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Grant Analysis

Purpose & Target

Provides investigators access to the NICHD's Chemical Synthesis and Optimization Facility for preclinical services.
The core objective is to advance non-hormonal contraceptive and reproductive health related product development towards Investigational New Drug (IND) or Investigational Device Exemption (IDE)-enabling studies.
Target recipient types are broad, including universities, nonprofits, for-profit organizations, and various government entities.
The grant is SECTOR-SPECIFIC focusing on healthcare, particularly reproductive health, pharmaceuticals, and biotechnology research and development.
Geographic scope is global, with eligibility for both U.S. and non-U.S. entities.
Key filtering criteria for initial screening include the project's focus on preclinical development towards IND/IDE and the presence of validated targets.
This is a recurring opportunity with multiple application cycles per year until April 2026, and is a reissue of a previous program.

Financial Structure

This is a Resource Access Award (X01), which means it provides access to the specialized facility and its services, not direct financial funding.
There are no funds or budgets associated with these X01 resource access awards provided to the applicant.
Applicants will not receive any direct financial awards.
The funding opportunity does not require cost sharing or matching funds from the applicant.
Pre-award costs are allowable only as outlined in the NIH Grants Policy Statement.

Eligibility Requirements

Eligible Organizations

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status)
For-Profit Organizations (including Small Businesses)
Local Governments (State, County, City/Township, Special District Governments)
Indian/Native American Tribal Governments (Federally Recognized, or other)
Federal Governments (Eligible Agencies)
Other entity types: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations.
Non-domestic (non-U.S.) Entities (Foreign Institutions) and non-domestic components of U.S. Organizations are eligible.

Required Registrations

System for Award Management (SAM) with an active and annually renewed registration, including a Unique Entity Identifier (UEI).
NATO Commercial and Government Entity (NCAGE) Code for foreign organizations (in lieu of CAGE code).
eRA Commons account for both the organization and all Program Directors/Principal Investigators (PD/PIs).
Grants.gov registration.
Note: All required registrations must be completed before the application is submitted.

Project Scope Eligibility

Projects must not propose clinical trials; this is strictly an X01 Resource Access Award.
Requested services may not exceed 12 months in duration, unless prior approval is obtained.
Services requested must not overlap with efforts already funded through the Public Health Services.
Priority may be given to programs currently receiving NIH support, though it is not a mandatory requirement.

Scientific Prerequisites

Projects focused on a defined molecular target must provide detailed target validation. Applications lacking or insufficiently addressing this may be de-prioritized.
Applications with chemical hits/leads or devices where the target and/or mechanism of action are unknown or unverified may be de-prioritized.

Application Process

Application Deadlines and Review Cycles

Application Due Dates (by 5:00 PM local time of applicant organization):
- October 3, 2023
- April 3, 2024
- October 3, 2024
- April 3, 2025
- October 3, 2025
- April 3, 2026 (latest and final deadline for this NOFO)
Scientific Merit Review (internal administrative evaluation) occurs in November and May following the application due dates, with the last review in May 2026.
Earliest Start Date (for accessing the facility) is typically December or June, following the respective review cycles, with the last earliest start date being June 2026.

Submission Process

Applications must be submitted electronically through either the NIH ASSIST system, an institutional system-to-system (S2S) solution, or the Grants.gov Workspace.
Applicants are responsible for tracking their application status in the eRA Commons.
Incomplete or non-compliant applications will not be reviewed.

Required Application Materials

SF424 (R&R) Application Guide: General instructions must be followed, along with any program-specific instructions detailed in this NOFO.
Letter of Intent (Optional): Due 30 days before the application due date. Should include proposed activity title, PD/PI contact information, key personnel, participating institutions, and the funding opportunity number. Sent via email to the Scientific/Research Contact.
Research Plan (PHS 398):
- Specific Aims: Describe a single service request and its potential impact.
- Research Strategy (limited to 6 pages): Must include background, project importance, how the service leads to IND/IDE studies, defined deliverables, anticipated timelines, milestones, alternative strategies, patent position discussion (if applicable), project advancement plan, and expected impact. Requires justification for target validation if applicable, and detailed descriptions of all requested services.
- Preliminary Data: Required for certain service requests (e.g., protein production, in vitro studies).
- Reagent Transfer Protocol: If reagents are transferred, describe testing methods, assay, safety protocols, and commitment to timely data sharing (e.g., within two weeks).
Resource Sharing Plan: Required, adhering to SF424 (R&R) Guide. Excess reagents generated by the facility will be stored there and shared publicly one year post-completion for IP/publication purposes.
Data Management and Sharing Plan: Not applicable to this NOFO.
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys); publications are not permitted.
PHS Human Subjects and Clinical Trials Information: Required if human subjects research is involved (note: clinical trials themselves are not allowed under this NOFO).

Post-Submission Requirements

Successful applicants will receive specific instructions on how to access the facility's resources; this is not a traditional Notice of Award.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood of the project to exert a sustained and powerful influence on the relevant research field(s).

Specific Review Criteria (evaluated by internal NIH staff)

The likelihood that the requested service will lead to significant advances of the compound/method/device towards clinical evaluation.
Assessment of the proposed strategy for its well-reasoned and reasonable approach, including:
- Clearly defined Markers for success.
- A realistic Timeline for completion.
- Specific Milestones (for service requests spanning 6 months to one year).
For service requests (e.g., target enablement, screening, toxicology), evaluation of the applicant's demonstration, discussion, or justification regarding:
- Protein production capabilities.
- Novel chemical entities.
- Potential off-target effects (e.g., due to pan-agonism or antagonism).
If applicable, assessment of the applicant's capacity to:
- Possess adequate resources to evaluate materials provided by the CSOF in a timely manner (e.g., within two weeks).
- Utilize an appropriate assay for screening that effectively generates data.
- Conduct work concurrently with the facility, including the ability to manage rapid iterative deliverables.

Additional Review Considerations (not scored, but assessed)

Foreign Organizations: Evaluation of whether the project leverages unique international talent, resources, populations, or environmental conditions not readily available or augmenting U.S. resources.
Resource Sharing Plans: Assessment of the reasonableness of proposed Resource Sharing Plan(s) or the rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Review of the plans for validating these resources.
Project Period: Consideration of whether the requested project period (maximum one year of service access) is fully justified and reasonable for the proposed research.

Compliance & Special Requirements

Regulatory Compliance

Adherence to all instructions in the SF424 (R&R) Application Guide and any specific deviations outlined in this NOFO is mandatory.
Compliance with the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under Sections 301 and 405 of the Public Health Service Act, along with 42 CFR Part 52, 45 CFR Part 75, and 2 CFR Part 200.
This initiative is not subject to intergovernmental review (E.O. 12372).

Data and Resource Sharing

Applicants granted access will be required to adhere to the Chemical Screening and Optimization Facility (CSOF) contractor's data sharing plan.
NIH emphasizes balancing timely scientific data sharing with intellectual property (IP) protection, aligning with NIH guidelines.
All reagents and resources generated by the CSOF during the project will become publicly available one year after the service completion, allowing time for IP protection or publication.

Research Ethics and Safety

If the project involves human subjects research, applicants must comply with the instructions for the PHS Human Subjects and Clinical Trials Information form.
For projects involving Select Agents, detailed plans for monitoring, use, transfer, biosafety, biocontainment, and security must be provided.
Strict safety protocols for handling chemicals and a commitment to timely data sharing with the facility are required for any reagents transferred to the applicant's institution.

Unique Aspects and Limitations

This opportunity is an X01 Resource Access Award, meaning it provides access to a specialized facility and its services (e.g., chemical synthesis, HTS, crystallography, ADME/DMPK studies), not direct financial funding.
Clinical trials are explicitly not allowed; the focus is solely on preclinical product development.
Applicants must collaborate closely with NICHD staff for all communications regarding the facility's services throughout the project duration.
Projects with undefined or unverified targets/mechanisms of action may be de-prioritized during the evaluation process.

Strategic Opportunities

This award provides a unique opportunity to accelerate preclinical development towards IND/IDE-enabling studies by leveraging state-of-the-art resources and expertise at the NICHD facility.

Grant Details