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: International Agency for Research on Cancer (IARC) Monographs Program (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-CA-14-503

Companion Funding Opportunity

None

Number of Applications

Eligible applicant organization may submit only one application in response to this FOA, as described in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.393, 93.396, 93.399

Funding Opportunity Purpose

This limited competition Funding Opportunity Announcement (FOA) solicits the renewal application for the International Agency for Research on Cancer (IARC) Monographs on the Evaluation of Carcinogenic Risks to Humans. The IARC Monographs program, which is supported in large part by the NCI, critically evaluates the published scientific evidence on carcinogenic hazards to humans. Monograph volumes are considered critical references that inform health policy and cancer research worldwide about carcinogenic risks to reduce cancer burden globally.

Key Dates
Posted Date

September 4, 2014

Open Date (Earliest Submission Date)

November 18, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

December 18, 2014, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2015

Advisory Council Review

May 2015

Earliest Start Date

July 2015

Expiration Date

December 19, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

This limited competition Funding Opportunity Announcement (FOA) solicits the renewal application for the International Agency for Research on Cancer (IARC) Monographs on the Evaluation of Carcinogenic Risks to Humans. The IARC Monographs program, which is supported in large part by the NCI, critically evaluates the published scientific evidence on carcinogenic hazards to humans. Monograph volumes are considered critical references that inform health policy and cancer research worldwide about carcinogenic risks to reduce cancer burden globally.

Background

Origin of the IARC Monographs. The IARC was founded in 1965 as a specialized cancer agency of the World Health Organization to promote international collaboration in cancer research. In response to frequent requests about chemical carcinogens, the IARC was charged by the IARC Governing Council with the task of providing expert, independent opinion on suspected carcinogens that could be of value to cancer researchers but also inform policy decisions by health agencies and other governmental authorities worldwide. In 1971, the IARC Monographs program was instituted as a means to evaluate chemical agents using a systematic and scientifically rigorous process with subject matter experts who conducted the original research. Since then, the types of agents considered by this program have expanded beyond simple chemicals to include complex mixtures, physical agents, biological organisms, life-style factors, and environmental exposures. The NCI has funded the IARC Monographs program since 1982 to support two Working Groups each year to produce two Monograph volumes.

Selection and Evaluation of Agents by the IARC Monographs Program.

The IARC Monographs program convenes meetings of advisory groups to prioritize suspected cancer agents that are suggested by individuals and organizations worldwide. Advisory groups are composed of senior officials and scientists from international health agencies and cancer research institutions. Agents are prioritized by the extent of human exposure, suspicion of carcinogenicity, public health relevance and public concern. Agents previously reviewed by the IARC Monographs program can be reevaluated if new and compelling studies emerge. In addition to the advisory group recommendations, other agents can be assessed if warranted by significant new scientific studies or an urgent public health need.

High priority agents are evaluated by Working Groups convened by the IARC Monographs program. The program selects Working Group members on the basis of area of expertise, level of experience and the absence of real or apparent conflicting interests, with consideration given to demographic diversity and balance of scientific views. A Working Group may evaluate one or more agents or families of related agents. Each agent (or agent family) is evaluated separately.  The results of each evaluation are presented as a monograph, which contains a critical and comprehensive review of the published scientific literature followed by an evaluation of the weight of the evidence that the agent can increase the risk of cancer. For each agent, four sets of data are considered, each evaluated by a subcommittee of the Working Group: 1) Exposure-related data, including production, occurrence and exposure; 2) Cancer epidemiology in humans; 3) Carcinogenicity in experimental animals; and 4) Mechanistic and other relevant data, including carcinogenic mechanisms, genotoxicity, susceptibility, and adverse effects. These volumes are freely available as full text PDFs and are used by health organizations and scientists globally to guide policy and research. A full description of the IARC Monographs program procedures and review can be found at http://monographs.iarc.fr/ENG/Preamble/index.php.

Impact of the IARC Monographs. Since 1971, the IARC Monographs program has convened 109 Working Groups, evaluated over 900 agents, and published 103 volumes. From this work, 113 agents have been classified as "carcinogenic to humans", 66 as "probably carcinogenic ", 285 as "possibly carcinogenic" and 505 as "not classifiable". The list of all classified agents can be found at http://monographs.iarc.fr/ENG/Classification/index.php. National and international health agencies worldwide use the IARC Monographs as the scientific base to formulate policies and implement actions to limit exposures to known, probable, and possible carcinogens. In particular, the IARC Monographs provide a crucial resource about carcinogens to low- and middle-income countries, whose health ministries may have limited resources to rigorously evaluate cancer hazards.

Requirements for this FOA

The IARC Monographs program should have a leading role in assessing global carcinogenic risks and serve as an authoritative reference for health agencies worldwide. At a minimum, the NCI support should enable the convening of two Working Groups to produce two Monograph volumes. The number and type of agents to be evaluated will be decided by IARC Monographs program as best befitting the needs for global cancer prevention. For the purpose of this FOA, "agents" are defined broadly to include: chemicals; complex mixtures; physical agents; biological organisms; behaviors and life style factors; and environmental exposures and occupations.

