INTERAGENCY COUNCIL ON BIOMEDICAL IMAGING IN ONCOLOGY
Announcement and Call for Requests
Due Date for Requests: Monday, October 13, 2003
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 11th meeting of the Interagency Council on Biomedical Imaging in
Oncology will take place on November 24, 2003. This announcement summarizes the
purpose of this Interagency Council, how it functions, the types of advice it
provides, and its composition and membership.
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 Council is chaired by Dr. Ellen Feigal, Acting Director, Division
of Cancer Treatment and Diagnosis, National Cancer Institute. 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 provides 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, 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 summaries from the 1999, 2000, 2002, and 2003 Forum and Workshops can be
reviewed at http://www3.cancer.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 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.
CMS will provide information on its coverage and reimbursement processes,
and facilitate future interactions of imaging technology developers with CMS
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, CMS, NCI or with
other investigators; and
- Written summary of the session, detailing the agenda
topic, participants, 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 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 October 13, 2003. The Council meets three 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 is 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 the standardized format as outlined in the pdf
document attached below. 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 CMS, present for the presentation and discussion? Will you have
data to present?
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 discussion.
All letters will be kept on file with the Council at the NCI.
Provision of background material
The requestor will submit background materials within one week 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 decisions.
Contact
Jaime Kenyon, M.P.H.
Council Coordinator
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
kenyonj@mail.nih.gov
Request
to Present to the Interagency Council (Word document)
Request
to Present to the Interagency Council (Printable PDF form)
