[Federal Register: November 15, 2005 (Volume 70, Number 219)]
[Rules and Regulations]
[Page 69276-69277]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no05-5]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 25
[Docket No. 2004N-0461]
Environmental Assessment; Categorical Exclusions
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulation on environmental impact considerations to expand existing
categorical exclusions to include approvals of humanitarian device
exemptions (HDEs) and establishment of special controls as categories
of actions that do not individually or cumulatively have a significant
effect on the human environment and for which neither an environmental
assessment (EA) nor an environmental impact statement (EIS) is
required. FDA is taking this action in accordance with the National
Environmental Policy Act (NEPA).
DATES: This rule is effective December 15, 2005.
FOR FURTHER INFORMATION CONTACT: Rosa M. Gilmore, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 240-276-2346.
SUPPLEMENTARY INFORMATION:
I. Introduction
In the Federal Register of November 24, 2004 (69 FR 68280), FDA
published a proposed rule (the November 2004 proposed rule) to amend
its regulation on environmental impact considerations to expand
existing categorical exclusions to include approvals of HDEs and
establishment of special controls as categories of actions that do not
individually or cumulatively have a significant effect on the human
environment and for which neither an EA nor an EIS is required.
Interested persons were given until December 27, 2004, to comment on
the proposal. FDA received two comments on the proposed rule.
II. Summary of Comments and FDA's Response
(Comment 1) One comment opposed FDA's proposal to expand existing
categorical exclusions to include approvals of HDEs and establishment
of special controls on the basis that a more rigorous standard should
be applied before approval of ``dangerous devices.''
(Response) This comment seemed to misunderstand the proposed rule.
FDA is not excluding any products from the statutorily required safety
review under the Federal Food, Drug, and Cosmetic Act. The rule
excludes certain categories of actions from the need to prepare an EA
or EIS under the NEPA.
(Comment 2) This comment did not express an opinion on the proposed
rule.
III. Background and Regulatory Authorities
NEPA requires all Federal agencies to assess the environmental
impacts of its actions and to ensure that the interested and affected
public is informed of environmental analyses. The Counsel on
Environmental Quality (CEQ) is responsible for overseeing Federal
efforts to comply with NEPA. Both CEQ and FDA have issued regulations
governing agency obligations and responsibilities under NEPA. CEQ's
regulations implementing the procedural requirements of NEPA can be
found at 40 CFR parts 1500 through 1508 and FDA's NEPA policies and
procedures can be found at 21 CFR part 25.
CEQ's and FDA's regulations, 40 CFR 1508.4 and 21 CFR 25.5(a)(1),
respectively, define ``categorical exclusion'' to mean a category of
actions which have been found by procedures adopted by the Federal
agency not to individually or cumulatively have a significant effect on
the human environment and for which, therefore, neither an EA nor an
EIS is required. When categorically excluding an action, an agency must
determine that there are no extraordinary circumstances related to the
action that may result in the action having significant environmental
effects.
FDA published final regulations governing compliance with NEPA as
implemented by the CEQ regulations in the Federal Register of July 29,
1997 (62 FR 40570). The July 29, 1997, final rule listed certain device
actions as categories of actions that do not individually or
cumulatively have a significant effect on the human environment and for
which neither an EA nor an EIS is required.
IV. Summary of the Final Rule
FDA received two comments on the proposed rule, however, neither
comment related to the statutory and regulatory authority of that
proposal. Therefore, the discussion of the statutory and regulatory
authority set out in the preamble of the proposed rule (69 FR 68280 at
68281 through 68282) remains relevant to this final rule and will not
be repeated here.
A. Special Controls
FDA is amending its environmental impact regulations under Sec.
25.34 to include as a category of action that does not individually or
cumulatively have a significant effect on the human environment and for
which neither an EA nor EIS is required, classification or
reclassification of a device, including the establishment of special
controls, if the action will not result in increases in the existing
levels of use of the device or changes in the intended use of the
device or its substitutes. FDA issues special controls in order to
assure that class II devices provide a reasonable assurance of safety
and effectiveness.
[[Page 69277]]
Under these conditions, FDA believes that it is appropriate to
categorically exclude the establishment of a special control from the
requirement to prepare an EA or EIS.
B. HDE
FDA is amending Sec. 25.34 to include approval of an HDE as a
category of action that does not individually or cumulatively have a
significant effect on the human environment and for which neither an EA
nor EIS is required. Because humanitarian use devices are limited by
definition to use for treating or diagnosing diseases or conditions
affecting fewer than 4,000 individuals in the United States per year,
any environmental impact associated with use of a humanitarian use
device is very limited. FDA approves few HDEs, further limiting any
potential environmental impact. FDA's experience in reviewing HDEs has
shown that no HDE reviewed thus far has had a significant environmental
impact.
V. Environmental Impact
The agency has determined that under 21 CFR 24.30(h) 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.
VI. 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), 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 not a significant regulatory action 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 this final rule provides for an exclusion
from the requirement to prepare an EA or EIS and, as such, relieves a
burden, the agency certifies that this final rule will not have a
significant economic impact on substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before finalizing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $115 million, using the most current (2003) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
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 Executive order and, consequently, a
federalism summary impact statement is not required.
VIII. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
List of Subjects in 21 CFR Part 25
Environmental impact statements, Foreign relations, Reporting and
recordkeeping requirements.
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Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of the Food and Drug
Administration, 21 CFR part 25 is amended as follows:
PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS
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1. The authority citation for 21 CFR part 25 continues to read as
follows:
Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C.
4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR,
1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR,
1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980
Comp., p. 356-360.
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2. Section 25.34 is amended by revising paragraph (b) and adding
paragraph (i) to read as follows:
Sec. 25.34 Devices and electronic products.
* * * * *
(b) Classification or reclassification of a device under part 860
of this chapter, including the establishment of special controls, if
the action will not result in increases in the existing levels of use
of the device or changes in the intended use of the device or its
substitutes.
* * * * *
(i) Approval of humanitarian device exemption under subpart H of
part 814 of this chapter.
Dated: October 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-22563 Filed 11-14-05; 8:45 am]
BILLING CODE 4160-01-S