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)
National Cancer Institute (NCI)
Office of AIDS Research (OAR)

Funding Opportunity Title

Administrative Supplements for U.S. - Brazil Biomedical Collaborative Research

Activity Code

Administrative Supplement

Additional funds may be awarded as supplements to parent awards using the following Activity Code(s):

Administrative supplement requests must be submitted on paper for the following activity codes:

P01 Research Program Projects
P30 Center Core Grants
P50 Specialized Center
U19 Research Program – Cooperative Agreements
U54 Specialized Center- Cooperative Agreements
UM1 Multi-Component Research Project Cooperative Agreements

UM2 Center with Complex Structure Cooperative Agreements

Administrative supplement requests may be submitted electronically for the following activity codes:

R01 Research Project Grant
R21 Exploratory/Developmental Research Grant Award
R21/R33 Phased Innovation Award
R24 Resource-Related Research Projects

R25 Education Projects
R33 Exploratory/Developmental Grants Phase II
U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

PA-14-328

Companion Funding Opportunity

None

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

93.856, 93.855, 93.393, 93.394, 93.395, 93.396, 93.399

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) announces an opportunity for eligible investigators receiving research funding from The National Institutes of Health (NIH) to request administrative supplement support. The “parent” awards and the proposed administrative supplements must be in areas of cancer, allergy, immunology, and/or infectious diseases (including HIV/AIDS and its co-morbidities). The overall goal of this supplement program is to enhance ongoing research efforts through collaborations with Brazilian scientists in these scientific areas under the new U.S.-Brazil Collaborative Biomedical Research Program.  

Key Dates
Posted Date

August 28, 2014

Open Date (Earliest Submission Date)

New Date: September 27, 2014 per NOT-AI-14-070. (Previously September 23, 2014)

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

New Date: October 27, 2014 per NOT-AI-14-070, (Previously October 23, 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)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

December 2014

Expiration Date

New Date: October 28, 2014 per NOT-AI-14-070. (Previously October 24, 2014)

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Background

The NIH supports international collaborative biomedical research to advance science and expand biomedical knowledge. Scientists in the United States of America and the Federative Republic of Brazil have had a long and productive history in scientific cooperation. Recognizing that enhanced cooperation in biomedical research can advance scientific discovery and is of mutual benefit to the United States and Brazil, the NIH, the Brazil Ministry of Health (MS), and the Brazil Ministry of Science, Technology, and Innovation (MCTI) signed a Letter of Intent (LOI) in June 2014 to develop a coordinated program that will foster collaborative health research focused on areas of mutual interest and shared scientific priority.

The NIH and the engaged Brazilian Ministries plan to jointly fund each collaborative project selected for funding through this joint program (see details below).

General Requirements for Collaborative Arrangements

U.S. and Brazil collaborating investigators should work together to prepare and submit applications for funding in response to this FOA and to a corresponding announcement by the Brazilian Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (CNPq).  The U.S. administrative supplement request submitted to NIH and the counterpart Brazilian application submitted to CNPq must use the same title and contain the same scientific content and budget, which specifies the funding needs of each collaborating scientist/institution, (written in English).  It is strongly advised that to the greatest degree possible the U.S. administrative supplement request and the Brazilian application be fully harmonized or consist of the same text. 

Supplement requests from eligible NIH-funded investigators must be submitted in response to this FOA for administrative review at the NIH as outlined below. In the “Letter of Confirmation", U.S. applicants must expressly agree to provide directly a complete English copy of the request to their Brazilian counterparts.  The NIH will not consider for funding any request that has not met this sharing requirement. Potential U.S. applicants concerned about confidentiality or proprietary information should take this requirement into account before deciding what information to submit in their supplement request to NIH.

Eligibility of the Brazilian counterpart for CNPq funding through this collaborative program will be determined by CNPq.  A corresponding funding opportunity announcement will be published (in Portuguese and in English) by CNPq to invite Brazilian investigators to apply for funding under the joint U.S.-Brazil Collaborative Biomedical Research Program.   Applications from Brazilian investigators will be reviewed in parallel by CNPq using Brazilian selection factors that are harmonized with NIH selection factors. Brazilian applicants will also be required to submit as part of their applications a copy of the NIH supplement request (that must be provided to them by their U.S. collaborator). Therefore, it is expected that the Brazilian collaborator will contact the U.S. Program Director(s)/Principal Investigator(s) [PD(s)/PI(s)] and request copies of their supplement request in response to this announcement for submission of the Brazilian application. All materials submitted by Brazilian applicants will be reviewed confidentially during CNPq review process.

Merit-based funding decisions will be made by NIH and CNPq with consideration of the research priorities of both parties. Both the U.S. and Brazilian projects must be determined to be eligible and responsive (in the parallel processes conducted by the NIH and CNPq) to be considered for funding under the program. For this program, NIH will only fund the part of the collaborative research performed by U.S. grantees and CNPq will only fund the part of the collaborative research performed by the Brazilian investigators, with the exception noted below.

Note 1: As appropriate, CNPq will utilize “Ciencia sem Fronteiras” (Science Without Borders) program funds to support portions of Brazilian applications that provide funding for Brazilian postdoctoral fellows conducting research in the laboratory of their NIH-supported collaborator.  Therefore, Brazilian applicants are encouraged to consider the inclusion of such fellowships in the applications.  NIH-supported applicants who anticipate hosting a Brazilian Science without Borders fellow as an element of the collaboration should include a statement in the Research Strategy and (if applicable) the Budget Justification from the US PD/PI acknowledging that laboratory space and research funding (if necessary) will be provided.  Any funding requirements needed to accommodate a fellow should be reflected in the submitted budget of either the US Awardee or the Brazilian applicant.

Note 2: Whereas the U.S. parts of these collaborative projects will be funded as administrative supplements, the Brazilian parts will be funded as new one-year awards. Brazilian collaborators should check the CNPq funding announcement for details.

Research Objectives and Requirements for Supplement Requests
IMPORTANT:  The research proposed by the NIH grantee in their administrative supplement request must meet all the criteria stated above and be within the original scope of the NIH-supported parent award.  The NIH funding mechanism to support this program, i.e., administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives as long as they are within the original scope of the project.  Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes. A grant in the first or last year of the competitive segment may not be eligible. Check the eligibility section for details and possible exceptions. Awardees are encouraged to review their Notice of Awards to ensure they meet the IC’s supplement requirements.

Supplement Scope and Specific Requirements

Supplemental NIH funding under this program may be requested only to support research activities enhancing existing eligible parent grants or cooperative agreements through collaboration between U.S.-based NIH grantees and Brazilian scientists.

A collaboration with an eligible Brazilian investigator (submitting a corresponding Brazilian application to CNPq) must be properly documented and formalized as instructed in this FOA. The Brazilian collaborating investigator must also carefully follow all CNPq application procedures to be considered eligible for review. Both U.S. and Brazilian applications have to be considered eligible and responsive (by the NIH and CNPq, respectively). If these requirements are not met, administrative supplement requests to NIH will not be considered. 

Funding under this program will support collaborative research projects only. Applications requesting funds for research infrastructure will not be considered.

Nature of Collaborative Research Activities

The intent of this initiative is to foster, stimulate, and/or expand collaborative basic, translational, and applied research between eligible NIH awardees and eligible Brazilian researchers in the areas of cancer, allergy, immunology, and infectious diseases including HIV and its co-morbidities.

Research activities proposed for the supplemental funding must remain within the peer-reviewed scope of the NIH-supported eligible parent grant or cooperative agreement; this research may be basic, translational, behavioral, clinical, preventive, and/or epidemiological in nature. 

Human subjects and/or animal research may be proposed for supplements but only if human subjects and/or animal research have been originally approved for the eligible parent grant or cooperative agreement.  Clinical trials are not permitted under this program (see below).

Applications that involve bioinformatics and genome-editing methods are encouraged.

Research Areas

Provided that supplements remain within the scope of eligible parent awards, the research activities supported through supplements under this program may be focused on areas relevant to infection-associated cancers, allergy, immunology and infectious diseases (including HIV/AIDS and its co-morbidities). Projects that are supported under this FOA in cancer research are limited to infection-associated cancers (see below). Other research areas that are of interest to this collaborative program include (but are not limited to):

Basic Immunology

Basic human immunology is of particular interest as is host immune response and/or regulation of the inflammatory response to microbial and/or viral infection.  Additionally, studies that elucidate the underlying mechanisms that result in immune memory and protection in response to vaccination are of interest.  Topics of interest relevant to immunity to infection and/or vaccination include, but are not limited to:

  • Activation of innate immune cells and signaling pathways
  • Positive and negative regulation of inflammation
  • Mechanisms by which the innate immune system directs subsequent adaptive immune responses
  • Generation and maintenance of effector and memory antigen-specific T and B lymphocytes
  • Regulation of antibody production and mechanisms of antibody-mediated protection
  • Definition of biomarkers of protective immune responses
  • Characterization of innate and adaptive mucosal immune responses
  • Mechanisms of immune-mediated pathogenesis triggered by responses to microbial infection
  • Effect of viral and microbial infections, and environmental pollutants on innate immunity and epithelial/mucosa functions and their contribution to the pathogenesis of asthma and allergic diseases

Infectious Diseases (other than HIV/AIDS)

Research on infectious diseases (non-HIV/AIDS) may focus on bacterial, parasitic, viral, or fungal diseases.  Of special interest are:

In addition, areas of special interest include:

  • Antimicrobial resistance, including mechanisms of resistance
  • Resistance in disease vectors and vector biology
  • Host-pathogen interactions including immune responses to infectious diseases or vaccines, and the role of immune responses in pathogenesis

HIV/AIDS and co-morbidities/co-infections

HIV/AIDS research may focus on:

  • HIV co-infections including:
    • Tuberculosis
    • Hepatitis C 
    • Hepatitis B
  • Complications associated with long-term HIV disease and antiretroviral therapy, including:
    • AIDS-defining and non-AIDS-defining malignancies
    • Metabolic disorders
    • Cardiovascular disease
    • Conditions associated with aging
  • Neurologic and neurocognitive disorders

To take advantage of the unique strengths of the Brazilian response to the HIV epidemic, a number of types of studies will be given priority: 

  • Impact of Brazil’s treatment strategies on the outcomes of treated HIV disease, specifically focusing on differences in the incidence, prevalence and mechanisms governing the onset of non-infectious co-morbidities in treated HIV-disease
  • Delineating the demographics of the care continuum for the Brazilian epidemic and comparing the social and structural barriers seen in the epidemics in Brazil and the United States, which slow and prevent the full scale implementation of antiretroviral therapy   
  • Exploring the epidemiologic and/or biologic interactions between HIV and TB, in patients including children and pregnant women 
  • Defining patterns of transmission of TB
  • Evaluating the structural, environmental, host and microbiological factors contributing to transmission, disease activation, treatment success, relapse or emergence of TB drug resistance
  • Defining novel HIV vaccine candidates, including but not limited to identification of candidate novel immunogens, and novel adjuvants
  • Developing novel prevention interventions that are idealized for implementation in key populations in Brazil, including pregnant and breastfeeding women
  • Developing combination prevention strategies for HIV/AIDS prevention among high-risk populations including men that have sex with men (MSM)
  • Developing genetic editing mechanisms to achieve clearance of the virus.

Research toward a cure for HIV/AIDS is of particular interest, including studies on:

  • HIV reservoirs, latency, and persistence
  • Screening and testing of novel compounds
  • Adherence to treatment regimens
  • Research at the individual, community, and population levels on developing and implementing a cure for HIV/AIDS

Research toward a cure for HIV/AIDS should take advantage of screening and/or testing of molecules that are unique to South American compound libraries or research programs, or define how these molecules influence the basic mechanisms of latency and persistence.

Cancer Research

Applications in the area of cancer research are limited to infection-associated cancers.

Areas of interest in HIV-associated cancers include:

  • Epidemiology of HIV-associated cancers in the era of antiretroviral therapy, including assessment of risk factors (e.g. tobacco, alcohol, drug use, infections, diet, and nutrition) that impact cancer in the context of HIV infection in Brazil
  • Identifying biological differences between AIDS-defining and non-AIDS-defining tumors, including differences in the tumor sequences and tumor gene expression
  • Determining pathogenic or immunologic mechanisms involved in the interactions between HIV, other opportunistic infections and oncogenic viruses such as human papilloma virus (HPV), human herpes viruses (EBV and HHV-8),  and hepatitis B and C viruses, that lead to increased cancer risks or cancer development
  • Understanding the pathogenesis and pathobiology of HIV-associated cancers (AIDS-defining and non-AIDS-defining), including the role of long-term antiretroviral therapy   
  • Optimizing the diagnosis, prevention and treatment of HIV-associated cancers, including development of biomarkers for early detection, progression, or response to treatment of HIV-associated cancers
  • Comparing the complications and outcomes of treating cancers in HIV-infected versus HIV-uninfected populations
  • Improving clinical outcomes by integrating cancer screening services (e.g. cervical and anal cancer screening) and treatment with HIV care

Areas of particular interest in cancers associated with chronic infection (other than HIV) include:

Studies of epidemiology, biology, prevention, diagnosis, and treatment for cancers associated with chronic infections, including, but not limited to HPV, helicobacter pylori, hepatitis B and C, Epstein-Barr Virus and HTLV1.

Research involving human subjects (clinical research) is permitted under this FOA.

Restrictions to Scientific Activities: The following activities are NOT allowed for these administrative supplements:

Human subject research or animal research if such activities have not been approved for the parent awards;

Clinical trials of drugs, biologics, or diagnostics (see NIH definition of clinical trials in the Application Guide SF424) if such activities have not been approved for the parent awards;  For NIH definitions of clinical research vs. clinical trials, please see https://grants.nih.gov/grants/glossary.htm#C; and

Research involving Select Agents (see 42 CFR 73 for the Select Agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens).

NOTE: Investigators considering application for these administrative supplements are strongly encouraged to contact the NIH Program Official assigned to the parent award for feedback about the eligibility of that award and whether the activities to be proposed meet the requirements defined for these administrative supplements.

For more information please refer to specific Questions and Answers site for this FOA:

http://www.niaid.nih.gov/researchfunding/qa/Pages/PA-supp-US-Brazil.aspx

Section II. Award Information
Funding Instrument

The funding instrument will be the same as the parent award. 

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

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

Non-competing Administrative Supplements

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Up to $3,000,000 will be available in Fiscal Year 2015 for NIH-funded scientists.

Award Budget

Individual Administrative Supplement requests are be limited to $100,000 direct costs (or to 25 percent of the direct costs for the current budget year of the "parent" award, if that amount is lower than $100,000).

The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the peer reviewed and approved project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes.

Award Project Period

The project and budget periods must be within the currently approved project period for the existing parent award.   

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

All organizations administering an eligible parent award may apply for a supplement under this announcement.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are 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.

  • 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.
  • 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.

Eligible Individuals (Program Director/Principal Investigator)

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

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

All the requests for supplemental funding must be based on collaborations involving eligible awardees and qualifying Brazilian investigators.   Additional specific requirements and eligibility conditions apply.

Applicant organizations may submit more than one application, provided that each is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center.  Each U.S. PD/PI can only submit one administrative supplement request, even if the U.S. PD/PI has more than one eligible grant or cooperative agreement.

Eligible “Parent” Grants or Cooperative Agreements. This supplement program is limited to active grants or cooperative agreements using the following NIH funding mechanisms: R01, P01, U01, U19, U54, UM1, P30 (only for pilot projects to the Developmental Core with no additional funding to infrastructure), P50, R21, R21/R33, R24, R25, R33, and UM2. Moreover, to be eligible as a “parent” award, the grant or cooperative agreement must either be:

  • Funded by the NIH Institutes participating in this program ; or
  • Focused on HIV/AIDS and its co-morbidities (may be issued by any of the NIH Institutes/Centers)

In addition:

Qualifying non-AIDS/HIV awards must be issued by NCI or NIAID, or with award serial numbers containing either “CA” or “AI”; AND

All “parent” awards must remain active through the entire period of the supplement; no-cost extensions cannot be used to accommodate this requirement. NIAID awardees can review the administrative supplements to grants and cooperative agreements website for more details.

(http://www.niaid.nih.gov/researchfunding/sop/pages/adminsupp.aspx#req)

NOT eligible as parent awards are grants or cooperative agreements that:

  • Use other NIH funding mechanisms than those listed above; or
  • Are NOT funded by either NCI or NIAID unless they are HIV/AIDS related applications; or would expire or be in a "no-cost extension" status at any time before the end of the one year project period.  
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must prepare applications using current forms in accordance with the Application Guide.

For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this announcement, or use the eRA Commons streamlined submission process.

2. Content and Form of Application Submission

All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) 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.

Page Limitations

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

Application Submission

Electronic submission of request for administrative supplements is only available for single-project activity codes for which competing applications are submitted electronically. Visit the list of single-project Activity Codes Processed Electronically by eRA to determine if the single-project activity code of the parent award has transitioned to electronic submission.  Submission of requests for administrative supplements for all other activity codes must use paper.

If the administrative supplement may be submitted electronically, then you may either (A) submit using the SF424 (R&R) Application Forms and Grants.gov/Apply, (B) submit using the streamlined submission process of eRA Commons, or (C) submit using the paper-based PHS 398 Application forms and the PHS 398 Application Guide.

Applicants submitting paper applications must use the PHS 398 Application Forms and the PHS 398 Application Guide.

Instructions for Submissions using Grants.gov/Apply for electronic-based submissions

For single project grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically as a Revision application type on the R&R Cover Form. Prepare applications using the SF424 (R&R) application forms associated with this announcement. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

NIH now offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User’s Guide for submitting through this system is available.

Include the Research Strategy and any other required documentation (described below) as a PDF file using the “Add Other Attachments” function.  Budget information should be entered for the grantee institution in the fields provided. There is no template or form available for subaward information; instead, all subaward information should be included as a separate attachment showing the funds requested (by budget period) using the same categories provided for the grantee institution. Also include a budget justification for the subawardee institution in the same file.

Instructions for Submissions using the PHS 398 Application Forms (for paper-based submissions)

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, to:

Margarita R. Ossorio Goldman, M.Sc.
Regional Program Officer Americas and the Caribbean
Office of Global Research
NIAID/NIH/DHHS
5601 Fishers Lane, Room 1E63A
Rockville, MD 20852
Phone: (301) 496-0070
Voice mail: (301) 451-2597
FAX: (301) 480-2954
Email: mo122x@nih.gov

On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.

PHS 398 Research Plan (Research Plan)

All instructions in the Application Guide must be followed for all Research Plan sections applicable to the proposed supplement activities. At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities. The relationship of the supplement request to the parent award should be described. It is strongly encouraged that the request include engagement of a fellow(s) and, if it does, hosting a Science Without Borders Fellow should be included in the research plan. NIH-supported applicants who anticipate hosting a Brazilian Science without Borders fellow as an element of the collaboration should include a statement in the Research Strategy acknowledging that laboratory space and research funding (if necessary) will be provided. 

Project/Performance Site Locations (Project/Performance Sites)

All instructions in the Application Guide must be followed, with the following additional instructions:

  • Include the primary site where the proposed supplement activities will be performed.
  • If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
Senior/Key Personnel Form

All instructions in the Application Guide must be followed, with the following additional instructions:

  • List the PD/PI as the first person (regardless of their role on the supplement activities).
  • List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
R&R Detailed Budget Form (for use with electronic submissions)

All budgets should be submitted using the R&R Detailed Budget form, regardless of the form used for the parent award, and should only include funds requested for the additional supplement activities.

In addition to the required standard budget for NIH funding (for expenses on the U.S. side), U.S. applicants are strongly encouraged to include in their requests a copy of the budget being requested by their Brazilian counterparts for CNPq funding (for expenses on the Brazilian side in Brazilian currency).

Budget for the Entire Proposed Period of Support (for use with paper-based submissions)

A proposed budget should be submitted using the PHS 398 budget forms, in accordance with the PHS 398 Application Guide, and should only include funds requested for the additional supplement activities.

In addition to the required standard budget for NIH funding (for expenses on the U.S. side), U.S. applicants are strongly encouraged to include in their requests a copy of the budget being requested by their Brazilian counterparts for CNPq funding (for expenses on the Brazilian side in Brazilian currency).

Other Project Information (for use with electronic submissions); Appendix (use with paper-based submissions)

All instructions in the Application Guide must be followed, with the following additional instructions:

IACUC Documentation and IRB Documentation (Uploaded via the Other Attachments Section for electronic submissions)

  • If applicable, include documentation that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects’ involvement is planned for the supplement component.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

Planned Enrollment Report

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

 
PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

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

Organizations must submit applications as described above. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

For paper-based application submission, information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 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 using the instructions specified above.

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:
For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and/or responsiveness by the awarding Institute or Center. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Not Applicable

Section V. Application Review Information
1. Criteria

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

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

Overall Impact

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:

  • Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?
  • Will the administrative supplement increase or preserve the likelihood that the fellowship will enhance the candidate's potential for, and commitment to, a productive, independent scientific research career in a health-related field?
  • Will the administrative supplement increase or preserve the likelihood for the candidate to maintain a strong research program?
  • Will the administrative supplement enhance the productivity of collaborative research involving U.S. and Brazilian scientists?
  • Will the administrative supplement increase or preserve the potential benefit of the instrument requested for the overall research community and its potential impact on NIH-funded research?

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

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, NIH staff 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, NIH staff 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

NIH staff 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

NIH staff 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.

2. Review and Selection Process

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information
1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. 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. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

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

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

3. Reporting

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the  Non-Competing Grant Progress Report, PHS 2590 or RPPR, and financial statements as required 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)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

Scientific/Research Contact(s)

Melanie C. Bacon
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3215
Email:  mbacon@niaid.nih.gov

Polly Sager
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-1884
Email: psager@mail.nih.gov

Conrad Mallia
Division of Allergy Immunology and Transplantation
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3491
Email: cmallia@mail.nih.gov

Paul C. Pearlman, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5354
Email: paul.pearlman@nih.gov

Natalie Tomitch
Office of AIDS Research (OAR)
Telephone: 301-451-0098
Email: tomitchn@mail.nih.gov

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Emily Linde
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2943
Email: lindee@mail.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@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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