3722 Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices

C. Legend

Unless disclosure is required by FOIA

as amended (5 U.S.C. 552), as

determined by the freedom of

information officials of DHHS or by a

court, data contained in the portions of

an application that have been

specifically identified by page number,

paragraph, etc., by the applicant as

containing restricted and/or proprietary

information shall not be used or

disclosed except for evaluation

purposes.

Dated: January 12, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–1539 Filed 1–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Allergenic Products Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Allergenic

Products Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on February 10, 2000, 8:30 a.m. to

3:30 p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: William Freas or

Pearline K. Muckelvene, Center for

Biologics Evaluation and Research

(HFM–71), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852, 301–827–0314, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12388. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will receive

an update on the organizational changes

of the Laboratory of

Immunobiochemistry, its regulatory

activities (including reference

replacements and lot release statistics)

and its research activities. The

committee will hear presentations and

discuss the following regulatory issues:

(1) Potency limits for standardized

allergen vaccines, (2) selection of

allergen extracts for standardization,

and (3) a proposed algorithm for the

standardization of new allergens.

Procedure: On February 10, 2000,

from 8:30 a.m. to 3:30 p.m., the meeting

is open to the public. Interested persons

may present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by January 26, 2000. Oral

presentations from the public will be

scheduled between approximately 11

a.m. and 12 m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before February 3, 2000, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: January 11, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–1543 Filed 1–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0132]

FDA Modernization Act of 1997;

Guidance on Medical Device Tracking;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the revised guidance

document entitled ‘‘Guidance on

Medical Device Tracking.’’ This

guidance document, which replaces the

previous guidance issued on February

12, 1999, provides guidelines to

manufacturers and distributors

concerning their responsibilities for

medical device tracking under the

Federal Food, Drug, and Cosmetic Act

(the act) as amended by the Food and

Drug Administration Modernization Act

of 1997 (FDAMA).

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the

guidance document entitled ‘‘Guidance

on Medical Device Tracking’’ 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 on ‘‘Guidance on

Medical Device Tracking’’ to the contact

person (address below). See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

guidance.

FOR FURTHER INFORMATION CONTACT:

Chester T. Reynolds, Center for Devices

and Radiological Health (HFZ–300),

Food and Drug Administration, 2094

Gaither Rd., Rockville, MD 20850, 301–

594–4618.

SUPPLEMENTARY INFORMATION:

I. Background

Section 211 of FDAMA (Public Law

105–115) amended the tracking

provisions of section 519(e) of the act

(21 U.S.C. 360i(e)) to authorize FDA, at

its discretion, to issue orders that

require a manufacturer to track a class

II or class III device if: (1) The failure

of the device would be reasonably likely

to have serious adverse health

consequences; (2) the device is intended

to be implanted in the body for more

than 1 year; or (3) the device is life

sustaining or life supporting and used

outside a device user facility. The

FDAMA tracking provisions became

effective on February 19, 1998.

The revised final guidance replaces

the February 1999 guidance and

clarifies the devices that must be

tracked. Agency experience indicates

that industry and other interested

parties are confused about the term

‘‘replacement heart valves’’ because

there is more than one type. The

category of replacement heart valves

that must be tracked is limited to

mechanical heart valves only and does

not include human allograft (tissue)

heart valves. The revised guidance

document includes this descriptive

limitation.

Agency experience also indicates that

industry and other interested parties are

confused about which infusion pumps

are subject to medical device tracking

because the types of fluids the pumps

are intended to deliver may not be clear

from indications for use set out in

labeling. The previous guidance stated

that infusion pumps, except those

designated and labeled for use

Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices 3723

exclusively for fluids with low potential

risks, such as enteral feeding or antiinfectives, were subject to tracking. The

agency has reevaluated the types of

infusion pumps subject to tracking and

the best way to describe them in the

guidance document. The revised

guidance explains that tracking is

required only for electromechanical

infusion pumps that are used outside a

user facility. This was the agency’s

position in 1993 when tracking was

originally implemented (58 FR 43442 at

43449). The phrase ‘‘electromechanical

only’’ will be used to describe the

pumps rather than a reference to the

classification regulation. FDA believes

this will clarify the guidance because

the terms used in the classification

language for infusion pumps may

include types that do not require

tracking.

