Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

Medications Development Program Projects for Substance-Related Disorders (P01)

Activity Code

P01 Research Program Projects

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DA-12-005

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

With this Funding Opportunity Announcement (FOA), the National Institute on Drug Abuse (NIDA) solicits investigator-initiated program project (P01) grant applications that advance the discovery/development of new or existing therapeutics for the treatment of substance-related disorders (SRDs). Research projects in a program project grant must be closely related to a central theme that can be conducted effectively and efficiently through a coordinated collaborative approach using common resources, facilities, and instruments. Each research project within the P01 award must be supportable on its own merit. The scientific merit of each research project is assessed independently as well as within the context of the whole program. This initiative is designed to support an array of translational research programs, each comprised of at least three interrelated preclinical and/or clinical projects. As part of the program project, applicants are encouraged to develop synergistic collaborations with industry that enhance and strengthen the overall developmental potential of the proposed work. While the inclusion of an Administrative Core or other core is optional, it is expected that the PD/PI (or a multi-PI-coordinating group) will be responsible for the overall coordination of the program project and communication between components. Program projects can focus on the development of any sort of novel treatment strategies for cocaine, methamphetamine, cannabis, nicotine or opioid SRDs. 

Key Dates
Posted Date

March 29, 2011

Letter of Intent Due Date

June 29, 2011

Application Due Date(s)

July 29, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November 2011

Advisory Council Review

January 2012

Earliest Start Date(s)

April 2012

Expiration Date

July 30, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

The development of safe and effective medications for the treatment of Substance-Related Disorders (SRDs) including substance use (i.e., abuse and dependence) and substance-induced disorders (e.g., intoxication, delirium, psychotic disorder, and anxiety disorder) is a public health priority. According to the 2009 SAMHSA National Survey of Drug Use and Health (NSDUH 2009), an estimated 8.9% of the population aged 12 or older (22.5 million people) can be classified with a substance-use disorder. Of these, 7.8 million people (3.1% of the population) were in need of treatment, yet only 19% received adequate care. The prevalence of problems stemming from illicit- and/or licit drug use has remained constant – or slightly increased – over the past two years (NSDUH 2009; MTF survey, 2010). The individual, societal and economical burden of SRDs is enormous.

In addition to existing behavioral and/or therapeutic strategies, the development of safe and effective pharmacotherapies is urgently needed to successfully treat persons with SRDs.  Although there are approved medications for the treatment of nicotine dependence and for opiate use disorders, none exists for the treatment of cocaine, methamphetamine, or cannabis use disorders. Additionally, over the past year, industry has begun to scale back or discontinue their CNS drug-development programs for a variety of reasons (Paul et al., 2010, Nat Rev Drug Discovery 9: 203-204), which limits the number of novel medications available for testing for SRD indications.  

Paradoxically, numerous recent advances in molecular biology, medicinal chemistry, genetics, epigenetics, imaging, and neuroscience offer an improved understanding of the complexities underlying SRDs, and innovative opportunities now exist for the discovery/development of safe and effective medications. Potential pharmacotherapies could target, for example, specific receptor subtypes, membrane enzymes, intracellular organelles, or peptides known to interact with specific neurotransmitter systems implicated in the pathophysiological processes of SRDs. (Please see NIDA Addiction Treatment Discovery Program, 2009 for additional information concerning putative targets of interest.) For many of these targets, several compounds already exist and may be ready for the next developmental step. Therefore, NIDA seeks to support an array of drug development program projects to help fill this therapeutic gap.

The research studies in this P01 should be comprised of at least three independent, interrelated projects. Work can be at the pre-clinical and/or clinical level and focused on the development of pharmacotherapies for cocaine, cannabis, methamphetamine, nicotine or opioid SRDs. Although this list is NOT meant to be all inclusive, program projects can be aimed at the development of the following types of treatments:

1) Novel pharmacotherapies (i.e., new chemical entities),

2) Already-marketed pharmacotherapies,

3) Immunotherapies (e.g., vaccines, monoclonal antibodies),

4) Combinations of medications, and/or 

5) Novel delivery devices/technologies.

Program Project themes for the development of medications could encompass, but are not limited to, the following:

Within a program project applicants may propose both preclinical and/or clinical projects if the projects are well integrated. Programs that include both preclinical and clinical projects should be designed to test medications or new chemical entities which show promise in later-stage preclinical development, are ready for initial testing in human subjects (Phase I), and, if feasible, can be evaluated in efficacy trials (Phase II) within the lifetime of the grant.

As part of the program project, applicants are encouraged to develop synergistic collaborations with industry that enhance and strengthen the overall developmental potential of the proposed work. Such collaborations should be documented by a letter(s) of support within the application and a memorandum of understanding (MOU) should be in place (if necessary) by the time of the award. There will be no requirement for an Administrative or Shared Resource Core, but a coordinating group led by the PD/PI will be responsible for the overall coordination of the program project and communication between components. The description for the day-to-day proceedings and decision making processes should be outlined in an organization and governance structure for the program and included within the Program Overview section.   

Section II. Award Information
Funding Instrument

Grant.

Application Types Allowed

 

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIDA intends to commit $3,000,000 in FY 2012.

Award Budget

The budget limit of each application is $1M in any given year in direct costs. Applicants may request support for up to 5 years (a total of $5M direct costs)..

Award Project Period

The maximum period is 5 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 (non-U.S.) components of U.S. Organizations are not  allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 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/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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/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 PHS398 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.     

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 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.

Letter of Intent

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

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

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-12-005
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD  20892-9550
Rockville, MD  20852 (for express/courier service)

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Director - DA-12-005
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD  20892-9550
Rockville, MD  20852 (for express/courier service)
Telephone: 301-443-2755

Page Limitations

All application instructions outlined in the PHS 398 Application Instructions are to be followed, with the following additional requirements:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Program projects are expected to be broadly-based investigative efforts with a well-defined central focus or objective. The P01 must support a minimum of three interrelated research projects that contribute to the program objectives. The P01 must be led by a Project Director/Principal Investigator (PD/PI) who possesses recognized scientific and administrative competence. The PD/PI must show a substantial commitment to the program project.  Multiple PD/PIs may be designated within the proposed program. In either case, there is no minimum person-months requirement for individuals identified as PD/PI(s). The reviewers will assess whether the level of effort is adequate to achieve the proposed goals. If there are deficiencies in time and effort as evaluated by the SRG, it may negatively impact the application’s score. Additional information on implementation plans and policies, and procedures that formally allow more than one PD/PI on individual research projects is available at: http://grants.nih.gov/grants/multi_pi.

The PD/PI is responsible for the overall coordination and development of the program project; ensuring the interaction and collaboration among scientists conducting research; identifying rapidly (with the assistance of colleagues) aspects of various projects that may need to be decreased or expanded; and recognizing the potential need for additional resources or reallocation of resources

Applications submitted in response to this FOA must use the paper PHS 398 application package and instructions (http://grants1.nih.gov/grants/funding/phs398/phs398.html) and include the modifications to the instructions described below.  Applications must be complete at the time of submission.

Application Research Strategy Length: Each P01 application should be comprised of the following:

1) Program Overview: This element should contain the essential organizational and administrative characteristics of the program project. The program project is expected to have appropriate and effective administrative and organizational capabilities to support multidisciplinary research, to foster synergy, and to support planning and evaluation activities. A description of how the individual research projects and cores will interact with each other to achieve their individual goals and the goals of the program project should be included. This section should not exceed 12 pages;

2) Individual Research Projects: There must be at least 3 individual research projects. The narrative for each proposed project should have a clear description of major objectives and goals, its integration with the other components, and its relationship to the overall P01 program. Each component narrative should include a subsection on integration among the projects and contribution to P01 Goals. In addition to the specific aims page (1 page per project), the Research Strategy section is limited to 12 pages per project;

3) Shared Resource Core(s): Individual cores are optional. If included, each core must provide essential facilities or services for two or more individual research projects. Each core component’s narrative should include a discussion of contributions that would be made to the P01 as a whole. For core components, the research project components to be served should be made clear. The narrative should include how the shared resource core will contribute to the overall goals of the P01 and how existing or proposed research projects will benefit from utilizing the core. This section should not exceed 6 pages.

Applications should be organized as follows.

SECTION I

Face Page

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells

Table of Contents

Detailed Summary Budget for Program Project Initial Budget Period

Budget for Entire Proposed Program Project Period Direct Costs Only

Biographical Sketches and Research Support Information for all key personnel in the entire application.

SECTION II

Overall Program Project

Overall Program Goals and Specific Aims (limited to 1 page)

Overall Program Project Strategy (limited to 12 pages)

Program Related Publications

Literature Citations

Letters of Support

Multiple PD/PI Leadership Plan (Required if Multiple PDs/PIs)

Individual Research Projects (repeat this section for each Research Project, numbering the Research Projects 1, 2, 3, etc consecutively)

Title Page (Title, Project Leader Name, Degree)

Description, Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells

Detailed Budget for Initial Budget Period

Budget for Entire Proposed Period of Support

Resources

Detailed Budget for First 12-Month Period for Any Included Consortium/Subcontract Arrangement

Budget Estimate for Each Year of Any Included Consortium/Subcontract Arrangement

Resources for Consortium/Subcontract Arrangement

Research Plan

Specific Aims (limited to one page) 

Research Strategy (limited to 12 pages)

References/Literature Cited

Human Subjects

Protection of Human Subjects

Inclusion of Women and Minorities

Targeted/Planned Enrollment Table

Inclusion of Children

Vertebrate Animals

Select Agent Research

Consortium/Contractual Arrangements

Letters of Support

Resource Sharing Plan(s)

Individual Cores (Repeat this section for each core, naming the cores with capital letters A, B, C, etc consecutively)

Title Page (Title, Core Director Name, Degree)

Description, Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells

Detailed Budget for Initial Budget Period

Budget for Entire Proposed Period of Support

Resources

Detailed Budget for First 12-Month Period for Any Included Consortium/Subcontract Arrangement

Budget Estimate for Each Year of Any Included Consortium/Subcontract Arrangement

Resources for Consortium/Subcontract Arrangement

Core Services Plan

Specific Aims (limited to one page)

Core Services Strategy (limited to 6 pages)

References/Literature Cited

Human Subjects

Protection of Human Subjects

Inclusion of Women and Minorities

Targeted/Planned Enrollment Table

Inclusion of Children

Vertebrate Animals

Select Agent Research

Consortium/Contractual Arrangements

Letters of Support

Resource Sharing Plan(s)

Checklist(s) – Include a Checklist for each participating institution

Additional Information and Instructions

Overall Program Project (limited to 12 pages)

This element should contain the essential organizational and administrative characteristics of the program project.  The program project is expected to have a scientifically and administratively qualified Project Director/Principal Investigator with responsibility for the scientific, administrative, budgetary, and operational aspects of the program project. The PD/PI should be an outstanding, productive, senior researcher, as documented by publications, patents, honors, and similar indices of stature. The PD/PI is responsible for overall coordination and development of the program project with the responsibility to provide leadership essential to the success of the program project, to ensure interaction and collaboration among scientists conducting research, to monitor ongoing research and identify (with the assistance of colleagues) research to be expanded or decreased and needs for additional resources or reallocation of resources.  Multiple PD/PIs are allowed; however, very strong justification for the need of such arrangement is expected to be provided. Also, a Leadership Plan is expected to be provided (immediately following this element; for information on completing the Leadership Plan see Section IV.2 above).

The leaders of the individual research projects and cores should be experienced, independent and productive investigators. They should evidence stature and leadership, or a potentially strong leadership role, in their respective fields. A range of expertise relevant to the program project’s goals should be present. The rationale for selecting the individual research projects and cores as well as their respective leaders should be included.  Investigators are expected to commit to data sharing and ongoing communications with other investigators in the program project. 

The program project is expected to have appropriate and effective administrative and organizational capabilities to support multidisciplinary research, to foster synergy, and to support planning and evaluation activities. Administrative and organizational arrangements should promote joint planning and evaluation activities as well as collaborations and interactions within, between and among elements of the program project. This should include: (a) an overall programmatic structure that effectively promotes scientific interactions and provides for internal quality control of research and publications, and (b) an administrative organization that has clear lines of authority, is managed efficiently and cost effectively, and enables effective use and leverage of resources.  Depending on the nature of the program project, additional considerations may include the use of (a) an external advisory structure that is charged to provide appropriate and objective advice and evaluation, as needed, to the PD/PI; and (b) an internal advisory, decision-making, and priority setting process to support the activities of the program project. A description of how the individual research projects and cores will interact with each other to achieve their individual goals and the goals of the program project should be included.

Individual Research Projects (Research Strategy is limited to 12 pages each)

There must be at least 3 individual research projects. Each Research Project (or Core) should include a Title page and a one page Specific Aims.  Each research project leader is expected to be scientifically and administratively well qualified, with responsibility for the scientific, administrative, budgetary, and operational aspects of the research project and for coordination with the PD/PI and other core/research project directors. Research may focus on any area of NIDA's mission, but must bear an essential relationship to the program project’s integrating theme. Each research project must interact with at least one other research project of the program project and may interact with one or more cores.  Individual research projects should describe the interactions with other research projects and cores of the program project and explain the expected impact of those interactions on the overall goals of the program project.

