[Federal Register Volume 65, Number 150 (Thursday, August 3, 2000)]
[Rules and Regulations]
[Pages 47668-47669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-19627]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. 99N-2151]


New Animal Drug Applications; Sheep as a Minor Species

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to reclassify sheep as a minor species for all data 
collection purposes. This reclassification will allow sponsors of new 
animal drug applications (NADA's) to extrapolate human food safety data 
from a major species such as cattle to sheep. In particular, this will 
enable the extrapolation of the tolerances for residues of new animal 
drugs in cattle to sheep.

DATES:  This rule is effective September 5, 2000.

FOR FURTHER INFORMATION CONTACT: Meg Oeller, Center For Veterinary 
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-7581, e-mail: moeller@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 26, 1999 (64 FR 40321), FDA 
published a proposed rule to revise the definition of minor species in 
Sec. 514.1(d)(1)(ii) (21 CFR 514.1(d)(1)(ii)) by deleting the following 
language: ``Sheep are a minor species with respect to effectiveness and 
animal safety data collection requirements; sheep are a major species 
with respect to human safety data collection requirements arising from 
the possible presence of drug residues in food.'' This change makes 
sheep a minor species for all data collection purposes in support of 
NADA's.
    As stated in the preamble to the proposed rule (64 FR 40321), new 
data that have become available since publication of the minor species 
final rule (48 FR 1922, January 14, 1983) allow the agency to conclude 
that sheep should be a minor species with respect to all data 
requirements. The new data concern the similarity of drug metabolism 
between sheep and cattle rather than consumption levels. While 
consumption levels can be a factor in determining whether a species 
should be classified as major or minor, the agency believes that the 
body of evidence concerning drug metabolism is more significant in 
determining the major/minor status of sheep than consumption data 
because it demonstrates the reliability of data extrapolated from 
cattle, a major species, to sheep.

II. Comments

    FDA received seven comments on the proposed rule, six comments from 
organizations, and one from an individual. All the comments supported 
the proposed rule. The following is a summary of the comments:
    (Comment 1) Six comments expressed the opinion that this change 
would lower research and development costs for sponsors seeking 
approval of new animal drugs for sheep.
    (Comment 2) Six comments noted that the sheep industry suffers from 
a lack of animal drug availability to the detriment of the industry and 
animal health.
    (Comment 3) Four of the comments praised the agency for its 
science-based approach to this issue.
    Thus, FDA is adopting the rule as proposed.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 
1995 (Public Law 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; distributive impacts; 
and equity). The agency believes that this final rule is consistent 
with the regulatory philosophy and principles identified in the 
Executive Order. In addition, the final 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

[[Page 47669]]

options that would minimize any significant impact of a rule on small 
entities. FDA estimates that the final rule will not impose any 
compliance costs on the animal drug industry, but rather expects it to 
provide a small cost savings for any company submitting an NADA for an 
animal drug to be used in sheep. Because this final rule makes no 
mandates on other government entities and will result in expenditures 
less than $100 million in any one year, the agency certifies that the 
final 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.

IV. Discussion

    The benefit of this final rule will be to lessen the preapproval 
study requirements of NADA's for animal drugs to be used in sheep. It 
is therefore expected to lower research expenses and provide an impetus 
for sponsors to submit NADA's for minor use species rather than rely on 
extra-label use of animal drugs on sheep. More specifically, it would 
eliminate the need for a radio-labeled total residue study that can be 
costly and prohibitive for sponsors of new animal drugs for small 
markets such as sheep. FDA believes this study is unnecessary in this 
instance due to the similarities in the metabolism of most drugs in 
cattle and sheep. A more flexible approach that allows for this 
interspecies data extrapolation, along with the continued residue 
depletion studies, would encourage NADA submissions by decreasing 
research costs while continuing to protect human food safety. Apart 
from these cost savings, FDA does not expect this final rule to impose 
any other compliance burdens on sponsors of new animal drugs.
    FDA is amending the animal drug regulations to reclassify sheep as 
a minor species for all data collection purposes, thereby allowing 
extrapolation of data from closely related species such as cattle to 
sheep. Currently, FDA considers sheep as a minor species for the 
purpose of the data necessary to demonstrate animal safety and 
effectiveness only. It currently considers sheep as a major species for 
the purpose of human food safety requirements. Because new data have 
led FDA to believe there are not significant differences in the 
metabolism of most drugs between ruminant species, FDA is reclassifying 
sheep as a minor species for all data collection purposes. Thus, most 
data packages supporting an NADA for use in sheep will be able to rely 
on the required human food safety data collected for cattle.

V. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) 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. In the 
proposed rule, the agency mistakenly made this determination under 21 
CFR 25.33(d)(4), which applies to action on minor species NADA's.

VI. The Paperwork Reduction Act of 1995

    The NADA's regulation, Sec. 514.1, contains collections of 
information requirements previously approved under OMB Control No. 
0910-0032. FDA is amending the new animal drug regulation to reclassify 
sheep as a minor species for all data collection purposes. This 
reclassification does not change the reporting or recordkeeping burden, 
thus clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 is not required.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the order and, consequently, a federalism 
summary impact statement is not required.

List of Subjects in 21 CFR Part 514

    Administrative practice and procedure, Animal drugs, Confidential 
business information, 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 
514 is amended as follows:

PART 514--NEW ANIMAL DRUG APPLICATIONS

    1. The authority citation for 21 CFR part 514 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360b, 371, 379e, 381.


    2. Section 514.1 is amended by revising paragraph (d)(1)(ii) to 
read as follows:


Sec. 514.1  Applications.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Minor species means animals other than cattle, horses, swine, 
chickens, turkeys, dogs, and cats.
* * * * *

    Dated: July 28, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-19627 Filed 8-2-00; 8:45 am]
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