It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Many rural communities have experienced dramatic increases in prescription drug use that have led to increases in injection drug use, opioid overdose, and incidence of acute HCV, as well as potential for localized HIV and HCV outbreaks similar to the 2015 outbreaks in Scott County, Indiana. Rising overdose deaths and substance abuse treatment rates indicate sharp increases in opioid use, including injection use in rural areas, such as Appalachia, the Southwest US, as well as other areas across the country. The demographic profile of rural people who inject drugs (PWID) differs from PWID involved in previous urban HIV and HCV epidemics; i.e., rural PWID include higher percentages of non-Hispanic whites under 30 years of age.

Rural communities face challenges in implementing services to prevent and control substance abuse, HIV and hepatitis C virus (HCV) infections and co-morbid conditions including hepatitis B virus (HBV) infection and sexually transmitted diseases (STDs). Access to public health services including HIV, HCV, HBV or STD testing and treatment are limited. These areas have low population densities and are often located far away from concentrations of health care services for drug treatment, infectious disease management, and syringe services programs (SSPs) (where permitted by law). Rural areas often lack public transport links to metropolitan areas with well-developed services, and motor vehicle ownership often is relatively low, despite the need for private transportation. Stigma and confidentiality in small communities pose additional challenges to establishing and maintaining those services. State-level public health surveillance systems often have difficulty detecting infectious disease outbreaks in rural areas and may lack field staff experienced with rural PWID networks.

High rates of medical use of prescription opioids often have led to high rates of non-medical use of prescription opioids in rural areas; and high rates of non-medical use of prescription opioids often lead to high rates of opioid addiction, injection drug use, and unmet needs for substance abuse services in these communities.

State and local laws and law enforcement policies often limit the local availability of some services, with some exceptions that enable the delivery of more services in response to local conditions. The US Department of Health and Human Services recently released guidance to enable state and local authorities to re-direct federal assistance for syringe service programs: https://www.aids.gov/pdf/hhs-ssp-guidance.pdf.

This FOA will support biphasic, i.e., two-stage, multi-method research projects that inform community response and promote comprehensive, integrated approaches to prevent HIV and HCV infection along with associated comorbidities, such as HBV infection and STDs, among people who inject drugs (PWID) in rural US communities. Opioid injection and its consequences (e.g., HIV, HCV, HBV, STDs and overdose) are the primary foci here. These projects should yield evidence of the effectiveness of community response models and best practices in responding to opioid injection epidemics that can be implemented by public health systems in similar rural communities in the US.

Applicants are encouraged to visit the Frequently Asked Questions site for more information at https://www.drugabuse.gov/supplemental-information-nida-rfas-da-17-014-da-17-023

The joint Funding Opportunity Announcement (FOA) will use the UG3/UH3 Cooperative Agreement mechanism to accomplish the required activities for the awards. The UG3/UH3 Cooperative Agreement mechanism involves two phases (UG3 = Phase I Exploratory-Developmental Cooperative Agreement; UH3 = Phase II Exploratory-Developmental Cooperative Agreement). The UG3 phase supports a project with specific milestones to be accomplished by the end of the first 2-year budget period. The UH3 phase is to provide funding for up to 3 additional years to those projects that successfully completed the milestones set forth in the UG3 phase. UG3 projects that have met their milestones will be administratively considered by NIH/NIDA and CDC/NCHHSTP and prioritized for transition to the UH3 phase. Investigators responding to this FOA must address both UG3 and UH3 phases in their application.

All projects must include a Go/No-Go Transition Milestone to be assessed at the end of the UG3 phase. Funding of the UG3 (Phase 1) does not guarantee support of the UH3 (Phase 2) award for research implementation, and it is anticipated that not all funded UG3 projects will transition to the UH3 phase. Transition to the UH3 phase will be determined by a programmatic evaluation by NIH/NIDA and CDC/NCHHSTP that is based on Go/No-Go Transition Milestone accomplishment as outlined below. Continued programmatic priorities and availability of funds also affect the decision to transition to the UH3 award. Appeals of the transition decision will not be accepted.

The companion announcement to this FOA is RFA-DA-17-023 which will support building capacity for a laboratory to perform next generation sequencing (advanced molecular detection) using Global Hepatitis Outbreak and Surveillance Technology (GHOST), to be developed in collaboration with CDC’s Division of Viral Hepatitis. The GHOST laboratory will support next generation sequencing for research projects supported by this FOA. GHOST is a comprehensive system that includes next-generation sequencing (NGS) technologies, bioinformatics and computational approaches. GHOST will aid in establishing HCV transmission links, outbreak investigations and molecular surveillance. The GHOST laboratory will enable state and local health departments to investigate HCV outbreaks and to identify HCV transmission networks among PWID. By delineating transmission networks, the site selected under RFA-DA-17-023 will provide sequence data to guide public health interventions for disrupting transmission of HCV disease in PWID communities. The GHOST laboratory will accept specimens from participating sites funded under this FOA (RFA-DA-17-014) and participate in testing specimens, depositing sequences and analyzing transmission links among PWID using GHOST. In addition to collecting specimens from all participating sites funded under this FOA, the GHOST laboratory also will be responsible for storing and shipping specimens to CDC for syphilis testing, phylogenetic mapping for HIV and HCV, and, as needed for validation of GHOST testing.

