Health Services and Economic Research on the Prevention and Treatment of Drug, Alcohol, and Tobacco Abuse (R03)

Health Services and Economic Research on the Prevention and Treatment of Drug, Alcohol, and Tobacco Abuse (R03) is sponsored by National Institute on Drug Abuse (NIDA) and National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH). This Funding Opportunity Announcement encourages Small Grant (R03) applications on health services and economic research to improve the quality of prevention, treatment, and recovery support services for drug, alcohol and tobacco abuse.

Expired PA-18-069: Health Services and Economic Research on the Prevention and Treatment of Drug, Alcohol, and Tobacco Abuse (R03 Clinical Trial Optional) 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 Drug Abuse ( NIDA ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) Funding Opportunity Title Health Services and Economic Research on the Prevention and Treatment of Drug, Alcohol, and Tobacco Abuse (R03 Clinical Trial Optional) 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 . March 22, 2016 - Notice of Change to the Specific Areas of Research Interest for PA-15-252. See Notice NOT-DA-16-016 .

(Applies to current announcement) Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PA-18-569 , R01 Research Grant PA-15-251 , R01 Research Project Grant PA-18-070 , R21 Exploratory/Developmental Grant PA-18-068 , R34 Planning Grant Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) encourages small grant applications (R03) to conduct rigorous health services and economic research to maximize the delivery of efficient, high-quality drug, tobacco, and alcohol prevention, treatment, and recovery support services.

Examples of such research include: (1) clinical quality improvement; (2) quality improvement in services organization and management; (3) implementation research; (4) economic and cost studies; and (5) development or improvement of research methodology, analytic approaches, and measurement instrumentation used in the study of drug, alcohol, and tobacco prevention, treatment, and Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Standard 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. 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) dates apply by 5:00 PM local time of applicant organization.

All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates. 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.

Required Application Instructions It is critical that applicants follow the instructions in (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 This Funding Opportunity Announcement (FOA) encourages R03 grant applications to conduct rigorous health services and economic research to maximize the delivery of efficient, high-quality drug, tobacco, and alcohol prevention, treatment, and recovery support services.

Health services research forms the link between research to develop behavioral and pharmacological interventions and the adoption and optimal utilization of these as evidence-based practice.

Health services research may focus on underlying processes and mechanisms that contribute to the efficacy, effectiveness, and sustainability of interventions, and in domains such as accessibility, utilization, effectiveness, appropriateness, and costs of services. The type and quality of those services and the outcomes they produce are affected by the way health services are organized, managed, delivered, and financed.

The R03 grant mechanism supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. The R03 is intended to support discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding.

Research is sought to learn how health services stakeholders (providers, public and private payers, school administrators, community agencies, child welfare systems, criminal and juvenile justice systems, workplace settings, governmental regulators, etc.) can improve standards of care for individuals with problematic drug, tobacco, and/or alcohol use, integrate interventions for them within health care settings, improve services to prevent initiation and progression from use to abuse and addiction, and improve the adoption, dissemination, implementation and use of evidence-based prevention, treatment, and business practices.

Research may focus on individual-level (patient/client and/or provider) behaviors as they affect access, engagement, adherence, and retention in health services, and/or program (e.g., content, dosage, training, format), organizational- and/or systems-level issues (e.g., financing, organizational structures and processes, management practices, health technologies) that affect the availability, accessibility, utilization, effectiveness, fidelity, cost, efficiency and quality of drug, tobacco, and alcohol health services.

This FOA encourages the development of rigorous hypothesis-driven and theory-based study designs and data analytic methods that will support a new generation of health services research. Research is sought that is generalizable to diverse settings, provider characteristics, and client and/or community problems, attributes, and behaviors.

Client-level factors include developmental appropriateness; gender sensitivity; cultural competency; equity in systemic process and outcomes; co-occurring mental, social, and medical conditions; and risk for infectious diseases.

This FOA also encourages research on systems-level factors, including, but not limited to, organizational, environmental, community, and provider attributes, processes, and practices that influence quality and outcomes..

