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 Drug Abuse (http://www.nida.nih.gov/nidahome.html) on behalf of the NIH.
Funding Opportunity Title	Phased Economic Studies Ancillary to Planned Health Care Delivery and Financing Pilots, Demonstrations, and Other Experiments (R21/R33)
Activity Code	R21/R33 Phased Innovation Award
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-RM-11-024
Companion FOA	RFA-RM-11-023, R01 Research Project Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.310
FOA Purpose	This funding opportunity announcement (FOA) solicits applications for Phased Innovation (R21/R33) grant awards to support health economics research conducted alongside planned large-scale health care delivery and financing pilots, demonstrations, and other experiments (PDEs) that are intended to reduce health care costs or cost growth while maintaining or improving patient outcomes. This FOA provides support for up to two years (R21 phase) for research planning activities and feasibility studies, followed by possible transition to up to four years of expanded research support (R33 phase). The total project period for an application submitted in response to this FOA may not exceed five years. This FOA requires measurable R21 milestones to be completed prior to the transition to the R33 phase. This FOA is a component of the Common Fund initiative on Health Economics for Health Care Reform (http://nihroadmap.nih.gov/healtheconomics).

Posted Date	October 7, 2011
Open Date (Earliest Submission Date)	January 8, 2012
Letter of Intent Due Date	January 8, 2012
Application Due Date(s)	February 8, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June/July 2012
Advisory Council Review	August, 2012
Earliest Start Date(s)	September 1, 2012
Expiration Date	February 9, 2012
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

Background and Purpose

Concerns about high and ever-rising health care expenditures and the efficiency and quality of health care have accelerated in recent years. These concerns along with changing market forces, burgeoning health care workforce shortages and compensation issues, and the recent enactment of the federal Affordable Care Act (P.L. 111-148), have motivated public and private insurers, large employers, health care providers, and various research and policy centers to devise and examine new ways to structure, organize, and pay for health care.

Health policy journals and newsletters regularly publish reports on these activities. However, scientifically valid, replicable findings and studies considering the full range of outcomes relevant to these innovations are needed. The purpose of this FOA is to solicit high-quality, health economics research ancillary to planned, large-scale federal and non-federal pilots, demonstrations, or other experiments (PDEs) in health care payment, structure, or organization that are examining ways to increase value by reducing or controlling costs while maintaining or enhancing quality and outcomes. This FOA runs in parallel with another separate funding opportunity announcement focused on economic studies ancillary to completed or ongoing PDEs to improve the value of health care (RFA- RM-11-023).

Nature of the Research Opportunity

This initiative is funded through the NIH Common Fund (http://commonfund.nih.gov/), which supports cross-cutting programs that are expected to have exceptionally high impact and that are relevant to the missions of more than one NIH Institute or Center. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

Because of the Affordable Care Act and other initiatives, a number of large-scale PDEs geared toward reducing costs or controlling cost growth while maintaining or improving patient outcomes are being planned. This FOA is intended to enhance the knowledge generated from these PDEs by supporting researchers interested in studying relevant and complementary scientific questions alongside these experiments. For example, a given PDE focused on a service delivery innovation intended to reduce costs may be limited in its ability to examine questions related to all relevant aspects of outcomes or quality in a rigorous manner. Conversely, a PDE examining a quality improvement innovation that also has the potential to reduce costs may not have the resources to collect the requisite data nor the appropriate expertise to examine cost or economic efficiency questions thoroughly. As another example, a PDE may not be amenable to a randomized design, but an ancillary study could develop and implement an appropriate data collection and statistical adjustment method for potential endogeneity or selectivity bias, thereby enhancing the study’s ability to generate causal inferences. Providing funding for ancillary science while these PDEs are being planned provides an ideal opportunity to integrate rigorous economic research ancillary to these projects, potentially strengthening both. The Phased Innovation (R21/R33) grant mechanism is appropriate for this purpose. This mechanism provides the opportunity for planning and developmental activities to occur alongside the planning period for the parent PDEs under the R21 phase followed by the conduct of the ancillary research appropriately timed with the conduct of the parent PDE during the R33 phase. This mechanism allows for milestone-driven research, supporting a phased research project with a stepped approach for implementation.

Especially relevant to this FOA are ancillary research projects that are informed by or test hypotheses generated from economic theory. Also especially relevant are ancillary projects that propose approaches of high scientific rigor to support causal inferences (e.g., randomized control trials or research designs that otherwise address potential biases due to sample selection or endogeneity). Projects involving multidisciplinary teams led by a health economist, or with the substantial involvement of a health economist, are encouraged.

PDEs relevant to this FOA include large-scale PDEs with potentially broad generalizability, PDEs focused on health-cost drivers, and experiments in organizational forms. In general PDEs should be geared toward reducing costs or controlling cost growth while maintaining or improving patient outcomes. Research projects that are ancillary to, or that could inform the design or evaluation of, innovations called for under the Affordable Care Act (P.L. 111-148), are also especially relevant.

Applications must include documentation of permission (e.g. a data use agreement) from the parent PDE to use the sample, data, or other relevant information from the parent PDE. Ancillary projects must not interfere with the PDE or unduly burden participants. Approved procedures and policies from the parent PDE must be followed. 

Applications proposing to examine specific clinical interventions without a primary focus on the effects of structure, organization, or payment arrangements, e.g. efficacy or effectiveness studies of specific medications or procedures, are not responsive to this FOA and will not be reviewed.

Examples of Research Sought

Examples of the broad types of research projects sought under this FOA may include, but are not limited to, those that use the following designs to examine the effects of health care structure, organization, or payment innovations on cost, quality of care, and/or patient outcomes:

• Research to expand the scope of planned PDEs. Examples may include, but are not limited to applications that propose to enhance the scientific yield of the planned parent PDE by collecting and analyzing additional data and/or by examining scientific questions additional to those considered in the planned PDE.
• Research to enhance the scientific design and yield of planned multi-site (e.g. multi-state) PDEs. Examples may include, but are not limited to, applications that propose to prospectively collect and analyze comparable data across study sites to address additional scientific questions that could not otherwise be answered by the parent PDE.

Examples of the types of PDEs that may be the basis for the proposed ancillary research relevant to this FOA may include, but are not limited to, the following:

• Care delivery organization innovations such as patient-centered medical homes, accountable care organizations, ambulatory intensive care services, and integrated medical and behavioral health care.
• Payment innovations such as pay-for-performance, bundled payment, voucher or money follows the person, gainsharing, or value-based purchasing programs.
• Innovations in the use of health information technology, including electronic health records for care coordination, especially across multiple health care organizations.

Examples of specific ancillary research topics that may be relevant to this FOA include, but are not limited to, the following:

• The pro- and anti-competitive effects, as well as the resulting effects on market prices and the efficiency of production, of joint contracting by clinically and financially integrated health care entities.
• The effects of innovative payment structures on organizational-level economic efficiency, quality of care, and patient outcomes.
• The effects of adopting meaningful use of electronic health records on the efficiency of health care delivery, and the costs and quality of care.
• The organizational factors and processes that affect health care organizations abilities to reduce costs and improve outcomes in response to health care value-enhancing payment and policy innovations.
• The outcome and cost effects of payment, structure, or organization innovations on subsets of patients, such those from vulnerable populations or those with multiple chronic conditions.

The developmental and/or planning portion for the research occurs during the R21 phase of the research plan and implementation and/or further research conduct occurs within the R33 phase. Transition from the R21 to the R33 is dependent on completion of milestones delineated in the application and an administrative review (see Section IV.6). Examples of how the phased program of this FOA could be implemented include, but are not limited to, the following:

• The R21 portion of the application could propose variable selection and validation, development/refinement and successful testing of data collection methods and tools (such as questionnaires) for the proposed ancillary economic or scientific questions. Upon achievement of these milestones and proof of feasibility, the R33 would provide funds to implement these data collection methods and tools (for example at baseline and at identified follow-up intervals) and conduct the hypothesis-driven analyses alongside the conduct of the parent PDE.
• The R21 portion of the application could propose developing analytic models or novel theoretical frameworks for the proposed ancillary economic or scientific questions while planning with the sponsor or investigators of the parent PDE. Upon completion, the R33 phase would pursue the analytic plan grounded in these frameworks.
• The R21 portion of the application could propose to pilot planned data collection and test hypotheses in a single site. If successful, the R33 portion of the award could expand this effort to multiple sites.

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 $2 million across this FOA and its companion (RFA-RM-11-023) to fund approximately 5 awards, contingent on NIH appropriations, and the submission of a sufficient number of scientifically meritorious applications.
Award Budget	Support for the R21 phase cannot exceed two years and direct costs are limited to $275,000 over the R21 two-year period, with no more than $200,000 in direct costs in any single year of the R21 phase. The R33 phase may not exceed four years and direct costs are limited to $2 M with no more than $500,000 in direct cost in any single year.
Award Project Period	The total project period for an application submitted in response to this FOA may not exceed five years. Awards will support milestone-driven exploratory/feasibility studies (up to two year R21 phase), with possible transition to an expanded research phase (up to four year R33 phase). Applications for R21 or R33 support alone are not responsive to this FOA.

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

Foreign components, as defined in the NIH Grants Policy Statement, are not 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:

Sarah Q. Duffy, Ph.D.
National Institute on Drug Abuse
Division of Epidemiology, Services, and Prevention Research
6001 Executive Boulevard
Bethesda, MD 20892
(Use 6001 Executive Boulevard, Rockville, MD, 20852 for FedEx)
Telephone: 301-451-4998
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.

• The R21/R33 Phased Innovation Award application must be submitted as a single application with one PHS398 Cover Page Supplement component and one Research & Related Budget component.
• The total length of the Research Strategy section cannot exceed 12 pages including justification statement, milestones, tables, graphs, figures, diagrams and charts.
• The Research Strategy should contain separate sections that describe both the R21 and R33 phases, as appropriate. Separate specific aims and separate research design and methods could be presented as needed for the R21 and R33 phases. It is not necessary to repeat information or details that are described in the R21 section.
• MILESTONES FOR THE R21 PHASE: Milestones should be placed at the end of the Research Strategy section and are included in the 12-page limit.
• The Milestone section must propose milestones for completion of the R21 part of the project, a discussion of the suitability of the proposed milestones for assessing success in the R21 phase, and a discussion of the implications of successful completion of these milestones for the proposed R33 study. Milestones should be specific, quantifiable and scientifically justified; they should not be simply a restatement of the R21 specific aims. Milestones may be provided for the R33 phase at the discretion of the applicant.
• In preparing the R21/R33 application, investigators should consider that the application will be assigned a single overall impact/priority score. Thus, clarity and completeness of the application with regard to specific goals and the feasibility of each phase and the Milestones are critical. Milestones that are not sufficiently rigorous scientifically to be valid for assessing progress in the R21 phase will reflect poorly on the scientific merit of the application as a whole.
• Any preliminary data that will support or justify the proposed hypothesis, rationale or development plan. However, preliminary data are not required for an R21/R33 application.

Prior to award, the Program Officer will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel as indicated in the Summary Statement. The Program Officer and the applicant will negotiate and agree on a final set of R21 milestones. These will be incorporated into the terms and conditions of the award and will be the basis for judging the success of the R21 work.

For funded applications, when the R21 phase has been completed, the Project Director(s)/Principal Investigator(s) (PD(s)/PI(s)) will submit a progress report to the Program Officer. The progress report should clearly indicate which milestones were or were not completed successfully. In the latter case, an explanation should be provided as to why the milestone was not met. Receipt of this progress report will trigger an administrative program review that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on IC-approved successful completion of negotiated scientific milestones, on program priorities, and on the availability of funds.

For funded applications, peer review is not anticipated between the two phases of the project, although IC staff reserves the right to conduct a program review with outside opinions.

Both conventional development applications and high-risk, high-reward applications are encouraged. Dependent upon the nature of the risk in the application, success rates in moving to the R33 stage are expected to vary.

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.

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/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.

Additional Special Eligibility Criteria

All applications must include a letter or statement documenting that patients, samples, data and/or materials are or will be made available from the parent PDE. Documentation is required that the proposed project has the approval of the parent PDE's organization/leadership as well as any external funders. In addition, a memorandum of understanding between the ancillary project and the planned parent PDE must be provided prior to funding.

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(s)/PI(s)s 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.

For this particular announcement, note the following:

The R21/R33 Phased Innovation grant supports planning activities and feasibility studies followed by possible transition to expanded research support. An R21/R33 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, the feasibility, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21/R33 applications; however, they may be included if available.

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? Does the project have the potential to generate information that could lead to meaningful reductions in health care costs or cost growth? How will the proposed research directly affect patient care, health-care delivery, health care financing, health care systems, public health, and/or health policy? Does the project build upon a large-scale PDE with potentially broad generalizability?

Investigator(s)

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

Are the scientific hypotheses clearly stated? Are they generated by a sound, apt, economic theory or conceptual model? Does the proposed research design support causal inferences? Does the application contain adequate information to support the feasibility of the PDE (e.g. approvals, funding commitments) to continue as well as the planned ancillary study (e.g. letters of support)?

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

Not applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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.

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

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’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]

Sarah Q. Duffy, Ph.D.
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse (NIDA)
Telephone: (301) 451-4998
Email: [email protected]

Nakela M. Cook, M.D., M.P.H.
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: (301) 435-0383
Email: [email protected]

David Clark, Dr.P.H.
Behavioral and Social Sciences Research Branch
National Institute of Dental and Craniofacial Research (NIDCD)
Telephone: (301) 594-4814
Email: [email protected]

Wendy Nielson, Ph.D.
The Office of Behavioral and Social Science Research (OBSSR)
The Office of the Director, NIH
Telephone: (301) 496-0979
Email: [email protected]

Deborah Hirtz M.D.
Office of Clinical Research
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-5821
Email: [email protected]

Kate Bent, Ph.D.
Chief, Healthcare Delivery and Methodologies Integrated Review Group
Center for Scientific Review, NIH
6701 Rockledge Drive, Room 3160, MSC 7770
Bethesda, MD   20892-7770 (20817 for Fed Ex/delivery)
Telephone: 301-435-0695
Email: [email protected]

Edith Davis
National Institute on Drug Abuse (NIDA)
6001 Executive Blvd
Bethesda, MD 20892-9560
Telephone: 410-360-4734
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.