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.

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

As reported by the CDC (http://www.cdc.gov/hiv/risk/gender/msm/facts/index.html), men who have sex with men (MSM) bear a greater burden of HIV/AIDS than any other population group in the US, comprising only 2% of the population but 56% of individuals living with HIV/AIDS. This burden is disproportionately experienced by African American and Hispanic MSM, who account for 36% and 22% of new HIV infections respectively. Although the same level of surveillance data is not available for other populations, the CDC reports that men from other racial/ethnic minority groups, including American Indians/Alaska Natives, Native Hawaiians, and Other Pacific Islanders, have a higher incidence of and mortality due to HIV than non-Hispanic White men. Although the incidence of HIV infection is lower among Asian American MSM than for other racial/ethnic groups, this rate is increasing, and existing studies find similar levels of HIV-related risk behavior among young Asian American MSM relative to their African American and Hispanic peers. Similarly, although the incidence of HIV infection is higher in urban areas than rural areas, the infection rate in rural areas is growing, and rural MSM often have limited access to HIV counseling and preventive services compared to their urban counterparts. The growing rate of HIV infection among MSM from health disparity populations is driven largely by young men between the ages of 13 and 24, who account for nearly one-third of new HIV infections.

Despite a sizable portfolio of existing research on preventive HIV interventions for MSM, there remains a dearth of evidence-based interventions for young MSM that are available for broad dissemination in the US. For example, among the 84 evidence-based HIV behavioral interventions identified by the CDC (http://www.cdc.gov/hiv/prevention/research/compendium/rr/complete.html), only 9 are tailored for MSM. Of these 9 interventions, 4 were evaluated with samples including African Americans, 5 including Hispanics/Latinos, and 1 including Asian Americans. None of the interventions were tested with significant numbers of Native Hawaiians/Other Pacific Islanders, or American Indians/Alaska Natives, and none identified a specific focus on low-income or rural populations. Furthermore, only 2 of the 9 interventions include youth under 18. Therefore, there is a critical need to consolidate the extensive knowledge from existing research regarding HIV prevention interventions with subpopulations of MSM to develop and evaluate interventions with broad applicability across diverse populations of young MSM, particularly those under 18.

The purpose of this initiative is to support behavioral HIV prevention interventions that have broad applicability to adolescent MSM (aged 13-18) from diverse populations in the US, including health disparity populations. For the purposes of this FOA, MSM is used as an umbrella term to refer to males who are sexually attracted to and/or engage in sexual activity with males. This umbrella term comprises males with a range of sexual identities (e.g. gay, bisexual, two-spirit, queer, heterosexual, etc.) and includes individuals who are currently sexually active as well as those who have not yet initiated sexual activity. The term Health disparity populations refers to NIH-designated US health disparity populations, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, and rural populations.

Interventions may include an adaptation of an existing evidence-based intervention to be appropriate for a wider range of populations or further testing of a new intervention that has not been evaluated in a large scale, multi-site intervention trial. Projects should involve collaborations among researchers, community organizations, healthcare providers, public health organizations, consumer advocacy groups, faith-based organizations, or other relevant stakeholders with expertise in HIV prevention and research in different US population groups. It is expected that the intervention or interventions to be tested have been developed or modified with community input to be culturally sensitive and acceptable to the populations targeted. Projects that involve adolescent MSM in the conduct of the research (e.g., as peer educators, consultants, advisory board members, etc.) are strongly encouraged.

Behavioral interventions may use any variety of intervention approaches to produce attitude and behavior change related to HIV risk using any modality (in-person, online, individual-, couple-, group-, or community-level, etc.). Interventions that involve the direct delivery of HIV-related medical services (e.g., HIV testing, pre-exposure prophylaxis (PrEP)) are not responsive to this initiative. However, use of existing HIV-related services may be examined as an outcome of the behavioral intervention.

The behavioral intervention trial is expected to include the following features:

