Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

Integrating Substance Abuse Prevention and Treatment within HIV/AIDS Service Delivery Settings (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number

RFA-DA-14-011

Companion Funding Opportunity

RFA-DA-14-009, R01 Research Project Grant
RFA-DA-14-010, R01 Research Project Grant
RFA-DA-14-012, R21 Exploratory/Developmental Grant
RFA-DA-14-007, U01 Research Project – Cooperative Agreements

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.279  

Funding Opportunity Purpose

To improve understanding of the intersection of HIV/AIDS and drug abuse, this Funding Opportunity Announcement (FOA) is part of a multipronged 2014 expansion of HIV and AIDS related research within the context of drug and alcohol abuse among understudied populations and in understudied settings that show promise for the development of effective prevention and treatment efforts. In addition to this funding opportunity, others included in the 2014 expansion address HIV/AIDS and substance use among the homeless and unstably housed (RFA-DA-14-009); substance use, HIV, and Black/African American women and young Men who have Sex with Men (MSM) (RFA-DA-14-010); exploratory research on comorbid HIV, chronic pain, and substance use among older adults (RFA-DA-14-012), and Seek, Test, Treat, and Retain Data Harmonization Coordinating Center (RFA-DA-14-007).

Efforts to prevent, detect, and treat drug and alcohol abuse, addiction, and their consequences can be improved by integrating existing evidence-based approaches into clinical settings in which high-risk populations are currently engaged in care for common co-occurring conditions. Of high priority are those settings in which individuals receive ongoing care for HIV/AIDS, but which do not routinely deliver evidence-based drug and alcohol abuse screening, prevention, and treatment services. Such settings include freestanding or hospital-based comprehensive HIV centers, community-based AIDS service organizations, and other HIV service providers supported by the Ryan White HIV/AIDS Program and other state and federal funds for HIV services. Service integration is equally needed in prevention-oriented settings (including sexually-transmitted infection [STI] clinics) where screening for drug and alcohol problems can be integrated with screening for HIV and other conditions. NIDA encourages hypothesis-driven research project applications to test implementation strategies for integrating evidence-based substance abuse services with HIV care in these settings.  

Key Dates
Posted Date

June 10, 2013

Open Date (Earliest Submission Date)

October 15, 2013

Letter of Intent Due Date(s)

October 15, 2013

Application Due Date(s)

November 15, 2013), 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.

AIDS Application Due Date(s)

November 15, 2013

Scientific Merit Review

February/March 2014

Advisory Council Review

May 2014

Earliest Start Date

July 2014

Expiration Date

November 16, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in 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.

Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Background

To improve understanding of the intersection of HIV/AIDS and drug abuse, this Funding Opportunity Announcement (FOA) is part of a multipronged 2014 expansion of HIV and AIDS related research within the context of drug and alcohol abuse among understudied populations and in understudied settings that show promise for the development of effective prevention and treatment efforts. In addition to this funding opportunity, others included in the 2014 expansion address HIV/AIDS and substance use among the homeless and unstably housed; substance use, HIV, and Black/African American women and young Men who have Sex with Men (MSM); and exploratory research on comorbid HIV, chronic pain, and substance use among older adults.

Medical care settings routinely provide for the detection, prevention, and treatment of a wide range of chronic diseases and health conditions. However, services related to the prevention and treatment of substance abuse remain serious exceptions to these standard provisions. The result is fragmented, incomplete care and missed opportunities for drug and alcohol abuse prevention and treatment. Such service fragmentation is apparent in settings providing testing, support services, and ongoing care for HIV/AIDS. Substance use increases the risk of contracting HIV and other infectious diseases, including Hepatitis C (HCV), tuberculosis (TB), and sexually transmitted infections (STIs). Thus, most patients receiving ongoing treatment for these conditions could benefit from an integrated care plan that includes drug and alcohol abuse screening, and prevention and treatment services.

There exist numerous drug and alcohol prevention interventions and addiction treatment services with demonstrated efficacy or effectiveness. Treatment of substance abuse leads directly to reduced HIV risk and reduced risk of related co-infections. Engaging HIV-infected substance abusers in effective addiction treatment reduces drug-related HIV risk behaviors (Gowing et al., 2011) and can simultaneously promote engagement and adherence to HIV treatment regimens (Uhlmann et al., 2010); likewise, engagement in antiretroviral therapy is associated with reductions in injection drug use and sexual risk behaviors (Fu et al,. 2012). As such, addressing both conditions in an integrated fashion can have dually beneficial outcomes. However, persistent stigma associated with substance abuse may be associated with the delay or withholding of evidence-based HIV care (Westergaard et al., 2012). Research is needed to identify and address the barriers and facilitators of implementing effective interventions and service delivery models for substance abuse and HIV prevention and treatment in an integrated fashion in comprehensive HIV centers and related settings.

