Chemical Screening and Optimization Facility (X01 Clinical Trial Not Allowed)

The Chemical Screening and Optimization Facility (X01 Clinical Trial Not Allowed), reissued under PAR-23-193, is administered by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a component of the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services. This program provides investigators access to a state-of-the-art facility designed to advance preclinical research in non-hormonal contraception and reproductive health-related product development. Although there are no monetary funds distributed under this opportunity, applicants may receive in-kind access to specialized research resources and technical support through the NICHD’s Chemical Synthesis and Optimization Facility. The facility is equipped for a range of preclinical services including protein generation, X-ray crystallography, high throughput screening, structure-activity relationship studies, hit-to-lead optimization, and drug metabolism and pharmacokinetic analysis. The ultimate objective is to advance preclinical candidates toward Investigational New Drug (IND) or Investigational Device Exemption (IDE) readiness, supporting the NIH mission to improve reproductive health options and reduce unintended pregnancies. This opportunity is open to a wide variety of organizations including higher education institutions, nonprofits, for-profit entities, local, state, tribal, and federal government bodies, as well as foreign institutions. Applicant organizations must maintain active registrations in SAM.gov, eRA Commons, and Grants.gov prior to submission. Applications are accepted semiannually with due dates on October 3 and April 3 of each year through April 3, 2026. Letters of Intent are requested thirty days before each application due date. Although the Letter of Intent is not mandatory, it is encouraged to assist NICHD staff in planning the administrative review process. The facility will not consider projects proposing clinical trials or those with undefined molecular targets or mechanisms of action. Applicants are strongly encouraged to contact the Scientific/Research Contact prior to submission to confirm the appropriateness of the requested services. The review process for this NOFO does not involve standard NIH peer review. Instead, requests are evaluated administratively by NICHD staff based on the scientific merit of the proposed service request, alignment with program priorities, and availability of contractor capacity. Evaluation criteria include the clarity of project aims, rationale for the requested service, defined milestones and deliverables, feasibility, and the likelihood that results will advance the applicant’s research toward clinical development. Applications lacking sufficient target validation or proposing unverified mechanisms may be deprioritized. No funds will be disbursed to applicants; instead, successful applicants will gain coordinated access to the facility’s resources for up to twelve months. Applications must be submitted electronically through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system interface. The required Research Strategy section is limited to six pages and must specify the service requested, background justification, defined deliverables, milestones, and expected impact. Applicants must comply with all requirements outlined in the SF424 (R&R) Application Guide, including completion of applicable registrations. The NOFO also specifies that applicants provide a resource sharing plan ensuring that any materials generated under this award will be made publicly available one year following the completion of services, respecting intellectual property and data-sharing policies. Key program dates include an open date of September 3, 2023, multiple application deadlines through April 3, 2026, and review dates occurring approximately one month after each submission. The earliest project start dates range from December 2023 through June 2026, depending on the application cycle. This opportunity remains active through its expiration date of April 4, 2026. All inquiries related to scientific or research questions should be directed to Christopher C. Lindsey, Ph.D., at the NICHD, reachable by telephone at 301-538-9761 or by email at chris.lindsey@nih.gov. Administrative and financial inquiries can be directed to Margaret Young at 301-642-4552 or margaret.young@nih.gov. As a no-funds X01 Resource Access Award, this program is best suited for research teams seeking access to high-value NIH research infrastructure rather than direct monetary support.