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No more than two requests for support from the same principal investigator may
be received on any given receipt date. An individual agent has three chances to
be approved by DCIDE. After three unsuccessful attempts, subsequent requests
focusing on the same agent will be returned without review.
DCIDE is not open to funded Federal laboratories.
Please read the application advice, below, before submitting a DCIDE request.
CHANGES OCCUR FREQUENTLY.
Application
Please use the PHS
398 form to request support. Send original and 4 copies to the contact
person. Please observe the type size and line spacing requirements. In a
document not to exceed 25 single-spaced pages, requestors are to supply the
following information:
-
Face Page, AA: Complete relevant information. This is not a request for
funding. No human subjects or vertebrate animals will be used.
-
Form Page 2, BB: Abstract: a summary of the project to fit into the box
provided.
-
Form Page 3, CC: Table of Contents: Adapt to the information being supplied.
Please number pages consecutively.
-
Form Page 6, FF: Biographical Sketch for the requestor.
-
Form Page 7, GG: Other Support: Use this format, with any expansion necessary,
to describe all current and anticipated sources of support for the project.
This includes a summary of the status of past, planned, or ongoing negotiations
with companies relating to licensing or future development of the product, as
well as reasons that negotiations to license have not been successful to date.
-
Research Plan Section: The following should be included in the Research Plan,
substituting for the usual PHS 398 form information:
-
Background: a summary of the field from which the discovery has emerged that
will allow evaluators to appreciate the scientific and medical importance of
the imaging agent.
-
Hypothesis: a clear statement of the hypothesis(-ses) that will be tested and
the model and/or methodology required for biochemical validation or
certification of the probe/agent.
-
Request: a clear statement of specifically what is needed (and therefore
requested from the National Cancer Institute) to bring the compound to IND
status. Also, a clear statement about the anticipated role of the requestor or
requestor institution in the development of the project once NCI becomes
involved.
-
Justification: an explanation of why the imaging agent represents a
particularly innovative or promising approach to the prevention, detection,
diagnosis, or treatment of cancer.
-
Uniqueness: a discussion of related or similar molecules already under
development by NCI or industrial (or other) sponsors and why this particular
imaging agent should be given priority by the NCI in light of possible
competition.
-
Contact with relevant FDA staff: a disclosure of the current stage of
discussions with the relevant FDA staff about IND filings for the imaging
agent.
-
Checklist, II: Complete the relevant information.
-
Appendix (not included in page limitation): background preprints and reprints.
-
Intellectual Property: Each DCIDE applicant must include a letter with his or
her application from the appropriate authorized staff person overseeing
intellectual property and/or technology transfer for his or her affiliated
institution or company verifying that she/he has reviewed the DCIDE request and
that application is or is not eligible for consideration by the DCIDE program.
The letter should include a statement by the applicant disclosing any patents,
issued or pending, and/or licenses, granted and/or pending, with respect to the
product of the application as well as any known patents that block the
development of the products of the application. In the event that an
application requires the use of a non-commercially available
technology/material which is patented by a third party, applicant must provide
documentation that the third party patent holder does not object to the
applicant's use. If a technology/material is found not to be eligible for use
in the DCIDE application and is central to the investigator's proposal,
application to the DCIDE program is not encouraged.
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