[Federal Register Volume 70, Number 219 (Tuesday, November 15, 2005)]
[Rules and Regulations]
[Pages 69276-69277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22563]


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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.

0
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

0
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