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 the Homeless and Unstably Housed (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-14-009

Companion Funding Opportunity

RFA-DA-14-010, 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 substance use, HIV, and Black/African American women and young Men who have Sex with Men (MSM) (RFA-DA-14-010); 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 invites research grant applications focused on homeless or unstably housed persons to elucidate the interconnections among substance use, HIV/AIDS and other co-morbidities. The FOA encourages studies on the development, implementation, evaluation, and dissemination of effective HIV-prevention interventions, research related to the epidemiology of HIV infection and substance use, and health services studies to improve the quality of substance use prevention and treatment services for the homeless and unstably housed populations.  

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


Purpose & Objectives

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 substance use, HIV, and Black/African American women and young Men who have Sex with Men (MSM) (RFA-DA-14-010); the integration of substance abuse and HIV prevention and treatment within HIV/AIDS service delivery settings (RFA-DA-14-011); and exploratory research on comorbid HIV, chronic pain, and substance use among older adults (RFA-DA-14-012). This FOA invites research grant applications focused on homeless or unstably housed persons to elucidate the interconnections among substance use, HIV/AIDS and other co-morbidities. The FOA solicits (1) studies on the development, implementation, evaluation, and dissemination of effective HIV-prevention interventions, (2) research related to the epidemiology of HIV infection and substance use, and (3) health services studies to improve the quality of substance use prevention and treatment services for homeless and unstably housed populations.

In the United States, the current rate of homelessness in the general population is estimated to be 21 homeless persons per 10,000 people. Using the January 2011 point-in-time count data, 636,017 people experienced homelessness on any given night in the United States. The prevalence of HIV infection among the homeless and unstably housed individuals is higher in the United States than in any other country worldwide. Homelessness and marginal housing is associated with higher incidence of drug use, HIV and sexual risk behaviors, HIV infections, and poorer health outcomes. Homelessness and unstable housing are also associated with unemployment, recent incarceration, family dissolution, mental illness, and other health problems.  Efforts to move these populations toward stable housing often require attention to a variety of issues, including, but not limited to disruptive health conditions, provision or re-establishment of social welfare benefits, employment, and reunification of families involved in the child welfare system. The involvement and coordination of multiple service systems are typically required.

Reducing HIV-related mortality and morbidity in this population requires comprehensive and integrated prevention and health care delivery systems that work effectively across multiple systems within the public and private sectors (child welfare, juvenile justice, criminal justice, education, and other social service systems). Given the current resource constraints on health delivery systems, new approaches are needed to ensure effective and efficient delivery and use of HIV/AIDS and substance abuse prevention and treatment services among homeless and unstably housed populations. In general, structural interventions have been fewer in number than those focusing on individuals in service or outreach settings. The complexity of needs associated with being homeless or unstably housed creates challenges for achieving internal validity with traditional experimental designs, and exploration of rigorous alternatives is needed.

Applications that consider rigorous alternatives to common randomized control trial designs to test interventions (e.g., optimization-type trials, Solomon 4-group designs) are encouraged. Vulnerable populations exist across the age span.  Important gaps remain in serving youth, particularly those at greatest risk such as ethnic minority gay youth, who have particularly high rates of homelessness and new HIV cases. Although Native Americans are overrepresented among homeless populations and some data indicate that among the homeless they are more likely to be substance abusers as well, very little research has focused on this sub-population. Additional vulnerable populations receiving less attention include: youth in and transitioning out of the foster care system, run away youth, women, women of color, women with children, pregnant/parenting teens, victims of intimate partner violence and military veterans.

Homeless and unstable housing studies should examine co-morbidities and co-occurrence of HIV/AIDS, HIV and sexual risk behaviors, substance use and other drug-related co-morbidities in the homeless and unstably housed. Examples of research topics include, but are not limited to the following:

* Epidemiologic studies utilizing systems science methodologies (e.g., agent based modeling, system dynamics modeling, network analysis), or geographic information systems (GIS).

* Social network studies exploring access, intervention and retention of homeless or unstably housed persons in substance use or HIV prevention or treatment interventions, treatments, or services.

* Studies employing innovative technology approaches/interventions (e.g. mobile devices, social media) to reach, provide services, and retain homeless persons.

* Studies focusing on gay youth, with particular attention to observational or intervention research focusing on the multiple conditions that often accompany homelessness in this population (e.g., estrangement from families of origin, substance use, juvenile justice or criminal justice system involvement).

* Studies focusing on the Native American homeless population that might include understanding the unique trajectories to homelessness and disparities in the health consequences of homelessness, exploring the sexual and social network risks for HIV and substance abuse, intervention strategies, or willingness to use or access services.

*Comprehensive interactions addressing housing needs (e.g., sustained, stable housing) and other multiple needs of the population (e.g., with coordination of services for substance abuse disorder and other co-occurring needs such as economic support, psychiatric care, child and family welfare, etc.) with the objective of reducing HIV transmission or acquisition risk, or improving health outcomes for HIV seropositives.

* New or adapted models of HIV prevention intervention addressing the needs of homeless youth, particularly ethnic minority and sexual minority youth, women, ethnic minority women, women with children and military veterans.

* Novel interventions addressing structural and organizational factors (e.g., access/utilization of health care, neighborhood context, etc.) to facilitate sustained stable housing for HIV-seropositives, and persons at highest risk for HIV acquisition.

* Studies examining access and utilization of services, capacities of service providers to retain patients and facilitate adherence to both substance abuse and HIV treatment regimens among the homeless and marginally housed.

* Studies examining organizational level interventions and outcomes for implementing evidence based practices in organizations that address HIV and HIV-risk behaviors among homeless and unstably housed populations.

* Research assessing the impact of the Affordable Care Act on integration of substance use, HIV and other behavioral health services into health care systems, and also examining access and utilization of these services by homeless and unstably housed populations.

*Quasi-natural experiments assessing changes in housing policy and how this influences HIV, substance use and other co-morbidities.

The following areas of research will NOT be considered responsive to the FOA:

*Formative or qualitative research only.

*Primary focus of prospective or descriptive epidemiology (e.g., investigations of the health risk or protective factors without addressing mechanisms or systems).

This announcement is aligned with both U.S. Department of Housing and Urban Development and the U. S. Interagency Council on Homelessness Opening Doors: Federal Strategic Plan to Prevent and End Homelessness, and the White House's Office of AIDS Policy's National HIV/AIDS strategy.

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 the homeless and unstably housed 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 this vulnerable population. 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-14-009 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.

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

NIH intends to fund an estimate of 4-8 awards, corresponding to a total of $4 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.

Because the nature and scope of the proposed research will vary, it is anticipated that the size and duration of each award will also vary.

Award Project Period

Support may be requested for up to five 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 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 (PDs/PIs)

All PDs/PIs 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-14-009
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-14-009 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 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)

Bethany Griffin Deeds, PhD, MA
Deputy Branch Chief, Epidemiology Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1935
Email: deedsb@nida.nih.gov  

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Heidi Young
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 703-243-8267
Email: youngh@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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NIH Funding Opportunities and Notices



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