Veterinary Feed Directive, 75515-75527 [2013-29696]
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[FR Doc. 2013–29593 Filed 12–11–13; 8:45 am]
BILLING CODE 4910–13–P
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.
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).
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SUMMARY:
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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).
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way
• Federal eRulemaking Portal: https://
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 https://
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 https://
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: Sharon.Benz@fda.hhs.gov.
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
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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
§ 514.1(b)(9)
B. Definitions (Proposed § 558.3(b))
C. General Requirements Related to VFD
Drugs (Proposed § 558.6(a))
D. Responsibilities of the Veterinarian
Issuing the VFD (Proposed § 558.6(b))
E. Responsibilities of the Medicated Feed
Distributor (Proposed § 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 VFDrelated provisions of the ADAA in 2000
(see § 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 foodproducing 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
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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 § 558.3
(21 CFR 558.3) which currently includes
a relatively prescriptive, federally
defined, code of veterinary professional
conduct known as the veterinarianclient-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
§ 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
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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-thecounter (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 foodproducing 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
§ 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
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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
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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 VFDrelated 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
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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 foodproducing 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
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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 § 558.6 to make it more
user-friendly. Proposed § 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,
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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
§ 558.3(b)(7) which currently includes a
relatively prescriptive, federallydefined, 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
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§ 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
§ 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 § 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 § 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
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animal feed, including VFD drugs, FDA
does not believe that the explicit VCPR
requirement as defined in § 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
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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.
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.
emcdonald on DSK67QTVN1PROD with PROPOSALS
C. Continued Access to Category I Type
A 2 Medicated Articles by Unlicensed
Feed Mills
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.
For many years, FDA has restricted
access to certain Type A medicated
articles in an effort to avoid creating
1 https://www.avma.org/KB/Policies/Pages/
Principles-of-Veterinary-Medical-Ethics-of-theAVMA.aspx.
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.
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.
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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 § 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 § 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 onfarm 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
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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 § 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 § 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
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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 § 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 § 558.6(e)).
As noted in FDA’s proposed VFD rule
that was published in the Federal
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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 § 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 nonVFD 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 § 558.6(e)
in this proposed rule.
III. Proposed Regulations
A. Conforming Changes (Proposed
§ 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 § 558.6(b)(3).
B. Definitions (Proposed § 558.3(b))
The definitions of terms used in the
medicated feed regulations of part 558,
including the VFD drug regulations in
§ 558.6, can be found in § 558.3(b). FDA
proposes to amend § 558.3(b) as follows:
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As discussed earlier in section II.C,
FDA proposes to revise the definition of
Category II in § 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
§ 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 § 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 § 558.3(b)(9). We are
proposing revisions to that definition for
improved clarity. Please note that onfarm mixers that only manufacture
medicated feeds for use in their own
animals are not distributors.
Proposed § 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 § 558.3(b)(11) and one
affirmation statement provision is
currently found in § 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 § 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.
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C. General Requirements Related to VFD
Drugs (Proposed § 558.6(a))
As noted in section II.A, proposed
§ 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 § 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 § 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 § 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 § 558.6(a)(6) revises the
required cautionary labeling statement
for all VFD drugs and feeds.
emcdonald on DSK67QTVN1PROD with PROPOSALS
D. Responsibilities of the Veterinarian
Issuing the VFD (Proposed § 558.6(b))
Proposed § 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 § 530.3(i), as
discussed in section II.B.
Proposed § 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 § 558.6(b)(3) includes a
revised list of information that the
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veterinarian would be required to
provide on the VFD.
Proposed § 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 § 558.6(b)(3)(vii) would
require animal identification to include
species and production class.
Proposed § 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 § 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 § 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 § 558.6(b)(3)(xiii) would
revise the statement required to be
included in each VFD indicating that
extralabel use is not permitted.
Proposed § 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 § 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 § 558.3(b)(12). The
three options are as follows: (1)
§ 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) § 558.6(b)(6)(ii): The
VFD may be used for any of the
approved combination VFD drugs
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specifically cited on the VFD; or (3)
§ 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 § 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 § 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 § 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 § 558.6(c))
Proposed § 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
§ 558.6(b)(3) are incomplete and
considered invalid.
Proposed § 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
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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 § 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 §§ 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 § 558.6(c)(7) retains the
statutory requirement for medicated
feed distributors that consign VFD drugcontaining feeds to another distributor
to receive an acknowledgement letter
from that person. This section
references a revised definition of
‘‘acknowledgement letter’’ found in
proposed § 558.3(b)(11). Proposed
§ 558.6(c)(7) also includes an explicit 1year recordkeeping requirement for
acknowledgment letters.
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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
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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 https://www.regulations.gov
(enter Docket No. FDA–2010–N–0155),
and is also available on FDA’s Web site
at https://www.fda.gov/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
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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, § 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 § 558.6(d)(1) (and
proposed § 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
§ 558.6(c)(4) are the same as the current
requirements under § 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.
