Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	Phased Services Research Studies of Drug Use Prevention, Addiction Treatment, and HIV in an Era of Health Care Reform (R21/R33)
Activity Code	R21/R33 Phased Innovation Award
Announcement Type	New
Related Notices	March 26, 2012 - See Notice NOT-DA-12-011. The National Institute on Drug Abuse (NIDA) will hold a technical assistance webinar on Tuesday, May 1, 2:30 - 4:30 PM Eastern Time.
Funding Opportunity Announcement (FOA) Number	RFA-DA-13-001
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	This funding opportunity announcement (FOA) solicits applications for Phased Innovation (R21/R33) research projects to conduct rigorous, objective services research to monitor and examine changes in drug use prevention, addiction treatment, and associated HIV and viral hepatitis services, that may occur as a result of healthcare reform. This FOA provides support for up to two years (R21 phase) for research planning activities and feasibility studies, followed by possible transition of up to four years of expanded research support (R33 phase). The total project period for an application submitted in response to this FOA may not exceed five years.

Posted Date	February 6, 2012
Open Date (Earliest Submission Date)	July 22, 2012
Letter of Intent Due Date	July 22, 2012
Application Due Date(s)	August 22, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	October/November, 2012
Advisory Council Review	January 2013
Earliest Start Date(s)	April 30, 2013
Expiration Date	August 23, 2012
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

Background

The Affordable Care Act of 2010 (ACA) and other recent health care reform legislation may profoundly affect the availability, delivery, cost, and quality of drug use prevention and addiction treatment services, including HIV and viral hepatitis testing, counseling, and treatment provided to this population. It may also affect the demand for these services, the providers of these services, and the systems in which these services are delivered. Individual access to these services may be directly affected in a number of ways. The proposed expansion of insurance coverage may particularly affect persons at high risk of drug use, viral hepatitis, HIV, and addiction (e.g., young, low-income males). Specific benefit plan requirements, including naming addiction treatment as an essential benefit in insurance plans and extending parity, may enhance coverage for these services. Guaranteed issue provisions and the removal of lifetime and annual coverage limits may increase access to HIV/AIDS treatment and related health care services for drug involved individuals. Moreover, this legislation may change the role of local, state, and federal programs that have traditionally funded the majority of drug use prevention and addiction treatment services and many of the HIV/AIDS services received by this population. Other provisions, such as the Prevention and Public Health Fund and the development of a National Prevention and Health Promotion Strategy, may increase resources and services available to prevent drug use, viral hepatitis, and HIV, and facilitate more integration of drug use prevention with other chronic-disease prevention. Provisions in the ACA may also re-shape the systems in which these services are offered and accessed, potentially moving them into general medical settings. These include an increased emphasis on primary care, a focus on integrated care models (e.g., medical homes, accountable care organizations), and enhanced funding of Federally Qualified Health Centers which may improve their ability to deliver and coordinate these services.

Such fundamental changes in financing and organization, if implemented, may lead to significant improvements. However, regulations and other implementation aspects of healthcare reform are under development, and the ultimate effects of the resulting changes on access, utilization, delivery, quality, and cost need to be examined. The goals of this FOA are to generate high-quality research findings that inform policy, prevention, and clinical practice, as well as future research agendas in an era of potentially rapid and fundamental health care sector change.

A wide range of research designs and methods may be relevant to this FOA, but the research must focus on the impact of health care reform on access, availability, delivery, utilization, quality and/or cost of drug use prevention, addiction treatment, and associated HIV and viral hepatitis services. This FOA is not intended to fund intervention studies or clinical effectiveness research. Where feasible, rigorous pre-post designs generating high-quality national level data on the effects of health reform on drug use prevention, addiction treatment, associated viral hepatitis, and HIV services may be especially relevant. In-depth analyses of detailed data on non-national samples, such as longitudinal data from large systems of care or select subpopulations, may provide valuable evidence about the effects of specific coverage and policy changes on access, utilization, process, costs, and outcomes. Analyses of administrative data may provide evidence of innovative service delivery models built to take advantage of health reform efforts. Surveys of nationally representative samples of insurers, state officials, providers, clinicians, patients, or communities involved in these services may provide important information about the effects of health reform, particularly in the context of theory-based, hypothesis-driven research. Mixed-methods studies may be helpful in disentangling complex findings and examining process factors that are not amendable to survey designs. Where possible, applicants are encouraged to incorporate baseline measures to permit analysis of change. In addition, given the potential for great impact of health care reform on programs supported by the Health Resources and Services Administration (HRSA), the Federally Qualified Health Centers (and other Community Health Centers and/or Health Center Program Grantees), HRSA's HIV/AIDS Bureau programs, and other HRSA affiliated programs may be particularly useful partners for research.

Applicants may examine the impact of health care reform on drug use prevention services alone, addiction treatment services alone, or on both prevention and treatment domains. In addition, applicants are strongly encouraged to include special attention to the effect of health care reform on some element of HIV prevention or HIV/AIDS treatment services for drug-involved populations. Applications addressing HIV services will be given priority consideration for funding.

