FDA 1932 Veterinary Adverse Drug Reaction, Lack of Effectiveness,

Section

9a
VETERINARY ADVERSE DRUG REACTION,
LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT
FORM FDA 1932

Form Approved: OMB No. 0910-0645
Expiration Date:

(Forward to address at left. Attach all correspondence that pertains to this reaction.)

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to respond to, a collection of information unless it displays a currently
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valid OMB control number.
NOTE: This report is required by law (21 CFR 514.80 and section 512 (l) of the Federal Food, Drug and Cosmetic Act (FDCA)).
Failure to report can result in withdrawal of approval of the application (21 CFR 514.80 (h) and section 512 (e) of the FDCA).
The data elements marked with an asterisk [*] require a value or text to be entered. An asterisk at the section level applies to all fields within that section.
An asterisk at the subsection level applies to all fields within that subsection. Otherwise, asterisks apply to individual fields.

PART A
ADMINISTRATIVE AND IDENTIFICATION INFORMATION
Regulatory Authority - RA (A.1)*
RA Name

Street Address

City

State/County

Mail/Zip Code

Country (3 Character Code)
Marketing Authorization Holder - MAH (A.2)
MAH Information (A.2.1)*

Business Name

Street Address

City

State/County

Mail/Zip Code

Country (3 Character Code)
Person Acting on Behalf of the MAH Information (A.2.2)

Title
Telephone Number

First Name

Last Name

Fax Number

e-Mail Address

Person(s) Involved in the AER (A.3)
Primary Reporter (A.3.1)
Last Name*
Telephone Number

First Name
Fax Number

e-Mail Address

Business Name

Street Address

City

State/County

Mail/Zip Code

Country (3 Character Code)*

Primary Reporter Category (A.3.1.1)*
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Other Reporter (A.3.2)
Last Name

First Name

Telephone Number

Fax Number

e-Mail Address

Business Name

Street Address

City

State/County

Mail/Zip Code

Country (3 Character Code)

Other Reporter Category (A.3.2.1)
AER Information (A.4)
Unique AER Identification Number (A.4.1)*
Original Receive Date (A.4.2)*
Day

Month

Date of Current Submission (A.4.3)*

Year

Day

Month

Year

Type of Report (A.4.4 )
Type of Submission (A.4.4.1)*
Reason for Nullification Report (A.4.4.2)
Type of Information in Report (A.4.4.3)
PART B
DESCRIPTION OF THE AE
Animal Data (B.1)
The fields within this section (B.1) are applicable only if an animal is associated with the report.
Number of Animals Treated (B.1.1)

Number of Animals Affected (B.1.2)*

Attending Veterinarian's Assessment of Animal Health Status Prior to VMP (B.1.2.1)
Species (B.1.3)*

Breed (B.1.4.1.1)
Animal 1

Breed (B.1.4)
Purebred Information (B.1.4.1)
Breed (B.1.4.1.1)
Animal 2

Breed (B.1.4.1.1)
Animal 3

Crossbred Information (B.1.4.2)
Breed (B.1.4.2.1)

Gender (B.1.5)
Female Physiological Status (B.1.7 )
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Breed (B.1.4.2.1)

Reproductive Status (B.1.6)

Breed (B.1.4.2.1)

Measured, Estimated,Unknown Weights (B.1.8.1)*

Weight (B.1.8)

Minimum Weight in Kilograms (B.1.8.2)

Maximum Weight in Kilograms (B.1.8.3)

Measured, Estimated , Unknown Age (B.1.9.1)*

Age (B.1.9)

Minimum Age (B.1.9.2)

Minimum Age Units (B.1.9.2.1)

Maximum Age (B.1.9.3)

Maximum Age Units (B.1.9.3.1)
VMP(s) Data and Usage (B.2)
(Repeat Fields B.2.1-B.2.6.5 for Additional VMP(s))

Registered or Brand Name (B.2.1)*

Product Code (B.2.1.1)

Registration Identifier (B.2.1.2 )*

ATCvet Code (B.2.1.3)*

Company or MAH (B.2.1.4 )
The following fields (B.2.1.5-B.2.1.7.1.2.3) are applicable only if an animal is associated with the report.
MAH Assessment (B.2.1.5)
RA Assessment (B.2.1.6)
Explanation Relating to Assessment (B.2.1.6.1)
Route of Exposure (B.2.1.7)
Dose per Administration (B.2.1.7.1)
Numeric Value for Dose (B.2.1.7.1.1)

