76924 Federal Register / Vol. 65, No. 237 / Friday, December 8, 2000 / Rules and Regulations

STATE COUNTY RATE PER

ACRE

SAN JUAN

SKAGIT

SKAMANIA

SNOHOMISH

THURSTON

WAHKIAKUM

WHATCOM

WEST VIRGINIA ........................................ ALL COUNTIES .............................................................................................................. 25.35

WISCONSIN ............................................... ALL COUNTIES .............................................................................................................. 19.02

WYOMING ................................................. ALBANY .......................................................................................................................... 6.32

CAMPBELL

CARBON

CONVERSE

GOSHEN

HOT SPRINGS

JOHNSON

LARAMIE

LINCOLN

NATRONA

NIOBRARA

PLATTE

SHERIDAN

SWEETWATER

FREMONT

SUBLETTE

UINTA

WASHAKIE ..................................................................................................................... 19.02

BIG HORN

CROOK

PARK

TETON

WESTON

ALL OTHER ZONES .................................. ......................................................................................................................................... 6.35

[FR Doc. 00–31277 Filed 12–7–00; 8:45 am]

BILLING CODE 6717–01–M

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: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

new animal drug regulations to

implement the veterinary feed directive

(VFD) drugs section of the Animal Drug

Availability Act of 1996 (ADAA). A VFD

drug is intended for use in animal feed.

Its use is permitted only under the

professional supervision of a licensed

veterinarian in the course of the

veterinarian’s professional practice.

This new regulation states the

requirements for distribution and use of

a VFD drug and animal feed containing

a VFD drug.

DATES: This rule is effective January 8,

2001.

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, email: ggraber@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of July 2, l999

(64 FR 35966), FDA proposed

regulations to establish the requirements

relating to distribution and use of VFD

drugs and animal feeds containing VFD

drugs. We provided 90 days for

comment on the proposed rule.

Prior to 1996, we had only two

options for regulating the distribution of

animal drugs: (1) Over-the-counter

(OTC), and (2) prescription. However,

we determined that certain new animal

drugs, vital to animal health, should be

approved for use in animal feed, only if

these medicated feeds were

administered under a veterinarian’s

order and professional supervision. For

example, veterinarians are needed to

control the use of certain antimicrobials.

This control is critical to reducing

unnecessary use of such drugs in

animals and to slowing or preventing

any potential for the development of

bacterial resistance to antimicrobial

drugs. Safety concerns relating to

difficulty of diagnosis of disease

conditions, high toxicity, or other

reasons may also dictate that the use of

a medicated feed be limited to use by

order and under the supervision of a

licensed veterinarian.

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. 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, an organization that

represents major sectors of animal

agriculture, and with support from State

regulatory agencies, Congress enacted

legislation in 1996 that amended the

Federal Food, Drug, and Cosmetic Act

(the act) in ways intended to facilitate

the approval and marketing of new

Federal Register / Vol. 65, No. 237 / Friday, December 8, 2000 / Rules and Regulations 76925

animal drugs and medicated feed. This

legislation, the ADAA (Public Law 104–

250), among other things, established a

new class of restricted feed use drugs

that may be distributed without

invoking State pharmacy laws (21

U.S.C. 354).

Although statutory controls on the use

of VFD drugs are similar in some

respects to those for prescription animal

drugs regulated under section 503(f) of

the act (21 U.S.C. 353(f)), the

implementing VFD regulations are

tailored to the unique circumstances

relating to the manufacture and

distribution of medicated animal feeds.

This final rule will ensure the

protection of public health while

enabling animal producers to obtain and

use needed drugs as efficiently and costeffectively as possible.

To date, we have approved one VFD

drug, tilmicosin, an antimicrobial

approved for administration via animal

feed for control of swine respiratory

diseases (§ 558.618 (21 CFR 558.618)).

The current regulation for tilmicosin, at

§ 558.618(d)(4), specifies required

cautionary labeling for the VFD drug

and any feed manufactured from the

VFD drug and describes the information

that the attending veterinarian must

provide as part of the VFD. The

proposed cautionary labeling in

§ 558.6(f) was in substance the same as

the tilmicosin cautionary labeling but

had minor word differences. To assure

consistency in cautionary labeling for

tilmicosin and any future VFD drugs,

we have revised our proposed

cautionary labeling in § 558.6(f) to

conform to tilmicosin cautionary

language in § 558.618(d)(4). Section

558.618(d)(4) is therefore being removed

as its provisions are now a part of this

final rule at §§ 558.6(a)(4) [content of

VFD] and 558.6(f) [cautionary labeling].

