Secondary Analysis and Integration of Existing Data to Elucidate Cancer Risk and Related Outcomes (R01 Clinical Trial Not Allowed) is sponsored by National Cancer Institute (NCI). This grant supports research involving the secondary analysis and integration of existing data to gain new insights into cancer risk and related outcomes. This can include understanding factors that cause cancer and developing risk-reduction strategies.

PAR-25-095: Secondary Analysis and Integration of Existing Data to Elucidate Cancer Risk and Related Outcomes (R01 Clinical Trial Not Allowed) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Cancer Institute ( NCI ) National Human Genome Research Institute ( NHGRI ) National Institute of Dental and Craniofacial Research ( NIDCR ) Funding Opportunity Title Secondary Analysis and Integration of Existing Data to Elucidate Cancer Risk and Related Outcomes (R01 Clinical Trial Not Allowed) R01 Research Project Grant Notices of Special Interest associated with this funding opportunity March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity Exploratory/Developmental Grants See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) 93. 393, 93.

121, 93. 866, 93.

172 Funding Opportunity Purpose Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) along with other participating Institutes encourages submission of applications proposing to conduct secondary data analysis and integration of existing datasets and database resources, with the ultimate aim to elucidate cancer risk and related outcomes (e.g., risk prediction or reduction, survival, or response to treatment, etc.).

The goal of this initiative is to address key scientific questions relevant to cancer by supporting the analysis of existing clinical, environmental, surveillance, health services, vital statistics, behavioral, lifestyle, genomic, and molecular profiles data. Applicants are encouraged to leverage and perform innovative analyses of the existing data.

Applications may include new research aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions in cancer research.

Funding Opportunity Goal(s) The overall goals of this NOFO are to identify cancer risks and risk reduction strategies, to identify factors that cause cancer in humans, and to discover and develop mechanisms for cancer prevention and preventive interventions in humans. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) 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.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of 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 Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) along with other participating Institutes encourages submission of applications proposing to conduct secondary data analysis and integration of existing datasets and database resources, with the ultimate aim to elucidate cancer risk and related outcomes (e.g., risk prediction or reduction, survival, or response to treatment, etc.).

The goal of this initiative is to address key scientific questions relevant to cancer by supporting the analysis of existing clinical, environmental, surveillance, health services, vital statistics, behavioral, lifestyle, genomic, and molecular profiles data. Applicants are encouraged to leverage and perform innovative analyses of the existing data.

Applications may include new research aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions in cancer research. This NOFO runs in parallel with another NOFO of identical scientific scope, PAR-25-096, which utilizes the Exploratory/Developmental Grant (R21) mechanism.

NIH and other research funding organizations support numerous studies that generate a large amount of phenotypical, exposure, behavioral, clinical and genomic data, which continue to be made available to the scientific community. Many of these datasets have not been analyzed to their full potential and further investigation will provide opportunities to answer important research questions at a relatively low cost.

Several NCI programs support population science research that spans the cancer control continuum, e.g., in genomic, epidemiology, surveillance, health services, behavioral science, and cancer survivorship to understand and clarify cancer risk, progression, and outcomes. These studies generate a wealth of individual- and population-level data, including molecular, lifestyle, clinical, demographic, and environmental data.

Leveraging these various types of existing data through innovative data modeling and analysis allows new questions to be addressed and helps to advance the field of cancer research.

NIH has made it a priority to make data more Findable, Accessible, Interoperable and Reusable (FAIR) to researchers to further biomedical research, through several sharing policies , including the 2015 Genomic Data Sharing (GDS) Policy and the 2023 NIH Policy for Data Management and Sharing .

Enhanced data sharing is also a key priority of the NCI, as highlighted by the NCI Cancer Moonshot Public Access and Data Sharing Policy and by the National Cancer Plan goal to maximize data utility by sharing and using available data to achieve rapid progress against cancer.

NIH requirements for data sharing in grant proposals, combined with public and private sector initiatives by donors, journals, and foundations, have led to unprecedented amounts of available data for secondary research, which have been successfully utilized to discover novel biomarkers of disease and to find novel uses for existing therapeutics.

The goal of this initiative is to encourage applications from institutions/organizations that propose to conduct innovative secondary data analyses to address knowledge gaps in cancer control using innovative approaches and integration of existing datasets with the ultimate aim of further elucidating cancer risk and related outcomes.

The initiative will stimulate innovative methods and leveraging of existing data sources whose number is expected to continue increasing as more data becomes available through data sharing.

