Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Fogarty International Center (FIC)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Cancer Institute (NCI)

Funding Opportunity Title

Limited Competition: Fogarty International Research Collaboration - Basic Biomedical (FIRCA-BB) Research Award (R03)

Activity Code


R03 Small Research Grants Program

Announcement Type

Reissue of PAR-08-222

Related Notices

Funding Opportunity Announcement (FOA) Number

PAR-11-037

Companion FOA

PAR-11-036 , R03 Small Research Grants Program

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

 93.989, 93.866, 93.173, 93.121, 93.279, 93.113, 93.273, 93.853, 93.399  

FOA Purpose

This Funding Opportunity Announcement (FOA), the “Fogarty International Research Collaboration – Basic Biomedical (FIRCA-BB) Research Award” facilitates collaborative basic biomedical research between scientists supported by the National Institutes of Health (NIH) and investigators in low-and middle-income countries (LMIC).  Special consideration will be given to proposed research that addresses significant global health problems, (particularly those of high relevance to a LMIC country or region) and that includes research capacity building as a major aim of the proposed project.  

Key Dates
Posted Date
Open Date (Earliest Submission Date)

December 10, 2010

Letter of Intent Due Date

December 10, 2010

Application Due Date(s)

January 10, 2011, January 10, 2012, (January 10, 2013 Date Removed per NOT-TW-12-004), by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

June/July 2011, June/July 2012, June/July 2013

Advisory Council Review

October 2011, October 2012, October 2013

Earliest Start Date(s)

December 2011, December 2012, December 2013   

Expiration Date

(New Date January 11, 2012 per NOT-TW-12-004), Original Date January 11, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

 The Fogarty International Center is dedicated to advancing the mission of the National Institutes of Health by supporting and facilitating global health research conducted by U.S. and international investigators, building partnerships between health research institutions in the U.S. and abroad, and training the next generation of scientists to address global health needs. This FOA contributes to the FIC mission, by strengthening research collaborations between NIH funded scientists  and scientists in Low-and Middle-Income Countries (LMICs), particularly those with the least economic resources.  This FOA responds to a number of goals in the new FIC strategic plan (http://www.fic.nih.gov/about/plan/strategicplan_08-12.htm)  

The main objectives of the FIRCA program are to:  (1) support collaborative efforts in behavioral and social sciences research between NIH-funded scientists and LMIC scientists (referred to as the “LMIC collaborator/PD/PI”) on research of high scientific merit, relevant to global health and of mutual interest and benefit; (2) help achieve Fogarty International Center's strategic plan goals including implementation science, chronic disease, infectious diseases (non-AIDS) and, maternal and child health including the Global Health Initiative (http://www.theglobalhealthinitiative.org/); and (3) help build research capabilities and foster further sustained and productive research and research collaborations at the LMIC institution.

The opportunity to collaborate internationally provides a means of access to new information and perspectives, innovative concepts and methods, emerging research techniques and technologies, and unique populations and environments important for addressing global health problems.

The FIRCA will extend and enhance the research interests of both the NIH-funded scientist and the collaborating LMIC scientist, and will help build the research and research capabilities of the LMIC investigator and institution. 

The research capacity building goal of the FIRCA is served by both the direct research collaboration between the teams involved in the research and also by the associated training and consultation at the LMIC site. This training and consultation may also involve other investigators and students at the LMIC site thereby helping to build institutional capacity.  The NIH funded PI may spend up to three months of the year under the FIRCA teaching and consulting at the LMIC site. In such case a formal detailed plan with proposed curriculum, audience, schedule and time frame should be presented as part of the research plan.

All non-AIDS-related basic biomedical research topics that are supported by the NIH and that do not involve behavioral and social sciences research topics are eligible for inclusion under the FIRCA-BB program.     Research topics related to human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS) are not eligible for FIRCA funding.  Investigators working on topics related to HIV/AIDS and wishing to conduct collaborative research involving LMIC countries should note the other opportunities listed at (http://grants.nih.gov/grants/guide/notice-files/NOT-TW-07-002).

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

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.  

Award Budget

Budget for direct costs for up to $50,000 per year and project duration of up to three years may be requested for a maximum of $150,000 direct costs over a three year period.

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed three years.

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

Section III. Eligibility Information
1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Foreign (non-U.S.) components of U.S. Organizations are  allowed.