II. Comments on the Proposed Rule

We received eight letters commenting

on the proposed rule. One was from a

feed manufacturer. The balance were

from associations representing the

veterinary profession, feed

manufacturers, the animal health

industry, animal producers, and feed

control regulators. Generally, the

comments were quite supportive of the

VFD concept. Significant issues

addressed in the comments involved the

means of transmission of VFD’s, the

length of time a VFD would be valid, the

appropriateness of refills or reorders,

and our proposed automatic

classification of VFD drugs as Category

II drugs.

Following is our response to

comments, grouped by issue:

A. Transmission of VFD’s

(Comment 1) All eight comments

mentioned this issue. Comments were

evenly split, with the veterinary

profession, producers, and drug

industry desiring maximum use of

paper, facsimile, phone, e-mail, and

new technology as it develops. The feed

industry and feed control regulators

opted for paper copy with the

possibility of facsimile transmission

with proper safeguards. They did not

support phone transmission.

Objections to facsimile and other

electronic transmission of VFD’s were

based on a perceived lack of security of

transmitted information, difficulty in

substantiating authenticity of the VFD,

and ability of the client to forward a

VFD to multiple distributors. In the case

of phone transmission, comments

stressed the possibility of fraudulent

orders, risk of error in reducing the

order to writing, and the burden placed

on the manufacturer/distributor to

authenticate the VFD order. One

comment stated that the oversight by the

veterinarian is the underlying reason

that Congress created VFD drugs. The

comment contended that this oversight

is lost when we allow a VFD feed to be

distributed in the absence of a signed,

original VFD physically present at the

distributor at the time of distribution.

Proponents of the use of a wide range

of methods for VFD transmission

suggest that distribution would be

unnecessarily delayed for lack of a

written and signed form physically

present at the distributor. Two

comments suggested that FDA be open

to new innovations in electronic

transmission such as a web-based server

that would require the use of secure

user (veterinarian owned) accounts

using user-names, passwords, and

electronic signatures. We are not

opposed to the use of new innovations

and technologies. We would not object

to a system that can be demonstrated as

being in compliance with applicable

regulations and practices that govern

such systems.

We believe we must accommodate

those situations where prompt hand

delivery of a VFD is not possible, but

immediate delivery of a VFD feed is

necessary. To accomplish this, we will

allow transmission by facsimile or other

electronic means provided safeguards

are in place to prevent misuse. The

industry must provide assurances that

these technologies, as appropriate, are

in compliance with part 11 (21 CFR part

11). Using a computer as a web-based

server to create, modify, maintain, or

transmit required records as well as

using electronic signatures for those

records is subject to part 11. It would be

up to industry to prove that a system is

capable of its intended purpose. Part 11

‘‘applies to all records in electronic form

that are created, modified, maintained,

archived, retrieved, or transmitted

under record requirements in any of the

agency’s regulations or records

submitted to the agency,’’ unless

specifically excepted by regulation(s). In

order for electronic records to be used

in lieu of paper records, they must be

in compliance with the provisions

stated in § 11.2. These electronic records

and signatures, computer systems

(including hardware and software),

controls, and accompanying

documentation must be readily

available for and subject to inspection

by FDA.

We disagree with the comment that

facsimile transmission of the VFD poses

a significant problem as the client may

reproduce the copy to place multiple

orders. While the possibility exists that

a client may submit the copy of the VFD

to several distributors to obtain

additional VFD feed, the distributor will

become aware of the irregularity when

an original VFD doesn’t arrive within 5

days. Such a violation is difficult to

hide.

One comment asked who is held

responsible, the veterinarian, feeder

(client), or feed distributor, if the actual

VFD is not properly distributed. While

all bear responsibility, the veterinarian

is most in control. Thus, we believe it

is the veterinarian’s obligation to assure

that the original VFD is distributed to

the feed distributor with the timeliness

required by § 558.6(b)(4). The client has

responsibility for notifying the

veterinarian where to send the original

VFD. We recognize there may be

instances where a VFD may not be

presented to a distributor for several

days, and there may be instances where

the VFD is issued but never used. If it

is determined that a VFD may be

refilled, it is possible that the VFD may

be required by one distributor first and

later by another for refill. In these

situations, the client must keep the

issuing veterinarian advised when a

VFD is moved from one distributor to

another, to ensure that the original VFD

is moved to the new distributor or a new

VFD is issued.

