Fda 2301 Transmittal Of Periodic Reports And Promotional Material

Form Approved: OMB No. 0910-0284
Exp. Date: 7/31/2023. See PRA statement on pg. 3.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

TRANSMITTAL OF PERIODIC REPORTS
AND PROMOTIONAL MATERIAL
FOR NEW ANIMAL DRUGS

Note: Required by 21 CFR 514.80. Failure to make the
reports is a basis for withdrawal of the NADA/ANADA.

1. NADA NO. or ANADA NO.

(See Instructions on Back)

2. Name of Applicant

3. Date Report Submitted 4. Date Report Due

5. Drug Trade Name

6. Chemical Name

7. Combined Report (List NADA numbers involved. See Instructions.)

8. Report Period

(MM) (DD) (YYYY)

From:
9. Type of Report (Check One)
6/12/18/24 Month
Follow Up

To:

Annual

(MM) (DD) (YYYY)

Promo/Ad

Other (specify)

Information Required – Periodic and Special

10.

(See CFR 514.80. Check Column A if “None.”)

A – None

B – None
(a) Adverse Drug
Experiences

C – Description (Volume Number(s), Tab(s), Pages of Report)
(1) Total No. of
Reports

(2) No. of
Product Defects

(3) No. of Complaints
Affecting Animals

(4) No. of
Animals Reacted

(b) Clinical Data (Animal
Experience)
(c) Mailing Pieces and/or
Advertising Material
(d) Current Package
Labeling

Please Provide on Separate Sheet

(e) Quantity Marketed

Please Provide on Separate Sheet

11.

Information Required – Promotional Material Only
A – Date of Issuance

B – Type of Material

C – Identification (Code No., etc.)

15. Return Address of Applicant/Agent

12. Name/Title of Responsible Official/US Agent (Type of Print)

13. Signature of Above Official/Agent

14. Email Address

FORM FDA 2301 (6/21)

16. Telephone & Fax Number of Applicant/Agent

Previous Edition is Obsolete

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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
1.
7.

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.

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).

10(a)(1).
10(a)(4).
10(e).

(3) An adverse event occurring in humans from exposure during manufacture, testing, handling,
or use of a new animal drug.
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).
Enter the numeric value of the amount of total packages sold or distributed domestically or for export for the
reporting time period. Include all the domestic and export product sold or distributed by the applicant and
distributors. Enter the numeric value for the total amount sold or distributed for the year in the annual total.
For example, if 500 cases of 100 mL bottles @ 200 mg lincomycin hydrochloride/1 mL, each case
containing 6 bottles, were distributed/sold during the reporting time period, enter "3,000" since the
calculated number of packages (100 mL bottles @ 200 mg/1 mL) would amount to 3,000 bottles. If 1250
bottles of 1000 tablet bottles @ 25mg/1 tablet were distributed, enter "1250" since the calculated quantity
would amount to 1250 bottles. Returned Products: When product is sold or distributed and returned, subtract
the returned amount from the monthly total (in packages).

FORM FDA 2301 (6/21)

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(Instructions)

Submit two copies of the report to:
Food and Drug Administration
Center for Veterinary Medicine
Document Control Unit, HFV-199
MPN 2, E150
12225 Wilkins Avenue
Rockville, MD 20852

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 1 hour per response, including the time to
review instructions, search existing data sources, gather and maintain the data needed and complete and review the
collection of information. Send comments regarding this burden estimate or any other aspect of this information
collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
“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 number.”

FORM FDA 2301 (6/21)

Page 3 of 3

(Instructions/Burden Statement)