[Federal Register Volume 78, Number 239 (Thursday, December 12, 2013)]
[Proposed Rules]
[Pages 75515-75527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-29696]


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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its animal drug regulations regarding veterinary feed directive (VFD) 
drugs. FDA's VFD regulation, which became effective on January 8, 2001, 
established requirements relating to the distribution and use of VFD 
drugs and animal feeds containing such drugs. This proposed amendment 
is intended to improve the efficiency of FDA's VFD program.

DATES: Submit either electronic or written comments on the proposed 
rule by March 12, 2014. Submit comments on information collection 
issues under the Paperwork Reduction Act of 1995 (the PRA) by January 
13, 2014, (see the ``Paperwork Reduction Act of 1995'' section).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0155, by any of the following methods, except that comments on 
information collection issues under the PRA must be submitted to the 
Office of Information and Regulatory Affairs, Office of Management and 
Budget (OMB) (see the ``Paperwork Reduction Act of 1995'' section).

Electronic Submissions

    Submit electronic comments in the following way
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following way:
     Mail/Hand delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2010-N-0155 for this rulemaking. All comments 
received may be posted without change to http://www.regulations.gov, 
including any personal information provided. For additional information 
on submitting comments, see the ``Comments'' heading of the 
SUPPLEMENTARY INFORMATION section.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sharon Benz, Center for Veterinary 
Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6864, email: [email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Background
    A. History
    B. Judicious Use Policy for Medically Important Antimicrobials
II. Highlights of the Proposed Rule
    A. User-Friendly Reorganization of the VFD Regulation
    B. Increased Flexibility for Licensed Veterinarians Issuing VFDs
    C. Continued Access to Category I Type A Medicated Articles by 
Unlicensed Feed Mills
    D. Increased Flexibility for Food Animal Producers Purchasing 
VFD Feeds
    E. Lower Recordkeeping Burden for All Involved Parties
III. Proposed Regulations
    A. Conforming Changes (Proposed Sec.  514.1(b)(9)
    B. Definitions (Proposed Sec.  558.3(b))
    C. General Requirements Related to VFD Drugs (Proposed Sec.  
558.6(a))
    D. Responsibilities of the Veterinarian Issuing the VFD 
(Proposed Sec.  558.6(b))
    E. Responsibilities of the Medicated Feed Distributor (Proposed 
Sec.  558.6(c))
IV. Legal Authority
V. Preliminary Regulatory Impact Analysis
VI. Paperwork Reduction Act of 1995
VII. Environmental Impact
VIII. Federalism
IX. Comments

Executive Summary

Purpose of Proposed Rule

    The purpose of this rulemaking is to revise FDA's VFD regulations 
to improve the efficiency of the VFD program.
    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 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 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)). In the decade since those 
regulations were issued, stakeholders informed FDA that the VFD process 
is overly burdensome. In response to those concerns, FDA published an 
advance notice of proposed rulemaking in March 2010, and a draft 
proposed regulation in April 2012.
    As FDA begins to implement the judicious use principles for 
medically important antimicrobial new animal drugs approved for use in 
food-producing animals, based on the framework set forth in Guidance 
for Industry (GFI) 209 (published April 13, 2012), it is 
critical that the Agency makes the VFD program as efficient as possible 
for stakeholders while maintaining adequate protection for human and 
animal health. The provisions included in this proposed rule are based 
on stakeholder input received in response to multiple opportunities for 
public comment, including an advance notice of

[[Page 75516]]

proposed rulemaking (ANPRM) (75 FR 15387, March 29, 2010) and draft 
text of proposed amendments to the current VFD regulations (77 FR 
22247, April 13, 2012). FDA proposes that if this rule is finalized, it 
will become effective 60 days after publication of the final rule in 
the Federal Register.

Summary of Major Provisions

    The proposed rule, if finalized, will make several major changes to 
the current VFD regulations in 21 CFR part 558:
     In order to provide increased flexibility for licensed 
veterinarians issuing VFDs, FDA is proposing to revise the definition 
of the term ``Veterinary Feed Directive'' in Sec.  558.3 (21 CFR 558.3) 
which currently includes a relatively prescriptive, federally defined, 
code of veterinary professional conduct known as the veterinarian-
client-patient relationship (VCPR). Specifically, the Agency proposes 
to remove the explicit VCPR provision and replace it with the 
requirement that veterinarians ordering the use of VFD drugs must do so 
``in compliance with all applicable veterinary licensing and practice 
requirements.'' The purpose of this revision is to provide greater 
flexibility for veterinarians by deferring to the veterinary profession 
and individual states for the specific criteria for acceptable 
veterinary professional conduct, rather than relying on a more rigid, 
one-size-fits-all, Federal standard. From a practical standpoint, this 
enables the veterinary profession and individual states to adjust the 
specific criteria for a VCPR to appropriately align with current 
veterinary practice standards, technological and medical advances, and 
other regional considerations. For example, greater flexibility could 
allow veterinarians to more effectively provide services to food animal 
producers in remote geographical areas where veterinary professional 
resources are limited and distances are great.
     In order to prevent potential shortages of antimicrobial 
drugs needed by food animal producers for judicious therapeutic uses on 
their farms and ranches, FDA is proposing to revise the definition of 
``Category II'' drugs in Sec.  558.3. Under current regulations, all 
animal drugs approved for use in or on animal feed are assigned to one 
of two categories, depending on their potential to create unsafe drug 
residues in edible tissues--Category I drugs having the lowest 
potential and Category II drugs having the highest potential. In order 
to reduce the potential of creating unsafe drug residues, access to 
Category II drugs is restricted to licensed feed mills because these 
facilities are technically better suited to handle these drugs in a 
concentrated form. However, existing regulations include a provision 
that says all VFD drugs, regardless of their potential to create unsafe 
drug residues, are Category II drugs. Thus, under current regulations, 
if an over-the-counter (OTC) Category I drug changes to VFD status, it 
automatically becomes a Category II drug, which, in turn, limits its 
availability only to licensed feed mills. FDA is concerned that the 
automatic recategorization of drugs from Category I to Category II once 
they switch to VFD status is likely to cause a supply chain obstruction 
for VFD feeds once the Agency's policy regarding the judicious use of 
medically important antimicrobial drugs in food-producing animals is 
fully implemented. To avoid this outcome, FDA proposes to revise the 
definition of Category II to eliminate the automatic classification of 
VFD drugs into Category II. This would permit those medically important 
antimicrobials used in animal feed that are currently Category I drugs 
to become VFD drugs consistent with FDA's judicious use policy. At the 
same time, products containing these drugs would remain available 
through the current feed mill distribution system.
     In order to lower the recordkeeping burden associated with 
the use of VFD drugs, FDA is proposing to align the recordkeeping 
requirements for VFD drugs with the current Good Manufacturing 
Practices (cGMP) recordkeeping requirements for medicated feeds, thus 
reducing the recordingkeeping burden for VFD drugs from 2 years to 1 
year. Under current Sec.  558.6, all involved parties (the 
veterinarian, the distributor, and the client) must keep their copy of 
the VFD on file and available for FDA inspection for 2 years. In 
addition, VFD feed distributors must also keep receipt and distribution 
records of the VFD feeds they manufacture and make them available for 
FDA inspection for 2 years. However, the cGMP regulations for medicated 
feed manufacturing in 21 CFR part 225 require that such records be kept 
for only 1 year. Feed mill operators have told FDA that this 
discrepancy is difficult to manage and that they would like to see all 
feed manufacturing record retention requirements kept the same at 1 
year. Based on our experience, FDA does not believe the extra 1 year of 
recordkeeping for VFD drugs is warranted for any of the involved 
parties. The value added by the second year of record retention has not 
been shown to justify the associated paperwork burden. Therefore, FDA 
is proposing to reduce the recordkeeping requirement for copies of VFDs 
for all involved parties, and for manufacturing receipt and 
distribution records for VFD distributors, from 2 years to 1 year.

