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

Early Career Award in Chemistry of Drug Abuse and Addiction (ECHEM)  (R21/R33)

Activity Code

R21/R33 Phased Innovation Award

Announcement Type

Reissue of PAS-10-274

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-13-350

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.279 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) seeks to facilitate the entry of new-to-NIH investigators into basic chemistry research applied to drug abuse and addiction.

Key Dates
Posted Date

September 11, 2013

Open Date (Earliest Submission Date)

September 16, 2013  

Letter of Intent Due Date(s)

Not Applicable  

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Standard AIDS dates apply by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

Standard dates apply  

Advisory Council Review

Standard dates apply  

Earliest Start Date

Standard dates apply  

Expiration Date

September 8, 2016

Due Dates for E.O. 12372

Not Applicable 

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). 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.


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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


Purpose

This Funding Opportunity Announcement (FOA) seeks to facilitate the entry of new-to-NIH investigators into basic chemistry research applied to drug abuse and addiction. 

Background

NIDA-funded research has furthered our understanding of the neurobiological mechanisms underlying drug addiction, but much remains to be learned. In particular, there is a need for research in the basic biological and chemical sciences to identify and explicate the neural mechanisms underlying drug abuse and addiction. Research into the chemistry of drug abuse can identify new targets for interventions or new chemical templates for treating toxic side effects of drugs/drugs of abuse.  Moreover, the development of appropriate probes or new technologies has the potential to advance the field at a rapid rate. The study of the genetic, molecular, cellular, circuit-based, and behavioral mechanisms involved in addiction and the development of associated therapeutic strategies may all benefit from synthetic chemical research and approaches.

To date, NIDA grantees have synthesized a number of ligands, targeting a wide variety of targets for several different research purposes. Ligands have been developed, for example, that target receptors, transporters, ion channels and enzymes by which drugs of abuse have been shown to interact; multiple structural analogs have been synthesized including ligands that have been shown to possess dual functions (e.g., mu agonist-delta antagonist); and, imaging agents have been synthesized that target both transporters and receptors (e.g., [11C] RTI-121 as a selective radioligand for PET studies of the dopamine transporter). Yet, there remains a need to develop new research probes or therapeutic compounds that are specific and efficacious. 

Objectives

This announcement is intended to encourage early career chemists (or chemists new to NIH) to develop probes that aid basic research investigations on drug abuse and/or identify new or better templates as lead compounds with potential for conducting structure activity relationship (SAR)-function studies. Importantly, this includes the identification of new chemical entities (NCEs) with therapeutic potential for drug abuse and addiction. Applicants responding to this FOA should explain their rationale for the proposed work, the inclusion of pharmacologic assessments, and the relationship of the research proposed in the context of a broader medications development pipeline (e.g., Target Identification > Probe/ligand screening > Synthesis of ligands > Assay development > Proof of concept > Lead optimization, etc.).

Nevertheless, appropriate theoretical justification and sound hypotheses should be provided to engender confidence that the project is well thought out and feasible. Researchers interested in seeking funding for developmental research projects within the later stages of medications development, especially those not new to NIH who may already have preliminary data, are referred to other announcements such as PAR-13-270 entitled, "Grand Opportunities in Medications Development”. 

An R21/R33 Phased Innovation Award has two phases: (1) R21 for milestone-driven exploratory or feasibility studies with a possible transition to, (2) the R33 for expanded development.

Transition to the R33 depends on the ability of the applicant to meet predefined milestones (which are evaluated in peer review and negotiated with NIDA Scientific/Research Contract prior to the R21 award), as well as program priorities and the availability of funds. NIDA anticipates that a maximum of 50%-70% of the funded R21 phase awards will progress to the R33 award. 

There are four research areas of particular interest for this FOA as follows:

1. Development of new and innovative molecular probes/ligands for receptors, transporters, ion channels, enzymes or other justifiable neurobiological targets associated with drug addiction and pain. Specific targets of interest include, but are not limited to:

All SAR projects that might ultimately aid in the development of new probe/potential drug synthesis and/or aid in the understanding of neurochemical mechanisms of drug addiction are important areas of research under this FOA. Research aimed at the development of novel receptor-specific antagonists, agonists, partial agonists, negative and/or positive allosteric modulators, or the identification of pharmacophores for potential drug design would all be responsive projects. See also the NIDA Addiction Treatment Discovery Program Guide for Compound Submitters for additional possibilities.

