[Code of Federal Regulations] [Title 21, Volume 9] [Revised as of April 1, 2007] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR1404.205] [Page 239] TITLE 21-FOOD AND DRUGS CHAPTER III--OFFICE OF NATIONAL DRUG CONTROL POLICY PART 1404_GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)--Table of Contents Subpart B_Covered Transactions Sec. 1404.205 Why is it important if a particular transaction is a covered transaction? The importance of a covered transaction depends upon who you are. (a) As a participant in the transaction, you have the responsibilities laid out in Subpart C of this part. Those include responsibilities to the person or Federal agency at the next higher tier from whom you received the transaction, if any. They also include responsibilities if you subsequently enter into other covered transactions with persons at the next lower tier. (b) As a Federal official who enters into a primary tier transaction, you have the responsibilities laid out in subpart D of this part. (c) As an excluded person, you may not be a participant or principal in the transaction unless-- (1) The person who entered into the transaction with you allows you to continue your involvement in a transaction that predates your exclusion, as permitted under Sec. 1404.310 or Sec. 1404.415; or (2) A(n) Office of National Drug Control Policy official obtains an exception from the Director of National Drug Control Policy to allow you to be involved in the transaction, as permitted under Sec. 1404.120.