[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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