Notice Number: NOT-HD-05-005

Key Dates
Release Date: January 10, 2005

In November of 1997, the governments of India and the United States, the former represented by the Department of Biotechnology (DBT), Ministry of Health and Family Welfare, Indian Council of Medical Research (ICMR), and the Council of Scientific and Industrial Research (CSIR), the latter represented by the Department of Health and Human Services (DHHS) and the United States Agency for International Development (USAID), mutually agreed to support Indo-U.S. collaborative research and related activities on contraception and reproductive health research.

Program Structure

The Indo-U.S. Program on Contraception and Reproductive Health Research (CRHR) is administered by a Secretariat consisting of staff from the U.S. and Indian nodal agencies. The nodal agencies for this program are the U.S. National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH), DHHS, and the Department of Biotechnology (DBT) of the Indian Ministry of Science and Technology.

In addition to the Secretariat, the overall scientific goals and procedures of the program are overseen by a Joint Working Group (JWG) consisting of independent U.S. and Indian investigators and staff from participating agencies with expertise covering the range of topics to be addressed by the CRHR program.

Scope of the Program

The goal of the CRHR program is to "build upon previous research cooperation by drawing on the expertise of Indian and U.S. scientists and institutions to promote and support collaborative research that will result in expanded contraceptive options and improved reproductive health." To address shared concerns in contraception and reproductive health, Indian and U.S. scientists will undertake a coordinated program involving participation in collaborative, peer-reviewed research projects, scientific workshops and conferences, research training, and technology transfer. This cooperation will be based on mutual benefit, trust, and a shared commitment to the advancement of scientific knowledge and its application to improve health.

Specific areas to be addressed within this program include, but are not limited to:

• New reversible contraceptive methods and companion diagnostics;
• Long-acting injectable contraceptives for women;
• Barrier methods for contraception and sexually transmitted disease prevention;
• Microbicide and spermicide research;
• Immuno-contraception;
• Basic, applied, and clinical research, including the development and use of transgenic animal models for the study of reproductive health;
• Development of improved methods of surveillance and diagnosis of sexually transmitted diseases (STDs) and reproductive tract infections (RTIs);
• Epidemiological studies, including studies on STDs and RTIs; and
• Social, behavioral, and intervention research related to all of the above.

In addition, since the publication of the last Notice for the CRHR program (NOT-HD-03-009) several areas have emerged as high priority. These include:

• Studies to further elucidate the role of males in reproductive health: topical areas would include male reproductive biology and its impact on reproductive health outcomes, and contraception development and use by males and females;
• New advances in proteomics for research in reproductive health and contraception; and
• Enhanced appreciation of the social/behavior factors influencing reproductive health and contraception in both males and females.

Application Requirements

Support of the U.S. components of CRHR projects will be accomplished using the NIH Small Grant (R03) award mechanism as described in the Program Announcement for the NIH Small Research Grant Program (http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html).

Applications for R03 grants can be characterized as follows:

• Applicants for an R03 award may request a project period of up to two years and a budget for direct costs of up to two $25,000 modules or $50,000 per year;
• Small grant support is for new projects only; competing continuation applications will not be accepted.
• Small grant support may not be used for thesis or dissertation research;
• Only one revision of a previously reviewed small grant application may be submitted;
• The Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) of an application for a small grant may not exceed a total of 10 pages;
• A Progress Report is not needed; competing continuation applications for a small grant will not be accepted; and
• The appendix may include only original, glossy photographs or color images of gels, micrographs, etc. provided that a photocopy (may be reduced in size) is also included within the page limits of the research plan. No publications or other printed material, with the exception of preprinted questionnaires or surveys may be included in the appendix.

Examples of the types of projects supported by NICHD through the small grant (R03) mechanism include: Pilot or feasibility studies; development of research methodology; applied research; high risk/high payoff studies; development of new research technology; small-scale, self-contained projects; and analysis of existing datasets.

The application should propose a research project involving a collaborative effort between the U.S. Principal Investigator and an Indian scientist. Because this is a joint partnership between U.S. (NICHD) and Indian (DBT) agencies , i nvolving both dollar and rupee funding decisions, it is essential that:

• Both NIH/NICHD 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;
• Justification must be provided for the collaboration and must include all necessary supporting documents and signed agreements from respective institutions; and
• U.S. applications must complete the requisite budgetary sections in the PHS 398 form, and must include a description and justification of the Indian component of the project.

Application Submission

U.S. Applications:

U.S. applicants must submit applications according to standard procedures described in the R03 Program Announcement. All applications must be completed using the most current version of the PHS 398 application form. The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the Notice number (NOT-HD-05-005) on the label. In addition, the Notice title ( Indo-U.S. Program on Contraception and Reproductive Health Research ) and number (NOT-HD-05-005) must be typed on line 2 of the face page of the application form. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. Personal deliveries of applications are no longer permitted.

The deadline for the submission of R03 applications for U.S. funding is March 22, 2005.

Indian Applications:

The Indian collaborator(s) must submit appropriate materials as determined by the Indian Secretariat (see contact information listed below).

Evaluation Procedures

NIH Small Grant (R03) applications assigned to the NICHD are evaluated for scientific and technical merit by Scientific Review Groups convened by the NICHD Division of Scientific Review, according to standard NIH review criteria.

After the initial and independent merit review by both partners, the JWG will conduct a secondary review, coordinated by the CRHR Secretariats, which will:

• Consider the results of the respective primary reviews conducted according to the established institutional review procedures for the nodal agencies, NICHD and DBT;
• Determine responsiveness to program areas listed above;
• Assess the strength of the collaboration; and
• Determine relative priorities in the context of current CRHR program objectives.

Final funding decisions will be made based on mutual agreement of both nodal agencies, NICHD and DBT, and the availability of funds.

CRHR Secretariats

U.S. Secretariat CRHR

Daniel J. Raiten, Ph.D.
Office of Prevention Research and International Programs
National Institute of Child Health and Human Development
National Institutes of Health
6100 Executive Boulevard, Room 2A01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-7568
Email: raitend@mail.nih.gov

Indian Secretariat CRHR

B.M. Gandhi
Adviser, Department of Biotechnology
Block-2, 7th Floor, CGO Complex
Lodhi Road, New Delhi-110003,
Telephone: 4360984
Fax: 4380984, 4362884
Email: Gandhi@dbt.nic.in

Inquiries

For further information, contact:

Daniel Raiten, Ph.D.
Office of Prevention Research and International Programs and
Endocrinology, Nutrition and Growth Branch
Center for Research on Mothers and Children
National Institute of Child Health and Human Development
National Institutes of Health
6100 Executive Boulevard, Room 2A01, MSC 7510
Bethesda, MD 20892-7510
Telephone: +1 301-435-7568 (direct)
+1 301-435-7565 (main office)
+1 301-435-0009 (fax)
Email: raitend@mail.nih.gov

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