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 NIH Office of the NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/). The FOA will be administered by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) on behalf of the NIH.
Funding Opportunity Title	Determinants and Consequences of Personalized Health Care and Prevention (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	February 1, 2013 - See Notice NOT-RM-13-010. Notice Announcing Frequently Asked Questions (FAQs).
Funding Opportunity Announcement (FOA) Number	RFA-RM-12-024
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.310
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) solicits U01 applications for economic research on the determinants and consequences of personalization in health care and prevention. The objective of the research program is to support foundational research on economic aspects of individualized health interventions that will provide a framework for subsequent applied analyses. Program Director(s)/Principal investigator(s) for projects funded under this FOA are required to participate in a Steering Committee that will help identify key strategies to support critical research advances in this field. Research to be supported by this FOA includes analyses and development of research tools to advance understanding of: factors that affect the value of personalized interventions to individuals and their families, health care providers and payers, and society at large; incentives and constraints facing individuals and their families, health care providers, research organizations, drug and device manufacturers, and others and how they affect the actual and optimal extent to which interventions are tailored to patients personal characteristics or preferences; and strategies to promote improvements in health and cost outcomes through personalization of health care and preventive interventions. The purpose of this FOA is to expand generalizable understanding of the determinants and consequences of personalization in health care and prevention; it is not primarily intended to support evaluation of specific interventions or strategies for addressing particular health conditions.

Posted Date	November 21, 2012
Open Date (Earliest Submission Date)	January 28, 2013
Letter of Intent Due Date(s)	January 28, 2013
Application Due Date(s)	February 28, 2013, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June 2013
Advisory Council Review	August 2013
Earliest Start Date	September 30, 2013
Expiration Date	March 1, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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

Efforts to protect and improve health involve identifying, selecting, and implementing interventions that address individuals health conditions, risks, prognoses, and quality of life. The specific interventions that are most appropriate often depend on factors that vary greatly across individuals. Clinical practice has always taken the characteristics of individual patients into account. However, new technologies of genomics, metabolomics, and other molecular approaches to characterizing individual variation raise the prospect of greatly expanded opportunities for tailored interventions that capitalize on individual characteristics. In many cases, such interventions are indicated (or not) on the basis of companion diagnostic tests that ascertain an individual’s genotype or other molecular-based marker of suitability for the intervention. The research, development, implementation, and delivery of these precision interventions and the companion diagnostics necessary to provide them to individual patients are affected by incentives and market conditions that could lead to either under- or over-provision of effective personalized interventions. For example, the regulatory and patent conditions that apply to diagnostic tests differ markedly from those that apply to therapeutic drugs and devices, and this mismatch may distort the economic incentives for investment in developing more highly personalized interventions. Research is needed to understand the incentives and market conditions that affect the process through which greater personalization is encouraged and incorporated in health care and prevention.

The genomic revolution has focused attention on the idea of personalized medicine, but many non-genomic aspects of personalization in health care and prevention are arguably at least as important in determining health outcomes and health care practice, utilization, and cost. However, little is known about how individual characteristics and preferences affect real-world clinical practice and delivery of health care and preventive interventions and the costs and health outcomes that result. Research is needed to identify the range of different kinds and degrees of personalization in health care and prevention and to understand their roles in determining health outcomes and health care costs.

Variation in individuals and providers access to, or ability to make effective use of, intervention alternatives based on personal characteristics and preferences may affect individual health outcomes, overall public health, health disparities, and the growth of health care costs. Expanded development and use of increasingly personalized interventions may influence public health positively or negatively through their effects on costs and the broader allocation of resources. Greater availability of genomic information may lead to expanded medical testing in patients and their relatives, with implications for costs and health outcomes. Availability of information about genetic risks may affect behavior and outcomes in insurance and labor markets. Research is needed to understand the nature and determinants of these kinds of effects and to characterize the appropriate tools and frameworks for analyzing and evaluating them.

