[Federal Register Volume 64, Number 127 (Friday, July 2, 1999)]
[Proposed Rules]
[Pages 35966-35972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16857]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 514, and 558
[Docket No. 99N-1591]
Animal Drug Availability Act; Veterinary Feed Directive
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the animal drug regulations to implement the Veterinary Feed Directive
(VFD) drugs section of the Animal Drug Availability Act (ADAA). A VFD
drug is intended for use in animal feeds, and such use of the VFD drug
is permitted only under the professional supervision of a licensed
veterinarian. The proposed regulation would establish the requirements
relating to the distribution and use of VFD drugs and animal feeds
containing VFD drugs.
DATES: Written comments on this proposed rule must be submitted by
September 30, 1999. Comments on the information collection provisions
must be submitted by August 2, 1999.
ADDRESSES: Submit written comments on this proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Submit written comments regarding
the information collection to the Office of Information and Regulatory
Affairs, Office of Management and Budget (OMB), New Executive Bldg.,
725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Wendy Taylor,
Desk Officer for FDA. All comments must be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: George Graber, Center for Veterinary
Medicine (HFV-220), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-6651, e-mail: ggraber@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has determined that certain new animal drugs, vital to animal
health, should be approved for use in animal feed, but only if such
medicated feeds are administered under a veterinarian's order and
supervision. This limitation is important for a number of reasons. For
example, control of the usage of certain antimicrobials is critical to
reducing unnecessary use of such drugs in animals and to slowing or
preventing the development of bacterial resistance to antimicrobial
drugs. In addition, safety concerns relating to, among other things,
difficulty in diagnosing disease conditions and high toxicity may also
require that the use of a drug in animal feed be limited to use by
order and under the supervision of a licensed veterinarian.
Before the passage of the ADAA, the Federal Food, Drug, and
Cosmetic Act (the act) provided FDA only two options for regulating the
distribution of animal drugs: Over-the-counter (OTC) and prescription.
Although prescription status affords certain controls, the regulation
of animal drugs for use in medicated feeds under traditional
prescription systems has proven unworkable. The prescription legend
invokes the application of State pharmacy laws, and FDA usually defers
to State law concerning dispensing of prescription drugs. Pharmacy laws
in a significant number of States prohibit feed manufacturers from
possessing and dispensing prescription animal drugs and medicated feed
containing those drugs. Pharmacy laws in other States require the
presence of a pharmacist at the feed manufacturing facility that uses
prescription drugs in the manufacture of medicated feeds. As a
practical matter, the application of State pharmacy laws to medicated
feeds would burden State pharmacy boards and impose costs on animal
feed manufacturers to such an extent that it would be impractical to
make these critically needed new animal drugs available for animal
therapy. After considerable deliberation with, and support from, the
Coalition for Animal Health, and with support from State regulatory
agencies, Congress enacted legislation in 1996 establishing a new class
of restricted feed use drugs that may be distributed without invoking
State pharmacy laws. The ADAA (Pub. L. 104-250) amended the act to
create section 504 (21 U.S.C. 354), VFD drugs.
Although statutory controls on the distribution and use of VFD
drugs are similar to those for prescription animal drugs regulated
under section 503(f) of the act (21 U.S.C. 353(f)), the proposed
implementing VFD regulations are tailored to the unique circumstances
relating to the distribution of animal feeds containing a VFD drug.
This proposal would ensure the protection of public health while
enabling animal producers to obtain and use needed drugs as efficiently
and cost-effectively as possible. Unlike prescription drugs, VFD drugs
would not be regulated by State pharmacy bodies. Historically, FDA has
cooperated with State feed control offices in regulating the
manufacture and use of medicated feeds. Investigations and inspections
to measure compliance at FDA licensed feed manufacturing establishments
are carried out by FDA or by State feed regulatory personnel
commissioned by FDA. Most States maintain active inspection programs
for medicated feed establishments that are not required to be licensed
by FDA. We anticipate that State feed offices will continue assisting
FDA by enforcing VFD regulations.
To date, one VFD drug has been approved; tilmicosin, an
antimicrobial approved for administration via animal feed for control
of swine respiratory diseases (Sec. 558.618 (21 CFR 558.618)). The
regulation for tilmicosin, in addition to specifying the approved
conditions of use, describes the information that the attending
veterinarian must provide as part of the VFD form. At the time of
publication of the final rule for VFD's, the regulation at Sec. 558.618
will be amended, if needed, to be consistent with the final rule.
II. Discussion of the Proposed Rule
By amending part 558 (21 CFR part 558), the proposed rule would
implement section 504 of the act, which created VFD drugs.
