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

3724 Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices

because these devices are necessary for

the administration of a drug that

provides a significant public health

benefit. The drug, which was approved

by FDA on December 23, 1999, is used

for the treatment of neonates with

hypoxic respiratory failure associated

with clinical or echocardiographic

evidence of pulmonary hypertension.

The drug improves oxygenation and

reduces the need for extracorporeal

membrane oxygenation.

The guidance document is intended

to set forth the controls and testing that

FDA believes ensure the safety and

effectiveness of the nitric oxide

administration apparatus, nitric oxide

gas analyzer, and nitrogen dioxide gas

analyzer. It also intends to provide

comprehensive directions to enable a

manufacturer to submit a 510(k)

premarket notification demonstrating

substantial equivalence for any or all

three device types.

The guidance document identifies the

risks associated with these types of

devices and contains information that

will help manufacturers address those

risks. The guidance outlines the controls

that should be incorporated in the

devices for controlling risks, testing that

should be completed for each device,

and suggested methods for developing

preclinical criteria. Other elements of

the guidance document include: (1)

General device description; (2) specific

description of the information to

support applications for each device;

and (3) general considerations for each

device, such as software and hardware

testing.

II. Significance of Guidance

This guidance document represents

the agency’s current thinking on the

premarket notification submissions for

the nitric oxide delivery apparatus,

nitric oxide analyzer, and nitrogen

dioxide analyzer. 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 1 guidance consistent

with GGP’s.

III. Electronic Access

In order to receive the ‘‘Guidance

Document for Premarket Notification

Submissions for Nitric Oxide Delivery

Apparatus, Nitric Oxide Analyzer, and

Nitrogen Dioxide Analyzer’’ 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 (1157) followed by

the pound sign (#). Then follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the guidance document 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

‘‘Guidance Document for Premarket

Notification Submissions for Nitric

Oxide Delivery Apparatus, Nitric Oxide

Analyzer, and Nitrogen Dioxide

Analyzer,’’ 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. The

‘‘Guidance Document for Premarket

Notification Submissions for Nitric

Oxide Delivery Apparatus, Nitric Oxide

Analyzer, and Nitrogen Dioxide

Analyzer’’ will be available at http://

www.fda.gov/cdrh/ggpmain.html.

IV. Comments

Interested persons may, on or before

April 24, 2000, submit to the Dockets

Management Branch (address above)

written comments regarding this

immediately in effect guidance

document. 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 may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: January 13, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–1535 Filed 1–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–0298]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: New; Title of Information

Collection: Evaluation of New Medicare

Members of Medicare+Choice Plans;

Form No.: HCFA–R–0298 (OMB# 0938-

New); Use: The objective of this survey

is to understand the special information

needs of new Medicare members, their

sources of information, their preferred

distribution channels, their

understanding of the traditional

Medicare program and their

understanding of their particular

+Choice plan, and the impact National

Medicare Education Program activities

may have on new members’ decisions to

choose a +Choice plan or change their

plan; Frequency: On occasion; Affected

Public: Individuals; Number of

Respondents: 3000; Total Annual

Responses: 3000; Total Annual Hours:

1212.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.