The LMIC collaborator/PD/PI must be from an institution located in a LMIC defined by the World Bank, according to Gross National Income (GNI) per capita as “low-income,” “lower-middle-income,” and “upper-middle-income” (see: http://data.worldbank.org/about/country-classifications/country-and-lending-groups). For the purposes of this announcement, Hong Kong and Taiwan are considered high income, and thus not eligible.

LMIC institutions may only apply if they meet the eligibility requirements for LMIC collaborating institutions listed above and the PD/PI and Collaborating Investigators meet the criteria listed below in Section 1.B., “Eligible Individuals.”

Occasionally, scientific opportunities may arise that warrant a formal collaborative effort between the PD/PI and individuals from more than one country.  Such applications may be considered only after consultation with the FIC Program Officer.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.

 The scientist who applies as the PD/PI must either (1) be an NIH-funded Investigator or (2) have previously been the LMIC collaborator on an awarded FIRCA.

The LMIC collaborator/PD/PI on a FIRCA must be employed at a LMIC institution that meets the eligibility requirements described in Section 1.A., “Eligible Institutions.”

Applicants may already be FIRCA grantees on another FIRCA at the time of the application.  Applicants may submit more than one application, provided that each application is scientifically distinct.

Eligible Funding Mechanisms for Consideration as FIRCA Companion Grant

The following NIH research project grant mechanisms are eligible as FIRCA  companion grants (and must be both active and funded at the start of the proposed FIRCA budget period, except for resubmissions):

R01, R37 (MERIT), P01, and U01. An R03 or R21 is an eligible companion grant only if the performance site of both the R03 or R21 and the FIRCA grant are in the same LMIC(s). PIs of sub-projects of a program project (P01) or cooperative agreement (U01 and U19) are eligible.

Grants reviewed under an FIC's Funding Opportunity Announcement (e.g. the Fogarty International Center (FIC) “Ecology of Infectious Diseases (EID)” Research Program) but awarded by Institutions/Organizations outside of NIH, are eligible.

Among the mechanisms not generally accepted are:  training grants, Small Business Innovation Research (R43/R44) and Small Business Technology Transfer (R41/R42) Awards.

The active funded  companion grant may have been awarded by any NIH Institute or Center (IC), regardless of whether the IC is listed as a participating component in this FOA. To be eligible, the grant must have a minimum of 12 months of funding, which may include a no-cost extension, remaining at the time of the initial FIRCA application deadline.  For the follow-up application from the LMIC collaborator as PD/PI no active grant for the former FIRCA collaborator is necessary. 

The FIRCA research application may be directly (e.g. the specific aims of FIRCA application are closely associated with that of the companion grants) or indirectly (e.g. the specific aims of FIRCA application are not related to that of the companion grant, but the research methods are similar to that of the companion grant) related to the companion grant. The proposed research can be an extension or a new direction of the companion grant research, but it must not overlap with the specific aims and research already supported by the companion grant or by other sources.

To continue the collaboration under the FIRCA program, LMIC collaborators on previously funded FIRCA grants that have ended, or will end before the new FIRCA application deadline, must apply for a FIRCA as PD/PI either with their original FIRCA collaborator or a new collaborator as justified by the needs of the research. Current grantees and collaborators may want to consider whether their collaboration has developed to the point where they can submit a Research Project (R01) grant application (direct foreign grant or domestic grant with a foreign component). 

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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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.

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:

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

The letter of intent should be sent to:

Xingzhu Liu, M.D., Ph.D.
FIRCA-BSS Program Officer
Division of International Training and Research
Fogarty International Center (FIC)
Building 31, Room B2C39
31 Center Drive, MSC-2220
Bethesda, MD  20892-5475
Telephone: 301-496-1653
Email: Xingzhu.Liu@nih.gov

Required and Optional Components

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

Page Limitations
 
PHS 398 Research Plan Component

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

 
Resource Sharing Plans

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

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide , with the following modifications:

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations 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 in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

Allowable costs include: purchases of supplies, equipment and technical assistance for the LMIC site; salary support or consultant fee for the LMIC collaborator/PD/PI; and travel for the high income country (HIC) and LMIC collaborators and their research associates as justified by the needs of the collaborative research.  If the NIH funded PD/PI submits a detailed formal plan for extended teaching and consultation at the LMIC site, additional travel costs for this purpose may be budgeted.

Awards are made to the PD’s/PI’s institution to support a collaborative research project that will be carried out mainly at the LMIC collaborator’s/PD’s/PI’s research site.  The major portion (at least 70%) of the funds and items purchased with these funds must be used at the LMIC site to support this research in accordance with the following allowed budget allocations:

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component 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 Central Contractor Registration (CCR). 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, NIH. Applications that are incomplete will not be reviewed.

