Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	Integration of Drug Abuse Prevention and Treatment in Primary Care Settings (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-DA-12-008
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.279
FOA Purpose	Efforts to prevent, detect, and treat drug abuse and addiction and its consequences can be improved by integrating existing evidence-based approaches into primary care settings. NIDA solicits translation and implementation research project applications to identify the most effective strategies and service delivery models for accomplishing this goal. Applicants should propose hypothesis-driven studies to achieve the integration of substance abuse prevention interventions and/or treatment services in public or private-sector settings where patients receive primary care services including office-based practice settings, family practice, pediatric and adolescent medicine, obstetrics, general practice, and emergency departments.

Posted Date	May 20, 2011
Open Date (Earliest Submission Date)	September 30, 2011
Letter of Intent Due Date	September 30, 2011
Application Due Date(s)	October 31, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not applicable
Scientific Merit Review	February/March 2012
Advisory Council Review	May 2012
Earliest Start Date(s)	July 2012
Expiration Date	November 1, 2011
Due Dates for E.O. 12372	Not Applicable

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.

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

Primary care settings routinely provide detection, prevention and treatment of a wide range of chronic diseases and health conditions in patients of all ages, however, services related to the prevention and treatment of substance use remain serious exceptions. The result is fragmented and incomplete care and missed opportunities for the prevention and treatment of substance abuse.

There exist a number of prevention interventions and treatment services approaches with demonstrated efficacy or effectiveness. However, further research is needed to identify and address the barriers and facilitators of implementing these interventions and service delivery models in primary care settings.

This FOA will support multidisciplinary translation and implementation research to enhance adoption of evidence-based prevention, screening, detection, and treatment of substance abuse, across the age spectrum of clinical populations in primary care settings. Primary care is defined in terms of obstetric, pediatric, adolescent medicine, family practice, general practice, or internal medicine specialties, as well as specialties that widely practice primary care such as emergency medicine. Projects can utilize a variety of organizational settings in which primary care services are delivered, including those which are outside of traditional office practices or medical centers. Applicants are encouraged to consider building upon existing projects, platforms, and practice networks such as those supported by the Health Resources and Services Administration (HRSA), the Agency for Children and Families (ACF), the Centers for Disease Control and Prevention (CDC), or the Agency for Healthcare Research and Quality (AHRQ). NIDA anticipates that findings from this initiative will help inform prevention and treatment practice under provisions of the Patient Protection and Affordable Care Act of 2010 (PPACA).

NIDA is interested in promoting the integration of both prevention and treatment services into primary care settings. Because the state of the science as well as salient service delivery settings are often markedly different in these domains, NIDA’s interests in prevention and treatment topics are described separately below. Applicants are neither expected nor required to attend to both domains in a single application.

Substance Use Prevention in Primary Care Settings

The 2009 Institute of Medicine Report on Prevention of Mental Disorders and Substance Abuse among Children, Youth, and Young Adults (http://www.iom.edu/~/media/Files/Report%20Files/2009/Preventing-Mental-Emotional-and-Behavioral-Disorders-Among-Young-People/Preventing%20Mental%20Emotional%20and%20Behavioral%20Disorders%202009%20%20Report%20Brief%20for%20Policymakers.pdf) identified a wide range of programs with evidence of efficacy in the prevention of substance use, but noted the need to disseminate these programs more widely and to increase the understanding of the dissemination and implementation process. In particular, primary care settings represent underutilized bases for prevention programs. Obstetric, pediatric, and adolescent medicine settings provide primary care medical homes for children from the prenatal period through late adolescence, and other settings such as emergency departments often deliver a range of primary care services to those who do not have a personal physician. Examples of effective practices that could be implemented in these settings (or in conjunction with them) include family support and skills training for parents and children; prenatal nurse visitation programs; family interventions that incorporate assessment; brief interventions, particularly those incorporating motivational interviewing; and interactive computer interventions that provide patients with individualized behavior change messages. These prevention interventions have demonstrated a variety of effects addressing risk and protective factors for substance use and abuse. Many of these interventions also have demonstrated positive outcomes for youth development in other domains such as school performance, delinquency, externalizing behaviors, psychiatric disorder, smoking, and sexual risk behavior. Interventions included in applications for this FOA should have evidence of efficacy or effectiveness through experimental or rigorous quasi-experimental trials. Compendia of rigorously tested interventions which demonstrate evidence of efficacy or effectiveness can be found in publications such as the 2009 IOM report (see above) and the NIDA publication Preventing Drug Use among Children and Adolescents: A Research Based Guide for Parents, Educators, and Community Leaders (Second Edition) (http://www.nida.nih.gov/pdf/prevention/RedBook.pdf).

