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

2012 NIDA Translational Avant-Garde Award for Medication Development for  the Treatment of  Substance –Use Disorders (DP1)

Activity Code

DP1

Announcement Type

Reissue of RFA-DA-11-009

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DA-12-010

Companion FOA

PAR-11-269, X02 Pre-application for the 2012 NIDA Translational Avant-Garde Award for Medication Development for the Treatment of Substance-Use Disorders (X02)

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.279 

FOA Purpose

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 Substance-Use Disorders (SUDs). Through this FOA, the National Institute on Drug Abuse (NIDA) is committed to advancing the development of safe and efficacious medications for the treatment of SUDs stemming from tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opiate use. Medications can be either small molecules or biologics. Biologics include vaccines and recombinant therapeutic proteins created by biological processes. Applications may focus on the treatment of substance use (i.e., abuse or dependence) disorders and specific clinical manifestations of these disorders such as withdrawal, craving, or relapse.  Applications that focus on the development of new formulations of marketed medications that are available for other indications, or new combinations of existing medications that hold promise for the treatment of SUDs, are also within the scope of this RFA.

The 2012 Translational Avant-Garde Award competition will proceed in two phases. The first phase is a pre-application phase in response to PAR-11-269.  Pre-applications will be evaluated by a group of NIDA-assembled external reviewers. Those investigators whose submissions are judged to be the most outstanding will be notified in the summary statement of the X02 of the opportunity to submit full applications under this FOA, RFA-DA-12-010 (DP1).  The 2012 Avant-Garde awardees will be selected from this group of applicants.

 
Key Dates
Posted Date

July 29, 2011

Open Date (Earliest Submission Date)

January 21, 2012

Letter of Intent Due Date

Not Applicable.

Application Due Date(s)

February 21, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

March 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

July 1, 2012

Expiration Date

February 22, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

The purpose of this funding opportunity is to advance the development of safe and efficacious medications (small molecules or biologics) for the treatment of Substance-Use Disorders (SUDs). Small molecules are organic compounds with drug-like properties, whereas biologics may include, for example, vaccines or recombinant therapeutic proteins. Clinical indications may include disorders stemming from tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opiate use. Applications may focus on the treatment of substance use (i.e., abuse or dependence) disorders and specific clinical manifestations of these disorders 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 SUDs 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 the translation of basic scientific discoveries into medications. Research on the neurobiology of addiction has identified an increasing number of genetic, cellular and biological targets where a therapeutic intervention could benefit patients with SUDs. Translation of these scientific discoveries into therapeutic interventions requires deliberate, persistent, and focused commitment and effort. The NIDA Translational Avant-Garde Award provides this level of support and commitment by offering academic and industrial scientists with a unique opportunity to realize the therapeutic potential of their scientific discoveries and advance them one step closer to regulatory approval. Projects responsive to these coupled announcements could be undertaken at any juncture along the drug development path from late discovery (i.e., 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/or 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 the facilitation of further development by NIH may be essential. NIH resources (such as those offered by the NIH Bridging Interventional Development Gaps 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.

Applications focusing solely on novel target discovery, new animal model generation, or 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 R21 or 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 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 (e.g., identifying new targets (individual proteins, cellular pathways or circuits) 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 studies of marketed drug products.

5. Phase III clinical 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 (i.e., 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 medications 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.  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 translational research projects 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 partnerships are often vital to the translational research process.

Awardees will be required to commit the major portion (at least 51% or 6.1 person months) 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 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

NIDA intends to commit approximately $3 million for 2-3 awards in fiscal year 2012.

Award Budget

Awards will be for up to $1,000,000 in direct costs each year for five years, plus applicable Facilities and Administrative (F&A) costs to be determined at the time of award.

Award Project Period

The maximum period is 5 years. 

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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 (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

 Applications with multiple PDs/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

 Given the individualized nature of this award, an applicant can submit only one application.

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.

All application instructions outlined in the SF 424 (R&R) Application Guide (SF424 Application Guide - ) 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.

The application items include all those required for the Translational Avant-Garde Award pre-applications (X02) submitted under PAR-11-269. The contents of these items must be substantially the same as those submitted in the pre-application.  In addition, applicants submitting applications in response to this DP1 FOA must arrange to have three letters of reference submitted on their behalf and must submit information on human and vertebrate animal subjects, if applicable.

