Substance Use/Substance Use Disorder Dissertation Research Award (R36 Clinical Trials Not Allowed)

Substance Use/Substance Use Disorder Dissertation Research Award (R36 Clinical Trials Not Allowed) is sponsored by National Institutes of Health (NIH). Supports dissertation research on substance use and substance use disorders.

PAR-25-347: Substance Use/Substance Use Disorder Dissertation Research Award (R36 Clinical Trials Not Allowed) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. 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 ) Funding Opportunity Title Substance Use/Substance Use Disorder Dissertation Research Award (R36 Clinical Trials Not Allowed) Notices of Special Interest associated with this funding opportunity January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs.

See Notice NOT-OD-26-029 March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose This NOFO is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial.

Applicants to this NOFO are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Funding Opportunity Goal(s) To support basic, clinical, translational, and implementation research in the field of substance use. To develop new knowledge and approaches for the prevention, diagnosis, and treatment of drug use, misuse, and addiction, drug overdose, and related health outcomes, including HIV/AIDS.

Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/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 How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) 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.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of 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. Notice of Funding Opportunity Description NIDA supports projects that enable doctoral degree candidates to receive training in clinical research, including clinical trials.

However, trainees cannot be supported under the R36 mechanism to conduct independent clinical trials (see https://grants. nih. gov/policy/clinical-trials/definition.

htm for a definition). If the R36 project involves a proposed or ongoing clinical trial, the trial must be led by a mentor or a more experienced investigator, who is responsible for completing all required approvals. The doctoral candidate can be a part of the research team and can use the data generated during the clinical trial in the proposed project.

However, the research experience of the doctoral candidate must be supervised by a more experienced Principal Investigator (PI). The descriptions below are examples of research areas supported by this program and are provided to help potential applicants determine whether a particular scientific topic is appropriate for this initiative. These descriptions are not intended to be comprehensive.

In addition, given the complexity of SU/D research, it is permitted to conduct the proposed dissertation research in conjunction with an ongoing research study or to use extant data. Research studies focused on high-priority NIDA HIV/AIDS topics ( https://nida. nih.

gov/about-nida/organization/offices/hiv-research-program-hrp/about-hiv-research-program ) and minority health and NIH-designated populations that experience health disparities are also encouraged. Applicants are strongly encouraged to discuss their proposed research plan with a program official. Studies in cognitive neuroscience to understand the neural basis of interrelationships between addictive and cognitive processes.

Studies of innovative methods for the design of probes and new chemical entities that include the application of computer-aided discovery and drug design methods. Studies of pharmacokinetics and pharmacodynamics of substances to characterize drug absorption, disposition, elimination, and kinetics.

Studies of the genetic and epigenetic basis of vulnerability and adaptation and the identification of molecular mechanisms underlying substance preference and related behaviors Both methodological and applied studies using data analytic strategies applied to data with exceptionally complex volume, velocity and variety (i.e. “big data” approaches).

Studies of basic HIV and SU using big data approaches to understand interactions of substance misuse with non-neuronal cells and tissues impacted by HIV infection. Studies in the clinical neurobiology of HIV/AIDS to investigate how SU affects the onset, progression, and severity of HIV/AIDS-related alterations of the central nervous system. Etiology and Epidemiology Studies of multiple factors that influence drug use outcomes.

That is, studies that examine genetic, neurological, biomedical, familial, behavioral, environmental, social, cultural, developmental, psychopathological, and psychological factors, their interactions, and mediating characteristics.

Studies of the underlying physiological and psychosocial mechanisms associated with the transition from lower to higher levels of drug involvement and from higher levels of drug involvement to SUDs, including addiction.

Development and improvement of techniques for studying substance misuse, including enhancements in measurement, development of improved sampling procedures, and refinement of analytic methods for various populations across human development.

Development of innovative approaches to identify both physical (ecological) and social environmental/contextual characteristics of local communities that influence SU, emerging SU patterns, and adverse drug-related outcomes. Delineation of the underlying dynamic causal mechanisms associated with SU patterns and adverse drug-related outcomes by integrating individual, family, peer, and community level factors.

Mechanistic studies and research that address critical time points in development which may influence risk or resilience. Research to assess the impact of mental health interventions in childhood on subsequent SU. Studies to assess the nature, scope, and consequences of substance-related trauma, violence, and crime, including violent and nonviolent crime.

Research to assess the impact of SU on adverse behavioral, social, and health consequences (e.g., trauma, violence, educational attainment, HIV) as well as the role of adverse consequences on further drug involvement. Studies that apply insights from genetics, neurobiology, neurocognition, and physiology to inform prevention interventions and test the effects of prevention interventions.

Studies on the efficacy or effectiveness of SU prevention programs to address emerging drug trends (e.g. e-cigarette use, synthetic drug use, resurgent drug epidemics). Studies on interventions and approaches to prevent opioid misuse and opioid use disorder in older adolescents and in adults.

