Contains Nonbinding Recommendations
Draft — Not for Implementation
#188
Guidance for Industry
Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft guidance should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may be submitted electronically on the Internet at http://www.regulations.gov. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document, contact Dr. Lynn Post, Director Division of Surveillance, Office of Surveillance/Compliance, HFV-210, Food and Drug Administration, 7519 Standish Pl, Rockville, MD 20855, 240-276-9191.
Additional copies of this draft guidance document may be requested from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm123602.htm or http://www.regulations.gov
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine
Month Day 2010
Table of Contents
III. GUIDANCE AND INSTRUCTIONS 5
ADMINISTRATIVE AND IDENTIFICATION INFORMATION 6
A.1 Regulatory Authority (RA) (Text Field) 6
A.2 Marketing Authorization Holder (MAH) 7
A.3 Person(s) Involved in the AER 7
Guidance for Industry1
Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine2
This draft guidance, when finalized, will represent the Food and
Drug Administration’s (FDA or Agency) current thinking on this
topic. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. You can use an
alternative approach if the approach satisfies the requirements of
the applicable statutes and regulations. If you want to discuss an
alternative approach, contact the FDA staff responsible for
implementing this guidance. If you cannot identify the appropriate
FDA staff, call the appropriate number listed on the title page of
this guidance.
The purpose of this guidance is to assist applicants (referred to as Marketing Authorization Holder (MAH) in this guidance) and nonapplicants with filling out Form FDA 1932, “Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.” As required by Food and Drug Administration (FDA) regulations at 21 CFR 514.80, an applicant must report adverse drug experiences3 (ADEs) and product/manufacturing defects on Form FDA 1932.
As part of FDA’s ongoing effort to harmonize the Agency’s adverse event (AE) regulatory reporting data elements with those of other nations as well as streamline reporting for product and manufacturing defects, FDA revised Form FDA 1932.4 The changes to Form FDA 1932 are the product of discussions undertaken between the United States, Japan, and the European Union as part of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). FDA revised Form FDA 1932 to bring the AE reporting data elements on the form more in line with the data elements developed as a result of the VICH discussions.5 In addition, the Agency has included new data elements to gather information specific only to the FDA. This information will enable FDA to process and review electronic and paper reports.
This document is intended to provide guidance on how to complete Form FDA 1932. Form FDA 1932 can be completed as follows:
through the Rational Questionnaire6;
through the FDA Electronic Submissions Gateway (ESG) for gateway-to-gateway reporting; or
by filling out the paper form.
This guidance document is not intended to provide guidance on how to electronically transmit the Form FDA 1932 to FDA. FDA intends to provide additional guidance on the electronic transmission of the information in a separate document. If you need additional information for appropriate transmission of the information based on the FDA electronic transmission standard, please refer to Guidance for Industry #108, “How to Submit Information in Electronic Format to CVM using the FDA Electronic Submission Gateway.” Furthermore, this guidance does not address voluntary reporting on Form FDA 1932a.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidance documents means that something is suggested or recommended, but not required.
Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360b(l)) requires applicants to establish and maintain records and make such reports of data relating to experience with uses and other data or information received or obtained by the applicant with respect to such drug as required by regulation or order. Section 514.80 (b) (21 CFR 514.80(b)) of FDA regulations requires applicants of approved new animal drug applications (NADAs) and approved abbreviated new animal drug applications (ANADAs) to report ADEs and product and manufacturing defects. This continuous monitoring of approved NADAs and ANADAs affords the primary means by which FDA’s Center for Veterinary Medicine (CVM) obtains information regarding potential problems with the safety and efficacy of marketed approved new animal drugs as well as potential product/manufacturing problems.
CVM relies on adverse event reports (AERs) to facilitate a determination under section 512(e) (21 U.S.C. 360b(e)) as to whether there may be grounds for suspending or withdrawing approval of the NADA or ANADA (21 CFR 514.80(a)(3)). In addition, the information contained in veterinary AERs assists CVM in working with firms to minimize ADEs due to problems in manufacturing, previously unidentified, or uncommon side effects, and in reducing ADEs due to off-label (also known as extralabel) use of an animal drug.
Furthermore, manufacturing/product defect cases must be reported as a Three-day NADA/ANADA Field Alert Report if they meet the criteria in 21 CFR 514.80(b)(1). Adverse drug events and manufacturing/product defect cases involving animals must be submitted as a Fifteen-day NADA/ANADA Alert Report based on the criteria in 21 CFR 514.80 (b)(2)(i) and (ii) or as a periodic report based on the criteria in 21 CFR 514.8 (b)(4)(iv). If a nonapplicant elects to report directly to FDA (after forwarding reports of ADEs to the applicant), the nonapplicant should submit the report on Form FDA 1932, pursuant to 21 CFR 514.80(b)(3).
1. Guidance for Completing Form FDA 1932
Under FDA regulations, Form FDA 1932 must be used for the reporting of ADEs and product/manufacturing defect(s) (see 21 CFR 514.80(d)). The paper and electronic versions of Form FDA 1932 contain data elements necessary for us to process and access the report.7 However, not every data element will be applicable for every report. For example, if the ADE only involved a human, there may not be a data entry for data elements asking about the animal involved (i.e., breed, production class, reproductive status of the animal, etc.)
Complete all applicable data elements if the information is available. The data elements that are required to be filled out by everyone are marked on Form FDA 1932 with a single asterisk. Although there are data elements that are not marked with an asterisk, we strongly encourage you to submit that information, because it will help FDA process and review the report.
FDA has indicated which data elements are required as follows:
The required elements for the paper form are indicated on the paper form itself;
The required data elements for the gateway-to-gateway electronic transmissions are indicated in the technical specification documents; and
The required data elements for the web-based Rationale Questionnaire are indicated on the screen during data entry and also through software functionality (e.g., upon submission of the report, the system will notify the reporter if a required field is empty).
According to 21 CFR 514.80(b)(1), the applicant must submit a three-day NADA/ANADA field alert report providing for information pertaining to product and manufacturing defects that may result in serious ADEs. This provision of the regulation can be satisfied by submitting Form FDA 1932 (paper form) to the appropriate FDA District Office or local resident post (see 21 CFR 514.80(b)(1)). Currently, FDA does not have the electronic capability to share with the FDA District Office or local resident post electronic reports submitted through the web-based Rational Questionnaire or a gateway-to gateway electronic submission. If the MAH elects to submit a three-day NADA/ANADA field alert report directly to FDA’s CVM, the MAH may use any of the three previously-mentioned methods for providing the information. However, if the MAH chooses to submit this report directly to FDA’s CVM, this does not alleviate the MAH’s responsibility to submit this report (via telephone or other telecommunication means, and paper form) to the FDA District Field Office or local FDA resident post (see 21 CFR 514.80(b)(1)).
2. Instructions for Completing Form FDA 1932
Type or print all entries in a font no smaller than 8 point.
The values and codes for the lists of categories will be specified in FDA technical specification for electronic transmission and can be obtained from the CVM Electronic Submissions webpage.
The values for U.S. state codes and the 3-character International Organization for Standardization (ISO) 3166 code can be found in the List of U.S. States & Territory Codes and List of ISO 3-Digit Country Codes, respectively.
The RA is the government agency or authority to which this AER is to be submitted initially based on which RA has the authority to regulate the product.
Enter the RA name, street address, city, state/county, mail/zip code, and country (3-character ISO 3166 code). The RA for Veterinary Medicinal Products (VMPs) in the United States is the FDA, Center for Veterinary Medicine, entered as follows:
RA Name: Food and Drug Administration, Center for Veterinary Medicine
Street Address: 7500 Standish Place (HFV-199), Room 403
City: Rockville
State/County: MD
Mail/Zip Code: 20855
Country: USA
The MAH is the applicant (sometimes referred to as the company or the firm) or the nonapplicant (such as the firm’s distributor). The MAH is responsible for reporting the AE information to the RA who is responsible for regulating the veterinary medicinal product (VMP). For purposes of this guidance document, the term veterinary medicinal product has the same meaning as “new animal drug,” as defined in section 201(v) of the Act, 21 U.S.C. 321(v).
