# Labeling of Drugs for Use in Milk-Producing Animals

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URL: https://www.frixlaw.com/law-library/documents/fr%3A96-8247

## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** April 4, 1996
- **Citation:** 61 FR 15003

## Text

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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A96-8247. Public record. Not legal advice.