and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Environmental Health Sciences (NIEHS) |
|
Funding Opportunity Title |
Centers for Oceans and Human Health (P01) |
Activity Code |
P01 Research Program Projects |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-ES-11-012 |
Companion FOA |
|
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. |
|
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.113, 47.050 |
FOA Purpose |
This funding opportunity announcment (FOA) issued by the National Institute of Environmental Health Sciences (NIEHS), and the National Science Foundation (NSF) solicits grant applications that address research approaches to problems that are relevant to oceans and human health. The purpose of Centers for Oceans and Human Health (COHH) is to provide linkages between members of the ocean sciences and biomedical communities in order to support interdisciplinary research in areas where improved understanding of marine processes and systems has potential to reduce public health risks. This FOA will solicit grant applications that address harmful algal bloom (HAB) research, marine pollution (e.g., chemical toxicants assessment of long-term chronic exposures versus acute exposures; aspects of global climate change that influence ocean related human health outcomes; and development of statistical and bioinformatic tools to link developed oceanographic models with less well developed human health exposure and disease models). COHH awards are expected to create an environment conducive to interdisciplinary and reciprocally beneficial collaborations among biomedical scientists (e.g., epidemiologists, pharmacologists, toxicologists, microbiologists, cell and molecular biologists) and ocean scientists (e.g., biological and physical oceanographers, geochemists, and ecologists) with the common goal of improving our knowledge of the impacts of the ocean on human health. |
Posted Date |
September 15, 2011 |
Letter of Intent Due Date |
October 22, 2011 |
Application Due Date(s) |
November 22, 2011 |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
April 2012 |
Advisory Council Review |
August 2012 |
Earliest Start Date(s) |
September 2012 |
Expiration Date |
November 23, 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.
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
Oceans occupy greater than 70% of the planet’s surface and 60 % of the human population lives within 75 miles of coastal waterways or ocean coasts. Thirteen out 15 of the world’s largest cities lay on or near coasts and the proximity of human populations to ocean coasts is not surprising when our past, current and future dependence on coastal waterways for food, commerce, travel and recreation are taken into consideration. The largest source of protein in the world is fish and more fish are harvested throughout the world than cattle, sheep, poultry or eggs. Billions of dollars are turned over annually from fishing, and other commercial ventures, which certainly include travel and recreational use of coastal waterways. Human populations are extremely dependent on the ocean for work, food, travel and recreation and many aspects of health maintenance are also associated with the oceans. Consequently, human activities can be associated with several point and non-point sources of chemical pollutants and toxicants, draining into the oceans and coastal waterways daily, as well as 2.8 billion tons of industrial waste being released into the oceans annually by the US alone. This marine pollution causes significant damage to marine ecology and has multiple potential negative impacts on human health. It is clearly recognized that the oceans are a sustaining, re-invigorating resource that demands proper stewardship because our well being and health outcomes are at risk. Increasing marine temperatures associated with global climate change introduces additional variables that may further escalate human health risks associated with oceans.
In April 2004, the National Institute of Environmental Health Sciences (NIEHS) and the National Science Foundation (NSF) (hereafter "the Government" or "the Participating Agencies") announced funding for four joint Centers for Oceans and Human Health. The Centers for Oceans and Human Health (COHH) aimed to provide linkages between members of the ocean sciences and biomedical communities in order to support interdisciplinary research in areas where improved understanding of marine processes and systems has potential to reduce public health risks and enhance existing biomedical capabilities. These Centers were expected to create environments conducive to interdisciplinary and reciprocally beneficial collaborations among biomedical scientists (e.g., epidemiologists, pharmacologists, toxicologists, microbiologists, cell and molecular biologists) and ocean scientists (e.g., biological and physical oceanographers, geochemists, and ecologists) with the common goal of improving our knowledge of the impacts of the ocean on human health. The NIEHS and the NSF support complementary sets of scientific expertise and disciplines that were brought together to address/study a number of human health effects that are directly related to oceans, the micro-organisms that thrive in the oceans, climatic and geophysical oceanic processes and pollution.