NOTE: Should no GHOST site be funded under RFA-DA-17-023, each of the funded Community Response sites funded under this FOA will collect, store, and ship specimens to CDC for syphilis testing and phylogenetic mapping for HIV and HCV, as well as for GHOST testing. Applications should describe how specimens will be collected, stored and shipped for these scenarios.to allow testing of de-identified specimens by CDC. CDC results will not be used for diagnostic or treatment purposes.

Applicant organizations applying under this FOA also are welcome to apply to RFA-DA-17-023 (for the GHOST laboratory) as long as this is done with a separate application (e.g., separate aims, objectives, research strategy, budget, etc.). Single applications for that combine both FOAs will not be accepted.

RFA-DA-17-023 (GHOST laboratory) applications will be scored and rank ordered separately from applications to this FOA. It is anticipated that only one GHOST laboratory application will be funded. No preference will be given to organizations that apply for one or both FOAs.

Projects to be funded in multiple sites by this FOA will have an initial phase, funded for two years under the UG3 mechanism, which will include epidemiologic and policy assessment, followed by formulation of local plans for new or modified services in response to these assessments, including plans for implementation and evaluation. The assessments of local epidemiology should address drug use and its infectious disease consequences (e.g., HIV, HCV, HBV, and STDs), and other adverse health consequences (e.g., overdose), as well as assessment of local infrastructure and policy that may facilitate or inhibit program and service improvements. Typical infrastructure includes public health testing facilities, community health centers including federally qualified health centers, HIV prevention and Ryan White planning groups, and HIV prevention and treatment services supported through these mechanisms, drug use coalitions, and drug treatment facilities. Although opioid injection is the primary focus, injection of other substances and non-injection substance use among PWID should be addressed.

Multi-method projects are expected with a clear plan for integrating approaches such as analysis of PWID networks, epidemiologic surveys, laboratory analyses, document reviews, ethnographic methods, program data surveys, and collection of biologic specimens. These assessments are expected to engage stakeholders and provide foundations for optimized community-based programming to facilitate: linkage to prevention services, including SSPs (unless prohibited by law) and treatment for substance abuse; testing, care, and treatment for HIV, HCV, and HBV; detection and management of STDs; and improving surveillance to detect outbreaks. Programming to prevent new opioid use, prevent transitions to injection, and prevent overdose, also should be included. Consideration should be given to improving the quality and speed of screening and diagnostic testing for blood-borne pathogens including HIV, HCV, HBV and STDs. In short, the UG3 should provide data that can identify and address steps necessary to fill gaps in the local public health and health care systems to mitigate existing injection epidemics and prevent new ones.

The new or modified programming and the data collected to inform policy that result from the UG3 phase will be the subject of the UH3 phase of the Community Response Projects and will be supported for a maximum of three years. These projects should propose an integrated model of service delivery and include a plan for evaluating the initial efficacy of this model with particular attention to evaluation of outcomes for interventions that fill gap areas. The plan also should address factors related to successful implementation and sustainability. There should be an estimate of the PWID population to be served and scientific justification for the study aims to be undertaken.

Efforts are encouraged to identify innovative service delivery approaches such as telehealth, justice system-based programs, integration with existing clinical infrastructure, or the use of non-traditional service delivery venues. Novel approaches to service financing are encouraged, including braiding of funding streams and incorporation of public and third-party insurance, particularly where Medicaid expansion has occurred. Collaborations with state and/or local health departments are considered to be a key factor for the successful community engagement of appropriate implementing partners, as well as for strengthening and developing local data collection systems that will sustain monitoring and response to future drug use and injection epidemics and their infectious disease consequences. Although the primary focus is on services that prevent HIV, HCV, and other consequences of opioid injection, approaches are encouraged that incorporate efforts to address structural factors which may influence drug use in these communities.

