Administrative Supplements for U.S. – India Bilateral Collaborative Research on the Prevention of HIV/AIDS (NOT-AI-07-022)

Administrative Supplements for U.S. – India Bilateral Collaborative Research on the Prevention of HIV/AIDS (NOT-AI-07-022) is sponsored by National Institutes of Health (NIH). This initiative fosters, stimulates, or expands collaborative prevention research and research training between current NIH grantees and Indian researchers working on HIV/AIDS.

NOT-AI-07-022: Notice: Administrative Supplements for U.S. – India Bilateral Collaborative Research on the Prevention of HIV/AIDS 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: March 30, 2007 - See Notice (NOT-AI-07-030) This addendum is to clarify eligibility and application requirements for applicants responding to this Notice.

March 28, 2007 - See Notice (NOT-RR-07-010) NCRR will participate in the activities described in this Notice. Release Date: February 8, 2007 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 ) 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. 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: 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 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: 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.

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; 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).

I nvestigator - 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.

E nvironment - 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: 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).

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).

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).

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.

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 (LOI) to submit an application should be submitted no later than March 1, 2007, by email to [email protected] .

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: Name of NIH-funded Principal Investigator, grantee Institution, title of grant, grant number of parent grant and name of Indian collaborator and affiliated Indian Institution. Summary of the intended project, including a statement of the added value of the international collaboration and potential for sustainability.

Timetable for the project clearly showing that the supplement can be completed within the timeframe of the parent grant.

Letters of Intent Due: March 1, 2007 Supplement Application Due: April 18, 2007 Funding: By end of August 2007 Grantees wishing to apply for a supplement should submit an application that includes the following: A cover letter citing this NOTICE, NOT-AI-07-018, and requesting an administrative supplement 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; A brief proposal describing the project: (Note: Items a-h below should be prepared and submitted jointly by the NIH-grantee and Indian partners): An abstract (jointly prepared by NIH-grantee and Indian partners) 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.

Biographical sketches of all key personnel (two-page limit per person) Specific Aims and appropriateness of the NIH grant as a basis for the supplemental application Specific Aims of the supplemental project with an explanation of how they relate to the Specific Aims of the NIH grant 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.) 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 [email protected] for issues related to electronic submission. One signed, original application should be sent to: National Institute of Allergy and Infectious Diseases National Institutes of Health National Institute of Allergy and Infectious Diseases National Institutes of Health Please note: Applications should NOT be sent to the NIH Center for Scientific Review (CSR).

Direct inquiries regarding scientific, programmatic, and review matters to the appropriate Program Official listed below: Division of International Training and Research Fogarty International Center National Institutes of Health 31 Center Drive, MSC 2220 Telephone: (301) 496-1492 E-mail: [email protected] 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 E-mail: [email protected] Coordinator, HIV/AIDS Research National Institute on Alcohol Abuse and Alcoholism National Institutes of Health Telephone: (301) 402-9389 E-mail: [email protected] National Institute of Allergy and Infectious Diseases National Institutes of Health Telephone: (301) 496-6714 E-mail: [email protected] Health Scientist Administrator National Institute of Child Health and Human Development National Institutes of Health E-mail: [email protected] Katherine Davenny, M.

P. H.

Associate Director, AIDS Research Program National Institute on Drug Abuse National Institutes of Health Telephone: (301) 443-2146 E-mail: [email protected] Associate Director, International Programs and Chief, International Prevention and Policy National Institute of Mental Health Division of Mental Disorders National Institutes of Health Telephone: (301) 443-1187 E-mail: [email protected] Direct inquiries regarding administrative and fiscal matters to: Grants Management Specialist National Institute of Allergy and Infectious Diseases National Institutes of Health 6700-B Rockledge Drive, Room 2241 Bethesda, MD 20892 (express zip 20817) Direct Line: (301) 402-6580 E-mail: [email protected] Weekly TOC for this Announcement NIH...

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