Notice: Administrative Supplements for U.S. – India Bilateral Collaborative Research on the Prevention of HIV/AIDS

Notice Number: NOT-AI-07-022

Update: The following update relating to this announcement has been issued:

Key Dates
Release Date: February 8, 2007

Issued by
John E. Fogarty International Center (FIC), (www.fic.nih.gov)
National Cancer Institute (NCI), (www.nci.nih.gov)
National Center for Research Resources NCRR, (http://www.ncrr.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID), (www.niaid.nih.gov)
National Institute of Child Health and Human Development (NICHD), (www.nichd.nih.gov)
National Institute of Mental Health (NIMH), (www.nimh.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (www.niaaa.nih.gov)
National Institute on Drug Abuse (NIDA), (www.nida.nih.gov)

Background

The National Institutes of Health (NIH) supports international collaborative research and research training on HIV/AIDS and the exchange of scientific information by HIV/AIDS researchers around the world.  Scientific cooperation between the United States (U.S.) and India has taken place for over forty years under a variety of bilateral agreements.  Recognizing that enhanced cooperative research and research training focused on HIV/AIDS would be of mutual benefit to the United States and India, the U.S. Secretary of Health and Human Services (HHS) and the Indian Minister of Health and Family Welfare signed a “Joint Statement for Collaboration on Prevention of Sexually Transmitted Diseases and HIV/AIDS” [http://www3.niaid.nih.gov/research/resources/US-IndiaStatmnt_HIV_STD.pdf or www.globalhealth.gov/IndiaHIVJointStatementJune2006.pdf  ) in June 2006. 

The lead U.S. agency identified to implement activities under this Joint Statement is the HHS National Institutes of Health, and the lead Indian agencies are the Indian Council for Medical Research (ICMR) and the Department of Biotechnology (DBT).  The Joint Statement calls for the establishment of a Joint Working Group (JWG) to develop strategic plans for collaboration and to facilitate the expedited review and clearance of proposed bilateral projects.  Both the United States and India have pledged funds to support joint activities pursued under this program.  This announcement invites applications for research collaboration that might be considered for funding as elements of the Joint Program.

Based on the merit of the requests received, and the availability of funds, the NIH may award up to $2,000,000 in FY 2007 in supplemental funding in connection with this funding opportunity.  The Government of India has pledged to match the overall U.S. funds.  In connection with this announcement, NIH intends to obligate some funds to support one-year administrative supplements to existing NIH grants to allow the initiation or expansion of U.S. and Indian research and research training cooperation.  Complementary funds will be provided by the Indian Government to support Indian collaborators identified in applications that are found to be highly meritorious following review and evaluation in both countries. 

Research and Research Training Objectives

The intent of this initiative is to foster, stimulate or expand collaborative prevention research and research training between current NIH grantees and Indian researchers working on HIV/AIDS.  This initiative will also serve to build HIV/AIDS research capacity at Indian institutions.  Highest priority will be given to collaborative research and research training projects that focus on HIV prevention research, including microbicide, behavioral, and vaccine research. 

It is anticipated that projects supported through this program may result in sufficient preliminary data to allow the researchers to apply and successfully compete for investigator-initiated grants (R01) or other NIH grant programs (R03, R21). 

Basic, translational, behavioral, clinical, or epidemiological research relevant to HIV/AIDS prevention may be proposed under this program.  Examples of research areas responsive to this solicitation include:

  1. Prevention research:  microbicides, alcohol use, drug abuse, vaccines, pre-and post exposure prophylaxis, behavioral interventions (e.g., associated with lower HIV risk behaviors, associated with consequences of HIV, and adherence to therapy), mother-to-child transmission (MTCT); and
  2. Epidemiology research:  incidence and prevalence studies that may include:  molecular epidemiology, behavioral epidemiology, and clinical outcomes (including co-infections and co-morbidities, durability of therapy, and resistance to ART).

IMPORTANT:  The research or research training proposed by the NIH grantee in the collaboration 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.  Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.  While applicants must provide evidence of ongoing or proposed scientific collaborations specific to the research or research training proposed in the grant application, this initiative may not require joint funding; however, joint review and approval of proposals by the U.S. and India is required.  Applications may (and are encouraged to) include a budget for the Indian collaborators that would be funded by the Indian Government (allocated in Indian Rupees).

Budget/Administrative Issues

In FY 2007, up to $2,000,000 will be available for administrative supplements to currently funded research and research training grant awards. These administrative supplements are generally limited to 25 percent of the Council-approved direct costs for the current budget year of the project or $100,000, whichever is less.  Awards will be for one year and the existing grant must have at least one year remaining at the time that the supplement is awarded.

Applications for supplemental funding to NIH research and research training grants will be accepted.  Applications to supplement projects in the AIDS Malignancy Consortium, AIDS Cancer Specimen Resource, Centers for AIDS Research (CFAR), HIV/AIDS Clinical Trial Networks, International Epidemiologic Database to Evaluate AIDS (IeDEA), U.S. Military HIV Research Program (USMHRP), and Indo-U.S. Vaccine Action Program (VAP) are especially encouraged.  For Fogarty grantees, only AIDS International Training and Research Program (AITRP) and Fogarty International Clinical Research Scholars Program (previously known as the Fogarty/Ellison Fellowship) awardees with current collaborations or clinical scholar sites in India may respond to this solicitation.

