[Federal Register Volume 59, Number 51 (Wednesday, March 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6007]
[[Page Unknown]]
[Federal Register: March 16, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93D-0012]
Uniform Labeling of Drugs for Dairy and Beef Cattle; Guideline;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guideline entitled ``Guideline for Uniform Labeling
of Drugs for Dairy and Beef Cattle'' prepared by the Center for
Veterinary Medicine (CVM). This guideline was formulated to promote
uniform labeling of drug products for cattle by recommending use of
geometric symbols on labels to identify certain target animals and
certain categories of drug products. Using the recommendations within
the guideline should promote correct use of animal drugs and, thus,
reduce drug residues in milk and meat products. The guideline was made
available in a draft form (58 FR 8054) and this notice summarizes the
received comments.
DATES: Written comments may be submitted at any time. Received comments
will be considered to determine if further revision of the guideline is
necessary.
ADDRESSES: Submit written requests for single copies of the guideline
to the Communications and Education Branch (HFV-12), Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send two self-addressed adhesive labels to assist
that office in processing your requests. Submit written comments on the
guideline to the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
Requests and comments should be identified with dockets number found in
brackets in the heading of this document. A copy of the guideline and
received comments are available for public examination in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1642.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guideline entitled ``Guideline for Uniform Labeling of Drugs for Dairy
and Beef Cattle.'' The guideline is based on a draft guideline for
which a notice of availability was published in the Federal Register of
February 11, 1993 (58 FR 8054).
This guideline was developed as a part of the agency's ongoing
efforts to protect the public health from harmful residues in food
resulting from improper use of animal drugs. The agency continues to
strive to ensure that the directions for use and other information in
animal drug labeling is clear and followed in practice. The agency's
efforts in this regard resulted in changes to provisions regarding
proper labeling and storage of drugs on dairy farms in the Grade A
Pasteurized Milk Ordinance (PMO) which specifies standards,
requirements, and procedures that must be followed to ensure the safety
of milk. Implementation of the PMO changes revealed, however, that many
of the labels for animal drugs approved for use in cattle are confusing
to both veterinarians and lay persons. For example, drug users were
confused regarding whether products were for lactating dairy cattle or
other classes of cattle. Furthermore, these individuals had difficulty
distinguishing between prescription and over-the-counter drugs.
As a result of these findings, the agency developed the system of
symbolic representations set out in this guideline. The system is
designed to assist users of animal drugs by making the labeling
information more understandable. The system was tested and evaluated,
on a limited basis, in workshops, training sessions, and meetings with
dairy producers, veterinarians, State regulatory personnel and dairy
sanitarians. The labeling features provided in this guideline were
developed in conjunction with this testing. The agency is making the
symbolic system available in this guideline, for use on a voluntary
basis, to further evaluate the effectiveness of this type of system. In
this regard, the agency intends to distribute the symbolic system to
producers and veterinarians for their use and feedback. The agency will
subsequently evaluate use of the symbolic system set out in the
guideline to determine whether the system or some variation of the
system is useful as well as whether a symbolic system or some other
type of labeling changes should be incorporated into the agency's
regulations.
Two comments were received in response to the notice published in
the Federal Register, one from a drug manufacturer, the other from a
manufacturer's association. The drug manufacturer's main concern was
size and prominence of the proposed symbols, and the lack of an
exemption for use on small volume parenterals. The manufacturer also
mentioned the emphasis on cattle without considering any approved use
in other species; whether the colors are appropriate and legible;
whether inclusion of a narrative description of the symbol is needed;
and the excessive size of some symbols. The manufacturer's association
stated that the guideline did not clearly state the problem and thus
failed to provide a case for a change in the labeling scheme. The
association noted that the original coverage was expanded from dairy
cows to beef cattle, calves, and veal; that use of the human Rx symbol
would be misleading; that the new symbols can be confusing; and that
the current voluntary symbols are adequate.
CVM has considered these comments and concluded that use of the
guideline, though voluntary, would promote a more uniform and clearer
labeling, would more clearly indicate the drug category, should result
in more uniform use, and should aid in the reduction of illegal
residues in milk and meat.
The guideline recommends use of certain symbols to designate the
drug's OTC or Rx status, class of target animal, milk discard time, and
slaughter withholding times. The guideline represents a cooperative
effort with the animal drug industry to promote labeled use of certain
drugs and to reduce drug residues in meat and milk products.
The guideline summarizes the codified labeling requirements for
over-the-counter (OTC) and Rx animal drugs and prior CVM labeling
recommendations. It has been prepared for voluntary use by the animal
drug industry to promote the uniform labeling of animal drug products,
primarily for that used in cattle. The guideline recommends that labels
of drugs include easily interpreted geometric symbols to indicate the
category of drug product and animal for treatment. Use of the guideline
would promote proper animal drug use and thus reduce drug residues in
milk and meat products.
Labeling revised in conformance with this guideline must be the
subject of an approved supplemental new animal drug application prior
to its use.
Guidelines state practices or procedures that may be useful but are
not legal requirements. The guideline represents the agency's position
at the time of its issuance. A person may follow the guideline or may
choose to follow alternate practices or procedures. If a person chooses
to use an alternate practice or procedure, that person may wish to
discuss the matter further with the agency to prevent an expenditure of
money and effort on activities that may later be determined to be
unacceptable. The guideline does not bind the agency, and it does not
create or confer any rights, privileges, or benefits for or on any
person. When a guideline states a requirement imposed by statute or
regulation, however, the requirement is law and its force and effect
are not changed in any way by virtue of its inclusion in the guideline.
Interested persons may submit further comments at any time. Submit
written comments on the guideline to the Dockets Management Branch
(address above) or to the contact person (address above). FDA will
consider these comments in determining whether further amendments to,
or revisions of, the guideline are warranted. Comments should be
submitted in duplicate (except that individuals may submit one copy),
identified with the docket number found in brackets in the heading of
this document. The guideline and received comments may be seen in the
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: March 10, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-6007 Filed 3-15-94; 8:45 am]
BILLING CODE 4160-01-F
