SIDC - FDA

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE CZECH REPUBLIC’S STATE INSTITUTE FOR DRUG CONTROL

The Czech Republic’s State Institute for Drug Control (SIDC) is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding SIDC-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

FDA understands that some of the information it receives from SIDC may include non-public information exempt from public disclosure under the laws and regulations of the Czech Republic, which is confidential commercial information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. FDA understands that this non-public information is shared in confidence and that SIDC considers it critical that FDA maintain the confidentiality of the information. Public disclosure of this information by FDA could seriously jeopardize any further scientific and regulatory interactions between SIDC and FDA. SIDC will advise FDA of the non-public status of the information at the time that the information is shared.

Therefore, FDA certifies that it:

1. has the authority to protect from public disclosure such non-public information provided to FDA in confidence by SIDC;
    
2. will not publicly disclose such SIDC-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 SIDC that the information no longer has non-public status. FDA takes into account that personal privacy information might be shared by SIDC to FDA solely with previous written authorization from the individual who is the subject of the personal privacy information;
    
3. will inform SIDC promptly of any effort made by judicial or legislative mandate to obtain SIDC-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of SIDC-provided non-public information, FDA 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
    
4. will promptly inform SIDC of any changes to the United States of America’s laws, or to any relevant policies or procedures, that would affect FDA’s ability to honor the commitments in this document.

Signed on behalf of FDA:

_________/s/______________
Deborah M. Autor, Esq.
Deputy Commissioner
Global Regulatory Operations and Policy

Date: Sept 23, 2012

The United States Food and Drug Administration
10903 New Hampshire Avenue
Building 31
Silver Spring, MD 20993
United States of America

Telephone: +1 (301) 796 8400
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