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

Pre-Application for the 2011 NIDA Translational Avant-Garde Award for Medication Development for Diseases of Addiction (X02)

Activity Code

X02 for submission and consideration of pre-applications. The X02 pre-application is a first step in applying for a Translational Avant-Garde Award.

Announcement Type

Reissue of FOA PAR-10-095

Related Notices

Funding Opportunity Announcement (FOA) Number

PAR-11-102

Companion FOA

RFA-DA-11-009, DP1 Grant Mechanism

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

 93.279

FOA Purpose

The purpose of this funding opportunity announcement (FOA) is to encourage pre-applications for The NIDA Translational Avant-Garde Award. The NIDA Translational Avant-Garde Award is designed to support dedicated and talented basic and/or clinical researchers with the vision, drive and expertise necessary to translate research discoveries into medications for the treatment of diseases of addiction. Through this FOA, the National Institute on Drug Abuse (NIDA) is committed to making significant advances in the development of safe and efficacious products for the treatment of disorders stemming from tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opiate use or abuse.  

Key Dates
Posted Date
Open Date (Earliest Submission Date)

February 17, 2011

Letter of Intent Due Date
Application Due Date(s)

March 17, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

April 2011

Advisory Council Review

Not applicable

Earliest Start Date(s)

Not applicable

Expiration Date

March 18, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

The purpose of this funding opportunity is to advance the development of safe and efficacious products (“small molecules” or biologics) for the treatment of disorders of addiction. “Small molecules” are organic compounds with traditional drug-like properties, while “biologics” may include vaccines and recombinant therapeutic proteins. Clinical indications may include disorders stemming from tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opiate use or abuse. 

Nicotine dependence is the most common form of chemical dependence in the United States. CDC morbidity and mortality report released in September 2010 indicates that previous declines in smoking prevalence in the United States have stalled during the past 5 years. Considering the widespread occurrence of tobacco smoking, and devastating consequences of tobacco addiction, applications to develop therapeutics to facilitate smoking cessation efforts are highly encouraged.   

Applications may focus on the specific symptoms of the addictive disorder such as withdrawal, craving or relapse. Testing of new formulations of marketed medications that are available for other indications, or new combinations of existing medications, which may be promising candidates for the treatment of diseases of addiction is within the scope of this Translational Avant-Garde Award.

The NIDA Translational Avant-Garde Award complements NIDA’s traditional investigator-initiated grant programs by supporting applications with an emphasis and focus on translation of scientific discoveries into medications. Research on the neurobiology of addiction has identified an increasing number of genetic, cellular and biological targets where therapeutic intervention could benefit patients suffering from the consequences of drug abuse. Translation of these scientific discoveries into therapeutic interventions requires additional deliberate, persistent, and focused commitment and effort. The NIDA Translational Avant-Garde Award brings this level of support and commitment by providing academic and industrial scientists with a unique opportunity to realize the therapeutic potential of their scientific discoveries and to push them one step closer to regulatory approval. Those steps could be taken at any juncture along the drug development path from Lead Optimization/Early Safety up to Phase II Clinical trials.

Through this FOA, NIDA seeks to attract exceptionally talented investigators to the mission of expanding the number and breadth of lead compounds in the pipeline for drug addiction treatment, optimizing these leads, and advancing them to clinical testing.  Subsequent to efforts supported through this FOA, private sector commitment to further development is highly desirable; however, it is recognized that NIH facilitation of further development may be essential.  NIH resources (such as those offered by the NIH RAID Program) and traditional mechanisms of NIDA grant support may be utilized to continue successful projects.  For this reason, applicants will be expected to submit a two-part pre-application describing (1) their research project (Individual Mission Plan) as well as (2) a comprehensive plan for further development beyond their project timeline (Overall Translational Path). Refer to Special Instructions in Section IV of this FOA for details.

Pre-applications focusing solely on novel target discovery, new animal model generation, development/testing of new human laboratory models or mechanistic studies of neurobiology of addiction are not appropriate for the NIDA Translational Avant-Garde Award. Basic science projects, such as exploratory projects of hypothesis testing and exploring novel paradigms, are appropriate for other NIH funding mechanisms, such as the R01. In contrast, applicants for the NIDA Translational Avant-Garde award are expected to have assembled a robust body of background data in the basic science and discovery phases to be poised for transition to the pre-clinical and clinical phases of medication development.  NIDA expressly seeks to promote research projects that are ready for clinical translation and can accelerate the development of new medications. Accordingly, only those applicants who conduct research studies positioned on a stage between late drug Discovery and Phase II Clinical Trials are appropriate to apply.  That is, for “small molecules”, the earliest stage of eligibility for this Award is already having small-molecule compounds with the proof of desired pharmacological activity. For biologics, the profiling of promising product candidates in animal models of drug addiction will be allowed as the earliest starting point.

