National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.
X01 Resource Access Award
See Part 2, Section III. 3. Additional Information on Eligibility.
The purpose of this notice of funding opportunity (NOFO) is to provide investigators with a mechanism to request services from the state-of-the-art Biological Testing Facility that would advance their contraceptive development or reproductive health programs. This NOFO aims to position innovative and validated methods for future regulatory submission and/or clinical development. Applicants do not need to have current NIH funding to apply, but priority may be given to programs receiving NIH support at the time of application submission.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development's mission is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all.
September 7, 2026; January 4, 2027; May 3, 2027; September 6, 2027; January 3, 2028; May 1, 2028; September 4, 2028; January 2, 2029; May 7, 2029
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
October 2026, February 2027, June 2027, October 2027, February 2028, June 2028, October 2028, February 2029, June 2026
Not Applicable
November 2026, March 2027, July 2027, November 2027, March 2028, July 2028, November 2028, March 2029, July 2026
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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.
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. Additionally, it is essential to support the development of new therapies related to reproductive health. This notice of funding opportunity (NOFO) supports the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in its mission to develop novel, safe and effective contraceptive methods for men and women and to enable research investment opportunities in reproductive health related indications that include an understanding of long-term impacts on fertility and infertility..
Purpose and Scope
The NICHD uses a state-of-the-art Biological Testing Facility (BTF) for advancing both contraceptive- and reproductive health-related product development with the capabilities and capacity for preclinical and Investigational Device Exemption (IDE) or Investigational New Drug (IND)-enabling studies (e.g., fertility studies, pharmacology, toxicology, reproductive tract histopathology, sperm morphology). The long-term objective is the enablement of an IND/IDE study of a preclinical candidate, which offers a safe, effective therapy.
The purpose of this 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 inclusive of an understanding of long-term impacts on fertility and infertility. 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 do not need 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 available to support that goal include but are not limited to fertility studies, pharmacology, toxicology, reproductive tract histopathology, and sperm morphology and motility, services that are designed to help advance IND or IDE applications for FDA submission. The facility has the capability to advance multiple projects simultaneously across the entire development continuum.
Highest priority will be given to late-stage preclinical compounds and devices. Applicants are strongly encouraged to contact the Scientific/Research Contact to discuss potential requests prior to submission. Projects with only chemical hits and/or leads or devices with unknown targets and/or mechanisms of action will be deprioritized, though investigators are still encouraged to initiate discussions with the Scientific/Research Contact prior to application submission.
Important Notes
Types of Activities
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) uses the Biological Testing Facility (BTF) for the interest of but not specifically limited to the support of the following activities:
The long-term objective is the enablement of an IND/IDE study of a preclinical candidate that offers a safe, effective therapy.
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 must be validated prior to X01 submission, and the basis of validation must be justified by applicable data and/or literature citations in the application. 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).
NICHD Data Sharing Expectations and Requirements
X01 recipients that access the BTF will be required to adhere to the separate award conditions that are associated with the BTF'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 the timely sharing of scientific data and the protection of intellectual property (IP), following the NIH guidelines for data sharing and IP. Applicants should discuss projects with the COR (Contracting Officer Representative) for the BTF/Scientific Program Lead/Program Officer and other proposed collaborators early to avoid agreements that prohibit or unnecessarily restrict data sharing.
Considerations for Proprietary Data
NIH recognizes that the extent of data sharing may be limited by restrictions imposed by licensing limitations attached to materials needed to conduct the research or by existing or anticipated agreements, such as those with the original compound supplier. Additionally, timelines for sharing may be delayed by plans to seek IP claims, such as patent filing. For example, in this initiative, many of the chemicals to be investigated and much of the data to be generated may be proprietary, intended to become proprietary, or confidential to the original compound supplier, and the supplier may have significant business value that needs to be protected or withheld from the public domain. These considerations will be addressed in the data use agreement, as outlined above.
See Section VIII. Other Information for award authorities and regulations.
Other: A financial assistance mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-applications.
The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Not Allowed: Only accepting applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.
Not applicable; there are no funds associated with a resource access award. The number of projects granted access to the resource is contingent upon the number of meritorious applications and the capacity of the Biological Testing Facility.
Not applicable. There is no budget associated with X01 Resource Access Awards.
The scope of the proposed project should determine the project period. The maximum project period is one year.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions - Includes all types
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.
Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information
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.
All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
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.
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 How to Apply - Application Guide.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.
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 NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
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.
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.
For this NOFO, the Research Strategy is limited to 6 pages.
The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Specific Aim:
Applicants are expected to provide a single specific aim in their application. The specific aim should refer directly to the services requested and should clearly and concisely describe the potential impact of the proposed study/studies. The specific aim must be able to be achieved within one year of the time of study approval.
Research Strategy:
The research strategy should provide a clear outline of requested services, including but not limited to:
For studies focused on a defined molecular target (e.g., an inhibitor of a specific molecular target), the target must be validated prior to submission of the X01, and the basis of validation must be detailed.
Applications do not need to include finalized study protocols at the time of submission, but a general protocol description should be detailed enough to support the request. The facility has a number of standard protocols in place. However, if a specialized protocol is required, it must be submitted to NICHD for review and comment within 30 days of award notification unless granted an extension by NICHD staff.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.
The following modifications also apply:
The Resource Sharing Plan must satisfy the following requirements, which will be incorporated into the task order:
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.
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 How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply Application Guide.
See Part 2. 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
Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
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 How to Apply – Application Guide.
This initiative is not subject to intergovernmental review.
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 Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the How to Apply - 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 How to Apply - 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.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described in the policy
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular NOFO, 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.
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.
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Specific to this NOFO: X01s requesting facility access do not receive peer review. A committee with the appropriate expertise composed of NIH staff will evaluate requests to determine their overall merit. Reviewers will evaluate the following additional items while determining scientific and technical merit but will not give separate scores for these items.
For this NOFO, the following review criteria will be used:
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals (as applicable), the committee will consider the progress made in the last funding period.
For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Not Applicable
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 under Additional Review Criteria.
The following will be considered in making decisions:
Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO.
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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.
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 2.4.4 Disposition of Applications.
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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
An X01 does not result in a Notice of Award. Instead, successful applicants will receive instructions on accessing the resources described in this NOFO.
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
Cybersecurity plans and procedures must at minimum include the following:
All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings. Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.
For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.
As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.
Not Applicable
A Data Management and Sharing Plan is not applicable for this NOFO.
Not applicable. An X01 does not results in a Notice of Award. Instead, successful applicants will receive instructions on accessing the resources described in this NOFO.
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.
Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
nichd_fib_nofos@mail.nih.gov
Applications submitted to this NOFO will not undergo peer review. Questions should be directed to the Scientific/Research Contact(s).
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
nichdgrantsmanagement@mail.nih.gov
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 2 CFR Part 200.