[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR10.110]

[Page 111]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents
 
              Subpart B--General Administrative Procedures
 
Sec. 10.110  Settlement proposals.

    At any time in the course of a proceeding subject to this part, a 
person may propose settlement of the issues involved. A participant in a 
proceeding will have an opportunity to consider a proposed settlement. 
Unaccepted proposals of settlement and related matters, e.g., proposed 
stipulations not agreed to, will not be admissible in evidence in an FDA 
administrative proceeding. FDA will oppose the admission in evidence of 
settlement information in a court proceeding or in another 
administrative proceeding.