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)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Funding Opportunity Title

 Health Services and Economic Research on the Prevention and Treatment of Drug, Alcohol, and Tobacco Abuse (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

Reissue of PA-08-264

Related Notices

  • 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

PA-12-128

Companion FOA

PA-12 -127, R01 Research Project Grant
PA-12 -129, R03 Small Grant Program

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.279, 93.272 

FOA Purpose

This Funding Opportunity Announcement (FOA) issued by the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) encourages Exploratory/Developmental (R21) grant applications on health services and economic research to improve the quality of prevention, treatment, and recovery support services for drug, alcohol and tobacco abuse.  Such research projects might emphasize any of the following subjects: (1) clinical quality improvement; (2) organization and delivery of services; (3) implementation research; (4) economic and cost studies; or (5) development or improvement of research methodology, analytic approaches, and measurement instrumentation used in the study of drug, alcohol, and tobacco prevention, treatment, and recovery services.  

Key Dates
Posted Date

March 19, 2012

Open Date (Earliest Submission Date)

May 16, 2012

Letter of Intent Due Date

Not Applicable.

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply  

Advisory Council Review

Standard dates apply  

Earliest Start Date(s)

Standard dates apply

Expiration Date

May 8, 2015

Due Dates for E.O. 12372

Not Applicablehttp://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch10.htm#construction_grants_intergovernmental_review

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.


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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

This Funding Opportunity Announcement (FOA) issued by the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), encourages R21 grant applications for exploratory/developmental health services research leading to improvements in the quality of drug, tobacco, and alcohol prevention, treatment, and recovery support services. Health services research forms the link between research to develop behavioral and pharmacological interventions and the adoption of these as evidence-based practice. Health services research may focus on underlying processes and mechanisms that contribute to the efficacy, effectiveness, and sustainability of interventions, and in domains such as accessibility, utilization, effectiveness, appropriateness, and costs of services.  How prevention, treatment, and recovery support services are organized, managed, delivered, and financed also affects the type and quality of those services and the outcomes they produce.

Research is sought to learn how prevention, treatment, and recovery support stakeholders (providers, public and private payers, school administrators, community agencies, criminal justice systems, workplace settings, governmental regulators, etc.) can improve standards of care for individuals with problematic drug, tobacco, and/or alcohol use, integrate interventions for them within health care settings, improve services to prevent initiation and progression from use to abuse, and improve the adoption, dissemination, and implementation of evidence-based prevention, treatment, and business practices.  Research may focus on individual-level (patient/client and/or provider) behaviors as they affect access, engagement, adherence, and retention in prevention, treatment, and/or recovery support services, and/or program (e.g., content, dosage, training, format), organization, or systems-level issues (e.g., financing, organizational structures and processes, management practices, health technologies) that affect the availability, accessibility, utilization, effectiveness, fidelity, cost, and quality of drug, tobacco, and alcohol prevention, treatment, and recovery support services.

This FOA encourages the development of rigorous hypothesis-driven and theory-based study designs and data analytic methods that will support a new generation of health services research. Research is sought that is generalizable to diverse settings, provider characteristics, and client and/or community problems, attributes, and behaviors.  Client-level factors include developmental appropriateness; gender sensitivity; cultural competency; equity in systemic process and outcomes; co-occurring mental, social, and medical conditions; and risk for infectious diseases.  Systems-level, organizational, environmental, community, and provider attributes, processes, and practices that influence quality and outcomes are also important to understand. 

In developing project aims, investigators are strongly encouraged to integrate factors related to addressing the spread and prevention or treatment of infectious disease among substance users/abusers, including the development of a continuum of services encompassing HIV and/or HCV screening, counseling, and risk-prevention or reduction interventions, and ensuring those with HIV or HCV receive appropriate health care and other needed services.

NIDA and NIAAA are interested in services research that builds on the investments of other entities that address drug use and abuse, including but not limited to NIDA's Clinical Trials Network (CTN), NIDA's Criminal Justice Drug Abuse Treatment Studies (CJ-DATS), the Substance Abuse and Mental Health Services Administration (SAMHSA), Federally Qualified Health Centers, Administration for Children and Families (ACF), Office of Juvenile Justice and Delinquency Prevention (OJJDP), Department of Education, state agencies, and private foundations. In addition, NIDA and NIAAA are interested in services research building on other NIH supported clinical research platforms, e.g. the NIH Clinical and Translation Science Awards Consortium (CTSAs) and the NIH Patient-Reported Outcomes Measurement Information System (PROMIS). A description of alcohol services research within the context of NIAAAs overall research program is provided at http://pubs.niaaa.nih.gov/publications/StrategicPlan/NIAAASTRATEGICPLAN.htm.

