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) invites applications to establish a Coordinating Center (CC) for the Small Cell Lung Cancer (SCLC) Consortium (Consortium) that will be focused on prevention, diagnosis, treatment, and mechanisms of treatment resistance in SCLC.

The CC will:

• support the administrative coordination of the U01 SCLC Consortium;
• create and support database(s) for -omics or other data pertinent to the Consortium;
• secure centralized tissue banking for specimens submitted by the members of the Consortium and a virtual biospecimen database that would include all tissue resources of the Consortium;
• provide centralized biostatistics, bioinformatics and data analysis support, establish SCLC in vivo and in vitro model repositories and distribution units;
• support meeting and communications coordination among members of Consortium, and form and maintain a Consortium website.

The projects for the consortium will be selected from applications to the companion FOAs focused on prevention, diagnosis, therapy, and treatment resistance.

Companion FOAs of the SCLC Consortium include:

• PAR-16-049, "Therapeutic Development and Mechanisms of Resistance" (U01) and
• PAR-16-051, "Innovative Approaches to the Diagnosis and Prevention of Small Cell Lung Cancer (U01)."

The Recalcitrant Cancer Research Act of 2012 calls upon the National Cancer Institute (NCI) to develop scientific frameworks that will help provide the strategic direction and guidance needed to make true progress against recalcitrant or deadly cancers. Small cell lung cancer (SCLC) is a recalcitrant cancer as defined by its five-year relative survival rate of less than 7% and the loss of approximately 30,000 lives per year. Treatment of SCLC has not changed in the last 30 years -standard therapeutic interventions used today reflect the prevailing state-of-the-art from the early 1980s. Avoidance of the use of tobacco is the only known way to prevent the disease - no screening method has proved effective, responses to chemotherapy are not durable and are difficult to understand, and life expectancy after diagnosis tends to be very short. The limited early diagnostic and therapeutic approaches available for SCLC patients, as well as the limited availability of research materials, provide an impetus for the evaluation of new and missed opportunities that can build upon the existing portfolio of SCLC research to make additional progress against this disease.

Five research opportunities for expanding NCI’s research programs for SCLC were recommended by a panel of SCLC experts convened by NCI and are delineated in the 2014 Scientific Framework for Small Cell Lung Cancer (SCLC).

1. Building better research tools for the study of SCLC by (a) optimizing the collection of tumor tissue specimens representing distinct phases of SCLC, and (b) developing new tumor models that reflect the phases of SCLC found in the clinic;

2. Expanding comprehensive genomic profiling studies of clinically-annotated SCLC specimens to improve the basic understanding of the frequency, distribution, and range of molecular abnormalities that exist at diagnosis and following therapeutic relapse;

3. Investigating new diagnostic approaches for populations at high risk of developing SCLC;

4. Focusing therapeutic development efforts on specific molecular vulnerabilities of SCLC; and

5. Examining mechanisms underlying both the high initial rate of response to primary SCLC therapy and the rapid emergence of drug and radiation resistance following completion of treatment.

This funding opportunity announcement (FOA) focuses on the establishment of a Coordinating Center (CC) of the SCLC Consortium in support of projects addressing all 5 recommendations above.

The overall goals of the CC are to:

1. Support the administrative coordination of the U01 SCLC Consortium;

2. Create and support database(s) for -omics or other data pertinent to the SCLC Consortium;

3. Secure centralized tissue banking for specimens submitted by the members of the U01 SCLC Consortium and a virtual biospecimen database that would include all tissue resources of the U01 SCLC Consortium;

4. Provide centralized biostatistics, bioinformatics and data analysis support;

5. Establish SCLC in vivo and in vitro model repositories and distribution units;

6. Support meeting and communications coordination among members of the U01 SCLC Consortium; and

7. Form and maintain a Consortium website.

Besides the 7 mandatory goals, the CC may propose optional activities such as, but not limited to:

• providing centralized pathology services with optional projects for development of protocols related to specimen collection, pre-analytical considerations, and standardization;
• conducting immunotherapy monitoring services;
• establishing a high throughput screening facility for new SCLC treatment agents;
• securing additional centralized services for the U01 SCLC Consortium.

Note: Because the onset of funding of the CC will coincide with that of the projects within the SCLC Consortium, the detailed scope of research resources that the CC will provide remains to be determined. Therefore, the CC needs to have broad expertise and flexible capabilities in bioinformatics, biostatistics, tissue banking, and modelling approaches relevant to the support of SCLC research. Measures will be implemented to avoid overlap between the scope of the CC and individual projects.