Regarding telephone orders, one

comment stated that there is precedence

for telephone orders in that

veterinarians currently telephone in

prescription drug orders. The orders are

reduced to writing by the pharmacist

without a followup hard copy of the

prescription being sent. We do not agree

that the situations are the same. The

pharmacist who fills a prescription has

76926 Federal Register / Vol. 65, No. 237 / Friday, December 8, 2000 / Rules and Regulations

extensive training in drug use and

potential misuse. Further, a limited

amount of information is required in a

typical prescription order. Conversely,

an extensive amount of information is

required in a VFD. A feed mill

employee, while skilled in

manufacturing feed, may not have the

necessary skills to routinely assure a

complete and accurate transmission of a

VFD or to recognize a potentially

inaccurate VFD order. We believe that

allowing a telephone order to the feed

mill would jeopardize the integrity of

the VFD process. Therefore, we have not

included telephone orders as an option

for transmitting a VFD and have added

§ 558.6(b)(5) to state that a VFD may not

be transmitted by phone.

B. Refills and Length of Time VFD is

Valid

(Comment 2) One comment suggested

that FDA determine whether refills or

reorders are appropriate. Another

comment suggested that the veterinarian

should be allowed to determine when

refills or reorders are necessary. Two

comments stated that a single VFD

could cover multiple production groups

when a disease outbreak is anticipated

in subsequent groups of animals passing

through a production facility.

Concerning the length of time a VFD is

valid, two comments stated that the

VFD should be valid for up to 6 months.

Two other comments stated the opinion

that the duration of a VFD should be

determined on a case-by-case basis as

part of the VFD drug approval process.

We believe that there are situations

when refills and expiration dates,

possibly of several months, are

appropriate to medicate multiple

production groups and provide efficient

treatment of sick animals. We further

believe that allowances of this type will

vary considerably depending on the

drug and its use. Since we cannot

predict what types of drugs and disease

situations will be presented in the

future, the issues of refills and reorders

and the duration of time a VFD can be

valid need to be considered on a drugby-drug basis as part of the new animal

drug approval process. We recognize

this could result in different conditions

for different VFD drugs, which is

additional support for the role of the

professional (veterinarian) and the need

for a complete VFD. Therefore, we have

not attempted to specify the allowable

number of refills or reorders, or the

duration of time a VFD can be valid.

This will be dealt with when the new

animal drug application (NADA) for the

VFD drug is reviewed during the

approval process.

C. Classification of VFD Drugs as

Category II Drugs

(Comment 3) Two comments asked

that we reexamine our decision to

automatically classify VFD drugs as

Category II drugs. We continue to

believe that classifying VFD drugs as

Category II drugs is appropriate.

Classifying a drug as Category II adds

additional regulatory controls because

feed manufacturing facilities must

possess a medicated feed mill license

and be registered with FDA in order to

manufacture a Type B or Type C

medicated feed from a Category II, Type

A medicated article. Registered feed

mills are required to be inspected at

least every 2 years. Such inspections

will help the agency ensure that VFD

requirements are met.

Therefore, our decision to

automatically classify VFD drugs as

Category II drugs remains and is so

reflected in the final rule.

D. Responses to Remaining Comments

(Comment 4) Two comments

suggested that the ‘‘notification letter’’

of proposed § 558.6(d)(1) and the

‘‘acknowledgment letter’’ of

§ 558.6(d)(2) be combined into a single

letter to reduce the paperwork burden.

We are unable to agree to this because

these letters serve different purposes

and are sent to different entities. The

notification letter is sent by the

distributor to FDA to notify the agency

that the distributor has begun

distributing VFD feeds. In contrast, the

acknowledgment letter is sent to the

distributor by a purchaser stating that it

will sell the VFD feed only to a

producer with a valid VFD, or to

another distributor who provides a

similar acknowledgment letter.