• Representation from each NIH-designated US health disparity population in sufficient numbers to conduct valid subgroup analyses. Non-Hispanic Whites not belonging to a health disparity population (i.e., not socioeconomically disadvantaged or rural) should also be included to determine the impact of the intervention on documented HIV-related health disparities. Participants must reside in the United States or US Territories or Possessions.
• Inclusion of sufficient numbers of MSM across the adolescent age spectrum (13-18) to allow for valid analysis of potential age differences (i.e., projects should not be limited a single age group, such as 18-year olds).
• Inclusion of participants from different regions across the country (i.e., projects should not be limited to a single state or locality).
• Testing of the same intervention or suite of interventions to all included populations, rather than distinct interventions offered to different populations. Interventions may be modified or adapted to be appropriate and acceptable to the various populations, but the core intervention elements should be consistent across groups.
• Testing of interventions that are sufficiently flexible to address the wide range of factors that contribute to HIV-related risk among adolescent MSM, including but not limited to lack of knowledge about HIV transmission, substance use, traumatization and violence exposure, social isolation, stigma and discrimination, and high-risk sexual behavior in the context of committed, concurrent, and transactional sexual relationships.
• The presentation of information regarding existing HIV-related resources and services at the local, regional, or national level as appropriate.
• Mechanisms to update intervention content over the course of the study to address new evidence or information related to HIV infection/transmission and/or new HIV-related language or terminology used by the target populations.
• Intervention components that are designed to produce sustained behavior change after the intervention is completed.
• A pragmatic clinical trial research design that utilizes real-world community or clinical settings and personnel to deliver the intervention.
• Use of both attitudinal outcomes (participant knowledge about HIV, self-efficacy regarding skills learned, etc.) and behavioral outcomes (condom use, HIV testing, reduction of drug use, etc.)

Areas of specific interest include but are not limited to the following:

• Multi-level interventions that include a combination of individual, group (such as couples, peers, family members, etc.), and/or community-level intervention elements.
• Projects that include health information technology applications (e.g., personal health records, behavior monitoring tools, health information portals, etc.) and/or social media as intervention elements.
• Projects that include highly vulnerable but understudied populations of adolescent MSM, such as youth who are homeless, in foster care, or involved in the criminal justice system.

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

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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 allowed.

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

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.

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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, including Supplemental Grant Application Instructions 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.

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

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

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

The letter of intent should be sent to:

Maryline Laude-Sharp, PhD
Telephone: 301-451-9536
Fax: 301-480-4049
Email: [email protected]

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

• For this specific FOA, the Research Strategy section is limited to 30 pages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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

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

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

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

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

Research Strategy: Provide a conceptual framework or logic model that specifies how the intervention(s) will reduce HIV risk behavior or improve HIV-related outcomes in the population groups, how the intervention will reduce or eliminate disparities in these health outcomes, and how intervention benefits will be sustained after the intervention is completed. Describe how relevant stakeholders, such as representatives from community organizations, healthcare providers, public health organizations, consumer advocacy groups, and/or faith-based organizations, will be included as members of the investigative team.

Describe preliminary studies that demonstrate the work of the investigative team done across NIH-designated health disparity populations. Describe the process that was used to identify and select the intervention(s) to be tested in the trial and how input from community stakeholders informed this process. Describe how the intervention(s) will be modified or tailored to be appropriate across health disparity and non-disparity populations. Describe the attitudinal and behavioral outcomes to be examined.

Describe plans to conduct analyses to detect differences in intervention effects across health disparity populations and between health disparity and non-health disparity populations. Provide appropriate power calculations to justify the proposed sample size for each population. Because the level of current evidence regarding differences in HIV-related risk behaviors and outcomes varies across health disparity populations, it is expected that the sample size needed to conduct valid subgroup analysis may vary across groups.

Protection of Human Subjects: Describe recruitment sites and recruitment/retention strategies for each health disparity population (Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, and rural populations) and non-health disparity populations.

Describe the human subjects considerations regarding the inclusion of adolescents under the age of 18, in particular how parental consent and child assent issues will be handled. Applicants are directed to the HHS Office for Human Research Protections (OHRP) Research with Children Frequently Asked Questions webpage (http://www.hhs.gov/ohrp/policy/faq/children-research/) for guidance on this topic.

Provide a Data and Safety Monitoring Plan per the instructions in the SF424 (R&R) Application Guide. A Data and Safety Monitoring Board (DSMB) will be established by NIMHD after the award is made. It is therefore not necessary to describe the DSMB in the application.

Inclusion of Women and Minorities: To the extent possible, identify the anticipated distribution of participants within racial/ethnic minority groups according to granular ethnicity, such as tribal affiliation for American Indians/Alaska Natives, Pacific Island of familial origin for Other Pacific Islanders, and country of familial origin for Hispanics/Latinos, Asian Americans, and Blacks/African Americans.

Inclusion of Children: Provide the anticipated age distribution of participants across the age range of 13 to 18. Relevant age groupings are expected to vary according to the nature of the project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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.

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 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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by NIMHD, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications that do not include participants from each NIH-designated US health disparity population (Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, and rural populations) or include youth across the age range from 13 to 18 will be considered non-responsive. Applications that propose to test medical interventions, such as offering PrEP or free HIV testing, will be considered non-responsive.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

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).