Examples of possible projects include (but are not restricted to):

• Implementation of interactive computer and web-based substance use prevention interventions in doctor’s offices or other clinic settings.
• Nurse- or other practitioner-delivered programs incorporated into existing prenatal or well-baby programs.
• Screening and prevention intervention for fetal alcohol syndrome as well as other alcohol, tobacco, and drug use in prenatal or perinatal settings.
• Parent training programs incorporated into existing medical center outreach programs or existing multi-disciplinary programs such as those in behavioral pediatric practices.
• Coordinated screening and delivery of indicated or selected prevention interventions for high risk youth and their parents using emergency departments as primary care portals.
• Screening and referral to brief interventions for violence and substance use prevention in pediatric settings.

Applications should provide a clear conceptual framework for the interventions chosen. Studies should attend to and evaluate issues related to the translation and implementation of programs into primary care settings, linking these to the conceptual framework. These issues may include: stakeholder participation; policy development/implementation; organizational change; training, supervision, consultation and other activities related to quality assurance and quality control; fidelity to core elements; adaptational strategies related to setting, provider, and/or population, including cultural and linguistic considerations; confidentiality and regulatory compliance; cost/reimbursement implications; and long-term sustainability. The conceptual framework also should target proximal, intermediate, and longer-term outcomes, as appropriate, with a plan for evaluating these outcomes.

Applications should include multidisciplinary teams of investigators and include experience in the areas of implementation science, prevention intervention, and service provision. Teams should include expertise in either the original development of the intervention of interest or substantial experience in refining or testing the intervention.

A range of primary care practice settings will be considered including office practices, provider/practice networks, medical centers (including emergency departments), community health centers (including federally-qualified health centers), public health facilities, and school- or other facility based clinics. Clinical trial networks of practitioners and/or practice settings, and networks of settings established for the purpose of this project also will be considered. Integration of prevention and primary care may occur through augmentation of existing practice settings and services; new or reconfigured services within multidisciplinary teams; or new community partnerships such as collaborations between practice settings and other providers, or partnerships involving community organizations. Interventions should be feasible and well-matched to the study setting(s), with evidence of adequate and appropriate staffing, technology, facilities, etc. For example, settings that make use of multidisciplinary teams that include social services and health education may be better able to accommodate interventions that make use of outreach models, while computerized interventions may be more easily integrated into independent office practices.

Substance Abuse Treatment in Primary Care Settings

For adult and adolescent patients with active substance use disorders, the provision of treatment services has largely been segregated into the specialty care system, which treats only a fraction of persons in need of addiction treatment. Moreover, patients with active substance use disorders may be more likely to visit a primary care physician for a co-occurring medical condition than to seek treatment for their substance abuse disorder directly. Primary care practitioners have the potential to identify developing problems and to effectively deliver screening for drug abuse and related conditions (e.g., smoking; alcohol dependence; HIV and HCV); brief interventions; pharmacotherapies (including opioid dependence treatment and smoking cessation); and referral for needed specialty medical treatment, behavioral counseling, and follow-up care. However, primary care practices have been slow and somewhat reluctant to integrate such care into routine clinical practice. Multiple potential models of service integration have been tested in a variety of health care settings, but implementation research is needed to guide broader systems change efforts. Provisions within the Patient Protection and Affordable Care Act (PPACA) suggest potentially productive arenas for implementation research.

Integration of substance abuse treatment in primary care may occur, for example, through augmentation of existing practice settings and services; introduction of new or reconfigured services within multidisciplinary teams; or formation of new community partnerships such as collaborations between practice settings and other community organizations. A range of primary care practice settings may be proposed as research sites, including office practices, provider/practice networks, medical centers (including emergency departments), community health centers (including federally-qualified health centers), public health facilities, and other health clinics where patients routinely receive primary care services. Studies should focus on testing alternative service delivery models for implementing evidence-based treatment approaches in these settings; that is, studies should not propose to test the efficacy or effectiveness of clinical treatments, but rather should test implementation strategies and/or service delivery models by which those established practices can be effectively integrated into primary care settings.

Applicants are encouraged to consult and, where possible, incorporate NIDA-supported products in study designs. Such products include resources available through NIDAMED (http://www.drugabuse.gov/nidamed/); the NIDA publication, Principles of Drug Addiction Treatment: A Research-Based Guide (2nd Ed.); and Blending Products and training resources available through SAMHSA’s Addiction Technology Transfer Centers (http://www.nida.nih.gov/blending/).