Units of Value for Dose (B.2.1.7.1.1.1)
Interval of Administration (B.2.1.7.1.2)

Numeric Value for Interval of Administration (B.2.1.7.1.2.1)
Units of Value for Interval of Administration (B.2.1.7.1.2.1.1)
Date of First Exposure (B.2.1.7.1.2.2)
Day

Month

Date of Last Exposure (B.2.1.7.1.2.3)

Year

Day

Month

Active Ingredient(s) (B.2.2)
Dosage Form (B.2.2.2)
Active Ingredient(s) (B.2.2.1)*
Strength (B.2.2.1.1)*
Strength (Numerator)

Strength (Denominator)
Strength Unit (B.2.2.1.1.1)*

Strength Unit (Numerator)
Active Ingredient Code (B.2.2.1.2)
FORM FDA 1932 (1/10)
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Strength Unit (Denominator)

Year

Active Ingredient(s) (B.2.2.1)
Strength (B.2.2.1.1)
Strength (Numerator)

Strength (Denominator)
Strength Unit (B.2.2.1.1.1)

Strength Unit (Numerator)

Strength Unit (Denominator)

Active Ingredient Code (B.2.2.1.2)
Active Ingredient(s) (B.2.2.1)
Strength (B.2.2.1.1)
Strength (Numerator)

Strength (Denominator)
Strength Unit (B.2.2.1.1.1)

Strength Unit (Numerator)

Strength Unit (Denominator)

Active Ingredient Code (B.2.2.1.2)
Lot Number (B.2.3)

Expiration Date (B.2.3.1)

Day

Month

Year

The following fields (B.2.4-B.2.5.1) are applicable only if an animal is associated with the report.
Who Administered the VMP (B.2.4 )

Use According to Label (B.2.5)

Explanation for Off-Label Use Code (B.2.5.1)

Product/Manufacturing Defect Information (B.2.6)
The following fields (B.2.6.1-B.2.6.5) are applicable only if reporting a product/manufacturing defect.
Manufacturing Site Identifier Number (B.2.6.1)
Manufacturing Date (B.2.6.2)

Day

Manufacturer's Identifier Type (B.2.6.1.1)
Month

Number of Defective Items (B.2.6.3)

Defective Item Units (B.2.6.3.1)

Number of Items Returned (B.2.6.4)

Returned Item Units (B.2.6.4.1)

ORA District Field Office (B.2.6.5)

FORM FDA 1932 (1/10)
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Year

Adverse Event Data (B.3)
Narrative of AE (B.3.1)*

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Adverse Clinical Manifestations (B.3.2)*

The following fields (B.3.3-B.5.1) are applicable only if an animal is associated with the report.
Day

Date of Onset of AE (B.3.3)*

Month

Year

Length of Time Between Exposure to VMP(s) and Onset of AE (B.3.4)
Duration of AE (B.3.5)
Duration (B.3.5.1)

Duration Time Units (B.3.5.1.1)

Serious AE (B.3.6)*

Treatment of AE (B.3.7)
Outcome to Date (B.3.8)

Ongoing (B.3.8.1)

Recovered/Normal (B.3.8.2)

Recovered with Sequela (B.3.8.3)

Died (B.3.8.4)

Euthanized (B.3.8.5)

Unknown (B.3.8.6)

Previous Exposure to the VMP (B.3.9)

Previous AE to the VMP (B.3.10)
Dechallenge - Rechallenge Information (B.4)

Did AE Abate After Stopping
the VMP (B.4.1)

Did AE Reappear After Re-introduction
of the VMP (B.4.2)
Assessment of AE (B.5)

Attending Veterinarian's Assessment (B.5.1)
Supplemental Documents (B.6)
Attached Document Name (Filename if Electronic) (B.6.1)
Attached Document Type (B.6.2)
US Only Specific Information (B.7)
Report Identifier (B.7.1)*

Domestic vs Foreign Category (B.7.2)*
US-Based Pharmacovigilance Contact Person for the MAH (B.7.3)

Title
Telephone Number
FORM FDA 1932 (1/10)
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First Name
Fax Number

Last Name
e-Mail Address