Department of Health and Human Services

Part 1. Overview Information

Key Dates

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

Purpose

The purpose of this FOA is to support transdisciplinary research projects to investigate the influence of environmental exposures during specific time windows of susceptibility on breast cancer risk. For the purposes of this FOA, transdisciplinary research is defined as research that involves scientists from multiple disciplines, as well as community partners, working interactively on a common problem to develop novel cross-disciplinary methods, insights, and research approaches that would not have occurred with a traditional single-disciplinary investigation. Windows of susceptibility are defined as specific time periods in which an individual is particularly susceptible to breast cancer risk associated with environmental exposures. Applications must propose a transdisciplinary research project focused on a common research theme related to the role of environmental exposures in breast cancer. The project should be designed to address one or more potential windows of susceptibility and facilitate the integration of experimental model and human studies to accelerate understanding of the contribution of environmental factors to breast cancer risk, the underlying mechanisms, and the potential for prevention strategies. Applications must also include community-academic partnerships with defined community engagement activities.

This FOA is published in parallel with RFA-ES-14-011 "Coordinating Center for the Breast Cancer and the Environment Research Program (U01)". Projects and the Coordinating center funded under these FOAs together will constitute the Breast Cancer and the Environment Research Program (BCERP). Collectively, the BCERP will form a consortium of multi-disciplinary teams that will work collaboratively to conduct high-quality, transdisciplinary research focused on the impacts of environmental exposures during specific windows of susceptibility on breast cancer risk. The BCERP Consortium will also develop and implement strategies to translate and communicate these research findings to appropriate stakeholders.

Given the disparate impact of breast cancer on women and strong evidence that environmental exposures at specific stages of female breast development can influence breast cancer risk, the BCERP program is specifically focused on female breast cancer. Applications that focus on male breast cancer will be considered non-responsive to this announcement and will not proceed to review. Investigators interested in submitting an application on male breast cancer are encouraged to contact the Scientific/Research staff listed under "agency Contacts" in Section VII.

Background

Researchers have long accepted that breast cancer is a complex disease and that both genetic and environmental factors contribute and interact with each other to increase breast cancer risk. The identification of different environmental factors that influence breast cancer risk presents a tremendous opportunity to prevent breast cancer. The BCERP, a joint effort by the NIEHS and the NCI, began in 2003 (RFA-ES-03-001 ) and was renewed in 2010 (RFA-ES-09-008 , RFA-ES-09-009 , RFA-ES-09-010 ). The BCERP represents one of the first research initiatives to directly examine the influence of environmental exposures at likely windows of susceptibility, such as puberty, to evaluate how environmental exposures influence early events that may affect the risk for female breast cancer. A focus on earlier windows of susceptibility is important since lack of progress in identifying environmental determinants of breast cancer risk may be attributable in part to the focus of previous research on adult exposures after the relevant windows may have passed. In addition, the BCERP is a unique transdisciplinary program that strives to combine epidemiologic, basic and social sciences, as well as advocate communities, to better understand and advance breast cancer prevention. This approach is vital to stimulate new research approaches and accelerate the translation of research findings into disease prevention. As such, a major focus of the BCERP is to ensure that new findings are disseminated to girls and women at risk by engaging breast cancer advocates and other community groups in the appropriate translation of the research findings for their local communities. Additional details about the BCERP program, including previously funded research, publications and community engagement activities, can be found at http://bcerp.org/index.htm .

Concurrently, in response to the 2008 Breast Cancer and Environmental Research Act, the NIEHS and NCI established the Interagency Breast Cancer and Environmental Research Coordinating Committee (IBCERCC). The goals of the IBCERCC were to develop a report to outline the current state of research on breast cancer and the environment; identify key research questions, methodologies, and knowledge gaps; and make recommendations for accelerating the identification and mitigation of the environmental causes of breast cancer. A copy of the full IBCERCC report is available at http://www.niehs.nih.gov/about/boards/ibcercc/ .