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the investigative team have relevant research experience and expertise related to all US-designated health disparity populations? Does the project include relevant stakeholders on the investigative team, such as representatives from community organizations, healthcare providers, public health organizations, consumer advocacy groups, and/or faith-based organizations?

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? Does the application describe novel and innovative strategies to recruit and retain diverse adolescent MSM and engage them in the proposed intervention(s)?

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?

Is an appropriate conceptual model provided that explains how the intervention will produce sustainable improvements in HIV-related outcomes and reduce or eliminate health disparities in these outcomes? Have the intervention approaches been appropriately informed by relevant community stakeholders? Are the intervention approaches appropriately tailored for the target populations? Are appropriate attitudinal and behavioral outcomes of the intervention identified? Are appropriate plans described to analyze differences within and across health disparity and non-health disparity populations and across age groups? Is the analytic plan accompanied by appropriate power calculations?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? Are health disparity populations and non-health disparity populations sufficiently represented? Are MSM across the age range of 13-18 sufficiently represented? Will the proposed sample be appropriately geographically diverse, with representation from different regions across the country?

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 score, but will not give separate scores for these items.

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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.

Not Applicable

Not Applicable

Not Applicable

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.

Not Applicable

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).

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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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) convened by NIMHD, 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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 Minority Health and Health Disparities. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75 and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Designing and performing the proposed clinical trial in compliance with the requirements of this FOA.
• Coordinating project activities technically, scientifically and administratively at the awarded institution and coordinating project activities at other sites that are be supported by the award.
• Defining objectives and approaches; collecting and analyzing data; and publishing results, interpretations, and conclusions of studies conducted under the terms and conditions of the award.
• Ensuring that appropriate Institutional Review Board approvals and certifications for research involving human subjects for all participating sites, collaborators or partners are obtained.
• Selecting external members for and participating in the project Steering Committee.
• Organizing an annual face-to-face meeting of the project Steering Committee.
• Reporting on study conduct, safety measures, data collection and analysis to the NIMHD-appointed Data and Safety Monitoring Board (DSMB).
• Submitting interim progress reports, when requested, to the NIMHD Program Official including as a minimum, summary data on protocol performance and participant accrual.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIH Project Scientists(s) will:

• Serve as a contact point for all facets of the scientific interaction with the awardee. As required for the coordination of activities and to expedite progress, NIMHD may designate additional NIH staff to provide advice to the awardee on specific scientific and/or analytic issues.
• Review and comment on critical stages in the program implementation.
• Provide technical assistance and guidance regarding recruitment and retention of participants from health disparity populations.
• Convene meetings/workshops to address emerging areas of high priority.
• Facilitate communication between U01 awardees to share project information as appropriate.
• Participate in the project Steering Committee meetings as a voting member.
• The NIMHD Project Scientist or designee may be co-authors on study publications. In general, to warrant co-authorship, NIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.

The NIMHD Program Official will:

• Interact with the Program Director(s)/Principal investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the Program Director/Principal Investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee, DSMB, and related meetings.
• Assist with the NIMHD's monitoring of award supported activities;
• Facilitate the establishment of an NIMHD-appointed DSMB.
• Make recommendations for continued funding based on: a) overall study progress, including sufficient participant and/or data accrual; and b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements).
• Additionally, the Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Establishing and participating in a Steering Committee consisting of: 1) the PD(s)/PI(s) who will serve as Chair(s); 2) two external members selected by the PD(s)/PI(s) and 3) the NIMHD Project Scientist. Each member will have one vote. The Steering Committee will meet in person at least once a year and will convene by telephone or in-person as needed. The Steering Committee will serve as the primary governing board for research activities, priority setting and assessment of progress and patient accrual. Major scientific decisions regarding adjustments to the study protocol will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIMHD Program Official, and will provide periodic supplementary reports upon request.
• Communicating and providing information to the NIMHD-appointed DSMB. The DSMB will review study progress, safety data and interim results, as appropriate, and provide guidance to the NIMHD. Study investigators shall not communicate with DSMB members regarding study issues, except as authorized by the DSMB’s Executive Secretary.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) 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.

eRA Service Desk (Questions regarding ASSIST, 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)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Jennifer Alvidrez, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9567
Email: [email protected]

Maryline Laude-Sharp, PhD
National Institute on Minority Health & Health Disparities (NIMHD)
Telephone: 301-451-9536
Email: [email protected]

Priscilla Grant, JD
National Institute on Minority Health & Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

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 Part 75.