Palliative Care in Geriatric Populations is sponsored by National Institutes of Health (NIH). This Funding Opportunity Announcement encourages research grant applications focused on palliative care in geriatric populations.

Expired PA-17-225: Advancing the Science of Geriatric Palliative Care (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute on Aging ( NIA ) National Center for Complementary and Integrative Health ( NCCIH ) National Institute of Nursing Research ( NINR ) National Institute on Minority Health and Health National Cancer Institute ( NCI ) National Heart, Lung, and Blood Institute ( NHLBI ) Funding Opportunity Title Advancing the Science of Geriatric R01 Research Project Grant December 15, 2017 - This PA has been reissued as PA-18-502 .

November 09, 2017 - Notice of NHLBI Participation in PA-17-225. See Notice NOT-HL-17-558 . Reminder: FORMS-E Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2018.

- Updates to Active Funding Opportunity Announcements to Prepare for Policy Changes Impacting Due Dates On or After January 25, 2018. July 10, 2017 - Notice of NCI's Participation on PA-17-225. See Notice NOT-CA-17-054 .

May 19, 2017 - Notice of Update to Application Forms Package for PA-17-225. See Notice NOT-AG-17-009 . May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018.

See NOT-OD-17-062 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PA-17-226 , R21 Exploratory/Developmental Grant Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.

866, 93. 361, 93. 307, 93.

213, 93. 393, 93. 837, 93.

838, 93. 839, 93. 840, 93.

233 Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) encourages research grant applications focused on palliative care in geriatric populations.

This FOA covers studies in a variety of settings including hospitals (and specific sites within hospitals including specialty medical or surgical wards, intensive care units, and emergency departments), post-acute care settings, outpatient clinics and doctors offices, patients homes and other residential settings, assisted living facilities, nursing homes, hospices, and other healthcare or community settings.

This FOA encourages both prospective studies and analyses of existing datasets, health and medical records, claims data, or other sources. Leveraging ongoing cohorts, intervention studies, networks, data and specimen repositories, and other existing research resources and infrastructure are encouraged.

Study designs may include observational approaches, quasi-experimental designs, and Open Date (Earliest Submission Date) Letter of Intent Due Date(s) dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. The first standard application due date for this FOA is June 5, 2017.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. AIDS Application Due Date(s) New Date December 15, 2017 per issuance of PA-18-502 .

(Original Expiration Date: May 8, 2020 ) It is critical that applicants follow the Research (R) Instructions (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 I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description As the population of older adults continues to increase, the prevalence of diseases and conditions common in aging is expected to rise.

Cardiovascular diseases, cancer, chronic lung diseases, dementia, and chronic kidney disease will likely continue to be the greatest sources of morbidity and mortality, as well as the costliest conditions to healthcare systems. However, older Americans infrequently have just one chronic health condition. In 2010, over two-thirds of Medicare beneficiaries had more than one chronic condition, and 14% had 6 or more chronic conditions.

Disability and greater care needs associated with these conditions is leading to an increase in residence in nursing homes and other long-term care facilities. Healthcare costs will continue to grow, with health-related spending expected to top 20% of gross domestic product by 2025. Serious illnesses resulting from the progression of chronic health conditions pose particular challenges for health care decision-making.

While treatments with curative intent may forestall complications and relieve some symptoms, disease progression ultimately leads to increased disability and symptom burden that compromise quality of life.

In addition, among patients with multiple morbidities, treatments for co-occurring conditions may antagonize each other (also known as therapeutic competition), and patients must evaluate tradeoffs among multiple sub-optimal treatment options.

As a result, patients values, preferences, and goals become essential to inform Providing care that is consistent with a patient’s values, preferences, and goals is a cornerstone of palliative care, an interdisciplinary, patient-centered approach that aims to improve quality of life for persons with advanced illness and their families.

Palliative care focuses on several objectives including relief of symptoms and suffering, communication of prognosis and treatment options in the context of patients goals, and coordination of care within and across healthcare settings. Palliative care is not synonymous with hospice nor end-of-life care.

