[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR514.12]

[Page 72-73]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 514--NEW ANIMAL DRUG APPLICATIONS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec.  514.12  Confidentiality of data and information in an investigational new animal drug notice.

    (a) The existence of an INAD notice will not be disclosed by the 
Food and

[[Page 73]]

Drug Administration unless it has previously been publicly disclosed or 
acknowledged.
    (b) The availability for public disclosure of all data and 
information in an INAD file shall be handled in accordance with 
provisions established in Sec.  514.11.