In developing project aims, investigators are strongly encouraged to integrate factors related to addressing the spread and prevention or treatment of infectious disease among substance users, including the development of a continuum of services encompassing HIV and/or HCV screening, counseling, and risk-prevention or reduction interventions, and ensuring those with HIV or HCV receive appropriate health care and other needed services.

NIDA and NIAAA are interested in health services research that builds on the investments of other entities that address drug use and abuse, including but not limited to NIDA's Clinical Trials Network (CTN), NIDA's Criminal Justice Drug Abuse Treatment Studies (CJ-DATS), NIDA’s Seek, Test, Treat and Retain (STTR) initiative, NIDA’s Juvenile Justice Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS), the Substance Abuse and Mental Health Services Administration (SAMHSA), Federally Qualified Health Centers, Administration for Children and Families (ACF), Office of Juvenile Justice and Delinquency Prevention (OJJDP), Department of Education, state agencies, and private foundations.

In addition, NIDA and NIAAA are interested in health services research building on other NIH supported clinical research platforms, e.g. the NIH Clinical and Translation Science Awards Consortium (CTSAs) and the NIH Patient-Reported Outcomes Measurement Information System (PROMIS). A description of alcohol services research within the context of NIAAAs overall research program is provided at http://pubs. niaaa.

nih. gov/publications/StrategicPlan/NIAAASTRATEGICPLAN. htm .

NIDA and NIAAA encourage timely reporting of findings, facilitation of practitioner access to and use of findings, and interweaving research questions with the information needs of service providers through collaborative partnerships.

In this time of broad change in the U.S. healthcare delivery system, there is an urgent need for high quality health services research on drug, tobacco, and alcohol prevention, treatment, and recovery support services.

With the expansion of health insurance coverage to millions of Americans including a disproportionate percentage of persons at high risk for drug, tobacco, and use disorders research is needed to understand variation in realized access, utilization, quality, cost, and outcomes.

Related topics include comparative effectiveness research on evidence-based prevention and therapeutic interventions and business practices; models for integrating screening and treatment for drug, alcohol, and/or tobacco use into general medical settings; processes or mechanisms through which capacity to implement quality improvements in health services is increased; chronic care and recovery support systems for addiction; workforce issues associated with increased demand for services; and economic studies to identify efficient and economic models for organizing and financing services.

In addition, despite strong research evidence demonstrating the effectiveness of a variety of psychosocial, behavioral, and pharmacological interventions for health services, many have not been widely adopted or effectively implemented.

Although there is a growing implementation sciences literature, much remains unknown about the process by which science-based interventions enter practice, including the decision-making processes that prevention and treatment providers, agencies, or communities use to select interventions for adoption; on the organizational characteristics, leadership and management, and business practices that impact the effectiveness of interventions; on the need for fidelity versus adaptation; on the performance of interventions, services, or programs in usual, routine settings; or on how to improve service quality overall.

Research is needed in three related areas of implementation science; namely, 1) conceptual and/or theory-driven models of organizational- and systems-level change as they pertain to the implementation, sustainability, and scale-up of science-based programs and practices; 2) the development and testing (including head-to-head comparisons) of systematic, measurable and replicable implementation strategies for optimizing the adoption, uptake, and sustainability of evidence-based interventions and practices with fidelity across multiple real-world settings and contexts; and 3) descriptive and conceptual models and research addressing the de-adoption of organizational policies, practices, and programs that are not aligned with science-based practice.

Further, it is critical that effectiveness studies be designed with implementation, sustainability, and scale-up issues in mind.

Research is also needed to help health service providers understand how to incorporate evidence based interventions, recovery support, and business practices into substance abuse prevention and treatment systems, general health care settings, and related community and social service programs addressing the needs of drug, tobacco, and alcohol using populations.

This may include re-engineering existing systems of care; adapting new services and business practices to fit with existing clinical and organizational structures; developing infrastructure capacity (including workforce capacity) to implement and sustain improved delivery of health and/or recovery support service; testing different approaches (for example, in-person versus web-based) and venues (e.g., child welfare, school, veterans court) for service delivery; and re-evaluating practices and services over time to ensure their continued availability, fidelity, and value.

