Veterinary Feed Directive, 31707-31735 [2015-13393]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[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]



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Vol. 80

Wednesday,

No. 106

June 3, 2015

Part III





Department of Health and Human Services





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 Food and Drug Administration





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21 CFR Parts 514 and 558





 Veterinary Feed Directive; Final Rule

Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules 
and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 514 and 558

[Docket No. FDA-2010-N-0155]
RIN 0910-AG95


Veterinary Feed Directive

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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

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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

I. Background

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 options--OTC and Rx--did 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 the

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April 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

    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 
(Sec.  558.3 (21 CFR 558.3)), clarify the general requirements for VFD 
drugs (Sec.  558.6(a) (21 CFR 558.6(a))), clarify the responsibilities 
of the VFD drug sponsor (Sec.  514.1(b) (21 CFR 514.1(b)), and clarify 
specific responsibilities of the veterinarian issuing the VFD (Sec.  
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 (Sec.  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.

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.
    The order of the discussion reflects the order in the regulatory 
text and not the order of significance of a particular issue. To make 
it easier to identify comments and FDA's responses, the word 
``Comment,'' in parentheses, appears before the comment's description, 
and the word ``Response,'' in parentheses, appears before FDA's 
response. Each comment is numbered to help distinguish between 
different comments. The number assigned to each comment is for 
organizational purposes and does not signify the comment's value or 
importance.
    In addition to the comments specific to this rulemaking that we 
address in the following paragraphs, we received general comments 
expressing views about public health, the use of antimicrobials, 
antimicrobial resistance, antibiotic alternatives, animal husbandry 
practices, meat consumption,

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food labeling, genetically modified organisms, chemicals in food, 
hormones in food, food (feed) additives, pesticides, fertilizers, trade 
policy, inspection frequency, violation penalties, and Agency funding. 
These comments express broad policy views and do not address specific 
points related to this rulemaking. Therefore, these general comments do 
not require a response.

A. Definitions Section (Sec.  558.3)

1. Category II Drug (Sec.  558.3(b)(1)(ii))
    The December 2013 NPRM proposed to remove VFD drugs from the 
definition of Category II drugs. In this final rule, we are keeping our 
proposed definition, which means that VFD drugs will no longer be 
automatically designated as Category II drugs. Category I drugs will 
remain defined as drugs that do not require a withdrawal period at the 
lowest use level in each species for which they are approved. Category 
II drugs will be defined as drugs that require a withdrawal period at 
the lowest use level for at least one species for which they are 
approved, or are regulated on a ``no-residue'' basis or with a zero 
tolerance because of a carcinogenic concern, regardless of whether a 
withdrawal period is required. As a result of this change, VFD drugs 
will be designated as either Category I or II based on the definitions 
in the final rule, including the existing VFD drug products that 
previously were automatically designated as Category II drugs.
    (Comment 1) There were multiple comments supporting FDA's proposed 
change to the definition of ``Category II'' drugs to discontinue the 
automatic designation of VFD drugs as Category II drugs. These comments 
supported Category I and II definitions that use a public health risk-
based approach to designate drugs based on the potential for unsafe 
drug residues in edible tissues as reflected by drug withdrawal 
periods. At least one comment also recognized that without this change, 
farm animals may be unable to receive the treatment they need due to 
supply chain disruptions. This comment noted that limiting the 
manufacturing of VFD feed from Type A medicated articles to licensed 
feed mills by automatically designating them as Category II would cause 
a serious disruption in VFD feed availability and unnecessarily cause 
harm to animals. The comment further noted that the proposed change to 
remove the automatic designation should greatly reduce the supply chain 
consequences.
    (Response 1) We agree that this approach provides a consistent 
scientific rationale for designating VFD drugs as Category I or II and 
will help prevent potential VFD feed supply chain concerns. Therefore, 
in this final rule, we are keeping the definition proposed in the 
December 2013 NPRM.
    The definitions proposed in the December 2013 NPRM designate drugs 
as Category II if a withdrawal period is required at the lowest 
approved use level for any species, or if the drug is regulated on a 
``no-residue'' basis or with a zero tolerance because of a carcinogenic 
concern regardless of whether a withdrawal period is required. The 
category in which a new animal drug is placed determines whether the 
Type A medicated article of that drug can be handled by a licensed or 
unlicensed mill. Type A medicated articles are the most concentrated 
form of the new animal drug and are used in the manufacture of another 
Type A medicated article, or a Type B or C medicated feed. A Type B 
medicated feed is intended solely for the manufacture of other Type B 
or Type C medicated feeds and contains a substantial quantity of 
nutrients with the new animal drug. A Type C medicated feed is intended 
as the complete feed for the animal or may be added on top of a usual 
ration, or offered as a supplement with other animal feed. A Type C 
medicated feed has the lowest concentration of the new animal drug. In 
order to reduce the potential to create unsafe drug residues, the 
manufacturing of medicated feeds with Category II Type A medicated 
articles is restricted to licensed feed mills. Licensed feed mills are 
generally better suited technically to manufacture feeds containing 
Category II drugs and are subject to more extensive good manufacturing 
practice requirements than unlicensed feed mills.
    When the VFD regulations were implemented, FDA stated that 
``classifying a drug as Category II adds additional regulatory controls 
because feed manufacturing facilities must possess a medicated feed 
mill license and be registered with FDA. . . . Registered feed mills 
are required to be inspected at least every 2 years. Such inspections 
will help the Agency to ensure that VFD requirements are met'' (65 FR 
76924 at 76926). Since the regulations for VFD drugs were implemented 
over a decade ago, FDA's experience has not shown a continued need to 
ensure VFD requirements are met by automatically designating all VFD 
drugs as Category II drugs. Since January 8, 2001, when the initial VFD 
regulations became effective, FDA has only issued three warning letters 
for violations related to noncompliance with the VFD regulations (Ref. 
3). Furthermore, licensed feed mills are now required to be inspected 
according to risk instead of at a set frequency. Drug categorization 
determines whether a facility needs to be licensed to handle the drug 
in the Type A form and is meant to provide additional regulatory 
oversight for the manufacturing of the drug to minimize the potential 
for drug residues to occur. In contrast, VFD designation is intended 
primarily to provide for veterinary supervision of the use of medicated 
feeds containing VFD drugs (VFD feeds). For VFD drugs that would 
otherwise be categorized as Category I drugs (i.e., do not require a 
withdrawal period at the lowest use level), FDA does not believe it is 
necessary to limit the manufacture of VFD feeds to licensed feed mills. 
Whether manufactured at a licensed or unlicensed feed mill, VFD feeds 
can only be used when authorized by a lawful VFD issued by a 
veterinarian.
    In addition, we agree this change will help prevent the potential 
supply chain disruptions for VFD feeds that otherwise are likely to 
occur once the Agency's policy regarding the judicious use of medically 
important antimicrobial drugs in food-producing animals is fully 
implemented. The existing definition of Category II drugs includes a 
provision that says all VFD drugs are Category II drugs, regardless of 
their potential to create unsafe drug residues. Thus, if FDA's policy 
regarding the judicious use of medically important antimicrobials were 
implemented with the definitions in the current regulations, drugs 
currently designated as Category I drugs that transition from OTC to 
VFD marketing status would automatically move from Category I to 
Category II. FDA is concerned that this automatic designation would 
cause supply chain disruptions for VFD feeds because the Type A 
medicated articles would be restricted to use by licensed feed mills, 
which number less than 1,000. Currently, since these drugs are OTC 
Category I drugs, they are able to be used in the Type A form by 
unlicensed feed mills, which number in the tens of thousands, including 
farms that manufacture their own medicated feed for their own animals.
    For these reasons, FDA is revising the definition of Category II to 
eliminate the automatic designation of VFD drugs into Category II. Once 
those medically important antimicrobial drugs that are currently 
marketed OTC are converted to VFD status as part of the implementation 
of FDA's judicious use policy, they will be placed in Category

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I or II based on whether they have a withdrawal period at the lowest 
use level for at least 1 species in which they are approved or whether 
they are regulated on a ``no residue'' basis or with a zero tolerance 
because of carcinogenic concern, as defined in Sec.  558.3. As a 
result, five of these medically important antimicrobial new animal 
drugs are expected to remain in Category I; approximately three drugs 
are expected to move from Category I into Category II. Each of these 
drugs account for multiple drug product approvals, conditional 
approvals, or index listings. Type A medicated articles for the drugs 
that remain in Category I will continue to be available for use by the 
unlicensed feed mills currently using these drugs as OTC drugs in 
medicated feeds, thus reducing the potential for supply chain 
disruption.
    (Comment 2) FDA also received multiple comments opposing the 
proposed change to the definition of a ``Category II'' drug. Most of 
these comments stated a concern about unlicensed feed mills handling 
Type A medicated articles for drugs that are VFDs or antimicrobials. 
The shared concern was that there would not be sufficient controls in 
place, or oversight over unlicensed feed mills, to ensure that these 
drugs are handled according to the requirements of the VFD regulation. 
One comment was concerned that without requiring VFD drugs to first go 
through a licensed feed mill, coupled with the proposed removal of the 
explicit Federal VCPR requirement and the proposed change to the 
definition of distributor, FDA would have no way to monitor the 
majority of VFD drug use.
    (Response 2) At the time VFD regulations were initially issued in 
December 2000, FDA was concerned that adherence to VFD regulations 
would require additional regulatory oversight for the proper use of VFD 
drugs in VFD feed. After over a decade of experience, FDA has only 
issued three warning letters for compliance issues in the handling of 
VFD drugs as Type A medicated articles by licensed feed mills, or as 
Type B or C VFD feed by unlicensed feed mills (Ref. 3). Furthermore, 
unlicensed feed mills routinely handle Category I Type A medicated 
articles and are also required to adhere to current good manufacturing 
practices (CGMPs). Although FDA may not inspect unlicensed feed mills 
at the same frequency as licensed feed mills, they are inspected for 
cause when surveillance tools, such as tissue residue or feed sampling, 
determine that a problem has occurred (Ref. 4). State regulatory 
Agencies also inspect licensed and unlicensed feed mills (Ref. 5). 
Therefore, FDA does not believe VFD drugs require continued automatic 
designation as Category II drugs.
    FDA recognizes that feed mill licensing is one method for FDA to 
maintain an inventory of feed mills that handle and use Type A VFD 
medicated articles; however, feed mill licensing is not the only way 
for FDA to be aware of VFD drug use. Furthermore, with respect to the 
concern raised in one of the comments that the change in the Category 
II definition, taken together with other proposed changes would 
diminish FDA's ability to monitor VFD use, the Agency is taking 
measures to address that concern. First, FDA has reintroduced an 
explicit VCPR requirement into the provisions for veterinarian 
supervision and oversight in the regulatory text. Second, FDA has also 
chosen not to proceed with the proposed changes to the definition of 
distributor outlined in the December 2013 NPRM and has clarified 
elsewhere in this document particular actions of on-farm processors 
that make them distributors.
    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. These 
education and training efforts are important for supporting effective 
implementation and compliance with the final rule. As products change 
to VFD status under the process outlined in GFI #213, FDA will engage 
in general surveillance, as well as for-cause inspection assignments. 
These assignments will be risk-based and in response to adverse 
observations. In order to engage in a risk-based work planning 
approach, FDA intends to gather information, such as VFD use and the 
volume of VFD feed being produced within the industry. This information 
would be gathered through multiple sources, such 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. This information will 
allow FDA to focus inspectional resources within the industry based on 
risk.
    Therefore, FDA is removing VFD drugs from the definition of 
Category II drugs. Instead of automatic Category II designation, VFD 
drugs will now be categorized according to the risk of drug residues 
based on whether they have a withdrawal period at the lowest level use 
in any species for which they are approved, or whether they are 
regulated on a ``no residue'' basis or with a zero tolerance because of 
carcinogenic concern. This includes the existing approved VFD drug 
products, each of which will either remain in Category II or be 
redesignated as Category I drugs based on whether they meet the 
definition of Category I or the revised definition of Category II.
2. Veterinary Feed Directive Drug (Sec.  558.3(b)(6))
    In the December 2013 NPRM, we proposed changes to better align the 
definition of ``veterinary feed directive (VFD) drug'' in FDA's 
regulations with the statutory definition in section 504 of the FD&C 
Act (21 U.S.C. 354) and to provide additional clarity. We did not 
receive comments specifically related to our proposed change in 
definition. However, upon further review we are providing more clarity 
to the VFD drug definition in this final rule by using the statutory 
definition in the FD&C Act. That definition of a ``veterinary feed 
directive (VFD) drug'' states that it is ``[a] drug intended for use in 
or on animal feed which is limited by an approved application filed 
pursuant to section 512(b), a conditionally-approved application filed 
pursuant to section 571, or an index listing pursuant to section 572 to 
use under the professional supervision of a licensed veterinarian. . . 
.'' This change in Sec.  558.3(b)(6) provides consistency between the 
statute and the regulation and helps to reduce the potential for 
confusion.
3. Veterinary Feed Directive (Sec.  558.3(b)(7))
    FDA did not receive specific comments regarding the addition of 
language in the proposed VFD definition in Sec.  558.3(b)(7) stating 
that a VFD may be issued in hardcopy or through electronic means. 
However, upon further review, we are removing this duplicative language 
because similar language appears in Sec.  558.6(b) concerning the 
responsibilities of the veterinarian issuing the VFD. Section 558.6(b) 
provides more clarity by specifying that a fax also can be used. This 
change avoids duplication in the regulatory text and helps to reduce 
potential reader confusion about whether transmitting a VFD by fax is 
allowed.
    Also to help reduce the potential for confusion, FDA is removing 
the duplicative language concerning the oversight and supervision 
requirements

[[Page 31713]]

for issuing a VFD from the definition of a veterinary feed directive 
(Sec.  558.3(b)(7)) and from the general requirements related to 
veterinary feed directive drugs (Sec.  558.6(a)(1)), because the same 
requirements are also in the provision (Sec.  558.6(b)) that discusses 
the responsibilities of the veterinarian issuing the VFD. FDA received 
many comments concerning the oversight and supervision requirements for 
veterinarians issuing a VFD, which are addressed in the discussion of 
the responsibilities of the veterinarian issuing the VFD (558.6(b)). 
This change eliminates duplication in the regulatory text and clarifies 
that the requirement for oversight and supervision is the 
responsibility of the veterinarian.
4. Distributor (Sec.  558.3(b)(9))
    In the December 2013 NPRM, we proposed to change the definition of 
``distributor.'' In particular, we proposed to change the phrase ``any 
person who distributes a medicated feed containing a VFD drug to 
another person'' to ``any person who consigns a medicated feed 
containing a VFD drug to another person.'' Many of the comments we 
received expressed concern that this definitional change was meant to 
narrow the scope of who is defined as a distributor.
    (Comment 3) Some comments requested that we maintain the current 
definition that a distributor is any person who distributes a medicated 
feed containing a VFD drug to another distributor or to the client-
recipient of the VFD. These comments were concerned that use of the 
term ``consigns'' instead of ``distributes'' in the proposed definition 
would exempt operations that were previously considered to be 
distributors. Some of these comments thought that the proposed changes 
would narrow the scope of the definition such that it would exclude 
from the distributor notification requirements the majority of 
facilities where medicated feeds are mixed. One comment supported the 
definition of distributor proposed in the December 2013 NPRM.
    (Response 3) We used the term ``consigns'' in place of the term 
``distributes'' with the intent to provide additional clarity; however, 
the comments we received indicated this proposed terminology was more 
confusing. In addition, many comments perceived this change as an 
attempt to narrow the definition of distributor. As stated in the 
December 2013 NPRM, our intent was to improve the clarity of this 
definition, not to narrow the scope. As a result of the comments 
received and the discussions that occurred at public meetings about 
this proposed change, we are retaining the existing term 
``distributes'' as part of the definition of distributor.
    In the December 2013 NPRM, we noted that ``on-farm mixers that only 
manufacture medicated feeds for use in their own animals are not 
distributors.'' Based on the comments, we would like to provide 
additional clarity. Some comments perceived this statement to exempt 
all on-farm mixers from requirements that apply to distributors. 
However, this statement was intended to describe a limited and specific 
situation in which FDA does not intend to consider on-farm mixers to be 
distributors. By on-farm mixers, we were specifically referring to any 
person who is mixing VFD feed on a ``farm'' as that term is defined in 
21 CFR 1.227, who is only feeding that VFD feed to their own animals on 
that farm. In addition, the on-farm mixer must only be manufacturing 
VFD feed for their use in their own animals on their own farm (e.g., 
animal production facility), meaning that the ownership of the feed 
mill, the animals, and the animal production facility must be the same 
and the on-farm mixer must be the person using the VFD feed. In 
contrast, for example, when Person A mixes VFD feed on their farm for 
their own animals, but also mixes feed and distributes it to Person B's 
farm, Person A is acting as a ``distributor'' as that term is defined 
in Sec.  558.3 and, therefore, will be required to comply with the 
distributor requirements. Another example is when Person C operates a 
feed mill and owns animals, but distributes the feed to Person D who 
raises Person C's animals on Person D's farm (e.g., a contract grower), 
that person (Person C) who operates the feed mill would also be a 
distributor under the definition.
    (Comment 4) Some comments requested that all facilities that 
dispense feed to an animal production facility be required to submit a 
notification to FDA. One comment suggested we define a distributor as 
``any person who consigns a medicated feed containing a VFD drug to 
another distributor or to an animal production facility.''
    (Response 4) FDA does not believe it is necessary to require that 
all persons who dispense VFD feed to an animal production facility 
submit a notification to FDA. For example, if a person purchases a Type 
B VFD feed and then mixes it on their farm into a Type C VFD feed and 
feeds it to their own animals on their farm in accordance with a lawful 
VFD, they are dispensing VFD feed to an animal production facility 
because the mixing operations are not part of the animal production 
facility. However, they are not acting as a ``distributor'' as that 
term is defined in Sec.  558.3 because they are not distributing to 
another person. When a person who dispenses VFD feed to an animal 
production facility obtains the VFD feed from a distributor, they are 
required to submit a VFD or acknowledgment letter to the distributor 
from whom they obtained the VFD feed. This documentation allows FDA to 
identify users of VFD feed from the distributor's records for purposes 
of surveillance, inspection, or investigation. In addition, should a 
person who dispenses VFD feed to an animal production facility obtain a 
VFD Type A medicated article for manufacture of the VFD feed, the 
sponsor of the VFD Type A medicated article is required to maintain a 
record of distribution.
    (Comment 5) One comment was concerned that the required one-time 
notification to FDA that someone is a distributor of VFD feeds could 
discourage distribution and sale of floor stock.
    (Response 5) The requirement for a person distributing VFD feed to 
notify FDA when they first engage in such distribution is a statutory 
requirement. (See section 504(a)(3)(C) of the FD&C Act.) We understand 
that some businesses may choose not to engage in the sale of floor 
stock. However, in order to adequately protect public and animal 
health, FDA must be able to track the distribution of VFD feed, and 
one-time notification to FDA upon first engaging in the distribution of 
a VFD feed provides the minimum information needed for this tracking. 
We do not agree that the minimal burden of a one-time notification to 
FDA would be a significant factor in discouraging the distribution of 
floor stock. Furthermore, FDA believes there is no compelling reason to 
treat distributors who only sell floor stock differently from 
distributors who distribute VFD feed through other sales models.
    (Comment 6) One comment requested clarification on whether a 
manufacturer of a Type B VFD feed who distributes the Type B VFD feed 
to an animal producer who then makes a Type C VFD feed needs to get an 
acknowledgement letter from the animal producer as opposed to a VFD.
    (Response 6) When a manufacturer of a Type B VFD feed distributes 
the Type B VFD feed to an animal producer, the animal producer may 
manufacture a Type C VFD feed to either feed the VFD feed to his or her 
own animals and/or further distribute the Type C VFD feed to another 
distributor or client-recipient. If the Type B VFD feed is being 
shipped to an animal producer who is not a

