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

The purpose of this Funding Opportunity Announcement (FOA) is to provide funding to expand specific activities under the U.S.-South Africa Program for Collaborative Biomedical Research (R01). The goal of the revision application is to increase the number of underrepresented scientists engaged in research collaboration in support of emerging public health needs in the areas of tuberculosis (TB), HIV/AIDS biomedical and behavioral science, and HIV-related co-morbidities, including malignancies. For the purpose of this FOA, underrepresented scientists are defined as Black South Africans at South African historically disadvantaged institutions (HDIs) and other Universities of Technology.

The National Institutes of Health (NIH) of the United States (U.S.) Department of Health and Human Services (DHHS) supports international collaborative biomedical research to advance science and expand biomedical knowledge.

Scientific cooperation between the U.S. and the Republic of South Africa was initiated in 1995 and has grown in recent years. Recognizing that enhanced cooperative biomedical research would be of mutual benefit to the U.S. and South Africa, the NIH Director and the President of the Medical Research Council (MRC) of the Republic of South Africa signed a Memorandum of Understanding (MOU) in January, 2013 to develop a new U.S.-South Africa Program for Collaborative Biomedical Research. A working group, made up of members from both the NIH and MRC, developed strategic plans for collaboration. Both the NIH and MRC have allocated resources to support joint activities pursued under this program.

The intent of the original award (RFA-AI-14-009) was to foster, stimulate, and/or expand basic, translational, behavioral and applied research that would advance scientific discovery and engage U.S. and South African researchers working collaboratively in the areas of TB, HIV/AIDS biomedical and behavioral science, and HIV-related co-morbidities, including malignancies. Awards made in response to RFA-AI-14-009 reflect the highest possible scientific standards, as well as shared interests, international and local public health needs and priorities, and involve mutually advantageous collaborations among institutions, including participating communities and other partners.

The primary objective of this FOA is to provide supplementary funds to current R01 awardees to add or expand activities focused on establishing or enhancing substantive research opportunities for underrepresented scientists in the biomedical research workforce in South Africa. This group of scientists (Black South Africans at South African HDIs and other Universities of Technology) has been identified by the South African Medical Research Council (SAMRC) as underrepresented in the biomedical workforce of South Africa.

The method used to support this need is through supplementary funds to current South African awardees funded in response to RFA-AI-14-009 or with direct NIH R01 funding to a South African institution or organization. Funding received through revision applications, formerly known as competing supplements, may be used to increase support in a current budget period for expansion of the project's approved scope or research protocol.

Current U.S. and South African awardees and their collaborators funded in response to RFA-AI-14-009, as well as South African scientists with direct NIH R01 funding to a South African institution, may apply for supplementary funds to engage in collaborative research projects with underrepresented scientists. The funds must be used to support collaborative research and other activities designed to increase and enhance the research skills of underrepresented scientists participating in South African research in the areas of tuberculosis (TB), HIV/AIDS biomedical and behavioral science, and HIV-related co-morbidities, including malignancies .

Specific Research Areas of interest include

HIV Transmission and prevention

• Understanding HIV transmission dynamics.
• Informing development of new biomedical prevention strategies through understanding host/virus interactions associated with HIV acquisition, establishment of infection and disease progression.
• Prevention of mother-to-child HIV-transmission (MTCT) in the era of South Africa Option B policy.
• Effects of maternal HIV infection and antiretroviral treatment on HIV-exposed uninfected children.
• HIV prevention particularly in young/adolescent women.
• Combination prevention strategies.
• The role of food insecurity and nutrition in prevention, care and treatment of HIV/AIDS.

HIV/AIDS Treatment and Care Continuum

• Best approaches to optimizing durability of ART regimens beyond the first line regimen. For example, how can adherence best be supported to prevent regimen failure? Can resuming second line regimens be successful with adherence support when there is loss of virologic control, rather than switching to third line regimens?
• Research towards a cure for HIV/AIDS including pediatric HIV functional cure.
• Identification of infected individuals and linkage to and retention in medical care.
• Research on adherence to HIV treatment, including use of mobile technologies.
• Approaches to monitoring antiretroviral therapy (ART) treatment.
• Interplay or impact of non-communicable diseases with HIV disease and its management.
• Chronic inflammation and aging in treated HIV disease.

