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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.
UNIFIED AGENDA
Veterinary Feed Directive
5 actions from March 29th, 2010 to April 2015
March 29th, 2010
ANPRM
75 FR 15387
June 28th, 2010
ANPRM Comment Period End
December 12th, 2013
NPRM
78 FR 75515
March 12th, 2014
NPRM Comment Period End
April 2015
Final Rule
TABLE OF CONTENTS
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DATES:
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Executive Summary
Purpose of Final Rule
Summary of Major Provisions
Costs and Benefits
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 ( 558.3)
1. Category II Drug ( 558.3(b)(1)(ii))
2. Veterinary Feed Directive Drug ( 558.3(b)(6))
3. Veterinary Feed Directive ( 558.3(b)(7))
4. Distributor ( 558.3(b)(9))
5. Animal Production Facility ( 558.3(b)(10))
6. Combination VFD Drug ( 558.3(b)(12))
B. Veterinary Feed Directive Drugs ( 558.6)
1. General Requirements Related to VFD Drugs ( 558.6(a))
a. VFD Retention and Transmission Requirements ( 558.6(a)(4))
b. Caution Statement on Labeling ( 558.6(a)(6))
c. Length of Time VFD and Records Must Be Kept ( 558.6)
2. Responsibilities of the Veterinarian Issuing the VFD ( 558.6(b))
a. Veterinarian Oversight, Supervision and the Veterinarian Client-Patient Relationship (VCPR) ( 558.6)(b)(1)).
b. Veterinarian Licensing Information
c. Name of Animal Drug ( 558.6(b)(3)(vi))
d. Client Name and Address ( 558.6(b)(3)(ii))
e. Premises at Which the Animals Specified in the VFD Are Located ( 558.6(b)(3)(iii))
f. Expiration Date ( 558.6(b)(3)(v))
g. Approximate Number of Animals To Be Fed the VFD Feed by the Expiration Date on the VFD ( 558.6(b)(3))
h. Refills or Reorders Authorized on the VFD ( 558.6(b)(3)(xii))
i. Combination Drugs ( 558.6(b)(6)(xiv))
j. Veterinarian Must Issue a Written VFD ( 558.6(b)(7))
k. Contents of the VFD
3. Responsibilities of Any Person Who Distributes an Animal Feed Containing a VFD Drug or a Combination VFD Drug ( 558.6(c))
4. Other Comments
IV. Legal Authority
V. Final Regulatory Impact Analysis
VI. Paperwork Reduction Act of 1995
A. Reporting Requirements
Description of Respondents: VFD Feed Distributors, VFD Drug Sponsors
B. Recordkeeping Requirements
C. Third-Party Disclosure Requirements
VII. Environmental Impact
VIII. Federalism
IX. References
List of Subjects
PART 514NEW ANIMAL DRUG APPLICATIONS
PART 558NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Footnotes
TABLES
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Table 1Estimated Annual Reporting Burden1
Table 2Estimated Annual Recordkeeping Burden
Table 3Estimated Annual Third-Party Disclosure Burden
DATES:
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This rule is effective October 1, 2015.
FOR FURTHER INFORMATION CONTACT:
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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:
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Executive Summary
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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 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
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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 thechanges 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 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 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
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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
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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 ( 558.3)
B. Veterinary Feed Directive Drugs ( 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
I. Background
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A. History
Before 1996, FDA had only two options for regulating the distribution of animal drugs: (1) Over-the-counter (OTC) and (2) by prescription (Rx). Drugs used in animal feeds were generally approved as OTC drugs. Although the Federal Food, Drug, and Cosmetic Act (the FD&C Act) did not prohibit the approval of prescription drugs for use in animal feed, such approvals would be impractical because many States have laws that would require a feed mill to have a pharmacist onsite to dispense prescription drugs. As additional animal drugs were developed, FDA determined the existing regulatory optionsOTC and Rxdid not provide the needed safeguards or flexibility for these drugs to be prescribed or administered through medicated feed. FDA believed that these drugs, particularly certain antimicrobial drugs, should be subject to greater control than provided by OTC status. FDA believed this control would be critical to reducing unnecessary use of such drugs in animals and to slowing or preventing the potential for the development of bacterial resistance to antimicrobial drugs administered through medicated feed.
In 1996 Congress enacted the ADAA to facilitate the approval and marketing of new animal drugs and medicated feeds. As part of the ADAA, Congress recognized that certain new animal drugs intended for use in animal feed should only be administered under a veterinarian's order and professional supervision. Therefore, the ADAA created a new category of products 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 by an approved application, conditionally approved application, or index listing to use under the professional supervision of a licensed veterinarian. In order for animal feed containing a VFD drug (VFD feed) to be fed to animals, a licensed veterinarian must first issue an order, called a veterinary feed directive (or VFD), providing for such use. In the Federal Register of December 8, 2000 (65 FR 76924), FDA issued a final rule amending the regulations in part 558 (21 CFR part 558) relating to new animal drugs for use in animal feed to implement the VFD-related provisions of the ADAA. In that final rule, FDA stated that because veterinarian oversight is so important for assuring the safe and appropriate use of certain new animal drugs, the Agency should approve such drugs for use in animal feed only if these medicated feeds are administered under a veterinarian's order and professional supervision. In addition, the final rule noted that safety concerns relating to the difficulty of disease diagnosis, drug toxicity, drug residues, antimicrobial resistance, or other reasons may dictate that the use of a medicated feed be limited to use by order and under the supervision of a licensed veterinarian.
