FDA Form 2301 Transmittal of Periodic reports and Promotional Material

Saving, Retrieving, or Emailing your data can only be done with the Adobe Acrobat/Designer, Adobe Approval, or the Adobe Reader Extensions Server, and not with the free Adobe Reader.

Section
Save Data

2301

Print

Next Page

Retrieve Data

Reset Form

TRANSMITTAL OF PERIODIC REPORTS
AND PROMOTIONAL MATERIAL FOR
NEW ANIMAL DRUGS

E-mail Form

1. NADA NO.
or
ANADA NO.

Form Approved: OMB No. 0910-0284
Expiration Date: June 30, 2006
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.

(See Instructions on Back)
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
(MO)

4. DATE REPORT DUE

(YR)

(MO)

(YR)

FROM
TO
9. TYPE OF REPORT (Check one)

10.

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)".)

NONE
A

ITEM
B

DESCRIPTION (Volume Number(s), Tab(s), Pages of Report)
C
(3) NO. OF COMPLAINTS
(4) NO. OF ANIMALS
(1) TOTAL NO. OF REPORTS (2) NO. OF PRODUCT
DEFECTS
AFFECTING ANIMALS
REACTED

(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

Stability
Data

Clinical
Data

Labels

Promotional
Material

13. SIGNATURE OF ABOVE OFFICIAL / AGENT

14. RETURN ADDRESS OF APPLICANT / AGENT

15. TELEPHONE & FAX NUMBER OF APPLICANT / AGENT

FORM FDA 2301 (3/04)

Page 1 of 3 Pages

PREVIOUS EDITION IS OBSOLETE

PSC Media Arts (301) 443-1090

EF

Save Data

Print

Next Page

Previous Page

Retrieve Data

Reset Form

E-mail Form

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 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 (3/04)

Page 2 of 3 Pages (INSTRUCTIONS)

Save Data

Print

Previous Page

Retrieve Data

Reset Form

E-mail Form

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 (3/04)

Page 3 of 3 Pages (BURDEN STATEMENT)