National Institutes of Health (NIH)
National Cancer Institute (NCI)
Funding Opportunity Title
Validation of Molecular Diagnostics to Predict Patient Outcomes Using Specimens from Multi-Site Cancer Trials (R01)
R01 Research Project Grant
Reissue of PA-08-134
Funding Opportunity Announcement (FOA) Number
Catalog of Federal Domestic Assistance (CFDA) Number(s)
This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), encourages the submission of Research Project Grant (R01) applications from institutions and organizations to validate the clinical utility of new molecular diagnostics for determining prognosis or predicting response to therapy or toxicity for cancer. The Cancer Diagnosis Program (CDP) and the Cancer Therapy Evaluation Program (CTEP) at the NCI are cooperatively sponsoring this FOA with the purpose to transition of candidate biomarkers from initial correlative observations into diagnostics that are suitable for use in clinical trials to assess the clinical validity of a marker. This program will support research projects to improve clinical decision-making in the care of cancer patients and as such will support studies that use tumor specimens linked to specific treatment and clinical outcome information. This FOA is not appropriate for molecular diagnostics discovery projects.
November 16, 2011
Open Date (Earliest Submission Date)
January 5, 2012
Letter of Intent Due Date
Application Due Date(s)
Standard dates apply , by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Standard dates apply, by 5:00 PM local time of applicant organization.
Scientific Merit Review
Standard dates apply
Advisory Council Review
Standard dates apply
Earliest Start Date(s)
Standard dates apply
January 8, 2015
Due Dates for E.O. 12372
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 the submission of Research Project Grant (R01) applications to perform validation of the clinical usefulness of new molecular diagnostics that are becoming critical components for determining prognosis or predicting response to therapy for cancer. Advances in cancer biology and powerful technologies are providing increased opportunities for analyzing aberrations in genes, proteins and molecular profiles and for developing more effective therapeutics and prognostic and predictive markers to inform their use for individual patients. However, prior to clinical laboratory implementation, the technical and analytical performance characteristics (e.g., stability, accuracy and reproducibility) of the assay for the marker need to be established. Secondly, determining clinical utility of a molecular diagnostic i.e., the evidence that the marker separates two subgroups of patients with different outcomes within a large population, requires correlation of laboratory test results with clinical parameters. Therefore, access to clinically-annotated specimens collected from multi-institutional, well-controlled clinical studies is absolutely essential for assessing the clinical usefulness of the test. The ultimate goal of this FOA is to evaluate the clinical utility of analytically validated molecular diagnostic tests to improve clinical decision-making in the care of cancer patients (e.g., to meet criteria for enrollment or to assign a specific treatment arm). This FOA is not appropriate for molecular diagnostics discovery projects.
This FOA will utilize the Research Project Grant (R01) mechanism, and is suitable for projects where proof-of-principle of the proposed technology or methodology has already been established and supportive preliminary data are available. This FOA runs in parallel with an FOA of identical scientific scope, PA-12-014, which utilizes the Exploratory/Developmental Grant (R21) mechanism.
Despite a large body of published reports on diagnostic and prognostic factors in cancer patients, the rate of acceptance of new markers to inform treatment decisions for cancer patients has been slow and very few such markers and laboratory assays are used in clinical practice. Prognostic biomarkers are indicators of the natural history of disease and the pathological process and estimation of probability of recurrence. Predictive markers are distinct from prognostic markers in that they provide an estimate of probability of response to therapy. Both types of markers are unlikely to be clinically useful unless their prognostic or therapeutic relevance is established in well-designed validation studies. The steps involved in test validation are meant to answer the key question whether the test is ready for implementation in the clinical laboratory. In order to answer this question the analytical performance characteristics must be established along with the clinical utility of the test.