Costs and Benefits

    The estimated one-time costs to industry from this proposed rule, 
if finalized, are $920,000, most of which are costs to review the rule 
and prepare a compliance plan. This equates to annualized costs of 
about $131,000 at a 7 percent discount rate over 10 years. We estimate 
that the total government costs associated with reviewing the VFD drug 
labeling supplements that are expected to be submitted by all four VFD 
drug sponsors to be $1,200.
    The expected benefit of this proposal is a general improvement in 
the efficiency of the VFD process. FDA estimates the annualized cost 
savings associated with the reduced requirements of the VFD process to 
be $19,000 over 10 years at a 7 percent discount rate (annualized at 
$16,000 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 $5.55 million annually.

I. Background

A. History

    Before 1996, FDA had only two options for regulating the 
distribution of animal drugs: (1) OTC and (2) 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 have historically been impractical because many states have 
laws prohibiting feed manufacturers from dispensing prescription drugs. 
As newer animal drugs were developed, FDA determined that the existing 
regulatory options--OTC and Rx--did not provide the needed flexibility 
and safety for these drugs to be prescribed or administered through 
medicated feed. FDA believed that such drugs should be subject to 
greater control than provided by OTC status, particularly certain 
antimicrobial drugs. This control is critical to reducing unnecessary 
use of such drugs in animals and to slowing or preventing any potential 
for the development of bacterial resistance to antimicrobial drugs.
    After considerable deliberation between FDA and the animal 
agriculture industry, and with the support of State

[[Page 75517]]

regulatory Agencies, 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 determined that certain new animal drugs 
should be approved for use in animal feed but only if these medicated 
feeds were 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 to use under the professional supervision of a licensed 
veterinarian in the course of the veterinarian's professional practice. 
For animal feed containing a VFD drug to be used in 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 
new animal drug regulations 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. As an example, 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 began implementing the final 
rule relating to VFDs. Although currently there are few approved VFD 
drugs, FDA has received comments from stakeholders characterizing the 
current VFD process as being overly burdensome. When veterinary 
oversight of a medicated feed is determined to be necessary, it is 
essential that such oversight be facilitated through an efficient VFD 
process.
    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 an ANPRM in the Federal 
Register of March 29, 2010 (75 FR 15387). The 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 draft text of a proposed VFD regulation 
(hereinafter, ``draft proposed regulation'') in the Federal Register of 
April 13, 2012 (77 FR 22247), based on the considerable public input 
provided to the ANPRM docket, and requested comment on this draft text. 
The provisions included in this proposed rule reflect the public input 
FDA received. FDA proposes that if this rule is finalized, it will 
become effective 60 days after publication of the final rule in the 
Federal Register.

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). This final guidance 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 provides two recommended principles 
regarding the appropriate or judicious use of medically important 
antimicrobial drugs: (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.
    Implementation of these judicious use principles, particularly the 
second principle, 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. Currently, the vast majority of the 
antimicrobial animal drug products that are the focus of GFI 
209 are feed-use drugs--that is, they are products approved 
for use in or on animal feed. All but a few of these products are 
currently available OTC without veterinary oversight or consultation 
and would be affected by the recommendation to switch to VFD status. It 
is critical, therefore, that the VFD process be as efficient as 
possible when FDA's judicious use policy is fully implemented because 
an overly burdensome VFD process could lead to unanticipated 
disruptions in the current channels of commercial feed distribution.

II. Highlights of the Proposed Rule

    The primary purpose of this rulemaking is to improve the efficiency 
of the VFD program, while still ensuring that VFD drugs are used in a 
manner that affords adequate protection for human and animal health. 
The key changes in this proposal include:
     User-friendly reorganization of the VFD regulation;
     increased flexibility for licensed veterinarians issuing 
VFDs;
     continued access to Category I Type A medicated articles 
by unlicensed feed mills;
     increased flexibility for animal producers purchasing VFD 
feeds; and
     lower recordkeeping burden for all involved parties.

A. User-Friendly Reorganization of the VFD Regulation

    The proposed rule, if finalized, will revise and reorganize the 
existing VFD regulation at Sec.  558.6 to make it more user-friendly. 
Proposed Sec.  558.6 includes only three subsections, (a), (b), and 
(c), in contrast to the existing regulation, which has six subsections. 
In addition, for ease in identifying what is expected from each party 
involved in the VFD process, the proposed rule organizes the provisions 
by affected party or stakeholder group. Subsection (a) contains general 
provisions that are common to all affected parties, including 
veterinarians, distributors, and clients (including clients that are 
on-farm mixers handling VFD drugs and feeds for use in their own 
animals). Subsection (b) contains specific provisions for veterinarians 
and subsection (c) contains specific provisions for animal feed 
distributers. Consistent with public comments we received on the ANPRM 
and draft regulation, these revisions are intended to make it clearer 
what is expected from each of these parties. Important aspects of 
subsection (b) include that the veterinarian issuing the VFD must be 
licensed and must assure that the VFD is complete and accurate before 
it is issued. The veterinarian must also assure that the terms of the 
VFD are in compliance with the conditions for use approved, 
conditionally approved, or indexed for the VFD drug. Important aspects 
of subsection (c) include that the VFD feed distributor is responsible 
for assuring that the VFD is complete before filling the order. The VFD 
feed distributor must also assure that the medicated feed is 
manufactured and labeled in accordance with the VFD and in conformity 
with the approved,

[[Page 75518]]

conditionally approved, or indexed conditions of use. See section III 
for a more detailed description of these provisions.

