Federal Register / Vol. 65, No. 185 / Friday, September 22, 2000 / Notices 57355

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Office of Community Services; Grant

to the Community Economic

Development and Information

Technology

AGENCY: Office of Community Services,

ACF, DHHS.

ACTION: Award announcement.

SUMMARY: Notice is hereby given that a

noncompetitive grant award is being

made to the Community Economic

Development and Information

Technology to support their national

demonstration project to conduct a food

e-commerce system for poor residents

living in America’s public housing

projects to shop on-line for nutritional

food.

This one-year project is being funded

noncompetitively because it is expected

to provide valuable information useful

to this Department and other

practitioners regarding research and

demonstration initiatives related to

welfare reform and the well being of

low-income children and families. The

national project will demonstrate that

the New Digital Economy can offer new

opportunities to all low-income

communities. The cost of the project is

$63,315 for one year.

CONTACT FOR FURTHER INFORMATION:

Catherine Rivers, Administration for

Children and Families, Office of

Community Services, 370 L’Enfant

Promenade, SW., Washington, DC

20447, Phone: 202–401–5252.

Dated: September 18, 2000.

Donald Sykes,

Director, Office of Community Services.

[FR Doc. 00–24414 Filed 9–21–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Office of Community Services; Grant

to the National Association of Farmers’

Market Nutrition Programs

AGENCY: Office of Community Services,

ACF, DHHS.

ACTION: Award announcement.

SUMMARY: Notice is hereby given that a

noncompetitive grand award is being

made to the National Association of

Farmers’ Market Nutrition Programs to

initiate a Nationwide Farmers’ Market

Connections Campaign to serve lowincome communities, limited resource

farmers, and low-income women and

children who participate in the WIC

Program.

This one-year project is being funded

noncompetitively because it is expected

to provide valuable information useful

to this Department and other

practitioners regarding research and

demonstration initiatives related to

welfare reform and the well being of

low-income children and families. The

nationwide campaign will be piloted in

four states, and will promote the

development and coordination of

farmers’ markets and marketing services

among federal, state and local agencies.

The cost of the project is $33,000 for one

year.

Contact for Further Information:

Catherine Rivers, Administration for

Children and Families, Office of

Community Services, 370 L’Enfant

Promenade, SW., Washington, DC

20447, Phone: 202–401–5252.

Dated: September 18, 2000.

Donald Sykes,

Director, Office of Community Services.

[FR Doc. 00–24415 Filed 9–21–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Gastroenterology and Urology Devices

Panel of the Medical Devices 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: Gastroenterology

and Urology Devices Panel of the

Medical Devices 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 October 19, 2000, 9:30 a.m. to

5 p.m.

Location: Best Western Washington

Gateway Hotel, Grand Ballroom, 1251

West Montgomery Ave., Rockville, MD.

Contact Person: Jeffrey W. Cooper,

Center for Devices and Radiological

Health (HFZ–470), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–1220,

ext. 122, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 12523. Please call the

Information Line for up-to-date

information on this meeting.

Agenda: The committee will discuss,

make recommendations, and vote on a

premarket approval application for a

device for the treatment of

vesicoureteral reflux.

Procedure: 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 October 12, 2000. Oral

presentations from the public will be

scheduled between approximately 10

a.m. and 10:30 a.m., and between

approximately 3:30 p.m. and 4 p.m.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before October 12,

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: September 15, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–24337 Filed 9–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1458]

Draft Guidance for Infant/Child Apnea

Monitor 510(k) Submissions;

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 ‘‘Guidance for Infant/Child

Apnea Monitor 510(k) Submissions.’’

This guidance is not final nor is it in

effect at this time. This draft guidance

describes minimum performance,

testing, labeling, and clinical criteria for

the infant/child monitor. Upon

considering comments on the draft

document, FDA will modify the

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