[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR809.4]



[Page 84-85]

 

                        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



[[Page 85]]



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]