[Federal Register: September 30, 2004 (Volume 69, Number 189)]
[Page 58449-58450]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004D-0412]

Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Sirolimus Test Systems; 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance document entitled ``Class II Special 
Controls Guidance Document: Sirolimus Test Systems.'' This guidance 
document describes a means by which sirolimus test systems may comply 
with the requirement of special controls for class II devices. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
final rule to classify sirolimus test systems into class II (special 
controls). This guidance document is immediately in effect as the 
special control for sirolimus test systems but it remains subject to 
comment in accordance with the agency's good guidance practices (GGPs).

DATES: Submit written or electronic comments on this guidance at any 

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Class II Special Controls 
Guidance Document: Sirolimus Test Systems'' 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 one self-addressed adhesive 
label 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 guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 

[[Page 58450]]

http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments with the docket number 

found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Avis Danishefsky, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1243, ext. 161.


I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying sirolimus test systems into class II (special 
controls) under section 513(f)(2) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This guidance document 
will serve as the special control for sirolimus test systems.
    Many aspects of this guidance document, especially those concerning 
performance characteristics and risks to health, were developed using 
information FDA obtained from the Therapeutic Drug Management and 
Toxicology Roundtable, a working group composed of representatives from 
laboratory medicine and device manufacturers.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act (21 U.S.C. 
360(k)) for a device that has not previously been classified may, 
within 30 days after receiving an order classifying the device in class 
III under section 513(f)(1) of the act, request FDA to classify the 
device under the criteria set forth in section 513(a)(1) of the act. 
FDA shall, within 60 days of receiving such a request, classify the 
device by written order. This classification shall be the initial 
classification of the device. Within 30 days after the issuance of an 
order classifying the device, FDA must publish a notice in the Federal 
Register announcing such classification. Because of the timeframes 
established by section 513(f)(2) of the act, FDA has determined, under 
Sec.  10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to 
allow for public participation before issuing this guidance as a final 
guidance document. Therefore, FDA is issuing this guidance document as 
a level 1 guidance document that is immediately in effect. FDA will 
consider any comments that are received in response to this notice to 
determine whether to amend the guidance document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's GGPs regulation 
(Sec.  10.115). The guidance represents the agency's current thinking 
on sirolimus test systems. 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 
requirements of the applicable statute and regulations.

III. Electronic Access

    To receive ``Class II Special Controls Guidance Document: Sirolimus 
Test Systems'' by fax, 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 (1300) followed by the pound sign (). 
Follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so by 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 Internet access. Updated on a 
regular basis, the CDRH home page includes device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of cleared submissions, approved applications, and 
manufacturers' addresses), small manufacturer's assistance, information 
on video conferencing and electronic submissions, Mammography Matters, 
and other device-oriented information. The CDRH Web site may be 
accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.
 Guidance documents are also available on the Division of 

Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    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 (the PRA) (44 U.S.C. 3501-3520). 
The collections of information addressed in the guidance document have 
been approved by OMB in accordance with the PRA under the regulations 
governing premarket notification submissions (21 CFR part 807, subpart 
E, OMB control number 0910-0120). The labeling provisions addressed in 
the guidance have been approved by OMB under OMB control number 0910-

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Comments received may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: September 21, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-22012 Filed 9-29-04; 8:45 am]