Notice Number: NOT-CA-10-025
Release Date: May 27, 2010
Request Receipt Date: July 15, 2010
Earliest Anticipated Start Date for Supplement Awards: September 1, 2010
National Cancer Institute (NCI) (http://cancer.gov/)
The National Cancer Institute (NCI) announces the opportunity for grantees to seek supplemental funding for existing NCI-funded grants. The purpose of this initiative is to accelerate translational research focused on immune response modifiers (IRMs).
This initiative is a part of the NCI Special Translational Research Acceleration Projects (STRAP) Program. The overall purpose of the STRAP Program is to accelerate integrated research and development, including support of collaborative activities. A STRAP should take advantage of an opportunity to move translational research projects to the point of initiating clinical studies. Unique aspects of the STRAP Program are to support translational projects that would be delayed or are not easily done through the usual NCI funding mechanisms and to provide to these projects NCI resources that have been identified by the scientific community as critical to progress.
The STRAP Program follows the concept of translational research as a set of developmental pathways focused on various clinical goals (as defined by the NCI-sponsored Translational Research Working Group, http://clincancerres.aacrjournals.org/content/14/18/5664.full.pdf+html).
This administrative supplement funding opportunity from the STRAP Program is focused on the Immune Response Modifier (IRM) pathway (http://clincancerres.aacrjournals.org/cgi/repNo.rint/14/18/5692.pdf).
Any proposed activities to be supported by supplemental funding should be within the overall scope of the active parent NCI grant. These activities should address gaps in the developmental milestones defined for the proposed IRM pathway.
For this one-time announcement, the NCI expects to fund one STRAP and to commit up to $2 million in total costs to this IRM STRAP initiative. No additional funding is planned. One-time supplemental funding will be provided to the grants collaborating in the STRAP. Supplemental funds may be carried over to support the approved STRAP activities in subsequent years, within the funding duration of that parent grant. Funding may not exceed the number of years remaining on the parent grant. Each collaborating parent grant must have at least 2 remaining years of funding.
Areas of Scientific Priorities
IRM-relevant Developmental Milestones. An IRM translational pathway defines a number of distinct milestones to translate a basic scientific concept in immunoprevention or immunotherapy to early clinical testing. For example: Identification of a target with clinical potential; Immune modulating agent(s), Formulations and combination regimens; Assays for immune responses; Assays for relevant patient subsets; Correlative studies (effects on targets versus outcomes); Access to clinical materials; Preclinical toxicology/safety assessment; and Early phase clinical trial.
The plan submitted in the STRAP request should address the particular IRM milestones for the proposed pathway.
Targets for IRM STRAP research: it is expected that by the end of the project period, IRM STRAP administrative supplement awardees will have completed at a minimum all preclinical stages of technology development needed to secure approvals for clinical trials.
Scientific Areas of IRM Opportunities. This focuses on four broad scientific areas:
Within these four areas, the following target antigens and immune modifying agents (IMAs) have been identified through input from the scientific community.
For further discussion, see:
Other Directions. Requestors may propose other target antigens or IMAs for development, but they must provide clear and compelling scientific justification(s) for their choices.
Additional Resources for the IRM STRAP Program
Investigators are encouraged to contact NCI regarding the availability of IL-15 and/or IL-12, and/or other IRMs, such as IL-7 or 1-methyl-tryptophan. Requests will be considered case-by-case, based on merit and availability. IMAs may also be provided by commercial and/or academic collaborators. In all cases, a letter of collaboration should be provided.
NCI staff may assist investigators in requested activities, such as accomplishing material transfers, tracking project milestones, communicating across the team and with the NCI, and facilitating access to other appropriate, available NCI/NIH resources.
General Attributes of NIH Administrative Supplements. Administrative supplements can be used to cover cost increases that are associated with achieving certain new research objectives as long as they are within the original scope of the project. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.
Although the financial plans of the NCI provide support for this program, administrative supplement awards pursuant to this initiative are contingent upon the availability of funds and the receipt of a sufficient number of meritorious requests.
Pre-Submission Consultation. Before submitting a request, interested researchers are strongly encouraged to contact their NCI Program Directors to verify whether the awards intended to serve as “parent” grants and the proposed developmental activities meet the eligibility criteria outlined above.
IMPORTANT: The research proposed by an NCI grantee in the supplement application must be within the original scope of the NCI-supported grant project. The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives as long as they are within the original scope of the project. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.
Requests for the NCI IRM STRAP administrative supplements must be prepared and submitted to the NCI as described in the IRM STRAP Program Guidelines (http://ccct.cancer.gov/STRAP_Program). These Guidelines define specific forms and documents to be included in the requests. All requestors must follow the component structure and provide the information required as defined in these Guidelines. There are some requirements that are specific to linked requests. Note that specific components of the requests must be signed by the Authorized Organizational Representative (OAR).
The NIH Center for Scientific Review (CSR) and the NCI Division of Extramural Activities (DEA) ARE NOT involved in receipt and processing of these requests. Supplement requests are not to be submitted electronically via Grants.gov (and the eRA Commons) or electronically or on paper to the Division of Receipt and Referral, CSR.
This Notice is a one-time announcement and formal requests must be received on or before July 15, 2010.Requests must be signed by the Authorized Organizational Representative (AOR) at the requestor institution.
Applicants are strongly encouraged to submit requests electronically as an e-mail attachment in PDF format; however, the signature of the AOR must be clearly visible. The e-mail address for electronic submission is: NCIIRMSTRAP@mail.nih.gov.
Applicants may instead submit applications on paper (original and 2 copies) to:
Dr. Abdul Tawab-Amiri
Coordinating Center for Clinical Trials
Office of the Director
National Cancer Institute
6120 Executive Boulevard, EPS Suite 300, MSC 7227
Bethesda, MD 20892-7227 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (non-U.S.P.S. delivery)
Inquiries on Parent Grant Eligibility and Suitability for Administrative Supplements under this Initiative:
Contact the Program Director designated as a Program Official for a given eligible grant award.
Inquiries about the STRAP Program in General and about Request Preparation and Submission:
Dr. Abdul Tawab-Amiri (see contact information above)
Inquiries on Budgetary Aspects:
Office of Grants Administration
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-U.S.P.S. delivery)
Inquiries regarding Availabilities of IMAs and Other Materials:
Dr. Stephen Creekmore
Biological Resources Branch
Building 1052, Room 251
Frederick, MD 21702-1201
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)