Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI) National Heart, Lung, and Blood Institute (NHLBI) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Environmental Health Sciences (NIEHS)
Funding Opportunity Title	Spatial Uncertainty: Data, Modeling, and Communication (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	October 10, 2014 - This PA has been reissued as PA-15-010. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PA-11-238
Companion FOA	PA-11-239, R21 Exploratory/Developmental Grant PA-11-240, R03 Small Grant Program
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.393, 93.399, 93.837, 93.273, 93.855, 93.856, 93.865, 93.279, 93.113
FOA Purpose	The purpose of this funding opportunity announcement (FOA) is to support innovative research that identifies sources of spatial uncertainty (i.e., inaccuracy or instability of spatial or geographic information) in public health data, incorporates the inaccuracy or instability into statistical methods, and develops novel tools to visualize the nature and consequences of spatial uncertainty.

Posted Date	June 17, 2011
Open Date (Earliest Submission Date)	September 5, 2011
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	September 8, 2014
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

This funding opportunity announcement (FOA) will use the R01 funding mechanism to support research that identifies sources of spatial uncertainty (i.e., inaccuracy or instability of spatial or geographic information) in public health data, incorporates the inaccuracy or instability into statistical methods, and develops novel tools to visualize the nature and consequences of spatial uncertainty.

Background

A. Spatial Uncertainty

Spatial uncertainty is the lack of, or the error in, knowledge about an object’s geographic position (i.e., longitude, latitude, and altitude), which leads to uncertainty about the spatial relationship among its neighbors. For example, an error in a patient's residential address will introduce spatial uncertainty about where the patient lives and this error will further bias any association between the patient's health status and specific environmental exposure. Spatial uncertainty in public health information is ever present -- from data collection and model specification to interpretation, visualization, and communication. Estimates of disease patterns or trends contain a certain degree of uncertainty. Bias may be introduced if the uncertainty is ignored or misunderstood.

B. Sources of Spatial Uncertainty

The quality of spatial information in the original data about patients and other factors can be uncertain. Uncertainty can be due to varying quality in data collection methods or to errors in the assignment of patients' residential addresses to geographic locations. It can also be a result of sparse sampling sites for monitoring people's exposures to environmental pollutants. In addition, and more importantly, in the era of electronic health records, scientists are challenged with massive data volumes that come from multiple sources including federal, state, and local agencies. With the addition of extra data and their varying quality, the completeness and accuracy of the geographic information needs to be investigated and validated so that scientists can better take advantage of the full content of the available data and use it to effectively guide improvement in reducing disease burden. Efficiently and accurately integrating these spatially referenced data will offer a unique challenge and opportunity for research on disease control.

Statistical methods may contribute to analytical effects of spatial uncertainty through the choice of assumptions and available methods to analyze different data. Inappropriate choice of assumptions or statistical models propagates the spatial uncertainty issue. For example, choice of an environmental exposure assignment algorithm or assumptions about time lag between exposure and disease onset may lead to uncertainty. Other sources of uncertainty, such as the choice of underlying statistical regression model, may be unmeasured or ignored in this situation. Statistical uncertainty may also vary from place to place.

Spatial uncertainty may arise from the choice of methods to visualize disease patterns and relationships between variables. Different choices of classification schemes, cutpoints (boundaries between categories in a map legend), and spatio-temporal windows for data representation can have an impact on pattern recognition, and may affect conclusions about the spatial-temporal relationships among phenomena.

Purpose of Funding Opportunity Announcement (FOA)

It will require a team of epidemiologists, statisticians, and experts in data visualization or health communication to attack the spatial uncertainty issue thoroughly. This FOA will facilitate multidisciplinary collaborations among scientists to promote research in identifying, quantifying, reducing, and communicating spatial uncertainty in health research to improve disease control and prevention. It will also facilitate integration of data collection, information technology, visualization tools, statistical models, and health communication to reduce spatial uncertainty in planning, implementing and evaluating disease control programs.

A. Spatial Uncertainty in Data

Advanced disease surveillance systems and electronic health data systems generate a large volume of data. Meanwhile, rapidly growing numbers of data sources have led to the generation of complex datasets that pose significant challenges for researchers using them to conduct data analyses. Spatial uncertainty takes one or a combination of several forms.

