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NIBSC - FDA, Statement of Authority and Confidentiality Commitment

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE HEALTH PROTECTION AGENCY ACTING THROUGH ITS NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL 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. § 20.89 to disclose non-public information to the Health Protection Agency acting through its National Institute for Biological Standards and Control (NIBSC) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

NIBSC understands that some of the information it receives from FDA 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. NIBSC understands that this non-public information is shared in confidence and that FDA considers it critical that NIBSC maintain the confidentiality of the information. Public disclosure of this information by NIBSC could seriously jeopardize any further scientific and regulatory interactions between FDA and NIBSC. FDA will advise NIBSC of the non-public status of the information at the time that the information is shared.

Therefore, NIBSC certifies that it:

  1. has the authority to protect from public disclosure such non-public information provided to NIBSC in confidence by FDA;
     
  2. will not publicly disclose such FDA-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 FDA that the information no longer has non-public status;
     
  3. will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from NIBSC. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, NIBSC 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 FDA of any changes, that it becomes aware of, to the United Kingdom’s laws, or to any relevant policies or procedures, that would affect NIBSC’s ability to honor the commitments in this document.

Signed on behalf of NIBSC:

__________/s/______________
Stephen Inglis, Ph.D.
Director of the National Institute
for Biological Standards and Control

 Blanche Lane
South Mimms
Potters Bar
Hertfordshire
EN6 3QG

 THE UNITED KINGDOM

Tel. +44(0) 1707 641000
Facsimile: +44 (0) 1707 641050

Date: October 7, 2011

 
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