[Federal Register Volume 77, Number 72 (Friday, April 13, 2012)]
[Proposed Rules]
[Pages 22247-22249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8844]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2010-N-0155]


Veterinary Feed Directive; Draft Text for Proposed Regulation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; draft text for proposed regulation.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of draft text for a proposed regulation intended to 
improve the efficiency of FDA's Veterinary Feed Directive (VFD) 
program. The Agency is making this draft text for a proposal available 
because of the complex scientific and regulatory issues involved, and 
because of the potential impact that changes to the VFD regulations may 
have on stakeholders. The Agency invites the public to submit comments 
with questions and concerns about the draft text for a proposed 
regulation.

DATES: Submit either electronic or written comments by July 12, 2012.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0155, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2010-N-0155 for this rulemaking. All comments 
received may be posted without change to http://www.regulations.gov, 
including any personal information provided. For additional information 
on submitting comments, see the ``Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sharon Benz, Center for Veterinary 
Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6864, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    This document is related to two other documents published elsewhere 
in this issue of the Federal Register, wherein FDA is announcing: (1) 
The availability of a guidance document entitled ``The Judicious Use of 
Medically Important Antimicrobial Drugs in Food-Producing Animals'' 
(GFI 209) and (2) the availability of a draft guidance 
document entitled ``New Animal Drugs and New Animal Drug Combination 
Products Administered in or on Medicated Feed or Drinking Water of 
Food-Producing Animals: Recommendations for Drug Sponsors for 
Voluntarily Aligning Product Use Conditions With GFI 209'' 
(draft GFI 213).
    In the Federal Register of March 29, 2010 (75 FR 15387), FDA 
published an advance notice of proposed rulemaking (ANPRM) with a 90-
day comment period requesting comments on all aspects of the VFD 
regulations. FDA published a subsequent document in the Federal 
Register of June 28, 2010 (75 FR 36588), extending the ANPRM comment 
period for an additional 60 days.
    While FDA encouraged comments on all aspects of the VFD 
regulations, the Agency requested input specifically on whether 
efficiency improvements need to be made to the current VFD regulations. 
The Agency received considerable comments from stakeholders suggesting 
that efficiency improvements are needed for the VFD regulations. FDA 
reviewed comments to the docket and, based on its review of those 
comments, developed draft text of regulatory language intended to 
implement specified changes to the existing regulations in part 558 (21 
CFR part 558).
    Comments to the docket confirmed that this is a very complex issue 
that potentially affects many different stakeholder interests. Having 
carefully considered the comments and other relevant information, the 
Agency has prepared draft text for revisions to the existing regulatory 
language in part 558. Because stakeholders' interests are varied, 
striking the proper regulatory balance between sufficient veterinary 
oversight for VFD drugs and increased efficiency of the VFD process is 
a challenging proposition. Given the number and the nature of the 
comments received, and given the considerable impact proposed revisions 
potentially could have on stakeholders, FDA believes it is appropriate, 
before publishing an additional proposed rule, to offer stakeholders an 
opportunity to review and comment on our draft text of proposed 
revisions to the codified language in part 558.
    For that reason, as provided for in Sec. Sec.  10.40(f)(4) and 
10.80(b)(2) (21 CFR 10.40(f)(4) and 21 CFR 10.80(b)(2)), FDA has 
decided to publish the draft text of proposed revisions to the codified 
language that the Agency has developed in response to public comments 
on this issue. FDA believes that, by making this document available 
under the provisions of Sec. Sec.  10.40(f)(4) and 10.80(b)(2) and 
allowing an additional public comment period prior to publishing an 
additional proposed rule under the provisions of 21 CFR 10.40(b), the 
Agency will be able to develop a more informed proposal. When FDA 
publishes the proposed rule, the Agency will provide a detailed 
discussion of proposed changes to existing regulations.
    The proposed revisions announced in this document were developed in 
conjunction with other initiatives designed to transition certain new 
animal drug products containing medically important antimicrobial drugs 
from an over-the-counter (OTC) status to a status that requires 
veterinary oversight. Specifically, the draft text of proposed 
revisions to part 558 reflect principles expressed in FDA's guidance 
document entitled ``The Judicious Use of Medically Important 
Antimicrobial Drugs in Food-Producing Animals'' (GFI 209). 
Further, this draft text of proposed revisions is also consistent with 
the specific recommendations described in FDA's draft guidance document 
entitled ``New Animal Drugs and New Animal Drug Combination Products 
Administered in or on

