Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Environmental Health Sciences (NIEHS)

National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Mental Health (NIMH)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Nursing Research (NINR)
National Center on Research Resources (NCRR)
Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title

Deepwater Horizon Disaster Research Consortia: Health Impacts and Community Resiliency (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

New

Related Notices

  • December 17, 2010 - See Notice NOT-ES-11-003 Effective immediately, NIEHS will no longer accept applications related to the Deepwater Horizon Gulf Oil Spill submitted under program announcements on the Mechanism for Time-Sensitive Research Opportunities in Environmental Health Sciences.
  • November 23, 2010 - See Notice NOT-ES-11-001 Notice of Change in Dates for Pre-Application Meeting and Webinar.

Funding Opportunity Announcement (FOA) Number

RFA-ES-11-006

Companion FOA

None

Number of Applications

See  Section III. 3. Additional Information on Eligibility.

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

93.113, 93.399, 93.837, 93.846, 93.242, 93.307, 93.361,  93.389  

FOA Purpose

The intent of this FOA is to create one or more consortia of university-community partnerships to: address health issues of concern to the residents of the Gulf States affected by the DWH disaster; enhance capacity to respond to potential future disasters and to prevent or minimize adverse health effects arising from them.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

December 21, 2011

Letter of Intent Due Date

December 21, 2010

Application Due Date(s)

January 21, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2011

Advisory Council Review

May 2011

Earliest Start Date(s)

June 2011

Expiration Date

January 22, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 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

NOTE: The NIEHS will be holding an informational meeting at the Battle House in Mobile, Alabama on November 23 for those interested in submitting an application in response to this FOA.  NIEHS will also be hosting an informational webinar on December 8th.  More information about these upcoming events and registration forms can be found at: www.niehs.nih.gov/gulfresearchconsortia

1. Research Objectives

Purpose

The National Institute of Environmental Health Sciences (NIEHS), in partnership with the National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin (NIAMS), National Institute of Mental Health (NIMH), National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Nursing Research (NINR), National Center for Research Resources (NCRR), and the Office of Behavioral and Social Sciences Research (OBSSR) solicits applications to:  1) examine impacts of the Deepwater Horizon (DWH) disaster on health, illness and quality of life for the general population residing in the Gulf coast region; and 2) increase the scientific evidence base needed to strengthen the resiliency of vulnerable populations along the Gulf coast to prepare for and recover from the effects of the DWH and similar disasters.  In addition to the potential for exposure to oil, dispersants and other chemical mixtures, residents in the Gulf region are experiencing economic hardship, job loss, resettlements and other forms of psychological distress which may all adversely impact health and quality of life.  The intent of this RFA is to create one or more community-based participatory research consortia of university-community partnerships to address health issues of concern to the residents of the Gulf States affected by the DWH disaster and to enhance capacity to respond to potential future disasters and prevent or minimize adverse health effects arising from them.  By developing multi-project programs of basic and applied research, that may include population and associated laboratory-based research projects, it is anticipated that the interplay and impact of multiple stressors on human health and well-being and potential underlying mechanisms will be better understood. In addition, findings will establish the evidence base needed to inform recovery and to develop strategies to prevent illness and promote the health and well-being of populations in this and future man-made or natural disasters.

Background

The release of millions of gallons of crude oil following the DWH disaster poses unpredictable risk to people living along the Gulf Coast.  To date there have been very limited studies on the human health effects of oil spills. Studies have primarily evaluated acute physical and psychological effects and alterations in specific physiological functions of workers, community volunteers involved with cleanup, and the general population. Acute effects reported in past oil spills include dermal erythema, edema, irritation and dermatitis; redness, watering and itchy eyes; respiratory symptoms such as cough, throat irritation, shortness of breath, wheezing; neurological symptoms such as headache, dizziness, irritability, confusion and weakness of extremities; and psychological symptoms including irritability, confusion and those that typify mood and anxiety disorders. 

There is experimental and epidemiological evidence suggesting that components of crude oil, namely volatile organic compounds (VOCs), polyaromatic hydrocarbons (PAHs), and heavy metals can have long-term harmful effects on human health.  There are multiple routes by which populations may be exposed, including inhalation, dermal contact, or ingestion.  For example, contaminants may bioaccumulate within the food chain, leading to potentially long-lasting implications for health.  Vulnerable populations, especially pregnant women, the developing fetus, young children and adolescents, the elderly and environmentally and economically disadvantaged persons, may be exquisitely sensitive to adverse health effects resulting from the DWH disaster.  Moreover, the Gulf Coast region has unique vulnerabilities – there is an intersection of health disparities, environmental health threats, and compromised or limited access to medical care – all of which may be critical determinants of how communities respond to this and future disasters.  