We are, however, combining

§ 558.6(d)(2)(i) and (d)(2)(ii) of the

proposed rule, which required in

paragraph (d)(2)(i) that a distributor

obtain an acknowledgment letter and in

paragraph (d)(2)(ii) that a distributor

obtain a statement affirming that a

consignee-distributor has complied with

‘‘distributor notification’’ requirements.

Both requirements may now be met in

a single letter under § 558.6(d)(2).

(Comment 5) Two comments asked

for other changes in the VFD. One

comment asked that § 558.6(a)(3) be

changed to read: ‘‘You must complete

all of the information required on the

VFD in writing, and sign it; VFD’s that

contain incomplete information will be

considered invalid.’’ A similar comment

asked that we consider as unacceptable

a VFD that is not filled out completely.

We agree with these suggestions and

have incorporated them into

§ 558.6(a)(3) and (a)(4) in the final rule.

(Comment 6) Two comments asked

that the VFD drug sponsor provide VFD

forms in triplicate to the veterinarian

and that the veterinarian be required to

use them. We agree with this comment

in part. We addressed it in the proposed

rule by revising the new animal drug

regulations at § 514.1(b)(9) (21 CFR

514.1(b)(9)) to require the sponsor of a

VFD drug to include in the NADA a

format for a VFD form as described in

§ 558.6(a)(4) of this regulation. One

comment additionally suggested that

using the VFD drug sponsor’s VFD form

would eliminate the problem of

partially completed forms generated by

a veterinarian. While we have not made

it mandatory that the VFD drug sponsor

provide copies of this form for use by

the veterinary profession, we believe

that they will make the forms available

in triplicate for the sake of efficiency

and completeness of the veterinarian’s

VFD transmissions. Nevertheless, we

continue to give the veterinarian the

option of creating his/her own VFD.

(Comment 7) One comment asked that

we clarify what we mean by the term

‘‘immediately’’ in § 558.6(b)(4), relating

to length of time a veterinarian has to

provide the signed original VFD to the

distributor as followup to a facsimile or

electronic transmission. One comment

suggested that we use the term

‘‘promptly.’’ Another comment

suggested that the time be 24 hours. We

have revised the regulation to read, ‘‘the

distributor receives the original signed

VFD within 5 working days of receipt of

the facsimile or other electronic order.’’

We feel this is sufficient time for the

client to place the order and the

distributor to receive the signed original

mailed by the veterinarian.

Additionally, a comment suggested

that the client should not be required to

wait to receive the VFD medicated feed

until the distributor receives the original

VFD. We agree, but to alleviate concern

that a client may receive medicated feed

containing a VFD drug without

receiving a copy of the VFD, we have

added § 558.6(c)(4) that reads: ‘‘All

involved parties must have a copy of the

VFD before distribution of a VFD feed

to the ultimate user.’’ The copy need not

be an original and may be transmitted

by facsimile or other electronic means.

(Comment 8) One comment

recommended that the facsimile of the

VFD order be on company letterhead.

We anticipate that when veterinarians

do not use the VFD drug sponsor’s VFD,

they will be issuing the VFD on their or

their own firm’s stationary. However,

even if they do not use letterhead paper,

the veterinarian is required to include

Federal Register / Vol. 65, No. 237 / Friday, December 8, 2000 / Rules and Regulations 76927

his/her name (and signature), address,

and license number on the VFD.

Therefore, we do not think it is

necessary to require them to use

company stationary.

(Comment 9) One comment objected

to our inclusion of VFD drugs in

§ 510.300(a)(4) (21 CFR 510.300(a)(4))

because doing so would essentially

confer prescription drug status on VFD

drugs for submission of promotional

materials. Proposed modifications to

§ 510.300 do not make a VFD drug a

prescription drug. Section 504(c) of the

act (21 U.S.C. 354(c)) states that VFD

drugs cannot be prescription articles.

Section 504(b) of the act establishes

misbranding criteria for both labeling

and advertising for VFD’s. Thus, routine

requirements for submitting advertising

for VFD drug experience reports under

§ 510.300(a)(4) should be the same as

requirements for submitting labeling.

We have not changed the proposed

provision in the final rule.

