[Federal Register Volume 67, Number 179 (Monday, September 16, 2002)]
[Notices]
[Pages 58433-58434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23507]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0028]


Medical Devices; Class II Special Controls Guidance Document; 
Cyclosporine and Tacrolimus Assays; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Class II Special Controls 
Guidance Document; Cyclosporine and Tacrolimus Assays; Guidance for 
Industry and FDA.'' These assays are used as an aid in the management 
of transplant patients receiving these drugs. Elsewhere in this issue 
of the Federal Register, FDA is issuing a final rule to reclassify 
cyclosporine and tacrolimus assays into class II (special controls).

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Class II Special Controls 
Guidance Document; Cyclosporine and Tacrolimus Assays; Guidance for 
Industry and FDA'' to the Division of Small Manufacturers, 
International, and Consumer Assistance (HFZ-220), Center for Devices 
and Radiological Health, Food and Drug Administration, 1350 Piccard 
Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to 
assist that office in processing your request, or fax your request to 
301-443-8818. Submit written comments concerning this guidance to the 
Dockets Management Branch (HFZ-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jean M. Cooper, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Road, 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 from class III (premarket approval) to class II (special 
controls) after reviewing information contained in reclassification 
petitions submitted by Dade Behring, Inc., and Microgenics, Inc. FDA 
also 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 draft guidance by 
April 22, 2002. FDA received two comments that were supportive of the 
proposed reclassification, but these comments suggested specific 
recommendations for changes to the guidance. The guidance has been 
revised to reflect consideration of these comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
agency's current thinking on special controls for cyclosporine and 
tacrolimus assays. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
applicable statute and regulations. Following the effective date of 
this final classification rule, any firm submitting a 510(k) premarket 
notification for a

[[Page 58434]]

cyclosporine or tacrolimus test system will need to address the issues 
covered in the special 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.

III. Electronic Access

    In order to receive ``Class II Special Controls Guidance Document; 
Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA'' via 
your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 
or 301-827-0111 from a touch-tone telephone. Press 1 to enter the 
system. At the second voice prompt press 1 to order a document. Enter 
the document number (1380) followed by the pound sign ([numsign]). 
Follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. The Center for Devices and Radiological Health 
(CDRH) maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with access to the Internet. Updated on a 
regular basis, the CDRH home page includes device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturers' assistance, information on video 
conferencing and electronic submission, Mammography Matters, and other 
device-oriented information. The CDRH home page may be accessed at 
http://www.fda.gov/cdrh. ``Class II Special Controls Guidance Document; 
Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA'' 
will be available at http://www.fda.gov/cdrh/ode/guidance/1380.pdf.

IV. Paperwork Reduction Act

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in part three of this guidance has been 
submitted to OMB for review and was approved under OMB control number 
0910-0231.

V. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the guidance. Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 19, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-23507 Filed 9-13-02; 8:45 am]
BILLING CODE 4160-01-S