Notice of Availability of Administrative Supplements for Research on Collaborative Projects with Indian Investigators on Low-Cost Medical Devices

Notice Number: NOT-EB-10-002

Key Dates
Release Date:  June 9, 2010
Opening Date: September 10, 2010
Earliest Anticipated Start Date: November 10, 2010
Expiration Date: September 10, 2011

Issued by
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov)

Purpose

The purpose of this program is to encourage collaborative research and/or technology development between scientists and engineers in the United States and India.  The National Institute of Biomedical Imaging and Bioengineering (NIBIB) announces the availability of administrative supplements for current NIBIB-supported research grants. 
Supplements will be provided to develop appropriate diagnostic and therapeutic medical technologies for low-resource settings.  Appropriate medical technologies are useable, cost effective, sustainable, and effective in meeting a significant clinical need in a low-resource setting.  Collaborations should be aimed at developing medical technologies that can significantly impact underserved populations within the United States and/or India.  Within this context grantees can apply for supplements to:

The supplemental funds will support investigators based in the United States who are collaborating with Indian investigators. In addition, Indian collaborators are expected to apply to the Department of Biotechnology (DBT) in India, Dr. T. S. Rao (tsrao@dbt.nic.in), for complementary funding.

Background

A 2008 workshop in Hyderabad, India examined the needs and opportunities for low-cost 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 ).
Diagnostic technologies identified at the 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 solicitation, 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, hypothyroidism, and other conditions might be implemented with of lab-on-a-chip, microfluidic technologies.

The examples identified above are intended to be illustrative only.  Applicants are encouraged to submit proposals for any collaborative technology development or device that would be appropriate in a low-resource setting.

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 low-resource 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.

Eligibility

Currently supported NIBIB R01, R21, U01, U54, U41, P01 and P41 awards may be supplemented. To be eligible, the parent NIBIB grant must have at least 12 months remaining at the time the supplement is awarded. The research proposed in the supplement application must be accomplished within the competitive segment.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project. The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as they are within the original scope of the project. Cost increases must result from modifications that take advantage of collaborative opportunities that increase the value of the project, consistent with its originally approved objectives and purposes.

Request for Administrative Supplements should follow the policies of the NIH, and NIBIB guidelines: http://www.nibib.nih.gov/Funding/Strategies/DASTAdminSuppl.
Investigators must adhere to all special requirements for collaborative biomedical research in India. 

Submitting an Administrative Supplement Request to the NIBIB and grant request to DBT

To be considered for an administrative supplement, you must submit a request in writing directly to the designated points of contact at the NIBIB not to the Division of Receipt and Referral, Center for Scientific Review. The supplement request must be signed by the Authorized Organizational Representative of the organization.  Supplement requests should describe and justify the need for additional funding; and provide a budget in the same format as the parent grant.

A separate application from the collaborator in India must also be submitted to the Indian Department of Biotechnology (DBT) for consideration of support for the Indian investigators. The DBT call for proposals can be accessed at the following URL: http://dbtindia.nic.in . The DBT call for proposals and this Notice are intended to support US-India research collaboration toward the same goals, with funding for the US investigator(s) from NIBIB and for the Indian investigators(s) from the DBT.

            Details for the NIBIB Submission

Requests under this notice should use the PHS 398 forms (rev. 11/2007; available at  http://grants.nih.gov/grants/funding/phs398/phs398.html) and include the following elements in the request packet. Font size restrictions apply as designated within the PHS398 (rev. 4/2006) instructions.)

1) Cover Letter – A cover letter should reference this Notice (NOT-EB-10-002), a request for an Administrative Supplement, and include the following information:

2) PHS 398 Form Page 1 (Face page) MS Word PDF

Details for Department of Biotechnology Application

Application details regarding the DBT call for proposals can be accessed at the following URL: http://dbtindia.nic.in.

3) PHS 398 Form page 2 MS Word  PDF

Note: The project “summary” is that of the administrative supplement, not the parent grant.

4) A brief proposal describing the project, including:

a) Introduction (not to exceed one page)

b) Scope of the supplement and the anticipated contribution of the requested supplement, including the following (not to exceed six pages):

c) Budget for the supplement with a justification that details the items requested, including Facilities and Administrative costs.  See Budget and Funding Information below.

d) Biographical Sketch for all new key personnel, including collaborator(s) in India  (those who are additions on the supplemental project) MS Word  PDF

e) Human Subjects/ Vertebrate Animal documentation (if applicable). Include a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a supplement award being made. 
Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative supplement activity and the parent grant should be noted.  When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities.  Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions (http://grants1.nih.gov/grants/funding/phs398/phs398.html). 

f) PHS 398 Checklist Form MS Word  PDF

Selection Factors

Administrative supplement requests submitted to the NIH will be reviewed administratively by NIBIB Program and Grants Management Staff. Selection factors will include the following:

Budget and Funding Information

Budget

Budgets for Administrative Supplements should be in the same budget format as the parent grant.  Any no-cost extension must be in place before submission.  The supplement may not exceed time period of parent grant.

A meritorious application will take full advantage of the opportunity to coordinate and utilize two sources of research and research training funding afforded by this US - India program.  NIH funds will be awarded to successful applicants as supplements to the NIBIB parent grant in US dollars.  DBT funds will be separately awarded to successfully competing Indian collaborators, via their institutions, in Indian rupees.  Applicants may submit a budget plan to utilize requested NIH funding that includes expenditures for any activities included in the US proposal. However, applicants should seek funding to meet Indian partner expenses via the application process invited in the DBT Call for Proposals.  NIBIB requests applicants to submit a description of both budget plans submitted under the NIBIB and DBT solicitations for NIBIB staff review.

Applications prepared in response to this program should describe all research and technology development to be undertaken through the proposed or expanded collaboration, including those to be conducted by the Indian collaborator(s). Applications should clearly specify which research or technology development elements will be performed in the US and which will be conducted in India. The budget submitted for NIBIB funding should describe the funding requirements for all elements of the collaboration to be funded in US Dollars.  Collaborative research or technology development to be funded in Indian Rupees also should be included in the detailed budget submitted to NIBIB, but may be identified as “requiring no NIBIB funding” due to a separate funding application being submitted to DBT for rupee funding through the companion program described above.  It is anticipated that Indian collaborators will prepare and submit applications in response to the DBT call for applications, and that these applications’ budgets will include descriptions of research and technology development to be undertaken with US Dollar funding described as “requiring no DBT funding”.

Budget amounts for supplements are expected to vary.  Supplements are limited to 25 percent of the direct cost of the parent grant or $75,000 direct costs per year, whichever is less. Supplements may be requested for up to two years provided the parent grant will remain active during this time. Funds must be used subject to the following constraints:

How to Apply

Do NOT send applications to the NIH Center for Scientific Review. 
Applicants should send an electronic copy of the supplement request as an e-mail attachment in PDF format to the email mailbox NIBIBUSIndia@mail.nih.gov.

Inquiries

Inquiries and discussion of plans for responding to this Notice are strongly encouraged.

John W. Haller, Ph.D.
Liaison for International Activities
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health
Phone: (301) 451-4780
Email:  hallerj@mail.nih.gov    

Nancy Curling
Chief Grants Management Officer
National Institute of Biomedical Imaging and Bioengineering, NIH
6707 Democracy Blvd.
Suite 900
Bethesda, MD 20892-5469
Phone: (301); 496-9315  
Email:  curlingn@mail.nih.gov    


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