[Federal Register: November 24, 2004 (Volume 69, Number 226)]
[Proposed Rules]
[Page 68280-68282]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no04-20]
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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: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
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 environmental impact statement (EIS)
is required. Regulations issued by the Council on Environmental Quality
require that all Federal Agencies assess the environmental impact of
their major actions and ensure that the interested and affected public
is informed of environmental analyses. FDA is taking this action in
accordance with the National Environmental Policy Act (NEPA).
DATES: Submit written or electronic comments on the proposed rule by
December 27, 2004. FDA proposes that any final regulation based on this
proposal become effective 30 days after its date of publication in the
Federal Register.
ADDRESSES: You may submit comments, identified by 2004N-0461, by any of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
E-mail: fdadockets@oc.fda.gov. Include [Docket No. 2004N-
0461] in the subject line of your e-mail message.
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and Docket No(s). or Regulatory Information
[[Page 68281]]
Number (RIN) for this rulemaking. All comments received will be posted
without change to http://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For detailed instructions
on submitting comments and additional information on the rulemaking
process, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number(s), found in brackets in the heading of
this document, into the ``Search'' box and follow the prompts and/or go
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Rosa M. Gilmore, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-827-2970.
SUPPLEMENTARY INFORMATION:
I. National Environmental Policy Act
NEPA requires all Federal Agencies to assess the environmental
impact of major actions and to ensure that the interested and affected
public is informed of environmental analyses. The Council 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. In the
Federal Register of March 15, 1973 (38 FR 7001), FDA issued its first
regulations to implement NEPA. FDA amended these regulations in the
Federal Register of April 15, 1977 (42 FR 19986), based on
consideration of revised guidelines for preparing EISs issued by CEQ.
In 1978, CEQ replaced its guidelines with regulations implementing the
procedural requirements of NEPA (40 CFR parts 1500 to 1508). To comply
with CEQ regulations, in the Federal Register of April 26, 1985 (50 FR
16636), FDA revised its NEPA policies and procedures (part 25 (21 CFR
part 25)).
The CEQ regulations, which are binding on all Federal executive
agencies, establish procedures for implementing NEPA. Agencies may
adopt procedures to supplement CEQ's regulations. In adopting NEPA-
implementing procedures, Federal Agencies are directed by CEQ to reduce
paperwork (40 CFR 1500.4(p) and 1500.2(b)) by using several means,
including the use of categorical exclusions. Under the CEQ regulations,
agencies are required to review their policies and procedures and, in
consultation with CEQ, revise them as necessary to ensure full
compliance with the purpose and provisions of NEPA (40 CFR 1507.3).
CEQ defines categorical exclusions 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 (40 CFR
1508.4). 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.
In the Federal Register of July 29, 1997 (62 FR 40570), FDA
published final regulations governing compliance with NEPA as
implemented by the CEQ regulations. The 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.
II. Special Controls
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990
(SMDA) (Public Law 101-629), the Food and Drug Administration
Modernization Act (FDAMA) (Public Law 105-115), and the Medical Device
User Fee and Modernization Act (Public Law 107-250) established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the act (21 U.S.C. 360c) established three
classes of devices that receive varying levels of regulation, depending
on the regulatory controls needed to provide reasonable assurance of
their safety and effectiveness. Class II devices are those for which
general controls by themselves are insufficient to provide reasonable
assurance of safety and effectiveness, but for which there is
sufficient information to establish special controls to provide such
assurance, including performance standards, post market surveillance,
patient registries, development and dissemination of guidelines,
recommendations, and other appropriate actions the agency deems
necessary (section 513(a)(1)(B) of the act).
