National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Funding Opportunity Title
NIDA Avant-Garde Award Program for HIV/AIDS and Drug Use Research (DP1)
DP1 NIH Director’s Pioneer Award (NDPA)
Reissue of RFA-DA-14-008
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
The NIDA Avant-Garde Award Program for HIV/AIDS Research supports individual scientists of exceptional creativity who propose high-impact research that will open new areas of HIV/AIDS research and/or lead to new avenues for prevention and treatment of HIV/AIDS among drug abusers. The term “avant-garde” is used to describe highly innovative approaches that have the potential to be transformative. The proposed research should reflect approaches and ideas that are substantially different from those already being pursued by the investigator or others. The NIDA Avant-Garde award supports innovative, basic research that may lead to improved preventive interventions or therapies; creative, new strategies to prevent disease transmission; novel approaches to improve disease outcomes; and creative approaches to eradicating HIV or improving the lives of those living with HIV.
February 13, 2014
Open Date (Earliest Submission Date)
June 29, 2014
Letter of Intent Due Date(s)
Application Due Date(s)
July 29, 2014, July 29, 2015, July 29, 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)
Scientific Merit Review
November 2014, November 2015, November 2016
Advisory Council Review
January 2015, January 2016, January 2017
Earliest Start Date
April 2015, April 2016, April 2017
July 30, 2016
Due Dates for E.O. 12372
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.
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
This award is designed to support individual scientists of exceptional creativity who propose cutting edge – and possibly transformative – approaches to major challenges in biomedical and behavioral research on HIV/AIDS that are relevant to drug abuse. The term “avant-garde” is used to describe highly innovative approaches and ideas that have the potential to be transformative. The NIDA Avant-Garde award supports high priority AIDS research such as innovative, basic research that may lead to improved preventive interventions or therapies; creative, new strategies to prevent disease transmission; novel approaches to improve disease outcomes; and creative approaches to eradicating HIV or improving the lives of those living with HIV. The award is intended to support high-impact research that will open new areas of HIV/AIDS research and/or lead to new avenues for treatment and prevention of HIV/AIDS among drug abusers. Examples of studies of relevance to drug abuse include: studies using populations with significant numbers of drug users or samples from drug using populations; studies using in vitro systems and/or animal models that test the effects of drugs of abuse on HIV pathogenesis, progression, or treatment; and studies to develop interventions or treatments that are tailored to substance using populations. Proposed research should reflect ideas and approaches that are substantially different from those already being studied by the investigator or others. This announcement defines biomedical and behavioral research broadly—the emphasis is on creativity and potential impact rather than a particular discipline or research area. The award is meant to support individuals who intend to pursue research directions that are not readily supported by other NIH grant mechanisms. The program is not intended simply to expand the funding of an already supported research project, but rather to support highly creative researchers to pursue visionary concepts and approaches to research on HIV/AIDS.
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.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed
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 $2M in each fiscal year (FY15-FY17) to fund 2-3 awards each year.
Application budgets are limited to $500,000 in direct costs per year.
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.
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
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.
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.
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.
Only one PD/PI (i.e. no multiple PDs/PIs) may be designated. NIH intramural investigators are not eligible for support under this program.
Investigators at all career levels who meet the eligibility criteria and are currently engaged in research are eligible to submit applications. The research proposed need not be in a conventional biomedical or behavioral discipline; if the individual’s experience is in non-biological areas, however, he/she must demonstrate a commitment to exploring topics of biomedical or behavioral relevance to HIV/AIDS and drug abuse.
This initiative is to support investigators who intend to pursue new research directions – research that is distinct from that currently or previously conducted by the investigator. Applications for projects that are extensions of ongoing research are not be submitted.
DP1 awardees are required to commit a large portion (at least 35% or 4.2 person months) of their research effort to activities supported by the Avant-Garde Award program.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
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.
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.
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:
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.
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.
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 2,500,000.
Total Non-Federal Funds: Enter $0.
Total Federal & Non-Federal Funds: Enter $2,500,000. (See note below.)
Estimated Program Income. Enter $0.
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 - $2.5 million - should be entered in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds". 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 Avant-Garde Award project. 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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Bibliography & References Cited: Do not use. Reference citations cannot be attached here, but may be included in the essay.
Equipment: Do not use.
Other Attachments: Do not use.