The IARC Monographs program is expected to fulfill this role by providing scientific leadership and administrative support for convening Advisory and Working Groups as well as preparing and publishing Monographs of high scientific clarity and accuracy. The IARC Monographs program is expected to have substantial responsibility in ensuring its continued self-evaluation and improvement.

Accordingly, the applicant team must have appropriate leadership capabilities in leading integrative research efforts in identifying cancer hazards. Specific expertise is required in forming and convening proficient panels to prioritize and evaluate carcinogenic agents that are of high importance to health agencies and the scientific community worldwide. These attributes include recruiting outstanding scientists of appropriate expertise and experience to serve on Advisory and Working Groups, convening Working Groups to produce comprehensive and scientifically authoritative evaluations that are free of conflict of interest, and publishing and disseminating the findings efficiently. The IARC Monographs program applicant must demonstrate the appropriate expertise and experience in the areas defined above. The applicant institution must have the necessary infrastructure to meet the specific requirements defined in this FOA.

The main strategic requirements that must be met by the IARC Monographs program applicant are summarized as follows:

  • Demonstrate scientific expertise in the relevant areas, including epidemiology, toxicology, carcinogenesis, and cancer bioassays, to facilitate the identification and review of scientific studies for Working Group evaluations;
  • Ability to recruit experts to form international Advisory and Working Groups that are scientifically rigorous, meritorious and widely respected;
  • Ability to select candidate carcinogenic agents that are of high relevance and concern to the global cancer community, particularly to low- and middle-income countries;
  • Capacity to prepare and produce Monographs that are comprehensive, authoritative and impactful;
  • Ability for effective global communication and outreach to health agencies, the scientific community, and the general public; and
  • Collaboration with international partners to improve the quality, transparency, and efficiency of systematic review as well as accessibility of evaluation results and data.
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.

Application Types Allowed

Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NCI intends to commit $859,000 in FY 2015 to fund one award.

Award Budget

The application budget is limited to $859,000 in total costs per year and should reflect the actual needs of the project.

Award Project Period

Applicants may request a project period of 5 years.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

This is a limited competition FOA. Only the awardee institution for the International Agency for Research on Cancer (IARC) Monographs Program is eligible to apply.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are  eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are 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) (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.

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.

While multiple PDs/PIs are allowed, applicants are strongly encouraged to consider a single PD/PI option. 

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

The eligible applicant organization may submit only one application in response to this FOA.

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in 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.

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. 

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. Additional requirements are provided below.

Activities budgeted under this FOA must be sufficient for convening at least two Working Groups each year to produce two Monograph volumes.

Under Budget Justification, relate the requested budget to other support for the Monograph program. Include the scale of that support (approximate costs in U.S. dollars) and the scope of activities required (in terms of number of Working Groups/number of monographs).

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: 

Research Strategy: The Research Strategy should consist of the following subsections described below.

Sub-section A. Overview. In this sub-section, address the following aspects:

  • The overall strategy of the IARC Monographs program to provide scientific and administrative leadership with emphasis on the selection and evaluation of agents and recruitment of appropriate international experts;
  • The capacity to conduct systematic review of scientific studies related to carcinogenic agents;
  • The ability to develop a synthesis of the science regarding an agent and determine its carcinogenicity based on the weight of the evidence;
  • The capability for maximizing the global impact of the Monograph series; and
  • The ability to self-evaluate and implement improvements for the Monograph program.

Sub-section B. Progress Report. In this sub-section, summarize Progress to Date and milestones achieved during the current funding period. List the main accomplishments in the following areas:

  • Identification, prioritization, and evaluation of carcinogenic agents;
  • Significant findings from the convened Advisory and Working Groups;
  • Accessibility of the IARC Monographs data and global participation in the IARC Monographs process; and
  • Relevant global communications and outreach to health agencies, scientific community, and the general public.

Sub-section C. Proposed Monograph Program. Address the requirements defined in Section I of this FOA and describe the aspects identified below.

  • Improvements for timely selection of candidate carcinogenic agents that are of high relevance and concern to the global cancer community (including low- and middle-income countries).
  • Steps to improve the search and evaluation of scientific publications and other data sources (including high-content and high-throughput data).
  • Plans for organizing and convening Advisory and Working Groups and approaches to ensure that these panels are scientifically rigorous.
  • Any relevant ongoing or planned collaborations to improve the quality, transparency and efficiency of review of selected agents.
  • Plans for increasing accessibility of the program's findings and data, including digitization of the Monographs into a database format and dissemination of results globally to health agencies, the scientific community, and the general public.
  • Plans to promote effective self-correcting/self-improving actions.

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

  • The application should address a Data Sharing Plan.
  • The evaluation of agents under the Monograph program may involve various secondary analyses of original publically available data. If such intermediary data are generated and are not included in their entirety in the published monographs, they are expected to be available and accessible by qualified investigators and health agencies.

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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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 Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. 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, the application will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NCI, NIH. An incomplete or not responsive application will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

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.