Research Objectives

This FOA will support multidisciplinary implementation research to enhance the adoption of evidence-based prevention, screening, and treatment of substance abuse across the age spectrum of clinical populations, and in HIV centers and closely related medical settings. Clinical settings of greatest interest as study sites for this FOA are those that are primary providers of medical services for persons with HIV/AIDS or at highest risk for HIV/AIDS. Such settings include freestanding or hospital-based comprehensive HIV centers, community-based AIDS service organizations, and other HIV service providers including but not limited to those supported by the Ryan White HIV/AIDS Program and other state and federal funds for HIV services.

Applicants should partner with organization(s) having sufficient infrastructure and patient flow to support robust implementation studies of novel service delivery models and/or discrete evidence-based alcohol and drug abuse prevention or treatment interventions. Study sites may include one or more large medical centers, or an existing network or coalition of HIV/AIDS service provider organizations; the latter may be particularly appropriate in geographically remote areas or those with relatively low HIV prevalence. Applications proposing to conduct research solely in specialty addiction treatment settings, or solely in non-medical settings – i.e., without the direct involvement of one or more specialty HIV care settings – will be considered non-responsive to this FOA.

Definitions

NIDA requests applications that test the implementation of (a) a service delivery model, and/or (b) one or more specific, evidence-based substance abuse prevention or treatment interventions.  For the purpose of this FOA, a “service delivery model” refers to the manner in which clinical services are organized, managed, administered, and/or reimbursed.  Such studies might test, for example, the implementation of a chronic care model which requires the reallocation of existing responsibilities to alternative or additional clinical staff (e.g., case managers).  In addition or by contrast, studies might elect to test the implementation of a specific evidence-based practice (for example, contingency management as a mechanism for promoting retention in care). The goal of either approach should be to enhance the integration of HIV and substance abuse prevention/treatment services within the focal care setting, and to identify appropriate, cost-effective, sustainable, and scalable methods for achieving this integration.  In neither case should investigators be developing or testing novel clinical treatments or preventive interventions.

This FOA calls for implementation research projects rather than clinical trials of new interventions or incremental adaptations of existing evidence-based interventions.  Implementation research is the scientific study of methods to promote the integration of evidence-based clinical interventions and best practices into healthcare practice and policy.  It seeks to understand the behavior of healthcare professionals and support staff, healthcare organizations, healthcare consumers and family members, and policymakers in context as key variables in the adoption, implementation and sustainability of evidence-based interventions, service delivery models, and clinical practice guidelines. Implementation research studies should not assume that empirically-supported interventions can be transferred into any service setting without attention to local context, nor that a unidirectional flow of information (e.g., publishing a recommendation, trial, or guideline) is sufficient to achieve practice change. Likewise, implementation strategies that are limited to clinician training activities are generally insufficient to achieve sustained organizational change. Relevant studies should contribute to a broader knowledge base about how interventions can be most effectively, cost-effectively, and sustainably transported to real-world practice settings, which will likely require more than the distribution of information about the interventions. 

Applicants are encouraged to read the standing NIH program announcement on dissemination and implementation research (PAR-13-055) for a more complete definition of implementation science and its scope in healthcare research. Applicants are also encouraged to consult and draw upon existing NIH implementation research resources, including literature, conceptual models and measures, available from the NIH Office of Behavioral and Social Science Research [http://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/index.aspx] and the National Cancer Institute [http://cancercontrol.cancer.gov/is/]. 

This FOA encourages hypothesis-driven research studies to test conceptual frameworks of the implementation process around a focal clinical practice or service delivery model.  Operational research or program evaluation studies (i.e., projects without a hypothesis-driven, prospective implementation research design) will not be considered responsive to this FOA. Studies may employ randomized designs but are not required to do so. Applicants are encouraged to propose innovative yet rigorous study designs best suited for testing their proposed research hypotheses given the implementation strategy, service delivery model, and/or intervention to be implemented, and the settings in which this work will be conducted.  Because of practical concerns around cost, scale-up and sustainability, implementation interventions relying on clinician training alone will be of low priority relative to more robust, systemic, sustainable, and scalable approaches.

