Expired PAR-13-390: Indo-US Collaborative Program on Affordable Medical Devices (R03)

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	NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) 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.

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:

Glucose monitoring for diabetics;
Low-cost platform technologies for multiple (multivalent) diagnostic tests;
A multiplex, lab-on-a-chip technology for Sexually Transmitted Diseases (STDs) and other infections;
Point-of-care diagnostics for screening infant diseases;
A pre-screening test for blood bank safety;
Diagnostic test for the early detection of cardiovascular disease;
Point-of-care tests and reagents for cancer screening;
Networked and mobile technologies for diagnostic devices;
Diagnostic screening devices simple enough to be operated by people with minimal education (10th grade);
Non-invasive or minimally-invasive screening technologies (e.g. low-cost imaging, microfluidics, microchip technologies);
Diagnostic assay development for low-cost screening kits;
Technology and assay development related specifically to screening newborns for heritable disorders; and
Appropriate, low-cost diagnostic imaging devices for low-resource settings.

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:

Foster joint activities between US and Indian scientists on affordable diagnostic and therapeutic technologies.
Address medical needs in low-resource settings, and take advantage of opportunities and technological advances, with 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.

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:

Cardiovascular diseases
- Immediate needs include detection and monitoring of cardiovascular diseases in low-resource settings.
- New methods for delivering treatment of cardiovascular disease are also needed.
Cancer Screening
- Appropriate technologies for point of care screening and diagnosis that are sufficiently simple to be operated after minimal training by allied health workers
- Quantitative tools for monitoring therapy, screening for post-therapeutic relapse and for pre-clinical models are needed.
- Low cost point of care cancer treatment technologies (such as cryotherapy)
- Low-cost technologies that help collect robust patient-reported data on outcomes to support clinical research efforts
- Technologies that improve the sensitivity or portability of (or reduce the cost of) detecting molecular biomarkers from body fluids such as serum, plasma, urine, sputum, etc.
- Technologies that can be used in conjunction with imaging to improve the sensitivity and specificity of early cancer detection
- Low-cost technologies for the collection and stabilization/preservation of patient samples for transport and subsequent diagnostic analysis
- Low-cost technologies that improve quality, reproducibility and reliability of immunohistological diagnosis
- Low cost technologies for assessment of minimal residual disease
- Low cost technologies for non-invasive diagnosis.
- Technologies for developing low-cost drug delivery systems
Endocrine Disorders
- Diagnostic and therapeutic technologies for endocrine disorders, specifically diabetes, are needed
- New or reengineered low-cost technologies for the diagnosis and treatment of GI tract diseases
Maternal/Neonatal/Infant Health
- There is a need to focus on high-priority problems and implement technologies that will have a significant impact.
- There is a need to screen newborns for treatable conditions with high morbidity and mortality such as hemoglobinopathies, hypothyroidism, and other metabolic or inherited disorders
- For example, technologies are needed to help prevent hypothyroidism.
Trauma and Injury needs include:
- Low-cost prostheses and prosthetic materials
- Low-cost imaging for tertiary care hospitals
- Mobile or portable imaging devices
- Low-cost EMS technologies such as a trauma backpack
- Improved, low-cost telemedicine technologies
- Low-cost hemostats, surgifoam, gelfoam, implants, sutures, pre-loaded syringes, fixative
- Low-cost C-arm, ultrasound, and CT
- Rehabilitation technologies, particularly for children who have been injured
- Low-cost wheelchairs
- Technologies for airway clearing
- Technologies for CNS assessment
Translational Research
- Technologies developed in the West may need to be re-engineered to suit local needs in India. For example, technologies such as flow cytometers and insulin pumps could be re-engineered using locally-available standard components.
Diagnostic and Other Infectious Diseases devices suitable for use in less-resourced settings.
- Semi-quantitative HIV viral load
Tuberculosis diagnostics applicable to HIV positive or negative patients with the following applications:
- Distinguish latent, reactivation, or primary tuberculosis infection.
- Devices appropriate for use in BCG vaccinated populations.
- Distinguish immune reconstitution inflammatory syndrome (IRIS) from recrudescence of tuberculosis during TB treatment.
- Improved detection of hepatic or renal toxicity due to TB treatment.
- Detection of TB in children, detection of paucibacillary TB, detection of extrapulmonary TB.
- Technologies for monitoring treatment compliance (i.e. non-invasive samples suitable for determining drug levels).
- Development of hand held ultrasound devices suitable for detection of abscesses of lymph node enlargement.
- Chronic Respiratory Diseases monitoring and development.

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

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

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.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account 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:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.

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:

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

The letter of intent should be sent to:

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: [email protected]

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