[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.50]

[Page 42]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 601_LICENSING--Table of Contents
 
                Subpart F_Confidentiality of Information
 
Sec. 601.50  Confidentiality of data and information in an investigational new 


drug notice for a biological product.

    (a) The existence of an IND notice for a biological product will not 
be disclosed by the Food and Drug Administration unless it has 
previously been publicly disclosed or acknowledged.
    (b) The availability for public disclosure of all data and 
information in an IND file for a biological product shall be handled in 
accordance with the provisions established in Sec. 601.51.
    (c) Notwithstanding the provisions of Sec. 601.51, the Food and 
Drug Administration shall disclose upon request to an individual on whom 
an investigational biological product has been used a copy of any 
adverse reaction report relating to such use.

[39 FR 44656, Dec. 24, 1974]