| Title: | FDA Changes Affirmation of Compliance Codes for the Center for Veterinary Medicine and Lo |
|---|---|
| Date: | 2013-05-01 |
| To: | abi |
| Links: | previous, original, next |
From: Food and Drug Administration
FDA has made changes to certain Affirmations of Compliance (AofC) codes, as detailed below.
Use of these codes affirms that the product identified in an FDA line meets the requirements specific to the code. While use of the code is voluntary, transmission may help expedite the FDA admissibility review process.
FDA WILL BE DELETING SEVERAL AofC CODES THIRTY DAYS FROM ISSUANCE OF THIS NOTIFICATION. THE CODES TO BE DELETED ARE:
ANA Abbreviated New Animal Drug Number (replaced with VAN)
CFR Code of Federal Regulations Section
DHC Dioxin Health Certificate
INA Investigational New Animal Drug Number (replaced with VIN)
LF1 Low Value-Food/Food Related Products <= $200
LF2 Low Value-Food/Food Related Products >$200 but <=$500
LF3 Low Value-Food/Food Related Products >$500 but <=$10000
LR1 Low Value-Non Rx Rad. Emitting Products <= $200
LR2 Low Value-Non Rx Rad. Emitting Products >$200 but <=$10000
MFA Medicated Feed Application Number
NAD New Animal Drug Application Number (replaced with VNA)
PAC Private Analytical Certificate Date
NEW FDA AFFIRMATION OF COMPLIANCE (AofC) CODES FOR VETERINARY PRODUCTS ARE AVAILABLE IMMEDIATELY:
VAN Veterinary Abbreviated new Animal Drug Number
VFL Veterinary Medicated Feed License Application Number
VIN Veterinary Investigational New Animal Drug Number
VMS Veterinary Minor Species Index File (MSIF)
VNA Veterinary New Animal Drug Application Number
VAN - Veterinary Abbreviated New Animal Drug Number
This affirmation and qualifier should be the Veterinary Abbreviated New Animal Drug Number (VAN) issued by FDA/Center for Veterinary Medicine (CVM) for the animal drug product identified in the FDA line. This number is the approval number for an abbreviated new animal drug application. Animal drugs have to be shown to be generally safe and effective for each use in each animal species for which they are intended. In addition to the general requirements for efficacy and safety for animal use, animal drugs intended for use in food producing animals must not leave unsafe residues in edible tissues or other food products for human consumption.
This application is used when a sponsor is pursuing approval of a generic drug. It is "abbreviated" because certain requirements of 21 CFR 514 can be met by referencing an approved VNA (Veterinary New Animal Drug Application Number) for which the patent protection or a period of exclusivity has expired.
Example: VAN 299-1234 (six digit number) The qualifier begins with a "2.”
VFL - Veterinary Feed Mill License
This affirmation and qualifier should be the Veterinary Medicated Fee Mill License number issued by FDA/Center for Veterinary Medicine (CVM) for animal feeds containing new animal drugs. The qualifier is the FDA license number assigned by FDA/CVM.
The FDA application Form FDA 3448 and instructions for filling out the form that can be used by a new licensee can be found at:
http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm
Example: VFL 500-000 (six digit number) the qualifier begins with a "5"
VIN - Veterinary Investigational New Animal Drug Number
This affirmation and qualifier should be the Veterinary Investigational New Animal Drug
Number issued by FDA/Center for Veterinary Medicine (CVM) for the product identified in the line.
Investigational new animal drugs are animal drugs that may be distributed solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of animal drugs for a particular purpose. An unapproved new animal drug (distributed in accordance with 21 CFR Part 511) can be used for research for the collection of data intended to be submitted in support of an VNA (Veterinary New Animal Drug Application Number) approval; or a generic VIN (Veterinary Investigational New Animal Drug Number).
Example: VIN 12-345
VMS - Veterinary Minor Species Index File
This affirmation and qualifier should be used for the product identified in the line when the intended use of the drug in a minor species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually.
The index of Legally Marketed Unapproved New Animal Drugs can be found at:
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm125452.htm
Example: VMS 123-456 (six digit number)
VNA - Veterinary New Animal Drug Application Number
When the sponsors believe that sufficient data have been collected to establish the safety and effectiveness of their drug product, they may apply for approval. A New Animal Drug Application (NADA) is submitted along with supporting data, including all adverse effects associated with the drug's use. The NADA must also include information on the drug's chemistry; composition and component ingredients; manufacturing methods, facilities, and controls; proposed labeling; analytical methods for residue detection and analysis if applicable; an environmental assessment; and other information.
Example: VNA 123-456 (six digit number)
VNA 1-234 (approval prior to 1990 may have four digits x-xxx)
If you have any questions regarding AofC usage pertaining to veterinary products, please contact CVMImportRequests@fda.hhs.gov.
AofC codes can be queried via ABI. Contact your ABI vendor or service provider. Specifications for the query, ABI application Identifier OP, are in the Other Government Agency chapter of the CATAIR document, Pages OGQ-5 and OGQ-13 - 14.
URL for the CATAIR document on cbp.gov: www.cbp.gov/xp/cgov/trade/automated/automated_systems/abi/catair/chapters/
CSMS #13-000328