Prior to SMDA, the statutory definition of class II contemplated
only the establishment of mandatory performance standards under section
514 of the act (21 U.S.C. 360d). The SMDA, however, broadened the
definition of a class II device to provide options in addition to the
establishment of a performance standard. Consistent with the pre-SMDA
definition of a class II device, FDA had categorically excluded
issuance, amendment, or repeal of a standard for a class II device
(Sec. 25.34(c)). Because the agency may now establish special controls
that include options in addition to mandatory performance standards,
FDA is proposing to amend its environmental impact regulation under
Sec. 25.34 to expand the existing categorical exclusions. FDA proposes
to include issue, amendment, or repeal of a rule related to the
establishment of any special control, if it will not result in an
increase in the existing levels of use or changes in the intended use
of a device or its substitutes.
Generally, FDA issues special controls in order to assure that
class II devices provide a reasonable assurance of safety and
effectiveness. The categorical exclusion does not apply if the action
will result in increases in the existing levels of use of the device or
changes in the intended use of the device or its substitutes. 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.
III. Humanitarian Device Exemption
The SMDA added section 520(m) to the act (21 U.S.C. 360j(m)) to
encourage the development of devices intended for use in the treatment
or diagnosis of diseases or conditions that affect or are manifested in
fewer than 4,000 individuals in the United States (humanitarian use
devices). Accordingly, section 520(m) of the act authorizes FDA to
exempt humanitarian use devices from the ``effectiveness requirements''
of sections 514 and 515 of the act (21 U.S.C. 360e) (i.e., ``reasonable
assurance that the device is effective''). FDA may grant such an
exemption provided that the following occurs: (1) The device is
designed to treat or diagnose a disease or condition that affects fewer
that 4,000 individuals in the United States; (2) the device would not
be available to a person with such disease or condition unless the
exemption is granted; (3) no comparable device (other than the device
that has been granted such an exemption) is available to treat or
diagnose the disease or condition; and (4) the device will not expose
patients to an unreasonable or significant risk of illness or injury,
and the probable benefit to health from
[[Page 68282]]
using the device outweighs the risk of injury or illness from its use,
taking into account the probable risk and benefits of currently
available devices or alternative forms of treatment.
There are two steps to obtaining approval of a humanitarian use
device. First, the applicant must submit a request for humanitarian use
device designation to FDA's Office of Orphan Products Development
(Sec. 814.100(c)(1) (21 CFR 814.100(c)(1))). Next, the applicant must
submit an HDE application (Sec. 814.100(c)(2)). Approval of an HDE
authorizes marketing of the device. Designation of a device as a
humanitarian use device is not a ``major federal action'' subject to
analysis under NEPA because it is a determination that a device is
eligible to apply for HDE approval and is not a final determination
that any particular device may be marketed. A determination that a
device is eligible to apply for HDE approval cannot by itself affect
the environment. (See Alliance for Bio-Integrity v. Shalala, 116 F.
Supp. 2d 166, 174 (D.D.C. 2000)).
FDA is proposing to amend 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. Additionally, FDA approves few HDEs (34 over
the 7 years the program has been in effect), further limiting any
potential environmental impact. Finally, FDA's experience in reviewing
HDEs has shown that no HDE reviewed thus far has had a significant
environmental impact.
IV. Environmental Impact
The agency has determined under 21 CFR 25.30(h) that this proposed
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 EIS is required.
V. Analysis of Impacts
FDA has examined the impacts of this proposed 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 proposed rule is not a significant regulatory action as defined by
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 proposed rule provides for an exclusion
from the requirement to prepare an EA or EIS and, as such, relieves a
burden, the agency certifies that the proposed rule will not have
significant 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 proposing ``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 $110 million. FDA does not expect this proposed rule
to result in any 1-year expenditure that would meet or exceed this
amount.
VI. Paperwork Reduction Act of 1995
This proposed rule does not contain information collection
provisions that are subject to review by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
List of Subjects
21 CFR Part 25
Environmental impact statements, Foreign relations, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of the Food and Drug
Administration, it is proposed that 21 CFR part 25 be amended as
follows:
PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS
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.
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 a humanitarian device exemption under subchapter H
of part 814 of this chapter.
Dated: November 8, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-25974 Filed 11-23-04; 8:45 am]
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