National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Funding Opportunity Title
HIV/AIDS, Drug Use, and Vulnerable Populations in the US (R21)
R21 Exploratory/Developmental Research Grant Award
Reissue of PA-09-237
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
Despite progress in HIV/AIDS treatment and prevention and reductions in HIV/morbidity and mortality, HIV/AIDS health disparities remain a challenge that must be addressed. This FOA encourages research to identify the role(s) that drug abuse plays in fueling the epidemic in vulnerable groups (racial/ethnic minorities, men who have sex with men (MSM), youth) in the United States and to develop effective interventions to prevent new infections and to improve the health and well-being of those living with HIV/AIDS. This FOA will support studies in vulnerable populations to: 1) understand the contribution of drug abuse (both injection and non-injection) to the acquisition and/or transmission of HIV; 2) study disease progression and disease outcomes; 3) develop and/or improve prevention and treatment interventions, particularly comprehensive, integrated interventions; 4) improve the availability, delivery and quality of evidence-based prevention and treatment services across a variety of settings; and 5) address organizational, structural, and/or community level factors including social, drug-using, and sexual networks associated with health disparities.
September 10, 2012
Open Date (Earliest Submission Date)
December 7, 2012
Letter of Intent Due Date
Application Due Date(s)
AIDS Application Due Date(s)
Standard dates apply, by 5:00 PM local time of applicant organization.
Scientific Merit Review
Standard dates apply
Advisory Council Review
Standard dates apply
Earliest Start Date(s)
Standard dates apply
January 8, 2016
Due Dates for E.O. 12372
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.
There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more.
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
Three decades into the epidemic, HIV/AIDS in the U.S. continues to evolve, and the role of drug abuse in fueling the epidemic has also evolved. Despite progress in HIV/AIDS treatment and prevention and reductions in HIV/morbidity and mortality, HIV/AIDS health disparities remain a challenge that must be addressed. This announcement encourages research to identify the role(s) that drug abuse plays in fueling the epidemic in vulnerable groups and to develop effective interventions to prevent new infections and to improve the health and well-being of those living with HIV/AIDS. To do this, it is essential that research be directed toward understanding the factors (biological, behavioral, psychosocial, environmental, institutional, etc.) responsible for the profoundly disproportionate burden of HIV/AIDS among vulnerable groups (racial/ethnic minorities, sexual minorities, youth) in the United States.
This Funding Opportunity Announcement (FOA) will support studies in vulnerable populations to: 1) understand the contribution of drug abuse (both injection and non-injection) to the acquisition and/or transmission of HIV; 2) study disease progression and disease outcomes in drug using populations; 3) develop and/or improve prevention and treatment interventions, particularly comprehensive, integrated interventions; 4) improve the availability, delivery and quality of evidence-based prevention and treatment services across a variety of settings; and 5) address organizational, structural, and/or community level factors including social, drug-using, and sexual networks associated with health disparities.
There is increasing evidence that outreach to encourage HIV testing (seek), HIV testing (test), engagement in care (treat), and retention in care (retain) are essential for reducing HIV-related morbidity and mortality as well as for reducing community viral load and ultimately HIV transmission. In the U.S., racial/ethnic and sexual minorities are disproportionately affected by HIV. Approximately 20% of HIV-infected Americans are unaware of their HIV status and thus, unknowingly transmit HIV. About 50% of transmissions are from persons unaware of their infection. Rates of undiagnosed HIV vary by race/ethnicity and transmission category. Minorities have higher rates of undiagnosed infections (African Americans had 9 times the rates, and Latinos had 3 times the rates of whites). These disparities are likely due to inaccurate perception of risk and lack of access and/or utilization of health care resources, particularly HIV testing. Even when tested, minorities are disproportionately late testers; they receive an AIDS diagnosis less than three years after their initial HIV diagnosis. National estimates suggest that only 28% of HIV-infected individuals have suppressed viral load--minorities are less likely to be virally suppressed. The National HIV/AIDS Strategy has as one of its aims to reduce HIV-related health disparities and sets targets for 2015 of: increasing the proportion of HIV-diagnosed gay and bisexual men with undetectable viral load by 20%; increasing the proportion of HIV-diagnosed Blacks with undetectable viral load by 20%; and increasing the proportion of HIV-diagnosed Latinos with undetectable viral load by 20%.
