FDA - The Administration
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
THE PHARMACEUTICAL ADMINISTRATION,
THE MEDICAL DEVICES DEPARTMENT,
AND THE FOOD & NUTRITION SERVICES
OF THE ISRAEL MINISTRY OF HEALTH
The Pharmaceutical Administration, the Medical Devices Department, and the Food & Nutrition Services of the Israel Ministry of Health (collectively “the Administration”) is authorized to disclose non-public information to the United States Food and Drug Administration of the Department of Health and Human Services (HHS/FDA) regarding Administration-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
HHS/FDA understands that some of the information it receives from the Administration 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. HHS/FDA understands that this non-public information is shared in confidence, and that the Administration considers it critical that HHS/FDA maintain the confidentiality of the information. Public disclosure of this information by HHS/FDA could seriously jeopardize any further scientific and regulatory interactions between HHS/FDA and the Administration. The Administration will advise HHS/FDA of the non-public status of the information at the time that the information is shared.
Therefore, HHS/FDA certifies that it:
- has the authority to protect from public disclosure such non-public information provided to HHS/FDA in confidence by the Administration;
- will not publicly disclose the Administration-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 the Institute that the information no longer has non-public status;
- will inform the Administration within two working days of any effort made by judicial or legislative mandate to obtain Administration-provided non-public information from HHS/FDA. If such judicial or legislative mandate orders disclosure of Administration-provided non-public information, HHS/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
- will promptly inform the Administration of any changes to HHS/FDA’s laws, or to any relevant policies or procedures, that would affect HHS/FDA’s ability to honor the commitments in this document.
HHS/FDA and the Administration should establish a mechanism for regular meetings to develop plans for joint work.
Nothing in this commitment is intended to diminish or otherwise affect the authority of HHS/FDA to carry out its regulatory responsibilities and programs. In addition, no provision of this commitment restricts HHS/FDA from conducting its own inspection of a therapeutic product manufacturing facility within the jurisdictional boundaries of the Administration when needed to meet the needs of its own regulatory programs.
___/s/ Murray M. Lumpkin_____ for Date: 15 Dec 2005
Andrew C. von Eschenbach, M.D.
Acting Commissioner of Food and Drugs
Food and Drug Administration
UNITED STATES OF AMERICA
5600 Fishers Lane
Rockville , MD 20857
(301) 827-2410 (ph)
(301) 443-3100 (fax)