[Federal Register Volume 75, Number 59 (Monday, March 29, 2010)]
[Proposed Rules]
[Pages 15387-15388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6872]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 514, and 558
[Docket No. FDA-2010-N-0155]
Veterinary Feed Directive
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA or the agency) is
announcing an advance notice of proposed rulemaking (ANPRM) to solicit
comments from the public regarding potential changes to its current
regulation relating to veterinary feed directive (VFD) drugs. FDA's VFD
regulation, which became effective on January 8, 2001, established
requirements relating to the distribution and use of VFD drugs and
animal feeds containing such drugs. FDA is undertaking a review of
these requirements in an effort to identify possible changes to improve
efficiency. Therefore, the agency is requesting public comment on all
aspects of the VFD regulation, particularly suggestions relating to
improving efficiency. This information may be used to help draft a
proposed rule in the near future.
DATES: Submit electronic or written comments by June 28, 2010.
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, disk, 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 number 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: Neal Bataller, Center for Veterinary
Medicine (HFV-230), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-9201, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Before 1996, two options existed for regulating the distribution of
animal drugs, including drugs in animal feed: (1) Over-the-counter
(OTC) and (2) prescription. In 1996, Congress passed and the President
signed into law the Animal Drug Availability Act (ADAA) (Public Law
104-250), to facilitate the approval and marketing of new animal drugs
and medicated feeds. As part of the ADAA, Congress determined that
certain new animal drugs should be approved for use in animal feed but
only if these medicated feeds were administered under a veterinarian's
order and professional supervision. Therefore, the ADAA created a new
category of products called veterinary feed directive drugs (or VFD
drugs). VFD drugs are new animal drugs intended for use in or on animal
feed which are limited to use under the professional supervision of a
licensed veterinarian in the course of the veterinarian's professional
practice.
In the Federal Register of December 8, 2000 (65 FR 76924), FDA
issued a final rule amending the new animal drug regulations to
implement the VFD-related provisions of the ADAA. FDA reaffirmed that
certain new animal drugs should be approved for use in animal feed only
if these medicated feeds are administered under a veterinarian's order
and professional supervision. Veterinarian oversight is important for
assuring the safe and appropriate use of certain new animal drugs. For
example, safety concerns relating to the difficulty of disease
diagnosis, drug toxicity, drug residues, antimicrobial resistance, or
other reasons may dictate that the use of a medicated feed be limited
to use by order and under the supervision of a licensed veterinarian.
It has been 9 years since FDA began implementing the final rule
regulating VFDs. Although, currently there are few approved VFD animal
drug products, FDA has received a number of informal general comments
that characterize the current VFD process as being overly burdensome.
In addition, there are concerns that the process in its current form
will become particularly problematic to administer in the future as the
number of approved VFD animal drugs increases. When veterinary
oversight of a medicated feed is determined to be necessary, it is
critically important that such oversight be facilitated through an
efficient VFD process. In response to these concerns, the agency is
undertaking a review of the VFD regulations to determine whether
changes are warranted to improve the program's efficiency.
II. Agency Request for Comments
The purpose of this document is to solicit public comment on
whether such efficiency improvements are needed and, if so, on possible
revisions to the VFD regulations. Such comments are welcome on all
aspects of the VFD regulation. To facilitate FDA's review of
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submitted comments, please organize your comments based on the major
categories of requirements included in the current VFD regulation at 21
CFR 558.6. These categories of requirements are listed following this
paragraph. (See A through F.) If your comment addresses an issue
outside of one of these categories, please categorize your comment as
G. ``Other:''
A. Conditions that must be met by veterinarians issuing a VFD;
B. What veterinarians must do with a VFD (e.g., disposition of
original VFD and copies);
C. Records that must be kept related to the VFDs;
D. Notification requirements for distributors of animal feeds
containing a VFD drug;
E. Additional recordkeeping requirements that apply to
distributors;
F. Cautionary statements required for VFD drugs and animal feeds
containing VFD drugs; and
G. Other.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.
Dated: March 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6872 Filed 3-26-10; 8:45 am]
BILLING CODE 4160-01-S