Specifically, the proposed rule would amend Sec. 558.3(b) by adding
necessary definitions at Sec. 558.3(b)(6) through (b)(11). The proposed
rule would also redefine Category II drugs at Sec. 558.3(b)(1)(ii) to
include all VFD drugs, a reflection of
[[Page 35967]]
our safety concerns for all medicated feeds containing VFD drugs. A
proposed new Sec. 558.6 would be added to list the requirements for the
distribution and use of VFD drugs and feeds that contain VFD drugs.
A VFD drug is limited to use under a valid veterinary-client-
patient relationship where the veterinarian assumes the responsibility
for safe and effective use of the VFD and the client has agreed to
follow the instructions of the veterinarian. Proposed Sec. 558.6(a)(1)
through (a)(4) lists the responsibilities of the veterinarian issuing a
VFD.
The information required to be included in the VFD will vary from
drug to drug. Proposed Sec. 558.6(a)(5) describes information that may
be required in a VFD. The specific VFD approval regulation will
identify the information required in a VFD for a particular animal
drug. FDA is particularly concerned that VFD drugs be used only in
accordance with the approved uses.
The length of time a VFD may be valid (expiration date) and the
number of refills or reorders, if any, that will be permitted will be
specific to the VFD drug. As part of the VFD drug approval process, FDA
will determine whether refills or reorders are allowed, and if so, the
number of refills or reorders. We request your comment on this proposed
approach and on how much latitude should be given the veterinarian in
ordering use of VFD drugs consistent with the control over drug use as
envisioned by the ADAA; i.e., should reorders be permitted and for what
length of time should the order be valid? The American Association of
Swine Practitioners (AASP) addressed this issue in a response dated
January 20, 1997, to the ADAA advanced notice of proposed rulemaking in
the Federal Register of November 21, 1996 (61 FR 59209) (Docket No.
96N-0411). The AASP stated that it is imperative that the rule allow
flexibility in issuance and content of the VFD in order to be practical
in its application to various types of production systems. For example,
the AASP inquired whether a single VFD can be applicable to multiple
groups of pigs when a farm's history predicts recurring disease
outbreaks in the transition between production stages, such as
postweaning.
As a practical matter, FDA anticipates that practicing
veterinarians would not want to attempt to create their own practice-
specific VFD's because of the time involved and the amount of specific
information required. We expect VFD drug manufacturers to provide
veterinarians with preprinted VFD's in triplicate. We are thus
proposing to amend Sec. 514.1(b)(9) (21 CFR 514.1(b)(9)) to require
submission of a VFD format as a part of the new animal drug application
(NADA) for each VFD drug.
Proposed Sec. 558.6(b)(1), (b)(2), and (b)(3) describe the proper
distribution and recordkeeping requirements for each of the three
copies of the VFD. The client and the veterinarian each keep a copy,
and the original is given to the distributor supplying the VFD feed to
the client. Under proposed Sec. 558.6(b)(4), to expedite delivery, a
veterinarian may fax a VFD to the distributor provided the veterinarian
immediately forwards the original to the distributor and a copy to the
client. Proposed Sec. 558.6(c) would require that the involved parties
(veterinarian, distributor, and client) keep the VFD for 2 years after
the date of issuance and make it available for inspection and copying
by FDA.
In addition to facsimile transmission of VFD's, we are considering
permitting the veterinarian to telephone or e-mail VFD orders to the
distributor. This would facilitate rapid movement of VFD feeds when
immediate personal contact among the veterinarian, client, and
distributor is not practical, and the situation demands the VFD feed be
fed immediately to the animals. This approach would require that the
veterinarian provide complete VFD information to the feed distributor
by telephone or electronic means. In the case of telephone orders, the
distributor would be responsible for reducing the telephone order to
writing and keeping this order in its files. The veterinarian would
follow the telephone call with prompt issuance of a signed, written VFD
to the distributor and a copy to the client. Even though use of either
electronic transmission or telephone will require that the veterinarian
followup with signed written copies to both distributor and client,
there is still concern about telephone orders. A concern is that there
will be less control over the distribution process when the required
information is not initially in writing, and reliance is placed on the
client or distributor for proper interpretation of oral instructions.
We are seeking comments on the policy reflected in the proposed rule
allowing only fascimile transmission of VFD's, and whether that policy
should be changed to allow use of the telephone and e-mail for
transmitting VFD orders. Specifically, we invite comments on how to
ensure transmission of clear, complete, and secure information via
telephone or electronic means, and on the mechanics of promptly
providing a signed copy of the VFD to all involved parties while
avoiding undue duplication of effort and paperwork.
Proposed Sec. 558.6(d)(1) discusses the statutory requirement of
ADAA that all distributors of medicated feed containing VFD drugs,
whether feed manufacturers or other suppliers in the feed distribution
chain, notify us of their intent to distribute such feed upon first
engaging in distribution. A ``distributor'' is defined in proposed
Sec. 558.3(b)(9) as any person who distributes a medicated animal feed
containing a VFD drug to a client who presents a VFD or to another
distributor. The term ``distributor'' includes all entities marketing
VFD feeds, from the manufacturer of such feed to all suppliers in the
distribution chain. To assist us in maintaining an accurate data base
of distributors, proposed Sec. 558.6(d)(1)(iv) would require that
distributors notify us within 30 days if they change business name or
address. We regard this as an extension of Sec. 558.6(d)(1)
notification requirement, necessary to keep original notification
information current.
To accommodate the many levels of distribution, proposed
Sec. 558.6(d)(2) would allow a distributor to ship medicated feeds
containing a VFD drug to a consignee in the absence of a VFD. The
regulations would only allow this if the consignee furnishes an
``acknowledgment letter'' affirming that it will only distribute
medicated feed bearing or containing a VFD drug to a VFD holder or
another distributor who furnishes a similar acknowledgment letter.
Proposed Sec. 558.6(d)(2) also is intended to ensure that all parties
involved in distribution of VFD drugs understand the requirement of
shipping medicated animal feeds containing VFD drugs only to consignees
who have notified FDA. Proposed Sec. 558.6(e)(ii) would require that
distributors keep records of receipt and distribution of all medicated
animal feeds containing VFD drugs. We believe that the usual and
customary records of purchase and sales kept by distributors will
satisfy this requirement. FDA would examine receipt and distribution
records to verify compliance with these proposed regulations.
Proposed Sec. 558.6(f) would specify the wording of a cautionary
statement that is required by statute to be included in all labeling
and advertising for VFD drugs and medicated feeds containing VFD drugs.
This ``cautionary'' labeling requirement is exempt from the scope of
the Paperwork Reduction Act (the PRA) because it is a ``public
disclosure of information originally supplied by the Federal Government
for the purpose of disclosure to the public'' (5 CFR 1320.3(c)(2)).
[[Page 35968]]
Under section 512(a)(1) of the act (21 U.S.C. 360b(a)(1)), an
animal drug is unsafe unless it is approved and its labeling and use
comply with the approval. In addition, section 512(a)(4) of the act,
which allows for some extra-label use of animal drugs, specifically
prohibits extra-label use in animal feed. This prohibits the extra-
label use of VFD drugs in animal feed. Therefore, a VFD drug not used
in accord with its approval would be an unapproved new animal drug and
would be considered to be unsafe under section 512 of the act.
Consequently, the VFD drug would be adulterated under section 501(a)(5)
of the act (21 U.S.C. 351(a)(5)), and an animal feed bearing or
containing such VFD drug would be adulterated under section 501(a)(6)
of the act. A VFD drug and any feed bearing or containing a VFD drug
would be considered to be misbranded under section 504(b) of the act if
the labeling or advertising fails to contain the cautionary statements
prescribed in these regulations or fails to conform to the approved
conditions and indications for use.
In order to implement those provisions of the act prohibiting
extra-label use and promotion of VFD drugs, and to clarify that
reporting and recordkeeping requirements for labeling and promotional
material under Sec. 510.300 (21 CFR 510.300) are also applicable to VFD
drugs, the proposed rule would revise Sec. 510.300(a)(4) to add ``or a
veterinary feed directive drug'' after ``if it is a prescription new
animal drug.'' This would require that promotional material for VFD
drugs be submitted at the time of initial dissemination and publication
in accord with Sec. 510.300(a)(4) and (b)(3), respectively.
III. 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.
IV. Analysis of Impacts
FDA has examined the impact of the proposed rule under Executive
Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612),
and under the Unfunded Mandates Reform Act (Pub. L. 104-4). Executive
Order 12866 directs 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 Regulatory
Flexibility Act requires agencies to examine regulatory alternatives
for small entities if the rule may have a significant impact on a
substantial number of small entities. The Unfunded Mandates Reform Act
requires agencies to prepare an assessment of anticipated costs and
benefits before enacting any rule that may result in an expenditure in
any one year by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100 million (adjusted annually for
inflation).
FDA concludes that this proposed rule is consistent with the
principles set forth in the Executive Order and in these two statutes.
We estimate that the present value of the proposed rule's annual
compliance costs on industry in the first year would range from about
$315,000 to $571,000. These costs will increase yearly as more VFD
drugs are approved and should total about $2.8 million in year 10
(after amortization at a 7-percent discount rate). It is important to
note that these costs will be incurred each year only if those using
this new class of drugs believe that the accompanying health benefits
outweigh these costs. As a result, the proposed rule is not a
significant regulatory action as defined by the Executive Order and so
is not subject to review under the Executive Order. We have further
determined that the proposed rule will not have a significant economic
impact on a substantial number of small entities. Further, because this
proposed rule makes no mandates on other government entities and will
result in expenditures of less than $100 million by the private sector
in any one year, we need not prepare additional analyses under the
Unfunded Mandates Reform Act.
FDA is proposing to amend the animal drug regulations to reflect
the creation of a new category of drugs for use in animal feeds,
referred to as VFD drugs. A VFD drug is a drug intended for use in or
on animal feed that is limited to use under the professional
supervision of a licensed veterinarian. Certain drugs can be approved
for feed use only if used under a veterinarian's supervision. Statutory
creation of VFD drugs provides the agency with a means for controlling
the distribution and use of certain animal drugs that is more practical
and less burdensome to industry than the existing prescription system.
The proposed new system would be as effective as the prescription drug
system in controlling the distribution and use of VFD drugs, but with
requirements tailored to the unique circumstances that exist for the
distribution of medicated feeds. The most critical aspect of this
system is the direct involvement of a veterinarian in the selection and
use of the VFD drug. Thus, the proposal would maintain public health
protection while enabling livestock producers to obtain needed drugs as
efficiently and cost-effectively as possible.
A. Benefits
Quantifying the benefits of the new system for VFD drugs is
difficult because it requires that the treatment benefits of each VFD
drug be compared to the drug that it replaces in the treatment regimen.
Because almost all of the VFD drugs are as yet unidentified, it is not
possible to make these determinations. It is reasonable, however, to
assume that because each VFD drug would be assigned the VFD
classification during the drug approval process, each drug would have
some safety or toxicity concerns that would prevent its approval as an
OTC drug for use in feed. Because these drugs would otherwise have to
be approved in a prescription drug form, the proposed VFD drug rules
provide for greater availability and use. Moreover, because the rule
does not require that a VFD drug be used in place of either OTC
medicated feeds or prescription drugs in a nonfeed form, consumers
(veterinarians and animal producers) are expected to use VFD drugs only
where they believe that the VFD drug's benefits outweigh their costs.
B. Costs
Complying with the VFD drug provisions would impose some costs on
industry and government. A percentage of these costs, however, or even
an amount greater than the costs shown here, would be incurred
independently of the VFD rules if the same animal drug and its approved
indication for treatment were approved under the current animal drug
approval system as a prescription drug intended for use other than in
or on an animal feed. From a broader perspective, therefore, the rule
may result in a decrease in net costs, or a net benefit to the
industry, as the VFD drug rule requirements may be less costly than the
prescription drug requirements.
The costs imposed by the VFD drug proposal are dependent on the
number of drugs that would be approved each year as VFD drugs. Although
it is difficult to predict this number, because the VFD drugs are a new
creation, the agency estimates that the average number of animal drugs
that would be approved as VFD drugs is about one per
[[Page 35969]]
year. Likewise, the number of VFD's that will be issued annually is
dependent on many factors, some of which are difficult to predict. For
purposes of this analysis, however, the agency assumes that each VFD
drug will be issued from 250,000 to 500,000 times each year. Due to the
uncertainty surrounding this initial estimate, the agency invites
comment on the appropriate number of times an average VFD drug will be
issued annually.
The VFD system is intended to retain the existing distribution
mechanisms for drugs intended for use in feeds and for medicated feeds
while maintaining more control over the availability of certain animal
drugs that are intended for use in animal feed and that raise safety
issues. The major cost of compliance would result from the paperwork
that would be necessary to track the VFD drugs and feeds. One of the
cost components would be the cost of filing the VFD's by the
veterinarian, distributor, and animal producer. The agency estimates
that filing each VFD by the veterinarian, distributor, and animal
producer or their records clerks will take only about 1 minute. The
first year cost of this task is estimated to total $218,000 to $437,000
based on the hourly wages for records clerks and animal producers
calculated from data in Employment and Earning, pp. 206 and 209,
January 1996; and Monthly Labor Review, p. 76, September 1997. After
the VFD drug system becomes more routine and the total number of VFD's
issued increases with the years, it is likely that the compliance time
per VFD will decrease.
Another first year cost is the requirement that VFD drug
distributors notify FDA of their intent to distribute the drugs. The
agency estimates that there will be up to 20,000 distributors over
time, but that only about 25 percent of them will notify the agency in
the first year. Based on agency estimates of 15 minutes to write the
notification at a middle manager's wage of about $19 per hour, and 10
minutes for a GS-7 Government employee to process the notification,
total notification costs in the first year are estimated at about
$35,000. We cannot estimate the cost of the requirement that
distributors notify us when they change their business name or address,
but believe it to be negligible. The compliance cost of the VFD,
whether by the VFD drug manufacturer or the veterinarian, is estimated
at about $1,000 for the initial one page layout and $0.05 for each
triplicate form. This amounts to $14,000 to $26,000 per year per VFD
drug. The $1,000 cost for the layout (format) would be incurred by the
VFD drug sponsor under the proposal in Sec. 514.1(b)(9) to require
submission of the format with the NADA. Storage costs for the normal
three copies of the VFD previously mentioned, and fax copies if that
form of transmission is used, amount to $25,000 to $50,000 in the first
year, assuming that about 15,000 copies fit into a large file cabinet
at about $500 per cabinet.
The final compliance cost concerns the acknowledgment letters
written by the distributors of the VFD drugs. We estimate that about
5,000 letters will be written annually for the first 3 years and that
each letter will take 15 minutes to prepare. At the middle manager's
wage rate mentioned previously, we estimate this provision to cost only
about $24,000 annually for the first 3 years.
In sum, FDA estimates the total first year compliance costs to be
from about $315,000 to $571,000, including costs to both industry and
government, or about $1.25 per VFD issued. FDA has not included the
cost of the veterinarian's time to write and explain the VFD to the
animal producer because it is very likely that a comparable amount of
time would be spent by veterinarians counseling animal producers in
other animal treatments in the absence of the VFD drug system.
Regardless, the net effect of the entire VFD drug system is expected to
be a net benefit, or decrease in net costs, as the consumers of these
drugs will only use them if they expect a greater net benefit over
currently available treatment alternatives.
In future years, compliance costs would increase for several
reasons. First, distributor notifications would increase in the second
year as an estimated 75 percent of those that do not notify us in the
first year perform this obligation (this rate may be overestimated to
the extent that it takes more years before all distributors begin to
handle medicated feeds containing VFD drugs). Second, and more
importantly, there may be, on average, about one more VFD drug approved
in each succeeding year that would steadily increase the total issuance
and filing costs. Compliance costs per VFD issued, however, would
decrease slightly in the future because the one-time-only costs already
would have been incurred.
The estimated total nondiscounted compliance costs in year 2 range
from about $640,000 to $1,151,000. Discounting these costs at 7 percent
per year results in a final second year cost estimate of about $598,000
to $1,076,000. At some year in the future, the increasing number of
VFD's issued will reach a point at which issuances of the newly
approved VFD's will be offset by the decreasing issuances of older
VFD's as their sales volume decreases. Although the agency does not
know in which year this will occur, it can be determined that the
present value of the annual compliance costs will not continue to
increase. The agency invites comment on all compliance cost estimates
included in this analysis.
C. Regulatory Flexibility Analysis
The Small Business Administration (SBA) defines all manufacturers
of drugs and prepared feeds for animals having 500 employees or fewer
to be a small business. We have included feed distributors in this
category also. FDA estimates that only about 2 percent of the affected
facilities belong to large conglomerates with an overall employee count
of higher than 500. Therefore, the remaining 98 percent of the affected
facilities would be considered small businesses according to SBA's
standards. SBA defines veterinary services for livestock as small
businesses if annual revenues are less than $5 million. Because,
according to the American Veterinary Medical Association, ``Veterinary
Market Statistics, 1997,'' large animal veterinarians earn about
$60,000 per year on average, the agency assumes that virtually all
large animal veterinary practices are small businesses. Likewise, most
livestock production facilities would be considered small businesses by
SBA, because SBA defines small business as those businesses with
revenues under $500,000, except for beef cattle feedlots, for which the
limit is $1.5 million. Consequently, the proposed rule would ultimately
affect a substantial number of small businesses. The rule will not,
however, have a significant effect on these small business, as the cost
of the additional veterinary service and paperwork burdens are
estimated at about $1.25 per VFD issued. Such costs would constitute an
insignificant percentage of the revenue of the affected firms even if
several VFD drugs are issued to a producer each year. Thus, in
accordance with the Regulatory Flexibility Act, FDA certifies that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
D. Unfunded Mandate Reform Act
The Unfunded Mandates Reform Act requires (section 202) that
agencies prepare an assessment of anticipated costs and benefits before
proposing any expenditure by State, local, and tribal governments, in
the aggregate, or by the private sector of $100 million (adjusted
[[Page 35970]]
annually for inflation) in any one year. The publication of the
proposal creating the VFD drug system is not expected to result in
expenditures of funds by State, local, and tribal governments or the
private sector in excess of $100 million annually. Therefore, FDA is
not required to perform a cost/benefit analysis according to the
Unfunded Mandates Reform Act.
V. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by OMB under the PRA (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection provisions are shown in this section V with an estimate of
the annual reporting and recordkeeping burden (Tables 1 and 2 of this
document). 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.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our 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 implements provisions of the ADAA of
1996 (Pub. L. 104-250), which, by adding section 504 to the act,
created a new class of animal drugs called VFD drugs. The proposed rule
establishes regulatory requirements for the distribution and use of VFD
drugs. VFD drugs are new animal drugs intended for use in or on animal
feed whereby such use is permitted only under the professional
supervision of a licensed veterinarian operating within the confines of
a valid veterinarian-client-patient relationship.
The VFD ordered by the veterinarian must be issued in accordance
with the format described under proposed Sec. 558.6(a). We are
proposing to amend the new animal drug regulations in Sec. 514.1(b)(9)
to require the VFD drug sponsor to submit such format as part of the
NADA. The format may be used by the sponsor to produce forms in
triplicate for use by the veterinarian or it may be supplied to the
veterinarian for use in preparing a practice-specific form.
Veterinarians are required to complete the VFD in triplicate,
authorizing a client-recipient to obtain and use a medicated feed
containing a VFD drug. The original copy of the VFD must be forwarded
either by the veterinarian or the client-recipient to the distributor
providing the VFD. In addition, the veterinarian issuing the VFD and
the client-recipient of the VFD must retain a copy of each VFD for 2
years from date of issuance. Any person who distributes medicated feed
containing VFD drugs must file with us 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. Distributors are also
required to keep records of receipt and distribution of medicated
animal feeds containing VFD drugs for 2 years. An acknowledgment letter
must be provided to a distributor by a consignee who is not the
ultimate user of the medicated feed containing a VFD drug. The
acknowledgment letter affirms that the consignee will not ship such
medicated animal feed to an animal production facility that does not
have a VFD, and will not ship such feed to another distributor without
receiving a similar acknowledgment letter. To maintain an accurate data
base for distributors of VFD drugs, a distributor is required to notify
us of any change in name or business address.
Certain capital costs are involved with respect to the reporting
and recordkeeping requirements for VFD drugs. Specific details of cost
estimates are found in section IV.B of this document. We estimate that
approximately 375,000 VFD's will issue annually. The estimated cost for
producing 375,000 VFD's in triplicate annually is $19,750 ($1,000 for
the initial one-page layout and $0.05 for each triplicate form). For
maintaining records of VFD's, the estimated cost is $37,500. This cost
estimate is based on the fact that the veterinarian, client-recipient
and distributor must each keep a copy of the VFD. Thus, a total of
1,125,000 copies of VFD's will be filed (375,000 VFD's x 3). We
estimate that it will take 75 large file cabinets to store all copies
of VFD's, assuming 15,000 copies can be stored in a large file cabinet.
The estimated cost per file cabinet is $500, resulting in a total cost
of $37,500 (75 cabinets x $500).
Description of Respondents: Veterinarians, distributors of animal
feeds containing VFD drugs, and clients utilizing medicated feeds
containing VFD drugs.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR Sections No. of Frequency per Total Annual Responses Hours per Total Hours Capital Costs
Respondents Response Response
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(a)(3) through (a)(5) 15,000 25 375,000 0.25 93,750 $12,250
558.6(d)(1)(i) through (d)(1)(iii) 5,000 1 5,000 0.25 1,250
558.6(d)(1)(iv) 100 1 100 0.25 25
558.6(d)(2) 5,000 1 5,000 0.25 1,250
514.1(b)(9) 1 1 1 3.0 3
Total hours/cost 96,278 12,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no operating or maintenance costs associated with this collection of information.