[[Page 31714]]

distributor, the animal producer must provide a VFD for the receipt of 
the Type B VFD feed from the distributor. If the Type B VFD feed is 
being shipped to an animal producer who is a distributor that has sent 
a one-time notification to FDA, the animal producer must supply either 
an acknowledgment letter or a VFD for the receipt of the Type B VFD 
feed from the distributor. (Note: In order for the animal producer to 
receive a Type B or Type C VFD feed without a VFD in hand, he or she 
must have previously notified FDA that he or she is a distributor.) If 
the animal producer provides an acknowledgment letter to the 
distributor from whom the animal producer receives the VFD feed, the 
animal producer must either receive an acknowledgment letter or a VFD 
prior to further distributing the VFD feed to another person, or have a 
VFD on hand prior to feeding the Type C VFD feed to his or her own 
animals. We have revised the definition of acknowledgment letter in 
(Sec.  558.3(b)(11)) to clarify that when an animal producer is acting 
as a distributor as defined in (Sec.  558.3(b)(9)), they may provide an 
acknowledgment letter even if they are the ultimate user of some of the 
VFD feed.
5. Animal Production Facility (Sec.  558.3(b)(10))
    The December 2013 NPRM did not propose a change to the definition 
of animal production facility. However, we received comment on the 
definition.
    (Comment 7) A few comments requested that FDA define ``animal 
production facility'' more broadly to include the location where the 
medicated feed is made. These comments cited a concern that movement of 
VFD feed would be limited by this definition because shipment of VFD 
feed to an animal production facility must frequently go beyond the 
gate to a facility or feed mill where the animals are not housed.
    (Response 7) The term animal production facility is defined as ``a 
location where animals are raised for any purpose, but does not include 
the specific location where medicated feed is made.'' (Sec.  
558.3(b)(10)). The definition of animal production facility does not 
hinder the movement of feed between a feed mill and an animal 
production facility. VFD feed may be shipped from a distributor 
directly to an animal production facility, or may first be delivered to 
a facility or feed mill that is located where the animals are not 
housed. Provided the recipient of such feed has a lawful VFD and is the 
owner of both the facility or feed mill to which the feed was delivered 
and the animal production facility, further movement of that VFD feed 
to the actual animal production facility would not be limited and we 
would not consider such further movement to be the activity of a 
``distributor.''
6. Combination VFD Drug (Sec.  558.3(b)(12))
    In the December 2013 NPRM, we added a definition for the term 
``combination veterinary feed directive (VFD) drug.'' In the final 
rule, we have further clarified that definition to align the language 
with the statutory definition of a veterinary feed directive drug.

B. Veterinary Feed Directive Drugs (Sec.  558.6)

1. General Requirements Related to VFD Drugs (Sec.  558.6(a))
a. VFD Retention and Transmission Requirements (Sec.  558.6(a)(4))
    In the December 2013 NPRM, we proposed that VFDs would no longer be 
specifically required to be produced in triplicate; however, all three 
involved parties (veterinarian, distributor, and client) still would be 
required to receive and keep a copy of the VFD, either electronically 
or in hardcopy. If the VFD is transmitted electronically, the 
veterinarian would no longer be required to send the original in 
hardcopy to the distributor.
    (Comment 8) Many comments supported these changes. Some comments 
indicated that there was some confusion about whether an electronic 
copy of the VFD would satisfy the recordkeeping requirement.
    (Response 8) To improve the clarity of this section, we have 
revised the regulatory text to more precisely indicate the 
recordkeeping requirements. An electronic copy of the VFD is sufficient 
for recordkeeping purposes. The original no longer needs to be sent to 
the distributor. As we stated in the December 2013 NPRM, this hardcopy 
requirement has become outdated by modern electronic communication and 
presents an unnecessary burden on the industry.
    This revision further reduces the number of paper copies requiring 
physical recordkeeping space. The December NPRM, however, did not 
specify who should maintain the original. Because of the confusion 
indicated in the comments, we are revising the rule to specify that the 
original should be maintained by the veterinarian who issued the VFD 
and should be maintained in the manner it was generated, either 
electronic or hardcopy. The client and distributor should each also 
have a copy of the VFD, and that copy may be electronic or hardcopy.
    (Comment 9) A few comments addressed the regulatory requirements 
for electronically generated documents. One comment asked what 
requirements would apply to records with an electronic signature. 
Another comment urged FDA to not require compliance with 21 CFR part 11 
(part 11) for VFDs transmitted and stored electronically.
    (Response 9) The regulations in part 11 (Electronic Records; 
Electronic Signatures) describe FDA's standards for assessing whether 
electronic records and electronic signatures are trustworthy and 
reliable and generally equivalent to paper records with handwritten 
signatures. Electronic records, such as an electronic VFD that meets 
the requirements of part 11, may be used in lieu of a paper VFD (i.e., 
VFDs that are generated and signed on paper). As we have previously 
stated in GFI #120: Veterinary Feed Directive Regulation Questions and 
Answers, published on March 26, 2009, part 11 applies to records in 
electronic form that are created, modified, maintained, archived, 
retrieved, or transmitted, under any FDA records requirements. 
Therefore, electronic VFDs issued by veterinarians must be compliant 
with part 11, and VFDs received and electronically stored by 
distributors and clients must be compliant with part 11. Part 11 does 
not apply to paper records that are, or have been, transmitted by 
electronic means (such as facsimile, email attachments, etc.). Part 11 
requires a one-time certification that the electronic signatures in 
their system, used after August 20, 1997, are intended to be the 
legally binding equivalent of the signer's handwritten signature (Ref. 
6). Additional information about part 11 compliance, including 
information on how FDA intends to exercise enforcement discretion with 
regard to certain part 11 requirements during the reexamination of part 
11, can be found in GFI Part 11, Electronic Records; Electronic 
Signatures--Scope and Application (Ref. 7).
    (Comment 10) One comment suggested that a paper VFD process would 
be unwieldy, costly, and burdensome.
    (Response 10) There are relative advantages and disadvantages to 
generating and keeping records in either electronic or paper form. We 
believe that businesses should be able to decide what format 
(electronic or hard copy) they would like to use to fulfill the 
recordkeeping requirements. For that reason, we proposed regulations 
that removed the explicit requirement that

[[Page 31715]]

VFDs be issued in triplicate and that the original VFD be transferred 
from the veterinarian (either directly or through the client) to the 
distributor. The final regulatory text allows businesses to decide, 
based on their unique business structure and operation, which 
recordkeeping format (electronic or paper) to use to fulfill the VFD 
recordkeeping requirements.
b. Caution Statement on Labeling (Sec.  558.6(a)(6))
    (Comment 11) One comment requested clarification about the caution 
statement required on labeling and advertising for VFD drugs and feeds 
containing VFD drugs. The comment recognized that for products in paper 
bags this would be appropriate, but wondered what would be required for 
feed that is delivered in bulk where there is no container.
    (Response 11) As reflected in the regulatory text, all labeling and 
advertising for VFD drugs, combination VFD drugs, and feeds containing 
VFD drugs or combination VFD drugs must prominently and conspicuously 
display the cautionary statement. In section 201(m) of the FD&C Act (21 
U.S.C. 321(m)), ``labeling'' is defined as ``all labels and other 
written, printed, or graphic matter (1) upon any article or any of its 
containers or wrappers, or (2) accompanying such article.'' Packaged 
food typically has a label affixed to the package or container; 
however, any labeling or advertising would also need to contain the 
statement. Bulk food typically does not have a label affixed to the 
container, but is accompanied by labeling to meet other requirements of 
the FD&C Act, such as displaying the common or usual name of the animal 
food, as well as any other information already required by existing 
regulations. FDA would expect that the caution statement be on this 
labeling, as well as any other labeling or advertising for the bulk 
food.
c. Length of Time VFD and Records Must Be Kept (Sec.  558.6)
    In the December 2013 NPRM, we proposed to reduce the length of time 
a VFD and records related to a VFD must be kept from the currently 
required 2 years to 1 year. We received many comments related to this 
requirement. After further considering this issue, we are retaining the 
existing 2-year recordkeeping requirement.
    (Comment 12) We received many comments requesting FDA to maintain 
the current 2-year recordkeeping requirement. We also received several 
comments supporting the proposed 1-year recordkeeping period. Some of 
these comments supported the 1-year requirement because many VFD 
records are also required to be kept under the CGMP recordkeeping 
requirements for medicated feeds found in part 225 (21 CFR part 225), 
and those requirements specify a 1-year retention period. A few 
comments requested a requirement that records related to VFDs be kept 
for a period shorter than 1 year, or longer than 2 years.
    (Response 12) In response to comments and after further 
consideration of the issue, we are requiring that VFDs and all required 
records related to VFDs for veterinarians, clients, and distributors be 
kept for a period of 2 years. This record retention period is the same 
as the current record retention requirement. Our purpose in proposing 
the 1-year recordkeeping requirement in the December 2013 NPRM was to 
better align the VFD recordkeeping requirements with those in the CGMP 
regulations in part 225 for medicated feed. All records required under 
part 558 of this chapter must be kept for 2 years. In addition, as 
discussed elsewhere in this document, we believe it is important that 
all parties be required to maintain VFD receipt and distribution 
records for 2 years, irrespective of whether the party is required to 
maintain receipt and distribution records under part 225 of this 
chapter. We believe that there are several benefits to a 2-year VFD 
record retention period.
    The first benefit is that a 2-year VFD recordkeeping requirement 
aligns with the recently published Current Good Manufacturing Practice 
and Hazard Analysis and Risk-Based Preventive Controls for Food for 
Animals proposed rule (78 FR 64736; October 29, 2013). This proposed 
rule includes new CGMP requirements for operations that manufacture, 
process, pack, and hold animal food, including animal feed, and 
proposes a 2-year records retention period. Some of those recordkeeping 
requirements would also fulfill the VFD recordkeeping requirements. We 
believe that, because many operators manufacturing or distributing 
animal feed bearing or containing VFD drugs may be required to comply 
with these proposed CGMP requirements, they would benefit from such a 
recordkeeping requirement alignment.
    In addition, while we still believe that a longer retention period 
ordinarily will not be critical in order to investigate violative drug 
residues in edible animal tissues, the longer record retention period 
would provide a more complete history of records, which is useful in 
identifying patterns of noncompliance with the VFD regulations during 
regular inspections.
    As discussed elsewhere in this document, this final rule adds 
clarifying language that distributors who manufacture animal feed 
bearing or containing VFD drugs must keep VFD feed manufacturing 
records for 1 year in accordance with part 225. These manufacturing 
records are not required to be kept for 2 years unless they are also 
required to be kept under part 558 of this chapter (e.g., the VFD and 
distribution records).
2. Responsibilities of the Veterinarian Issuing the VFD (Sec.  
558.6(b))
a. Veterinarian Oversight, Supervision and the Veterinarian Client-
Patient Relationship (VCPR) (Sec.  558.6)(b)(1)).
    FDA is requiring that any veterinarian issuing a VFD be licensed to 
practice veterinary medicine and operate in compliance with appropriate 
State defined veterinarian-client-patient relationship (VCPR) 
requirements or Federally defined VCPR requirements where no applicable 
and appropriate State VCPR requirements exist. Some States' licensing 
and practice requirements specify that a VCPR as defined by that 
State's law must exist before a VFD can be issued. In those States with 
VCPR requirements that include the key elements of a VCPR as described 
in the Federal definition (Sec.  530.3(i)), FDA intends to defer to the 
State VCPR requirement. This has the advantage of being able to 
leverage the accountability that comes with State licensing board 
oversight to ensure compliance with the VCPR requirement, while 
providing States the flexibility to adapt their VCPR requirements 
appropriately to local conditions. Although elements of a VCPR are 
discussed in the paragraphs that follow, FDA believes that in order for 
the State defined VCPR requirements to sufficiently ``include the key 
elements of a VCPR as defined in Sec.  530.3(i),'' the State defined 
VCPR must at least address the concepts that the veterinarian: (1) 
Engage with the client to assume responsibility for making clinical 
judgments about patient health, (2) have sufficient knowledge of the 
patient by virtue of patient examination and/or visits to the facility 
where patient is managed, and (3) provide for any necessary followup 
evaluation or care. In States where the practice requirements do not 
require that a VFD be issued within the context of a State defined 
VCPR, FDA is requiring that the VFD be issued within the context of a 
Federally defined valid VCPR.

[[Page 31716]]

    (Comment 13) The majority of comments supported maintaining a 
veterinarian-client-patient relationship (VCPR) as a requirement for 
issuing a VFD. A large number of those comments asked FDA to maintain 
the Federal definition of a VCPR because some States either do not 
define VCPR in their State licensing and practice requirements, or they 
include a VCPR requirement for dispensing prescription drugs or 
controlled substances, but not for issuing a VFD. Many comments raised 
the specific concern that the veterinarian who issues a VFD should be 
required to have recently seen the animals specified in the VFD or 
visited the farm on which the animals were kept.
    (Response 13) FDA agrees that a veterinarian-client-patient 
relationship is an important element of veterinary supervision and 
oversight of the VFD process. As stated in the December 2013 NPRM, our 
intent in revising the VCPR provisions was to ``appropriately defer to 
existing regulatory oversight standards for veterinary professional 
conduct,'' which are overseen by the State organizations responsible 
for the licensing of veterinarians. We did not intend to eliminate 
requiring a VCPR for the issuance of a lawful VFD. Instead, we intended 
to broaden the concept of supervision and oversight to include a VCPR 
and other practice requirements as defined by the State to allow for 
practice variations and the need for flexibility among State 
requirements.
    After reviewing the comments, it is clear that some people have 
interpreted our proposed changes as a relaxation of the existing VCPR 
requirement. We acknowledge that not all States currently require that 
a VCPR must exist before a VFD can be issued and that there is some 
uncertainty as to when or if such States will choose to establish such 
a requirement subsequent to finalization of this rule. To address 
potential gaps in those States that currently lack VCPR requirements 
applicable to VFDs, we are changing the regulatory text to specify that 
in those States that require a VCPR that includes the key elements of 
the Federally defined VCPR in order for a veterinarian to issue a VFD, 
the veterinarian issuing the VFD must be operating within the context 
of a VCPR as that term is defined by the State. In all other cases, the 
veterinarian must be operating within the context of a valid VCPR as 
defined by FDA in Sec.  530.3(i).
    A review of the States that have VCPR requirements in place that 
are applicable to the issuance of VFDs reveals that those VCPR 
requirements typically provide that the animals or premises must 
recently have been seen by the veterinarian, or that the veterinarian 
otherwise have on-farm knowledge of the animals sufficient to make a 
diagnosis. Some States go further, requiring that the animals must have 
been seen by the veterinarian within a certain timeframe, or that the 
veterinarian has performed an actual examination of the animals. FDA, 
therefore, believes that recognizing State professional standards for 
issuing a VFD in accordance with VCPR requirements as prescribed by 
State law or, where no applicable State VCPR requirements exist, 
requiring the VFD to be issued in compliance with Federally defined 
VCPR requirements, addresses the concern raised by these comments that 
some States currently lack VCPR requirements applicable to VFDs, as 
well as the concern that the veterinarian should be required to have 
recently seen the animals specified in the VFD or visited the farm on 
which the animals are kept.
    (Comment 14) A large number of comments did not specifically 
mention a VCPR requirement, but more broadly supported veterinary 
supervision and oversight of the VFD process.
    (Response 14) We agree that veterinary supervision and oversight is 
important in the issuance of a VFD. We believe that the requirements we 
have included in the regulatory text will help ensure adequate 
veterinarian oversight and supervision over the use of VFD drugs in 
animal feed and are responsive to the comments received.
    (Comment 15) A number of comments supported the proposed intent of 
the December 2013 NPRM to defer to State standards for the practice of 
veterinary medicine. These comments supported allowing flexibility for 
States to set practice standards that address the particular needs and 
concerns of the State, including the issue of veterinary shortages. 
Several comments also supported the intention to recognize professional 
expertise and oversight by State licensing boards to enforce 
professional conduct and practice requirements.
    (Response 15) We agree that the practice of veterinary medicine has 
traditionally been regulated at the State level and that the States 
generally are in a better position to establish and enforce the 
requirements of the practice of veterinary medicine. However, not all 
States have appropriate VCPR requirements specifically applicable to 
the issuance of a VFD. As a result, we believe that the approach we 
proposed in the December 2013 NPRM to defer to State practice standards 
needs to be supplemented with Federally defined VCPR requirements that 
apply to States without such requirements, so that all VFDs will 
continue to be issued under veterinary supervision and oversight within 
the context of a defined and appropriate VCPR. This approach addresses 
both our original intent, as well as the concerns raised in the 
comments.
    (Comment 16) A number of comments raised the concern that there is 
a shortage of veterinarians, or veterinarians with specialized 
expertise, in certain geographical areas. One comment said that the 
regulation did not fully address the veterinary shortage issue. A few 
comments requested that the rule should include an exemption for farms 
that have limited access to veterinarians, or FDA should make funds 
available to ensure the farms have access to veterinarians for 
treatment of sick animals. One comment requested that FDA work with 
USDA on an assistance program for small farmers to enable access to 
veterinary care and support the study of large animal medicine so more 
veterinarians will enter the field. At least one comment cited studies 
from the American Veterinary Medical Association (AVMA) and the 
Cornucopia Institute documenting the lack of access to affordable and 
competent veterinarians in rural areas. This comment also stated that, 
according to the American College of Poultry Veterinarians, there are 
only 235 veterinarians available to the poultry industry in the United 
States. One comment suggested that an exemption be made for farmers who 
cannot access a veterinarian and for species where the drug 
administration route of best efficacy is feed or water.
    (Response 16) We recognize and share the concerns raised in the 
comments regarding the challenges that animal producers may face in 
accessing qualified veterinary care. In light of these concerns, FDA 
also carefully considered the feedback received on this issue from the 
April 2012 draft proposed regulation and the 2013 public meetings with 
stakeholders in rural areas to identify regulatory changes that might 
help to mitigate this concern. For example, FDA's intent in proposing 
in the December 2013 NPRM to remove the ``one-size-fits-all'' Federally 
defined VCPR standard was to allow the veterinary profession and States 
the flexibility needed ``to adjust the specific criteria for a VCPR to 
appropriately align with current veterinary practice standards, 
technological and medical advances, and other regional considerations'' 
(78 FR 75515 at 75518). In the NPRM, we stated that this greater 
flexibility ``could allow veterinarians to

