Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title
Limited Competition: Coordinating Center (CC) for the Small Cell Lung Cancer (SCLC) Consortium (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
Related Notices


Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Assistance Listing Number(s)
93.393, 93.394
Funding Opportunity Purpose

The purpose of this limited competition Funding Opportunity Announcement (FOA) is to continue support for the Coordinating Center (CC) for the Small Cell Lung Cancer (SCLC) 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 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.

Key Dates

Posted Date
September 29, 2021
Open Date (Earliest Submission Date)
October 17, 2021
Letter of Intent Due Date(s)

Not Applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
Not Applicable November 17, 2021 Not Applicable December 2021 January 2022 February 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
November 18, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in 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 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.

Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description


The purpose of this limited competition Funding Opportunity Announcement (FOA) is to continue support for the Coordinating Center (CC) for the Small Cell Lung Cancer (SCLC) Consortium (Consortium) that is 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 services for in vivo and in vitro models 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;
  • 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.


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 dramatically 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 still 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.

In 2017 the NCI established the Small Cell Lung Cancer Consortium (SCLC-C) in response to the Recalcitrant Cancer Research Act of 2012. The original three program announcements (PAR-16-049, PAR-16-050, and PAR-16-051) mobilized scientists and clinicians to respond to the needs and opportunities in SCLC research. The PAR-16-049 for therapy and drug or radiation resistance-aimed studies and the PAR-16-051 for early detection and diagnostic studies were renewed in 2019 as a joint PAR-19-361 “SCLC Consortium: Biology, Therapy, and Resistance (U01 Clinical Trials Not Allowed)”. The latter PAR is currently active until March 2022. The PAR-16-050 for the U24 Coordinating Center was active for one submission cycle only and the grant funding for the coordinating center will finish its 5th year in FY2022.

In February 2019, the SCLC Progress Working Group, a subcommittee of the NCI Clinical Trials and Translational Research Advisory Committee, convened a meeting at the NCI to assess the current state and needs of SCLC research. Among the recommendations of the working group were the following needs:

• Greater efforts to investigate the transcriptome, epigenome, metabolome, and microenvironment of SCLC

• Increased resources for the storage and sharing of cell and mouse models, including increased molecular characterization with clinical annotation

• Development of models for immunotherapy

• Continued efforts to develop blood-based and imaging approaches for screening and diagnosis

• New approaches to prevention

These recommendations expanded the original five research priorities by the most recent needs and opportunities that stem from a rapidly expanding field of SCLC research. A coordination of efforts provided by the SCLC-C was deemed critical.

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

Specific Objectives and Scope of this FOA

The overall goals of the CC are to:

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

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

3. Secure centralized 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 with special emphasis on models for SCLC immunotherapy

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 new 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 maintain the current and establish new 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 provide only limited clinical and/ormedical information, including treatment history, histopathology, and Next-Generation sequencing data are now available. CellMiner-SCLC integrates drug sensitivity and genomic data, including high-resolution methylome and transcriptome from 118 patient-derived small cell lung cancer (SCLC) cell lines, providing a resource for research into this "recalcitrant cancer."

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). 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

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.  

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NCI intends to commit up to $1,400,000 total cost in FY 2022 to fund one award. Future year amounts will depend on annual appropriations.

Award Budget

Application direct cost budgets are limited to $940,000 per year. Budgets need to reflect the actual needs of the proposed project. The award includes $135,000 direct cost per year for collaborative projects for the SCLC Consortium members. These projects will be proposed annually and evaluated by the Consortium Steering Committee.

Award Project Period

The maximum project period is five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Only the current awardee(s) of the Small Cell Lung Cancer (SCLC) Consortium Coordinating Center (U24), funded under PAR-16-050, is/are eligible to apply.

Foreign Institutions

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. 

Required Registrations

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.
  • 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 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.
  • – Applicants must have an active DUNS number and SAM registration in order to complete the registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in 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.

Letter of Intent

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

Page Limitations

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

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

Applicants are encouraged to designate a contact PD/PI (based in the application submitting institution) and a second PD/PI, who would share the responsibilities but would also be capable of leading the entire SCLC (in case the lead PD/PI is unable to continue serving in this role). If only one PD/PI is designated, applicants must identify a PD/PI potential replacement candidate, i.e., a senior investigator who will be qualified to take over the PD’s/PI’s responsibility for the entire SCLC if such need arises.

R&R Budget

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

Budget forms appropriate for the specific component will be included in the application package.

Leadership Effort Commitment: Each individual designated as a PD/PI must commit a minimum of 1.8 person-months of effort per year. This minimal effort level must be maintained throughout the entire project period. If the CC has multiple leads, then each lead who is not the contact PD/PI must dedicate a minimum of 1.2 person-months effort to the CC for the life of the award.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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 the unique features of the institution and the team to serve as the CC for the SCLC Consortium;
  • Revew achievements of the CC for the past 5 years
  • 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.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects 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.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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 (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 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 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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

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.


Post Submission Materials

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.

Section V. Application Review Information

1. Criteria

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.

Overall Impact

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).

Scored Review Criteria

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.


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?  


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?   


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?      


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?


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?

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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.

Vertebrate Animals

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.


Not Applicable


For Renewals, the committee will consider the progress made in the last funding period.


Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

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 will receive a written critique.

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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. 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.

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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 recipient's business official.

Recipients 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see and

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.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at or call 1-800-368-1019 or TDD 1-800-537-7697.

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 and 2 CFR Part 200.206 “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

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, 2 CFR Part 200 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 recipients 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 for the project as a whole resides with the recipients, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

Primary Responsibilities of PDs/PIs

The PD(s)/PI(s) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under this program. The PD(s)/PI(s) assume responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the research supported by the SCLC Consortium in accordance with these terms and conditions of the award.

Specific PD(s)/PI(s) responsibilities and rights will be to:

  • Participating in an external evaluation process of the SCLC Consortium coordinated by NCI Program Staff;
  • Overseeing, directing, and coordinating scientific and administrative activities of the SCLC Consortium;
  • Defining research goals, determining and/or approving experimental approaches, and setting project milestones and timelines;
  • Overseeing the conduct of research at the SCLC Consortium, including such aspects as: experimental activities, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and preparation of results for publications;
  • Ensuring the timely sharing of SCLC Consortium-generated data across the entire NCI SCLC program as appropriate, and upon request from NCI Program Staff;
  • Warranting security of all databases
  • Participating in the activities of the SCLC Consortium Steering Committee as voting members;
  • Accepting and implementing all scientific and policy recommendations approved by the SCLC Consortium Steering Committee to the extent consistent with applicable grant regulations;
  • Committing an effort to the SCLC Consortium CC of at least 1.2 person-months by each multi-PD/PI; or at least 1.8 person-month by single PD/PI
  • Providing other information as might be requested by Project Scientist (e.g., on annual Center milestones, goals for throughput, procedures, etc.)
  • Monitoring the completion of established goals and benchmarks within the timeframe and budget proposed;
  • Coordinating and encouraging inter-consortium collaborations;
  • Participating in the annual PD/PI meeting organized by NCI and the International Association for the Study of Lung Cancer (IASLC);
  • Working closely with the NCI Program Officials or Project Scientist (see below) on the coordination and management of SCLC Consortium activities. These actions involve (but will not be limited to) participation in annual meetings and teleconferences with NCI scientific and program staff and other awarded programs and investigators, as needed;
  • Ensuring that proper process management methods are executed for planning, monitoring, and managing the workload over the award period, and are expected to provide update reports to NCI Program Staff upon request;
  • Leading the receipt of proposals, review, and approval of the use of restricted funds for collaborative efforts.

Recipients 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.

