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.

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

Purpose

The National Institute on Drug Abuse (NIDA) supports a program of longitudinal cohort studies that addresses the intersection of HIV and substance use. This program is a multidisciplinary platform to support basic, epidemiologic, and clinical research on HIV and HIV-associated co-morbidities and co-infections among populations with substance use and substance use disorders (SUDs) and to address research questions at the individual and population level. The purpose of this notice of funding opportunity (NOFO) is to support the continuation of NIDA's HIV Cohorts Program, encouraging existing and new sites to address new emerging and/or high priority research on multidisciplinary aspects of HIV/AIDS and substance use in alignment with NIH-HIV research priorities in order to inform policy or practice. Cohort sites supported under this program are required to report to and collaborate with a NIDA funded Coordinating Center, including participating in research agendas addressing NIDA’s high priority areas.

Background

Since the start of the HIV epidemic, cohort studies of people living with HIV (PLWH) and key populations at risk for HIV acquisition have made important contributions to the understanding of HIV virology, seroconversion dynamics, the natural and treated histories of HIV infection, the impact of HIV-associated co-morbidities (e.g., HCV) and complications including the role of substance use and SUDs.

Longitudinal cohorts of at-risk individuals can provide crucial information about acute or early phases of infection, as well as disease transmission. Cohort studies provide a continuous source of data collection with the ability to address new or emergent public health problems, changes in drug use patterns and uptake of screening, prevention, or new treatments. Cohorts can also add to the understanding of processes such as aging, co-morbidities, social dimensions of HIV and substance use epidemics, as well as structural factors such as state and local policies, health insurance, and availability of relevant services.

Research Objectives and Scope

Research by each site should focus on high-risk populations or PLWH, who use substances. This RFA will seek applications from investigators working with HIV populations most affected by HIV (i.e., those at highest risk or living with HIV) in the United States. These can include sexual and gender minorities, racial/ethnic minorities, people involved in the criminal justice system and sex workers. Cohort populations should reflect social and economic characteristics of affected populations. Rural and metropolitan populations are welcome. This initiative also targets priority jurisdictions identified by the Ending the HIV Epidemic (EHE) initiative, although other jurisdictions will be considered with an epidemiologic justification (e.g., rural counties affected by opioid epidemics).

Applicants must demonstrate the capacity to:

• Be responsive to changes to substance use and HIV epidemics, such as new substance use patterns, introduction of new substances; emergent co-morbidities including infectious diseases such as Mpox, COVID-19 and others, changes to public health policies, or to HIV/substance use treatments or prevention strategies. Applicants are strongly encouraged to include research that focuses on HIV-associated infectious co-morbidities (e.g., HCV, other sexual-transmitted disorders [STD]) and HIV-associated non-infectious co-morbidities, such as neurocognitive or other central nervous system impairment, mental health disorders and relevant medical disorders. [Note: The main focus of research should be the intersection of HIV and Substance Use, with co-morbidities as co-factors.]
• Partner with the end-user of the knowledge/data that would be generated (e.g., prevention specialists, Public Health officials, health departments, justice systems, policymakers, community organizations, etc.) and should thoroughly explain how the knowledge would be used to inform decisions and implement change. The involvement of the end-user is to ensure that the proposed data and methods will be useful. The partnerships with key end-users can be existing, or new relationships initiated based on success of previous stakeholder engagement and preparation to implement proposed work in a new setting.
• Collect data that can be used to inform policy and practice and include collaborations with potential end-users of cohort data such as those involved in HIV planning processes (e.g., EHE, Ryan White, CDC prevention funding) as well as service providers and provider organizations (e.g., health systems, federally qualified health centers [FQHCs], harm reduction sites).
• Participate in the collection of common data elements and biospecimens and participate in activities related to multi-site research such as data harmonization by working in concordance with the Data Coordinating Center. All sites are expected to collaborate and share all their data at least twice a year with the Data Coordinating Center.
• Assess variables that reflect system and structural factors that can affect HIV acquisition, utilization of prevention or treatment services, HIV viral suppression, substance use and/or factors that can influence dissemination of emergent prevention and care interventions.

Research projects should address populations and research questions not captured by other HIV studies currently funded by NIH, including those co-funded by NIDA such as the WIHS/MACS Combined Cohort Study (MWCCS), the Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) or the NIAID Limited Interaction Targeted Epidemiology (LITE) cohorts while also being able to work with these outside cohorts on research questions where complementary of age, patterns of substance use, etc., may be desirable.

Common Scientific Agenda and Collaboration with Data Coordinating Center:

All sites are expected to collaborate and share all their data, at least twice a year, with the Data Coordinating Center at the University of Washington which will provide technical assistance, support, and resources. Clinical data and biological samples collected via the cohort(s) are expected to be available for sharing and use by the scientific community. Sites will also be expected to participate in collaborative activities including at least one annual meeting and monthly/quarterly conference calls with the Data Coordinating Center.

Common Scientific Agenda

All sites are also expected to participate in a common scientific agenda. The scientific areas listed below outline high priority research areas for NIDA that should be accomplished by each site during the five-year award period. There needs to be a clear justification of the clinical assessments, specimen collections, surveys and other measures, the frequency of participant visits and sampling from the cohort studies. Applications may propose additional research areas that are contemporary and are of high significance to the cooccurring HIV and substance use epidemics.

• Substance use and SUDs: drug use trends, types of drug use and frequency in relation to HIV risk and outcomes, risks associated with overdose related death
• HIV-related co-morbidities (HCV, Neurocognitive disorders) COVID-19; MPox and other sexually transmitted disorders), medical consequences, epidemiology, prevention, treatment, and outcomes in acute and chronic HIV
• Implementation: HIV and SUD services, uptake, and delivery. Point-of-care rapid testing, referral, and treatment, geocoding
• HIV viral loads: in relation to substance use, treatment, and co-morbidities
• Treatment: HIV and SUD treatment uptake and adherence, linkage to care
• Social determinants of health: socioeconomic factors, social support, trauma/violence, stigma, discrimination, life transitions, and food insecurity and the mechanisms of action through which they may affect health outcomes among people living with or at risk of HIV acquisition
• Brain and CNS: behavioral and psychiatric abnormalities, neurocognitive alterations in the context of substance use and HIV
• Genomic and phenotypic data in the context of HIV, co-morbidities, and substance use

Research Strategy:

Sites funded under this RFA will serve as a national resource for research addressing the intersection of HIV and substance use in the United States. Applications should include multidisciplinary teams and should select key populations at risk for HIV acquisition or populations of PLWH. Variables should reflect substance use in the study population with particular attention to its relevance for HIV acquisition, transmission, response to HIV treatment and/or viral suppression. Studies should address variables related to policy and practice such as HIV, substance use and other health care/public health service utilization, health insurance, key HIV risk populations and PLWH, people who experience marginalized social and sexual identities. Data collection should address stigma and discrimination as well as resource constraints (e.g., food, shelter, access to reliable transportation, access to reliable and private internet connectivity), particularly those which may limit participation in public health or health care services.

Data collection should reflect current best clinical and methodologic practices and can include biospecimen collection, behavioral data from surveys or interviews, electronic health records and other methods that are consistent with study aims and objectives.

The research strategy should include collaborations with potential end-users of cohort data such as those involved in HIV planning processes (e.g., EHE, Ryan White, CDC prevention funding) as well as service providers and provider organizations (e.g., health systems, FQHCs, harm reduction sites) or others (prevention specialists, Public Health officials, health departments, justice systems, policymakers, community organizations, etc.). Applications must thoroughly explain how the knowledge/data would be used to inform decisions, policy, practice and/or implement change.

Applications need to address NIH and NIDA’s highest priority areas of research:

Research Priorities | NIH Office of AIDS Research

NIDA HIV Priority Areas

Sites should consider their capacity to address areas of interest such as the following:

• System and structural level factors that lead to HIV acquisition
• Social determinants of HIV and substance use, including factors that increase exposure to HIV and substance use 
• New or emerging substance use patterns and recovery approaches
• Long-term HIV/substance use outcomes and medical consequences such as those associated with aging and HIV
• Capturing the effects of systemic interventions to increase prevention, diagnosis, and treatment, including differences in HIV testing service, utilization, etc. that occur in different settings such as community organizations, FQHCs, and health systems.

