Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the Office of Strategic Coordination, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the NIH Director (http://dpcpsi.nih.gov/osc/). This FOA will be administered by the National Institute on Alcohol Abuse and Alcoholism http://www.niaaa.nih.gov/ on behalf of the NIH.
Funding Opportunity Title	Economic Research on Incentives for Efficient Use of Preventive Services (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-RM-11-012
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.310
FOA Purpose	This FOA solicits R01 applications for economic research on the role of incentive arrangements in promoting efficient use of preventive services and interventions, specifically considering both costs and health outcomes. The objective of the research program is to advance general knowledge about how incentives can be structured to improve both health and cost outcomes through more efficient use of preventive services; it is not primarily to advance specific knowledge about any particular preventive intervention or prevention of any particular health condition. This FOA is a component of the Common Fund initiative on Health Economics for Health Care Reform (http://nihroadmap.nih.gov/healtheconomics).

Posted Date	August 22, 2011
Open Date (Earliest Submission Date)	October 15, 2011
Letter of Intent Due Date	October 15, 2011
Application Due Date(s)	November 15, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not applicable
Scientific Merit Review	March-April, 2012
Advisory Council Review	May, 2012
Earliest Start Date(s)	July 1, 2012
Expiration Date	November 16, 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

PURPOSE

This FOA solicits R01 applications for economic research on the role of incentive arrangements in promoting efficient use of preventive services and interventions, specifically considering both costs and health outcomes. The objective of the research program is to advance general knowledge about how incentives can be structured to improve both health and cost outcomes through more efficient use of preventive services; it is not primarily to advance specific knowledge about any particular preventive intervention or prevention of any particular health condition.

RESEARCH OBJECTIVES

Many different services, interventions, and behaviors contribute to preventing future health problems, either by reducing occurrences (primary prevention) or by reducing the severity of the consequences of health problems once they have occurred (secondary prevention). Preventive interventions may operate through a wide range of medical, social, and individual avenues that influence health behaviors and outcomes. Examples include:

• screening procedures and vaccines that may be applied to entire populations or subpopulations identified as having elevated risk for a particular condition or infectious disease;
• medications and clinical interventions, such as aspirin, anti-hypertensive medications, or diabetes management, that reduce risk or improve outcomes of other therapeutic interventions;
• policies, regulations, services, and accommodations that enhance access to health care services;
• school-, employment-, or community-based activities and arrangements that promote health and safety and reduce risky behaviors;
• public facilities and features of the built environment that contribute to healthy lifestyles and activities;
• food, product, and construction standards, inspections, and labeling;
• transportation safety policies;
• counseling interventions, educational programs, and information campaigns to increase awareness of health improvement strategies;
• taxes, subsidies, and regulations that affect either risky or health-promoting behaviors; and
• individual behaviors that promote health (including reducing or refraining from behaviors that increase health risks).

Economic efficiency considerations suggest that preventive interventions should be used to the point where the additional benefits they confer are balanced by the extra costs they impose. Incentives that affect the private decisions of consumers and service providers can lead to under- or over-use of preventive services relative to levels that would achieve the greatest health benefit at least cost. The manner in which many preventive services are financed and delivered creates incentives that can make it difficult to achieve efficient levels of use. In addition, limited information about the effectiveness and costs of specific interventions, as well as individual-level variation in risks for various health outcomes, make it difficult to characterize the appropriate level of use of preventive services in many cases. And because the rewards of effective prevention generally are realized in the future while the costs are incurred in the present, behavioral biases and poor information may lead individuals to under- or over-use preventive services.

This FOA seeks to advance knowledge about how incentive structures can be designed to generate improvements in the allocation of resources devoted to primary and secondary prevention, with the overall goals of improving population health and reducing health system costs. Incentives structures may be designed to affect delivery of health services or to influence upstream factors such as the built environment and other social determinants of health. Some incentives may operate by influencing demand or supply behaviors through market-like signals such as taxes and subsidies, payment and reimbursement arrangements, and strategies to allow those who make current investments in prevention (e.g., employers, insurers) to capture the future financial benefits that flow from those investments. Other kinds of incentives may incorporate insights from behavioral economics, such as well-chosen default options or other kinds of nudges , to address time-inconsistent preferences or overcome inertia in decision-making at the individual level. Design of insurance policies or other employment- or tax-related benefits can also influence use of preventive services. Information-based strategies provide further avenues for incentive-driven change through their influence on the decisions of individuals and firms about investing in prevention.

Advancing understanding of the use of incentives to encourage more efficient use of preventive services may also entail studies to understand sources of heterogeneity in the use of such services, including examination of motivations and behaviors of consumers/patients, health service providers, service purchasers and payers, and those involved in the delivery of services such as employers and schools/teachers. Extant knowledge implies that levels of use that are appropriate for members of one group (defined, for example, by age and/or gender) would constitute over- or under-use by members of other population groups. Research may also fruitfully consider factors that determine and distinguish appropriate (efficient) levels from insufficient or excessive levels of demand or supply for preventive services, and the degree of heterogeneity that may characterize efficiency in this context. Cost-effectiveness analysis may be useful in assessing the value of adjusting screening intervals or the appropriate target population groups for particular interventions.

This announcement encourages research that examines preventive interventions that are delivered in clinical settings as well as interventions that take place outside the traditional health care delivery system. For example, the effects of social and environmental determinants of health may be of particular importance in the primary and secondary prevention of diseases such as asthma, diabetes, and hypertension, where success depends on self-care. Similarly, important aspects of adult behavioral health and risk-taking may be influenced by the social and educational environment in early childhood. As another example, the built environment and school and workplace policies can have important roles in preventing obesity, a chronic disease with important effects on health care costs and health outcomes. This FOA encourages research to identify and evaluate incentive structures that can affect adoption and use of prevention strategies through avenues as diverse as educational interventions, innovative transportation alternatives, nudges to increase physical activity, and measures that can lead to improved availability of healthy food.

Changes in the availability or use of preventive services may lead to perverse changes in health-related behaviors or in the use of other health services, with attendant effects on health outcomes and/or costs. Examples of such effects include driving more dangerously in response to improvements in vehicle safety equipment or changes in diet and exercise patterns in response to assumed protectiveness of statin drugs. Research may examine incentive-based strategies to influence such behavioral responses to preventive interventions, and assessment of the health and cost effects of changes in use of preventive services should consider the possible role of behavioral responses where possible.

Research to be supported under this program will involve empirical studies that are grounded in a clear theoretical framework and aimed at drawing policy-relevant conclusions for how to improve the allocation of prevention resources. Empirical analyses may focus on one or a few specific interventions or health conditions, but the analytic framework and interpretation of findings should aim to draw meaningful implications across a range of preventive interventions. Of particular interest are studies that can provide strategies to encourage more efficient use of preventive interventions that have important implications for overall health system costs or for population health. All applications submitted in response to this announcement should address incentive-based strategies for reducing health care costs and/or improving health outcomes through more efficient use of preventive services.

SPECIFIC AREAS OF RESEARCH INTEREST

Examples of research projects that could be supported under this FOA include but are not limited to:

• Analysis and evaluation of employer-based incentive arrangements to encourage appropriate use of effective preventive services.
• Analysis of relationships between insurance benefit design, characteristics of services, providers, and markets, and over- or under-use of preventive services.
• Examination of the decisions that lead to under-provision or under-use of relatively low-cost and highly cost-effective preventive services, identification of the underlying incentives (for providers, consumers, others) that encourage such under-provision or under-use, and evaluation of strategies to modify incentives to achieve more efficient use.
• Examination of the decisions that lead to over-provision or over-use of costly and relatively cost-ineffective preventive services (or use of ineffective services), identification of the underlying incentives (for providers, consumers, others) that encourage such over-provision or over-use, and evaluation of strategies to modify incentives to achieve more efficient use.
• Studies of the determinants of (non-)compliance with accepted guidelines for frequency of screening interventions such as mammography and colonoscopy.
• Analysis of behavioral economics approaches to overcome behavioral impediments to effective adoption, implementation, and use of prevention services.
• Studies of incentive-based strategies to promote implementation of effective prevention activities conducted outside of the traditional health care system as a way to improve health and reduce health care costs.
• Analysis of changes in provider incentives and resulting changes in use of preventive services in the context of demonstration projects or experiments that assess innovations in structure, organization, and financing of health care delivery.
• Analysis of the role of uncertainty about health risks and the effectiveness of preventive interventions in different population groups in attenuating incentives for appropriate provision and use of preventive services to identify areas where research advances on risks and prevention effectiveness would lead to more efficient use of prevention resources.

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	NIH intends to commit approximately $1.6 million in FY 2012 to fund approximately 4 awards, contingent on NIH appropriations and the submission of a sufficient number of scientifically meritorious applications.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project.
Award Project Period	The project period should be determined by the scope of the proposed project. The maximum project 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 - NIH Intramural Program
• 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 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.

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:

Gregory Bloss, M.A.
National Institute on Alcohol Abuse and Alcoholism
Division of Epidemiology and Prevention Research
5635 Fishers Lane, Room 2075
Bethesda, MD 20892-9304
(Use Zip Code 20852 for FedEx)
Telephone: 301-443-3865
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, 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.

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/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 and responsiveness by the Common Fund Health Economics Program, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

The requests by NIH intramural scientists will be limited to the incremental costs required for participation.   As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PD/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

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? Will the project generate knowledge that can lead to meaningful improvements in health outcomes and/or reductions in health care costs? Will achievement of the aims support policy-relevant conclusions for how to improve the allocation of prevention resources? Will the conclusions apply to preventive interventions that have important implications for overall health system costs and/or population health? Will the conclusions apply across a range of preventive interventions?

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? Does the project team include extensive and appropriate research expertise in economics, health outcomes, and preventive intervention research?

Innovation

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

Approach

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

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

Is the proposed empirical analysis grounded in a clear theoretical framework? Does the project address incentive-based strategies for reducing health care costs and/or improving health outcomes through more efficient use of preventive services? Does the analysis use an appropriate time frame for considering health outcomes and costs? Will the empirical analysis support meaningful conclusions about the causal effects of incentive-based strategies to encourage more efficient use of preventive interventions?

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

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 the Center for Scientific Review, 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 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.

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

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]

Gregory Bloss, M.A.
Division of Epidemiology and Prevention Research
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-3865
Email: [email protected]

John W. R. Phillips, Ph.D.
Division of Behavioral and Social Research
National Institute on Aging (NIA)
Tel: 301-496-3138
Email: [email protected]

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

Nancy Breen, Ph.D.
Economist, Health Services and Economics Branch
Applied Research Program
National Cancer Institute (NCI)
Telephone: 301-496-4675
Email: [email protected]

Karen Huss, Ph.D., R.N., APN-BC, FAAN, FAAAI, FAHA
Program Director, Office of Extramural Programs
National Institute of Nursing Research (NINR)
Telephone: 301-594-5970
Email: [email protected]

Valerie L. Durrant, Ph.D.
Chief, Population Sciences and Epidemiology (PSE) Integrated Review Group
Center for Scientific Review, NIH
6701 Rockledge Drive, Room 3136, MSC 7770
Bethesda, MD 20892-7770 (20817 for Fed Ex/delivery)
Telephone: 301-408-9882
Fax: 301-480-1056
Email: [email protected]

John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
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.