At the same time, there are widely disseminated practices, programs, and treatments, with insufficient scientific evidence to guide the delivery of the best possible services. For example, the value and optimal use of laboratory data, including biomarkers, in monitoring those in treatment is unclear.

Likewise, the optimal timing and dosage of many evidence-based medications, and how those vary by patient characteristics, is similarly unclear. The role of medication side effects and how those might be mitigated to improve adherence is understudied in the substance use disorder field.

These, and other questions of practical importance to front line clinicians, might be addressed through pragmatic clinical trials or other novel Specific Areas of Research Interest NIDA and NIAAA’s health services research programs are comprehensive in nature.

The following section addresses drug (marijuana, opioids, prescription drugs), alcohol, comorbidity, and tobacco prevention and treatment health services research topics of specific interest to NIDA and NIAAA. Research on other related topics is also encouraged for this funding announcement. Potential applicants are strongly encouraged to contact Scientific/Research staff prior to submitting an application.

Clinical Quality Improvement studies that may improve the appropriateness, effectiveness, safety, and efficiency of prevention, treatment, and recovery interventions, and services delivered to individuals in a variety of settings including substance abuse and mental health treatment programs; schools; general health care settings; criminal and juvenile justice systems; child welfare systems, and social service agencies.

Such research could include services for special populations (e.g., children, adolescents, women, veterans, racial and sexual minorities, geriatric populations, justice-involved populations, those with or at risk of contracting HIV/HCV); adaptive service delivery strategies to adjust the level, dosage, and type of interventions and services over time in response to changing needs; continuity of care; development of performance measures and standards of care to improve assessment of patient needs, treatment progress, and outcomes; use of information technology to increase effectiveness, efficiency, and potency of prevention intervention and health service delivery; training and supervision of behavioral healthcare professionals; integration of prevention interventions into primary care; juvenile justice and child welfare; integration of alcohol, tobacco, or drug treatment in primary care and in treatment for co-morbid mental disorders; the efficacy of widely used but untested prevention and treatment approaches; revising payment mechanisms to incentivize high quality care, reimbursing for care coordinated across social services and medical systems, or paying for management of addiction as a chronic condition; and strategies to enhance the availability of prevention and treatment services in criminal justice settings.

Quality Improvement in Services Organization and Management studies that address organizational contexts and service delivery models; the interaction of providers and programs within and across systems, and at multiple levels (e.g., program, practice network, state); and their collective impact on quality of service delivery.

Research topics may include testing models for collaboration, co-location, or integration of drug, alcohol, and tobacco prevention, treatment, and recovery support services with medical settings; management and human resources issues including workforce recruitment, training and retention; the use of best practices, performance measures, and standards of care to improve assessment of client needs, treatment progress, and outcomes; effects of state, payer, and institutional policies on treatment accessibility, cost, duration, and quality; and use of health information technology to facilitate cross-systems collaboration and Implementation Research studies that seek to explain and ultimately improve the uptake of evidence-based prevention and treatment practices, including HIV prevention and treatment in real-world service delivery settings.

Such studies might include the measurement or enhancement of organizational capacity for innovation and adoption; tests of organizational change strategies to implement evidence-based practices; comparative tests of alternative approaches to dissemination and implementation; development of measures and methods for assessing adoption, implementation, fit, fidelity, and sustainability of evidence-based practices; and identification of systems-level factors that facilitate or impede the diffusion and adoption of evidence-based practices.

Other areas that implementation research can offer insight include the processes through which science-based interventions enter broad practice, such as the decision-making processes that clinicians, service providers, agencies or communities use to select interventions for adoption; the processes through which interventions may be adapted to meet the unique needs of specific settings, and populations receiving interventions; utilizing technology to facilitate uptake and sustainability, and using technology to improve the operational practice and characteristics that impact the effectiveness and reach of interventions.

Research on the de-adoption of programs, policies, and practices that have been shown to be ineffective is also of interest. Proposed studies in this area should test or apply conceptual models that allow results to contribute to the broader field of Economics Research Rigorous studies that rely on the theories and methods of economics ultimately directed at providing findings to inform practice or policy.

