[Federal Register Volume 63, Number 116 (Wednesday, June 17, 1998)]
[Rules and Regulations]
[Pages 32978-32980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16063]


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

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.

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

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

[[Page 32979]]

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

[[Page 32980]]

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