Animal Drug Availability Act; Veterinary Feed Directive

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: [email protected].

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

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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)).

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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

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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

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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