Studies should employ a conceptual model for the proposed implementation process, and the primary outcomes should be measured in terms of the effectiveness of the implementation strategy for achieving the goal of service integration and delivery. Patient-level outcomes may be incorporated to assess the reach of the intervention(s) or as a check on the fidelity of service delivery, but assessing impact of the service model/clinical intervention on substance abuse/HIV outcomes (as in an effectiveness trial) should not be the primary focus of the proposed research.

Areas of Research Interest

NIDA is interested in promoting the integration of substance abuse and HIV prevention and treatment services within HIV care settings. While models for screening, brief intervention and referral to treatment (SBIRT) for substance abuse may be tested, applicants are encouraged to consider a broad array of prevention and treatment service delivery models that may be optimal for clinics focused on HIV and other infectious diseases. Study designs (including the selection of focal clinical practices and implementation strategies) should consider the unique structural, organizational, financial, personnel, and patient population characteristics associated with these settings and how these influence the fit, feasibility, and sustainability of a selected service delivery model or intervention. An ideal, comprehensive service delivery model would ensure alcohol and drug abuse screening for all clinic patients, with subsequent delivery of indicated prevention or treatment services as needed, and follow-up to ensure engagement, adherence, and retention in both HIV and substance abuse treatment or receipt of prevention interventions. Applicants may address prevention, treatment, or both service domains in their proposed research. Studies may include alcohol and tobacco along with drug abuse as targets for prevention and treatment.

Applicants are encouraged to develop projects that are informed by and are responsive to the goals of the National HIV/AIDS Strategy, including implementation research on the integration of substance abuse and mental health screening in programs that serve communities with high rates of new HIV infections; risk reduction interventions to reduce sexual transmission of HIV among substance using populations; linkage of HIV-positive individuals to needed medical and social services including drug abuse treatment and (for injection drug users) access to sterile needles and syringes, to support reduction of HIV transmission risk. 

Applicants are also encouraged to review the results of HRSA’s Special Projects of National Significance (SPNS) Program, “Integrating Buprenorphine Therapy into HIV Primary Care Settings,” for illustrative examples of service delivery models that could be further tested for replication, implementation, and scale-up, or on which prospective, hypothesis-driven implementation studies of other evidence-based clinical practices could be modeled. This SPNS program is illustrative; applications are not limited to a focus on opioid dependence.  Implementation of evidence-based pharmacotherapies and/or behavioral counseling strategies to address alcohol abuse, stimulant abuse, and other substance use that places users at high risk for exposure to or transmission of HIV are of equal interest.

Many HIV care settings currently offer some form of assessment for substance abuse and referral to treatment services.  It is essential that available services are evidence-based, accessible, and actually received.  Toward that end, studies seeking to change existing clinical practice to promote the adoption of evidence-based practices, and the de-adoption of existing practices that lack an adequate evidence base, are encouraged.

Studies may consider the integration of substance abuse and HIV services within a single physical setting, or across multiple settings/locations.  However, the ultimate goal is to provide seamless, integrated care for patients. Toward that end, service delivery models that rely on referral of patients to one or more physically separate specialty care settings – without structural supports to ensure receipt of the referred service and ongoing coordination of care among service providers – are discouraged.

Other examples of possible research topics include (but are not restricted to):

IC Specific Considerations

National Addiction & HIV Data Archive Program (NAHDAP): NIDA strongly encourages investigators to deposit and/or utilize data sets affiliated with NAHDAP hosted by Interuniversity Consortium for Political and Social Research (ICPSR). For details, please see the following website (http://www.icpsr.umich.edu/icpsrweb/NAHDAP/). For questions or additional information on this program, please contact Dr. Kathy Etz at ketz@nida.nih.gov.

NIDA encourages data harmonization to increase comparability, collaboration, and scientific yield of clinical research on drug abuse and HIV. Towards that end, awardees conducting research directly related to integrating substance abuse prevention and treatment within HIV/AIDS service delivery settings should employ, whenever possible, measures that are consistent across other grants on this topic in order to harmonize data within the following domains: demographic information, substance use history, mental health functioning, HIV testing status, HIV risk behavior, biological markers of HIV, and access/utilization of and adherence to HIV treatment. Awardees are also expected to use monies within the grant to cover travel expenses to attend annual meetings of all grantees funded under RFA-DA-14-011 on data harmonization, to be held in Washington DC. For additional information and examples of data harmonization in other NIDA grants, please see: http://www.drugabuse.gov/researchers/research-resources/data-harmonization-projects/seek-test-treat-retain/addressing-hiv-in-criminal-justice-system

and http://www.drugabuse.gov/researchers/research-resources/data-harmonization-projects/seek-test-treat-retain/addressing-hiv-among-vulnerable-populations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse:  In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing.  NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV.  This policy applies to all NIDA funded research conducted domestically or internationally.  For more information, see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

References cited:

Gowing L, Farrell M, Bournemann R., et al. 2011. Substitution treatment of injecting opioid users for prevention of HIV infection.  Cochrane Database of Systematic Reviews, CD004145.

