the information. Public disclosure of this information by the Australian Therapeutic Goods Administration could seriously jeopardize any further scientific and regulatory interactions between USFDA and the Australian Therapeutic Goods Administration. US FDA will advise the Australian Therapeutic Goods Administration of the non-public status of the information at the time that the information is shared.
Therefore, the Australian Therapeutic Goods Administration certifies that it:
_______________/s/______________ Date: 11/8/2004
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