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 Biomedical Imaging and Bioengineering (NIBIB)
National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy ShriverNational Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title

Indo-US Collaborative Program on Affordable Medical Devices (R03)

Activity Code

R03 Small Grant Program

Announcement Type

Reissue of PAR-11-044

Related Notices

  • September 18, 2014 - See NOT-EB-14-007. Notice of Change in Due Date for PAR-13-390 "Indo-US Collaborative Program on Affordable Medical Devices (R03)".
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • February 3, 2014 - See Notice NOT-HD-14-008. Notice of NICHD’s Participation.

Funding Opportunity Announcement (FOA) Number

PAR-13-390

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.286, 93.393, 93.394, 93.395, 93.399, 93.855, 93.856, 93.865

Funding Opportunity Purpose

The goal of this funding opportunity announcement is to (i) foster joint activities between US and Indian scientists on affordable diagnostic and therapeutic technologies, and (ii) address medical needs in low-resource settings, taking advantage of opportunities and technological advances, to aid the development of appropriate affordable medical devices. To address needs and opportunities, Indian and U.S. scientists will undertake a coordinated program that will involve collaborative, peer-reviewed research and technology development projects.  Collaboration between engineers and scientists in the U.S. and India will be based on mutual benefit, trust, and a shared commitment to development of diagnostic or therapeutic technologies for people in low-resource settings.

Key Dates
Posted Date

November 13, 2013

Open Date (Earliest Submission Date)

December 23, 2013

Letter of Intent Due Date(s)

30 days before the application due date

Application Due Date(s)

January 23, 2014, January 23, 2015 (this date has been removed per NOT-EB-14-007), January 22, 2016, 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)

May 7, 2014, May 7, 2015 (this date has been removed per NOT-EB-14-007), May 7, 2016, by 5:00 PM local time of applicant organization.

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

Scientific Merit Review

July 2014, July 2015 (this date has been removed per NOT-EB-14-007), July 2016

Advisory Council Review

October 2014, October 2015 (this date has been removed per NOT-EB-14-007), October 2016

Earliest Start Date

December 2014, December 2015 (this date has been removed per NOT-EB-14-007), December 2016

Expiration Date

May 8, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

This Funding Opportunity Announcement (FOA) encourages Small Research Grant (R03) applications for its Collaborative Program on Affordable Medical Devices.  The Republic of India and the United States of America invite collaborative research projects involving U.S. and Indian investigators to develop new, affordable medical devices for lower resource settings.  This FOA will support Small Research Grants to U.S. investigators to develop appropriate diagnostic and therapeutic medical technologies for lower resource settings, and enable product development and/or technology transfer of appropriate technologies.  Appropriate medical technologies are those that are useable, cost effective, sustainable, and effective in meeting a significant clinical need in a lower resource setting.  Collaborations between U.S. and Indian investigators should be aimed at developing medical technologies that can significantly impact underserved populations within the United States and/or India. NIBIB encourages efforts towards reengineering existing medical devices so that medical technologies will have a significant impact on diseases of the poor. The NIBIB program places specific emphasis on the need for more translational types of research and medical technology development.  NIAID is interested in research applications that address chronic respiratory disease, primary immunodeficiencies, HIV, and tuberculosis. The NCI invites applications that promote technology research for development of cancer screening, detection, diagnosis and treatment. The proposed technology/devices should be cost effective and widely applicable in low and middle income country settings and offer capabilities comparable to those available in clinical settings of higher income countries.

The collaboration must involve a U.S. investigator (PD/PI) from an eligible U.S. institution and at least one Indian collaborator who is affiliated with an eligible Indian institution (either a non-profit or a Department of Scientific and Industrial Research (DSIR, India)-recognized academic institution as determined by Department of Biotechnology (DBT), India). Collaborations not satisfying this requirement are not eligible for this FOA and will not undergo peer review. Applications supported by this program must involve integrated research projects that are enhanced by the inclusion of scientific expertise of both U.S. and Indian institutions.  Successful applications will include a well-presented justification for the bilateral collaboration and detailed experimental approaches that will be completed by each country.  Research applications should be submitted as a single application by the U.S. institution to the NIH; it is anticipated that the Indian PD/PI will be submitting a corresponding packet to DBT.

Background

The National Institutes of Health supports research on the development of medical technology that is appropriate for low resource settings.  One step toward better health and the elimination of global health disparities is through collaborative biomedical research and technology development.  A 2008 workshop in Hyderabad, India examined the opportunities for collaboration and the needs for affordable diagnostic and therapeutic medical technologies for use in underserved settings. The full report from the workshop may be accessed at the following URL: (http://dbtindia.nic.in/Final%20Report.doc ). In addition, NCI held a workshop addressing similar topics in August 2011 (http://ncifrederick.cancer.gov/events/cancerdetection), and is currently developing a new effort in low cost Cancer Detection, Diagnostic and Treatment Technologies for global health applications. For more information about an upcoming workshop, see http://ncifrederick.cancer.gov/events/PointOfCare/agenda.pdf, and a recent notice of intent for NCI to publish an RFA in this area: http://grants.nih.gov/grants/guide/notice-files/NOT-CA-13-015.html

Diagnostic technologies identified at the 2008 Hyderabad workshop included, but were not limited to:

There is great potential for improved technology to expand the current reach of biomedical systems into presently underserved areas. For example, there is a need to develop multiplexed, “lab-on-chip” technologies to bring multiple biomarker tests onto a single, universal platform that could be used in remote clinics, low-resource settings, and hospitals.  Under this FOA, applications could be developed for the diagnosis of sexually transmitted diseases, rainy season diseases, fevers, and other infections. As another example, newborn screening for the detection of hemoglobinopathies, primary immunodeficiencies, hypothyroidism, and other heritable conditions might be implemented with new technologies including, but not limited to lab-on-a-chip or microfluidic technologies.

