NCI > Resources for Scientists > Announcements > Interagency Council on Biomedical Imaging in Oncology:
INTERAGENCY COUNCIL ON BIOMEDICAL IMAGING IN ONCOLOGY
Announcement and Call for Requests
Due Date for Requests: Wednesday, February 6
Ellen G. Feigal, M.D.
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
The National Cancer Institute (NCI), Food and Drug Administration (FDA),
and the Centers for Medicare and Medicaid Services (CMS) are pleased to
announce that the sixth meeting of the Interagency Council on Biomedical
Imaging in Oncology will take place on March 20, 2002. This announcement
summarizes the purpose of this newly created Interagency Council, how it
will function, the types of advice it will provide, and its composition
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, CMS, 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
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, CMS, 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
trials imaging network (ACRIN). FDA is responsible for determining the
safety and efficacy of specific products proposed for marketing and for
monitoring those products while they are on the market. CMS 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
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
CMS will provide information on its coverage and reimbursement processes,
and facilitate future interactions of imaging technology developers with
The products of the Interagency Council will be:
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 CMS 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 due date for requests is February 6, 2002. The Council will consider
additional calls for requests after the sixth Interagency Council meeting
has taken place on March 20, 2002. The Council expects to meet about four
times each year, if it receives enough requests to do so.
The Council may schedule discussions 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:
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 requestor 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.
If it 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
All letters will be kept on file with the 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 CMS coverage or reimbursement
to Present to the Interagency Council (Printable PDF form)