Guidances Under Development for 2012

CVM Guidance Documents Under Development
(expected to publish as drafts or finals by the end of December 2012)

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 expect to publish by the end of 2012. 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
2012 Guidance Agenda

Title of Guidance	Contact
Draft Guidance for Industry (GFI #213) on Revising Approved Conditions of Use for New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals to Align with GFI #209	William Flynn, Center for Veterinary Medicine (HFV-1), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9084; William.flynn@fda.hhs.gov
Draft Guidance for Industry – Ensuring Safety of Animal Feed Maintained and Fed On-Farm	Phares Okelo, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, MPN4, Rm. 2661 Rockville, MD 20855, 240-453-6862, phares.okelo@fda.hhs.gov
Draft Guidance for Industry - Antibiotic Residues in Distillers Grains Used as Animal Food	Eric Nelson, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-9201, eric.nelson@fda.hhs.gov
Final Guidance for Industry - Fermentation Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use - Chemistry, Manufacturing, and Controls Information	Michael Popek, Center for Veterinary Medicine (HFV-144), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8269, michael.popek@fda.hhs.gov
Draft Guidance for Industry - Active Controls in Studies to Demonstrate the Effectiveness of a New Drug for Use in Companion Animals	Lisa Troutman, Center for Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8322, lisa.troutman@fda.hhs.gov
Draft Guidance for Industry - Unapproved Drugs	Tracy Forfa, Center for Veterinary Medicine, Food and Drug Administration, (HFV-1), 7519 Standish Place, MPN-4, Rockville, MD 20855, tracy.forfa@fda.hhs.gov
Final Guidance for Industry (GFI #217)- Evaluating the Effectiveness of Anticoccidial Drugs in Food and Anticoccidial Drug Combinations in Animals	Emily R. Smith, (HFV-135), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD  20855, 240-276-8344, emily.smith2@fda.hhs.gov
Draft Guidance for Industry - Regulation of Stem Cell Products for Animal Use	Lynne Oliver, Center for Veterinary Medicine, (HFV-114), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8321, e-mail: lynn.oliver@fda.hhs.gov
Final Guidance for Industry (GFI #209)- Judicious Use of Antimicrobial Drugs in Food-Producing Animals	William Flynn, Center for Veterinary Medicine (HFV-1), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9084; William.flynn@fda.hhs.gov
Final Guidance for Industry - VICH GL51 - Statistical Evaluation of Stability Data	Mai Huynh, Center for Veterinary Medicine (HFV-Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8344, mai.huynh@fda.hhs.gov
Final 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-214), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-9048, margarita.brown@fda.hhs.gov
Revised Guidance For Industry (GFI#61) - FDA Approval of Animal Drugs for Minor Uses and 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 - MUMs Designation	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 - Minor Use Minor Species Indexing	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