[Federal Register: December 19, 2003 (Volume 68, Number 244)]
[Page 70816-70817]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 

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.


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-

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]