Part 1. Overview Information

Key Dates

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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The National Institute on Drug Abuse (NIDA) Epidemiology Research Program promotes work that informs and facilitates real-world responses designed to reduce the burden of substance use, misuse, and/or addiction on the Nation’s health. Accurate characterization of drug use and availability is essential to the identification of priority research needs and to inform prevention and services efforts to reduce the burden of drug use and drug use disorders on the nation's health.

The landscape of drug use and misuse in the United States has become increasingly complex in recent years. The U.S. continues to grapple with the consequences of the opioid crisis, which was identified as a nationwide public health emergency in 2017. The burden of drug overdose deaths worsened during the COVID-19 pandemic and remains at historically high levels, with an estimated 110,000 fatal overdose deaths in the U.S. in 2022. The drug market continues to evolve with threats posed by illicitly manufactured fentanyl, counterfeit prescription medications, and new psychoactive substances. Moreover, new drug combinations and adulterated drugs are an increasing concern, in part because people who use drugs may not be aware of what drugs or drug combinations they are taking. The United Nations World Drug Report 2023 described the diversification of the drug market and of new drug combinations, which can include mixtures of controlled drugs along with other substances such as veterinary medicines and industrial volatiles as “a growing challenge for monitoring and treating drug use,” also noting that the names for “different mixtures and their content may vary across time and place.”

The diversity in drug use patterns across communities in the US is another important aspect of the complexity of the drug use landscape. To address the need to monitor the consequences of drug use and to capture local diversity in patterns of drug use, NIDA supported the Community Epidemiology Work Group (CEWG) for 37 years. The National Drug Early Warning System (NDEWS) was first funded by NIDA in 2014 as an expansion of its longstanding CEWG.

Purpose

The purpose of this notice of funding opportunity (NOFO) is to fund a single Coordinating Center to enhance the NIDA Epidemiology Research Program’s research efforts to identify and address emerging drug threats in a timely fashion. Working collaboratively with NIDA, the Center will use multiple sources of data to identify and track key indicators related to drug use, including the availability and use of new psychoactive substances or new combinations of substances and other consequences of drug use, with a particular emphasis on "leading" and real-time indicators that can facilitate the early identification of emerging drug threats, providing opportunities for intervention. This initiative aims to assess the current availability of data relevant to the understanding and early detection of drug use patterns and trends in communities across the United States; identify, compile, analyze, and triangulate data and resources from multiple sources to identify and contextualize emerging drug threats; and disseminate findings, data, and resources to key audiences in communities who can use the data to inform their response.

This initiative seeks innovation and direction from the scientific community in devising and targeting data identification, compilation, analysis, and dissemination while maintaining NIDA scientific input to assure consistency with NIDA goals. The proposed approach should involve engaging an Early Warning Network composed of local experts on drug use from selected communities (Sentinel Sites) and a broader network of community-based health researchers in the bi-directional exchange of actionable information related to emerging drug patterns and trends in communities across the United States. Research conducted in international settings is not sought, however, the approach proposed should consider U.S. Border and global drug issues and the impact on drug availability and drug use patterns in the U.S. A theoretical framework should guide the selection of measures, methods, and analyses.

Specific responsibilities of the Coordinating Center include providing operational, administrative, and logistical support by executing the following:

1. Establish a Scientific Advisory Group (SAG) to provide guidance and direction. The SAG should assist with identifying opportunities and novel approaches for identifying and combining research data to enhance our understanding of emerging drug use trends. This includes guidance on: establishing procedures for combining data from different sources and jurisdictions; procedures for presentation, interpretation and analysis of data within and across sources; establishing methods for assessing trends over time; and dissemination of data and findings including identifying communication channels and end users for whom the data may inform their response. The SAG will also advise on how best to engage the Early Warning Network in supporting data identification and compilation, monitoring, interpretation, dissemination, and use of data. The Coordinating Center will plan, organize, and conduct twice per year virtual or in-person meetings of the SAG, or more often as needed.
2. Engage an Early Warning Network composed of two components: local health experts on drug use from selected communities (Sentinel Sites) and a broader network of community-based health researchers to support the bi-directional sharing of information and insights into drug use patterns in their communities. The Network should include a broad range of perspectives, including people with lived experience, and should serve as a resource for identifying local data sources and contacts, for the interpretation of data compiled by the Coordinating Center, and for ongoing communication in identifying and monitoring new psychoactive substances or combinations of substances, patterns of use, and associated consequences. The Network can also identify and facilitate linkages to key audiences who can use the data, including organizations that serve people who use drugs. The Coordinating Center will facilitate the bi-directional communication with Early Network Members, and plan, organize, and conduct virtual meetings of the Early Warning Network Sentinel Sites, including at least one joint meeting with the SAG. More frequent shorter conference calls may be established in response to emerging drug issues.
3. Identify, compile, analyze, and triangulate research data and resources from multiple sources to assess and contextualize emerging drug threats:

• Establish key community-level indicators for monitoring drug use trends, early identification of new psychoactive drugs and drug combinations, and associated consequences, including overdose and transmission of pathogens such as HIV and Hepatitis C.
• Identify and maintain timely sources of data with clear relevance for the early identification of emerging issues related to drug use and combinations, monitoring trends in availability, use, and associated consequences
• Coordinate with relevant parties to obtain, extract, and integrate research relevant datasets.
• Establish quality control procedures for the data.
• Conduct cross-site and cross-source data analyses to identify, assess, and contextualize emerging issues. Applicants are encouraged to consider regional and socio-demographic factors, including gender, race/ethnicity, pregnancy status, and other roots of health disparities in their research

Examples of data sources include the Drug Enforcement Agency (DEA), Substance Abuse and Mental Health Services Administration (SAMHSA), Centers for Disease Control and Prevention (CDC), Medical Examiners, Harm Reduction Programs, and Poison Control Centers. Examples of data types include treatment admissions data, drug use data, law enforcement seizures, nonfatal or fatal overdose data (e.g., hot spot data), internet and social media data (e.g., data mining), EMS data, toxicology data, drug checking data, drug paraphernalia testing data, wastewater data, and other novel or innovative sources of information.

4. Disseminate contextualized research findings, data, and resources to potential end users of the data to inform their response. The overarching goal of NDEWS is to facilitate real time response to emerging drug issues, by supporting research on the identification and dissemination of signals of emerging drug use patterns in communities across the United States. Applications must include a comprehensive plan for how the Coordinating Center applicants will disseminate information regarding new drug threats, including the types of information to be disseminated, how the information will be disseminated and tracked (i.e. communication channels), and anticipated audiences who can use the data to inform a public health response. In addition to disseminating information to end users, the dissemination approach should also include the development and maintenance of a public website/dashboard to facilitate sharing and dissemination of data, research findings, and resources to multiple audiences, including the service providers, planners, policymakers, and the general public. Examples of possible dissemination are developing emerging drug profiles based on descriptive analyses across multiple sources and sites; conducting webinars on topics of interest to stakeholders; developing annual community site profiles based on descriptive analyses of key indicators; developing an annual report that briefly and concisely summarizes findings. 

The Coordinating Center shall maintain a web-based project collaboration and document management system that meets applicable federal requirements to facilitate: (a) communication between Coordinating Center, Scientific Advisory Group, Early Warning Network, and NIDA staff; (b) document sharing and storage; and (c) dissemination of relevant data collection forms, research findings, timelines, and other documents.

While this initiative is an outgrowth and expansion of NIDA's previous efforts monitoring drug use at the community level including the current NDEWS and CEWG, applications should propose a Network model suited to the specific approach proposed. Selected Sentinel Sites should include diverse communities across the US based on region, demographic composition, and urbanicity. The emphasis of this NOFO is on use of timely data from existing sources, however the application may also propose novel data collection such as conducting web-based surveys or crowdsourcing, using qualitative methods such as focus groups, or conducting on the ground epidemiologic investigations on topics of immediate crisis or need, providing functional feedback to impacted communities.

New (non-renewal) applications should include a plan for the transition of NDEWS to a new Coordinating Center at the time of funding. All applications should include a plan for the potential transition of NDEWS to a new Coordinating Center at the end of the funding period.

Special Considerations

NIDA applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards. Upon award, these considerations will be included in the Notice of Grant Award.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

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

1. Eligible Applicants

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

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• 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
• Regional 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

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. 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.

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 SF424 (R&R) Application Guide.

2. Cost Sharing

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

Number of Applications

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.

Letter of Intent

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:   NIDALetterofintent@mail.nih.gov

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

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 SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All applications must include an “Other Attachment” entitled “Transition Plan.” The Transition Plan must describe a plan for the potential transition of NDEWS to a new Coordinating Center at the end of the funding period. Additionally, new (non-renewal) applications must include in their Transition Plan (in the same attachment) a description of the plan for the transition of NDEWS to a new Coordinating Center at the beginning of the funding period. 

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

As part of the research plan, all applications must include a plan for dissemination of information regarding new drug threats. This should be described under the heading “Dissemination Plan” within the approach. 

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. 

Other Plan(s):

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 SF424 (R&R) 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 SF424 (R&R) Application Guide.

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 SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

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 SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. 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

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission 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.

Important reminders:

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 SF424 (R&R) 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.

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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.

Overall Impact

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).

Scored Review Criteria

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.

Significance

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?

Investigator(s)

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?

Innovation

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? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO:

To what extent have the investigators presented a well-conceived plan for the dissemination of information regarding new drug threats?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable 

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Specific to this NOFO:

Other Attachment: Transition Plans

• To what extent is the plan for the transition of NDEWS at the end of the funding period reasonable? 
• For new applications, to what extent is the plan for the transition of NDEWS at the beginning of the funding period reasonable?  

