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

FY12 NIDA Avant-Garde Award Program for HIV/AIDS Research (DP1)

Activity Code

DP1

Announcement Type

Reissue of RFA-DA-11-002

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-DA-12-011

Companion FOA

PAR-11-256, X02 Pre-application

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.279

FOA Purpose

The NIDA 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 research proposed must be in an area described in the Trans – NIH Plan for HIV-Related Research http://www.oar.nih.gov/strategicplan/.

Key Dates
Posted Date

July 29, 2011

Open Date (Earliest Submission Date)

February 27, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

March 27, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not applicable.

Scientific Merit Review

April 2012

Advisory Council Review

August 2012

Earliest Start Date(s)

September, 2012

Expiration Date

March 28, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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 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. 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. 

Avant-Garde awardees are required to commit the major portion (at least 51% or 6.1 person months) of their research effort to activities supported by the Avant-Garde Award Program for HIV/AIDs Research.

For additional information, consult the FAQs at http://drugabuse.gov/avgp.html.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

NIDA expects to commit approximately $2 million to fund 2-3 awards in FY 2012.

Award Budget

$500,000 in direct costs each year for five years, plus standard F&A costs, which will be determined at the time of award.

Award Project Period

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 (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

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

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

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

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 should not be submitted.  DP1 awardees are required to commit the major portion (at least 51% or 6.1 person months) of their research effort to activities supported by the Avant-Garde Award program.  Those who will not be able to meet this requirement should not submit pre-applications.

Only one PD/PI (i.e., no multiple PDs/PIs) may be designated.  NIH intramural investigators are not eligible for support under this program.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Individuals may submit only one application as a PD/PI in response to this FOA.  There is no limit to the number of applications that an institution may submit.

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.

Required and Optional Components

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

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirement:

SF 424(R&R) Cover Component

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

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

Item Number 12.  Proposed Project:  Start date: 9/30/2012; End date: 7/31/2017.

Item Number 15a.  Total Federal Funds Requested:  Enter $2,500,000.

Item Number 15c. Total Federal & Non-Federal Funds:  Enter $2,500,000. (See note below.)

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

Note:  The Budget Request is entered only on Lines 15a and c, as described above.  Funds may be requested for personnel (including co-investigators and collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total – $2.5 million -- should be entered on Lines 15a and c. Applicable Facilities and Administrative (F&A) costs will be determined at the time of award and should not be included in the budget request.  A detailed budget is not requested and will not be accepted.

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

Complete as appropriate.

Other Project Information Component

Item 1-6.b. Complete as required on the form.

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

Item Number 7. Project Summary/Abstract:  Attach an abstract (not to exceed 30 lines) describing the goals of the project.  Text only – no figures, animations, or Web links are allowed. 

Item Number 8. Project Narrative:  Attach Public Health Relevance Statement:  In 2-3 sentences written in plain language describe how the proposed research can positively impact HIV/AIDS treatment or prevention among drug abusers. 

Item Number 9.  Bibliography & References Cited:  Do not use.  Reference citations are not required, but may be included in the essay and would be included in the five-page limit.

Item Number 10.  Facilities & Other Resources: Upload a brief statement (1 page maximum) of the facilities to be used for the conduct of the research.

Item Number 11.  Equipment:  Do not use.

Item Number 12.  Most Significant Research Accomplishment :  Attach a description of no more than one page of the applicant’s single most significant publication or research accomplishment; this must be essentially the same as that submitted in the X02 application.  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.

SF 424(R&R) Senior/Key Person Profile Expanded Component

Profile – PD/PI – Attach Biographical Sketch:  Complete only for Project Director/Principal Investigator. Do not submit profiles for other senior/key personnel.  Attach the two-page biographical sketch using the format shown in the Application Guide, Section 4.5, omitting Sections A and D. The biosketch should contain Section B (Positions and Honors) and Section C (peer-reviewed publications or manuscripts in press in chronological order).  Do not include Section A (Personal Statement) or Section D (Research Support).  Do not exceed the two-page limit.

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

PHS398 Cover Page Supplement

Complete all fields.

