[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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