B. Increased Flexibility for Licensed Veterinarians Issuing VFDs

    FDA proposes to modify provisions in the existing regulation at 21 
CFR part 558 relating to professional conduct by veterinarians issuing 
orders for VFD drugs in several important ways. First, in order to 
provide greater flexibility for veterinarians, FDA is proposing to 
revise the definition of the term ``Veterinary Feed Directive'' in 
Sec.  558.3(b)(7) which currently includes a relatively prescriptive, 
federally-defined, code of veterinary professional conduct known as the 
VCPR. Specifically, the Agency proposes to remove the explicit VCPR 
provision and replace it with the requirement that veterinarians 
ordering the use of VFD drugs must be ``in compliance with all 
applicable veterinary licensing and practice requirements.'' The 
purpose of this revision is to provide greater flexibility for 
veterinarians by deferring to the veterinary profession and individual 
states for the specific criteria for acceptable veterinary professional 
conduct, rather than relying on a more rigid, one-size-fits-all, 
Federal standard. As discussed further below, the veterinary profession 
and individual state veterinary medical licensing boards already 
embrace the concept of a VCPR as an element of veterinary licensing and 
practice requirements. From a practical standpoint, this proposal would 
enable the veterinary profession and individual states to adjust the 
specific criteria for a VCPR to appropriately align with current 
practice standards, technological and medical advances, and other 
regional considerations. For example, providing for this greater degree 
of flexibility is of particular importance for those veterinarians 
providing services to producers in remote geographical areas where 
veterinary professional resources are limited and distances are great. 
Further, this proposal provides greater flexibility for veterinarians 
working in consultation with other animal health professionals, such as 
poultry pathologists and fish health biologists. The need for greater 
flexibility in a veterinarian's professional relationship with his or 
her clients and patients will become increasingly important as FDA's 
judicious use policy for medically important antimicrobial dugs is 
implemented.
    Second, FDA is proposing to further revise the definition of the 
term ``Veterinary Feed Directive'' in Sec.  558.3(b)(7) to explicitly 
incorporate the concept of veterinary ``supervision or oversight.'' 
Section 504(a)(1) of the FD&C Act (21 U.S.C. 354(a)(1)) states that a 
veterinary feed directive drug is a drug intended for use in or on 
animal feed which is limited to use under the professional 
``supervision'' of a licensed veterinarian. In addition, the second 
judicious use principle of GFI 209 recommends veterinary 
``oversight'' when using medically important antimicrobial drugs in 
food-producing animals. Therefore, to better align the VFD regulations 
with the statute and with the judicious use principles outlined in GFI 
209, we propose to incorporate the phrase ``supervision or 
oversight'' in the revised definition of VFD. Thus, the proposed 
revised definition for VFD would require that a veterinarian may only 
issue a VFD for the use of VFD drugs in animals that are under his or 
her ``supervision or oversight.''
    Third, the current definition of ``Veterinary Feed Directive'' in 
Sec.  558.3(b)(7) includes another requirement for professional 
veterinary conduct, which also is derived from the VFD provisions in 
section 504 of the FD&C Act. This requirement is found in the phrase 
``. . . licensed veterinarian in the course of the veterinarian's 
professional practice . . .'' which also appears in the first sentence 
of the current definition in Sec.  558.3(b)(7). (See section 504(a)(1) 
of the FD&C Act.) FDA proposes to retain this provision in the revised 
definition of the term ``VFD.''
    By combining these three elements, the proposed revised requirement 
for veterinarians issuing orders for the use of VFD drugs found in this 
rule, as derived from the proposed revised definition of the term 
``VFD,'' would include language stating that a licensed veterinarian 
may only issue a VFD for the use of VFD drugs in animals ``under his or 
her supervision or oversight in the course of his or her professional 
practice, and in compliance with all applicable veterinary licensing 
and practice requirements.''
    It is important to remember that this provision would only apply to 
on-label animal drug use. The statutory provision for an explicit, 
federally defined VCPR, which was introduced with the Animal Medicinal 
Use Clarification Act of 1994 (AMDUCA) (Pub. L. 103-396) (see section 
512(a)(4)(A)(i) of the FD&C Act (U.S.C. 360b(a)(4)(A)(i))) and defined 
by regulation (see Sec.  530.3(i)), continues to apply in circumstances 
involving extralabel animal drug use. However, because AMDUCA 
specifically prohibits extralabel use of animal drugs in or on animal 
feed, including VFD drugs, FDA does not believe that the explicit VCPR 
requirement as defined in Sec.  530.3(i) is necessary in the context of 
VFD drug use.
    Furthermore, since extralabel use is not an option for medicated 
feeds, including medicated feeds containing VFD drugs, the final use 
and labeling of such feeds must also conform to an FDA-approved, or 
conditionally approved, new animal drug application or index listing 
(see section 512(a)(2) of the FD&C Act). In other words, the terms of 
the VFD, such as intended use or dosage regimen, are constrained by the 
conditions of use found in an approved application, conditionally 
approved application, or index listing. Therefore, when completing the 
VFD order, the veterinarian needs to make sure the VFD is consistent 
with the conditions of use in the approved application, conditionally 
approved application, or index listing; similarly, when filling a valid 
VFD, the medicated feed manufacturer must assure that the final 
medicated feed is manufactured and labeled in conformity with both the 
VFD and the approved, conditionally approved, or indexed conditions for 
use. If the conditions of use specified on a VFD are not in conformity 
with an approved new animal drug application, conditionally approved 
application, or index listing, the VFD is considered invalid and the 
medicated feed described on the VFD may not be manufactured or 
distributed.
    This proposed revision is not intended to lower the standard for 
professional conduct by veterinarians. Instead of continuing to impose 
explicit, federally defined VCPR requirements on veterinarians using 
VFD drugs in their professional practice, these proposed revisions 
would, consistent with the approach to regulating veterinary 
professional conduct in the context of prescription animal drug use, 
recognize and appropriately defer to existing regulatory oversight 
standards for veterinary professional conduct. This includes VCPR 
standards that have been established by the veterinary profession and 
individual state veterinary medical licensing boards. The Agency 
believes that state veterinary medical licensing boards are well suited 
for this role because of their unique perspective on factors such as 
the local availability of professional veterinary medical resources and 
the needs of their individual agricultural communities. However, while 
each state's veterinary medical practice code may be somewhat 
different, the practice of veterinary medicine in the United States is, 
to a great extent, guided by the American

[[Page 75519]]

Veterinary Medical Association (AVMA) and its Principles of Veterinary 
Medical Ethics,\1\ which acts as a unifying standard for all 
veterinarians. AVMA's Principles of Veterinary Medical Ethics include 
an explicit VCPR provision.
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    \1\ https://www.avma.org/KB/Policies/Pages/Principles-of-Veterinary-Medical-Ethics-of-the-AVMA.aspx.
---------------------------------------------------------------------------

    As noted earlier, the Agency intends to provide for greater 
flexibility by deferring to the veterinary profession and individual 
states for the specific criteria for complying with the concept of a 
VCPR as an element of veterinary licensing and practice requirements. 
This would allow the specific criteria for a VCPR to be adjusted as 
appropriate to align with the most recent practice standards, 
technological and medical advances, and practical considerations in 
particular regions of the country.

C. Continued Access to Category I Type A \2\ Medicated Articles by 
Unlicensed Feed Mills
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    \2\ A ``Type A medicated article'' is intended solely for use in 
the manufacture of another Type A medicated article or a Type B or 
Type C medicated feed. It consists of a new animal drug(s), with or 
without carrier (e.g., calcium carbonate, rice hull, corn, gluten) 
with or without inactive ingredients.
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    Under the current VFD regulations, all medicated feed distributors, 
licensed or unlicensed, are able to manufacture and sell medicated 
feeds containing VFD drugs. The only difference is that licensed 
facilities are able to start the manufacturing process with a VFD Type 
A medicated article and unlicensed facilities must start with a VFD 
Type B \3\ or Type C \4\ medicated feed. In other words, unlicensed 
feed mills are not allowed access to any VFD Type A medicated articles 
under current regulations. FDA proposes to amend the VFD regulations to 
allow unlicensed feed mills to have continued access to the Type A 
medicated articles they currently use when these drugs change from OTC 
to VFD status.
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    \3\ A ``Type B medicated feed'' is intended solely for the 
manufacture of other medicated feeds (Type B or Type C). It contains 
a substantial quantity of nutrients including vitamins and/or 
minerals and/or other nutritional ingredients in an amount not less 
than 25 percent of the weight. It is manufactured by diluting a Type 
A medicated article or another Type B medicated feed.
    \4\ A ``Type C medicated feed'' is intended as the complete feed 
for the animal or may be fed ``top dressed'' on (added on top of 
usual ration) or offered ``free-choice'' (e.g., supplement) in 
conjunction with other animal feed. It contains a substantial 
quantity of nutrients including vitamins, minerals, and/or other 
nutritional ingredients. It is manufactured by diluting a Type A 
medicated article or a Type B medicated feed. A Type C medicated 
feed may be further diluted to produce another Type C medicated 
feed.
---------------------------------------------------------------------------

