[Federal Register Volume 72, Number 192 (Thursday, October 4, 2007)]
[Notices]
[Pages 56770-56771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19573]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. [2001D-0193 (formerly 01D-0193)]
Guidance for Industry and Food and Drug Administration Staff;
Biological Indicator Premarket Notification Submissions; 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 ``Biological Indicator (BI)
Premarket Notification (510(k)) Submissions.'' The agency is issuing
this guidance document to provide information that will help
manufacturers prepare premarket notification submissions for these
devices. The document provides guidance regarding performance
characteristics for biological indicator devices, which are intended to
monitor the effectiveness of sterilizers used in healthcare facilities.
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Biological Indicator (BI) Premarket Notification
(510(k)) Submissions'' 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
240-276-3151 or 1-800-638-2041. 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
[[Page 56771]]
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to either http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Sheila Murphey, Center for Devices
and Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3747.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance is for biological indicator devices intended for use
in health care facilities to monitor the effectiveness of sterilizers.
Biological sterilization process indicators are class II devices
identified in 21 CFR 880.2800(a). In the Federal Register of May 21,
2001 (66 FR 27985), FDA invited interested persons to comment on the
draft guidance entitled ``Premarket Notifications [510(k)] for
Biological Indicators Intended to Monitor Sterilizers Used in Health
Care Facilities; Draft Guidance for Industry and FDA Reviewers.''
FDA received five comments on the draft guidance. Many of the
comments are addressed by the voluntary consensus standards that have
been recognized by FDA since the draft was issued and that are now
cited in the guidance. We addressed comments that suggested the
statistics in the validation protocol were too restrictive by
clarifying that these statistics are examples, not thresholds. We also
revised the guidance for clarity and brevity in response to the
comments received.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on ``biological indicator premarket
notification submissions.'' 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
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Biological Indicator (BI) Premarket
Notification (510(k)) Submissions'' you may either send an e-mail
request to [email protected] to receive an electronic copy of the
document or send a fax request to 240-276-3151 to receive a hard copy.
Please use the document number 1320 to identify the guidance you are
requesting.
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://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 USC 3501-3520). The
collections of information in 21 CFR part 807, subpart E have been
approved under OMB Control Number 0910-0120. The labeling provisions
addressed in the guidance have been approved 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 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. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: September 26, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-19573 Filed 10-3-07; 8:45 am]
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