Examples of possible treatment services research topics include (but are not restricted to):

• Testing the implementation of elements of a medical home model or other integrated service delivery models consistent with the PPACA;
• Studying the effectiveness of using behavioral health specialists or patient navigators to support the delivery and coordination of patient services within and across care settings;
• Developing and testing implementation strategies to promote office-based prescribing of addiction pharmacotherapies;
• Developing and testing methods for improving the coordination of communication between behavioral health and primary care providers within and across settings (including integrated treatment plans, team treatment approaches, electronic health records, etc.);
• Testing alternative training strategies to promote appropriate identification and treatment of substance abusing patients in primary care settings;
• Testing the effect of alternative reimbursement mechanisms on the level and quality of care integration or coordination, with particular attention to addressing barriers inherent in existing reimbursement approaches; and
• Developing and testing quality improvement measures and mechanisms including innovative application of technological solutions to promote integrated or coordinated care.

Applications should include a brief review of the evidence base for the proposed clinical intervention that is the focus of the implementation design (i.e., citations of trials demonstrating evidence of efficacy or effectiveness in the reduction of substance use or associated risk factors). This FOA is not intended to support the development or testing of novel clinical treatments, but rather to test implementation strategies to integrate evidence-based practices into primary care settings. Because of the nascent state of implementation science in substance abuse treatment research, it is not expected that the proposed implementation strategy itself will have a significant empirical evidence base, but it should be grounded in an existing conceptual model that provides the framework for the proposed hypotheses, data collection, and analysis. 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)).

Applications should include multidisciplinary teams of investigators with experience in the areas of treatment services research (including experience with the intervention to be implemented), implementation science, and service provision. The research team should include individual(s) from the practice setting(s) in which the study is to be conducted.

Funding Instrument	Grant
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIDA intends to commit $4,000,000 in FY 2012 to fund 5-7 new awards..
Award Budget	Direct Costs will vary with the scope of the project but may not exceed $500k per year.
Award Project Period	A project duration 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.

Higher Education Institutions:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) 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 four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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.

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.

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.

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

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

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

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

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

Director - DA-12-008
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550

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 application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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.

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.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the 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/PIs 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/PI 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 and responsiveness by the National Institute on Drug Abuse, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

All applications should include a conceptual framework which incorporates the core elements of the prevention or treatment intervention (i.e., those elements that account for its effects), as well as program, organizational, and other factors that are likely to influence successful adoption and implementation of the intervention in a primary care practice setting. The conceptual framework should be integrated into the data collection plan and provide a basis for evaluating both implementation outcomes (i.e., adoption, fidelity, and/or sustainability at the practitioner, practice setting, and/or service delivery system level), as well as patient-level outcomes to assess efficacy of the intervention in the context of the tested implementation strategy and practice setting.

Data collection should include information on program costs and any short-term, quantifiable benefits to consumers, providers, or other systems of service delivery to parents, children, or youth, as applicable to the setting and intervention. Potential sources of reimbursement for the prevention or treatment services provided also should be assessed in consideration of feasibility and sustainability.

Practice components of the project may include existing clinical practice research networks (including, for example, those coordinated by HRSA, ACF, CDC, or ARHQ,), or networks assembled for the purpose of this project, with appropriate staffing for coordination and management of the study. Letters of support from partnering organizations and proposed study sites should be included.

Budgets should provide for the PD/PI’s attendance at an annual meeting to occur in the Washington DC area for the purpose of coordinating key measures of process and outcome, and reviewing progress.

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

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:

This FOA seeks applications for projects that will test strategies for integrating evidence-based prevention and/or treatment practices into primary care settings. As such, reviewers will consider the strength of the evidence base for the proposed clinical intervention as it relates to drug abuse prevention and/or treatment. Applicants should briefly review studies supporting the efficacy or effectiveness of the practice(s) to be implemented.

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).

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/PIs, 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?

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

Not applicable.

Renewals

Not applicable.

Revisions

Not applicable

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

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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Use of existing platforms, projects, and provider networks, particularly those supported by NIH and other Federal agencies

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.

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 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.

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.

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.

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

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: [email protected]

Richard Jenkins, Ph.D.
Prevention Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
Telephone: 301-443-1923
Email: [email protected]

Lori J. Ducharme, Ph.D.
Services Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
Telephone: 301-443-2279
Email: [email protected]

Mark Swieter, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1389
Email: [email protected]

Maryellen Connell
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 301- 774-3803
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92

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://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.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.