That solicitation, RFA-ES-03-003, drew on the recommendations contained in the strategic plans of the Participating Agencies (NIEHS Strategic Plan 2000; NSF Geosciences Beyond 2000; and Environmental Science and Engineering for the 21st Century: The Role of the National Science Foundation); those highlighted by the Ocean Studies Board of the National Research Council (From Monsoons to Microbes: Understanding the Oceans Role in Human Health, National Academy Press, 1999); and those discussed at a Government-sponsored Roundtable on Oceans and Human Health in Research Triangle Park, NC, December, 2001.
This FOA presents an ongoing opportunity to continue the development of this new paradigm for studying adverse relationships between the oceans and human health. Research priorities identified in this OHH solicitation include recommendations made by the National Science and Technology (NCST) Joint Subcommittee on Ocean Science and Technology (JSOST) report, Charting the Course for Ocean Science in the United States for the Next Decade: An ocean research priorities plan and implementation strategy; and the Interagency Oceans and Human Health Research Implementation Plan: A Prescription for the Future by the Interagency Working Group on Harmful Algal Blooms, Hypoxia, and Human Health (Sandifer, P., C. Sotka, D. Garrison, and V. Fay. 2007); and The Interagency Oceans and Human Health Research Implementation Plan: A Prescription for the Future, Interagency Working Group on Harmful Algal Blooms, Hypoxia, and Human Health of the Joint Subcommittee on Ocean Science and Technology. Washington, DC.
This FOA is soliciting applications that address: HAB research; marine pollution (e.g., chemical toxicants); uses models or sentinels in the assessment of long-term chronic exposures versus acute exposures; and development of statistical and bioinformatic tools to link developed oceanographic models with less well developed human health exposure and disease models.
It is anticipated that COHH will be multidisciplinary research programs in the diverse areas of oceanography, climatology, ecology, biomedical science, and computational biology. These Centers will participate in a national network of investigators and will foster an interconnected research approach dedicated to understanding the physical, chemical, and biological complexities linking oceans and human health.
Investigators applying under this FOA may focus on one or more of the suggested topics that link oceanographic sciences with human health outcomes.
Harmful algal blooms
Human health outcomes related to oceans have been documented as far back as 800 B.C. when illness resulting from the consumption of contaminated fish was recorded in Homer’s Odyssey. In present times, human illnesses are still primarily caused by consumption of contaminated seafood but are also caused by inhalation of aerosolized toxins. Each year in the United States alone, over 60,000 cases of poisoning by exposure to harmful algal blooms (HABs) are reported. HABs release marine toxins that are frequently associated with fish kills, bird kills, and marine mammal kills. Adverse health outcomes in humans range from acute neurotoxic disorders, such as saxitoxin, brevetoxin, and ciguatera poisonings like paralytic shellfish poisoning, neurotoxic shellfish poisoning and ciguatera finfish poisoning, to more chronic diseases, e.g., chronic liver disease caused by microcystins and amnesic shellfish poisoning from domoic acid exposure. Presently it is not known what is responsible for or triggers outbursts of HABs. Methodologies for early detection or remote sensing of outbreaks would provide a major mechanism for reducing/preventing exposures to marine toxins released by HABs. This FOA will support studies that address mechanisms of HAB toxin toxicity; elucidation of toxin synthesis; and remote sensing and prediction of HAB events, including approaches that utilize satellite data. Studies that apply high-throughput genomic, proteomic, and metabolomic technologies in combination with measures of sea surface temperature, sea surface salinity, stream flow, wind speed, and or precipitation to address mechanisms of toxicity and remote sensing of HAB events are encouraged.
