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

Avenir Award Program for Research on Substance Abuse and HIV/AIDS (DP2)

Activity Code

DP2  NIH Director’s New Innovator Awards

Announcement Type

New

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

RFA-DA-15-007

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

Avenir means future in French, and this award looks toward the future by supporting early stage investigators proposing highly innovative studies. The award will support those in an early stage of their career who may lack the preliminary data required for an R01 grant, but who propose high impact research and who show promise of being tomorrow's leaders in the field. NIDA has developed two Avenir Award Programs, one for HIV/AIDS research and the other for genetics or epigenetics studies. The Avenir Award Program for Research on Substance Abuse and HIV/AIDS will support creative individuals who wish to pursue innovative research at the nexus of substance abuse and HIV/AIDS.  The Avenir Award Program for Research on Substance Abuse and HIV/AIDS will support research approaches for substance using populations with or at risk for HIV/AIDS that may lead to improved preventive interventions, improved therapies and/or long term retention in care, and ultimately, eradication of HIV.

Key Dates
Posted Date

April 4, 2014

Open Date (Earliest Submission Date)

October 12, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

November 12, 2014, November 12, 2015, November 14, 2016, 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)

November 12, 2014, November 12, 2015, November 14, 2016, 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

March 2015, March 2016, March 2017

Advisory Council Review

May 2015, May 2016, May 2017

Earliest Start Date

July 2015, July 2016, July 2017

Expiration Date

November 15, 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

Avenir means future in French, and this award looks toward the future by supporting early stage investigators proposing highly innovative studies at the nexus of substance abuse and HIV/AIDS. This award is designed to support creative individuals who wish to pursue innovative research approaches for substance using populations with or at risk for HIV/AIDS. Research that may lead to improved preventive interventions, improved therapies and/or long term retention in care or implementation strategies, and ultimately, eradication of HIV. The award will support those in an early stage of their career who may lack the preliminary data required for an R01 grant, but who propose high impact research and who show promise of being tomorrow's leaders in the field.

Through the Avant-Garde Award Program for HIV/AIDS Research (DP1), NIDA has supported highly innovative researchers proposing potentially transformative research. While open to investigators at all career stages, the Avant-Garde Award has not attracted many early stage investigators. Therefore, the Avenir award is designed to complement the Avant-Garde award by focusing on early stage investigators. Avenir applicants may propose research in any area of high priority HIV/AIDS research that has the potential to open new areas of HIV/AIDS research and/or lead to new avenues for treatment and prevention of HIV/AIDS among substance abusers.

Avenir awardees are required to commit at least 25% of their research effort to activities supported by the Avenir award.

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

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

Funds Available and Anticipated Number of Awards

NIDA intends to commit $1.5M in each fiscal year (FY 2015-2017) to fund 2-3 awards.

Award Budget

Application budgets are limited to $300,000 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 project 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 not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not 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.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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 the purpose of this FOA, multiple PD(s)/PI(s) are not allowed.

Applicants must meet the definition of an Early Stage Investigator (ESI). An ESI is a new investigator (defined as a PD/PI who has not competed successfully for a significant NIH independent research award) who is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent). A complete list of NIH grants that do not disqualify a PD/PI as a new investigator can be found at: http://grants.nih.gov/grants/new_investigators/. Frequently Asked Questions about the NIH Early Stage Investigator (ESI) Policy can be found at http://grants.nih.gov/grants/new_investigators/.

An extension to the 10-year period may be granted under special circumstances (e.g., family care responsibilities, extended periods of clinical training, disability or illness, etc.). To request an extension, an applicant MUST complete the “Form for Requesting an Extension in the Early Stage Investigator (ESI) Period” (http://grants.nih.gov/grants/new_investigators/esi_extension_add.htm). A request for extension must be approved at the time the Avenir Award application is submitted. It may take up to several weeks for the approval process, so applicants should plan accordingly.

Applicants are responsible for reviewing and/or updating their degree information in their eRA Commons account in a timely fashion. Applicants should allow several weeks for an extension request to be processed. NOTE: If an applicant is not identified as an ESI in the eRA Commons, it may result in the application not being reviewed.