    For many years, FDA has restricted access to certain Type A 
medicated articles in an effort to avoid creating unsafe levels of drug 
residues in edible animal tissues. Under current regulations, all 
animal drugs approved for use in or on animal feed are assigned to one 
of two categories, depending on their potential to create unsafe 
residues--Category I drugs having the lowest potential and Category II 
drugs having the highest potential. FDA regulations at Sec.  
558.3(b)(1)(i) (21 CFR 558.3(b)(1)(i)) define Category I as those drugs 
that require no withdrawal period at the lowest use level in each 
species for which they are approved. Section 558.3(b)(1)(ii) (21 CFR 
558.3(b)(1)(ii)) defines Category II, in part, as those 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. In order 
to reduce the potential of creating unsafe drug residues, access to 
Category II Type A medicated articles is restricted to licensed feed 
mills (see Sec.  558.4(a)) because these facilities are technically 
better suited to handle these drugs in this concentrated form. 
Unlicensed facilities can safely handle Category II drugs after they 
have been diluted to a Type B or Type C feed, as well as Category I 
Type A medicated articles. But the current definition of Category II 
drugs also includes a provision that says all VFD drugs, regardless of 
their potential to create unsafe residues, are Category II drugs. Thus, 
under current regulations, if an OTC Category I drug changes to VFD 
status, it automatically becomes a Category II drug which, in turn, 
limits the availability of its Type A medicated article to licensed 
feed mills.
    FDA is concerned that the automatic recategorization of drugs to 
Category II once they switch to VFD status is likely to cause a supply 
chain obstruction for VFD feeds once the Agency's judicious use policy 
regarding medically important antimicrobial drugs is fully implemented. 
This is because the majority of the OTC feed-use antimicrobials that 
are the focus of GFI 209 are currently Category I drugs, 
making their Type A medicated articles readily available to tens of 
thousands of unlicensed feed mills, including on-farm mixers, located 
throughout the United States. Therefore, if all of these drugs were to 
switch dispensing status from OTC to VFD, and automatically become 
Category II drugs, these unlicensed facilities will now be forced to 
purchase VFD drugs as Type B or Type C medicated feeds from licensed 
facilities, which currently number fewer than 1,000. This limited 
number of licensed facilities would have great difficulty meeting the 
demands of the tens of thousands of unlicensed facilities in the United 
States. FDA believes this would result in shortages of antimicrobial 
drugs needed by food animal producers for judicious therapeutic uses on 
their farms and ranches, thus compromising animal health. To avoid this 
outcome, FDA proposes to revise the definition of Category II in Sec.  
558.3(b)(1)(ii) by removing the final clause that currently reads ``. . 
. or are a veterinary feed directive drug,'' thereby eliminating the 
automatic classification of VFD drugs to Category II. This would permit 
those medically important antimicrobials used in animal feed that are 
already Category I drugs to become VFD drugs consistent with FDA's 
judicious use policy, but remain available through the current feed 
mill distribution system.
    Furthermore, FDA has reconsidered its previous position that all 
VFD drugs should be classified as Category II drugs (see final rule of 
December 8, 2000 (65 FR 76924 at 76926)). Based on our experience with 
VFD drugs (e.g., investigating animal drug residue violations, cGMP 
inspections), the Agency no longer believes that the enhanced 
inspection requirements for licensed feed mills are necessary to assure 
the safe and effective use of VFD drugs that would otherwise be 
classified as Category I drugs. This is because (as noted in section 
II.E) feed-use drugs, in general, have a very safe record of use and 
Category I feed-use drugs, because of their extremely safe 
pharmacological and toxicological profile, have the lowest potential of 
creating unsafe drug residues at their approved dose levels.

D. Increased Flexibility for Food Animal Producers Purchasing VFD Feeds

    A number of stakeholders responding to the ANPRM and draft proposed 
regulation requested that FDA remove the requirement for veterinarians 
to include the amount of medicated feed to be dispensed on the VFD, as 
is currently required in Sec.  558.6(a)(4)(vi). Although this request 
was voiced by respondents from several different food animal production 
industries, each of them based their request on the difficulty of 
predicting, prior to feeding, exactly how much medicated feed a 
particular flock, herd, pen, house, or tank of animals will actually 
consume during a specific period of drug administration. Feed 
consumption rates can vary significantly depending on several factors, 
including environmental conditions. However, the most important sources 
of variability lie

[[Page 75520]]

in the animals' health status at the beginning of drug administration 
and how quickly these animals respond to treatment. Regardless of 
species, healthy animals generally eat more than sick animals. It is 
difficult to predict how quickly animals will respond to treatment and 
how quickly they will return to their normal feed consumption rate. In 
an effort to purchase or manufacture the right amount of medicated 
feed, food animal producers often monitor feed consumption rates during 
the treatment period and later make adjustments in feed orders 
accordingly.
    As noted by several stakeholders, if the veterinarian is required 
to specify on the VFD the amount of medicated feed to be dispensed, he 
or she may overestimate that amount in order to make sure the food 
animal producer does not run out of feed before the end of the 
treatment period. Unfortunately, this will often times result in 
leftover medicated feed on the farm. Alternatively, if the amount of 
medicated feed listed on the VFD is too little, the food animal 
producer may need to get another VFD to complete the course of 
treatment. FDA acknowledges stakeholders' concerns about the 
variability of feed consumption rates and therefore, in response to 
these concerns, proposes to eliminate the requirement for veterinarians 
to specify the amount of medicated feed to be dispensed on the VFD. FDA 
believes that the proposed new requirements for veterinarians to 
specify on the VFD the duration of use and the approximate number of 
animals to be fed the medicated feed, along with the current 
requirement to include the level of VFD drug in the feed, should 
provide adequate control over the total amount of medicated feed 
authorized by the VFD.

E. Lower Recordkeeping Burden for All Involved Parties

    Another commonly heard suggestion from stakeholders responding to 
the ANPRM and draft proposed regulation is the need to reduce the VFD 
recordkeeping burden from 2 years to 1 year. Under the current VFD 
regulation, all involved parties (the veterinarian, the distributor, 
and the client) must keep their copy of the VFD on file and available 
for FDA inspection for 2 years (see current Sec.  558.6(c)). In 
addition, VFD feed distributors must also keep receipt and distribution 
records of the VFD feeds they manufacture and make them available for 
FDA inspection for 2 years (see current Sec.  558.6(e)).
    As noted in FDA's proposed VFD rule that was published in the 
Federal Register on July 2, 1999 (64 FR 35966), the usual and customary 
manufacturing records kept by distributors to comply with the cGMP 
regulations in 21 CFR part 225 satisfies the VFD receipt and 
distribution recordkeeping requirement as well (see 21 CFR part 225, 
subpart E (licensed feed mill distributors) and subpart I (unlicensed 
feed mill distributors)). However, the cGMP regulations in part 225 
only require that such records be kept for 1 year, in contrast to the 
2-year requirement for VFD feeds in Sec.  558.6(e). Feed mill operators 
have told us that this discrepancy is difficult to manage and that they 
would like to see all feed manufacturing record retention requirements 
kept the same at 1 year, thus eliminating the need for two separate 
filing systems: One for non-VFD feed records (1-year record retention) 
and one for VFD feed records (2-year record retention).
    Based on our experience, FDA does not believe the extra 1 year of 
recordkeeping for VFD drugs is warranted for any of the involved 
parties. The value added by the second year of record retention has not 
been shown to justify the associated paperwork burden. FDA compliance 
investigations regarding violative drug residues in edible animal 
tissues are normally completed within the first year of their detection 
and nearly all of these are associated with dosage form drugs (i.e., 
non-feed use drugs). Therefore, FDA is proposing to reduce the 
recordkeeping requirement for copies of VFDs for all involved parties, 
and for manufacturing receipt and distribution records for VFD 
distributors, from 2 years to 1 year. Because the usual and customary 
records of purchase and sales kept by distributors to comply with the 
cGMP regulations in part 225 adequately support the VFD inspection 
program, we have not included the VFD receipt and distribution 
recordkeeping requirement found in current Sec.  558.6(e) in this 
proposed rule.

III. Proposed Regulations

A. Conforming Changes (Proposed Sec.  514.1(b)(9)

    The CFR citation noted in the new animal drug application 
regulations at 21 CFR 514.1(b)(9) would be revised to reflect the new 
VFD format provision found in proposed Sec.  558.6(b)(3).