Marine pollution
Deep offshore oil drilling near the coastline of Louisiana has produced one of the largest anthropogenic environmental disasters in history. The massive spill in the Gulfof Mexico is the largest spill in the history of the United States. Scientists have estimated that the recent oil spill in the Gulf of Mexico maybe spewed as much 184 million gallons of crude oil covering approximately 572 miles of Gulf Coast shoreline, threatening fisheries, tourism, and the habitat of hundreds of bird species. Additionally, over 1.8 million gallons of dispersant chemicals were released to help break up the oil. The short term and long term chronic impacts and risks to human health currently are not known, but clearly major oil spills resulting from deep shore oil drilling operations can be a major source of chemical pollution in the marine environment. There are multiple additional sources of marine pollution that also may impact human health and ecological systems. These include but are not limited the following: oil that is introduced into marine environments via: routine machine maintenance; drainage; or natural seepage. There are additional toxic materials introduced into marine environments via agricultural runoff, which includes: runoff from barnyards; and runoff from feedlots that includes pesticides and fertilizers. Additional sources of marine pollution come from urban and industrial runoff. These sources include: runoff from building and paved surfaces; storm water drainage; sewage; automotive emissions and other air pollutants. Vast marine dumping and removal/dredging procedures can result in marine contamination with: sewage sediment, including domestic, municipal and industrial garbage; harbor/waterway sediment; and pollution from industrial toxic by-products.
Climate change and OHH
Global climate change has become one of the most visible environmental concerns of the 21st century. Climate change will affect ocean and coastal ecosystems through increasing temperatures, sea level rise, changes in precipitation patterns, changes in ocean pH and salinity, and more frequent and intense extreme weather events. Climate may also affect the distribution and concentrations of chemical contaminants in coastal and ocean waters, for example through release of chemical contaminants previously bound up in polar ice sheets or sediments or through changes in volume and composition of contamination runoff. As a result, many ocean-borne diseases, including those described above, are expected to worsen. A better understanding of how global warming will alter ocean-related human health risks and vulnerabilities is needed. This FOA encourages research and methodical development applications to help quantify and forecast ocean-related human health threats under current and future climate scenarios.
HAB Research: Examples of research topics to be addressed include, but are not limited to:
Marine Pollution: Examples of research topics to be addressed include, but are not limited to:
Climate Change and OHH: Examples of specific topics of interest include, but are not limited to:
Development of models and statistical and bioinformatic tools: Additionally, this FOA encourages:
Description of Center:
Applications must contain three independent research projects that are equivalent to R01 applications, an administrative and planning core, and may request one or more facility cores, which support at least two of the R01 type projects described in the application.
Budget requests must set aside travel support for an annual program meeting minimally for all project leads associated with the application and other personnel deemed necessary by the PD(s)/PI(s) . Moreover, each Administrative Core must set aside $5,000.00 of total budget each year to support an annual program meeting between Centers and the R01 component of this program, described in RFA-ES-11-013.
Centers established under this FOA will have in common support for the following three basic elements: research projects; an administrative core; and facility cores. For the purpose of this FOA, a Center for Oceans and Human Health (COHH) is defined as an interdisciplinary collaborative arrangement among a group of scientists located at the same or different institutions, committed to conducting at least three individual but interrelated and interdependent research projects that address the goals of this FOA. Plans for interaction among the components within Centers must be explicitly described.
A. Research Projects
Each Center will minimally support three meritorious research projects with a conceptual theme focusing on oceans and human health. Research projects must be interdisciplinary and address one or more of the identified special emphasis areas including but not limited to: HABs; marine pollution; statistics/bioinformatics; and the interaction of global climate change with oceans and human health.
Research projects should unite the skills of basic and clinical biomedical scientists with physical, chemical, and biological oceanographic scientists. A Center will be asked to describe a plan for promotion and support of interdisciplinary planning, implementation and synthesis of research across and within individual projects. Hypotheses and specific aims developed and described for research projects must demonstrate the thematic, interdisciplinary, and collaborative nature of the Center application. This requirement is meant to promote interdisciplinary collaboration in development and design of Center research projects as well as continued collaboration throughout the duration of Center support.
B. Administrative and Planning Core
The administrative structure should include, in addition to the Center Director, a Co-Director, a business manager, an internal steering committee, and an external advisory committee. The Director and Co-Director should possess complementary expertise in biomedical and oceanographic sciences. An individual with expertise in either field can be Director or Co-Director. Both fields should be covered by the Director and Co-Director team. The external advisory committee (EAC) should consist of a group of three to five scientists, having expertise appropriate for the Center's research focus, who are outside the applicant institution. The membership of the advisory committee must be approved by the Participating Agencies post review. Names of potential EAC members should not be solicited or submitted in the application. Please only submit a description of planned committee by representation based on area of expertise. Individuals in senior leadership positions should provide intellectual, administrative, and scientific leadership for the Center and are critical to its overall effectiveness and evolution. These individuals should be in place and committed to a defined percent effort.