In particular, concern has been raised that the recent confluence of natural and man-made disasters along the Gulf Coast may impact mental health and behavior.  Those who may already suffer from mental illness, or who may have inadequate housing and preexisting physical conditions, are especially vulnerable.  Economic and social stressors act to exacerbate existing stress from these disasters.  Increases in suicide, substance abuse, and post-traumatic stress disorder have been observed among Gulf residents over the past five years.  Moreover, there is concern that children will experience more behavioral and mental health problems as a consequence of the DWH disaster. Therefore, effects of the DWH disaster on the health of the Gulf Coast population will be complex and multi-dimensional, requiring consideration not only of multiple types and routes of potential exposures, but also of a wide array of physical, psychological, and socioeconomic stressors. For most people, strong and unpleasant emotional and physical responses to disasters (e.g., hopelessness, helplessness, depression, sleeplessness, anxiousness, physical pain, confusion, fear, anger, grief, shock, guilt, mistrust of others) fade or improve with support from friends and family.  What we know from prior technological and other disasters is that, in general, events that involve massive destruction of homes and community institutions as well as physical injury and loss of life and possessions are associated with widespread distress, worsening of existing health conditions, and increased risk of new and persistent mental health conditions.  While the DWH disaster may not have all of these characteristics, many people and communities are losing valued and vital resources and a sense of control in the form of individual jobs and income, businesses, community/cultural identity.  Another health related facet of the DWH disaster is concern about human health effects of environmental contaminants.  We know from research after prior technological disasters that concerns about possible exposure or perceptions that people were exposed rather than actual exposure are an issue.  Concerns or perceptions about exposure to chemicals and other contaminants can have a powerful effect on psychological and physical health.

Objectives

The objectives of this FOA are to:  1) investigate  health outcomes from exposure to the DWH disaster, including identification of those at greatest risk for exhibiting adverse physical, mental and behavioral effects as a consequence of the disaster and other stressors encountered by residents;  and 2) develop community-based approaches to respond to this and future disasters, for example, by comparing current strategies to innovative designs to reduce the impact of disasters on illness in the Gulf Coast population. 

Results from this FOA will provide the necessary scientific evidence base to promote the protection of populations living along the Gulf Coast, who are at greatest risk for adverse physical, psychological and behavioral health consequences resulting from the DWH disaster. Ultimately, research findings from the Gulf Coast should contribute to the evidence base needed to improve preparedness and response aimed at minimizing health effects in future disaster contexts.

Scope

Applications for research consortia responding to this FOA are expected to address one or more potential health outcomes resulting from the DWH disaster. In addition, due to the continuing impact of this and past and future disasters along the Gulf coast, applicants should include in the proposal a community-based participatory research (CBPR) project to evaluate and enhance capacity to prevent adverse impacts and respond to disasters. 

The intent of this FOA is to focus on the health impacts of the DWH disaster on the general population residing in the Gulf Coast regions most affected by the DWH disaster. NIEHS is conducting a separate cohort study focused on the potential health effects in clean-up and recovery workers [http://www.niehs.nih.gov/about/od/programs/gulfworkerstudy.cfm ]. Therefore, proposals focusing on health consequences of clean-up or recovery workers will be considered outside the scope of this FOA and will be considered non-responsive and not be reviewed.

Over the last several years, residents of the Gulf region have experienced repeated hurricanes and now the DWH disaster, which have caused widespread environmental damage, economic loss, disruption of families and communities and significant changes in quality of life and behavior. As a consequence of accumulated exposure to these various stressors, along with potential exposure and uncertainty about exposure to chemical contaminants and related health risks, a significant effect on increasing individual- and community-level susceptibility to adverse health outcomes is a concern.  Therefore, consortia that propose to consider combined effects of multiple stressors on health and well being is strongly encouraged.

In order to be responsive to this FOA, each proposed consortium must be focused on:

Programmatic Goals and Required Components

Research activities to be supported are expected to be highly responsive to the needs of local communities in the Gulf Coast regions affected by the DWH disaster, innovative and multidisciplinary in approach and leadership.  Each research consortium is encouraged to consider a combination of basic and applied research that may include population and associated laboratory-based research projects.  It is anticipated that an interdisciplinary team approach incorporating interrelated projects will be better positioned to understand the interplay and impact of multiple stressors on human health and well-being and potential underlying mechanisms for effects observed. 

