Part 1. Overview Information

Key Dates

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.

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

Clinical genetic testing is becoming increasingly routine in clinical practice, and genome-scale sequencing is leading to the identification of many genomic variants with vastly differing clinical relevance. Many of these tests reveal a large number of variants of unknown significance (VUS) due to a variant’s rarity or to differences in the interpretation of its role by clinical laboratories or clinicians, potentially leading to inappropriate medical interventions. Though variants have been identified for certain Mendelian disorders, for the majority of variants in the human genome currently, there is no clear understanding of their impact on human health.

NIH established a clinical genomics infrastructure to develop an openly accessible knowledgebase that promotes data sharing and provides standardized infrastructure and tools for determining the clinical relevance of genetic variants through two initiatives: the Clinical Genomics Resource (ClinGen) and the Clinical Variant Database (ClinVar) of clinical variation. ClinVar (http://www.ncbi.nlm.nih.gov/clinvar/) is a publicly and freely available database maintained by the National Center for Biotechnology Information (NCBI) that aggregates information about genomic variation and its relationships to human health. ClinGen (https://www.clinicalgenome.org/) is an NHGRI-funded central resource, additionally supported by NCI and NICHD. ClinGen defines the clinical relevance of genes and variants for use in precision medicine and research by standardizing clinical annotation and interpretation of variants and implementing evidence-based expert consensus assertions. ClinGen's integrated infrastructure supports disease/disorder specific Expert Panels to determine the clinical applicability of genes and/or variants utilizing genomic, clinical, computational, and functional data. ClinGen has developed a clinical validity framework for identifying and assigning the level of evidence to support determination of gene-disease relationships. Furthermore, ClinGen has implemented standard approaches for curation and interpretation of both sequence and copy number variants. Variants evaluated by ClinGen-endorsed Expert Panels are deposited in ClinVar. Based on its rigorous and transparent procedures, ClinGen's expert curated variant pathogenicity interpretations have been recognized by the Food and Drug Administration (FDA) as the first public genetic variant database that can be used to validate genetic variant information in regulatory submissions. The ClinGen framework and tools can be found at: https://www.clinicalgenome.org/tools/.

Sharing of genomic data is critical for the determination of clinical significance of a gene and its variants. To that end, ClinVar is a community submission-driven knowledgebase that can receive submissions of varying complexity ranging from primary submitters for a single variant to authoritative assertions of clinical significance prepared by Expert Panels. ClinVar utilizes a four-star rating system to provide information about the level of review of the submissions. ClinVar assigns three stars for ClinGen approved Expert Panel submissions. As a result of their FDA recognition, ClinGen Expert Panel submissions are additionally marked in ClinVar with an FDA Recognized Database label (as an example, see: https://www.ncbi.nlm.nih.gov/clinvar/variation/239906/). ClinGen has developed the procedures to support the formation of Expert Panels along with a suite of curation interfaces and tools to support their Expert Panel curation activities. These procedures, interfaces, and tools facilitate a systematic process for analyzing evidence in a uniform and streamlined manner by Expert Panels.

Currently, ClinGen-established Expert Panels span a number of disease areas including, but not limited to: cardiovascular diseases, hearing loss, hemostasis/thrombosis, hereditary cancers, inborn errors of metabolism, neurodevelopmental disorders, neuromuscular disorders, ocular disorders, and RASopathies. ClinGen continues to consider additional disease areas as new opportunities arise, as well as new genes or variants within existing domains (https://www.clinicalgenome.org/affiliation/). ClinGen Expert Panels typically function within an overarching Clinical Domain Working Group (CDWG), which represents a high-level organizational structure covering a broad disease area, and may include multiple different Expert Panels covering specific sub-areas within that domain. Externally formed Expert Panels are expected to integrate into an appropriate CDWG. In cases where the proposed disease area does not fall within an established CDWG, ClinGen will oversee the Expert Panel’s activity until an appropriate CDWG is identified or established.

The Expert Panels are required to collaborate with ClinGen and ClinVar utilizing the ClinGen suite of curation interfaces and tools and to submit their underlying data to these resources in order to share data with the field. Training on these tools is required and is provided through ClinGen online resources and/or staff for new curation groups. NIH-funded Expert Panel PD(s)/PI(s), coordinators, and other key staff are expected to participate in ClinGen working groups and share curation procedures and outcomes with ClinGen and ClinVar.

