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

HIV/AIDS Implementation Science Targeting Drug Using Populations: A Collaboration with PEPFAR (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • April 6, 2011 - See Notice NOT-DA-11-015 Notice of Clarification Regarding Eligible Countries.

Funding Opportunity Announcement (FOA) Number

RFA-DA-12-002

Companion FOA

None

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, in collaboration with the Office of the Global AIDS Coordinator, is soliciting applications for support for implementation science projects that will inform the President’s Emergency Program for AIDS Relief (PEPFAR) as they develop more efficient and cost-effective methods to deliver HIV prevention, treatment, and care for drug using populations.

Key Dates
Posted Date

February 16, 2011

Open Date (Earliest Submission Date)

July 1, 2011

Letter of Intent Due Date

July 1, 2011

Application Due Date(s)

August 1, 2011,, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

 Not applicable

Scientific Merit Review

October/November, 2011

Advisory Council Review

January, 2012

Earliest Start Date(s)

April, 2012

Expiration Date

August 2, 2011

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

Background

The President’s Emergency Plan for AIDS Relief (PEPFAR) is a global health initiative launched in 2003 with the goal of combating the devastation due to HIV/AIDS around the world.  The HIV burden of diseases is high and growing among drug using populations in many part of the word, access to services is suboptimal  and barriers persist limiting the implementation and scaling up of core prevention services.  A rigorous implementation science research agenda is needed to improve program delivery in PEPFAR countries and to increase the global impact of proven HIV/AIDS modalities in prevention, treatment, and care for drug users, particularly persons who inject drugs. Implementation science research is the multidisciplinary field that addresses issues of scale-up of the implementation of prevention, treatment and care services in diverse settings.  Implementation science studies the effectiveness and cost-effectiveness of interventions; its goal is the translation and integration of research findings related to evidence-based interventions into healthcare policy and best-practices and, hence, to improve the quality and effectiveness of HIV/AIDS prevention, treatment, programs, and health services and care for persons who use drugs.  Efficacious interventions developed to prevent or treat HIV/AIDS in a particular setting often yield disappointing results on scale-up in diverse settings.  Another issue is how to choose between competing interventions and the feasibility of scaling up different interventions. Implementation science research seeks to understand the underlying causes of gaps between expected results and observed outcomes.  Implementation science research recognizes that structural factors in the environment, economics, laws, policies, regulations, culture, gender, behavior, and social circumstances are all factors that may complicate adapting and scaling up interventions from one setting or population to another.  Because drug abuse is stigmatized and drug use is criminalized in many countries and often dealt with punitively rather than from a public health perspective, implementation science research may be particularly useful in identifying barriers and test strategies that overcome low coverage and/or delays in accessing services.  Implementation science can then test possible approaches to reduce these barriers and thus facilitate the adoption and adaptation of HIV/AIDS interventions in drug using populations.

While scientific knowledge available to prevent and treat HIV/AIDS has expanded substantially, scientific advances regarding the implementation of effective interventions have not kept pace and barriers persist in translating and using scientific findings for scaling up services. There is an unmet urgent need for implementation science research to inform approaches and investments for public health programming, particularly in low and middle-income countries (LMIC) experiencing a high burden of HIV disease among persons who use drugs. Implementation research is needed to understand how best to: 1) improve the dissemination of effective interventions, 2) improve the transfer and scaling-up of interventions from one setting or population/sub-population of drug users to another, 3) optimize the combination of prevention interventions into comprehensive strategies and tailor them to different geographical areas characterized by different epidemiological patterns, 4) conduct comparative effectiveness studies to better inform choices between competing mixes of core interventions.   All of these are made even more relevant as countries must plan for sustainability of interventions within the context of more limited resources. The answers to these questions will help improve the operations and efficiency of organizing, delivering, and expanding access to proven prevention, treatment, or care intervention that can reduce the burden of HIV diseases.

Research Objectives

The intent of this FOA is to solicit implementation science research relevant to programs supported by the PEPFAR.  Studies should address the challenges that PEPFAR encounters in the implementation of HIV/AIDS prevention, treatment, and care programs in drug using populations.  Studies should reflect the HIV/AIDS needs and priorities of the countries or regions in which they are to be conducted and take into account the cultural, legal, political, policy and economic context, and the health system infrastructure and capacity to organize and deliver effective interventions for persons who use drugs.

The primary drug using populations of interest consist of heterosexual male and female injection drug users, drug using MSM subgroups (e.g., club drug users, IDU, or any other drug using MSM group) and/or sex workers who use drugs and any other high risk groups that use drugs.

Injection and non-injection drug use are major international public health problems. Even though drug users are known to be at a very high risk for acquisition and transmission of HIV, the level of global attention and resources directed toward implementing evidence-based HIV prevention, treatment, and care for this population remains sub-optimal. Despite the wealth of evidence indicating the effectiveness of a large variety of HIV prevention and treatment interventions, in many countries these interventions have yet to be adopted or if adopted, have not been implemented in an accessible and equitable manner, and coverage rates for core interventions are low.

In an attempt to address this gap, various international agencies (e.g., United Nations Program on HIV/AIDS (UNAIDS), UNODC, and the World Health Organization (WHO) have published technical guides for countries to use to help them set targets for universal access to HIV prevention, treatment, and care for drug users and design optimal HIV prevention programs.  PEPFAR in their recent guidance to the field supported the implementation of these interventions and included community-based outreach as a core intervention strategy (www.pepfar.gov).

A critical element of this technical guide is the notion of comprehensiveness and integration to produce the most significant mix of high quality and sustained reductions in HIV risk behavior and infections.  The comprehensive package of HIV prevention, treatment, and care interventions for drug users can include:

1.Community-based outreach

2. Medically Assisted Therapy (MAT) and other drug dependence treatment modalities;

3. HIV counseling and testing;

4. Antiretroviral treatment (ART) as HIV prevention;

5. Condom programming for IDUs and their partners;

5. Sexually transmitted infection (STI) prevention and treatment;

6. Needle and syringe programs (NSPs);

7. Structural interventions;

8. Targeted information, education, and communication;

9. Vaccination, diagnosis, and treatment of viral hepatitis; and

10. Prevention, diagnosis, and treatment of TB.

Evidence suggests that comprehensive, accessible, and culturally appropriate sets of high coverage preventive, treatment, health services and care interventions implemented in an environment where laws, policies, and regulations are supportive are required to optimize their overall impact of reducing HIV burden.  Specifically, a large body of evidence suggests that when discrete HIV prevention interventions are combined, taking into account the cultural context and the nature and scope of the epidemics, more significant and sustained reductions in risk can be achieved.  Knowing the interventions that are effective for drug using populations (see list above), the question becomes how does one go about  planning for the implementation of an effective mix of high quality/high coverage  interventions and integrate these interventions in different settings.  That is where implementation science research comes into play.

Within implementation science, a study can be rigorous if it focuses on tracking outcomes of an intervention with a clear description of the context and how the context may facilitate or impede achieving the desired outcomes.  Applicants should address plans to provide a comprehensive package of interventions and benchmarks of success such as increased syringe access, collection and disposal and MAT coverage.  While this FOA focuses on innovative approaches to integrating multiple interventions and different levels of coverage, it may also determine where integration of services is inadvisable or not possible and where stand-alone approaches are more appropriate.  

A major goal of this announcement is to determine how to best integrate and adapt efficacious interventions in diverse settings (e.g., community, facility-based and or closed settings) for different drug using populations and sub-populations in order to optimize health outcomes (e.g., reducing morbidity, mortality).  Globally, drug-using populations are frequently not reached by intervention programs (e.g., female non-injection and injection drug users, pregnant female injection and non-injection drug users, transactional and commercial sex workers, and amphetamine-type stimulant users). Drug users tend to be diagnosed later in the course of HIV infection and may not be effectively linked to care after diagnosis.  To date there has been no systematic implementation research on comprehensive HIV prevention, treatment, and care for drug users.  Given PEPFAR’s interest in reducing HIV transmission, morbidity and mortality associated with injection drug use by effectively providing and expanding access to services  for drug using populations across diverse settings throughout the world, this collaborative effort with PEPFAR is ideal for launching a meaningful implementation research initiative that combines field based, real-time and real-world opportunities with a rigorous science-based approach.

This initiative solicits research to evaluate the effectiveness and cost-effectiveness of various models of program integration to prevent the further spread of HIV among persons who use drugs, including poly-substance users that will result in greater availability, expanded access, lower-threshold regulations facilitating use of services and reducing the burden of disease.  It will support regional collaborations, across countries in the same region of the world (e.g., Southeast Asia, Central Asia, Eastern Europe) as well as within countries (e.g., multiple provinces or cities) and among sub-populations within countries. This initiative is aimed at developing research and program capability such as initiating and/or scaling up capacity to capture, analyze, and disseminate data.  In doing so, applicants are encouraged to leverage existing international resources. Because sustainability and country ownership of programs is a goal of PEPFAR programs, it is essential that applicants provide training to local partners/collaborators to facilitate sustainability and engage where feasible, governmental and civil society sectors.

