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 Aging (http://www.nia.nih.gov/) on behalf of the NIH.
Funding Opportunity Title	Integrating Comparative Effectiveness Research Findings into Care Delivery through Economic Incentives (R21)
Activity Code	R21 Exploratory/Developmental Research Grant Award
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-RM-11-001
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestics Assistance (CFDA) Number(s)	93.310
FOA Purpose	This Funding Opportunity Announcement (FOA) solicits exploratory and developmental research (R21) applications from institutions/organizations proposing to advance knowledge on the ways in which comparative effectiveness research (CER) can be used to maximize the value of health care delivery in the United States. Specifically, the research sought under this announcement should inform the ways in which findings from CER can be incorporated into the incentives faced by providers, consumers, and payers, in order to bring about meaningful changes in clinical practice that could improve the quality of care for patients while helping to restrain growth in health care costs. The FOA is a component of the Common Fund initiative on Health Economics for Health Care Reform (http://nihroadmap.nih.gov/healtheconomics).

Posted Date	November 12, 2010
Open Date (Earliest Submission Date)	December 18, 2010
Letter of Intent Due Date	December 18, 2010
Application Due Date(s)	January 18, 2011 , by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June/July 2011
Advisory Council Review	August, 2011
Earliest Start Date(s)	September 1, 2011
Expiration Date	January 19, 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

For nearly all of the past three decades, spending on health care in the United States grew more rapidly than the overall economy and, as a result, the share of national income devoted to health care rose sharply. Although many factors contributed to that growth, the bulk of the long-term rise resulted from expansions in the technological capabilities of medicine which allowed health care providers to diagnose and treat illness in ways that were not previously possible. The health care system’s rapid adoption of emerging medical technologies has provided enormous clinical benefits. However, technological change has been cited as one of the key factors underlying the growth in health care spending, in part because the added clinical benefits of new medical services are not always weighed against the added costs before those services enter common clinical practice. Newer, more-expensive diagnostic or therapeutic services are sometimes used in cases in which older, cheaper alternatives could offer comparable outcomes for patients, and expensive services that are known to be highly effective in some patients are occasionally used for other patients for whom clinical benefits have not been rigorously demonstrated. That suggests that some medical services could be used more selectively without harming, and possibly improving, patient outcomes, thereby increasing the value attained from health care spending. Towards that goal, the purpose of this Funding Opportunity Announcement (FOA) is to promote research on how economic incentives can promote the integration of comparative effectiveness research (CER) findings into the decision calculus of payers, providers, and patients

Technological advances are likely to yield new medical services in the future, fueling further spending growth and imposing tradeoffs between spending on health care and spending on other priorities. If the health care system adopts new services rapidly and applies them broadly in the future as it has tended to do in the past then large increases in health care spending are likely to continue. If new or existing costly services are used more selectively in the future, then smaller increases in health care spending are possible. The question of future growth in health care spending is of paramount importance. For the federal government, the future rate of growth in health care costs will be the principal determinant of the country’s future fiscal health; for persons with private insurance, the future rate of growth in health care costs will be a large determinant of future wage growth because wage earnings tend to grow more slowly when health care costs grow more rapidly.

Research on the comparative effectiveness of medical treatments provides a basis for improving quality of care by ensuring that medical services are used when they are most appropriate and efficacious. In addition, many analysts suggest that CER could significantly restrain growth in health care costs if it helped to ensure that costly medical technologies are used only when they confer benefits that are significantly greater than the benefits conferred by less expensive treatment options. Recent legislation has significantly expanded federal support for CER. For example, the American Recovery and Reinvestment Act provided $1.1 billion in direct support for comparative effectiveness studies. Also, the Patient Protection and Affordable Care Act provides for the establishment of the nonprofit Patient-Centered Outcomes Research Institute, which will identify research priorities and conduct CER.

That expanded support will make additional CER data available and could possibly raise awareness of alternative therapies for various illnesses and their relative benefits. In order for CER findings to improve the quality of medical care and affect health care costs, however, it will be necessary for various actors in the health care system, including both payers and providers, as well as patients and their families, to incorporate those findings into their decision making. Such a result is most likely if the incentives facing those various parties evolve to encourage evidence-based choices that reflect CER. This FOA solicits research that advances knowledge on how CER findings can be implemented to maximize the value of health care delivery in the United States. The research sought under this announcement should inform the ways in which findings from CER can be incorporated into the incentives faced by providers, consumers, and payers, in order to bring about meaningful changes in clinical practice that could improve the quality of care for patients while helping to restrain growth in health care costs. This FOA focuses on the context of the United States health care system. Studies of the CER experience in other countries may also be proposed under this FOA, however, provided that they directly inform the ways in which CER findings could be incorporated into care delivery in the United States, with its unique institutions and mix of public and private payers.

The topics discussed below provide a non-exhaustive list of examples of the research topics intended under this announcement.

