Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Cancer Institute (NCI)

Funding Opportunity Title

U.S.-South Africa Program for Collaborative Biomedical Research (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

  • February 4, 2014 - See Notice NOT-CA-14-031. National Cancer Institute (NCI) Participation in this FOA.

Funding Opportunity Announcement (FOA) Number

RFA-AI-14-018

Companion Funding Opportunity

RFA-AI-14-009, RFA-AI-14-010

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.855, 93.856, 93.865, 93.394, 93.395 93.396

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to establish a new U.S.-South Africa Program for Collaborative Biomedical Research.  Research areas supported under this program include TB, HIV/AIDS biomedical and behavioral science, and HIV-related co-morbidities, including malignancies. This opportunity is specifically designed to promote partnerships between eligible NIH intramural investigators (e.g. those conducting research within the laboratories and clinics of the NIH) and eligible South African investigators (e.g., those conducting research in eligible laboratories in South Africa).

Key Dates
Posted Date

January 24, 2014

Open Date (Earliest Submission Date)

March 22, 2014

Letter of Intent Due Date(s)

March 22, 2014

Application Due Date(s)

April 22, 2014, by 5:00 PM local time of applicant organization.

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

AIDS Application Due Date(s)

April 22, 2014, by 5:00 PM local time of applicant organization.

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

Scientific Merit Review

July 2014

Advisory Council Review

October 2014

Earliest Start Date

November 2014

Expiration Date

April 23, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Background

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.

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to establish a new U.S.-South Africa Program for Collaborative Biomedical Research.  Research areas supported under this program include: TB, HIV/AIDS biomedical and behavioral science, and HIV-related co-morbidities (including malignancies). This opportunity is specifically designed to promote partnerships between eligible NIH intramural investigators (e.g., those conducting research within the laboratories and clinics of the NIH) and eligible South African investigators (e.g., those conducting research in eligible laboratories in South Africa).

The intent of this FOA is to foster, stimulate, and/or expand basic, translational, behavioral and applied research that will advance scientific discovery and engage U.S. and eligible South African researchers working collaboratively in the areas of TB, HIV/AIDS biomedical and behavioral science, and HIV-related co-morbidities, including malignancies.  Clinical trials (any phase) are not supported under this FOA.  Proposed research should reflect the highest bioethical and 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.

Eligible U.S. NIH intramural scientists and South African investigators working in partnership will prepare and submit a single joint application.  Applications must include at least one Program Director (PD)/Principal Investigator (PI) affiliated with an institution from each country. This opportunity is being published in conjunction with two similar opportunities for U.S. extramural investigators to collaborate with eligible South African investigators: RFA-AI-14-010,  R21 Exploratory/Developmental Grant and RFA-AI-14-009, R01 Research Project Grant

This FOA encourages New Investigators, and in particular Early Stage Investigators, to participate in this research program.

Research Objectives

To promote basic, translational, behavioral, clinical, preventive, or epidemiological collaborative research in the areas of TB, HIV/AIDS and HIV-related co-morbidities, including malignancies. 

Specific Research Areas of interest include:

HIV Transmission and prevention

HIV/AIDS Treatment and Care Continuum

HIV and AIDS-associated Cancers

Tuberculosis

Applications including clinical trials (stage I, II, III, or IV) are not responsive to this FOA and will not be reviewed.  Clinical research using human specimens will be allowed.

In addition this FOA will not support any research with select agents.

Applications not including at least one PD/PI affiliated with an NIH Institute or Center and one PD/PI affiliated with an eligible South African Institution (listed as the contact PD/PI) are not responsive and will not be reviewed.

For more information please refer to specific Questions and Answers sites for the FOAs:

For the U01: http://www.niaid.nih.gov/researchfunding/qa/Pages/RFA-AI-14-018.aspx

For the R01: http://www.niaid.nih.gov/researchfunding/qa/Pages/RFA-AI-14-009.aspx

For the R21: http://www.niaid.nih.gov/researchfunding/qa/Pages/RFA-AI-14-010.aspx

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

The NIH intends to commit an estimated total of $0.6 million to fund up to 4 awards in FY 2015.

Award Budget

Application budgets are limited to $225,000 (total costs) per year.  South African costs are limited to $175,000 (total costs) per year.

