It is critical that applicants follow the Research (R) 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) invites grant applications for the Research Specialist Award (R50) in any area of NCI-funded cancer research. This FOA is specifically for laboratory-based scientists.

The Research Specialist Award is designed to encourage the development of stable research career opportunities for exceptional scientists who want to continue to pursue research within the context of an existing NCI-funded basic, translational, clinical, or population science cancer research program, but not serve as independent investigators. These non-tenure track scientists, such as researchers within a research program, are vital to sustaining the biomedical research enterprise. It is anticipated that only exceptional scientists who want to pursue research within the context of an existing NCI-funded cancer research program, but not serve as independent investigators, will be competitive for this award.

The Research Specialist Award is intended to provide salary support and sufficient autonomy so that individuals are not solely dependent on NCI-funded grants held by others for cancer research career continuity. Over the past decade, there has been a major expansion in the scope of approaches, technologies, and expertise required to effectively address any research question. A typical research activity includes molecular, genomic, phenotypic, and functional characterizations, each of which entails sophisticated technologies and understanding (e.g., deep sequencing, bioinformatics, imaging, flow cytometry, animal modeling, etc.). Accompanying the increases in the number of required approaches is the growing need for exceptional scientists with extensive research experience in each of those areas who provide continuity, stability and detailed scientific knowledge beyond that of a technician or a trainee. There is already a clustering of individual small research groups around central cores that specialize in different expertise (e.g., nuclear magnetic resonance [NMR], mass spectrometry [MS], sequencing, fluorescence-activated cell sorting [FACS], biochemistry, animal models, etc.), such that many experiments are performed, at least in part, through such cores. In addition, with the generation of large datasets ("big data") that are publicly available, there is a growing need for IT experts within many research programs or departments that previously did not rely on these skill sets. Data scientists (e.g., informaticians, statisticians, epidemiologists, behavioral scientists, and population scientists) are found primarily in computational biology groups or in data-rich big science groups. The need for such individuals is rapidly expanding to many other types of research groups.

There has been a continuing shift in the way research is organized, with increased reliance on a cadre of Research Specialists in laboratories, cores, and other scientific support facilities. Extramural institutions have begun to address the need for such scientists by providing staff support for cores that serve multiple research programs. Moreover, individual research programs have created Research Specialist positions using their grant support. However, neither of these positions currently provides the individual with either the recognition or independent funding mechanism that will attract and maintain the best scientists. These examples and many others highlight the need to create a career path for highly trained researchers who will play an increasingly important role in advancing biomedical research.

The Research Specialist Award (Lab Scientist) is intended to provide salary support for a sustained period of time and encourage the development of a stable career for exceptional researchers who want to pursue particular research activities within the context of a research program, but not be independent investigators. These scientists, such as researchers within a research program, are vital to sustaining the biomedical research enterprise. The award is intended for laboratory research-oriented investigators with significant, relevant experience, who have shown clear evidence of productivity and research excellence in the field of their training, and would like to support a particular research activity (e.g., a research program), with the goal of making significant contributions to behavioral, biomedical (basic or clinical), computational, bioimaging or bioengineering research that is relevant to the NCI mission. The proposed new research support is intended to provide salaries and sufficient autonomy so that individuals are not solely dependent on NCI-funded grants held by others for career continuity. As the PD/PI, Research Specialists would have the option, with prior NCI approval, to move to other research programs or institutions while maintaining funding from this award (e.g., if the Unit Director's laboratory is closed, etc.).

The Unit Director must be a NCI-funded Program Director/Principal Investigator (PD/PI) with an established working relationship with the Research Specialist. The Research Specialist must, at the time of the R50 application submission, be supported by the Unit Director's NCI-funded grant(s), Furthermore, the Unit Director must be the PD/PI of NCI funded research grant(s) that have at least 1 full funding year remaining (exclusive of no cost extensions and supplements) at the time of award of the R50. The Unit Director, together with the Research Specialist, is responsible for planning, directing, monitoring, and executing the NCI-funded research currently being conducted within the laboratory. Only one Unit Director may be designated on an application.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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)
• 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) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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.

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.

Multiple PDs/PIs are not permitted for the Research Specialist Award. Only single-PD/PI Research Specialist applications are allowed. Applications with multiple-PD/PI Research Specialists will not be accepted.

The Research Specialist must be the PD/PI of the application. The Unit Director must not be the PD/PI. However, the Unit Director must be included as Senior/Key Personnel participating as an Other Significant Contributor. See Section IV.2 SF424(R&R) Senior/Key Person Profile for requirements for the Unit Director.