It has been over a decade since FDA issued the final rule relating to VFDs. Although currently there are only a few approved VFD drugs, FDA has received comments from stakeholders characterizing the current VFD process as being overly burdensome. In response to these concerns, the Agency began exploring ways to improve the VFD program's efficiency. To that end, FDA initiated the rulemaking process through the publication of the March 2010 ANPRM. The March 2010 ANPRM requested public comment on whether efficiency improvements are needed and, if so, what specific revisions should be made to the VFD regulations. Subsequent to this, FDA published theApril 2012 draft proposed regulation based on the considerable public input it had received in response to the March 2010 ANPRM, and the Agency requested comment on this draft language also.
Recognizing that there would be challenges faced by animal producers and veterinarians as FDA phases in veterinary oversight of the therapeutic use of certain medically important antimicrobials, in the spring of 2013, FDA and the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service jointly sponsored a series of public meetings in various locations throughout the country (2013 public meetings). These meetings provided a forum to discuss potential challenges faced by animal producers in areas that may lack access to adequate veterinary services and to explore possible options for minimizing adverse impacts.
After considering the feedback received during the 2013 public meetings, as well as comments received on our March 2010 ANPRM and April 2012 draft proposed regulation, FDA published the December 2013 NPRM.
B. Judicious Use Policy for Medically Important Antimicrobials
On April 13, 2012, FDA finalized a guidance document entitled The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals (GFI #209) (Ref. 1). This guidance document represents the Agency's current thinking regarding antimicrobial drugs that are medically important in human medicine and used in food-producing animals. Specifically, GFI #209 discusses FDA's concerns regarding the development of antimicrobial resistance in human and animal bacterial pathogens when medically important antimicrobial drugs are used in food-producing animals in an injudicious manner. In addition, GFI #209 recommends two principles for assuring the appropriate or judicious use of medically important antimicrobial drugs in food-producing animals in order to help minimize antimicrobial resistance development: (1) Limit medically important antimicrobial drugs to uses in animals that are considered necessary for assuring animal health and (2) limit medically important antimicrobial drugs to uses in animals that include veterinary oversight or consultation.
On December 13, 2013, FDA finalized a second guidance 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 (Ref. 2). GFI #213 outlined a timeline and provided sponsors with specific recommendations on how they could voluntarily modify the use conditions of their medically important antimicrobial drug products administered in feed or water to align with the two judicious use principles announced in GFI #209. Once the use conditions of the affected products are changed, these products can no longer be legally used for production purposes, and can only be used for therapeutic purposes with the supervision of a licensed veterinarian.
Implementation of the judicious use principles set forth in GFI #209, particularly the second principle recommending that affected products be limited to uses in animals that include veterinarian oversight or consultation, reinforces the need for FDA to reconsider the current VFD program and how best to make the program more efficient and less burdensome for stakeholders while maintaining adequate protection for human and animal health. The majority of the antimicrobial animal drug products that are the focus of GFI #209 and GFI #213 are drugs approved for use in or on animal feed. All but a few of these drugs are currently available OTC without veterinary oversight or consultation and would be affected by the Agency's recommendation in the guidances to switch these products' marketing status from OTC to VFD. Therefore, it is important that the VFD process be as efficient as possible when FDA's judicious use policy is fully implemented to facilitate transition of these products from OTC to VFD marketing status. In addition, an overly burdensome VFD process could disrupt the movement of medicated feeds through commercial feed distribution channels, thereby impacting the availability of medicated feed products needed for addressing animal health issues.
II. Overview of the Final Rule
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This final rule amends FDA's regulations found in parts 514 and 558 (21 CFR parts 514 and 558) to change and clarify certain definitions ( 558.3 (21 CFR 558.3)), clarify the general requirements for VFD drugs ( 558.6(a) (21 CFR 558.6(a))), clarify the responsibilities of the VFD drug sponsor ( 514.1(b) (21 CFR 514.1(b)), and clarify specific responsibilities of the veterinarian issuing the VFD ( 558.6(b) (21 CFR 558.6(b))). Also, in this final rule we clarify the specific responsibilities of any person who distributes an animal feed containing a VFD drug ( 558.6(c) (21 CFR 558.6(c))).
In this rulemaking, the Agency finalizes many of the provisions in the December 2013 NPRM. In addition, the final rule reflects revisions the Agency made in response to comments on the December 2013 NPRM and certain revisions made by the Agency on its own initiative after considering all of the comments it received. Based on the changes to the final rule from the proposed rule, the Agency has determined that the effective date for the final rule should be 120 days after publication.
2015-13393.pdf
2015-13393.pdf
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