Specific Research Objectives and Scope of the NOFO Analyses that incorporate the vast amount of genomic, clinical, environmental, surveillance, health services, vital statistics, behavioral, and other types of data obtained in recent years, have great potential to illuminate the complex interactions among the environment, behavior, genes, and gene products, to redefine cancer across the continuum, and to lead to novel hypotheses regarding prevention and treatment of cancer.

Applicants are encouraged to leverage existing data and perform innovative analyses of the existing data. Applications may include new aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions.

Specifically, this NOFO encourages applications that leverage existing data and could include one or more of (but not limited to) the following aspects: Link together and analyze through system epidemiology approaches longitudinal multi-level/domain data types, including genomic, other omics, biomarker, environmental, socio-demographic, behavioral, economic, clinical, health care delivery, disease, screening, and vital statistics (e.g., mortality) data to study specific cancer types and/or across cancers and related conditions; data can be obtained from registry, case-control, cohort, and clinical studies and should be appropriately combined and harmonized; linking could be performed by matching entities (e.g., people, direct links of the same respondents) or through external variables (e.g., geocodes, different geographic levels) to assess for multi-level influences (e.g., census tract, county, or state).

Facilitate utilization of newly developed or updated resources, tools, and guidelines in population-scale cancer research (e.g., human genome reference or other molecular annotations, Informatics tools, or population descriptors guidelines).

Employ innovative analytic techniques that demonstrate or promote methodological advances in genomic and epidemiologic cancer research and that accelerate population-scale genomics research, e.g., through integration of multiple data types derived from humans and obtained through various single cell and/or bulk tissue molecular techniques (germline and/or somatic genomics, transcriptomics, proteomics, metabolomics) to better understand complex interactions among genes and gene products in the context of cancer.

Assess cancer-related behavioral health questions and risk factors (e.g., physical performance, anthropometric testing, dietary intake, exercise, physical and social environment, cancer screening, tobacco or alcohol use, sleep hygiene, etc.) through innovative methods, tools, or technology.

Advance image analysis and extraction of behavioral and environmental information (e.g., street-level digital images, aerial images, medical images, etc.) and accelerate or automate geospatial data cleaning, processing, and analysis to address cancer related questions. Develop analytical strategies for cancer surveillance.

Advance research in healthcare delivery to better understand factors that affect methods of cancer detection (screen versus symptom) and/or inequitable use of primary and secondary prevention strategies. Serve cancer survivors and their communities by predicting and assessing patients' diagnosis, trajectory, comorbidities, response to treatment, and symptom management.

Address questions related to health disparities and augment implementation and translation of research findings into practice by generating or improving related methods, tools, or technology (e.g., for medical image processing in low resource settings to improve precision risk management, or for reducing machine learning biases from inaccurate data representation of the complexity of society).

This NOFO capitalizes on NCI and NIH past investments in several programs that have supported from basic biological to clinical biomedical research by leveraging the generated molecular, lifestyle, clinical, and environmental data to conduct new investigations in cancer control and population sciences, including cancer healthcare delivery, surveillance, behavior, epidemiology, and population-scale 'omics research.

All data analyses must concern research designed to elucidate cancer etiology, incidence, prevalence, natural history, pathophysiology, or related outcomes, including cancer related conditions and disorders. NCI focus . Applicants should consider the relevance of their proposed analyses to those NCI programs and priorities that can be tackled through the study of existing data.

Potential applicants are encouraged to speak with the listed NCI program officials to discuss the relevance of the proposed research topic(s). NIA focus. NIA welcomes applications that analyze and/or integrate genetic, 'omics, behavioral, social, and other datasets for the contribution of aging as a risk factor for the pathogenesis of adult cancers.

Potential applicants are encouraged to communicate with the NIA program officials to discuss their research interests and their relevance to this NOFO. NIDCR focus. NIDCR supports secondary data analysis and data integration research in the assessment of cancer risk, progression, and outcomes that are relevant to oral, oropharyngeal, and salivary gland cancers.

NIDCR will also consider applications that incorporate new statistical or computational methods to help improve the accessibility and/or speed of dissemination of data resources. Potential applicants are encouraged to speak with the listed NIDCR program officials to discuss the relevance of the proposed research topic(s). NHGRI focus.

NHGRI welcomes applications that develop new approaches for elucidating the genetic architecture of human health and disease which are broadly generalizable across diseases, phenotypes, and health outcomes (e.g., risk prediction or reduction, survival, or response to treatment) in addition to cancer.