[[Page 31717]]

more effectively provide services to food animal producers in remote 
geographical areas where veterinary professional resources are limited 
and distances are great'' (78 FR 75515 at 75518). We believe this 
proposed change provides the flexibility needed for States with a VCPR 
requirement for VFDs to address the concern regarding access to 
qualified veterinary care. As stated in ``Response 13,'' of this 
section, for States that do not have an appropriate VCPR requirement as 
part of their VFD regulations, we are adding a requirement to this 
final rule that when issuing VFDs, veterinarians must operate within 
the context of a valid VCPR as defined by FDA in Sec.  530.3(i). We 
believe that this approach strikes the appropriate balance, allowing 
adequate flexibility for States to account for limited veterinary 
resources while still providing a Federal assurance of appropriate 
oversight.
    As veterinary oversight of the therapeutic use of certain medically 
important antimicrobials is phased in, FDA will continue to seek 
opportunities to work with our Federal, State, and other stakeholder 
partners to help address the practical issues associated with limited 
access to veterinary services in certain parts of the country.
    (Comment 17) A few comments raised the concern that requiring 
veterinarian supervision and oversight would impose an unreasonable 
financial burden on small farmers. As a solution, these comments stated 
that a VCPR should be required only for confinement agricultural 
feeding operations and farms with more than $300,000 turnover, and 
small producers should be exempt from VCPR requirements. One comment 
suggested an exemption for species where the feed or water route of 
administration is the only practical means of effectively administering 
antimicrobial therapy.
    (Response 17) We disagree that the requirements for veterinarian 
supervision and oversight should not apply to the VFDs issued to small 
farmers or for certain species. Section 504 of the FD&C Act (21 U.S.C. 
354) requires that VFD drugs be used under a veterinarian's 
supervision. As a result, veterinary supervision for the use of VFD 
drugs is required, whether or not certain animal producers or 
operations would be exempt from State or Federally defined VCPR 
requirements. Therefore, exempting small animal producers or certain 
species from VCPR requirements would not likely result in any cost 
savings for their use of VFD drugs because the statute requires the 
veterinarian to be involved in the issuance of a VFD. In addition, it 
would be difficult and confusing for veterinarians to determine whether 
such an exemption would apply. For these reasons, FDA does not believe 
that this proposal is a viable solution.
    Furthermore, FDA does not believe that continuing to require a 
VCPR, whether State or Federally defined, to issue a VFD results in an 
unreasonable financial burden on animal producers. FDA continues to 
believe that veterinary oversight of the use of medically important 
antimicrobial drugs in feed is a critical measure for ensuring 
judicious use of these drugs in support of efforts to minimize 
antimicrobial resistance. Maintaining a requirement for an appropriate 
VCPR is a fundamental element of providing for meaningful veterinary 
oversight. FDA will continue to seek opportunities to work with our 
Federal, State, and other stakeholder partners to help address the 
practical issues that arise as veterinary oversight of the therapeutic 
use of certain medically important antimicrobials is phased in.
    (Comment 18) A few comments stated that the requirement for 
supervision and oversight was not clear, or advocated for specific 
requirements to be included as part of supervision and oversight. These 
comments requested more specific guidelines describing the amount of 
time the veterinarian must spend on the farm or ranch, how recently the 
veterinarian must have seen the animals or farm, whether the 
veterinarian needs to see the animals or visit the farm in person, and 
what it means for a veterinarian to be familiar with the client's 
operation. The comments also expressed concern that veterinarians be 
licensed in each State where there is a facility under the operation, 
and that the facility should be recently visited so that the 
veterinarian is familiar with the local conditions in which the animals 
are raised.
    (Response 18) We have addressed these concerns by including more 
specific language about the requirements for veterinary supervision and 
oversight, including compliance with State licensing and practice 
requirements and the continued role of a VCPR in Sec.  558.6(b)(1). The 
State and Federal definitions of VCPR set out the requirements for the 
veterinarian to establish an appropriate relationship with the client 
and the animal(s) for which services are being provided.
    The first element of the Federal VCPR is that ``A veterinarian has 
assumed the responsibility for making medical judgments regarding the 
health of (an) animal(s) and the need for medical treatment, and the 
client (the owner of the animal or animals or other caretaker) has 
agreed to follow the instructions of the veterinarian'' (Sec.  
530.3(i)(1)). For the States that define a VCPR, all but one State 
includes in their definition a statement about the responsibility the 
veterinarian assumes in making medical judgments about the animal's 
health. Many of the States go further and specify the owner or animal 
producer's responsibility to follow the veterinarian's instructions.
    The second element of the Federal definition of VCPR states that 
``There is sufficient knowledge of the animal(s) by the veterinarian to 
initiate at least a general or preliminary diagnosis of the medical 
condition of the animal(s) . . .'' (Sec.  530.3(i)(2)). In addition, 
the definition states that ``[s]uch a relationship can exist only when 
the veterinarian has recently seen and is personally acquainted with 
the keeping and care of the animal(s) by virtue of examination of the 
animal(s), and/or by medically appropriate and timely visits to the 
premises where the animal(s) are kept'' (Sec.  530.3(i)(3)). Typically, 
a veterinarian has an ongoing relationship with the client and the 
client's animals being treated such that the veterinarian is familiar 
with the animal production operation and has made previous visits to 
their facility(s). This relationship also allows the veterinarian to 
provide education to the client about appropriate use of medication, 
including storage, use, and withdrawal times. FDA expects that a 
veterinarian will only authorize use of a VFD feed in animals for which 
he or she has such knowledge and familiarity. For the States that 
define a VCPR, all but one State includes in their definition a 
statement about the veterinarian's knowledge of or acquaintance with 
the animal or operations. Most of the States that incorporate this 
knowledge or acquaintance criterion in their VCPR definition provide 
similar detail to the Federal definition about what constitutes 
sufficient knowledge, such as requirements that the veterinarian has 
recently seen and is personally acquainted with the keeping and care of 
the animal(s) by an examination or medically appropriate and timely 
visits. Some States are even more specific and specify the time period 
in which the animal must have been seen by the veterinarian. A few 
States do not have a knowledge or acquaintance criterion, but instead 
require that the veterinarian has actually examined the animal or a 
representative segment of the consignment or herd. Thus, in most 
States, these requirements regarding responsibility are the same or 
similar to the current Federal definition.

[[Page 31718]]

    The third element of the Federal VCPR is that ``The practicing 
veterinarian is readily available for followup in case of adverse 
reactions or failure of the regimen of therapy'' (Sec.  530.3(i)(3)). 
The State VCPR definitions vary the most among each other and from the 
Federal definition in what they require regarding followup care. Seven 
States that define VCPR do not specify in their VCPR a requirement for 
followup veterinary availability. The primary role of the veterinarian 
in issuing a VFD is the supervision and oversight needed for the 
issuance of the VFD and feeding of the VFD feed. Even though some 
States do not have specific requirements about how readily available 
the veterinarian must be for followup, these States all have a 
requirement that the veterinarian is knowledgeable of, or acquainted 
with the animals, or farm, and/or the veterinarian has assumed the 
responsibility for making medical judgments regarding the health of the 
animal and its need for medical treatment.
    Most of the States that have a VCPR requirement that applies to the 
issuance of VFDs define a VCPR in a manner consistent with the Federal 
VCPR. Like the Federally defined VCPR, the key elements of a VCPR for 
many of these States includes the requirements that the veterinarian 
issuing a VFD assume responsibility for the medical care of the animal 
and have sufficient knowledge of the animal or herd based on having 
recently seen and being personally acquainted with the keeping and care 
of the animals and/or perform an actual examination of the animal or 
herd or make timely visits to the operation. For that reason, we 
believe that deferring to the State VCPR standard for those States that 
define an appropriate VCPR applicable to VFDs will allow States the 
needed flexibility to factor regional considerations into their VCPR 
requirements while, at the same time, continuing to provide sufficient 
protection for human and animal health. In those States that do not 
define a VCPR that includes the key elements in the Federally defined 
VCPR, or in the States that define a VCPR but do not require it for the 
issuance of a VFD, the veterinarian is required to issue the VFD within 
the context of a valid VCPR as that term is defined by FDA at Sec.  
530.1(i). FDA will work with States to finalize its list of the States 
that have an appropriate VCPR that applies to VFDs. Once that task is 
complete, FDA will communicate that information to the public as part 
of the implementation of this final rule. FDA will also continue to 
work with the States and veterinary associations to foster the adoption 
of VCPR definitions that are sufficiently rigorous to ensure meaningful 
veterinary supervision and oversight.
    With respect to the comment suggesting that a veterinarian who 
writes VFDs for a particular animal production operation needs to be 
licensed in each State where that operation has a facility, we disagree 
that such a requirement is necessary unless such licensing is required 
by the States where those facilities are situated. In other words, the 
veterinarian needs to be in compliance with the licensing requirements 
in the State(s) in which he or she is practicing veterinary medicine. 
The State laws and rules for licensing and practice determine for what 
activities a license is necessary and whether reciprocity or other 
programs that recognize licensure in another State may apply. It is the 
responsibility of the veterinarian to be familiar with the licensing 
and practice requirements for his or her activities in each State in 
which he or she practices veterinary medicine. A client who operates in 
multiple States may engage with one veterinarian who is in compliance 
with all of those States' licensing requirements, or may choose to 
engage more than one veterinarian to ensure that a veterinarian is 
available who complies with each of those States' licensing and 
practice requirements.
    (Comment 19) Some comments raised concerns with FDA's proposed 
language and the potential impacts on public health if the Federal VCPR 
standard is eliminated. Comments also expressed concern with the lack 
of a description or explanation in the NPRM of how the Federal standard 
is overly burdensome, how State regulations and voluntary ethical 
principles will adequately substitute for a VCPR, and why a Federally 
defined VCPR is unnecessary to ensure appropriate use of VFD drugs when 
it is appropriate to guide drug use in other contexts.
    (Response 19) As discussed elsewhere in this document, our 
intention was not to eliminate a VCPR standard, but instead to provide 
the flexibility of relying on States' standards for veterinary 
professional conduct, which are based on current veterinary practice 
standards, technological and medical advances, and other regional 
considerations. As discussed elsewhere in this document, based on the 
State defined VCPR standards that exist currently, we believe that an 
appropriate State defined VCPR standard affords a level of veterinarian 
supervision and oversight similar to the Federal VCPR standard, and 
helps ensure animals are being provided VFD drugs judiciously and for 
approved indications. Therefore, we do not think that this change will 
affect public health.
    We stated in the December 2013 NPRM that our intent was to provide 
greater flexibility for veterinarians by deferring to the individual 
States for the specific criteria for acceptable veterinary professional 
conduct. In the final rule, the Agency has affirmed its decision to 
defer to State practice standards for acceptable veterinary 
professional conduct when those standards require a VCPR for the 
issuance of a VFD that includes the key elements of the Federally 
defined VCPR standard. In response to comments that some State practice 
standards do not require a VCPR for the issuance of a VFD, and because 
a VCPR is an important part of veterinarian supervision and oversight 
in the VFD process, we will require adherence to the Federally defined 
VCPR if an applicable and appropriate State VCPR standard is not in 
place.
    As we have stated previously, many States have defined VCPR, and 
require a VCPR to exist in order for a veterinarian to issue a VFD. 
Many States also explicitly adopt the AVMA Principles of Veterinary 
Medicinal Ethics as part of their practice requirements, which includes 
a VCPR definition (Ref. 8). For States with a VCPR definition that does 
not include key elements of the Federally defined VCPR, or who do not 
require a VCPR for issuing a VFD, language in the regulatory text 
requires veterinarians to issue VFDs in compliance with the Federally 
defined valid VCPR. For the reasons stated previously, FDA believes a 
hybrid State and Federal VCPR approach is appropriate to help ensure 
sufficient veterinary oversight and supervision for the use of VFD 
drugs in or on animal feed.
    (Comment 20) Several comments were concerned that the elimination 
of the Federally defined VCPR as proposed in the NPRM would result in 
FDA no longer being able to take enforcement action against 
veterinarians who issue a VFD for animals outside the context of a 
VCPR. Several comments supported FDA engaging in outreach and education 
to feed mills and veterinarians on the subject of veterinarian 
supervision and oversight as it pertains to VFDs as part of this 
Agency's compliance and enforcement processes.
    (Response 20) We agree that it is important for regulations to be 
enforceable. The approach in the regulatory text allows either the 
States

[[Page 31719]]