[[Page 22248]]

Medicated Feed or Drinking Water of Food-Producing Animals: 
Recommendations for Drug Sponsors for Voluntarily Aligning Product Use 
Conditions With GFI 209'' (draft GFI 213). The 
notices of availability for GFI 209 and draft GFI 213 
are both published elsewhere in this issue of the Federal Register.
    FDA acknowledges that in order to facilitate the transition of 
certain new animal drug products from an OTC status to a status that 
requires veterinary oversight, existing requirements related to the 
distribution and use of VFD drugs must be updated and streamlined. As 
reflected in the draft text of proposed revisions to part 558 in this 
document, some of the key changes being considered include (1) 
providing for alignment between the criteria for appropriate veterinary 
supervision or oversight and those established as part of veterinary 
licensing and practice requirements, (2) providing veterinarians 
greater flexibility to exercise their professional discretion to 
authorize producer access to appropriate VFD drugs, and (3) 
streamlining administrative procedures. To facilitate the transition 
from OTC to VFD status, FDA believes it is critically important that 
changes such as these be implemented to minimize impacts on 
veterinarians, the animal feed industry, and animal producers.
    FDA is requesting comments on the draft text of proposed revisions 
to part 558 as well as comments on any other aspect of the VFD 
regulations, including aspects of the regulations not specifically 
addressed in the draft text of the proposal. FDA recognizes that it is 
critically important that the Agency work with the veterinary and 
animal producer communities, the end users of the affected products, to 
ensure that their concerns are taken into consideration as these 
changes are implemented. With this in mind, FDA is very interested in 
receiving comments on the practical implications of these changes for 
animal producers, particularly those with smaller operations in remote 
locations. The Agency is also interested in receiving input on how 
impacts or disruption to animal producers could be minimized.
    FDA acknowledges that one issue of concern is the ability of 
producers, particularly those with smaller operations in remote 
locations, to have adequate access to veterinary services. Therefore, 
as steps are taken to phase in the changes discussed in this document, 
FDA recognizes the need to concurrently engage key stakeholders on this 
broader issue. Therefore, FDA intends to work collaboratively with U. 
S. Department of Agriculture (USDA) to engage the veterinary community 
and other stakeholders to explore strategic approaches (e.g., new 
models, pilot programs) to address this issue.
    FDA encourages the submission of comments on the draft text of this 
proposed regulation so that practical implementation concerns are 
adequately considered and addressed. However, FDA is also exploring 
other venues for seeking and obtaining input, particularly from animal 
producers, such as through listening sessions held in various parts of 
the country. FDA is working closely with the USDA to identify 
mechanisms for obtaining this critical input.
    The draft text of the proposed regulation is provided in this 
document and in the docket (refer to the docket number in brackets in 
the heading of this document). The Agency emphasizes that the draft 
text of the proposed revisions does not represent final Agency action 
or the Agency's final decision on this regulation.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments on this document. 
It is only necessary to send one set of comments. Identify comments 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

    Accordingly, 21 CFR part 558 is proposed to be amended as follows:

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

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

    2. In Sec.  558.3, republish the introductory text of paragraph 
(b), and revise paragraphs (b)(1) and (b)(7) to read as follows:


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

* * * * *
    (b) The following definitions apply to terms used in this part:
    (1) New animal drugs approved for use in animal feed are placed in 
two categories as follows:
    (i) Category I--These drugs require no withdrawal period at the 
lowest use level in each species for which they are approved.
    (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.
* * * * *
    (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 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, conditionally 
approved, or indexed by the Food and Drug Administration (FDA).
* * * * *
    3. Revise Sec.  558.6 to read as follows:


Sec.  558.6  Veterinary feed directive drugs.