For this particular announcement, note the following:

The emphasis of this FOA is on maximizing the potential and scientific value of the IARC Monographs program as a unique international and collaborative resource that provides timely and authoritative scientific evaluations of carcinogenic risks to humans that are relevant to the global scientific and health communities. Reviewers will assess the special opportunities presented by the IARC Monographs program in addressing the goal of this FOA and furthering the prioritization and identification of carcinogenic hazards to reduce cancer burden worldwide.

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.

Significance

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

Specific for this FOA: How well will the IARC Monographs program serve its strategic goals of providing timely and authoritative scientific evaluations of carcinogenic risks to humans that are relevant to the global scientific and health communities? What will be the global influence of the IARC Monographs program on informing the scientific community and health agencies about carcinogenic risks, and in guiding cancer health policy and prevention, particularly for low- and middle-income countries? 

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific for this FOA: Are the expertise of the PD/PI and other key personnel in appropriate scientific areas adequate and sufficient for the overarching objective of the IARC Monographs program to rigorously evaluate carcinogenic risks to humans? Are their commitments adequate for these goals? Has the PD/PI demonstrated sufficient leadership in recruiting appropriate experts and convening effective Advisory and Working Groups to produce scientifically rigorous evaluations that are relevant, timely, and significant? 

Innovation

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

Specific for this FOA: Are the proposed approaches innovative in identifying, prioritizing, and comprehensively evaluating human cancer risks? Are the proposed approaches innovative for communicating and disseminating information globally to relevant audiences?  

Approach

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

Specific for this FOA: Are the proposed functions and activities of the IARC Monographs program to be supported by the NCI award well described and adequate? Are they sufficient for convening at least two Working Groups each year to produce two Monograph volumes? Are the resources of the IARC Monographs program (organization, personnel, infrastructure, and collaborations) in place and adequate to support its overall objectives? What is the likelihood that the proposed strategies will optimally identify and prioritize agents for evaluation that are of high relevance and concern to the global cancer community? Are the plans and approaches for Advisory and Working Groups sufficient to ensure that these panels are scientifically rigorous, meritorious and widely respected?  Are improvements or refinements proposed to make the processes involved more efficient, and the results more accessible and impactful globally?  

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?  

Environment

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

Specific for this FOA: Is the environment of the awardee institution, along with international organizational interactions, collaborations, and outreach, adequate to support the IARC Monographs program in accomplishing its goal of producing rigorous evaluations of carcinogenic hazards of significance and concern to global health agencies and communities? 

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 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.

Inclusion of Women, Minorities, and Children 

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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • Will receive a written critique.

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

Applications will be assigned 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.
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

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 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.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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:

The PD/PI will have the primary responsibility for defining objectives and approaches, and for planning, conducting, analyzing, and publishing results, interpretations, and conclusions from the project. The PD/PI assumes responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the research activities in accordance with terms and conditions of the award.

Specific activities include:

  • Planning, coordinating, and overseeing the activities for organizing and convening Advisory and Working Groups, and preparation of Monograph volumes;
  • Selecting experts to serve on the multidisciplinary Advisory and Working Groups to engender balanced viewpoints and high scientific rigor while avoiding conflicts of interest;
  • Conducting pre-meeting activities including systematic literature reviews and review of preliminary subgroup working papers;
  • Convening Working Group meetings, facilitating review of subgroup papers and developing consensus drafts of findings;
  • Conducting post-meeting activities to ensure the accuracy and clarity of the final Monograph text and rapid dissemination of the findings;
  • Providing logistical and administrative support for all activities of Advisory and Working groups;
  • Implementing methods to improve the transparency and efficiency of literature selection and review as well as incorporate public datasets to support evaluations;
  • Collaborating with relevant health agencies and institutions globally to share methods to improve systematic review, carcinogen assessment, and data harmonization and accessibility; and
  • Providing information to the NCI Program Official concerning progress by submitting annual progress report in a standard format.

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

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

A designated NCI Program staff member, acting as a Project Scientist, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NCI Project Scientist will not attend peer review meetings of renewal or supplemental applications. If such participation is essential, this individual will seek a waiver according to the NCI procedures for management of conflict of interest.

The responsibilities of the NCI Project Scientist will include the following aspects:

  • Maintaining substantial programmatic involvement in the development of the project and making recommendations to the awardee;
  • Monitoring the performance of the IARC Monographs program and making recommendations to the NCI on the allocation of funds; and
  • Serving as a liaison between the IARC Monographs program and other NCI and NIH programs to stimulate broader interactions, recommend agents for evaluation, identify resource individuals, disseminate results and leverage existing NIH resources and infrastructures.

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

An NCI Program staff member, acting as the Program Official, will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. If this individual becomes substantially involved in the IARC Monographs program activities, he/she will not attend peer review meetings of renewal and/or supplemental applications or will seek NCI waiver if such participation is essential.

Areas of Joint Responsibility include:

  • None; all responsibilities are divided between awardees and NIH staff as described above.

Dispute Resolution:

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 Steering Committee 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.

3. Reporting

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

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. 

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Ron Johnson, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6250
Email: rjohnso2@mail.nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: hines@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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