The timing of this FOA allows for collection of baseline data and conducting research through the early stage of health care reform implementation. As of this writing, states, systems, and provider agencies have begun taking preliminary steps toward implementing reforms scheduled in 2014. This pre-implementation activity varies across states and healthcare sectors and may itself be an important consideration in the design of applications in response to this FOA. At the same time, however, NIDA recognizes that there is the possibility that provisions of the legislation may not persist unchanged through their intended implementation date or beyond. The current unprecedented era of state and federal budget cutbacks suggests that meaningful changes in health care delivery are likely to emerge regardless of the ultimate implementation of the Affordable Care Act, and this should be considered in study designs. Applicants are encouraged to design studies that can be adapted in response to unanticipated changes in ACA, other elements of health care reform, or the broader economic climate in which prevention, treatment, and HIV services are delivered. This may include studying the consequences of late-stage changes to specific provisions of the ACA or the elimination of aspects of health care reform for service delivery systems, providers, and clients. NIDA’s use of the R21/R33 mechanism is intended to permit both the grantee and program staff to thoroughly assess the continued relevance, feasibility, and value of the proposed research at a time roughly synchronous with expected health reform implementation.

Examples of research topics relevant to this FOA include but are not limited to the following areas:

Demand

Changes in demand for drug use prevention, addiction treatment, viral hepatitis, and associated HIV services related to changes in insurance coverage, including analyses of the effects of benefit package designs;

The effect of the insurance expansion and the treatment gap overall as well as among specific vulnerable populations;

Changes in insurance enrollment of individuals with or at risk for drug use, addiction, and HIV, factors related with that enrollment, and the effect of strategies to increase enrollment;

Availability

The availability and delivery of drug use prevention, addiction treatment, and associated HIV services, including the effects of ACA provisions on the number, type and location of settings in which they are delivered;

The effect of ACA provisions on disparities in service availability by gender, age, racial/ethnic, and rural/urban location;

Efforts undertaken by providers to promote newly-available drug use prevention, addiction treatment, viral hepatitis, and HIV services and/or to reach newly-covered populations;

The role of accountable care organizations, patient-centered medical homes, Federally Qualified Health Centers, Health Center Controlled Networks and other organizational systems in availability and delivery of drug use prevention, addiction treatment, and associated HIV services.

Quality

The uptake of evidence-based prevention and treatment practices practices (e.g. behavioral interventions; pharmacotherapies; etc.) for drug abuse and HIV in the context of health care reform, including persistent or emergent barriers to their adoption;

Identification and assessment of the quality of new service delivery models, including service coordination, patient centered medical homes, integration in primary-care settings and federally qualified community health centers;

The impact of health care reform provisions on the delivery of patient-centered care for those with addictive disorders and HIV/AIDS;

Financing and Cost

The effect of changes in insurance coverage, program financing, and payment models on the delivery of drug use prevention, addiction treatment, and associated HIV services across a variety of settings, including consideration of how health care reform affects other funding streams;

Changes in benefit packages related to these services;

Changes in the costs of producing these services and of expenditures on them;

The effect of changes in the receipt of these services as health care reform is implemented, and the social (e.g. medical, productivity, criminal justice) costs associated with drug use, addiction, and HIV/AIDS;

System-Level Impacts

The changing focus, role, and influence of legacy funding sources on drug use prevention, addiction treatment, and associated HIV services, and the resulting effects on program administration, community participation in planning, and service providers;

The impact of relevant health reform provisions on the availability, credentials, and competence of the workforce delivering these services in specialty and other settings;

Changes in the specialty treatment system, including industry consolidation, and strategic alignment with primary care delivery settings or other specialty providers;

Changes in the provision and financing of screening and indicated prevention services.

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.

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	The National Institute on Drug Abuse intends to commit $1,500,000 in FY 2013 to fund 4-5 awards.
Award Budget	Direct costs will vary with the scope of the project. Support for the R21 phase may be for one or two years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $150,000 in direct costs in any single year of the R21 phase. The R33 phase may not exceed four years and direct costs are limited to $1.5M with no more than $375,000 in direct cost in any single year of the R33 phase.
Award Project Period	Support for the R21 phase may be for one or two years. The R33 phase may not exceed four years. The entire project may not exceed 5 years. Conversion to the R33 phase is contingent on meeting the R21 milestones, programmatic review, and availability of funds.

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations 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 Director(s)/Principal Investigator(s) (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.

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.

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.

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

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

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

• Descriptive title of proposed 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: NIDALetterofIntent@mail.nih.gov

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-13-001
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 submission of applications for this FOA. 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, with the following modification:.

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

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(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/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 components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

NIDA recognizes there may be provisions of health care reform legislation that may changed through their intended implementation date or beyond, and that a variety of other circumstances (including unprecedented pressure on state and local budgets) may impact health care delivery regardless of formal health reform implementation. Therefore, applicants are encouraged to design studies that can be modified should specific elements of health care reform change or be eliminated, including studying the consequences of such late-stage changes on service delivery systems, providers, and clients. Applicants should describe such strategies in the Approach section of their Research Plan.