Unfortunately, some of the most vulnerable populations for HIV infection do not see themselves as being at risk. For example, African American men who have sex with men (MSM) have similar, sometimes lower levels of risk behavior than their white counterparts, yet much higher rates of infection. Similarly, African American women typically do not engage in high levels of risk behavior but are more often exposed to risky partners than women in other ethnic/racial groups. The high prevalence of HIV/AIDS in minority communities increases the risk of transmission because transmission depends on the reservoir of infection (i.e., HIV prevalence) as well as the levels of risk behaviors that transmit infection. HIV/AIDS risk behaviors, in turn, are influenced by economic, social, and political systems that reinforce socioeconomic disparities.
CDC HIV incidence estimates for 2006-2009 highlight the populations where HIV is most heavily concentrated and have led to the National HIV/AIDS Strategy to prioritize prevention efforts to those with disproportionate rates of new infections—gay and bisexual men and African Americans and Latinos. CDC has estimated that the overall HIV incidence has remained relatively stable 2006-2009, except for young (aged 13-29) MSM, who had a 34% increase. This increase was driven by a 48% increase among young, black MSM. There were no statistically significant changes in HIV incidence due to injection drug use 2006-2009, but Blacks accounted for a disproportionate (48%) proportion of incident infections. In 2009, 23% of new HIV infections occurred in women and were principally due to heterosexual transmission. Of new HIV infections in women in 2009, 57% occurred in African Americans, 21% were in whites, and 16% were in Latinas. 2009 estimated rates of new HIV infection per 100, 000 were 103.9 for African American males, 39.9 for Latino males, and 15.9 for white males; for females the rates were 39.7 for African Americans, 11.8 for Latinas, and 2.6 for whites.
There are stark disparities in death rates from HIV disease. The age-adjusted rate of death due to HIV disease has been highest among African Americans and second highest among Latinos. Data from 2008 indicate that persons dying of HIV disease increasingly consist of women (28%), African Americans (55%), residents of the South (53%), and persons 45 years of age or older (61%). Part of this is accounted for by African Americans taking longer to seek medical care and having lower CD4+ cell counts at the time of diagnosis. But even minorities in care are less likely to receive highly active antiretroviral therapy (HAART). While minorities are less likely be adherent to HAART, there are data suggesting that even when on HAART, minorities may have poorer virologic outcomes. Pharmacogenomic differences in medication efficacy or toxicity and differences in the course of comorbid medical conditions may contribute to disparate outcomes.
A range of methodological approaches including basic, clinical, epidemiological, prevention, and treatment research as well as multidisciplinary studies are needed to address the complex interplay of biomedical, behavioral, and social factors that lead to HIV/AIDS disparities among vulnerable populations.
This FOA includes, but is not limited to, the types of studies described below:
Studies are encouraged, but not limited to:
Prevention efforts should target the most at-risk populations, with consideration of the role of non-injection as well as injection drug use and co-morbidities (mental health, infectious disease, etc.). Many conditions associated with HIV infection suggest the need to intervene at organizational, structural, or community levels, as well as providing constructive attention to social, drug using, and sexual networks.
Studies may include:
Health Services Research
Health services research is encouraged to improve the quality, delivery, efficiency, implementation, and effectiveness of prevention and treatment services for vulnerable populations with drug use disorders who may be infected with and/or affected by HIV/AIDS. To address these goals, research studies may focus on examining the effectiveness of evidence-based HIV prevention and treatment services for vulnerable populations in naturalistic settings and the extent to which financing systems, organizational structures and processes, management practices, and health technologies affect the accessibility, utilization, effectiveness, cost and quality of drug abuse and HIV/AIDS treatment and prevention services. Also of interest is research on ways stakeholders (providers, payers, school administrators, corrections officials, governmental regulators, etc.) can improve standards of care for HIV+ drug users. New study designs, measurement instruments, and data analytic methods to facilitate a new generation of health services research are needed.
Studies may include but are not limited to:
Medical Consequences of Drug Abuse, HIV, and Co-Occurring Infections
Research is needed on the medical/clinical consequences of licit and illicit drugs of abuse, HIV, and co-occurring bacterial and viral infections such as hepatitis B, C, and D, tuberculosis (TB), sexually transmitted infections/diseases (STIs/STDs).
