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 and Substance Use among   Black/African American Women and Young MSM (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

RFA-DA-14-010

Companion Funding Opportunity

RFA-DA-14-009, R01 Research Project Grant
RFA-DA-14-011, R01 Research Project Grant
RFA-DA-14-012, R21 Exploratory/Developmental Grant
RFA-DA-14-007, U01 Research Project – Cooperative Agreements

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.279 

Funding Opportunity Purpose

To improve understanding of the intersection of HIV/AIDS and drug abuse, this Funding Opportunity Announcement (FOA) is part of a multipronged 2014 expansion of HIV and AIDS related research within the context of drug and alcohol abuse among understudied populations and in understudied settings that show promise for the development of effective prevention and treatment efforts. In addition to this funding opportunity, others included in the 2014 expansion address HIV/AIDS and substance use among the homeless and unstably housed (RFA-DA-14-009); the integration of substance abuse and HIV prevention and treatment within HIV/AIDS service delivery settings (RFA-DA-14-011); exploratory research on comorbid HIV, chronic pain, and substance use among older adults (RFA-DA-14-012); and Seek, Test, Treat, and Retain Data Harmonization Coordinating Center (RFA-DA-14-007).

This FOA seeks R01 research grant applications 1) to conduct research that expands our understanding of the intersection between substance use and HIV among Black/African American women (BAAW) and young Black/African American men who have sex with men (YBAAMSM), and 2) to develop and test interventions that improve HIV prevention and care among BAAW and YBAAMSM, with attention to substance use and its consequences.  These populations bear a disproportionate burden of HIV infection in the US. Infections of BAAW have plateaued since the mid-2000s but there is considerable local variation. YBAAMSM have shown continued and consistent increases in HIV acquisitions since the early days of the epidemic and represent the population with the greatest increase in new cases during recent years. Individual HIV risk behaviors in these populations are not elevated relative to Caucasian; however, social and structural factors appear to amplify risk and reduce engagement in preventive services, screening and care among BAAW and YBAAMSM. Despite these common social/structural factors, there are important differences with, for example, BAAMSM cases being disproportionately in younger ages than those for BAAW. More attention to unique and common factors in these populations is needed to improve our understanding of HIV risk and transmission, as well as the development of more effective intervention strategies.   

Key Dates
Posted Date

June 10, 2013

Open Date (Earliest Submission Date)

October 15, 2013

Letter of Intent Due Date(s)

October 15, 2013

Application Due Date(s)

November 15, 2013, by 5:00 PM local time of applicant organization.

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

AIDS Application Due Date(s)

November 15, 2013, by 5:00 PM local time of applicant organization.

Scientific Merit Review

February/March 2014

Advisory Council Review

May 2014

Earliest Start Date

July 2014

Expiration Date

November 16, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

To improve understanding of the intersection of HIV/AIDS and drug abuse, this Funding Opportunity Announcement (FOA) is part of a multipronged 2014 expansion of HIV and AIDS related research within the context of drug and alcohol abuse among understudied populations and in understudied settings that show promise for the development of effective prevention and treatment efforts. In addition to this funding opportunity, others included in the 2014 expansion address HIV/AIDS and substance use among the homeless and unstably housed; the integration of substance abuse and HIV prevention and treatment within HIV/AIDS service delivery settings; and exploratory research on comorbid HIV, chronic pain, and substance use among older adults. Blacks/African Americans represent about 13% of the U.S. population, yet accounted for 44% of new HIV diagnoses among adults and adolescents 13 years and older in 2010, with MSM and women bearing the greatest burden of the disease. HIV rates are particularly high among Blacks/African-Americans in the South. More cases tend to be concentrated in inner cities of metropolitan areas, although cases are increasingly identified among Blacks/African-Americans in suburban areas. In the Southeast region of the United States, cases often occur outside of metropolitan areas in small towns and rural locales where access to services may be limited. In order to achieve the goals of the National HIV/AIDS Strategy (NHAS) of reducing new HIV cases and increasing knowledge of serostatus, more intensive interventions are needed to reduce new cases and to get more HIV+ people into care. Getting people in care is consistent with NIDA’s “Seek, Test, Treat, and Retain” strategy.