Uhlmann S, Milloy M, Kerr T, et al. 2010. Methadone maintenance therapy promotes initiation of antiretroviral therapy among injection drug users.  Addiction, 105:907-913.

Fu T, Westergaard R, Lau B, et al. 2012. Changes in sexual and drug-related risk behavior following antiretroviral therapy initiation among HIV-infected injection drug users. AIDS, 26:2383-2391.

Westergaard R, Ambrose B, Mehta S, Kirk G. 2012. Provider and clinic-level correlated of deferring antiretroviral therapy for people who inject drugs: A survey of North American HIV providers. J Int AIDS Soc, 15:10.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIH intends to commit $3 million in FY2014 to fund an estimated 4-6 awards.

Award Budget

Direct costs will vary with the scope of the project but may not exceed $500,000 per year.

Award Project Period

A project period of up to 5 years may be requested.  

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.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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.

Required Registrations

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.

Program Directors/Principal Investigators (PDs/PIs)

All PDs/PIs must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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.

2. Cost Sharing

This FOA 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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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.

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:

The letter of intent should be sent to:  NIDALetterofIntent@mail.nih.gov

Applicants are encouraged to send the letter of intent by email to the address above, but if necessary the letter may be sent to:

Director - DA-14-011
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD  20892-9550

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

Applications should include multidisciplinary teams of investigators who collectively have experience in the areas of implementation science, prevention and/or treatment (as appropriate), and HIV service provision. If a specific clinical intervention is to be implemented, applicant teams should demonstrate inclusion of expertise in that intervention to ensure fidelity of implementation.  The research team should include individual(s) from the practice setting(s) in which the study is to be conducted. 

R&R or Modular Budget

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

Applicants should request funds to cover travel expenses to attend annual meetings of all grantees funded under RFA-DA-14-011 on data harmonization, to be held in Washington DC.

PHS 398 Cover Letter

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: Applications proposing to implement one or more specific preventive interventions or clinical (pharmacological or behavioral) therapies must include a succinct review of the evidence base supporting that intervention (i.e., citations of peer-reviewed articles reporting results from one or more well-designed randomized clinical trials demonstrating  effectiveness in the reduction of substance use or associated risk factors).  It is not expected that the proposed implementation strategy itself will have a significant empirical evidence base, as this is the key element to be tested in the proposed studies.  However, the implementation approach should be clearly grounded in an existing conceptual framework, which should guide the selection of hypotheses, measures, study design, and analysis plan. Applications should balance concerns about the feasibility of the research (i.e., the need to use project resources to conduct the study) and the potential for sustainability of the intervention beyond the life of the project (i.e., staffing, technology, and other resources readily available in the study site(s)). The findings of these studies should inform specific strategies for integrating drug abuse and HIV services in HIV care settings, while also contributing to the broader body of knowledge about implementation science.

Applicants should briefly summarize this evidence base, including citation of the results of one or more well-designed, randomized clinical trials supporting the effectiveness of the practice(s) to be implemented.

Letters of Support: Letters of support are essential for indicating feasibility of the proposed study and program buy-in, including (if appropriate) willingness of sites to be randomized to a delayed intervention or control condition.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

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.

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 by the Center for Scientific Review and responsiveness by NIDA, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post-Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information


1. Criteria

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.

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

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or 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?   

Innovation

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

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal 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

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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 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) Genome Wide Association Studies (GWAS).

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:

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 National Advisory Council on Drug Abuse. The following will be considered in making funding decisions:

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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 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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post-submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Lori J. Ducharme, Ph.D.
Services Research Branch, DESPR
National Institute on Drug Abuse (NIDA)
Telephone:  301-443-2279
Email:  Lori.Ducharme@nih.gov  

Peer Review Contact(s)

Mark Swieter, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1389
Email: mswieter@mail.nih.gov

Financial/Grants Management Contact(s)

Edith Davis
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 410-360-4734
Email: Edith.Davis1@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.

Authority and Regulations

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 Parts 74 and 92.


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