In addition, sites are strongly encouraged to:

• Expand existing populations: Increasing the representation of PLWH, ensuring the representation of sexual and gender minorities, ethnic/racial minorities and people with lived experiences, factors that contribute to HIV risk and poor treatment outcomes such as homelessness, engaging in sex work, and criminal justice involvement. EHE priority jurisdictions should be addressed in the application with epidemiologic justification provided for non-EHE jurisdictions such as rural areas affected by opioid epidemics.
• Demonstrate their capacity to recruit and follow populations of adequate sample size and power (i.e., >500). Smaller sample sizes need justification with respect to local epidemiology and factors such as population and service density.
• Sites with established cohorts should demonstrate their capacity to, and describe plans to, refresh samples and continue to recruit participants and comply with the NIH data sharing policy.

The Research Strategy should:

• Describe how substance use in the population will be characterized i.e., specific drugs used, level and history of use, form of administration, continuum cascade of substance use, and/or changing patterns over time including initiation.
• Describe methods for the recruitment, enrollment, and retention of cohort participants, describing previous experience with recruitment and retention of longitudinal samples.
• Describe the data collection methods and their appropriateness for the variables of interest, as well as the primary analyses of data, providing a rationale for the analytic methods selected and the statistical power for major analyses.
  • Include specific proposed data elements, such as clinical data, summary health histories, biologic specimens, socio-behavioral data, or treatment variables that will support the study aims Given the requirement of data sharing across cohort sites, the discussion should address how proposed data elements could incorporate common or shared platforms.
• Provide justification of the priority research domains for the cohort study and for the approaches to achieving the study aims. The study rationale should indicate how the cohort will address gaps in current NIH-funded HIV cohort research (e.g., MWCCS, CNICS, LITE) and indicate where it might complement existing cohort research.
• Describe experience with participation in multi-site research, particularly where data sharing was integrated into the research.
• Applications also should describe the administrative and organizational structure for the project and how it will facilitate attainment of the aims and objective of the proposed research. Where biospecimens are routinely collected, applications should describe procedures for processing, storage, and sharing for use by the scientific community.
• Document alignment with EHE plans or other appropriate HIV service plans (e.g., CDC/Ryan White planning processes) and provide a plan for engaging local decision makers, as well as document how cohort data can inform local decisions about resource allocation and service delivery.
• For renewal applications, applicants should provide a rationale for continued funding including information regarding any new data collection.
• Renewal applicants must provide plans to demonstrate program relevance and to ensure representation of current HIV/substance use epidemic patterns.

Applications Not Responsive to this NOFO include:

The following types of applications will be considered non-responsive and will be returned without review:

• Studies that do not have the capacity to adhere to data sharing requirements and data harmonizing activities with the data coordinating center (transferring data, common data elements or biorepository data sharing) as specified above.
• Studies with less than 500 participants without adequate justification.
• Applications with a primary focus on research related to end organ or systemic disease related to comorbidities such as cardiac, liver, or chronic kidney diseases, hypertension, and bone disorders.
• Studies that do not focus on HIV infection and substance use and/or outcomes.

Plan for Enhancing Diverse Perspectives (PEDP)

• This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310, 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 material. The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

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

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 Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their 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.

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 SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) 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. The additional instructions apply:

Plan for Enhancing Diverse Perspectives (PEDP)

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity
• The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate.
• Where possible, applicant(s) should align their description with these required elements within the research strategy section
• 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 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review 

Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally   under represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

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. The additional instructions apply:

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).