Other Attachments: Attach a description of no more than one page of the applicant’s single most significant publication or research accomplishment. Applicants should submit one single accomplishment, not a summary of several accomplishments, multiple publications, or background narratives. Publications or other documents will not be accepted.
Profile - Project Director/Principal Investigator Field - 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.
Profile - Senior Key Person 1: Do not use. Submit information only for PD(s)/PI(s). Information on collaborators or other key personnel is not required but may be included in the Essay.
All instructions in the SF424 (R&R) Application Guide must be followed.
Specific Aims: Do not use.
Research Strategy: Upload the Essay here. Describe the applicant’s innovative vision for, and the significance of, the HIV/AIDS biomedical or behavioral problem to be addressed, and the applicant's qualifications to engage in groundbreaking research. 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. No detailed scientific plan should be provided since the research strategy is expected to evolve during the tenure of the grant. The essay should include the following sections in the order given with the headings as shown below:
Project title: The project title must be included at the beginning of the essay.
Statement of research effort commitment: A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of 35% or 4.2 person months of his/her research effort to the project supported by the Avant-Garde Award Program for HIV/AIDS Research. Applications without such a statement will be considered incomplete.
Project description: What is the scientific problem or challenge that will be addressed, and why is this important? What are the pioneering, and possibly high-risk, approaches that, if successful, might lead to groundbreaking or paradigm-shifting results and how might these results benefit substance users? If the initial strategy/approach does not work out as planned, what alternative strategies/approaches might be employed?
Evidence of innovativeness: What concrete evidence can you provide for your claim of innovativeness? For example, qualities common to many highly innovative people include an interest in, and the ability to integrate, diverse sources of information; an inclination to challenge paradigms and take intellectual risks; persistence in the face of failure; an ability to be flexible and a willingness to take a new view of a vexing problem; an ability to attract the right collaborators; and the energy and concentration necessary to plan and execute effective strategies for accomplishing goals.
How the planned research differs from your past or current work: Describe how the project represents a new and distinct direction for your research.
Compatibility with the goal of the Avant-Garde Award Program for HIV/AIDS Research: Why is the planned research uniquely suited to the stated goal of the Avant-Garde Award Program for HIV/AIDS Research, rather than a traditional grant mechanism? How will the planned research move the field forward in a truly transformative way?
Information on collaborations may be included in the essay. Literature references 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 Avant-Garde 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Appendix materials are not allowed and will not be accepted.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
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.
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.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. 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.
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 aspect 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 June 29 and must be submitted no later than 5:00 p.m. (local time of applicant organization), July 29.
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 June 29 and must be submitted no later than 5:00 p.m. (local time of applicant organization), July 29. 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.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
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 Avant-Garde Award Program for HIV/AIDS Research (DP1) applications are meant to support individual scientists of exceptional creativity who propose pioneering -- and possibly transforming -- approaches that, if successful, will have a major impact on a broad area of biomedical or behavioral research. Avant-Garde Award applications do not require preliminary data, scientific aims, or a detailed research plan. Accordingly, reviewers, in both review phases,will emphasize the following:
1) the significance and innovation of the proposed project;
2) the investigator (evidence for past innovation; and the PD/PI's demonstrated ability to devote 35% or more research effort on the DP1 project); and
3) the suitability of the proposed project for the Avant-Garde Award mechanism, which includes evidence that the proposed research is of sufficient risk/potential impact that it is more suitable for the Avant-Garde Award program than for a traditional grant mechanism, and that the proposed research represents a new research direction for the PD/PI. A new research direction is defined as a significant departure from the direction of ongoing or previously funded research in the PD/PI’s laboratory.
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 November or December 2014 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 April.
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.
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).
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.
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 Avant-Garde 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 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?
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 Avant-Garde 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 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?
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 Avant-Garde 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?
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
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?
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? Given that the Avant-Garde Award Program for HIV/AIDS Research supports an exceptional investigator who is focused on a transformative idea, does the scientific environment provide the level of support needed to execute such a creative program of study?
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.
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.
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.
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.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 Advisory Council on Drug Abused. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, 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)
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
Contact CenterTelephone: 800-518-4726
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Jacques Normand, Ph.D.
National Institute on Drug Abuse (NIDA)
Mark Swieter, PhD
National Institute on Drug Abuse (NIDA)
National Institute on Drug Abuse (NIDA)
Telephone: 301-933-6196Email: email@example.com
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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