[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.130]

[Page 93-94]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
                        Subpart F--Miscellaneous
 
Sec. 312.130  Availability for public disclosure of data and information in an IND.

    (a) The existence of an investigational new drug application will 
not be disclosed by FDA unless it has previously been publicly disclosed 
or acknowledged.
    (b) The availability for public disclosure of all data and 
information in an investigational new drug application for a new drug 
will be handled in accordance with the provisions established in 
Sec. 314.430 for the confidentiality of data and information in 
applications submitted in part 314. The availability for public 
disclosure of all data and information in an investigational new drug 
application for a biological product will be governed by the provisions 
of Secs. 601.50 and 601.51.
    (c) Notwithstanding the provisions of Sec. 314.430, FDA shall 
disclose upon request to an individual to whom an investigational new 
drug has been given a copy of any IND safety report relating to the use 
in the individual.
    (d) The availability of information required to be publicly 
disclosed for investigations involving an exception from informed 
consent under Sec. 50.24 of this chapter will be handled as follows: 
Persons wishing to request the publicly disclosable information in the 
IND that was required to be filed in Docket Number 95S-0158 in the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, shall

[[Page 94]]

submit a request under the Freedom of Information Act.

[52 FR 8831, Mar. 19, 1987. Redesignated at 53 FR 41523, Oct. 21, 1988, 
as amended at 61 FR 51530, Oct. 2, 1996; 64 FR 401, Jan. 5, 1999]