Examples of Successful Predictive Markers. Recently, several anticancer therapies, including immunotherapy and targeted therapies, have provided alternative treatment options to cancer patients. A signaling pathway inhibitor Vemurafenib, which targets mutated BRAF, has conferred improved overall and progression-free survival in patients with advanced melanoma compared to standard chemotherapy, but only in those patients whose tumors harbor the mutated BRAF. Based on these results, Vemurafenib was approved by the FDA for treatment of patients whose metastatic melanoma carry BRAF V600E mutation, as determined by an FDA-approved test. The introduction of epidermal growth factor receptor (EGFR) inhibitors in the clinic led to the identification of molecular markers, i.e., EGFR activating mutations in patients with non-small-cell lung carcinoma (NSCLC) or gene amplification in patients with colorectal carcinoma, that predict sensitivity to EGFR inhibitors. Crizotinib was also recently FDA-approved to treat a small subset of NSCLC patients who have EML4-ALK fusion gene resulting in activated ALK kinase this drug targets.
Several other genetic alterations (i.e., mutations, fusion genes, insertions/deletions or gene amplifications) within a tumor directly activate an oncogene, e.g., activating mutations in KIT gene in gastrointestinal stromal tumor and ERBB4 gene in cutaneous melanoma, mutations and internal tandem duplication in the FLT3 gene in acute myeloid leukemia, BCR-ABL fusion gene in chronic myelocytic leukemia and HER2/neu gene amplification in breast carcinoma. In these examples, the presence of a specific DNA alteration within the tumor predicts a positive therapeutic response to a particular drug because the drug targets a protein encoded by oncogenic drivers that are critical for tumor growth. Another type of genetic marker predicting response is mutation downstream of the drug’s target. As an example, metastatic colon cancers with mutated KRAS gene are refractory to treatment with EGFR-specific monoclonal antibody therapy. These molecular defects would inform stratification of cancer patients into actionable molecular subtypes who are likely to respond to specific treatment for their improved outcome.
Although these molecular subtypes of cancer patients selected for treatment by the presence of specific molecular marker often experience impressive responses to molecularly targeted therapy, most will suffer from disease progression and recurrence. Therefore, acquired alterations such as new mutations or gene amplification that lead to the development of drug resistance are also critical for molecularly characterizing tumors and to predict drug response.
Principles of Test Validation. Assay validation has both analytic and clinical components. It is essential that analytical performance of the assay is established before the evidence of clinical utility is obtained. Analytical performance characteristics of the assay need to address the following parameters:1) specificity and sensitivity, 2) accuracy i.e., closeness of the test result to the true value, 3) intra- and inter-assay variability, 4) upper and lower limit of detection, 5) cut-off points and 6) reproducibility. Analytical validation process should establish parameters for the assay to correctly classify biologic samples as positive or negative for the marker.
Clinical validation study design and analysis however must address the specific intended clinical use for the assay, such as determining prognosis or predicting response of the particular tumor to generic class of treatments (e.g., endocrine or chemotherapy) or specific agent (e.g., targeted therapy or immunotherapy). Thus, it requires correlation of analytically validated assay with clinical data from for example case-control studies, retrospective data collection or prospective clinical trials. The study should also address how well the marker predicts outcome, i.e., difference of outcomes for patients who are positive versus those who are negative for the marker. The magnitude of the marker effect to influence outcome or treatment decisions and cut-off points need to be validated to establish clinical utility of the test.
Clinically Annotated Specimen Collections. Availability of specimens with associated clinical annotation is an important consideration for reliably establishing the clinical utility of the prognostic or predictive markers. Specimens collected within multi-site clinical trials are especially suitable for retrospective and prospective analyses of associations between outcomes and molecular characteristics. Archived specimens from a large population of untreated patients should be adequate to estimate recurrence in marker-defined subgroups of patients. Specimens from randomized trials with a survival or progression-free survival endpoints are required to establish the clinical validity of marker for predicting response to specific treatment. Tissue specimens should be available in sufficiently large numbers to permit statistically powered analyses and to ensure that the patients included in the biomarker study are representative of the patients that will be used in clinical testing in the community. Large numbers of archived specimens (i.e., peripheral blood mononuclear cells, marrow, tumor tissue, lymph nodes, plasma/serum) from uniformly treated patients that are associated with carefully annotated demographics, diagnosis, overall and progression-free survivals, and toxicity are available from the NCI sponsored Cancer Centers and multi-institutional research programs and also the NCI Clinical Trials Cooperative Oncology Group Program, an integrated national network of clinical investigators and institutions that conduct phase II and III clinical trials. Archived specimens associated with clinical data can therefore be of great importance for establishing the medical utility of prognostic or predictive biomarkers and offer improved diagnostics for use in cancer patients care.