A.2.1 MAH Information (Text Field)
Provide the business name, street address, city, state/county, mail/zip code, and country (3-character ISO code) of the MAH.
A.2.2 Person Acting on Behalf of the MAH Information (Text Field)
Enter the title, first name, last name, telephone number, fax number, and e-mail address of the person acting on behalf of the MAH.
Enter the name of the veterinarian involved in this AER as one of the reporters, if a veterinarian is involved in the AE.
A.3.1 Primary Reporter (Text Field)
The primary reporter is the person or organization, as determined by the MAH, who holds or provides the most pertinent information related to this AER. If the reporter requests not to be identified, enter “Withheld” in the Last Name field.
Provide the last name, first name, telephone number, fax number, e-mail address, business name, street address, city, state/county, mail/zip code, and country code (3-character ISO 3166 code) of the individual or organization reporting the primary information for this AER.
A.3.1.1 Primary Reporter Category (List)
This field is a list of values regarding the role or involvement of the primary reporter. For an agent acting on behalf of the owner (e.g., horse trainer or pet sitter), choose “Animal Owner.” Choose “Patient” only when the affected species in the AE is a human. Only use “Physician” when the affected species in the AE is a human, unless a physician is reporting on an animal.
Enter a choice from the List of Reporter Categories.
A.3.2 Other Reporter (Text Field)
The other reporter, as determined by the MAH, is the person or organization who also possesses pertinent information related to this AER. For example, if the primary reporter is the veterinarian, the other reporter may be the animal owner. If the other reporter requests not to be identified, enter “Withheld” in the Last Name field.
Provide the last name, first name, telephone number, fax number, e-mail address, business name, street address, city, state/county, mail/zip code, and country (3-character ISO 3166 code) of the other reporter.
A.3.2.1 Other Reporter Category (List)
This field is a list of values regarding the role or involvement of the other reporter. For an agent acting on behalf of the owner (e.g., horse trainer or pet sitter), choose “Animal Owner.” Choose “Patient” only when the affected species in the AE is a human. Choose “Physician” only when the affected species in the AE is a human, unless a physician is reporting on an animal.
Enter a choice from the List of Reporter Categories.
A.4.1 Unique Adverse Event Report Identification Number (Text Field)
This globally unique AER identification number is designated by the MAH or RA. It consists of a 3-character ISO 3166 country code, 8- character MAH or 8-character RA identifier code, and a unique number (e.g., USA-GAPINDUS-000001, USA-USFDACVM-000002). The country code is for the country where the AE occurred. Refer to the globally unique identification number in all future correspondence regarding this case, e.g., provided in follow-up reports. If the case has a hospital case number or other nonapplicant case number, provide these numbers in the narrative B.3.1.
MAH identifier code: This is an 8-character code assigned by each MAH to identify itself.
RA identifier code: This is an 8-character code assigned by each RA to identify itself. In the United States, the two RA identifier codes are:
USFDACVM (FDA’s CVM)
APHISCVB (United States Department of Agriculture’s Animal and Plant Health Inspection Service, Center for Veterinary Biologics)
Enter the unique AER identification number.
A.4.2 Original Receive Date (Date Field — Day, Month, Year)
For ADE reports submitted in accordance with 21 CFR 514.80 (b)(2)(i), (b)(3), and (b)(4)(iv)(A), the original receive date is the date of first communication to the MAH responsible for reporting the AER to the FDA. For reports submitted in accordance with 21 CFR 514.80 (b)(1) and (b)(4)(iv)(A), the original receive date is the date that the MAH first became aware of the manufacturing/product defect. This date remains the same for follow-up or future submissions concerning this AER.
Enter the date that the AER was received by your company.
A.4.3 Date of Current Submission (Date Field — Day, Month, Year)
Enter the date of the submission of this AER to the RA.
A.4.4 Type of Report
A.4.4.1 Type of Submission (List)
This field is a list of values regarding the type of report being submitted to the RA. Choose the values represented by this AER from the List of Type of Submission.
The “Expedited” (fifteen-day NADA/ANADA alert report) report provides information on each serious, unexpected adverse drug event. These reports should be submitted on Form FDA 1932 in accordance with 21 CFR 514.80 (b)(2)(i).
The Three-Day NADA/ANADA Field Alert Report contains information pertaining to the VMP that is the subject of the manufacturing/product defect(s) that may result in serious adverse events. These reports should be submitted on Form FDA 1932 in accordance with 21 CFR 514.80 (b)(1).
A “Follow-up” adverse event report provides additional information to a previously submitted initial AER. These reports should be submitted on Form FDA 1932 in accordance with 21 CFR 514.80 (b)(2)(ii).
“Nullification” is a specific type of follow-up report that describes why the initially submitted AER needs to be nullified.
A “Periodic” is an adverse event or manufacturing/product defect report included in the Drug Experience Report. These reports should be submitted on Form FDA 1932 in accordance with 21 CFR 514.80(b)(4).
A.4.4.2 Reason for Nullification Report (Text)
If “Nullification” was chosen in A.4.4.1, Type of Submission, provide a reason for the nullification of the report. CVM will determine prior to nullifying the report if the reason provided is valid.
A.4.4.3 Type of Information in Report (List)
This field is a list of values regarding the type of information in the AER. Choose the value represented by this AER from the List of Type of Information In Report.
For purposes of this document, a spontaneous report is an AER that is voluntarily reported to the MAH for the identification of possible AEs following the use of a marketed VMP(s). Explanations of the type of information in the report are as follows:
“Safety Issue” is a spontaneous report that involves a perceived illness or other injury. This may refer to both animal and human AEs.
“Clinical Study Safety Issue” is a safety issue that occurred in a clinical study using an approved VMP, regardless of how or why the VMP is used.
“Lack of Expected Effectiveness” is a spontaneous report that involves a lack of expected effectiveness (LOEE).
“Clinical Study Lack of Effectiveness” is a lack of expected effectiveness that occurred during a clinical study using an approved VMP, regardless of how or why the VMP is used.
“Both Safety Issue and Lack of Expected Effectiveness” represents both a safety issue and LOEE occurring in the same case.
These terms describe an AER where either humans or animals were exposed to the VMP that had a manufacturing/product defect and an AE occurred:
Manufacturing/Product Defect (Safety)
Manufacturing/Product Defect (LOEE)
Manufacturing/Product Defect (both safety and LOEE)
Clinical Studies:
If the AER is associated with a clinical study utilizing an approved VMP, provide the approved VMP name in B.2.1, Registered or Brand Name, and the NADA/ANADA number as part of the B.2.12, Registration Identifier.
Lack of expected effectiveness (LOEE):
A LOEE is considered to be an AE. Complete Form FDA 1932 in the same manner as a safety report. Include the number of animals treated and affected.
Examples of LOEE:
1. A dog is treated with hookworm anthelmintic. Hookworm eggs are identified in the feces. Number treated = 1, number reacted = 1
2. Five mares are treated with an estrus suppressant but estrus is not suppressed in three of them. Number treated = 5, number reacted = 3
Examples of Both Safety Issue and LOEE:
A dog is treated with a heartworm preventive. The dog acquires heartworm disease, a life-threatening situation, after being given the preventive; this is a safety issue. The drug did not prevent the disease; this is a lack of expected effectiveness issue.
An animal is appropriately treated with an antibiotic. The animal succumbs to the infection and dies. The animal died; this is a safety issue. The drug did not cure the animal as expected; this is a lack of expected effectiveness issue.
A calf is injected with a hormone pellet for weight gain but does not gain as expected and further experiences a rectal prolapse. The animal has a rectal prolapse; this is a safety issue. The animal did not gain as expected; this is a lack of expected effectiveness issue.
Use this same principle for “Clinical Study Safety and Lack of Effectiveness.”