Rather, these are parts of the spectrum of care for serious illness that is addressed by palliative care from diagnosis through terminal stages of disease. Moreover, palliative care does not necessarily entail withholding or curbing treatment. Relief of symptoms, enhancing quality of life, and many other specific aspects of goal-concordant care may, in fact, involve optimal medical or surgical treatment of disease.

Furthermore, proactive approaches to disease management, such as pre-habilitation strategies prior to surgery to improve functional recovery, can be consistent with goal-concordant care.

However, without knowing patients values and preferences, care may be inconsistent or even run counter Most evidence for the effectiveness of palliative care to date has been based on a model of consultation or co-management by specialty-trained palliative care clinicians. However, the demand for palliative care specialists far outpaces their supply.

Disease-focused specialists may be well poised to incorporate aspects of palliative care into their practices, such as basic management of pain, anxiety, and depressive and other symptoms, and effective basic patient-centered discussions about prognosis, goals of care, and code status.

Research to identify and implement these aspects of care may be particularly suited to such specialties as oncology, cardiology, pulmonary/critical care medicine, nephrology, neurology, and others.

Among surgical specialties, typically acute presentations and rapidly shifting health status, potentially burdensome interventions, need for more appropriate outcome measures, and surgical cultural norms pose unique challenges for palliative care research. Much of the existing evidence base for palliative care has been in hospital settings.

Further research should also include other health system and community settings, care delivery models, and relevant outcomes. Such research is needed to identify specific populations or settings for which particular palliative care practices may or may not be appropriate.

Research can also guide alternatives for preventable emergency department visits, hospitalizations, and other avoidable utilization among seriously ill patients in the community. Innovative approaches such as tele-medicine may be particularly useful in specific settings such as rural areas where access to healthcare is limited.

Finally, as the role of informal caregivers expands alongside current trends toward aging in place, more research is needed on the role of intimate partners and adult children in care and decision-making for older individuals This Funding Opportunity Announcement (FOA) encourages research grant applications focused on palliative care in geriatric populations.

This FOA covers studies in a variety of settings including hospitals (and specific sites within hospitals including specialty medical or surgical wards, intensive care units, and emergency departments), post-acute care settings, outpatient clinics and doctors offices, patients homes and other residential settings, assisted living facilities, nursing homes, hospices, and other healthcare or community settings.

This FOA encourages both prospective studies and analyses of existing datasets, health and medical records, claims data, or other sources. Leveraging ongoing cohorts, intervention studies, networks, data and specimen repositories, and other existing research resources and infrastructure are encouraged. Study designs may include observational approaches, quasi-experimental designs, and interventional studies.

Topics of interest among Institutes and Centers (ICs) participating in this FOA are summarized below. Applicants are encouraged to contact the Scientific/Research contact listed in Section VII to ensure that proposed aims are consistent with the mission(s) of the intended IC(s).

Where IC topic areas overlap, applicants are especially encouraged to contact the respective IC representatives to discuss appropriate arrangements for dual The NIA is interested in studies that focus on palliative care in individuals and populations with age-related diseases, conditions, and/or special problems and needs associated with older age, such as multiple chronic conditions, polypharmacy, cognitive impairment/dementia, age-related disabilities, and other geriatric syndromes.

Topics of interest include, but Development and evaluation of health care models and approaches aligned with patient values, preferences and goals in seriously ill older adults with multiple chronic conditions, Alzheimer’s disease and related dementias, or other age-related conditions.

Development and evaluation of assessment tools in older adults with complex care needs; e.g., multiple chronic conditions, frailty/multiple age-related disabilities, cognitive impairment/dementia.

Development and evaluation of strategies to incorporate palliative care approaches for aging-related conditions by health care practitioners who are not palliative care specialists, or collaborative approaches between palliative care specialists and clinicians from other disciplines. (See also research objectives of other participating IC’s below for specific disciplines.)

Evaluation of decision support tools, palliative care consultation triggers, communication aids, and advance care planning approaches for seriously ill older patients and their surrogate decision-makers (when present) or for seriously ill, unbefriended older patients to achieve goal-concordant care, with particular attention to revisiting both shifting goals and differing family member perspectives.

Evaluation of discontinuing medications or other treatments in older adults with serious illnesses to reduce treatment complexity, mitigate drug interactions and other adverse effects, or achieve preferred treatment tradeoffs, and barriers to such discontinuation among patients, their families, Understanding the impact of single or multiple symptoms on function, disease outcomes, quality of life, and decision-making in seriously ill older adults, particularly with multiple morbidities.

Symptoms may include pain, fatigue or increased fatigability, dyspnea, nausea/vomiting, constipation, pruritus, anorexia, sleep disturbance, delirium, anxiety, and depressive symptoms. (Applicants are encouraged to see RFA-AG-16-013 for further discussion of fatigability.)

Development of pharmacologic or non-pharmacologic strategies to relieve symptoms (as in the previous bullet) in older adults through consideration of aging physiology, concurrent conditions or treatments, altered symptom perception, or other aging-related changes.

Understanding and addressing gender, ethnic, geographic, and socioeconomic disparities in access, delivery, and outcomes of palliative care for older adults and/or their caregivers.

Approaches to incorporating and analyzing patient-centered variables relevant to goal-concordant care in older adults that are not routinely captured in research or clinical care settings; e.g., functional assessment, values and treatment preferences, subjective well-being, social support, financial status, and cultural factors.

Addressing systemic challenges to conducting research studies of palliative care in older adults, such as barriers to care, high rates of disability and mortality, and adherence among patients, caregivers, family Analysis of the effects of coverage policies of Medicare and other care funders on timely access to appropriate palliative care, and of the effects of care coordination, payment bundling, or other organizational and financing innovations on timely access to appropriate palliative care.

Development and evaluation of enhanced analytic methods for quasi-experimental and observational studies of palliative care strategies in older adults that address time-dependency, multimodal treatment, matching of control subjects, or other important parameters.

NIA-supported Research Centers may be particularly useful for accessing recruitment resources, analytic capabilities, specimens, specialized expertise, and other aging-related research resources. More information about each of these Centers programs can be found at their respective links: Alzheimer's Disease Research Centers , Centers on the Demography and Economics of Aging , Claude D.

Pepper Older Americans Independence Centers , Edward R. Roybal Centers for Translation Research in the Behavioral and Social Sciences of Aging , and Resource Centers for Minority Aging Research .

Institute of Nursing Research (NINR) NINR’s focus includes science that assists individuals, families and family caregivers in managing the complex experiences of advanced symptoms in serious, advanced illness; to mitigate the effects of advanced symptom burden on individual and caregiver health and well-being; and to optimize planning for end-of-life decision-making and goal-concordant care.

NINR is particularly interested in studies that address issues such as management of pain and other advanced symptoms and behavioral, emotional, social, spiritual and informed decision-making support.

Interventions that address supportive, palliative, and hospice needs across a continuum of services in coordination with individuals, families and their health care teams In addition to the overall objectives, examples of specific research topics include, but are not limited to: Develop, test and evaluate minimally invasive methods including tools, technologies and assessments to monitor physiological, behavioral and emotional status, including advanced symptoms and individual- and caregiver-reported outcomes, that are effective and acceptable to older adults Identify similarities and differences and/or develop, test and evaluate interventions addressing the needs of older individuals and their family caregivers for advanced symptom management, including behavioral, emotional, social, spiritual and informed decision-making support across populations of advanced diseases such as advanced heart failure and other cardiovascular diseases, advanced renal disease, advanced hepatic disease, advanced respiratory conditions including advanced COPD, and advanced cancers.

Develop, test and evaluate assessments and interventions during the palliative care period that assess and improve grief, bereavement and loss outcomes for older adults.

Identify optimal non-pharmacological methods for managing advanced or complex symptoms including, but not limited to, pain, dyspnea, fatigue, nausea, delirium, sleep disturbance, pruritus, etc. in older adults Identify multidimensional palliative care needs of older adults and their family caregivers including, but not limited to, physical, psychosocial, behavioral, emotional and spiritual needs and develop, test and evaluate innovative interventions/models of care that address these needs.

