Fillable Transmittal Of Periodic Reports (Page 2 of 3) in pdf

INSTRUCTIONS FOR COMPLETION OF FORM FDA 2301

Copies of this form may be obtained by writing to:

Food and Drug Administration

Center for Veterinary Medicine (HFV-212)

7519 Standish Place

Rockville, MD 20855

Enter the NADA number assigned to the drug. If fewer than six digits, add leading zeros.

A combined report may be submitted for NADAs or ANADAs [See 514.80 (c)]. Whenever an applicant

is required to submit a periodic drug experience report under 514.80(b)(4) with respect to more than one

approved NADA or ANADA for preparations containing the same new animal drug so that the same

information is required to be reported for more than one application, the applicant may elect to submit as

a part of the report for one such application (the primary application) all the information common to such

applications in lieu of reporting separately and repetitively on each. If the applicant elects to do this, the

applicant must do the following:

(1) State when a report applies to multiple applications and identify all related applications for which the

report is submitted by NADA or ANADA number.

(2) Ensure that the primary application contains a list of the NADA or ANADA numbers of

all related applications.

(3) Submit a completed Form FDA 2301 to the primary application and each related application

with reference to the primary application by NADA/ANADA number and submission date

for the complete report of the common information.

(4) All other information specific to a particular NADA/ANADA must be included in the report

for that particular NADA/ANADA.

Check this box if report is a follow-up to one previously submitted or is a response to an FDA request.

Reports for all NADA/ANADA involved should be submitted on the anniversary date of the earliest

approved NADA/ANADA involved (primary application).

10(a).

Adverse drug experience is any adverse event associated with the use of a new animal drug, whether or

not considered to be drug related, and whether or not the new animal drug was used in accordance with the

approved labeling (i.e., used according to label directions or used in an extralabel manner, including but

not limited to different route of administration, different species, different indications, or other than

labeled dosage). Adverse drug experience includes, but is not limited to:

(1) An adverse event occurring in animals in the course of the use of an animal drug product

by a veterinarian or by a livestock producer or other animal owner or caretaker.

(2) Failure of a new animal drug to produce its expected pharmacological or clinical effect

(lack of expected effectiveness).

(3) An adverse event occurring in humans from exposure during manufacture, testing, handling,

or use of a new animal drug.

10(a)(1).

Enter total number of complaints being reported. Each complaint may involve one or more adverse drug

reactions. A complaint is defined as a report involving one situation or incident and may involve one or

more animals.

10(a)(4).

Enter total number of animals experiencing reactions involved in item 10(a)(3).

10(e).

Report the quantity marketed in units of highest concentration and the largest marketing package size.

In the case of a dosage form product, e.g., tablets which are formulated on body weight range basis,

give the quantity marketed of specific strength and package size separately without converting into

highest concentration and the largest marketing package size unit.

FORM FDA 2301 (10/15)

Page 2 of 3

(Instructions)

Transmittal Of Periodic Reports Page 2

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