This program requires that the principles of community-based participatory research (CBPR) be utilized to develop the overall goals of a consortium and to design a framework to conduct and disseminate a consortium’s research.  CBPR is defined as scientific inquiry conducted in communities and in partnership with researchers. The process of scientific inquiry is such that community members, affected persons, or other key stakeholders in the community's health have the opportunity to be full participants in each phase of the work (from conception - design - conduct - analysis - interpretation - conclusions – to communication of results).  CBPR is characterized by substantial community input in the development of the research objectives.

Each application should represent a full partnership between:

Applications should demonstrate linkage(s) to a community-based or local disease-based organization(s) representing the Gulf regions most affected by DWH within the proposal or will be considered non-responsive and returned without review to the applicant.  The overall construction and execution of a consortium should follow CBPR principles.  In addition, research projects studying community vulnerability-resilience, should demonstrate and employ the principles of CBPR in its design and implementation. 

Each proposed consortium is expected to consist of the following components:

Shared Resources (i.e., Research Support Cores or “Cores”) may be established as appropriate to support the research projects of the consortium. Such cores may be located in community settings as well as universities, as appropriate to meet the needs of the proposed projects.

Information about the range of potential short- and long-term health effects in communities affected by the DWH disaster is lacking or sparse.  Examples of health endpoints of interest include but are not limited to:

Moreover, there is considerable evidence that vulnerable populations may be more susceptible to the effects of the DWH disaster and other stressors.  Examples of vulnerable population groups include but are not limited to:

Consortium Components (required)

Research Projects:

Each consortium requires a minimum of three research projects, at least one of which must address a health outcome(s) of concern to the community as a consequence of the DWH disaster, and at least one of which must address vulnerability and resilience along the Gulf Coast. 

Specific types or areas of research appropriate as relevant projects include but are not limited to:

DWH disaster-associated health effects research

DWH-related exposure assessment and biomonitoring research

Community vulnerability and resilience research

The community vulnerability and resilience research project should employ CBPR principles in the design, implementation, and dissemination of the research as described above. Specifically, this project should:

Specific examples of research topics of interest of participating NIH components are outlined below.

National Institute of Environmental Health Sciences (NIEHS)

The mission of the NIEHS is to reduce the burden of human illness and disability by understanding how environment influences the development of human disease. Understanding the mechanistic underpinnings linking exposure to health outcome is inherent to the mission of NIEHS. Therefore, in the context of this FOA, the NIEHS is particularly interested in supporting toxicological and population-based studies to understand the consequences that exposure to DWH contaminants may have on human health.  Such research is particularly pertinent to vulnerable populations, such as pregnant women, children, subsistence fisher people, and communities of people of color or low socioeconomic status. 

In addition to the general research topics described above, examples of research topics of interest to NIEHS include but are not limited to the following:

National Cancer Institute (NCI)

NCI is interested in identifying the consequences of toxic exposures related to the DWH disaster on the sequence of events leading to cancer. It is likely that a long follow-up period and very large numbers of study participants would be needed to meaningfully assess cancer risks from DWH disaster exposures. However, setting up the research studies now will build capacity and provide an opportunity for research on DWH disaster related exposures and determinants of the sequence of events, from biomarkers of exposure through early damage that might influence cancer risk, and genomic factors, such as genetic susceptibility, that may modify those biomarkers along the continuum to cancer. Examples of research projects that could be undertaken within the time frame of the FOA include, but not limited to:

National Heart, Lung, and Blood Institute (NHLBI)

The NHLBI is interested in several aspects of research related to the DWH disaster that address cardiovascular, pulmonary, and hematologic consequences of toxic exposures, as well as effects on sleep disorders.  Identification of the mechanisms underlying tissue injury, repair and subsequent development of cardiovascular, pulmonary and hematologic diseases are of interest, as are clinical investigations studying the psychosocial aspects of the oil spill, including economic consequences, psychological stress, and impact of the disaster on health behaviors.  Examples of areas and topics of investigation include, but are not limited to, those described below.

