57356 Federal Register / Vol. 65, No. 185 / Friday, September 22, 2000 / Notices

guidance so that it is applicable to

apnea monitors for patients of all ages.

Elsewhere in this issue of the Federal

Register, FDA is proposing to classify

the apnea monitor into class II with this

guidance document as the special

control. FDA is issuing this draft

guidance because the agency believes it

is necessary to provide reasonable

assurance of the safety and effectiveness

of the apnea monitor.

DATES: Submit written comments on the

draft guidance by December 21, 2000.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the

draft guidance document entitled

‘‘Guidance for Infant/Child Apnea

Monitor 510(k) Submissions’’ 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written comments on the draft guidance

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. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

guidance.

FOR FURTHER INFORMATION CONTACT:

Joanna H. Weitershausen, Center for

Devices and Radiological Health (HFZ–

450), Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850, 301–443–8609, ext. 164.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of February

21, 1995 (60 FR 9762), FDA issued a

proposed rule setting forth requirements

for a mandatory performance standard

for the infant apnea monitor (hereinafter

referred to as the 1995 proposal).

Elsewhere in this issue of the Federal

Register, FDA is withdrawing the 1995

proposal. Because of reduced mortality

rates for infants at risk for death due to

apparent life-threatening events, and

after considering other factors, FDA no

longer believes that a mandatory

performance standard is needed for this

class II device.

In conjunction with the withdrawal of

the 1995 proposal, FDA is proposing

also to create a separate classification

for the apnea monitor device. This

proposal, which also appears elsewhere

in this issue of the Federal Register,

will remove apnea monitors from their

current classification within the generic

type of device known as the breathing

(ventilatory) frequency monitor (21 CFR

868.2375). The proposed rule will

classify the apnea monitor as a group in

class II (special controls), with an

industry guidance document issued by

FDA as the special control. The generic

apnea monitor will include devices

used to monitor apnea, i.e., the

cessation of breathing, in all patient

populations. The infant/child apnea

monitor used on infants and children

under 3 years of age will fall within the

generic type of device proposed for

classification as the apnea monitor.

The draft guidance describes

minimum performance characteristics,

testing procedures and criteria, labeling,

and, as appropriate, clinical testing

recommendations for infant/child apnea

monitors. After considering comments

on this draft guidance and further

evaluating appropriate clinical study

parameters, FDA intends to modify the

guidance so that the final guidance

document is applicable as the special

control for the apnea monitor used on

patients in other age groups, as well as

infants and children.

II. Significance of Guidance

This guidance document represents

the agency’s current thinking on infant/

child apnea monitor 510(k)

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 applicable

statute, regulations, or both. As noted

above, the agency believes the

performance, testing, labeling, and

clinical criteria in this draft guidance

are applicable as well to apnea monitors

used on patients of other ages. FDA

intends to modify the final guidance

document accordingly. FDA invites

comments on how this guidance may be

adapted to apply to apnea monitors

used on patients other than infants and

children.

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 draft guidance

entitled ‘‘Guidance for Infant/Child

Apnea Monitor 510(k) Submissions’’ via

your fax machine, call the CDRH FactsOn-Demand system at 800–899–0381 or

301–827–0111 from a touch-tone

telephone. Press 1 to enter the system

and enter the document number (1178)

followed by the pound sign (#). 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

Center for Devices and Radiological

Health (CDRH) home page includes

‘‘Guidance for Infant/Child Apnea

Monitor 510(k) Submissions,’’ 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

for Infant/Child Apnea Monitor 510(k)

Submissions’’ is available at http://

www.fda.gov/cdrh/ode.

IV. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

draft guidance by December 21, 2000.

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. The draft guidance and

received comments may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: September 1, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–24336 Filed 9–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–1965, HCFA–

2649, HCFA–5011A & HCFA–5011B]

Agency Information Collection

Activities: Submission For OMB

Review; Comment Request

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

Federal Register / Vol. 65, No. 185 / Friday, September 22, 2000 / Notices 57357

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the 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.

1. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Request for

Hearing—Part B Medicare Claim and

Supporting Regulations in 42 CFR

405.821; Form No.: HCFA–1965 (0938–

0034); Use: Section 1869 of the Social

Security Act authorizes a hearing for

any individual who is dissatisfied with

any determination and amount of

benefit paid. This form is used so that

a party may request a hearing by a

Hearing Officer because the review

determination failed to satisfy the

appellant. Frequency: Annually,

Quarterly and Monthly; Affected Public:

Individual or Households, and Not-forprofit institutions; Number of

Respondents: 55,000; Total Annual

Responses: 55,000; Total Annual Hours:

9,167.

2. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Request for

Reconsideration of Part A Insurance

Benefits and Supporting Regulations in

42 CFR 405.711; Form No.: HCFA–2649

(0938–0045); Use: Section 1869 of the

Social Security Act authorizes a hearing

for any individual who is dissatisfied

with the intermediary’s Part A

determination or the benefit amount

paid. This form is used by a party to

request a reconsideration of the initial

determination of benefits. Frequency:

Annually, Quarterly and Monthly;

Affected Public: Individuals or

Households, and Not-for-profit

institutions; Number of Respondents:

62,000; Total Annual Responses:

62,000; Total Annual Hours: 15,500.

3. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Request for Part

A Medicare Hearing by an

Administrative Law Judge and

Supporting Regulations in 42 CFR 498

Subpart D and E; Form No.: HCFA–

5011A–U6 (0938–0486); Use: Section

1869 of the Social Security Act

authorizes a hearing for any individual

who is dissatisfied with the

intermediary’s Part A determination or

the amount paid. This form is used by

the beneficiary or other qualified

appellant to request a hearing by an

Administrative Law Judge if the

reconsideration determination fails to

satisfy the appellant. Frequency:

Annually, Quarterly and Monthly;

Affected Public: Individuals or

Households, and Not-for-profit

institutions; Number of Respondents:

10,000; Total Annual Responses:

10,000; Total Annual Hours: 2,500.

4. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Request for Part

B Medicare Hearing by an

Administrative Law Judge and

Supporting Regulations in 42 CFR 498

Subpart D and E; Form No.: HCFA–

5011B–U6 (0938–0567); Use: Section

1869 of the Social Security Act

authorizes a hearing for any individual

who is dissatisfied with the carrier’s

Part B determination or the amount

paid. This form is used by the

beneficiary or other qualified appellant

to request a hearing by an

Administrative Law Judge if the hearing

officer’s decision fails to satisfy the

appellant. Frequency: Annually,

Quarterly and Monthly; Affected Public:

Individuals or Households, and Not-forprofit institutions; Number of

Respondents: 10,000; Total Annual

Responses: 10,000; Total Annual Hours:

2,500.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s Web Site Address at http://

www.hcfa.gov/regs/prdact95.htm, or Email your request, including your

address and phone number, 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 designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: August 3, 2000.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–24344 Filed 9–21–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Indian Health Service

Research and Demonstration Projects

for Indian Health

AGENCY: Indian Health Service, DHHS.

ACTION: Notice of Single Source

Cooperative Agreement With the Center

for Native American Health, College of

Public Health, University of Arizona.

SUMMARY: The Indian Health Service

(IHS) announces continuation of an

award of a cooperative agreement to the

Center for Native American Health

(CNAH), College of Public Health,

University of Arizona, for a

demonstration project to build and

expand on a unique collaborative

partnership that currently exists among

the CNAH, the IHS, and the Indian

tribes located in the southwestern part

of the country. This award is for a final

1-year continuation of a project

previously funded for a 2-year period

(September 1, 1998 through August 31,

2000). The continuation will be effective

September 1, 2000, through August 31,

2001. Funding for the continuation

period is $229,288 plus an annual inkind contribution by the University of

$94,696.

The award is issued under the

authority of the Public Health Service

Act, Section 301(a). A general program

description is contained in the Catalog

of Federal Domestic Assistance, number

93.933.

The specific objectives of the project

are: to increase opportunities for subspecialty medical care at reservation

health care facilities; to increase the

availability of telemedicine at

reservation health care facilities; to

enhance community health planning

and prevention activities; to facilitate

counseling of high school level Indian

students for entry into health careers;

and to demonstrate the possibilities of

replication of this collaborative project

at other sites.

Justification for Single Source: This

project has been awarded for an

additional 1-year continuation on a noncompetitive single source basis. The

CNAH is a unique organization within

the University that is guided by an