[Federal Register Volume 69, Number 226 (Wednesday, November 24, 2004)]
[Proposed Rules]
[Pages 68280-68282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25974]


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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: [email protected]. 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]
BILLING CODE 4160-01-S