Examples of the three types of manufacturing/product defects with adverse events:
1. Safety Issue. A dog is prescribed chewable tablets for pain. The inner seal of the bottle is missing and/or the cap does not close properly and the tablets spill out. The dog eats 40 tablets and vomits.
2. LOEE Issue. A calf is injected with a hormone pellet for weight gain but does not gain as expected. At injection, it was noted that the pellets had a waxy, discolored appearance.
3. Both Safety and LOEE Issue. A cat is injected with an anesthetic agent. The technician notes that the solution is somewhat cloudy upon injection. The cat does not achieve an expected plane of anesthesia and also develops a fever and a painful lump at the injection site.
Manufacturing/Product Defect with No Adverse Events: Select this term for all other manufacturing/product defect events.
Except for B.1.1, data in Part B relates to the affected animals only. In the case of human exposure, conform the descriptive information to patient privacy laws as pertinent to the country of occurrence (e.g., Health Insurance Portability and Accountability Act Privacy Rule in the United States).
If more than one companion animal is involved in an AE, use a separate Form FDA 1932 and Unique AER Identification Number for each animal’s case. Provide a cross-reference for each case by entering the Unique AER Identification Number in the narrative in B.3.1.
For livestock species, if the AE concerns a group of animals of the same species, where the range between the smallest and largest animal is reasonably close so that a meaningful assessment of the AE can be made, then you may use a single Form FDA 1932 to report the group information. Describe information concerning the group in the narrative in B.3.1. If there is too much variability among animals in the group to allow reasonable assessment of the AE, then complete a separate Form FDA 1932 for each animal. Use a separate Unique AER Identification Number for each of these case reports.
B.1.1 Number of Animals Treated (Numeric Field)
This is the number of animals being directly treated by the VMP(s). This does not include animals being indirectly exposed to the use of the VMP(s). This number represents all animals treated, not just those affected by the treatment (as reported in B.1.2, Number of Animals Affected
If the actual number is unknown, estimate the number of animals treated. Report a number greater than zero, rather than a percentage, for the number of animals treated.
Provide the number of animals being directly treated by the VMP(s).
B.1.2 Number of Animals Affected (Numeric Field)
This is the total number of animals affected by the AE, whether through direct or indirect exposure (e.g., treated during pregnancy or lactation, commingled, infectious spread, etc.). If the actual number of affected animals is unknown, estimate the number of animals affected. Use a number greater than zero, rather than a percentage of the number of animals treated. If the AE involved a lack of expected effectiveness, the number of animals affected is greater than zero.
Since the number of animals affected in the AE represents the total number of animals affected, whether by direct or indirect exposure, the number of animals affected may be greater than the number of animals treated. The following are examples:
1. A pregnant dog is treated with a VMP. She has no clinical signs. Two of her puppies have adverse clinical signs. The number entered in B.1.1, Number of Animals Treated, would be“1.” The number entered in B.1.2, Number of Animals Affected, would be “2.”
Two cows are treated with a pour-on VMP. These 2 cows and 7 more cows corralled with them experience an adverse clinical sign of a rash. The number entered in B.1.1, Number of Animals Treated, would be “2.” The number entered in B.1.2, Number of Animals Affected, would be “9.”
Provide the number of animals adversely affected by the VMP(s).
B.1.2.1 Attending Veterinarian’s Assessment of Animal Health Status Prior to VMP (List)
This field is a list of values regarding the attending veterinarian’s assessment of the health status of the animal(s) involved in the AE prior to their exposure to the VMP. The definitions of these values will be left to the veterinarian’s medical opinion. “Unknown” may be chosen if the attending veterinarian does not provide the information, or if there is no attending veterinarian.
In the case of human exposure, this would be the assessment by the attending physician.
Choose the value for health status of the animal(s) from the List of Attending Veterinarian’s Health Status Assessment.
B.1.3 Species (List)
This field is a list of values regarding the species of animal affected. Select one species per AER.
Choose the value for animal species represented in B.1.2, Number of Animals Affected, from the List of Species.
For AEs involving multiple species, make a separate report for each species and provide a description and a cross-reference for each case using the Unique AER Identification Number in the narrative in B.3.1
The species list is not intended to be all-inclusive. If the species list does not contain a value for your animal, choose “Other” and describe the species in the narrative in B.3.1.
In the case(s) where the affected species in the AE is human, choose “human” as the species.
In the case of a hybrid, choose the appropriate “Other” category from the species list. Examples:
Wolf/Dog Hybrid, choose “Other Canids” as the species and “Wolf Hybrid” as the breed
Zebra/Horse Hybrid, choose “Other Equids” as the species and “Equine Hybrid” as the breed
B.1.4 Breed (List)
This field is a list of values regarding the breed(s) of animal(s) affected.
Choose the value for the breed of the animal(s) associated with the species chosen in B.1.3 from the List of Breeds.
Breed values have not been provided for every species listed in B.1.3. If the breed list does not contain a value for your animal, choose “Other” and describe the breed in the narrative in B.3.1. In the case of a human exposure, the breed is not applicable.
The term (Unspecified) allows identification of breed if the “general” breed could be identified but not the specific one, e.g. Poodle (Unspecified) because it is not known if this is a standard, miniature, or toy poodle.
B.1.4.1 Purebred Information
The “Purebred Indicator” identifies an animal made up of only one breed. For reports of herds with multiple purebred animals of different breeds, report the breed for each animal. The field is repeatable to allow the capture of several breeds in a herd.
Choose the “Purebred Indicator” to identify an animal made up of only one breed, and choose the correct breed from the Type of Breed list of values.
B.1.4.2 Crossbred Information
The “Crossbred Indicator” identifies an animal made up of more than one breed.
Choose the “Crossbred Indicator” and up to three breeds from the Type of Breed list of values to describe a crossbred animal.
Following are examples of how to populate these fields for specific animals of different species and breeds:
Tennessee Walking Horse: Choose Purebred Indicator; Tennessee Walking Horse
(This animal is a purebred Tennessee Walking Horse.)
Horse of undetermined breeds: Choose Crossbred Indicator; Crossbred Equine/Horse (This animal is a crossbred animal but the breed makeup is not known.)
Labrador Retriever: Choose Purebred Indicator; Labrador Retriever
(This animal is a purebred Labrador Retriever.)
“Heinz 57” Dog: Choose Crossbred Indicator; Crossbred Canine/Dog
(This animal is a crossbred animal but the breed makeup is not known.)
Labrador Retriever Mix: Choose Crossbred Indicator; Labrador Retriever
(This animal is a crossbred animal with Labrador Retriever being a known breed but the
remainder of the breed makeup is not known)
Labrador Retriever/German Shepherd Mix: Choose Crossbred Indicator; Labrador Retriever; German Shepherd
(This animal is a crossbred animal composed of at least 2 breeds with Labrador Retriever and German Shepherd being the known breeds
Poland China/Tamworth/Landrace: Choose Crossbred Indicator; Poland China; Tamworth; Landrace
(This animal is composed of 3 breeds with Poland China, Tamworth, and Landrace being the known breeds.)
“Heinz 57” Cats are identified as Domestic Shorthair, Domestic Mediumhair, or Domestic Longhair according to the length of their hair coat.
If the cat has short hair: Choose Crossbred Indicator; Domestic Shorthair
Siamese/Domestic Shorthair Mix: Choose Crossbred Indicator; Siamese; Domestic Shorthair
(This animal is a crossbred animal with Siamese and Domestic Shorthair being the known breeds.)
Persian Mix: Choose Crossbred Indicator; Persian
(This animal is a crossbred animal with Persian being the known breed but the remainder of the breed makeup is not known.)
Examples for herds:
The herd consists of purebred Angus, Angus/Shorthorn mixes, and Charolais/Angus/ Shorthorn mixes:
Choose Purebred indicator; Angus;
Repeat the field;
Choose Crossbred indicator; Angus; Shorthorn; Charolais
The herd consists of various types of purebreds but the individual breeds are not known: Choose the Purebred indicator; “Mixed” as the breed
The herd consists of various types of crossbreds, but their makeup is not known or there are a great many different contributing breeds: Choose the Crossbred indicator; “Mixed” as the breed
B.1.5 Gender (List)
This field is a list of values that describes whether the affected animal(s) is male or female.
Choose the value for the gender of the animal(s) reported in B.1.2, Number of Animals Affected, from the List of Gender Categories.
Choose “Mixed” where a group is reported, and the group represents both male and female animals. If “Mixed” is chosen, describe the gender of the animals involved in the narrative in B.3.1. Choose “Unknown” when the gender is not known for the single animal affected or when the gender is not known for all animals in the group. If “Unknown” is chosen, describe the known gender of any of the animals in the group in the narrative in B.3.1.
B.1.6 Reproductive Status (List)
This field is a list of values that describes whether the affected animal(s) is intact or neutered.
Choose the value for the reproductive status of the animal(s) reported in B.1.2, Number of Animals Affected, from the List of Reproductive Status Categories.
Choose “Mixed” where group information is reported, and the group represents both intact and neutered animals. If “Mixed” is chosen, describe the reproductive status of the group in the narrative in B.3.1. Choose “Unknown” when the reproductive status is not known for the single animal affected or when the reproductive status is not known for all animals in the group. If “Unknown” is chosen, describe the known reproductive status of any of the animals in the group in the narrative B.3.1.
B.1.7 Female Physiological Status (List)
This field is a list of values that describes the pregnancy and lactation status of the affected female animal(s). Choose value for the female physiological status of the animal(s) reported in B.1.2, Number of Animals Affected, from the List of Female Physiological Status Categories.
Choose “Not Applicable” if there are only male animals and/or neutered female animals. For a mixed group of male and female animals, choose the physiological status appropriate for the female animals. If the group has multiple different physiological statuses, choose “Mixed” and describe the physiological status of the group in the narrative in B.3.1. If only one of the physiological factors is known, provide the physiological status of the animal in the narrative in B.3.1. Choose “Unknown” if the pregnancy and/or lactating status of the animal(s) is not known.
B.1.8 Weight
This field describes the weight of the animal(s) involved in the AE. Enter the weight in kilograms (kg).
B.1.8.1 Measured, Estimated, Unknown Weights (List)
This list describes how the weight of the affected animal(s) was determined.
Measured — the animal was weighed.
Estimated — the animal was not weighed but an estimation of its weight can be made.
Unknown — the animal’s weight is not known.
If the weight is “Unknown”, then B.1.8.2, Minimum Weight, and B.1.8.3, Maximum Weight, can’t contain a numeric value.
Choose the value from the List of Precision Categories for Weight and Age Data.
B.1.8.2 Minimum Weight (Numeric Field — Extended to 2 decimals)
This is the minimum weight of the affected animals, or the weight of a single affected animal. If only a single animal is affected, enter its numerical weight in the minimum weight field. If a group of animals is affected, enter the numerical weight of the smallest individual animal or an average weight of a subgroup of the smallest animals within the group.
B.1.8.3 Maximum Weight (Numeric Field — Extended to 2 decimals)
This is the maximum weight of the affected animals. Enter the numerical weight of the largest individual animal or an average weight of a subgroup of the largest animals within the group. Do not use this field if the case involves only a single animal.
B.1.9 Age
B.1.9.1 Measured, Estimated, Unknown Age (List)
This list describes the method used to determine the age of the affected animal(s).
Measured — the age of the animal(s) is known.
Estimated — the age of the animal(s) is not known, but an estimation of the age can be made.
Unknown — the age of the animal(s) is not known.
If the age is “Unknown”, then B.1.9.2, Minimum Age, and B.1.9.3, Maximum Age, cannot contain numeric values.
Choose the value from the List of Precision Categories for Weight and Age Data.
B.1.9.2 Minimum Age (Numeric Field)
This is the age of the youngest of the affected animals, or the age of a single affected animal. If only a single animal is affected, enter its numerical age in the minimum age field. If a group of animals is affected, enter the age of the youngest individual animal or an average age of a subgroup of the youngest animals within the group to represent the minimum age of the group.
Enter the numerical minimum age for the animal(s) reported in B.1.2, Number of Animals Affected.
B.1.9.2.1 Minimum Age Units (List)
Choose from the List of Time Units, the unit that is associated with the numerical minimum age reported in B.1.9.2, Minimum Age.
B.1.9.3 Maximum Age (Numeric Field)
This is the age of the oldest of the affected animals. For groups of animals, either use the numerical age of the oldest individual animal or an average age of a subgroup of the oldest animals within the group. Do not use this field if the case involves only a single animal.
Enter the numerical maximum age for the animal(s) reported in B.1.2, Number of Animals Affected.
B.1.9.3.1 Maximum Age Units (List)
Choose from the List of Time Units the unit that is associated with the numerical maximum age reported in B.1.9.3, Maximum Age.
Fields B.2.1 – B.2.5.1 are repeatable for each VMP involved in the AE. Do not combine different VMPs within the same data fields. Use the repeatable function to describe each VMP separately.
Use fields B.2.6.1 – B.2.6.5 for AER involving product/manufacturing defects.
B.2.1 Registered or Brand Name (Text Field)
Specifically, this is the name by which the product is presented by the MAH. This is known in various countries as the Registered, Brand, Proprietary or Trade Name of the product.
If the reporting MAH does not own or is not responsible for the VMP, and if the registered or brand name(s) is not available, enter the active ingredient(s) in B.2.2.1, Active Ingredient.
For AEs related to more than one VMP held by the reporting MAH, submit separate reports for each VMP. Give each a separate globally unique identification number as described in A.4.1, Unique AER Identification Number.
Provide the complete/entire registered or brand name for the VMP(s) involved in the AE.
B.2.1.1 Product Code (Text Field)
The product code is the National Drug Code (NDC) number for U.S. FDA-regulated products. This code is a combination of the labeler and product code components of the NDC number. The labeler code of the NDC number is a 6-digit number. The product code of the NDC number is either a 4- or 3-digit number. If the product code of the NDC number is a 3-digit number, then include an asterisk (“*”) prior to the 3 digits (e.g., *123). Separate the labeler code and product code of the NDC number by a dash (“-”) (e.g., 012345-*123, 012345-1234). Include leading zeros.
Provide the product code for the VMP(s) involved in the AE.
B.2.1.2 Registration Identifier (Text Field)
The registration identifier is a combination of the 3-character ISO 3166 code for the country where the VMP is approved, the 8-character RA Identifier Code, and the registration number of the VMP involved in the AE.
Registration Number: For FDA-regulated VMPs, the registration number is the 1-character application/file identifier followed by the 6 numbers assigned by FDA for that application/file (e.g., A200999, N199999, I999999).
The following table lists the 1-character application/file identifiers.
Application/File Type |
1-Character Application/File Identifier |
Abbreviated New Animal Drug Application |
A |
Generic Investigational New Animal Drug Application |
J |
Investigational New Animal Drug |
I |
New Animal Drug Application |
N |
MUMS Index File |
Z |
Unapproved Animal Drug Products |
D |
Provide the registration identifier (application number) for your VMP(s). Choose the appropriate 3- character ISO 3166 Country Code and RA Identifier code from the List of ISO 3-Digit Country Codes and List of Identifier Codes for Regulatory Authorities, respectively.
For the VMP(s) for which you are not responsible, provide the registration identifier, if known.
If the registration identifier cannot be determined due to insufficient information from the reporter, enter “Cannot Be Determined.”
Domestic Reports (Approved U.S. FDA Products)
Domestic reports are those AERs that involve an FDA-regulated VMP, regardless of the country in which the AE occurs.
For FDA-approved VMP(s), the registration identifier is the 3-character country code, 8-character RA Identifier Code, and FDA Application/File Number (e.g., USA-USFDACVM-N199999, USA-USFDACVM-I999999, USA-USFDACVM-A200999). Following are some examples of domestic reports:
An AE occurring in the United States with an FDA-approved VMP.
An AE occurring in Germany with an FDA-approved VMP (e.g., U.S. military personnel bought the VMP on a military base in Frankfurt).
