[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR809.4]

[Page 84]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 809.4  Confidentiality of submitted information.

    Data and information submitted under Sec. 809.10(c) that are shown 
to fall within the exemption established in Sec. 20.61 of this chapter 
shall be treated as confidential by the Food and Drug Administration and 
any person to whom the data and information are referred. The Food and 
Drug Administration will determine whether information submitted will be 
treated as confidential in accordance with the provisions of part 20 of 
this chapter.

[45 FR 7484, Feb. 1, 1980]