Guidances Under Development

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data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Guidances Under Development</h1> <p class="article-subtitle text-center">Center for Veterinary Medicine (CVM) Guidance Documents Under Development for 2024</p> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fanimal-veterinary%2Fguidance-industry%2Fguidances-under-development" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=Guidances%20Under%20Development&url=https://www.fda.gov%2Fanimal-veterinary%2Fguidance-industry%2Fguidances-under-development" target="_blank" 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hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <p>(Expected to publish as drafts or finals by the end of December 2024.)</p> <h3>Introduction</h3> <p>The following list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the CVM is considering. We currently intend to develop guidance on each topic; however, the Center is neither bound by this list of topics, nor required to issue every guidance document on this list. We are not precluded from developing guidance documents on topics not on this list. This list includes <a href="#CPG">Compliance Policy Guides.</a></p> <h3 style="text-align: center;">Guidance for Industry (GFI)</h3> <div class="table-responsive"> <table class="table table-bordered" summary="2019 Guidance Agenda"> <thead> <tr> <th scope="col" style="width: 50%;">Title of Guidance</th> <th scope="col" style="width: 50%;">Contact</th> </tr> </thead> <tbody> <tr> <td>Draft GFI #49 – Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis (Revision)</td> <td>Paulette Salmon, Center for Veterinary Medicine (HFV-133), 7500 Standish Place, Rockville, MD 20855, 240-402-6556, <a href="mailto:paulette.salmon@fda.hhs.gov">paulette.salmon@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #80 – Utility Studies for Anti-Salmonella Animal Food Additives (Revision)</td> <td>Xin Li, Center for Veterinary Medicine (HFV-222), 7500 Standish Place, Rockville, MD 20855, 240-402-5899, <a href="mailto:xin.li@fda.hhs.gov">xin.li@fda.hhs.gov</a></td> </tr> <tr> <td>GFI #120 – Veterinary Feed Directive Regulation Questions and Answers (Revision)</td> <td>Kelly Louviere, Center for Veterinary Medicine (HFV-200), 7500 Standish Place, Rockville, MD 20855, 240-402-5815, <a href="mailto:kelly.louviere@fda.hhs.gov">kelly.louviere@fda.hhs.gov</a></td> </tr> <tr> <td>GFI #152 – Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern (Revision)</td> <td>Ruby Singh, Center for Veterinary Medicine (HFV-150), 7500 Standish Pl., Rockville, MD  20855, 240-402-0794, <a href="mailto:ruby.singh@fda.hhs.gov">ruby.singh@fda.hhs.gov</a></td> </tr> <tr> <td>GFI #187A – Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach</td> <td>Laura R. Epstein, Center for Veterinary Medicine (HFV-1), 7500 Standish Place, Rockville, MD 20855, 301-796-8558, <a href="mailto:Laura.Epstein@fda.hhs.gov">laura.epstein@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #187B – Heritable Intentional Genomic Alterations in Animals: The Approval Process</td> <td>Laura R. Epstein, Center for Veterinary Medicine (HFV-1), 7500 Standish Place, Rockville, MD 20855, 301-796-8558, <a href="mailto:Laura.Epstein@fda.hhs.gov">laura.epstein@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #210 – The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species</td> <td>Lucy Lee, Center for Veterinary Medicine (HFV-50), 7500 Standish Place, Rockville, MD 20855, 240-402-0563, <a href="mailto:lucy.lee@fda.hhs.gov">lucy.lee@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #217 – Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals (Revision)</td> <td>Prajwal Regmi, Center for Veterinary Medicine (HFV-135), 7500 Standish Place, Rockville, MD 20855, 240-402-0577 <a href="mailto:prajwal.regmi@fda.hhs.gov">prajwal.regmi@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #227 – Chemistry, Manufacturing, and Control (CMC) Technical Section Filing Strategies (Revision)</td> <td>Heather Longstaff, Center for Veterinary Medicine (HFV-145), 7500 Standish Place, Rockville, MD 20855, 240-402-0651, <a href="mailto:heather.longstaff@fda.hhs.gov">heather.longstaff@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #228 – Designing Effectiveness Studies for Drugs Intended to Enhance Animal Production (Growth, Feed Efficiency, Carcass Leanness, Reproduction, Milk Production)</td> <td style="vertical-align: top;">Christina Edwards, Center for Veterinary Medicine (HFV-137), 7500 Standish Place, Rockville, MD 20855, 240-402-0824, <a href="mailto:christina.edwards@fda.hhs.gov">christina.edwards@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #251 – Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease</td> <td>Laura R. Epstein, Center for Veterinary Medicine (HFV-1), 7500 Standish Place, Rockville, MD 20855, 301-796-8558, <a href="mailto:Laura.Epstein@fda.hhs.gov">laura.epstein@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #256B - Compounding Animal Drugs from Bulk Drug Substances: Compounding in Federally-Registered Facilities that are Subject to CGMP</td> <td>Cindy Burnsteel, Center for Veterinary Medicine (HFV-200), 7500 Standish Place, Rockville, MD 20855, 240-402-0817, <a href="mailto:cindy.burnsteel@fda.hhs.gov">cindy.burnsteel@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #260 – Type VII Veterinary Master File for Pre-Investigational Development and Research Involving Novel or Rapidly Evolving Technologies</td> <td>Hilary Hoffman, Center for Veterinary Medicine (HFV-101), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, <a href="mailto:hilary.hoffman@fda.hhs.gov">hilary.hoffman@fda.hhs.gov</a></td> </tr> <tr> <td>GFI #273 – Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals</td> <td>John Mussman, Center for Veterinary Medicine (HFV-133), 7500 Standish Place, Rockville, MD 20855, 240-402-0589, <a href="mailto:john.mussman@fda.hhs.gov">john.mussman@fda.hhs.gov</a></td> </tr> <tr> <td>GFI #276 – Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs </td> <td>Steve Fleischer, Center for Veterinary Medicine (HFV-110), 7500 Standish Place, Rockville, MD 20855, 240-402-0809, <a href="mailto:steven.fleischer@fda.hhs.gov">steven.fleischer@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #277 – Diversion or Reconditioning of Damaged, Contaminated, or Adulterated Food for Use as Animal Food</td> <td>Jennifer Erickson, Center for Veterinary Medicine (HFV-230). 7500 Standish Place, Rockville, MD 20855, 240-402-7382, <a href="mailto:jennifer.erickson@fda.hhs.gov">jennifer.erickson@fda.hhs.gov</a></td> </tr> <tr> <td>GFI #278 – Human User Safety in New and Abbreviated New Animal Drug Applications</td> <td>Steve Fleischer, Center for Veterinary Medicine (HFV-110), 7500 Standish Place, Rockville, MD 20855, 240-402-0809, <a href="mailto:steven.fleischer@fda.hhs.gov">steven.fleischer@fda.hhs.gov</a></td> </tr> <tr> <td>GFI #279 – Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting</td> <td style="vertical-align: top;">Ian Henricks, Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 208585, 240-402-0853, <a href="mailto:ian.hendricks@fda.hhs.gov">ian.hendricks@fda.hhs.gov</a></td> </tr> <tr> <td>GFI #281 – Infectious Otitis Externa Drugs for Topical Use in Dogs</td> <td>Lea Cranford, Center for Veterinary Medicine (HFV-110), 7500 Standish Place, Rockville, MD 20855, 240-402-0615, <a href="mailto:lea.cranford@fda.hhs.gov">lea.cranford@fda.hhs.gov</a></td> </tr> <tr> <td>GFI #282 – Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals</td> <td>Christa Johnson, Center for Veterinary Medicine (HFV-112), 7500 Standish Place, Rockville, MD 20855, 240-402-0258, <a href="mailto:christa.johnson@fda.hhs.gov">christa.johnson@fda.hhs.gov</a></td> </tr> <tr> <td>GFI #284 – Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Foods</td> <td>Karen Donnelly, Center for Veterinary Medicine (HFV-228), 7500 Standish Place, 240-402-9802, <a href="mailto:karen.donnelly2@fda.hhs.gov">karen.donnelly2@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #285 – Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs </td> <td>Amy Simms, Center for Veterinary Medicine (HFV-147), 7500 Standish Place, Rockville, MD 20855, 240-402-0648, <a href="mailto:amy.simms@fda.hhs.gov">amy.simms@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #287 – Raw Data for Safety and Effectiveness Studies</td> <td>Laurie Hanna, Center for Veterinary Medicine (HFV-133), 7500 Standish Place, Rockville, MD 20855, 240-402-0586, <a href="mailto:laurie.hanna@fda.hhs.gov">laurie.hanna@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #288 – Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use </td> <td>Lijuan He, Center for Veterinary Medicine (HFV-140), 7500 Standish Place, Rockville, MD 20855, 301-796-5122, <a href="mailto:lijuan.he@fda.hhs.gov">lijuan.he@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #289 – Use of Zootechnical Substances in Animal Food</td> <td>Kelly Louviere, Center for Veterinary Medicine (HFV-200), 7500 Standish Place, Rockville, MD 20855, 240-402-5815, <a href="mailto:kelly.louviere@fda.hhs.gov">kelly.louviere@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #291 - Animal Food Intended to Affect the Structure or Function of the Animal</td> <td>Kelly Louviere, Center for Veterinary Medicine (HFV-200), 7500 Standish Place, Rockville, MD 20855, 240-402-5815, <a href="mailto:kelly.louviere@fda.hhs.gov">kelly.louviere@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #292 – Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles </td> <td>Heather Longstaff, Center for Veterinary Medicine (HFV-145), 7500 Standish Place, Rockville, MD 20855, 240-402-0651, <a href="mailto:heather.longstaff@fda.hhs.gov">heather.longstaff@fda.hhs.gov</a></td> </tr> <tr id="293"> <td>Draft GFI #293 – FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients</td> <td>Charlotte Conway, Center for Veterinary Medicine (HFV-220), 7500 Standish