The UG3 and UH3 projects should reflect the demographic composition of local opioid injection epidemics. These epidemics have been characterized by younger individuals than in past urban opioid injection epidemics, but this may vary by locality. There is also particular concern about minors and young adults because of the chronic, relapsing nature of opioid misuse and injection and the long-term effects of these conditions on physical, psychosocial and neurocognitive development. These epidemics especially have been characterized by affecting young, non-Hispanic white and rural PWIDs who have transitioned from use of prescription oral opioids to heroin and other opioid injection. Recruitment is encouraged to include minors (those under the age of 18 years), as appropriate, as well as representation of all genders, sexual minorities, and racial/ethnic minorities. The local epidemics that are the focus of the UG3/UH3 projects may have social, sexual, or drug use network connections to other HIV-infected populations (e.g., gay men or sex workers) or to HIV or HCV epidemics in nearby communities---these may warrant examination in these UG3/UH3 projects (e.g., analysis of partner patterns) but these should not become the primary focus of the UG3/UH3 projects.

Only domestic projects taking place in the United States will be supported. Applications must target communities at greatest risk of adverse events related to opioid abuse (e.g., HIV or HCV transmission, opioid overdose deaths). Resources that may be helpful in identifying areas with documented evidence of significant opioid-related HIV risk include: (1) CDC data on overdose deaths: http://www.cdc.gov/drugoverdose/data/statedeaths.html; (2) data sources outlined in the Department of Health and Human Services Implementation

Guidance to Support Certain Components of Syringe Services Programs, 2016 (Appendix 1, Section I): https://www.aids.gov/pdf/hhs-ssp-guidance.pdf; (3) recent CDC estimates of county-level HIV and HCV vulnerability by van Handel et al., County-level Vulnerability Assessment for Rapid Dissemination of HIV or HCV Infections among Persons who Inject Drugs, United States, Journal of Acquired Immuno-Deficiency Syndromes (2016) and (4) CDC Surveillance for Viral Hepatitis United States, 2014 https://www.cdc.gov/hepatitis/statistics/index.htm

Applicants will need to demonstrate that their projects target rural areas of the United States. They should provide a rationale for this rural focus that makes use of the multiple US government criteria for rural geography and/or other allowances based on population size that are mentioned below. There are a number of different geographic classifications for rural including those developed by the US Census Bureau, the National Center for Health Statistics, the US Department of Agriculture and the Health Resources and Services Administration (HRSA). These definitions vary in their level of restrictiveness and their relationship with rural health and public health service programs. The following is a HRSA-supported website that provides links for these criteria and an interactive decision tool that may be helpful to applicants in developing their rationale: https://www.ruralhealthinfo.org/am-i-rural/help. In addition, projects that are based in Micropolitan Statistical Areas, as defined by the US Office of Management and Budget https://www.whitehouse.gov/sites/default/files/omb/assets/bulletins/b10-02.pdf will be considered responsive as will projects that are based in Metropolitan Statistical Areas of 250,000 persons or less.

Because of the epidemiology of opioid use in Appalachia and the limited public health resources in this region, applications targeting rural counties in the Appalachian Region are particularly encouraged. The Appalachian Regional Commission (ARC) has committed up to $750,000 through the multi-agency POWER 2016 initiative for first year funding of projects. POWER 2016 targets federal resources to help communities and regions that have been affected by job losses in coal mining, coal power plant operations, and coal-related supply chain industries due to the changing economics of US energy production. For this initiative, ARC funds will be awarded only to projects serving coal- impacted communities in the Appalachian Region which are those located within and targeted to communities or regions that have been impacted, or can reasonably demonstrate that they will be impacted, by employment loss in coal mining, coal power plants, or in the supply chain industries of either. Supply chain industries include, but are not necessarily limited to, manufacturers of mining equipment and parts for coal-fired powerplants as well as transportation companies that carry coal. For information about ARC and the 420 counties in the Appalachian Region, see www.arc.gov/counties.

Projects funded under this FOA will be expected to collaborate with a site to be funded under RFA-DA-17-023 to build capacity for Global Hepatitis Outbreak and Surveillance Technology (GHOST), a comprehensive system that includes next-generation sequencing (NGS) technologies, bioinformatics and computational approaches. GHOST will aid in establishing HCV transmission links, outbreak investigations and molecular surveillance. The GHOST laboratory enables state and local health departments to investigate HCV outbreaks and to identify HCV transmission networks among PWID. By delineating transmission networks, the selected site will provide sequence data to guide public health interventions for disrupting transmission of HCV disease in PWID communities. Together with CDC’s Division of Viral Hepatitis Laboratory Branch, the funded GHOST laboratory will accept specimens from participating Community Response Project sites funded under this FOA and provide viral sequences that will be automatically analyzed at each site, using the GHOST website, to identify HCV transmission links among PWID. In coordination with the CDC laboratory, the GHOST laboratory will participate in testing specimens, depositing sequences and analyzing transmission links among PWID using GHOST. The GHOST laboratory is expected to be integrated with the programs of other sites namely to be testing specimens from them.