Application budgets need to reflect the actual needs of the proposed project.  The maximum amount available per application is $225,000 (total costs) per year for a period of up to 5 years; this amount includes the NIH intramural investigator's costs attributed to the proposed research project which is limited to $50,000 per year. 

Indirect cost for foreign grantees are limited to 8%. F&A costs requested by consortium participants are not included in the direct costs limitation; see NOT-OD-05-004, November 2, 2004.

Award Project Period

The scope of the proposed project should determine the project period. The maximum period is 5 years.

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Governments

Other

NIH Institutes and Centers and eligible South African institutions.  An eligible National Research Foundation (NRF) South African Institution is defined as a legally constituted public higher education institution or organization wherein research is one of the primary purposes for its existence, including the training of postgraduate students.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) from South Africa 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 allowed.

Required Registrations

Applicant Organizations

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

The application must list at least one eligible NIH intramural investigator as a PD(s)/PI(s), and one Investigator affiliated with a National Research Foundation (NRF) of South Africa eligible institution as a PD(s)/PI(s). South African investigators must be listed as the contact PD/PI and eligible NRF South African Institutions must be the applicant institutions.

Applicants from South Africa for this FOA should 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). Postgraduate students, full or part-time, are not eligible to apply. All tenured NIH intramural investigators and tenure-track NIH intramural investigators are eligible to be PD(s)/PI(s).

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

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

Section IV. Application and Submission Information


1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

The letter of intent should be sent to:

Julie Schneider
Center for Global Health
National Cancer Institute
BG 9609 RM 3W564 MSC 9723
9609 Medical Center Dr
Rockville, MD 20850-9723
Telephone: 240-276-5795
Fax: 301- 480-2954
Email: js787g@nih.gov

Page Limitations

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

Required and Optional Components

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

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Facilities and Other Resources: Applicants should include a description of available resources, 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:

Short-term Scientific Exchanges (optional):

Applications incorporating short-term scientific exchanges of NIH intramural investigators to South Africa for up to one month can be supported if they are a component of the proposed research project. The host laboratory in South Africa will provide laboratory costs during the exchange; however, NIH intramural scientists cannot receive salary or per diem from the South African government. 

Alternatively, this program can support an eligible South African researcher to visit the NIH for a period of one week to six months who: 1) is proficient in spoken and written English; and 2) is not already at NIH. No support will be provided for dependents under this program. Salary support must be provided by the home institution. The short-term-scientist exchange component cannot be used to support eligible South African researchers who are already in an NIH intramural laboratory or who have been previously identified for support from other sources.

Applicants proposing short-term scientific exchanges must include the following documents as a discrete component under Other Attachments (total: eight page limit):

A description of the collaborative research activities to be undertaken in the sponsor's laboratory, specifying what is to be accomplished and how it fits in the overall research strategy of the application (three page limit).

A letter of support that includes a brief description of the visit including a timeline, specific goals, how the visit relates to the proposed research project and how it will promote or enhance collaborations between the NIH intramural laboratory and the eligible South African counterpart (one page limit).

A letter of invitation from the chief of the hosting laboratory indicating tentative dates (one page limit).

A short curriculum vitae, including full contact information, identification of three scientists willing to serve as references, and no more than five publications (two page limit).   

A letter of assurance by the eligible South African investigator that he/she will return to South Africa at the end of the exchange (one page limit).

All letters required for short term scientific exchanges (Letter of Support, Letter of Invitation and Letter of Assurance) must be included in the short term scientific exchange component of the application.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

The South African costs are associated with the eligible South African investigator and the applicant organization. NIH intramural investigator costs are those required by the NIH intramural investigator for carrying out the proposed work specifically identified with the project.

NIH INTRAMURAL INVESTIGATOR COSTS: Intramural investigator costs may include salary for contract staff to be specifically hired under a temporary appointment for the project, consultant costs, supplies, and other items typically listed under Other Expenses.  Budget requests from the NIH intramural program may not include any salary and related fringe benefits for career, career conditional or other federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative costs).  Although the budget request may not include salary support for such individuals, it should indicate percent effort for any key personnel.  Resources required need to be determined before the research protocol can be approved by the respective NIH Institute/Center.  Once the intramural investigator costs are known, the extramural applicant will enter this amount in the “Other” line in the budget section of the application, and attach appropriate justification and documentation, including any spreadsheets as appropriate.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Applicants should clearly describe the specific aims of the project and indicate which partner of the collaboration (U.S., South Africa, or jointly) will be responsible for accomplishing the proposed research.  

