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Male and Female Contraceptive Development (R43/R44 Clinical Trial Optional)
NOTE: The Solicitations and topics listed on this site are copies from the various SBIR agency solicitations and are not necessarily the latest and most up-to-date. For this reason, you should use the agency link listed below which will take you directly to the appropriate agency server where you can read the official version of this solicitation and download the appropriate forms and rules.
The official link for this solicitation is: https://grants.nih.gov/grants/guide/rfa-files/RFA-HD-19-004.html
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Available Funding Topics
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The purpose of this Funding Opportunity Announcement (FOA) is to invite SBIR applications to support and facilitate the development of new and/or improved contraceptive products for men and women.
Background
In the United States, a large proportion of births, 33%, are unintended—either mistimed or unwanted. According to official U.S. government statistics, for the 2012-2015 period, women aged 15 to 44 reported that 20 percent of births in the last five years were mistimed (the woman wanted a pregnancy, but it occurred sooner than she wanted it) and 13 percent were unwanted (the mother never wanted a baby, or a baby of that birth order—second, third, fourth, etc.) (Key Statistics from the National Survey of Family Growth, I-listing; Mosher et al., 2012).
Reducing the proportion of unintended pregnancies will be facilitated by increasing the diversity of acceptable choices available to both men and women.
Research Objectives and Scope
Projects must be focused on the development of new and/or improved contraceptive products, or novel assay platforms that facilitate and support contraceptive development. Any proposed product must have characteristics consistent with the ultimate development of a safe, and effective contraceptive acceptable to women and men. All proposals for Phase II programs focused on contraceptive product development must include in vivo product testing.
Contraception product development programs of high priority are:
- Pre-coital contraception.
- Male and female contraceptives based on nonsteroidal action.
- New and improved delivery devices for contraception.
- Multipurpose prevention technology (MPT) products with adequate contraceptive and anti-infective properties. Proposed MPT products must have a validated contraceptive mechanism of action but may investigate potential anti-infective properties with appropriate rationale and/or supporting data.
Applications that include the following are not responsive to this FOA:
- Applications based on mechanism of contraceptive action that may act post-fertilization
- Applications that include basic research.
- Applications based on a mechanism of contraceptive action that is not validated.
- Applications that include contraceptive target identification or validation.
- Applications for the development of female contraceptive methods that require the administration of exogenous steroidal hormones.
See Section VIII. Other Information for award authorities and regulations.