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:

The Research Strategy should:

• Describe how substance use in the population will be characterized i.e., specific drugs used, level and history of use, form of administration, continuum cascade of substance use, and/or changing patterns over time including initiation.
• Describe methods for the recruitment, enrollment, and retention of cohort participants, describing previous experience with recruitment and retention of longitudinal samples.
• Describe the data collection methods and their appropriateness for the variables of interest, as well as the primary analyses of data, providing a rationale for the analytic methods selected and the statistical power for major analyses.
  • Include specific proposed data elements, such as clinical data, summary health histories, biologic specimens, socio-behavioral data, or treatment variables that will support the study aims Given the requirement of data sharing across cohort sites, the discussion should address how proposed data elements could incorporate common or shared platforms.
• Provide justification of the priority research domains for the cohort study and for the approaches to achieving the study aims. The study rationale should indicate how the cohort will address gaps in current NIH-funded HIV cohort research (e.g., MWCCS, CNICS, LITE) and indicate where it might complement existing cohort research.
• Describe experience with participation in multi-site research, particularly where data sharing was integrated into the research.
• Applications also should describe the administrative and organizational structure for the project and how it will facilitate attainment of the aims and objective of the proposed research. Where biospecimens are routinely collected, applications should describe procedures for processing, storage, and sharing for use by the scientific community.
• Document alignment with EHE plans or other appropriate HIV service plans (e.g., CDC/Ryan White planning processes) and provide a plan for engaging local decision makers, as well as document how cohort data can inform local decisions about resource allocation and service delivery.
• For renewal applications, applicants should provide a rationale for continued funding including information regarding any new data collection.
• Renewal applicants must provide plans to demonstrate program relevance and to ensure representation of current HIV/substance use epidemic patterns.

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 SF424 (R&R) 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.

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 non-responsive will not be reviewed.

Applications must include annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. 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.

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

Any instructions provided here are in addition to the instructions 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?

Specific to this NOFO:

• How adequately does the application describe inclusion of populations most affected by HIV as their population of focus?  
• How adequately does the application demonstrate their ability to be responsive to changes to substance use and HIV epidemics?
• To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project? 

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?

Specific to this NOFO:

• How does this application include a multidisciplinary team who have experience working with HIV populations most affected by HIV?
• To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required 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?

Specific to this NOFO:

• To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

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:

• How well does the application describe how substance use in the population will be characterized i.e., specific drugs used, level and history of use, form of administration, continuum cascade of substance use, and/or changing patterns over time including initiation?
• How well does the application describe methods for the recruitment, enrollment, and retention of cohort participants, describing previous experience with recruitment and retention of longitudinal samples?
• How well does the application describe the data collection methods and their appropriateness for the variables of interest, as well as the primary analyses of data, providing a rationale for the analytic methods selected and the statistical power for major analyses?
• How well does the application provide justification of the priority research domains for the cohort study and for the approaches to achieving the study aims?
• How well does the application describe experience with participation in multi-site research, particularly where data sharing was integrated into the research?
• To what degree does the application demonstrate their ability to participate in the collection of common data elements and biospecimens and participate in activities related to multi-site research such as data harmonization by working in concordance with the Data Coordinating Center?
• How well does the application describe the administrative and organizational structure for the project and how it will facilitate attainment of the aims and objective of the proposed research?
• Where biospecimens are routinely collected, how well does the application describe procedures for processing, storage, and sharing for use by the scientific community?
• How adequately does the application demonstrate their capacity to collaborate and share all their data with the Data Coordinating Center at least twice a year and participate in a common scientific research agenda?
• How well does the application demonstrate their capacity to make data available for the scientific community through the coordinating center?
• How adequately does the application describe collaborations with potential end-users of cohort data such as those involved in HIV planning processes (e.g., EHE, Ryan White, CDC prevention funding) as well as service providers and provider organizations (e.g., health systems, FQHCs, harm reduction sites) or others (prevention specialists, Public Health officials, health departments, justice systems, policymakers, community organizations, etc.)?
• How well does the application thoroughly explain how the knowledge/data would be used to inform decisions, policy, practice and/or implement change?
• How adequately does the application demonstrate their ability to collect data that can be used to inform policy and practice and include collaborations with potential end users of cohort data such as those involved in HIV planning processes as well as service providers and provider organizations?
• How well does the application demonstrate their ability to assess variables that reflect system and structural factors that can affect HIV acquisition, utilization of prevention or treatment services, HIV viral suppression, substance use and/or and factors that can influence dissemination of emergent prevention and care interventions?
• For renewal applications, to what extent does the application provide a rationale for continued funding including information regarding any new data collection?
• For renewal applications, to what extent does the application provide plans to demonstrate program relevance and to ensure representation of current HIV/substance use epidemic patterns?
• Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

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?

