Sleep, Circadian Rhythms, and Substance Use Disorders

Sleep, Circadian Rhythms, and Substance Use Disorders is sponsored by National Institute on Drug Abuse (NIDA). Encourages research into the biological mechanisms linking sleep/circadian rhythms and substance use disorders, aiming to identify therapeutic targets.

Expired RFA-DA-25-045: Mechanistic Studies to Investigate the Interrelationship Between Sleep and/or Circadian Rhythms and Substance Use Disorders (R01 Clinical Trials Not Allowed) 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 ) Funding Opportunity Title Mechanistic Studies to Investigate the Interrelationship Between Sleep and/or Circadian Rhythms and Substance Use Disorders (R01 Clinical Trials Not Allowed) R01 Research Project Grant 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 The purpose of this notice of funding opportunity (NOFO) is to support research project applications to expand our knowledge on the biological mechanisms of the interrelationship between sleep/circadian rhythms and substance use disorders (SUDs).

These basic science experimental studies will offer insights into the fundamental processes that link SUDs to disorders of sleep/circadian rhythms and vice-versa, and may also have implications for managing risks associated with developing SUDs and/or identifying new targets for prevention and therapeutics. This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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.

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 Substance use disorders (SUDs) and disorders of sleep/circadian rhythms are intricately interconnected. Sleep dysregulation including insufficient sleep duration, altered sleep architecture, poor sleep quality and irregular circadian rhythm is prevalent in >75% of individuals with SUDs and represents a challenge to recovery.

Conversely, acute and chronic exposure to addictive substances influences sleep and circadian rhythms. The substantial overlap between neuronal systems and processes involved in SUD and sleep/circadian rhythm likely underlies these interactions.

However, this has not been systematically investigated at a mechanistic level and the regulation of sleep/circadian rhythms has not been fully integrated with the neurobiology of SUD mechanisms and risk factors.

Mechanistic studies that determine the directionality of sleep and SUD interactions are needed to understand fundamental processes linking SUD and sleep/circadian dysregulation, and further, to identify new targets for prevention and improved therapy. There are several brain regions and neurotransmitter substrates that regulate arousal, sleep/circadian rhythms, as well as motivation and reward.

Diverse systems including locus coeruleus noradrenergic neurons, serotonergic neurons in the raphe, basal forebrain cholinergic neurons, midbrain dopaminergic neurons, hypothalamic hypocretin (orexin) - ergic neurons, the endocannabinoid and histaminergic systems and their projections regulate arousal and sleep while also having known roles in reward-related behaviors.

However, little is known about how these brain regions, neural circuits, neurotransmitter, and receptor systems mechanistically intersect to cause a bidirectional interaction between sleep/circadian rhythms and SUDs.

The goal of this Notice of Funding Opportunity (NOFO) is to support basic and pre-clinical research project applications that explore the mechanisms that underlie the interrelationship between sleep and/or circadian rhythms and SUDs. Applicants may propose research projects using behavioral, cognitive, cellular, circuit, genetic, molecular, imaging, pharmacological, and/or computational approaches.

The National Institute on Drug Abuse (NIDA) seeks to stimulate research targeted at understanding the mechanisms that underlie the intersection of sleep and/or circadian rhythms and SUDs. These studies will investigate how sleep, alterations in sleep homeostasis, alterations in circadian rhythms and/or sleeping disorders influence substance use, substance dependence, withdrawal, relapse and/or recovery from SUDs.

Interdisciplinary teams with the ability to integrate research expertise in sleep/circadian rhythms­­ with the neurobiology of SUDs are encouraged. Research questions of programmatic interest include, but are not limited to: How does sleep/circadian rhythm mechanistically influence substance use, substance dependence, reward, withdrawal and/or relapse? Does restoring sleep duration and/or architecture influence the trajectory of SUDs?

What are the underlying mechanisms? What are the neurobiological mechanisms by which addictive substances alter sleep/circadian rhythms? How does alteration in sleep/circadian rhythms induced by addictive substances mechanistically influence the addiction trajectory?

What brain regions, signaling molecules, neurotransmitter systems, brain circuits, genetic and epigenetic mechanisms underlie the effect of sleep/circadian disturbances in the development, progression or exacerbation of SUDs? What are the mechanisms by which neurocognitive constructs relevant to SUDs such as learning, memory, emotional regulation, social cognition, and decision-making are impacted by sleep/circadian disruption?

What are the mechanisms underlying the effect of sleep/circadian disruptions on large-scale brain network dynamics? Are there sex and gender differences in the impact of sleep/circadian disruption on SUDs or in the effect of acute or chronic exposure to drugs on sleep physiology or circadian rhythms? What are the underlying mechanisms?