Additional Eligibility Requirements:

• The Research Specialist must have an advanced degree (e.g., Masters, Ph.D., D.V.M., D.D.S., or M.D.) in an area of biomedical science or biomedical engineering and have demonstrated research accomplishments in their primary discipline.
• At the time of application submission, the Research Specialist must have been contributing to the Unit Director's NCI-funded research for at least the previous 2 years.
• The Research Specialist must have a full-time, non-tenure track position at the academic or research institution and be supported (including salary) for at least 6 person-month effort on the Unit Director's NCI-funded research grants (where the Unit Director is the PD/PI) during Federal Fiscal Year 2019.
• The Research Specialist will be required to commit a minimum of 6-person month effort on NCI-funded research grants during the life of the R50 award. The Research Specialist may engage in other duties as part of the remaining 6 person-month effort not covered by this award.
• The Research Specialist must have demonstrated professional accomplishments consonant with his or her career status, and should have demonstrated cancer research experience in the areas of behavioral, biomedical (basic or clinical), computational or bioengineering research that is relevant to the NCI mission.
• The Research Specialist must not have held or applied for independent investigator grant support (e.g., including but not limited to: R00; R01; R03; R21; R43; R44) within the past 5 years.

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101).

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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) 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.

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 activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Christine Siemon
National Cancer Institute (NCI)
Telephone: 240-276-6180
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

The Research Specialist must be the PD/PI of the application. The Unit Director must not be the PD/PI. However, the Unit Director must be included as Senior/Key Personnel participating as an Other Significant Contributor. Both the Research Specialist and the Unit Director must include a Biosketch as it states in the Application Guide.

Additional Unit Director Requirements:

• The Unit Director must be the PD/PI of an NCI-funded research grant that will have at least 1 full funding year remaining (exclusive of no cost extension and supplements) in the current competitive segment at the time the R50 is awarded.
• The Unit Director must be currently supporting the Research Specialist with the above stated NCI grant(s) and be committed to both the Research Specialist and the Research Specialist's research.
• Only one (1) Unit Director may be designated on the application. Applications that list more than one (1) Unit Director, or in which the Unit Director does not indicate eligible NCI grant support will not be reviewed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Application budgets may request the following two expenses in direct costs per year:

1) salary support for the Research Specialist commensurate with their level of funded effort (at least 6 person-months) on NCI-funded research grants during Federal Fiscal Year 2019; and,

2) travel costs to attend research meetings/conferences not to exceed $2,500 per year

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

Specific Aims: Do not use. Specific Aims are not allowed.

Research Strategy: Upload the Research Strategy as a single attachment and organize the Research Strategy using the instructions provided below. Start each section of the document with the appropriate section heading:

1) Research Program(s) engaging the Research Specialist's activity/effort: Describe the NCI-funded research program(s) of the Unit Director's laboratory which the Research Specialist currently supports. Explain the spectrum and type of research program/lab to which the Research Specialist currently contributes and is likely to contribute in the future.

2) Role of the Research Specialist in Research Program(s): Describe the particular activity of the Research Specialist in the NCI-funded research program(s) described above and the need for the Research Specialist to ensure success of the program(s). This section should explain how the Research Specialist's qualifications, experience, productivity, accomplishments and training are critical to achieving the research goals of the Unit Director's NCI-funded research. Describe how the Research Specialist has a history of making seminal contributions to new methodologies, approaches, assays, or other research innovations that helped advance the Unit Director's research goals. Describe the Research Specialist's plans for meeting the objectives of the Unit Director's NCI-funded research program(s) over the next 5 years. This plan should also describe the Research Specialist's career goals.

Letters of Support: Institutions must include Letters of Support for the applicant who is applying for the Research Specialist Award. Applications that are missing Letters of Support will not be reviewed.

Two types of Letters of Support are required for this application:

1) A letter of support from the Unit Director, which should detail the following:

a) The Unit Director must document a strong, well-established cancer research program related to the Research Specialist's area of expertise, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the Research Specialist.

b) Include a statement attesting to the Research Specialist's current level of effort (during Federal Fiscal Year 2019) on the Unit Director's NCI-funded research grants and include a list of the NCI-funded grant(s) numbers.

c) Include a statement describing the length of time that the Unit Director and the Research Specialist have been working together.

d) Provide a description of how the Research Specialist is an integral part of the institution's cancer research program and their commitment to the Research Specialist career track now and in the future.

e) The Unit Director should document that they have sufficient NCI-funded research support (at least 1 full funding year remaining in the competitive segment, excluding no cost extensions or supplements, at the time of R50 award) to cover the costs of the research project(s) in excess of the allowable costs of this award.

2) At least three letters of recommendation from PDs/PIs of other research programs who can attest to the Research Specialist's qualifications and contributions to cancer research.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA..