The administrative core should promote joint planning and evaluation activities as well as collaborations and interactions among different components of the Center. The Center must have appropriate and adequate management capabilities to conduct research and to evaluate the performance of the Center in achieving the goals of the FOA. Objective criteria for evaluation, including intermediate markers for assessing the impact of the science conducted by each Center in elucidating connections between the oceans and human health, are required as part of this core.
In addition, each Center should describe a mechanism for data sharing and technology transfer with other Centers and with potential end users of research results, such as state public health and environment agencies. It is anticipated that a Center will devote no more than 10 percent of its budget to the administrative core.
C. Facility/Service Cores
Centers may support shared core resources common to two or more research projects. Each Center may support facility cores that provide a technique, service, or instrumentation to enhance ongoing research efforts. Examples of such facilities include: biostatistics and/or bioinformatics, genomics and proteomics, exposure assessment, and sensor development. Budgeted Center projects as well as research projects external to the Center may have access to facility cores. The application should provide a total operational budget for each facility core together with the percentage of support requested from the Center grant. The application should explain the organization and proposed mode of operation of each core, including a plan for usage, priority setting, allocation of resources, and any applicable charge back system. Allocation among various components of the Center should be balanced and well justified.
Funding Instrument |
Grant |
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 |
NIEHS and NSF intend to fund an estimate of 3-4 awards, corresponding to a total of $4.2 million, for FY 2012. Future year amounts will depend on annual appropriations. |
Award Budget |
Direct costs are limited to $900,000 per year for a 5-year period. |
Award Project Period |
The total project period for an application submitted in response to this funding opportunity may not exceed 5 years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
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 Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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 Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.
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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
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.
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
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.
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:
The letter of intent should be sent to:
Linda K. Bass, Ph.D.
Scientific Review Officer
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
530 Davis Drive (Mail Drop: K3-03)
Research Triangle Park, NC 27560
Telephone: (919) 541-1307
Fax: (919) 316-4606
Email: [email protected]
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:
Linda K. Bass, Ph.D.
Scientific Review Officer
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
530 Davis Drive (Mail drop: K3-03)
Research Triangle Park, NC 27560
Telephone: (919) 541-1307
Fax: (919) 316-4606
Email: [email protected]
All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following requirements:
Description
Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.
The program project grant application should be structured as a series of separate but interrelated project proposals. State the proposed program’s broad, long-term objectives, specific aims, and the significance to the mission of NIEHS. Define the relevance of each proposed project and shared resource core to the overall theme and goals of the program.
Detailed Budget for Initial Budget Period
Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.
Use PHS-398 Form Page, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," to present the total budget for all requested support for the first year. For each category, such as "Personnel," "Equipment," etc., give the amount requested for each Research Project component and each Core unit, with subtotals.
If consortium arrangements involving other institutions or organizations are anticipated, include total (direct and indirect) costs associated with such third-party participation in the Consortium/Contractual Costs category. Costs for purchased services should be itemized under the "Other Expenses" category.
Budget for Entire Proposed Period of Support
Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.
Use PHS-398 Form Page, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," to prepare a budget, by category, that provides totals for each year of requested support. Requests for any increases in succeeding years must be justified in the individual Research Project component and Core unit budgets.
Budgets for Individual Research Project Components and Core Components
Prepare Detailed Budget for Initial Budget Period for each component.
Prepare Budget for Entire Proposed Period of Support for each component.
Budget Justifications and Explanations
Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations.
Biographical Sketch
Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.
Biographical sketches are required for all key personnel participating in the Research Project components and Core units. Compile all biographical sketches starting with the overall program project leader followed by all other investigators, including the individual project/ core leaders, in alphabetical order. Do not repeat biographical sketches in the individual research projects or shared resources cores.
Resources
Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.
Complete the "Resources" page of PHS-398 for the overall project. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources.
