Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI)
Funding Opportunity Title	Validation and Advanced Development of Emerging Technologies for Biospecimen Science (R33)
Activity Code	R33 Exploratory/Developmental Grants Phase II
Announcement Type	Reissue of RFA-CA-12-005
Related Notices	December 20, 2013 - This RFA has been reissued as RFA-CA-14-006.
Funding Opportunity Announcement (FOA) Number	RFA-CA-13-004
Companion Funding Opportunity	RFA-CA-13-001, R21 Exploratory/Developmental Grant RFA-CA-13-002, R33 Exploratory/Developmental Grants Phase II RFA-CA-13-003, R21 Exploratory/Developmental Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.393, 93.394, 93.395
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), solicits grant applications proposing technically innovative feasibility studies focused on the advanced development and validation of cancer-relevant technologies that address issues related to pre-analytical variations in the collection, processing, handling, and storage of biospecimens or their derivatives. The overall goal is to develop technologies capable of interrogating and/or maximizing the quality and utility of biospecimens or their derived samples for downstream analyses. This FOA will support the development of tools, devices, instrumentation, and associated methods to assess sample quality, preserve/protect sample integrity, and establish verification criteria for quality assessment/quality control and handling under diverse conditions. This FOA solicits R33 applications; this mechanism is suitable for projects where proof-of-principle of the proposed technology or methodology has already been established and supportive preliminary data are available. Projects proposing to use established technologies where the novelty resides in the biological or clinical question being pursued are an example of a topic not appropriate for this solicitation as non-responsive and will not be reviewed. This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program.

Posted Date	November 9, 2012
Open Date (Earliest Submission Date)	January 20, 2013
Letter of Intent Due Date(s)	January 20, 2013; April 20, 2013; August 20, 2013
Application Due Date(s)	February 20, 2013; May 20, 2013; September 20, 2013, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June/July 2013; October/November 2013; February/March 2014
Advisory Council Review	October 2013; January 2014; May 2014
Earliest Start Date	December 2013; April 2014; July 2014
Expiration Date	September 21, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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), solicits grant applications proposing research projects on the advanced development and validation of cancer-relevant technologies that address issues related to pre-analytical variations in the collection, processing, handling, and storage of biospecimens or their derivatives. The overall goal is to develop technologies capable of interrogating and/or maximizing the quality and utility of biospecimens or their derived samples for downstream analyses.

FOA Emphasis: This FOA will support the development of tools, devices, instrumentation, and associated methods to assess sample quality, preserve/protect sample integrity, and establish verification criteria for quality assessment/quality control and handling under diverse conditions. The R33 mechanism is suitable for projects where proof-of-principle of the proposed technology or methodology has already been established and supportive preliminary data are available. Projects proposing to use established technologies where the novelty resides in the biological or clinical question being pursued is an example of a topic not appropriate for this solicitation as non-responsive and will not be reviewed.

This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program (http://innovation.cancer.gov).

Since its inception in 1998, the IMAT Program has focused on stimulating and accelerating the development, integration, maturation, and dissemination of the most novel and highly innovative technologies in support of cancer research and medicine. Together with the NCI's other technology-focused programs, the IMAT Program continues to support the development of tools and methods that enable cancer researchers to make new discoveries, enhance our understanding of cancer etiology and proliferation, improve detection capabilities, develop diagnostic methods and treatment strategies, conduct large population studies, address and reduce disparities in clinical care, and assist in clinical decision-making.

The current issuance of the IMAT Program consists of four separate FOAs that cover the following three areas:

• Innovative Molecular Analysis Technology Development for Cancer Research (RFA-CA-13-001, using the R21 funding mechanism), which is intended to support research projects that are centered on the inception and preliminary development of highly innovative molecular analysis technologies with potentially high impact on cancer research;
• Emerging Molecular Analysis Technology Development for Cancer Research (RFA-CA-13-002, using the R33 funding mechanism), designed to support further development (beyond the initial phase) of emerging molecular analysis technologies that have the potential to be transformative when used for cancer research and/or in cancer-relevant clinical care; and
• Innovative and Applied Emerging Technologies in Biospecimen Science is centered on the development and validation of novel technologies to improve or assess the quality of cancer-relevant biospecimens for research or clinical care. The emphasis is on issues related to pre-analytical variations in the collection, processing, handling, and preservation of cancer-relevant biospecimens or their derivatives to improve their quality and utility for cancer research or patient clinical care.
  • RFA-CA-13-003 (R21): Supports an early-stage feasibility study (inception through preliminary development) to demonstrate core functional capabilities of the proposed technology.
  • This FOA, RFA-CA-13-004 (R33): Assumes completion of the initial phase of development and supports the advanced development and robust validation of the technology.

Additional information about the IMAT Program and its individual FOAs can be found at http://innovation.cancer.gov.

