[Federal Register Volume 61, Number 66 (Thursday, April 4, 1996)]
[Proposed Rules]
[Pages 15003-15005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8247]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

[Docket No. 96N-0007]


Labeling of Drugs for Use in Milk-Producing Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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[[Page 15004]]


SUMMARY: The Food and Drug Administration (FDA) is proposing to revise 
two animal drug regulations to allow greater flexibility in the 
labeling of drugs for use in milk-producing animals. The 96-hour 
withdrawal time limitation would be removed from the regulations. The 
animal drug regulations would be further modified so that the 
withdrawal time is based only on hours after last treatment, not on a 
12-hour milking schedule. This proposal is aligned with the goals 
stated by the National Performance Review.

DATES: Written comments by June 18, 1996.

ADDRESSES: Written comments to the Dockets Managements Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. Comments should be identified with the docket 
number found in brackets in the heading of this document. Received 
comments may be seen at 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:

I. Background

    Under Sec. 510.105(c)(2) (21 CFR 510.105(c)(2)), information is 
provided regarding the labeling of drugs used in milk-producing 
animals. Specifically, the regulation states that: ``The label should 
bear the warning, `Milk that has been taken from animals during 
treatment and within -- hours (---- milkings) after the latest 
treatment must not be used for food,' the blanks to be filled in with 
the number of hours (not to exceed 96) * * *. '' Under Sec. 510.106, 
information is provided regarding the labeling of antibiotic and 
antibiotic-containing drugs intended for use in milk-producing animals. 
The regulation states that:
     * * * the label of such drugs shall bear * * * the statement 
``Warning: Milk that has been taken from animals during treatment 
and for -- hours (---- milkings) after the latest treatment must not 
be used for food'', the first blank being filled in with the figure, 
which shall not be greater than 96, that the Commissioner has 
authorized the manufacturer of the drug to use, and the second 
figure shall be the first number divided by 12.

II. Proposed Actions

    The maximum 96-hour limitation was based on FDA's perception of a 
practical withdrawal time for the dairy industry. However, FDA now 
recognizes that a withdrawal time longer than 96 hours may be desirable 
and practical in certain circumstances. FDA is proposing to remove the 
96-hour limitation to allow the possibility of longer withdrawal times 
to be considered for milk-producing animals. Withdrawal periods longer 
than 96 hours may be considered on a case-by-case basis depending on 
the use and safety of the drug.
    In addition, a 12-hour milking schedule is used in Sec. 510.106 to 
calculate the number of milkings that occur during the withdrawal 
period. While a 12-hour milking interval was reflective of dairy 
practice when this regulation was written, an 8-hour milking schedule 
also is in common use in the dairy industry today. FDA is proposing to 
revise the regulation so that the length of the milking cycle is not 
specified. This revision would allow any reasonable milking interval to 
be used as long as milk is discarded for the assigned number of hours 
after the latest drug treatment.
    This proposal is aligned with the goals stated by the National 
Performance Review. This proposed rule is a result of the President's 
directive to conduct a comprehensive review of all rules to identify 
those that are obsolete and burdensome and to delete or revise them. 
The agency has determined that this rule is in need of revision as 
described herein.

III. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(11) 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.

IV. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
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). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
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. Because the proposed rule clarifies FDA policy and 
simplifies the process for submitting certain applications, the agency 
certifies that the proposed 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.

 V. Paperwork Reduction Act of 1995

     FDA tentatively concludes that the labeling requirements proposed 
in this document are not subject to review by the Office of Management 
and Budget because they do not constitute a ``collection of 
information'' under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.). Rather, the proposed warning statements are ``public 
disclosure of information originally supplied by the Federal Government 
to the recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)).

VI. Federalism

    FDA has analyzed this proposal in accordance with the principles 
and criteria set forth in Executive Order 12612 and has determined that 
this proposal does not warrant the preparation of a Federalism 
Assessment.

VII. Request for Comments

    Interested persons may, on or before June 18, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

List of Subjects in 21 CFR Part 510

     Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 510 be amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:


[[Page 15005]]

    Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).

    2. Section 510.105 Labeling of drugs for use in milk-producing 
animals is amended in the first sentence of paragraph (c)(2) by 
removing the phrase, ``(not to exceed 96)''.
    3. Section 510.106 is amended by revising the first sentence to 
read as follows:


Sec. 510.106  Labeling of antibiotic and antibiotic-containing drugs 
intended for use in milk-producing animals.

    Whenever the labeling of an antibiotic drug included in the 
regulations in this chapter suggests or recommends its use in milk-
producing animals, the label of such drugs shall bear either the 
statement ``Warning: Not for use in animals producing milk, since this 
use will result in contamination of the milk'' or the statement 
``Warning: Milk that has been taken from animals during treatment and 
for -- hours after the latest treatment must not be used for food'', 
the blank being filled in with the figure that the Commissioner has 
authorized the manufacturer of the drug to use. * * *

    Dated: March 28, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-8247 Filed 4-3-96; 8:45 am]
BILLING CODE 4160-01-F