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The United States Food and Drug Administration, a part of the Department of Health and Human Services (HHS/FDA), is authorized under 21 C.F.R. § 20.89 (“Communications with Foreign Government Officials”) to disclose non-public information to the Medical Products Agency of Sweden (MPA) regarding HHS/FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
MPA understands that some of the information it receives from HHS/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. MPA understands that this non-public information is shared in confidence, and that HHS/FDA considers it critical that MPA maintain the confidentiality of the information. Public disclosure of this information by MPA could seriously jeopardize any further scientific and regulatory interactions between HHS/FDA and MPA. HHS/FDA will advise MPA of the non-public status of the information at the time that the information is shared.
Therefore, MPA certifies that it:
This commitment will become effective upon HHS/FDA's signing of a similar commitment and will remain in effect until cancelled by MPA or HHS/FDA upon 30 days' written notice.
___________/s/_____________ Date: March 29, 2006 |