Priority questions include, but are not limited to:

What are the optimal combination and coverage rates of interventions for preventing the further spread of HIV among drug using populations?

Which integrated HIV/AIDS prevention programs for drug users are effective and most cost-effective in different epidemic country patterns?

How to effectively integrate a continuum of preventive, treatment, and care programs for drug using populations into the health sector?

What approaches are best for monitoring these programs?  How to rapidly scale up prevention interventions-expand availability, access, improve quality and increase coverage of different component interventions?

How to effectively introduce new programs in local areas that don’t have HIV prevention strategies?

How to effectively introduce low threshold programs that expand access and uptake of interventions?

What practices improve recruitment and retention in NSPs, MAT care and adherence to ARV?

How to most effectively engage multi-sectors of the government to facilitate sustainability?

Which prevention interventions are most effective points of entry to access care and treatment?

How best to integrate services, early identification/detection, prioritization of care and treatment needs, and cross-training of health care providers for co-infections such as TB and HCV?

What strategies for addressing HIV and common co-morbidities are most effective in primary care?

How should clinic visits and lab testing (CD4 and/or HIV viral load) be spaced to support a durable response to first- line ARV therapies among drug using populations?

How can HIV prevention be optimally integrated with treatment and care services?

What are the best system-level approaches for the management of complex HIV-associated co-morbidities when specialty care is not accessible at primary HIV clinics?

How do mass communication strategies or other behavioral or structural interventions improve demand and uptake of HIV testing, HIV prevention, linkage to treatment, and retention in treatment?

How does health care staff training and mentoring impact quality of care delivered?

How to improve capacity by assessing the safety, efficiency, and effectiveness of alternative staffing approaches, including task shifting, task sharing, and involvement of informal health care providers?

How best to apply communication technology to improve data collection (e.g., diagnosis and tracking of disease) and impact?

How can mass communication and new technologies be used to provide public health information and provide training for health care workers?

Applications must include:

Applications should include a training plan for local collaborators and a plan for sustaining training and intervention programs at study end. Training might be on-the-job, instructor-led, online courses, or may include collaborations with local universities to develop curricula and implement certificate-granting programs.  

Key sustainability components might include establishing partnerships with NGOs and in-country governments. 

Dissemination plans should include disseminating study findings to the population that was studied (local community), in-country stakeholders, and the broader world community (e.g., scientific publications, etc.). 

SPECIAL REQUIREMENTS

To promote the development of a collaborative program among award recipients, a number of issues need to be addressed in applications. Applicants should demonstrate their ability and willingness to work cooperatively with the Awarded Institution, partnering institutions (e.g., subcontractors), and foreign government organizations by providing letters of support from the various collaborating institutions.

Applicants have to demonstrate links with the country PEPFAR program and research has to be consistent with the priorities of the country level HIV/AIDS plan and where appropriate the PEPFAR Partnership Implementation Plan,

Multidisciplinary teams with expertise and experience with biomedical and behavioral interventions and use qualitative and ethnographic methods are expected.

Collaborations between US and foreign-based organizations are strongly encouraged.

Multi-PI applications will be accepted. 

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

NIDA intends to commit $4,000,000 to fund 8-10 awards in FY 2012.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

 The maximum period is 5 years.  

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

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Foreign (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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.   

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.

All proposed research projects must take place in counties that meet the following criteria:

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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov 

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:

Director - DA-12-002
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD  20892-9550
Rockville, MD  20852 (for express/courier service)

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.

PHS 398 Research Plan Component

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

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:.

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.

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 the National Institute on Drug Abuse, 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.

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?  

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?   

Innovation

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

Approach

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

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

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

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

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s convened by the National Institute on Drug Abuse) , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

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

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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 (NIDA)
Telephone:  301-443-1470
Email: jnormand@mail.nih.gov

Peer Review Contact(s)

Mark Swieter, Ph.D.
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 o(NIDA)
Telephone: 301-253-8729
Email: pfleming@mail.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.

Special Considerations

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

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


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NIH Funding Opportunities and Notices


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