HEAL Initiative: Research Studies to Develop and Implement Interventions to Prevent Opioid Misuse in Community Health Centers (RFA-DA-23-048)

HEAL Initiative: Research Studies to Develop and Implement Interventions to Prevent Opioid Misuse in Community Health Centers (RFA-DA-23-048) is sponsored by National Institute on Drug Abuse (NIDA) / NIH HEAL Initiative. This funding opportunity supports interdisciplinary teams to study the development, adaptation, and/or implementation of interventions to prevent misuse of opioids and other substances in community health centers.

Expired RFA-DA-23-048: HEAL Initiative: Research Studies to Develop and Implement Interventions to Prevent Opioid Misuse in Community Health Centers (R61/R33 Clinical Trial Required) 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 ) Components of Participating Organizations National Institute on Drug Abuse ( NIDA ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Nursing Research ( NINR ) National Institute on Minority Health and Health Disparities ( NIMHD ) National Center for Complementary and Integrative Health ( NCCIH ) National Cancer Institute ( NCI ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention ( ODP ) Funding Opportunity Title HEAL Initiative: Research Studies to Develop and Implement Interventions to Prevent Opioid Misuse in Community Health Centers (R61/R33 Clinical Trial Required) R61 / R33 Exploratory/Developmental Phased Award NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) 93.

279, 93. 361, 93. 393, 93.

273, 93. 307, 93. 213 Funding Opportunity Purpose This funding opportunity announcement (FOA) is part of the Helping to End Addiction Long-term (HEAL) Prevention Initiative, a portfolio of research focused on the prevention of opioid misuse and opioid use disorder funded under NIH’s HEAL Initiative.

The National Institute on Drug Abuse (NIDA) seeks to address the urgency and magnitude of the opioid crisis by developing and testing new or adapted interventions to prevent opioid misuse among patients served by community health centers (CHCs), and/or developing and testing implementation strategies for screening and referral to preventive interventions for misuse of opioids and other substances among patients served by CHCs.

Research will be supported through exploratory/developmental phase awards (R61/R33) that may not exceed 5 years, allocating up to two years of funding for development of the project and up to four years for a full test of the research aims. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization.

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 the Research (R) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from 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 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 Part 2. Full Text of Announcement Section I.

Funding Opportunity Description The National Institute on Drug Abuse (NIDA) seeks to establish the evidence base for interventions that can effectively prevent opioid and other substance misuse in community health centers (CHCs), a setting which serves populations at increased risk for substance misuse.

While there are effective interventions to prevent substance misuse, generally, there is a gap in interventions designed for use in CHCs, and knowledge as to the factors that support implementation of those interventions is lacking.

This FOA seeks to address the urgency and magnitude of the opioid crisis in populations that experience health disparities by developing and testing new or adapted interventions to prevent opioid misuse among patients served by community health centers (CHCs), and/or by developing and testing implementation strategies for screening and referral to preventive interventions for misuse of opioids and other substances among patients served by CHCs.

This announcement is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://heal.

nih. gov/ . CHCs are well positioned to serve as a formal point of entry into evidence-based opioid misuse prevention services because they reach a large population impacted by the opioid crisis and are located across the nation in areas with limited health care resources.

CHC patients are more likely to experience social and health conditions (e.g., mental disorder diagnosis) that are risk factors for substance misuse and negatively impact their overall health, suggesting prevention may be beneficial for this population.

In recent years, CHCs have increased their capacity to provide mental health and substance use treatment services, with 93% of health centers providing mental health treatment and 67% providing substance use treatment services. Despite this capacity, screening for substance use risk (rather than treatment need) and referral to prevention services is uncommon.

This initiative seeks research that will ultimately enhance the capacity of CHCs to screen patients for opioid and substance use risk and refer them to or provide opioid and other substance use prevention services.

The two areas of research interest are studies to: (1) develop and test new or adapted interventions to prevent opioid misuse among patients served by community health centers (CHCs), and/or (2) develop and test implementation strategies for screening and referral to preventive interventions for misuse of opioids and other substances among patients served by CHCs.

Research projects should be developed in consultation and partnership with CHCs. Strong partnerships are critical for ensuring that proposed research activities are responsive to the needs of the community and maximize the likelihood that interventions developed and tested can be sustained.