HIV and AIDS-associated Cancers

• Epidemiology of HIV-associated cancers in the era of antiretroviral therapy.
• Studies that identify biological differences between AIDS-defining and non-AIDS defining cancers.
• Understanding interactions of HIV with human papilloma virus (HPV), human herpes viruses (EBV and HHV-8), hepatitis B and C viruses, herpes simplex virus (HSV) and other oncogenic viral co-infections that lead to increased cancer risks.
• Studies on pathogenesis and pathobiology of HIV-associated cancers.
• Strategies for optimizing diagnosis, prevention and treatment of HIV-associated cancers.
• Studies on complications and outcomes of treating cancers in HIV-infected vs. HIV uninfected populations.

Tuberculosis

• Research on TB pathogenesis and biomarkers.
• Latent TB infection, pathogenesis, diagnosis, and treatment.
• Scale-up of TB prevention and treatment strategies.
• Novel approaches and better understanding of current modalities.
• TB prevention.
• TB treatment.
• Discovery and development of point-of-care diagnostics and diagnostic strategies.
• TB epidemiology including novel surveillance methods, such as mobile technologies and mathematical modeling.
• Maternal and pediatric TB.  

Examples of research activities that may be addressed include, but are not limited to, the following:

• Develop and implement collaborative research projects on topics of relevance to HDIs and other Universities of Technology, and conducted by underrepresented scientists with research mentorship provided by current NIH awardees.
• Design and implement research opportunities for underrepresented scientists at HDIs or other Universities of Technology through scientist exchanges between underrepresented scientists and experts in the fields of TB, HIV/AIDS biomedical and behavioral science, and HIV-related co-morbidities, including malignancies.
• Conduct workshops or symposia to bring together underrepresented scientists, expert researchers, and clinicians performing research in these fields, to disseminate research findings, exchange experiences related to practical research in these fields, and apply appropriate research approaches and techniques to research of importance to South African public health needs.

The following will not be supported under this FOA.

• Clinical trials (stage I, II, III, or IV).
• Any research with select agents.
• Applications that do not include underrepresented scientists at historically disadvantaged institutions (HDIs) as designated by the South Africa Medical Research Council (SAMRC) or other Universities of Technology..

Support for Revision Applications for the U.S.-South Africa Program for Collaborative Biomedical Research is available under two separate FOAs that are being published concurrently. This FOA is soliciting revision applications to the R01 awarded applicants, whereas the companion FOA solicits support for revision applications to current U01 awardees.

For more information please refer to specific Questions and Answers sites for the FOAs: For the current FOA (RFA-AI-16-039), see http://www.niaid.nih.gov/researchfunding/qa/Pages/RFA-AI-16-039.aspx. For the companion FOA (RFA-AI-16-040), see http://www.niaid.nih.gov/researchfunding/qa/Pages/RFA-AI-16-040.aspx.

See Section VIII. Other Information for award authorities and regulations.

 

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.

Revision applications will only be accepted from South African institutions/organizations with active NIH R01 funding (direct award) and from active NIH R01 institutions/organizations funded in response to RFA-AI-14-009.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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.

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.

For the revision application, South African awardees of a parent grant, either those funded in response to RFA-AI-14-009 or those with direct award NIH R01 funding, will be the PD(s)/PI(s) of the revision application, and if applicable, will maintain the same relationship (e.g., PD(s)/PI(s) or collaborator) with the U.S. scientist (i.e., PD(s)/PI(s) funded in response to RFA-AI-14-009 or collaborators on awards funded through RFA-AI-14-009). Applicants must partner with underrepresented scientists at HDIs or other Universities of Technology as either a multiple PD(s)/PI(s) or a collaborating partner on the revision application; however the South African awardee PD(s)/PI(s) must be the contact PD(s)/PI(s). Eligible underrepresented scientists at the South African HDIs or other Universities of Technology listed below may serve as a PD(s)/PI(s) or collaborating partners.

Historically disadvantaged institutions (HDIs) as designated by the South Africa Medical Research Council (SAMRC):

• University of Fort Hare
• University of Limpopo
• Walter Sisulu University
• University of Venda
• University of Zululand
• University of the Western Cape
• Mangosuthu University of Technology
• Sefako Makgatho Health Science University

South African Universities of Technology:

• Cape Peninsula University of Technology
• Central University of Technology
• Durban University of Technology
• University of Mpumalanga
• Sol Plaatje University
• Tshwane University of Technology
• Vaal University of Technology

South African PD(s)/PI(s) and South African collaborators must be either permanently employed at an eligible South Africa research institution or be in a long-term contract (at least for the minimum of the duration of the project). Note that postgraduate students, full or part-time, are not eligible to serve as PD(s)/PI(s) or collaborating partners.

