[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: 21CFR3.5]

[Page 21-22]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 3--PRODUCT JURISDICTION--Table of Contents
 
   Subpart A--Assignment of Agency Component for Review of Premarket 
                              Applications
 
Sec. 3.5  Procedures for identifying the designated agency component.

    (a)(1) The Center for Biologics Evaluation and Research, the Center 
for Devices and Radiological Health, and the Center for Drug Evaluation 
and Research have entered into agreements

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clarifying product jurisdictional issues. These guidance documents are 
on display in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, and 
are entitled ``Intercenter Agreement Between the Center for Drug 
Evaluation and Research and the Center for Devices and Radiological 
Health;'' ``Intercenter Agreement Between the Center for Devices and 
Radiological Health and the Center for Biologics Evaluation and 
Research;'' ``Intercenter Agreement Between the Center for Drug 
Evaluation and Research and the Center for Biologics Evaluation and 
Research.'' The availability of any amendments to these intercenter 
agreements will be announced by Federal Register notice.
    (2) These guidance documents describe the allocation of 
responsibility for categories of products or specific products. These 
intercenter agreements, and any amendments thereto, are nonbinding 
determinations designed to provide useful guidance to the public.
    (3) The sponsor of a premarket application or required 
investigational filing for a combination or other product covered by 
these guidance documents may contact the designated agency component 
identified in the intercenter agreement before submitting an application 
of premarket review or to confirm coverage and to discuss the 
application process.
    (b) For a combination product not covered by a guidance document or 
for a product where the agency component with primary jurisdiction is 
unclear or in dispute, the sponsor of an application for premarket 
review should follow the procedures set forth in Sec. 3.7 to request a 
designation of the agency component with primary jurisdiction before 
submitting the application.