Awards under this Funding Opportunity Announcement (FOA) are meant to stimulate development of the field of economic analysis of personalized health interventions, generating theoretical models and analytic tools and frameworks that will be suitable for application across a broad range of specific interventions, health conditions, and populations. Such models and tools are essential to understanding how resources devoted to development and delivery of personalized interventions can be allocated to generate the greatest health benefit at the least cost. At its conclusion, the research program supported by this FOA should produce a solid foundation for applied analyses of specific interventions that are relevant to specific NIH Institutes and Centers as well as further advances in basic economic research in this area. Projects supported under this announcement should advance understanding of the economic determinants, consequences, and value of personalization in health care and prevention in terms of patients and their families, providers, developers of interventions, markets, and the population as a whole. Outcomes of interest include health of individuals, families, groups, and overall public health and associated health care costs. The nature of personalization is explicitly understood to encompass a range of perspectives on individual or familial variation, including variation at the genomic or other molecular level as well as variation in terms of other kinds of characteristics or preferences, such as phenotype, clinical response, preferences, or behavior.

Priority areas of research interest under this announcement include:

• theoretical research to develop models of economic and behavioral factors that promote or obstruct effective development, adoption, and implementation of more highly personalized interventions and of the potential for such interventions to improve health, reduce costs, or both;
• methodological research to develop tools suited for analysis or evaluation of personalization in clinical or public health practice;
• economic research on market structures, behavior, and outcomes related to development, adoption, availability, reimbursement, and utilization of personalized interventions and companion tests or diagnostics;
• studies to identify incentive-based, regulatory, or public investment strategies pertaining to personalized health care or preventive interventions that lead to improvements in economic performance, reductions in health care costs, or improvements in public health.

Additional areas of research interest in which projects could be supported under this announcement include but are not limited to:

• observational research to characterize current practices affecting availability and use of interventions tailored to individual characteristics and preferences;
• studies of the value of information associated with individual characteristics or preferences, how the value of information varies across health conditions, demographic groups, types of interventions, etc.;
• analyses of the implications of information asymmetries for performance and outcomes in product, service, labor, or insurance markets, particularly in the context of expanded availability of biological markers of individual health risks;
• econometric studies of the effects of personalization on population health outcomes, utilization, or cost.

Consistent with the purpose of this FOA, research supported under this announcement should aim to advance generalizable understanding of the determinants and consequences of personalization in health care and prevention. Applications that propose projects that are limited to empirical evaluation of a particular personalized intervention are not responsive to this FOA and will not be reviewed.

The research to be supported by this FOA aims to advance the objectives of the NIH Common Fund. Proposed research projects should be transformative, with potential to lead to dramatic research advances; catalytic, generating meaningful advances toward improving individual and public health and controlling health care costs through better economic understanding of this area; synergistic, capitalizing on trans-disciplinary research perspectives to understand the complexities inherent in improving efficiency in the production of health through use of personalized interventions; cross-cutting, by creating generalizable new knowledge applicable to a range of health conditions or populations usually addressed by various NIH Institutes and Centers; and unique, by pursuing research advances that would not be supported through other channels or funding mechanisms.

Prior to developing this FOA, the NIH Common Fund Health Economics Program convened a teleconference on July 19, 2012, with experts in health economics and personalized health care and prevention to identify key research gaps and opportunities in this area. A summary of discussion during the teleconference is available at http://commonfund.nih.gov/Healtheconomics/meetings.aspx. The views expressed during the discussion are those of the participants and do not necessarily reflect the views of the NIH or of reviewers of applications submitted in response to this FOA. Some of the ideas and suggestions posed by participants in the teleconference may be suitable for development as projects that could be supported under this FOA while other such ideas and suggestions may not.

In addition, the Institute of Medicine (IOM) Roundtable on Translating Genomic-Based Research for Health hosted a meeting on July 17-18, 2012, Assessing the Economics of Genomic Medicine: A Workshop. Although the NIH Common Fund Health Economics Program had no involvement in the planning or support for that meeting, some of the ideas expressed in the presentations and discussions may be relevant to the purpose of this FOA. Information on the IOM meeting is available at http://www.iom.edu/Activities/Research/GenomicBasedResearch/2012-JUL-17.aspx.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The total amount of funds available for this FOA is approximately $2.7 million for FY2013, contingent upon receiving scientifically meritorious applications. Six to eight awards are anticipated from this solicitation.
Award Budget	Application budgets are not limited, but must reflect the actual needs of the proposed project.
Award Project Period	The requested project period should be determined by the project's scope, up to a maximum of five 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
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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 Research 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)

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 SF424 (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.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (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 6 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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

1. To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
2. Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
3. Of an application with a changed grant activity code.