What is the impact of sleep/circadian disturbances during adolescence on the risk for the development of SUDs? What is the underlying neurobiology? How does this differ from the impact on adults?

An explicit justification of the potential application to SUDs is required. Preclinical studies are not required to include a substance-using population but are expected to inform our understanding of SUD-relevant neurocircuitry and/or cognition. The proposed research should pertain to at least one of the stages of the substance use trajectory, including, but not limited to acquisition, escalation, and/or relapse.

Applications may be targeted to cocaine-, opioid-, nicotine-, methamphetamine-, stimulant-, prescription drug-, cannabinoid-use disorders or polysubstance use including alcohol. Applications Not Responsive to this NOFO The following types of studies are not responsive to this NOFO and will not be reviewed: Projects focused solely on alcohol use disorders, caffeine or non-drug reinforcers.

Projects focused exclusively on developing animal models. Projects focused on research that is descriptive and/or observational and not directly targeted at mechanistically interrogating the relationship between sleep/circadian rhythms and SUD’s.

Projects focused on research that does not pertain to at least one of the stages of the substance use trajectory, including, but not limited to initiation, escalation, withdrawal and/or relapse. Other application considerations: Preliminary data are not required but may be included if available.

Applicants are encouraged to provide a strong premise for testing a novel hypothesis based upon the scientific literature as well as evidence of the team’s ability to carry out the proposed studies through published or technical preliminary data. Collaborative research teams to foster the sharing of conceptual and/or technical expertise are strongly encouraged.

Plan for Enhancing Diverse Perspectives (PEDP) The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams.

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

To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project.

Consistent with federal law, the race, ethnicity, or sex of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review. The PEDP will be submitted as Other Project Information as an attachment (see Section IV).

Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance materials. 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 provides 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 NIDA intends to commit $2M in FY2025 to fund three-five awards across this NOFO and the companion NOFO, RFA-DA-25-044. Application budgets will be limited to $300,000 in direct costs/year. The proposed budget needs to reflect the actual needs of the proposed project.

The scope of the proposed project should determine the project period. The maximum project period is five years. 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 All organizations administering an eligible parent award may apply for a supplement under this NOFO.

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 (Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete 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 NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

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.

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 How to Apply - Application Guide . 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 How to Apply - 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 subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed 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 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, with the following additional instructions Plan for Enhancing Diverse Perspectives (PEDP) In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity.

Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.

The PEDP may be no more than 2 pages in length and should include: Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project; Description of how the PEDP will advance the scientific and technical merit of the proposed project; Anticipated timeline of proposed PEDP activities; Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to: Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).

Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process. Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds. Description of planned partnerships that may enhance geographic and regional diversity.

Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.

Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers. Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to: Selection or hiring of personnel for a research team based on their race, ethnicity, or sex. A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex. For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP guidance materials .

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed. PEDP implementation costs Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.

nih. gov/grants/policy/nihgps/html5/section_7/7. 1_general.

htm ). 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: Research Strategy : The following must be described in the Research Strategy: Significance : a) A compelling justification must be included for how the proposed studies will dramatically enhance our mechanistic understanding of the interrelationship between sleep/circadian rhythms and SUDs.

Innovation : a) Description of how the proposed project disrupts existing paradigms, explores unanticipated biological phenomena or unexpected results with regard to the mechanisms that underlie the interrelationship between sleep/circadian rhythms and SUDs, b) Description of the novel direction for the proposed research in uncovering mechanisms of the interrelationship between sleep/circadian rhythms and SUD.

Approach: a) Description of prior published work and/or preliminary data which demonstrate that the proposed studies will be successful in elucidating mechanisms that underlie the interrelationship between sleep/circadian rhythms and SUDs, b) Description of the expertise of the team in the neurobiology of SUDs and/or sleep/circadian rhythms and the team's ability to integrate research expertise, c) Well-designed experiments with adequate control conditions and statistical analyses to test the proposed hypothesis, and d) A timeline for the studies over the proposed funding period.

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide . Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical 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.

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide. 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. 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 .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII . All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form .

Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide . See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. Applications must include a PEDP submitted as Other Project Information as an attachment.

Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review. Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy Section V. Application Review Information Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system. For this particular announcement, note the following: Preliminary data are not required, but may be included if available.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

As part of the overall impact score, reviewers should consider and indicate how the Plan to Enhance Diverse Perspectives affects the scientific merit of the project. Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

For example, a project that by its nature is not innovative may be essential to advance a field. Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous?

If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

To what extent does the application provide a compelling justification that the proposed studies will dramatically enhance our mechanistic understanding of the interrelationship between sleep/circadian rhythms and SUDs? Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training?

If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?