or FDA to take enforcement action, depending upon the VCPR requirements 
at issue. If a veterinarian issues a VFD without complying with 
applicable State licensing and practice requirements, including VCPR, 
the State may take enforcement action and FDA may determine the 
resulting animal food to be adulterated or misbranded. If the Federally 
defined valid VCPR standard is applicable and the veterinarian fails to 
comply, FDA may act to enforce compliance. In addition, if the 
veterinarian is not complying with State licensing or practice 
requirements, or is not issuing a VFD within the context of the 
applicable State or Federally defined VCPR, the VFD issued will not be 
lawful. A VFD drug is limited by the terms of its approval, conditional 
approval, or index listing to use in or on animal feed only under a 
lawful VFD. If animal feed containing a VFD drug is fed to animals 
without a lawful VFD, then the VFD drug would be considered unsafe 
under section 512(a)(1) of the FD&C Act (21 U.S.C. 360b(a)(1)) and 
adulterated under section 501(a)(5) (21 U.S.C. 351(a)(5)) of the FD&C 
Act. In addition, the animal feed bearing or containing the VFD drug 
will be considered adulterated under section 501(a)(6) of the FD&C Act. 
A VFD drug and animal feed containing such a drug also will be 
considered misbranded under section 502(f) of the FD&C Act (21 U.S.C. 
352(f)) unless the drug and feed are labeled, distributed, held, and 
used in compliance with the applicable VFD requirements.
    FDA is committed to working with the State entities that license 
veterinarians in order to ensure that appropriate action is taken if 
the veterinarian does not issue VFDs in the context of an appropriate 
VCPR, or does not follow State licensing or practice requirements.
    (Comment 21) A few comments requested clarification about the use 
of the terms ``veterinary supervision'' and ``veterinary oversight'' as 
used in the VFD regulation. The comments asked whether ``oversight'' 
means something different than the term ``supervision'' which is used 
in section 504, or whether the two terms are meant to be synonymous. 
The comments were concerned that oversight could be performed in place 
of supervision and that it was a less-stringent standard. One comment 
requested that FDA define ``supervision or oversight'' to mean that the 
veterinarian has visited the premises at least once per year or 
documented why an alternative visitation schedule is more appropriate.
    (Response 21) For purposes of this regulation, the term 
``oversight'' is meant to be a synonym of ``supervision.'' The phrase 
``supervision or oversight'' was introduced in order to tie the 
oversight language FDA has used in other documents to the concept of 
veterinary ``supervision,'' which is the term used in section 504 of 
the FD&C Act. As discussed previously, the VCPR which is required for 
issuing a VFD controls how recently a veterinarian needs to have 
examined the animals or operation. As a result, FDA does not find it 
necessary to define the phrase ``supervision or oversight'' to mean 
that the veterinarian has visited the premises within a specific 
timeframe.
    (Comment 22) A few comments were concerned about a potential 
conflict of interest between the veterinarian and the client. One 
comment said that the veterinarian should not have a fiduciary tie to 
production. One comment said that an oversight committee should be 
established to independently approve antibiotic use.
    (Response 22) We understand the concern raised by these comments. 
However, most State practice requirements have a standard of ethics 
that addresses what constitutes a conflict of interest and the ethical 
standards veterinarians must observe in such circumstances. The 
requirement for the veterinarian issuing the VFD to comply with all 
State practice requirements includes compliance with standards of 
ethical conduct.
    We disagree that an oversight committee should be established to 
independently approve antibiotic use. Currently, there are several 
points of oversight in the use of antibiotics. The drug is first 
reviewed for safety and effectiveness as part of the approval or 
indexing process. During this process, parameters are set that limit 
the drug's use to certain conditions and for certain approved uses, as 
reflected on the drug's approved labeling (Refs. 9, 10, and 11). In 
addition, VFD drugs are required to be used under a veterinarian's 
supervision. The veterinarian's role is to make a medically-based 
decision as to whether a particular VFD drug or combination VFD drug is 
appropriate for the treatment, control, or prevention of a specific 
disease. Should the veterinarian determine that a VFD drug should be 
used, he or she can only use the drug as stated on the approved 
labeling of that drug. Extralabel use (ELU) of medicated feed, 
including VFD feed, is prohibited by statute.
    Furthermore, as part of the effort to implement the objectives of 
the National Strategy for Combating Antibiotic Resistance published in 
September 2014, FDA will be working with veterinary organizations, 
animal producer organizations, and other partners to identify and 
implement measures to foster stewardship of antibiotics in animals. 
These measures include educational outreach to veterinarians and animal 
producers to advance antibiotic stewardship and judicious use of 
antibiotics in agricultural settings (Ref. 12).
    (Comment 23) Several comments supported ELU being allowed by 
veterinarians for VFD drugs.
    (Response 23) ELU of a new animal drug in or on animal feed is 
illegal and results in the drug and feed being deemed unsafe under 
section 512(a) of the FD&C Act and adulterated under sections 501(a)(5) 
and (6) of the FD&C Act.
b. Veterinarian Licensing Information
    In the December 2013 NPRM, we proposed to remove the requirement 
that veterinarians include their license number and the name of the 
issuing State on the VFD. We received several comments on this issue 
and, after consideration of these comments, we are finalizing our 
proposal to not require veterinary licensing information on the VFD.
    (Comment 24) One comment requested that we require the veterinarian 
to list their license number and State of licensure on the VFD for 
traceability and accountability. This comment indicated that these 
requirements were not a burden on the veterinarian because 
veterinarians use preprinted forms, and adding this information to 
their electronic signature is a one-time effort that takes only minutes 
to complete. A few comments supported the proposed change because they 
thought the required name and address of the veterinarian on the VFD 
would be sufficient if follow up with the veterinarian ever became 
necessary.
    (Response 24) We disagree that including the veterinarian's license 
number and State of issuance on the VFD is necessary for traceability 
or accountability. The issuing veterinarian's name and address is 
sufficient for FDA to work with the State veterinary licensing boards 
to determine licensure status, in the event that there is a concern 
that a VFD has been illegally issued. Also, many State licensing boards 
maintain an online database that allows the public to search for a 
veterinarian's licensing status by their name.
    We disagree that the low burden is outweighed by the benefit of 
requiring this information, because we do not believe that this 
information provides any additional benefit to determining the 
licensure status of veterinarians.

[[Page 31720]]

Even if this information were to be required on the VFD, we would still 
need to perform an investigation into the licensing status of the 
issuing veterinarian in the event that there was a concern and the 
veterinarian's name and address is sufficient information to perform 
that investigation. In addition, some veterinarians may choose not to 
use preprinted forms or electronic signatures. For veterinarians who do 
not use preprinted forms or electronic signatures, the recordkeeping 
burden would be substantially greater than the comment suggests. 
Because this information would create a time burden for the 
veterinarian and does not provide information that aids our ability to 
investigate a veterinarian's licensure status, we are not including 
this requirement in the final regulatory text.
c. Name of Animal Drug (Sec.  558.6(b)(3)(vi))
    (Comment 25) One comment requested clarification on whether it is 
allowable to use an approved generic VFD drug as a substitute for an 
approved pioneer VFD drug in cases where the pioneer VFD drug is 
identified on a VFD.
    (Response 25) The veterinarian is required to write the name of the 
VFD drug on the VFD. The veterinarian may choose to write the name of 
the pioneer or a generic (if available) VFD drug to complete this 
requirement. The veterinarian may choose to specify that a substitution 
by the feed manufacturer of either the pioneer or generic VFD drug 
identified on the form is not allowed. If the veterinarian does not 
specify that a substitution is not allowed, the feed manufacturer may 
use either the approved pioneer or an approved generic VFD drug to 
manufacture the VFD feed. However, the feed manufacturer may not 
substitute a generic VFD drug for a pioneer VFD drug in a combination 
VFD feed if the generic VFD drug is not part of an approved combination 
VFD drug.
d. Client Name and Address (Sec.  558.6(b)(3)(ii))
    (Comment 26) A few comments requested clarification about whether 
the feedlot manager's information is the correct information for the 
client name and address.
    (Response 26) The client name and address should reflect the client 
in the veterinarian-client-patient relationship, which is typically the 
person responsible for feeding the animals the VFD feed. In many cases, 
a feedlot manager may be the appropriate individual.
e. Premises at Which the Animals Specified in the VFD Are Located 
(Sec.  558.6(b)(3)(iii))
    The December 2013 NPRM proposed to retain the existing requirement 
that the location of the animals be specified on the VFD. In the 
proposed language, this requirement was listed separately from the 
required information about the number and species of animals. The NPRM 
also proposed to allow the issuing veterinarian, at his or her 
discretion, to provide more detailed information about the location of 
the animals to be fed the VFD feed. The regulatory text in this final 
rule reflects the approach proposed in the NPRM.
    (Comment 27) A few comments suggested that the site or location at 
which the animals are located be determined broadly (i.e., the location 
of the premises where animals are located, but not the specific pen or 
confinement unit). A few comments were concerned that animals move 
throughout their life cycle and it may be difficult to identify one 
location.
    (Response 27) We expect that, in response to the requirement to 
enter information describing the premises where the animals are 
located, the veterinarian would enter information about the location of 
the animals that would allow someone to locate the animals. Typically, 
the address would be an appropriate way to identify the location; 
however, other generally recognized geographical indicators such a 
global positioning system (GPS) coordinate may be appropriate if a 
street address does not exist.
    We recognize that an address for a facility may not provide enough 
information to identify the location of animals in a case where the VFD 
is meant to authorize that a very specific group of animals receive the 
animal feed bearing or containing the VFD drug. As a result, the 
veterinarian may use his or her discretion to enter additional 
information on the VFD that more specifically describes the location of 
the animals such as the site, pen, barn, stall, tank, or other 
descriptor. The veterinarian should consult with the client to 
determine whether the animals will remain at this more specific 
location until the expiration date of the VFD.
    We understand that some groups of animals that are of similar age, 
weight range, etc., are managed in a similar manner, but may be housed 
in different physical locations. For example, a group of weaned pigs 
may be moved out of a nursery facility and transferred to multiple 
grow-out facilities for finishing. If a VFD is intended to authorize 
the use of a VFD feed in an identified group (approximate number) of 
animals that are located at more than one physical location, it is 
acceptable for a veterinarian to include multiple specified locations 
for that group of animals on the VFD. The veterinarian may write a VFD 
that covers animals in multiple locations (animal production 
facilities) to be fed the VFD feed by the expiration date on the VFD, 
provided he or she can do so in compliance with professional licensing 
and practice standards and provided the VFD feed is supplied to such 
multiple locations by a single feed manufacturer (distributor).
f. Expiration Date (Sec.  558.6(b)(3)(v))
    The December 2013 NPRM proposed to add new language to the 
requirement that the veterinarian enter the expiration date of the VFD 
on the form. The new language limits the veterinarian to using the 
expiration date that is specified in the approval, conditional 
approval, or index listing. Where such date is not specified, the 
veterinarian can write a VFD with an expiration date that does not 
exceed 6 months after the date of issuance of the VFD. The regulatory 
text in this final rule reflects this approach, with clarified 
language.
    (Comment 28) Many comments supported the 6-month expiration period. 
Some comments also requested that the VFD expire when an animal is 
deceased, at 6 months, or based on the expiration date specified in the 
approved labeling, whichever is shorter.
    (Response 28) We agree that a maximum 6-month expiration date in 
the absence of an expiration date specified in the approval, 
conditional approval, or index listing is appropriate. The date of 
expiration should be calculated by the calendar date, not the number of 
days. This will allow for easy calculation by veterinarians in the 
field. For example, using a 6-month expiration date for a VFD, if the 
VFD is written on July 10, then the expiration date would be January 10 
of the following year. Using the same 6-month expiration date example, 
but having the VFD written on the last day of the month, the VFD 
expiration date would be the last day of the sixth month even if that 
month has fewer days. Thus, in this example, if the VFD is written on 
August 31, the expiration date would be the following February 28 
during a regular calendar year, or February 29 during a leap year.
    With respect to the comments requesting to have the VFD expire when 
an animal is deceased, at 6 months, or based the expiration date 
specified in the approved labeling, whichever is shorter, we do not 
agree with these

[[Page 31721]]

comments. Having the VFD expire when an animal is deceased is not 
practical because one death in a herd or flock of animals would result 
in an unlawful VFD. However, if there is no expiration date specified 
in the approval, conditional approval, or index listing, the 
veterinarian may write an expiration date shorter than 6 months based 
on their medical judgment and taking into account factors such as the 
life cycle of the animals being treated. If there is an expiration date 
specified in the approval, conditional approval, or index listing, then 
the veterinarian has to use that date and may not write a shorter or 
longer expiration date for the VFD. Deviating from the expiration date 
specified by the approval, conditional approval, or index listing would 
constitute ELU, which is prohibited by section 512(a) of the FD&C Act.
    (Comment 29) Many comments requested the expiration period be 
shorter than 6 months. One comment requested that the VFD expire at the 
end of treatment. Some comments recommended expiration periods of 21 
and 30 days. One comment recommended that the maximum expiration period 
be shortened to 90 days if VFD drugs are used for unapproved uses or 
for longer than 6 months, with the possibility of extension upon 
reassessment.
    (Response 29) We disagree that a shorter expiration period is 
necessary for VFD drugs that do not specify an expiration date in their 
approval, conditional approval, or index listing. Even though a VFD can 
be written for a 6-month period does not mean the veterinarian will 
write all VFDs with a 6-month expiration date. The veterinarian will 
use his or her medical judgment to determine what expiration date is 
appropriate for the VFD, based on many factors including, but not 
limited to, the type of animal production facility and operation, the 
VFD drug or combination VFD drug at issue, the intended use of the VFD 
drug, and the health status, treatment history, and life cycle of the 
animals.
    Also, a maximum expiration period of 6 months does not necessarily 
mean that the animals will consume the feed containing the VFD drug for 
6 months. Rather, an expiration period of 6 months means that the 
authorization to feed the specified VFD product is lawful for 6 months. 
The veterinarian is also required to include on the VFD the duration of 
use, which limits the amount of time the animal feed bearing or 
containing the VFD drug can be fed. The duration of use must follow the 
duration that is specified in the approval, conditional approval, or 
index listing even if it is a shorter timeframe than the expiration 
date. If the veterinarian issues a new VFD after the expiration date of 
the first VFD, they can use their medical judgment, taking into account 
factors such as the life cycle and treatment history of the animal, to 
consider what expiration date would be appropriate for the new VFD, up 
to the 6-month maximum for VFD drugs that do not specify an expiration 
date in the approval, conditional approval, or index listing.
    We disagree that a shorter VFD expiration period should be in place 
for VFD drugs used for unapproved uses, or those used longer than 6 
months. Medicated feeds, including those bearing or containing a VFD 
drug, cannot legally be used in an extralabel (unapproved) manner; such 
use is prohibited by statute. As explained previously, the expiration 
date of the VFD does not control how long the VFD drug is to be used, 
but rather defines when it must be used by (i.e., the period of time 
for which the authorization is lawful).
    (Comment 30) Some comments requested that the maximum expiration 
date of a VFD be longer than 6 months. Most of these comments requested 
that the VFD expiration date be a maximum of 1 year.
    (Response 30) We disagree that a maximum expiration date for a VFD 
should be longer than 6 months for VFD drugs that do not have an 
expiration date specified in their approval, conditional approval, or 
index listing. We think that a 6-month maximum VFD expiration date 
permits veterinarians, based on their medical judgment and knowledge of 
the animal production operation, to determine on a case-by case basis 
whether the maximum 6-month period is an appropriate expiration date 
for the VFD or whether a more limited period is warranted. When deemed 
appropriate, we expect that flexibility in applying the VFD expiration 
date can substantially reduce the administrative burden associated with 
issuing VFDs for a given animal production operation. Limiting the 
expiration to a maximum of 6 months ensures that the veterinarian is 
required, at least every 6 months, to review whether factors such as 
the type of animal production operation, animal health, or the need to 
use a VFD drug have changed when considering whether to issue another 
VFD.
    (Comment 31) Several comments requested clarification about how the 
VFD expiration date relates to refills and reorders, the duration of 
use and the concept of standing orders. Several comments supported VFD 
drugs having clear limits on the duration of use. These comments did 
not specifically recommend an expiration date, but offered support for 
the risk criteria in GFI #152, ``Evaluating the Safety of Antimicrobial 
New Animal Drugs with Regard to Their Microbiological Effects on 
Bacteria of Human Health Concerns.'' Several comments were concerned 
that a VFD drug could be continuously used. Some of these comments 
requested that FDA not permit the continuous use of a VFD drug.
    (Response 31) As previously discussed, the VFD expiration date 
defines the period of time for which the authorization to feed an 
animal feed containing a VFD drug is lawful. This period of time may be 
specified in the approved labeling of a given VFD drug (e.g., 45 days 
for tilmicosin) or, if not specified in the labeling, the veterinarian 
must specify an expiration date that does not exceed 6 months. The 
duration of use is a separate concept than the expiration date and 
determines the length of time as established as part of the approval, 
conditional approval or index listing process that the animal feed 
containing the VFD drug is allowed to be fed to the animals. This 
period of time is specified in the labeling of the VFD drug (e.g., 21 
days for tilmicosin). For example, the currently approved VFD drug 
tilmicosin has an expiration date of 45 days, which means the client 
has 45 days to obtain the VFD feed and complete the 21 day course of 
therapy (Sec.  558.618). Animals cannot legally be fed the VFD feed 
after the VFD expiration date.
    We acknowledge the comments seeking limits on the duration of use 
of VFD drugs. However, the duration of use of VFD drugs (i.e., how long 
the drug is to be given to the animals) is not determined by the VFD 
regulation, but rather is established as part of the approval, 
conditional approval, or index listing process and is based on the 
scientific information submitted about the VFD drug. A VFD issued by a 
licensed veterinarian authorizes a client to feed the VFD feed to the 
client's animals. The expiration date of a VFD is the length of time 
that such authorization is lawful. In contrast, the duration of use 
limits the length of time that the animals can be fed the animal feed 
containing the VFD drug. Thus, in the example of tilmicosin, the 
approval allows a VFD expiration date of 45 days, but the duration of 
use (i.e., how long the drug is to be given to the animals) is limited 
to 21 days.
    Similar to the concept of refilling a prescription for 30 tablets 
with another 30 tablets, a refill or reorder in the VFD

[[Page 31722]]

context is meant to apply when the feed authorized under the VFD has 
been exhausted. The refill or reorder would provide authorization to 
obtain and feed additional VFD feed in the same total quantity and 
under the same conditions of the existing VFD by the expiration date of 
that VFD. A veterinarian can only authorize refills or reorders if the 
labeling of the product in question explicitly permits them. Currently, 
there are no approved VFD drugs that allow refills or reorders as a 
condition of their approval, conditional approval, or index listing.
    FDA anticipates that the appropriate use of refills or reorders 
could vary considerably depending on the VFD drug and its use. Since we 
cannot predict what disease conditions, and what types of VFD drugs for 
the treatment, control, or prevention of those diseases, may exist in 
the future, appropriate limitations regarding refills and reorders and 
how they relate to the expiration date of the VFD must be considered on 
a case-by-case basis as part of the new animal drug approval process. 
In the context of antimicrobial VFD drugs, FDA envisions that the 
refill/reorder concept will have limited applicability.
    The term ``standing order'' is not used in the regulatory text 
included in this final rule, but has been used in public meetings and 
by industry to refer to the situation in which a veterinarian issues a 
VFD for a VFD drug that does not have a label-defined VFD expiration 
date; therefore, the veterinarian is required to apply a VFD expiration 
date that does not exceed 6 months from the time the VFD is issued. In 
such a case, the veterinarian, in the context of a VCPR, would use his 
or her medical judgment and knowledge of the animal production facility 
and operation to determine the therapeutic needs for the VFD drug by 
the expiration date established by the veterinarian. As a result, the 
client would have the VFD authorization in place and could more quickly 
get the animal feed containing the VFD drug manufactured if and when 
the animals needed treatment. In addition, this practice would allow 
for clients with limited access to veterinarians to be able to receive 
a VFD within the confines of a VCPR and use it at a later date, but 
within the expiration date of the VFD, when the need for use of the 
animal feed containing the VFD drug occurs.
g. Approximate Number of Animals To Be Fed the VFD Feed by the 
Expiration Date on the VFD (Sec.  558.6(b)(3))
    In the December 2013 NPRM, FDA proposed removing the requirement 
for a veterinarian to identify the amount of feed to be manufactured 
under the VFD, and modified the requirement to identify the number of 
animals to instead require the veterinarian to identify the approximate 
number of animals to be treated under the VFD.
    (Comment 32) Multiple comments supported changing the requirement 
to identify the amount of feed manufactured to instead identify the 
approximate number of animals on the VFD. These comments recognized the 
current problems with calculating the amount of feed, including the 
need to write additional VFDs when feed volume is underestimated and 
recordkeeping for delivery of feed that only partially fulfills the 
amount of feed on the VFD. One comment also stated that this change 
will allow the amount of feed required to be determined by the feed 
manufacturer, which is how other feed orders are filled.
    (Response 32) FDA agrees that the requirement to state the 
approximate number of animals instead of the amount of feed resolves 
the problems noted in the comments. FDA agrees that the feed 
manufacturer, in consultation with the client, has the experience 
necessary to determine the amount of feed that should be manufactured 
in order to treat the approximate number of animals identified by the 
veterinarian on the VFD.
    (Comment 33) Several comments were concerned that the approximate 
number of animals was not clearly defined and were unsure how FDA 
intended to use the information in enforcing the VFD regulations. These 
comments were unsure of the scientific basis for specifying the number 
of animals. The comments were also concerned that the number of animals 
can change between the time the VFD is issued and the time it expires, 
and the requirement would add to increased time and costs. The comments 
requested clarification on the responsibility of the feed mill to 
address discrepancies between the number of animals and amount of feed.
    (Response 33) FDA agrees that further clarity is needed for 
stakeholders to correctly calculate the approximate number of animals. 
Therefore, FDA is including additional language in the regulatory text 
at Sec.  558.6(b)(3)(viii) to clarify how the approximate number of 
animals should be calculated. The approximate number of animals is the 
potential number of animals of the species and production class 
identified on the VFD that will be fed the VFD feed or combination VFD 
feed manufactured according to the VFD at the specified premises by the 
expiration date of the VFD. Because the VFD authorization targets the 
animals that need to be fed the VFD feed, FDA believes the approximate 
number of animals is an appropriate mechanism to limit the scope of use 
authorized by the VFD.
    FDA recognizes that the number of animals to be covered under the 
VFD can change by the expiration date; animals may leave or enter the 
group being fed the VFD feed manufactured under the VFD for a variety 
of reasons. This is why FDA chose to include the term ``approximate'' 
in the requirement. FDA believes that veterinarians typically have 
enough information about the animal production operation to determine 
the approximate number of animals that will be entering or leaving the 
operation over a specific period of time.
    FDA does not agree that determining the approximate number of 
animals will increase time or costs. Calculating the approximate number 
of animals should take less time than complying with the previous 
requirement to calculate the amount of feed because the calculation 
will include fewer factors to take into consideration. Furthermore, 
using the approximate number of animals may decrease costs because 
clients will have the flexibility to work directly with their feed 
supplier to ensure that the appropriate amount of feed is provided for 
the approximate number of animals authorized by the VFD. This reduces 
the burden of seeking an additional VFD in those cases where, if the 
previous requirement to specify the amount of feed on the VFD were 
still in effect, the veterinarian may have underestimated the amount of 
VFD feed the animals would consume.
    FDA expects the feed mill to share expertise and work with the 
client and veterinarian to determine the appropriate amount of feed to 
be manufactured for the approximate number of animals authorized by the 
VFD and to retain the necessary records to document the amount of feed 
that was manufactured under the VFD. FDA expects that feed mills will 
only distribute VFD feeds in quantities that are commensurate with the 
approximate number of animals as specified by the veterinarian in the 
VFD. FDA anticipates that, as part of its inspectional activities, it 
will consider such factors as whether the amount of feed manufactured 
is reasonable relative to the approximate number of animals specified 
in the VFD.
    (Comment 34) One comment was concerned that using the approximate 
number of animals would lead to overuse or stockpiling of medicated 
feeds, and would potentially remove veterinarian oversight from the 
process.

[[Page 31723]]

    (Response 34) FDA disagrees with this comment. The veterinarian, 
with input from the client, will be responsible for identifying the 
approximate number of animals on the VFD. This level of veterinarian 
involvement is similar to the veterinarian's current role in 
identifying the amount of feed. FDA expects that feed mills will only 
distribute VFD feeds in quantities that are commensurate with the 
approximate number of animals specified in the VFD. In addition, the 
client has the responsibility to use the VFD feed within the 
constraints of the VFD as written by the veterinarian.
    Furthermore, FDA does not believe that this change will lead to 
over-purchasing, stockpiling or unregulated use of VFD drugs or the VFD 
feeds manufactured with them. Medicated feeds can be susceptible to 
decomposition if they are stored for lengthy periods of time, making it 
unlikely that clients would stockpile economically valuable medicated 
feeds. In addition, other requirements on the VFD limit use of the VFD 
feed to a specified group of animals for a specified time period, which 
will help to regulate use and prevent stockpiling. FDA believes that 
feed mills will be able to more accurately determine the amount of feed 
to manufacture because they can work with the client as batches of feed 
are shipped under the VFD to adjust the amount of feed as feed 
consumption rates change among the animals. The Agency believes this 
will help to prevent overuse.
    Therefore, FDA is revising the current requirement for the number 
of animals to be treated in Sec.  558.6(b)(3)(viii) to mean an 
approximate number of animals to be fed the VFD feed by the expiration 
date on the VFD, due to the difficulty in determining the exact number 
of animals to be treated during the duration of the VFD. In addition, 
FDA is removing the existing requirement in Sec.  558.6(a)(4)(vi) for 
veterinarians to specify the amount of feed to be fed to the animals 
listed on the VFD, as discussed elsewhere in this document. 
Veterinarians will instead be required in Sec.  558.6(b)(3)(x) to 
include the duration of VFD drug use on the VFD in addition to the 
level of VFD drug in the feed, as is currently required.
h. Refills or Reorders Authorized on the VFD (Sec.  558.6(b)(3)(xii))
    In the December 2013 NPRM, FDA added to the language that requires 
the number of refills or reorders to be entered on the VFD to account 
for refills or reorders allowed as part of a conditional approval, or 
index listing in addition to an approval. FDA has updated the proposed 
language to clarify that when an approval, conditional approval, or 
index listing is silent on refills or reorders, they are not allowed.
    (Comment 35) Some comments supported refills or reorders to 
continue to be entered on the VFD if refills or reorders are permitted 
by the approval, conditional approval, or index listing. A subset of 
these comments requested clarification about how refills or reorders 
relate to the other provisions of the VFD regulation and what the 
phrase ``permitted by the approval, conditional approval, or index 
listing'' means. One comment suggested that the need for refills or 
reorders be determined based on the duration of the disease period. One 
comment asked FDA to remove this requirement because it is likely to 
cause confusion among animal producers, veterinarians, and feed mills, 
as many existing OTC products that are changed to VFD status under the 
GFI #213 process do not have a refill listed on their label.
    (Response 35) We agree that if a refill or reorder is permitted as 
part of the VFD drug approval, conditional approval, or index listing, 
the veterinarian is required to indicate on the VFD whether he or she 
is authorizing a refill or reorder and if so, the number of refills or 
reorders authorized within the limitations permitted by the approval, 
conditional approval, or index listing. In order for a refill or 
reorder to be permitted, it must be explicitly allowed in the VFD drug 
approval, conditional approval, or index listing. Clarifying language 
has been added to the regulatory text specifying that when the labeling 
for an approval, conditional approval, or index listing is silent in 
regards to refills or reorder, a refill or reorder is not permitted.
    A refill or reorder is meant to apply to when the feed authorized 
under the VFD has been exhausted. The refill or reorder would provide 
authorization to obtain and feed additional VFD feed in the same total 
quantity and under the same conditions of the existing VFD by the 
expiration date of the VFD. Currently, there are no approved VFD drugs 
that allow refills or reorders as a condition of their approval, 
conditional approval, or index listing. A veterinarian can only 
authorize refills or reorders if the labeling of the product in 
question explicitly permits them. Therefore, refills or reorders are 
not permitted for an approval, conditional approval, or index listing 
of a VFD drug if the label of such product is silent on the labeling 
about refills or reorders.
    Although there are no refills or reorders permitted for any current 
VFD drug approvals, there may be future VFD drugs that may be 
appropriately refilled or reordered as authorized by the veterinarian 
on the VFD according to their professional judgment up to the maximum 
number permitted by the VFD drug approval, conditional approval, or 
index listing. FDA anticipates that the appropriate use of refills or 
reorders could vary considerably depending on the VFD drug and its use. 
Since we cannot predict what disease conditions, and what types of VFD 
drugs for the treatment, control, or prevention of those diseases, may 
exist in the future, appropriate limitations regarding refills and 
reorders and how they relate to the expiration date of the VFD must be 
considered on a case-by-case basis as part of the new animal drug 
approval process. In the context of antimicrobial VFD drugs, FDA 
envisions that the refill/reorder concept will have limited 
applicability.
    If a veterinarian writes a VFD that authorizes a refill or reorder 
for a VFD drug that does not permit a refill or reorder, or if the 
authorization exceeds the number of refills or reorders permitted, FDA 
would consider that to be ELU of the VFD drug. ELU of a drug on or in 
animal feed is prohibited by statute.
    (Comment 36) Some comments supported limiting the number of refills 
or reorders. Several comments were concerned that without a limit to 
refills or reorders, the non-specific use of antibiotics for long 
periods of time would be allowed, or that veterinarians could write 
unlimited refills. A few comments requested that the requirement to 
list the number of refills or reorders on the VFD should be removed 
because it is difficult for the feed manufacturer to track.
    (Response 36) FDA agrees that limiting refills or reorders is 
appropriate. However, those limitations should be based on the safety 
and effectiveness data, and intended use as evaluated and determined at 
the time of the VFD drug approval, conditional approval, or index 
listing. The approvals and index listings for the current VFD drugs do 
not permit refills or reorders.
    FDA disagrees that the requirement to list the number of the 
refills or reorders on the VFD should be removed. Should a veterinarian 
authorize refills or reorders for a VFD drug as permitted by its 
approval, conditional approval, or index listing, this is necessary 
information for the feed mill to appropriately manufacture and for the

[[Page 31724]]

client to appropriately feed the VFD feed.
i. Combination Drugs (Sec.  558.6(b)(6)(xiv))
    In the December 2013 NPRM, FDA proposed a new provision that would 
require the issuing veterinarian to include one of three ``affirmation 
of intent'' statements on the VFD regarding the use of a VFD drug in an 
approved, conditionally approved, or indexed combination in medicated 
feed. These ``affirmation of intent'' statements would either: (1) 
Allow the VFD drug to be used in any approved, conditionally approved, 
or indexed combination in VFD feed; (2) allow the VFD drug to be used 
only in specific approved, conditionally approved, or indexed 
combinations in VFD feed; or (3) not allow the VFD drug to be used in 
any approved, conditionally approved, or indexed combination in VFD 
feed. We received several comments on this new provision and have 
revised the language in the regulatory text to provide additional 
clarity in response to the comments received.
    (Comment 37) A few comments expressed concern that the veterinarian 
would not have sufficient knowledge of approved combination VFD drugs. 
They were concerned that the veterinarian would write a VFD allowing a 
combination VFD drug that was not approved, conditionally approved, or 
indexed, or that he/she would not authorize a VFD for a combination VFD 
drug that was approved, conditionally approved, or indexed.
    (Response 37) We understand this concern and have clarified the 
language in the regulatory text to more explicitly state the three 
``affirmation of intent'' statements the veterinarian may make. These 
``affirmation statements'' facilitate the process by which a 
veterinarian indicates his or her intent for authorizing the use of a 
VFD drug with other drugs (i.e., approved, conditionally approved, or 
indexed combination VFD drugs) to make combination VFD feeds. If such 
statements were prepopulated on the VFD provided by the sponsor, we 
anticipate that the veterinarian would only have to circle, provide a 
check mark, or use another method to clearly indicate whether the VFD 
drug: (1) May be used in any approved, conditionally approved, or 
indexed combination in VFD feed; (2) may be used in only specific 
approved, conditionally approved, or indexed combinations in VFD feeds; 
or (3) may not be used in any approved, conditionally approved, or 
indexed combination in VFD feed. If the VFD drug is approved, 
conditionally approved, or indexed for use in multiple combination VFD 
feeds, and the veterinarian does not want the VFD drug to be used in 
all approved, conditionally approved, or indexed combinations in 
medicated feeds, then the veterinarian would need to specify the 
combination VFD feed(s) in which the veterinarian is authorizing the 
VFD drug to be used.
    This process of affirming intent will reduce the opportunity for a 
veterinarian to mistakenly authorize an illegal combination of drugs 
when he or she chooses to only authorize the VFD drug to be used in 
certain combination VFD feeds. In addition, veterinarians that create 
their own VFD can rely on the drug labeling to determine whether the 
drug is approved, conditionally approved, or indexed to be used in 
combination with another drug or drugs. In the situation where a VFD is 
authorizing the use of two or more VFD drugs in an approved, 
conditionally approved, or indexed combination in VFD feed, the VFD 
must contain information for all of the individual VFD drugs in the 
combination. A VFD that authorizes an unapproved combination is not a 
lawful VFD because ELU of medicated feeds, including feeds containing 
VFD drugs, is prohibited. We think that this approach balances reducing 
the risk of an illegal combination being mistakenly included on a VFD 
with the need for a veterinarian to be able use his or her medical 
judgment to limit the use of a VFD drug in combination with other 
drugs.
    (Comment 38) One comment requested that additional information be 
provided in the preamble to the final rule explaining how currently 
approved, conditionally approved, or indexed combinations of drugs 
would be used when drugs included in such combinations are changed from 
OTC drugs to VFD drugs.
    (Response 38) We agree that it would be helpful to further clarify 
the use of approved, conditionally approved, or indexed combination new 
animal drugs containing a VFD drug and one or more OTC or VFD drugs 
after such drugs in currently used combinations are changed from OTC to 
VFD. If any component drug in an approved, conditionally approved, or 
indexed combination drug is a VFD drug, the combination drug is a 
combination VFD drug and its use must comply with the VFD requirements. 
This is because combination drug products must meet the requirements of 
the drug in the combination that is most strictly regulated. In 
addition, section 504 of the FD&C Act requires a VFD in order to feed 
an animal feed bearing or containing a VFD drug to an animal. This is 
the case whether the VFD drug is being used in or on the feed by 
itself, or in combination with other OTC or VFD drugs.
    An analogous situation is when an approved, conditionally approved, 
or indexed combination drug contains both Category I and Category II 
drugs. If the animal feed bearing or containing the combination drug is 
manufactured from a Category II Type A medicated article, the mill must 
be licensed and follow the requirements for a licensed medicated feed 
mill (which are stricter requirements).
j. Veterinarian Must Issue a Written VFD (Sec.  558.6(b)(7))
    (Comment 39) One comment requested that FDA modify the requirement 
that a veterinarian may not transmit a VFD by phone to state that the 
veterinarian must not verbally transmit a VFD because technology may 
allow for a written VFD to be transmitted by a phone.
    (Response 39) FDA proposed in the December 2013 NPRM to change this 
provision for the reasons stated in the comment. FDA finalizes this 
change in the regulatory text.
k. Contents of the VFD
    (Comment 40) One comment requested that mixing directions not be 
allowed on a VFD because they are on the label directions.
    (Response 40) We understand that non-required information that is 
placed on the VFD can create confusion and make it more difficult to 
locate required information on the form. FDA recommends the amount of 
information on the VFD be limited to the required and discretionary 
information listed in Sec.  558.6(b)(3) and (4). FDA also recommends 
that non-required information the veterinarian chooses to include on a 
VFD in addition to the mandatory and discretionary information listed 
in Sec.  558.6(b)(3) and (4) be in a place and manner that does not 
interfere with the information listed in Sec.  558.6(b).
    (Comment 41) A few comments requested that a uniform VFD format be 
required.
    (Response 41) FDA understands that a uniform VFD format would help 
clients, veterinarians, and distributors (including feed mills) quickly 
identify relevant information on the VFD. However, FDA believes that 
requiring a specified format for the VFD would be too prescriptive. In 
this final rule, FDA is updating the regulatory text in Sec.  
514.1(b)(9) to clarify that as part of the application process, the 
sponsor must

[[Page 31725]]

submit a form that accounts for the information in Sec.  558.6(b)(3) 
that the veterinarian must ensure is on the VFD and the optional 
information in Sec.  558.6(b)(4) that the veterinarian may include at 
his or her discretion. This change will help reduce confusion as to 
whether a specific format is required. It will also ensure that when a 
company distributes a VFD form tailored to that company's products, the 
veterinarian will have an opportunity to complete all of the required 
and optional information specified in the regulation. We believe that 
having the VFD form that is provided by the VFD drug manufacturer 
include the required and discretionary information elements in Sec.  
558.6(b) is the best approach. Although many companies distribute for 
use by veterinarians a VFD form that is specific to their own products, 
a veterinarian may also create or use a different VFD as long as it 
contains all of the required information.
3. Responsibilities of Any Person Who Distributes an Animal Feed 
Containing a VFD Drug or a Combination VFD Drug (Sec.  558.6(c))
    In the December 2013 NPRM, we proposed to remove the requirement 
for distributors to keep records of receipt and distribution from Sec.  
558.6(e). We proposed this change because we were changing the 
retention period for records under the VFD rule from 2 years to 1 year 
and these records were already required to be kept by manufacturers to 
comply with the CGMP requirements set forth in part 225. However, as we 
considered this final rule, it became apparent that a distinction 
should be made between distributors who manufacture VFD feed and those 
who do not manufacture VFD feed, but only distribute VFD feed. The 
final rule provides that all distributors, regardless of whether they 
manufacture animal feeds bearing or containing VFD drugs or not, must 
keep records of receipt and distribution for 2 years from the date of 
issuance in accordance with Sec.  558.6(c)(3). Although this 
requirement is duplicative for distributors that manufacture animal 
feeds bearing or containing VFD drugs and must comply with part 225, it 
is not duplicative for distributors who do not manufacture animal feeds 
bearing or containing VFD drugs and do not have to comply with part 
225. In addition, we believe it is important that all distributors be 
required to maintain receipt and distribution records because these 
records are an important tool to trace the animal feed in the event of 
a recall or investigation of a potentially misbranded or adulterated 
product. Furthermore, by explicitly stating all VFD recordkeeping 
requirements in part 558, distributors are not required to refer to 
another part of the regulation to determine their specific VFD 
recordkeeping requirements.
    Also, we have added clarifying language that distributors who 
manufacture animal feed bearing or containing VFD drugs must keep VFD 
feed manufacturing records for 1 year in accordance with part 225 of 
this chapter. These manufacturing records are not required to be kept 
for 2 years unless they are also required to be kept under part 558 
(e.g., the distributor's copy of the VFDs and receipt and distribution 
records).
4. Other Comments
    (Comment 42) Multiple comments supported the proposed rule's intent 
to provide additional efficiency and flexibility in issuing VFDs. 
Several comments mentioned that providing drugs through animal feed is 
an important drug delivery tool. Several comments stated that the rule 
was a step in the right direction, but wanted more done to reduce 
antimicrobial use. Some comments supported the revisions to clarify 
that conditionally approved and indexed VFD drugs are included.
    (Response 42) FDA believes that the rule achieves its intent to 
provide additional efficiency and flexibility in issuing VFDs. FDA 
recognizes the importance of animal feed as a drug delivery tool. FDA 
recognizes that certain revisions to this rule will facilitate a 
broader effort to assure the judicious use of antimicrobials in food-
producing animals. FDA agrees that this rule provides additional 
clarity that VFD drugs that are conditionally approved or indexed drugs 
are also subject to the requirements in this final rule.
    (Comment 43) Many comments indicated that FDA's approach should be 
mandatory, not voluntary. Some comments were concerned that the 
voluntary approach had no mechanism for enforcement or metric for 
success. Other comments were concerned that there were loopholes in the 
rule. One comment thought the rule was not strong enough to stop 
antibiotic use and antimicrobial resistance.
    (Response 43) Many of these comments were unclear as to whether 
they were referring to the implementation of this rule or FDA's efforts 
to promote the judicious use of antibiotics in food-producing animals 
as outlined in the Agency's guidance documents GFIs #209 and #213. To 
the extent that these comments were applicable to the enforceability of 
this rule, FDA disagrees that this approach is voluntary. The 
requirements in the regulatory text are mandatory. As stated in the 
December 2013 NPRM, the Agency is amending the VFD regulations to make 
the VFD program as efficient as possible for stakeholders while 
maintaining adequate protection for human and animal health as FDA 
implements the judicious use principles for medically important 
antimicrobial new animal drugs approved for use in food-producing 
animals.
    While not directly relevant to this rulemaking, FDA disagrees with 
the comments that say a voluntary approach to judicious use of 
antimicrobials cannot be effective. As of June 30, 2014, all sponsors 
of medically important antimicrobial new animal drug products covered 
by GFI #213 have agreed in writing that they intend to engage in the 
judicious use strategy by seeking withdrawal of approvals relating to 
any production uses and changing the marketing status of their products 
from OTC to use by VFD or prescription in order to limit the remaining 
therapeutic uses of these products in food-producing animals to use 
under the oversight or supervision of a licensed veterinarian. While 
GFI #213 specified a 3-year timeframe (until December 2016) for drug 
sponsors to voluntarily complete the recommended changes to their 
antimicrobial products, some sponsors have already begun to implement 
these changes (Ref. 13).
    (Comment 44) Several comments requested clarification on how FDA 
intends to enforce the VFD requirements as drugs change from OTC status 
to VFD status as part of the implementation of GFI #213. These comments 
asked whether there would be a period of regulatory discretion, or the 
allowance of in-commerce labeling changes, in order to handle product 
on the market when the change occurs.
    (Response 44) This question touches upon the broader implementation 
of GFI #213 and does not pertain specifically to the changes in this 
the December 2013 NPRM. However, we understand the practical 
implications of accommodating drug products already in distribution 
channels and are working to develop and provide further guidance to 
facilitate an orderly transition of medically important antimicrobial 
drugs from OTC to a marketing status (VFD or prescription) that 
requires veterinary oversight.
    (Comment 45) One comment asked FDA to delay the implementation of 
the amended VFD regulation until after the implementation of GFI #213. 
This comment suggested that there was a conflict of interest in FDA 
issuing this

[[Page 31726]]

final rule before stakeholders had committed to GFI #213.
    (Response 45) We have carefully considered all comments in 
finalizing this rule. As discussed in the December 2013 NPRM, it is 
important that the changes to increase efficiency in the VFD program 
occur prior to the transition of the existing medically important 
antimicrobial drugs approved for use in animal feed from their existing 
OTC status to VFD status as part of the implementation of GFI #213. 
Furthermore, at this time, all sponsors of the drugs identified in GFI 
#213 have publicly committed to fully engage in this Agency's judicious 
use strategy which calls for phasing out the use of medically important 
antimicrobials in food-producing animals for food production purposes 
and phasing in the oversight of a licensed veterinarian for the 
remaining therapeutic uses of such drugs (Ref. 13).
    (Comment 46) Some comments suggested that FDA should collect and 
publicly report data about whether the effort to end subtherapeutic use 
of antibiotics is working. A few comments thought that VFDs should be 
submitted to FDA for compilation, analysis, and public reporting. A few 
comments opposed submitting VFDs to FDA because of the additional 
reporting burden. One comment further opposed the submission of VFDs to 
FDA because VFDs would not be an accurate tool in estimating 
antimicrobial use because they are reflective of the amount of 
antimicrobials authorized, not the amount of antimicrobials used. 
Another comment thought that FDA's access to VFDs during inspections 
was sufficient to assess compliance.
    (Response 46) In response to the suggestion that FDA collect and 
publicly report data about whether the effort to end subtherapeutic use 
of antibiotics is working, FDA notes that the Agency has already 
committed to publishing information every 6 months about the progress 
of GFI #213 implementation (Ref. 13). In addition, FDA provides ongoing 
updates on its Web site regarding sponsor actions related to GFI #213 
implementation (Ref. 13).
    FDA does not agree that VFDs should be submitted for compilation, 
analysis and public reporting. Compliance with VFD regulations cannot 
be assessed by only reviewing the VFD. The VFD must be considered in 
the context of the operation. This review is ordinarily done during an 
inspection or investigation. FDA agrees that VFD data would not be an 
accurate reflection of antimicrobial use because the VFD only 
represents the amount of antibiotics authorized to be used, not the 
amount that actually is used. FDA currently receives antimicrobial 
sales and distribution data, collects antimicrobial resistance data 
under NARMS, and is developing additional mechanisms for collecting on-
farm information regarding antimicrobial use and resistance (Ref. 15). 
It would be administratively burdensome for FDA to also receive, 
compile, and house VFDs in a central location. Furthermore, there are 
disclosure laws that would require FDA to redact most, if not all, of 
the information required on a VFD because it is considered confidential 
commercial information.
    (Comment 47) Several comments were concerned that the changes to 
this rule did not sufficiently protect public health.
    (Response 47) As previously discussed, it was not FDA's intention 
in the December 2013 NPRM to remove or lessen public health 
protections. The previous and current VFD regulatory text contains many 
provisions that are designed to protect public health. The VFD drug 
designation provides public health protection by allowing FDA to limit 
a drug's use in or on animal feed by requiring administration under a 
veterinarian's supervision and oversight as authorized in the VFD. When 
an animal drug has been designated a VFD drug, the veterinarian, 
distributor, and client must adhere to additional regulatory 
requirements than are applicable to the use of other animal drugs in 
medicated feed. These additional regulatory requirements are designed 
to protect public health by ensuring accountability for those 
individuals involved in the use of the VFD drug and VFD feed. These 
regulatory requirements also are designed to allow FDA to review the 
use of the VFD drug and VFD feed to ensure that the VFD drug and VFD 
feed are used according to the conditions and indications of use as 
specified in the approval, conditional approval or index listing, and 
within the supervision and oversight of a licensed veterinarian.
    The veterinarian, distributor, and client all have several joint 
obligations that are intended to protect public health. The VFD feed 
may only be fed to animals by or upon a lawful VFD issued by the 
veterinarian. Public health is protected by limiting use of VFD drugs 
and VFD feed to use under the supervision of a veterinarian as 
indicated on the VFD because the veterinarian has medical expertise to 
determine when and how a VFD drug may be appropriately used in animals. 
All of these involved parties share responsibility in ensuring that a 
lawful VFD has been issued and the VFD feed is manufactured and used 
according to the terms of the VFD as issued by the veterinarian. 
Moreover, the regulations require that VFD drugs and VFD feed contain a 
caution statement that the VFD drug and resulting VFD feed are 
restricted to use by or on the order of a licensed veterinarian. In 
addition to the VFD, these involved parties also each have their 
specific responsibilities in ensuring that the VFD drug and resulting 
VFD feed is labeled and used according to the approval, conditional 
approval, or indexed conditions of use (not used in an extralabel 
manner). The VFD, VFD drug, and VFD feed are all required to contain a 
statement that ELU is not permitted. During the approval, conditional 
approval, or indexing process, FDA sets limitations on how animal drugs 
can be used based on the scientific evidence offered by the sponsor to 
show that the drug is safe and effective for the conditions of use. 
Public health is protected by limiting use of VFD drugs and VFD feed to 
conditions of use that are based on scientific evidence of safety and 
effectiveness that has been reviewed by FDA.
    The veterinarian has several specific obligations that are intended 
to protect public health. The veterinarian is responsible for using his 
or her professional veterinary judgment to determine whether a VFD 
should be issued and what terms the VFD should contain as allowed by 
the relevant approval, conditional approval, or index listing. The 
veterinarian issuing the VFD is required to be licensed to practice 
veterinary medicine and be operating in compliance with applicable 
licensing and practice requirements. FDA has clarified that compliance 
with applicable licensing and practice requirements includes the 
expectation that the veterinarian is issuing the VFD in the context of 
an appropriate VCPR as discussed elsewhere in this document. The 
veterinarian is required to issue the VFD in writing and ensure that 
all of the required information is fully and accurately included on the 
VFD. The required information reflects several public health 
protections including, but not limited to information that: (1) 
Describes VFD drug, VFD feed, and the indication for which the VFD feed 
is authorized to be used; (2) describes the animal or group of animals 
to receive the VFD feed; (3) limits the use of the VFD feed based on 
the duration of feeding, the expiration date and the allowance of 
refills or reorders, if any; (4) allows or limits the use of the VFD 
drug in combination

[[Page 31727]]

with other animal drugs; and (5) limits the use of the VFD feed based 
on withdrawal times, special instructions or necessary cautionary 
statements. The veterinarian is also required to provide to the 
distributor and client a copy of the VFD. By providing the distributor 
and client with the required information on the written VFD, the 
veterinarian ensures that the distributor and client have the necessary 
information to manufacture and use the VFD feed according to the 
approval, conditional approval, or index listing, and under the 
veterinarian's supervision and oversight.
    The distributor also has several specific obligations that are 
intended to protect public health. The distributor may only fill a VFD 
if the VFD contains all of the required information. This requirement 
provides an additional opportunity for the VFD to be reviewed to ensure 
that it is complete and prohibits the distribution of the VFD feed if 
it is not. The distributor is also required to keep for 2 years the 
records of receipt and distribution of all of the VFD feed it 
distributes. This requirement protects public health by requiring 
records that would be important for tracing the VFD feed through the 
distribution system if a problem with the VFD feed were to occur. The 
distributor must notify FDA prior to that party's first distribution of 
VFD feed and must notify FDA of any changes in the distributor's 
contact information or ownership. This notification allows FDA to 
protect public health by maintaining an inventory of VFD feed 
distributors to be used for inspection and investigational purposes.
    The VFD regulation also includes requirements specific to the 
client (animal producer) that are intended to protect public health. 
For example, the client may only feed the VFD feed to animals by or 
upon a lawful VFD issued by a licensed veterinarian in the course of 
the veterinarian's professional practice. As explained previously, the 
client is obligated to use the VFD feed as indicated on the VFD and as 
allowed in the VFD drug's approval, conditional approval, or index 
listing. Furthermore, the VFD feed cannot be fed to the animals after 
the expiration date of the VFD. These requirements protect public 
health by ensuring that the VFD feed is being fed to the animals under 
the veterinarian's supervision and oversight in accordance with the VFD 
and the conditions of approval, conditional approval, or index listing 
for the VFD drug or combination VFD drug at issue.
    FDA has the responsibility for enforcing these requirements and 
ensuring that VFD drugs and VFD feeds are used according to these 
requirements that are intended to protect public health. The 
requirements for the veterinarian, distributor, and client allow FDA to 
review the use of VFD drugs and VFD feed in the field to determine 
whether VFD drugs and VFD feeds are being used consistent with the VFD 
issued by the veterinarian, as well as in accordance with the VFD 
drug's approval, conditional approval, or index listing.
    FDA intends to use a phased enforcement strategy for implementation 
of this final rule. 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. These education and training efforts are important for 
supporting effective implementation and compliance with the final rule. 
As products are changed to VFD status under the GFI #213 process, FDA 
will then engage in general surveillance, as well as for-cause 
inspection assignments. These assignments will be risk-based and in 
response to adverse observations.
    (Comment 48) A few comments requested that a prescription be 
required for farmers to use antibiotics for animals.
    (Response 48) Congress enacted legislation in 1996 establishing a 
new class of restricted feed use drugs that may be distributed without 
invoking State pharmacy laws, veterinary feed directive drugs. The 
resulting language in section 504(c) of the FD&C Act explicitly states 
that veterinary feed directive drugs are not prescription drugs. 
However, use of a VFD drug requires supervision from a veterinarian and 
other restrictions that control access to the animal feed containing 
the VFD drug as it moves through the distribution chain. The regulatory 
text for this final rule continues to implement the restrictions and 
supervision as required by the statute.
    (Comment 49) Several comments were concerned about the potential 
for the use of antibiotics in animals to result in drug residues in 
human food.
    (Response 49) During the drug approval process, drug withdrawal 
requirements are considered and withdrawal limitations set. These 
withdrawal requirements are based on scientific information and state 
how soon an animal or products derived from an animal can become food 
for humans after a drug has been administered. FDA works closely with 
other Federal and State Agencies to monitor human food for unsafe drug 
residues and has a compliance program to take enforcement action when 
unsafe drug residues occur (Ref. 16).
    (Comment 50) A few comments stated that antibiotic use has an 
environmental impact.
    (Response 50) FDA is required under the National Environmental 
Policy Act of 1969 (NEPA) to evaluate all major FDA proposed actions to 
determine if they will have a significant impact on the human 
environment. To implement NEPA mandates, the FDA's Center for 
Veterinary Medicine (CVM) requires sponsors to submit to FDA during the 
approval process for the proposed use of their animal drug either an 
environmental assessment (EA) or a claim that it is within a 
categorical exclusion established by FDA. Categorical exclusions apply 
to classes of actions which FDA has determined do not individually or 
cumulatively significantly affect the quality of the human environment, 
and are ordinarily are excluded from the requirement to prepare an EA 
or an environmental impact statement (EIS). If a sponsor claims a 
categorical exclusion, CVM will determine whether the categorical 
exclusion applies and, if so, whether there are extraordinary 
circumstances that would require at least an EA. When an EA is 
submitted, CVM will evaluate the information contained in the EA, and 
may include additional information in the EA when warranted. If CVM 
determines that the proposed action may significantly impact the 
quality of the environment, an EIS must be prepared. If CVM makes a 
finding of no significant impact on the environment (FONSI) based on 
the EA, it will issue a FONSI, stating CVM's conclusion not to prepare 
an EIS (Ref. 17).
    (Comment 51) Several comments requested training and outreach on 
the new VFD requirements. One comment specifically requested that we 
mandate training on the VFD process for veterinarians prior to allowing 
them to issue VFDs.
    (Response 51) We agree that training and outreach are important 
components in successfully implementing these regulatory changes. We 
are engaging professional and trade associations, as well as other 
stakeholders, to leverage our education and outreach opportunities. 
However, we do not agree that training should be mandated for 
veterinarians prior to allowing them to lawfully issue VFDs. The 
requirements for veterinarians issuing a VFD are not very different or 
more complicated than other veterinary medical activities that 
veterinarians perform on a daily basis. We think that voluntary 
training or self-education, using materials developed by

[[Page 31728]]

FDA or other organizations, will be sufficient.

IV. Legal Authority

    FDA's authority for issuing this final rule is provided by section 
504 of the FD&C Act (21 U.S.C. 354) relating to veterinary feed 
directive drugs. In addition, section 701(a) of the FD&C Act (21 U.S.C. 
371(a)) gives FDA general rulemaking authority to issue regulations for 
the efficient enforcement of the FD&C Act.

V. Final Regulatory Impact Analysis

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this final rule is not a significant 
regulatory action as defined by Executive Order 12866. We have 
developed a final regulatory impact analysis (FRIA) that presents the 
benefits and costs of this final rule to stakeholders and the 
government.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the final rule would impose average 
annualized costs that amount to about 0.1 percent or less of average 
annual revenues on small entities, FDA concludes that it is very 
unlikely that the final rule will result in a significant impact on a 
substantial number of small entities.
    The summary analysis of benefits and costs included in the 
Executive Summary of this document is drawn from the detailed FRIA, 
which is available at https://www.regulations.gov (enter Docket No. FDA-
2010-N-0155), and is also available on FDA's Web site at https://www.fda.gov. Section 202(a) of the Unfunded Mandates Reform Act of 1995 
requires that Agencies prepare a written statement, which includes an 
assessment of anticipated costs and benefits, before proposing ``any 
rule that includes any Federal mandate that may result in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more (adjusted annually 
for inflation) in any one year.'' The current threshold after 
adjustment for inflation is $141 million, using the most current (2013) 
Implicit Price Deflator for the Gross Domestic Product. FDA does not 
expect this final rule to result in any 1-year expenditure that would 
meet or exceed this amount.

