Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Notices 33561

schools which offer graduate programs

in behavioral health and mental health

practice, and other public or private

nonprofit health or educational entities

to assist the disadvantaged to enter the

graduate from health professions

schools. Some programs provide for the

repayment of health professions

education loans for disadvantaged

students.

The following income figures were

taken from poverty thresholds

published by the U.S. Bureau of the

Census, using an index adopted by a

Federal Interagency Committee for use

in a variety of Federal programs. That

index includes multiplication by a

factor of 1.3 for adaptation to health

professions and nursing programs

which support training for

disadvantaged individuals or those from

disadvantaged backgrounds. The

income figures have been updated to

reflect increases in the Consumer Price

Index through December 31, 1999.

Size of parents’ family* Income

level**

1 ................................................ $11,100

2 ................................................ 14,400

3 ................................................ 17,200

4 ................................................ 22,000

5 ................................................ 26,000

6 or more .................................. 29,200

* Includes only dependents listed on Federal

income tax forms.

** Rounded to the nearest $100. Adjusted

gross income for calendar year 1999.

Dated: May 18, 2000.

Claude Earl Fox,

Administrator.

[FR Doc. 00–12991 Filed 5–23–00; 8:45 am]

BILLING CODE 4160–15–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Establishment of Interagency Council

on Biomedical Imaging in Oncology in

Call for Requests to Present

The National Cancer Institute (NCI),

Food and Drug Administration (FDA),

and the Health Care Financing

Administration (HCFA) are pleased to

announce the formation of an

Interagency Council on Biomedical

Imaging in Oncology. This

announcement summarizes the purpose

of this newly created Interagency

Council, how it will function, the types

of advice it will provide, its

composition and membership, and the

time of the first Council meeting.

Name of Committee: The National

Cancer Institute, Food and Drug

Administration, and the Health Care,

Financing Administration Interagency

Council on Biomedical Imaging in

Oncology.

Due Date for Request: June 8, 2000.

Contract Person: Ellen G. Feigal,

Deputy Director, Division of Cancer

Treatment and Diagnosis, National

Cancer Institute, 31 Center Drive,

Building 31, Room 3A44, Bethesda, MD

20892–2440, Tel; 301 496–6711, Fax:

301 496–0826, E-mail: ef30d@nih.gov.

SUPPLEMENTARY INFORMATION:

What Is the Interagency Council?

The Interagency Council is a newly

created multi-agency group designed to

serve as a sounding board for

investigators and manufacturers

attempting to take emerging medical

imaging technology to market. It

consists of a core staff from the FDA,

HCFA, and NCI with experience and

knowledge concerning the decisionmaking processes for their agency for

medical imaging products. Additional

agency staff may be added to the core

group on specific matters when needed.

The purpose of the Council is to provide

multi-agency advice that may help

guide imaging technology developers in

the fight against cancer. the Council will

provide advice on projects or project

proposals brought voluntarily by

investigators and technology/device

developers in industry and academia. It

offers a new, multi-agency perspective

to the communication with government

agencies that is already available to

investigators and companies.

Why Does the Nation Need This?

In September, 1999, the NCI and the

National Electrical Manufacturer’s

Association co-sponsored the First NCIIndustry Forum and Workshop on

Biomedical Imaging in Oncology. This

meeting included senior leadership

from industry, FDA, HCFA, NCI, and

researchers from academia. We gathered

to discuss ways to align investment in

imaging technologies with the

biomedical opportunities and unmet

clinical needs in cancer. Participants

asked the NCI to convene meetings

between the multiple government

agencies and industry to facilitate

forward movement of promising

technologies into the marketplace. The

overall goal is to bring effective

technologies into clinical use so that an

impact on the public health can be

achieved. The summary of the Forum

and Workshop and follow-up comments

to that conference can be reviewed on

http://dino.nci.nih.gov/dctd/forum.

What Will the Interagency Council Do?

The three agencies participating in the

Interagency Council all have different

roles in the development of medical

imaging technologies. NCI has created

and is expanding a Biomedical Imaging

Program. This effort currently funds

innovative device and technology

development, small animal imaging, in

vivo cellular and molecular imaging

centers, and a clinical trails imaging

network (ACRIN). FDA is responsible

for determining the safety and efficacy

of specific products proposed for

marketing and for marketing and for

monitoring those products while they

are on the market. HCFA is responsible,

as a Federal health insurance provider,

for determining coverage and

reimbursement for products and

services in the marketplace for their

beneficiaries. By participating in the

Council, these three agencies will be

able to provide coordinated assistance

to sponsors as they go through the

development and regulatory processes

necessary to bring products to market.

The specific roles envisioned by the

participants in the Council are as

follows:

NCI will provide input on scientific

and medical issues, information on the

initiatives and research resources

available to fund or develop imaging

technologies, explain the process for

gaining access to such resources, and

facilitate future interactions of imaging

technology developers with NCI staff or

with other NCI-sponsored investigators.

FDA will provide information on the

issues that may need to be addressed to

establish that a product is safe and

effective, explain its existing guidance

and procedures, and facilitate future

interactions of imaging technology

developers with its regulatory staff. How

FDA may interact with sponsors is

defined in statutes, regulations, and

performance goals, and FDA expects

that the Council will provide a

mechanism to explain to imaging

technology developers how to work

within existing processes to bring

products to market.

HCFA will provide information on its

coverage and reimbursement processes,

and facilitate future interactions of

imaging technology developers with

HCFA staff.

The products of the Interagency

Council will be:

• Suggestions on the scientific and

medical issues related to proposals, and

information regarding available

resources, potential relevant contacts for

investigators within FDA, HCFA, NCI or

with other investigators; and

• Written summary of the session,

detailing the agenda topic, participants,

33562 Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Notices

and proposed plans or advice given or

discussed.

