Description
This guidance is intended for sponsors of approved applications for new animal drugs and new animal drug combination products containing medically important antimicrobial new animal drugs for use in or on medicated feed or water of food-producing animals. The guidance contains information for sponsors of such new animal drugs and combination products to facilitate voluntary changes to the conditions of use for such new animal drugs and combination products consistent with FDA’s recommendations included in the guidance document entitled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals” (Judicious Use Guidance, GFI #209). In particular, the purpose of this guidance is to provide sponsors with specific recommendations on how to supplement their approved new animal drug applications to align with FDA’s GFI #209.
Scope & Applicability
Product Classes
5Products subject to clinical investigation guidance.
Final feed administered to animals
drug that contains more than one active ingredient or administered simultaneously
Combination products containing medically important antimicrobial drugs; Administered in or on medicated feed or drinking water of food-producing animals.; Products administered in medicated feed or drinking water
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
Stakeholders
7Entities responsible for approved applications for new animal drugs
entity submitting an abbreviated new animal drug application
Holders of abbreviated new animal drug applications
responsible for justifying omission of studies
Professional providing oversight for antimicrobial drug use; Veterinarian is to determine the actual duration that the drug will be used; Professional ordering the duration of use for antimicrobial drugs
Professional authorized to issue a VFD order; Federal law restricts medicated feed containing this VFD drug to use by or on the order of a licensed veterinarian.
Entity developing the antimicrobial drug
Regulatory Context
Attributes
1Residue chemistry parameter for food safety
Identified Hazards
Hazards
1Public health threat resulting from loss of effectiveness of antimicrobial therapies; Efforts to mitigate the development of antimicrobial resistance.; Public health concern that labeling changes aim to mitigate.; development and spread of antimicrobial resistance encouraged by certain practices
Related CFR Sections (7)
- 21CFR514.4§ 514.4 Substantial evidence.
(a) Definition of substantial evidence. Substantial evidence means evidence consisting of one or more adequate and well-controlled studies, such as a study in a target species, study in laboratory animals, field study, bioequivalence study, or an in vitro study, on the basis of which it could fairlyRead full regulation →
- 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 →
- 21CFR514.8§ 514.8 Supplements and other changes to an approved application.
(a) Definitions.Read full regulation →
- 21CFR558.6§ 558.6 Veterinary feed directive drugs.
(a) General requirements related to veterinary feed directive (VFD) drugs.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 →
- 21CFR25.40§ 25.40 Environmental assessments.
(a) As defined by CEQ in 40 CFR 1508.9 , an EA is a concise public document that serves to provide sufficient evidence and analysis for an agency to determine whether to prepare an EIS or a FONSI. The EA shall include brief discussions of the need for the proposal, of alternatives as required by secRead full regulation →
- 21CFR314.153§ 314.153 Suspension of approval of an abbreviated new drug application.
(a) Suspension of approval. The approval of an abbreviated new drug application approved under § 314.105(d) shall be suspended for the period stated when:Read full regulation →
See Also (8)
- CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers (Status: Final)
- CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission (Status: Final)
- CVM GFI #137 Analytical Methods Description for Type C Medicated Feeds (Status: Final)
- CVM GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals (Status: Final)
- CVM GFI #218 Cell-Based Products for Animal Use (Status: Final)
- CVM GFI #229 Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle (Status: Final)
- CVM GFI #252 Small Entity Compliance Guide Antimicrobial Animal Drug Sales and Distribution Reporting (Status: Final)
- CVM GFI #3 General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals (Status: Final)