Research positioned at the following stages is not appropriate for NIDA Translational Avant-Garde Award support:

1.         Pre-Discovery (understanding the underlying neurobiology of drug addiction; basic causes of disease at the level of genes, proteins and cells).

2.         Target Identification and Validation (identifying new targets (individual proteins or cellular pathways) which can potentially interact with and be affected by a drug molecule, and confirming their role in disease in in vitro and in animal models of addiction).

3.         Early Discovery (searches for small-molecule compounds or biologics that act on previously validated targets to alter the disease course; random screening of chemical libraries; medicinal chemistry efforts utilizing Structure-Activity-Relationship studies for the sole purpose of improving the affinity and selectivity of ligands, without regard to measures that are relevant to pharmacokinetic or toxicological properties; development of robust assays to test compounds in high throughput screens).

4.         Phase II clinical efficacy studies of marketed medications in their currently available dosage forms.

5.         Phase III clinical efficacy studies.

Although not intended to be entirely inclusive, the following list of research efforts provides examples of project components that will be appropriate for support under the NIDA Translational Avant-Garde Award program:

The research proposed must fit along a defined research continuum leading to practical applications. It may elect to enter at a specific point within the translational continuum (late Discovery (=Lead Optimization/Early Safety) to Phase II clinical trial), and exit when the project has been developed enough to enable the next stage of testing (for example, completion of preclinical development directly enabling IND filing). Given the lengthy process of treatment development, it is recognized that, during the period of research support under this award, not all projects will develop treatments to the point of enabling clinical efficacy testing; however, substantial progress toward this goal is expected.  Pre-applications must clearly define the planned entry and exit points along the treatment development continuum during the requested period of support, as well as long-term plans for further development.

In summary, the NIDA Translational Avant-Garde Award is meant to support individuals who intend to pursue research directions that are not readily supported by other NIH grant mechanisms. Examples of projects that may be more suitable for the NIDA Translational Avant-Garde Award are those that lack an immediate hypothesis-testing component, such as projects focused on bulk synthesis, dosage formulation, and preclinical or clinical safety testing, and projects that would involve the use of unique, proprietary methods.  For this initiative, it is strongly recommended that trans-disciplinary teams be formed as establishing such partnership is often vital to the translational research process.

Awardees are required to commit the major portion (at least 51%) of their research effort to activities supported by the Translational Avant-Garde Award program. Those who will not be able to meet this requirement should not submit pre-applications.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

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

Funds Available and Anticipated Number of Awards

No awards will be made under this announcement.  Through the associated FOA (RFA-DA-11-009), NIDA expects to commit approximately $ 1.5 million per year for 5 years to fund 2-3 awards..

Award Budget

No awards will be made under this announcement. Awards through RFA-DA-11-009 will be for $500,000 in direct costs each year for five years, plus standard F&A costs, which will be determined at the time of award..

Award Project Period

No awards will be made under this announcement. Awards through RFA-DA-11-009, will be for $500,000 in direct costs each year for five years, plus standard F&A costs, which will be determined at the time of award..

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  allowed.

Required Registrations

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

All Program Directors/Principal Investigators (PD/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 (Project Director/Principal Investigator)

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

Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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. Investigators who have not been previously involved in drug abuse research are also encouraged to apply. Recipients of the NIDA Translational Avant-Garde Award (DP1) are required to commit the major portion (at least 51% or 6.1 person months) of their research effort to activities supported by the award. There are no citizenship or permanent residency requirements.

Pre-applications with multiple PD/PIs are not allowed.

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. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The following instructions are specific to the Avant-Garde Award X02 pre-applications and are exceptions to the general SF424 instructions.  Pre-applications that do not conform to the specific instructions detailed below will not be reviewed.

NOTE: Letters of reference are not required and will not be accepted with pre-applications.  Reference letters will be required of those applicants submitting full (DP1) applications to  

All application instructions outlined in the SF 424 (R&R) Application Guide (SF424 Application Guide - Adobe Forms B) are to be followed, incorporating “Just-in-Time” information concepts, with the following exceptions, which are specific requirements for Translational Avant-Garde Award applications. Applications that do not conform to the specific instructions detailed below will not be reviewed.

All of the following must be submitted for the pre-application to be considered complete:

1.     SF424 (R&R) COVER COMPONENT:

Item Number 1. Type of Submission: Must be “Pre-Application”

Item Number 8. Type of Application:  Must be “New”.

