(Response 41) FDA understands that a uniform VFD format would help
clients, veterinarians, and distributors (including feed mills) quickly
identify relevant information on the VFD. However, FDA believes that
requiring a specified format for the VFD would be too prescriptive. In
this final rule, FDA is updating the regulatory text in Sec.
514.1(b)(9) to clarify that as part of the application process, the
sponsor must

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

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

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

FDA or other organizations, will be sufficient.

IV. Legal Authority

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

V. Final Regulatory Impact Analysis

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

VI. Paperwork Reduction Act of 1995

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

A. Reporting Requirements

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

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

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

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

B. Recordkeeping Requirements

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

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

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

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

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

C. Third-Party Disclosure Requirements

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

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

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

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

VII. Environmental Impact

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

VIII. Federalism

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

IX. References

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

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

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

List of Subjects

21 CFR Part 514

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

21 CFR Part 558

    Animal drugs, Animal feeds.

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

PART 514--NEW ANIMAL DRUG APPLICATIONS

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

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

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

Sec.  514.1  Applications.

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

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

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

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

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

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

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

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

Sec.  558.6  Veterinary feed directive drugs.

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

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

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

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


[Federal Register Volume 78, Number 242 (Tuesday, December 17, 2013)]
[Notices]
[Page 76291]
[FR Doc No: 2013-29928]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP14-249-000.
    Applicants: WBI Energy Transmission, Inc.
    Description: 2013 Revised Non-conforming Negotiated Rate SA--FT-
513, 1056, 1109 to be effective 12/1/2013.
    Filed Date: 12/3/13.
    Accession Number: 20131203-5048.
    Comments Due: 5 p.m. ET 12/16/13.

    Docket Numbers: RP14-250-000.
    Applicants: Stingray Pipeline Company, L.L.C.
    Description: Revise System Map to be effective 1/1/2014.
    Filed Date: 12/4/13.
    Accession Number: 20131204-5099.
    Comments Due: 5 p.m. ET 12/16/13.

    Docket Numbers: RP14-251-000.
    Applicants: Saltville Gas Storage Company L.L.C.
    Description: Saltville Gas Storage Company L.L.C., Petition for
Approval of Stipulation and Agreement.
    Filed Date: 12/4/13.
    Accession Number: 20131204-5130.
    Comments Due: 5 p.m. ET 12/16/13.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR Sec.  385.211 and Sec.  385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
may be considered, but intervention is necessary to become a party to
the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated December 05, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-29928 Filed 12-16-13; 8:45 am]
BILLING CODE 6717-01-P