The examples identified above are intended to be illustrative only.  Applicants are encouraged to submit applications for any collaborative technology development or device that would be appropriate in a lower-resource setting.  Furthermore, applicants are expected to describe the impact of their technology on low-resource settings.

To facilitate the development of collaborations between US and Indian investigators, the NIBIB and DBT have established an online networking group at LinkedIn.com: http://www.linkedin.com/groups?home=&gid=2949818&trk=anet_ug_hm.  Specific areas of common interest are grouped under discussion groups on this site. Scientists, engineers, and clinicians with common interests in appropriate medical technologies for less-resourced settings can be found on the LinkedIn website group, Indo-US Coalition for Low-Cost Medical Technologies.  Interested US and Indian investigators are encouraged to participate in this group.

Goals

The goals of this FOA are to:

To address needs and opportunities, Indian and U.S. scientists will undertake a coordinated program that will involve collaborative, peer-reviewed research and technology development projects. Collaboration between engineers and scientists in the U.S. and India will be based on mutual benefit, trust, and a shared commitment to development of diagnostic or therapeutic technologies for people in low-resource settings.

Scope

Medical technologies developed through Indo-US collaboration will benefit low-resource settings globally. New technologies need to be developed as collaboration between engineers, clinicians, technologists, laboratory scientists and global health experts.

Emphasis will be placed on technologies that increase healthcare access, address global health disparities and/or address the diagnosis and treatment of diseases of the poor.  Several areas of focus have emerged that include technologies that address chronic disease and conditions listed below:

Applicants are strongly encouraged to consult with a Scientific/Research Contact for this FOA as plans for an application are being developed.  This early contact will provide an opportunity to clarify the applicant's understanding of program goals and guidelines

Successful applicants will be invited to discuss their progress on funded grants through an annual teleconference / webinar jointly hosted by DBT and NIH.

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
Resubmission

The OER Glossary and the SF424 (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

Budgets for direct costs of up to $75,000 per year may be requested.

Award Project Period

Project duration of up to two years may be requested.

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 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 not allowed.

Required Registrations

Applicant Organizations

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

The Indian collaborator must be affiliated with an eligible Indian institution (either a non-profit organization or a Department of Scientific and Industrial Research (DSIR, India) recognized academic institution) as determined by the Department of Biotechnology (DBT), India. Collaborations not satisfying this requirement are ineligible for the FOA and will not undergo peer review.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

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

Section IV. Application and Submission Information


1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

The letter of intent should be sent to:

Dr. Vinay Pai
Program Director,
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
6707 Democracy Blvd, Ste. 200
Telephone: 301-451-4781
Fax: 301-480-1614
Email: paiv@mail.nih.gov

Page Limitations

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

Required and Optional Components

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

The application must propose a research project involving a collaborative effort between the U.S. PD/PI and an Indian scientist. Since this is a joint partnership between U.S. (NIH) and Indian (DBT) agencies, involving both dollar and rupee funding decisions, it is essential that both NIH and DBT receive the identical Research Plan with all pertinent details and a description of the relative role of the U.S. and Indian collaborators. It is the responsibility of the collaborative team to insure that appropriate application materials are received by the Indian Secretariat of the program at DBT including all relevant IRB approvals, Material Transfer Agreements (MTA) or other materials as required by DBT.

Letters of Support: The US PD/PI is expected to provide a letter of support from their Indian collaborator indicating:

Applications lacking such a letter of support will be considered incomplete and will not undergo peer review.

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

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:

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

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

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

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

For this particular announcement, note the following:

The R03 small grant 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 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? Are the proposed technologies significant for low-resource settings?

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? 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? Is there evidence of the potential for a meaningful and successful collaboration with an Indian partner?

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? If the application proposes reengineered devices or technologies, will they accelerate the translation or expand the potential utilization of existing medical devices for low-resource settings?

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?  

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? Is there evidence of US and Indian institutional support? As an international collaboration, is the collaborative team well described and justified, in terms of why this research should be done via an international collaboration, are the respective roles of the Indian and US collaborating investigators and institutions well described, and how will this research project be coordinated?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed project involves 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 Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

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) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Vinay Pai, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4781
Email: paiv@mail.nih.gov

Alan Embry, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-3751
Email: embrya@mail.nih.gov

Julie Schneider, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-496-6343
Email: schneidj@mail.nih.gov

Peer Review Contact(s)

J. Thomas Peterson, Ph.D.
Center for Scientific Review (CSR)
Telephone:  301-408-9694
Email:  petersonjt@csr.nih.gov

Financial/Grants Management Contact(s)

Nancy Curling
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-9315
Email: curlingn@mail.nih.gov

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-5601
Email: adevine@niaid.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 301-496-8634
Email: crystal.wolfrey@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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NIH Funding Opportunities and Notices



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