Federal Register / Vol. 62, No. 240 / Monday, December 15, 1997 / Notices 65709

Ombudsman the name and IND number

of any investigational biological product

trial that was placed on clinical hold

during the past 12 months that they

want the committee to review.

Submissions should be made by January

12, 1998, for the February meeting; by

March 31, 1998, for the May meeting; by

June 30, 1998, for the August meeting;

and by September 29, 1998, for the

November meeting to Amanda Bryce

Norton, FDA Chief Mediator and

Ombudsman (address above).

Dated: December 9, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32678 Filed 12–12–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Product, Establishment, and Biologics

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 the

1998 meetings 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),

establishment license applications

(ELA’s), and biologics license

applications (BLA’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.

DATES: The next meetings will be held

on January 13, 1998; April 14, 1998; July

14, 1998; and October 13, 1998.

FOR FURTHER INFORMATION CONTACT: Joy

A. Cavagnaro, Center for Biologics

Evaluation and Research (HFM–4), 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 continues CBER’s effort to

promote the timely, efficient, and

consistent review of PLA’s, ELA’s, and

BLA’s.

FDA regulations on filing PLA’s,

ELA’s, and BLA’s are found in 21 CFR

601.2 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).

CBER’s standing RTF oversight

committee consists of senior CBER

officials, a senior official from the FDA’s

Center for Drug Evaluation and

Research, and the FDA Chief Mediator

and Ombudsman. Meetings will

ordinarily 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. If there are no RTF

decisions to review, however, the

meeting may be cancelled. FDA intends

to post any meeting cancellation on the

CBER home page at ‘‘http://

www.fda.gov/cber/confmeet.htm’’.

Publication of any meeting cancellation

will be made only as time permits.

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

such 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 within CBER will notify the

sponsor.

Dated: December 9, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32677 Filed 12–12–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Orthopaedic and Rehabilitation

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: Orthopaedic and

Rehabilitation Devices Panel of the

Medical Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on January 12, 1998, 11 a.m. to 6

p.m., and January 13, 1998, 7:30 a.m. to

5:30 p.m.

Location: Parklawn Bldg., conference

rooms G and H, 5600 Fishers Lane,

Rockville, MD.

Contact Person: Jodi H. Nashman,

Center for Devices and Radiological

Health (HFZ–410), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–2036, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12521. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On January 12, 1998, the

committee will discuss and make

recommendations for reclassification

petitions for non- and semi-constrained

shoulders and uni- and total

patellofemorotibial knees. On January

13, 1998, the committee will discuss

and make recommendations for the

reclassification petitions for

patellofemoral knees and constrained

elbows, and for the classification of

calcium sulfate pre-formed pellets

(plaster of paris pellets).

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 January 5, 1998. Oral

presentations from the public regarding

the reclassification petitions for nonand semi-constrained shoulders and

uni- and total patellofemorotibial knees

will be scheduled between

approximately 11 a.m. and 12 m. on

January 12, 1998. Oral presentations