B. Definitions (Proposed Sec.  558.3(b))

    The definitions of terms used in the medicated feed regulations of 
part 558, including the VFD drug regulations in Sec.  558.6, can be 
found in Sec.  558.3(b). FDA proposes to amend Sec.  558.3(b) as 
follows:
    As discussed earlier in section II.C, FDA proposes to revise the 
definition of Category II in Sec.  558.3(b)(1)(ii) by removing the 
final clause that currently reads ``. . . or are a veterinary feed 
directive drug.''
    The definition of ``veterinary feed directive (VFD) drug'' in 
proposed Sec.  558.3(b)(6) would be revised to include animal drugs 
that have been conditionally approved under section 571 of the FD&C Act 
(U.S.C. 360ccc), and to clarify that the use of a VFD drug in or on 
animal feed must be authorized by a valid veterinary feed directive.
    FDA also proposes to revise the definition of ``veterinary feed 
directive'' in proposed Sec.  558.3(b)(7) to include animal drugs that 
have been conditionally approved under section 571 of the FD&C Act and 
to replace the current federally defined VCPR requirement with a more 
broadly defined standard for veterinary professional conduct, as 
discussed in section II.B. The revised definition would also clarify 
that VFDs must be written, meaning nonverbal, and that they may be 
issued in hardcopy or through electronic media.
    Additionally, several stakeholders responding to the ANPRM and 
draft proposed regulation were unclear about what is a medicated feed 
distributor. The term ``distributor'' as used in part 558 is defined in 
Sec.  558.3(b)(9). We are proposing revisions to that definition for 
improved clarity. Please note that on-farm mixers that only manufacture 
medicated feeds for use in their own animals are not distributors.
    Proposed Sec.  558.3(b)(11) would revise the definition of 
``acknowledgement letter'' for clarity. Under current regulations, 
acknowledgement letters must include three affirmation statements and 
this proposal would require the same three affirmations. However, two 
of these three affirmation statement provisions are currently found in 
Sec.  558.3(b)(11) and one affirmation statement provision is currently 
found in Sec.  558.6(d)(2). This proposal would simply put all three 
provisions together in the definition of ``acknowledgement letter'' for 
clarity. The revised definition would also clarify that acknowledgement 
letters must be written, meaning nonverbal, and that they may be sent 
in hardcopy or through electronic media.
    Proposed Sec.  558.3(b)(12) includes the new term ``combination 
veterinary feed directive (VFD) drug'' to account for combination 
animal drugs used in or on animal feed that include one or more VFD 
drugs.

[[Page 75521]]

C. General Requirements Related to VFD Drugs (Proposed Sec.  558.6(a))

    As noted in section II.A, proposed Sec.  558.6(a) contains general 
provisions that are common to all involved parties (the veterinarian, 
the distributor, and the client). This includes clients that are also 
on-farm mixers that only manufacture VFD feeds for use in their own 
animals.
    Proposed Sec.  558.6(a)(1) establishes that a VFD may only be 
issued by a licensed veterinarian for the use of VFD drugs in animals 
under his or her supervision or oversight in the course of his or her 
professional practice, and in compliance with all applicable veterinary 
licensing and practice requirements.
    Proposed Sec.  558.6(a)(3) reminds stakeholders that the extralabel 
use (ELU) of any medicated feed, including medicated feeds containing 
VFD drugs, is not permitted under Federal law. (See section 
512(a)(4)(A) of the FD&C Act.) Several stakeholders responding to the 
ANPRM and draft regulation requested that FDA allow ELU for VFD feeds. 
AMDUCA legalized, for the first time, ELU of approved drugs in animals. 
However, AMDUCA specifically prohibits ELU of such drugs in or on 
animal feed. (See Pub. L. 103-396.)
    Proposed Sec.  558.6(a)(4) establishes that all involved parties 
(the veterinarian, the distributor, and the client) must retain their 
copy of the VFD for 1 year. This proposal would lower the current 2-
year recordkeeping requirement, as discussed in section II.E.
    Proposed Sec.  558.6(a)(6) revises the required cautionary labeling 
statement for all VFD drugs and feeds.

D. Responsibilities of the Veterinarian Issuing the VFD (Proposed Sec.  
558.6(b))

    Proposed Sec.  558.6(b)(1) reiterates that a VFD may only be issued 
by a licensed veterinarian for the use of VFD drugs in animals under 
his or her supervision or oversight in the course of his or her 
professional practice, and in compliance with all applicable veterinary 
licensing and practice requirements. This would replace the current 
federally defined VCPR provision that cites Sec.  530.3(i), as 
discussed in section II.B.
    Proposed Sec.  558.6(b)(2) clarifies that, when issuing a VFD, the 
veterinarian must issue a VFD that is in compliance with the conditions 
for use approved, conditionally approved, or indexed for the VFD drug. 
In other words, a VFD that is written for an extralabel use fails to 
comply with Federal law and is invalid. (See section 504(a)(2)(B) of 
the FD&C Act.)
    Proposed Sec.  558.6(b)(3) includes a revised list of information 
that the veterinarian would be required to provide on the VFD.
    Proposed Sec.  558.6(b)(3)(v) includes a new provision that, in 
cases where the expiration date is not specified in the approval, 
conditional approval, or index listing, the expiration date of the VFD 
cannot exceed 6 months after the date of issuance.
    Proposed Sec.  558.6(b)(3)(vii) would require animal identification 
to include species and production class.
    Proposed Sec.  558.6(b)(3)(viii) would revise the current 
requirement for the number of animals to be treated to mean an 
approximate number of animals to be fed the medicated feed prior to 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 valid 
VFD.
    Proposed Sec.  558.6(b)(3)(x) would remove the existing requirement 
for veterinarians to specify the amount of feed to be fed to the 
animals listed on the VFD, as discussed in section II.D. Veterinarians 
would instead be required to include the duration of drug use on the 
VFD in addition to the level of drug in the feed, as is currently 
required.
    The proposal would remove the current requirement in Sec.  
558.6(a)(4)(xi) for veterinarians to include their license number and 
name of the issuing state on the VFD. This information is not needed by 
VFD recipients (clients and distributors) to assure the safe and 
effective use of VFD drugs and is not customarily used by FDA or state 
inspectors in compliance investigations.
    Proposed Sec.  558.6(b)(3)(xiii) would revise the statement 
required to be included in each VFD indicating that extralabel use is 
not permitted.
    Proposed Sec.  558.6(b)(3)(xiv) is a new provision that would 
require a veterinarian who issues a VFD for the use of medicated feed 
containing a VFD drug that is also one of the component drugs in an 
approved combination VFD drug to include one of three ``affirmation of 
intent'' statements on the VFD. Each of the three statements, found in 
proposed Sec.  558.6(b)(6), provides a different option for 
veterinarians regarding their authorization for the use of a VFD drug 
as a component of an approved combination VFD drug. The definition of 
``combination VFD drug'' can be found in proposed Sec.  558.3(b)(12). 
The three options are as follows: (1) Sec.  558.6(b)(6)(i): The VFD 
cannot be used to authorize any combination VFD drug (i.e., only 
medicated feed containing the VFD drug alone can be distributed using 
the VFD); or (2) Sec.  558.6(b)(6)(ii): The VFD may be used for any of 
the approved combination VFD drugs specifically cited on the VFD; or 
(3) Sec.  558.6(b)(6)(iii): The VFD may be used for any approved 
combination VFD drug.
    In all cases, the VFD may be used to authorize the distribution and 
use of medicated feed containing the VFD drug alone.
    Proposed Sec.  558.6(b)(4) would allow the veterinarian, at his or 
her discretion, to enter additional information on the VFD to more 
specifically identify the animals authorized to be treated with or fed 
the medicated feed.
    Proposed Sec.  558.6(b)(5) would add a new provision for 
combination VFD drugs that include more than one VFD drug component. No 
such combinations have yet been approved, conditionally approved, or 
indexed, but in the event that such combination VFD drug is approved, 
conditionally approved, or indexed in the future, the veterinarian 
would need to include in the VFD certain drug-specific information for 
each component VFD drug in the combination.
    The proposal would no longer specifically require that VFDs be 
produced in triplicate but all three involved parties (the 
veterinarian, the distributor, and the client) would still 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 a hardcopy to the distributor.
    Proposed Sec.  558.6(b)(9) would clarify that veterinarians may not 
issue a VFD verbally, including verbal transmission by telephone. 
However, transmission of a written (nonverbal) VFD by telephones that 
are capable of this function (i.e. smartphones) is allowed.