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDA, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Drug Abuse. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website. 

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Provide timely notification to the NIDA Project Scientist, Early Warning Network, and other key audiences of emerging psychoactive substances or substance combinations, new drug use patterns, or sudden increases in consequences detected.
• Integrate and manage data acquired.
• Support the conduct of data analyses and defining approaches, innovations, methods, and measures.
• Provide expertise and leadership in addressing issues of broad applicability, such as informed consent, data sharing standards, analysis methodology, and dissemination.
• Facilitate integration of data from community sentinel sites and other sources.
• Facilitate data quality monitoring through rigorous data management and identification of data biases and errors as they arise.
• Provide leadership for and participate in group activities, including project update meetings.
• Provide integrative, organizational, and logistical support for the entire program, including tracking, scheduling, facilitating work group meetings and conference calls, and preparing concise minutes or summaries of meetings for distribution.
• Compile meeting minutes, deliver summary meeting reports, and coordinate post-meeting follow-up.
• Provide technical or logistical support for meetings of subcommittees and work-groups including conference call lines and webinar support.
• Plan and host meetings of the Scientific Advisory Group and Early Warning Network Sentinel Sites.
• Provide a forum for bidirectional communication across the broader Early Warning Network.
• Coordinate timely dissemination of methods, tools, data, research findings, documentation, and other resources to key public health audiences who can act on the information provided.
• Coordinate smooth and timely transition. 
• A PD/PI on a U01 awarded under this NOFO will be expected to maintain significant effort commitment not smaller than that stated in the application (2.4 person-months).
• Recipient will retain custody of and have primary rights to data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS and NIH policies. 

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIDA Project Scientist. A designated NIDA Program Official(s) acting as a Project Scientist(s) will have the following responsibilities:

• Serve as a resource for specific information on NIDA's programmatic intentions and priorities, and help to foster collaborations between researchers, public health, and public policy partners both within and across other Federal agencies to increase the value of research to these participants.
• Play an active role in developing innovative methodological strategies to support data compilation, analysis, triangulation, and dissemination.
• Identify relevant research questions, and may potentially cooperate with recipient in development, design, and coordination of research plans and study reports.
• Participate in regular meetings with the PD/PI, and as needed meetings with the team.
• In instances where significant involvement in the design of studies and/or analysis of results has occurred, the NIDA Project Scientist may cooperate with the recipient as coauthor in preparing publications of data resulting from the research. Publications involving NIDA staff will require internal clearances.

NIDA Program Official. A NIDA program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIDA Program Official, who will not participate in the research or the preparation of publications, will be responsible for the oversight of the cooperative agreement. The Program Official carries primary responsibility for:

• Periodic review and monitoring and approval of the progress of the research plans in relation to their stated objectives, including consistent communication with the PI and the Coordinating Center staff as well as requests for additional reports or documentation.
• Making recommendations regarding continuance of the program. The NIDA Program Official will be responsible for monitoring the conduct of the project and overseeing the Coordinating Center grant. The Program Official will receive and review all required progress reports to determine that satisfactory progress is being made and will work collaboratively with the NIDA Grants Management Specialist to assure high quality business management of the program, including the most effective use of Federal financial assistance provided through this cooperative agreement.

Additional NIH staff may participate in project related meetings and work groups, as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.

Areas of Joint Responsibility include:

• Members of the Scientific Advisory Group and NDEWS Early Warning Network Sentinel Sites will be proposed by the recipient in agreement by the NIDA Project Scientist.
•  Agendas for Scientific Advisory Group and Early Warning Network Sentinel Site meetings will be developed by the recipient and agreed upon by the NIDA Project Scientist. 
• The recipient, the NIDA Project Scientist, and other relevant NIDA staff will participate together in Scientific Advisory Group meetings, NDEWS Early Warning Network Sentinel Site meetings and additional conference calls as needed, to facilitate development of the network and exchange of information on emerging drug use issues.
• The recipient and NIDA Project Scientist will provide input on emerging issues and new psychoactive substances to be monitored.
• The recipient will work with the NIDA Project Scientist to review the relevance, quality of the data, and level of fit and match of data.
• The dissemination plan will be developed by the recipient and agreed upon by the NIDA Project Scientist.
• Status reports in the format of conference calls with NIDA program staff will take place on a monthly basis, or more frequently, as needed. These reports will include information concerning project progress, obstacles and steps taken to remedy them. Status reports will also discuss the results of dissemination efforts as they become available.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

MeLisa R. Creamer, PhD, MPH 
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1933 
Email: melisa.creamer@mail.nih.gov

Dharmendar Rathore, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6965
Email: dharmendar.rathore@nih.gov

Jennifer Schermerhorn 
National Institute on Drug Abuse (NIDA)  
Telephone: 301-827-6704
Email: schermerhornj@mail.nih.gov 

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.