Item Number 12.  Proposed Project:  Start date: 9/30/2011; End date: 9/29/2016 Item Number 15a.  Total Federal Funds Requested:  Enter $0

Item Number 15c. Total Federal & Non-Federal Funds:  Enter $0.

Item Number 15d: Estimated Program Income: Enter $0.

2.     RESEARCH & RELATED PROJECT/PERFORMANCE SITE LOCATIONS. Complete as appropriate.

3.     RESEARCH & RELATED Other Project Information Component:

Item Number 1. Are Human Subjects Involved?  Check “No”. Detailed plans regarding protection of human subjects, inclusion of women and minorities, targeted/planned enrollment, and inclusion of children are not required and should not be submitted with this pre-application.  This information will be required from only those individuals who submit a full application in response to RFA–DA-11-009.

Item Number 2. Are Vertebrate Animals Used? Check “No”. Detailed information regarding the use of vertebrate animals is not required at the time of submission. This information will be required only from those individuals, who submit a full application in response to RFA-DA-11-009.

Item Number 7. Project Summary/Abstract:  Attach a one page (maximum) abstract of 300 words or less describing the goals of the project. Text only, in PDF format – no figures, animations, or Web links are allowed.

The abstract should contain a brief statement describing how the proposed research project is ready for clinical translation, how it can accelerate the development of new medications, and how it will have the potential for major practical impact. 

Item Number 8. Project Narrative:  Attach Public Health Relevance Statement in PDF format:  In 2-3 sentences using plain language, concretely describe Practical Outcome (the endpoint of a practical value that the proposed research would enable), Discovery Application (a clear vision for future implementation that extends the expected project endpoints), and Impact (an analysis of the significance of the project impact on disease and medical practice – “how can patients finally benefit from this?”).

Item Number 9.  Bibliography & References Cited:  Do not use. 

Item Number 10.  Facilities & Other Resources:  One page maximum. 

Item Number 11.  Equipment:  Do not use.

Item Number 12.  Other Attachments (in PDF format):  

Research Accomplishments and Qualifications: Attach a description of no more than one page of the PD/PI’s specific accomplishments and qualifications in the area of translational research (e.g. expertise in developing of innovative small molecules or biologics for the treatment of diseases). Provide concrete evidence of the PD/PI’s ability to successfully oversee the proposed project and to successfully apply the proposed technologies and methodologies. What is expected is a summary of specific and relevant accomplishments, not a list of multiple publications and not background narratives. Publications or similar documents will not be accepted.

4.     RESEARCH & RELATED Senior/Key Person COMPONENT

Profile – PD/PI – Attach Biographical Sketch:  Complete items only for Project Director/Principal Investigator. Do not submit profiles for other senior/key personnel.  Attach PD/PI’s biographical, two pages maximum, PDF format, following the sample format shown in the URL in Section 4.5.2 of the Application Guide, omitting Section D, Research Support.)   No other biographical sketches are to be submitted.

Profile – PD/PI – Attach Current and Pending Support:  Attach a list of Current and Pending Support from all sources, including current year direct costs and percent effort devoted to each project. Use the format shown in Section 3.1.1.8 of the Application Guide. A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of 51% or 6.1 person months of his/her research effort to the project supported by the Translational Avant-Garde Award.

Profile – Senior Key Person 1:  Do not use.  Submit information only for PD/PI.  Information on collaborators or other key personnel is not required but may be included in the Essay.

Note: Pre-applications found not to comply with the page limit requirements or that contain attachments other than those specified will not be reviewed.

5.     PHS398 COVER PAGE SUPPLEMENT

Item Number 2: Human Subjects: Omit

Item Number 4: Human Embryonic Stem Cells: Enter “yes” or “no” as appropriate.

6.     PHS398 RESEARCH PLAN ATTACHMENTS

Item Number 1. Introduction to Application (for Resubmission or Revision only): Omit

Item Number 2: Specific Aims: Omit.

Item Number 3: Research Strategy: Upload the Essay (limited to 5 pages) here.

1) Essay:  Using a maximum of five pages, compose an essay consisting of two key parts: (A) the Overall Translational Path and (B) the Individual Mission Plan. The Overall Translational Path must demonstrate an understanding of the translational process and the research continuum from discoveries to patients. It should also describe how the proposed research fits into the continuum. The Individual Mission Plan must contain a sound research plan specifically indicating how this particular research will contribute to the translational process.  The proposed research must have entry and end points along the Translational Path.  References are not required but, if included, must fit within the 5 page limit.

A) Overall Translational Path: Demonstrate an understanding of the translational process and the research continuum from basic concept to novel therapies for the treatment of diseases of addiction in relation to the proposed research project. Where is project placed along the Overall Translational Path? What is the overall plan for developing the proposed treatment, including the patient population and primary endpoints envisioned for the first clinical efficacy trial?  Include a description of the current status of the intellectual property (IP) protection as well as plans for protection of future IP. Also describe any private sector support for continuation of development beyond the period of the award or plans to seek such support from the public or private sector.

B) Individual Mission Plan: Present a sound research plan specifically indicating how this particular research project will contribute to the translational process. The proposed project must have entry and exit points along the Overall Translational Path.  The Individual Mission Plan should include the following.

Theoretical Rationale: Describe the “proof of principle” background, ensuring that prior developmental work has laid the groundwork for a successful translational project. What existing evidence (e.g., from target validation studies or from treatment evaluations in animal models of addiction) provides a rationale for moving forward with the proposed translational project?

Project Description: What are the specific goals of the project during the 5-year period of support?  At the time of award, what would be the entry point along the Overall Translational Path?  For example, would the project begin at the stage of lead optimization, at the stage of cGMP synthesis and IND-enabling preclinical development, or at some other stage?  At the end of the 5-year project, what is the anticipated exit point along the overall product development continuum?  For example, is the research project expected to progress to the stage of selecting a drug candidate for future IND-enabling studies, to the stage of IND filing, to the completion of Phase I studies, or to some other stage? What are the key steps or milestones on a path from the present level of applicant’s research knowledge to the practical application? Does the research project directly or indirectly enable a follow-up study in human subjects or involve the study of human subjects?

Suitability for NIDA Translational Avant-Garde Award program: Why is the planned research uniquely suited to the stated goals of the Translational Avant-Garde Award program, rather than a traditional grant mechanism? 

References are not required but, if included, must fit within the 5 page essay limit.  Figures and illustrations may be included but must also fit within the 5 page limit.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide must be followed, with the following exceptions or additional requirements:

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed.

Appendix

Appendices are not allowed and will not be accepted.

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Reviewkeep if RFA, delete if not RFA: , NIH. Applications that are incomplete keep if RFA, delete if not RFA: 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

Review Process

Pre-applications that are complete will be evaluated by a multidisciplinary group of outside experts with expertise in translational research convened by NIDA, who will evaluate the pre-applications based on the criteria listed below.  PIs with the most outstanding pre-applications will be notified of the opportunity to submit full applications for the NIDA Translational Avant-Garde Award (DP1) in response to RFA-DA-11-009. Please note that RFA-DA-11-009 includes additional review criteria of significance, investigator(s), innovation, approach, and environment.

Using the three review criteria below, reviewers will assess 1) the likelihood that meaningful progress will be made toward the development of an innovative small molecule or biologic to address unmet medical needs in the drug addiction treatment field, 2) that there is an absence of alternative funding to pursue this direction, and 3) that there is compelling justification for needing the NIDA Translational Avant-Garde Award to pursue the stated goals and objectives.

Programmatic Requirements for Translational Research. Does the research project clearly identify the practical outcome of the research efforts? Does the research project represent a significant leap from incremental knowledge-gathering to a practical application (a translational endpoint)? Is the project original? Will it yield meaningful advances in the field of medication development for diseases of addiction? Is the research project built on a thorough analysis of pre-existing evidence and will progress already made allow for advancing the translation process? Are the project’s entry and exit points on the Translational Path well-defined and well-justified? What is the quality of the plans for evaluating the process and outcomes of the translational effort, the probability of success, and the estimated timeframe for development? Does the application acknowledge potential problem areas and consider alternative tactics?

Investigator(s).  Are the PD/PI, collaborators, and other researchers well suited to the project?  That is, is there sufficient evidence of the investigator’s expertise in drug discovery and development and/or translational research, and is there demonstrated ability by the investigator to devote at least 51% or 6.1 person months of his/her effort to activities supported by this Award? If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? 

The suitability for Translational Avant-Garde Award mechanism: How well has the case been made that the proposed project carries much higher levels of translational need and potential impact than investigator-initiated NIH-supported research projects in basic and clinical sciences?

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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.

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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

Scientific/Research Contact(s)

Elena Koustova, PhD, MBA
Division of Basic Neuroscience & Behavioral Research
National Institute on Drug Abuse (NIDA)
Telephone: 301-496-8768  
Email: koustovae@mail.nih.gov

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

Nora Chiang, PhD
Division of Pharmacotherapies and Medical Consequences of Drug Abuse
Chemistry and Pharmaceutics Branch Research
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-5280
Email: nchiang@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Carol Alderson
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 301-933-6196
Email: aldersoc@nida.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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