Research Strategy: Applicants should propose a single Research Strategy for the combined efforts of the two organizations (U.S. NIH intramural and eligible South African collaborators). The Research Strategy should provide a complete description of the research, demonstrating the integration of the collaborative efforts.  Proposed research must reflect the highest bioethical and scientific standards and stimulate basic, translational, behavioral, clinical, preventive, or epidemiological research between U.S.-based researchers and South African researchers.  Proposed research must promote shared interests and address national, local, and regional public health needs and priorities, and involve mutually advantageous collaborations.  Contingency plans addressing solutions to setbacks and delays should also be included.

Letters of Support: Applicants from South Africa should include a Letter of Support from their Institution confirming NRF South African eligible status.

Applications must also include a letter from the respective NIH Institute/Center Scientific Director or their Designee to confirm that the intramural scientist from the respective NIH Institute/Center will be able to collaborate on the project.

Letters required for short term scientific exchanges (Letter of Support, Letter of Invitation and Letter of Assurance) should not be included here; rather these must be included in the short term scientific exchange component of the application.

Multiple PD/PI Leadership Plan: Applicants should include a Collaboration Plan clearly defining the interactions between and integration of the U.S. and eligible South African investigator's efforts, how information and resources will be exchanged among the groups, plans for communication, processes for making decisions on scientific direction, and procedures for resolving conflicts.  If a short term scientific exchange is proposed, explain how it will promote or enhance collaborations between the NIH intramural laboratory and the eligible South African counterpart.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

Foreign Institutions

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.

3. Submission Dates and Times

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

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

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

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

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the proposed project likely to stimulate basic, translational, behavioral, clinical, preventive, or epidemiological research between U.S.-based researchers and eligible South African researchers?  Does the proposed research address an area of local, national (South African), or regional (African) priority?  Will the research contribute to global understanding of important health issues? Will the proposed research be mutually advantageous to collaborations among institutions and with participating communities and other partners? 

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Are the roles of the U.S. and South Africa investigators clear and is the collaboration well defined?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves a Short-term Scientific Exchange, how does the exchange enhance the collaboration and support the proposed research project?

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?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

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.

Select Agent Research

Not Applicable

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

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 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 as follows:

The PD(s)/PI(s), one of which must be an NIH intramural scientist, will have the primary responsibility for refining the research objectives, approaches and details of the project within the guidelines of the Funding Opportunity Announcement and for performing the scientific activity.

The responsibility for the planning, direction and execution of the overall proposed research project will be solely that of the eligible South African Principal Investigator in close collaboration with the NIH Intramural Scientist. 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 will have substantial scientific involvement that is above and beyond the normal stewardship role in awards, as described below:

NIH Intramural Scientist: The NIH Intramural Scientist will be an NIH intramural tenured or tenure-track staff member with scientific expertise in the research area proposed in the application. The role of the NIH Intramural Scientist is to provide substantial scientific input to the project without duties associated with programmatic stewardship for the project. The NIH Intramural Scientist may have primary responsibility for one or more specific aims within the proposed project. The NIH Intramural Scientist may provide advice and technical assistance to the PD/PI, may participate in monitoring the progress of ongoing research, and assist in the analysis, interpretation, and reporting of findings in the scientific literature and to the community at large and the public policy community within the Federal government though various media. The NIH Intramural Scientist is subject to the same publication/authorship policies as the official NIH publication policy governing extramural NIH staff.  

NIH Extramural Program Official: An agency program official or IC program director 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:

All responsibilities are divided between awardees and NIH staff as described above.

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.

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact 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)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

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

Mark Pineda, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone:301-496-7934
Email: mpineda@niaid.nih.gov

Joan Romaine, M.P.H.
Office of AIDS Research (OAR)
Telephone: 301-435-7693
Email: OAR-Initiatives@mail.nih.gov

Lynne Mofenson, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6870
Email: LM65D@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Jennifer Schermerhorn
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-2649
Email: schermerhornj@niaid.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

Section VIII. Other Information

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

Authority and Regulations

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


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