NHGRI is particularly interested in applications to develop novel methods for integrating multiple types of genomic data and other data types. Projects that focus only on tumor genomics will not be appropriate for NHGRI funding. NHGRI encourages leveraging data available through NHGRI’s Genomic Data Science Analysis, Visualization, and Informatics Lab-Space ( AnVIL ).

Applicants are encouraged to collaborate with investigators holding publicly as well as non-publicly available data sets, using innovative statistical strategies to harmonize and link methodologically comparable datasets and sharing with the research community the harmonized datasets. Applicants are encouraged to leverage the large volume of data publicly available to the scientific community.

Some examples currently include (but are not limited to) the following: Genotype and phenotype datasets deposited in the database of Genotypes and Phenotypes (dbGaP) ; Gene expression profiles deposited in Gene Expression Omnibus (GEO) and high-throughput functional genomics experiments and assays deposited in the ArrayExpress archive; DNA/RNA binding and DNA accessibility/methylation experiments deposited in the Encyclopedia of DNA Elements (ENCODE) ; Genotype and RNA-seq data across tissue sites and cell lines deposited in the Genotype-Tissue Expression (GTeX) and Developmental GTeX (dGTeX) projects; Proteomic data measured by mass spectrometry in cancer biospecimens from CPTAC and ICPC deposited in the Proteomic Data Commons (PDC) ; Multidimensional maps of genomic changes across cancer types based on paired tumor and normal tissue sets collected from cancer patients deposited in The Cancer Genome Atlas Program (TCGA) ; Sequencing data from human samples deposited in the NCBI Short Read Archive (SRA) and in the NCI Cancer Data Service (CDS) ; Harmonized cancer genomic datasets deposited in the NCI Genomic Data Commons (GDC) ; Imaging information linked to clinical and genomic data across cancer sites available in The Cancer Imaging Archive (TCIA) and the NCI Imaging Data Commons (IDC) ; Data on therapy outcomes from clinical trials and patient registries such as the Pediatric Proton Consortium Registry (PPCR) ; Epidemiological, clinical, and molecular data from established cancer cohorts such as the follow-up of the Prostate, Lung, Colorectal and Ovarian (PLCO) Trial and others in the Cancer Epidemiology Descriptive Cohort Data (CEDCD) , as well as from newer cancer cohorts such as the Connect for Cancer Prevention Study ; The Surveillance, Epidemiology, and End Results (SEER) Program Data & Software , including SEER*Stat, SEER-Medicare, SEER-Medicaid, SEER-CHAPS, and SEER-MHOS; Data from the NCI funded research network of US healthcare delivery systems Population-based Research to Optimize the Screening Process (PROSPR) DataShare , the Patterns of Care (POC) initiative, the Social Determinants of Health Dataset , and other healthcare delivery datasets ; Population-level health survey data such as the National Health Interview Survey (NHIS), the National Health and Nutrition Examination Survey (NHANES) , the Behavioral Risk Factor Surveillance System (BRFSS) , the Medical Expenditures, Panel Survey (MEPS) , the Health Information National Trends Survey (HINTS) , the Tobacco Use Supplement to the Current Population Survey (TUS-CPS) , TUS-CPS datasets linked to other US Census Bureau research datasets and National Death Index registry (e.g., the Tobacco Longitudinal Mortality Study (TLMS) and sub-linkages); Behavioral and social science data in the Inter-university Consortium for Political and Social Research (ICPSR) data repository; Genetic and health information from half a million UK participants stored in the UK Biobank ; Electronic Health Record (EHR) data, genomic data, physical measurements, survey responses and wearable data collected from the All of Us Research Program participants; Data available through the Data and Specimen Hub (DASH) , including the Environmental influences on Child Health Outcomes (ECHO) data; The NIH Common Fund-supported Gabriella Miller Kids First Data Resource Center and the trans-NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Data Coordinating Center Data Hub ; Genetic, lifestyle, and exposure data from Veterans partners in the Million Veteran Program (MVP) ; Genomic, other 'omic, and phenotype data available through NHGRI’s Genomic Data Science Analysis, Visualization, and Informatics Lab-Space (AnVIL) ; Other datasets, including those listed in the NIH resources page and HHS data hub page .

This mechanism can also be used to retrospectively harmonize measures across disparate datasets and to merge secondary data sets with other data sets to better address important research hypotheses. For example, if allowed by informed consent, genetic datasets could be matched with hospital datasets or vital statistics.

