Participating Organization(s)	National Institutes of Health (NIH) National Science Foundation (NSF)
Components of Participating Organizations	National Institute of Environmental Health Sciences (NIEHS) Geosciences Directorate, Division of Ocean Sciences (GEO/OCE)
Funding Opportunity Title	Oceans, Great Lakes and Human Health (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	November 22, 2011 - NIH Extends Application Due Dates of Nov 21-23 to Nov 28. See Notice NOT-OD-12-018. November 21, 2011 - Deadline for Applications Due on November 21 and 22, 2011 will have their deadline extended until Wednesday, Nov. 23. See NOT-OD-12-016. November 2, 2011 - See Notice NOT-ES-12-002. The purpose of this Notice is to add "Ship Time Request" information to this RFA.
Funding Opportunity Announcement (FOA) Number	RFA-ES-11-013
Companion FOA	RFA-ES-11-012, P01 Research Program Projects
Number of Applications	Applicant organizations may submit more than one application, provided that each application is scientifically distinct. Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.113, 47.050
FOA Purpose	This funding opportunity announcement (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 Oceans, Great Lakes and Human Health (OGLHH) 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 marine or Great Lakes harmful algal bloom (HAB) research, marine or Great Lakes pollution, (e.g., chemical toxicants assessment of long-term chronic exposures versus acute exposures; aspects of global climate change that influence ocean or Great Lakes related human health outcomes; and development of statistical and bioinformatic tools to link developed oceanographic or Great Lakes models with less well developed human health exposure and disease models.) OHH 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 and Great Lakes on human health.

Posted Date	September 15, 2011
Open Date (Earliest Submission Date)	October 22, 2011
Letter of Intent Due Date	October 22, 2011
Application Due Date(s)	(Extended to November 28, 2011 per NOT-OD-12-018), Previous Date: November 23, 2011; Original Date November 22, 2011, by 5:00 PM local time of applicant organization.
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	(Extended to November 29, 2011 per NOT-OD-12-018), Previous Date: November 24, 2011; Original 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 SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The nature of the research opportunity described by this FOA is to solicit applications that will support interdisciplinary approaches to continue the development of this new paradigm for studying adverse relationships between the oceans and human health.

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 of 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 is 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 introduce 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 purpose of Centers for Oceans and Human Health (COHH) was 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. The COHH programs 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; Environmental Science and Engineering for the 21st Century: The Role of the National Science Foundation); and 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.

Investigators applying under this FOA may focus on one or more of the suggested topics that link oceanographic sciences with human health outcomes.

It is anticipated that OHH awards will be multidisciplinary research programs in the diverse areas of oceanography, climatology, ecology, biomedical science, and computational biology. These grants will participate with 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.

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

There are multiple sources of marine pollution that impact human health and ecological systems. These include but are not limited to the following: oil that is introduced into marine environments via major spills; routine machine maintenance; drainage; offshore drilling and natural seepage. Additional toxic materials are introduced into marine environments via agricultural runoff, which includes: runoff from barnyards; runoff from feedlots; pesticides and fertilizers. There are multiple sources of urban and industrial runoff from: building and paved surfaces; storm water drainage; sewage; automotive emissions; and air pollutants. Vast marine dumping and removal/dredging procedures result in marine contamination with: sewage sediment; domestic, municipal and industrial garbage; harbor and waterway sediment; and industrial toxic by-products.

Great Lakes Human Health Issues

This initiative will address the associations between the Great Lakes and human health risks and health outcomes. The Great Lakes Basin serves as a major source of drinking water to populations living in the region, as well as providing avenues of recreation, transportation and commerce. Consequently, there are human health risks and outcomes that are associated with pollution in the Great Lakes Basin. Cyanobacterial (blue green algae) species that produce cyanotoxins pose health hazards via exposure through consumption or recreational activities. Microcystins are cyclic nonribosomal peptides produced by cyanobacteria (blue -green algae). They are cyanotoxins and can be very toxic for plants and animals including humans. Their hepatotoxicty may cause serious damage to the liver. Microcystins can strongly inhibit protein phosphatases type 1 (PP1) and 2A (PP2A). There is also evidence that there may be a relationship between liver and colorectal cancers and cynaobacterial contamination of drinking water in China.

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.

Development of Marine Natural Products:

Nature has traditionally been the source of new pharmaceuticals. Over 50% of drugs on the market today are either extracted from natural sources or produced by synthesis using natural products as templates or starting materials. Despite new approaches to drug discovery, it seems likely that natural products, which have evolved over millions of years of selective pressures, provide one of the most important components of this process.

The marine environment constitutes the greatest source of chemical diversity on the planet. Representatives of every phylum are found in the sea; twelve phyla are exclusively marine. More than 200,000 species of invertebrates and algae in the ocean have been described. However, it is estimated that this number is only a small percentage of the total number of species yet to be discovered. Based upon such diversity, the ocean represents a virtually untapped resource for discovery of novel chemicals with pharmaceutical potential.

An important application of bioactive compounds derived from the marine environment is their use as molecular probes, i.e., as non-drug substances that can be used to probe important biochemical processes. Very often, marine-derived compounds possess unique biological properties that render them of use in basic biology. For example, discovery of the potent marine toxin tetrodotoxin led to a much more refined understanding of the receptors for human pain. Similarly, the red tide toxin okadaic acid and the sponge metabolite illimaquinone are now in use to probe basic cellular processes. In addition, marine natural products have provided visual markers for proteins specified by antibodies, for cellular events mediated by calcium, and for elucidating mechanisms of tissue-specific gene expression.

