80_FR_31813 80 FR 31707 - Veterinary Feed Directive

80 FR 31707 - Veterinary Feed Directive

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 106 (June 3, 2015)

Page Range31707-31735
FR Document2015-13393

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.

Federal Register, Volume 80 Issue 106 (Wednesday, June 3, 2015)
[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Rules and Regulations]
[Pages 31707-31735]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13393]



[[Page 31707]]

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: [email protected].

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 http://www.regulations.gov (enter Docket No. FDA-
2010-N-0155), and is also available on FDA's Web site at http://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. 
http://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 http://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; (http://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; (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf).
3. FDA, Warning Letters (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm).
4. ``Compliance Program Guidance Manual: Feed Manufacturing'' (CPGM 
7371.004); (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/UCM113430.pdf).
5. The Association of American Feed Control Officials (AAFCO), 
Regulatory Page (http://www.aafco.org/Regulatory).
6. ``Guidance for Industry: Veterinary Feed Directive Regulation 
Questions and Answers'' (GFI #120), March 26, 2009; (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052660.pdf).
7. ``Guidance for Industry Part 11, Electronic Records; Electronic 
Signatures--Scope and Application'' August 2003; (http://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 (http://www.fda.gov/AnimalVeterinary/ResourcesforYou/AnimalHealthLiteracy/ucm219207.htm).
10. FDA, Conditional Approval Explained: A Resource for 
Veterinarians (http://www.fda.gov/animalveterinary/resourcesforyou/ucm413948.htm).
11. FDA, Drug Indexing (http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm070206.htm).
12. White House, National Strategy for Combating Antibiotic-
Resistant Bacteria (http://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf).
13. FDA, FDA Secures Full Industry Engagement on Antimicrobial 
Resistance Strategy (http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm403285.htm).
14. FDA, List of Affected Products (http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/ucm390429.htm).
15. FDA, FDA's Plans to Monitor Progress (http://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 (http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074660.htm).
17. FDA, Environmental Impact Considerations (http://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



                                                                                                        Vol. 80                           Wednesday,
                                                                                                        No. 106                           June 3, 2015




                                                                                                        Part III


                                                                                                        Department of Health and Human Services
                                                                                                        Food and Drug Administration
                                                                                                        21 CFR Parts 514 and 558
                                                                                                        Veterinary Feed Directive; Final Rule
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                                                  31708             Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations

                                                  DEPARTMENT OF HEALTH AND                                (see § 558.6 (21 CFR 558.6)) (65 FR                    also updates the VFD requirements to
                                                  HUMAN SERVICES                                          76924, December 8, 2000). In the decade                improve the efficiency of the process.
                                                                                                          since FDA published its VFD                            These regulatory enhancements are
                                                  Food and Drug Administration                            regulations, various stakeholders have                 important for facilitating the transition
                                                                                                          informed the Agency that the existing                  of a large number of OTC feed-use
                                                  21 CFR Parts 514 and 558                                VFD process is overly burdensome. In                   antimicrobial drugs to their new VFD
                                                  [Docket No. FDA–2010–N–0155]
                                                                                                          response to those concerns, FDA                        status.
                                                                                                          published several documents inviting                      FDA intends to use a phased
                                                  RIN 0910–AG95                                           public input on ways to improve the                    enforcement strategy for
                                                                                                          VFD process, including an advance                      implementation of this final rule as OTC
                                                  Veterinary Feed Directive                               notice of proposed rulemaking                          drugs become VFD drugs under GFI
                                                  AGENCY:    Food and Drug Administration,                (ANPRM) (75 FR 15387, March 29,                        #213. FDA first intends to provide
                                                  HHS.                                                    2010) (March 2010 ANPRM); draft                        education and training for stakeholders
                                                                                                          regulatory text for proposed regulation                subject to this final rule such as
                                                  ACTION:   Final rule.
                                                                                                          (77 FR 22247, April 13, 2012) (April                   veterinarians, clients (animal
                                                  SUMMARY:   The Food and Drug                            2012 draft proposed regulation); and a                 producers), feed mill distributors and
                                                  Administration (FDA) is amending its                    notice of proposed rulemaking (NPRM)                   other distributors. Such education and
                                                  animal drug regulations regarding                       (78 FR 75515, December 12, 2013)                       training efforts are important for
                                                  veterinary feed directive (VFD) drugs.                  (December 2013 NPRM).                                  supporting effective implementation
                                                  FDA’s current VFD regulation                               The VFD rule is the third of three core             and compliance with the final rule. FDA
                                                  established requirements relating to the                documents that FDA is using to                         will then engage in risk-based general
                                                  distribution and use of VFD drugs and                   announce and implement its policy                      surveillance, as well as for-cause
                                                  animal feeds containing such drugs.                     framework for the judicious use of                     inspection assignments. FDA intends to
                                                  This amendment is intended to improve                   medically important antimicrobial drugs                use information such as history of VFD
                                                  the efficiency of FDA’s VFD program                     in food-producing animals. The first                   use and the volume of VFD feed being
                                                  while protecting human and animal                       document, Guidance for Industry (GFI)                  produced to focus inspectional
                                                  health.                                                 #209, entitled ‘‘The Judicious Use of                  resources within the industry based on
                                                                                                          Medically Important Antimicrobial                      risk. FDA anticipates that it will utilize
                                                  DATES:   This rule is effective October 1,              Drugs in Food-Producing Animals,’’
                                                  2015.                                                                                                          various sources for obtaining such
                                                                                                          published April 2012, set forth FDA’s                  information including such sources as
                                                  FOR FURTHER INFORMATION CONTACT:                        framework for instituting several key                  FDA food and drug registration
                                                  Sharon Benz, Center for Veterinary                      measures for ensuring the appropriate or               information, feed mill licensing
                                                  Medicine (HFV–220), Food and Drug                       judicious use of medically important                   information, the VFD distributor
                                                  Administration, 7519 Standish Pl.,                      antimicrobial drugs in food-producing                  notifications FDA receives, and VFD
                                                  Rockville, MD 20855, 240–402–5939,                      animals. These measures include
                                                                                                                                                                 distribution records maintained by drug
                                                  email: Sharon.Benz@fda.hhs.gov.                         eliminating the feed and water use of
                                                                                                                                                                 sponsors and VFD distributors.
                                                  SUPPLEMENTARY INFORMATION:                              medically important antimicrobial drugs
                                                                                                                                                                    The provisions included in this final
                                                                                                          for production purposes in food-
                                                  Executive Summary                                                                                              rule are based on stakeholder input
                                                                                                          producing animals and bringing all
                                                                                                          remaining therapeutic uses under the                   received in response to multiple
                                                  Purpose of Final Rule                                                                                          opportunities for public comment,
                                                                                                          oversight of licensed veterinarians. The
                                                    The purpose of this rulemaking is to                  second document, GFI #213, entitled                    including the March 2010 ANPRM,
                                                  revise FDA’s VFD regulations to                         ‘‘New Animal Drugs and New Animal                      April 2012 draft proposed regulation,
                                                  improve the efficiency of the VFD                       Drug Combination Products                              and the December 2013 NPRM.
                                                  program while continuing to protect                     Administered in or on Medicated Feed                   Summary of Major Provisions
                                                  public health (human and animal                         or Drinking Water of Food-Producing
                                                  health).                                                Animals: Recommendations for Drug                        This final rule makes several
                                                    In 1996, Congress enacted the Animal                  Sponsors for Voluntarily Aligning                      important changes from the proposed
                                                  Drug Availability Act (ADAA) (Pub. L.                   Product Use Conditions with GFI #209,’’                rule and several major changes to the
                                                  104–250) to facilitate the approval and                 published December 2013, outlined a                    current VFD regulations in part 558 (21
                                                  marketing of new animal drugs and                       detailed process and timeline for                      CFR part 558):
                                                  medicated feeds. In passing the ADAA,                   implementing the measures identified                     • The definition of ‘‘Category II’’ in
                                                  Congress created a new regulatory                       in GFI #209. Once GFI #213 is fully                    part 558 is revised to remove the
                                                  category for certain animal drugs used                  implemented, affected feed-use                         automatic Category II designation for
                                                  in or on animal food (animal feed)                      antimicrobial drugs are expected to                    VFD drugs. Instead, the categorization of
                                                  called veterinary feed directive drugs (or              transition from over-the-counter (OTC)                 VFD drugs will be determined on a case-
                                                  VFD drugs). VFD drugs are new animal                    to VFD marketing status. Given that                    by-case basis based on the likelihood
                                                  drugs intended for use in or on animal                  most of the products affected by this                  that the particular drug at issue will
                                                  feed which are limited to use under the                 effort are feed-use antimicrobial drugs                produce an unsafe residue in edible
                                                  professional supervision of a licensed                  this VFD regulation plays an important                 products derived from treated animals,
                                                  veterinarian. Any animal feed                           role since it outlines the requirements                as is currently the case for non-VFD feed
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                                                  containing a VFD drug can only be fed                   associated with veterinary                             use drugs.
                                                  to animals based upon an order, called                  authorization, distribution, and use of                  • The definition of veterinary feed
                                                  a veterinary feed directive (VFD), issued               VFD drugs in animal feed.                              directive (VFD) drug is revised to
                                                  by a licensed veterinarian in the course                   The VFD drug process as outlined in                 simply refer to the statutory definition
                                                  of the veterinarian’s professional                      this final rule includes important                     to provide further clarity.
                                                  practice. FDA published final                           controls regarding the distribution and                  • The proposed definition of
                                                  regulations implementing the VFD-                       use of VFD drugs. In addition to                       combination veterinary feed directive
                                                  related provisions of the ADAA in 2000                  providing accountability, this final rule              (VFD) drug is revised to reflect the


