Part 1. Overview Information

Key Dates

October 3, 2023, April 3, 2024, October 3, 2024, April 3, 2025, October 3, 2025, April 3, 2026

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Not Applicable

November 2023, May, 2024, November 2024, May 2025, November 2025, May 2026

Not Applicable

December 2023, June 2024, December 2024, June 2025, December 2025, June 2026

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Nearly half of all pregnancies in the United States are unintended. There is a critical need for fertility regulation methods that fit the needs of women and men throughout their reproductive lives. Concurrent with this, there is a critical need to facilitate the development of new reproductive health related therapies. This notice of funding opportunity announcement (NOFO) supports the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in its mission to develop novel, safe and effective non-hormonal contraceptive methods for men and women and to enable research investment opportunities in reproductive health related indications.

Purpose and Scope

The NICHD has a state-of-the-art Chemical Synthesis and Optimization Facility for advancing both non-hormonal contraceptive and reproductive health related product development. This facility has the capabilities and capacity for preclinical services including Investigational Device Exemption (IDE) or Investigational New Drug (IND)-enabling studies (e.g., protein generation, X-ray crystallography, high throughput screening, structure activity relationships, hit-to-lead generation, drug metabolism).

The purpose of this notice of funding opportunity announcement (NOFO) is to provide investigators with a mechanism to request services from this facility that would advance their contraceptive or reproductive health related development program. Contractor efforts for reproductive health related investments are contingent on available funding and contractor availability. Investigators developing a reproductive health related therapy and/or device are strongly encouraged to discuss their potential service request with the Scientific/Research Contact prior to submission.

This NOFO aims to position innovative and validated methods for future clinical development. Applicants are not required to have current NIH funding to apply, but priority may be given to programs receiving NIH support at the time of application submission.

Potential services to support this goal include, but are not limited to, protein generation , optimization of protein crystallization, protein co-crystallization with ligand, crystallization analysis, high throughput screening, computational chemistry, chemical optimization, Absorption Distribution Metabolism Excretion (ADME) studies, Drug Metabolism Pharmacokinetic (DMPK) studies, and formulation optimization in pursuit of an IND or IDE package for FDA submission. Services provided will not exceed 12 months in planned duration, unless approved prior to application submission. The facility has the capability to advance multiple projects simultaneously across the entire development continuum.

It is envisioned that a primary purpose of this resource will be for the advancement of both early and advanced stage preclinical compounds and devices. Applicants with chemical(s) hits and/or leads, or device(s) where the target and/or mechanism of action is unknown will be deprioritized; however, they are strongly encouraged to contact the Scientific/Research Contact for suggestion(s). Interested parties are encouraged to reach out to the Scientific/Research Contact to discuss potential services prior to application submission.

Researchers granted access to resource services will be required to work with the NICHD for all communications with the facility over the course of the project. Requested services may not overlap with efforts already funded through the Public Health Services.

Important Notes

• Researchers granted access to resource services will be required to work with NICHD staff for all communications with the facility over the course of the project.
• Service requests will not exceed 12 months in duration unless approved prior to application submission.
• More than one X01 request per applicant can be submitted per cycle.
• Requested services may not overlap with efforts already funded through this PHS.

Types of Activities

The Eunice Kennedy Shriver National Institute of Child Health and Human Development utilizes the Chemical Screening and Optimization Facility (CSOF) for the interest of, but not specifically limited to, the support of the following activities:

1) Protein synthesis optimization, pilot scalability and production of a validated target for, but not limited to: reversible male and/or female contraception, fertility, polycystic ovarian syndrome, fibroids, endometriosis, dysmenorrhea, adenomyosis, gynecologic and/or pelvic pain, and vulvodynia, premature birth, placenta health, improving lactation quality and quantity, preeclampsia, perinatal microbiome, gestational diabetes, necrotizing enterocolitis, broncopulmonary dysplasia, mastitis, Autism, Down's syndrome, and sepsis.

2) X-ray crystallography optimization and analysis of synthesized proteins with and without co-crystallization of a ligand.

3) High throughput screening (HTS) of validated assay(s) (target or cellular based) including defined positive and negative controls and proposing a secondary screen (confirmatory or counter screen) for identified hits (including positive and negative controls).