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 and the Table of Page Limits must be followed, with the following exceptions or additional requirements for this specific FOA:

The following documents must be included in the application:   Abstract, Public Health Relevance Statement, Essay, Biographical Sketch (PD/PI only), List of Current and Pending Research Support, a description of the PD/PI‘s most significant research accomplishment, Facilities and other Resources, and, if applicable, plans for Protection of Human Subjects from Research Risks and Vertebrate Animal Subjects. All documents must be in PDF format and must comply with page limits shown below.   No additional documents should be uploaded to the application. (See detailed information on each component below.). 

SF424 (R&R) COVER COMPONENT:

Item 4a. Agency Routing Identifier:  Enter “N/A”.

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

Item Number 12.  Proposed Project:  Start date: 7/1/2012; End date: 6/30/2017

Item Number 15a. Total Federal Funds Requested:   Enter $ 5,000,000

Item Number 15c. Total Federal & Non-Federal Funds:  Enter $ 5,000,000 (See note below.)

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

Note:   The Budget Request is entered only on Lines 15a and c, as described above.  Funds may be requested for personnel (including co-investigators and collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total $5 million -- should be entered on Lines 15a and c.  Applicable Facilities and Administrative (F&A) costs will be determined at the time of award and should not be included in the budget request.  A detailed budget is not requested and will not be accepted.

SF 424(R&R) Project/Performance Site Locations Component:

Complete as appropriate.

SF 424(R&R) Other Project Information Component:

Items 7-12 are the same as in the X02 pre-application except for correction of minor typographical errors.

Item Number 7. Project Summary/Abstract:  Attach a one page (maximum) abstract of 300 words or less describing the goals of the project. The abstract must be substantially the same as that submitted in response to PAR-11-269.  Only minor changes, such as fixing typographical errors, will be allowed.  Text only, in PDF format – no figures, animations, or Web links will be 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.  Reference citations are not required, but may be included in the Essay and would count toward the 5-page limit.

Item Number 10.  Facilities & Other Resources:  Upload a brief statement (one page maximum) of the facilities to be used for the conduct of the research.  

Item Number 11.  Equipment:  Do not use.

Item Number 12.  Research Accomplishments and Qualifications: The text must be essentially the same as that submitted in the pre-application (X02) in response to PAR-11-269. Using a maximum of one page, describe the PD/PI‘s specific accomplishments and qualifications in the area of translational research (e.g., expertise in developing 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.

SF 424(R&R) Senior/Key Person Profile Expanded 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 PD/PI 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.

PHS 398 Research Plan Component

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

Research Plan Attachments

UPLOAD DOCUMENTS TO THE FOLLOWING FIELDS ONLY:

2.3 Research Strategy: Upload 5-page Essay here. 

The essay must be substantially the same as that submitted in the pre-application (X02) in response to PAR-11-269.

Essay:  Using a maximum of 5 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 'exit' points, including clearly defined milestones, along the Translational Path. References are not required but, if included, must also 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 SUDs in relation to the proposed research project. Where is the 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? Applicants should address how they will manage IP issues to be able to move the technology forward towards development, consistent with achieving the goals of this program. Also describe any private sector support for the 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 describe clear 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 of drug development? 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.

2.6 Protection of Human Subjects: If research involving human subjects is mentioned in the essay, upload the Human Subjects Plan using Part II, Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan.

2.7 Inclusion of Women and Minorities: Upload, as appropriate. See Part II Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan, Sections 4.2 and 5.6.

2.8 Targeted/Planned Enrollment Table:  Upload, as necessary, see Part II Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan, Section 4.3.

2.9 Inclusion of Children:  Upload, as necessary, see Part II Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan, Sections 4.4 and 5.7.

2.10 Vertebrate Animals:  If research involving vertebrate animals is mentioned in the essay, you must address the five points discussed in the Application Guide, Section 5.5.10 Vertebrate Animals.

2.11 Select Agent Research:  Upload the requested information, if applicable. See Part I PHS 398 instructions 5.5.11, Select Agent Research. 

DO NOT USE THE FOLLOWING:

2.1 Introduction to application

2.2 Specific Aims

2.4 Inclusion Enrollment Report

2.5 Progress Report publication List

2.12 Multiple PD/PI Leadership plan

2.13 Consortium/Contractual arrangements

2.14 Letters of support

Letters of Reference:

Letters of reference are an important component of the application. Applicants must arrange to have three (and no more than three) letters of reference submitted on their behalf. Applications that are missing letters of reference may be considered incomplete and may not be reviewed.  Late letters will not be accepted.  Applicants are responsible for monitoring the submission of their letters to ensure that three letters have been submitted prior to the submission deadline.  Applicants are encouraged to check the status of their letters in their eRA Commons accounts.

Letters may be submitted beginning January 21, 2012, and must be submitted no later than 5:00 p.m. (EST) February 21, 2012, 2012.

To submit a letter of reference, the referee will need the following information:

Letters of reference are confidential. Applicants will not have access to the letters. E-mail confirmations will be sent to both the applicant and the referee.  The confirmation sent to the applicant will include the referee‘s name and the date and time the letter was submitted.   The confirmation sent to the referee will include the referee and applicant‘s names, a confirmation number, and the date and time the letter was submitted. 

Note: Since e-mail can be unreliable, it is the applicant‘s responsibility to check the status of his/her letters of reference periodically in the eRA Commons.

Applicants are strongly encouraged to send the following to their referees or to send their referees the following link to this information: (http://nihroadmap.nih.gov/pioneer/LettersofReferenceFormat.aspx).  (Note: Referees will not be able to submit letters without this information).

INSTRUCTIONS FOR REFEREES:

Letters may be submitted to the eRA Commons at: (https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new) beginning January 21, 2012 and must be submitted no later than 5:00 p.m. (EST) February 21, 2012.   Late letters will not be accepted and applications with fewer than three letters may not be reviewed. Letters must be submitted electronically – paper copies will not be accepted.

The applicant‘s name should be placed at the top of the letter.  Although signatures are not required, the letter must include a signature block with the referee‘s full name, title, institution, and contact information.  

In two pages or less, describe the applicant‘s qualities that support the applicant‘s claim to be able to advance the development of novel therapy development products for the treatment of substance use disorders. When possible, give specific examples that illustrate these qualities. Address the likelihood that the applicant will conduct translational research in the proposed research area.

Note:  The letter submission page can be accessed without signing into the Commons, and referees do not need to be registered in the Commons.  Referees must provide the applicant‘s Commons User Name (User ID) and the other information below:

REFEREE INFORMATION (the individual providing the letter of reference):

APPLICANT INFORMATION (applicants must send this information to their referees):

E-mail confirmations will be sent to both the applicant and the referee following submission of the letter.  The email confirmation will include a Confirmation Number that will be required only when submitting a revised or changed/corrected letter.  Please print the confirmation email for your records. 

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:

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 Review and responsiveness by NIDA, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

 In particular, reviewers will evaluate the following Review Criteria:

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? Has the application made a compelling case that the proposed project carries much higher levels of translational need and potential influence than investigator-initiated NIH-supported research projects in basic and clinical sciences? 

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, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? In particular, 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 research effort to activities supported by this Award?    

Innovation

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

Approach

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

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

Does the 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?  Is the proposed work likely to advance the development of a potential/existing medication toward regulatory approval by the FDA for a SUD indication?   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?

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 the National Institute on Drug Abuse, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

Review of applications for this FOA will be conducted by an interview process. Investigators will be interviewed by a panel of distinguished external scientists; interviews will be held in March 2012 in the Washington, D.C. area.  A second level of review will be conducted by the National Advisory Council on Drug Abuse. The Director of NIDA will make the final selection of awardees based on the evaluations of the interview panel, the recommendations of the Advisory Council, and programmatic considerations.  Final selections will be announced publicly, and awards made, by the end of May 2012.

Applications will be evaluated based on the likelihood that each applicant will make meaningful progress toward the development of an innovative small molecule or biologic to address an unmet medical need in the drug addiction treatment field, the absence of alternative funding to pursue this research elsewhere, and a compelling justification for needing the NIDA Translational Avant-Garde Award to pursue the stated translational goals and objectives.

As part of the scientific peer review, all applications:

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

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 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. 

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)

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

Kristopher Bough, PhD
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  

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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