 Other Submission Requirements:

Project Summary Abstract: In addition to the standard application instructions, for FIRCA applications from the NIH funded PD/PI’s institution, please include in this section the name of the LMIC collaborator, collaborator country and institution, and the companion grant number and project period (e.g., “This research will be done primarily in Peru at Lima University in collaboration with Jorge Smith, with the companion grant being R01HL00000, 9-30-2006 to 9-30-2011”).  For applications from previous FIRCA collaborator’s Institution in the LMIC, please include the FIRCA grant number, and project period.

Attachment: For all FIRCA applications, upload a letter of support (on institutional letterhead, and in Other Research Plan Sections) from the LMIC collaborator/PD/PI’s institution, confirming the investigator’s  role in the project.  Please include full contact information, including email address and telephone and fax numbers for the LMIC collaborator/PD/PI.  Provide a statement in the same letter, confirming the LMIC organization’s willingness to comply with all pertinent U.S. Federal regulations and policies. Refer to the following NIH Grants Policy Statement regarding grants to foreign institutions (http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch16.htm#_Toc271265275)Project/Performance Site Locations: Provide the full name and address of the LMIC institution where the research will be performed (or the collaborating U.S. institution if the application is from a LMIC institution).

Research Strategy Plan: Preliminary Studies/ Progress Report:  All FIRCA applications should include, at the beginning of this section, a description of the nature of the proposed collaboration.  Also discuss any relevant previous collaborative arrangement(s). 

Research Strategy Plan::  At the end of this section, outline the proposed contributions of the NIH-funded investigator and the LMIC collaborator/PD/PI to the study. An optional plan for extended teaching and consultation by the NIH funded collaborator at the LMIC site may be included.  In this case please outline the proposed curriculum for teaching and consultation activities for up to three months. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

The R03 small research grants program supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field.

Investigator(s)    

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

If the LMIC collaborator is submitting as the PD/PI, is she/he able to undertake and direct the continuation of the research efforts independently but with some level of collaboration with the original (or new) FIRCA collaborator as justified by the needs of the research?  How will this award continue to enhance the LMIC PD/PI’s research and career development and help her/him towards achieving a position of scientific leadership in her/his home country and field?  

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? Does the project make use of unique or special expertise, resources, circumstances, or environment at the LMIC site to frame or address the research question?  Does the project propose innovative or special ways to incorporate capacity building or training into the research program at the LMIC site?  

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

For applications designating multiple PDs/PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PDs/PIs?  Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts?

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? Has the LMIC collaborator/PD/PI’s home institution made a convincing commitment (e.g., provided a research/academic appointment and salary support)?  Are the resources necessary to perform the research available or obtainable? 

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

Research Capacity Building

How will the award contribute to building needed research capacity/capability at the LMIC site? For new FIRCA collaborations does the collaboration have the potential to enhance the research capability of the LMIC collaborator/PD/PI and the LMIC site?  Does the research constitute a substantial scientific endeavor of the LMIC collaborator/PD/PI, including creative and scientific input to the research proposal?  If the PD/PI is from the LMIC site, how will the award contribute to advancing his/her research and career, research at the PD’s/PI’s institution and the field of research in the PD/PI’s country? 

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable.

Revisions

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

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/priority 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

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

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 . Following initial peer review, recommended applications will receive a second level of review by the FIC Advisory 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 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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.

Applicants can obtain information and research interests for each of the sponsoring ICs listed on the first page of this announcement at their websites, or by contacting the IC program contact listed in Section VII, “Agency Contacts.”  Some of the participating ICs have provided additional statements of interest:

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
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

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

FIC/NIH:

Xingzhu Liu, M.D., Ph.D.
FIRCA-BSS Program Officer
Division of International Training and Research
Fogarty International Center (FIC)
National Institutes of Health
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: 301-496-1653
Fax: 301-402-0779
Email:   Xingzhu.Liu@nih.gov

NIA/NIH:
Dallas W. Anderson, Ph.D.
Program Director, Population Studies
Dementias of Aging Branch
Division of Neuroscience
National Institute on Aging (NIA)
National Institutes of Health
7201 Wisconsin Avenue, MSC-9205
Gateway Building, Suite 350
Bethesda, MD 20892-9205
Telephone: 301-496-9350
Fax: 301-496-1494
Email: Dallas.Anderson@nih.gov

NIAAA/NIH

Peggy Murray, PhD.
Senior Advisor for International Research
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
5635 Fishers Lane, room 2013, Rockville, MD 20852
Phone:  301-443-2594
Email:  pmurray@mail.nih.gov

