2301 Transmittal of Periodic Reports and Promotional Material

Section

2301

TRANSMITTAL OF PERIODIC REPORTS
AND PROMOTIONAL MATERIAL FOR
NEW ANIMAL DRUGS

1. NADA NO.
or
ANADA NO.

(See Instructions on Back)

Form Approved: OMB No. 0910-0284
Expiration Date: January 31, 2010
See OMB statement on page 3.
Note: Required by 21 CFR 514.80. Failure to make
the reports is a basis for withdrawal of the NADA/
ANADA.

2. NAME OF APPLICANT

3. DATE REPORT
SUBMITTED

5. DRUG TRADE NAME

6. GENERIC NAME

7. COMBINED REPORT (List NADA numbers involved. See Instructions.)

8. REPORT PERIOD

4. DATE REPORT DUE

(MO) (YR)

FROM

(MO) (YR)

TO

9. TYPE OF REPORT (Check one)

10.
NONE
A

6 MONTH

ANNUAL

FOLLOW-UP

OTHER (Specify)

INFORMATION REQUIRED - PERIODIC AND SPECIAL
(See CFR 514.80. Check Column A if "None." Always complete Column C, for items "(d)" & "(e)".)
DESCRIPTION (Volume Number(s), Tab(s), Pages of Report)
C
(1) TOTAL NO. OF REPORTS (2) NO. OF PRODUCT
(3) NO. OF COMPLAINTS
(4) NO. OF ANIMALS
DEFECTS
AFFECTING ANIMALS
REACTED

ITEM
B
(a) ADVERSE
EXPERIENCES
(b) CLINICAL DATA
(Animal Experience)

(c) MAILING PIECES
AND/OR ADVERTISING
MATERIAL
(d) CURRENT PACKAGE
LABELING
(e) QUANTITY MARKETED

11.

INFORMATION REQUIRED - PROMOTIONAL MATERIAL ONLY
DATE OF ISSUANCE
A

TYPE OF MATERIAL
B

12. NAME / TITLE OF RESPONSIBLE OFFICIAL / AGENT (Type or print)

IDENTIFICATION (Code No., etc.)
C

Amount
Marketed

13. SIGNATURE OF ABOVE OFFICIAL / AGENT

14. RETURN ADDRESS OF APPLICANT / AGENT

15. TELEPHONE & FAX NUMBER OF APPLICANT / AGENT

FORM FDA 2301 (3/07)

Page 1 of 3 Pages

PREVIOUS EDITION IS OBSOLETE

Stability
Data

Clinical
Data

Labels

Promotional
Material

INSTRUCTIONS FOR COMPLETION OF FORM FDA 2301
Copies of this form may be obtained by writing to:
Department of Health and Human Services
Public Health Service
Food and Drug Administration (HFV-12)
7519 Standish Place, Room 3508
Rockville, MD 20855
1.

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

7.

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.

9.

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

10(a)(4).
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 (3/07)

Page 2 of 3 Pages (INSTRUCTIONS)

Submit two copies of the report to:
Department of Health and Human Services
Public Health Service
Food and Drug Administration (HFV-199)
7500 Standish Place, Room N403
Rockville, MD 20855
Public reporting burden for this collection of information is estimated to average 30 minutes per response, including the
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden to:
Department of Health and Human
Services Public Health Service
Food and Drug Administration (HFV-199)
7519 Standish Place, Room 3508
Rockville, MD 20855
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number.

FORM FDA 2301 (3/07)

Page 3 of 3 Pages (BURDEN STATEMENT)