[[Page 35971]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR Sections No. of Frequency per Total Annual Records Hours per Total Hours Capital Costs
Recordkeepers Recordkeeping Recordkeeper
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(c)(1) and (d)(2)(i) 112,500 10 1,125,000 .0167 18,788 $37,500
558.6(e)(ii) 5,000 75 375,000 .0167 6,263
Total hours/cost 25,051 37,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no operating or maintenance costs associated with this collection of information.
To permit FDA to implement certain provisions of the VFD procedure,
the OMB approved a portion of this collection of information under the
emergency processing provisions of the PRA (5 CFR 1320.13), on a
temporary basis, OMB control number 0910-0363. Estimates in the
preceding burden chart have been changed from those in the emergency
approval (62 FR 64847, December 9, 1997) based upon FDA's experience in
implementing certain elements of the VFD procedure.
In compliance with section 3507(d) of the PRA (44 U.S.C. 3507(d)),
FDA submitted to OMB the information collection provisions of this
proposed rule for review. Interested persons are requested to send
comments regarding this burden estimate or any other aspect of this
information collection, including suggestions for reducing the burden,
by August 2, 1999, to the Office of Information and Regulatory Affairs,
(address above).
VI. Public Comments Procedures
On June 1, 1998, the President instructed all Federal agencies to
ensure the use of ``plain language'' in all new documents. As part of
this initiative, FDA has drafted the codified portion of this document
using the principles of ``plain language'' set forth by the President.
The agency seeks public comment on the clarity of this proposed rule.
FDA invites interested persons to submit comments regarding these
proposed regulations to the Dockets Management Branch (address above).
To ensure that public comments have maximum effect in developing the
final regulations, FDA urges you to identify clearly the specific
section or sections of the proposed regulation that each comment
addresses. Comments should be confined to issues pertinent to the
proposed rule and explain the reason for any recommended change.
Comments are to be identified with the docket number found in brackets
in the heading of this document. FDA will accept comments after the
deadline September 30, 1999, but are not obligated to consider or
include in the administrative record for the final rule those comments
received after the close of the comment period. Received comments may
be seen in the office above between 9 a.m. and 4:30 p.m., Monday
through Friday.
List of Subjects
21 CFR part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 510, 514, and 558 be amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Sec. 510.300 [Amended]
2. Section 510.300 Records and reports concerning experience with
new animal drugs for which an approved application is in effect is
amended in paragraph (a)(4) by adding the phrase ``or a veterinary feed
directive drug,'' after the phrase ``if it is a prescription new animal
drug''.
PART 514--NEW ANIMAL DRUG APPLICATIONS
3. The authority citation for 21 CFR part 514 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 360b, 371, 379e, 381.
4. Section 514.1 is amended by adding paragraph (b)(9) to read as
follows:
Sec. 514.1 Applications.
* * * * *
(b) * * *
(9) Veterinary feed directive (VFD). Three copies must be submitted
in the format described under Sec. 558.6(a)(3), (a)(4), and (a)(5) of
this chapter.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
5. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
6. Section 558.3 is amended by revising paragraph (b)(1)(ii) and by
adding paragraphs (b)(6) through (b)(11) 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, or are a veterinary feed directive drug.
* * * * *
(6) A ``veterinary feed directive (VFD) drug'' is a drug intended
for use in or on animal feed and which is limited by an approved
application filed under section 512(b) of the Federal Food, Drug, and
Cosmetic Act to use by the order and under the professional supervision
of a licensed veterinarian.
(7) A ``veterinary feed directive'' is a written statement issued
by a licensed veterinarian in the course of the veterinarian's
professional practice that orders the use of a veterinary feed
directive 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 the veterinary feed directive drug in or
on an animal feed to treat the client's animals only in accordance with
the Food and Drug Administration
[[Page 35972]]
approved directions for use. A veterinarian may issue a VFD only if a
valid veterinarian-client-patient relationship exists, as defined in
Sec. 530.3(i) of this chapter.
(8) A ``medicated feed'' means a Type B medicated feed as defined
in paragraph (b)(3) of this section or a Type C medicated feed as
defined in paragraph (b)(4) of this section.
(9) For the purposes of this part, a ``distributor' means any
person who distributes a medicated feed containing a VFD drug to
another distributor or to the client-recipient of the VFD.
(10) An ``animal production facility'' is a location where animals
are raised for any purpose, but does not include the specific location
where medicated feed is made.
(11) An ``acknowledgment letter'' is a written communication
provided to a distributor by a consignee who is not the ultimate user
of medicated feed containing a VFD drug. An acknowledgment letter
affirms that the consignee will not ship such medicated animal feed to
an animal production facility that does not have a VFD, and the
consignee will not ship such feed to another distributor without
receiving a similar written acknowledgment letter.