The proposed projects must be focused on the validation and advanced development of technologies and methodologies that improve the quality and utility of biospecimens and/or samples derived from biospecimens for cancer research and clinical care. The proposed technology may be targeted for the biospecimen/sample preparation needs of basic, preventative, diagnostic, translational, epidemiological, health disparities, and/or clinical cancer research or for broad potential use in cancer research

In addition, all projects proposed in response to this FOA must involve all of the following general attributes:

• Potential for substantial improvements over conventional approaches and/or adding qualitatively new research capabilities not provided by current technologies.
• Transformative Potential. The emphasis of the IMAT program is on technologies that have significant potential to transform research in laboratory and/or clinical settings.

Responsive technologies include relevant techniques, tools, instrumentation, devices, and associated methods. These technologies must focus on the procurement, preservation and/or preparation of specified molecular and/or cellular targets. Each application submitted in response to this FOA should contain a clear description of the novelty of the proposed technology and its anticipated long-term use to advance cancer research or clinical care (see "Statement of Potential Impact," above).

Projects in any area of technology development for cancer-related biospecimen science are encouraged provided that the technology proposed meets the requirement for transformative potential. Technologies may target all levels of biospecimen procurement, preservation, and/or preparation for analysis.

General areas of interest include, but are not limited to, the following:

• Novel technologies to benchmark or otherwise assess the biological integrity of classes of molecular analytes (i.e., determine fitness-for-purpose);
• Novel technologies and techniques to provide high-quality preservation of specific classes of molecules, sub-cellular components, whole cells or bulk tissue;
• New methods, tools, and procedures that may generally facilitate the preparation of biospecimens for classes of molecular analysis (e.g., genomic sequencing, profiling of protein or RNA extract);
• Technologies that can facilitate and/or enhance molecular analyses in cancer epidemiology (e.g., by allowing for rigorous and/or expeditious collection of various relevant types of biospecimens);
• Technologies or tools that may help overcome various barriers in research on the incidence, prevalence, mortality, and burden of cancer among members of underserved populations; and
• Technologies to facilitate the collection of relevant biological data for examining the factors contributing to cancer health disparities (e.g., for cancer sub-types and differences across individuals with diverse racial/ethnic backgrounds).

IMPORTANT NOTE: Researchers uncertain as to whether their intended technology development project meets the requirements of this FOA are encouraged to contact the program official listed below (under Scientific/Research Contact).

The following aspects/characteristics remain outside the scope of the IMAT Program and this FOA. Applications proposing projects with any of the following characteristics will not be reviewed:

• Pursuit of a biological or clinical hypothesis for which the novelty resides in the biological or clinical question (i.e. traditional biological-hypothesis driven research);
• Use of existing technologies (for which proof-of-concept has already been obtained) that may be ready for the targeted applications without substantial further developmental efforts;
• Technologies for whole-body or in vivo imaging methods;
• Inclusion of clinical trials or toxicology studies beyond those required to demonstrate the capabilities of the technology;
• Biomarker discovery or biomarker validation;
• Development of specific contrast agents;
• Development of drugs or therapies; and/or
• Projects focused primarily on software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling (including those applicable to drug and/or patient responses) with the exception of projects which include software development for embedding in new devices or limited amounts of computational efforts as might be needed to develop new devices or methods;

Applications that may have appropriate scientific scope but do not include the required specific components (e.g., Statement of Potential Impact) will also be considered non-responsive to this FOA and will not be reviewed. For example, not reviewed will be applications that fail to provide the following elements:

• Tangible information that reviewers can use to assess whether the proposed project is truly exploring more than incremental technical advances to existing technologies;
• Tangible information that reviewers can use to assess the potential of the proposed project for transforming cancer research.

Related IMAT FOA: Applicants proposing projects that are for investigating the feasibility or the exploratory stage of development of an innovative technology, rather than advanced development and validation of an emerging technology, should consider applying to the parallel FOA (RFA-CA-13-003) that uses the NIH R21 mechanism.

Other technology-related funding opportunities. Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software solutions should consider one of the Informatics Technologies for Cancer Research (ITCR; http://itcr.nci.nih.gov) opportunities or one of the Biomedical Information Science and Technology Initiative (BISTI; http://bisti.nih.gov) opportunities.

Researchers who emphasize the assessment of whole body or in vivo imaging technologies as the primary focus of their projects should contact the Cancer Imaging Program (CIP; http://imaging.cancer.gov/) for information on appropriate funding opportunities.

An annual 2-day meeting of all investigators funded through this program will be held to share progress and research insights that may lead to further progress in the program.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Resubmission, only for applications submitted in response to this FOA or prior issuance of this FOA (RFA-CA-12-005). The OER Glossary and the SF424 (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. NCI intends to fund an estimate of 2 awards, corresponding to approximately $700,000 in total costs for fiscal year 2014. Future year amounts will depend on annual appropriations.
Award Budget	Direct costs are limited to $900,000 over a 3-year period, with no more than $300,000 in direct costs allowed in any single year. Application budgets must reflect actual needs of the proposed project.
Award Project Period	The total project period may not exceed 3 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

• 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 of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• 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

Other

• 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
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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 SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (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 6 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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide. Resubmissions are only eligible for applications originally submitted to this FOA or a prior issuance of this FOA (RFA-CA-12-005).