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date 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.

It is anticipated that the terms of award will include, but not be limited to, the following:

1) Funds freed up through the R50 will be restricted from any other use without NCI prior approval. Competitive renewal applications should not include the research specialist position and associated personnel funds. If requested, those funds will not be included in the award if the application is funded.

2) The requested salary support for the Research Specialist should be commensurate with the level of effort on the Unit Director's NCI-funded research grants (where the Unit Director is the PD/PI) during Federal Fiscal Year 2019. A Research Specialist is required to spend at least 6 person-months of his/her effort on NCI-funded research grant(s).

3) The award would allow application for travel funds, but not cover research expenses. Research expenses must be covered from other sources such as separate R01, P01, or P50 grants awarded to the Institution.

4) A Research Specialist would have the option, with prior NCI approval, to move to another research program or institution (e.g., if the Unit Director's laboratory is closed, if the institution closes a core, etc.).

5) If the Research Specialist applies for future NCI research support, the Research Specialist Award will be taken into consideration in making funding decisions if ESI status is claimed.

6) The R50 must be relinquished if any other independent grant support is obtained by the Research Specialist.

7) Award of the R50 (including support recommended for future years) will be contingent upon the Research Specialist's Unit Director being supported by an NCI-funded research grant(s) and upon the Research Specialist devoting 6 person-months to NCI-funded research grants.

8) Change of PD/PI will not be allowed on the R50.

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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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. See Section III of this FOA for information on registration requirements.

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. 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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

Research Specialist Award applications do not require preliminary data, specific aims, and/or a detailed research plan.

Accordingly, reviewers will emphasize the following:

1) Personal accomplishments of the Research Specialist, both individually and within the context of the nominating research program/lab;

2) The Unit Director's level of accomplishments, research productivity and adequate NCI funding support;

3) The scope of the particular activity being proposed and the suitability of the Research Specialist;

4) The importance of the Research Specialist, as well as the commitment of the Unit Director, to the proper and successful functioning of the program/lab;

5) The letter of support from the Unit Director and letters of recommendation from other investigators; and

6) The contributions of the Research Specialist to the nominating program/lab to date.

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.

Is the contribution of the Research Specialist important to supporting research that addresses an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? Can the Research Specialist help to achieve the goals of the Unit Director's project and improve scientific knowledge, technical capability, and/or clinical practice? How will successful completion of the goals of the program change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Will the proposed research area/programs benefit in terms of productivity and contributions from the Research Specialist's participation? Is there a satisfactory and appropriate relationship of the research plan to the Research Specialist's goals and experience? How solid is the foundation of the proposed research and how strong are the proposed hypotheses?

Is the Research Specialist well suited to supporting the Unit Director's project? Does the Research Specialist have the appropriate experience and training? Has the Research Specialist demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the Research Specialist supports a collaborative project do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Are the Research Specialist's level of training, experience, and competence commensurate with the purposes of the award? Does the application demonstrate the importance of the Research Specialist's role in the NCI-funded cancer research program of the Unit Director? Has the applicant been critical for and contributed to the successes of the Unit Director's cancer research program? Does the application indicate appropriate commitment of time and effort for the proposed work? Are the career goals of the Research Specialist appropriate for the R50? Do the letters of reference address the Research Specialist's potential for continued success/productivity?

Do the particular activities of the Research Specialist challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the Research Specialist's concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?

In what ways has the Research Specialist contributed to the innovation of the Unit Director's area of cancer research?

Are the overall strategy, methodology, and analyses appropriate to the particular activity of the applicant goals of the program(s)? Has the Research Specialist included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Has the Research Specialist presented strategies to ensure a robust and unbiased approach, as appropriate for the work being described? Are potential problems, alternative strategies, and benchmarks for success presented? If the activity is in the early stages of development, will the applicant be able to establish feasibility, and will particularly risky aspects be managed? Does the Research Specialist present adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Is it likely that the Research Specialist will develop new research directions and/or approaches that will allow progress in the Unit Director's area of cancer research? How will the Research Specialist contribute important and reliable data to the Unit Director's cancer research?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

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

Evaluate the level of accomplishment and commitment of the Unit Director. Does the Unit Director document that they have sufficient NCI-funded research or resource support to cover the costs of the Research Specialist's research or resource provision activities? Is there clear commitment from the Unit Director to ensure that a minimum of 6-person month effort will be devoted directly to NCI-funded research?

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.

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

For research that involves human subjects but does not involve one of the 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 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

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

Not applicable

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.

Not applicable

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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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.

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.
• 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Christine Siemon
National Cancer Institute (NCI)
Telephone: 240-276-6180
Email: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
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 Part 75.