Develop, test and evaluate interventions/models of palliative care that addresses issues associated with frailty in older adults. Develop, test and evaluate interventions that address transitions across the palliative and end-of-life care continuum, with the aim of maintaining continuity/coordination of care.

Evaluate the unique needs related to end-of-life issues in older adults (e.g., management of multiple conditions, assessment and management of advanced or complex symptoms, advance care planning and communication relating to advance care planning). Test the acceptability and effectiveness of palliative care strategies across gender or ethno-cultural perspectives among older adults.

Interdisciplinary collaborations that include nurse scientists in the project team are strongly encouraged. Additionally, applicants are encouraged to engage the resources and expertise of existing Palliative Care Networks such as the Palliative Care Research Cooperative Group , when appropriate.

Institute on Minority Health and Health Disparities (NIMHD) Racial/ethnic minorities may have unique preferences, decision-making, self-care strategies, access and use of informal or complementary therapies, caregiving, and family and social networks that support geriatric care which affect their choice and use of palliative care.

Minorities are less likely to use Advanced Directives and Hospice Care and are more likely to die in hospitals after undergoing aggressive care and accruing financial burdens, and there remains an overall distrust of the health care system and institutions, as well as underutilization of current palliative care services.

Minorities are also more likely to have multiple chronic diseases and a greater impact on health-related quality of life based on these diseases, thus requiring more complex care, and they are more likely to experience racially discordant care.

Less is known about geriatric palliative care among populations stratified by socioeconomic status independent of race/ethnicity, among those living in underserved rural residences, and among those of sexual and gender NIMHD is interested in supporting research on one or more minority or health disparity populations (African Americans/Blacks, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minority populations) that focuses on understanding the mechanisms and pathways that contribute to disparities in palliative care by examining the interplay of factors from multiple levels, e.g., individual, family, community, clinician, and health systems.

Research may propose using available secondary data, health system data and/or collection of primary data. Research topics of interest include but are not limited to: Identifying values, preferences and goals for race/ethnic minorities or other health disparity populations' patients, families, and caregivers and how these affect palliative care outcomes.

Understanding the role of individual, family, culture, clinician, health system, and social factors that impede or strengthen palliative care.

How to effectively address health determinants from environmental, cultural, social and system levels within patient-centered Improvement and exploration of new and existing palliative care indicators/variables able to distinguish the quality, values, preferences and goals that are particular to minority or health disparity populations, such as functional assessment, symptom burden, quality of life, values and treatment preferences, subjective well-being, social support, financial status, cultural factors, and other biological or psychosocial variables.

Understanding and strengthening patient-clinician interactions, communication, medical decision-making and continuity of care. For example, assessing ways to improve awareness and knowledge of care options, address patient preferences, minimize clinician biases, address trust barriers, address system barriers, increase coordination of care, and manage expectations.

Understanding the context of care settings (e.g. hospital, clinic, community, and home-based settings), how these effect health outcomes, and what influences the patterns of choice, utilization, and quality of the Understanding the role and use of self-management, cultural, traditional, and spiritual approaches among minority and health disparity populations within palliative care.

Understanding attitudes and preferences regarding advance care planning among minorities and health disparity populations, as well as compliance with advance care planning by clinicians and health care systems. Understand how advance care planning models can be improved to address barriers, attitudes, values, and goals for minority and health disparity populations, clinicians, and health care systems.

Center for Complementary and Integrative Health (NCCIH) NCCIH is committed to the rigorous investigation of promising complementary and integrative health approaches, including natural products and mind and body interventions.

These complementary health approaches are widely used by the public, and they are increasingly recognized to provide options to symptom management (e.g., chronic pain, sleep disturbance, mild depression, anxiety, etc.). For this FOA, natural products include botanicals, pre/probiotics, and products marketed as dietary supplements.

Mind and body approaches are frequently being integrated into palliative care delivery to manage these symptoms.