An AE occurring in Japan with an FDA-approved VMP (e.g., Japanese visitor bought VMP in Hawaii and used product in Tokyo).
Unapproved Animal Drug Products
These are veterinary products that are not FDA approved but that are marketed in the U.S. and that are commonly used in veterinary practice. Some examples include: oral health care products, subcutaneous fluids, chemotherapeutic agents, injectable vitamins, and heparin. If the MAH chooses to submit a report for a VMP that is not FDA approved, we recommend Form FDA 1932 be used to submit the report.
Contact the Pharmacovigilance Liaison in CVM’s Division of Surveillance at [add e-mail address for Electronic Submissions mailbox] for a “D Number” for use as part of the registration identifier to which this product would be submitted.
Foreign Reports
Foreign reports are those AERs that involve a VMP that is the same as or similar to8 an FDA-regulated VMP but that is not the FDA-approved product (i.e., may have different labeling, different brand name, etc.). If the MAH chooses to submit a report for a VMP that is the same as or similar to an FDA-approved product, we recommend Form FDA 1932 be used to submit the report.
Same pharmaceutical VMP: The VMP originates from the same MAH with the same active ingredient(s) and formulation as the product approved in the United States. For example, the product has a different name, or the label is in a different language, or the product has different indications than the FDA-regulated VMP.
Example: the FDA-approved VMP named “Newcomer” is registered with the European Medicines Agency as “Forthright.” The registration identifier is GBR-EUEMEA00-xxxxxxxx.
Similar pharmaceutical VMP: The VMP is from the same MAH, containing the same active ingredient(s), major excipients with the same or similar pharmaceutical function, and at least one common registered species as the product approved in the United States. For example, the product has a different strength, formulation, or is a product not approved in the U.S.
Example: the FDA-approved VMP contains the active ingredient at 50 milligrams (mg)/milliliter (ml). The Canadian-approved VMP contains the active ingredient at 70 mg/ml. The registration identifier is CAN-CANHCVDD-xxxxx.
If the registration identifier cannot be determined due to insufficient information from the reporter, enter “Cannot Be Determined.”
B.2.1.3 Anatomical Therapeutic Chemical Vet (ATCvet) Code (Text Field)
The ATCvet code is an Anatomic Therapeutic Chemical system for the classification of substances intended for therapeutic use, and can serve as a tool for the classification of VMPs. More information about the ATCvet code is available at http://www.whocc.no/atcvet/.
B.2.1.4 Company or MAH (Text Field)
Provide the name(s) of the company or MAH that owns the VMP(s) involved in the AE.
B.2.1.5 MAH Assessment (List)
This is the assessment by the MAH of the association between the use of the VMP and the AE. Each VICH region may have its own requirements for this assessment.
Choose a value from the List of Assessment Categories.
B.2.1.6 RA Assessment
This is the assessment by the RA of the association between the use of the VMP and the AE. Each RA may have its own requirements for this assessment.
Choose a value from the List of Assessment Categories
B.2.1.6.1 Explanation Relating to Assessment (Text)
This is the explanation of the assessment provided by the MAH or the RA about the association between the use of the VMP and the AE.
Enter the explanation of the assessment provided by the MAH or the RA.
B.2.1.7 Route of Exposure (List)
This is the route by which the VMP was administered. Field B.2.1.7, Route of Exposure, and subfields are repeatable for each route of exposure for any given VMP.
Choose from the List of Routes of Exposure the route of exposure for the VMP(s).
B.2.1.7.1 Dose per Administration
This is the actual dose administered to the animal involved in the AE. Field B.2.1.7.1, Dose per Administration, and subfields are repeatable if different doses of the VMP are given over time.
In the case of herds where a specified dose is given to animals of different weights, enter the dose that would be given to the average animal and describe in the narrative in B.3.1. For example, the dose is 1.5 milliliters (ml) per 50 kg, and the product is given to animals that range from 500 to 1500 kg. Enter the dose as if given to a 1000 kg animal — 30 ml.
B.2.1.7.1.1 Numeric Value for Dose (Numeric Field)
This is the quantity/volume of the actual dose given, e.g., number of tablets, number of boluses, amount of feed, quantity of solution, etc. For example, the veterinarian gives the animal 10 ml of the VMP, which has strength of 13 milligrams (mg)/ml (as reported in B.2.2.1.1 – B.2.2.1.1.1). The numeric value reported in this field would be “10.”
Enter the numeric value for the dose administered.
B.2.1.7.1.1.1 Units of Value for Dose (List)
These are the units that qualify the numeric value for dose.
Choose from the list of values for List of Units of Measurement or List of Units of Presentation, the unit associated with the numeric value for dose entered in B.2.1.7.1.1, Numeric Value for Dose.
B.2.1.7.1.2 Interval of Administration
This is the frequency of administration of the VMP(s) involved in the AE. Field B.2.1.7.1.2, Interval of Administration, and subfields are repeatable if there are multiple frequencies of administration for the same given dose per administration.
B.2.1.7.1.2.1 Numeric Value for Interval of Administration (Numeric Field)
This is a number that characterizes the frequency of administration of the VMP(s). Enter the numeric value for the interval of administration.
B.2.1.7.1.2.1.1 Units of Value for Interval of Administration (List)
These are the units that qualify the numeric value of the interval of administration. Do not use this field unless a value is provided in B.2.1.7.1.2.1, Numeric Value for Interval of Administration.
Use the List of Time Units to choose the units for interval of administration associated with the numeric value provided in B.2.1.7.1.2.1, Numeric Value for Interval of Administration.
B.2.1.7.1.2.2 Date of First Exposure (Date Field — Day, Month, Year)
This field request information regarding the date on which the animal was first treated with the VMP. Enter the “Day,” “Month,” and “Year” for the date of first exposure for each VMP, if multiple VMPs are involved in the AE.
Enter the date on which the animal was first exposed to the VMP.
B.2.1.7.1.2.3 Date of Last Exposure (Date Field — Day, Month, Year)
This is the date on which the animal was last treated with the VMP. Enter the “Day,” “Month,” and “Year” for the date of last exposure for each VMP, if multiple VMPs are involved in the AE. If the treatment with the VMP is still ongoing, enter the date the report was received by the MAH.
Enter the date on which the animal was last exposed to the VMP.
Examples of how to enter information for Interval of Administration Fields and Exposure Dates
A tablet given once on August 1, 2006, is entered as follows:
Enter the number “1” in B.2.1.7.1.2.1, Numeric Value for Interval of Administration, to represent “once.”
Enter the day “01” in the day field of B.2.1.7.1.2.2, Date of First Exposure.
Enter the month “08” in the month field of B.2.1.7.1.2.2, Date of First Exposure.
Enter the year “2006” in the year field of B.2.1.7.1.2.2, Date of First Exposure
A tablet given once per day from August 1, 2006, to February 10, 2007, is entered as follows:
Enter the number “1” in B.2.1.7.1.2.1, Numeric Value for Interval of Administration, to represent “once.” Choose the unit “day” for B.2.1.7.1.2.1.1, Units of Value for Interval of Administration. The “per” is understood and does not need to be entered.
Enter the day “01” in the day field of B.2.1.7.1.2.2, Date of First Exposure.
Enter the month “08” in the month field of B.2.1.7.1.2.2, Date of First Exposure.
Enter the year “2006” in the year field of B.2.1.7.1.2.2, Date of First Exposure.
Enter the day “10” in the day field of B.2.1.7.1.2.3, Date of Last Exposure.
Enter the month “02” in the month field of B.2.1.7.1.2.3, Date of Last Exposure.
Enter the year “2007” in the year field of B.2.1.7.1.2.3, Date of Last Exposure.
B.2.2 Active Ingredient(s)
Provide the active ingredient(s) for your VMP(s).
Fields B.2.2.1 – B.2.2.1.2 are repeatable for each VMP involved in the AE. In cases where the user has altered the physical characteristics of the VMP prior to administration (e.g., mixing VMPs together, diluting the VMP, etc.), this field and its subfields are to be entered with the characteristics of the VMP as labeled. In such cases, leave the Dose per Administration field (B.2.1.7.1) blank and describe the dose administered in the narrative in B.3.1.
B.2.2.1 Active Ingredient(s) (Text Field)
For VMP(s) where the reporting MAH does not own or is not responsible for the VMP(s), provide brand name(s) in B.2.1, Registered or Brand Name, or active ingredient(s) in B.2.2.1, Active Ingredient.
Provide the active ingredient(s) for your VMP(s).
B.2.2.1.1 Strength (Numeric Fields)
Strength is the concentration of the active pharmaceutical ingredient of the VMP(s) involved in the AE and is a ratio of the active pharmaceutical ingredient (numerator) to the units of the product (denominator), and is reported as a ratio of the 2 quantities. Complete the information for both the numerator and denominator.
Provide the numeric strength of the active ingredients for the VMP(s) for which the reporting MAH is responsible based on the labeled, approved strength. Report the strength and its associated strength unit for each active ingredient in the VMP. If the strength administered was not the concentration as labeled on the product, provide a description of the strength of the active ingredient(s) in the narrative in B.3.1
For VMP(s) for which the MAH is not responsible, provide the labeled, approved strength, if known.
Report terms typically used to describe premixes, such as parts per million (ppm) or grams (g)/ton, as g/kg, for example, 100 g/10 kg Type A Medicated Article.
B.2.2.1.1.1 Strength Unit (List)
For the numeric strength entered in B.2.2.1.1, choose the strength unit from the List of Units of Measurement or List of Units of Presentation.
Examples of how to enter information for Strength and Strength Unit:
100 mg active ingredient to 1 kg of product = 100 mg/1 kg
Strength (numerator), enter “100”
Strength (denominator), enter “1”
Strength Unit (numerator), enter “mg”
Strength Unit (denominator), enter “kg”
2. 100 mg active ingredient in each tablet = 100 mg/1 tablet
Strength (numerator), enter “100”
Strength (denominator), enter “1”
Strength Unit (numerator), enter “mg”
Strength Unit (denominator), enter “tablet”
B.2.2.1.2 Active Ingredient Code (List)
This is a list of values of the active ingredient substance associated with the unique ingredient identifier (UNII) codes. The UNII code is a non-proprietary, free, unique, unambiguous, non semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. The UNII code is generated by the joint FDA/United States Pharmacopeia (USP) Substance Registration System (SRS).
Provide the active ingredient code for your VMP(s).
Click on the following link for the list of the codes:
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
(Then click the link on the left side of the page for UNIIs, Preferred Substance Names, and their Identified Synonyms)
B.2.2.2 Dosage Form (List)
This is a list of values of the labeled dosage form of the VMP(s) involved in the AE.
Choose a value for the labeled dosage form of the VMP(s) involved in the AE from the List of Dosage Forms.
B.2.3 Lot Number (Text Field)
Enter the lot number of the VMP(s) involved in the AE.
Use a separate field for each lot number. Fields B.2.3 – B.2.3.1 are repeatable if there are multiple lot numbers involved in the AE.
B.2.3.1 Expiration Date (Date Field — Day, Month, Year)
Enter the expiration date of the VMP(s) involved in the AE.
B.2.4 Who Administered the VMP(s) (List)
This field is a list of values describing the individual who administered the VMP(s) to the animal involved in the AE.
Choose from the List of Administrators of VMP(s) the role of the person(s) who administered the VMP(s). For an agent acting on behalf of the animal owner, choose “Animal Owner.” For an agent acting on behalf of the veterinarian, choose “Other Health Professional.” In cases where multiple people administered the VMP(s) (e.g., the veterinarian administered the VMP at their place of business and the animal owner continued the treatment at home), choose “Multiple Administrators” and provide a detailed explanation of each person’s role in the narrative in B.3.1. Choose “Patient” for when the affected species in the AE is human and for cases where an animal inadvertently exposed itself to the VMP.
B.2.5 Use According to Label (List)
This is a list of values (Yes, No, or Unknown) describing whether the VMP(s) was used according to its labeled recommendations/directions of use.
Choose “Yes” if the VMP(s) was used according to its labeled recommendations/directions of use.
Choose “No” if the VMP was used in an off-label use manner. Choose “Unknown” if the information is not available. If the VMP was used according to the label, and an AE involving human exposure results, choose “Yes.”
Examples:
Human applied topical medication to cat according to label directions and now has a headache. Choose “Yes.”
Human applied topical medication to cat according to label directions but accidentally splashed some on self and now has a skin rash. Choose “Yes.”
Human accidentally ingested anti-anxiety medication prescribed for dog and now has a nervous twitch. Choose “No.”
B.2.5.1 Explanation for Off-Label Use Code (List)
Provide information for this field if “No” was chosen in the Use According to Label field (B.2.5).
This field is a list of values that describes how the VMP was used in an off-label manner.
Choose a code from the List of Explanation for Off-Label Use – Coding System.
The choices allow selection of various off-label uses in one animal or a single off-label use in a number of animals. For multiple varied off-label uses in a group of animals, use code “120.” The choices flow from left to right, with the initial criterion being used in the labeled species. Note that “species” refers to the actual species, e.g., cattle. Subcategories such as production type, breed, and age subdivisions are captured under “Indication.”
The next criterion is route of administration, followed by dosing and treatment regimen, and flowing across to include various permutations of other types of off-label use. The corresponding codes (in incremental numbers) are formed by all combinations among the 8 different terms that are considered relevant. If “Other” is chosen, provide an explanation of off-label use in the narrative in B.3.1.
B.2.6 Product/manufacturing defect Information
The fields within this subsection (B.2.6.1 – B.2.6.5) need only be completed for product/manufacturing defect AERs. Fields B.2.6.1–B.2.6.5 are repeatable if there are multiple manufacturers involved in the AE.
B.2.6.1 Manufacturing Site Identifier Number (Text Field)
The manufacturing site identifier number identifies the site where the product/manufacturing defect issue occurred.
Enter the manufacturer’s 7 to 10 digit FDA Establishment Identifier (FEI Number) or 9-digit Data Universal Numbering System (D-U-N-S®) Number.
B.2.6.1.1 Manufacturer’s Identifier Type (List)
Identify the Manufacturing Site Identifier Number Type, i.e., whether it is an FEI or D-U-N-S number. Choose a code from the List of Manufacturer Site Identifiers.
B.2.6.2 Manufacturing Date (Date Field — Day, Month, Year)
Provide the date the VMP was manufactured.
B.2.6.3 Number of Defective Items (Numeric Field)
Provide the number of defective items of the VMP described in the AE, based on the applicable retail unit. For example, if a product is sold as 20 syringes per carton, enter the number of defective syringes.
B.2.6.3.1 Defective Item Units (List)
Choose the unit from the List of Package Types associated with the defective items from field B.2.6.3.
Examples of how to enter information for Number of Defective Items and Defective Item Units:
1. The product is sold in bottles. Twelve bottles in the shipped carton were leaking.
Number of Defective Items = 12
Defective Item Units = Bottles
2. The product is sold as 100 syringes per carton. Three cartons were shipped. Twenty of the syringes in the shipped cartons arrived crushed.
Number of Defective Items = 20
Defective Item Units = Syringes
B.2.6.4 Number of Items Returned (Numeric Field)
Provide the number of VMP items returned as described in the AE. For example, if a product is sold as 20 syringes per carton, enter the number of syringes returned.
B.2.6.4.1 Returned Item Units (List)
For the items reported in B.2.6.4, select the unit type from the List of Package Types.
Examples of how to enter information for fields, Number of Items Returned, and Returned Item Units:
1. The product is sold in bottles. Twelve bottles in the shipped carton were leaking. One of the leaking bottles was returned.
Number of Returned Items = 1
Returned Item Units = Bottles
2. The product is sold as 100 syringes per carton. Three cartons were shipped. Twenty of the syringes in the shipped cartons arrived crushed. All twenty of them were returned.
Number of Returned Items = 20
Defective Item Units = Syringes
B.2.6.5 Office of Regulatory Affairs (ORA) District Field Office (List)
This field is a list of values for selecting the ORA District Field Office or local FDA resident post to which the product/manufacturing defect information is being submitted for three-day NADA/ ANADA field alert reports.
Use the List of ORA District Field Offices to provide the office to which the AE is being sent. Choose “Not Applicable” if the report was not sent to an FDA ORA District Field Office or local FDA resident post.
B.3.1 Narrative of AE (Text Field)
Provide a detailed narrative description of the AE, including a chronological history that clearly identifies relevant information, such as:
health status of the affected animal(s) at the time the VMP was administered
relevant medical history
reason for using the VMP(s)
administration of VMP(s)
possible contributing factors
clinical signs
sites of response
severity of response
pertinent laboratory and other diagnostic test results
treatment of the AE
outcome
date of death (if applicable)
necropsy results, including accurate description of gross pathology and accurate description of histopathologic findings including a pathologist’s assessment
comments on assessments from veterinarian or MAH
other significant information pertaining to the adverse event
If multiple laboratory tests were performed, a chart trending the results for each test date is recommended as an attachment. Provide a description of all attached documents at the end of the narrative.
If the AER was generated by a poison control center or other contract organization, provide the case number (if available). If the AER relates to an animal in a clinical or pilot study, provide the study number (i.e., approved animal study protocol number).
For VMP product/manufacturing defect reports, enter a detailed description of: 1) the defect and the investigation results; 2) actions taken by the MAH/manufacturer/distributor to address the problem, including any corrective actions taken; and 3) any notifications that have been issued to alert the vendor/manufacturer to the defect issues. Provide the lot numbers(s) in the follow-up report if these were unknown in the initial report.
B.3.2 Adverse Clinical Manifestations (List)
These fields are lists of values for the clinical signs that occurred during the AE.
Choose from the VeDDRA Vocabulary for adverse clinical manifestations. Refer to the VeDDRA9 medical terminology to describe the adverse clinical manifestations. VeDDRA terminology for animal and human AEs is the clinical dictionary used to describe adverse clinical manifestations.
The most current list, as well as the full explanation and Guidance Notes on the Use of VeDDRA Terminology for Reporting Adverse Events in Animals, can be downloaded from the European Medicines Agency Website at http://www.ema.europa.eu/htms/vet/phvwp/eudravigilance.htm
Choose the lowest level term as used in VeDDRA for each adverse clinical manifestation observed in the AE. In the case of human AEs, choose only those terms designated as “H” (Exclusively Human) or “C” (Common). For animal adverse events, choose terms designated as “A” (Exclusively Animal) or “C” (Common).
When reporting a VMP product/manufacturing defect, choose “Uncoded Sign” and describe the nature of the defect in the narrative in B.3.1.
B.3.3 Date of Onset of AE (Date Field — Day, Month, Year)
Enter the date of onset of the AE. If the actual date is unknown, enter the approximate date information using the reporter’s description in the fields “Length of Time Between Exposure to VMP and Onset of AE” (B.3.4 below), and “Date of First Exposure” (B.2.1.7.1.2.2 above).
B.3.4 Length of Time Between Exposure to VMP(s) and Onset of AE (List)
This field is a list of values for the length of time between the first exposure to the VMP and the onset of the AE. This field is used for cases where there is a clear time relationship between the administration of the VMP(s) and the onset of AE(s). When a clear time relationship is difficult to ascertain, such as for a lack of expected effectiveness, this field may be left empty.
Choose a value from the List of Length of Time Between Exposure and Onset of AE.
B.3.5 Duration of the AE
This section describes the actual or approximate length of time the AE lasted.
B.3.5.1 Duration (Numeric Field)
This is the numeric value for the duration of the AE. For example, if the AE lasted 3 days, enter “3” in this field. If the AE is ongoing, enter the number based on the onset date entered in B.3.3, Date of Onset of AE, and the date entered in A.4.2, Date AER Received by MAH.
In the case of the animal’s death, this field is not applicable.
Enter the numeric value for the duration of the AE.
B.3.5.1.1 Duration Time Units (List)
This is a list of values for the unit associated with the numeric value for duration specified in B.3.5.1, Duration. For example, if the AE lasted 3 days, choose “Days.”
Choose from the List of Time Units the time unit value associated with the numeric value for duration specified in B.3.5.1, Duration.
B.3.6 Serious AE (List)
This is a list of values (Yes or No) characterizing the seriousness of the AE.
“Serious,” as used in this document, means the AE was serious according to the following definition in FDA regulations at 21 CFR 514.3:
Serious adverse drug experience is an adverse event that is fatal, or life-threatening, or requires professional intervention, or causes an abortion, or stillbirth, or infertility, or congenital anomaly, or prolonged or permanent disability, or disfigurement.
Choose “Yes” or “No” to answer whether or not the AE was serious.
B.3.7 Treatment of AE (List)
This is a list of values (Yes, No, or Unknown) describing whether or not the human or animal affected received treatment.
Select whether there was treatment for the AE. If the human or animal involved in the AE was treated, describe the treatment and the outcome from such treatment in the narrative in B.3.1.
B.3.8 Outcome to Date (Numeric Fields B.3.8.1 – B.3.8.6)
This is the medical status of the animal(s) affected in the AER at the time the AE is reported to the RA. Fields B.3.8.1 – B.3.8.6 list the possible outcomes experienced by animals affected by the AER. In each field, enter the number of animals that experienced the listed outcome. The total number of animals entered in fields B.3.8.1 – B.3.8.6 should equal the number entered in B.1.2, Number of Animals Affected. We recommend that you do not enter percentages in these fields for group reports.
Determine and enter the number of animals for each of the categories below.
If there are no animals represented by a given category, enter “0.”
B.3.8.1 Ongoing — Enter the number of animals described in the AER with ongoing clinical manifestations.
B.3.8.2 Recovered/Normal — Enter the number of animals described in the AER that have recovered or returned to normal health.
B.3.8.3 Recovered with Sequela — Enter the number of animals described in the AER that have recovered but are left with an altered health status.
B.3.8.4 Died — Enter the number of animals described in the AER that died (not including those that have been euthanized).
B.3.8.5 Euthanized — Enter the number of animals described in the AER that were euthanized.
B.3.8.6 Unknown — Enter the number of animals with an unknown outcome.
B.3.9 Previous Exposure to the VMP (List)
This is a list of values (Yes, No, or Unknown) describing whether or not the affected animal(s) had been exposed to the VMP on a date previous to this AER. This field applies only to exposures outside the dates mentioned in B.2.1.7.1.2.2, Date of First Exposure, and B.2.1.7.1.2.3, Date of Last Exposure.
Select whether there was previous exposure to the VMP. If there was a previous exposure to the VMP, choose “Yes” and provide the dates of the previous exposure in the narrative in B.3.1. Choose “No” if there was no previous exposure. Choose “Unknown” if the information was not available from the reporter.
B.3.10 Previous AE to the VMP (List)
This is a list of values (Yes, No, Unknown, or Not Applicable) describing whether or not the affected animal(s) experienced an AE when exposed to the VMP on a date previous to this AER.
This field refers only to clinical manifestations identified during a previous exposure to the VMP.
Select whether there was a previous AE to the VMP. Choose “Yes” if there was a previous AE and “No” if there was not a previous AE to the VMP. If “Yes” is chosen, describe the clinical signs of the previous AE in the narrative in B.3.1. Choose “Unknown” if the information was not available from the reporter. Choose “Not Applicable” if there was no previous exposure, i.e., if “No” was selected in B.3.9, Previous Exposure to the VMP.
B.4 Dechallenge-Rechallenge Information
This section addresses dechallenges or rechallenges related to AEs involving a single VMP.
Dechallenge is the removal, withdrawal, or discontinuance of a VMP from the animal’s therapeutic regimen. Dechallenge also includes a substantial dosage reduction. Rechallenge is the reintroduction of a VMP after the occurrence of a positive dechallenge. It also includes a substantial increase in dosage following a previous reduction which produced improvement in the clinical manifestations.
Use the narrative in B.3.1 to describe dechallenge-rechallenge information for multiple VMP AEs.
B.4.1 Did AE Abate After Stopping the VMP (List)
This is a list of values (Yes, No, Unknown, or Not Applicable) for whether the AE abated after stopping the VMP. Choose a value for whether the AE abated after stopping the VMP. If the VMP is neither stopped nor re-introduced, choose “Not Applicable.” Choose “Unknown” if the information was not available from the reporter.
B.4.2 Did AE Reappear After Reintroduction of the VMP (List)
This is a list of values (Yes, No, Unknown, or Not Applicable) for whether the AE reappeared after re-introduction of the VMP. Choose a value for whether the AE reappeared after reintroduction of the VMP. If the VMP is neither stopped nor re-introduced, choose “Not Applicable.” Choose “Unknown” if the information was not available from the reporter.
B.5.1 Attending Veterinarian’s Assessment (List)
This is a list that describes the assessment of the attending veterinarian regarding the association between the VMP(s) and the AE (where the species affected is not human).
Choose from the List of Attending Veterinarian’s Causality Assessment the value that best describes the attending veterinarian’s assessment (if applicable). Choose “No Assessment” if a veterinarian has not been consulted about the AE. If the AE was evaluated by a physician, the value for the physician’s assessment may be entered here and details given in the narrative in B.3.1.
The fields in this section can be voluntarily used by the MAH, or used by the MAH upon request from the RA for additional information on a specific AER. This section provides for the attachment of additional documents containing information relevant to the AE, such as medical record, radiology, clinical chemistry reports, newspaper articles, and letters.
If submitting by regular mail in hard copy, affix attachments to the paper form of Form FDA 1932. If submitting a CD, label the CD with the FDA CVM Application/File Type Number, the Unique Adverse Event Report Identification Number, and the date (see A.4.3) the AER was submitted to the FDA’s CVM.
B.6.1 Attached Document Name (Filename if Electronic) (Text Field)
Specify the filename of the attached document, including the 3-character document type extension, such as:
.pdf — Portable document format
.jpg, .jpeg — Image file format
.tiff — Tagged image file format
.rtf — Rich tech format
.txt — Text format
.xls — Spreadsheet file format
.doc, docx — Word processing document formats
.wpd — Word processing document format.
Examples of filenames:
Documents for Princess.doc.
Spreadsheet of Princess lab results.xls
Photographs of Princess before and after treatment.jpg
Newspaper article about the product.pdf
B.6.2 Attached Document Type (List)
This is a list of values that describes the type of document that is attached, e.g., medical record.
Choose from the List of Attached Document Type.
This section contains data elements only collected for AERs being sent to the United States. This information allows FDA to accept, process, and store data correctly in the database.
B.7.1 Report Identifier (Text Field)
The format for the report identifier is the 1-character application/file identifier followed by the 6-number identifier assigned by FDA for that application/file (e.g., A200999). The application/file number is the NADA or ANADA numbers to which the report is being sent.
The following table represents the 1-character application/file identifiers.
Application/File Type |
1-Character Application/File Identifier |
Abbreviated New Animal Drug Application |
A |
New Animal Drug Application |
N |
MUMS Index File |
Z |
Unapproved Animal Drug Products |
D |
The report identifier is the same as the registration number segment in the Registration Identifier field (B.2.1.2).
Registration Number — For FDA-regulated VMPs, the registration number is the 1-character application/file identifier followed by the 6 numbers assigned by FDA for that application/file (e.g., A200999, N199999, I999999).
Enter the Report Identifier.
B.7.2 Domestic vs. Foreign Report Category (List)
This field is a list of values for reporting both a U.S.-approved and non U.S.-approved product that is the same as or similar to a U.S.-approved VMP(s).
Choose a value from the List of Domestic and Foreign Report Categories.
Domestic Reports
Domestic reports are those AERs that involve an FDA-regulated VMP, regardless of the country in which the AE occurs.
Foreign Reports
Foreign reports are those AERs that involve a VMP that is the same as or similar to an FDA-regulated VMP.
Foreign — Same [category]: The VMP originates from the same MAH with the same active ingredient(s) and formulation as the product approved in the United States. For example, the product has a different name, or the label is in a different language, or the product has different indications than the FDA-regulated VMP.
Foreign — Similar [category]: The VMP is from the same MAH, containing the same active ingredient(s), major excipients with the same or similar pharmaceutical function, and at least one common registered species as the product approved in the United States. For example, the product has a different strength, formulation, or is a product not approved in the U.S.
The following are examples of the different domestic and foreign report categories.
Domestic:
U.S.-approved VMP and AE occurred in the United States
Report is sent to the FDA
Report Category = Domestic
U.S.-approved VMP and AE occurred in Germany (e.g., U.S. military personnel purchased product on a military base in Frankfurt)
Report is sent to the FDA
Report Category = Domestic
U.S.-approved VMP and AE occurred in Japan (e.g., Japanese visitor purchased product in Hawaii, used in Tokyo)
Report is sent to the FDA
Report Category = Domestic
Foreign — Same [category]:
Germany-approved product and AE occurs in Germany
Report is sent to the United States because the MAH has a “same” VMP approved by FDA
Report Category = Foreign — Same
Foreign — Similar [category]:
Canada-approved product and AE occurs in Canada
Report is sent to the United States because the MAH has a “similar” VMP approved by FDA
Report Category = Foreign — Similar
B.7.3 U.S.-Based Pharmacovigilance Contact Person for the MAH (Text Field)
This section includes fields to enter information about the person within the United States who is acting on behalf of the MAH and is the contact person for the FDA for any Pharmacovigilance issues about the report.
Provide the person’s title, first name, last name, telephone number, fax number, and e-mail address
1 This guidance has been prepared by the Office of Surveillance and Compliance in the Center for Veterinary Medicine (CVM) at the Food and Drug Administration (FDA).
2 This title harmonizes this guidance with the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) draft guidance document, “Pharmacovigilance of Veterinary Medicinal Products Data Elements for Submission of Adverse Event Reports” (VICH GL42), but identifies it as having some FDA-specific application. Certain terms, such as Marketing Authorization Holder (MAH) and Veterinary Medicinal Product (VMP) originate from this harmonization.
3 The terms adverse drug event and adverse drug experience may be used interchangeably.
4 On November 20, 2009, FDA published a notice in the Federal Register (74 FR 60265) announcing its intention to revise Form FDA 1932, among other things. The notice gave the public an opportunity to comment on proposed data elements to be included on a revised version of Form FDA 1932. Form FDA 1932 was revised on ______, 2010 (OMB Control No. 0910-0645).
5 VICH GL42 is currently under discussion at Step 6. This guidance is available on the Internet at http://www.fda.gov/RegulatoryInformation/Guidances/default.htm#.
? The Rational Questionnaire is a user-friendly, web-based questionnaire that displays a series of questions to be answered by the person submitting the report. These questions are intended to ensure proper collection of the information that is needed by FDA to appropriately evaluate the reported incident.
7 The third option for submission, gateway-to-gateway electronic transmission, collects the same information in Form FDA 1932, but it is not considered an electronic version of the form. CVM intends to exercise enforcement discretion if firms choose to submit reports via gateway-to-gateway electronic transmission to satisfy their reporting obligation under 21 CFR 514.80(d).
8 The terms “same pharmaceutical VMP” and “similar pharmaceutical VMP” are also defined in VICH draft guidance document, “Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AER's)” (VICH GL-24). VICH GL-24 is at step 4 in the VICH process.
9 Veterinary Dictionary for Drug Regulatory Activities
| File Type | application/msword |
| File Title | Guidance for Industry |
| Author | Jonna Capezzuto |
| Last Modified By | Jonna Capezzuto |
| File Modified | 2010-03-11 |
| File Created | 2010-03-11 |