(Comment 10) One comment

suggested that FDA consider a provision

to revoke a veterinarian’s right to order

use of VFD drugs if the veterinarian fails

to have a valid veterinarian-clientpatient relationship (VCPR) or fails to

provide complete VFD information to

the feed distributor. Normally, this type

of action would be handled by State

veterinary license authorities. However,

the act does provide FDA with other

regulatory options.

Section 504 of the act states ‘‘* * *

When labeled, distributed, held, and

used in accordance with this section, a

veterinary feed directive drug and any

animal feed bearing or containing a

veterinary feed directive drug shall be

exempt from section 502(f) [of the act].’’

Under section 502(f) of the act (21

U.S.C. 352(f)) a drug or device is

misbranded unless its labeling bears

adequate directions for lay use. (See 21

CFR 201.5.)

VFD drugs and animal feed bearing or

containing veterinary feed directive

drugs are exempt from the statutory

requirements for adequate directions for

lay use only when they are distributed

under a VFD issued by a licensed

veterinarian within the confines of a

valid VCPR and contain complete and

accurate information as required by

§ 558.6.

If the order for a VFD drug is not

based upon a valid VCPR or fails to

provide complete information as

required by § 558.6, then the VFD drug

is subject to section 502(f) of the act.

Since a VFD drug, by its very nature,

cannot bear adequate directions for lay

use, a VFD drug subject to 502(f) of the

act is misbranded and the veterinarian

who issued the VFD may be held

responsible for causing the misbranding

of the VFD drug or the feed containing

the VFD drug in violation of the act.

We have made nonsubstantive

wording and restructuring changes to

§§ 514.1(b)(9), 558.3(b)(6), and

558.6(a)(2), (c)(1), (c)(2), and (c)(3) for

the sake of clarity.

III. Conforming Changes

FDA has made conforming changes to

§§ 514.1(b)(9) and 510.300, and is

removing § 558.618(d)(4).

IV. Environmental Impact

We have carefully considered the

potential environmental effects of this

final rule and have determined 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.

V. Federalism

We have analyzed this final rule in

accordance with the principles set forth

in Executive Order 13132. We have

determined that the rule does not

contain policies that have substantial

direct effects on the States, on the

relationship between the National

Government and the States, or on the

distribution of power and

responsibilities among the various

levels of government. Accordingly, we

conclude that the rule does not contain

policies that have federalism

implications as defined in the order

and, consequently, a federalism

summary impact statement is not

required.

VI. Analysis of Impacts

We have examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612) (as amended by subtitle

D of the Small Business Regulatory

Fairness Act of 1996 (Public Law 104–

121)), and the Unfunded Mandates

Reform Act of 1995 (Public Law 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). We

believe that this final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

order. In addition, the final rule is not

a significant regulatory action as defined

by the Executive order and so is not

subject to review under the Executive

order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities unless the rule is not expected

to have a significant impact on a

substantial number of small entities. As

this final rule will not impose

significant new costs on any firms under

the Regulatory Flexibility Act (5 U.S.C.

605(b)), we certify that the final rule

will not have a significant economic

impact on a substantial number of small

entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

VII. Unfunded Mandates Reform Act of

1995

Section 202(a) of the Unfunded

Mandates Reform Act of 1995 requires

that agencies prepare an assessment of

the anticipated costs and benefits before

requiring any expenditure by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million or more (adjusted annually

for inflation).

The Unfunded Mandates Reform Act

of 1995 does not require FDA to prepare

a statement of costs and benefits for the

final rule, because the rule is not

expected to result in any 1-year

expenditure that would exceed $100

million adjusted for inflation. The

current inflation-adjusted statutory

threshold is $110 million.

VIII. Paperwork Reduction Act of 1995

This final rule contains information

collection provisions that are subject to

review by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520). A description of these provisions

is given below. Included in the estimate

is the time for reviewing instructions,

searching existing data sources,

gathering and maintaining the data

needed, and completing and reviewing

each collection of information.

Title: Animal Drug Availability Act;

Veterinary Feed Directive

Description: FDA is publishing this

final rule to implement provisions of the

ADAA which, by adding section 504 to

the act, created a new class of animal

drugs called VFD drugs. This final 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 VCPR.

76928 Federal Register / Vol. 65, No. 237 / Friday, December 8, 2000 / Rules and Regulations

The VFD ordered by the veterinarian

must be issued in accordance with the

format described under § 558.6(a). We

are amending the new animal drug

regulations at § 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.