National Institute of Arthritis and Musculoskeletal and Skin (NIAMS)

NIAMS is interested in research related to the effects of the DWH disaster on skin and the musculoskeletal system, including but not limited to the following health effects of exposure to oil or oil dispersants:

National Institute of Mental Health (NIMH)

In the context of this FOA, NIMH is encouraging research applications that will move beyond what is already known regarding the range of anticipated mental and behavioral health consequences of trauma and loss, the natural course of recovery for most people, and the general risk factors for distress and disorder to answer innovative questions that will transform response strategies to disasters of various scope.  Accordingly, NIMH is primarily interested in efforts to assemble mental health care models drawing on a continuum of intervention approaches.  Through this FOA, NIMH is encouraging efforts to build models to serve the Gulf Coast region in the wake of the DWH disaster that may then be utilized in other future disaster contexts where there is an urgent and critical need to reestablish and disseminate care that is sensitive to the nature of the disaster, impacted population(s), availability of resources, and the status of health and mental health infrastructure.  NIMH is seeking evidence on feasibility of implementing and data on the relative advantages (economic, functional. and clinical) of a continuum of public health and clinical intervention strategies.  It is hoped that by rigorously examining some of the following strategies (clearly not all are highly relevant to the DWH disaster and its aftermath), the field will begin to develop a toolbox of transportable approaches that can be deployed after future unforeseen events.

Examples of topics of investigation include, but not limited to, those described below:

National Institute of Nursing Research (NINR)

NINR is interested in research related to the effects of the DWH disaster that result in acute and chronic diseases, particularly their symptom management, of children and adults. Examples of areas and topics of interest include, but are not limited to, the following:

National Center for Research Resources (NCRR)

NCRR-funded research centers and networks in the Gulf region have established versatile resources and capabilities that support a wide variety of biomedical and behavioral research, including clinical and translational research and community-based participatory research addressing health disparities. NCRR’s Clinical and Translational Science Award (CTSA) sites support Biostatistics, Epidemiology, Research Design, Research Ethics, Research Management, Research Communications, Community Engagement, Research Evaluation, Informatics, Regulatory Knowledge, and Translational Science. Cost-efficient use of these and other comparable core resources supported through the Institutional Development Award (IDeA) program and the Research Centers in Minority Institutions (RCMI) program is encouraged. Applicants can budget the cost to work or partner with NCRR-supported cores and/or investigators to study health impacts across the spectrum of basic, clinical and translational science.

Administrative Core

Through the required Administrative Core, the Principal Investigator and leadership team, including community members, provide guidance in fulfilling the stated objectives of the consortium.  The Administrative Core oversees the organizational, budgeting, and reporting aspects of the consortium and provides leadership for the scientific and programmatic activities.  To accomplish this, the Administrative Core infrastructure should promote cross-disciplinary interactions among all of the projects and cores as well as with other consortia within the program. 

The structure of this core will provide the Principal Investigator and leadership team with a mechanism for:

To demonstrate how the core will achieve its administrative functions, the applicant will include a description of how lines of communication among consortium members, and with other consortia will be established or already exist.  To aid the Principal Investigator and leadership team in evaluating and guiding how the consortium activities are addressing the goals set forth for the consortium, establishment of an External Scientific Advisory Committee to provide guidance on the scientific merit of the research and a Community Advisory Committee to provide guidance on community interaction and participation is recommended. 

Community Outreach and Dissemination Core

The required Community Outreach and Dissemination Core (CODC) provides an integral mechanism to develop bidirectional communication among the academic institutions, community partners, local health agencies, and others on consortia research related to DWH health effects and community vulnerability and resilience.  A key objective of the CODC is that the academic researchers work in partnership with community stakeholders to develop translation of research findings in a culturally appropriate manner that is useful to various professional and public audiences.  Hence, an important element will be to ensure that findings related to resilience are transferred to those responsible for community preparedness, response, and recovery. 

Examples of activities that may be conducted include but are not limited to:

Consortium Components (optional)

Research Support Cores

Each Research Consortium may include at least one shared resource (i.e., facility support core) as appropriate for the research being conducted. The intent is that this Core will provide essential, centralized services or resources that will result in an economy of effort and/or savings in the overall costs of the consortium. Examples of Research Support Cores that may be appropriate include: data management and bioinformatics cores; biospecimen handling and biorepository facilities; analytical equipment and services; fixed or mobile participant examination and specimen collection facilities in community settings (e.g., hospitals, community health centers, local public health departments, schools). 

Alternately, research consortia may make use of existing resource support at the host or member institutions.

Other considerations

Applicant teams responding to this FOA should include specialists from a number of different disciplines, such as basic biological sciences, exposure sciences, clinical sciences, social and behavioral sciences, and health systems research. 