Research Objectives

This FOA aims to build upon emerging findings from the BCERP while also drawing upon the expert recommendations of the IBCERCC. The continuing goal of the BCERP is to support integrated scientific research to enhance our knowledge of environmental and genetic factors underlying breast cancer risk over the lifespan of a woman. This FOA will build upon current successes of the BCERP and explore additional research questions by:

• Expanding investigations to include additional intermediate risk factors for breast cancer (such as high breast density and benign breast disease) to increase our understanding of how these factors are impacted by environmental exposures at specific life stages.
• Expanding investigations to additional windows of susceptibility (such as prenatal, post-puberty adolescence, time at first birth and menopause) and explore additional exposures and mechanisms within windows already under investigation.
• Providing opportunities to test new transdisciplinary research hypotheses to advance research and facilitate preventive strategies.

One prominent goal is to place greater emphasis on leveraging and building upon existing knowledge, community partner interests, and the creation of transdisciplinary teams in generating research hypotheses and study designs for individual research projects. In addition, an emphasis will be placed on promoting coordination between the BCERP Consortium and the broader breast cancer and environmental health science research communities.

Structure of the BCERP Consortium

The BCERP Consortium will include 6-8 transdisciplinary research projects with community-academic partnerships and a Coordinating Center to integrate efforts across the individual projects. All BCERP projects will work collaboratively with the BCERP Coordinating Center and NIH staff to establish a common Vision and Mission Statement for the Consortium as well as identify shared resources that can support needs across projects and maximize the collaborative nature and impact of the program. Members of the BCERP Consortium will be required to participate in Consortium networking/collaborative activities, including a yearly face-to-face meeting for the exchange of information across research projects as well as to the broader public. In addition, BCERP members will participate, as appropriate, in "working group" subcommittees formed around topics that cross-cut the BCERP Consortium (such as specific windows of susceptibility, specific exposures, and/or community engagement). The Coordinating Center, in conjunction with NIH staff, will facilitate collaborations among the research projects and community partners as well as provide logistical support for all Consortium interactions. The BCERP Consortium will be governed by a Steering Committee comprised of representatives from the funded research projects (including academic and community partners), the Coordinating Center and NIH program staff. (See section, below, on Program Governance).

Key questions the BCERP Consortium will collectively address include:

• Which classes of environmental exposures influence intermediate risk factors to increase breast cancer risk?

• What are the underlying mechanisms linking environmental exposure at different life stages with alterations in the mammary gland?
• How do genetics, social determinants of health, or lifestyle factors modify the impact of environmental exposures and contribute to the overall risk of breast cancer?
• What strategies for prevention are indicated by the connections between exposure, intermediate risk factors, and underlying mechanisms?
• How can findings be best translated into effective risk messages for various communities or to inform policy?

Requirements for BCERP Research Projects

As described above, this FOA will support individual transdisciplinary research projects that span experimental model and human studies to investigate the influence of environmental exposures during specific time windows of breast cancer risk. Each project must also include a community-academic partnership with defined community engagement activities. Applications are also encouraged to focus on intermediate risk factors that may precede breast cancer (in lieu of, or in addition to, examining breast cancer development directly). Specific application elements are discussed in more detail below. Applicants are strongly encouraged to contact NIH Scientific/Research staff prior to submission to determine if their application meets the goals of the BCERP Consortium.

1. Community-academic partnership and community engagement activities

Applicants must partner with breast cancer organization(s) and/or members of the engaged community. The application must focus on a community-identified concern related to environmental stressors and breast cancer risk, and include collaborative activities that are jointly conducted by the researcher(s) and community partner(s). Community partners may be representatives of advocacy, support or research organizations; community leaders; liaisons to Native American, Latino or African-American populations; community health workers, etc. The community partner(s) should actively represent breast cancer concerns and be skilled in outreach, education, social work, or public health. The partnership between the research scientists and the community partners is to draw upon each of their respective strengths, allowing for the integration of their unique perspectives and expertise into identifying research priorities. The partnership should also facilitate bi-directional communication between researchers and the engaged community over the course of the research study. The inclusion of additional collaborators with expertise to further complement the community-academic partnership is also encouraged. Such expertise may include behavioral or social scientists, communication specialists, or health care professionals engaged with the participating community.

