[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: 21CFR5.32]

[Page 43]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
Subpart B--Redelegations of Authority from the Commissioner of Food and 
                                  Drugs
 
Sec. 5.32  Authority relating to determination of product classification and assignment of primary jurisdiction.

    The Chief Mediator and Ombudsman, Office of the Ombudsman, Office of 
the Senior Associate Commissioner, Office of the Commissioner, as 
product jurisdiction officer is authorized to make a determination under 
section 563 of the Federal Food, Drug, and Cosmetic Act (the act) 
respecting the classification of a product as a drug, biological 
product, device, or a combination product subject to section 503(g) of 
the act, and to assign primary responsibility respecting the 
organizational component of the Food and Drug Administration that will 
regulate the product.

[65 FR 34962, June 1, 2000]