[Federal Register Volume 65, Number 237 (Friday, December 8, 2000)]
[Rules and Regulations]
[Pages 76924-76930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31151]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 514, and 558

[Docket No. 99N-1591]


Animal Drug Availability Act; Veterinary Feed Directive

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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, e-mail: [email protected].

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

[[Page 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 cost-
effectively 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 (Sec. 558.618 (21 CFR 558.618)). The 
current regulation for tilmicosin, at Sec. 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 Sec. 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 
Sec. 558.6(f) to conform to tilmicosin cautionary language in 
Sec. 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 Secs. 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 Sec. 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 Sec. 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

[[Page 76926]]

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 Sec. 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 drug-by-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 Sec. 558.6(d)(1) and the ``acknowledgment letter'' of 
Sec. 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 Sec. 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 
Sec. 558.6(d)(2).
    (Comment 5) Two comments asked for other changes in the VFD. One 
comment asked that Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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

[[Page 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 
Sec. 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 Sec. 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 
Sec. 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-client-patient 
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 
Sec. 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 Sec. 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 
Secs. 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 Secs. 514.1(b)(9) and 510.300, 
and is removing Sec. 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.

[[Page 76928]]

    The VFD ordered by the veterinarian must be issued in accordance 
with the format described under Sec. 558.6(a). We are amending the new 
animal drug regulations at 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.
    In response to a comment, we combined Sec. 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 
Sec. 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
----------------------------------------------------------------------------------------------------------------
                                                Annual
      21 CFR Section            No. of       Frequency per      Total Annual         Hours per      Total Hours
                              Respondents      Response           Responses          Response
----------------------------------------------------------------------------------------------------------------
558.6(a)(3) through (a)(5)   15,000              25            375,000                  0.25       93,750
558.6(d)(1)(i) through        5,000               1              5,000                  0.25        1,250
 (d)(1)(iii)
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
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                Table 2.--Estimated Annual Recordkeeping Burden1
----------------------------------------------------------------------------------------------------------------
                                                Annual
      21 CFR Section            No. of       Frequency per  Total Annual Records     Hours per      Total Hours
                             Recordkeepers   Recordkeeping                            Record
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\1\There 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.


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

[[Page 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:


Sec. 514.1  Applications.

* * * * *
    (b) * * *
    (9) Veterinary feed directive. Three copies of a veterinary feed 
directive (VFD) must be submitted in the format described under 
Sec. 558.6(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:


Sec. 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 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 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 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 
veterinarian-client-patient relationship (see definition at 
Sec. 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.

[[Page 76930]]

    (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 
Sec. 558.3(b)(11), from the consignee-distributor. The letter must 
include a statement affirming that the consignee-distributor 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.''


Sec. 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