SAMHSA is interested in supporting substance use disorder treatment and recovery support services related to projects related to this RFA. This includes evidence-based substance use disorder prevention and treatment interventions for clients living with or at high risk for HIV, HCV and related comorbidities in rural communities impacted by opioid injection drug use. SAMHSA's specific interests include client referrals and linkages to medication-assisted treatment (MAT), antiretroviral therapy (ART), Hepatitis A virus (HAV) and HBV vaccination, HCV treatment and syringe service programs (SSPs) along with methods for collecting information confirming client receipt of these types of services. SAMHSA also is interested in supporting testing clients for HIV, HCV, HBV and other sexually transmitted infections (STIs)

Applications including the following types of studies will be considered non-responsive and will not be reviewed:

• Phase III clinical trials
• Cohort studies
• Studies of communities outside the United States or its territories
• Studies whose aims are not focused on the areas identified by the FOA
• Studies that do not include collaboration with a state or local health department, as evidenced by a letter of support and description of collaborative activities in the application
• Studies not focused on rural communities
• Studies that do not include collaboration with a state or local substance abuse agency

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at

http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see (http://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html) for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

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)
• 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 not 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 Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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. 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 NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to: [email protected]

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative, the letter may also be sent to:

Office of Extramural Policy and Review
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550

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 FOA.

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 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 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:

Specific Aims: Provide the overall goals or hypotheses for the entire project and indicate separate Specific Aims to be accomplished in the UG3 phase and in the UH3 phase.

Research Strategy: In preparing the application, investigators should consider that the application will be assigned a single overall impact score. Thus, clarity and completeness of the application with regard to specific goals and the feasibility of each phase and the transition milestones are critical.

For all applications, separate sections that describe the UG3 and the UH3 phases are required. It is not necessary to repeat information or details that are described in the UG3 section in the UH3 section.

The following elements need to be addressed in the Research Strategy:

UG3 Section

The UG3 section should describe the methods to be used to evaluate current epidemiology, services available to the community, patterns of service use, and relevant laws and policies governing services that are related to the prevention and treatment of HIV, HCV and associated comorbidities of injection drug use (e.g., HBV, STDs, opioid overdose) among PWID. The UG3 phase should include services such as drug treatment (including medication-assisted treatment), SSPs and access to syringes outside of program environments (e.g., non-prescription access from pharmacies or other retailers), and referral for HBV vaccination.

The UG3 application should describe multi-method projects with a clear plan for integrating data from diverse approaches such as, public health surveillance, epidemiologic surveys, laboratory analyses, PWID network analysis, document reviews, ethnographic methods, program data surveys, collection of biologic specimens and data from outcomes of referral and linkage, as well as HIV, HCV and drug treatment outcomes.

The UG3 assessments are expected to engage local stakeholders (e.g., public health, clinical care, drug treatment, law enforcement) and provide foundations for optimized community-based programing to: facilitate testing, care, and treatment for HIV, HCV, and HBV; facilitate entry into SSPs (unless legally prohibited) and treatment for substance use disorders (including medication-assisted treatment); prevent overdose; and improve detection and management of STDs and related comorbidities. Consideration also should be given to improving the quality and speed of screening and diagnostic testing for blood-borne pathogens including HIV, HCV, and HBV and STDs.

UH3 Section

The UH3 section should include a description of service delivery model(s) that will be evaluated. A comprehensive, integrated model of service delivery is expected, although not all possible elements may be possible to implement for reasons of local policy and/or logistics. Applicants are encouraged to establish or scale-up evidence-based substance abuse harm reduction and HIV and HCV prevention services including: SSPs, medication assisted treatment, provision of naloxone to reverse overdose, testing for HIV, HCV, and HBV, linkage to antiretroviral therapy (ART) for HIV-infected PWID, linkage to HCV treatment for PWID with HCV infection and referral to vaccination services to prevent HBV and HAV infections. These services should consider non-traditional forms of delivery and consideration of novel fixed sites (e.g., jails, emergency departments, drug treatment settings, SSPs), information technology, as well as mobile or other community-based approaches.

The UH3 project should include description of primary outcome measures that will be used to evaluate service delivery models, including indicators for monitoring opioid use and unsafe injection use, entry into HIV and HCV treatment, viral suppression of HIV, and HCV reinfection.

The UH3 also should include steps to sustain monitoring and evaluation systems for public health agencies to provide epidemic surveillance and continue surveillance beyond the life of this project by state and local health departments.

A description of the analytic plan for the UH3 phase of the research, including statistical and other methods to be employed should be included.

The UH3 should collect cost data that can be used to evaluate the utility of the implementation of new or enhanced services during this project phase.