NIDA and NIAAA encourage timely reporting of findings, facilitation of practitioner access to and use of findings, and braiding of research questions with the information needs of service providers through collaborative partnerships.

Significance

This FOA is issued during a time of broad changes in the U.S. healthcare delivery system that renders urgent the need for high quality health services research on drug, tobacco, and alcohol prevention, treatment, and recovery support services.  With the expansion of health insurance coverage to millions of Americans – including a disproportionate percentage of persons at high risk for drug, tobacco, and alcohol use and addiction – research is needed to understand variation in realized access, utilization, quality, cost, and outcomes of prevention, treatment, and recovery support services.  Related topics include comparative effectiveness research on evidence-based prevention and therapeutic interventions and business practices; models for integrating prevention, screening, and treatment for drug, alcohol, and/or tobacco use into general medical settings; processes or mechanisms through which capacity to implement quality improvements in prevention and treatment is increased; chronic care and recovery support systems for addiction; workforce issues associated with increased demand for services; and economic studies to identify efficient and cost-effective models for organizing and financing services.

In addition, despite research demonstrating the effectiveness of a variety of psychosocial, behavioral, and pharmacological interventions for prevention, treatment, and recovery support, many have not been widely adopted or effectively implemented.  Little research has focused on the process through which science-based interventions enter practice, including the decision-making processes that prevention and treatment providers, agencies, or communities use to select interventions for adoption; on the organizational characteristics, leadership and management, and business practices that impact the effectiveness of interventions; on the need for fidelity versus adaptation; on the performance of interventions, services, or programs in usual, routine settings; or on how to improve service quality overall.  Research is needed to help service providers understand how to incorporate evidence based prevention and treatment interventions, recovery support, and business practices into substance abuse prevention and treatment systems, general health care settings, and related community and social service programs addressing the needs of drug, tobacco, and alcohol using populations.  This may include reengineering existing systems of care; adapting new services and business practices to fit with existing clinical and organizational structures; developing infrastructure capacity (including workforce capacity) to implement and sustain improved prevention, treatment, and/or recovery support service delivery; testing different approaches (for example, in-person versus web-based) and venues (e.g., child welfare, school, veterans court) for service delivery; and reevaluating practices and services over time to ensure their continued availability, fidelity, and value.

Specific Areas of Research Interest

NIDA and NIAAA’s health services research program is comprehensive in nature.  The following section addresses drug, alcohol, and tobacco prevention and treatment health services research topics of specific interest to NIDA and NIAAA, but other research topics may be appropriate for this funding announcement.  Potential applicants are encouraged to contact Program staff prior to submitting an application (see section VII.1, below).

Clinical Quality Improvement – studies that may improve the appropriateness, effectiveness, safety, and efficiency of prevention, treatment, and recovery interventions, and services delivered to individuals in a variety of settings including substance abuse and mental health treatment programs; schools; general health care settings; criminal justice systems; and social service agencies. Such research could attend to services for special populations (e.g., children, adolescents, women, veterans, geriatric populations, those at HIV/HCV risk); adaptive service delivery strategies to adjust the level, dosage, and type of interventions and services over time in response to changing needs; continuity of care; development of performance measures and standards of care to improve assessment of patient needs, treatment progress, and outcomes; use of information technology to enhance care delivery; training and supervision of behavioral healthcare professionals; integration of prevention interventions into primary care; integration of alcohol, tobacco, or drug treatment in primary care and in treatment for co-morbid mental disorders; the efficacy of widely used but untested prevention and treatment approaches; revising payment mechanisms to incentivize high quality care, reimbursing for care coordinated across social services and medical systems, or paying for management of addiction as a chronic condition; and strategies to enhance the availability of prevention and treatment services in criminal justice settings.

Quality Improvement in Services Organization and Management – studies that attend to organizational contexts and service delivery models; the interaction of providers and programs within and across systems, and at multiple levels (e.g., program, practice network, state); and their collective impact on quality of service delivery.  Research topics may include testing models for collaboration, co-location, or integration of drug, alcohol, and tobacco prevention, treatment, and recovery support services with medical settings; management and human resources issues including workforce recruitment, training and retention; the use of best practices, performance measures, and standards of care to improve assessment of client needs, treatment progress, and outcomes; effects of state, payer, and institutional policies on treatment accessibility, cost, duration, and quality.