Responsibilities of the community partners include, but are not limited to, communicating community concerns regarding environmental exposures of high and relevant importance to the Consortium investigators, representing the community perspective when designing the study and helping translate and communicate study findings to community members, policy makers and/or other stakeholders, from their own perspectives. Responsibilities of the research scientists may include, but are not limited to, clarifying what information the proposed study can and cannot provide, summarizing the scientific literature on exposure-related health risks, and interpreting study results in light of the current state of evidence.

The types of effort appropriate for community partners include, but are not restricted to:

• Identifying research questions in conjunction with investigators to ensure that the research application addresses the concerns of the community with respect to environmental/occupational exposures and/or stressors that may be related to breast cancer risk.
• Translating and communicating research findings in culturally appropriate formats and language to members of the engaged breast cancer communities.
• Developing and disseminating educational materials resulting from research findings to the engaged community.
• Engaging in outreach activities such as workshops, forums and town hall meeting for the engaged community.

In addition, once the BCERP Consortium has been formed, community partners are expected to participate collaboratively with other community partners and research projects within the BCERP Consortium. Their participation will also be sought in the development and dissemination of Consortium key messages resulting from the breadth of research findings emanating from the Consortium as a whole.

2. Address a specific window(s) of susceptibility

Applicants must focus on an identified window of susceptibility and should propose research to identify and explore the underlying mechanisms of exposures during these specific windows that lead to altered risk of breast cancer. The study of multiple windows is also acceptable. For purposes of this FOA, a window of susceptibility is defined as a specific developmental period (such as in utero, neonatal, pubertal, sexual maturity, pregnancy, lactation, post-involution, menopause) during which an individual is particularly susceptible to breast cancer risk associated with environmental exposures. The exposure - response focus needs to be on alterations that occur in, or likely affect, the breast/mammary gland and are expected to change the risk of cancer development.

3. Transdisciplinary research approach.

Applicants must propose novel transdisciplinary hypotheses that can be tested in a complementary manner in both experimental studies using in vivo or in vitro models and human studies (defined as research that directly involves individuals or groups of individuals or that uses data from humans, such as information on their behavior or samples of their tissue). Transdisciplinary research should focus on a common research theme related to the role of environmental exposures in breast cancer. The project should be designed to facilitate the integration of the laboratory (i.e., animal and in vitro) and human research to collectively increase understanding of the contribution of environmental factors to breast cancer risk, the underlying mechanisms, and the potential for prevention strategies. Areas of animal and human research that are of interest under this FOA include, but are not limited to:

• Research to investigate the influence of life stage-specific exposures to environmental factors on breast density and the potential subsequent impact on breast cancer risk.

• Research on life stage-specific exposures that predispose an indi vidual to develop atypical breast lesions and that increase the risk of breast cancer subtypes from specific lesions.
• Research on the influence of environmental exposures on breast development and the ability to disrupt normal developmental processes (such as hormonal and inflammatory signaling) across life stages and the relationship to breast cancer risk.

• Research to identify factors (such as genetics) that increase susceptibility of subpopulations (as defined by age, race, ethnicity, or social conditions) to the impacts of environmental exposures at specific life stages in relation to breast cancer risk

Laboratory-based studies should take advantage of the most currently available and relevant in vitro and in vivo mammary gland biology models, recent technological advances (imaging technologies, various omics approaches and other high-throughput methods), and unique reagents. Although new subject recruitment and follow-up are not strictly prohibited, it is anticipated that human-based research will most likely be ancillary studies using existing epidemiological, clinical or population studies that are uniquely positioned to study windows of susceptibility related to breast cancer risk. Multiple-PD/PI projects are encouraged to promote a transdisciplinary approach.

4. Focus on intermediate risk factors that precede breast cancer.

This FOA encourages studies that address the influence of the environment on at least one "intermediate risk factor" for breast cancer in lieu of, or in addition to, examining breast cancer development directly. For purposes of this FOA, an intermediate risk factor is defined as an established risk factor for breast cancer that may be attributable to a shared etiological pathway(s) linking environmental exposure(s) at specific life stages with future disease. Intermediate factors should be observable in humans prior to breast cancer occurrence and potentially serve as predictive markers of environmentally induced breast cancer risk. Such factors include, but are not limited to, markers of pubertal development and growth, breast density, and benign breast disease.

