§ 510.302 - Reporting forms.

Link to an amendment published at 68 FR 15365, Mar. 31, 2003.

(a) The information described in § 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 § 510.300(b)(2) or § 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.

Effective Date Note:

At 68 FR 15365, Mar. 31, 2003, § 510.302 was removed, effective June 30, 2003.