Building/leveraging upon existing NIH supported studies or research centers and consortia is strongly encouraged.  For example, a consortium could be built around an NIEHS-supported Environmental Health Sciences Core Center, NIEHS and NSF supported Oceans and Human Health Centers (http://www.niehs.nih.gov/research/supported/centers/oceans/index.cfm), NIMHD-supported Health Disparities Center, NCI Cancer Centers (cancercenters.cancer.gov) or NCI’s Epidemiology and Genetics Research Program-supported Epidemiology Consortia (epi.grants.cancer.gov/Consortia/cohort.html), the Centers for Population Health and Health Disparities (http://cancercontrol.cancer.gov/populationhealthcenters/cphhd/index.html), NCRR-supported centers and networks (note: add links).  A consortium could be developed to leverage previously collected biological specimens or previously studied populations for baseline comparisons of pre-DWH exposures.

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, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The following NIH components NIEHS, NCI, NHLBI, NIAMS, NIMH, NIMHD, NINR, NCRR and OBSSR intend to commit an estimated total of $5.3M for 3-4 awards from appropriated funds and unrestricted gift funds provided by BP America, Inc.

Award Budget

An applicant may request a budget for direct costs of up to $1.2 million dollars for each budget year requested.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is five years.   

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

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 PHS398 Application Guide.

Individuals are reminded of the federal regulations regarding financial conflicts of interest (42 CFR Part 50, Subpart F, and 45 CFR Part 94) which, depending on the circumstances, may apply to the significant financial interests of an investigator, including remuneration for services such as private consulting arrangements (e.g., serving as an expert witness).  Applicant organizations and their PD/PIs are further reminded of applicable regulations and policies with regard to availability of research results, sharing of research data, access to research data, and sponsored research agreements (see NIH Grants Policy Statement, Part II, Subpart A; 59 Fed. Reg. 55674 (Nov. 8, 1994).

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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

 Other - Special Eligibility Criteria

Applicants must propose a multi-project research consortium that represents a full partnership between academic researchers/institutions and community organizations residing in the Gulf region affected by the DWH disaster. The consortium should employ the principles of community-based participatory research (CBPR) to develop the overall goals of the consortium and to design a framework to conduct and disseminate a consortium’s research.

In order to be considered responsive each consortia application must successfully meet the following minimum requirements:

Proposals focusing on health consequences of clean-up or recovery workers will be considered outside the scope of this FOA and will be returned as non-responsive.

Given the purpose of this FOA, it is expected that community partners identified in the application will reside in the Gulf affected by the DWH disaster (i.e., Alabama, Florida, Louisiana, Mississippi and Texas bordering the Gulf of Mexico). Inclusion of minority or disadvantaged populations is encouraged.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research (per project/core)
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Leroy Worth, Ph.D.
Scientific Review Officer
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
530 Davis Drive, Room 3080
Durham, NC 27713
Email: worth@niehs.nih.gov
Telephone: 919-541-0670
Fax: 919-316-4606

Please note that submission of the Letter of Intent by Email is preferred.

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Leroy Worth, Ph.D.
Scientific Review Officer
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
530 Davis Drive, Room 3080
Durham, NC 27713
Email: worth@niehs.nih.gov
Office:  919-541-0670

Page Limitations

All page limitations described in the PHS398 Application Guide must be followed, with the following exceptions or additional requirements:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

The applications submitted in response to this FOA are complex, and the scientific and programmatic information needed to adequately assess a proposal is not fully accommodated within the instructions accompanying the PHS 398 form.  Therefore, applicants need to follow the guidelines provided below

The supplemental instructions for multi-project U19 applications consist of the following categories of information

Section l.  This section consolidates the budget information, the list of all professional and non-professional personnel, biosketches for all key personnel, institutional environment and resources and for the entire applicant’s Consortium.  

Form Page 1 - Face Page. Complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.  When multiple PDs/PIs are proposed, use the Face Page-Continued page to provide items 3a-3h for all PDs/PIs.  The Contact PI should be listed on block 3 of Form Page 1-Face Page, with additional PDs/PIs listed on the Face Page-Continued.

Form Page 2. Using Page 2 of Form 398, provide a succinct but accurate description (abstract) of the OVERALL multi-project application addressing the major, common theme of the program.  Do not exceed the space provided.

List the performance sites where the research will be conducted.

Under "Key Personnel", list the PD(s)/PI(s) of the multi-project application, followed by the Project and Core Leaders of the component research projects and cores, and other key personnel and then other significant contributors.

Form Page 3 - One complete Table of Contents, for the entire consortium similar in format to the PHS 398 Form Page 3, must be provided and should follow the overall page numbering indicated above. Bearing in mind that the application will be reviewed project by project, prepare a detailed Table of Contents that will enable reviewers to find specific information readily. Projects/cores should be identified by number or letter, title, and name of the project/core leader. The page location of a COMPOSITIE BUDGET should be indicated in the "Table of Contents."

Form Page 4. Detailed Composite Budget - Detailed Composite Budget for First 12-month Period. Summarize the budget for the entire Program. (Follow the PHS 398: "Detailed Budget for Initial Budget Period.") Continuation pages may be used if needed to list all personnel.

Composite Budget for All Years, All Projects. PHS 398 Form Page 5 (Budget for Entire Proposed Period of Support). Summarize the budget for the entire Program for the requested additional years of support. Applicants may request a project period of up to five years.

Individual Budgets. Using duplicate copies of PHS 398 Form Pages 4 and 5, prepare a separate budget for each individual project, sub-contract and core unit. In the upper left hand corner, identify the project number and title or core title and project. All proposed costs must be fully justified for both the initial 12-month and future year budgets as indicated in the PHS 398 instructions.

Biographical Sketches. Provide biographical sketches for all KEY investigators and Other Significant Contributors, including consultants. Note: Do not include members of the Scientific Advisory Board or the Community Advisory Board. The Principal Investigator's biographical sketch should precede all others; others should follow in alphabetical order. Use duplicate copies of the Biographical Sketch Format page for each investigator. Include only one copy of each biosketch in the application. Item A is the Personal Statement; Items B and C includes “Positions and Honors,” and “Selected Peer-review Publications”; and Item D provides information on research support. List both selected ongoing and completed (during the last 3 years) research projects (federal or non-federal support). See http://grants.nih.gov/grants/funding/phs398/biosketchsample.pdf for an example biographical sketch. Begin with the projects that are most relevant to the research proposed in this application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch. Note: Do not include person months or direct costs. This section is limited to 4 pages.

Resources. Using the Resources Format page, investigators must describe how the scientific environment will contribute to the probability of success of the project, unique features of the environment, and for Early Stage Investigators, the institutional investment in the success of the investigator (e.g. resources, classes, etc.). If more than one campus or location will be involved, briefly describe each setting. If unique resources are available, briefly describe these and their relevance to the proposed program.

Section ll. Program Overview This section is unique to the multi-project application.  The information requested in this section, for the most part, is not covered in the PHS 398 and includes: an overall “Consortium Introduction” describing the major theme, goals and objectives; the community-based participatory nature of the Consortium and the interactions between the projects and cores and community organizations. This narrative section summarizes the overall research plan for the multi-project application and is limited to (12) pages.  This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program – by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems.  Summarize the special features in the environment and/or resources that make this application strong or unique. a description of the role of the Principal Investigator; a description of the organizational structure of the applicant’s consortium including an administrative and a management plan to achieve an integrated coordinated research consortium

Bibliography and References Cited/Progress Report Publication. This list of publications should follow the same format as Research Plan item 5 (see PHS 398 Instructions).

Section lll- Vl. Research Plans for Projects and Cores. These sections contain the research plans for the individual research projects, Research Support Cores, Administrative Core, and Community Outreach and Dissemination Core and follows the guidelines established in the PHS 398.  Note: according to the Restructured Research Plan, as indicated in NOT-OD-09-149, the Research Strategy section should consist of significance, innovation, approach and either preliminary studies (new applications) or progress report (for renewal/revision applications), as applicable.  The Research Strategy section is limited to 12 pages for research projects and cores.  

All Projects and Cores.

SECTION III

Research Projects. Follow the instructions in the PHS 398 for the Research Plan, as appropriate, for describing the project. In addition, each individual project should clearly state its relevance to the overall program and its primary theme, its contribution to and its interactions with the other projects and the extent of its dependence on the cores. Research Projects should be designated as Project 1, Project 2, etc.

SECTION IV

Administrative Core. Follow instructions in the PHS 398 for the Research Plan as is appropriate for describing the Administrative Core. This section should detail information introduced in the Introduction regarding the Principal Investigator and the Organizational Structure of the consortium. This section should include an administrative and management plan that will achieve an integrated, coordinated multi-disciplinary research program. A narrative description should be provided that includes the planning and coordination of research activities and community outreach and dissemination activities; the integration of cross-disciplinary research; and the oversight of fiscal and resource management. Indicate who will be responsible for each of these activities. Describe the role(s) of advisory groups and consultants. Relevant experience of the PI and leadership team may also be cited.

SECTION V

Community Outreach and Dissemination Core.  Follow the instructions in PHS 398 Research Plan as is appropriate for describing the Community Outreach and Dissemination Core (CODC). A narrative description should be provided that describes how the goals of the CODC relate to the scientific research of the application, and how the Core Leader will interact with the Project Leaders. Indicate how this Core will coordinate with established stakeholder groups.

SECTION VI (optional)

Research Support Cores. Follow the instructions in PHS 398 Research Plan as is appropriate for describing the Research Support Core. Information that should be included is as follows:

Section VII 

Plan for Sharing Data. A data-sharing plan should be developed for the overall program. The precise content will vary depending on the data being collected and how the investigator(s) is planning to share the data. For example, applicants may briefly describe the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. For NIH instructions and policy see http://grants.nih.gov/grants/policy/data_sharing/index.htm.

Section VIII

Checklist. Fill out the PHS 398 Checklist Form Page; refer to the PHS 398 for further instructions. One checklist, placed at the end of the application is to be submitted.

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 PHS398 Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.  

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

Steering Committee Meetings

Because the DWH Research Consortia use the cooperative agreement funding mechanism, the PI must budget for attendance at 2 steering committee meetings per year.  In addition to the PI, travel must also be budgeted for at least one community member.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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 initial review for scientific merit will emphasize two aspects: (1) The overall impact of the Consortium as a whole; i.e., the consortium as a whole focuses on health concerns of community members residing in the Gulf States as a consequence of the DWH disaster. Reviewers will provide an overall impact/priority score that considers the extent of community engagement in addition to the five Scored Review Criteria (Significance, Investigator, Innovation, Approach, and Environment);

(2) The impact of the individual Research Projects and Cores that are reviewed independently.  Reviewers will provide an overall impact/priority score for each project and core in consideration of the five Scored Review Criteria (Significance, Investigator, Innovation, Approach, and Environment).  There are additional review criteria specific for the Community Outreach and Dissemination Core, the Administrative Core and Research Support Cores (described below).

Overall Impact - Overall

Reviewers will provide an overall impact/priority 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 - Overall

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?

Does the overall consortium focus on studies and approaches that will increase the evidence-base to enhance community resiliency of those most affected by the DWH disaster?

If successful, would the consortium provide data, information and knowledge to inform the affected residents, community groups, health departments in the decision-making processes related to public health?

Investigator(s)

Are the PD/PIs, 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 experience and scientific leadership of the consortium allow him/her to effectively direct a multi-project consortium?

Is there evidence that the leadership team has experience in working with local community groups residing in the Gulf States most affected by the DWH disaster? 

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?   

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? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Is there evidence of community participation in the overall development of the consortium objectives?  

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?

Additional Review Criteria - Overall

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/priority score, but will not give separate scores for these items.

Extent of Community Engagement

Overall Impact - Research Projects and Cores

In addition to the Overall Impact score for the Overall Consortium, reviewers will provide an overall impact/priority score for each Research Project and Core to reflect their assessment of the likelihood for the project/core 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/core proposed).

Scored Review Criteria - Research Projects and Cores

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?

Investigator(s)

Are the PD/PIs, 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?

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?  

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?

For the Community Vulnerability and Resilience Research project only these additional review criteria should be considered:

Will the proposed study apply evidence-based research in a community setting to translate research findings into improvements in the practice of community preparedness, prevention, and resiliency?  Will the CBPR approach in the study enhance the potential for dissemination of research findings and long-term sustainability of positive community practices?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion 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?

Additional Review Criteria

The following will be considered by the review panel in evaluating specified cores below.

Additional Review Criteria for the Administrative Core:

Additional Review Criteria for the Research Support Cores:

Additional Review Criteria for Community Outreach and Dissemination Core (CODC)

·       Vision and Objectives:

·       Translating research information into improved community resiliency:

·       Ensuring consortium understanding of community and other stakeholder needs:

·       Leadership and staff expertise:

Additional Review Criteria - Research Projects and Cores

As applicable for the project/core proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

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/priority 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  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

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

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 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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:

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

An NIH Project Scientists will be assigned to each of the awarded U19 consortia. This staff member is a scientist from the staff of any of the participating NIH institutes who is selected because of relevant scientific content area expertise and experience with regard to the scientific goals and objectives of a given U19 award. These staff members will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice and coordination. However, the role of the NIH staff will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the DWH Disaster Research Consortia Steering Committee and that NIH will be given the opportunity to offer input into this process. There will be no more than 9 NIH Project Scientists participating as members of the Steering Committee; however, there will be only one NIH vote, reached by consensus. The Project Scientists will have the following substantial involvement

Areas of Joint Responsibility include:

Management and Governance

All involved investigators of the Program will meet two times a year in order to share information and assess progress. The Steering Committee will serve as the main coordinating body of the Consortium. The Steering Committee members will meet at least once a year with the NIEHS Worker Cohort Study to coordinate research efforts and findings. The Steering Committee may add additional members. Other government staff may attend the Steering Committee meetings if their expertise is required for specific discussions.