Studies to develop and test the efficacy or effectiveness of interventions in contexts opportune for providing/delivering preventions and services, including health care, criminal/juvenile justice, workplace, and child welfare, among other systems and settings.

Methodological research to improve the analysis of complex prevention trial data—for example, statistical modeling for multi-level data, analysis of longitudinal data, and research examining complex interactions between qualitative and quantitative outcome data.

Studies on the adoption, implementation, and sustainability of evidence-based SU prevention interventions, including analysis of data to determine factors that account for quality of implementation and outcomes, or program sustainability. Pilot SU prevention or drug-related HIV prevention studies designed to identify novel approaches to risk reduction, such as through new technologies or new modalities.

Research aimed at developing improved SU and HIV prevention strategies for high-risk populations, understudied populations, and populations who experience greater rates of SU and/or serious adverse consequences of SU. Utilizing relevant research from the animal model literature (e.g., avoidance and impulsivity paradigms) to develop or improve treatments/interventions.

Utilizing relevant research from the developmental (e.g., basic research on familial and peer influences during adolescence) or social psychology (e.g., basic research on stereotyping) literature to improve treatments Stage I studies developing or adapting behavioral interventions that promote adherence to pharmacotherapy to treat substance misuse.

Developing and assessing treatment provider training procedures for evidence-based treatments (e.g., computerizing training procedures; this can include initial training as well as supervision requirements). Developing interventions to promote adherence to medical treatment regimens. Computerizing, or partially computerizing evidence-based treatments for SUDs, as well as for HIV prevention interventions for individuals in SU treatment.

Developing interventions to reduce pain in individuals dependent on prescription drugs or individuals with co-occuring SU and chronic pain.

Research involving secondary analyses of existing behavioral treatment research data sets to identify predictors, moderators, or mediators of treatment outcome, mechanisms of action of treatment, or secondary effects of treatment on participants in various contexts (e.g., peer group, school, work, family) or on participants' family members (e.g., children).

Conducting secondary analysis of combined behavioral and pharmacological treatment clinical trials. Research on instrument development and/or psychometric analysis of tools for the clinical assessment of SU, treatment efficacy, treatment fidelity, and HIV risk, or for constructs believed to be related to mechanisms of action of behavioral treatment efficacy.

Research to develop and test a therapy module to be added to an existing therapy to address targeted issues (e.g., adding an HIV risk reduction module to a family therapy for substance using adolescents). Research to integrate innovative health technologies into new or existing behavioral and integrative treatments.

Research testing a principle of behavior change among substance users in treatment (e.g., by adding more frequent or multi-method assessments to an existing study in order to track behavior change over time). Development of improved medication compliance markers. Development of medications to treat SUDs, including medications for smoking cessation.

Studies of developmental cognitive processes of rewards, losses, social cues in decision-making, and value incentives relevant to treatment and integration of relevant developmental cognitive processes into the development of treatments. Studies to inform our understanding of how peer influence contributes to decision-making processes in group treatment settings.

Studies that use neuroimaging and other techniques to characterize specific neurobiological circuitry during adolescence to inform treatment development (e.g., to determine incentive-motivational circuitry that can be involved in emotional regulation, drug seeking, addiction, reward, relapse, and maintenance of behavioral change). Development of devices to treat SUDs.

Development of the Digital Therapeutics Program, which takes advantage of the growing opportunities in remotely delivering effective interventions for SUDs. Development of novel clinical outcome assessment, which measures and instruments that can be used to evaluate the safety and efficacy endpoints in clinical trials of treatments for SUDs.

Clinical quality improvement studies to examine factors that may improve the appropriateness, effectiveness, safety, and efficiency of treatment and recovery interventions, as well as services delivered to individuals, individuals experiencing substance misuse and chronic pain in a variety of settings including SU and mental health treatment programs, schools, general health care settings, criminal and juvenile justice systems, child welfare systems and social service agencies.

Quality improvement studies 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 the quality of service delivery.

Implementation science studies that seek to identify effective strategies for enhancing the adoption, adaptation, and sustainment of evidence-based treatment practices. Studies that examine causal models of implementation success or failure are especially encouraged. Studies examining the effects of practice and policy changes on service quality and outcomes, including unintended consequences.

Economic studies falling within NIH’s priorities for health economics research as described in NOT-OD-16-025. Studies developing or applying new methods, technologies or other innovative tools to improve the rigor and reach of health services research. Studies to identify and address barriers and facilitators to implementing evidence-based prevention interventions in settings and systems.

Studies on strategies for implementation of evidence-based prevention interventions and approaches into health care and other service systems and settings (e.g., juvenile justice, child welfare, Federally Qualified Health Centers, community-based organizations). Through this dissertation award program, NIDA seeks to foster research on females (both humans and in animal models) and sex differences in all areas of SU research.

From basic cellular and genetics research to epidemiology, prevention, treatment, and services research, investigators are encouraged to explore the possible importance of sex differences in their chosen area of study and to explore SU issues specific to females.