4) Structure Activity Relationships (SAR) based on new chemical entities, including but not limited to, computational assays of HTS results, pharmacophore generation, quantitative structure-activity relationship (QSAR) models and resulting chemical probes, resulting in hit-to-lead compound(s) using a primary and confirmatory assay (target-based assay and/or cellular assay).

5) Evaluation of lead compound(s) that possess freedom to operate in DMPK studies, and/or ADME studies for further optimization for male and/or female contraception.

6) Scalable quantity of identified lead compound.

The long-term objective is the enablement of an IND/IDE study for a preclinical candidate, that offers a safe, non-hormonal based therapy for contraception that acts prior to fertilization and does not act via the hypothalamic-pituitary-gonadal axis.

Target Validation

An important component of any early stage product development project is to conduct the necessary research to demonstrate that if the proposed modulation is successful (e.g., inhibition of a specific enzyme), the desired result will be achieved (e.g., infertility). This is commonly referred to as "validation". When a specific and defined molecule is targeted for modulation (e.g., inhibition of a specific enzyme), the specific molecule is referred to as a "target" and the validation process is referred to as "target validation". If the proposed research is focused on a defined molecular target (e.g., an inhibitor of a specific molecular target), the target should be validated prior to X01 submission, and the basis of validation should be detailed. If more than one specific molecule is targeted (e.g., two related enzymes), the same principles apply for the two molecules (i.e. demonstration that a well characterized modulation of both molecules will achieve the desired result).

Applications that lack or do not sufficiently address target validation may be de-prioritized.

Investigators are encouraged to contact the Scientific/Research Contact should they have any questions.

NICHD Data Sharing Expectations and Requirements

NIH recognizes that the extent of data sharing may be limited by restrictions imposed by product development related logistics, such as pre-existing licensing limitations and/or agreements, developing, authoring, and filing patents, etc.

X01 recipients will be required to adhere to the separate award conditions associated with the CSOF contractor’s plan for data sharing and any limitations to the extent of, or timelines for, data sharing to ensure that the proper balance is maintained between maximizing timely sharing of scientific data and enabling the protection of intellectual property (IP), following the NIH guidelines for data sharing and IP.

Applicants are strongly encouraged to discuss their proposed projects with the Program Staff prior to application submission.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Christopher C. Lindsey, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-538-9761
Email: [email protected]

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Research Strategy section is limited to 6 pages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Applicants are expected to request a single service in their application. The specific aim should refer directly to the service requested and should clearly and concisely describe the potential impact of the proposed study.

Research Strategy:

The research strategy should provide a clear description of requested services including:

• The relevant background to justify the request, the importance of the research/development project and the overall program, and how completion of the requested service will set the stage for the next well-planned objective leading towards an IND/IDE enabling study
• Defined deliverables (e.g., protein synthesis and scale up, high throughput screening assays, hit-to-lead optimization, etc.)
• Anticipated timelines to accomplish the described task
• Milestones that clearly describe and quantify a path towards advancement of the project
• Alternate strategies that showcase problem solving abilities should it be required
• Research strategies that discuss chemical series development must discuss strategies to achieve and confirm a patent position for new chemical entities
• Discussion of project advancement plan upon the successful completion of the described request (with a clear definition of how success is defined within the strategy)
• Description of the expected impact of those services on product development

For studies focused on a defined molecular target (e.g., development of a modulator of a specific molecular target), the target should be validated, and the basis of validation should be detailed prior to X01 submission. Applicants are strongly encouraged to contact the Scientific/Research Contact for questions.

Applicants with chemical(s) hits and/or leads, or device(s), where the target and/or mechanism of action is unknown or not verified may be deprioritized; however, they are strongly encouraged to contact the Scientific/Research Contact for suggestion(s).

Approach

Describe all services and defined deliverables requested with justifications and expected impact. For applications requesting screening or optimization, provide an abbreviated research plan, and an alternative research plan, for the request and provide well-defined markers for success.