PHS 398 Research Plan Component

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

Research Plan Attachments

UPLOAD DOCUMENTS TO THE FOLLOWING FIELDS ONLY:

2.3 Research Strategy: Upload 5-page Essay here.  See detailed instructions for Essay below.

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

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

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

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

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

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

DO NOT USE THE FOLLOWING:

21 Introduction to application

2.2 Specific Aims

2.4 Inclusion Enrollment Report

2.5 Progress Report publication List

2.12 Multiple PD/PI Leadership plan

2.13 Consortium/Contractual arrangements

2.14 Letters of support

Detailed Instructions for Essay:

The essay text must be substantially the same as that submitted in the pre-application in response to PAR-11-256. Only minor changes, such as fixing typographical errors, will be allowed.  In five pages maximum, describe the applicant’s innovative vision for addressing a major HIV/AIDS biomedical or behavioral problem or challenge, the importance of this problem or challenge, and the applicant’s qualifications to engage in groundbreaking research. No detailed scientific plan should be provided since the research plan 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.

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?  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 goals 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?

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

Information on collaborations may be included in the Essay.

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 February 27, 2012, and must be submitted no later than 5:00 p.m. March 27, 2012.

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

Funding Opportunity Number (FOA) for this announcement:  RFA-DA-12-011

The applicant’s eRA Commons User Name (Note:  Referees do not need to be registered in the Commons and do not need their own Commons User Name – only the Commons User Name of the applicant is required);

The applicant’s first and last name (note – the name must match exactly the applicant’s name in the Commons);

The URL to the letter submission page (https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new);

The letter of reference submission dates begin February 27, 2012.  Deadline for receipt of letters is 5:00 p.m. March 27, 2012.

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

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

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

Instructions for Referees:

Letters may be submitted to the Commons at (https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new) beginning February 27, 2012     and must be submitted no later than 5:00 p.m. March 27, 2012...  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):

Referee’s First and Last Name (Required)

Referee’s Middle Initial (MI) (Not Required)

Referee’s Email Address (Required)

Referee’s Institution/Affiliation (Required)

Referee’s Department (Required)

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

Applicant’s Commons User Name (User ID), (Required) (Important – this must be the applicant’s, not the referee’s, Commons User Name (User ID).  The letter will not be linked to the appropriate application if the Applicant’s User Name is not entered here.)

Applicant’s Last Name (Required).  (Note: must match exactly the applicant’s name in the Commons)

Funding Opportunity Number (FOA) of this announcement:   RFA-DA-12-011. (Required)

Confirmation Number (Required only when resubmitting a letter, that is, when submitting a revised or changed/corrected letter for the current FOA)

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

Resource Sharing Plan

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

Appendix

Appendices are not allowed and will not be accepted.

Foreign Organizations

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

3. Submission Dates and Times

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

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below. 

The following scored review criteria will also be used in assessing the merits of the applications.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  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 make a major contribution to the HIV/AIDS field?  What is the likelihood that the proposed work will open new avenues of research and/or have broad public health impact by leading to new HIV/AIDS prevention and treatment interventions that may benefit substance users?

Investigator(s)    

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

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 Avant-Garde Award 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 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? Are the idea, the individual, and the strategy cohesive?   

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?  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?   

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriateScientific Review Group(s) convened by NIDA , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.
Review of applications for this FOA will be conducted by an interview process. Investigators will be interviewed by a panel of distinguished external scientists; Interviews will be held in the Washington, D.C. area on April 25-26, 2012.  A second level of review will be conducted by the National Advisory Council on Drug Abuse. The Director, NIDA, will make the final selection of awardees based on the evaluations of the interview panel, the recommendations of the Advisory Council, and programmatic considerations. Final selections will be announced publicly, and awards made, by September, 2012.
As part of the scientific peer review, all applications:

. 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 business official.

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

 A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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

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

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

Scientific/Research Contact(s)

Jacques Normand, Ph.D.
Director, AIDS Research Program
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd
Rm 5274 MSC 9581
Bethesda, MD 20892
Telephone: 301-443-1470
Fax: 301-594-5610
Email: jnormand@nida.nih.gov

Peer Review Contact(s)

Mark Swieter, Ph.D.
Chief
Extramural Affairs Branch
Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, Maryland  20892-8401
Telephone:  (301) 435-1389
FAX:  (301) 443-0538
Email:  mswieter@nida.nih.gov

Financial/Grants Management Contact(s)

Carol Alderson
Grants Management Branch
National Institute on Drug Abuse/NIH/DHSS
6001 Executive Blvd., MSC 9541
Rockville, MD 20892-9541
Telephone: 301-933-6196
Fax: 301-594-6849
Email: aldersoc@nida.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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