The Steering Committee will be responsible for coordinating the activities being conducted by the Consortium. To address particular issues, the Steering Committee may establish working groups as needed.

Consortium Steering Committee

The Consortium Steering Committee will consist of the Principal Investigator(s), a community member of each grant awarded in this program, and NIH Staff. The chairperson of the steering committee will be selected by the Government and serve a one-year term. The Steering Committee will serve as the main governing board of the Consortium established under this RFA. The committee will meet by regularly scheduled teleconference and bi-annually in person. The Steering Committee will be responsible for making scientific and administrative recommendations to the NIEHS and participating ICs.

The Steering Committee will be responsible for coordinating the activities being conducted by the Consortium. Development of community responsive data sharing plans and/or intervention/prevention dissemination plans will be part of the Steering Committee responsibilities. To address particular issues, the Steering Committee may establish working groups as needed, which may include representatives from the Consortium, and the NIH and possibly other experts. Such groups might include ones to: 1) address data management issues; 2) analyze the project data; 3) develop quality standards and methods to assess data quality; and 4) handle communication issues and develop principles for reporting findings. Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

NIEHS

Claudia Thompson, PhD
Acting Chief, Susceptibility and Population Health Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-04
Research Triangle Park, NC 27709
Telephone: 919-541-4638
Email: thomps14@niehs.nih.gov

NCI

Gary L. Ellison, PhD, MPH
Epidemiologist
Program Director, Modifiable Risk Factors Branch
Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 5108
6130 Executive Blvd, MSC 7324
Bethesda, MD 20892-7324
Telephone: 301-402-1853
Email: ellisong@mail.nih.gov

NHLBI

Peter Kaufmann, PhD
Deputy Chief
Clinical Applications and Prevention Branch
National Heart, Lung and Blood Institute
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: 301-435-2467
Email: kaufmannp@nhlbi.nih.gov  

NIAMS

Carl C. Baker, M.D, Ph.D.
Program Director, Keratinocyte Biology and Diseases
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd
Suite 800
Bethesda, MD 20892-4872
Telephone: (301) 594-5017
Email: bakerc@mail.nih.gov

NIMH

Farris Tuma, Sc.D.
Division of Adult Translational Research and Treatment Development
Traumatic Stress Disorders Research Program
National Institute of Mental Health
6001 Exec Blvd, Room 7111, MSC 9632
Bethesda, Maryland 20892
Telephone: 301-443-3648
Email: ftuma@mail.nih.gov

NIMHD

Nathan Stinson, Jr., PhD, MD, MPH
Acting Director, Division of Extramural Activities & Scientific Programs
Acting Scientific Director, Intramural Research Program 
National Institute on Minority Health and Health Disparities
6707 Democracy Blvd, Suite 800
Bethesda, Maryland 20892-5465
Telephone: 301-594-8704
Email: stinsonn@mail.nih.gov

NINR

Paul A. Cotton, PhD, RD
Program Director, Health Behavior & Minority Health
Division of Extramural Activities
National Institute of Nursing Research
National Institutes of Health (NIH)
6701 Democracy Blvd, Ste. 710
One Democracy Plaza
Bethesda, MD 20892-4870 (Courier zip: 20817)
Telephone: 301-402-6423
Email: Paul.Cotton@NIH.Gov

NCRR

Heng Xie, M.D., M.P.H., Ph.D.
Supervisory Medical Officer
Division for Clinical Research Resources
National Center for Research Resources, NIH
6701 Democracy Blvd., Democracy I, Rm. 908
Bethesda MD 20892-4874 (Regular mail)
Bethesda MD 20817 (FedEx)
Telephone: 301-443-8063
E-mail: XieHe@mail.nih.gov

OBSSR

Deborah H. Olster, Ph.D.
Office of Behavioral and Social Sciences Research
National Institutes of Health
Room B1C19, Bldg 31
31 Center Drive
Bethesda, MD 20892
Telephone: 301 402-1147
Email: olsterd@od.nih.gov

Peer Review Contact(s)

Leroy Worth, Ph.D.
Scientific Review Officer
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
530 Davis Drive, Room 3080
Durham, NC 27713
Telephone: 919-541-0670
Email: worth@niehs.nih.gov

Financial/Grants Management Contact(s)

Dorothy Duke
Chief Grants Management Officer
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
530 Davis Drive
Durham, NC 27713
Telephone: 919-541-2749
Email: duke3@niehs.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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