Biological Testing Facility for Contraception & Reproductive Health

The National Institutes of Health, through the Eunice Kennedy Shriver National Institute of Child Health and Human Development, is issuing a Notice of Funding Opportunity under the X01 activity code to provide investigators access to a state-of-the-art Biological Testing Facility. This resource is intended to advance the development of contraceptive and reproductive health-related products, with a high priority placed on late-stage preclinical compounds and devices. The facility offers a wide range of technical services to support Investigational New Drug and Investigational Device Exemption enabling studies, including pharmacokinetics, pharmacodynamics, ADME, toxicity, fertility studies, and reproductive tract histopathology. This is a resource access award, meaning there are no funds associated with the grant. The maximum project period is one year, and services provided cannot exceed 12 months unless prior approval is granted. Eligible applicants include for-profit organizations, such as small businesses, and other eligible institutions. Applicants must maintain active registrations in the System for Award Management, possess a Unique Entity Identifier, and be registered with eRA Commons. Applications involving foreign subawards are considered noncompliant and will not be funded. Evaluation is conducted via an internal administrative review by NIH staff, focusing on the research strategy and the validity of biological or chemical resources. Recipients must adhere to strict cybersecurity requirements, including multifactor authentication and a 48-hour incident notification window to HHS. Additionally, the award prohibits the use of resources to support racial preferences, the denial of the human sex binary, illegal immigration, or harm reduction initiatives related to substance abuse. All protocols must be reviewed by an Institutional Review Board or Independent Ethics Committee.