[Federal Register Volume 65, Number 150 (Thursday, August 3, 2000)]
[Rules and Regulations]
[Pages 47668-47669]
From the Federal Register Online via the Government Publishing 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: [email protected].
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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