The objective of this FOA is to promote validation studies for molecular diagnostics to prove their clinical usefulness to improve cancer patients outcome. Therefore, the specific purpose of this FOA is to develop assays that will be suitable for validation in clinical trials to assess the clinical validity of a marker and to provide evidence that the use of marker improves outcomes.
Examples of clinical utility of molecular diagnostics include, but are not limited to the following:
Analytically Validated Tests. R01 projects should be designed to determine whether analytically valid assay results are associated with clinical endpoints using retrospective or prospective tissue collections in clinical settings similar to the proposed use of the assay. Analytical validation of the assay involves a systematic evaluation to ensure that the assay meets acceptable standards of performance to be used for analyses of clinical specimens. Applicants should demonstrate that the proposed assay has the sensitivity, specificity and reproducibility adequate to answer the clinical question. Procedures for standardization of an assay should be established and the assay should be completely developed including cut-off points to measure prediction accuracy before the clinical utility validation step.
Validation of Clinical Utility. The aim of clinical validation studies should be to define marker sensitivity and specificity for clinical endpoint determination and to support its clinical utility. Successful responses to this FOA should clearly describe the clinical question that the proposed marker will address and describe how the prognostic or predictive strategy will impact existing approaches on the care of patients.
The R01 Research Project is expected to engage investigators into fully developed validation research projects using large specimen cohorts from multi-site trials proceeding to full validation using a training set and an independent validation set of specimens with a potential for clinical application. Validation of a marker in an independent test set (samples that were not used for the initial validation) is essential to confirm the strength of the association with clinical outcome. Both training and validation step should be based on cohorts of patients that are sufficiently homogenous for therapeutically relevant assay to be developed. The applicant should provide a power analysis to indicate that the number of specimens is statistically significant to assess association between the results of the validated assay and the clinical endpoint within the context of the intended use.
Clinical Specimens. The applicant should secure the access to high-quality clinical specimens that are uniformly treated in multi-center trials so that candidate biomarkers identified in discovery research that are important for tumor prognosis or response to therapy are validated and transitioned into diagnostics to be used in subsequent clinical trials. Generally, well-annotated tumor and other biospecimen cohorts collected retrospectively during large multi-institutional treatment trials are especially suitable for these studies. Prospective collections seem more suitable in the context of ongoing projects; thus the investigators need to provide specific information about the arrangements for collection and analysis of patients outcome data especially if follow-up will be required beyond the end of the award period.
This FOA is not appropriate for molecular diagnostics discovery projects. The emphasis of this program is on the transition of discovery research into new assays for the clinical management of patients with cancer. Therefore, studies to pursue initial exploration of the relationship between candidate markers and clinical parameters are not appropriate to this FOA. Candidate assays/markers generated in exploratory study could be further validated into clinically applicable assays through the currently offered funding opportunity for an R01 type of projects or the parallel PA-12-014, using the R21 Exploratory/Developmental Research grant mechanism for the pilot projects that are useful to establish the feasibility of molecular markers.
Application Types Allowed
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Application budgets are not limited, but need to reflect actual needs of the proposed project.
Award Project Period
Scope of the proposed project should determine the project period. The maximum period is 5 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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, 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
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
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 Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) 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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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 submission of applications for this FOA. 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, with the following additional instructions:
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.
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) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions 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.
All PD(s)/PI(s) 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(s)/PI(s) 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.
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.
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.
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.
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?
Are the PD(s)/PI(s), 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
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?
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?
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.
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.
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.
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.
For Renewals, the committee will consider the progress made in the last funding period.
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), in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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(s)/PI(s) 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
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’s 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
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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
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.
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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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