Service requests:

• For protein synthesis and scale up production
  • Data indicating ability to generate protein in sufficient quantities (at least 2.0 mg/L at >90% purity)
• For X-ray crystallography using protein
  • Data indicating ability to generate protein in sufficient yield (at least 2.0 mg at >90% purity)
• Screening of a chemical library using a biological assay
  • Low throughput Chemical Screening (LTS, less than 96 well format)
  • High throughput Chemical Screening (HTS, equal to or greater than 96 well format)
• Chemical screening optimization to identify lead chemical series
• Chemical screening optimization of a lead chemical series
• In vitro studies (DMPK and ADME)
  • Include preliminary data (i.e. microsome studies, in vivo data)

If applicable, the following should also be discussed:

• If active compounds have been identified, outline in detail what is known about them including: freedom to operate and/or prior art history, chemical characterizations, physical properties and drug-like properties, toxicity and safety
• If no novel active compounds have been identified, provide details of assays and any known active chemical entities including (e.g., cLogP, LogP, tPSA, MW)
• Gene expression profile of target gene/protein
• Any known pathologies associated with target(s)
• Anticipated benefit of deliverables to the drug development program and how it will advance the project

For any request involving the transfer of reagents (e.g. synthesized compounds, proteins, and/or devices) for testing in the applicant’s institution, describe how materials will be tested, the assay to be used (including variability of assay), safety protocols for handling chemicals, and the data shared with the facility in a timely fashion (e.g. two weeks).

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

• The Resource Sharing Plan must satisfy the following requirements, which will be incorporated into the task order:
• Excess quantities of reagents generated by the facility will be stored at the Chemical Screening and Optimization Facility.
• All resources generated by the facility will be shared after one-year post completion of the service provided (allowing time to address intellectual property concerns or publication).
• Upon completion of the requested activity, all reagents associated with the activity will become publicly available after a period of one-year by the point of contact affiliated with this NOFO.

Other Plan(s):

A Data Management and Sharing Plan is not applicable to this NOFO.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Not applicable. No funds are associated with this NOFO.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

For this particular announcement, note the following:

The X01 Resource Access Program invites eligible institutions to seek access to NIH research resources, which are specified in each X01 NOFO. This includes programs where institutions will request access to submit to the resource (e.g., high throughput screening assays) as well as programs where access to a specific NIH research resource is needed to conduct certain research. Important factors in the peer review of X01 applications are the need for, and potential benefit of, gaining access to the resource, specifications for any assays proposed, timelines for completion and plans for follow-on studies.

Applications will not undergo standard peer review; instead, applications to this NOFO will be evaluated through an objective internal review process.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

X01 applications requesting services do not receive peer review. A committee with the appropriate expertise comprised of NIH staff will evaluate requests to determine their overall merit.

For this particular announcement, the following review criteria will be used:

• Is the requested service likely to lead to significant advances of the compound/method/device towards clinical evaluation?
• For a given well-reasoned and reasonable strategy are the following included:
  • Markers for success
  • Timeline
  • Milestones (for applications requesting services for 6 months to one year)
• For service requests (e.g. target enablement, screening, toxicology) has the applicant adequately demonstrated, discussed, justified or considered:
  • Protein production
  • Novel chemical entities
  • Off-target effects due to pan-agonism or antagonism
• If applicable:
  • Does the applicant have adequate resources to evaluate materials produced (e.g., small molecules, protein) by the CSOF in a timely fashion (e.g. two weeks)?
  • Does the applicant have an appropriate assay for screening (e.g., generating data)?
  • Does the applicant demonstrate reasonable ability to conduct work (e.g., assay development) concurrent with the facility including rapid iterative deliverables?

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

X01 applications will undergo an internal administrative evaluation by NIH staff. Applications submitted for this funding opportunity will be administratively evaluated using the criteria shown above.

The following will be considered in making decisions:

• Scientific and technical merit of the proposed project as determined by administrative review
• Contracting facility available capacity at the time of review
• Impact of the requested services on resources available to support other projects
• Relevance of the proposed project to program priorities

Applicants will receive a written notification whether or not they will be granted access to the contractor

Applications will compete for available funds with all other recommended applications submitted

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

An X01 does not result in a Notice of Award (NoA). Rather, selected applicants will receive access to resources described in this NOFO. Successful applicants will receive instructions for next steps.

2. Administrative and National Policy Requirements

An X01 does not result in a Notice of Award. Instead, successful applicants will receive instructions on accessing the resources described in this NOFO.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

Not applicable. An X01 does not result in a Notice of Award. Instead, successful applicants will receive instructions on accessing the resources described in this NOFO.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Christopher C. Lindsey, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-538-9761
Email: [email protected]

Applications submitted to this NOFO will not undergo peer review. Questions should be directed to the Scientific/Research Contact(s).

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.