In response to a comment, we

combined § 558.6(d)(2)(i) and (d)(2)(ii)

of the proposed rule, which required in

paragraph (d)(2)(i) that a distributor

obtain an acknowledgment letter and in

paragraph (d)(2)(ii) that a distributor

obtain a statement affirming that a

consignee-distributor has complied with

‘‘distributor notification’’ requirements.

Both requirements may now be met in

a single letter under § 558.6(d)(2). This

change does not entail a substantive

modification to the reporting burden, so

the estimates in table 1 of this document

have not changed.

Description of Respondents:

Veterinarians, distributors of animal

feeds containing VFD drugs, and clients

using medicated feeds containing VFD

drugs. In the Federal Register of July 2,

1999 (64 FR 35966), FDA requested

comments on the proposed collection of

information. No comments were

received on the estimated annual

burdens. The annual burden estimates

therefore remain unchanged.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

558.6(a)(3) through (a)(5) 15,000 25 375,000 0.25 93,750

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 3

Total Hours 96,278

1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual Records Hours per

Record Total Hours

558.6(c)(1) and (d)(2) 112,500 10 1,125,000 0.0167 18,788

558.6(e)(ii) 5,000 75 375,000 0.0167 6,263

Total Hours 25,051

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Individuals and organizations may

submit comments on this burden

estimate or on any other aspect of these

information collection provisions,

including suggestions for reducing the

burden, and should direct them to

George Graber, Center for Veterinary

Medicine (HFV–220), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. The information

collection provisions in this final rule

have been approved under OMB control

number 0910–0363. This approval

expires October 31, 2002. An agency

may not conduct or sponsor, and a

person is not required to respond to, a

collection of information unless it

displays a currently valid OMB control

number.

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, 21 CFR parts 510,

514, and 558 are amended to read as

follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for part 510

continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

§ 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

Federal Register / Vol. 65, No. 237 / Friday, December 8, 2000 / Rules and Regulations 76929

paragraph (a)(4) by adding the phrase

‘‘or a veterinary feed directive drug’’

following ‘‘if it is a prescription new

animal drug’’.

PART 514—NEW ANIMAL DRUG

APPLICATIONS

3. The authority citation for 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:

§ 514.1 Applications.

* * * * *

(b) * * *

(9) Veterinary feed directive. Three

copies of a veterinary feed directive

(VFD) must be submitted in the format

described under § 558.6(a)(4) 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:

§ 558.3 Definitions.

* * * * *

(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 new animal drug approved

under section 512(b) of the Federal

Food, Drug, and Cosmetic Act (the act)

for use in or on animal feed. Use of a

VFD drug must be 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 (VFD) drug in or on an animal

feed. This written statement authorizes

the client (the owner of the animal or

animals or other caretaker) to obtain and

use the VFD drug in or on an animal

feed to treat the client’s animals only in

accordance with the directions for use

approved by the Food and Drug

Administration (FDA). A veterinarian

may issue a VFD only if a valid

veterinarian-client-patient relationship

exists, as defined in § 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

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:

§ 558.6 Veterinary feed directive drugs.

(a) What conditions must I meet if I

am a veterinarian issuing a veterinary

feed directive (VFD)?

(1) You must be appropriately

licensed.

(2) You must issue a VFD only within

the confines of a valid veterinarianclient-patient relationship (see

definition at § 530.3(i) of this chapter).

(3) You must complete the VFD in

writing and sign it or it will be invalid.

(4) You must include all of the

following information in the VFD or it

will be invalid:

(i) You and your client’s name,

address and telephone and, if the VFD

is faxed, facsimile number.

(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)(4)(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.

(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.

(5) You must produce the VFD in

triplicate.

(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

the client).

(2) You must keep one copy of the

VFD.

(3) You must give the client a copy of

the VFD.

(4) You may send a VFD to the client

or distributor by facsimile or other

electronic means provided you assure

that the distributor receives the original

signed VFD within 5 working days of

receipt of the facsimile or other

electronic order.

(5) You may not transmit a VFD by

telephone.

(c) What are the VFD recordkeeping

requirements?

(1) The VFD feed distributor must

keep the VFD original for 2 years from

the date of issuance. The veterinarian

and the client must keep their copies for

the same period of time.

