STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE HEALTH PROTECTION AGENCY ACTING THROUGH ITS NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL

The Health Protection Agency acting through its National Institute for Biological Standards and Control (NIBSC), is authorized to disclose non-public information to The United States Food and Drug Administration (FDA) regarding NIBSC-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

FDA understands that some of the information it receives from NIBSC 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. FDA understands that this non-public information is shared in confidence and that NIBSC 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 NIBSC and FDA. NIBSC 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 NIBSC;
    
2. will not publicly disclose such NIBSC-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 NIBSC that the information no longer has non-public status;
    
3. will inform NIBSC promptly of any effort made by judicial or legislative mandate to obtain NIBSC-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of NIBSC-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 NIBSC of any changes, that it becomes aware of, 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. M.Sc
Deputy Commissioner
Global Regulatory Operations and Policy

United States Food and Drug Administration
10903 New Hampshire Avenue
Building 31
Silver Spring, MD 20993
UNITED STATES OF AMERICA

Telephone: +1.301.796.4600
Facsimile: +1.301.595.7937

Date: January 5, 2012