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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the new

animal drug regulations to remove the existing 96-hour withdrawal time

limitation, eliminate the requirement to calculate and label on the

basis of the number of 12-hour milking periods that have elapsed since

treatment, and permit a milk-discard or withdrawal time to be

calculated by elapsed hours since treatment. The agency is taking these

actions to allow greater flexibility

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in the labeling of new animal drugs for use in milk-producing animals.

The increased flexibility will make it easier and more economical for

sponsors to comply with the regulations. These actions are part of

FDA's continuing effort to achieve the objectives set forth in the

President's ``National Performance Review'' initiative, which is

intended to provide a comprehensive review of all rules to identify

those that are obsolete and burdensome and to delete or revise them.

DATES: July 17, 1998.

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

In the Federal Register of April 4, 1996 (61 FR 15003), FDA

published a proposed rule to amend the new animal drug regulations to:

(1) Remove the existing regulatory limitation regarding a milk-discard

or withdrawal time of not more than 96 hours, (2) eliminate the

requirement to calculate and label on the basis of the number of 12-

hour milking periods that have elapsed since the last treatment, and

(3) permit a milk-discard or withdrawal time to be calculated on the

basis of hours that have elapsed from the most recent treatment.

The requirements for labeling of new animal drugs intended for use

in milk-producing animals at Secs. 510.105 and 510.106 (21 CFR 510.105

and 510.106) of the new animal drug regulations provide for specific

labeling for antibiotics, antibiotic-containing drugs, and other drugs

intended for use in milk-producing animals.

The maximum 96-hour limitation in Sec. 510.105 was based on FDA's

perception that 96 hours constituted a maximum 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. Accordingly, in the proposed rule, FDA proposed

to remove the 96-hour limitation to allow the possibility of longer

withdrawal times to be considered for milk-producing animals on a case-

by-case basis depending on the use and safety of the drug.

Similarly, the 12-hour milking schedule in Sec. 510.106 was

established to calculate the number of milkings that occur during the

withdrawal period. The 12-hour milking interval was considered to be

generally reflective of dairy practice when this regulation was

published; however, alternative milking schedules are in common use in

the dairy industry today. Accordingly, in the proposed rule, FDA

proposed to revise the regulation so that the length of the milking

cycle is not specified, eliminating the reference to the milking

interval as long as milk is discarded for the assigned number of hours

after the latest drug treatment.

No comments were received on the proposed rule.

Because the agency has determined that the underlying rationale in

support of the proposed amendment remains sound and because no comments

were received, the revisions set forth in the proposed rule are

reflected in the final rule. In addition, in the final rule, the agency

has deleted the phrase ``(in ________ milkings)'' in Sec. 510.105 to

make it consistent with Sec. 510.106 as amended. Also, in the final

rule, the agency has added the word ``violative'' before the word

``residues'' in the first sentence of Sec. 510.105(c)(2) and the second

sentence of Sec. 510.106 to clarify that labeling statements do not

refer to any residues at or below permitted tolerance levels that might

be present.

Accordingly, the final rule: (1) Removes the existing regulatory

limitation regarding a milk-discard or withdrawal time of not more than

96 hours, (2) eliminates the requirement to calculate and label on the

basis of the number of 12-hour milking periods that have elapsed since

the last treatment, (3) permits a milk-discard or withdrawal time to be

calculated on the basis of hours that have elapsed from the most recent

treatment, and makes minor corrections for purposes of consistency and

clarification.

These amendments will apply only to future approvals and will not

affect currently approved new animal drugs unless a sponsor submits a

supplement providing for revised labeling.

As stated in the proposal, these revisions are consistent with the

goals of the President's National Performance Review. The agency's

actions are part of its continuing effort to achieve the objectives set

forth in that initiative, which is intended to provide a comprehensive

review of all rules to identify those that are obsolete and burdensome

and to delete or revise them.

