[Federal Register: December 19, 2003 (Volume 68, Number 244)]
[Notices]
[Page 70816-70817]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de03-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D-0525]
Guidance for Industry and FDA Staff; Premarket Notification
Submissions for Chemical Indicators; 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 ``Premarket Notification [510(k)]
Submissions for Chemical Indicators.'' The document provides guidance
for industry and other interested parties regarding the submission of
chemical indicators such as process indicators, chemical integrators,
and air removal indicators used in test packs.
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 ``Premarket Notification
[510(k)] Submissions for Chemical Indicators'' 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. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Chiu Lin, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8913, ext. 143.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance is for chemical indicators intended for use in health
care facilities. Chemical indicators are Class II devices identified in
21 CFR 880.2800. The chemical indicators discussed in the guidance
document include process indicators, chemical integrators, and air
removal indicators used in test packs such as the Bowie Dick Test Pack.
In the Federal Register of January 27, 2003 (68 FR 3887), FDA
invited interested persons to comment by April 28, 2003, on the draft
guidance entitled ``Chemical Indicators Premarket Notification [510(k)]
Submissions; Draft Guidance for Industry and FDA.'' FDA received one
comment. FDA considered the comment and revised the guidance document
for clarity.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices (GGPs) regulation (21 CFR 10.115). The guidance represents
the agency's current thinking on chemical
[[Page 70817]]
indicators used in health care facilities. 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. 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 USC 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-
0485.
IV. Electronic Access
To receive a copy of ``Premarket Notification [510(k)] Submissions
for Chemical Indicators'' by fax machine, call the Center for Devices
and Radiological Health (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 (1420) 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 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 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.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding the guidance
at any time. 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 submit two paper copies of any mailed
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. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: December 4, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-31384 Filed 12-18-03; 8:45 am]
BILLING CODE 4160-01-S