VI. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, 
description, and respondent description of the information collection 
provisions are shown in the following paragraphs with an estimate of 
the burden for annual reporting, recordkeeping, and third-party 
disclosure, including one-time burdens triggered upon implementation of 
this final rule. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    Title: Veterinary Feed Directives.
    Description: The final rule will revise existing OMB control number 
0910-0363 for veterinary feed directives by providing for greater 
efficiencies to the VFD process.
    In 1996, the ADAA was enacted to facilitate the approval and 
marketing of new animal drugs and medicated feeds. Among other things, 
the ADAA created a new category of new animal drugs 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 in the course 
of the veterinarian's professional practice.
    Currently, there are two VFD drugs under five approved animal drug 
applications. However, FDA has received feedback from stakeholders 
characterizing the current VFD process as being overly burdensome. In 
response to these concerns, FDA began exploring ways to improve the VFD 
program's efficiency. To this end, FDA published an ANPRM inviting 
public comment on possible VFD program efficiency improvements on March 
29, 2010 (75 FR 15387). Based on the considerable public input received 
in response to the ANPRM, on April 13, 2012, FDA issued for public 
comment draft text for proposed revisions to the current VFD regulation 
at part 558 (77 FR 22247).
    On December 12, 2013 (78 FR 75515), FDA issued a proposed rule 
which contained proposed revised information collection requirements at 
78 FR 75522 to 75525. Many of the information collection requirements 
carry over from existing OMB control number 0910-0363; however, the 
section numbers for some of the information collection requirements 
have been redesignated in this final rule. Those one-time information 
collection requirements that are the direct result of this final rule 
are shown in tables under the heading ``One-Time Costs.'' The remaining 
information collection requirements associated with this final rule are 
shown in tables under the headings ``Annual'' or ``Recurring Costs.''

A. Reporting Requirements

Description of Respondents: VFD Feed Distributors, VFD Drug Sponsors
    Currently, under Sec.  558.6(d)(1) (redesignated as Sec.  
558.6(c)(4)) a distributor of animal feed containing a VFD drug must 
notify FDA prior to the first time he distributes such VFD feed and 
this notification is required one time per distributor. Therefore, all 
active distributors of VFD feed must have already made notification to 
FDA of their intention to distribute such feed in order to be in 
compliance with the current regulation. In addition, a distributor must 
provide updated information to FDA within 30 days of a change in 
ownership, business name, or business address.
    Because the reporting requirements for distributors under 
redesignated Sec.  558.6(c)(4) are the same as the current requirements 
under Sec.  558.6(d)(1), there is no new reporting burden for 
distributors other than the one-time burden hours and costs described 
in Table 1. FDA understands that current VFD feed distributors must 
review the final rule in order to determine which actions are necessary 
to comply with the new regulation. For these current VFD feed 
distributors we estimate review of the rule will take a one-time hourly 
burden of 4 hours to complete.
    Burden hours and costs are derived from the Final Regulatory Impact 
Analysis (FRIA) associated with this final rule. Wage rates have been 
adjusted in the tables throughout to that reported in the FRIA.

[[Page 31729]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
           21 CFR 558.6/Activity               Number of    responses  per       Total      Average burden  per response    Total hours     Total costs
                                              respondents      respondent      responses               in hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                One-Time Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of the Rule (VFD Feed Distributors)           1,376               1           1,376  4...........................           5,504    \2\ $529,000
                                           -------------------------------------------------------------------------------------------------------------
    Total One-time Reporting Burden.......  ..............  ..............  ..............  ............................           5,504         529,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Annual (Recurring) Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(c)(4)--A distributor must notify FDA         \3\ 300               1             300  0.125 (8 minutes)...........            37.5              NA
 prior to the first time it distributes a
 VFD drug.
558.6(c)(6)--A distributor must notify FDA              20               1              20  0.125 (8 minutes)...........             2.5             N/A
 within 30 days of any change in
 ownership, business name, or business
 address.
                                           -------------------------------------------------------------------------------------------------------------
    Total Annual Reporting Hours..........  ..............  ..............  ..............  ............................              40  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ 1,376 distributors have notified FDA of their intent to distribute a VFD drug and will need to review the rule. 1,376 VFD feed distributors x
  approximately $96 per hour for review at the general and operations manager level x 4 hours of one-time review = approximately $529,000. Estimate
  rounded to be in accordance with the FRIA (see FRIA).
\3\ 1,376 distributors have already notified FDA of their intent to distribute a VFD drug. FDA expects that 300 new distributors will choose to
  distribute VFDs each year.

    The number of respondents multiplied by the number of responses per 
respondent equals the total responses. The total responses multiplied 
by the average burden per response equals the total hours.
    There are additional reporting burdens for current VFD drug 
sponsors under OMB control numbers 0910-0032 (New Animal Drug 
Applications) and 0910-0669 (Abbreviated New Animal Drug Applications), 
described as follows:
    All labeling and advertising for VFD drugs, combination VFD drugs, 
and feeds containing VFD drugs or combination VFD drugs also are 
reported to FDA under OMB control number 0910-0032 and must prominently 
and conspicuously display the following cautionary statement: 
``Caution: Federal law restricts medicated feed containing this 
veterinary feed directive (VFD) drug to use by or on the order of a 
licensed veterinarian'' (Sec.  558.6(a)(6)). This labeling statement is 
not subject to review by OMB because it is a ``public disclosure[s] of 
information originally supplied by the Federal government to the 
recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)). Therefore, an hourly and cost burden estimate for label 
supplement changes to the new specimen labeling for the Type A 
medicated article and the representative label for use by the feed 
manufacturer are not included.
    The VFD must also include the following statement (Sec.  
558.6(b)(3)(xiii)): ``Use of feed containing this veterinary feed 
directive (VFD) drug in a manner other than as directed on the labeling 
(extralabel use) is not permitted.'' The burden associated with 
including this verbatim statement is not subject to review by OMB under 
the PRA (5 CFR 1320.3(c)(2)).
    The veterinarian may restrict VFD authorization to only include the 
VFD drug(s) cited on the VFD or such authorization may be expanded to 
allow the use of the cited VFD drug(s) along with one or more OTC 
animal drugs in an approved, conditionally approved, or indexed 
combination VFD drug. The veterinarian must affirm his or her intent 
regarding combination VFD drugs by including one of the following 
statements on the VFD:
    1. ``This VFD only authorizes the use of the VFD drug(s) cited in 
this order and is not intended to authorize the use of such drug(s) in 
combination with any other animal drugs.''
    2. ``This VFD authorizes the use of the VFD drug(s) cited in this 
order in the following FDA-approved, conditionally approved, or indexed 
combination(s) in medicated feed that contains the VFD drug(s) as a 
component.'' [List specific approved, conditionally approved, or 
indexed combination medicated feeds following this statement.]
    3. ``This VFD authorizes the use of the VFD drug(s) cited in this 
order in any FDA-approved, conditionally approved, or indexed 
combination(s) in medicated feed that contains the VFD drug(s) as a 
component.'' (Sec.  558.6(b)(6)).
    The burden associated with including these verbatim statements is 
not subject to review by OMB under the PRA (5 CFR 1320.3(c)(2)). The 
hourly and cost burdens to include these statements on the VFD as part 
of the rule are considered de minimis; however, as there are several 
other changes to the information on the VFD form itself that will occur 
as the result of this final rulemaking.
    Section 558.6(b)(3) includes various changes to the information 
that would need to be included on the VFD form that is filled out by 
the veterinarian in order for the VFD to be valid, including but not 
limited to, deleting the requirement that the veterinarian must include 
the amount of feed needed to treat the animals. Each of the three drug 
sponsors that currently market VFD drugs have created VFD forms for 
their products. Three VFD drug sponsors x six VFD forms x 16 hours per 
respondent to make form changes = 96 total hours to change the VFD 
forms. Changes to the VFD form for the six approved VFD forms (for each 
of the three current VFD drug sponsors, there are separate VFD forms 
for each approved species and their related indication(s)) equals six 
VFD forms x $1,331 cost per form = approximately $8,000 one-time cost 
(see FRIA). NOTE: The hourly and cost burden estimates to include the 
revised verbatim statements

[[Page 31730]]

noted in this document (on the VFD form itself) are not subject to 
review by OMB under the PRA. We are unable to measure these hours and 
costs separately, but consider them to be de minimis. The cost to 
change the VFD form is considered to include these statement changes.

B. Recordkeeping Requirements

    Description of Respondents: VFD Feed Distributors, Food Animal 
Veterinarians, and Clients (Food Animal Producers).
    Under current Sec.  558.6(f) and redesignated Sec.  558.6(a)(1), an 
animal feed containing a VFD drug or a combination VFD drug may be fed 
to animals only by or upon a lawful VFD issued by a licensed 
veterinarian. Veterinarians issue three copies of the VFD: One for 
their own records, one for their client, and one to the client's VFD 
feed distributor (current Sec.  558.6(b)(1)-(3) and redesignated Sec.  
558.6(a)(4) and redesignated Sec.  558.6(b)(8)-(9)). The VFD includes 
information about the number and species of animals to receive feed 
containing one or more of the VFD drugs, along with all other 
information as required under Sec.  558.6. Under current Sec.  
558.6(b)(4), if the veterinarian sends the VFD to the client or 
distributor by electronic means, he or she must assure that the 
distributor receives the original, signed VFD within 5 working days. 
Also, under current Sec.  558.6(c), all involved parties (the 
veterinarian, the distributor, and the client) must retain a copy of 
the VFD for 2 years. In addition, VFD feed distributors must also keep 
receipt and distribution records of VFD feeds they manufacture and make 
them available for FDA inspection for 2 years (see current Sec.  
558.6(e)).
    Veterinarians and clients must review the rule to ensure compliance 
with their respective new requirements. In Table 2, we estimate the 
hourly burden of this one-time review for both groups. (Review of the 
rule by VFD feed distributors is accounted for in Table 1.)
    Recordkeeping costs are calculated as follows: 750,000 VFDs (an 
average of 375,000 VFDs issued for each of the two VFD drugs) issued in 
triplicate equals 2,250,000 VFDs issued and stored in files per 
year.\1\
---------------------------------------------------------------------------

    \1\ Distributors may receive an acknowledgement letter in lieu 
of a VFD when distributing VFD feed to another distributor. Such 
letters, like VFDs, are also subject to a 2-year record retention 
requirement. Thus, the recordkeeping burden for acknowledgement 
letters is included as a subset of the VFD recordkeeping burden.
---------------------------------------------------------------------------

    Assuming that currently all VFDs are issued and stored in hardcopy, 
we estimate it takes 300 large file cabinets to store these paper copy 
VFDs for 2 years, assuming 15,000 copies can be stored in a large file 
cabinet (see 64 FR 35966 at 35970). We estimate the average cost of a 
new file cabinet to be $600. Thus, we estimate that the current capital 
outlay for industry to store hardcopy VFDs for the required 2 years is 
$180,000 ($600 x 300 equals $180,000).
    In the 2013 proposed rule, FDA proposed to reduce the recordkeeping 
requirement for copies of VFDs for all involved parties (proposed Sec.  
558.6(a)(4)) from 2 years to 1 year. After considering public comment, 
FDA has decided not to reduce the recordkeeping requirement from 2 
years to 1 year in this final rule. However, as included in Sec.  
558.6(b)(8), the veterinarian will no longer be required to assure that 
a paper copy is received by the distributor within 5 working days of 
receipt if the original was faxed or otherwise transmitted 
electronically. This hardcopy requirement has become outdated by modern 
electronic communication and presents an unnecessary burden on the 
industry. This provision reduces the number of paper copies requiring 
physical recordkeeping space.
    We anticipate approximately one-half of the food animal industry 
will use electronic VFD generation and recordkeeping during the next 3 
years of the information collection. As the use of computers for 
electronic storage of records has increased substantially since 2000 
and is expected to continue to do so regardless of this final rule, the 
only marginal cost that would offset some of the reduction in file 
cabinet storage space costs would be the additional computer storage 
space that may be needed for electronic VFD forms. Because the cost of 
electronic storage capacity on computers has become extremely low, FDA 
regards this as a negligible cost and has not estimated it.
    Also, we anticipate that computer storage will eliminate the need 
for large amounts of physical space devoted to file cabinets. If, as we 
expect, one-half of the VFD recordkeepers (veterinarians, distributors, 
and clients) use electronic recordkeeping, this would result in a cost 
savings of $19,575 annually ($21.75 per square foot per year rental 
cost of space x 6 square feet per file cabinet x 150 filing cabinets = 
$19,575 annual savings for switching to computer storage) (Thorpe, K., 
J. Edwards, and E. Bondarenko, Cassidy Turley Commercial Real Estate 
Services. ``U.S. Office Trends Report--2nd Quarter 2013.'' Page 10. 
https://www.cassidyturley.com/Research/MarketReports/Report.aspx?topic=U_S_Office_Trends_Report&action=download, 2nd Quarter 
2013).
    In summary, we anticipate that the capital costs for recordkeeping 
will be reduced from $180,000 (storing all VFDs as hardcopies in file 
cabinets for 2 years) to $90,000 (as described in the FRIA, there is a 
50 percent reduction in file cabinet costs due to electronic 
recordkeeping for 2 years (i.e., to $90,000)) plus $19,575 annual 
savings to keep VFD records, reflecting the reduction in rental and 
space costs for file cabinets.
    Whether a paper copy is filed or whether the VFD is filed 
electronically, we calculate that the time spent to file the VFD is the 
same at 0.167 hours. As stated previously, distributors may receive an 
acknowledgement letter in lieu of a VFD when distributing VFD feed to 
another distributor. Such letters, like VFDs, are also subject to a 2-
year record retention requirement. Thus, the recordkeeping burden for 
acknowledgement letters is included as a subset of the VFD 
recordkeeping burden. This combined recordkeeping burden, estimated at 
18,788 hours in the 2000 final rule, is still cited in Table 2 of the 
currently approved Information Collection Request (ICR) for Sec.  558.6 
(OMB control number 0910-0363).

[[Page 31731]]



                                                     Table 2--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
       21 CFR Section 558.6/activity           Number of      records per   Total  records       Average burden  per        Total hours     Total costs
                                             recordkeepers   recordkeeper                      recordkeeper  in hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Estimated One-time Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of the Rule (Food Animal                      3,050               1           3,050  1...........................           3,050    \2\ $255,000
 Veterinarians).
Review of the Rule (Clients)..............          10,000               1          10,000  0.5 (30 minutes)............           5,000     \3\ 244,000
Recordkeeping by Electronic Storage for 2   ..............  ..............  ..............  ............................  ..............    \4\ (90,000)
 years.
                                           -------------------------------------------------------------------------------------------------------------
    Total One-time Recordkeeping Burden...  ..............  ..............  ..............  ............................           8,050         409,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Estimated Annual Recordkeeping Burden \5\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Filing of VFD copies......................          14,426             156       2,250,000  0.0167 (1 minute)...........      \6\ 37,575             N/A
                                           -------------------------------------------------------------------------------------------------------------
    Total Annual Recordkeeping Hours......  ..............  ..............  ..............  ............................          37,575  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this one-time collection of information.
\2\ A total of 3,050 veterinarians x approximately $84 per hour x 1 hour of one-time review = approximately $255,000. Estimate rounded to be in
  accordance with the FRIA (see FRIA).
\3\ A total of 10,000 clients x approximately $49 per hour x 0.5 hours one-time review = approximately $244,000. Estimate rounded to be in accordance
  with the FRIA (see FRIA).
\4\ There will be a one-time savings in capital costs for recordkeeping of $90,000 (as described in the FRIA, there is a 50% reduction in cost due to
  electronic recordkeeping for 2 years (i.e., 50% reduction in cost of file cabinets needed) and there will be $19,575 annual savings, reflecting the
  reduction in rental and space costs for file cabinets.
\5\ There are no capital costs or operating and maintenance costs associated with this annual collection of information.
\6\ 14,426 recordkeepers (3,050 food animal veterinarians + 1,376 distributors + 10,000 clients = 14,426) x 156 records per recordkeeper = 2,250,000
  records (3 copies x 750,000 VFDs) x 0.0167 hours to file each record = 37,575 hours.

    The number of respondents multiplied by the number of records per 
recordkeeper equals the total records. The total records multiplied by 
the average burden per recordkeeper equals the total hours.

C. Third-Party Disclosure Requirements

    Description of Respondents: VFD Drug Sponsors, Food Animal 
Veterinarians, VFD Feed Distributors, and Clients (Food Animal 
Producers).
    VFD drug sponsors manufacture and label VFD drugs for use in 
medicated animal feed. FDA understands that sponsors must review the 
rule to ensure compliance with their disclosure requirements. In Table 
3 we estimate the hourly burden of this review. (Review of the rule by 
VFD feed distributors is accounted for in Table 1 and by veterinarians 
and clients in Table 2.)
    Section Sec.  558.6(b)(8) would allow veterinarians to send VFDs to 
the client or distributor via fax or other electronic means (as is 
currently permitted under Sec.  558.6(b)(4)). However, if a VFD is 
transmitted electronically, the veterinarian would no longer be 
required to assure that the original, signed VFD is given to the 
distributor within 5 days.
    FDA estimates that a veterinarian currently requires about 0.25 
hours to issue a VFD (i.e., research, fill out, and deliver all copies, 
including the original, signed VFD to the distributor). At a 
compensation rate of about $84, the labor cost of currently issuing 
VFDs is estimated at $15.70 million (the estimated average of 750,000 
VFDs issued annually x 0.25 hours to issue each VFD x $84 per hour = 
approximately $15.70 million (rounded to be in accordance with the 
FRIA)). FDA estimates that the effect of this rule would be to reduce 
the average time to issue a VFD by 50 percent, or about 0.125 hours per 
VFD. This would result in a cost of about $7.85 million annually (the 
estimated average of 750,000 VFDs issued annually x 0.125 hours to 
issue each VFD x $84 per hour = approximately $7.85 million (rounded to 
be in accordance with the FRIA)), a cost savings of about $7.85 million 
($15.70 million - $7.85 million = approximately $7.85 million.
    Currently, a distributor may only distribute a VFD feed to another 
distributor for further distribution if the originating distributor 
(consignor) first obtains a written acknowledgement letter from the 
receiving distributor (consignee) before the feed is shipped (current 
Sec.  558.6(d)(2)). Because this current requirement is the same as 
that being finalized in Sec.  558.6(c)(8), there is no new reporting 
burden.