• Geocoding is a procedure that converts information about locations (addresses, zip codes, counties, etc.) of people, homes, health care providers, etc., to geographic coordinates (latitude and longitude). In population-based public health data, geocoding is commonly obtained by an automated procedure and the results are well known to contain positional errors.
• To protect privacy and confidentiality of people, geographic information in disease data usually is not released if there is a potential to identify individuals. For example, if there are just one or two cases of patients with a rare disease in a county, then the county-level number of disease cases will not be released. This practice gives rise to gaps or incompleteness in data. Another method for protecting privacy is to mask individuals locations through shifting the locations of all the individuals by a random distance, or through data aggregation from point-level (longitude and latitude) to area-level such as census block group, census tract, or county; however, this introduces error and uncertainty that is unquantifiable and indeed unknowable by the data user.
• Spatial uncertainty also arises when data come through a variety of data collection schemes at varying spatial scales. An example of this situation is that cancer incidence rates are available at county-level, while environmental exposures of people are measured at just few isolated monitoring sites, and socio-economic covariates come at census-tract level. This type of spatial mismatch among different data sources has long been identified as a Change of Support Problem in the literature. However, concrete statistical methodology has not yet been developed to handle the mismatches via computationally feasible algorithms.
• Boundaries of spatial units may evolve across time and that adds another layer of mismatches to a spatio-temporal level. For example, in 2001, Broomfield, Colorado, was officially incorporated as a new county, comprised of portions taken from four different counties. The mismatches in county codes prior to and after year 2001 make it a challenge to calculate and interpret trends in disease rate for that county. Various methods exist for areal interpolations of spatially mismatched data due to boundary shifts, but the resulting estimates will contain error and uncertainty.

This FOA encourages research projects to improve data collection and quality control in the following types of data: a) disease registry data, such as through improvements in geocoding methods; b) small-area demographic data and intercensal estimates; c) historic risk factor exposure data to account for latency of disease development; d) residential histories of patients to address uncertainty in exposure assessment; e) use of remote sensing and image data alone or in combination with data from fixed monitoring sites to construct exposure assessment; f) data on multiple types of exposures to account for possible cumulative exposure effects; g) electronic health record data and new media sources that give a more comprehensive view of disease surveillance, control, and prevention; and h) linked data from various data sources.

B. Statistical Methods to Model Spatial Uncertainty

In statistical decision theory, all sources of uncertainty are assessed through probability models. Standard methods measure the uncertainty of an estimate through standard errors and confidence intervals. In the current statistical methods, point and interval estimates of individual parameters are produced to generate realizations of spatial processes in which uncertainty may arise, and then sensitivity analysis is performed to assess the impact of spatial uncertainty in which parameter values are changed to learn how much changes to that parameter affect the final output. With larger, more complex, and detailed datasets available, future research in statistical methods should be directed toward an overall modeling framework to better articulate relationships among environmental exposures, social risk factors, behaviors, new treatments, incidence, prevalence, mortality, and survival rates, and to better estimate spatial uncertainty of the multiple factors through hierarchical models.

Examples of specific statistical methods that may be developed in response to this funding opportunity include, but are not limited to:

• Methods for incorporating spatial uncertainty from various sources, such as physical activity, diet, food environment, etc.;
• Methods for integrating data across spatial and temporal scales such as census tracts and counties at multiple time periods;
• Methods for quantifying spatial uncertainty in maps at different levels of aggregation;
• Methods for quantifying spatial uncertainty in cluster identification algorithm; and
• Methods for large, complex, and detailed datasets (e.g., spatial data mining) that help with gaining new knowledge in disease or exposure patterns.

C. Geographic Information System (GIS) as a Tool to Address and Visualize Spatial Uncertainty

Disease control research increasingly relies on GIS methods and technology for the analysis of disease outcomes across different geographies and population subgroups. The multifaceted capabilities of GIS proved suitable for addressing the complexity of factors that affect disease burden, more so than the traditional maps and simple statistics. The growing popularity of GIS applications in the health field has raised concern among scientists and practitioners about the uncertainty that propagates through spatial analyses, from data collection, through data integration, to the results, and, consequently, may lead to inaccurate or ill-informed decisions. The error-aware GIS would address the problem by assessing and storing spatial uncertainty and could analyze and present the propagation of spatial uncertainty in GIS analyses. An intelligent GIS would have all of these capabilities and would in addition provide users with suggestions on how to improve the quality of their results, either by using better models, collecting more or better data, or improving resolution. Specifications were outlined on how an error-aware GIS should look, but the ideas were never operationalized. More recently, the Data Uncertainty Engine (DUE) was developed as the closest realization to an operational error-aware GIS. DUE helps users to assess and store uncertainties in environmental data and provides functions to generate realizations (random draws) of uncertain data for visualization and use in uncertainty propagation analyses. While this is a very important milestone in handling spatial uncertainty, we are still far from the error - free GIS and spatial analysis. Clearly, many important technical problems have been solved; however, the question of how GIS users deal with the problems of spatial uncertainty also needs to be addressed, and, just as with the development of improved methods for handling uncertainty, this represents an important task for the greater scientific community.

Examples of specific GIS methods that may be developed in response to this funding opportunity include, but are not limited to:

• An integral GIS that identifies, categorizes, stores, assesses, and visualizes spatial uncertainty in public health and exposure data; and
• User-friendly tools for performing uncertainty analysis in existing GIS frameworks.

D. Communication of Spatial Uncertainty

Identifying end-user types for spatial uncertainty information, understanding the needs of end-users and effectively communicating spatial uncertainty to them are major tasks for researchers. End-users, which include, but are not limited to, policy makers, public health officials, researchers, and the general public, have varying concepts and understanding of spatial uncertainty and its impact. As spatial uncertainty is better characterized and quantified through data collection and analysis, it becomes more important to effectively represent that information in a way that is useful and interpretable. This FOA will support research on sound methods for communicating uncertainty to a variety of audiences. Appropriate topics include, but are not necessarily limited to:

• Studies of end-users' cognitive perception of visual displays of spatial uncertainty;
• Development of an internet resource that accumulates best practices for visualizing uncertainty;
• Development of visualization skills that communicate the hot-spot disease clusters and the uncertainty of their locations to end-users;
• Development of visualization techniques that communicate to end-users about uncertainty in people's environmental exposure patterns and the association between disease and environmental exposure; and
• Translation of statistical concepts of uncertainty into maps.

E. Specific Areas of Interests of Participating Institutes/Centers

The National Cancer Institute (NCI) is interested in general methodology of spatial statistical models and visualization tools that are applicable to disease control and prevention especially as related to cancer and cancer patients.

The National Institute of Allergy and Infectious Diseases (NIAID) is interested in the development of spatial and temporal statistical/mathematical models to predict the spread and transmission of infectious diseases such as HIV/AIDS, malaria, tuberculosis, and other emerging and re-emerging infectious diseases and allergic diseases. The prediction will be used to guide local prevention efforts to ensure care relevance to the local population. The spread of infectious agent (spore release, infected vector, infected host) exhibits spatial and temporal patterns. Estimates of disease patterns or trends contain a certain degree of uncertainty that makes the identification of the source of exposure and the calculation of the amount of exposure difficult. Bias may be introduced if the uncertainty is ignored or misunderstood. Examples of specific interests to NIAID include:

• Development of statistical methods to analyze outbreak to determine whether there was a spatial pattern in the incubation periods;
• Development of statistical tests to compare the incubation period distributions to determine if there is a significant distance effect;
• Development of mathematical models to study dispersion modeling at finer scales, for example within a building or within the vicinity of the release location; and
• Development of methods to evaluate the sensitivity of the methods developed and to identify sources of spatial uncertainty.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) will consider applications that apply spatial statistical models and visualization tools to scientific questions that address: child health; determinants of health, development, and productivity among defined populations using probability samples; and demography and demographic change.

The National Institute on Drug Abuse (NIDA) will consider only spatial uncertainty applications that are directly relevant to the intersection of HIV and drug use, abuse, and addiction. "Drug use" refers to use of tobacco, alcohol, marijuana, prescription and illicit drugs, emerging addictive substances, and poly drug use.

The National Heart, Lung, and Blood Institute (NHLBI), National Institute on Alcohol Abuse and Alcoholism (NIAAA), and National Institute of Environmental Health Sciences (NIEHS) are interested in the general methodological issues of spatial uncertainty.

Funding Instrument	Grant
Application Types Allowed	New Renewal Resubmission Revision The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project.
Award Project Period	The scope of the proposed projects should determine the project period. The maximum period is 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:

• 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 Organizations)

Foreign (non-U.S.) components of U.S. Organizations 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 Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the 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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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.

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 application submission. 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, 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 SF424 (R&R) Application Guide , with the following modification:

• Al applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix

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

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations 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/PIs 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/PI 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, NIH. Applications that are incomplete will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

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

Innovation

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

Approach

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

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

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

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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), 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 be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate National Advisory Council or Board. The following will be considered in making funding decisions:

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

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 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.

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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]

Li Zhu, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-594-6546
Email: [email protected]

Charlotte A. Pratt, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0382
Email: [email protected]

Wenxing Zha, Ph.D.
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0633
Email: [email protected]

Misrak Gezmu, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-3722
Email: [email protected]

Regina M. Bures, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9485
Email: [email protected]

Bethany G. Deeds, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1935
Email: [email protected]

Caroline H. Dilworth, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7727
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Barbara Liesenfeld
Office of Grants Administration
National Cancer Institute (NCI)
6120 Executive Boulevard, EPS Suite 243
Bethesda, MD 20892-7150 (For U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-496-3265
Email: [email protected]

Note: NCI GM will also address issues on behalf of NHLBI

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
5635 Fishers Lane, Room 3021
Bethesda, MD 20892-9304
Telephone: 301-443-4704
Email: [email protected]

Ann Devine
Chief, Grants Management Program
National Institute of Allergy and Infectious Diseases (NIAID)
6700B Rockledge Dr, Room 2114
Bethesda, MD 20892-7610
Telephone: 301-402-5601
Email: [email protected]

Bryan S. Clark
Chief Grants Management Officer
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Blvd, Room 8A01A
Bethesda, MD 20892-7510
Telephone: (301) 435-6975
Email: [email protected]

Heidi Young
National Institute on Drug Abuse (NIDA)
6001 Executive Blvd, Room 4218
Bethesda, MD 20892-9560
Telephone: 703-243-5024
Email: [email protected]

Wanda Boggs
National Institute of Environmental Health Sciences (NIEHS)
530 Davis Dr, Room 3063
Durham, NC 27713
Telephone: 919-316-4638
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.