65708 Federal Register / Vol. 62, No. 240 / Monday, December 15, 1997 / Notices

Mailstop K–07, Atlanta, Georgia 30341–

3724, telephone 770–488–1874.

SUPPLEMENTARY INFORMATION: The

following persons will serve on the

Performance Review Board which

oversees the evaluation of performance

appraisals of Senior Executive Service

members of the Department of Health

and Human Services in the Centers for

Disease Control and Prevention, and the

Agency for Toxic Substances and

Disease Registry:

Claire V. Broome, M.D., Chairperson

Helene D. Gayle, M.D., M.P.H.

James M. Hughes, M.D.

Arthur C. Jackson

Richard J. Jackson, M.D., M.P.H.

Wanda K. Jones, Dr.P.H.

James S. Marks, M.D., M.P.H.

Peter J. McCumiskey

Linda Rosenstock, M.D., M.P.H.

Dated: December 8, 1997.

Claire Broome,

Deputy Director, Centers for Disease Control

and Prevention (CDC) and Deputy

Administrator, Agency for Toxic Substances

and Disease Registry (ATSDR).

[FR Doc. 97–32589 Filed 12–12–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Investigational Biological Product

Trials; Procedure to Monitor Clinical

Hold Process; Meeting of Oversight

Committee and Request for

Submissions

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

1998 meetings of its clinical hold

oversight committee, which reviews the

clinical hold orders that the Center for

Biologics Evaluation and Research

(CBER) has placed on certain

investigational biological product trials.

For each meeting, FDA is inviting any

interested biological product company

to use this confidential mechanism to

submit to the committee for its review

the name and number of any

investigational biological product trial

placed on clinical hold during the past

12 months that the company wants the

committee to review.

DATES: The next meetings will be held

on February 10, 1998; May 12, 1998;

August 11, 1998; and November 10,

1998. Biological product companies

may submit review requests for the

February meeting by January 12, 1998;

for the May meeting by March 31, 1998;

for the August meeting by June 30, 1998;

and for the November meeting by

September 29, 1998.

ADDRESSES: Submit clinical hold review

requests to Amanda Bryce Norton, FDA

Chief Mediator and Ombudsman, Office

of the Commissioner (HF–7), 5600

Fishers Lane, rm. 14–105, Rockville, MD

20857, 301–827–3390.

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: FDA

regulations in part 312 (21 CFR part

312) provide procedures that govern the

use of investigational new drugs and

biologics in human subjects. If FDA

determines that a proposed or ongoing

study may pose significant risks for

human subjects or is otherwise seriously

deficient, as discussed in the

investigational new drug regulations, it

may order a clinical hold on the study.

The clinical hold is one of FDA’s

primary mechanisms for protecting

subjects who are involved in

investigational new drug or biologic

trials. Section 312.42 describes the

grounds for ordering a clinical hold.

A clinical hold is an order that FDA

issues to a sponsor to delay a proposed

investigation or to suspend an ongoing

investigation. The clinical hold may be

ordered on one or more of the

investigations covered by an

investigational new drug application

(IND). When a proposed study is placed

on clinical hold, subjects may not be

given the investigational drug or

biologic as part of that study. When an

ongoing study is placed on clinical

hold, no new subjects may be recruited

to the study and placed on the

investigational drug or biologic, and

patients already in the study should

stop receiving therapy involving the

investigational drug or biologic unless

FDA specifically permits it.

When FDA concludes that there is a

deficiency in a proposed or ongoing

clinical trial that may be grounds for

ordering a clinical hold, ordinarily FDA

will attempt to resolve the matter

through informal discussions with the

sponsor. If that attempt is unsuccessful,

a clinical hold may be ordered by or on

behalf of the director of the division that

is responsible for the review of the IND.

FDA regulations in § 312.48 provide

dispute resolution mechanisms through

which sponsors may request

reconsideration of clinical hold orders.

The regulations encourage the sponsor

to attempt to resolve disputes directly

with the review staff responsible for the

review of the IND. If necessary, the

sponsor may request a meeting with the

review staff and management to discuss

the clinical hold.

CBER began a process to evaluate the

consistency and fairness of practices in

ordering clinical holds by instituting an

oversight committee to review clinical

holds (see 61 FR 1031 at 1033, January

11, 1996). CBER held its first clinical

hold oversight committee meeting on

May 17, 1995, and plans to conduct

further quality assurance oversight of

the IND process. The review procedure

of the committee is designed to afford

an opportunity for a sponsor who does

not wish to seek formal reconsideration

of a pending clinical hold to have that

clinical hold considered

‘‘anonymously.’’ The committee

consists of senior managers of CBER, a

senior official from the Center for Drug

Evaluation and Research, and the FDA

Chief Mediator and Ombudsman.

Clinical holds to be reviewed will be

chosen randomly. In addition, the

committee will review clinical holds

proposed for review by biological

product sponsors. In general, a

biological product sponsor should

consider requesting review when it

disagrees with FDA’s scientific or

procedural basis for the decision.

Requests for committee review of a

clinical hold should be submitted to the

FDA Chief Mediator and Ombudsman,

who is responsible for selecting clinical

holds for review. The committee and

CBER staff, with the exception of the

FDA Chief Mediator and Ombudsman,

are never advised, either in the review

process or thereafter, which of the

clinical holds were randomly chosen

and which were submitted by sponsors.

The committee will evaluate the

selected clinical holds for scientific

content and consistency with FDA

regulations and CBER policy.

The meetings of the oversight

committee are closed to the public

because committee discussions deal

with confidential commercial

information. Summaries of the

committee deliberations, excluding

confidential commercial information,

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 the status of a clinical

hold changes following the committee’s

review, the appropriate division will

notify the sponsor.

For each meeting, FDA invites

biological product companies to submit

to the FDA Chief Mediator and
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