CER and Payer Incentives

Individual private payers have little incentive to produce comparative effectiveness data on their own. Not only is doing so costly, but once a study has been completed, other competing payers might benefit from the information even if they didn t share in the cost of generating it. So private markets are expected to produce less CER data than would be socially optimal. However, for certain areas of clinical medicine, comparative data on the efficacy of competing therapies have been available for years (for example, from studies that were publicly funded). Despite this, it is not clear that private payers make optimal use of such data in coverage decisions or in setting payments even though they might have financial incentives to do so. One possible explanation is that payers are reluctant to be seen as denying useful care to patients. Another would be that payers believe that they would be unable to change prevailing clinical practice norms. This FOA solicits research that would identify ways in which payers could be encouraged to make greater use of findings from CER.

CER and Provider Incentives

Physicians and other providers are known to respond to financial incentives. For example, physicians tend to order more services when they are paid on a fee-for-service basis. This FOA solicits research on how provider incentives can be altered in ways that would help maximize the value of the care which they provide based on information from CER. Areas of interest include (but are not limited to) changes in the financial incentives that providers face and other types of changes such as nudges that are based on behavioral economics research. Also of interest is the question of what factors facilitate or obstruct the adoption of CER-based care delivery in accountable care organizations.

CER and Consumer Incentives

Research in health economics has established that consumption of medical care is at least somewhat sensitive to the level of cost-sharing which patients face. This FOA encourages research that would examine the welfare implications of basing cost-sharing levels on CER findings under some clinical circumstances. For example, for patients with a given condition, can economic efficiency be enhanced by lowering cost-sharing for medical services that have clear, demonstrated clinical benefits or, conversely, raising cost-sharing for services whose benefits have not been clearly demonstrated?

Assessing Potential Savings from Implementing CER Findings

If implementing CER findings resulted in more selective use of some costly services, future spending levels would probably be lower than they would otherwise be perhaps substantially so. But there is considerable uncertainty surrounding that question. For example, it cannot be known what future CER studies would find, and in any event, attaining significant cost savings may require difficult changes to the ways in which providers and patients make decisions concerning medical care. This FOA solicits research that would assess potential savings from implementing CER for public and private payers.

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. 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.

This initiative is part of the Common Fund program in Health Economics, designed to address the evolving needs of the health care sector for economic research. This program is planned to include multiple Funding Opportunity Announcements on topics related to reform of health care in the United States, with funding expected to total $68 million across seven years. For more information please see: http://commonfund.nih.gov/healtheconomics/

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	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. NIH intends to fund an estimate of 4-6 awards, corresponding to a total of $1 million, for fiscal year 2011. Future year amounts will depend on annual appropriations.
Award Budget	Budgets for direct costs of up to $200,000 in any single year and a project duration of up to two years may be requested for a maximum of $275,000 direct costs over the two-year project period
Award Project Period	Project can last up to 2 years

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions:

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For profit Organizations

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

Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign (non-U.S.) components of U.S. Organizations are allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project 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.

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:

Colin S. Baker, Ph.D.
National Institute on Aging
National Institutes of Health
Suite 533 Gateway Building
7201 Wisconsin Avenue
Bethesda, Maryland 20892-9205
Use Zip Code 20814 for FedEx
Telephone: 301-496-3131
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 application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

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 modifications:

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

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

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

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

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

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

This Funding Opportunity Announcement (FOA) solicits exploratory and developmental research (R21) applications from institutions/organizations proposing to advance knowledge on the ways in which comparative effectiveness research (CER) can be used to maximize the value of health care delivery in the United States. Specifically, the research sought under this announcement should inform the ways in which findings from CER can be incorporated into the incentives faced by providers, consumers, and payers, in order to bring about meaningful changes in clinical practice that could improve the quality of care for patients while helping to restrain growth in health care costs.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 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, 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 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?

Investigator(s)

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

Innovation

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

Approach

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

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

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

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 (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

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.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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]

Colin S. Baker, Ph.D.
National Institute on Aging(NIA)
Telephone: 301-496-3131
Email:[email protected]

Gregory Bloss, M.A.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Division of Epidemiology and Prevention Research
Telephone: 301-443-3865
FAX: 301-443-8614
E-mail: [email protected]

Sarah Q. Duffy, Ph.D.
Associate Director for Economics Research
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug AbuseTelephone: 301-451-4998
Email: [email protected]

David Clark, Dr.P.H.
National Institute of Dental and Craniofacial Research (NIDCR)
Behavioral and Social Sciences Research Branch
6701 Democracy Blvd, Room 650
Bethesda, MD 20892-4878
Telephone: 301-594-4814
Fax: 301-480-8319
Email: [email protected]

Karen Huss, Ph.D., R.N., A.P.R.N.-B.C.
National Institute of Nursing Research
Division of Extramural Activities
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.