Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Notices 27985

expressions of interest in taking a lead

in a critical appraisal. Two copies of any

comments are to be submitted, 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 are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: May 11, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12625 Filed 5–18–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0193]

Medical Devices Premarket

Notifications [510(k)] for Biological

Indicators Intended to Monitor

Sterilizers Used in Health Care

Facilities; Draft Guidance for Industry

and FDA Reviewers; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance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Health Care Facilities; Draft Guidance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.’’ This

draft guidance document provides

specific recommendations on data and

information medical device

manufacturers should submit in

premarket notifications (510(k)s) for

biological indicators intended to

monitor sterilizers used in health care

facilities. This draft guidance is neither

final nor is it in effect at this time.

DATES: Submit written comments on the

draft guidance by August 20, 2001.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the

draft guidance document entitled

‘‘Premarket Notifications [510(k)] for

Biological Indicators Intended to

Monitor Sterilizers Used in Health Care

Facilities; Draft Guidance for Industry

and FDA Reviewers’’ to the Division of

Small Manufacturers Assistance (HFZ–

220), Center for Devices and

Radiological Health, Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818. Submit

written comments concerning this draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the draft guidance

document.

FOR FURTHER INFORMATION CONTACT:

Chiu S. Lin, Center for Devices and

Radiological Health (HFZ–480), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8913.

SUPPLEMENTARY INFORMATION:

I. Background

FDA regulates biological indicators

intended to monitor sterilizers used in

health care facilities as class II medical

devices, requiring premarket

notification (510(k)). The effective

performance of sterilizers used in health

care facilities is important to prevent

nosocomial infections. Biological

indicators provide users with

information on the effectiveness of the

sterilization process. This draft

guidance document recommends the

kind of data and information you should

submit in a 510(k) for these devices. The

use of comprehensive, scientifically

sound review criteria helps ensure the

safety and effectiveness of these devices.

FDA recognizes that providing FDA

reviewers, 510(k) applicants, and other

interested parties information on its

review process can promote a consistent

and efficient regulatory process.

II. Significance of Guidance

This draft guidance document

represents the agency’s current thinking

on premarket notifications (510(k)) for

biological indicators intended to

monitor sterilizers 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 applicable

statute and regulations.

The agency has adopted good

guidance practices (GGPs), which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (21 CFR 10.115; 65 FR

56468, September 19, 2000). This draft

guidance document is issued as a Level

1 guidance consistent with the GGP

regulations.

III. Electronic Access

In order to receive ‘‘Premarket

Notifications [510(k)] for Biological

Indicators Intended to Monitor

Sterilizers Used in Health Care

Facilities; Draft Guidance for Industry

and FDA Reviewers’’ via your fax

machine, call the CDRH Facts-OnDemand 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 (1320) followed by the pound

sign (#). Follow the remaining voice

prompts to complete your request.

Persons interested in obtaining a copy

of the draft guidance may also do so

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 access to the

Internet. Updated on a regular basis, the

CDRH home page includes the civil

money penalty guidance documents

package, device safety alerts, Federal

Register reprints, information on

premarket submissions (including lists

of approved applications and

manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, Mammography Matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. ‘‘Premarket

Notifications [510(k)] for Biological

Indicators Intended to Monitor

Sterilizers Used in Health Care

Facilities; Draft Guidance for Industry

and FDA Reviewers’’ is also available at

http://www.fda.gov/cdrh/ode/guidance/

1320.pdf. Guidance documents are also

available on the Dockets Management

Branch Web site at http://www.fda.gov/

ohrms/dockets/default.htm.

IV. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

draft guidance by August 20, 2001.

Submit two copies of any 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. The draft guidance

document and received comments may

be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: May 8, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–12624 Filed 5–18–01; 8:45 am]

BILLING CODE 4160–01–S