Veterinary Feed Directive

Complete 27 page rule available at: https://www.gpo.gov/fdsys/pkg/FR-2015-06-03/html/2015-13393.htm https://www.gpo.gov/fdsys/pkg/FR-2015-06-03/pdf/2015-13393.pdf Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)] [Rules and Regulations] [Pages 31707-31735] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2015-13393] Veterinary Feed Directive AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA's current VFD regulation established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This amendment is intended to improve the efficiency of FDA's VFD program while protecting human and animal health. DATES: This rule is effective October 1, 2015. FOR FURTHER INFORMATION CONTACT: Sharon Benz, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5939, email: Sharon.Benz@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Executive Summary Purpose of Final Rule The purpose of this rulemaking is to revise FDA's VFD regulations to improve the efficiency of the VFD program while continuing to protect public health (human and animal health). In 1996, Congress enacted the Animal Drug Availability Act (ADAA) (Pub. L. 104-250) to facilitate the approval and marketing of new animal drugs and medicated feeds. In passing the ADAA, Congress created a new regulatory category for certain animal drugs used in or on animal food (animal feed) called veterinary feed directive drugs (or VFD drugs). VFD drugs are new animal drugs intended for use in or on animal feed which are limited to use under the professional supervision of a licensed veterinarian. Any animal feed containing a VFD drug can only be fed to animals based upon an order, called a veterinary feed directive (VFD), issued by a licensed veterinarian in the course of the veterinarian's professional practice. FDA published final regulations implementing the VFD-related provisions of the ADAA in 2000 (see Sec. 558.6 (21 CFR 558.6)) (65 FR 76924, December 8, 2000). In the decade since FDA published its VFD regulations, various stakeholders have informed the Agency that the existing VFD process is overly burdensome. In response to those concerns, FDA published several documents inviting public input on ways to improve the VFD process, including an advance notice of proposed rulemaking (ANPRM) (75 FR 15387, March 29, 2010) (March 2010 ANPRM); draft regulatory text for proposed regulation (77 FR 22247, April 13, 2012) (April 2012 draft proposed regulation); and a notice of proposed rulemaking (NPRM) (78 FR 75515, December 12, 2013) (December 2013 NPRM). The VFD rule is the third of three core documents that FDA is using to announce and implement its policy framework for the judicious use of medically important antimicrobial drugs in food-producing animals. The first document, Guidance for Industry (GFI) #209, entitled ``The Judicious Use of Medically Important Antimicrobial Drugs in Food- Producing Animals,'' published April 2012, set forth FDA's framework for instituting several key measures for ensuring the appropriate or judicious use of medically important antimicrobial drugs in food- producing animals. These measures include eliminating the feed and water use of medically important antimicrobial drugs for production purposes in food-producing animals and bringing all remaining therapeutic uses under the oversight of licensed veterinarians. The second document, GFI #213, entitled ``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,'' published December 2013, outlined a detailed process and timeline for implementing the measures identified in GFI #209. Once GFI #213 is fully implemented, affected feed-use antimicrobial drugs are expected to transition from over-the-counter (OTC) to VFD marketing status. Given that most of the products affected by this effort are feed-use antimicrobial drugs this VFD regulation plays an important role since it outlines the requirements associated with veterinary authorization, distribution, and use of VFD drugs in animal feed. The VFD drug process as outlined in this final rule includes important controls regarding the distribution and use of VFD drugs. In addition to providing accountability, this final rule also updates the VFD requirements to improve the efficiency of the process. These regulatory enhancements are important for facilitating the transition of a large number of OTC feed-use antimicrobial drugs to their new VFD status. FDA intends to use a phased enforcement strategy for implementation of this final rule as OTC drugs become VFD drugs under GFI #213. FDA first intends to provide education and training for stakeholders subject to this final rule such as veterinarians, clients (animal producers), feed mill distributors and other distributors. Such education and training efforts are important for supporting effective implementation and compliance with the final rule. FDA will then engage in risk-based general surveillance, as well as for-cause inspection assignments. FDA intends to use information such as history of VFD use and the volume of VFD feed being produced to focus inspectional resources within the industry based on risk. FDA anticipates that it will utilize various sources for obtaining such information including such sources as FDA food and drug registration information, feed mill licensing information, the VFD distributor notifications FDA receives, and VFD distribution records maintained by drug sponsors and VFD distributors. The provisions included in this final rule are based on stakeholder input received in response to multiple opportunities for public comment, including the March 2010 ANPRM, April 2012 draft proposed regulation, and the December 2013 NPRM. Summary of Major Provisions This final rule makes several important changes from the proposed rule and several major changes to the current VFD regulations in part 558 (21 CFR part 558): The definition of ``Category II'' in part 558 is revised to remove the automatic Category II designation for VFD drugs. Instead, the categorization of VFD drugs will be determined on a case-by-case basis based on the likelihood that the particular drug at issue will produce an unsafe residue in edible products derived from treated animals, as is currently the case for non-VFD feed use drugs. The definition of veterinary feed directive (VFD) drug is revised to simply refer to the statutory definition to provide further clarity. The proposed definition of combination veterinary feed directive (VFD) drug is revised to reflect the [[Page 31709]] changes to the veterinary feed directive (VFD) drug definition. The proposed definition of a ``veterinary feed directive'' is revised to remove language that is duplicated in the responsibilities of a veterinarian issuing a VFD. The proposed definition of the term ``distributor'' is revised to use the word ``distributes'' instead of the word ``consigns'' as had been proposed. The regulatory text proposed for Sec. 558.6(a)(4) and (b)(8) is revised to clarify that the veterinarian is required to keep the original VFD (in hardcopy or electronically) and the distributor and client must keep a copy of the VFD (in hardcopy or electronically). The current requirement that copies of the VFD and records of the receipt and distribution of VFD feed must be kept for a period of 2 years is retained instead of being changed to 1 year as was proposed. The final rule provides that the veterinarian must issue the VFD in the context of a valid veterinarian-client-patient relationship (VCPR) as defined by the State requirements applicable to where the veterinarian practices veterinary medicine. In States that lack appropriate VCPR requirements applicable to VFDs, the veterinarian must issue the VFD consistent with the Federally defined VCPR standard, which is set forth in FDA's regulations at Sec. 530.3(i) (21 CFR 530.3(i)). The VFD expiration date requirement in the final rule specifies that this is the date that authorization to feed the VFD feed to animals expires. Animals must not be fed the VFD feed after the expiration date of the VFD. The VFD requirement for approximate number of animals in the final rule specifies how the approximate number of animals should be determined. The final rule clarifies the affirmation of intent statements to be used in VFDs issued by licensed veterinarians to indicate whether a VFD drug may be used in conjunction with another drug in an approved, conditionally approved, or indexed combination VFD feed. The final rule clarifies the recordkeeping requirements to differentiate what records are required to be kept for distributors who manufacture VFD feed and those who do not manufacture the VFD feed. Costs and Benefits The estimated one-time costs to industry from this final rule are $1,411,000, most of which are simply costs to review the rule and prepare a compliance plan. This equates to annualized costs of about $201,000 at a 7 percent discount rate over 10 years. We estimate that the government costs associated with reviewing the six VFD drug labeling supplements that are expected to be submitted by the three current VFD drug sponsors to be $1,900. The expected benefit of this final rule is a general improvement in the efficiency of the VFD process. FDA estimates the annualized cost savings associated with the more efficient requirements of the VFD process to be $13,000 over 10 years at a 7 percent discount rate (annualized at $11,000 over 10 years at a 3 percent discount rate). Additionally, the reduction in veterinarian labor costs due to this rule is expected to result in a cost savings of about $7.87 million annually. Table of Contents I. Background A. History B. Judicious Use Policy for Medically Important Antimicrobials II. Overview of the Final Rule III. Comments on the Proposed Rule A. Definitions Section (Sec. 558.3) B. Veterinary Feed Directive Drugs (Sec. 558.6) IV. Legal Authority V. Final Regulatory Impact Analysis VI. Paperwork Reduction Act of 1995 A. Reporting Requirements B. Recordkeeping Requirements C. Third-Party Disclosure Requirements VII. Environmental Impact VIII. Federalism IX. References III. Comments on the Proposed Rule This section summarizes comments FDA received in response to the December 2013 NPRM and the Agency's response to those comments. FDA received about 2,000 individual comments submitted to the docket on the December 2013 NPRM. Some of the comments contained signatures by multiple individuals or organizations. Comments were received from veterinary, feed manufacturing, and animal production associations, as well as consumer advocacy groups and individuals. Many of the comments received from veterinarian, feed manufacturing, animal production associations, and individuals generally supported the changes and requested some additional changes or clarification on particular issues. Many of the comments received from consumer advocacy groups and individuals raised concerns over whether the changes would sufficiently protect public health. FDA is making changes in the final rule to address these concerns where the Agency has determined such changes to be appropriate.