For the purposes of the current FOA, mind and body interventions include various meditation approaches (e.g., mindfulness), hypnosis or guided imagery, meditative movement approaches (e.g., yoga, tai chi, qi-gong), body-based approaches (e.g., spinal manipulation, massage, mobilization, acupuncture), or a combination of these approaches (e.g., meditation and yoga, such as in mindfulness-based stress reduction (MBSR)).

NCCIH is interested in studying the impact of complementary health approaches for symptom management of chronic pain, sleep disturbances, mild depression and anxiety in the setting of palliative care for geriatric populations, their family members, and caregivers.

NCCIH encourages applications that develop hypotheses and conduct analyses of existing datasets, health and medical records, claims data, or other sources; leverage ongoing cohorts, intervention studies, networks, data and specimen repositories, and other existing research resources and infrastructure.

Study designs may include observational approaches, quasi-experimental designs, and interventional NCCIH is interested in supporting the development and optimization of mind and body interventions for application in geriatric palliative care, recognizing that the definitive studies of these interventions may sometimes require large multi-site efficacy, effectiveness or pragmatic trials that are outside the scope of this solicitation.

Investigators are encouraged to contact the NCCIH scientific contact for this FOA for further In addition to the overall objectives, examples of specific research topics of interest to NCCIH include, but are not limited to: Assess feasibility and acceptability of using complementary health approaches to manage chronic pain, sleep disturbance or mild anxiety or depression in older patients, their family members, and caregivers in the palliative care setting and their potential impact on medication use.

Develop and test adaptive mind and body interventions for palliative care using sequential, multiple assignment, randomized trials (SMARTs) design to determine the treatment options at decision points, possible tailoring variables, or a sequence of decision rules. Optimize mind and body interventions by evaluating which elements of a complex intervention are impactful potentially using a multiphase optimization strategy (MOST) design.

Develop approaches to assess the fidelity of an intervention across sites or to determine the optimal "dose" which could include studying the frequency and duration for an intervention. Utilization of existing datasets or claims data to evaluate the use of complementary health approaches for the management of pain or sleep disturbances for palliative care in the geriatric population.

Utilization of existing datasets, health or medical records, claims data or other sources to evaluate whether the use of natural products may result in medication-natural product interactions for the geriatric population in the palliative care setting. Assess different ways of integrating complementary health approaches into palliative care delivery.

Applicants are encouraged to enroll subjects who represent accurately the broad range of age, gender, race, ethnicity, health, and functional level in the geriatric population. Applicants are strongly discouraged from excluding subjects with cognitive impairment, frailty, or other age-related complicating conditions without compelling scientific justification.

Consideration of social factors is particularly encouraged in clinical studies, as inattention to such issues as socioeconomic status, built environment barriers, and attitudes and behaviors may likely threaten external Applicants are encouraged to consider using patient-reported outcome measures such as PROMIS , NIH Toolbox, and Neuro-QoL .

Applicants may also find useful a searchable database of published instruments to detect cognitive impairment in older adults . Cost-effectiveness and other economics-related outcomes are appropriate provided that studies are consistent with NIH s priorities for health economics research.

Applicants interested in conducting ancillary investigations or secondary analyses of aging-relevant population studies can search the NIA Population Studies Archive of Computerized Data on Aging , or publicly available databases for aging-related secondary analyses in the behavioral and VIII. Other Information for award authorities and regulations.

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Clinical Trials Not Allowed for due dates on or after January 25, 2018: Only accepting applications that do not propose clinical trials Need help determining whether you are doing a clinical trial?

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. Application budgets are not limited but need to reflect the actual needs of the proposed project. The maximum project period is 5 years.

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 Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession 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 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 Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted.

Registration can take 6 weeks or more, so applicants should begin the registration process as soon as Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal 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 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). Section IV. Application and Submission Information Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA.

See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the Research (R) Instructions (R&R) Application Guide , including Supplemental Grant Application Instructions 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 For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant All page limitations described in the SF424 Application Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Do not use the Appendix to circumvent page limits.

Follow all instructions for the Appendix as described in the SF424 (R&R) PHS Inclusion Enrollment Report When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. PHS Human Subjects and Clinical Trials Information Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered "Yes" to the question "Are Human Subjects Involved?"

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form