[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.31]

[Page 60-61]
 
                        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 B--Investigational New Drug Application (IND)
 
Sec. 312.31  Information amendments.

    (a) Requirement for information amendment. A sponsor shall report in 
an information amendment essential information on the IND that is not 
within the scope of a protocol amendment, IND safety reports, or annual 
report. Examples of information requiring an information amendment 
include:

[[Page 61]]

    (1) New toxicology, chemistry, or other technical information; or
    (2) A report regarding the discontinuance of a clinical 
investigation.
    (b) Content and format of an information amendment. An information 
amendment is required to bear prominent identification of its contents 
(e.g., ``Information Amendment: Chemistry, Manufacturing, and Control'', 
``Information Amendment: Pharmacology-Toxicology'', ``Information 
Amendment: Clinical''), and to contain the following:
    (1) A statement of the nature and purpose of the amendment.
    (2) An organized submission of the data in a format appropriate for 
scientific review.
    (3) If the sponsor desires FDA to comment on an information 
amendment, a request for such comment.
    (c) When submitted. Information amendments to the IND should be 
submitted as necessary but, to the extent feasible, not more than every 
30 days.

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 53 
FR 1918, Jan. 25, 1988; 67 FR 9585, Mar. 4, 2002]