and Human Services (HHS)
EXPIRED
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Participating Organization(s)
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National Institutes of Health (NIH) |
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National Cancer Institute (NCI) |
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Funding Opportunity Title
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Mitochondria in Cancer Epidemiology, Detection, Diagnosis and Prognosis (R21) |
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Activity Code
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R21
Exploratory/Developmental Research Grant Award
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Announcement Type
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Reissue of PA-08-144 |
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Related Notices |
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Funding Opportunity Announcement (FOA) Number
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PA-11-074
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Companion FOA
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Catalog of Federal Domestics Assistance (CFDA) Number(s)
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93.393, 93.394, 93.395, 93.396, 93.399 |
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FOA Purpose
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This funding opportunity announcement (FOA), issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), encourages Exploratory/Developmental Grant (R21) applications that propose to develop and validate new mitochondrial-related biomarkers for cancer early detection, diagnosis, prognosis, risk assessment, and response to preventive and ameliorative treatments.
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Posted Date
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December 9, 2010 |
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Open Date (Earliest Submission Date)
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January 16, 2011 |
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Letter of Intent Due Date
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Not Applicable |
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Application Due Date(s)
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Standard dates apply, by 5:00 PM local time of applicant organization. |
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AIDS Application Due Date(s)
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Standard dates apply, by 5:00 PM local time of applicant organization. |
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Scientific Merit Review
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Standard dates apply |
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Advisory Council Review
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Standard dates apply |
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Earliest Start Date(s)
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Standard dates apply |
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Expiration Date
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January 8, 2014 |
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Due Dates for E.O. 12372
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Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
This funding opportunity announcement (FOA), issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), encourages Exploratory/Developmental Grant (R21) applications that propose to develop and validate new mitochondrial-related biomarkers for cancer early detection, diagnosis, prognosis, risk assessment, and response to preventive and ameliorative treatments.
Related Funding Opportunity: Investigators, who are interested in proposing discrete, specified, circumscribed projects based upon strong preliminary data, should submit applications in response to the partner FOA of identical scientific scope (PA-11-073), which uses the NIH Research Project Grant (R01) funding mechanism.
Mitochondria are semiautonomous organelles within cells that play an important role in cellular energy metabolism, free radical generation, and apoptosis. Mitochondria contain their own genome, which encodes a number of proteins critical for energy metabolism, particularly in oxidative phosphorylation. The integrity of the mitochondrial genome is important for normal cell function. For example, a number of specific germline mutations in mitochondrial DNA (mtDNA) can cause Leber (hereditary) optic atrophy (neuropathy), whereas some somatic mutations of mtDNA are associated with both initiation and/or progression of cancer. One attractive hypothesis is that dysregulation of oxidative phosphorylation leads to an increase in reactive oxygen species (ROS), which then fuels additional mechanisms for initiation of genomic instability. There is also evidence that some of these mutations may represent additional means for tracking tumor progression. In addition, alterations in mtDNA may serve as early diagnostic markers for cancer development, or as an indicator of cumulative cellular damage that will lead to induction and progression of cancer.
Mitochondria typically contain multiple haploid copies of their own genome (16.5 kb), including most components of transcription, translation, and protein assembly. Mitochondria are able to maintain genomic independence from the nucleus, because of proto-mitochondrial genes having integrated into the nuclear genome throughout evolution. Therefore, most mitochondrial proteins are encoded by nDNA that has been imported into mitochondria. There are 21 major mitochondrial haplotype groups; there exist very large differences in the distributions of the major haplotypes amongst racial and ethnic groups.
Alterations in the mitochondrial genome are frequently associated with specific diseases. Specifically, the displacement region or D-loop non-coding region contains the replication origin of mtDNA. The D-loop region is the most common site of the somatic mutations in different cancers. The majority of these somatic mutations are homoplasmic (i.e., all copies of mitochondrial DNA have the same mutations) in nature, suggesting that the mutant mtDNA played an active role in tumor formation.
The number of copies of mtDNA per cell varies in normal and disease states. However, because cells contain multiple copies of mtDNA, there are often variable proportions of both mutant and wild type DNA in a given cell, leading to a heteroplasmic state. Only when the levels of mutated DNA reach a certain threshold, does the disease become manifest. In many different tumor types, mutations have been detected in mtDNA, including breast, colon, esophageal, endometrial, head and neck, liver, kidney, leukemia, lung, melanoma, oral, prostate, and thyroid cancer.
The recent surge in mitochondrial research has been driven by the identification of mitochondria-associated diseases and the role of mitochondria in apoptosis. Compelling data exists to support utilization of specific somatic mitochondrial mutations in initiation of and detection of different tumor types. It has been suggested that the extent of mtDNA mutations or identification of specific mutations might be useful in early detection, diagnosis, and prognosis of cancer outcome and/or in monitoring response to certain preventive and interventional modalities as well as therapies.
By virtue of their clonal nature and high copy number in cancer cells, mitochondrial mutations may provide a powerful molecular marker for noninvasive detection of cancer. Certain mtDNA haplogroups may be associated with increased risk of cancer. A few studies have compared haplogroup distributions in renal and prostate cancer patients to determine if there exists an association between mitochondrial genotype and cancer - it has been demonstrated that haplogroup U (one of the 21 major haplotype groups), was associated with increased odds ratios in both renal and prostate cancer.
Although most cancer cells harbor somatic mutations in mtDNA, the question of whether such mutations indeed contribute to either the initiation or progression of tumors, remains open to further research. It is likely that mtDNA mutations can initiate a cascade of events leading to a continuous increase in the production of ROS (persistent oxidative stress), a condition that can initiate tumor development. Recent evidence has implicated both environmental and behavioral factors as cause(s) of somatic mutations in mtDNA.
The underlying mechanisms responsible for the initiation and evolution of mtDNA mutations, including their roles in the development of cancer, are incompletely understood. Despite the growing evidence of somatic mtDNA mutations in cancer tissues, very little is known about their role(s) in cancer etiology. However, a number of conventional approaches/technologies can be adopted to answer these question(s). For instance, comparison of mtDNA mutations (or heteroplasmy) in healthy individuals and cancer patients, could reinforce the probable correlation with cancer. It is also not certain whether the mitochondrial genome can affect nuclear genome stability, and whether interaction between nuclear-mitochondria genome-associated proteins is involved in tumorigenesis. An understanding of the association of cancer risk with mtDNA (and nDNA) mutations may provide insights into cancer etiology.
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Funding Instrument
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Grant |
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Application Types Allowed
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New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
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Funds Available and Anticipated Number of Awards
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The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. |
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Award Budget
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Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. |
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Award Project Period
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The total project period for an application submitted in response to this funding opportunity may not exceed two years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions:
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For profit Organizations
Governments
Other
Foreign (non-U.S.) components of U.S. Organizations are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet Universal
Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Project Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide, with the following modifications:
Appendix
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD/PIs must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review , NIH. Applications that are incomplete will not be reviewed.
In order to expedite review, applicants are requested to notify the IC abbreviation Referral Office by email at [email protected]when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to subjects,
2) adequacy of protection against risks, 3) potential benefits to the subjects
and others, 4) importance of the knowledge to be gained, and 5) data and safety
monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.
As part of the scientific peer review, all applications:
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board . The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, CCR
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Mukesh Verma, Ph.D.
National Cancer Institute (NCI)
Executive Plaza North, Room Number 5100
6130 Executive Boulevard
Bethesda, MD 20892-7324
Telephone: (301) 594-7344
Email: [email protected]
(Epidemiology)
Jacob Kagan, Ph.D.
National Cancer Institute (NCI)
Executive Plaza North, Room Number 3146
6130 Executive Boulevard
Bethesda, MD 20892-7324
Telephone: (301) 435-1594
Email: [email protected]
(Early Detection)
James Tricoli, Ph.D.
National Cancer Institute (NCI)
Executive Plaza North, Room Number 6026
6130 Executive Boulevard
Bethesda, MD 20892-7324
Telephone: (301) 496-1591
Email: [email protected]
(Diagnosis and Prognosis)
Andrew Hruszkewycz, MD
National Cancer Institute (NCI)
6116 Executive Boulevard, Suite 700
Bethesda, MD 20892-8347
Telephone: (301) 496-8528
Email: [email protected]
Harold E Seifried, Ph.D.
National Cancer Institute (NCI)
Executive Plaza North, Room Number 3150
6130 Executive Boulevard
Bethesda, MD 20892-7324
Telephone: (301) 496-8573
Email: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Catherine E. Blount
Office of Grants Administration
National Cancer Institute (NCI)
6120 Executive Boulevard, ESP Suite 243,
MSC 7150
Bethesda, MD 20892-7150 (for U.S.
Postal Service express or regular mail)
Rockville, MD 20850 (for
express/courier delivery)
Telephone: (301-496-3179
E-mail: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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NIH Funding Opportunities and Notices
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