Part 1. Overview Information

Key Dates

Applications are accepted by continuous receipt.

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.

NA

Applications will be reviewed no later than 120 days after receipt of the application, with one meeting in each of the following windows: September 2023; November 2023; January 2024; March 2024; May 2024; July 2024; September 2024; November 2024; January 2025; March 2025; May 2025; July 2025; September 2025; November 2025; January 2026; March 2026; May 2026; July 2026.

Not applicable.

October 2023; December 2023; February 2024; April 2024; June 2024; August 2024; October 2024; December 2024; February 2025; April 2025; June 2025; August 2025; October 2025; December 2025; February 2026; April 2026; June 2026; August 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

With continued advances in our ability to identify and quantitate human genetic variation, there is great interest in applying state-of-the-art genomic technologies to identify genetic elements that contribute to human health and disease. For many studies, this requires special expertise and high-throughput technologies that can be more efficiently carried out via a centralized program as compared to individual investigator laboratories.

This Notice of Funding Opportunity (NOFO) allows NIH-supported investigators to apply for access to high-throughput DNA sequencing, genotyping, and epigenetic assay services carried out by CIDR. The services provided include careful quality control and data cleaning. A limited number of statistical analysis services are also offered. Detailed information about current CIDR offerings and a list of NIH Institutes that participate in the program can be found at https://cidr.jhmi.edu.

Specific Areas of Research Interest

This NOFO seeks projects that show promise of identifying genetic or epigenetic elements important to human health and disease, or that wish to add high quality genotype or next generation sequence data to existing collections of well phenotyped specimens from studies in which genetic data can be used to further characterize or stratify study participants. For gene discovery projects there should be strong evidence that the project proposed will have sufficient power to detect genetic or epigenetic factors affecting the trait under study.

Projects designed to generate large-scale genotype or sequence data from existing collections of human samples will also be considered. Applications for this class of studies need not be solely focused on testing genetic hypotheses, for example, genotyping or sequencing of large, well-phenotyped collections of samples for which gene discovery is not the primary goal. In such a study, genetic data could be used to stratify study participants into more refined groups or to collect genetic data to use as covariates when assessing primary outcomes or phenotypes. This could be especially advantageous for clinical trials, case-control, and natural history studies. Such projects must result in data that will be of broad utility to the community.

Appropriate projects would include but are not limited to: whole-genome, whole-exome, and custom-targeted next-generation sequencing; human genome wide association studies (GWAS); high-throughput custom SNP genotyping; and analyses of DNA methylation. Although the main focus of this NOFO is on human studies, some model organism studies are also appropriate.

Specific Requirements and Expectations for this Opportunity

Sharing data generated through access to the CIDR resource via this NOFO is an essential goal of the program. X01 recipients are expected to share genomic and associated phenotypic and metadata broadly with the scientific community as a condition of access to CIDR services. Applications with rich clinical and phenotypic data that can be broadly shared will be prioritized.

The X01 mechanism does not provide budgetary support for the proposed activities. X01 applicants with a linked, active research grant are expected to use funds from that award to support sample handling, statistical and informatic analysis, and data management to share phenotypic and risk factor data (e.g., environmental exposures, metadata, and other covariate data and outcomes). Applicants without a linked, active research grant may apply for other funds (e.g., a small research grant or administrative supplement) or may use other sources of funds to support these ancillary activities.

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)

Applications Involving the NIH Intramural Research Program

NIH intramural scientists from CIDR member Institutes may participate in this program as PD/PIs in accord with the Terms and Conditions provided in this NOFO. No funds will be provided to NIH intramural scientists under this program. If selected, investigator laboratory funds for CIDR genomic services will be provided through the NIH Intramural Research Program.Intellectual property will be managed in accordance with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

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.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

For this specific NOFO, the 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.

Total Federal Funds Requested: Enter $0.

Total Federal & Non-Federal Funds: Enter $0.

Estimated Program Income: Enter $0.

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.

Other Attachments: The application must include the following attachments.

Applications must list the phenotypic and clinical covariates, environment risk factors, metadata, and any other relevant measures that will be used in the analyses described in the X01 application (data dictionary), and the number of subjects with each variable (data summary), to demonstrate that the aims of the applicationcan be achieved with sufficient power. Example data dictionary and data summary templates can be found on the CIDR website: https://cidr.jhmi.edu/HowToApply.html. Prior to approval of access to CIDR services, program staff from the sponsoring NIH institute may negotiate modifications to the proposed variables with the applicant.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

Not Applicable

R&R Subaward Budget

Not Applicable

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: The Specific Aims should refer directly to the X01 request and should clearly and concisely describe the potential impact of the proposed research.

Research Strategy:

Significance:

For gene discovery projects:

1. Explain the public health significance of the trait(s) under study.
2. Document the evidence for a genetic component of the trait(s) and the likely strength of that component, including the heritability and complexity.
3. Describe earlier genetic studies on this disorder, and what has been found so far.
4. Describe known environmental risk factors for the trait(s), and any evidence for gene-environment interactions.
5. If this request is a direct follow-up of an earlier study, describe those results.

For projects to add genomic data to existing collections of specimens:

1. Provide a detailed description of the specimens, including the phenotypic and environmental covariates available.
2. Describe the primary aims or expected outcomes of the study.
3. Describe how the addition of genomic or epigenomic data will enhance the value of the existing study, and how it will impact the overall field of research.

For all studies: Provide any additional background that supports the value of the high-throughput service(s) requested.