Project overview
Each P01 program project application must include a minimum of three individual (albeit connected) research projects each of which is pertinent to the central goal of the program. If support of core resources is requested, a separate component describing and justifying these should be included.
Research Projects
The Research Projects should include:
Each individual project of a program project grant should represent both a separate and an interdependent research effort. Each research project should be prepared according to the application guide instructions. The overall format and page limits for an R01 application apply to each of the component projects. The special benefits associated with being part of the program project must also be addressed. Do not repeat the individual budget pages and biosketches.
Instead of the standard PHS 398 face page for each project, create a title page for the project that lists the project name and the name of the project director.
Specific Aims
Specific aims should be built around serving the goals of the program project.
Research Strategy
Approach. The special benefits associated with being part of the program project and the relationship of this project to the other projects and cores should be addressed.
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:
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, with the following modifications:
The plan for software sharing may be commented on during peer review with any other resource sharing plans.
The adequacy of the software sharing plans will be considered by program staff when making recommendations about funding applications as appropriate. In making such considerations, prior to funding, program staff may negotiate modifications of software sharing plans with the Principal Investigator(s). Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan.
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.
Foreign Institutions
Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.
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.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement.
Pre-award costs are allowable only as described in the NIH
Grants Policy Statement.
Applications must be 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 responsiveness by the National Science Foundation and the National Institute of Environmental Health Sciences, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Each Center must budget $5,000.00 per year to support annual OHH meetings in venues to be determined. These funds will be used to support costs associated with logistics of the annual OHH meeting, including facilities necessary for hosting the meeting and traveling outside speakers. Additionally, centers will be responsible for the support of traveling key personel to the annual OHH meetings.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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.
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).
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(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(s)/PI(s), 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?
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?
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.
Administrative and Planning Core
What is the decision-making process within the proposed Center? Is it adequate for the evaluation of research productivity, allocation of funds, and management of the resources? Are procedures clearly outlined to measure and track Center goals, outputs and outcomes?
How will the Administrative Core promote joint planning and evaluation activities as well as collaborations and interactions among different Research Projects of the Centers? What are the academic environment and resources in which the research will be conducted? Are there available and appropriate space, equipment, human subjects, animals, or other resources as required for potential interaction with scientist(s) from other departments to complete the scope of work as proposed?
What is the institutional commitment to the Center, including fiscal responsibility and management capability of the institution to assist the Program Director(s)/ Principal Investigator(s) and his/her staff in following DHHS, PHS, NIH and NSF policy?
Facility/Service Cores
What is the Core's utility to Center investigators? Does each Core provide services for two or more research projects that are judged to have substantial merit? What is the quality of the facility or services provided? What are the availability and/or adequacy of the physical space, laboratory, clinic and/or equipment proposed for the Core? What is the cost-effectiveness of the service provided? Are the qualifications of the personnel involved, their experience, and commitment to the Core appropriate?
Overall Center
Does the Center consist of a cohesive and multidisciplinary focus? Does a coordinated interrelationship exist between the research projects and cores? Are the components of the Center related to the common theme of the Center? What is the scientific gain of combining the component parts into a Center? For new applications, is there evidence of the degree of synergy (degree of interaction, collaborative research opportunities) that will be stimulated by the Center? How do the research projects and cores relate to the central theme and the ability of the Center to meet its long range goals? Will the specific scientific objectives of each project benefit significantly from, or depend upon collaborative interactions with other projects in the program (i.e., objectives that can be uniquely accomplished, specific contributions to the accomplishments of objectives in other projects, objectives that can be accomplished with greater effectiveness and/or economy of effort)? Have the investigators adequately conceptualized the Center s expected results and potential benefits to the broader public?
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.
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
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by NIEHS , in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned 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 National Advisory Environmental Health Sciences Council.. The following will be considered in making funding decisions:
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.
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 the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Not Applicable.
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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
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: [email protected]
Frederick L. Tyson, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-0176
Email: [email protected]
Donald L. Rice, PhD, MPH, Director
Division of Ocean Sciences
National Science Foundation (NSF)
Telephone: (703) 292-8582
Email: [email protected]
Linda K. Bass, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-1307
Email:
[email protected]
Lisa Archer Edwards, MBA
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-0751
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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