5. Environmental exposures of interest

For the purposes of this FOA, the environmental exposures of interest are broad and include chemical substances that people are exposed to in their environment, through consumer products and diet (such as industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, and air pollutants) as well as physical factors (such as radiation from environmental sources and light at night). Applicants are also encouraged to consider how lifestyle and behavioral factors (such as physical activity and weight gain in adulthood) and social and cultural influences (such as family, com munity, psychosocial/social, and societal factors) contribute to breast cancer risk in combination with environmental exposures. Applications that focus entirely or primarily on exposures such as alcohol, chemotherapeutic agents, radiation that is not a result of an ambient environmental exposure, active smoking, drugs of abuse, pharmaceuticals, and infectious or parasitic agents will be considered non-responsive to this announcement and will not proceed to review.

6. Participation in the BCERP Consortium

Successful applicants will function within the BCERP Consortium. Windows of Susceptibility awardees will be expected to contribute to the collective effort by providing new information on the impact of environmental stressors on the mammary gland and breast development, breast density and benign breast disease; the mechanisms of action related to specific exposures at the sub-cellular, cellular, and organ system levels in animal models and human populations; and the risk of developing breast cancer. Investigators are expected to share preliminary findings with the other BCERP Consortium participants and contribute to/share common resources amongst the Consortium as appropriate. Moreover, they will be expected to share confirmed findings on the relationship between exposures, individual susceptibility, and lifestyle choices on breast cancer risk with the public and engaged breast cancer communities. To the extent that common data elements can be collected across multiple research projects, BCERP members may be expected to share such data with the BCERP Coordinating Center to serve as a clearing house for data storage and management if it is determined that centralization of such data would be beneficial to the BCERP Consortium by the BCERP Steering Committee (see section below on BCERP Consortium Governance below). Finally, BCERP investigators will be expected to participate in internal evaluation activities conducted by the BCERP Coordinating Center (see RFA-ES-14-011 for additional details on the internal evaluation).

BCERP Consortium Governance

The BCERP Steering Committee will serve as the governing board for the BCERP. The Steering Committee will serve as a forum for the Windows of Susceptibility research projects and the Coordinating Center to share findings and progress across the Consortium on an ongoing basis, determine the need for redirection in scientific focus in order to accommodate new knowledge, and recommend new opportunities and directions for the BCERP. The Steering Committee will be the guiding entity for the BCERP. In the event that individual project site principal investigators cannot reach agreement on critical aspects of the project, such as common protocols, then the Steering Committee, in consultation with NIH Project Staff will make a final decision on how to proceed. Though the Steering Committee will make recommendations, NIEHS and NCI Staff will have final authority to approve any proposed recommendations, and activities must comply with NIH, DHHS, and Federal Guidelines.

Additional details on the composition and functions of BCERP Steering Committee are provided in Section VI.2, Cooperative Agreement Terms and Conditions of Award, Collaborative Responsibilities.

External Evaluation of BCERP

At the option of NIH Staff, BCERP awardees may be expected to participate in an external evaluation process (in addition to the internal evaluation activities conducted by the Coordinating Center). The purpose of the evaluation would be to monitor and assess the performance of the BCERP awardees in achieving the goals of the BCERP. This component includes evaluating the quality and innovation of the research conducted in the BCERP Consortium, including the Coordinating Center, as well as assessing critical intermediate determinants of the overall success, such as infrastructure development and capacity building, linkages and resource sharing arrangements within and among the BCERP Consortium, and the transdisciplinary nature of the research. Outcomes to be assessed will include quantity and quality of peer-reviewed publications, success of educational and outreach programs, and effectiveness of the transdisciplinary research model. All funded projects are required to maintain searchable records and to be prepared to share additional requested information with NIH when requested.

Section II. Award Information

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

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

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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) (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.

PDs/PIs for an application submitted under this FOA may not be the same PDs/PIs for the BCERP Coordinating Center (See RFA-ES-14-011) but may be members of the same institutions

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. 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.

