Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Notices 33129

already received PMA-approval

(generational changes).

(4) Class III devices that are

comparable to a PMA-approved device

but are under investigation for a new

indication for use. For purposes of

studying the new indication, no

significant modification to the device

were required.

(5) Pre-amendments Class III devices

that become the subject of an

investigational device exemption after

the Food and Drug Administration

requires premarket approval, that is, no

PMA application was submitted or the

PMA application was denied.

(6) Nonsignificant risk device

investigations for which the Food and

Drug Administration required the

submission of an investigational device

exemption.

The following information presents

the device number, category (in this

case, B), and criterion code.

G950165 B3

G950167 B2

G950169 B3

G950170 B4

G950172 B3

G950173 B1

G950174 B4

G950179 B1

G950180 B1

G950181 B1

G950183 B3

G950184 B1

G950187 B2

G950188 B1

G950189 B1

G950190 B4

G950191 B4

G950192 B6

G950193 B4

G950195 B1

G950196 B4

G950197 B3

G950198 B1

G950201 B1

G950202 B4

G950206 B1

G950208 B3

G950209 B4

Note: Some investigational devices may

exhibit unique characteristics or raise safety

concerns that make additional consideration

necessary. For these devices, HCFA and the

Food and Drug Administration will agree on

the additional criteria to be used. The Food

and Drug Administration will use these

criteria to assign the device(s) to a category.

As experience is gained in the categorization

process, this addendum may be modified.

[FR Doc. 96–16217 Filed 6–25–96; 8:45 am]

BILLING CODE 4120–01–P

[BPD–873–N]

Medicare Program; Announcement of

Collaborative Effort With the National

Institutes of Health to Study the

Effectiveness of Lung Volume

Reduction Surgery

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

We are announcing our participation

in a collaborative effort with the

National Heart, Lung and Blood

Institute of the National Institutes of

Health to study the effectiveness of lung

volume reduction surgery. The purpose

of this multi-centered randomized

study, which will include a prospective

registry examining the role of lung

volume reduction surgery, is to evaluate

the long-term outcome of the procedure

on function, morbidity, and mortality as

well as to define appropriate patient

selection criteria. We are issuing this

announcement so that interested

facilities and providers who monitor the

Federal Register are aware of this

collaborative effort. The National Heart,

Lung and Blood Institute announced in

the May 9 and 10, 1996 issues of the

Commerce Business Daily the

qualifications and experience required

for the clinical centers and the clinical

coordinating center to participate in the

program. It also described the patient

population who will be included in the

study and how the study will be

conducted.

On June 3, 1996, the National Heart,

Lung and Blood Institute made available

a formal request for proposals for

clinical centers and a clinical

coordinating center interested in

participating in the study through the

National Institutes of Health (NIH)

Request for Proposals (RFP) Gopher.

Users have access via the NIH Home

Page (World Wide Web) at http://

www.nih.gov. Once users are at the NIH

Home Page, they should select ‘‘Grants

& Contracts,’’ then select ‘‘R&D Requests

for Proposals (RFP).’’ Offerors that have

access to the NIH Gopher Server but not

the Internet can access the RFP by

pointing their gopher clients to

GOPHER.NIH.GOVPORT70. They

should select ‘‘Grant and Research

Information,’’ then select ‘‘R&D

Requests for Proposals (RFP).’’

FOR FURTHER INFORMATION CONTACT:

Karen McVearry, (410) 786–4643.

Authority: Sections 1102 and 1871 of the

Social Security Act (42 U.S.C. 1302 and

1395hh)

(Catalog of Federal Domestic Assistance

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program)

Dated: June 9, 1996.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

[FR Doc. 96–16216 Filed 6–25–96; 8:45 am]

BILLING CODE 4120–01–P

National Institutes of Health

National Cancer Institute; Notice of

Meeting of the National Cancer

Advisory Board

Pursusant to Section 10(d) of the

Federal Advisory Committee act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the meeting of the

National Cancer Advisory Board,

National Cancer Institute on July 18,

1996. The meeting will be open to the

public and attendance by the public will

be limited to space available.

The Committee Management Office,

National Cancer Institute, National

Institutes of Health, Executive Plaza

North, Room 630E, 9000 Rockville Pike,

Bethesda, Maryland 20892 (301/496–

5708), will provide summaries of the

meetings and rosters of the Board

members, upon request.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact Ms. Carole Frank, Committee

Management Specialist, at 301/496–

5708 in advance of the meeting.

Name of Committee: National Cancer

Advisory Board.

Contact Person: Dr. Marvin R. Kalt,

Executive Secretary, National Cancer

Institute, NIH, Executive Plaza North,

Room 600A, 6130 Executive Blvd.,

Bethesda, MD 20892–7405; (301) 496–

5147.

Date of Meeting: July 18, 1996.

Place of Meeting: National Cancer

Institute via telephone conference,

National Institutes of Health, Room 640,

6130 Executive Blvd., Rockville, MD

20852.

Open: 1 pm to approximately 2 pm.

Agenda: To discuss the NCAB

resolution for the 25th Anniversity of

the National Cancer Act.

Dated: June 21, 1996.

Susan K. Feldman,

Committtee Management Officer, NIH.

[FR Doc.96–16323 Filed 6–25–96; 8:45 am]

BILLING CODE 4140–01–M

Office of Extramural Research; Notice

of Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice