STATEMENT OF AUTHORITY
AND
CONFIDENTIALITY COMMITMENT FROM
THE AUSTRIAN FEDERAL OFFICE FOR SAFETY IN HEALTH CARE
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. § 20.89¹ to disclose non-public information to Austrian Federal Office for Safety in Health Care regarding FDA-regulated drugs, including pre- and post-market activities, as appropriate, as part of cooperative law enforcement or cooperative regulatory activities. FDA is further authorized under section 708(c) of the Federal Food, Drug, and Cosmetic Act² to share with a foreign government, as it deems appropriate and under limited circumstances, certain types of trade secret information.

The Commissioner of Food and Drugs has certified Austrian Federal Office for Safety in Health Care as having the authority and demonstrated ability to protect trade secret information from disclosure. FDA therefore may provide Austrian Federal Office for Safety in Health Care with certain types of trade secret information at FDA’s discretion and upon request by Austrian Federal Office for Safety in Health Care, based on the following certifications.

The Austrian Federal Office for Safety in Health Care understands that some of the information it receives from FDA may include non-public information exempt from public disclosure, such as commercially confidential information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. The Austrian Federal Office for Safety in Health Care understands that this non-public information is shared in confidence and that it is critical that Austrian Federal Office for Safety in Health Care maintains the confidentiality of exchanged non-public information. Public disclosure of exchanged non-public information by Austrian Office of Safety in Health Care could seriously jeopardize any further scientific and regulatory interactions between Austrian Federal Office of Safety in Health Care and FDA. FDA will advise Austrian Federal Office of Safety in Health Care of the non-public status of the information at the time that the information is shared.

Therefore, EE SAM certifies that it:

1. has the authority to protect from public disclosure such non-public information provided to Austrian Federal Office for Safety in Health Care in confidence by FDA; if and insofar as that Austrian Federal Office for Safety in Health Care is not legally bound to disclose that information to public according to the Austrian Duty to Grant Information Act . In the event that Austrian Federal Office for Safety in Health Care receives a request for disclosure of the non-public information provided by FDA that is held by Austrian Federal Office for Safety in Health Care, Austrian Federal Office for Safety in Health Care will in good faith rely on any appropriate exceptions provided in the Austrian Duty to Grant Information Act, to refuse disclosure of non-public information;
    
2. The Austrian Federal Office for Safety in Health Care may not need to rely on any appropriate exceptions provided in the Austrian Duty to Grant Information Act, to refuse disclosure of non-public information, if Austrian Federal Office for Safety in Health Care is in possession of 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 providing that the information no longer has non-public status;
    
3. The Austrian Federal Office for Safety in Health Care may not need to rely on any appropriate exceptions provided in the Austrian Duty to Grant Information Act, to refuse disclosure of non-public information, if Austrian Federal Office for Safety in Health Care is in possession of a written permission for disclosure by the sponsor of the information provided by FDA, or alternatively of a declaration from the Commissioner of Food and Drugs of a public health emergency under section 319 of the Public Health Service Act that is relevant to the information;
    
4. with respect to trade secret information concerning the inspection of a drug facility, Austrian Federal Office for Safety in Health Care has the authority to otherwise obtain such information and will use such FDA-provided information only for civil, administrative regulatory purposes in the context of its mission;
    
5. will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from Austrian Federal Office for Safety in Health Care. If such judicial or legislative mandate requires disclosure of FDA-provided non-public information, Austrian Federal Office for Safety in Health Care 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
    
6. will promptly inform FDA of any changes to the Austrian laws, or to any relevant policies or procedures, that would affect Austrian Federal Office for Safety in Health Care ability to honor the commitments in this document.

 

The Austrian Federal Office for Safety in Health Care understands that FDA-provided information may come to it from the European Medicines Agency (EMA) and/or the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) as a result of the Cooperation Agreement between EMA and the EU Member States Regulatory Authorities. The Austrian Federal Office for Safety in Health Care will protect such FDA-provided non-public information from public disclosure to the same extent that it will protect non-public information provided to it directly by FDA.

This text is not intended to create rights and obligations under international or other law.

Signed on behalf of Austrian Federal Office for Safety in Health Care