There are a number of common features that appear to be important in the HIV risk of Black/African American women (BAAW) and young Black/African American men who have sex with men (YBAAMSM). These include social and structural factors such as fewer economic resources and less access to health care. Histories of trauma are more common, along with exposure to discrimination and experience of its pernicious consequences. Although just as likely to have had HIV testing as other racial/ethnic groups, Blacks/African Americans tend to be diagnosed later than Caucasians. HIV risk may be greater in Black/African-American communities because of higher rates of other sexually transmitted infections and sexual mixing patterns that involve a greater proportion of same-race partners and more partnerships that cross socio-economic lines. Incarceration is more common among BAAW and YBAAMSM than among their Caucasian counterparts reflecting broad racial differences, but in the case of YBAAMSM also may reflect higher rates of juvenile justice system involvement for gay youth than non-gay youth. These two populations also have factors that are somewhat unique to each. For example, BAAW cases tend to be distributed over a wider range of ages than their MSM counterparts and different concerns arise regarding their social, sexual, and drug use networks. Injection drug use or having an injecting partner is more of a concern among BAAW, while sexual minority status and associated isolation and stigma may add to the difficulties in successfully engaging YBAAMSM. Applicants for this FOA should consider whether to target one or both populations.   

Black/African American Women (BAAW)

Women represented 25% of adults and adolescents over 13 years old in the United States who were living with an HIV infection diagnosis at the end of 2010.  Rates of HIV infection are disproportionately higher among BAAW than other racial groups, and 64% of new cases among women were among Blacks/African Americans compared to 18% among whites and 15% among Hispanics/Latinas. The rate of new HIV infections (per 100,000 population) among BAAW was 20 times higher than white women, and almost five times that of Latinas. HIV was among the top ten leading causes of death for Black/African American women in 2010. Substance use can contribute to women’s risk through their own use of alcohol, injection drug use or non-injection drug use, as well as the substance use of their partners. The role of injection drug use in HIV transmission has slowly declined in recent years; however, substances commonly used by BAAW such as crack cocaine and alcohol remain little studied. The role of drug using networks and spatial/geographic relationships among HIV cases, drug use, and other risk factors such as infectious disease or mental health comorbidities and the distribution of transactional sex, all need more attention. The roles of trauma, particularly past sexual abuse and coercion, also need to be considered along with the stigmas associated with HIV seropositive status and with risky behaviors such as substance use or transactional sex.

Research has tended to focus on young women, with some attention to developmental issues, while the life experiences and developmental considerations of other stages of adulthood have received less attention. The observation of earlier than normal onsets of physical problems related to metabolic functioning which may be attributable to HIV infection and subsequent treatments provides, another area where developmental issues are important, along with the functional consequences of HIV-related neurocognitive deficits. In general, more comprehensive models of risk and protective factors for prevention and care that consider lifespan as well as social/environmental and structural variables are needed. The impact of the Affordable Care Act on health care utilization and related risk and comorbid conditions is another important consideration for future research.

The number of risk reduction interventions for BAAW with evidence of efficacy that are available for dissemination has increased in recent years, including some that have substance use components. The interventions generally use individual or small group formats and despite some focus on individual circumstances unique to BAAW and efforts at adaptation to specific settings, they do not specifically address broad social/environmental or structural factors. Some recently developed interventions target reduction of risk-related substance use; however, these are less widely used than other interventions, and integration of substance use into prevention and care settings that do not routinely provide substance use screening, referral, or intervention continues to be an issue.  There are fewer interventions available targeting the prevention and care needs of HIV+ BAAW. The Affordable Care Act may shift intervention for prevention and care from community settings to primary care settings and interventions are needed which easily fit into these busy, time sensitive environments. The diversity of Black/African-American populations, which include immigrants and culturally distinct groups from Latin America, the Caribbean and Africa, has been under-appreciated, and elucidation of principles to enable implementation under a variety of cultural contexts is needed.

Young Black/African American MSM (YBAAMSM)

Black/African American men represented 11% of the male population in the U.S. in 2010, but 42% of HIV infection diagnoses. Black/African-American men who have sex with men account for disproportionate numbers of new cases, particularly among younger men. This is the one population segment where the numbers of new cases has continuously grown in recent years. Knowledge of HIV status is less common than among their Caucasian counterparts, and despite comparable rates of ever receiving HIV testing, the frequency of testing is lower and diagnosis of HIV is more likely to occur in the context of HIV-attributable symptoms. Incidence appears much greater among YBAAMSM under 25 and most of the HIV+ men in this age group are not aware of their HIV status. Moreover, the stigma and discrimination associated with drug use and HIV along with being MSM creates an environment which can serve as a deterrent from getting tested and seeking HIV treatment for YBAAMSM. These factors likely play a substantial role in the continuing disproportionate burden of new infections among these young men.

HIV sexual and substance use risk behaviors among YBAAMSM tend to occur at similar levels when compared to their Caucasian counterparts, and in some studies less drug use and more condom use has been reported. On the other hand, patterns of substance use differ with more use of cocaine-based stimulants, different classes of “club drugs,” and less use of methamphetamines than Caucasians. The effect of drug use on these relatively young people and their neurocognitive development is relatively little studied and developmental frameworks have influenced interventions for YBAAMSM less than for young women. Individual risk factors are likely to be amplified by social/environmental, as well a structural factors. Incarceration histories, unemployment, and homelessness are more common than among their Caucasian counterparts and the ways in which these factors, along with the lack of health insurance coverage, affect HIV prevention and care have not been well addressed. The effects of the Affordable Care Act for YBAAMSM may differ from that for BAAW because young men have fewer reasons to be engaged in primary care on a routine basis than their female counterparts. YBAAMSM also appear to make more use of community testing resources than Caucasian counterparts and these often are less well linked to other health care services. Hence, efforts at targeting and engagement may need more attention to linkage for HIV+ and for HIV- with significant risk factors such as problematic substance use, psychiatric disorder, or infectious disease comorbidities.

Higher rates of STIs among MSM, and among Black/African American communities generally combine with mixing patterns and keep STIs and HIV within the Black/African American community and pose network-based challenges to prevention. The overlap between substance use networks and sexual networks is not well documented. Though YBAAMSM are more likely to have female partners than their Caucasian counterparts, research is inconsistent regarding the risk behaviors of those with male and female partners compared with those who only have male partners and the impact of male and female partnerships on HIV among BAAW is surprisingly not well studied. The variation in epidemics among YBAAMSM across the country has received almost no attention despite lower HIV prevalence in many cities characterized by structural and environmental/social factors that are clearly implicated in the greater burden of HIV borne by YBAAMSM. Finally, there has been limited attention to factors associated with risk reduction outside of formal interventions, and factors associated with successful management of HIV infection.

An increasing number of prevention interventions targeting Black/African-American MSM with evidence of efficacy have become available in recent years, along with adaptations for Black/African-American cultural contexts of previously developed, efficacious interventions. These interventions generally do not address the developmental needs of YBAAMSM, and there has been no integration of what has been learned from effective substance use prevention among youth. Syndemic approaches to characterizing risk have begun to be used with this population, but this knowledge and perspective has not been integrated into existing interventions. Structural factors have not been integrated into interventions and the attention to community and social networks tends to rely on individual and small group formats. Cultural subgroups of YBAAMSM (e.g., Latin American, Caribbean, African immigrants) also have not been addressed. The needs of HIV+ YBAAMSM, as well as older Black/African American MSM also have received relatively little attention. The need to better identify those who are unaware of their HIV status is particularly critical, along with linkage to care and prevention-related services. The relative isolation of YBAAMSM within Black/African-American communities and associated issues of stigma and discrimination need integration into interventions, along with consideration of how to make use of the growing efforts to build community among Black/African-American gay men.

Specific Areas of Research Interest include but are not limited to the following (they may incorporate both BAAW and YBAAMSM or target the populations separately):

Basic Research:

* Investigate motivational aspects of substance use on sexual behavior among BAAW and YBAAMSM.

* Investigate substance use and developmental processes (including adult development) on metabolic functions and their disease consequences for HIV+ BAAW and/or YBAAMSM.

* Explore neurocognitive functioning (including HIV Associated Neurocognitive Disorders (HAND)), substance use, and functional status among HIV+ BAAW and/or YBAAMSM. 

Epidemiology

* Examine social and structural factors (e.g., access/utilization of health care, housing, neighborhood context, criminal justice involvement) and their associations with HIV-related substance use and sexual risk, as well as HIV prevalence and incidence among BAAW and/or YBAAMSM.

*Examine the role of psychosocial factors (e.g., self-esteem, shame associated with gay identity) and external factors (e.g., incarceration history) on the willingness of BAAW and/or YBAAMSM to seek HIV prevention and treatment services.

*Assess social and sexual network influences on substance use, sexual risk behavior, and HIV prevalence/incidence, with consideration of concordance among sexual and drug use networks, including potential effects of YBAMSM partnerships with women. Consideration of network influences on uptake of screening, prevention, and care also is needed. Characterize developmental influences on substance use and sexual risk factors (including lifespan development) for HIV sexual and substance use risk among BAAW and/or YBAAMSM.

* Investigate the influences of stigma and discrimination on HIV sexual and substance use risk behavior as well as their influences on uptake of screening, prevention and care.

* Develop syndemic approaches to characterize HIV sexual and drug use risk, considering factors that contribute to risk reduction and avoidance and which, particularly for YBAAMSM make use of our knowledge about substance use prevention, and associated protective factors.

* Evaluate the effects of provisions of the Affordable Care Act and their effects on HIV screening, risk behavior, and the effects on HIV disease status and comorbidities among HIV+ BAAW and/or YBAAMSM. Gender- and age-related variations are likely and need particular attention.

Prevention

*Expand efforts to optimize, adapt, and test evidence based interventions developed for other cultural groups, but not tested for Blacks/African Americans or specifically for BAAW and/or YBAAMSM to consider important developmental, social/environmental and structural factors.

*Build on existing knowledge about drug abuse prevention to create developmentally appropriate substance use and sexual risk reduction interventions for BAAW and/or YBAAMSM.

*Develop and test prevention interventions that tailor elements of the Seek, Test, Treat and Retain model of HIV prevention to the social context of BAAW, YBAAMSM, and settings most used by these populations.

*Support research that improves the uptake, dissemination, and implementation of efficacious prevention interventions in health care and other diverse settings, including non-traditional settings for BAAW and/or YBAAMSM, with greater consideration of local context and resources.

*Support prevention research that tests combination biomedical and behavioral approaches for BAAW and/or YBAAMSM.

* Develop and test strategies for economic empowerment of BAAW and/or YBAAMSM.

* Develop and test evidence-based prevention interventions that focus on community-level, structural factors for this population.

* Support the development, adaptation, and testing of prevention interventions that address multiple comorbidities in BAAW and/or YBAAMSM.

* Assess the role and impact of the Affordable Care Act on the integration into the health care system of prevention services for substance use, HIV, and comorbid conditions by BAAW and/or YBAAMSM.

Treatment

*Develop and test biomedical and behavioral interventions for the treatment of illicit stimulant use among BAAW and/or YBAAMSM with consideration of the efficacy of integrated HIV testing and sexual risk reduction strategies.

* Develop and test treatment models that integrate effective substance use treatment and HIV prevention and care interventions tailored to BAAW and/or YBAAMSM, and the health care settings they are most likely to use.

Services

* Identify strategies and develop novel designs for increasing opportunities for testing and diagnosis among BAAW and/or YBAAMSM who are unaware of their HIV status, and for linking HIV+ BAAW and/or YBAAMSM to treatment and care.

* Develop and test culturally tailored service delivery models to increase outreach to HIV+ BAAW and/or YBAAMSM out of treatment to improve their access to counseling, testing, treatment, and linkage to care as stated in the National HIV/AIDS Strategy as quality performance measures.

* Assess the role and impact of the Affordable Care Act on the uptake and utilization of health care services for substance use, HIV, and comorbid conditions by BAAW and/or YBAAMSM.

* Examine the effectiveness of evidence-based HIV treatment services for BAAW and/or YBAAMSM in naturalistic settings and the extent to which financing systems, organizational structures and processes, management practices, and health technologies affect the access, utilization, effectiveness, cost, and quality of drug abuse and HIV/AIDS treatment services.

* Develop and test dissemination and implementation strategies to ensure evidence-based approaches to HIV and substance use interventions are optimized and adapted in specialty care settings utilized by these populations.

* Assess and expand on interventions that promote integration of substance use into HIV prevention and care settings by including substance use screening, brief intervention, and referral to treatment.

* Characterization of structural/environmental factors (availability of services, neighborhood, SES, provider) and individual factors (sexual minority, self-esteem, sexual abuse, intimate partner violence, distrust) to provide better understanding of issues impeding access to and utilization of care and services by BAAW and/or YBAAMSM in order to inform new service delivery models.

IC Specific Considerations

National Addiction & HIV Data Archive Program (NAHDAP): NIDA strongly encourages investigators to deposit and/or utilize data sets affiliated with NAHDAP hosted by Interuniversity Consortium for Political and Social Research (ICPSR). For details, please see the following website (http://www.icpsr.umich.edu/icpsrweb/NAHDAP/). For questions or additional information on this program, please contact Dr. Kathy Etz at ketz@nida.nih.gov.

NIDA encourages data harmonization to increase comparability, collaboration, and scientific yield of clinical research on drug abuse and HIV. Towards that end, awardees conducting research directly related to HIV/AIDS and substance use among Black/African American women and young MSM should employ, whenever possible, measures that are consistent across other grants on this topic in order to harmonize data within the following domains: demographic information, substance use history, mental health functioning, HIV risk behavior, HIV testing and counseling, biological markers of HIV, use of and adherence to HIV treatment, and related issues unique to the intersection of HIV/AIDS, substance abuse, and these vulnerable populations. Awardees are also expected to use monies within the grant to cover travel expenses to attend annual meetings of all grantees funded under RFA-DA-14-010 on data harmonization, to be held in Washington DC. For additional information and examples of data harmonization in other NIDA grants, please see: http://www.drugabuse.gov/researchers/research-resources/data-harmonization-projects/seek-test-treat-retain/addressing-hiv-in-criminal-justice-system

and http://www.drugabuse.gov/researchers/research-resources/data-harmonization-projects/seek-test-treat-retain/addressing-hiv-among-vulnerable-populations

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.

This initiative corresponds to the priorities of the National HIV/AIDS Strategy for the United States, which seeks to “Adopt community-level approaches to reduce HIV infection in high-risk communities” as one of the principal means for achieving the central priorities of “Reducing HIV-related disparities and health inequities.”  (See, http://aids.gov/federal-resources/national-hiv-aids-strategy/overview/). These priorities are further represented within the NIH Office of AIDS Research (NIH OAR) Trans-NIH Plan for HIV Research. Applicants should include collaborations necessary for successful implementation and evaluation of the interventions (e.g., service settings, community organizations, representatives of targeted communities, jurisdictional health departments). Lastly, when possible, applicants should include clinical outcome measures in addition to behavioral outcome data.   

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

NIDA intends to fund an estimate of 6-8 awards, corresponding to a total of $4.5 million, for fiscal year 2014. Future year amounts will depend on annual appropriations.

Award Budget

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

Award Project Period

A project period of up to 5 years may be requested.   

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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:

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-14-010
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD  20892-9550

Page Limitations

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

Required and Optional Components

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

Applicants should request funds to cover travel expenses to attend annual meetings of all grantees funded under RFA-DA-14-010 on data harmonization, to be held in Washington DC.

PHS 398 Cover Letter

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

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

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

See more tips for avoiding common errors.

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

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 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(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?   

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 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 score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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 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’s business official.

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

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

Scientific/Research Contact(s)

Dionne Jones, Ph.D.
National Institute on Drug Abuse (NIDA)   
Telephone: 301-402-1984
Email: djones1@nida.nih.gov

Peer Review Contact(s)

Mark Swieter, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1389
Email: mswieter@mail.nih.gov

Financial/Grants Management Contact(s)

Edith Davis     
National Institute on Drug Abuse (NIDA)
Telephone: 410-360-4734
Email: edavis1@nida.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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