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 obtain 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:

Nancy Touchette
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-2486
Email: ntouchette@niaid.nih.gov

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

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, with the following additional instructions:

Facilities and Other Resources: Include a description of available resources associated with the expansion of scope proposed, naming which collaborative partner is contributing which resources, and a description of how resources will be shared (e.g., individual contributions of specific reagents, patient samples, compounds, and access to populations for epidemiologic studies).

Other Attachments: Provide the following additional materials specified below in support of the application.

Provide a PDF file with the name Collaboration Plan:" Applicants should include a Collaboration Plan clearly defining the interactions between the parent awardees (the U.S. PD(s)/PI(s) or collaborator and South African PD(s)/PI(s)) and the underrepresented scientists at the HDIs or other Universities of Technology in terms of plans for communication among the groups, processes for making decisions on scientific direction and planning activities, and procedures for resolving conflicts. This file should not describe interactions between PD(s)/PI(s) in Multiple PD/PI applications but should discuss the interactions between the PD/PI and the underrepresented scientist.

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:

Within the budget justification, applicants must specify how at least 67% of the funds will be used to support work to be performed at South African institutions/organizations.

Budget request amounts should include only the new work proposed under the revision application. Do not include requests for funds for activities ongoing and supported by the parent award.

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:

Specific Aims: Applicants should clearly describe the specific aims of the project and indicate which partner of the collaboration (the South African PD(s)/PI(s), the U.S. PD(s)/PI(s) or collaborating partner, and the underrepresented scientists at HDIs or other Universities of Technology) will be responsible for accomplishing each of the aims.

Research Strategy: The revision application should contain sufficient information from the original grant application to allow evaluation of the proposed supplement in relation to the goals of the original application.

Provide a description of the goals of the research or research activities and describe the plans to establish or enhance substantive research opportunities to benefit research opportunities for underrepresented scientists.

Describe the research opportunities or research project and how it will address critical research needs of South African HDIs or other Universities of Technology.

Outline the combined roles and responsibilities of all participating partners in the research, including contingency plans addressing solutions to setbacks or delays.

Include a financial management plan for the distribution and monitoring of funds to the HDIs or other Universities of Technology of the underrepresented scientists.

Letters of Support: Applicants from South Africa (parent awardee PD(s)/PI(s), as well as those from the institution of the underrepresented scientists) should include a Letter of Support from their Institution confirming National Research Foundation of South Africa eligibility status.

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 PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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? Is there a strong scientific premise for the project? 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?

Does the revision application provide sufficient detail within the plans to increase the likelihood that substantive research opportunities for underrepresented scientists within South Africa will be established or enhanced? Will the proposed activity address a gap in research opportunities at the HDIs or other Universities of Technology?

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 revision application include at least one underrepresented scientist at HDIs or other Universities of Technology as PD(s)/PI(s) or collaborating partners in the proposed research project or collaborative research activities?

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? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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?

Does the proposed research or research activities establish or enhance substantive research opportunities to benefit underrepresented scientists at HDIs or other Universities of Technology? Will these opportunities result in an increase in the participation of underrepresented scientists in the biomedical research enterprise?

Will the proposed research opportunities address critical research needs of South African HDIs or other Universities of Technology?

Does the proposed research or research activities increase the likelihood that TB, HIV/AIDS biomedical and behavioral science, and HIV-related co-morbidities, including malignancies, can be addressed adequately by underrepresented scientists?

Does the financial management plan clearly articulate the roles and responsibilities of the parent South African PD(s)/PI(s) awardee, the U.S. Extramural PD(s)/PI(s) or collaborating partner and the underrepresented scientists in the management of fiscal resources?

Does the Collaboration Plan clearly define the interactions between the parent awardees (the U.S. PD(s)/PI(s) or collaborating partner and South African PD(s)/PI(s)) and the underrepresented scientists in terms of how information will be exchanged among the groups, processes for making decisions on scientific direction, and procedures for resolving conflicts? Are contingency plans in place to address possible setbacks or delays?

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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

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

Not Applicable

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 Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 the Center for Scientific Review, 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate National Advisory Council or Board. 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Emily Erbelding M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-3384
Email: emily.erbelding@nih.gov

Polly Sager, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-1884
Email: PSAGER@niaid.nih.gov

Geraldina Dominguez, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-496-3204
Email: domingug@mail.nih.gov

Rohan Hazra, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Telephone: 301-435-6868
Email: hazrar@mail.nih.gov

Christopher Gordon, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1613
Email: cgordon1@mail.nih.gov

Robert Freund, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1050
Email: freundr@csr.nih.gov

Philip Smith
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2948
Email: philip.smith2@nih.gov

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: woodwars@mail.nih.gov

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov

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.