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                                                                    Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations                                          31709

                                                  changes to the veterinary feed directive                annualized costs of about $201,000 at a                preventing the potential for the
                                                  (VFD) drug definition.                                  7 percent discount rate over 10 years.                 development of bacterial resistance to
                                                     • The proposed definition of a                       We estimate that the government costs                  antimicrobial drugs administered
                                                  ‘‘veterinary feed directive’’ is revised to             associated with reviewing the six VFD                  through medicated feed.
                                                  remove language that is duplicated in                   drug labeling supplements that are                        In 1996 Congress enacted the ADAA
                                                  the responsibilities of a veterinarian                  expected to be submitted by the three                  to facilitate the approval and marketing
                                                  issuing a VFD.                                          current VFD drug sponsors to be $1,900.                of new animal drugs and medicated
                                                     • The proposed definition of the term                   The expected benefit of this final rule             feeds. As part of the ADAA, Congress
                                                  ‘‘distributor’’ is revised to use the word              is a general improvement in the                        recognized that certain new animal
                                                  ‘‘distributes’’ instead of the word                     efficiency of the VFD process. FDA                     drugs intended for use in animal feed
                                                  ‘‘consigns’’ as had been proposed.                      estimates the annualized cost savings                  should only be administered under a
                                                     • The regulatory text proposed for                   associated with the more efficient                     veterinarian’s order and professional
                                                  § 558.6(a)(4) and (b)(8) is revised to                  requirements of the VFD process to be                  supervision. Therefore, the ADAA
                                                  clarify that the veterinarian is required               $13,000 over 10 years at a 7 percent                   created a new category of products
                                                  to keep the original VFD (in hardcopy                   discount rate (annualized at $11,000                   called veterinary feed directive drugs (or
                                                  or electronically) and the distributor                  over 10 years at a 3 percent discount                  VFD drugs).
                                                  and client must keep a copy of the VFD                  rate). Additionally, the reduction in                     VFD drugs are new animal drugs
                                                  (in hardcopy or electronically).                        veterinarian labor costs due to this rule              intended for use in or on animal feed,
                                                     • The current requirement that copies                is expected to result in a cost savings of             which are limited by an approved
                                                  of the VFD and records of the receipt                   about $7.87 million annually.                          application, conditionally approved
                                                  and distribution of VFD feed must be                                                                           application, or index listing to use
                                                  kept for a period of 2 years is retained                Table of Contents                                      under the professional supervision of a
                                                  instead of being changed to 1 year as                   I. Background                                          licensed veterinarian. In order for
                                                  was proposed.                                              A. History                                          animal feed containing a VFD drug
                                                     • The final rule provides that the                      B. Judicious Use Policy for Medically               (VFD feed) to be fed to animals, a
                                                  veterinarian must issue the VFD in the                        Important Antimicrobials                         licensed veterinarian must first issue an
                                                  context of a valid veterinarian-client-                 II. Overview of the Final Rule                         order, called a veterinary feed directive
                                                                                                          III. Comments on the Proposed Rule                     (or VFD), providing for such use. In the
                                                  patient relationship (VCPR) as defined
                                                                                                             A. Definitions Section (§ 558.3)
                                                  by the State requirements applicable to                    B. Veterinary Feed Directive Drugs
                                                                                                                                                                 Federal Register of December 8, 2000
                                                  where the veterinarian practices                              (§ 558.6)                                        (65 FR 76924), FDA issued a final rule
                                                  veterinary medicine. In States that lack                IV. Legal Authority                                    amending the regulations in part 558 (21
                                                  appropriate VCPR requirements                           V. Final Regulatory Impact Analysis                    CFR part 558) relating to new animal
                                                  applicable to VFDs, the veterinarian                    VI. Paperwork Reduction Act of 1995                    drugs for use in animal feed to
                                                  must issue the VFD consistent with the                     A. Reporting Requirements                           implement the VFD-related provisions
                                                  Federally defined VCPR standard,                           B. Recordkeeping Requirements                       of the ADAA. In that final rule, FDA
                                                                                                             C. Third-Party Disclosure Requirements              stated that because veterinarian
                                                  which is set forth in FDA’s regulations
                                                                                                          VII. Environmental Impact                              oversight is so important for assuring
                                                  at § 530.3(i) (21 CFR 530.3(i)).                        VIII. Federalism
                                                     • The VFD expiration date                            IX. References
                                                                                                                                                                 the safe and appropriate use of certain
                                                  requirement in the final rule specifies                                                                        new animal drugs, the Agency should
                                                  that this is the date that authorization to             I. Background                                          approve such drugs for use in animal
                                                  feed the VFD feed to animals expires.                   A. History                                             feed only if these medicated feeds are
                                                  Animals must not be fed the VFD feed                                                                           administered under a veterinarian’s
                                                  after the expiration date of the VFD.                      Before 1996, FDA had only two                       order and professional supervision. In
                                                     • The VFD requirement for                            options for regulating the distribution of             addition, the final rule noted that safety
                                                  approximate number of animals in the                    animal drugs: (1) Over-the-counter                     concerns relating to the difficulty of
                                                  final rule specifies how the approximate                (OTC) and (2) by prescription (Rx).                    disease diagnosis, drug toxicity, drug
                                                  number of animals should be                             Drugs used in animal feeds were                        residues, antimicrobial resistance, or
                                                  determined.                                             generally approved as OTC drugs.                       other reasons may dictate that the use of
                                                     • The final rule clarifies the                       Although the Federal Food, Drug, and                   a medicated feed be limited to use by
                                                  affirmation of intent statements to be                  Cosmetic Act (the FD&C Act) did not                    order and under the supervision of a
                                                  used in VFDs issued by licensed                         prohibit the approval of prescription                  licensed veterinarian.
                                                  veterinarians to indicate whether a VFD                 drugs for use in animal feed, such                        It has been over a decade since FDA
                                                  drug may be used in conjunction with                    approvals would be impractical because                 issued the final rule relating to VFDs.
                                                  another drug in an approved,                            many States have laws that would                       Although currently there are only a few
                                                  conditionally approved, or indexed                      require a feed mill to have a pharmacist               approved VFD drugs, FDA has received
                                                  combination VFD feed.                                   onsite to dispense prescription drugs.                 comments from stakeholders
                                                     • The final rule clarifies the                       As additional animal drugs were                        characterizing the current VFD process
                                                  recordkeeping requirements to                           developed, FDA determined the existing                 as being overly burdensome. In response
                                                  differentiate what records are required                 regulatory options—OTC and Rx—did                      to these concerns, the Agency began
                                                  to be kept for distributors who                         not provide the needed safeguards or                   exploring ways to improve the VFD
                                                  manufacture VFD feed and those who                      flexibility for these drugs to be                      program’s efficiency. To that end, FDA
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                                                  do not manufacture the VFD feed.                        prescribed or administered through                     initiated the rulemaking process
                                                                                                          medicated feed. FDA believed that these                through the publication of the March
                                                  Costs and Benefits                                      drugs, particularly certain antimicrobial              2010 ANPRM. The March 2010 ANPRM
                                                    The estimated one-time costs to                       drugs, should be subject to greater                    requested public comment on whether
                                                  industry from this final rule are                       control than provided by OTC status.                   efficiency improvements are needed
                                                  $1,411,000, most of which are simply                    FDA believed this control would be                     and, if so, what specific revisions
                                                  costs to review the rule and prepare a                  critical to reducing unnecessary use of                should be made to the VFD regulations.
                                                  compliance plan. This equates to                        such drugs in animals and to slowing or                Subsequent to this, FDA published the