Specific for this NOFO:

To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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.

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 policy and procedures, 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 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that 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.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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 45 CFR Part 75.205 and 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 (DHHS) 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 recipient 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 award 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 the NIH as defined below.

The PD/PIs will have the primary responsibility for:

• Attend an annual meeting and participate in monthly conference calls with the NIDA program staff and the leadership of the Data Coordinating Center (DCC).
• Collaborate with the DCC and participate in research agendas addressing NIDA’s high priority areas.
• Work with the DCC in establishing common data elements for drug use and HIV data and apply them in collecting the data when appropriate.
• Engage in all NIDA and DCC coordinated activities related to data harmonization and data sharing so that data related to drug use, exposure, and HIV may be combined, and made available widely for use by researchers across US.
• Work with the DCC and NIDA to establish and implement standard procedures for collecting biospecimens.
• Provide updates at least annually on implementation of the PEDP.
• Will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
• Recipients are expected to publish and publicly disseminate results, data, and other products of the study, concordant with governance policies and protocols. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NIDA/NIH.

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

The NIDA Project Scientist and HIV Research Program (HRP) Directors will:

 Participate in the definition of objectives and approaches of the cohort studies

• Act as a resource to aid in resolving scientific and regulatory issues as they arise
• Engage in monthly conference calls with the Cohort PIs and the leadership of the DCC.
• Discuss opportunities for wide collaborations and presentations at the major scientific meetings

The NIDA Program Officer will:

• Be responsible for the normal scientific and programmatic stewardship of the award, including programmatic monitoring of the overall project and will be named in the award notice.
• Monitor the conduct and progress of the project to ensure milestones are accomplished in accordance with the timeline.
• Approve modifications to the research plan and/or study protocol(s), in consultation with the NIDA PS, HRP, and Steering Committee based on emerging data and/or other issues that impact progress of the project.
• Monitor performance and compliance with NIH procedures.
• Reviewing and evaluating requests for actions requiring prior NIH approval

Areas of Joint Responsibility include:

• The PD(s)/PI(s) and the PS will work collaboratively in evaluating the most appropriate research methods, data quality control strategies, medical safety monitoring, protocol design and implementation, data analysis and interpretation and publication and dissemination of study results.
• A Steering Committee (SC), composed of the principal investigator of the DCC, as well as the PD(s)/PI(s) of the various cohort studies, and NIDA Project Scientist. As the components of the SC may be geographically dispersed, the SC should meet with at least monthly conference calls, supplemented as deemed necessary by face to face meetings. Each full member will have one vote. The NIDA Project Scientist will have one vote.  All other NIH officials will participate in a non-voting capacity.  The SC chair will be selected by the steering committee by vote. The NIDA Program Official shall be consulted regarding the selection of the Chairperson and will have the option to veto the selection based on specific concerns regarding potential for bias or conflict of interest or lack of required expertise. Recipient members of the Steering Committee will be required to accept and implement all policies governing the studies approved by the established Governance Committee.
• The recipient and NIDA Project Scientist will discuss study progress via conference call on a monthly basis. These meetings will include information concerning study progress, obstacles and steps taken to remedy them and any protocol changes that may need to be considered. Recruitment, retention, and drop-out rates for each research protocol will be discussed as will any Human Subject issues as they arise.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The members will include: 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 DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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.

Awardees   will provide updates at least annually on implementation of the PEDP.

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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), 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 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 45 CFR Part 75 and 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

Sheba K. Dunston, EdD
National Institute on Drug Abuse (NIDA)
Telephone: 301- 402-1526
Email: Sheba.Dunston@nih.gov

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

Christina Rinaldi 
National Institute on Drug Abuse (NIDA)  
Telephone: 301-827-0937 
Email: christina.rinaldi@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 45 CFR Part 75 and 2 CFR Part 200.