[Federal Register: September 16, 2002 (Volume 67, Number 179)]
[Notices]
[Page 58433-58434]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16se02-88]
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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