Pl., Rockville, MD 20855, 240-402-6768, <a href="mailto:charlotte.conway@fda.hhs.gov">charlotte.conway@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #294 – Animal Food Ingredient Consultation (AFIC) </td> <td>Charlotte Conway, Center for Veterinary Medicine (HFV-220), 7500 Standish Pl., Rockville, MD 20855, 240-402-6768, <a href="mailto:charlotte.conway@fda.hhs.gov">charlotte.conway@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #___ - Viable Microorganisms in Animal Food</td> <td>Diego Paiva, Center for Veterinary Medicine (HFV-229), 7500 Standish Place, Rockville, MD 20855, 240-402-6785, <a href="mailto:diego.paiva@fda.hhs.gov">diego.paiva@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #___ – New Chemical Entity Exclusivity for Certain Combination New Animal Drug Products</td> <td>Dominique Martinez, Center for Veterinary Medicine (HFV-101), 7500 Standish Place, Rockville, MD  20855, 240-402-8989, <a href="mailto:dominique.martinez@fda.hhs.gov">dominique.martinez@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #___ – Feed-Use Combinations: Recommendations for Satisfying Approval Requirements Under the Animal Drug Availability Act (ADAA)</td> <td>Hilary Hoffman, Center for Veterinary Medicine (HFV-101), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, <a href="mailto:hilary.hoffman@fda.hhs.gov">hilary.hoffman@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #___ – Other Combination New Animal Drugs: Recommendations for Satisfying Approval Requirements</td> <td>Hilary Hoffman, Center for Veterinary Medicine (HFV-101), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, <a href="mailto:hilary.hoffman@fda.hhs.gov">hilary.hoffman@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #___ – Food Ingredients for the Control of Simple Halitosis (Bad Breath) in Pets</td> <td>Sara Sklenka, Center for Veterinary Medicine (HFV-221), 7500 Standish Place, Rockville, MD 20855, 240-402-6680, <a href="mailto:sara.sklenka@fda.hhs.gov">sara.sklenka@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #___ – Considerations for Species Grouping in Aquaculture Drug Development for Freshwater-Reared Salmonids and Catfish</td> <td>Cassandra Fox, Center for Veterinary Medicine (HFV-170), 7500 Standish Place, Rockville, MD 20855, 240-402-1893, <a href="mailto:cassandra.fox@fda.hhs.gov">cassandra.fox@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #___ – Predicted Environmental Concentrations (PEC) of Animal Drugs Used in Terrestrial Species</td> <td>Andrew Miglino, Center for Veterinary Medicine (HFV-160), 7500 Standish Place, Rockville, MD 20855, 240-402-1086, <a href="mailto:andrew.miglino@fda.hhs.gov">andrew.miglino@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #___ – Biomass Drug Substances </td> <td>Amy Simms, Center for Veterinary Medicine (HFV-147), 7500 Standish Place, Rockville, MD 20855, 240-402-0648, <a href="mailto:amy.simms@fda.hhs.gov">amy.simms@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #___ – Type B and C Medicated Feeds</td> <td>Heather Longstaff, Center for Veterinary Medicine (HFV-145), 7500 Standish Place, Rockville, MD 20855, 240-402-0651, <a href="mailto:heather.longstaff@fda.hhs.gov">heather.longstaff@fda.hhs.gov</a></td> </tr> <tr> <td>Draft GFI #___ – Post-Approval CMC Changes: New Drug Substance Source and Drug Product Manufacturing Sites</td> <td>Amy Simms, Center for Veterinary Medicine (HFV-147), 7500 Standish Place, Rockville, MD 20855, 240-402-0648, <a href="mailto:amy.simms@fda.hhs.gov">amy.simms@fda.hhs.gov</a></td> </tr> </tbody> </table> </div> <h3 id="CPG" style="text-align: center;">Compliance Policy Guide (CPG)<br> (Sub Chapter 600-659 – Veterinary Drugs; Sub Chapter 660-699 – Animal Feed)</h3> <div class="table-responsive"> <table border="0" cellpadding="0" cellspacing="0" class="table table-bordered table-striped" style="text-align: left;" summary="Compliance Policy Guides" width="100%"> <tbody> <tr> <th id="header1" scope="col">Title of CPG</th> <th id="header2" scope="col">Contact</th> </tr> <tr> <td headers="header1">Draft CPG Sec. 654.200 – Teat Dips and Udder Washes for Dairy Cows and Goats (Revision)</td> <td headers="header2">Nick Duckworth, Center for Veterinary Medicine (HFV-214), 7519 Standish Place, Rockville, MD 20855, 240-402-5616, <a href="mailto:nick.duckworth@fda.hhs.gov">nick.duckworth@fda.hhs.gov</a></td> </tr> <tr> <td headers="header1">Draft CPG Sec. 665.100 – Common or Usual Names of Animal Food Ingredients and the Use of Ingredients Listed in the Official Publication of the Association of American Feed Control Officials in Animal Food (Revision)</td> <td headers="header2" style="vertical-align: top;">Sara Sklenka, Center for Veterinary Medicine (HFV-221), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, <a href="mailto:sara.sklenka@fda.hhs.gov">sara.sklenka@fda.hhs.gov</a></td> </tr> </tbody> </table> </div> <p> </p>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date 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