Administrative supplement applications will undergo a program, budget, and grants management review within NIH that may include external scientific reviewers.  The supplement applications will be evaluated on the:

  1. Significance - Evidence that the supplement funding will support priority areas identified in this request and demonstration of significant collaboration between NIH-funded and Indian investigators, especially including new collaborations.
  2. Approach - The quality of the scientific project proposed, including planning process, project design, management, and the training/mentoring process; the expectation that the project can be conducted with the proposed resources and within the timeframe proposed and scope of the NIH grant; and the adequacy of the described plans to monitor the impact of the supplemental award;
  3. Innovation - The identification of a unique project or approach to solve a significant question or gap in AIDS prevention research: The degree to which the effort proposed maximizes the synergy between the unique resources supported by the parent grant and the choice of and collaboration with the Indian investigator(s).
  4. Investigator - Choice of appropriate scientists having the appropriate scientific qualifications, commitment, experience, and the degree to which the qualifications, experience, and level of effort of the investigators are complementary and likely to result in an investigation that neither could accomplish independently.
  5. Environment - The likelihood that the proposed project will achieve the stated goals, and evidence that the scientific expertise, and training/mentoring track record, facilities and administrative support needed for the collaboration to succeed are present. 

In addition, NIH-funded applications will be evaluated for evidence of commitment to international collaboration with Indian scientists/institutions and the likelihood of ongoing support for the collaboration from governments, and either institutions or other non-governmental organizations.

Reviewers also will examine the appropriateness of the budget in consideration of the study proposed and the research environment for the scientific projects and training/mentoring.

For applications that also include a training component the following criteria will also apply to the training components:

  1. Significance - The expected contribution of the research-training program described in the application to strengthen multidisciplinary approaches (biomedical, behavioral, social, and cultural), and sustainable laboratory, clinical or public research capacity at the Indian institution(s).
  2. Approach - The adequacy of the proposed mix of long-, medium- and short-term training to achieve the proposed objectives, and the adequacy of the process for matching trainees to appropriate mentors that will promote acquisition of research skills and development of research projects to fill recognized gaps in expertise at the Indian institution(s).
  3. Innovation - The ability of the proposed training program to take advantage of the NIH-funded and Indian institution's research infrastructure and of previous and current investments and support from FIC, NIH or other organizations, and the identification of innovative strategies for trainees to become actively involved in multidisciplinary HIV/AIDS and HIV-related research studies or intervention trials relevant to national health priorities conducted at the Indian institution(s).
  4. Investigators - The adequacy of the qualifications and ongoing collaboration between the investigators and the institutions named in the application to provide a suitable framework in which the proposed training will occur, and the extent and effectiveness of previous research training efforts made by the applicant and collaborators.
  5. Environment - The adequacy of the HIV/AIDS and HIV-related teaching and research facilities and other resources related to the overall training environment at the NIH-funded and Indian institution(s), and the strength of the NIH-supported institutional and Indian institutional commitments to the proposed HIV/AIDS and HIV-related research training program, including research support at Indian institution(s)  included in the application.

Criterion related to the Fogarty International Clinical Scholars Program:  The adequacy of the mentorship program for the U.S. and foreign scholars.

Administrative supplements may be submitted at any time, but no later than 5:00PM EST on April 18, 2007.  Supplemental funding will begin by the end of August 2007.

Concurrent to or as part of the NIH review, the ICMR and DBT also will engage in review of all applications.  Funding decisions will be made jointly and will consider the research priorities of both countries.  Requests for supplements under this announcement must comply with NIH policies for the inclusion of women, minorities, and children in research involving human subjects. 

Before any funds can be expended for in-country research activities in a foreign country, the grantee institution must show evidence of compliance with U.S. and Indian regulations for the conduct of research involving human subjects.  Additional information can be found at the HHS Office for Human Research Protections website: http://www.hhs.gov/ohrp.

Letters of Intent

Letters of Intent (LOI) to submit an application should be submitted no later than March 1, 2007, by email to usindia@mail.nih.gov. Before submitting a Letter of Intent, applicants are strongly encouraged to discuss the feasibility of their research or research training proposal with the relevant Institute or Center Program Director for the NIH research or research training project parent grant, including the appropriateness of using the existing parent grant for conducting the proposed work.
The letter of intent (two-page maximum) should include the following:

Schedule for Award

Letters of Intent Due:  March 1, 2007
Supplement Application Due:  April 18, 2007
Funding:  By end of August 2007

Application Procedure

Grantees wishing to apply for a supplement should submit an application that includes the following:

  1. A cover letter citing this NOTICE, NOT-AI-07-018, and requesting an administrative supplement
  2. Page 1 of the PHS398 grant application form, citing "U.S.-India Collaborative Research Supplement” in Line 2.  Applicants must complete Page 1, and also include the signatures of the NIH grant Principal Investigator and authorized institutional budget office official from the NIH grant;
  3. A brief proposal describing the project:  (Note:  Items a-h below should be prepared and submitted jointly by the NIH-grantee and Indian partners):
    1. An abstract (jointly prepared by NIH-grantee and Indian partners)
    2. Budget with justification (for NIH grantee please use PHS398 forms).  A separate budget for the Indian counterpart’s project should be included in Indian Rupees.
    3. Biographical sketches of all key personnel (two-page limit per person)
    4. Specific Aims and appropriateness of the NIH grant as a basis for the supplemental application
    5. Specific Aims of the supplemental project with an explanation of how they relate to the Specific Aims of the NIH grant
    6. For research projects, a detailed description of the project, monitoring plans, and expected outcomes, including:  subject population, methods, and data analysis.  For research training requests, a detailed description of the training program.  (This should be less than 7 pages and jointly prepared by the NIH grantee and Indian partner(s).  The 7-page limit does not include Letters of Support and Collaboration, etc.) 
    7. Roles of Key Staff
    8. A discussion of future plans for expanding, extending, or otherwise continuing the research or research training (jointly prepared by the NIH grantee and Indian partner(s))

Submission of Applications

A web-based system will be used for the receipt of applications.  Applications in pdf format must be submitted to URL: http://apps.niaid.nih.gov/dgfr. The web site will require you to enter the submission key "NIH2007" when you load your pdf file. Contact Joan Romaine at jromaine@niaid.nih.gov for issues related to electronic submission.  One signed, original application should be sent to: 

By U.S. Mail:

Kimberly Chatman
Grants Management Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health
6700B Rockledge Drive
Room 2241, MSC 7610
Bethesda, MD 20892-7610
 
(or)

By Express Courier:

Kimberly Chatman
Grants Management Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health
6700B Rockledge Drive
Room 2241, MSC 7610
Bethesda, MD 20817-7610

Please note:  Applications should NOT be sent to the NIH Center for Scientific Review (CSR). 

Inquiries

Direct inquiries regarding scientific, programmatic, and review matters to the appropriate Program Official listed below:

FIC
Jeanne McDermott, Ph.D.
Program Officer
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone:  (301) 496-1492
Fax:  (301) 402-0779
E-mail:  mcdermoj@mail.nih.gov

NCI
Kishor Bhatia, Ph.D., MRCPath
Director, Office of AIDS Malignancy Program
National Cancer Institute
National Institutes of Health
6120 Executive Boulevard, Room 6114, MSC 7204
Bethesda, MD 20892-7204 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for FedEx, UPS and other courier services)
Telephone:  (301) 496-4995
Fax:  (301) 480-4137
E-mail:  bhatiak@mail.nih.gov

NIAAA
Kendall Bryant, Ph.D.
Coordinator, HIV/AIDS Research
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane
Room 2069, MSC 9304
Rockville, MD 20892-9304
Telephone:  (301) 402-9389
Fax:  (301) 443-8614
E-mail:  kbryant@mail.nih.gov

NIAID
Janet M. Young, Ph.D.
Program Officer
Basic Sciences Program
Division of AIDS
National Institute of Allergy and Infectious Diseases
National Institutes of Health
6700B Rockledge Drive
Room 4152, MSC 7620
Bethesda, MD 20892-7620
Telephone: (301) 496-6714
Fax: (301) 402-3211
E-mail:  jyoung@niaid.nih.gov

NICHD
Danuta Krotoski, Ph.D.
Health Scientist Administrator
National Institute of Child Health and Human Development
National Institutes of Health
6100 Executive Blvd.
Room 2A01, MSC 7510
Bethesda, MD 20892-7510
Phone:  (301) 435-7566
Fax:  (301) 435-0009
E-mail:  krotoskd@mail.nih.gov

NIDA
Katherine Davenny, M.P.H.
Associate Director, AIDS Research Program
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd.
Room 4215, MSC 9581
Bethesda, MD 20892-9581
Telephone:  (301) 443-2146
Fax:  (301) 443-9127
E-mail:  kdavenny@nida.nih.gov

NIMH
Willo Pequenat, Ph.D.
Associate Director, International Programs and
Chief, International Prevention and Policy
National Institute of Mental Health
Division of Mental Disorders
National Institutes of Health
6001 Executive Blvd.
Room 6219B, MSC 9619
Bethesda, MD 20892-9619
Telephone:  (301) 443-1187
Fax:  (301) 443-9719
E-mail:  wpequegn@mail.nih.gov

Direct inquiries regarding administrative and fiscal matters to:

Kimberly Chatman
Grants Management Specialist
National Institute of Allergy and Infectious Diseases
National Institutes of Health
DHHS/NIH/NIAID/DEA/GMP
6700-B Rockledge Drive, Room 2241
Bethesda, MD 20892 (express zip 20817)
Direct Line:  (301) 402-6580
GMP:  (301) 496-7075
Fax:  (301) 493-0597
E-mail:  chatmank@niaid.nih.gov


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