Administrative coordination and governance of the Consortium

The CC will serve as a hub for the administrative coordination of the Consortium. Upon need and consent among Consortium members, the CC will coordinate conference calls and meetings.

The consortium PD/PIs will work with NCI staff to form a Steering Committee for the SCLC Consortium. The composition and specific functions of the Steering Committee will be agreed upon after awards are made. All PD/PIs should be willing to serve on the Steering Committee. The Steering Committee will communicate through periodic conference calls and annual in person meetings.

Resources provided by the CC

The CC will establish profiling databases as determined by the needs of the consortium. These should be built upon existing databases that have proven their utility and that provide state-of-the-art capabilities. The use of Consortium-defined Common Data Elements (CDEs) and standard vocabularies should be ensured. The expected datasets may include, but may not be limited to, genomic, epigenomic, proteomic, metabolomic, and/or clinical data. The CC will also establish and maintain a virtual tissue bank that would include all tissue resources held by individual institutions of the Consortium.

The CC will have capacity to accommodate specimen collections with appropriately annotated clinical information. While there is a general lack of SCLC tumor tissues and individual sample sizes are usually small, it is anticipated that non-tumor tissues from SCLC patients [e.g. blood, urine, upper respiratory tract swabs, sputum, circulating tumor cells (CTCs)] may be shared in the Consortium. The CC will also house cell lines, animal models (GEMMs, PDXs, CDXs) for sharing with all members of the Consortium and, if possible, with the research community in general.

Distribution of the above resources should be built into the scope of services provided by the CC.

CC applicants may also propose and budget for small methodology development projects and development of standard operating procedures that would be used for the benefit of the Consortium.

Biostatistics, bioinformatics, and data analysis services

The CC will provide centralized biostatistics, bioinformatics and data analysis services for projects within the Consortium. These services should be flexibly staffed upon the needs of the Consortium. The CC will also establish and maintain the central, state-of-the-art website that will include all necessary administrative and scientific information serving the Consortium. Links to the individual profiling databases with proper security restrictions for e.g. human subjects data and to analytical tools should be provided.

Consortium operation premises

The SCLC consortium will operate under the following premises:

• Sharing of profiling data with the Coordinating Center with the goal of amassing statistically significant omic (e.g. genomic, proteomic and/or epigenomic) profiling data from well-characterized human samples derived from various sources [i.e. circulating tumor cells (CTCs) from blood, tumor biopsies, surgical samples, autopsy samples]
• If available, sharing of human materials with the Coordinating Center with the goal of creating a bank of materials that may be shared with consortium members
• Sharing of SCLC models (in vitro, in vivo) with the Coordinating Center so that they may be distributed to consortium members
• Sharing of all data and results (including negative results) in quarterly teleconferences and annual workshops

NCI Resources for the Consortium

Frederick National Laboratory for Cancer Research (FNLCR) will serve as a valuable resource for the SCLC consortium. In 2014 NCI funded 23 clinical centers to collect blood samples from patients with SCLC, both newly diagnosed as well as at progression. The NCI Patient-Derived Models Repository is in the process of establishing patient-derived xenografts (PDXs) and in vitro patient-derived tumor and fibroblast cultures from primary patient tumor tissue and circulating tumor cells (CTCs) for distribution to the public. The Repository plans to make materials and resources available to the public in the future including: frozen tumor fragments for PDX generation; SCLC PDX and CDX models, derived cell lines, and DNA/RNA pellets. These models, associated clinical limited medical information including treatment history, histopathology, and next-gen sequencing data will be available through a public web site in 2016.

Approved oncology drugs for preclinical testing are available to the research community through the Division of Cancer Treatment and Diagnosis (DCTD) Developmental Therapeutics Program (DTP) or the Cancer Treatment and Evaluation Program (CTEP) Investigational Drugs Branch. Drug leads discovered through this FOA may be appropriate for entry in the NCI Experimental Therapeutics Program (NExT) for further development to clinical candidate status and testing in clinical trial.

Semantic services including terminology and metadata content, tools and services are available to the research community through NCI Center for Biomedical Informatics and Information Technology (CBIIT) Center for Biomedical informatics and Information Technology. Projects supported by this FOA may benefit from metadata, models and terminology support in creating research databases, biorepositories, clinical data elements and forms, or modeling and annotation for animal models resources.

Genomic data generated through this Consortium are expected to be shared in accordance with the NIH Genomic Data Sharing Policy. The NCI guidelines for implementing this policy are available at http://www.cancer.gov/grants-training/grants-management/nci-policies/genomic-data.

The collaborative activities and resources of the SCLC Consortium share many features with those of other NCI-funded consortia, including the Early Detection Research Network (EDRN). Applicants are encouraged to review and evaluate the potential of these resources for re-use.

The communication and material exchange with the contacts for NCI resources will be done directly by representatives of individual U01 projects with the optional involvement of the CC, if necessary

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) 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 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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

The PD/PI of the CC should have understanding of and research experience with lung cancer in general and SCLC in particular. Administrative leadership experience is necessary. Additional expertise in bioinformatics, animal models, and/or tissue banking is expected from the PD/PI or from peers in a multiple PD/PI collaboration.

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).

Domestic (US) applicants for the research project SCLC Consortium membership are encouraged to apply to this FOA, however, an awarded SCLC Consortium project is not a prerequisite for the eligibility to apply for and/or to receive the an award from this FOA.

Applicants must obtain 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, including Supplemental Grant Application Instructions 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 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:

Peter Ujhazy, MD, PhD
National Cancer Institute (NCI
Telephone: 240-276-5681
Fax: 240-276-7881
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 PI/PD should commit and maintain throughout the life of the award a minimum of 2.4 person-months of effort per year. For applications with multiple PD(s)/PI(s), a minimum of 1.2 person-months of effort per year is required

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, with the following additional instructions:

Specific aims: In addition to the specific aims and approach(es), applicants should include the relevance of the proposed activities to the objectives of this FOA.

Research strategy: The Research Strategy should clearly:

• State in the introduction the unique features of the institution and the team to serve as the CC for the SCLC Consortium;
• Address all seven mandatory functions and additional optional capabilities of the CC according to the directives in the "Specific Objectives and Scope of this FOA" section;
• Provide a timeline for achieving the goals;
• Address flexibility to realign resources and expertise based on the needs of the Consortium;
• List the innovative approaches that will be used to resolve challenges that are specific for SCLC research;

The Consortium website should be designed to accommodate a public site accessible for the broadest audience including patients, advocacy groups, and general public. This place should include the basic information about the Consortium, its goals, members' contact information, and the scope of projects. This part of the website will prospectively house also the future achievements of the Consortium (e.g. publications, discoveries, hand-offs for clinical testing, etc.) The website should also feature a restricted access site that will serve the members of the Consortium for sharing privileged and sensitive information, preliminary data, and information not ready for public release.

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:

All applications, regardless of the amount of direct costs requested for any one 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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 NOT-OD-13-030.

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.

This FOA is focused on the selection of the optimal site with the capacity to fulfill all functions of the Coordinating Center (CC) for the Small Cell Lung Cancer Consortium. While the CC will not directly produce scientific data, it is expected that it facilitates information, data, model, and specimen sharing and distribution in the most efficient way. Furthermore, the CC will provide various research expertise services such as adequate research expertise in bioinformatics, tissue and model banking and distribution, administrative management, website design, and in any additional research services proposed.

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

Specific to this FOA: Does the proposed Center address the needs of the research Consortium that it will serve? Is the scope of activities proposed for the CC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research Consortium?

Can the proposed CC maximize the usefulness of its resources to the scientific community? Will the integration of resources by the CC lead to results unattainable by any single member of the Consortium?

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?

Specific to this FOA: Are the PD(s)/PI(s) and other personnel well suited to their roles in the CC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing lung cancer research? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research?

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?

Specific to this FOA: Does the application propose novel organizational concepts and management strategies in coordinating the research Consortium the CC will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts and management strategies proposed?

Are optional methodology development projects proposed and are they novel?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Specific to this FOA: Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research Consortium the CC will serve? Are potential problems, alternative strategies, and benchmarks for success presented? If the CC is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the Consortium? Are an appropriate plan for work-flow and a well-established timeline proposed?

Are there sufficient experience and infrastructure for the administrative coordination of multi-institutional projects? Are profiling database(s) available that would be suited for the storage and management of genomic, proteomic, metabolomic, and/or clinical data upon the needs of the Consortium? Are adequate bioinformatics and biostatistics services available through the CC? Are there conditions for centralized tissue banking and a virtual tissue bank that would serve all members of the Consortium? Is there capacity for the storage and management of in vitro and in vivo models? For models and tissue banking, are appropriate quality control plans proposed? Is there expertise for the establishment and management of a state-of-the art Consortium website? Besides the required, are there any other centralized services that the CC can provide?

