[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: 21CFR822.23]

[Page 162]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 822--POSTMARKET SURVEILLANCE--Table of Contents
 
                    Subpart D--FDA Review and Action
 
Sec. 822.23  Is the information in my submission considered confidential?

    We consider the content of your submission confidential until we 
have approved your postmarket surveillance plan. After we have approved 
your plan, the contents of the original submission and any amendments, 
supplements, or reports may be disclosed in accordance with the Freedom 
of Information Act. We will continue to protect trade secret and 
confidential commercial information after your plan is approved. We will 
not disclose information identifying individual patients. You may wish 
to indicate in your submission which information you consider trade 
secret or confidential commercial.