Guidances Under Development for 2013

CVM Guidance Documents Under Development
(expected to publish as drafts or finals by the end of December 2013)

Introduction

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. Topics on the list remain as projects until they publish as final guidance.

CVM Guidance Documents Under Development list has been updated to include those documents expected to publish by the end of 2013. FDA also publishes an agency-wide Annual Guidance Agenda which includes CVM's Guidance Documents Under Development and is available for public comment.

Center for Veterinary Medicine
2013 Guidance Agenda

Title of Guidance	Contact
Draft Guidance for Industry – Marketed Unapproved New Animal Drugs	Nadine Steinberg, Center for Veterinary Medicine, Food and Drug Administration, (HFV-1), 7519 Standish Place, Rockville, MD 20855, 240-276- 8849, nadine.steinberg@fda.hhs.gov
Guidance For Industry (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	William Flynn, Center for Veterinary Medicine, Food and Drug Administration, (HFV-1), 7519 Standish Place, Rockville, MD 20855, 240-276- 9084, william.flynn@fda.hhs.gov
Draft Guidance for Industry – Inter-Center Coordination of the Regulatory Requirements for the Development of Genetically Engineered (GE) Animals for the Production of Human-Use Products	Malini Wileman, Center for Veterinary Medicine (HFV-2), Food and Drug Administration, Rockville, MD 20855, 240-276-9532, malini.wileman@fda.hhs.gov
Guidance For Industry (GFI #61) - FDA Approval of Animal Drugs for Minor Uses and for Minor Species (Revision)	Margaret Oeller, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-9005, margaret.oeller@fda.hhs.gov
Draft Guidance for Industry (GFI #210) – The Indexing of Legally Marketed Unapproved New Animal Drugs for Minor Species	Margaret Oeller, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-9005, margaret.oeller@fda.hhs.gov
Draft Guidance for Industry – Combination New Animal Drugs	Urvi Desai, Center for Veterinary Medicine, (HFV-108), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8297, urvi.desai@fda.hhs.gov
Draft Guidance for Industry – Presenting and Analyzing Target Animal Safety Study Data	Urvi Desai, Center for Veterinary Medicine, (HFV-108), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8297, urvi.desai@fda.hhs.gov
Draft Guidance for Industry – Medicated Feed Assays	Urvi Desai, Center for Veterinary Medicine, (HFV-108), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8297, urvi.desai@fda.hhs.gov
Draft Guidance for Industry – Question-Based Review for Animal Drugs	Urvi Desai, Center for Veterinary Medicine, (HFV-108), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8297, urvi.desai@fda.hhs.gov
Draft Guidance for Industry –CMC Guidances for Generic New Animal Drugs	Urvi Desai, Center for Veterinary Medicine, (HFV-108), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8297, urvi.desai@fda.hhs.gov
Guidance for Industry (GFI #23) – Medicated Free Choice Feeds (Revision)	Urvi Desai, Center for Veterinary Medicine, (HFV-108), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8297, urvi.desai@fda.hhs.gov
Draft Guidance for Industry (GFI #57) – Preparation and Submission of Veterinary Master Files (Revision)	Urvi Desai, Center for Veterinary Medicine, (HFV-108), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8297, urvi.desai@fda.hhs.gov
Guidance for Industry (GFI #171) – Waivers of In Vivo Demonstration (Revision)	Urvi Desai, Center for Veterinary Medicine, (HFV-108), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8297, urvi.desai@fda.hhs.gov
Guidance for Industry (GFI #204) – Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals	Urvi Desai, Center for Veterinary Medicine, (HFV-108), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8297, urvi.desai@fda.hhs.gov
Draft Guidance for Industry (GFI #218) – Cell-Based Products for Use in Animals	Lynne Boxer, Center for Veterinary Medicine, (HFV-114), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8321, lynne.boxer@fda.hhs.gov
Guidance for Industry (GFI #219) - Statistical Evaluation of Stability Data - VICH GL51(R)	Mai Huynh, Center for Veterinary Medicine (HFV-142), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8273, mai.huynh@fda.hhs.gov
Guidance for Industry (GFI #188) – Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine	Margarita Brown, Center for Veterinary Medicine (HFV-241), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-9048, margarita.brown@fda.hhs.gov
Draft Guidance for Industry (GFI #203) – Ensuring Safety of Animal Food Maintained and Fed On-Farm	Phares Okelo, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-453-6862, phares.okelo@fda.hhs.gov
Draft Guidance for Industry (GFI #221) – Recommendations for Preparation and Submission of Animal Food Additive Petitions	Sharon Benz, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6864, Sharon.benz@fda.hhs.gov
Draft Guidance for Industry (GFI #222) - Antibiotic Residues in Distillers Grains Used as Animal Food	Sharon Benz, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6864, Sharon.benz@fda.hhs.gov
Compliance Policy Guide – Salmonella Contamination of Feeds	Xin Li, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6863, xin.li@fda.hhs.gov
Draft Guidance for Industry – Design and Submission of Distributor Labeling	Xin Li, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6863, xin.li@fda.hhs.gov
Guidance for Industry – Declaring Color Additives in Animal Foods Small Entities Compliance Guide (SECG)	John Machado, Center for Veterinary Medicine (HFV-228), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6854, john.machado@fda.hhs.gov
Draft Guidance for Industry – Use of Nanomaterials in Food for Animals	Dragan Momcilovic, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6856, dragan.momcilovic@fda.hhs.gov
Guidance for Industry (GFI #214) – Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data - VICH GL35(R)	Margarita Brown, Center for Veterinary Medicine (HFV-241), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-9048, margarita.brown@fda.hhs.gov