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.

Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices 3725

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB desk officer: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: December 28, 1999.

John Parmigiani,

Manager, HCFA Office of Information

Services, Security and Standards Group,

Division of HCFA Enterprise Standards.

[FR Doc. 00–1602 Filed 1–21–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration.

[Document Identifier: HCFA–R–0262]

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: Reinstatement, with change, of

a previously approved collection for

which approval expired; Title of

Information Collection: The Adjusted

Community Rate Proposal (ACRP) M+C

Plan Benefit Package and Supporting

Regulations in 42 CFR 417.401, 22.1–

422.10, 422.50–422.80, 422.100–

422.132, 422.300–422.312, 422.400–

422.404, and 422.560–422.622; Form

No.: HCFA–R–0262 (OMB# 0938–0763);

Use: The plan benefit package data will

be used to approve managed care

organization benefits, approve adjusted

community rate pricing packages, and

support both managed care organization

and HCFA beneficiary information

campaign and marketing efforts.

Respondents include any M+C

organization that intends to offer an

M+C plan in calendar years 2001–2003.

This collection will also allow the

HCFA to provide a totally automated

submission and review capability,

replace text with data format, establish

a standard set of benefit descriptions/

definitions, provide a framework to

describe benefits, reduce variation in

benefit descriptions, and eliminate the

need to validate Medicare Compare

data; Frequency: Annual; Affected

Public: Business or other for-profit, and

Not-for-profit institution; Number of

Respondents: 300; Total Annual

Responses: 300; Total Annual Hours:

900.

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.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB desk officer: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: January 7, 2000.

John Parmigiani,

Acting Reports Clearance Officer, HCFA

Office of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–1603 Filed 1–21–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301) 443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: Assessment of the

Impact of the National Practitioner

Data Bank—NEW

Under the Health Resources and

Services Administration (HRSA),

Bureau of Health Professions (BHPr), the

Division of Quality Assurance (DQA) is

planning to conduct a survey to obtain

information on the degree of user

satisfaction with the National

Practitioner Data Bank’s (NPDB)

querying and reporting processes, how

users believe these processes can be

improved, and how users perceive the

usefulness of information they obtained

from the NPDB for licensing and

credentialing of health care entities, e.g.

managed care organizations, State

licensing boards for physicians and

dentists, and professional societies. The

study will also identify and survey non

user entities. The information obtained

in this study will be interpreted in

relation to similar information from

previous studies conducted by the DQA

and the Office of the Inspector General.

The estimated response burden is as

follows:

Questionnaire version Number of

respondents

Responses per

respondent Total responses Hours perresponse

Total burden

hours

Users Survey

Reporting:

Hospital ........................................................................ 1031 1 1031 .25 257.8

Group Practice ............................................................. 210 1 210 .25 52.5

HMOs ........................................................................... 161 1 161 .25 40.3