II. Environmental Impact

FDA has carefully considered the potential environmental effects of

this action and has determined under 21 CFR 25.30(k) that this action

is of a type that does not individually or cumulatively have a

significant effect on the human environment. This action revises the

labeling requirements for drugs, antibiotics, and antibiotic-containing

drugs intended for use in milk-producing animals, but will not cause an

increase in the existing level of use or cause a change in the intended

uses of the product or its substitutes. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

III. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive

Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612),

and under the Unfunded Mandates Reform Act (Pub. L. 104-4). 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, and distributive impacts and equity). The Regulatory

Flexibility Act requires agencies to examine the economic impact of a

rule on small entities. The Unfunded Mandates Reform Act requires

agencies to prepare an assessment of anticipated costs and benefits

before enacting any rule that may result in an expenditure in any one

year by State, local and tribal governments, in the aggregate, or by

the private sector, of $100,000,000 (adjusted annually for inflation).

This amendment to the new animal drug regulations will remove the

existing regulatory requirement that mandates a withdrawal time not

exceed 96 hours, and will permit withdrawal times to be calculated from

the most recent treatment rather than requiring a 12-hour milking

schedule. These actions will permit greater flexibility in the labeling

of new animal drugs for use in milk-producing animals. These amendments

will apply only to future approvals and will not affect currently

approved new animal drugs unless a sponsor submits a supplement

providing for revised labeling. The only compliance cost estimated for

this rule would be for those drugs that are currently being reviewed

for approval and are still unapproved on the date the final rule

becomes effective. To the extent that any of these drugs exist, their

sponsoring companies would incur a very small administrative expense of

preparing a supplement to the application to change the warning

language.

FDA concludes that this final rule is consistent with the

principles set forth in the Executive Order and in the two statutes. In

addition, the agency has

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determined that this rule is not a significant regulatory action as

defined by the Executive Order, 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 rule would clarify FDA policy, the

agency certifies that the 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.

Section 202 of the Unfunded Mandates Reform Act requires that

agencies prepare an assessment of anticipated costs and benefits before

proposing any expenditure by State, local, and tribal governments, in

the aggregate, or by the private sector of $100 million (adjusted

annually for inflation) in any one year. The final rule allowing

greater flexibility in the labeling of new animal drugs for use in

milk-producing animals is estimated to result in insignificant

expenditures of funds by the private sector, and none by State, local,

and tribal governments. Because the expenditures are estimated to be

insignificant, FDA is not required to perform a cost/benefit analysis

according to the Unfunded Mandates Reform Act.

IV. Paperwork Reduction Act of 1995

FDA has determined that this rule contains no collections of

information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-

3520). FDA concludes that the labeling requirements described in this

document are not subject to review by the Office of Management and

Budget (OMB) because they do not constitute a ``collection of

information'' but rather constitute warning statements that are a

``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)). For that portion of the labeling

statement required by Sec. 510.105(c)(2) that is not supplied to the

manufacturer (the number of hours necessary to avoid residue in milk

used for food), the necessary information is already required under a

separate regulation (Sec. 514.1(b)(7)(i)). This information has already

been cleared by OMB (OMB Control number 0910-0032).

V. Federalism

FDA has analyzed the final rule in accordance with the principles

set forth in Executive Order 12612 and has determined that this final

rule does not warrant the preparation of a Federalism Assessment.

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, 21 CFR part

510 is amended as follows:

PART 510--NEW ANIMAL DRUGS

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

follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

2. Section 510.105 is amended by revising paragraph (c)(2) to read

as follows:

Sec. 510.105 Labeling of drugs for use in milk-producing animals.

* * * * *

(c) * * *

(2) The label should bear the following 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 manufacturer has determined by

appropriate investigation is needed to insure that the milk will not

carry violative residues resulting from use of the preparation. If the

use of the preparation as recommended does not result in contamination

of the milk, neither of the above warning statements is required.

3. Section 510.106 is revised 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. The Commissioner

shall determine what such figures shall be from information submitted

by the manufacturer and which the Commissioner considers is adequate to

prove that period of time after the latest treatment that the milk from

treated animals will contain no violative residues from use of the

preparation. If the Commissioner determines from the information

submitted that the use of the antibiotic drug as recommended does not

result in its appearance in the milk, the Commissioner may exempt the

drug from bearing either of the above warning statements.

Dated: June 9, 1998.

William K. Hubbard

Associate Commissioner for Policy Coordination.

[FR Doc. 98-16063 Filed 6-16-98; 8:45 am]

BILLING CODE 4160-01-F