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                                                  31710             Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations

                                                  April 2012 draft proposed regulation                    Animals: Recommendations for Drug                      distributes an animal feed containing a
                                                  based on the considerable public input                  Sponsors for Voluntarily Aligning                      VFD drug (§ 558.6(c) (21 CFR 558.6(c))).
                                                  it had received in response to the March                Product Use Conditions with GFI #209’’                    In this rulemaking, the Agency
                                                  2010 ANPRM, and the Agency                              (Ref. 2). GFI #213 outlined a timeline                 finalizes many of the provisions in the
                                                  requested comment on this draft                         and provided sponsors with specific                    December 2013 NPRM. In addition, the
                                                  language also.                                          recommendations on how they could                      final rule reflects revisions the Agency
                                                     Recognizing that there would be                      voluntarily modify the use conditions of               made in response to comments on the
                                                  challenges faced by animal producers                    their medically important antimicrobial                December 2013 NPRM and certain
                                                  and veterinarians as FDA phases in                      drug products administered in feed or                  revisions made by the Agency on its
                                                  veterinary oversight of the therapeutic                 water to align with the two judicious                  own initiative after considering all of
                                                  use of certain medically important                      use principles announced in GFI #209.                  the comments it received. Based on the
                                                  antimicrobials, in the spring of 2013,                  Once the use conditions of the affected                changes to the final rule from the
                                                  FDA and the U.S. Department of                          products are changed, these products                   proposed rule, the Agency has
                                                  Agriculture’s (USDA) Animal and Plant                   can no longer be legally used for                      determined that the effective date for
                                                  Health Inspection Service jointly                       production purposes, and can only be                   the final rule should be 120 days after
                                                  sponsored a series of public meetings in                used for therapeutic purposes with the                 publication.
                                                  various locations throughout the                        supervision of a licensed veterinarian.                III. Comments on the Proposed Rule
                                                  country (2013 public meetings). These                      Implementation of the judicious use
                                                  meetings provided a forum to discuss                    principles set forth in GFI #209,                         This section summarizes comments
                                                  potential challenges faced by animal                    particularly the second principle                      FDA received in response to the
                                                  producers in areas that may lack access                 recommending that affected products be                 December 2013 NPRM and the Agency’s
                                                  to adequate veterinary services and to                  limited to uses in animals that include                response to those comments. FDA
                                                  explore possible options for minimizing                 veterinarian oversight or consultation,                received about 2,000 individual
                                                  adverse impacts.                                        reinforces the need for FDA to                         comments submitted to the docket on
                                                     After considering the feedback                       reconsider the current VFD program and                 the December 2013 NPRM. Some of the
                                                  received during the 2013 public                         how best to make the program more                      comments contained signatures by
                                                  meetings, as well as comments received                  efficient and less burdensome for                      multiple individuals or organizations.
                                                  on our March 2010 ANPRM and April                       stakeholders while maintaining                         Comments were received from
                                                  2012 draft proposed regulation, FDA                     adequate protection for human and                      veterinary, feed manufacturing, and
                                                  published the December 2013 NPRM.                       animal health. The majority of the                     animal production associations, as well
                                                                                                          antimicrobial animal drug products that                as consumer advocacy groups and
                                                  B. Judicious Use Policy for Medically                                                                          individuals. Many of the comments
                                                  Important Antimicrobials                                are the focus of GFI #209 and GFI #213
                                                                                                          are drugs approved for use in or on                    received from veterinarian, feed
                                                     On April 13, 2012, FDA finalized a                   animal feed. All but a few of these drugs              manufacturing, animal production
                                                  guidance document entitled ‘‘The                        are currently available OTC without                    associations, and individuals generally
                                                  Judicious Use of Medically Important                    veterinary oversight or consultation and               supported the changes and requested
                                                  Antimicrobial Drugs in Food-Producing                   would be affected by the Agency’s                      some additional changes or clarification
                                                  Animals’’ (GFI #209) (Ref. 1). This                     recommendation in the guidances to                     on particular issues. Many of the
                                                  guidance document represents the                        switch these products’ marketing status                comments received from consumer
                                                  Agency’s current thinking regarding                     from OTC to VFD. Therefore, it is                      advocacy groups and individuals raised
                                                  antimicrobial drugs that are medically                  important that the VFD process be as                   concerns over whether the changes
                                                  important in human medicine and used                    efficient as possible when FDA’s                       would sufficiently protect public health.
                                                  in food-producing animals. Specifically,                judicious use policy is fully                          FDA is making changes in the final rule
                                                  GFI #209 discusses FDA’s concerns                       implemented to facilitate transition of                to address these concerns where the
                                                  regarding the development of                            these products from OTC to VFD                         Agency has determined such changes to
                                                  antimicrobial resistance in human and                   marketing status. In addition, an overly               be appropriate.
                                                  animal bacterial pathogens when                         burdensome VFD process could disrupt                      The order of the discussion reflects
                                                  medically important antimicrobial drugs                 the movement of medicated feeds                        the order in the regulatory text and not
                                                  are used in food-producing animals in                   through commercial feed distribution                   the order of significance of a particular
                                                  an injudicious manner. In addition, GFI                 channels, thereby impacting the                        issue. To make it easier to identify
                                                  #209 recommends two principles for                      availability of medicated feed products                comments and FDA’s responses, the
                                                  assuring the appropriate or judicious                   needed for addressing animal health                    word ‘‘Comment,’’ in parentheses,
                                                  use of medically important                              issues.                                                appears before the comment’s
                                                  antimicrobial drugs in food-producing                                                                          description, and the word ‘‘Response,’’
                                                  animals in order to help minimize                       II. Overview of the Final Rule                         in parentheses, appears before FDA’s
                                                  antimicrobial resistance development:                      This final rule amends FDA’s                        response. Each comment is numbered to
                                                  (1) Limit medically important                           regulations found in parts 514 and 558                 help distinguish between different
                                                  antimicrobial drugs to uses in animals                  (21 CFR parts 514 and 558) to change                   comments. The number assigned to each
                                                  that are considered necessary for                       and clarify certain definitions (§ 558.3               comment is for organizational purposes
                                                  assuring animal health and (2) limit                    (21 CFR 558.3)), clarify the general                   and does not signify the comment’s
                                                  medically important antimicrobial drugs                 requirements for VFD drugs (§ 558.6(a)                 value or importance.
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                                                  to uses in animals that include                         (21 CFR 558.6(a))), clarify the                           In addition to the comments specific
                                                  veterinary oversight or consultation.                   responsibilities of the VFD drug sponsor               to this rulemaking that we address in
                                                     On December 13, 2013, FDA finalized                  (§ 514.1(b) (21 CFR 514.1(b)), and clarify             the following paragraphs, we received
                                                  a second guidance document, GFI #213,                   specific responsibilities of the                       general comments expressing views
                                                  entitled ‘‘New Animal Drugs and New                     veterinarian issuing the VFD (§ 558.6(b)               about public health, the use of
                                                  Animal Drug Combination Products                        (21 CFR 558.6(b))). Also, in this final                antimicrobials, antimicrobial resistance,
                                                  Administered in or on Medicated Feed                    rule we clarify the specific                           antibiotic alternatives, animal
                                                  or Drinking Water of Food-Producing                     responsibilities of any person who                     husbandry practices, meat consumption,


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                                                                    Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations                                          31711

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


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                                                  31712             Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations

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


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                                                                    Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations                                            31713

