FDA - IMB
STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT
UNITED STATES FOOD AND DRUG ADMINISTRATION OF THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
BY THE IRISH MEDICINES BOARD
The Irish Medicines Board (IMB) is authorized to disclose non-public information to the United States Food and Drug Administration of the Department of Health and Human Services (USFDA) regarding IMB-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
USFDA understands that some of the information it receives from IMB may include non-public information exempt from public disclosure such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. USFDA understands that this non-public information is shared in confidence, and that IMB considers it critical that USFDA maintain the confidentiality of the information. Public disclosure of this information by USFDA could seriously jeopardize any further scientific and regulatory interactions between USFDA and IMB. IMB will advise USFDA of the non-public status of the information at the time that the information is shared.
Therefore, USFDA certifies that it:
- has the authority to protect from public disclosure the non-public information provided to USFDA in confidence by IMB;
- will not publicly disclose the IMB-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 IMB that the information no longer has non-public status;
- will inform IMB within two working days of any effort made by judicial or legislative mandate to obtain IMB-provided non-public information from USFDA. If such judicial or legislative mandate orders disclosure of IMB-provided non-public information, USFDA 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
- will promptly inform IMB of any changes to USFDA´s laws, or to any relevant policies or procedures, that would affect USFDA´s ability to honor the commitments in this document.
/s/ Murray M. Lumpkin
_____________________________for Date: 20 Sept 05
Lester M. Crawford, D.V.M.., Ph.D.
Commissioner of Food and Drugs
United States Food and Drug Administration
UNITED STATES OF AMERICA
5100 Fishers Lane
Rockville, MD 20857
(301) 827-2410 (ph)
(301) 443-3100 (fax)