[Federal Register Volume 67, Number 179 (Monday, September 16, 2002)]
[Rules and Regulations]
[Pages 58328-58329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23508]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket Nos. 01P-0119 and 01P-0235]


Clinical Chemistry and Clinical Toxicology Devices; 
Reclassification of Cyclosporine and Tacrolimus Assays

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is reclassifying 
cyclosporine and tacrolimus assays from class III (premarket approval) 
to class II (special controls). These assays are used as an aid in the 
management of transplant patients receiving these drugs. FDA is also 
identifying the guidance document entitled ``Class II Special Controls 
Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for 
Industry and FDA'' as the special control the agency believes will 
reasonably ensure the safety and effectiveness of these devices. This 
reclassification is being taken after a review of petitions submitted 
by Dade Behring, Inc., and Microgenics, Inc. The agency is taking this 
action under the Federal Food, Drug, and Cosmetic Act (the act), as 
amended by the Medical Device Amendments of 1976 (the 1976 amendments), 
the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug 
Administration Modernization Act of 1997 (FDAMA). Elsewhere in this 
issue of the Federal Register, FDA is announcing the availability of a 
class II special controls guidance entitled ``Class II Special Controls 
Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for 
Industry and FDA.''

DATES:  This rule is effective October 16, 2002.

FOR FURTHER INFORMATION CONTACT:  Jean M. Cooper, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD, 20850, 301-594-1243.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 21, 2002 (67 FR 7982), FDA 
published a proposed rule to reclassify cyclosporine and tacrolimus 
assays after reviewing information contained in reclassification 
petitions submitted by Dade Behring, Inc., and Microgenics, Inc. FDA 
identified the guidance document entitled ``Class II Special Controls 
Guidance Document: Cyclosporine and Tacrolimus Assays; Draft Guidance 
for Industry and FDA'' as the special control capable of providing 
reasonable assurance of safety and effectiveness for these devices. 
These assays are used as an aid in the management of transplant 
patients receiving these drugs. Interested persons were invited to 
comment on the proposed rule by April 22, 2002. FDA received two 
comments that were supportive of its proposed reclassification, but the 
comments suggested specific recommendations for changes to the 
guidance.

II. FDA's Conclusions

    Based on a review of the available information referenced in the 
preamble to the proposed rule and placed on file in FDA's Dockets 
Management Branch, FDA concludes that the special controls, in 
conjunction with general controls, provide reasonable assurance of the 
safety and effectiveness of these devices. Elsewhere in this issue of 
the Federal Register, FDA is announcing the availability of the 
guidance document. The guidance document was revised to reflect 
consideration of the comments received. Following the effective date of 
this final classification rule, any firm submitting a 510(k) premarket 
notification for a cyclosporine or tacrolimus test system will need to 
address the issues covered in the special

[[Page 58329]]

control guidance. However, the firm need only show that its device 
meets the recommendations of the guidance or in some other way provides 
equivalent assurances of safety and effectiveness.
    FDA is now codifying the classification and the special control 
guidance document for cyclosporine and tacrolimus test systems by 
adding new Sec. Sec.  862.1235 and 862.1678. For the convenience of the 
reader, FDA is also adding a new Sec.  862.1(d) to inform the reader 
where to find guidance documents referenced in part 862.

III. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) 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.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Public Law 96-354) (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 options that would minimize any significant impact of a rule 
on small entities. Reclassification of cyclosporine and tacrolimus 
assays from class III to class II will relieve manufacturers of the 
cost of complying with the premarket approval requirements in section 
515 of the act. Furthermore, the special controls guidance document 
does not impose any new burdens on manufacturers; it advises 
manufacturers about ways to comply with the special controls that allow 
the agency to down classify these devices. By eliminating the need for 
premarket approval applications, reclassification will reduce 
regulatory costs with respect to these devices, impose no significant 
economic impact on any small entities, and may permit small potential 
competitors to enter the marketplace by lowering their costs. The 
agency therefore certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities. 
In addition, this final rule will not impose costs of $100 million or 
more on either the private sector or State, local, and tribal 
governments in the aggregate, and therefore a summary statement of 
analysis under section 202(a) of the Unfunded Mandates Reform Act of 
1995 is not required.

V. 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.

VI. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no new collections 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 862

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

    1. The authority citation for 21 CFR part 862 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 862.1 is amended by adding new paragraph (d) to read as 
follows:


Sec.  862.1  Scope.

* * * * *
    (d) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/cdrh/guidance.html.

    3. Section 862.1235 is added to subpart B to read as follows:


Sec.  862.1235   Cyclosporine test system.

    (a) Identification. A cyclosporine test system is a device intended 
to quantitatively determine cyclosporine concentrations as an aid in 
the management of transplant patients receiving therapy with this drug. 
This generic type of device includes immunoassays and chromatographic 
assays for cyclosporine.
    (b) Classification. Class II (special controls). The special 
control is ``Class II Special Controls Guidance Document: Cyclosporine 
and Tacrolimus Assays; Guidance for Industry and FDA.'' See Sec.  
862.1(d) for the availability of this guidance document.

    4. Section 862.1678 is added to subpart B to read as follows:


Sec.  862.1678   Tacrolimus test system.

    (a) Identification. A tacrolimus test system is a device intended 
to quantitatively determine tacrolimus concentrations as an aid in the 
management of transplant patients receiving therapy with this drug. 
This generic type of device includes immunoassays and chromatographic 
assays for tacrolimus.
    (b) Classification. Class II (special controls). The special 
control is ``Class II Special Controls Guidance Document: Cyclosporine 
and Tacrolimus Assays; Guidance for Industry and FDA.'' See Sec.  
862.1(d) for the availability of this guidance document.

    Dated: August 19, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-23508 Filed 9-13-02; 8:45 am]
BILLING CODE 4160-01-S