NIDCD/NIH:
Lana Shekim, Ph.D.
Director, Voice and Speech Programs
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institutes of Health
6120 Executive Boulevard, EPS-400C, MSC 7180
Bethesda, MD 20892-7180
Telephone: 301-496-5061
Fax: 301-402-6251
Email: lana.shekim@nih.gov

NIDCR/NIH:
Jason Wan, Ph.D.
Integrative Biology and Infectious Diseases Branch
Division of Extramural Research
National Institute of Dental and Craniofacial Research (NIDCR)
National Institutes of Health
6701 Democracy Boulevard, Room 648, MSC 4878
Bethesda, MD 20892-4878
Telephone: 301-594-9898
Fax: 301-480-8319
Email:   Jason.Wan@nih.gov

NIDA/NIH:
Steven W. Gust, Ph.D.
Director, NIDA International Program
National Institute on Drug Abuse (NIDA)
National Institutes of Health
31 Center Drive, MSC 8010
Building 31, Room 1B59
Bethesda, MD 20892-8010
Telephone: 301-443-6480
Fax: 301-443-9127
Email: Steve.Gust@nih.gov

NIEHS/NIH:

David M. Balshaw, Ph.D.
Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-27
79 T. W. Alexander Drive
Research Triangle Park, NC   27709
Telephone: (919) 541-2448
Fax: (919) 541-4937
Email: david.balshaw@nih.gov

NCI/NIH

Isis Mikhail, M.D., M.P.H., Dr.P.H.
Division of Cancer Control and Population Science
National Cancer Institute
6116 Executive Blvd, Room 609
Rockville, MD  20892
Telephone: 301-496-8159
Fax: 301-480-0075
Email: mikhaili@mail.nih.gov

NINDS/NIH

Yuan Liu, Ph.D.
Office of International Activities
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd, Room 2187
Bethesda, MD  20892
Telephone: 301-496-0012
Fax: 301-402-1501
Email: liuyuan@ninds.nih.gov

Peer Review Contact(s)

Dan Gerendasy, Ph.D.
Scientific Review Administrator
International Cooperative Programs
Center for Scientific Review
6701 Rockledge Drive, Room 5132
Bethesda, MD  20892-7843 (use ZIP 20817 for overnight mail)
Telephone: 301-594-6830
Fax: 301-480-1677
Email: Dan.Gerendasy@nih.gov

Financial/Grants Management Contact(s)

FIC/NIH:

Angela Smith
Grants Management Specialist
Fogarty International Center (FIC)
31 Center Drive, MSC-2022
Building 31, Room B2-C29
Telephone: 301-402-9592
Email:Angela.Smith@nih.gov

NIA/NIH:

Linda C. Whipp
Grants Management Officer
National Institute on Aging (NIA)
National Institutes of Health
7201 Wisconsin Avenue, MSC-9205
Gateway Building, Suite 2N212
Bethesda, MD  20892-9205
Bethesda, MD  20892-9205
Telephone:  301-402-7731
Email:  Linda.Whipp@nih.gov

NIAAA/NIH:

Judy Fox
Chief, Grant Management Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone:  301-443-4704
Email: jfox@mail.nih.gov

NIDCD/NIH:

Christopher Myers
Grants Management Officer
National Institute on Deafness and other Communication Disorders (NIDCD)
National Institutes of Health
6120 Executive Blvd., Suite 400B, MSC-7180
Bethesda, MD  20892-7180
Telephone:  301-435-0713
Email: Christopher.Myers@nih.gov

NIDCR/NIH:

Mary Greenwood
Grants Management Officer
National Institute on Dental and Craniofacial Research (NIDCR)
National Institutes of Health
6701 Democracy Blvd., Room 658, MSC-4878
Telephone:  301-594-4808
Email:  Mary.Greenwood@nih.gov

NIDA/NIH:

Carol Alderson
Grants Management Branch
National Institute on Drug Abuse (NIDA)
National Institutes of Health
6001 Executive Blvd., Room 4128, MSC-9541
Rockville, MD  20892-9541
Telephone:  301-594-5614
Email:  Carol.Alderson@nih.gov

NIEHS/NIH:

Dorothy Duke
Grants Management Officer
National Institute of Environmental Sciences
National Institutes of Health
79 TW Alexander Drive, Room 3403
Research Triangle Park, NC  27709
Telephone:  919-541-2749
Email:  Dorothy.Duke@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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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