Applicants also must hold an independent research position at a domestic (U.S.) institution as of September 1 of the fiscal year of the competition. For the purpose of this FOA, “independent research position” means a position that automatically confers eligibility, by the applicant’s institutional policy, for an investigator to apply for R01 grants, with an appropriate commitment of facilities to be used for the conduct of the proposed research. Investigators still in training or mentored status (postdoctoral fellows) are not eligible to apply unless they have a written commitment of an independent faculty position as of September 1 of the fiscal year of the competition that is certified by submission of the application from that institution.

Applicants may submit or have an R01 (or other equivalent) grant application pending concurrently with their Avenir Award application. However, if that pending grant is awarded in the fiscal year of the competition (fiscal years end September 30) with a start date of September 30 or earlier in that fiscal year, then the applicant is no longer eligible to receive the Avenir Award.

Awardees are required to commit at least 25% of their research effort each year to activities supported by the Avenir Award.  

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 with the following additional instructions:

Agency Routing Identifier:  Enter “N/A”.

Type of Application:  Must be “New”.

Proposed Project:  Start date: 07/01/2015; End date: 06/30/2020.

Total Federal Funds Requested:  Enter 1,500,000.

Total Non-Federal Funds: Enter $0.

Total Federal & Non-Federal Funds:  Enter $1,500,000. (See note below.)

Estimated Program Income:  Enter $0.

Note:  Note: The Budget Request is entered only in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" as described above. Funds may be requested for personnel (including collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total – $1.5 million -- should be entered in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" 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.

Cover Letter: Provide names and affiliations of significant collaborators for the Avenir Award project. Letters of collaboration and biosketches of collaborators are not allowed. Provision of names here is only to help exclude conflicts during reviewer assignment. Information regarding any collaborators may be included in the Essay.

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. With the following additional instructions:

Project Summary/Abstract:  Attach an abstract (not to exceed 30 lines) describing the goals of the project and relevance to HIV/AIDS and substance abuse.  Text only – no figures, animations, or web links are allowed.

Project Narrative:  In 2-3 sentences written in plain language describe how the proposed research can positively impact HIV/AIDS treatment or prevention among drug abusers. 

Bibliography & References Cited:  DO NOT USE. Reference citations are not required, but may be included in the essay and are included in the page limit.

Equipment: Do not use.

Other Attachments: Do not use. 

SF424(R&R) Senior/Key Person Profile

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

Profile – PD(s)/PI(s) – Attach Biographical Sketch:: Attach the PD/PI's biographical sketch using the sample format on the Biographical Sketch Format Page  shown in the Application Guide, omitting Section A (Personal Statement) and Section D (Research Support). No biographical sketches of potential collaborators or other key personnel are to be submitted and will not be accepted. 

Profile – PD(s)/PI(s) – 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 for "Other Support" as shown in the Application Guide. A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of 25% of his/her research effort to the project supported by the Avenir Award.

Profile – Senior Key Person 1: Do not use.  Submit information only for PD/PI.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Do not use.

Research Strategy:  Upload Essay here. Submit an essay that addresses (1) the significance and potential impact of the project to open new areas of HIV/AIDS research and/or lead to new avenues for treatment and prevention of HIV/AIDS among substance abusers and, (2) what makes the approaches exceptionally innovative and how the applicant will address risks and challenges, and (3) the applicant’s qualifications for this award. The description of the scientific plan should be written with a level of detail appropriate for reviewers who are broadly knowledgeable about HIV/AIDS and substance abuse but who may not be directly involved in the proposed area of research. To focus the essay on the goals of the Avenir Award program and the review criteria for applications, presentation of the proposed research as a series of specific aims is discouraged. Preliminary data are allowed but not required. The essay should include the following sections within the page limit, in the following order, with the headings shown:

Project Description:  Describe the scientific problem that you propose to address, its importance, and how solving this problem would have a major impact on HIV/AIDS prevention and/or treatment in substance using populations. Why is the planned research uniquely suited to the Avenir Award program, rather than a traditional grant mechanism? How is this project distinct from other research that may be supported in your laboratory or research group?

Innovativeness: The essay should describe the individual's view of the major challenges in HIV/AIDS biomedical or behavioral research to which he/she can make seminal contributions. State clearly and concisely what makes your project unusually innovative. If the approaches entail a high degree of risk, what will you do if these approaches are not successful?

Investigator Qualifications:  Provide evidence to support your claim of innovativeness and creativity in your research. For example, which personal qualities and experiences demonstrate your inclination to challenge paradigms and take intellectual risks, develop unique collaborations, integrate diverse sources of information, or develop novel approaches when new challenges or opportunities arise?