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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research;
• Short narrative of proposed research (single paragraph description);
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s);
• Names of other key personnel;
• Participating institution(s); and
• Number and title of this funding opportunity.

The letter of intent should be sent to:

Tony Dickherber, Ph.D.
Center for Strategic Scientific Initiatives, Office of the Director
National Cancer Institute, NIH
31 Center Drive, Room 10A33
Bethesda, MD 20892
Telephone: (301)547-9980
Email: [email protected]

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.

Applicants must include travel expenses for at least one PD/PI to attend the annual 2-day meeting of all investigators funded through this program.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims

In Specific Aims (within the standard page limit), include a brief sub-section "Statement of Potential Impact" on the expected potential of the proposed technology to transform cancer research and clinical practice. The following questions should be addressed.

• How is the technology potentially transformative and why may it be expected to produce an unusually high impact on biomedical research and medicine? (i.e., describe the potentially transformative application(s) that might be realized should this technology be successfully developed)?
• What are the pioneering approaches for which the potential for groundbreaking or paradigm-shifting results compensates and justifies any associated risks?
• What concrete evidence can be provided to substantiate the claim of innovativeness beyond currently available technologies?

Applications lacking the Statement of Potential Impact will not be reviewed.

Research Strategy

Within the standard page limit of the Research Strategy section, applicants must address the following required aspects:

• Validation of Biospecimen Science-relevant technology. Applications must focus on the advanced development and validation of technologies and methodologies that improve the quality and utility of biospecimens and/or samples derived from biospecimens for cancer research and clinical care. The proposed technology may be targeted for the biospecimen/sample preparation needs of basic, preventative, diagnostic, translational, epidemiological, health disparities, and/or clinical cancer research or for broad potential use in cancer research.
• Substantial Improvement and/or New Capabilities. All proposed technologies must offer the potential for substantial improvements over conventional approaches and/or add qualitatively new research capabilities not provided by current technologies.
• Transformative Potential (Statement of Potential Impact). Define clearly the novelty of the proposed technology and describe its anticipated cancer-relevant use. Provide tangible information substantiating the claimed transformative potential.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

• All applications, regardless of the amount of direct costs requested for any single year, should address a Data Sharing Plan.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) 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 applications before 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 before the deadline 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 SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(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 System for Award Management (SAM). 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 and responsiveness by the NCI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

No formal intellectual property management plan is required for R33 applications submitted in response to this FOA. Nevertheless, applicants are directed to the NIH policy on the dissemination of biological research resources (research tools) at http://www.ott.nih.gov/policy/rt_guide_final.html for guidelines pertinent to any future intellectual property commercialization plans they may consider.

Participation in Program Evaluation

All IMAT awardees will be expected to assist the NCI in the evaluation of the IMAT Program by providing additional specific information as needed. For example, the NCI program staff members may seek information relevant to such aspects as: progress towards the commercialization of the new technology (e.g., patents or licensing agreements, and further stages beyond the IMAT project period); the actual use of the technology supported by IMAT later in the pursuit of novel research directions (and any collaborations related to such pursuits); and any other aspects that may help optimize further NCI efforts to support development of new technologies.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115. For submission of short (up to 2 min) video clips (e.g., for depicting functional elements of the technology) applicants are required to follow instructions defined in NOT-OD-12-141.

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 score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, specific for this FOA: What is the potential of the proposed technology to transform cancer research or clinical practice if the project is successfully completed? Are the expectations in that area realistic and in line with the planned developmental efforts? Do the proposed milestones support a transformative capacity for a cancer-relevant field of research or clinical care?

Investigator(s)

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, specific for this FOA: Does the proposed technology offer clear and significant improvement over currently available methods and platforms? Will the proposed technology offer new possibilities for cancer research or oncological practice relative to the current methods? If the project focuses on a new cancer-relevant application of an existing technology, how innovative is the proposed new type of technology usage?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

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 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), convened by the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group 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 score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the NCI. 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 National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’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, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement. The use of RPPR is encouraged."

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.

In addition, all IMAT awardees will be expected to provide additional specific information that might be needed for the evaluation of the IMAT Program by the NCI.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Tony Dickherber, Ph.D.
Program Director
Center for Strategic Scientific Initiatives, Office of the Director
National Cancer Institute
31 Center Drive, Room 10A-33
Bethesda, MD 20892
Tel: (301) 547-9980
Email: [email protected]

Referral Officer
Division of Extramural Activities
National Cancer Institute
9609 Medical Center Drive, Room 7W412
Bethesda, Maryland 20892-9750 (for Express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
E-mail: [email protected]

Amy Knight
Grants Management Specialist
Office of Grants Administration
National Cancer Institute, NCI
8490 Progress Drive, Suite 400
Frederick, MD 21701-4998
Telephone: 301-631-3007
Fax: 301-631-3030
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.