[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR10.105]

[Page 113]
 
                        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. 10.105  Representation by an organization.

    (a) An organization may represent its members by filing petitions, 
comments, and objections, and otherwise participating in an 
administrative proceeding subject to this part.
    (b) A petition, comment, objection, or other representation by an 
organization will not abridge the right of a member to take individual 
action of a similar type, in the member's own name.
    (c) It is requested that each organization participating in FDA 
administrative proceedings file annually with the Dockets Management 
Branch a current list of all of the members of the organization.
    (d) The filing by an organization of an objection or request for 
hearing under Secs. 12.20 through 12.22 does not provide a member a 
legal right with respect to the objection or request for hearing that 
the member may individually exercise. A member of an organization 
wishing to file an objection or request for hearing must do so 
individually.
    (e) In a court proceeding in which an organization participates, the 
Commissioner will take appropriate legal measures to have the case 
brought or considered as a class action or otherwise as binding upon all 
members of the organization except those specifically excluded by name. 
Regardless of whether the case is brought or considered as a class 
action or as otherwise binding upon all members of the organization 
except those specifically excluded by name, the Commissioner will take 
the position in any subsequent suit involving the same issues and a 
member of the organization that the issues are precluded from further 
litigation by the member under the doctrines of collateral estoppel or 
res judicata.