[Federal Register Volume 65, Number 101 (Wednesday, May 24, 2000)]
[Notices]
[Pages 33561-33562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-13026]


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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: [email protected].

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 decision-making 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 NCI-Industry 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,

[[Page 33562]]

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 
multi-agency 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 half-day, 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:--------------------------------------------------
Professional title(s) and degree(s) of investigator:-------------------
Name of company and/or institution affiliation:------------------------
Address:---------------------------------------------------------------
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City:------------------------------------------------------------------
State:-----------------------------------------------------------------
Zip:-------------------------------------------------------------------
What is the question/issue that you want to raise:---------------------
----------------------------------------------------------------------
Do you need/want representatives from the three government agencies, 
e.g., NCI, FDA, and HCFA, present for the presentation and 
discussion?   Yes __  No __
Will you have data to present?   Yes __    No __
Will you be presenting confidential commercial or proprietary 
information?   Yes __ No __
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: [email protected].


    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