[Federal Register: October 31, 2003 (Volume 68, Number 211)]
[Notices]
[Page 62089-62090]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc03-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0221]
Guidance for Industry and FDA Staff; Class II Special Controls
Guidance Document: Endotoxin Assay; 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: Endotoxin Assay.'' This guidance document describes
a means by which an endotoxin assay 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 the
endotoxin assay into class II (special controls). This guidance
document is effective immediately as the special control for the
endotoxin assay, but it remains subject to comment in accordance with
the agency's good guidance practices (GGPs).
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 Control
Guidance Document: Endotoxin Assay'' 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. 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
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Comments should be identified
with the docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Freddie M. Poole, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-2096.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying the endotoxin assay 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 the endotoxin assay. 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 that FDA 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 will 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 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
(21 CFR 10.115). The guidance represents the agency's current thinking
on endotoxin 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
requirements of the applicable statutes and regulations.
III. Electronic Access
To receive ``Class II Special Controls Guidance Document: Endotoxin
Assay''
[[Page 62090]]
by 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 (1222) 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 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 home page 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 (44 USC 3501-3520) (the PRA). 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 No. 0910-0120). The labeling provisions addressed in the
guidance have been approved by OMB under the PRA under OMB control
number 0910-0485.
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 to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
or two paper copies of any written 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. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: October 17, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27393 Filed 10-30-03; 8:45 am]
BILLING CODE 4160-01-S