Examples of research areas appropriate for this announcement include: Sex differences in the basic behavioral, physiological, neurobiological, and genetic mechanisms underlying SU; and laboratory (both human and animal), clinical, and epidemiological studies of sex differences in the determinants of initiation, progression, maintenance of SU, and responsiveness to treatment.

Laboratory (both human and animal), field, and clinical research aimed at: (1) identifying sex differences in the consequences of SU, misuse, and addiction following acute use, chronic use, as well as residual effects following prolonged abstinence, and (2) examining substance-related consequences that are unique to females.

Clinical studies aimed at characterizing sex differences in the effects of substance exposure on the developing brain, or studies aimed at detecting sex differences in acute and chronic SU effects (and abstinence effects) on the brains of children, adolescents and adults.

The application of sex-specific theories and empirical research on the origins, pathways, and risk and protective factors related to SU, progression/transition, and maintenance, to the design, development, and testing of sex-sensitive prevention and treatment strategies and interventions to determine effectiveness and efficacy.

The development and testing of theoretically-based drug treatment approaches (including behavioral treatment and pharmacotherapies) that address sex-specific topics related to the effective and efficient delivery of SU treatment services. SU and HIV/AIDS research from a sex-based perspective that addresses the high priority topics of research listed here: https://nida. nih.

gov/about-nida/organization/offices/hiv-research-program-hrp/about-hiv-research-program . Applications Not Responsive to this NOFO The following types of studies are not responsive to this NOFO and will not be reviewed: Applications that involve a clinical trial but do not have a mentor or experienced investigator leading the trial. Applications that use alcohol alone as a misused substance See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A financial assistance 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 How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Not Allowed: 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. Grants to support dissertation research will provide no more than $50,000 in direct costs per year.

The salary proposed must be appropriately related to the existing salary structure at the recipient institution. Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

Applications may request a minimum of one and a maximum of two years of support. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 Organizations) 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 How to Apply-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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications .

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 Grants. gov registration; 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 their organization to develop an application for 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 How to Apply- Application Guide.

By the time of award, the dissertation candidate must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Furthermore, at the time of award the applicant must have completed all institutional requirements to enter the dissertation stage of their research program. Trainees who have received F31 funding are ineligible for the R36 Dissertation Award. Concurrent F31 and R36 applications are not allowed.

Multiple PD/PI applications are not allowed. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity 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. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply-Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply-Application Guide must be followed.

Instruction in the Responsible Conduct of Research (required): All applications must include a plan to fulfill NIH requirements for Instruction in the Responsible Conduct of Research (RCR). The attachment is limited to one page.

The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the instruction; 4) Duration of Instruction - the number of contact hours of instruction; and 5) Frequency of Instruction – instruction must occur during each career stage and at least once every four years.

Document any prior instruction during the applicant’s current career stage, including the inclusive dates instruction was last completed. See also NOT-OD-10-019 . Scientific Support Plan (required): All applications must include a plan for scientific support of the PD/PI.

The attachment is limited to two pages. Outline activities that will ensure that the PD/PI has a thorough understanding of the scientific principles and methods required for the proposed study. Describe plans for professional skills development to assist the PD/PI to transition to the next stage of their research career.

Highlight the time to be allocated by the advisor to guide and support the PD/PI so that they will complete the dissertation in a timely manner. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed.

Biographical Sketches must be provided for the PD/PI and the dissertation project advisor, and include the following: Highlight details that demonstrate the promise of the PD/PI as a research investigator in research areas relevant to the application. Document the mentoring experience of the advisor. All instructions in the How to Apply- Application Guide must be followed.

All instructions in the How to Apply-Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Explain how completion of the project will help the PD/PI to advance their research career goals.

Explain how the level of innovation for the project is appropriate for the PD/PI’s career stage. If the candidate is proposing to gain experience in a clinical trial as part of their research training, describe the relationship of the proposed research project to the clinical trial. Letters of Support: All letters must be combined into a single PDF file.

Letter of Certification (required) : The faculty advisor, dissertation committee chair, or university official directly responsible for supervising the dissertation research must submit a letter certifying that the PD/PI meets the eligibility criteria for this award.

Advisor and Reference Letters (required) : The faculty advisor and at least one other member of the dissertation committee must submit letters, each no longer than 2 pages, that assess (a) the doctoral candidate’s progress to date; and (b) the candidate’s commitment to SU(D) research and their prospect of becoming an independent investigator in this area.

The letters must address the institutional support and resources available to foster the completion of the dissertation project in a timely manner. Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions: Data Management and Sharing Plan is not applicable for this NOFO. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-definedclinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- 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 Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply-Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply-Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov. 4. Submission Dates and Times Part I.

Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications .

Applicants 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 How to Apply- Application Guide. 5.

Intergovernmental Review (E. O. 12372) This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7. 9.

1 Selected Items of Cost. 7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply-Application Guide.

Paper applications will not be accepted. Applicants must complete all required registrations before the application due date . Section III Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide