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 Aging (NIA) (NIA/NIH), (http://www.nia.nih.gov) on behalf of the NIH.
Funding Opportunity Title	Diffusion of Medical Technology and Effects on Outcomes and Expenditures (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-12-023
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 designed to explain the diffusion of health technologies both to understand trends in health outcomes and to improve the process leading from scientific advances to health benefits. Program Directors/Principal Investigators 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.

Posted Date	November 16, 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	July 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

By some estimates, about half of the growth in health care expenditures in recent decades is due to technological change in medicine but much of the improvement in outcomes should be attributed to the technological change as well. Macro-level estimates of the value of technological change in medicine in recent decades have shown the value of new technology has outweighed the cost in a global sense (Cutler & Rosen, 2008). But this is an overall, sector-wide estimate, masking potentially wide variations across regions, time periods, and classes of technology (Chandra & Skinner, 2012). Improving value in health care is an important and widely shared goal of health care reform, and a particular interest of NIH because of the NIH role in generating new technology in medicine.

Some technologies have diffused rapidly in the United States (e.g., prostate-specific antigen (PSA) tests, used extensively even for men well above recommended ages) and some very slowly (e.g., beta blockers prescribed shortly after myocardial infarction). Since 1960, most improvement in life expectancy in rich countries has been accounted for by what has been termed the Cardiovascular Revolution so a slow diffusion of advances in cardiovascular disease therapies in the United States could account for part of the failure of the United States to keep up with other rich countries in improvements in longevity.

Both to understand trends in health outcomes and longevity and to improve the process leading from scientific advances to health improvements, this announcement solicits applications for economic research designed to explain the diffusion of new health technologies. Which technologies are taken up quickly and which slowly, and how does the process contribute to better value in health care? How could the process be improved? A recent teleconference organized by the NIH Common Fund program in Health Economics included discussion of priorities and opportunities for research aimed at this question (summary available at http://commonfund.nih.gov/pdf/June_14_Technology_Diffusion_Call_summary_REV_8-20-12.pdf).

For the purpose of this announcement, technology refers to pharmaceuticals, devices, and procedures, or to innovations in the organization and delivery of medical care. Thus, technologies could include procedures such as laparoscopic or robotic surgery (with attendant equipment, teams, and training) or discrete changes in practice and organizational design such as care coordination for diabetics.

Economic explanations for the variability in speed of diffusion include barriers to entry into markets, distribution costs, the effects of market structure, the medical arms race and reputation effects for providers and hospitals, and quality competition versus price competition. Detailing practices of pharmaceutical firms and direct-to-consumer marketing may also play a role, for example, in fostering adoption of me-too drugs that produce little if any benefit over established drugs in the same class. In addition to characteristics of the technology itself, characteristics of the environment, including institutional and organizational differences, regulatory decisions, and insurance coverage decisions could all play a role in explaining differences in the pace and extent of penetration of new technologies (Acemoglu & Finkelstein, 2008). However, the empirical basis for many of these explanations is weak, and models examining the interaction among these factors as well as feedback loops have not been developed.

A discouraging finding of the RAND Health Insurance Experiment in the 1970s and 1980s was that high co-insurance and deductibles led to indiscriminate cutbacks in both highly cost-effective care (often preventive measures) and in less cost-effective care. In recent years several provisions for value-based insurance have been introduced both in private plans in the United States and in other countries, designed to provide incentives to adopt new technologies only when they clearly provide more benefits than existing care options. Studies are needed to estimate the likely effects of new forms of financing and organization for health care on the pace and type of technological change in the health sector.

The genomics revolution has led to a vision of a new era of personalized medicine and customized preventive care. The promise of new technology will only be realized, however, if effective technology is adopted and replaces ineffective technologies at a reasonable rate. While much of the existing literature on technology diffusion in medicine focuses on single technologies or single diseases, comparative studies, and studies addressing care of persons with multiple chronic diseases, are also needed. Many existing studies rely on analyses of data derived from reimbursement claims, which have only limited information about the clinical context and the precise nature of technologies used. Studies that develop new data sources with richer detail on technologies and clinical context are particularly needed.

Especially relevant to this announcement are studies relying on or testing economic theories of technological change and using econometric methods. Projects involving multidisciplinary teams led by a health economist, or with the substantial involvement of a health economist, are encouraged.

Examples of topics that would be responsive to this FOA include:

• How does adoption of new technology vary for different types and sizes of provider organizations large health care systems, accountable care organizations, small practices? Are some types of provider organization more likely in practice to avoid low-value technologies?
• How does adoption of new technology vary for different classes of pharmaceuticals, devices, and procedures? Studies of technologies with characteristics like those expected as part of personalized or precision medicine are encouraged.
• How has technological change affected the rate of growth of health sector expenditures? How do differences in the mix of technologies affect cross-sectional differences in health care expenditures? Studies that estimate the effect of technological change directly rather than as a residual are particularly encouraged. How can cross-national comparisons of technology diffusion in medicine, or cross-sectional comparisons of the health sector with other sectors, elucidate the effects of institutions, intellectual property considerations, or market structure?
• How are health care disparities (racial, socioeconomic, geographic) related to differences in the uptake of effective technology?
• How are the direction and pace of technological innovation in medicine affected by reimbursement methods and procedures for coverage decisions?
• What are the factors that promote the over generalized use of new technology into patient groups that have low or no likelihood of benefit?
• What are the features of the evidential base that influences the adoption of new technology or abandonment of older technologies?
• What are the effects on adoption of high-value technology of decision aids and other interventions to promote informed decision-making (about treatments, intensive care unit admissions, etc.) by patients or their surrogates?
• What factors affect the pace of abandonment of pharmaceuticals, devices, and procedures for which more effective technology exists?
• Has value-based insurance reimbursement affected the adoption of new technology in markets where it has been introduced?

Acemoglu, D. & Finkelstein, A. (2008). Input and technology choices in regulated industries: Evidence from the health care sector. Journal of Political Economy, 116, 837-880.

Chandra, A. & Skinner, J. (2012). Technology growth and expenditure growth in health care. Journal of Economic Literature 50, 645-680.

Cutler, D. M, Rosen, A. B., & Vijan, S. (2006). The value of medical spending in the United States, 1960-2000. New England Journal of Medicine, 355, 920-927.

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 FY13, contingent upon receiving scientifically meritorious applications. Five to seven 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 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:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• 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:

John Haaga
National Institute on Aging
Gateway Bldg. suite 533
7201 Wisconsin Avenue
Bethesda Maryland 20892
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 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.

SF424(R&R) R&R Budget Component

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.

PHS 398 Modular Budget Component

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 for responsiveness by the Common Fund Health Economics Program, NIH. Applications that are incomplete/non-responsive will not be reviewed.

Program Directors/Principal Investigators will be required to attend Steering Committee meetings. Application budgets should include funds for participation of one investigator in twice-yearly 1-day Steering Committee meetings.

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

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

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

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

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

Reviewers will provide an overall impact 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(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?

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 reside 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 Steering Committee 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 technology diffusion in the health sector 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.
• In addition, 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 Principal Investigator 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 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.

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]

John Haaga
National Institute on Aging (NIA)
Telephone: 301.496.3131
Email: [email protected]

Kathy Salaita
Center for Scientific Review
National Institutes of Health
Telephone: 301.435.1112
Email: [email protected]

Linda Whipp
National Institute on Aging (NIA)
Telephone: 301.402.7731
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.