    (a) General requirements related to veterinary feed directives 
(VFD):
    (1) A feed containing a VFD drug (a VFD feed) shall be fed to 
animals only by or upon a lawful VFD issued by a licensed veterinarian 
in the course of the veterinarian's professional practice.
    (2) VFDs may not be filled after the expiration date on the VFD.
    (3) Use and labeling of a VFD drug in feed is limited to the 
approved, conditionally approved, or indexed conditions of use. 
Extralabel use (i.e., actual or intended use other than as directed on 
the labeling) is not permitted.
    (4) All involved parties (the veterinarian, the distributor, and 
the client) must retain a copy of the VFD and any other required 
records for 1 year.
    (5) All involved parties must make the VFD and any other records 
specified in this section available for inspection and copying by FDA.
    (6) All labeling and advertising for VFD drugs and feeds containing 
VFD drugs must prominently and conspicuously display the following 
cautionary statement: ``Caution: Federal law restricts medicated feed 
containing this VFD drug to use by or on the order of a licensed 
veterinarian.''
    (b) Responsibilities of the veterinarian issuing the VFD:
    (1) The veterinarian may only issue a VFD for use in animals under 
his or her supervision or oversight in the course of his or her 
professional practice, and in compliance with all applicable

[[Page 22249]]

veterinary licensing and practice requirements.
    (2) The veterinarian must fully and accurately enter the following 
information on the VFD:
    (i) The veterinarian's name, address, and telephone number;
    (ii) The client's name, telephone number, and business or home 
address;
    (iii) The premises at which the animals specified in the VFD are 
located;
    (iv) The date of VFD issuance;
    (v) The expiration date of the VFD. This date cannot extend beyond 
the expiration date specified in the approval, conditional approval, or 
index listing, if such date is specified. In cases where the expiration 
date is not specified in the approval, conditional approval, or index 
listing, the expiration date of the VFD cannot exceed 6 months after 
the date of issuance;
    (vi) The name of the animal drug;
    (vii) The species and production class of animals to be fed the 
medicated feed;
    (viii) The approximate number of animals to be fed the medicated 
feed prior to the expiration date on the VFD;
    (ix) The indication for which the VFD is issued;
    (x) The level of drug in the feed and duration of use;
    (xi) The withdrawal time, special instructions, and cautionary 
statements necessary for use of the drug in conformance with the 
approval;
    (xii) The number of reorders (refills) authorized, if permitted by 
the drug approval, conditional approval, or index listing;
    (xiii) The statement: ``Extralabel use (i.e., use of this VFD feed 
in a manner other than as directed on the labeling) is not permitted''; 
and
    (xiv) The veterinarian's electronic or written signature.
    (3) The veterinarian may, at his or her discretion, enter the 
following information on the VFD to more specifically identify the 
animals authorized to be treated/fed the medicated feed:
    (i) A more specific description of the location of animals (e.g., 
by site, pen, barn, stall, tank, or other descriptor that the 
veterinarian deems appropriate);
    (ii) The approximate age range of the animals;
    (iii) The approximate weight range of the animals; and
    (iv) Any other information the veterinarian deems appropriate to 
identify the animals specified in the VFD.
    (4) The veterinarian must send the VFD to the feed distributor via 
hardcopy, fax, or electronically. If in hardcopy, the veterinarian may 
send the VFD to the distributor either directly or through the client.
    (5) The veterinarian must provide a copy of the VFD to the client.
    (6) The veterinarian may not transmit a VFD by phone.
    (c) Responsibilities of any person who distributes an animal feed 
containing a VFD drug:
    (1) The distributor may only fill a VFD if the VFD contains the 
information required in Sec.  558.6(b)(2).
    (2) The distributor may only distribute an animal feed containing a 
VFD drug that complies with the terms of the VFD.
    (3) A distributor of animal feed containing VFD drugs must notify 
FDA at the time it first distributes animal feed containing VFD drugs. 
The notification is required one time per distributor and must include 
the following information:
    (i) The distributor's complete name and business address;
    (ii) The distributor's signature or the signature of the 
distributor's authorized agent; and
    (iii) The date the notification was signed;
    (4) A distributor must submit the notification by letter or 
facsimile to the Food and Drug Administration, Center for Veterinary 
Medicine, Division of Animal Feeds (HFV-220), 7519 Standish Pl., 
Rockville, MD 20855, prior to beginning its first distribution.
    (5) A distributor must notify the Center for Veterinary Medicine 
within 30 days of any change in ownership, business name, or business 
address.
    (6) A distributor may only distribute a VFD feed to another person 
for further distribution if the distributor first obtains a written 
acknowledgment from the person to whom the feed is shipped stating that 
that person must not ship or move such feed to an animal production 
facility without a VFD, or ship such feed to another person for further 
distribution unless that person has provided the same written 
acknowledgment to the distributor's immediate supplier.

    Dated: April 5, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-8844 Filed 4-11-12; 11:15 am]
BILLING CODE 4160-01-P