Milestones: The Milestone section must propose at least 3 milestones for completion of the R21 part of the project, a discussion of the suitability of the proposed milestones for assessing success in the R21 phase, and a discussion of the implications of successful completion of these milestones for the proposed R33 study. Milestones should be specific, quantifiable, and scientifically justified; they should not be simply a restatement of the R21 specific aims. At least one milestone must involve an assessment of the continued feasibility and value of the proposed R33, using information obtained in the R21 phase, and specifically considering any changes in health care reform implementation or other relevant factors (e.g., state budgets) and their impact on the original research plan.

These milestones will be evaluated in the peer review process and negotiated with NIDA program staff prior to the award of the R21 phase. Although funded applicants are solely responsible for planning, directing, and executing the proposed project, the transition from the R21 feasibility phase of applications, and the eligibility for the R33 phase, will be determined by NIDA program staff in the context of the peer review recommendations and based on successful completion of negotiated scientific/technical milestones, program priorities, and availability of funds.

Stating well-defined, measurable milestones is critical to the application. These will vary depending on the nature of the proposed research, and should be tailored to the applicant’s specific research goals. Examples include but are not limited to the following:

Identifying the specific criteria for determining and demonstrating the availability, appropriateness, completeness, and validity of needed data, as well as acquisition of data sets required for subsequent analysis;

Identifying the computational tools and/or analytical approaches needed for the proposed analyses and demonstrating through pilot testing or preliminary analysis both the appropriateness and feasibility of the tools/approaches and the research team’s capacity to use them;

Using data or information obtained via exploratory or developmental work conducted in the R21 phase, a clear articulation of a conceptual model and the specific hypotheses to be tested in the R33;

Identifying the scope and characteristics of the population (organizations, programs, providers, patients) to be sampled in the larger study, articulating a final detailed sampling plan, and assessing the limitations of the sample for the proposed R33 research;

Assessment of the continued feasibility of the R33 project in light of findings from the R21 phase and any changes in the implementation of health care reform or other significant factors on which the study depends (e.g., state budgets that fund programs of interest).

Specific Instructions for Preparing a Combined R21/R33 Phased Innovation Award Application

The R21/R33 Phased Innovation Award application must be submitted as a single application with one PHS398 Cover Page Supplement component and one Research & Related Budget component.

The total length of the Research Strategy section cannot exceed 12 pages including justification statement, milestones, tables, graphs, figures, diagrams and charts.

The Research Strategy should contain separate sections that describe both the R21 and R33 phases, as appropriate. Separate specific aims and separate research design and methods could be presented as needed for the R21 and R33 phases. It is not necessary to repeat information or details that are described in the R21 section.

Milestones for the R21 phase are included in the 12 page limit, and should be described under a separate subheading.

In preparing the R21/R33 application, investigators should consider that the application will be assigned a single overall impact/priority score. Thus, clarity and completeness of the application with regard to specific goals and the feasibility of each phase and the Milestones are critical. Milestones that are not sufficiently rigorous scientifically to be valid for assessing progress in the R21 phase will reflect poorly on the scientific merit of the application as a whole.

Any preliminary data that will support or justify the proposed hypothesis, rationale or development plan may be included. However, preliminary data are not required for an R21/R33 application.

Prior to award, the Program Officer will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel as indicated in the Summary Statement. The Program Officer and the applicant will negotiate and agree on a final set of R21 milestones. These will be incorporated into the terms and conditions of the award and will be the basis for judging the success of the R21 work.

For funded applications, when the R21 phase has been completed, the Project Director(s)/Principal Investigator(s) (PD(s)/PI(s)) will submit a progress report to the Program Officer. The progress report should clearly indicate which milestones were or were not completed successfully. In the latter case, an explanation should be provided as to why the milestone was not met. Receipt of this progress report will trigger an administrative program review that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on IC-approved successful completion of negotiated scientific milestones, on program priorities, and on the availability of funds.

For funded applications, peer review is not anticipated between the two phases of the project, although IC staff reserves the right to conduct a program review with outside opinions.

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:

The R21/R33 Phased Innovation grant supports planning activities and feasibility studies followed by possible transition to expanded research support. An R21/R33 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, the feasibility, 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/R33 applications; however, they may be included if available.

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(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?

Does the application contain a credible plan for adapting the research or otherwise describing how the project can be completed or salvaged should relevant elements of the ACA be changed or fail to be implemented?

Does the study address an element of HIV prevention or HIV/AIDS treatment services for drug-involved populations?

Milestones: Are the proposed milestones appropriate, well-defined, quantifiable, and adequate to evaluate the feasibility of proceeding to the R33 phase of the application?

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

Not Applicable.

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) convened by the National Institute on Drug Abuse, 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.

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

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.

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.

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.

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: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
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

Sarah Q. Duffy, Ph.D
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
Telephone: (301) 451-4998
Email: duffys@nida.nih.gov

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

Edith Davis
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 410-360-4734
Email: edavis1@nida.nih.gov

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.