[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR3.5]
[Page 57-58]
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 clarifying product
jurisdictional issues. These guidance documents are on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 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
[[Page 58]]
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.
[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 24879, May 9, 2003]
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