| |
 |
|
|
 |
 |
 |
 |
 |
 |
 |
 |
| |
Pre-demand letters are potentially the single most important phase of an OIG investigation. Depending on your response to the OIG pre-demand letter, the OIG may decide to close its investigation, or assess draconian civil money penalties. DO NOT RESPOND TO AN OIG PRE-DEMAND LETTER WITHOUT FIRST CONTACTING GOLDBERG LEGAL SERVICES. You could be forfeiting your best opportunity to negotiate with the OIG.
Legal professionals and non-legal professionals alike may not be able to identify an OIG pre-demand letter. Below is a fictional pre-demand letter created for illustrative purposes only:
 January 1, 2007
Sad Hatter, MS, RBP, CBSP,
Responsible Official
University of Biosphere
Dolor, New Mexico 21000
Dear Mr. Hatter:
This letter is to advise you that the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) has preliminarily determined that University of Biosphere (UB) may be liable for civil money penalties and other sanctions under Part 73 of Title 42 of the Code of Federal Regulations for violations of the select agent program regulations, including: (1) failing to maintain an accurate, current inventory for each select agent; and (2) failing to immediately notify the Centers for Disease Control and Prevention (CDC) of the loss of a select agent.
Part 73 of Title 42 of the Code of Federal Regulations sets forth requirements regarding the possession, use, and transfer of select agents and toxins. 42 C.F.R. § 73.2. Those regulations require, in part, that an entity maintain an accurate, current inventory for each select agent. 42 C.F.R. § 73.17(a)(1). A registered entity must also immediately notify the CDC of the loss of a select agent. 42 C.F.R. § 73.19(a).
UB appears to have violated the select agent regulations. UB did not possess an accurate list of select agents at a CDC inspection on December 11, 2006. In addition, UB failed to notify the CDC that it lost regulated agents between April 4, 2006 and December 11, 2006.
Under 42 C.F.R. § 73.21, the OIG is authorized to impose civil money penalties of up to $250,000 against an individual and of up to $500,000 against any other person, including any entity, that is in violation of any of the requirements found in Part 73 of Title 42 of the Code of Federal Regulations. 42 C.F.R. § 1003.103(1).
We are writing to extend to you the opportunity to resolve this matter before the initiation of formal administrative proceedings. If you wish to submit information relevant to the OIG’s preliminary findings, or if you are interested in proposing an offer of settlement, please do so by February 14, 2007.
Sincerely,
Dottie T. Litigator
|
|
|
 |
| |
|
|
|
|
|
|
|
|
|
|
|
|