                                                 Table 3--Estimated Annual Third-Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                        Average
                                                             Number of      disclosures    Total annual     burden per
                 21 CFR Section/activity                    respondents         per         disclosures    disclosure in    Total hours     Total costs
                                                                            respondent                         hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       One-Time Third-party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of the Rule, Current VFD Drug Sponsors (General                 3               1               3               6              18      \2\ $2,500
 and Operations Managers)...............................
                                                         -----------------------------------------------------------------------------------------------

[[Page 31732]]

 
    Total One-Time Third-Party Disclosure Burden........  ..............  ..............  ..............  ..............              18           2,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                             Estimated Annual (Recurring) Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(b)(7)--Veterinarian issues VFD \3\................           3,050           245.9         750,000           0.125          93,750             N/A
                                                                                                             (8 minutes)
558.6(c)(8)--Acknowledgment letter generation...........       \4\ 1,000               5           5,000           0.125             625             N/A
                                                                                                             (8 minutes)
                                                         -----------------------------------------------------------------------------------------------
    Total Annual Third-Party Disclosure Hours...........  ..............  ..............  ..............  ..............          94,375  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Three current VFD drug sponsors x $140 x 6 hours of one-time review time = approximately $2,500 one-time cost. Estimate rounded to be in accordance
  with the FRIA.
\3\ A total of 3,050 veterinarians x 245.9 VFDs issued per year per respondent (on average) = 750,000 VFDs issued per year. This figure x 0.125 hours
  per form = 93,750 hours per year x $84 per hour = approximately $7,850,000 annual cost. Estimate rounded to be in accordance with the FRIA.
\4\ 1,000 VFD feed distributors (of the 1,376 total distributors) x 5 disclosures per respondent = 5,000 annual acknowledgement letters x 0.125 hours =
  approximately 625 hours.

    The number of respondents multiplied by the number of disclosures 
per respondent equals the total annual disclosures. The total annual 
disclosures multiplied by the average burden per disclosure equals the 
total hours.
    Additionally, we have clarified in the final rule that, if a 
distributor manufactures the VFD feed, the distributor must also keep 
VFD manufacturing records for 1 year in accordance with part 225 and 
that such records must be made available for inspection and copying by 
FDA upon request (Sec.  558.6(c)(4)). These record requirements are 
currently approved under OMB control number 0910-0152, Current Good 
Manufacturing Practice Regulations for Medicated Feed.
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

VII. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the final 
rule will not contain policies that would have substantial direct 
effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
the Agency concludes that the final rule does not contain policies that 
have federalism implications as defined in the Executive order and, 
consequently, a federalism summary impact statement is not required.

IX. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at https://www.regulations.gov. (We 
have verified the Web site addresses in this reference section, but we 
are not responsible for any subsequent changes to the Web sites after 
this document publishes in the Federal Register.)

1. ``Guidance for Industry: The Judicious Use of Medically Important 
Antimicrobial Drugs in Food-Producing Animals'' (GFI #209), April 
13, 2012; (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf).
2. ``Guidance for Industry: 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'' (GFI #213), December 2013; (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf).
3. FDA, Warning Letters (https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm).
4. ``Compliance Program Guidance Manual: Feed Manufacturing'' (CPGM 
7371.004); (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/UCM113430.pdf).
5. The Association of American Feed Control Officials (AAFCO), 
Regulatory Page (https://www.aafco.org/Regulatory).
6. ``Guidance for Industry: Veterinary Feed Directive Regulation 
Questions and Answers'' (GFI #120), March 26, 2009; (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052660.pdf).
7. ``Guidance for Industry Part 11, Electronic Records; Electronic 
Signatures--Scope and Application'' August 2003; (https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125125.pdf).
8. AVMA, Principles of Veterinary Medical Ethics of the AVMA 
(https://www.avma.org/KB/Policies/Pages/Principles-of-Veterinary-Medical-Ethics-of-the-AVMA.aspx).

[[Page 31733]]

9. FDA, From an Idea to the Marketplace: The Journey of an Animal 
Drug through the Approval Process (https://www.fda.gov/AnimalVeterinary/ResourcesforYou/AnimalHealthLiteracy/ucm219207.htm).
10. FDA, Conditional Approval Explained: A Resource for 
Veterinarians (https://www.fda.gov/animalveterinary/resourcesforyou/ucm413948.htm).
11. FDA, Drug Indexing (https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm070206.htm).
12. White House, National Strategy for Combating Antibiotic-
Resistant Bacteria (https://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf).
13. FDA, FDA Secures Full Industry Engagement on Antimicrobial 
Resistance Strategy (https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm403285.htm).
14. FDA, List of Affected Products (https://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/ucm390429.htm).
15. FDA, FDA's Plans to Monitor Progress (https://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/ucm378256.htm).
16. FDA, Compliance Policy Guide Sec. 615.200 Proper Drug Use and 
Residue Avoidance by Non-Veterinarians (https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074660.htm).
17. FDA, Environmental Impact Considerations (https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/EnvironmentalAssessments/default.htm).

List of Subjects

21 CFR Part 514

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
514 and 558 are amended as follows:

PART 514--NEW ANIMAL DRUG APPLICATIONS

0
1. The authority citation for 21 CFR part 514 is revised to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 371, 
379e, 381.

0
2. In Sec.  514.1, revise paragraph (b)(9) to read as follows:


Sec.  514.1  Applications.

* * * * *
    (b) * * *
    (9) Veterinary feed directive. Three copies of a veterinary feed 
directive (VFD) must be submitted in a form that accounts for the 
information described under Sec. Sec.  558.6(b)(3) and 558.6(b)(4) of 
this chapter.
* * * * *

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
3. The authority citation for 21 CFR part 558 is revised to read as 
follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.


0
4. In Sec.  558.3, revise paragraphs (b)(1)(ii), (b)(6), (b)(7), 
(b)(9), and (b)(11); and add paragraph (b)(12) to read as follows:


Sec.  558.3  Definitions and general considerations applicable to this 
part.

* * * * *
    (b) * * *
    (1) * * *
    (ii) Category II--These drugs require a withdrawal period at the 
lowest use level for at least one species for which they are approved, 
or are regulated on a ``no-residue'' basis or with a zero tolerance 
because of a carcinogenic concern regardless of whether a withdrawal 
period is required.
* * * * *
    (6) A ``veterinary feed directive (VFD) drug'' is a drug intended 
for use in or on animal feed which is limited by an approved 
application filed pursuant to section 512(b) of the Federal Food, Drug, 
and Cosmetic Act, a conditionally approved application filed pursuant 
to section 571 of the Federal Food, Drug, and Cosmetic Act, or an index 
listing under section 572 of the Federal Food, Drug, and Cosmetic Act 
to use under the professional supervision of a licensed veterinarian. 
Use of animal feed bearing or containing a VFD drug must be authorized 
by a lawful veterinary feed directive.
    (7) A ``veterinary feed directive'' is a written (nonverbal) 
statement issued by a licensed veterinarian in the course of the 
veterinarian's professional practice that orders the use of a VFD drug 
or combination VFD drug in or on an animal feed. This written statement 
authorizes the client (the owner of the animal or animals or other 
caretaker) to obtain and use animal feed bearing or containing a VFD 
drug or combination VFD drug to treat the client's animals only in 
accordance with the conditions for use approved, conditionally 
approved, or indexed by the Food and Drug Administration.
* * * * *
    (9) For the purposes of this part, a ``distributor'' means any 
person who distributes a medicated feed containing a VFD drug to 
another person. Such other person may be another distributor or the 
client-recipient of a VFD.
* * * * *
    (11) An ``acknowledgment letter'' is a written (nonverbal) 
communication provided to a distributor (consignor) from another 
distributor (consignee). An acknowledgment letter must be provided 
either in hardcopy or through electronic media and must affirm:
    (i) That the distributor will not ship such VFD feed to an animal 
production facility that does not have a VFD,
    (ii) That the distributor will not ship such VFD feed to another 
distributor without receiving a similar written acknowledgment letter, 
and
    (iii) That the distributor has complied with the distributor 
notification requirements of Sec.  558.6(c)(5).
    (12) A ``combination veterinary feed directive (VFD) drug'' is a 
combination new animal drug (as defined in Sec.  514.4(c)(1)(i) of this 
chapter) intended for use in or on animal feed which is limited by an 
approved application filed under section 512(b) of the Federal Food, 
Drug, and Cosmetic Act, a conditionally approved application filed 
under section 571 of the Federal Food, Drug, and Cosmetic Act, or an 
index listing under section 572 of the Federal Food, Drug, and Cosmetic 
Act to use under the professional supervision of a licensed 
veterinarian, and at least one of the new animal drugs in the 
combination is a VFD drug. Use of animal feed bearing or containing a 
combination VFD drug must be authorized by a lawful VFD.

0
5. Revise Sec.  558.6 to read as follows:


Sec.  558.6  Veterinary feed directive drugs.

    (a) General requirements related to veterinary feed directive (VFD) 
drugs. (1) Animal feed bearing or containing a VFD drug or a 
combination VFD drug (a VFD feed or combination VFD feed) may be fed to 
animals only by or upon a lawful VFD issued by a licensed veterinarian.
    (2) A VFD feed or combination VFD feed must not be fed to animals 
after the expiration date on the VFD.
    (3) Use and labeling of a VFD drug or a combination VFD drug in 
feed is limited to the approved, conditionally approved, or indexed 
conditions of use. Use of feed containing this veterinary feed 
directive (VFD) drug in a manner other than as directed on the labeling 
(extralabel use) is not permitted.
    (4) All involved parties (the veterinarian, the distributor, and 
the

[[Page 31734]]

client) must retain a copy of the VFD for 2 years. The veterinarian 
must retain the original VFD in its original form (electronic or 
hardcopy). The distributor and client copies may be kept as an 
electronic copy or hardcopy.
    (5) All involved parties must make the VFD and any other records 
specified in this section available for inspection and copying by FDA 
upon request.
    (6) All labeling and advertising for VFD drugs, combination VFD 
drugs, and feeds containing VFD drugs or combination VFD drugs must 
prominently and conspicuously display the following cautionary 
statement: ``Caution: Federal law restricts medicated feed containing 
this veterinary feed directive (VFD) drug to use by or on the order of 
a licensed veterinarian.''
    (b) Responsibilities of the veterinarian issuing the VFD. (1) In 
order for a VFD to be lawful, the veterinarian issuing the VFD must:
    (i) Be licensed to practice veterinary medicine; and
    (ii) Be operating in the course of the veterinarian's professional 
practice and in compliance with all applicable veterinary licensing and 
practice requirements, including issuing the VFD in the context of a 
veterinarian-client-patient relationship (VCPR) as defined by the 
State. If applicable VCPR requirements as defined by such State do not 
include the key elements of a valid VCPR as defined in Sec.  530.3(i) 
of this chapter, the veterinarian must issue the VFD in the context of 
a valid VCPR as defined in Sec.  530.3(i) of this chapter.
    (2) The veterinarian must only issue a VFD that is in compliance 
with the conditions for use approved, conditionally approved, or 
indexed for the VFD drug or combination VFD drug.
    (3) The veterinarian must ensure that the following information is 
fully and accurately included on the VFD:
    (i) The veterinarian's name, address, and telephone number;
    (ii) The client's name, business or home address, and telephone 
number;
    (iii) The premises at which the animals specified in the VFD are 
located;
    (iv) The date of VFD issuance;
    (v) The expiration date of the VFD. This date must not extend 
beyond the expiration date specified in the approval, conditional 
approval, or index listing, if such date is specified. In cases where 
the expiration date is not specified in the approval, conditional 
approval, or index listing, the expiration date of the VFD must not 
exceed 6 months after the date of issuance;
    (vi) The name of the VFD drug(s);
    (vii) The species and production class of animals to be fed the VFD 
feed;
    (viii) The approximate number of animals to be fed the VFD feed by 
the expiration date of the VFD. The approximate number of animals is 
the potential number of animals of the species and production class 
identified on the VFD that will be fed the VFD feed or combination VFD 
feed at the specified premises by the expiration date of the VFD;
    (ix) The indication for which the VFD is issued;
    (x) The level of VFD drug in the VFD feed and duration of use;
    (xi) The withdrawal time, special instructions, and cautionary 
statements necessary for use of the drug in conformance with the 
approval;
    (xii) The number of reorders (refills) authorized, if permitted by 
the drug approval, conditional approval, or index listing. In cases 
where reorders (refills) are not specified on the labeling for an 
approved, conditionally approved, or index listed VFD drug, reorders 
(refills) are not permitted;
    (xiii) The statement: ``Use of feed containing this veterinary feed 
directive (VFD) drug in a manner other than as directed on the labeling 
(extralabel use) is not permitted.'';
    (xiv) An affirmation of intent for combination VFD drugs as 
described in paragraph (6) of this section; and
    (xv) The veterinarian's electronic or written signature.
    (4) The veterinarian may, at his or her discretion, enter the 
following information on the VFD to more specifically identify the 
animals authorized to be treated/fed the VFD feed:
    (i) A more specific description of the location of animals (e.g., 
by site, pen, barn, stall, tank, or other descriptor that the 
veterinarian deems appropriate);
    (ii) The approximate age range of the animals;
    (iii) The approximate weight range of the animals; and
    (iv) Any other information the veterinarian deems appropriate to 
identify the animals specified in the VFD.
    (5) For VFDs intended to authorize the use of an approved, 
conditionally approved, or indexed combination VFD drug that includes 
more than one VFD drug, the veterinarian must include the drug-specific 
information required in paragraphs (b)(2)(vi), (ix), (x), and (xi) of 
this section for each VFD drug in the combination.
    (6) The veterinarian may restrict VFD authorization to only include 
the VFD drug(s) cited on the VFD or may expand such authorization to 
allow the use of the cited VFD drug(s) along with one or more over-the-
counter (OTC) animal drugs in an approved, conditionally approved, or 
indexed combination VFD drug. The veterinarian must affirm his or her 
intent regarding combination VFD drugs by including one of the 
following statements on the VFD:
    (i) ``This VFD only authorizes the use of the VFD drug(s) cited in 
this order and is not intended to authorize the use of such drug(s) in 
combination with any other animal drugs.''
    (ii) ``This VFD authorizes the use of the VFD drug(s) cited in this 
order in the following FDA-approved, conditionally approved, or indexed 
combination(s) in medicated feed that contains the VFD drug(s) as a 
component.'' [List specific approved, conditionally approved, or 
indexed combination medicated feeds following this statement.]
    (iii) ``This VFD authorizes the use of the VFD drug(s) cited in 
this order in any FDA-approved, conditionally approved, or indexed 
combination(s) in medicated feed that contains the VFD drug(s) as a 
component.''
    (7) The veterinarian must issue a written (nonverbal) VFD.
    (8) The veterinarian must send a copy of the VFD to the distributor 
via hardcopy, facsimile (fax), or electronically. If in hardcopy, the 
veterinarian must send the copy of the VFD to the distributor either 
directly or through the client.
    (9) The veterinarian must provide a copy of the VFD to the client.
    (c) Responsibilities of any person who distributes an animal feed 
containing a VFD drug or a combination VFD drug:
    (1) The distributor is permitted to fill a VFD only if the VFD 
contains all the information required in paragraph (b)(3) of this 
section.
    (2) The distributor is permitted to distribute an animal feed 
containing a VFD drug or combination VFD drug only if it complies with 
the terms of the VFD and is manufactured and labeled in conformity with 
the approved, conditionally approved, or indexed conditions of use for 
such drug.
    (3) The distributor must keep records of the receipt and 
distribution of all medicated animal feed containing a VFD drug for 2 
years.
    (4) In addition to other applicable recordkeeping requirements 
found in this section, if the distributor manufactures the animal feed 
bearing or containing the VFD drug, the distributor must also keep VFD 
feed manufacturing records for 1 year in accordance with part 225 of 
this chapter. Such records must be made available for inspection and 
copying by FDA upon request.

[[Page 31735]]

    (5) A distributor of animal feed containing a VFD drug must notify 
FDA prior to the first time it distributes animal feed containing a VFD 
drug. The notification is required one time per distributor and must 
include the following information:
    (i) The distributor's complete name and business address;
    (ii) The distributor's signature or the signature of the 
distributor's authorized agent; and
    (iii) The date the notification was signed.
    (6) A distributor must also notify FDA within 30 days of any change 
in ownership, business name, or business address.
    (7) The notifications cited in paragraphs (c)(5) and (c)(6) of this 
section must be submitted to the Food and Drug Administration, Center 
for Veterinary Medicine, Division of Animal Feeds (HFV-220), 7519 
Standish Pl., Rockville, MD 20855, FAX: 240-453-6882.
    (8) A distributor is permitted to distribute a VFD feed to another 
distributor only if the originating distributor (consignor) first 
obtains a written (nonverbal) acknowledgment letter, as defined in 
Sec.  558.3(b)(11), from the receiving distributor (consignee) before 
the feed is shipped. Consignor distributors must retain a copy of each 
consignee distributor's acknowledgment letter for 2 years.

    Dated: May 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13393 Filed 6-2-15; 8:45 am]
 BILLING CODE 4164-01-P