Implementation Research – studies that seek to explain and ultimately improve the uptake of evidence-based prevention and treatment practices, including HIV prevention and treatment, in real-world service delivery settings. Such studies might include the measurement or enhancement of organizational capacity for innovation adoption; tests of organizational change strategies to implement evidence-based practices; comparative tests of alternative approaches to dissemination and implementation; development of measures and methods for assessing adoption, implementation, fit, fidelity, and sustainability of evidence-based practices; and identification of systems-level factors that facilitate or impede the diffusion and adoption of evidence-based practices.  Proposed studies in this area should test or apply conceptual models that allow results to contribute to the broader field of implementation science.

Economic and Cost Studies – studies related to: (1) financing and purchasing of drug and alcohol treatment and prevention services, including studies of health insurance and payment mechanisms; (2) economic incentives used to improve the quality and economic efficiency of treatment and prevention services; (3) alternative delivery systems and managed care; (4) cost-benefit, cost-effectiveness, or cost-utility analyses; (5) service costs, production, and economic efficiency; and (6) research to develop or improve methods to be used in the economic study of drug and alcohol services. A broad array of applied, theoretical, and econometric research is sought including, but not limited to, that involving experimental and quasi-experimental designs, analyses of natural experiments, secondary analyses of existing data sources, dynamic simulation models, and descriptive studies that will facilitate the development of economic theory, empirically-testable hypotheses, or future experimental research. Multidisciplinary economic and financing research, integrating concepts, tools, and methods from more than one discipline, is also encouraged.

Implications of Policy Change for Service Quality – research examining the impacts (including unintended consequences) of local, state, and/or national policies that affect the organization, management, or financing of treatment and prevention services on quality of care and patient access, utilization, retention, and outcomes.  Given their financing and organization, alcohol and drug prevention and treatment services are often directly or indirectly impacted by laws, regulations and policies introduced with the intent of improving access, enhancing quality, and/or reducing costs.  Recent examples include a New York State policy curtailing smoking on the grounds of all state-funded addiction treatment programs; state-level changes in SSI benefit eligibility; legislative mandates for the use of evidence-based practices; the Wellstone-Domenici Act mandating parity in drug abuse and mental health benefit coverage; and most recently, passage of the Affordable Care Act of 2010.  Investigators are encouraged to leverage significant, naturally-occurring opportunities by developing timely, hypothesis-driven study designs that will measure the downstream effect of such policy changes on the quality, cost, availability, and utilization of alcohol and drug abuse prevention and treatment services.

Methods and Tools – developing, refining, and validating new approaches for conducting treatment and prevention services research.  Such research may include the development of study designs that strengthen causal inference and external validity; individual-, program-, and systems-level measurement tools and analytic approaches; simulation modeling of prevention and treatment service delivery alternatives, such as dynamic simulation models and agent-based models or other models based in complexity theory; quality-of-care indicators and performance measures; and new measurement instruments and statistical approaches appropriate for use in complex multisite systems trials (e.g., multilayer hierarchical linear modeling and methods to transform data and measures from diverse sources to enable group comparisons).

Scope of Funding Mechanism

The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, methodologies, models, or applications that could have a major impact on the field of health services research.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.

Special Considerations

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

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.  

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

The total project period for an application submitted in response to this funding opportunity may not exceed two years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.

Award Project Period

The maximum period is 2 years.  

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 eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory 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.

Page Limitations

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

PHS 398 Research Plan Component

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

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.

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout 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 in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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 SF 424 (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 SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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 Central Contractor Registration (CCR). 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, NIH. Applications that are incomplete 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.

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Overall Impact

Reviewers will provide an overall impact/priority 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(s)/PI(s), 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/priority 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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),in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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(s)/PI(s) 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, CCR 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 Non-Competing Continuation Grant Progress Report (PHS 2590) 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
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

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Redonna Chandler, Ph.D.
Services Research Branch
Division of Epidemiology, Services & Prevention Research
National Institute on Drug Abuse
Telephone: (301) 443-6504
Email:  rchandle@nida.nih.gov

Harold I Perl, PhD
Acting Chief
Prevention Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd
Room 5171, MSC 9589
Bethesda, MD 20892-9589
Send overnight mail to Rockville, MD 20852
Ph: 301-443-9982
Fax: 301-480-2542
Email: hperl@nida.nih.gov
www.nida.nih.gov

Robert Huebner, Ph.D.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
Telephone:  (301) 443-4344
Email: bhuebner@niaaa.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Edith Davis
Grants Management Branch
National Institute on Drug Abuse
Telephone: (410) 360-4734
Email: Edavis1@nida.nih.gov

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Telephone: (301) 443-4704
Email: jfox@mail.nih.gov

Section VIII. Other Information

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

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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