For both the UG3 and UH3 portions, the following elements need to be addressed in the Research Strategy:

• If appropriate, a description of any additional considerations needed to enroll persons under age 18 years.
• The investigator team as a whole need to include group experience in the delivery drug treatment and/or infectious disease services, as well as experience in the collection, processing, storage and shipment of specimens. Team experience of the group as a whole with cooperative agreements and other multi-site study models incorporating common protocols and data harmonization should be noted. This information should not repeat information on individuals' biosketches.
• Plans to protect the security of participants personally identifiable information. A discussion of any impediments that could require an addendum to the research plan, milestone, or timeline with a discussion of alternative approaches.
• A description of previous experience with cooperative agreements or with multi-site studies that included components such as common protocols or data harmonization.
• A strategy to collaborate with state and/or local health departments and substance abuse agencies during development and delivery of program services and for disease surveillance.
• A description of laboratory testing algorithms including plans for specimen storage, processing and shipment to local or CDC reference laboratories.
• Sites must test all study participants for HIV, HCV and HBV locally, and are encouraged to also test for syphilis as per CDC guidelines for diagnosis and treatment.
• Plans by local laboratories to conduct HBV and HCV tests as per CDC testing recommendations, including HCV RNA tests for antibody positive samples, at a minimum.
• Sites are encouraged to use HIV tests with sensitivity for early and acute HIV infection such as laboratory-based HIV combination antigen/antibody assays (http://stacks.cdc.gov/view/cdc/23447). In certain outreach situations, rapid point-of-care assays may be preferable and more feasible but persons with reactive rapid results should have venipuncture for laboratory-based confirmatory testing.
• Plans for HIV-infected participants to also receive commercial genotype sequencing of the pol gene (including the integrase region) to assess for drug resistance and the sequence of the pol gene will be sent to CDC.
• A plan to collect and send serum specimens from HIV- and HCV-infected participants to the GHOST site or to CDC to be analyzed using GHOST and to CDC for syphilis testing and phylogenetic mapping for HIV and HCV (CDC results will not be used for diagnostic or treatment purposes).
• A description of plans for referral of persons with HIV, HCV, and associated comorbidities to appropriate services in the community and methods for collecting information of their receipt of follow-up services.
• A description of how the provision of substance use disorder screening, assessment and treatment services will be included in the project and a plan to collect substance abuse treatment outcome data.

Timelines

Applicants are required to propose well-defined timelines for the entire project; i.e., both the UG3 and the UH3 phases. Applications must describe timelines that could include, but are not limited to, meeting specified enrollment targets including persons reached for HIV/HCV testing (and retention rates for the UH3 phase), detection of a targeted number of new HIV or HCV cases within the two-year period of the UG3 phase.

Applications lacking timelines for the UG3 and the UH3 phase will be considered incomplete and will not be reviewed

Applicants must include clearly identified milestones for successful completion of the UG3 phase at the end of Year 2 and transition to the UH3 phase for 3 years of additional funding. A restatement of an application specific aim is not considered an adequate transition milestone.

Applications lacking milestones for the transition from the UG3 to the UH3 phase will be considered incomplete and will not be reviewed

Examples of project milestones for the UG3 versus the UH3 phases of study could include, but are not limited to, the following types of benchmarks. Applications should provide a timeline for successful completion of the proposed activities.

An example of UG3 project milestones might include completion of the following during Phase I of the study:

• Developing and implementing research study protocols and consent forms necessary to support their proposed UG3 projects, including protocols that support core cross-site data collection (e.g., common survey or interview instruments, common laboratory methods and assays)
• Identifying stakeholders, facilitators, and resources and providing access to medical care, including HIV, HCV and STD testing, prevention, and treatment, and substance abuse treatment and prevention services.
• Obtaining appropriate local Institutional Review Board(s) approvals for all participating study sites, as required.
• Identifying and enrolling the targeted study populations, as proposed, with adequate sample sizes for the purpose of statistical analysis.

UH3 project milestones will include successful attainment of the UG3 project milestones as well as:

• The presence of a comprehensive, integrated service delivery plan for PWID that enables testing, prevention, and treatment of HIV, HCV, and associated comorbidities. Specifics may vary depending on local policies, but access to HIV and HCV screening and treatment, as well as verifiable linkage to prevention, care and treatment services will be expected. If warranted, this may include access to SSPs, access to opioid agonist therapy. Decisions to begin or defer HCV therapy and other associated HCV treatment outcomes will be considered.
• Adequate levels of HIV or HCV prevalence to warrant continued resources for data collection.
• Provisions for follow-up assessment and testing for HCV and STD infection or reinfection.
• Agreements to secure HCV laboratory services for sequencing and assessment of transmission networks. Participants with HIV infection should receive pol gene sequencing (including the integrase region) to assess for drug resistance as part of clinical care. HIV sequence data should be submitted to the state health department and CDC to evaluate for evidence of transmission networks.
• Indications that there is local commitment to continue programmatic improvements and program monitoring beyond the project period.

Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of laboratories, health department(s), and other collaborators. If co-funding or in-kind support is planned from non-NIH sources, letter(s) outlining details of the commitment (e.g. type, amount and source of support), signed by a business official on organization letterhead, and must be included in the Letters of Support.

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.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Projects funded under this FOA are expected to work collaboratively toward core data collection measures and methods that will enable the construction of data sets that are harmonized and facilitate progressive data sharing models. Consistent with achieving the goals of the program, finished, de-identified datasets are expected to be made available for the research community at the close of the study through deposit at the National Addiction and HIV Data Archive Program: https://www.icpsr.umich.edu/icpsrweb/content/NAHDAP/about.html or another site to be determined by the Executive Steering Committee of the cooperative agreement. Steps also are expected that enable sharing of research findings with the broader research and, public health, and health services communities. Applications are, therefore, expected to provide a well thought-out plan for widely sharing data and resources generated by the research project. After all awards have been made, the Executive Steering Committee, composed of members of the funding agencies and the individual project teams will develop a unified policy for data and resource release, such as harmonized interview instrument(s) and other data collection. During the study the Executive Steering Committee will consider as a group (and usually by consensus) various proposals to analyze aggregate data and will support such efforts. The application is expected to include a statement that the investigators will abide by the Executive Steering Committee’s data and resource policy, consistent with the relevant NIH policies, laws and regulations.

Use of Common Data Elements (CDEs) such as those defined on the on the National Library of Medicine website (https://www.nlm.nih.gov/cde/) is encouraged.

It is anticipated that applicants may propose new approaches for informed consent that improve participant understanding and allow for use of data across a range of health and other electronic platforms.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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 Policy on Late Application Submission.

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.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number 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 components of participating organizations, 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 NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: The UG3/UH3 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. A UG3/UH3 grant application is not required to have extensive preliminary data, background material or preliminary information, but these may be included if available. Appropriate justification for the proposed work can also be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will assign a single impact score for the entire application, which includes the UG3 and UH3 phases.

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).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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? Do applications target communities at greatest risk of adverse events related to opioid abuse? Do projects hold promise for advancing knowledge concerning burden of disease associated with opioid injection and its comorbidities and factors associated with utilization of care and prevention services among injectors? Will projects advance knowledge about providers and systems and their capacity to integrate injectors and their needs into existing or novel services?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?Do the PDs/PIs, co-investigators, and collaborators include key personnel who have demonstrated experience with rural PWID?

Do investigators have experience with systems for delivering drug treatment and/or infectious disease services? Are co-investigators or collaborators from state and/or local health departments included on the investigative team? Do investigators show evidence of adequate experience in collecting, processing and storing specimens for proper HIV, HCV, and STD testing? Do the investigators have experience with cooperative agreements or other multi-site studies that require collaboration among project sites such as common protocols, use of a common reference laboratory or data harmonization?

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? Does the project propose novel, plausible solutions to the problem of bringing drug use and infectious disease services to rural, low population density environments? Are novel approaches taken to bring comprehensive health services, including drug treatment services, to areas where such services do not exist?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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?

How well does the research project clearly identify a scientifically justifiable strategy for the UG3 phase of the project? How well does the project's conceptual framework clearly inform the analysis of data and potential pathways for the UH3 phase? How well does the research project represent a significant leap from incremental knowledge-gathering to a practical application---how well will this project help establish new standards for epidemiological and policy assessment and the use of data for program planning and evaluation? How successful is the UH3 phase in proposing novel intervention/service delivery approaches that have a clear pathway from the UG3 data?

How adequate, clear and well-justified are the monitoring and evaluation indicators and outcome variables for the UH3 phase? Are potential problem areas acknowledged and how adequately are alternative approaches considered? How achievable are the proposed milestones for the 2-year period of the UG3 grant? How well do HIV, HCV, HBV, and STD testing reflect CDC recommendations, and how adequate are the proposed services and resources for referral and linkage to HIV, HCV, HBV, and/or STD care and follow-up (including viral load or resistance testing, as appropriate) as per CDC or relevant clinical guidelines?

How adequately do applications describe plans for the collection, storage, and shipment of Samples to the GHOST Laboratory site to be funded under RFA DA 17-023, and to CDC via the GHOST laboratory site? Does the proposed collaboration with state or local health departments ensure that all public health reporting of infectious disease diagnoses (i.e., HIV and HCV) and linkage to care occurs and how adequate are the proposed procedures?