Applicants who plan to utilize data not currently in their possession (originated from another party) should confirm availability of the data and the willingness and permissibility of the original investigators to share the data for the purposes of the secondary analyses (letters of support and/or data access approval are encouraged), in accordance with all applicable rules for the protection of human subjects.

Collaborations and Authorship Projects developed in response to this NOFO should include complementary and integrated expertise and experience to conduct the proposed data analyses. Any publications resulting from awards funded under this NOFO must include acknowledgment of the source of shared data and any funding sources which supported the initial data collection.

If appropriate, applicants should discuss co-authorship plans with original and/or contributing investigator(s) prior to submitting an application. Awardees are expected to broadly share the cleaned and harmonized datasets, software, programmed codes, and analysis tools developed for the analysis of the data, when appropriate and consistent with the participant informed consent.

Costs for making data publicly available, when appropriate and not already available, may be included in the budget, as long as the archival activities are pertinent to the proposed secondary analyses. Plans for archiving must include adequate dataset documentation and explanation so that it can be used by researchers not associated with the original study.

Applications can be related to but must be distinct from the specific aims and methods of the original data collection. The primary analyzed data can be derived/redefined from existing data but should not be newly collected from study participants nor newly generated from existing biological specimens. The NOFO will allow up to 10% of the budget towards new data generation for validation of key findings.

Non-Responsive Applications The following types of studies are outside the scope of this NOFO and applications describing them will be considered non-responsive: Studies that propose to collect or generate new data for purposes other than limited validation of key findings; Studies that propose to analyze only data obtained from non-human samples; Studies that propose to carry out currently ongoing data analysis or to maintain and distribute data sets.

See Section VIII. Other Information for award authorities and regulations. Section II.

Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial? 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.

The budget is limited to $350,000 direct costs per year and should reflect the actual needs of the proposed project. The maximum project period is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) 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 their organization to develop an application for 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 How to Apply-Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity 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. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. The NOFO will allow up to 10% of the budget towards new data generation for validation of key findings.

All instructions in the How to Apply-Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Research Strategy: The Research Strategy should clearly describe the following within the appropriate section: Significance: All applications should include an overall strategy that leverages existing clinical, environmental, surveillance, vital statistics, behavioral, lifestyle, genomic, and molecular profiles data.

All data analyses must concern research designed to elucidate cancer etiology, incidence, prevalence, natural history, pathophysiology, or related outcomes, from basic biological research to clinical cancer research and cancer control and population sciences, including cancer healthcare delivery, surveillance, behavior, epidemiology, and population-scale 'omics research.

The study design should incorporate at least one of the following features: development or application of novel analytical approaches; exploration and integration of multiple clinical, environmental, surveillance, vital statistics, behavioral, lifestyle, genomic, and molecular data types; incorporation of additional studies or alternative datasets; and/or investigation of phenotypes not studied before using the proposed existing dataset.

Approach : Applications should clearly describe the proposed analytical methods, their feasibility, and innovation in comparison to other existing methods and include possible method evaluation and validation plans.

Applicants should demonstrate knowledge of the proposed dataset(s) and include details on data source, number of individuals, number and type of samples, type of clinical, environmental, surveillance, vital statistics, behavioral, lifestyle, genomic, and molecular information available and included in the analysis.

Applicants should address (including through statistical power calculations) how the proposed dataset(s) are suitable and sufficient to fulfill the research aims and describe approaches to overcome challenges associated with small sample sizes, be these cancer types, cell types, or unique human populations. The proposed analyses should be feasible within the timeline proposed.

This NOFO is tailored to cost-effective studies that reutilize existing resources for secondary data analysis, which may lead to findings that warrant experimental, clinical, or other validations. Any proposed new data generation within these applications should be limited (<10% of the budget) to the validation of key findings.

If appropriate to the proposed science, applicants should describe how their findings could be further tested or validated in a follow-up independent study.

While it is expected and understood that the research proposal will be constrained by the limited availability of existing data in groups currently underrepresented in biomedical research, the research plan should nevertheless adequately describe the investigators efforts, successes, and challenges in finding and including in the analysis any relevant available datasets representing these populations, as well as address the translational relevance of findings to these populations and/or specific needs for follow-up studies based on data to become available in the near future.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Awardees are expected to broadly share the cleaned and harmonized datasets, analysis tools and any other software developed for the secondary analysis and integration of the data, when appropriate and consistent with the participant informed consent.

Sharing of adequate documentation and explanation is also expected so that data and tools can be used by researchers not associated with the original study. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix. PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects