Identifying Non-coding RNA Targets for Early Detection of Cancer (R01)

Identifying Non-coding RNA Targets for Early Detection of Cancer (R01) is sponsored by National Institutes of Health (NIH). Supports research on non-coding RNAs and their targets in early-stage cancers for early detection and screening.

Expired PA-12-213: Identifying Non-coding RNA Targets for Early Detection of Cancer (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating National Cancer Institute ( NCI ) Funding Opportunity Title Identifying Non-coding RNA Targets for Early Detection of R01 Research Project Grant supersedes instructions in Section III. 3 regarding applications that are essentially the same.

May 30, 2013 ( NOT-OD-13-074 ) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013. Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PA-12-214 , R21 Exploratory/Developmental Research Grant Award Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), encourages research projects on non-coding RNAs (ncRNAs) and their targets in preneoplastic lesions and early stage cancers.

This FOA also encourages research projects to assess the usefulness of stable microRNAs (miRNAs) and ncRNAs to predict progression to cancer and as biomarkers for early cancer detection and screening. Building on both basic and biomarker research on microRNAs (miRNA), this FOA will further promote research on all classes of ncRNAs and support the translation of stable miRNAs into cancer screening or diagnostic tests.

Open Date (Earliest Submission Date) Letter of Intent Due Date dates apply, by 5:00 PM local time of applicant organization. AIDS Application Due Date(s) dates apply, by 5:00 PM local time of applicant organization.

Required Application Instructions It is critical that applicants follow the instructions in 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 Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), encourages research projects on non-coding RNAs (ncRNAs) and their targets in preneoplastic lesions and early stage cancers.

This FOA also encourages research projects to assess the usefulness of stable microRNAs (miRNAs) and ncRNAs to predict progression to cancer and as biomarkers for early cancer detection and screening. Building on both basic and biomarker research on microRNAs (miRNA), this FOA will further promote research on all classes of ncRNAs and support the translation of stable miRNAs into cancer screening or diagnostic tests.

This FOA will utilize the Research Project Grant (R01) mechanism to encourage the submission of research project grants to study of ncRNAs and stable miRNAs for early detection and screening as well as to develop and validate non-invasive ncRNA-based diagnostic tests. This FOA runs in parallel with an FOA, PA-12-214 , which utilizes the Exploratory/Developmental Grant (R21) mechanism. of early detection of preneoplastic lesions.

Detection and diagnosis of preneoplastic lesions and tumors early, before invasion and metastasis, have the potential to improve treatment and reduce cancer-related deaths. For example, 70 to 90 percent of colorectal cancer deaths could be prevented if precancerous polyps were detected with routine screening and surgically removed.

The Pap test is a cell-based biomarker for cervical cancer that has contributed significantly to the greater than 75% reduction in deaths due to cervical cancer in the US. For other cancers, such as ovarian and pancreatic cancers, there are no reliable screening tests. for novel biomarkers to differentiate between benign and precancerous lesions.

Distinguishing benign diseases and certain non-precancerous lesions from precancerous lesions can also aid in effective intervention, prevention, and treatment. Atypical ductal hyperplasia (ADH) and atypical lobular hyperplasia (ALH) are precancerous lesions that increase the risk of breast cancer 4-5 fold.

If these precancerous lesions could be distinguished from non-precancerous lesions, optimal treatment and follow-up could be chosen such as surgery, more frequent mammography, or magnetic resonance imaging (MRI).

These examples demonstrate the existence of an unmet need to develop methods to noninvasively and accurately detect cancers at their early stages of development and to accurately predict which precancerous lesions are likely to progress to cancer and which are not. RNAs. Non-coding RNAs (ncRNAs) are functional transcripts that do not code for proteins.

They are predominantly composed of small double-stranded RNAs (dsRNAs) and are important regulators of gene expression in many eukaryotes. Some ncRNAs trigger different types of gene silencing that are collectively referred to as "RNA silencing" or "RNA interference". A key step in the known silencing pathways is the processing of dsRNAs into short RNA duplexes of characteristic size and structure.

According to their origin or function, three types of naturally occurring small RNAs have been described: short interfering RNAs (siRNAs), repeat-associated short interfering RNAs (rasiRNAs) and microRNAs (miRNAs). Of these ncRNAs, miRNAs are the most widely studied and characterized.

Other classes of ncRNA are transfer RNA (tRNA), ribosomal RNA (rRNA), PIWI-associated RNAs (piRNAs), small nucleolar RNAs (snoRNAs), promoter-associated RNAs (PARs), telomere specific small RNAs (tel-sRNAs), ultra conserved ncRNAs (ucncRNAs), and long ncRNAs (lncRNAs), a very recently discovered new type of non-protein of stable microRNAs and ncRNAs as biomarkers for cancer detection.

Several properties of stable miRNAs, and perhaps other classes of ncRNAs, make them good candidate biomarkers for early cancer detection and for determining which preneoplatic lesions are likely to progress to cancer. First, expression patterns of miRNAs in human cancers appear to be tissue specific, and miRNA profiles appear to reflect developmental lineage and differentiation state of the tumors.

miRNA profiles have been reported to more accurately classify poorly differentiated tumors than do mRNA profiles. Second, unlike mRNAs that are rapidly degraded in blood, miRNAs are relatively stable as they are protected from endogenous RNase activity, either because they are bound to proteins or contained within endosomes.

Third, miRNAs can be quantitatively measured in human sera or plasma using quantitative reverse transcription polymerase chain reaction (qRT-PCR).

Specific Research Objectives This FOA encourages research on the discovery, characterization, and translation of all classes of ncRNAs and stable miRNAs to (1) improve early cancer detection, intervention, and prevention; (2) predict risk of progression from preneoplasia to cancer; (3) distinguish benign lesions from precancerous lesions; and (4) facilitate imaging-based diagnosis or topics relevant to this PA include, but are not limited to: Discovery and characterization of ncRNAs in early stage cancers and in precancerous lesions.

Determination of the utility of ncRNAs in body fluids to provide a basis for developing noninvasive assays for early diagnosis. Comparison of ncRNAs in precancerous lesions that progress to cancer with those in precancerous lesions that do not progress.

Combination of ncRNAs with other molecular markers, such as mRNA expression profiles and genetic variations, to improve sensitivity and Determination of the sensitivity and specificity of ncRNAs using high quality specimens from completed trials or cohorts. Discovery and evaluation of ncRNAs to be used in conjunction with image-based screening, diagnosis, and early detection.

Determine the molecular pathways targeted by ncRNAs that predispose to cancer initiation or progression. Determine whether interfering with oncogenic ncRNA processing, target selection, or associated pathways prevent cancer progression. This FOA strongly supports novel ideas and approaches to develop and systematically validate non-invasive ncRNAs for cancer early detection and screening.

For example, combining information on ncRNAs with that on other types of biomarkers can improve cancer risk assessment, detection, and prognosis. Specific genetic polymorphisms are associated with the risk of developing several types of cancer. In addition to BRCA1 and BRCA2, mutations in ATM, CHEK2, p53, and PTEN are associated with increased breast cancer risk.

Germline mutations in the DNA mismatch repair genes MSH2, MLH1, and MSH underlie hereditary non-polyposis colorectal cancer (HNPCC) or Lynch syndrome, a hereditary predisposition for cancer. These germline mutations can provide an estimate of an individual lifetime risk of developing cancer, as these mutations are stable if inherited.

However, they are not determinative, not everyone with germline mutations in the mismatch repair genes MSH2, MLH1, or MSH6 develop colorectal cancer. Moreover, they are not useful, in most situations, to predict short time risk that is highly relevant to early diagnosis.

Thus, there is a need to combine genomic mutations with ncRNA markers to develop marker panels for more accurate risk assessment and early The R01 mechanism is intended to encourage research projects that are built on strong preliminary results.

For example, projects to evaluate and validate ncRNA biomarkers for early detection and screening using high quality and well annotated specimens in proper cohorts, such as cancer prevention clinical trials.

Because of the nature of complexity in the validation of stable miRNAs and ncRNAs relevant biomarkers, multi-investigators and institutes, including international collaborations are encouraged for cancer early detection and screening. Section II.

Award Information Application Types Allowed Glossary and the SF 424 (R&R) Application Guide provide details on 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 Application budgets are not limited, but need to reflect actual needs of the proposed project. The maximum period is 5 years.

Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Native and Native Hawaiian Serving Institutions Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions 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 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 Faith-based or Community-based Organizations 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 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 Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually 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 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal 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) This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility 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. Section IV. Application and Submission Information 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 . 2. Content and Form of Application Submission It is critical that applicants follow the instructions in (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 For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Required and Optional Components 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 Page Limits must be followed.

PHS 398 Research Plan Component All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 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) All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Foreign (non-US) institutions must follow policies described 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 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. 4. Intergovernmental Review This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Pre-award costs are allowable only as described in the NIH Grants Policy Statement .

Requirements and Information 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 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/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. 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.

Requests of $500,000 or more for direct costs in any year 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) Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115 .

Section V. Application Review Information 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 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 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 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 Additional Review Criteria 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 Subjects Protection and Inclusion Guidelines .

Inclusion of Women, Minorities, and 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 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 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 Additional Review Considerations 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 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.

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).

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 Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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: May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact/priority Will receive a written critique.

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. 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: Scientific and technical merit of the proposed project as determined by scientific peer review. Relevance of the proposed project to program priorities. 3.

Anticipated Announcement 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 Grants Policy Statemen t .

Administration Information If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as 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’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. National Policy Requirements 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: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities . More information is 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 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 Section VII. Agency Contacts We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Application Submission Contacts Customer Support (Questions regarding Grants.

gov registration and submission, downloading or navigating forms) GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources) eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, tracking application status, post submission issues) Phone: 301-402-7469 or 866-504-9552 (Toll Free) Scientific/Research Contact(s) Division of Cancer Prevention (DCP) National Cancer Institute (NCI) 6130 Executive Boulevard, EPN 3138, MSC 7362 Bethesda,MD 20892-7362 (for U.S. Postal Service express or regular mail) Rockville, MD 20852 (for express/courier delivery) Telephone: (301) 594-7607 E-mail: [email protected] Division of Cancer Prevention (DCP) National Cancer Institute (NCI) 6130 Executive Boulevard, EPN, Room 3140, MSC 7362 Bethesda, MD 20892-7362 (for U.S. Postal Service express or regular mail) Rockville, MD 20852 (for express/courier delivery) Telephone: (301) 496-9424 E-mail: [email protected] Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due Financial/Grants Management Contact(s) Office of Grants Administration National Cancer Institute, NIH 8490 Progress Drive, Suite 4078 Telephone: (301) 631-3006 E-mail: [email protected] Section VIII.

Other Information 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 .

Authority and Regulations 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. Weekly TOC for this Announcement NIH... Turning Discovery Into Health ®