[Federal Register Volume 67, Number 35 (Thursday, February 21, 2002)]
[Notices]
[Pages 8031-8032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4209]


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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Cyclosporine and Tacrolimus Assays; Draft Guidance for Industry and 
FDA; 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availability of the draft guidance entitled ``Class II Special Controls 
Guidance Document: Cyclosporine and Tacrolimus Assays; Draft Guidance 
for Industry and FDA.'' Elsewhere in this issue of the Federal 
Register, FDA is issuing a proposed rule to reclassify cyclosporine and 
tacrolimus assays from class III to class II when used as an aid in the 
management of transplant patients. If these devices are reclassified, 
this draft guidance will serve as the special control for the 
reclassified devices. This draft guidance is neither final nor in 
effect at this time.

DATES: Submit written or electronic comments concerning this guidance 
by April 22, 2002.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance entitled ``Class II Special Controls Guidance 
Document: Cyclosporine and Tacrolimus Assays; Draft Guidance for 
Industry and FDA'' to the Division of Small Manufacturers, 
International, and Consumer Assistance (HFZ-220), Center for Devices 
and Radiological Health (CDRH), 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. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the draft guidance. Submit written 
comments concerning this draft guidance to the Dockets Management 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. Comments are to be identified with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jean M. Cooper, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1243.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance was developed as a special controls guidance to 
support the proposed reclassification of cyclosporine and tacrolimus 
assays from class III to class II. When final, this guidance will 
replace the document ``Guidance Criteria for Cyclosporine PMAs'' dated 
January 24, 1992. That document was intended to cover the basic 
science, clinical experience, and issues identified through the review 
of premarket approval applications (PMAs) for cyclosporine. The agency 
has updated that guidance. The revised guidance has been retitled 
``Class II Special Controls Guidance Document: Cyclosporine and 
Tacrolimus Assays; Draft Guidance for Industry and FDA.'' On its own 
initiative, the agency has included tacrolimus assays in addition to 
cyclosporine assays in the revised guidance because the tacrolimus 
assay has the same intended use as an aid in the management of 
transplant patients. The agency believes it is taking a least 
burdensome approach by including tacrolimus assays in the revised 
guidance and will include tacrolimus assays in the proposed 
reclassification.

II. Significance of the Guidance

    The draft guidance, when finalized, will represent the agency's 
current thinking on 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.
    The agency has adopted good guidance practices (GGPs), and 
published the final rule, which set forth the agency's regulations for 
the development, issuance, and use of guidance documents (21 CFR 
10.115). This draft guidance document is issued as a level 1 guidance 
in accordance with the GGP regulations.

III. Electronic Access

    In order to receive ``Class II Special Controls Guidance Document: 
Cyclosporine and Tacrolimus Assays; Draft 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 
(#). Follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the Internet. 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 the civil money 
penalty guidance documents package, 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 submissions, 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; Draft Guidance for Industry and FDA'' will be 
available at http://www.fda.gov/cdrh/ode/guidance/1380.pdf.

[[Page 8032]]

IV. Comments

    Interested persons may submit to Dockets Management Branch (address 
above) written or electronic comments regarding this draft guidance by 
April 22, 2002. Submit two copies of any comments, 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 
draft guidance and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 11, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-4209 Filed 2-20-02; 8:45 am]
BILLING CODE 4160-01-S