Applicants are strongly encouraged to address issues of patient/stakeholder engagement; scalability beyond the study sites/settings; sustainability beyond the funding period; and whether the proposed implementation strategy/process reduces inequities in service availability, access, utilization, cost, quality, or outcomes.

Applications should focus on primary prevention, developing and testing strategies that CHCs can take to scale in order to prevent the initiation of opioid/substance use or misuse and/or the progression to opioid or other substance use disorder.

Applications may include universal prevention interventions that are intended to be delivered to the entire CHC patient population (or all CHC patients in a particular age range) or selective or indicated prevention interventions that focus on a particular sample with demonstrated risk factors for substance use.

Investigators should provide a rationale for their level of intervention and a description of how they are defining their target population within the CHC setting. Examples of priority areas for the two categories of research supported are identified below.

Intervention research applications should be theory based, developing and testing prevention intervention strategies that can be easily integrated into the CHC setting, addressing the unique needs of the community served. Intervention studies may test new interventions or include efficacy and/or effectiveness studies of established interventions that are adapted for CHCs.

Intervention studies should test critical components of the prevention strategies for CHC patients to understand the intervention components that impact outcomes. Additionally, the measurement of implementation outcomes and inclusion of economic analyses is encouraged where feasible.

Topics of interest include but are not limited to: Studies to test models of integrating into CHCs existing, effective or promising, substance use prevention strategies that use established techniques (e.g., motivational interviewing, skill building). The integration should involve the inclusion of natural providers for the delivery of the intervention.

Research on interventions designed to prevent substance misuse by directly addressing known risk factors for substance misuse, such as: Interpersonal violence, community violence, and/or maltreatment Mental disorders (e.g., depression, anxiety, post-traumatic stress disorder, serious mental illness, suicide ideation and behaviors) Attention deficit and hyperactivity disorder (ADHD) Social determinants of health that impact substance use, including experiencing racism, homelessness, and/or economic and food insecurity Studies of evidence-based substance use prevention interventions that are adapted to incorporate technology, such as mobile health and telehealth delivery or models of consultation, or program delivery.

Testing of strategies to overcome stigma related to substance use and its consequences, such as discrimination based on risk factors for substance misuse and substance using behavior.

This might include incorporation of content and activities to reduce self-stigma on the part of participant populations, stigma in delivery of basic services for people experiencing risk for substance use (e.g., discriminatory channels for service; interactions withadministrative/non-service provider staff).

Implementation research applications should inform strategies to increase uptake, effectiveness, and sustainability of screening and referral to prevention among patients served by CHCs.

Implementation research topics of interest include, but are not limited to: Research to test implementation factors that support evidence-based prevention interventions in CHCs that have been tested in other settings, including: Research to address system fragmentation that impacts referral to prevention services (e.g., gaps for persons transitioning from pediatric or adolescent medicine practices to adult medicine practices; access for persons in specialty settings or social services systems who need linkage to health/behavioral health and prevention services) Studies of organizational and provider factors that contribute to implementation and sustainability of prevention interventions Testing of screening and referral strategies to improve enrollment and completion of prevention services delivered by the CHC Testing of implementation strategies to support CHC-based screening and referral to preventive services provided by other entities (e.g., local health department, community behavioral health center) Research of instruments or strategies to identify individuals at risk for substance use, including research to test risk-profiles from electronic health records to facilitate case identification, active referral and linkage to prevention interventions, and or consultation models innovative tools for identifying individuals at risk for substance misuse and engaging them in prevention services, including in prenatal care, dental care, specialist pain management, and other specialties Application of human factors research to test strategies to improve screening effectiveness, reduce provider burden, and improve implementation feasibility and sustainability of prediction algorithms, electronic health record tools, clinical decision support tools, or other technology Research to understand whether, to what extent, and under what conditions policies and/or novel funding strategies (e.g., Medicaid waivers, reimbursement for telehealth or consultation) improve uptake and sustainability of screening and referral to prevention interventions.

While not required, projects that capitalize on funding streams and technical assistance resources available to CHCs that promote sustainability are highly encouraged. National Institute of Nursing Research The National Institute of Nursing Research (NINR) supports research to solve pressing health challenges and inform practice and policy - optimizing health and advancing health equity into the future.

NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care.

Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses work, including homes, schools, workplaces, clinics, justice settings, and the community.

For this FOA, NINR is particularly interested in: Studies that address and mitigate the effects of social determinants of health on intervention uptake and effectiveness Studies that address and mitigate the effects of health system structural factors to achieve equity in intervention uptake and effectiveness Studies in community health centers that use a holistic and contextualized approach to address issues of substance misuse and co-occurring pain Studies of systems-level interventions or new models of care in community health centers to prevent opioid misuse while addressing pain management needs National Cancer Institute The National Cancer Institute (NCI) leads, conducts, and supports cancer research across the nation to advance scientific knowledge and help all people live longer, healthier lives.

The NCI is interested in supporting intervention research for individuals being screened for cancer as well as cancer survivors in the following areas that include, but are not limited to: Increase collaboration and coordination between oncologist and primary care providers (PCPs) and other pain specialists, in treating and/or monitoring treatment-induced long-term pain to facilitate safe prescribing practices and prevent opioid misuse and OUD Strategies that utilize patient navigators or community health workers to improve pain management or prevent OUD in cancer survivors Improving the quality of pain assessment and management among cancer survivors or patients with precancerous conditions (e.g., cirrhosis, chronic pancreatitis) to reduce the use of opioids Utilizing evidence-based approaches that recommend non-opioid management to treat pain Investigating how community health centers can extend their outreach by using remote interventions (i.e., telemedicine, use of electronic ambulatory devices) to assess, report, and manage pain due to cancer, cancer treatment, or pain from precancerous conditions Testing pain reporting mechanisms that are culturally and linguistically tailored for individuals with limited English proficiency or with limited health literacy Investigating novel approaches to assessing pain among different racial/ethnic groups Design, Analysis, and Sample Size for Intervention Studies that Assign and/or Deliver Interventions in Groups or Clusters Projects are encouraged to consider special research designs and methods for analysis and sample size that may be required in the following conditions: Participants are assigned to study arms in groups or clusters (e.g., families, clinics, communities, counties, states) and observations taken on individual participants are analyzed for intervention effects.

Appropriate intervention study designs include but are not limited to a parallel group- or cluster-randomized trial, a stepped-wedge group- or cluster randomized trial, a rigorous quasi-experimental design such as a group- or cluster-level regression discontinuity design or an interrupted time-series design, or a rigorous alternative.

Participants are assigned individually to study arms but receive at least some of their intervention in a group (in-person or virtual) or through a shared facilitator or provider. Appropriate study designs include an individually randomized group-treatment trial, a rigorous quasi-experimental design such as an individual-level regression discontinuity design, or a rigorous alternative.

Methods consistent with plans for assignment of participants and delivery of interventions should be documented in the application. Additional information and examples are available at ? https://researchmethodsresources.

nih. gov/ . R61/R33 Phases and HEAL Requirements Phases of the Award and Milestones Support for this research will be provided in two phases using the R61/R33 Exploratory/Developmental Phased Award mechanism for up to 5 years.

This includes initial support of up to 2 years for the R61 phase, followed by up to 4 years of support for the R33 phase. Transition to the R33 phase is contingent upon successfully meeting R61 milestones. The first phase (R61) is a planning phase that is expected to include scientific and operational development and planning activities.

Examples of activities that could be included are: partnership development and operationalization of stakeholder collaboration to support the project; development and feasibility testing of study elements including measurements, CHC clinical procedures, electronic health record, and other data availability; intervention adaptation; recruitment planning; and meeting study and administrative requirements (e.g., IRB approval, data use agreements, HEAL collaborative participation).

This phase will identify and meet pre-specified milestones ensuring that the results of this phase inform and provide a foundation for the second phase of the research. (See Section IV for more information on required milestones for the R61 award.) The R33 phase will be a clinical trial to test an intervention and/or implementation of prevention intervention in a CHC setting.

For transition to the R33 phase, recipients will be required to submit the transition package no less than two months before the completion of the R61 phase. The transition plan should include the R61 progress report describing in detail the progress towards the R61 milestones and a description of how research proposed for the R33 phase will be supported by the completion of the R61 phase milestones.