Do the proposed projects follow current CDC recommendations for HCV testing including HCV antibody (anti-HCV) testing with reflexive HCV RNA, if screened positive, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBcAg), and anti-HBsAg testing? How consistent is the confirmation of HIV infection status in relation to CDC’s 2014 testing recommendations (http://www.cdc.gov/hiv/pdf/hivtestingalgorithmrecommendation- final.pdf) with confirmatory testing with an HIV differentiation assay, if screened positive? Are strategies included to detect acute HIV infection (e.g., combination HIV antigen/antibody assays) in communities with documented HIV transmission and, if so, how adequate are these?

Do projects identify local resources and partners who can provide HIV and HIV co-morbid Infection prevention services for PWID as well as HBV, HCV and STD treatment so that PWID and do these adequately provide access to evidence-based interventions? Does the project include HIV prevention services that may include, but are not limited to, HIV and HCV testing that targets PWID, SSPs, medication-assisted treatment, provision of naloxone to reverse opiate overdoses, pre-exposure prophylaxis programs (PrEP), and linkage to antiretroviral therapy (ART) for HIV-infected PWID? If some of these services are unavailable or difficult to access during the UG3 project period, how strong is the justification and how adequate are efforts to remediate these gaps in plans for the UH3 phase of the study? How plausible is the rationale for engaging stakeholders who are not directly engaged as members of the project team, as stakeholder engagement will be crucial to the UG3 and UH3 projects?

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 children, justified in terms of the scientific goals and research strategy proposed?

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?

Does the application clearly describe how the applicant will partner with state and/or local health departments in their proposed activities? Does the application include supporting documentation such as letters of support, memoranda of understanding, etc. that clearly describe the nature of proposed collaborations with state and/or local health departments? Does the application include the same type of documentation for proposed collaborations with other parties such as additional state and local government agencies (e.g., law enforcement, courts, and criminal justice or social service administration), local health care providers, or academic researchers? Will the environment where the research will be conducted have adequate facilities to collect, process, and store clinical specimens for later testing?

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.

For research that involves human subjects but does not involve one of the six 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 six 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.

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 children 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.

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 Animal Section.

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.

Not Applicable

Not Applicable

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.

Not Applicable

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).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS). A Genome Data Sharing Plan should be included in each application. Any sequences from individuals need to be de-identified and made available through the NIH database dbGap (http://www.ncbi.nlm.nih.gov/gap). Informed consent forms must include language that enables sharing of de-identified genomic information derived from samples via this database or other databases.

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.

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

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:

• 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.
• Will receive a written critique.

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

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 FOA. Following initial peer review, recommended applications will receive a second level of review by the NIDA Advisory Council or Board. 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.

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.

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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 FOA 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.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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.

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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

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 45 CFR Part 75, 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 awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

• Prior to the end of the UG3, awardees will submit the transition package, which will include the UG3 progress report delineating progress toward achieving UG3 milestones.
• All aspects of their study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators.
• The awardee agrees to accept close coordination, cooperation, and participation of NIH, CDC and other federal staff in those aspects of scientific and technical management of the study including those outlined under "NIH, CDC, and Other Federal Staff Responsibilities" and to work cooperatively with other awardees where it is scientifically advantageous to pursue common methods and protocols.
• Awardees will participate in annual meetings of the awardees, will provide representation to the Executive Steering Committee (ESC, see below) and will support any other committees, task forces, and advisory panels related to the project, as needed and will participate in regularly scheduled conference calls with the awarding agencies. Project budgets should include travel for participation in these activities.
• Upon implementation of the project, each awardee will follow the procedures required by the protocol regarding study conduct and monitoring, data collection, and implementation of clinical guidelines or disease reporting, as needed.
• Awardees will store and provide to the GHOST site (or CDC in the event that a GHOST site is not funded) adequate volumes of specimens to perform testing through Global Hepatitis Outbreak and Surveillance Technology (GHOST), and to CDC (via the GHOST site) adequate volumes of serum for syphilis testing, phylogenetic analyses to map HIV transmission networks, and other tests as needed.
• Support or other involvement of industry or any other third party in the study--e.g., participation by the third party; involvement of project resources or citing the name of the project or the NIH support; or special access to project results, data, findings, or resources--may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur with the concurrence by the NIH Program Officer to ensure objectivity of research.
• Obtaining prior written approval of the NIH Grants Management Specialist in consultation with the NIH Program Officer for a change in any of the key personnel identified in the Notice of Award.
• Award recipients will own the rights in any tangible work products created under the terms of the cooperative agreement. Work products may include such things as research reports, papers, research, findings, training curricula, data sets, books, patient tools, and other materials. All such products shall be made accessible to the public under NIH’s Public Access Policy https://publicaccess.nih.gov/ and are subject to Government rights of access, as appropriate, in accordance with NIH’s legal directives and authorities.