Investigators and Approach:

1) Study Population: Clearly describe the study population. Include detailed information about how subjects were identified and sampled and the method(s) of phenotypic characterization. For case-control studies, provide inclusion and exclusion criteria and any matching done between cases and controls. Describe relevant environmental factors and how they were measured. If the subjects provided for this study are a subset of a family population, explain which individuals were included and how they were selected. Highlight special features of the study population that would enhance success. For existing collections of human specimens, describe the phenotypic and environmental covariates available.

2) Sample Information and Service(s) Requested: In table form, provide: sample description such as case/control status and/or collection site; number of samples included in the study; tissue source of the DNA; service requested; and any previous genotyping or sequencing. If data from other subjects will be included in the analysis, add row(s) to describe those samples.

Provide supporting text that justifies the choice of samples. Describe previous genotyping or sequencing done on these subjects. Describe the extraction methods used for each DNA source and the approximate DNA concentrations (see https://cidr.jhmi.edu for sample requirements).

3) Power and Effect Size: Use power analyses to describe the range of effect sizes detectable by the study. Address relevant features of the analytic plan, such as the genetic model(s) to be tested, the extent of multiple testing and what significance level would be used for testing. If appropriate, include parameters such as risk allele frequencies and the expected patterns of linkage disequilibrium. If the study design requires separate analysis of subject groups (e.g. phenotypic classes or ancestry groups) provide power analyses for each category. If there is a plan to test for gene-gene or gene-environment effects, address the power to detect these effects.

For sequencing studies, provide power calculations that include correction for the number of markers estimated. If there is a plan to sequence a discovery set and then validate via genotyping or custom sequencing, provide power for the validation set.

Formal power calculations are not required for studies to add genomic data to an existing collection of well-phenotyped samples. If sets of specific variants are targeted in the study, the expected frequencies of these variants should be estimated.

4) Data Analysis: Provide a thorough plan for data analysis (note that no funds are provided under this NOFO to support analysis or other activities, however applicants must demonstrate their ability to analyze the data to achieve the goals of the program). Include: analytical approaches to be used and their justification; plans for quality control analyses; methods to control for possible confounding effects such as genotype and/or phenotype uncertainty; how false positive rates will be controlled in light of multiple testing, etc. If relevant, also discuss how the trait or locus will be localized. For sequencing studies, include methods for variant filtering and follow up. If there is a plan to analyze the data obtained with earlier data, describe your strategy for that process.

Describe the role of each team member in the analysis process and summarize the team's experience with the approaches proposed.

5) Data Management: Describe the institutional computing resources available for this study, where and how the data will be stored, and how the data will be managed. Highlight the team's experience with management of large data sets (especially those similar to the proposed project) beyond information described on the biographical sketch. Also describe strategies to maintain data security.

6) Plans for the Next Phase: Describe plans for follow-up studies, for example, additional genotyping or sequencing and/or functional testing of selected variants.

7) Data Sharing: Briefly describe the data that will be shared and the anticipated data repository. Sharing of covariate and genomic data via a NIH-approved repository such as dbGaP (http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/about.cgi) or approved NIH cloud platform (https://datascience.nih.gov/nih-cloud-platform-interoperability-effort) consistent with the consent of study participants is a condition of access to CIDR services. Note that the covariates listed in the attached data dictionary and data summary are expected to be shared (see Section 2, Other Attachments ).

Letters of Support: If collaborations have been established, include letters of collaboration in the application that document the role of each collaborator. Letters should be combined into a single PDF and uploaded via the Letters of Support attachment. A letter from the sponsoring institute or center documenting permission to apply to this NOFO should also be included as specified in Section 7, below.

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.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• A Data Management and Sharing Plan is not applicable for 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.

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.

In order to expedite review, applicants are requested to notify the NHGRI Scientific Review Officer by email at [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Letter of Permission to Submit an Application:

It is expected that applications for access to CIDR genotyping and sequencing resources will be linked to a present or future research grant from a participating NIH Institute. All applicants must obtain permission from a CIDR NIH member Institute to submit an application in response to this NOFO. A complete list of participating Institutes and contacts for CIDR submission can be found at: https://cidr.jhmi.edu/Contact.html. If the project is not appropriate for a participating institute, contact the NIH liaison at [email protected]. It is recommended that you discuss your application with the staff from one of the NIH CIDR member Institutes four to six months in advance of the planned submission. A letter documenting the permission should be included in the application.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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 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.

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.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NHGRI Scientific Review Branch, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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]

The complete list of scientific contacts for CIDR member institutes can be found at https://cidr.jhmi.edu/Contact.html.

Barbara Thomas, PhD
National Human Genome Research Institute (NHGRI)
Phone: 301-402-8837
Email: [email protected]

Kimberly A McAllister, PhD
NIEHS - NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Phone: 984-287-3287
E-mail: [email protected]

Ran Zhang, PhD
National Institute of Neurological Disorders & Stroke (NINDS)
Telephone: 301-496-5745
Email: [email protected]

Alicia Y. Chou, MS
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-594-4874
E-mail: [email protected]

Melissa Rotunno, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7245
Email: [email protected]

Barbara Thomas, PhD
National Human Genome Research Institute (NHGRI)
Phone: 301-402-8837
Email: [email protected]

Not Applicable.

Jenny L Greer
NIEHS - NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Phone: 984.287.3332
E-mail: [email protected]

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email:[email protected]

Gabriel Hidalgo, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-827-4630
E-mail: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
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.