Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	NIDA Program Project Grant Applications (P01)
Activity Code	P01 Research Program Projects
Announcement Type	Reissue of PAR-10-244
Related Notices	PAR-16-393 NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) NOT-DA-13-028
Funding Opportunity Announcement (FOA) Number	PAR-13-259
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.279
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) announces the availability of support for collaborative research by multi-disciplinary teams which is of high priority to NIDA and leads to synergistic outcomes based on the synthesis of multiple research approaches. The NIDA Program Projects funding opportunity will support research in which the funding of three or more highly meritorious projects as a group enriches both the component projects and the overall program to offer significant scientific advantages over supporting the same projects as individual research grants (i.e., synergy). For the duration of the award, each Program must consist of a minimum of three research projects focused on issues critical to advance the mission and goals of NIDA.

Posted Date	July 3, 2013
Open Date (Earliest Submission Date)	August 25, 2013
Letter of Intent Due Date(s)	30 days prior to the application due date
Application Due Date(s)	Standard dates, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Standard dates, by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	September 8, 2016
Due Dates for E.O. 12372	Not Applicable

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

Program projects are expected to be broadly based investigative efforts with a clear, well-defined, and unifying goal or theme to establish the direction, objectives, and aims of the overall Program. The efforts should address critical issues of neuroscience, genetics, behavior, prevention, treatment, epidemiology, etiology, health services, HIV/AIDS, opportunistic infections which occur in drug abusing populations, medication development, or other research areas relevant to drug abuse. A Program will comprise at least three inter-related research projects judged to be independently scientifically meritorious, complementary of one another, and demonstrate an essential element of unity and interdependence, i.e, a system of research activities and projects directed toward a well-defined research program goal. The Program may also include common or shared resources (cores) required for the conduct of the research projects. If cores are included, each must provide infrastructure for a minimum of two contributing research projects and result in increased productivity contributing to synergy of the research effort as a whole. The application needs to justify that a Program is required for this desired level of integration and productivity.

The Program is expected to have appropriate and effective administrative and organizational capabilities to support multidisciplinary research, to foster synergy, to support shared equipment, facilities, or other resources whenever possible, and to support planning and evaluation activities. 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, additional considerations may include the use of (a) an external advisory structure (e.g., DSMB) 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.

The Program is expected to have a scientifically and administratively qualified Project Director/Principal Investigator (PD/PI) with responsibility for the scientific, operational, administrative, and budgetary aspects of the Program, e.g. coordinating and developing the Program, providing leadership, ensuring interaction and collaboration among scientists, monitoring ongoing research, identifying a need to expand or contract research within the Program, and identifying the need to seek additional or reallocate existing resources. The PD/PI should be an outstanding, productive, senior researcher, as documented by publications, patents, honors, and similar indices of stature.

More than one PD/PI (i.e., multiple PDs/PIs) may be designated, but the application must present strong rationale for choosing a multiple-PD/PI approach. Effort may be divided between administrative and scientific duties.

There must be at least 3 individual research projects which may focus on any area of NIDA's mission, but must bear an essential relationship to the program project’s integrating theme. The rationale for selecting the individual research projects and cores, as well as their respective leaders, should be explicit. Individual research projects must work in synergy to contribute to each other and to the Program overall. The combination of specific projects should produce a context and relationships which allow each research effort to share the creative strengths of the others and result in a greater contribution to the program goals than if each project were pursued separately. This enhanced productivity, or synergy, should be facilitated by the administrative and physical organization of the program, the composition of the research team, the selection of topics for study, coordinated scheduling of staff and support services, economies achieved through consolidated management, and in other ways as appropriate to the particular Program. Individual research projects should also each be of high scientific and technical merit.

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 and be adept at working with a multi-disciplinary team or a team with expertise in several specialized areas within a specific discipline. The research project lead has 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 leads. A range of expertise relevant to the Program goals should be present. The application should demonstrate past productive collaborations of the research team(s) or otherwise provide evidence of a strong collaborative environment for the proposed Program. All investigators must contribute to and share the responsibilities of fulfilling the Program goals and objectives.

Investigators who are considering pursuing a collaborative approach to a high-priority research problem are strongly encouraged to contact NIDA program staff early in the process to discuss a potential application. The discussion could include the choice of funding mechanism, relevance of the topic to NIDA’s mission, goals, and research priorities, planned budget, and the scope and approach of the proposed research.

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.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see http://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding- for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Renewal Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the numbers, quality, duration, and costs of the applications received.
Award Budget	Application budgets are not limited.
Award Project Period	The maximum project period is 5 years. Starting with new and renewal P01 grants funded in fiscal year 2013, only one more renewal will be allowed.

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
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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 eligible to apply.

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

Applicant organizations must complete the following registrations as described in the SF424 (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.

• System for Award Management (SAM) must maintain an active entity registration (formerly registration), to be renewed at least annually. Use the SAM.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) and component Project Leads that are not yet registered in eRA Commons must work with their institutional officials to register. Also, institutional officials at the applicant organization should ensure that the eRA Commons account for the contact PD/PI is affiliated with their organization.

eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants can access 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

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 and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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 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 activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Director - P01
Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 4245, MSC 9550
Bethesda, MD 20892-8401

[email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Core (Use for optional research cores and Administrative Core)	6
Project (Use for individual research project)	12

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

The following section supplements the instructions found in the SF 424 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Projects: minimum of 3 required
• Cores: optional

When preparing your application in ASSIST, use Component Type Overall .

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.In the Biographical Sketches include a concise personal statement of how the PDs/PIs have the following: (a) track record(s) of consistently producing highly significant research publications or products in one or more of the research areas proposed for the Program; (b) track record(s) demonstrating the ability to effectively and productively manage a large, interdisciplinary project in the proposed research area(s).

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

The PD/PI must show a substantial commitment of time and effort to the program, at least 3 calendar months. If the multi-PD/PI option is selected, each PD/PI must commit at least 2.4 calendar months time and effort.

Multi PD/PI applications must include a Leadership Plan which describes the governance and organizational structure of the Program leadership team, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the Program should be delineated for each PD/PI and other Program key personnel

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the specific aims for the Program as a whole.

Research Strategy: Provide information on the Program as a whole. Discuss role, responsibilities, and qualifications of the Program Principal Investigator/Project Director; discuss the research team. Discuss the synergy of and rationale for the Program cores and projects (i.e., the extent to which the integration and parallel pursuit of the projects and cores are likely to advance this research area to a greater extent than could be achieved as separate projects). Aspects of synergy include: interactions and links among components to show that the impact of a coordinated program project goes beyond the impact of individual research projects and cores; depth and breadth of expertise and experience not normally present in an individual research project grant; components which, as a group, enhance cost-effectiveness and quality control in resource utilization; a clear integration of program project components to an overarching theme that integrates and focuses the program project; an essential relationship of each research project and core component to the theme; plans for communication, coordination, and collaboration among research project investigators; potential of individual projects to inform the design and interpretation of other projects?

If the Program involves clinical research, concisely describe overall plans for: 1) protection of human subjects; 2) inclusion of minorities, sexes/genders, and children, justified in terms of the scientific goals and research strategy proposed; and, 3) the data in support of feasibility of recruiting sufficient participants from the proposed population(s) to achieve the stated objectives.

For renewal applications only, include a progress report which summarizes the aims and accomplishments of the Program during the prior funding period. See the SF 424 (R&R) instructions for details about what to include in the progress report. If a project from the prior funding period is being discontinued, explain in the overall progress report.

Progress Report Publication List: For renewal applications, provide a list of all publications that arose from Program during the prior funding period. It is encouraged that this be arranged as a table in which publications are organized based on the following categories: a) overall Program (for publications that were not clearly related to a given project); b) each Project; c) each Core (as appropriate). If the same publication appears in both a Project list and a Core, clearly indicate so at each place it appears.

Multiple PD/PI Leadership Plan: Required for applications designating multiple-PDs/PIs.

Letters of Support: Attach letters of support relevant to the Program as a whole. Letters of support relevant to specific projects or cores should be attached in the relevant Project or Core research plans.

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:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

When preparing your application in ASSIST, use Component Type CORE.

Neither administrative nor research cores are required, but one or more such cores are allowed. Any proposed core must be used by at least two projects. 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.

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

SF424 (R&R) Cover (Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Core)

• In the Project Director/Principal Investigator section, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific aims for the core.

Research Strategy: A core must provide infrastructure and result in increased productivity and synergy of the research Program as a whole. If a core is included, then it must be used by a minimum of two research projects. It is expected that leaders of any research cores will participate in developing the conceptual framework for the Program. While a research core(s) may function primarily as a service entity, core scientists often are involved in conducting original and developmental research.

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.

Core resources should not duplicate resources already available to Center investigators; however, fee-for-service core components are acceptable with adequate justification.

For renewal applications, discuss progress in this core during the prior funding period and rationale for any changes.

Letters of Support: Include letters of support relevant to the core only.

Progress Report Publication List: Include a list of publications that arose from this core during the prior funding period.

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

When preparing your application in ASSIST, use Component Type PROJECT'

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.

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

SF424 (R&R) Cover (Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project)

• In the Project Director/Principal Investigator section, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific aims for the Project

Research Strategy: Describe the research strategy for the project. Even though it is required that the three or more research projects included in the program be synergistic, this section should focus on this specific project and not the potential synergy between this project and the other projects and/or cores. Synergy should be discussed in the Overall Component.

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.

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 leads.

For renewal applications, include a Progress Report that discusses the progress in this Project during the prior funding period, and description of and rationale for significant changes that may have occurred during the prior funding period.

Letters of Support: Attach letters of support relevant to the specific research project.

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 modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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 before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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 SF424 (R&R) Application Guide.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Although a written "Request for Permission" is due at least 6 weeks prior to the application due date, NIDA strongly encourages investigators to submit the request for permission much earlier. The request can be sent by email (preferred) or regular mail to the NIDA Scientific/Research Contact listed in Section VII.

The following criteria will be used in the administrative staff review of these requests:

1. Relevance to NIDA: How is the unifying central theme important to the NIDA mission?

2. Programmatic priority: How will the proposed research significantly advance the mission of NIDA? Does it address an area of high research priority for NIDA?

3. Programmatic balance: How does the proposed research related to currently funded research by NIDA? By NIH? And by the investigative team?

4. Appropriateness for P01 funding: Are there three or more discrete, R01-level projects and if research cores are proposed, will the core(s) serve at least two projects? Is the proposed work appropriate for the P01 activity code?

If NIDA agrees to accept an application with more than $500,000 in direct costs in any year, a cover letter should be included with the application that identifies the NIDA program staff who agreed to accept the application.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Program 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 Program 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 Program that by its nature is not innovative may be essential to advance a field.

Significance

Does the Program address an important problem or a critical barrier to progress in the field? If the aims of the Program 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 Program? 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/PI have the ability to lead a scientific program as documented by scientific achievements, productivity, stature in a relevant field, and planned activities? Does the PD/PI have the ability to lead administrative and operational aspects of the program project, as noted by administrative skills, achievements? Is there adequate commitment of time and effort for the research and administrative functions of the program project? As a group, are research project 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 Program? 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 Program involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

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

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

Synergy

In assigning the impact score for the application as a whole, although primary emphasis will be placed on scientific merit of the research projects, the assessment of scientific synergy (i.e., the extent to which the integration and parallel pursuit of the projects and cores are likely to advance this research area to a greater extent than could be achieved as separate projects) should contribute significantly to the overall score.

This will include the following:

Are there sufficient interactions and links among components to show that the impact of a coordinated program project goes beyond the impact of individual research projects and cores? Does the approach taken make use of a depth and breadth of expertise and experience not normally present in an individual research project grant? Do the components, as a group, contribute resources that enhance cost-effectiveness and quality control in resource utilization? Is there a clear integration of program project components to an overarching theme that integrates and focuses the program project, as well as the presence of an essential relationship of each research project and core component to the theme? What are the nature, scope, and effectiveness of the plans for communication, coordination, and collaboration among research project investigators? What is the potential that results from individual projects to inform the design and interpretation of other projects?

Does the application clearly demonstrate the feasibility of the organizational structure to support research and interaction? Is there evidence of a collaborative integrated research approach and effort? Does the organizational structure have clear lines of authority that allow for efficient and cost-effective management and allocation of funds, as well as leveraging of resources to enable additional or future work? Are there arrangements for internal quality control of research, publications, and grant applications? Is there an appropriate, fully described internal process that allows for priority setting and decision making to sustain the Program? 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?

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

Vertebrate Animals

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

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

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

Renewals

For Renewals, the committee will consider the progress made in the last funding period. The progress will be evaluated for accomplishment of objectives for each of the prior projects, research cores, and the Center overall. Have investigators clearly and concisely described, for each project, core, and Center overall the specific aims, whether they were achieved, and what peer-reviewed articles were published that present the data related to those specific aims? Were the data published in high-impact journals? Were the quality and quantity of publications resulting from the prior center grant appropriate for the research that was proposed?

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident

Reviewers will consider each of the review criteria below in the determination of scientific merit of each proposed research project, and give a separate numerical (1 to 9) score for each criterion, as well as an overall impact score for the project. A 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?

Investigator(s)

Are the Project leader 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, do the investigators have complementary and integrated expertise; are their leadership and research track records appropriate for the project?

Innovation

Does the proposed project 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 human subjects 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? Is there adequate data in support of feasibility of recruiting sufficient participants from the proposed population to achieve the stated objectives?

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?

Each Core, if included, will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects:

Technical merit and justification of the proposed Core - Does each scientific core provide critical facilities or services for two or more funded research projects?

Qualifications, independent research track record, and commitment of the personnel involved in the Core;

Adequacy of plans for use of the Core by the research projects, including criteria for prioritization, and the benefit to the projects from Core resources or services;

Appropriateness of the timetable in relation to the scope of the proposed research support;

If human subjects, vertebrate animals, or biohazards are to be used in the core, the adequacy of these sections must be assessed and will be considered in determining the merit descriptor of the individual core.

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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 score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• 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/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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 or RPPR) 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 Telephone: 800-518-4726
Email: [email protected]

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, tracking application status, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Jag Khalsa, Ph.D.
Chief, Medical Consequences of Drug Abuse and Co-occurring Infections Branch
Division of Pharmacotherapies and Medical Consequences of Drug Abuse
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2159
Fax: 301-443-2599
Email: [email protected]

Meyer D. Glantz, Ph.D.
Assoc. Director for Science
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: [email protected]

Nancy Pilotte, Ph.D.
Chief, Functional Neuroscience Research Branch
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1316
Fax: 301-594-6043
Email: [email protected]

Steven Grant, Ph.D.
Chief, Clinical Neuroscience Branch
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-4877
Fax: 301-443-6814
Email: [email protected]

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

Cheryl Nathaniel
Grants Management Specialist
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 202-526-0108
Fax: 301-594-6849
Email: [email protected]

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

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