494 Federal Register / Vol. 65, No. 3 / Wednesday, January 5, 2000 / Notices

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

year 2000 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 meetings will be held on

February 10, 2000; May 11, 2000;

August 10, 2000; and November 9, 2000.

Biological product companies may

submit review requests for the February

meeting by January 20, 2000; for the

May meeting by March 30, 2000; for the

August meeting by June 29, 2000; and

for the November meeting by September

28, 2000.

ADDRESSES: Submit clinical hold review

requests to Steven H. Unger, FDA

Acting Ombudsman, Office of the

Commissioner (HF–7), 5600 Fishers

Lane, rm. 14–105, Rockville, MD 20857,

301–827–3390.

FOR FURTHER INFORMATION CONTACT:

Stephen M. Ripley, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION: FDA’s

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 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

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

20, 2000, for the February meeting; by

March 30, 2000, for the May meeting; by

June 29, 2000, for the August meeting;

and by September 28, 2000, for the

November meeting to Steven H. Unger,

FDA Acting Ombudsman (address

above).

Dated: December 28, 1999.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–109 Filed 1–4–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1094–N]

Medicare Graduate Medical Education

Consortia Demonstration

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces the

Medicare Graduate Medical Education

(GME) Consortia demonstration, which

will test how teaching hospitals and

affiliated organizations respond to the

incentive of shared direct GME

payments. HCFA is interested in newly

formed partnerships as well as already

existing GME consortia. HCFA plans to

conduct the demonstration with a

limited number of consortia, to be

chosen through a competitive

Federal Register / Vol. 65, No. 3 / Wednesday, January 5, 2000 / Notices 495

application process. An application

package can be obtained from HCFA,

which describes the demonstration and

the criteria to be used in reviewing

applications. Applications are due to

HCFA 90 days after the publication of

this notice.

DATES: Closing date for submission of

applications will be April 4, 2000, 5

p.m. E.S.T.

APPLICATIONS: To receive an application

package, and for further information,

contact Sid Mazumdar, (410) 786–6673.

ADDRESSES: Mail correspondence to the

following: Health Care Financing

Administration, Room C4–14–15, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850, Attention: Sid

Mazumdar.

I. Background

Section 4628 of the Balanced Budget

Act of 1997 requires a demonstration

which will permit direct Graduate

Medical Education payments ordinarily

paid to a teaching hospital to be paid to

a consortium. According to the

legislation, a qualifying consortium is to

consist of a teaching hospital (with one

or more residency programs) and at least

one of the following: a school of

allopathic or osteopathic medicine,

another teaching hospital (which can be

a children’s hospital), a Federally

Qualified Health Center, a medical

group practice, a managed care entity, or

an entity furnishing outpatient services.

The legislation gives authority to the

Secretary of Health and Human Services

to expand the definition of an

organization qualified to participate in a

consortium.

Organizations that are already

established will be able to begin the

demonstration in July 2000. Other

consortia will begin with the

demonstration payment in July 2001. No

consortium projects will begin after the

summer of 2001. Applying consortia

must provide letters of commitment

demonstrating that all participating

organizations agree to the proposed

system of governance and methodology

for distributing funds. HCFA will

evaluate applications on how the

proposed project will help achieve

stated goals; the system of

administration and decision making;

plans for quality improvement and

evaluation; and staff and capability for

education and training. Applicants will

be evaluated according to a numerical

scoring system corresponding to the

specific criteria that are described in the

application.

II. Payment Methodology

HCFA will pay to the consortium the

fraction (or entirety) of the direct

Graduate Medical Education (GME)

payment of the teaching hospital(s) that

the consortium agrees upon, subject to

HCFA’s approval. This amount will be

subtracted from HCFA’s payment to the

teaching hospitals. The demonstration

will be budget neutral, that is, it will

allow no more money to be paid to the

consortium than what the direct GME

payment would otherwise have been to

its participating entities. The

application package contains a more

detailed explanation of the payment

methodology.

Authority: Section 4628 of the Balanced

Budget Act of 1997, Public Law 105–33.

(Catalog of Federal Domestic Assistance

Program No. 93.779, Health Financing,

Demonstrations, and Experiments)

Dated: December 15, 1999.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 00–121 Filed 1–4–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–3028–N]

Medicare Program; Notice of the

Solicitation for Proposals To Expand

the Medicare Lifestyle Modification

Program Demonstration

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces our

solicitation for proposals to expand the

Medicare Lifestyle Modification

Program Demonstration to one

additional, national multi-site

cardiovascular lifestyle modification

program. The purpose of this

demonstration is to test the feasibility

and cost-effectiveness of providing

payment for cardiovascular lifestyle

modification program services to

Medicare beneficiaries. This

demonstration will test proven and

intensive programs designed to reduce

or reverse the progression of

cardiovascular disease of patients at risk

for invasive treatment procedures. The

expansion will allow for a comparison

between two different lifestyle

modification models across several

factors, including price. The

demonstration began October 1, 1999

and will be conducted over a 4-year

period. Currently, the demonstration is

being implemented at several sites

subscribing to one multi-site lifestyle

modification program model.

Enrollment for each multi-site program

is limited to 1,800 Part B eligible

Medicare beneficiaries who satisfy

specific clinical admission criteria.

DATES: Letters of Intent: Letters of Intent

must be received by the HCFA project

officer by February 4, 2000.

Proposals: Proposals (an original and

5 copies), each with a copy of the timely

letter of intent, must be received by the

HCFA project officer by April 4, 2000.

ADDRESSES: Letters of Intent and

Proposals: Department of Health and

Human Services, Health Care Financing

Administration, Attention: Armen

Thoumaian, Ph.D., Project Officer,

Medicare Lifestyle Modification

Program Demonstration, Office of

Clinical Standards and Quality, Mail

Stop: S3–02–01, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Demonstration Website:

www.hcfa.gov/quality/qlty-3.htm.

FOR FURTHER INFORMATION CONTACT:

Armen Thoumaian, Ph.D., (410) 786–

6672, or e-mail Athoumaian@hcfa.gov.

SUPPLEMENTARY INFORMATION:

I. Background

A. Problem

Research has provided evidence that

specific lifestyle changes can lead to a

decrease in the levels of cardiovascular

risk factors, resulting in lower morbidity

and mortality associated with coronary

artery disease (CAD). Lifestyle

modification programs are increasingly

becoming an approach to the secondary

prevention of coronary disease

morbidity. The programs may reduce

the incidence of hospitalizations and

invasive procedures among patients

with substantial coronary occlusion.

Studies have shown that controlling

single risk factors such as a low-fat diet,

smoking cessation, exercise, or stress

management are beneficial in the

treatment of cardiovascular disease.

Other psycho-social risk factors,

including depression and social

isolation, have already been shown to be

important. Multi-factorial risk reduction

programs that include reduction of some

or all of these risk factors in a

comprehensive cardiovascular lifestyle

management program, however, have

yet to be evaluated for their

effectiveness or long-term cost savings

in the Medicare population.

We currently pay for 12 weeks of

cardiac rehabilitation services for

Medicare patients who have a prior