For example, studies of the causal effects of health care benefit design, and payment mechanism and regulations on access, utilization, quality, and outcomes of services, are needed to inform future advances in those areas. Behavioral economic research investigating individuals decisions to enter and remain in treatment are needed to inform the design of services and the development of optimal coverage policies.

Cost and production function studies across settings that can determine how to provide high-quality services most efficiently, what such services cost, and how costs vary by various patient, provider, and environmental characteristics, are needed to inform the establishment of appropriate reimbursement rates.

Economic evaluations, including cost-effectiveness, cost-benefit, cost-utility, and budget impact analyses, are needed to inform the adoption of evidence-based interventions.

Research on these and other topics relevant to the optimization of service delivery, is sought and may employ a broad array of applied, theoretical, and econometric methods including, but not limited to, experimental and quasi-experimental designs, analyses of natural experiments, secondary analyses of existing data sources, dynamic simulation models, or descriptive studies that facilitate the development of economic theory, empirically-testable hypotheses, or future experimental research.

Multidisciplinary economics research integrating concepts, tools, and methods from multiple relevant disciplines, is also encouraged.

Implications of Policy Change for Service Quality research examining the impact (including unintended consequences) of local, state, and/or national policies that affect the organization or management of prevention and treatment services on quality of care and patient access, utilization, retention, and outcomes.

Alcohol and drug prevention and treatment services are often directly or indirectly impacted by laws, regulations and policies introduced with the intent of improving access, enhancing quality, and/or reducing costs Examples include legislative mandates for the use of evidence-based practices; patient prescribing limits for buprenorphine, and scope of practice policies Investigators are encouraged to leverage significant, naturally-occurring opportunities by developing timely, hypothesis-driven study designs that will measure the downstream effect of such policy changes on the quality, cost, availability, and utilization of alcohol and drug abuse prevention and treatment services.

Methods, Technology, and Other Tools Several areas of methodological work are of high interest, including but not limited to (1) leveraging technology to transform substance abuse prevention and treatment services delivery by increasing the effectiveness, efficiency, availability, and potency of existing prevention intervention and health services delivery; and (2) developing, refining, and validating new methods and approaches to advance existing technologies and to acquire and analyze complex data, including statistical methods, data visualization, technology platforms for collecting data, methods for rapid analysis and feedback, predictive analytics; innovative study designs and other emergent methods and technologies.

Research studies may also include the development of study designs that strengthen causal inference and external validity; individual-, program-, and systems-level measurement tools and analytic approaches; simulation modeling of prevention and treatment service delivery alternatives, such as dynamic simulation models and agent-based models or other models based in complexity theory; quality-of-care indicators and performance measures; and new measurement instruments and statistical approaches appropriate for use in complex multisite systems trials (e.g., multilayer hierarchical linear modeling and methods to transform data and measures from diverse sources to enable group HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing.

NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information see http://www.

nida. nih. gov/about/organization/nacda/CouncilStatement.

html . National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects.

Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at http://www. nida.

nih. gov/about/organization/nacda/CouncilStatement. html .

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community.

Please see ( http://ww2. drugabuse. gov/about/organization/nacda/points-to-consider.

html ) Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit ( www.

phenxtoolkit. org .) Please see NOT-DA-12-008 for further details.

Section II. Award Information 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 Optional: Accepting applications that either propose or do not propose clinical trial(s) 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. Budgets for direct costs of up to $50,000 per year may be The maximum project period is 2 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 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 . 2. Content and Form of Application Submission It is critical that applicants follow the instructions in (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) Application No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the PHS Human Subjects and Clinical Trials Information 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 or a delayed onset study record. Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed. Foreign (non-U.S.) institutions must follow policies 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 due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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.

NIH and Grants. gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.

gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. are responsible for viewing their application before the due date 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. 4. Intergovernmental Review This initiative is not subject to intergovernmental 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 . Requirements and Information 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 Electronically . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must for Applicants Experiencing System Issues .

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