7. Section 558.6 is added to subpart A to read as follows:
Sec. 558.6 Veterinary feed directive drugs.
(a) What conditions must be met if I am a veterinarian issuing a
veterinary feed directive?
(1) You must be appropriately licensed;
(2) You must issue a VFD only within the confines of a valid
veterinarian-client-patient relationship (as defined in Sec. 530.3(i)
of this chapter) in accordance with the format described in paragraphs
(a)(3), (a)(4), and (a)(5) of this section;
(3) You must complete the VFD in writing and sign it;
(4) You must produce the VFD in triplicate;
(5) You must include the following information in the VFD:
(i) Your name, address, and phone number and that of the client;
(ii) Identification and number of animals to be treated/fed the
medicated feed, including identification of the species of animals, and
the location of the animals;
(iii) Date of treatment and, if different, date of prescribing the
VFD drug;
(iv) Approved indications for use;
(v) Name of the animal drug;
(vi) Level of animal drug in the feed, and the amount of feed
required to treat the animals in paragraph (a)(5)(ii) of this section;
(vii) Feeding instructions with the withdrawal time;
(viii) Any special instructions and cautionary statements necessary
for use of the drug in conformance with the approval;
(ix) Expiration date of the VFD;
(x) Number of refills (reorders) if necessary and permitted by the
approval;
(xi) Your license number and the name of the State issuing the
license; and,
(xii) The statement: ``Extra-label use, (i.e., Use of this VFD feed
in a manner other than as provided for in the VFD drug approval) is
strictly prohibited.''
(xiii) Any other information required by the VFD drug approval
regulation.
(6) You must issue a VFD only for the approved conditions and
indications for use of the VFD drug.
(b) What must I do with the VFD if I am a veterinarian?
(1) You must give the original VFD to the feed distributor
(directly or through client);
(2) You must keep one copy of the VFD;
(3) You must give the client the second copy of the VFD;
(4) You may fax a VFD to the client or distributor, if you wish,
provided you immediately forward the signed written original to the
distributor and a copy to the client.
(c) What are the VFD recordkeeping requirements?
(1) The VFD must be kept by all involved parties (i.e.,
veterinarian, client, and VFD feed distributor) for a period of 2 years
from date of issuance.
(2) The VFD must be made available by all involved parties for
inspection and copying by FDA.
(3) VFD's transmitted by facsimile must be kept by all involved
parties along with copies distributed by the veterinarian.
(d) What are the notification requirements if I am a distributor of
animal feed containing a VFD drug?
(1) You must notify FDA only once, by letter, that you intend to
distribute animal feed containing a VFD drug.
(i) The notification letter must include the complete name and
address of each business site from which distribution will occur.
(ii) A responsible person from your firm must sign and date the
notification letter.
(iii) You must submit the notification letter, prior to beginning
your first distribution, to the Center for Veterinary Medicine,
Division of Animal Feeds (HFV-220), 7500 Standish Pl., Rockville, MD
20855; and
(iv) You must notify the Center for Veterinary Medicine at the
address provided in paragraph (d)(1)(iii) of this section within 30
days of any change in name or business address.
(2) If you are a distributor who ships an animal feed containing a
VFD drug to another consignee-distributor in the absence of a valid
VFD, you must obtain:
(i) An ``acknowledgment letter,'' as defined in Sec. 558.3(b)(11)
of this chapter, from the consignee-distributor; and
(ii) A statement affirming that the consignee-distributor has
complied with ``Distributor Notification'' requirements of paragraph
(d)(1) of this section.
(e) What are the recordkeeping requirements if I am a distributor?
(1) You must keep information specified in paragraph (c)(1) or
paragraph (d)(2)(i) of this section;
(2) You must keep records of receipt and distribution of all
medicated animal feed containing a VFD drug;
(3) You must keep these records for 2 years from date of receipt
and distribution; and
(4) You must make records available for inspection and copying by
FDA.
(f) What cautionary statements are required for VFD drugs and
animal feeds containing VFD drugs? All labeling and advertising must
prominently and conspicuously display the following cautionary
statement: ``Caution: Federal law limits this VFD drug product to use
under the professional supervision of a licensed veterinarian.
Medicated feed bearing or containing a VFD drug may be fed to animals
only when there exists a lawful veterinary feed directive issued by a
licensed veterinarian in the course of the veterinarian's professional
practice.''
Dated: June 25, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-16857 Filed 7-1-99; 8:45 am]
BILLING CODE 4160-01-F