2. The development of novel ligands for use in neuroimaging studies of addiction issought. New PD/PIs are needed who have the potential to develop novel radioligands for positron emission tomography (PET) and/or single photon emission computed tomography (SPECT) imaging in human brain. These radiotracers can be tested initially in preclinical models, but ideally would be used for clinical neuroimaging as potential biomarkers (e.g., PET ligands for receptors, ion channels, enzymes, transporters, etc.).

3. The application of newer areas of research, and their associated technologies. This would include areas such as genomics, transcriptomics (e.g., microarrays), proteomics, metabolomics, or lipidomics in the discovery and identification of new endogenous ligands that play a role in the underlying mechanisms of substance use disorders (SUDs). Data from these projects could be used for the identification and/or development of a diagnostic biomarker associated with drug dependence, or, perhaps, could include the development of a pharmacodynamic biomarker associated with (or ideally predictive of) a potential treatment outcome (good or bad) for drug dependence.

4. Research projects aimed at isolating, identifying, purifying and characterizing new lipid ligands, receptors, transporters, enzymes, etc. for the cannabinoid, vanilloid or other lipid-based targets, would also be supported.

Some examples of research topics are provided below. These are NOT intended to be exclusionary or exhaustive.  Applicants are strongly encouraged to contact program staff to discuss proposed studies or to obtain clarification.

Discovery

Synthesis

Probe and ligand development

Assays and Screens for Validation Studies

Lead Optimization & Delivery

Structural Studies

Computational modeling

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse:  In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing.  NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV.  This policy applies to all NIDA funded research conducted domestically or internationally.  For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:  The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects.   Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA's Web site at  http://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.

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

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

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

For the R21 award, direct costs are limited to $250,000 over a two-year period, with a maximum of $200,000 allowed in any single year. The R33 award will be limited to $250,000 in direct costs per year. 

Award Project Period

The total project period may not exceed 4 years. Awards will support milestone-driven exploratory/feasibility “proof of concept” studies (R21 phase, up to two years), with possible rapid transition to expedited development (R33 phase, up to three years, depending upon the requested period for the R21 phase). 

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.

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

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA is intended to encourage early career chemists (or chemists new to NIH) to develop probes that aid basic research investigations on drug abuse and/or identify new or better templates as lead compounds with potential for conducting SAR-function studies. A New Investigator is an NIH research grant applicant who has not yet competed successfully for a substantial, NIH research grant. For example, a PD/PI who has previously received a competing NIH R01 research grant is no longer considered a New Investigator. However, a PD/PI who has received a small grant (R03) or an Exploratory, Developmental Research Grant Award (R21) retains his or her status as a New Investigator. For a complete list of NIH grants that do not disqualify a PD/PI from being considered a New Investigator, please visit: http://grants.nih.gov/grants/new_investigators/index.htm.

An ESI, or Early Stage Investigator, is a New Investigator who has completed his or her terminal research degree or medical residency—whichever date is later—within the past 10 years and has not yet been awarded a substantial, competing NIH research grant. The dates that start the period of classification as an Early Stage investigator are entered in the investigators eRA Commons Profile (https://commons.era.nih.gov/commons/).

It is expected that ESIs will constitute the majority of funded NIs. Software within the eRA Commons will check first for New Investigator status based on the individual’s previous award history. A New Investigator is identified in the NIH eRA Commons by searching for evidence of previous substantial research grant awards. ESIs are identified in the eRA Commons  based on information entered about degree conferral date or the end of residency date, whichever is most recent.  

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

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.

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

Page Limitations

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

Required and Optional Components

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

All applications should include costs to attend an eCHEM consortium meeting to be held once per year. An eCHEM Consortium of awardees will meet annually in Bethesda, MD to discuss the diverse aspects of basic chemistry research as it applies to drug abuse and addiction.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

This FOA will utilize the Exploratory/Developmental Phased Innovation (R21/R33) grant mechanism. Applicants will submit a single application organized into two phases, beginning with discussion of the R21 phase followed by discussion of the R33 phase. Applicants applying for only the R21 mechanism or only the R33 mechanism will be considered unresponsive to this FOA and the application will not be reviewed.

R21 Component: The R21 phase of this FOA provides up to two years of preliminary support to demonstrate the feasibility of the R33 project. Since exploratory applications are expected to be descriptive and hypothesis-generating in nature, pilot data that provide support for the proposed hypotheses and aims (i.e., Proof of Concept) are not required. However, applicants are encouraged to provide evidence that they have the capability to conduct the research by documenting the availability of needed resources, the training and experience of the investigator(s) and/or the conduct of related studies. The studies proposed in the R21 phase should be hypothesis-generating in nature, and not necessarily hypothesis-confirming.  The goal of such studies should be directed towards demonstrating feasibility rather than completion of a full study.

Milestones: In the R21 Phase of their proposals, applicants must include at least three well-described, measurable scientific or technical milestones which demonstrate the feasibility of the R33 Phase. These milestones will be evaluated in the peer review process and negotiated with NIDA program staff prior to the award of the R21 phase.  Although funded applicants are solely responsible for planning, directing, and executing the proposed project, the transition from the R21 feasibility phase of applications, and the eligibility for the R33 development phase, will be determined by NIDA program staff in the context of the peer review recommendations and based on successful completion of negotiated scientific/technical milestones, program priorities, and availability of funds.

R33 Component: Depending upon the period requested for the R21 phase, the R33 phase may provide up to 3 years of additional support for actually conducting the research program. 

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

Specific Aims: 

Within the Specific Aims section, include headers titled "R21 Phase Specific Aims" and "R33 Phase Specific Aims". Under each header, state the specific objectives of the research and development effort, including the technical questions you will try to answer to determine the feasibility of the proposed approach. Since the R21 phase of this FOA is the exploratory/feasibility component, hypothesis testing, per se, may not be the driving force in developing such an application, and therefore, may not be applicable in the R21 phase. The R21 phase could include descriptive, novel and untested approaches.

Research Strategy:

Innovation: Include headers titled R21 Phase Innovation and R33 Phase Innovation, and address the Innovation for the R21 and R33 phases in the appropriate sub-section.

Approach: Include headers titled R21 Phase Approach and R33 Phase Approach, and address the Approach for the R21 and R33 phases in the appropriate sub-section.

Milestones and Timeline (limit, one-half page): Provide a timeline with specific milestones for accomplishing the proposed research, including specific milestones for progression from the R21 phase to the R33 phase.  Indicate when it is anticipated that essential components of the project (e.g., optimization of protocols, generation of reagents, critical experiments to verify the hypothesis, validation of novel tools or techniques) will be completed. The proposed timeline should be clearly delineated and should appear as the last element of the Research Strategy section.

The milestones proposed in the application should be well described, quantifiable, and scientifically justified to allow program staff to assess progress in the R21 phase. The milestones will be considered in evaluating the approach proposed by the investigator. A discussion of the milestones relative to the progress of the R21 phase and the implications of successful completion of the milestones for the R33 phase should be included. Applications lacking this information, as determined by NIH staff, will be returned to the applicant without review. The clarity and completeness of the R21/R33 application with regard to specific goals and feasibility milestones are critical.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

If not adding any modifications, replace the text above “with the following modifications” with “.” and delete the bullets below. If using either bullet 1 or bullet 2 as a modification, delete the bullet you are not using.  DO NOT KEEP BOTH BULLETS.

For R13/U13 FOAs, Resource Sharing Plans are never applicable.  Use the second bullet below and delete the first bullet.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions 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 applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

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 SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030

Section V. Application Review Information


1. Criteria

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

Overall Impact

Reviewers will provide an overall impact 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? 

More specifically, is the target or project question proposed appropriate and for the drug abuse field? Are the milestones laid out in a logical, step-wise, and well-thought out manner specific for the type of development proposed (i.e., research probe/potential new drug synthesis)?

Would successful completion of the aims contribute significantly to an effective strategy for developing new targets, probes, or ligands for the drug abuse field?  Does the investigator demonstrate a clear understanding of drug abuse and potential challenges one might face in attempting to develop new targets, probes or ligands for drug development in addiction? 

Investigator(s)    

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

As this FOA is designed specifically for NIs, does the new PD/PI provide adequate justification for their potential to carry out the proposed 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? 

If the identification of a target is proposed, is the methodology sound, and are the plans for validating the target appropriate? 

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? 

Based on the available methodologies, is the approach justified and technologically sound to meet the milestones proposed?  If problems arise, are the contingency plans adequate? 

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 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 Guidelines for the Review of Human Subjects.

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 Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable

Revisions

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

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 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 (for additional information, see http://grants.nih.gov/grants/foreign/.

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

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) by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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’s business official.

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

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

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 annual Non-Competing Progress Report (PHS 2590 or RPPR) 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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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

Scientific/Research Contact(s)

Kristopher J. Bough, Ph.D.
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-9800
Email: boughk@mail.nih.gov  

Peer Review Contact(s)

Mary Custer, Ph.D.
Center for Scientific Review
Telephone: 301-435-1164
Email: custerm@csr.nih.gov

Financial/Grants Management Contact(s)

Ericka Wells
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 410-254-1853
Email: wellse2@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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