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:

Sally Tilotta, PhD
National Institute of Environmental Health Sciences
P.O. Box 12233, MSC K3-03
Research Triangle Park, NC 27709
Phone: (919) 541-1446
Fax: (301) 480-3719
Email: sally.tilotta@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Research Strategy section is limited to 30 pages.

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.

Researchers and community partners are required to participate in the annual in person BCERP meeting. Applicants should include funds to cover such travel in the requested budget.

Collaborations with community partners are integral to the design and conduct of the research projects supported under this FOA and the BCERP Consortium as a whole. All applications should include budgetary support for the community partners that is commensurate with the level of their efforts proposed within the current application as well as the required time and support needed to fully participate in BCERP Consortium-wide activities (including attendance at the annual in-person meetings, Steering Committee duties, and participation on BCERP Consortium working groups.)

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: All applications must include at least one experimental research aim using in vivo or in vitro models. All applications must include at least one human-based research aim.

Research Strategy: The following items should be addressed by the applicant:

The application should describe the overall common research theme for the project, including how the proposed experimental model research, human study research and community engagement activities are all linked together to this theme, and the potential significance of the project as a whole. A justification must be provided for focusing on the proposed window(s) of susceptibility, environmental exposures, and if appropriate, intermediate risk factors for breast cancer risk of interest within the application. Applications should also address how the transdisciplinary approaches proposed are innovative and how they will accelerate understanding of the contribution of environmental factors to breast cancer risk, the underlying mechanisms, and the potential for prevention strategies.

For the Specific Aim using in vivo or in vitro models , the applicant should describe the underlying hypotheses to be addressed by the proposed experimental model research and how they relate to the overall research theme of the application. Applications should also include relevant background information specific to the experimental research, including but not limited to, supporting literature, biological rationale and supporting preliminary data as well as provide details on and a justification for the specific experimental research approach proposed. For applications to investigate the roles of cells, tissues, and/or organ systems remote to the breast, further justification for how the proposed mechanism under study may ultimately impact breast cancer risk needs to be presented.

For the human-based Specific Aim, a human study is defined in this FOA as research that directly involves individuals or groups of individuals or that uses data from humans, such as information on their behavior or samples of their tissue. The application should describe the underlying hypotheses to be addressed by the proposed human study research and how they relate to the overall research theme of the application. Applications should also include relevant background information specific to the human study proposed, including but not limited to, supporting literature, biological rationale and supporting preliminary data as well as provide details on and a justification for the specific human study approach proposed.

All applications must include a partnership with a breast cancer organization(s) and/or members of the engaged community. Applications must also include defined collaborative activities that are jointly conducted by the researcher(s) and community partner(s) to translate and disseminate research findings to relevant stakeholders. Without duplicating information described on Biosketches, the applicant should describe the relationship between community and academic partners, including but not limited to, previous work together. The application should also provide details on and the justification for the specific community engagement approach(es) proposed.

All applicants should state their willingness to collaborate and share information and resources among members of the BCERP Consortium, and briefly describe how the proposed research models, human study populations, or other unique aspects of the project could be leveraged to enhance the overall BCERP Consortium.

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:

• All applications, regardless of the amount of direct costs requested for any one year, must include a Data Sharing Plan.

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

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.

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, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

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.

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? Are the proposed transdisciplinary research activities likely to accelerate understanding of the impacts of environmental exposures during specific windows of susceptibility on breast cancer risk, the underlying mechanisms, and the potential for prevention strategies?

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? Do the investigators have experience working in transdisciplinary teams?

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? Does the application propose novel transdisciplinary methods, insights, and research approaches that would not have occurred with a traditional single-disciplinary investigation?

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? Are the proposed laboratory and human research aims well integrated and do they address the proposed common research theme related to the role of environmental exposures in breast cancer? Are steps proposed to disseminate applicable findings in appropriate formats to relevant stakeholders?

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?

Assessment of the Community-academic Partnership

Is there evidence of an active partnership between research scientists and community members, including evidence that community partners have been involved in formulating research questions? Does the proposed study benefit from the strengths and expertise of all members of the collaborative research team? Is the partnership adequate to ensure success of the proposed project?

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.

Collaborative Strengths

Does the application and/or history of the research team suggest that the investigators are willing to collaborate and share information among members of the BCERP Consortium, including the BCERP Coordinating Center, and abide by the priorities and policies agreed upon by the Steering Committee for collaborative studies? Do investigators bring particular expertise, facilities, research models, study populations, etc., that could potentially be leveraged to enhance the overall BCERP Consortium?

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

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) 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 National Institute of Environmental Health Sciences, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

Applications will be assigned to the 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 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.

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 (or multiple PDs/PIs, if applicable) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of projects conducted. The PD/PI assumes responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of BCERP research in accordance with terms and conditions of the award.

All PD(s)/PI(s) of the BCERP Consortium (Coordinating Center and Windows of Susceptibility research projects) will have the primary responsibility for:

• Overseeing the budget and activities of the award, as detailed, above.
• Cooperating with other BCERP investigators and community partners and NIH Staff, as appropriate, in the design and conduct of protocols, analysis of data, and reporting of results of research undertaken by the BCERP. This includes, but is not limited to:
  • Providing goals and estimated costs for procedures and protocols.
  • Sharing data, protocols and other research resources generated through the BCERP award.
  • Promoting and coordinating cross-BCERP scientific collaboration.
  • Ensuring training of study site personnel as needed for standardization of collaborative protocols across sites and for accurate and timely data entry.
• Facilitating the formation of and participating in appropriate Working Groups to promote the exchange of preliminary findings, experiences, protocols, and ideas across the BCERP.
• Interacting and complying with requests for information from the BCERP Steering Committee and other sub-committees as appropriate.
• Participating in the annual PD/PI scientific meetings, and monthly committee calls organized by the BCERP Coordination Center, as relevant.
• Cooperating in the program evaluation activities.
• Accepting and implementing all scientific, practical, and policy decisions approved by the BCERP Steering Committee to the extent consistent with applicable grant regulations.
• Serving on the BCERP Steering Committee (for details, see "Areas of Joint Responsibility" below).
• Providing information to the NIH Program Directors and Project Scientists concerning progress by submitting annual progress reports in a standard format.
• Complying with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.

The PD/PI(s) responsible for a BCERP Windows of Susceptibility project will have the following additional responsibilities:

• Determining and coordinating research approaches and procedures that can be standardized across the BCERP Consortium, and overseeing the analyses and interpretation of such research.
• Encouraging and coordinating cross-BCERP collaborations to test novel hypotheses in a complementary fashion across multiple BCERP Windows of Susceptibility projects.
• Overseeing the timely release of data according to approved plans.
• Complying with Coordinating Center requests, as directed by NIH Program Staff and the Steering Committee, to facilitate monitoring of BCERP progress.

The BCERP Consortium will be subject to periodic internal evaluation (coordinated by the BCERP Coordinating Center) and external evaluation (coordinated by the NIH). All BCERP Consortium Awardees will be expected to participate in such evaluations.

All BCERP Consortium awardee institutions/organizations will be expected to share with other BCERP awardees knowledge, data, research materials, and any other resources necessary and relevant to the BCERP Consortium.

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

One or more NIEHS and NCI Program Directors will be substantially involved in the BCERP Consortium as NIH Project Scientists. NIH Project Scientists will have substantial scientific and programmatic involvement that is above and beyond the normal stewardship role in awards.

NIEHS and NCI Project Scientist(s) will have the following responsibilities to all BCERP Consortium awardees:

• Have substantial involvement to guide, coordinate, and participate in the conduct of the BCERP Consortium activities.
• Attend and participate in all Steering Committee and subcommittee meetings of the BCERP Consortium.
• Coordinate and facilitate the interactions among the awardees under this U01 cooperative agreement.
• Serve as a liaison between the Steering Committee, the BCERP Consortium, the NIH and other federal agencies as needed.
• Monitor the operations of the BCERP Coordinating Center and Windows of Susceptibility projects, review their progress and compliance with the operating policies of the Steering Committee, and make recommendations on overall project directions and allocations of project funds.
• Facilitate and coordinate the exchange of information and interactions between Consortium awardees to support collaborative efforts.
• Along with the Coordinating Center, participate in organizing and coordinating annual BCERP Scientific meeting.
• Advise on the design of research activities, availability of resources, and/or management and technical performance of projects, as appropriate.
• Participate as collaborators to the BCERP investigators in some shared activities, if appropriate.
• Assist in avoiding unwarranted duplications of effort across the BCERP Consortium.
• Participate in the BCERP Consortium evaluation activities, including coordination of an external evaluation of the BCERP Program.
• Evaluate the adherence of BCERP awardees to any approved data sharing plans or intellectual property plans.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH reserves the right to adjust funding, withhold, suspend, or terminate the support to those BCERP awardee institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance. The NIH Program Official will be responsible for monitoring the level of performance and making recommendations for any corrective actions.

Areas of Joint Responsibility include:

A Steering Committee will serve as the governing board for the BCERP Consortium.

• The BCERP Steering Committee will have primary responsibility for:
  • Overseeing the overall organization of the BCERP initiative and for reviewing its research goals.
  • Monitoring and assessing transdisciplinary progress of the Consortium through facilitating program evaluation.
  • Developing the appropriate structure of Working Groups to promote the exchange of experiences, protocols, novel research findings, etc. across the BCERP.
  • Establishing advisory committees and subcommittees, as necessary, to serve the BCERP Steering Committee and the BCERP awardees.
  • Reviewing the potential for sharing resources located at individual Windows of Susceptibility project sites to serve the needs of other BCERP projects or the entire initiative.
  • Making recommendations for re-directing the Consortium's focus in order to accommodate new scientific opportunities and directions and maximize the transdisciplinary nature of the BCERP Consortium.
  • Sharing and reviewing annual progress among the components of the BCERP.
• The Steering Committee will be comprised of the following voting members:
  • The PD(s)/PI(s) of the BCERP Coordinating Center (RFA-ES-14-011), who will have one vote.
  • A research investigator or community partner representative of each individual BCERP Windows of Susceptibility research projects (RFA-ES-14-012), who will have one vote.
  • One NIEHS and one NCI project scientist, who will each have one vote, so long as the total NIH votes do not exceed 1/3 of the committee membership.
• Other NIH staff members may participate in Steering Committee meetings as non-voting members.
• The PD(s)/PI(s) and lead Community Partner for each Windows of Susceptibility award will agree to serve at least one 2-year term within the project period. Only one representative from each project will serve on the Steering Committee at a given time.
• Steering Committee representatives from each project will be elected at the initial BCERP Consortium meeting and should reflect a balance between research investigators and community partners.
• A Steering Committee Chair will be elected every twelve months from amongst the Steering Committee members by the committee. An individual may continue serving as Chair for more than one year if all committee members agree. NIH staff cannot serve as Steering Committee Chair.
• In the event that PD(s)/PI(s) cannot agree on critical aspects of the Consortium, such as common protocols, then the Steering Committee, in consultation with NIH Program Staff, will vote on a recommendation for how to proceed. NIEHS and NCI Staff will have final authority to implement proposed recommendations. All activities must comply with NIH, DHHS, and Federal Guidelines.
• Other guidelines for the Steering Committee, such as a quorum and frequency and type of meetings (in-person, remote), will be determined at its initial meeting. It is anticipated that the Steering Committee will meet at least once per month by teleconference.

The BCERP Steering Committee may establish an External Advisory Board, comprised of scientific experts from outside the BCERP initiative, to serve the NIH staff, the BCERP Steering Committee and the BCERP awardees.

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 comprised 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: http://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
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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)

Caroline Dilworth, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7727
Email: dilworthch@niehs.nih.gov

Gary L. Ellison, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6783
Email: ellisong@mail.nih.gov

Peer Review Contact(s)

Sally Tilotta, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1446
Email: Sally.Tilotta@nih.gov

Financial/Grants Management Contact(s)

Molly Puente, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1373
Email: puentem@niehs.nih.gov

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: perryc@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.

---

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

---

NIH... Turning Discovery Into Health^®

---

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.