Studies may include:
Clinical Neuroscience Research
Identifying vulnerable individuals with a higher propensity of engaging in HIV risk behavior and/or non-adherence to HIV treatment/prevention interventions is critical to HIV prevention and intervention. Translational studies are encouraged to better understand human neurocognitive and neurobiological factors that could influence disease progression and disease outcomes and could facilitate the development and/or improvement of prevention and treatment interventions in vulnerable populations. Studies may include:
Research topics include but are not limited to:
Drug Abuse Treatment
Given the high rates of co-occurring substance abuse and HIV (and related risk behaviors), integrated treatment approaches that promote the prevention of HIV (and related risk behaviors) in the context of substance abuse treatment is critical. For example, interventions that address risky sexual behavior, risky injection practices, and overall risk reduction behaviors can be important to integrate into ongoing protocols of substance abuse treatments for adolescent and adult populations. Relatedly, the intersection of substance abuse and mental health comorbidities (e.g., anxiety, depression) and stressful and adverse life events (e.g., child sexual abuse) may have even more profound or cumulative effects for increasing HIV risk behaviors, further highlighting the need for multi-pronged and integrated behavioral interventions that can target multiple areas of impaired functioning.
Another unmet and critical area of need is behavior interventions that can foster access to care and adherence to HIV treatment regimens. Given that high rates of adherence to HAART are needed long-term to achieve and maintain viral suppression, continued adherence to treatment regimens is clearly significant to reducing morbidity and mortality. However, substance abuse often impairs the ability and willingness of individuals to avail themselves of clinical care, including HIV testing and/or care, particularly if they are not yet HIV symptomatic. Interventions that can simultaneously reduce substance abuse and implement strategies to incentivize populations to access care would have significant public health importance.
Research topics include but are not limited to:
Clinical Trials Network Research
The Clinical Trials Network (CTN) involves academic and treatment researchers and community-based service providers in cooperatively developing, validating, refining, and delivering new treatment options. CTN conducts rigorous, multi-site studies of behavioral and pharmacological interventions to determine efficacy and/or effectiveness across a broad range of community-based treatment settings (CTPs) and diverse patient populations. Investigators are encouraged, when appropriate, to utilize the Clinical Trials Network (CTN) (http://www.drugabuse.gov/CTN/Index.htm) infrastructure as a platform for their studies and/or to conduct secondary data analyses on completed HIV Clinical Trials Network protocols www.ctndatashare.org.
Basic Neuroscience and Behavior Research
Studies may include but are not limited to:
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 seehttp://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.
Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see (http://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html) for details.
Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.
Application Types Allowed
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. The R21 is not renewable.
Award Project Period
The maximum period is 2 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
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
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
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 4-6 weeks prior to the application due date.
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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
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 submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
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, with the following modification:
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
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.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the 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.
All PD(s)/PI(s) 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, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
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).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
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?
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
If the project involves 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?
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?
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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
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
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Will Aklin, Ph.D.
Behavioral and Integrative Treatment Branch
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd., Rm. 3150, MSC 9593
Bethesda, MD 20892-9593
Phone: (301) 443-3207
Fax: (301) 443-6814
Albert Avila, Ph.D.
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse
Neuroscience Center, Room 4279
6001 Executive Boulevard
Bethesda, MD 20892-9555
Telephone: (301) 496-8804
Fax: (301) 594-6043
Richard A. Jenkins, PhD.
Prevention Research Branch
Division of Epidemiology, Services & Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd.
Rm. 5185 MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 443-1923
Fax: (301) 480-2542
Jag H. Khalsa, Ph.D.
Medical Consequences Branch
Division of Pharmacotherapies and Medical
Consequences of Drug Abuse (DPMC)
National Institute on Drug Abuse
6001 Executive Blvd., Room 4137, MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 443-2159
Fax: (301) 443-2599
Elizabeth Lambert, M.Sc.
Epidemiology Research Branch
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd.
Room 5147, MSC9589
Bethesda, MD 20892-9589
Telephone: (301) 402-1933
Fax: (301) 443-2636
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Blvd., MSC 9541
Rockville, MD 20892-9541
Telephone: (301) 253-8729
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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