[Federal Register: September 30, 2004 (Volume 69, Number 189)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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
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.
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-
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
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]
BILLING CODE 4160-01-S