Note: Information on collaborations may be included in the essay. Bibliographic citations are not required but if included must fit within the page limit.  Figures and illustrations may be included but must also fit within the page limit. Do not include links to websites to provide further information. No animations (movies) are allowed in any documents.

Letters of Support: Provide letters of support from significant collaborators for the Avenir Award project.

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

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but for this FOA, the resource sharing plans will be requested as just-in-time information if an award is being considered.

Appendix:  Appendix materials are not allowed

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. 

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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

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 will be considered incomplete and will 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 Commons accounts.

Letters may be submitted beginning, October 12 and must be submitted no later than 5:00 p.m. (local time of applicant organization), November 12.

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. Email 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 email can be unreliable, it is the applicant’s responsibility to check the status of his/her letters of reference periodically in the Commons.

Instructions for Referees:

Letters may be submitted to the Commons at

https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new

beginning October 12  and must be submitted no later than 5:00 p.m. (local time of applicant organization), November 12. Late letters will not be accepted and applications with fewer than three letters will 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 scientific innovativeness and creativity. When possible, give specific examples that illustrate these qualities. Address the likelihood that the applicant will conduct groundbreaking 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):

Email 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.

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.

For this particular announcement, note the following:

The Avenir Award (DP2) grant supports innovative research that has the potential to produce a major impact on HIV/AIDS biomedical or behavioral research.  A DP2 grant application does not have extensive background material, and the essay focuses on the goals of the Avenir Award program.

Preliminary data are not required but may be included. Accordingly, reviewers, in both review phases,  will emphasize the following: 1) the importance of the scientific problem and the potential impact of the research, 2) the novelty and innovativeness of the approach, and 3) evidence of the applicant's potential for creative and innovative research as an early stage investigator.

Applications that are complete will be reviewed in two phases by a multidisciplinary scientific review group of outside experts convened by The National Institute on Drug Abuse in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below. Applications will initially be evaluated for scientific and technical merit by outside reviewers. Overall impact scores and standard criterion scores will not be given. Subsequently, an editorial-style panel will consider the applications and the comments of the initial reviewers to select the most meritorious applications. Candidates selected by the panel will be invited to the Washington, D.C. area in March for interviews. Final selection of awardees will be made by the Director, National Institute on Drug Abuse, NIH, based on the outcome of the initial peer review, the recommendations of the second level of review, concurrence of National Advisory Council on Drug Abuse, and programmatic considerations. Final selections will be announced publicly, and awards will be made by June 30, 2014.

Applications that are not selected for interview phase of review will receive summary statements with brief reviewer comments. These applications will be designated as “Not Discussed” and will not receive a numerical impact score. Applications selected for the second phase of review (interview) will receive summary statements with brief reviewer comments and a numerical impact score. Criterion scores will not be provided for any application.

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? Given that the overarching goal of the Avenir Award Program for HIV/AIDS Research is to support cutting edge and possibly transformative research that addresses important challenges in HIV/AIDS that are relevant to drug abuse, does the application address a crucial biomedical or behavioral issue in a way that has the potential to be a major contribution to the HIV/AIDS field? What is the likelihood that the proposed work will open new avenues of research and/or lead to new HIV/AIDS prevention and treatment interventions that may benefit substance users? 

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? Given that the purpose of the Avenir Award Program for HIV/AIDS Research is to support individual scientists of exceptional creativity who are proposing research that is at the forefront of HIV/AIDS research, is there clear evidence (appropriate for the applicant's ESI career stage) that the applicant has the ability to address challenging research questions with solutions that are both highly innovative and result in major contributions to the field?  Are there indicators that demonstrate the investigator’s ability to pursue groundbreaking research that is at once high-risk and high-payoff?

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?  Given that the Avenir Award Program for HIV/AIDS Research focuses on the investigator’s vision for a broad and highly creative research project that has the potential to have a major influence on the field, is the project of higher risk than a traditional research project?  Does the project represent a distinctly new scientific direction rather than a mere refinement of existing studies of the applicant or other researchers?   

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion 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 human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. 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

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 score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 Institute on Drug Abuse Advisory Council. 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)

Finding Help Online: http://grants.nih.gov/support/index.html

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 CenterTelephone: 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)

Jacques Normand, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-1470
Email: jnormand@nida.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: pfleming@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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