E. Responsibilities of the Medicated Feed Distributor (Proposed Sec.  
558.6(c))

    Proposed Sec.  558.6(c)(1) would require medicated feed 
distributors who handle VFD drugs to make sure all VFDs are completely 
filled out before manufacturing the specified VFD feed. VFDs that do 
not include all the information required by proposed Sec.  558.6(b)(3) 
are incomplete and considered invalid.
    Proposed Sec.  558.6(c)(2) reminds medicated feed distributors that 
they may only distribute an animal feed containing a VFD drug or 
combination VFD drug that is in compliance with the terms of a valid 
VFD and is manufactured and labeled in conformity with the approved, 
conditionally approved, or indexed conditions of use for such drug. 
This dual responsibility is not new but is a very important concept 
that all VFD distributors must

[[Page 75522]]

understand. VFDs that are not in compliance with the conditions of use 
approved, conditionally approved, or indexed for the VFD drug are 
invalid and may not be used to authorize the distribution of a 
medicated feed containing a VFD drug.
    Proposed Sec.  558.6(c)(3) reminds distributors that, in addition 
to other applicable recordkeeping requirements found in this section, 
they must also keep VFD feed manufacturing records 1 year in accordance 
with part 225 of this chapter. Such records must be made available for 
inspection and copying by FDA upon request.
    Proposed Sec. Sec.  558.6(c)(4), (5), and (6) relate to the 
statutory requirement for one-time notification by distributors of 
their intent to distribute medicated feed containing VFD drugs. These 
provisions are very similar to those found at section 558.6(d)(1) of 
the current regulation.
    Proposed Sec.  558.6(c)(7) retains the statutory requirement for 
medicated feed distributors that consign VFD drug-containing feeds to 
another distributor to receive an acknowledgement letter from that 
person. This section references a revised definition of 
``acknowledgement letter'' found in proposed Sec.  558.3(b)(11). 
Proposed Sec.  558.6(c)(7) also includes an explicit 1-year 
recordkeeping requirement for acknowledgment letters.

IV. Legal Authority

    FDA's authority for issuing this proposed rule is provided by 
section 504 of the FD&C Act. 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. Preliminary Regulatory Impact Analysis

    FDA has examined the impacts of the proposed 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 proposed rule is not a 
significant regulatory action as defined by Executive Order 12866. We 
have developed a preliminary regulatory impact analysis (PRIA) that 
presents the benefits and costs of this proposed rule to stakeholders 
and the government.
    The summary analysis of benefits and costs included in the 
Executive Summary of this document is drawn from the detailed PRIA, 
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/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VI. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). A description of these provisions is given in 
the Description section that follows with estimates of the annual 
reporting, recordkeeping, and third-party disclosure burden. Included 
in each burden 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.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Veterinary Feed Directives.
    Description: The proposed rule would revise existing OMB control 
number 0910-0363 (expiration date December 31, 2014) for veterinary 
feed directives by lowering the recordkeeping burden without 
compromising human or animal safety, providing greater deference and 
flexibility to the veterinary profession for licensing and veterinary 
practice requirements, and ensuring continued access to Category I Type 
A medicated articles by unlicensed feed mills.
    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 few approved VFD drugs. 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 in March 2010. Based on the 
considerable public input received in response to the ANPRM, in April 
2012 FDA issued for public comment draft text for proposed revisions to 
the current VFD regulation.

Current and Proposed Information Collection Requirements

    The current veterinary feed directive regulation, Sec.  558.6, has 
information collection provisions contained at OMB control number 0910-
0363 (expiration date December, 31, 2014). Many of these provisions 
will be unaffected by the proposed rule, if finalized; therefore, this 
Paperwork Reduction Act section will concentrate on the changes being 
proposed in this rulemaking and will describe how the paperwork 
reduction implications will be affected.

Proposed Reporting Requirements

    Description of Respondents: VFD Feed Distributors.
    Currently, under Sec.  558.6(d)(1) (and proposed Sec.  558.6(c)(4)) 
a distributor of animal feed containing VFD drugs must notify FDA prior 
to the first time it distributes such animal feed and this notification 
is required one time per distributor. Therefore, all active 
distributors of animal feed must have already made notification to FDA 
of their intention to distribute animal feed containing VFD drugs 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 proposed 
Sec.  558.6(c)(4) are the same as the current requirements under Sec.  
558.6(d)(1), there is no new reporting burden. FDA understands that VFD 
feed distributors must review the rule in order to determine what 
actions are necessary to comply with the new regulation. For VFD feed 
distributors we estimate administrative review of the rule will take 4 
hours to complete.

[[Page 75523]]



                                                    Table 1--Estimated One-Time Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of                      Average  burden
               21 CFR 558.6/activity                   Number of      responses  per       Total       per  respondent    Total hours      Total costs
                                                      respondents       respondent       responses         in hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Administrative Review of the Rule (VFD Feed                  1,366                1            1,366                4            5,464     \2\ $387,000
 Distributors)....................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ A total of 1,366 VFD feed distributors times approximately $71 per hour times 4 hours of one-time review equals approximately $387,000. Estimate
  rounded to be in accordance with the PRIA.

    Number of Respondents multiplied by Number of Responses per 
Respondent equals Total Responses. Total Responses multiplied by 
Average Burden per Response equals Total Hours.

Proposed Recordkeeping Requirements

    Description of Respondents: VFD Feed Distributors, Food Animal 
Veterinarians, and Clients (Food Animal Producers).
    Under current Sec.  558.6(f) and proposed 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 proposed Sec.  
558.6(a)(4) and proposed Sec.  558.6(b)(7-8)). 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 administrative review for both groups. 
(Administrative 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 per VFD drug) issued in triplicate 
equals 2,250,000 VFDs issued and stored in files per year.\5\
---------------------------------------------------------------------------

    \5\ Distributors may receive an acknowledgment letter in lieu of 
a VFD when consigning VFD feed to another distributor. Such letters, 
like VFDs, would also be subject to a 1-year record retention 
requirement (see proposed Sec.  558.6(c)(7)). Thus, the 
recordkeeping burden for acknowledgment 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 currently 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 times 300 equals $180,000).
    In response to public comment to the ANPRM, FDA is proposing 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. 
Additionally, as included in proposed Sec.  558.6(b)(7), the 
veterinarian would also no longer be required to assure that a paper 
copy is received by the distributor within 5 days of writing the VFD 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 
proposed provision would further reduce 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 proposed 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.
    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 times 6 square feet per file cabinet times 150 filing 
cabinets equals $19,575 annual savings for switching to computer 
storage) (Thorpe, K., Edwards, J., and Bondarenko, E. 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 addition, the proposed reduction in the amount of time records 
would be required to be kept from 2 years to 1 year would further 
reduce the need for physical space and file cabinets. The recordkeepers 
still filing hardcopy VFDs would save $9,788 annually ($21.75 per 
square foot per year rental cost of space times 6 square feet per file 
cabinet times 75 filing cabinets equals $9,788 annual savings for 
reducing recordkeeping from 2 years to 1 year).
    In summary, we anticipate that the capital costs for recordkeeping 
will be reduced from $180,000 (storing all VFD copies in file cabinets 
for 2 years) to $45,000 (storing hardcopy VFD files in 75 file cabinets 
for 1 year), and an annual total cost savings of $29,363 for one-half 
of the industry filing VFDs electronically for 1 year ($19,575 savings 
for filing electronically plus $9,788 for reducing recordkeeping to 1 
year).
    As stated previously, both the current and proposed requirements 
state that the veterinarian, the distributor, and the client must keep 
a copy of the VFD. 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. Therefore, no revision to the paperwork 
burden for filing the VFD is needed.