These materials will be evaluated by NIH program staff to determine if the milestones were met. R33 funding decisions will be based on the original R61/R33 peer review recommendations, successful completion of transition milestones, any proposed changes to the R33 research based on R61 findings, program priorities, and availability of funds.

Funding of the R61 phase and completion of milestones does not guarantee funding of the R33 phase of the project. Community Health Center: Community Health Centers (CHCs) are safety net clinics that provide primary and preventive health care and health education to populations with limited access to health care. CHCs address social determinants of health and provide enabling services to reduce mortality and health disparities.

CHCs include health centers designated by Health Resources and Services Administration’s (HRSA) Health Center Program, including Federally Qualified Health Centers (FQHCs), which serve special populations, including individuals and families experiencing homelessness, migratory and seasonal agricultural workers, and residents of public housing, FQHC look-alikes, and school-based health centers.

CHCs also includes other primary care-based clinics that serve communities with limited access to care, including IHS Community Health Representatives, rural health care centers, HIV primary care clinics, and nurse-managed health clinics. Funding decisions will prioritize diversity in projects based on geographic distribution, types of CHCs, and patient populations served.

Applicants are encouraged to partner with CHCs in communities that serve populations that are not often represented in research. Applications will be considered non-responsive if they do not include: Aims for both the R61 and R33 phases of the project. Milestones for transition from the R61 to R33 phase of the project.

Documentation of partnership with a CHC, as defined by this FOA, that will serve as a research partner and site for the study. Outcomes related to prevention of substance use. Applications that only include pain-related outcomes will not be considered.

Studies that propose interventions that focus solely on changing provider prescribing behavior will be considered non-responsive. In addition to scientific diversity, applicants should strive to incorporate diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams.

Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems.

There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences.

Please refer to Notice of NIH's Interest in Diversity NOT-OD-20-031 for more details. The NIH HEAL Initiative will require a high level of coordination and sharing between investigators.

It is expected that NIH HEAL Initiative recipients will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities such as inclusion of common data elements and outcome measures across studies.

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 ) for details. Establishment of a Standard delta-9-THC Unit to be used in Research Applications proposing research on cannabis or its main psychotropic constituent delta-9-THC are required to measure and report results using a standard delta-9-THC unit in all applicable human subjects research. The goal is to increase the comparability across cannabis research studies.

A standard delta-9-THC unit is defined as any formulation of cannabis plant material or extract that contains 5 milligrams of delta-9-THC. A justification should be provided for human research that does not propose to use the standard unit. Please see https://grants.

nih. gov/grants/guide/notice-files/NOT-DA-21-049. html NOT-DA-21-049 for additional details.

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. drugabuse.

gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects .

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 ( http://grants.

nih. gov/grants/guide/notice-files/NOT-DA-12-008. html ) for further details.

See Section VIII. Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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 The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Only those application types listed here are allowed for this FOA. Required: Only accepting applications that propose clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The HEAL Initiative intends to commit $5. 25 million in FY 2023 to fund 5-7 awards. The following will be considered in making funding decisions: Scientific and technical merit of the proposed project as determined by scientific peer review.

Relevance of the proposed project to program priorities. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets must reflect the actual needs of the proposed project.

The R61 phase is limited to a budget of no more than $350,000 in direct costs per year. Unless well-justified, it is strongly recommended that applicants not request a budget of more than $750,000 in direct costs per year for the R33 phase. The maximum project period is 5 years.

This includes up to 2 years for the R61 phase and up to 4 years for the R33 phase, with the total project period for both phases not to exceed 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA. Section III.

Eligibility Information 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 (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 Recognized) 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) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. 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 possible. The NIH 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 late submission.

System for Award Management (SAM) 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.

NATO 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. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants. gov registrations; all registrations must be in place by time of submission.

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 submit an application. Grants. gov Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program 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 Investigator) 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 .

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 . 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, per 2. 3.

7. 4 Submission of Resubmission Application . This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

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 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ). Section IV.

Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution.

Links to apply using ASSIST or Grants. gov Workspace 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 instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. Although a letter of intent is not required, is not binding, and does not enter into the review of a susequent 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, prospecitve applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity 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: [email protected] All page limitations described in the SF424 Application Guide and the Table of 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 application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R)