(2) All involved parties must make the

VFD available for inspection and

copying by FDA.

(3) All involved parties (the VFD feed

distributor, the veterinarian, and the

client) must keep VFD’s transmitted by

facsimile or other electronic means for

a period of 2 years from date of

issuance.

(4) All involved parties must have a

copy of the VFD before distribution of

a VFD feed to the ultimate user.

(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.

76930 Federal Register / Vol. 65, No. 237 / Friday, December 8, 2000 / Rules and Regulations

(ii) A responsible person from your

firm must sign and date the notification

letter.

(iii) You must submit the notification

letter to the Center for Veterinary

Medicine, Division of Animal Feeds

(HFV–220), 7500 Standish Pl.,

Rockville, MD 20855, prior to beginning

your first distribution.

(iv) You must notify the Center for

Veterinary Medicine at the above

address 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

an ‘‘acknowledgment letter,’’ as defined

in § 558.3(b)(11), from the consigneedistributor. The letter must include a

statement affirming that the consigneedistributor has complied with

‘‘distributor notification’’ requirements

of paragraph (d)(1) of this section.

(e) What are the additional

recordkeeping requirements if I am a

distributor?

(1) You must keep records of receipt

and distribution of all medicated animal

feed containing a VFD drug.

(2) You must keep these records for 2

years from date of receipt and

distribution.

(3) 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 drug to

use under the professional supervision

of a licensed veterinarian. Animal feed

bearing or containing this veterinary

feed directive drug shall be fed to

animals only by or upon a lawful

veterinary feed directive issued by a

licensed veterinarian in the course of

the veterinarian’s professional practice.’’

§ 558.618 [Amended]

8. Section 558.618 Tilmicosin is

amended by removing paragraph (d)(4).

Dated: November 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–31151 Filed 12–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 556

Tolerances for Residues of New

Animal Drugs in Food; Moxidectin

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is updating the

animal drug regulations to correctly

reflect the tolerance for moxidectin in

cow’s milk. This document amends the

regulations to state the correct tolerance

is 40 parts per billion (ppb). This action

is being taken to improve the accuracy

of the agency’s regulations. Changes to

a current format are also being made.

DATES: This rule is effective December 8,

2000.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for

Veterinary Medicine (HFV–135), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

7578.

SUPPLEMENTARY INFORMATION:

Moxidectin solution is approved for

topical use in cattle for the treatment

and control of infections and

infestations of certain internal and

external parasites. When the November

2, 1999, approval of the use of

moxidectin in lactating dairy cows was

published in the Federal Register of

June 9, 2000 (65 FR 36616), the

tolerance for parent moxidectin in the

milk of cattle was incorrectly listed. At

this time, the regulations are being

amended in 21 CFR 556.426 to state the

correct tolerance is 40 ppb and,

editorially, to reflect current format.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

List of Subjects in 21 CFR Part 556

Animal drugs, Foods.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 556 is amended as follows:

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

1. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

2. Section 556.426 is amended by

revising paragraph (b) to read as follows:

§ 556.426 Moxidectin.

* * * * *

(b) Tolerances—(1) Cattle—(i) Liver

(the target tissue). The tolerance for

parent moxidectin (the marker residue)

is 200 parts per billion (ppb).

(ii) Muscle. The tolerance for parent

moxidectin (the marker residue) is 50

ppb.

(iii) Milk. The tolerance for parent

moxidectin (the marker residue in cattle

milk) is 40 ppb.

(2) [Reserved]

Dated: November 29, 2000.

David R. Newkirk,

Acting Deputy Director, Office of New Animal

Drug Evaluation, Center for Veterinary

Medicine.

[FR Doc. 00–31248 Filed 12–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. 00P–1343]

Medical Device; Exemption From

Premarket Notification; Class II

Devices; Barium Enema Retention

Catheters and Tips With or Without a

Bag

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is publishing an

order granting a petition requesting

exemption from the premarket

notification requirements for barium

enema retention catheters and tips with

or without a bag with certain

limitations. This rule will exempt from

premarket notification barium enema

retention catheters and tips with or

without a bag. FDA is publishing this

order in accordance with procedures

established by the Food and Drug

Administration Modernization Act of

1997 (FDAMA).

DATES: This rule is effective December 8,

2000.