[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR316.22]

[Page 174]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 316--ORPHAN DRUGS--Table of Contents
 
                Subpart C--Designation of an Orphan Drug
 
Sec. 316.22  Permanent-resident agent for foreign sponsor.

    Every foreign sponsor that seeks orphan-drug designation shall name 
a permanent resident of the United States as the sponsor's agent upon 
whom service of all processes, notices, orders, decisions, requirements, 
and other communications may be made on behalf of the sponsor. 
Notifications of changes in such agents or changes of address of agents 
should preferably be provided in advance, but not later than 60 days 
after the effective date of such changes. The permanent-resident agent 
may be an individual, firm, or domestic corporation and may represent 
any number of sponsors. The name of the permanent-resident agent shall 
be provided to: Office of Orphan Products Development (HF-35), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.