NIH, CDC, and Other Federal Staff Responsibilities. NIH and CDC staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The NIH and CDC Project Scientists will have access to the data and work with the PD(s)/PI(s) to ensure the objectives of the program are being met. The primary responsibility for the program resides with the awardee, although specific tasks and activities will be shared among the awardee and the NIH and CDC Project Scientists.
• NIH and CDC staff will act resources and facilitators for activities of the awardee, and will coordinate activities with federal and non-federal agencies outside of the project awardees. A project Executive Steering Committee (ESC) with representation from CDC, NIH and the project sites will be organized to facilitate regular communication among awardees, NIH, CDC and other federal agencies such as the Appalachian Regional Commission, SAMHSA, or HRSA which may have programmatic interests in the projects or may co-fund the overall RFA or individual projects. The ESC also may engage members who provide substantive scientific, programmatic, or clinical knowledge from academia, government, private industry or other relevant sectors.
• The NIH, as primary funder and administrator reserves the right to phase out or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting, and will do so with the consultation of other federal partners. NIH support of this study is contingent upon adequate participant recruitment based on the Grantee’s Milestone Accrual Plan submitted at the time of funding.
• The Grantee is expected to demonstrate best effort compliance. Failure to achieve minimally acceptable milestone recruitment levels may result in the withholding future support and/or negotiating an orderly close-out of this study.
• NIH and CDC will serve as resources to provide: scientific/programmatic support in the development and modification of study protocols and the design of project activities; advice in the selection of sources or resources; advice in management and technical performance; and assistance in the preparation of publications, as warranted.
• Participate in the monitoring of issues relating to recruitment, retention and follow-up of study participants, and monitoring of data integrity and quality control through consideration of the annual reports, site visits, patient logs, etc. This review may include, but is not limited to, compliance with the study protocol, meeting patient enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting as needed to the administration and evaluation core.
• NIH and CDC Scientific Program Officers will interact with the PD(s)/PI(s) on a regular basis to monitor progress. Monitoring may include: regular communication with the PD(s)/PI(s) and his/her staff, periodic site visits for discussion with the awardees research team, observation of field data collection and management techniques, fiscal reviews, and other relevant stewardship matters.
• CDC will take primary responsibility for matters such as reporting of communicable diseases, review of laboratory protocols, and provision of specialized laboratory testing. Testing of samples by CDC will utilize Global Hepatitis Outbreak and Surveillance Technology (GHOST), syphilis testing and phylogenetic analyses to map HIV transmission networks.
• Additionally, NIH and CDC will appoint Program Officials who will be responsible for the normal scientific and programmatic stewardship of the award; will be named in the award notice; and serve as Agency representatives to the Executive Steering Committee.

Areas of Joint Responsibility include:

• The PD(s)/PI(s) provide, in concert with the NIH staff, support necessary to ensure that sites and investigators, and NIH and other research partners fully comply with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.
• Awardees and NIH will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data on individual health care provider organization patients, health care providers and other institutions.
• All awardees and NIH will cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers and health care systems engaged in research in health care settings.
• The Project ESC will facilitate these joint activities and, in particular, provide facilitation of research protocols, human subjects and other regulatory protocols (including adverse event reporting), data harmonization, manuscript and other information dissemination planning, and initial clearance of manuscripts or other dissemination products.

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. It will have three members: a designee of the Grantee chosen without NIH staff voting, one NIH designee, and a third designee from CDC 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 awardee. This special dispute resolution procedure does not alter the awardee'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.

When multiple years are involved, awardees 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 progress report, 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 Award Term and Conditions for Recipient Integrity and Performance Matters.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Richard A. Jenkins PhD
National institute on Drug Abuse (NIDA)
Telephone: 301-443-1923
Email: [email protected]

Walter (Paul) Smutz, PhD
National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP)
Telephone: 404-718-8830
Email:[email protected]

Mark Swieter, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5844
Email: [email protected]

Edith Davis
National Institute on Drug Abuse (NIDA))
Telephone: (301) 827-6697
Email: [email protected]

Carla Harper
National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP)
Telephone: 770-488-2439
Email: [email protected]

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, 247 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75, USU Title 40, Subtitle IV - 40 USC Sec. 14306(a)(7) and USC Title 40, Subtitle IV - 40 USC Sec. 14306(b)(2) and the PHS Act (42 USC 241) and 31 USC 6305, the Federal Tort Claims Act [28 U.S.C. 2671-80 (1976)].