[[Page 75524]]



                                                  Table 2--Estimated One-Time Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                              Average
                                                             Number of       Number of                      burden per
                  21 CFR 558.6/activity                    recordkeepers    records per    Total records   recordkeeper     Total hours     Total costs
                                                                           recordkeeper                      in hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Administrative Review of the Rule (Food Animal                     3,050               1           3,050               1           3,050    \2\ $180,000
 Veterinarians).........................................
Administrative Review of the Rule (Clients).............          10,000               1          10,000             0.5           5,000     \3\ 154,000
Recordkeeping by Electronic Storage for 1 Year..........  ..............  ..............  ..............  ..............  ..............      \4\ 45,000
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............           8,050         379,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ A total of 3,050 veterinarians times approximately $59 per hour times 1 hour of one-time review equals approximately $180,000. Estimate rounded to
  be in accordance with the PRIA (see PRIA).
\3\ A total of 10,000 clients times approximately $31 per hour times 0.5 hours one-time review equals approximately $154,000. Estimate rounded to be in
  accordance with the PRIA (see PRIA).
\4\ We estimate that the capital costs for recordkeeping will be reduced from $180,000 (storing paper copies of all VFDs in file cabinets for 2 years)
  to $45,000 (one-half of VFDs stored as paper copies in 75 file cabinets for 1 year), and an annual cost savings of $29,363 for one-half of the
  industry filing VFDs electronically for 1 year ($19,575 savings for filing electronically plus $9,788 for reducing recordkeeping to 1 year).

    Number of Recordkeepers multiplied by Number of Records per 
Recordkeeper equals Total Records. Total Records multiplied by Average 
Burden per Recordkeeper equals Total Hours.

Proposed 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 administrative review. 
(Administrative review of the rule by VFD feed distributors is 
accounted for in table 1 and by veterinarians and clients in table 2.)
    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 VFD drug to use by or on the order of a licensed veterinarian'' 
(proposed Sec.  558.6(a)(6)). This verbatim statement is exempt from 
burden under the PRA because the Federal Government has provided the 
exact language for the cautionary statement. Therefore, the hourly and 
cost burdens 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 will not be counted.
    The VFD must also include the following statement (proposed Sec.  
558.6(b)(3)(xiii): ``Extralabel use (i.e., use of this VFD feed in a 
manner other than as directed on the labeling) is not permitted.'' This 
verbatim statement is also exempt from burden under the PRA.
    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:
    (i) ``The VFD drug(s) cited in this order may not be used in 
combination with any other animal drugs.''
    (ii) ``The VFD drug(s) cited in this order may be used in 
combination with the following OTC animal drugs to manufacture an FDA-
approved, conditionally approved, or indexed combination medicated 
feed.'' [List OTC drugs immediately following this statement.]
    (iii) ``The VFD drug(s) cited in this order may be used in 
combination with any OTC animal drugs to manufacture an FDA-approved, 
conditionally approved, or indexed combination medicated feed'' 
(proposed Sec.  558.6(b)(6)).
    These verbatim statements are also exempt from burden under the 
PRA. 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 VFD form itself that will occur as the 
result of this proposed rulemaking, if finalized.
    Proposed Sec.  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. Proposed Sec.  558.6(b)(7) 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 $59 (veterinarian wage 
rate, see PRIA), the labor cost of currently issuing VFDs is estimated 
at $11.09 million (the estimated average of 750,000 VFDs issued 
annually times 0.25 hours to issue each VFD times $59 per hour equals 
approximately $11.09 million (rounded to be in accordance with the 
PRIA)). 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 $5.55 million annually (the 
estimated average of 750,000 VFDs issued annually times 0.125 hours to 
issue each VFD times $59 per hour equals approximately $5.55 million 
(rounded to be in accordance with the PRIA)), a cost savings of about 
$5.55 million ($11.09 million - $5.55 million = approximately $5.55 
million.

[[Page 75525]]

    Currently, a distributor may only consign a VFD feed to another 
distributor if the originating distributor (consignor) first obtains a 
written acknowledgement letter from the receiving distributor 
(consignee) before the feed is shipped (Sec.  558.6(d)(2)). Because 
this current requirement is the same as that being proposed in Sec.  
558.6(c)(7), there is no new reporting burden.
    Proposed Sec.  558.6(c)(7), also includes an explicit recordkeeping 
requirement for acknowledgment letters. While the VFD final rule issued 
in December 2000 did not explicitly require distributors to retain 
acknowledgment letters for any specified period of time, a 2-year 
recordkeeping burden was accounted for in the PRA section of the final 
rule for this function as part of the VFD recordkeeping burden in Table 
2, noted as Sec.  558.6(d)(2) (65 FR 76928).\6\ FDA continues to 
believe, as we did in 2000, that medicated feed distributors 
customarily retain both acknowledgment letters and VFDs as a normal 
business practice. The purpose of this provision is to clarify that 
acknowledgment letters, like VFDs, must be retained only for 1 year.
---------------------------------------------------------------------------

    \6\ The recordkeeping burdens for VFDs and acknowledgement 
letters were combined because distributors may receive an 
acknowledgement letter in lieu of a VFD before distributing a 
medicated feed containing a VFD drug. 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 (0910-0363). As noted in the PRA 
section of the December 2000 final rule, ``[a]ny person who 
distributes medicated feed containing VFD drugs must file with [FDA] 
a one-time notification letter of intent to distribute, and retain a 
copy of each VFD serviced or each consignee's acknowledgment letter 
for 2 years.'' (65 FR 76928).

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                        Average
                                                             Number of      disclosures    Total annual     burden per
   21 U.S.C. 343m 21 CFR Section  (Labeling Activity)       respondents         per         disclosures    disclosure in    Total hours     Total costs
                                                                            respondent                         hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Administrative Review of the Rule, Current VFD Drug                    2               1               2               6              12      \2\ $1,200
 Sponsors (General and Operations Managers) \2\.........
558.6(b)(3) Changes to VFD Form by Drug Sponsors \3\....               2               2               4              16              64       \3\ 5,308
Veterinarian issues VFD \4\.............................           3,050           245.9         750,000           0.125          93,750       5,550,000
    Total...............................................  ..............  ..............  ..............  ..............          93,826       5,556,508
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Two current drug sponsors times $102 per hour times 6 hours of one-time review time equals approximately $1,200. Estimate rounded to be in
  accordance with the PRIA.
\3\ Two drug sponsors times two VFD forms per respondent equals four changes to the VFD form. With 16 hours per respondent to make form changes and
  correct Web site, equals 64 total hours to change the VFD forms. NOTE: The hourly and cost burdens to include the revised verbatim statements noted in
  this document (on the VFD form itself) are exempt under the PRA. We are unable to measure these hours and costs separately, but consider them to be de
  minimus. The cost to change the VFD form is considered to include these statement changes. Changes to the VFD form for the four approved VFD forms
  (there are separate VFD forms for each of the two indications per VFD drug) are four VFD forms times $1,327 cost per form equals $5,308.
\4\ A total of 3,050 veterinarians times 245.9 VFDs issued per year (on average) times 0.125 hours per form equals 93,750 hours per year times $59 per
  hour equals approximately $5,550,000. Estimate rounded to be in accordance with the PRIA.

    Number of Respondents multiplied by Number of Disclosures per 
Respondent equals Total Annual Disclosures. Total Annual Disclosures 
multiplied by Average Burden per Disclosure equals Total Hours.
    Additionally, as the usual and customary records of purchase and 
sales kept by distributors to comply with the cGMP regulations 
adequately supports the VFD inspection program, we have eliminated the 
VFD manufacturing recordkeeping requirement currently found in Sec.  
558.6(e) and instead refer to the 1-year manufacturing receipt and 
distribution recordkeeping requirement for medicated feed manufacturers 
in part 225 (proposed Sec.  558.6(c)(3)). These record requirements are 
currently found at OMB control number 0910-0152.
    Paperwork approval of new animal drug applications is contained 
under OMB control number 0910-0032, for Indexing of Legally Marketed 
Unapproved New Animal Drugs for Minor Species under OMB control number 
0910-0620, and for veterinary feed directives, OMB approval is 
contained under OMB control number 0910-0363.
    Interested persons are requested to send comments regarding 
information collection by January 13, 2014 to the Office of Information 
and Regulatory Affairs, OMB. To ensure that comments on information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: FDA 
Desk Officer, FAX: 202-395-6974, or emailed to [email protected]. All comments should be identified with the 
title, ``Veterinary Feed Directives, Reporting, Recordkeeping and Third 
Party Disclosure.''
    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has 
submitted the information collection provisions of this proposed rule 
to OMB for review. These requirements will not be effective until FDA 
obtains OMB approval. FDA will publish a notice concerning OMB approval 
of these requirements in the Federal Register.

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 proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would 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 tentatively concludes that the proposed rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently,

[[Page 75526]]

a federalism summary impact statement is not required.

IX. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

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, it is 
proposed that 21 CFR parts 514 and 558 be 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. Amend Sec.  514.1 by revising 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 the format described under Sec.  
558.6(b)(3) 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. Amend Sec.  558.3 by revising paragraphs (b)(1)(ii), (b)(6), (b)(7), 
(b)(9), and (b)(11) and by adding new 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 new animal drug 
approved under section 512(c) of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act), conditionally approved under section 571 of the 
FD&C Act, or listed in the index under section 572 of the FD&C Act, for 
use in or on animal feed. Use of a VFD drug in or on animal feed must 
be authorized by a valid veterinary feed directive.
    (7) A ``veterinary feed directive'' is a written (nonverbal) 
statement issued by a licensed veterinarian that orders the use of a 
VFD drug or combination VFD drug in or on an animal feed. This 
statement authorizes the client (the owner of the animal or animals or 
other caretaker) to obtain and use the VFD drug or combination VFD drug 
in or on an animal feed 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 (FDA). A 
veterinarian may only issue a VFD for the use of VFD drugs in animals 
under his or her supervision or oversight in the course of his or her 
professional practice, and in compliance with all applicable veterinary 
licensing and practice requirements. A veterinary feed directive may be 
issued in hardcopy or through electronic media.
* * * * *
    (9) For the purposes of this part, a ``distributor'' means any 
person who consigns 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 sent to a distributor (consignor) from another 
distributor (consignee) who is not the ultimate user of the medicated 
feed containing a VFD drug. An acknowledgment letter may be sent in 
hardcopy or through electronic media and must affirm:
    (i) That the consignee will not ship such medicated animal feed to 
an animal production facility that does not have a VFD,
    (ii) That the consignee will not ship such feed to another 
distributor without receiving a similar written acknowledgment letter, 
and
    (iii) That the consignee has complied with the distributor 
notification requirements of Sec.  558.6(c)(4) of this chapter.
    (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) approved under section 512(c) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act), conditionally approved under section 571 
of the FD&C Act, or listed in the index under section 572 of the act, 
for use in or on animal feed, and at least one of the component new 
animal drugs is a VFD drug. Use of a combination VFD drug in or on 
animal feed must be authorized by a valid veterinary feed directive.
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) A feed containing a VFD drug or a combination VFD drug (a VFD 
feed or combination VFD feed) shall be fed to animals only by or upon a 
lawful VFD issued by a licensed veterinarian. A veterinarian may only 
issue a VFD for the use of VFD drugs in animals under his or her 
supervision or oversight in the course of his or her professional 
practice, and in compliance with all applicable veterinary licensing 
and practice requirements.
    (2) VFDs may not be filled 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. Extralabel use (i.e., actual or intended use other 
than as directed on the labeling) is not permitted.
    (4) All involved parties (the veterinarian, the distributor, and 
the client) must retain a copy of the VFD for 1 year.
    (5) All involved parties must make the VFD and any other records 
specified in this section available for inspection and copying by FDA.
    (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 VFD drug to use by or on the order of a licensed veterinarian.''

[[Page 75527]]

    (b) Responsibilities of the veterinarian issuing the VFD:
    (1) The veterinarian must be licensed to practice veterinary 
medicine and may only issue a VFD for the use of VFD drugs in animals 
under his or her supervision or oversight in the course of his or her 
professional practice, and in compliance with all applicable veterinary 
licensing and practice requirements.
    (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.
    (3) The veterinarian must assure 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, telephone number, and business or home 
address;
    (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 cannot 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 cannot exceed 6 months after 
the date of issuance;
    (vi) The name of the animal drug;
    (vii) The species and production class of animals to be fed the 
medicated feed;
    (viii) The approximate number of animals to be fed the medicated 
feed prior to the expiration date on the VFD;
    (ix) The indication for which the VFD is issued;
    (x) The level of drug in the 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;
    (xiii) The statement: ``Extralabel use (i.e., use of this VFD feed 
in a manner other than as directed on the labeling) is not permitted'';
    (xiv) An affirmation of intent for combination VFD drugs as 
described in paragraph (6); 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 medicated 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) for 
each component VFD drug in the combination.
    (6) 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 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) ``The VFD drug(s) cited in this order may not be used in 
combination with any other animal drugs.''
    (ii) ``The VFD drug(s) cited in this order may be used in 
combination with the following OTC animal drugs to manufacture an FDA-
approved, conditionally approved, or indexed combination medicated 
feed.'' [List OTC drugs immediately following this statement.]
    (iii) ``The VFD drug(s) cited in this order may be used in 
combination with any OTC animal drugs to manufacture an FDA-approved, 
conditionally approved, or indexed combination medicated feed.''
    (7) The veterinarian must send the VFD to the feed distributor via 
hardcopy, fax, or electronically. If in hardcopy, the veterinarian may 
send the VFD to the distributor either directly or through the client.
    (8) The veterinarian must provide a copy of the VFD to the client.
    (9) The veterinarian may not issue a VFD verbally.
    (c) Responsibilities of any person who distributes an animal feed 
containing a VFD drug or a combination VFD drug:
    (1) The distributor may only fill a VFD if the VFD contains all the 
information required in paragraph (b)(3) of this section.
    (2) The distributor may only distribute an animal feed containing a 
VFD drug or combination VFD drug that 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) In addition to other applicable recordkeeping requirements 
found in this section, 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.
    (4) A distributor of animal feed containing VFD drugs must notify 
FDA prior to the first time it distributes animal feed containing VFD 
drugs. 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;
    (5) A distributor must also notify FDA within 30 days of any change 
in ownership, business name, or business address.
    (6) The notifications cited in paragraphs (c)(4) and (c)(5) 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.
    (7) A distributor may only consign a VFD feed to another 
distributor 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 1 year.

    Dated: December 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-29696 Filed 12-11-13; 8:45 am]
BILLING CODE 4160-01-P