[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]
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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: 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