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 children, justified in terms of the scientific goals and research strategy proposed?

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

Specific to this FOA: Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research Consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the CC proposed? Will the CC benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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.

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 Guidelines for the Review of Human Subjects.

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 children 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

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact 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 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 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. 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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Administrative management of the CC
• The high quality and timely execution of all CC services to the Consortium
• Overseeing efficient operations of the CC
• Ensuring compliance of the CC with mandatory regulations
• Warranting security of all databases
• Overseeing quality control in all data and materials collections
• Communication with the NCI-designated government representatives
• Ensuring that the tools developed within the CC under this FOA are freely available to all Consortium members.
• Committing and maintaining throughout the life of the award a minimum of 2.4 person-months of effort per year to the Coordinating Center investigator designated as the PD/PI. For applications with multiple PD(s)/PI(s), a minimum of 1.2 person-months of effort per year is required.

Awardees will retain custody of and have primary rights to the data, software, biospecimens, and models developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

A designated NCI Program Director(s) acting as a Project Scientist(s) will have the following responsibilities:

• Participating in the activities of the CC leadership;
• Providing technical assistance and advice to the awardees as appropriate (e.g., assisting in the development of the standard operating procedures and/or interpretation and reporting of the collected information);
• Monitoring progress of the resource as a whole and specific studies conducted.
• Conducting periodic conference calls and site visits for discussions with awardee research teams, observation of data collection and management techniques, other matters;
• Coordinating interactions, as appropriate and needed, with the NCI-supported programs especially with Developmental Therapeutics Program (DTP), CTEP, and FNLCR;
• Facilitating interactions/collaborations between the awardees and other NCI-sponsored programs, investigators, or organizations that may contribute to the CC goals;
• Serving as a liaison between the CC awardees and NCI staff members and investigators that may provide addition expertise and/or resources to the program;
• Monitoring the adherence of the awardees to the approved data sharing plans.

The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to the awardee if the team is unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly lower the level of performance.

Additional NCI staff members may be designated to have substantial involvement.

In addition, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship and programmatic stewardship of the award, and will be named in the award notice. The Program Official may also have substantial programmatic involvement (as a Project Scientist) and may be the same person as Project Scientist. In that case, the individual involved will not attend peer review meetings, or will seek NCI waiver according to the NCI procedures for management of conflict of interest.

Areas of Joint Responsibility include:

Steering Committee: The Steering Committee will be the main governing body for the Consortium.

The Steering Committee will be composed of the following voting members:

• One representative from each U01 project award (a PD/PI or a designated senior investigator) who will have one vote;
• One representative from the U24 (a PD/PI or a designated senior investigator) who will have one vote; and
• NCI Project Scientists who will have one total vote. The remaining Project Scientists will participate in Steering Committee meetings as non-voting members.

Additional NIH staff members, serving in an advisory capacity, may participate in these meetings as non-voting members. The decision on composition of additional NIH staff member advisors on the Steering Committee will be made by the existing voting members of the Steering Committee. These members may include representatives from NCI extramural divisions and a representative from the NCI CBIIT.

The Chair of the Steering Committee will be selected from the representatives of all awardees.

The Steering Committee will meet once every year, either face-to-face at locations selected by the Steering Committee in consultation with the NCI or by teleconference. The Coordinating Center (U24) awardee PI(s) will be responsible for arranging the annual Steering Committee Meeting in collaboration with the Steering Committee Chair and NCI Project Scientists.

The Steering Committee may decide to establish sub-committees for specific purposes. The NCI Project Scientists will serve on such sub-committees, as they deem appropriate.

Primary responsibilities of the Steering Committee include, but are not limited to, the following activities:

• Establishing Consortium policies and procedures;
• Establishing policies and procedures for collaborative projects, and protocols.
• Developing guidelines for the collection and distribution of specimen reference sets for collaborative research.
• Serving as a nucleus for a broader outreach to the entire extramural research community investigating SCLC.

Dispute Resolution Process:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Consortium chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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

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

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Peter Ujhazy, MD, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5681
Email: [email protected]

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

Tawana McKeither
National Cancer Institute (NCI)
Telephone: 240-276-5217
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.