HAB Research: Examples of research questions to be addressed include but are not limited to:

• The development of enhanced and or novel remote sensing and prediction of HAB events utilizing oceanic, geological and atmospheric measurements as well as retrospective analysis of satellite data will be encouraged.
• Studies that develop novel technologies for remote sensing;
• Studies that elucidate HAB toxin toxicity;
• Studies that enhance remote sensing capabilities and prediction of HAB events;
• Studies that investigate biologically active compounds, e.g., beta-Methylamine alanine (BMAA) a potent neuroxtoxin, or other biologically active compound that may increase human health risks; and
• Studies that improve integration of harmful algal bloom activities with existing monitoring and observational programs.

Marine Pollution: Examples of research questions to be addressed include but are not limited to:

• Studies focusing on human health risks associated with marine pollution from a number of sources, including but not limited to: agricultural and or urban runoff; marine dumping, and major spills that affect ecological systems and have demonstrable direct effects on human health outcomes.
• Studies on the impact of eutrification on growth kinetics of HAB organisms;
• Studies on bioaccumulation of marine pollutants in shellfish, finfish, and or marine mammals that are consumed and impact human health or health risks;
• Studies that identify the risks to humans from exposure in recreational waters;
• Studies that elucidate mechanisms of toxicity of marine chemical pollutants; and
• Studies that explore relationships of transport and fate to adverse human health outcomes.

Climate Change and OHH: Examples of specific topics of interest include, but are not limited to:

• Studies to determine how climate directly and/or indirectly impacts toxic algal blooms, including their initiation, development, termination, and other characteristics that influence the occurrence and severity of associated human disease;
• Studies to evaluate health risks associated with climate-change induced increases in the release and mobilization of chemical contaminants;
• Studies to determine synergistic interactions among ocean-related toxins, chemicals, and waterborne pathogens also likely to be impacted by climate change, and how changes in climate will impact these relationships; and
• Development of methods to detect, quantify and forecast ocean-related health threats, including improved surveillance and monitoring of disease-causing agents in coastal waters, marine organisms, aerosols, sediments, and exposed human populations.

Great Lakes: Studies associated environmental health concerns in the Great Lakes, including but not limited to:

• Studies to determine how climate directly and/or indirectly impacts toxic algal blooms, including their initiation, development, termination, and other characteristics that influence the occurrence and severity of associated human disease;
• Studies to evaluate health risks associated with climate-change induced increases in the release and mobilization of chemical contaminants;
• Understanding how toxins in land-based runoff and from water overflow interact with important marine species, especially those for human consumption, should be addressed and the potential for health risks of changing water quality should be established;
• Utilization of genomic and proteomic approaches to identifying cyanotoxin producing species and the physical, geological, and meteorological conditions associated with propagation of toxin production;
• Eutrification or urban run-off influences on the growth kinetics of cyanotoxin producing blue green algae; and
• Consumption of contaminated drinking water or freshwater shellfish/finfish that bioaccumulate pollutants associated with wastewater, industrial pollution or urban and or agricultural runoff and their effects on human health.

Development of models and statistical and bioinformatic tools: Additionally, this FOA encourages:

• The development of statistical and bioinformatics tools that link the developed oceanographic models with the less well developed human health exposure and disease models;
• Models or sentinels (cetaceans) to use to examine chronic vs. acute exposures to predict adverse human health outcomes; and
• Models to assess genetic susceptibility to marine toxicants based on ability to metabolize.

Development of Marine Natural Products: This FOA will support the discovery of marine natural products that can be used to:

• Develop new approaches in marine cell culture, aquaculture, and biochemical methods for production of marine pharmaceuticals;
• Apply molecular genetics to isolate and express biosynthetic genes and to express these pathways in expression hosts for the production of marine pharmaceuticals;
• Design new technologies to facilitate saline cultivation and large-scale fermentation of marine microorganisms;
• Expand exploration of marine plants and animals to less favorable environments, e.g., polar oceans and deep ocean environments, and to under investigated taxonomic groups, e.g., marine microorganisms;
• Implement novel sampling methods to access marine organisms for biomedical investigation; and
• Screen marine compounds and derivatives for potential pharmaceutical value, particularly for neurodegenerative, cardiovascular, and infectious diseases.

Funding Instrument	Grant
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIEHS and NSF intend to commit a total of $1.8 million in FY 2012 to fund two to four awards.
Award Budget	Application budgets are limited to $400,000 direct costs.
Award Project Period	The total project period for an application submitted in response to this funding opportunity may not exceed 5 years. Shorter, exploratory studies may be proposed for 2 to 3 years of funding.

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

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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 SF 424 (R&R) 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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

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 SF 424 (R&R) 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 must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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
• 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:

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]

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

Resource Sharing Plan

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

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

Appendix

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

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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 submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Science Foundation and the National Institute of Environmental Health Sciences, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

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/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?

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.

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

Not Applicable.

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:

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

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Environmental Health Sciences Council.

. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

Cooperative Agreement Terms and Conditions of Award

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.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

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.