Individual Cores (Services Strategy is limited to 6 pages each)

Individual cores are optional.  Each Research Project (or Core) should include a Title page and a one page Specific Aims. Each core leader is expected to be scientifically and administratively well qualified, with responsibility for the scientific, administrative, budgetary, and operational aspects of the core and for coordination with the PD/PI and other core/research project directors.  A Core can be a laboratory, a facility, a service, or other shared resource that supports other program project components in their activities. Cores are expected to support two or more research projects and each core should be clearly described in terms of the services and resources to be provided to other program project components. Issues to be addressed include: quality control, procedures for selecting projects that use the core, cost effectiveness, and increased efficiency.

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 PHS398 Application Guide, with the following modifications:

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide,

Foreign Organizations

Not applicable.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Institute on Drug Abuse., . Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

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

Overall Impact - Overall

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 - Overall

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 How will the successful completion of the aims facilitate the development of novel treatments for SRD?

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? Does the PD/PIs  have the ability to lead a scientific program as documented by scientific achievements, productivity, stature in a relevant field, and planned activities? Do the PD/PIs have the ability to lead administrative and operational aspects of the program project, as noted by administrative skills, and achievements? Is there adequate commitment of time and effort for the research and administrative functions of the program project? As a group, are the research projects and core investigators well suited to the components? Is there evidence of multidisciplinary backgrounds and interests?   

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 clearly demonstrate the feasibility of the organizational structure? Is the organizational and administrative structure/support conducive to its research and overall synergy? Is there an operational programmatic structure that effectively promotes productive scientific interactions and takes maximum advantage of the applicant institution's drug abuse research capacity? Are there arrangements for internal quality control of research, publications, and grant applications? Does the organizational structure have clear lines of authority that allow for efficient and cost-effective management and allocation of funds, as well as leverage of resources to enable additional or future work? Is there an appropriate, fully described internal process that allows for priority setting and decision making to sustain the program project? Is there appropriate specification of criteria and processes for determining and sustaining individual participation in the project based on productivity, research direction, and overall contribution?

Is there a clear integration for each of the research projects to fit synergistically within an overarching theme that integrates and focuses the program? Is there interdependent relationship(s) between each research project and the core component linking the overall theme, to show that the impact of the coordinated program project goes beyond the impact of multiple individual research projects?

If included, do the core components contribute resources that enhance cost-effectiveness and quality control in resource utilization as a group? Does the approach taken utilize optimally the depth and breadth of expertise and experience for each of the Investigators beyond what might normally be included in an individual research grant?

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?   

Criteria for the Individual Research Projects

Scored Review Criteria – Individual Projects

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An individual  research project 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?  Is the project well integrated into the overarching theme of the program project and interactive with other research components or cores? 

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)?

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?   

Criteria for the Individual Cores

Scored Review Criteria – Individual Cores

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

Significance. 

Does the core address important scientific activities of the program project?  If the aims of the core are achieved, how will it contribute to the function of the program project?  How will successful completion of the aims contribute to support of the concepts, methods, technologies, treatments, services, or preventative interventions carried out in other components of the program project?  Is there adequate justification for this core activity being conducted with the program project structure? 

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)?

Innovation. 

 Does the core utilize novel theoretical concepts, approaches or methodologies, instrumentation, or interventions in support of the program project?  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 core?  Are potential problems, alternative strategies, and benchmarks for success presented?   Are the arrangements and organizational structure adequately developed, well integrated, well reasoned, and integrated with other components of the program project? Is the justification for the need for core services or resources clearly stated and are there appropriate plans for resource allocation?  If the core activity 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 core proposed?  Will the core benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Additional Review Criteria - Overall

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.

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.

Industry Collaboration.  It is recommended that a proposed research program includes an industry collaborator or partner; if so,  does the collaboration enhance and strengthen the overall developmental potential of the proposed work?

Investigators. If the project includes a collaborative partnership with industry, do the collaborative PIs have complementary and integrated expertise? Is the proposed collaborative structure / partnership organized in such a manner that the contribution from the industrial partner  that it enhances the overall program and its likelihood of success (i.e., advancing a new therapeutic toward regulatory approval by the FDA)?   

Applications from Foreign Organizations

Not applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s)  convened by 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:

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the  National Advisory Council on Drug Abuse. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee 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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

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)

Kristopher Bough, PhD
Division of Pharmacotherapies and Medical Consequences (DPMCDA)
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-9800
Email: boughk@mail.nih.gov 

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Deborah Wertz
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 301-619-1715
Email: dwertz@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.

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.


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