Programmatic Involvement of NIH Staff

NCI program staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The substantially involved NCI program staff member(s), acting as Project Scientist(s), will coordinate in a centralized fashion various activities of the recipients. A designated NCI Program Director(s) acting as a Project Scientist(s) will have the following responsibilities:

  • Serve as voting members of the SCLC Consortium Steering Committee;
  • In collaboration with the PDs/PIs and the SCLC Consortium Steering Committee, ensure the SCLC program functions as a unified whole to achieve the goals of the program;
  • Coordinate collaborative research efforts that involve multiple Projects through pilot project solicitations and actively participate in the review of these project proposals;
  • Monitor the operations of the SCLC Consortium and make recommendations on overall project directions and allocations of project funds;
  • Assist in avoiding unwarranted duplications of effort across the SCLC Consortium recipients;
  • Review the progress of the CC and specific activities shared among the recipients;
  • Assist the recipients as a resource in stimulating their broader interaction with other NCI and NIH programs, including non-NIH programs if appropriate, to disseminate results and outcomes from the SCLC Consortium and effectively leverage existing NIH/NCI resources and infrastructure;
  • Co-organize and participate in the annual meeting of SCLC Consortium investigators;
  • Organize and conduct regular meetings to share progress either by teleconference, videoconference, or face to face, as needed among the recipients;
  • Ensure the availability of data and related resources developed during the course of the SCLC Consortium to the scientific community at large;
  • Participate in data analyses, interpretations, and co-authorship of SCLC publications as appropriate and jointly agreed through the SCLC Consortium Steering Committee;
  • Ensure that decisions, recommendations, and policies of the SCLC Consortium Steering Committee are consistent with applicable grant regulations;
  • Provide technical assistance and advice to the recipients as appropriate (e.g., interpretation and reporting of the collected information);
  • Facilitate interactions/collaborations between the recipients and other NCI-supported programs, investigators, or organizations that may contribute to the SCLC Consortium goals;
  • Serve as a liaison between the SCLC Consortium recipients and NCI staff members and investigators that may provide addition expertise and/or resources to the progra

The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to the recipient 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.

Additionally, an NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility

SCLC Consortium Steering Committee will serve as the primary governing body of the SCLC Consortium. The Steering Committee will be jointly established by all the awarded PDs/PIs of the SCLC Consortium and the NCI Program Staff members. The Steering Committee will provide strategic coordination for the activities of the SCLC Consortium and the SCLC program overall.

Details on the composition, functions, and responsibilities of SCLC Consortium Steering Committee are as follows:

Voting members of the Steering Committee will include:

  • One representative from each SCLC Consortium Project (U01) and Infrastructure (U24) grant; and
  • One representative from the NCI.

Non-Voting Members:

  • The Steering Committee may decide to add non-voting members as needed, e.g., representatives from NCI-supported research resources, scientific experts and/or patient advocates.

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

It is anticipated that the Steering Committee will formulate strategic decisions and policies for consortium-wide activities. The SCLC Consortium recipients will be required to accept and implement these decisions and policies to the extent consistent with applicable grant regulations. The activities of the Steering Committee are expected to include the following:

  • Establishing operational guidelines, quality control procedures, and consistent policies to meet the goals of the SCLC Consortium and monitoring the implementation of these guidelines and policies;
  • Developing quality assurance goals for all consortium functions, specimens, technology and data for the SCLC Consortium;
  • Reviewing progress of the CC and SCLC Projects on a regular basis;
  • Following-up on action items from the Steering Committee in a timely fashion;
  • Prioritizing and recommending pilot studies for execution;
  • Organizing annual meetings of SCLC investigators and clinicians;
  • Participating in the review of project proposals for collaborative supplements observing the COI rules.

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 recipient. This special dispute resolution procedure does not alter the recipient'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.

3. Reporting

When multiple years are involved, recipients 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at 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.

Section VII. Agency Contacts

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

Application Submission Contacts

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: (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: (preferred method of contact)
Telephone: 301-945-7573 Customer Support (Questions regarding registration and Workspace)
Contact Center Telephone: 800-518-4726

Scientific/Research Contact(s)

Peter Ujhazy, MD, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5681

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390

Financial/Grants Management Contact(s)

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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