34854 Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of the review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before August 2, 1996, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: June 13, 1996.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 96–16885 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96M-0199]

Bayer Corp.; Premarket Approval of

Technicon Immuno 1 CEA Assay

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Bayer

Corp., 511 Benedict Ave., Tarrytown,

NY, for premarket approval, under the

Federal Food, Drug, and Cosmetic Act

(the act), of Immuno 1 CEA Assay.

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of January 30, 1996,

of the approval of the application.

DATES: Petitions for administrative

review by August 2, 1996.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Peter E. Maxim, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1293.

SUPPLEMENTARY INFORMATION: On

September 29, 1994, Miles, Inc.,

Tarrytown, NY 10591, submitted to

CDRH an application for premarket

approval of Immuno 1 CEA Assay. The

device is an in vitro diagnostic device

intended to quantitatively measure

carcinoembryonic antigen (CEA) in

human serum on the Technicon

Immuno 1 system. Measurements of

CEA aid in the management of cancer

patients by monitoring CEA

concentrations. This diagnostic method

is not intended for use on any other

system.

In accordance with the provisions of

section 515(c)(2) of the act (21 U.S.C.

360e(c)(2)) as amended by the Safe

Medical Devices Act of 1990, this

premarket approval application (PMA)

was not referred to the Immunology

Devices Panel of the Medical Devices

Advisory Committee, an FDA advisory

committee, for review and

recommendation because the

information in the PMA substantially

duplicates information previously

reviewed by this committee.

On January 30, 1996, CDRH approved

the application by a letter to the

applicant from the Director of the Office

of Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act authorizes

any interested person to petition, under

section 515(g) of the act, for

administrative review of CDRH’s

decision to approve this application. A

petitioner may request either a formal

hearing under part 12 (21 CFR part 12)

of FDA’s administrative practices and

procedures regulations or a review of

the application and CDRH’s action by an

independent advisory committee of

experts. A petition is to be in the form

of a petition for reconsideration under

§ 10.33(b) (21 CFR 10.33(b)). A

petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of the review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before August 2, 1996, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: April 9, 1996.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 96–16972 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

Product and Establishment License

Applications, Refusal to File; Meeting

of Oversight Committee

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

meeting of its standing oversight

committee in the Center for Biologics

Evaluation and Research (CBER) that

conducts a periodic review of CBER’s

use of its refusal to file (RTF) practices

on product license applications (PLA’s)

and establishment license applications

(ELA’s). CBER’s RTF oversight

committee examines all RTF decisions

that occurred during the previous

quarter to assess consistency across

CBER offices and divisions in RTF

decisions.
Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices 34855

DATES: The meeting will be held in July

1996.

FOR FURTHER INFORMATION CONTACT: Joy

A. Cavagnaro, Center for Biologics

Evaluation and Research (HFM–5), Food

and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–0379.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 15, 1995 (60 FR

25920), FDA announced the

establishment and first meeting of

CBER’s standing oversight committee.

As explained in the notice, the

importance to the public health of

getting new biological products on the

market as efficiently as possible has

made improving the biological product

evaluation process an FDA priority.

CBER’s managed review process focuses

on specific milestones or intermediate

goals to ensure that a quality review is

conducted within a specified time

period. CBER’s RTF oversight

committee meetings continue CBER’s

effort to promote the timely, efficient,

and consistent review of PLA’s and

ELA’s.

FDA regulations on filing PLA’s and

ELA’s are found in 21 CFR 601.2(a) and

601.3. A sponsor who receives an RTF

notification may request an informal

conference with CBER, and thereafter

may ask that the application be filed

over protest, similar to the procedure for

drugs described under 21 CFR

314.101(a)(3) (see 57 FR 17950, April

28, 1992).

CBER’s standing RTF oversight

committee consists of senior CBER

officials, a senior official from FDA’s

Center for Drug Evaluation and

Research, and FDA’s Chief Mediator and

Ombudsman. Meetings, ordinarily, will

be held once a quarter to review all of

the RTF decisions. The purpose of such

a review is to assess the consistency

within CBER in rendering RTF

decisions.

Because the committee’s deliberations

will deal with confidential commercial

information, all meetings will be closed

to the public. The committee’s

deliberations will be reported in the

minutes of the meeting. Although those

minutes will not be publicly available

because they will contain confidential

commercial information, summaries of

the committee’s deliberations, with all

confidential commercial information

omitted, may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

If, following the committee’s review, an

RTF decision changes, the appropriate

division will notify the sponsor.

Dated: June 26, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–16971 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[R–48]

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

(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.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Hospital

Conditions of Participation—42 CFR

Part 482; Form No.: HCFA–R–48; Use:

Hospitals seeking to participate in the

Medicare and Medicaid programs must

meet the Conditions of Participation

(COP) for Hospitals, 42 CFR Part 482.

The information collection requirements

contained in this package are needed to

implement the Medicare and Medicaid

COP for hospitals. Frequency: Annually;

Affected Public: Not-for-profit

institutions, Federal Government, and

State, Local or Tribal Government;

Number of Respondents: 1,500; Total

Annual Responses: 1,500; Total Annual

Hours Requested: 53,522.

To request copies of the proposed

paperwork collections referenced above,

E-mail your request, including your

address, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections should be sent

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

Date: June 26, 1996

Kathleen B. Larson,

Director, Management Planning and Analysis

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 96–16897 Filed 7–2–96; 8:45 am]

BILLING CODE 4120–03–P

Health Resources and Services

Administration

Request for Nominations to the

Council on Graduate Medical

Education

AGENCY: Health Resources and Services

Administration, DHHS.

ACTION: Notice.

SUMMARY: The Health Resources and

Services Administration (HRSA) is

requesting nominations to fill retiring

members vacancies of the Council on

Graduate Medical Education (COGME).

DATES: Nominations must be received

by close-of-business on Friday, July 26,

1996.

ADDRESSES: Nominations and the

curricula vitae of nominees should be

sent to Enrique S. Fernandez, M.D., M.S.

Ed., Executive Secretary, Council on

Graduate Medical Education, Health

Resources and Services Administration,

5600 Fishers Lane, Parklawn Building,

Room 9A–27, Rockville, Maryland

20857.

FOR FURTHER INFORMATION CONTACT:

Enrique S. Fernandez, M.D., M.S.Ed., at

the above address, or phone (301) 443–

6190.

SUPPLEMENTARY INFORMATION: HRSA is

requesting nominations under the

authorities that established the Council

on Graduate Medical Education,

September 30, 1986, in accordance with

section 10(a)(2) of the Federal Advisory

Committee Act (Pub. L. 92–463).

COGME was authorized by Congress

in 1986 to provide an ongoing

assessment of physician workforce

trends and to recommend appropriate

Federal and private sector efforts to

address identified needs. Legislation

calls for COGME to serve in an advisory

capacity to the Secretary of the

Department of Health and Human

Services (DHHS), the Senate Committee

on Labor and Human Resources, and the