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(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Gregory Bloss
MSC 9304
5635 Fishers Ln, room 2075
Rockville, MD 20892
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 applications must contain a detailed, non-modular budget. Application budgets should include funds for participation of one investigator in twice-yearly 1-day Steering Committee meetings in Bethesda, MD.

Applicants should ignore the following warning that will be generated for applications requesting budgets of $250,000 or less per year: The direct cost requests of $250K or less each year (on the 424 R&R Budget page section F-K) must be in modules of $25K, using the PHS 398 Modular Budget Form and not the R&R Budget Form. Incorrect applications may be delayed in the peer review process or rejected.

Modular budgets will not be accepted for this FOA.

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:

• All 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-U.S.) 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 applications before 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 before the deadline 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 SF424 (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 SF424(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 System for Award Management (SAM). 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 PDs/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.

In order to expedite review, applicants are requested to notify the NIAAA Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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 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 lead to important advances in understanding of the economic determinants or consequences of personalization in health care or prevention or generate research tools to support such advances?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the project team include extensive and appropriate research expertise in economics and in the aspects of personalized health care or prevention addressed by the project aims?

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 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 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. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will 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 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.

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, SAM 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• All aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee.
• Awardees agree to the governance of the Steering Committee.
• Awardee(s) will agree to accept close coordination, cooperation, and participation of NIH Health Economics staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."
• Awardee(s) will provide goals and progress toward those goals at regular intervals as requested by the Steering Committee;
• Awardee(s) will ensure that resources (e.g. data sets; econometric models and estimation software) developed as part of this project are made publicly available and that results are published in a timely manner;
• Awardee(s) will adhere to the Steering Commitee policies regarding intellectual property, data release and other policies that might be established during the course of this activity that are consistent with applicable NIH policies, laws, and regulations.;
• Awardee(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The Project Scientists for each agreement will serve on the Steering Committee. The Project Scientists may work with the awardees on any issues that come before the Steering Committee.
• The Project Scientists will participate (with the other Steering Committee members) in the group process of discussing optimal research approaches to the study of personalized health care and prevention and providing advice on research protocols or approaches as warranted.
• The Project Scientists will serve as a liaison between the awardees and the appropriate NIH Institute and Center National Advisory Councils and the NIH Health Economics Working Group.
• The Project Scientists will periodically report progress to the Director of the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), and to the Directors of participating Institutes.
• The NIH reserves the right to withhold funding or curtail the study (or an individual award) in the event of substantive changes in the agreed-upon work scope with which NIH cannot concur, (b) human subject ethical issues that may dictate a premature termination; (c) or research not progressing well.
• Support or other involvement of industry or any other third party in the study--e.g., participation by the third party; involvement of study resources or citing the name of the study or NIH support; or special access to study results, data, findings or resources--may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NIH.
• Additionally, an agency program official or NIH Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of joint responsibility include:

A Steering Committee will serve as the main governing board for the network of cooperative agreements funded under this FOA. The Steering Committee membership will include the NIH Project Scientists and the PD(s)/PI(s) of each awarded cooperative agreement. The Steering Committee Chair will not be an NIH staff member but will be appointed by the co-chairs of the NIH Health Economics Working Group. Additional members of the NIH Health Economics Working Group may be appointed to the Steering Committee by the co-chairs of the NIH Health Economics Working Group, but the total number of NIH votes may not exceed the number of PD/PI votes on the Steering Committee. Other government staff may attend the Steering Committee meetings, if their expertise is required for specific discussions.

The Steering Committee will:

• Develop recommendations for uniform procedures and policies necessary to meet the goals of the FOA, including development of data sets and econometric approaches that can be used across populations, diseases and conditions.
• Schedule the time for, and prepare concise (3 to 4 pages) summaries of, the Steering Committee meetings, which will be delivered to members of the group within 30 days after each meeting. The Steering Committee will meet twice a year and with intermittent conference calls.
• Each full member (limited to one person per awarded project) will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will be: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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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Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Gregory Bloss
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301.443.3865
Email: [email protected]

Kathy Salaita, Sc.D.
Center for Scientific Review
Telephone: 301.435.1112
Email: [email protected]

Ms. Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Telephone: 301443-4704
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.