Finally, the agency added abdominal

aortic aneurysm stent grafts to the

devices that must be tracked. The

agency issued tracking orders for these

devices on September 28, 1999, which

were effective immediately. FDA

determined that these devices meet the

statutory tracking criteria under section

519(e) of the act because failure of the

device would be reasonably likely to

have serious adverse health effects. The

agency may add or remove devices from

the list of tracked devices as a result of

its review of premarket applications,

recall data, medical device reporting,

inspections, petitions, postmarket

surveillance, or other information.

II. Significance of Guidance

This guidance document represents

the agency’s current thinking on

medical device tracking requirements,

as amended by FDAMA. 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,

regulations, or both.

The agency has adopted Good

Guidance Practices (GGP’s), which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (62 FR 8961, February 27,

1997). This guidance document is

issued as a Level 2 guidance consistent

with GGP’s.

III. Electronic Access

In order to receive ‘‘Guidance on

Medical Device Tracking’’ via your fax

machine, call the CDRH Facts-OnDemand (FOD) system at 800–899–0381

or 301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at second

voice prompt press 2, and then enter the

document number (169) followed by the

pound sign (#). Then follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the 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 ‘‘Guidance

on Medical Device Tracking,’’ 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. ‘‘Guidance

on Medical Device Tracking’’ will be

available at http://www.fda.gov/cdrh/

ochome.html.

IV. Comments

Interested persons may, at any time,

submit to the contact person (address

above) written comments regarding this

guidance. Such comments will be

considered when determining whether

to amend the current guidance.

Dated: January 9, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–1542 Filed 1–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–5297]

Medical Devices; Guidance Document

for Premarket Notification

Submissions for the Nitric Oxide

Delivery Apparatus, Nitric Oxide

Analyzer, and Nitrogen Dioxide

Analyzer; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance document

entitled ‘‘Guidance Document for

Premarket Notification Submissions for

the Nitric Oxide Delivery Apparatus,

Nitric Oxide Analyzer, and Nitrogen

Dioxide Analyzer.’’ This guidance will

serve as a special control for nitric oxide

delivery apparatus; nitric oxide

analyzer; and nitrogen dioxide analyzer.

FDA’s Center for Devices and

Radiological Health (CDRH) believes

that this guidance is necessary to

provide reasonable assurance of the

safety and effectiveness of these devices.

The guidance document includes

material specific for the devices,

consensus standards for electrical

safety, electromagnetic compatibility,

software and hardware documentation,

and resistance to environmental effects.

DATES: Written comments concerning

this guidance document must be

received by April 24, 2000.

ADDRESSES: See the SUPPLEMENTARY

INFORMATION section for information on

electronic access to the guidance

document. Submit written requests for

single copies of the guidance document

entitled ‘‘Guidance Document for

Premarket Notification Submissions for

Nitric Oxide Delivery Apparatus, Nitric

Oxide Analyzer, and Nitrogen Dioxide

Analyzer’’ 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 self-addressed adhesive labels

to assist that office in processing your

request, or fax your request to 301–443–

8818. By April 24, 2000, written

comments concerning this guidance

document must be submitted to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Comments should be

identified with the docket number

found in brackets in the heading of this

document. After April 24, 2000,

comments must be submitted to the

contact person identified below.

FOR FURTHER INFORMATION CONTACT:

Michael G. Bazaral, Center for Devices

and Radiological Health (HFZ–450),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8609.

SUPPLEMENTARY INFORMATION:

I. Background

On January 11, 2000, FDA issued an

order to Datex-Ohmeda, Inc., under

section 513(f)(2) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360c(f)(2)) classifying the nitric

oxide administration apparatus, the

nitric oxide gas analyzer, and the nitric

dioxide analyzer into class II (special

controls). This guidance document is

intended to serve as the special control

for these devices.

FDA is making this guidance

document effective immediately