Will the Interagency Council Maintain

Confidentiality?

Council meetings will be closed to the

public. Information exchanged with the

Interagency Council will be held in

confidence by the participants,

consistent with applicable laws. The

NCI, FDA, and HCFA are all agencies in

the Department of Health and Human

Services, and by law are obligated to

protect from disclosure trade secrets and

confidential commercial information.

Who Can Present Before the Interagency

Council?

Any company or academic

investigator developing a device or

technology relevant to biomedical

imaging in cancer who seeks the

perspectives of a multi-agency

assessment and discussion may present.

What Is the Process?

The first due date for request is June

8, 2000. The Council will consider

additional calls for requests after the

initial Interagency Council meeting has

taken place on July 20, 2000. The

Council expects to meet about four

times each year, if it receives enough

requests to do so.

The Council may schedule discussion

of several similar types of products at a

single meeting. Generally, the Council

will give preference in scheduling

meetings to promising new technologies

that are viewed as important new

developments in cancer imaging.

Each meeting will be attended by the

available core members on the Council.

The core members also may invite

additional relevant staff within their

agency to attend the Council meetings.

Logistics for the meeting date, time, and

location will be coordinated by the

Council coordinator, and communicated

to all participants.

Request to Present

The requestor should follow a

standardized format that the Council

will make available on the Internet or

that can also be completed and sent by

hard copy. The information that the

requestor will need to provide includes:

• Name of investigator, professional

title(s) and degree(s) of investigator;

• Name of company and or/

institution affiliation;

• What is the question/issue that you

want to raise? Do you need/want

representatives from the 3 government

agencies, e.g., NCI, FDA, and HCFA,

present for the presentation and

discussion? Will you have data to

present?

Submit to: Council Coordinator (same

address as listed for contact

information).

Reply to Letter of Intent

Within approximately 3 working days

of receipt of the letter of request, the

Council coordinator will send a letter

acknowledging receipt of the request.

Within 30 days, and after consultation

with Council representatives, the

Council coordinator will either invite

the requester to a meeting (at the

requestor’s expense) if it appears that

the question or issue would benefit from

a multi-agency discussion, or indicate

the Council’s determination that a

meeting will not be provided. A letter of

invitation will ask the requestor to

provide specific questions or issues they

want to discuss with the Council, and,

at the discretion of the requestor,

relevant background information and

data in a packet not to exceed 25 pages.

It if is not thought that a multi-agency

discussion is required or desirable, then

a letter will be sent to requestor stating

the reason why such a meeting request

has been denied. If appropriate, the

letter may suggest other viable paths the

requestor might pursue.

If the Council has already met with

requestor before, the Council

coordinator will determine if this is a

new situation that requires a multiagency discussion.

All letters will be kept on file with

Council at the NCI.

Provision of Background Material

The requestor will submit background

materials within two weeks of receipt of

the letter from the Council. The Council

coordinator will distribute the

completed packet to the core members

of the Interagency Council, and to the ad

hoc members.

During the Session

Each session will last about a halfday, e.g., 3 to 4 hours, to discuss at most

2 or 3 issues. The general format of the

session will consist of the requestor

presenting their question/issue, and

background information including data,

when available. This will be a relatively

informal discussion that can be

interrupted as needed to answer

questions, and clarify issues. At the

conclusion of each topic, the Council

will summarize the main issues and

plans or set of actions that might be

considered.

Follow-Up After the Session

Within one week after the meeting,

the Council coordinator will prepare

minutes of the meeting noting the main

take-home points of the discussion and

the conclusions. It will include the

names of all participants in the session,

the question or issue being addressed,

and the proposed plans or advice given

or discussed. The coordinator will

obtain review and concurrence in the

minutes by each agency participating in

the meeting. The minutes will be sent to

the person requesting the meeting and

to agency representatives within four

weeks of the meeting. The Council will

keep one copy of the letter, as well as

the letter of request and the submitted

background information, on file at the

NCI.

What the Interagency Council Is Not

The Interagency Council is intended

to provide research groups with advice

on the spectrum of scientific, regulatory,

coverage and reimbursement issues that

affect the development of imaging

devices or technologies.

The Council’s advice does not replace

the legislatively mandated roles and

functions of the agencies individually.

In particular, the Interagency Council

does not approve funding of research

and development, and does not make or

guarantee FDA regulatory, or HCFA

coverage or reimbursement decisions.

Request to Present to the Interagency

Council

(Suggested format)

Name of investigator: llllllllll

Professional title(s) and degree(s) of investigator: llllllllllllllllll

Name of company and/or institution affiliation: llllllllllllllllll

Address: llllllllllllllll

lllllllllllllllllllll

City: llllllllllllllllll

State: llllllllllllllllll

Zip: llllllllllllllllll

What is the question/issue that you want to

raise: llllllllllllllllll

lllllllllllllllllllll

Do you need/want representatives from the

three government agencies, e.g., NCI,

FDA, and HCFA, present for the

presentation and discussion? Yes l

No l

Will you have data to present? Yes l

No l

Will you be presenting confidential

commercial or proprietary information?

Yes l No l

Submit applications to: Jaime Quinn, M.P.H.

Council Coordinator, National Cancer

Institute, 31 Center Drive, Building 31,

Room 3A44, Bethesda, MD 20892–2440.

Tel: 301–496–6711, Fax: 301–496–0826,

Email: jq14u@nih.gov.

Dated: May 16, 2000.

Alan Rabson,

Deputy Director, National Cancer Institute,

National Institutes of Health.

[FR Doc. 00–13026 Filed 5–23–00; 8:45 am]

BILLING CODE 4140–01–M