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75523
TABLE 1—ESTIMATED ONE-TIME REPORTING BURDEN 1
21 CFR 558.6/activity
Number of
respondents
Number of
responses
per
respondent
Total
responses
Average
burden per
respondent
in hours
Total hours
Total costs
Administrative Review of the Rule (VFD
Feed Distributors) .................................
1,366
1
1,366
4
5,464
2 $387,000
1 There
are no operating and maintenance costs associated with this collection of information.
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.
2A
emcdonald on DSK67QTVN1PROD with PROPOSALS
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 § 558.6(f) and proposed
§ 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 § 558.6(b)(1–3) and proposed
§ 558.6(a)(4) and proposed § 558.6(b)(7–
8)). Under current § 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
§ 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 § 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 § 558.6(c)(7)). Thus, the
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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
§ 558.6(a)(4)) from 2 years to 1 year.
Additionally, as included in proposed
§ 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.
recordkeeping burden for acknowledgment letters is
included as a subset of the VFD recordkeeping
burden.
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Fmt 4702
Sfmt 4702
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. https://
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.
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TABLE 2—ESTIMATED ONE-TIME RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR 558.6/activity
Administrative Review of the Rule (Food
Animal Veterinarians) ...........................
Administrative Review of the Rule (Clients) ......................................................
Recordkeeping by Electronic Storage for
1 Year ...................................................
Total ..................................................
Number of
records per
recordkeeper
Average
burden per
recordkeeper
in hours
Total records
Total hours
Total costs
3,050
1
3,050
1
3,050
2 $180,000
10,000
1
10,000
0.5
5,000
3 154,000
........................
........................
........................
........................
........................
4 45,000
........................
........................
........................
........................
8,050
379,000
1 There
are no operating and maintenance costs associated with this collection of information.
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).
2A
Number of Recordkeepers multiplied
by Number of Records per Recordkeeper
equals Total Records. Total Records
multiplied by Average Burden per
Recordkeeper equals Total Hours.
emcdonald on DSK67QTVN1PROD with PROPOSALS
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
§ 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
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Jkt 232001
§ 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
§ 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.
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Sfmt 4702
Proposed § 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 § 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
§ 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.
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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 (§ 558.6(d)(2)).
Because this current requirement is the
same as that being proposed in
§ 558.6(c)(7), there is no new reporting
burden.
Proposed § 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
75525
as § 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.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 U.S.C. 343m 21 CFR Section
(Labeling Activity)
Administrative Review of the Rule, Current VFD Drug Sponsors (General and
Operations Managers) 2 .......................
558.6(b)(3) Changes to VFD Form by
Drug Sponsors 3 ...................................
Veterinarian issues VFD 4 ........................
Total ..................................................
Number of
disclosures
per
respondent
Number of
respondents
Average
burden per
disclosure in
hours
Total annual
disclosures
Total hours
Total costs
2
1
2
6
12
2 $1,200
2
3,050
........................
2
245.9
........................
4
750,000
........................
16
0.125
........................
64
93,750
93,826
3 5,308
5,550,000
5,556,508
1 There
are no operating and maintenance costs associated with this collection of information.
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.
emcdonald on DSK67QTVN1PROD with PROPOSALS
2 Two
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 § 558.6(e) and instead refer to
the 1-year manufacturing receipt and
distribution recordkeeping requirement
for medicated feed manufacturers in
part 225 (proposed § 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 oira_
submission@omb.eop.gov. 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
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 § 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).
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Sfmt 4702
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,
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a federalism summary impact statement
is not required.
*
IX. Comments
Interested persons may submit either
electronic comments regarding this
document to https://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 https://
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
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.
2. Amend § 514.1 by revising
paragraph (b)(9) to read as follows:
■
§ 514.1
Applications.
*
*
*
*
*
(b) * * *
(9) Veterinary feed directive. Three
copies of a veterinary feed directive
(VFD) must be submitted in the format
described under § 558.6(b)(3) of this
chapter.
*
*
*
*
*
emcdonald on DSK67QTVN1PROD with PROPOSALS
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
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.
4. Amend § 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:
■
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§ 558.3 Definitions and general
considerations applicable to this part.
Jkt 232001
*
*
*
*
(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
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Fmt 4702
Sfmt 4702
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 § 558.6(c)(4) of this
chapter.
(12) A ‘‘combination veterinary feed
directive (VFD) drug’’ is a combination
new animal drug (as defined in
§ 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.
■ 5. Revise § 558.6 to read as follows:
§ 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.’’
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(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:
VerDate Mar<15>2010
21:24 Dec 11, 2013
Jkt 232001
(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.
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75527
(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
§ 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
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Agencies
[Federal Register Volume 78, Number 239 (Thursday, December 12, 2013)]
[Proposed Rules]
[Pages 75515-75527]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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: https://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 https://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 https://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: Sharon.Benz@fda.hhs.gov.
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.
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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
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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 https://www.regulations.gov (enter Docket No. FDA-
2010-N-0155), and is also available on FDA's Web site at https://www.fda.gov/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. https://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 oira_submission@omb.eop.gov. 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 https://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 https://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