Labeling of Drugs for Use in Milk-Producing Animals

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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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:

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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