[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.302]

[Page 44]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 510--NEW ANIMAL DRUGS--Table of Contents
 
                     Subpart D--Records and Reports
 
Sec. 510.302  Reporting forms.

    (a) The information described in Sec. 510.300, except that described 
in paragraphs (b) (1) and (2) of that section, shall be submitted 
appropriately identified with the new animal drug application(s) to 
which they relate in duplicate on Form FD-2301 ``Transmittal of Periodic 
Reports and Promotional Material for New Animal Drugs.''
    (b) All adverse experiences with new animal drugs as described in 
Sec. 510.300(b)(2) or Sec. 510.301(b) whether or not related to a 
required periodic report submitted on a Form FD-2301, shall be reported 
on Form FD-1932 ``Adverse Drug Reaction'' (except as provided in 
paragraph (c) of this section). Reports of adverse drug experiences may 
be submitted initially in the form of a written communication, but any 
such communication shall be followed promptly (but not necessarily 
within the prescribed 15 working days) by a completed Form FD-1932. A 
separate ``Adverse Drug Reaction'' form should be submitted for each 
patient where feasible.
    (c) In lieu of Form FD-1932 the holder of an approved new animal 
drug application may submit:
    (1) A computerized report if the information contained therein and 
the sequence in which it is presented are equivalent to that required by 
Form FD-1932 and the report is submitted in duplicate. Such reports will 
require initial approval by the Food and Drug Administration prior to 
use; and
    (2) Copies of reports of reactions appearing in the published 
scientific literature may be submitted.
    (d) Forms FD-1932 and FD-2301, with instructions for their use, may 
be obtained from the Food and Drug Administration, Department of Health 
and Human Services, Center for Veterinary Medicine, 7500 Standish Pl., 
Rockville, MD 20855.

[40 FR 13807, Mar. 27, 1975, as amended at 41 FR 35844, Aug. 25, 1976; 
54 FR 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992]