Biological Testing Facility for Contraception & Reproductive Health (X01 Clinical Trial Not Allowed)

Background
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is issuing this Notice of Funding Opportunity (NOFO) to provide investigators with access to a state-of-the-art Biological Testing Facility. The goal is to advance contraceptive development and reproductive health programs, addressing the critical need for effective fertility regulation methods. This initiative aims to support innovative and validated methods for future regulatory submission and clinical development.

Grant Details
The NOFO allows investigators to request services from the Biological Testing Facility (BTF) for advancing contraceptive and reproductive health-related product development. Services include but are not limited to: fertility studies, pharmacology, toxicology, reproductive tract histopathology, and sperm morphology studies. The facility supports preclinical and Investigational Device Exemption (IDE) or Investigational New Drug (IND)-enabling studies. Applicants are encouraged to discuss their service requests with NICHD staff prior to submission. The maximum project period for services is one year, focusing on late-stage preclinical compounds and devices. Projects that only involve chemical hits or devices with unknown mechanisms will be deprioritized.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local governments, state governments, tribal governments, and foreign organizations. Applicants do not need current NIH funding; however, priority may be given to those who do. Organizations may submit multiple applications as long as each is scientifically distinct.

Period of Performance
The maximum project period is one year, with services not exceeding this duration unless approved prior to application submission.

Grant Value
There are no funds associated with this resource access award; the number of projects granted access depends on the number of meritorious applications and the capacity of the Biological Testing Facility.

Place of Performance
The grant will be performed at the Biological Testing Facility operated by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.