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


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                                                  31714             Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations

                                                  distributor, the animal producer must                   production facility, further movement of               should each also have a copy of the
                                                  provide a VFD for the receipt of the                    that VFD feed to the actual animal                     VFD, and that copy may be electronic or
                                                  Type B VFD feed from the distributor.                   production facility would not be limited               hardcopy.
                                                  If the Type B VFD feed is being shipped                 and we would not consider such further                    (Comment 9) A few comments
                                                  to an animal producer who is a                          movement to be the activity of a                       addressed the regulatory requirements
                                                  distributor that has sent a one-time                    ‘‘distributor.’’                                       for electronically generated documents.
                                                  notification to FDA, the animal                                                                                One comment asked what requirements
                                                                                                          6. Combination VFD Drug                                would apply to records with an
                                                  producer must supply either an
                                                                                                          (§ 558.3(b)(12))                                       electronic signature. Another comment
                                                  acknowledgment letter or a VFD for the
                                                  receipt of the Type B VFD feed from the                    In the December 2013 NPRM, we                       urged FDA to not require compliance
                                                  distributor. (Note: In order for the                    added a definition for the term                        with 21 CFR part 11 (part 11) for VFDs
                                                  animal producer to receive a Type B or                  ‘‘combination veterinary feed directive                transmitted and stored electronically.
                                                  Type C VFD feed without a VFD in                        (VFD) drug.’’ In the final rule, we have                  (Response 9) The regulations in part
                                                  hand, he or she must have previously                    further clarified that definition to align             11 (Electronic Records; Electronic
                                                  notified FDA that he or she is a                        the language with the statutory                        Signatures) describe FDA’s standards for
                                                  distributor.) If the animal producer                    definition of a veterinary feed directive              assessing whether electronic records
                                                  provides an acknowledgment letter to                    drug.                                                  and electronic signatures are
                                                  the distributor from whom the animal                                                                           trustworthy and reliable and generally
                                                                                                          B. Veterinary Feed Directive Drugs                     equivalent to paper records with
                                                  producer receives the VFD feed, the                     (§ 558.6)
                                                  animal producer must either receive an                                                                         handwritten signatures. Electronic
                                                  acknowledgment letter or a VFD prior to                 1. General Requirements Related to VFD                 records, such as an electronic VFD that
                                                  further distributing the VFD feed to                    Drugs (§ 558.6(a))                                     meets the requirements of part 11, may
                                                  another person, or have a VFD on hand                                                                          be used in lieu of a paper VFD (i.e.,
                                                                                                          a. VFD Retention and Transmission
                                                  prior to feeding the Type C VFD feed to                                                                        VFDs that are generated and signed on
                                                                                                          Requirements (§ 558.6(a)(4))
                                                  his or her own animals. We have revised                                                                        paper). As we have previously stated in
                                                  the definition of acknowledgment letter                    In the December 2013 NPRM, we                       GFI #120: Veterinary Feed Directive
                                                  in (§ 558.3(b)(11)) to clarify that when                proposed that VFDs would no longer be                  Regulation Questions and Answers,
                                                  an animal producer is acting as a                       specifically required to be produced in                published on March 26, 2009, part 11
                                                  distributor as defined in (§ 558.3(b)(9)),              triplicate; however, all three involved                applies to records in electronic form
                                                  they may provide an acknowledgment                      parties (veterinarian, distributor, and                that are created, modified, maintained,
                                                  letter even if they are the ultimate user               client) still would be required to receive             archived, retrieved, or transmitted,
                                                  of some of the VFD feed.                                and keep a copy of the VFD, either                     under any FDA records requirements.
                                                                                                          electronically or in hardcopy. If the VFD              Therefore, electronic VFDs issued by
                                                  5. Animal Production Facility                           is transmitted electronically, the                     veterinarians must be compliant with
                                                  (§ 558.3(b)(10))                                        veterinarian would no longer be                        part 11, and VFDs received and
                                                     The December 2013 NPRM did not                       required to send the original in                       electronically stored by distributors and
                                                  propose a change to the definition of                   hardcopy to the distributor.                           clients must be compliant with part 11.
                                                  animal production facility. However, we                    (Comment 8) Many comments                           Part 11 does not apply to paper records
                                                  received comment on the definition.                     supported these changes. Some                          that are, or have been, transmitted by
                                                     (Comment 7) A few comments                           comments indicated that there was                      electronic means (such as facsimile,
                                                  requested that FDA define ‘‘animal                      some confusion about whether an                        email attachments, etc.). Part 11 requires
                                                  production facility’’ more broadly to                   electronic copy of the VFD would                       a one-time certification that the
                                                  include the location where the                          satisfy the recordkeeping requirement.                 electronic signatures in their system,
                                                  medicated feed is made. These                              (Response 8) To improve the clarity of              used after August 20, 1997, are intended
                                                  comments cited a concern that                           this section, we have revised the                      to be the legally binding equivalent of
                                                  movement of VFD feed would be                           regulatory text to more precisely                      the signer’s handwritten signature (Ref.
                                                  limited by this definition because                      indicate the recordkeeping                             6). Additional information about part 11
                                                  shipment of VFD feed to an animal                       requirements. An electronic copy of the                compliance, including information on
                                                  production facility must frequently go                  VFD is sufficient for recordkeeping                    how FDA intends to exercise
                                                  beyond the gate to a facility or feed mill              purposes. The original no longer needs                 enforcement discretion with regard to
                                                  where the animals are not housed.                       to be sent to the distributor. As we                   certain part 11 requirements during the
                                                     (Response 7) The term animal                         stated in the December 2013 NPRM, this                 reexamination of part 11, can be found
                                                  production facility is defined as ‘‘a                   hardcopy requirement has become                        in GFI Part 11, Electronic Records;
                                                  location where animals are raised for                   outdated by modern electronic                          Electronic Signatures—Scope and
                                                  any purpose, but does not include the                   communication and presents an                          Application (Ref. 7).
                                                  specific location where medicated feed                  unnecessary burden on the industry.                       (Comment 10) One comment
                                                  is made.’’ (§ 558.3(b)(10)). The                           This revision further reduces the                   suggested that a paper VFD process
                                                  definition of animal production facility                number of paper copies requiring                       would be unwieldy, costly, and
                                                  does not hinder the movement of feed                    physical recordkeeping space. The                      burdensome.
                                                  between a feed mill and an animal                       December NPRM, however, did not                           (Response 10) There are relative
                                                  production facility. VFD feed may be                    specify who should maintain the                        advantages and disadvantages to
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                                                  shipped from a distributor directly to an               original. Because of the confusion                     generating and keeping records in either
                                                  animal production facility, or may first                indicated in the comments, we are                      electronic or paper form. We believe
                                                  be delivered to a facility or feed mill                 revising the rule to specify that the                  that businesses should be able to decide
                                                  that is located where the animals are not               original should be maintained by the                   what format (electronic or hard copy)
                                                  housed. Provided the recipient of such                  veterinarian who issued the VFD and                    they would like to use to fulfill the
                                                  feed has a lawful VFD and is the owner                  should be maintained in the manner it                  recordkeeping requirements. For that
                                                  of both the facility or feed mill to which              was generated, either electronic or                    reason, we proposed regulations that
                                                  the feed was delivered and the animal                   hardcopy. The client and distributor                   removed the explicit requirement that


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                                                                    Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations                                          31715

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


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                                                  31716             Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations

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


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                                                                    Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations                                            31717

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


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                                                  31718             Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations

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


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                                                                    Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations                                          31719

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


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                                                  31720             Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations

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


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                                                                    Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations                                          31721

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


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                                                  31722             Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations

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


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                                                                    Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations                                          31723

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


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                                                  31724             Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations

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


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                                                                    Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations                                         31725

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


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                                                  31726             Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations

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


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                                                                    Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations                                         31727

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


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                                                  31728             Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations

                                                  FDA or other organizations, will be                     or by the private sector, of $100,000,000              for public comment draft text for
                                                  sufficient.                                             or more (adjusted annually for inflation)              proposed revisions to the current VFD
                                                                                                          in any one year.’’ The current threshold               regulation at part 558 (77 FR 22247).
                                                  IV. Legal Authority
                                                                                                          after adjustment for inflation is $141                    On December 12, 2013 (78 FR 75515),
                                                    FDA’s authority for issuing this final                million, using the most current (2013)                 FDA issued a proposed rule which
                                                  rule is provided by section 504 of the                  Implicit Price Deflator for the Gross                  contained proposed revised information
                                                  FD&C Act (21 U.S.C. 354) relating to                    Domestic Product. FDA does not expect                  collection requirements at 78 FR 75522
                                                  veterinary feed directive drugs. In                     this final rule to result in any 1-year                to 75525. Many of the information
                                                  addition, section 701(a) of the FD&C Act                expenditure that would meet or exceed                  collection requirements carry over from
                                                  (21 U.S.C. 371(a)) gives FDA general                    this amount.                                           existing OMB control number 0910–
                                                  rulemaking authority to issue
                                                                                                          VI. Paperwork Reduction Act of 1995                    0363; however, the section numbers for
                                                  regulations for the efficient enforcement
                                                                                                                                                                 some of the information collection
                                                  of the FD&C Act.                                           This final rule contains information
                                                                                                                                                                 requirements have been redesignated in
                                                                                                          collection provisions that are subject to
                                                  V. Final Regulatory Impact Analysis                                                                            this final rule. Those one-time
                                                                                                          review by the Office of Management and
                                                     FDA has examined the impacts of the                  Budget (OMB) under the Paperwork                       information collection requirements that
                                                  final rule under Executive Order 12866,                 Reduction Act of 1995 (44 U.S.C. 3501–                 are the direct result of this final rule are
                                                  Executive Order 13563, the Regulatory                   3520). The title, description, and                     shown in tables under the heading
                                                  Flexibility Act (5 U.S.C. 601–612), and                 respondent description of the                          ‘‘One-Time Costs.’’ The remaining
                                                  the Unfunded Mandates Reform Act of                     information collection provisions are                  information collection requirements
                                                  1995 (Pub. L. 104–4). Executive Orders                  shown in the following paragraphs with                 associated with this final rule are shown
                                                  12866 and 13563 direct Agencies to                      an estimate of the burden for annual                   in tables under the headings ‘‘Annual’’
                                                  assess all costs and benefits of available              reporting, recordkeeping, and third-                   or ‘‘Recurring Costs.’’
                                                  regulatory alternatives and, when                       party disclosure, including one-time                   A. Reporting Requirements
                                                  regulation is necessary, to select                      burdens triggered upon implementation
                                                  regulatory approaches that maximize                     of this final rule. Included in the                    Description of Respondents: VFD Feed
                                                  net benefits (including potential                       estimate is the time for reviewing                     Distributors, VFD Drug Sponsors
                                                  economic, environmental, public health                  instructions, searching existing data                     Currently, under § 558.6(d)(1)
                                                  and safety, and other advantages;                       sources, gathering and maintaining the                 (redesignated as § 558.6(c)(4)) a
                                                  distributive impacts; and equity). The                  data needed, and completing and                        distributor of animal feed containing a
                                                  Agency believes that this final rule is                 reviewing each collection of                           VFD drug must notify FDA prior to the
                                                  not a significant regulatory action as                  information.                                           first time he distributes such VFD feed
                                                  defined by Executive Order 12866. We                       Title: Veterinary Feed Directives.                  and this notification is required one
                                                  have developed a final regulatory                          Description: The final rule will revise             time per distributor. Therefore, all
                                                  impact analysis (FRIA) that presents the                existing OMB control number 0910–                      active distributors of VFD feed must
                                                  benefits and costs of this final rule to                0363 for veterinary feed directives by                 have already made notification to FDA
                                                  stakeholders and the government.                        providing for greater efficiencies to the              of their intention to distribute such feed
                                                     The Regulatory Flexibility Act                       VFD process.                                           in order to be in compliance with the
                                                  requires Agencies to analyze regulatory                    In 1996, the ADAA was enacted to                    current regulation. In addition, a
                                                  options that would minimize any                         facilitate the approval and marketing of               distributor must provide updated
                                                  significant impact of a rule on small                   new animal drugs and medicated feeds.                  information to FDA within 30 days of a
                                                  entities. Because the final rule would                  Among other things, the ADAA created                   change in ownership, business name, or
                                                  impose average annualized costs that                    a new category of new animal drugs                     business address.
                                                  amount to about 0.1 percent or less of                  called veterinary feed directive drugs (or
                                                  average annual revenues on small                        VFD drugs). VFD drugs are new animal                      Because the reporting requirements
                                                  entities, FDA concludes that it is very                 drugs intended for use in or on animal                 for distributors under redesignated
                                                  unlikely that the final rule will result in             feed, which are limited to use under the               § 558.6(c)(4) are the same as the current
                                                  a significant impact on a substantial                   professional supervision of a licensed                 requirements under § 558.6(d)(1), there
                                                  number of small entities.                               veterinarian in the course of the                      is no new reporting burden for
                                                     The summary analysis of benefits and                 veterinarian’s professional practice.                  distributors other than the one-time
                                                  costs included in the Executive                            Currently, there are two VFD drugs                  burden hours and costs described in
                                                  Summary of this document is drawn                       under five approved animal drug                        Table 1. FDA understands that current
                                                  from the detailed FRIA, which is                        applications. However, FDA has                         VFD feed distributors must review the
                                                  available at http://www.regulations.gov                 received feedback from stakeholders                    final rule in order to determine which
                                                  (enter Docket No. FDA–2010–N–0155),                     characterizing the current VFD process                 actions are necessary to comply with the
                                                  and is also available on FDA’s Web site                 as being overly burdensome. In response                new regulation. For these current VFD
                                                  at http://www.fda.gov. Section 202(a) of                to these concerns, FDA began exploring                 feed distributors we estimate review of
                                                  the Unfunded Mandates Reform Act of                     ways to improve the VFD program’s                      the rule will take a one-time hourly
                                                  1995 requires that Agencies prepare a                   efficiency. To this end, FDA published                 burden of 4 hours to complete.
                                                  written statement, which includes an                    an ANPRM inviting public comment on                       Burden hours and costs are derived
                                                  assessment of anticipated costs and                     possible VFD program efficiency                        from the Final Regulatory Impact
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                                                  benefits, before proposing ‘‘any rule that              improvements on March 29, 2010 (75                     Analysis (FRIA) associated with this
                                                  includes any Federal mandate that may                   FR 15387). Based on the considerable                   final rule. Wage rates have been
                                                  result in the expenditure by State, local,              public input received in response to the               adjusted in the tables throughout to that
                                                  and tribal governments, in the aggregate,               ANPRM, on April 13, 2012, FDA issued                   reported in the FRIA.




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                                                                    Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations                                                                                  31729

                                                                                                 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                             Number of                                             Average burden
                                                                                                  Number of                   responses                     Total
                                                          21 CFR 558.6/Activity                                                                                                     per response                  Total hours       Total costs
                                                                                                 respondents                     per                     responses                    in hours
                                                                                                                             respondent

                                                                                                                           One-Time Reporting Burden

                                                  Review of the Rule (VFD Feed Dis-                            1,376                             1                   1,376       4 ...........................           5,504         2 $529,000

                                                    tributors).

                                                       Total One-time Reporting Burden          ........................   ........................   ........................   ..............................          5,504              529,000

                                                                                                                    Annual (Recurring) Reporting Burden

                                                  558.6(c)(4)—A distributor must notify                        3 300                             1                      300      0.125 (8 minutes)                        37.5                      NA
                                                    FDA prior to the first time it distrib-
                                                    utes a VFD drug.
                                                  558.6(c)(6)—A distributor must notify                             20                          1                        20      0.125 (8 minutes)                         2.5                    N/A
                                                    FDA 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 × ap-
                                                  proximately $96 per hour for review at the general and operations manager level × 4 hours of one-time review = approximately $529,000. Esti-
                                                  mate 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 dis-
                                                  tribute VFDs each year.


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


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                                                  31730             Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations

                                                  noted in this document (on the VFD                      2,250,000 VFDs issued and stored in                    storage capacity on computers has
                                                  form itself) are not subject to review by               files per year.1                                       become extremely low, FDA regards this
                                                  OMB under the PRA. We are unable to                        Assuming that currently all VFDs are                as a negligible cost and has not
                                                  measure these hours and costs                           issued and stored in hardcopy, we                      estimated it.
                                                  separately, but consider them to be de                  estimate it takes 300 large file cabinets                 Also, we anticipate that computer
                                                  minimis. The cost to change the VFD                     to store these paper copy VFDs for 2                   storage will eliminate the need for large
                                                  form is considered to include these                     years, assuming 15,000 copies can be                   amounts of physical space devoted to
                                                  statement changes.                                      stored in a large file cabinet (see 64 FR              file cabinets. If, as we expect, one-half
                                                                                                          35966 at 35970). We estimate the                       of the VFD recordkeepers (veterinarians,
                                                  B. Recordkeeping Requirements                           average cost of a new file cabinet to be               distributors, and clients) use electronic
                                                     Description of Respondents: VFD                      $600. Thus, we estimate that the current               recordkeeping, this would result in a
                                                  Feed Distributors, Food Animal                          capital outlay for industry to store                   cost savings of $19,575 annually ($21.75
                                                  Veterinarians, and Clients (Food Animal                 hardcopy VFDs for the required 2 years                 per square foot per year rental cost of
                                                  Producers).                                             is $180,000 ($600 × 300 equals                         space × 6 square feet per file cabinet ×
                                                                                                          $180,000).                                             150 filing cabinets = $19,575 annual
                                                     Under current § 558.6(f) and                            In the 2013 proposed rule, FDA
                                                  redesignated § 558.6(a)(1), an animal                                                                          savings for switching to computer
                                                                                                          proposed to reduce the recordkeeping
                                                  feed containing a VFD drug or a                                                                                storage) (Thorpe, K., J. Edwards, and E.
                                                                                                          requirement for copies of VFDs for all
                                                  combination VFD drug may be fed to                                                                             Bondarenko, Cassidy Turley
                                                                                                          involved parties (proposed § 558.6(a)(4))
                                                  animals only by or upon a lawful VFD                                                                           Commercial Real Estate Services. ‘‘U.S.
                                                                                                          from 2 years to 1 year. After considering
                                                  issued by a licensed veterinarian.                                                                             Office Trends Report—2nd Quarter
                                                                                                          public comment, FDA has decided not
                                                  Veterinarians issue three copies of the                 to reduce the recordkeeping                            2013.’’ Page 10. http://
                                                  VFD: One for their own records, one for                 requirement from 2 years to 1 year in                  www.cassidyturley.com/Research/
                                                  their client, and one to the client’s VFD               this final rule. However, as included in               MarketReports/Report.aspx?topic=U_S_
                                                  feed distributor (current § 558.6(b)(1)–                § 558.6(b)(8), the veterinarian will no                Office_Trends_
                                                  (3) and redesignated § 558.6(a)(4) and                  longer be required to assure that a paper              Report&action=download, 2nd Quarter
                                                  redesignated § 558.6(b)(8)–(9)). The VFD                copy is received by the distributor                    2013).
                                                  includes information about the number                   within 5 working days of receipt if the                   In summary, we anticipate that the
                                                  and species of animals to receive feed                  original was faxed or otherwise                        capital costs for recordkeeping will be
                                                  containing one or more of the VFD                       transmitted electronically. This                       reduced from $180,000 (storing all VFDs
                                                  drugs, along with all other information                 hardcopy requirement has become                        as hardcopies in file cabinets for 2
                                                  as required under § 558.6. Under current                outdated by modern electronic                          years) to $90,000 (as described in the
                                                  § 558.6(b)(4), if the veterinarian sends                communication and presents an                          FRIA, there is a 50 percent reduction in
                                                  the VFD to the client or distributor by                 unnecessary burden on the industry.                    file cabinet costs due to electronic
                                                  electronic means, he or she must assure                 This provision reduces the number of                   recordkeeping for 2 years (i.e., to
                                                  that the distributor receives the original,             paper copies requiring physical                        $90,000)) plus $19,575 annual savings
                                                  signed VFD within 5 working days.                       recordkeeping space.                                   to keep VFD records, reflecting the
                                                  Also, under current § 558.6(c), all                        We anticipate approximately one-half                reduction in rental and space costs for
                                                  involved parties (the veterinarian, the                 of the food animal industry will use                   file cabinets.
                                                  distributor, and the client) must retain                electronic VFD generation and                             Whether a paper copy is filed or
                                                  a copy of the VFD for 2 years. In                       recordkeeping during the next 3 years of               whether the VFD is filed electronically,
                                                  addition, VFD feed distributors must                    the information collection. As the use of              we calculate that the time spent to file
                                                  also keep receipt and distribution                      computers for electronic storage of                    the VFD is the same at 0.167 hours. As
                                                  records of VFD feeds they manufacture                   records has increased substantially                    stated previously, distributors may
                                                  and make them available for FDA                         since 2000 and is expected to continue                 receive an acknowledgement letter in
                                                  inspection for 2 years (see current                     to do so regardless of this final rule, the            lieu of a VFD when distributing VFD
                                                  § 558.6(e)).                                            only marginal cost that would offset                   feed to another distributor. Such letters,
                                                     Veterinarians and clients must review                some of the reduction in file cabinet                  like VFDs, are also subject to a 2-year
                                                  the rule to ensure compliance with their                storage space costs would be the                       record retention requirement. Thus, the
                                                  respective new requirements. In Table 2,                additional computer storage space that                 recordkeeping burden for
                                                  we estimate the hourly burden of this                   may be needed for electronic VFD                       acknowledgement letters is included as
                                                  one-time review for both groups.                        forms. Because the cost of electronic                  a subset of the VFD recordkeeping
                                                  (Review of the rule by VFD feed                                                                                burden. This combined recordkeeping
                                                                                                             1 Distributors may receive an acknowledgement
                                                  distributors is accounted for in Table 1.)                                                                     burden, estimated at 18,788 hours in the
                                                                                                          letter in lieu of a VFD when distributing VFD feed
                                                     Recordkeeping costs are calculated as                to another distributor. Such letters, like VFDs, are   2000 final rule, is still cited in Table 2
                                                  follows: 750,000 VFDs (an average of                    also subject to a 2-year record retention              of the currently approved Information
                                                                                                          requirement. Thus, the recordkeeping burden for
                                                  375,000 VFDs issued for each of the two                 acknowledgement letters is included as a subset of
                                                                                                                                                                 Collection Request (ICR) for § 558.6
                                                  VFD drugs) issued in triplicate equals                  the VFD recordkeeping burden.                          (OMB control number 0910–0363).
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                                                                        Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations                                                                                                  31731

                                                                                                      TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
                                                                                                                                      Number of                                           Average burden
                                                                                                          Number of                                                 Total
                                                       21 CFR Section 558.6/activity                                                 records per                                          per recordkeeper                  Total hours                 Total costs
                                                                                                        recordkeepers                                              records
                                                                                                                                    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                   ........................   ........................   ........................   ..............................   ........................           4 (90,000)

                                                    for 2 years.

                                                        Total One-time Recordkeeping                    ........................   ........................   ........................   ..............................                 8,050                   409,000
                                                          Burden.

                                                                                                                       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           ........................   ........................   ........................   ..............................                37,575        ........................
                                                          Hours.
                                                     1 There are no operating and maintenance costs associated with this one-time collection of information.
                                                     2A total of 3,050 veterinarians × approximately $84 per hour × 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 × approximately $49 per hour × 0.5 hours one-time review = approximately $244,000. Estimate rounded to be in ac-
                                                  cordance 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) × 156 records per recordkeeper =
                                                  2,250,000 records (3 copies × 750,000 VFDs) × 0.0167 hours to file each record = 37,575 hours.


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

                                                                                                                        One-Time Third-party Disclosure Burden 1

                                                  Review of the Rule, Current VFD Drug
                                                    Sponsors (General and Operations
                                                    Managers) ............................................                         3                          1                          3                           6                       18                2 $2,500




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                                                  31732                   Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations

                                                                                       TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN—Continued
                                                                                                                                               Number of                                              Average
                                                                                                                    Number of                  disclosures               Total annual                burden per
                                                               21 CFR Section/activity                                                                                                                                        Total hours       Total costs
                                                                                                                   respondents                     per                   disclosures                disclosure in
                                                                                                                                               respondent                                               hours

                                                        Total One-Time Third-Party Disclo-
                                                          sure 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 gen-
                                                    eration ...................................................               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 × $140 × 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 × 245.9 VFDs issued per year per respondent (on average) = 750,000 VFDs issued per year. This figure ×
                                                  0.125 hours per form = 93,750 hours per year × $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) × 5 disclosures per respondent = 5,000 annual acknowledgement letters × 0.125
                                                  hours = approximately 625 hours.


                                                     The number of respondents                                            the human environment. Therefore,                                                  www.fda.gov/downloads/
                                                  multiplied by the number of disclosures                                 neither an environmental assessment                                                AnimalVeterinary/
                                                  per respondent equals the total annual                                  nor an environmental impact statement                                              GuidanceComplianceEnforcement/
                                                                                                                                                                                                             GuidanceforIndustry/UCM216936.pdf).
                                                  disclosures. The total annual                                           is required.                                                                 2. ‘‘Guidance for Industry: New Animal
                                                  disclosures multiplied by the average                                                                                                                      Drugs and New Animal Drug
                                                                                                                          VIII. Federalism
                                                  burden per disclosure equals the total                                                                                                                     Combination Products Administered in
                                                  hours.                                                                     FDA has analyzed this final rule in                                             or on Medicated Feed or Drinking Water
                                                     Additionally, we have clarified in the                               accordance with the principles set forth                                           of Food-Producing Animals:
                                                  final rule that, if a distributor                                       in Executive Order 13132. FDA has                                                  Recommendations for Drug Sponsors for
                                                  manufactures the VFD feed, the                                          determined that the final rule will not                                            Voluntarily Aligning Product Use
                                                  distributor must also keep VFD                                          contain policies that would have                                                   Conditions with GFI #209’’ (GFI #213),
                                                                                                                          substantial direct effects on the States,                                          December 2013; (http://www.fda.gov/
                                                  manufacturing records for 1 year in                                                                                                                        downloads/AnimalVeterinary/
                                                  accordance with part 225 and that such                                  on the relationship between the                                                    GuidanceComplianceEnforcement/
                                                  records must be made available for                                      National Government and the States, or                                             GuidanceforIndustry/UCM299624.pdf).
                                                  inspection and copying by FDA upon                                      on the distribution of power and                                             3. FDA, Warning Letters (http://www.fda.gov/
                                                  request (§ 558.6(c)(4)). These record                                   responsibilities among the various                                                 ICECI/EnforcementActions/
                                                  requirements are currently approved                                     levels of government. Accordingly, the                                             WarningLetters/default.htm).
                                                  under OMB control number 0910–0152,                                     Agency concludes that the final rule                                         4. ‘‘Compliance Program Guidance Manual:
                                                                                                                          does not contain policies that have                                                Feed Manufacturing’’ (CPGM 7371.004);
                                                  Current Good Manufacturing Practice
                                                                                                                                                                                                             (http://www.fda.gov/downloads/
                                                  Regulations for Medicated Feed.                                         federalism implications as defined in
                                                                                                                                                                                                             AnimalVeterinary/
                                                     The information collection provisions                                the Executive order and, consequently,                                             GuidanceComplianceEnforcement/
                                                  in this final rule have been submitted to                               a federalism summary impact statement                                              ComplianceEnforcement/
                                                  OMB for review as required by section                                   is not required.                                                                   UCM113430.pdf).
                                                  3507(d) of the Paperwork Reduction Act                                  IX. References
                                                                                                                                                                                                       5. The Association of American Feed Control
                                                  of 1995.                                                                                                                                                   Officials (AAFCO), Regulatory Page
                                                     Before the effective date of this final                                 The following references have been                                              (http://www.aafco.org/Regulatory).
                                                  rule, FDA will publish a notice in the                                  placed on display in the Division of                                         6. ‘‘Guidance for Industry: Veterinary Feed
                                                                                                                          Dockets Management (see ADDRESSES)                                                 Directive Regulation Questions and
                                                  Federal Register announcing OMB’s
                                                                                                                          and may be seen by interested persons                                              Answers’’ (GFI #120), March 26, 2009;
                                                  decision to approve, modify, or                                                                                                                            (http://www.fda.gov/downloads/
                                                  disapprove the information collection                                   between 9 a.m. and 4 p.m., Monday                                                  AnimalVeterinary/
                                                  provisions in this final rule. An Agency                                through Friday, and are available                                                  GuidanceComplianceEnforcement/
                                                  may not conduct or sponsor, and a                                       electronically at http://                                                          GuidanceforIndustry/UCM052660.pdf).
                                                  person is not required to respond to, a                                 www.regulations.gov. (We have verified                                       7. ‘‘Guidance for Industry Part 11, Electronic
                                                  collection of information unless it                                     the Web site addresses in this reference                                           Records; Electronic Signatures—Scope
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                                                  displays a currently valid OMB control                                  section, but we are not responsible for                                            and Application’’ August 2003; (http://
                                                                                                                          any subsequent changes to the Web sites                                            www.fda.gov/downloads/
                                                  number.
                                                                                                                          after this document publishes in the                                               RegulatoryInformation/Guidances/
                                                  VII. Environmental Impact                                                                                                                                  ucm125125.pdf).
                                                                                                                          Federal Register.)                                                           8. AVMA, Principles of Veterinary Medical
                                                    The Agency has determined under 21                                    1. ‘‘Guidance for Industry: The Judicious Use                                      Ethics of the AVMA (https://
                                                  CFR 25.30(h) that this action is of a type                                   of Medically Important Antimicrobial                                          www.avma.org/KB/Policies/Pages/
                                                  that does not individually or                                                Drugs in Food-Producing Animals’’ (GFI                                        Principles-of-Veterinary-Medical-Ethics-
                                                  cumulatively have a significant effect on                                    #209), April 13, 2012; (http://                                               of-the-AVMA.aspx).



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                                                                     Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations                                             31733

                                                  9. FDA, From an Idea to the Marketplace: The               (b) * * *                                               (9) For the purposes of this part, a
                                                       Journey of an Animal Drug through the                 (9) Veterinary feed directive. Three                 ‘‘distributor’’ means any person who
                                                       Approval Process (http://www.fda.gov/               copies of a veterinary feed directive                  distributes a medicated feed containing
                                                       AnimalVeterinary/ResourcesforYou/
                                                                                                           (VFD) must be submitted in a form that                 a VFD drug to another person. Such
                                                       AnimalHealthLiteracy/ucm219207.htm).
                                                  10. FDA, Conditional Approval Explained: A               accounts for the information described                 other person may be another distributor
                                                       Resource for Veterinarians (http://                 under §§ 558.6(b)(3) and 558.6(b)(4) of                or the client-recipient of a VFD.
                                                       www.fda.gov/animalveterinary/                       this chapter.                                          *       *    *     *     *
                                                       resourcesforyou/ucm413948.htm).                     *     *     *     *    *                                  (11) An ‘‘acknowledgment letter’’ is a
                                                  11. FDA, Drug Indexing (http://www.fda.gov/                                                                     written (nonverbal) communication
                                                       AnimalVeterinary/                                   PART 558—NEW ANIMAL DRUGS FOR
                                                       DevelopmentApprovalProcess/                                                                                provided to a distributor (consignor)
                                                                                                           USE IN ANIMAL FEEDS                                    from another distributor (consignee). An
                                                       MinorUseMinorSpecies/
                                                       ucm070206.htm).                                                                                            acknowledgment letter must be
                                                                                                           ■ 3. The authority citation for 21 CFR
                                                  12. White House, National Strategy for                                                                          provided either in hardcopy or through
                                                       Combating Antibiotic-Resistant Bacteria             part 558 is revised to read as follows:
                                                                                                                                                                  electronic media and must affirm:
                                                       (http://www.whitehouse.gov/sites/                     Authority: 21 U.S.C. 354, 360b, 360ccc,                 (i) That the distributor will not ship
                                                       default/files/docs/carb_national_                   360ccc–1, 371.                                         such VFD feed to an animal production
                                                       strategy.pdf).
                                                  13. FDA, FDA Secures Full Industry                       ■ 4. In § 558.3, revise paragraphs                     facility that does not have a VFD,
                                                       Engagement on Antimicrobial Resistance              (b)(1)(ii), (b)(6), (b)(7), (b)(9), and (b)(11);          (ii) That the distributor will not ship
                                                       Strategy (http://www.fda.gov/                       and add paragraph (b)(12) to read as                   such VFD feed to another distributor
                                                       AnimalVeterinary/NewsEvents/                        follows:                                               without receiving a similar written
                                                       CVMUpdates/ucm403285.htm).                                                                                 acknowledgment letter, and
                                                  14. FDA, List of Affected Products (http://              § 558.3 Definitions and general                           (iii) That the distributor has complied
                                                       www.fda.gov/AnimalVeterinary/                       considerations applicable to this part.
                                                                                                                                                                  with the distributor notification
                                                       SafetyHealth/AntimicrobialResistance/               *       *    *     *     *                             requirements of § 558.6(c)(5).
                                                       JudiciousUseofAntimicrobials/                          (b) * * *
                                                       ucm390429.htm).                                                                                               (12) A ‘‘combination veterinary feed
                                                                                                              (1) * * *                                           directive (VFD) drug’’ is a combination
                                                  15. FDA, FDA’s Plans to Monitor Progress
                                                       (http://www.fda.gov/AnimalVeterinary/
                                                                                                              (ii) Category II—These drugs require a              new animal drug (as defined in
                                                       SafetyHealth/AntimicrobialResistance/               withdrawal period at the lowest use                    § 514.4(c)(1)(i) of this chapter) intended
                                                       JudiciousUseofAntimicrobials/                       level for at least one species for which               for use in or on animal feed which is
                                                       ucm378256.htm).                                     they are approved, or are regulated on                 limited by an approved application filed
                                                  16. FDA, Compliance Policy Guide Sec.                    a ‘‘no-residue’’ basis or with a zero                  under section 512(b) of the Federal
                                                       615.200 Proper Drug Use and Residue                 tolerance because of a carcinogenic
                                                       Avoidance by Non-Veterinarians (http://                                                                    Food, Drug, and Cosmetic Act, a
                                                                                                           concern regardless of whether a                        conditionally approved application filed
                                                       www.fda.gov/ICECI/
                                                                                                           withdrawal period is required.                         under section 571 of the Federal Food,
                                                       ComplianceManuals/
                                                       CompliancePolicyGuidanceManual/                     *       *    *     *     *                             Drug, and Cosmetic Act, or an index
                                                       ucm074660.htm).                                        (6) A ‘‘veterinary feed directive (VFD)             listing under section 572 of the Federal
                                                  17. FDA, Environmental Impact                            drug’’ is a drug intended for use in or                Food, Drug, and Cosmetic Act to use
                                                       Considerations (http://www.fda.gov/                 on animal feed which is limited by an                  under the professional supervision of a
                                                       AnimalVeterinary/                                   approved application filed pursuant to
                                                       DevelopmentApprovalProcess/
                                                                                                                                                                  licensed veterinarian, and at least one of
                                                                                                           section 512(b) of the Federal Food,                    the new animal drugs in the
                                                       EnvironmentalAssessments/default.htm).
                                                                                                           Drug, and Cosmetic Act, a conditionally                combination is a VFD drug. Use of
                                                  List of Subjects                                         approved application filed pursuant to                 animal feed bearing or containing a
                                                  21 CFR Part 514                                          section 571 of the Federal Food, Drug,                 combination VFD drug must be
                                                                                                           and Cosmetic Act, or an index listing                  authorized by a lawful VFD.
                                                    Administrative practice and                            under section 572 of the Federal Food,                 ■ 5. Revise § 558.6 to read as follows:
                                                  procedure, Animal drugs, Confidential                    Drug, and Cosmetic Act to use under the
                                                  business information, Reporting and                      professional supervision of a licensed                 § 558.6   Veterinary feed directive drugs.
                                                  recordkeeping requirements.                              veterinarian. Use of animal feed bearing                 (a) General requirements related to
                                                  21 CFR Part 558                                          or containing a VFD drug must be                       veterinary feed directive (VFD) drugs.
                                                                                                           authorized by a lawful veterinary feed                 (1) Animal feed bearing or containing a
                                                    Animal drugs, Animal feeds.
                                                                                                           directive.                                             VFD drug or a combination VFD drug (a
                                                    Therefore, under the Federal Food,                        (7) A ‘‘veterinary feed directive’’ is a            VFD feed or combination VFD feed) may
                                                  Drug, and Cosmetic Act and under                         written (nonverbal) statement issued by                be fed to animals only by or upon a
                                                  authority delegated to the Commissioner                  a licensed veterinarian in the course of               lawful VFD issued by a licensed
                                                  of Food and Drugs, 21 CFR parts 514                      the veterinarian’s professional practice               veterinarian.
                                                  and 558 are amended as follows:                          that orders the use of a VFD drug or                     (2) A VFD feed or combination VFD
                                                  PART 514—NEW ANIMAL DRUG                                 combination VFD drug in or on an                       feed must not be fed to animals after the
                                                  APPLICATIONS                                             animal feed. This written statement                    expiration date on the VFD.
                                                                                                           authorizes the client (the owner of the                  (3) Use and labeling of a VFD drug or
                                                  ■ 1. The authority citation for 21 CFR                   animal or animals or other caretaker) to               a combination VFD drug in feed is
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                                                  part 514 is revised to read as follows:                  obtain and use animal feed bearing or                  limited to the approved, conditionally
                                                    Authority: 21 U.S.C. 321, 331, 351, 352,
                                                                                                           containing a VFD drug or combination                   approved, or indexed conditions of use.
                                                  354, 356a, 360b, 371, 379e, 381.                         VFD drug to treat the client’s animals                 Use of feed containing this veterinary
                                                  ■ 2. In § 514.1, revise paragraph (b)(9) to              only in accordance with the conditions                 feed directive (VFD) drug in a manner
                                                  read as follows:                                         for use approved, conditionally                        other than as directed on the labeling
                                                                                                           approved, or indexed by the Food and                   (extralabel use) is not permitted.
                                                  § 514.1    Applications.                                 Drug Administration.                                     (4) All involved parties (the
                                                  *      *      *       *      *                           *       *    *     *     *                             veterinarian, the distributor, and the


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                                                  31734             Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations

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


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                                                                    Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations                                                31735

                                                    (5) A distributor of animal feed                        (6) A distributor must also notify FDA               distributor only if the originating
                                                  containing a VFD drug must notify FDA                   within 30 days of any change in                        distributor (consignor) first obtains a
                                                  prior to the first time it distributes                  ownership, business name, or business                  written (nonverbal) acknowledgment
                                                  animal feed containing a VFD drug. The                  address.                                               letter, as defined in § 558.3(b)(11), from
                                                  notification is required one time per                     (7) The notifications cited in                       the receiving distributor (consignee)
                                                  distributor and must include the                        paragraphs (c)(5) and (c)(6) of this                   before the feed is shipped. Consignor
                                                  following information:                                  section must be submitted to the Food                  distributors must retain a copy of each
                                                    (i) The distributor’s complete name                   and Drug Administration, Center for                    consignee distributor’s acknowledgment
                                                  and business address;                                   Veterinary Medicine, Division of                       letter for 2 years.
                                                    (ii) The distributor’s signature or the               Animal Feeds (HFV–220), 7519                             Dated: May 28, 2015.
                                                  signature of the distributor’s authorized               Standish Pl., Rockville, MD 20855, FAX:                Leslie Kux,
                                                  agent; and                                              240–453–6882.                                          Associate Commissioner for Policy.
                                                    (iii) The date the notification was                     (8) A distributor is permitted to                    [FR Doc. 2015–13393 Filed 6–2–15; 8:45 am]
                                                  signed.                                                 distribute a VFD feed to another                       BILLING CODE 4164–01–P
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Document Created: 2015-12-15 15:09:13
Document Modified: 2015-12-15 15:09:13
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis rule is effective October 1, 2015.
ContactSharon Benz, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5939, email: [email protected]
FR Citation80 FR 31707 
RIN Number0910-AG95
CFR Citation21 CFR 514
21 CFR 558
CFR AssociatedAdministrative Practice and Procedure; Animal Drugs; Confidential Business Information; Reporting and Recordkeeping Requirements and Animal Feeds

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