Description
This guidance is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data. The guidance explains how the Office of New Animal Drug Evaluation (ONADE) categorizes possible changes to approved new animal drugs that require reevaluation of safety and/or effectiveness data and explains which administrative vehicle — a new original new animal drug application (new NADA) or a Category II supplemental application to the original new animal drug application (Category II supplemental NADA) — a sponsor should use when applying for approval of these changes. The goal of this guidance is to create greater consistency in how such applications are handled by sponsors and by ONADE.
Scope & Applicability
Product Classes
6The category of products covered by this guidance.
Final feed administered to animals
Manufactured from Type A medicated articles; The intermediate pre-blend is not considered a Type B medicated feed
A type of ATMP involving recombinant nucleic acids or viral vectors.
used to manufacture medicated feed; A concentrated form of a drug used to manufacture medicated feed.; Concentrated drug form used to manufacture medicated feed; single ingredient component for medicated feed; Medicated feed mill license is required to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article.; Concentrated drug form for manufacturing medicated feed; Concentrated form of animal drug used to manufacture medicated feed; Type A medicated articles fo
Medicated articles/feeds status
Stakeholders
2Entity responsible for submitting applications under section 524B
CVM division to be contacted regarding study planning.
Regulatory Context
Attributes
5Required information for RLD/RS and proposed products.; Product characteristic in ANDA background
Evaluation criteria that may trigger age restrictions on labeling.
Physiological state of calves or piglets before rumen development.
Change in regulatory status of the drug
Frequency and timing of drug administration
Related CFR Sections (5)
- 21CFR558.3§ 558.3 Definitions and general considerations applicable to this part.
(a) Regulations in this part provide for approved uses of drugs and combinations of drugs in animal feeds. Approved combinations of such drugs are specifically identified or incorporated by cross-reference. Unless specifically provided for by the regulations, a combination of two or more drugs is noRead full regulation →
- 21CFR510.3§ 510.3 Definitions and interpretations.
As used in this part:Read full regulation →
- 21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead full regulation →
- 21CFR514.106§ 514.106 Approval of supplemental applications.
(a) Within 180 days after a supplement to an approved application is filed pursuant to § 514.8 , the Commissioner shall approve the supplemental application in accordance with procedures set forth in § 514.105(a)(1) and (2) if he/she determines that the application satisfies the requirements of applRead full regulation →
- 21CFR514.8§ 514.8 Supplements and other changes to an approved application.
(a) Definitions.Read full regulation →
See Also (8)
- CVM GFI #5 Drug Stability Guidelines (Status: Final)
- CVM GFI #57 Preparation and Submission of Veterinary Master Files (Status: Final)
- CVM GFI #181 Blue Bird Medicated Feed Labels (Status: Final)
- CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions (Status: Final)
- CVM GFI #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals (Status: Draft)
- CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles (Status: Draft)
- CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA (Status: Final)
- CVM GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (Status: Final)