Specific Areas of Research Interest

This NOFO invites applications to establish Genomic Curation Expert Panels. These panels may identify clinical domains of high priority to participating NIH Institutes and Centers (ICs); select candidate genes that will have a high impact on clinical practice in these high priority areas; and analyze all relevant variant data utilizing the ClinGen procedures, interfaces, and tools to make determinations of clinical significance. Specific IC interests include:

• Eunice Kennedy Shriver National Institute of Child Health and Human Development: Of particular interest to NICHD are genes associated with gynecologic, andrologic, and reproductive health; poor pregnancy outcomes; high risk newborn conditions; rapid genome sequencing for diagnosing critically ill infants; structural birth defects; intellectual and developmental disabilities; and immunological basis for susceptibility to acute and chronic infections. To the extent possible, NICHD encourages curation efforts that emphasize inclusion of underrepresented populations. NICHD considers applications for pediatric conditions that are the focus of significant efforts at other NIH institutes to be of lower programmatic priority when those institutes are not participating in this NOFO.
• National Cancer Institute: Of interest to NCI are genes and germline variants potentially associated with inherited susceptibility to cancer development and/or to cancer response or resistance to therapy; these genes/variants should be curated across populations, with particular attention to underrepresented populations. NCI is also interested in somatic variants of clinical relevance for the diagnosis and treatment of cancer.
• National Center for Advancing Translational Sciences: Of interest to NCATS are genes and variants associated with rare diseases.
• National Eye Institute: Of interest to NEI are genes and variants associated with diseases of the visual system including those of the eye, central visual, and oculomotor pathways that are within the mission of the NEI. Priorities would be given to candidates that have not been investigated by other ClinGen Expert Panels. The clinical applicability of knowledge gained from the study of specific gene(s) and variant(s) should be addressed in the application.
• National Institute of Arthritis and Musculoskeletal and Skin Diseases: Of interest to NIAMS are genes and variants associated with rheumatic, musculoskeletal and skin diseases, within the mission of the NIAMS.
• National Institute on Deafness and Other Communication Disorders: Of interest to NIDCD are genes and variants associated with hearing loss (auditory system).
• National Institute of Mental Health: Of interest to NIMH are genes and variants associated with severe mental illnesses, such as autism and schizophrenia, within the mission of the NIMH.
• National Institute of Neurological Disorders and Stroke: Of interest to NINDS are genes and variants associated with neurological and neuromuscular diseases and stroke within the mission of the NINDS.

Because of the large number of diseases and limited funds for this program, investigators are encouraged to form collaborations with other researchers in the same disease area and submit one application, rather than competing or complementary applications. Disease areas that have already established an Expert Panel should provide compelling justification for the need for support through this initiative.

NIMH Area of Interest:

The NIMH is specifically interested in the genetic architecture of mental illness and related traits.

Applicants should contact the scientific contacts at National Human Genome Research Institute and NIMH to determine which Institute is most appropriate for their application.

Scope

The scope of this NOFO is to establish Expert Panels in areas of high priority to the participating ICs. The Expert Panel will select and review genes and/or genetic variants within the specified domain that have the potential for clinical applicability utilizing the procedures and tools developed by ClinGen. The role of the Expert Panel is to evaluate the strength of existing publicly available evidence supporting the clinical significance or actionability of the selected genes to support clinical practice and submission to ClinVar.

• Expert Panels are expected to identify a clinical domain or genes/variants within the scope of the participating IC priorities, ensuring that these do not duplicate current ClinGen-supported Expert Panel efforts (https://clinicalgenome.org/affiliation/).
• Genes and/or variants should be selected for curation based on their potential for clinical actionability. Depending on the number of genes or variants proposed, individual working groups may be established that will report to the Expert Panel. If the gene(s) are already being examined by another Expert Panel, joint efforts with the existing panel should be established or the need for another panel should be justified.
• Panel members should reflect the breadth of expertise required to ascertain the clinical actionability of the genes identified and be led by a chair and co-chair (if needed). It is recommended that Expert Panels include medical professionals caring for patients relevant to the disorder or disease, medical geneticists, clinical laboratory diagnosticians and/or molecular pathologists who report such findings, researchers relevant to the disease, and statisticians.
• Members of Expert Panels should represent multiple institutions (at a minimum 3), be international in scope, and be considered by the community to be experts in the field. There is no predefined number of members needed for an Expert Panel. In line with ClinGen’s commitment to enhancing diversity across clinical genomics, outlined in its Justice, Equity, Diversity, and Inclusion (JEDI) Action Plan (https://clinicalgenome.org/tools/justice-equity-diversity-and-inclusion-jedi-action-plan/), JEDI principles should be considered when defining panel membership.
• Expert Panels should be supported by staff members who will assist in the curation process. These include: a project coordinator; curation scientists, such as clinical fellows, genetic counselors, or researchers in the field; and bioinformatics specialists. These individuals are required to use ClinGen rules and tools to review existing information in preparing summary materials for Expert Panel decision-making. Experience with other Expert Panels indicates that the most successful groups have a project coordinator, bioinformaticians, and curation scientists who undertake the initial curation that is then reviewed by the Expert Panel.
• Panel meetings can occur remotely, though at least one annual face-to-face meeting is recommended. Scheduling this meeting either in association with a regularly attended professional meeting or in conjunction with the annual ClinGen/DECIPHER Curating the Clinical Genome conference (https://clinicalgenome.org/about/events/) is encouraged.
• Utilizing the ClinGen/ClinVar framework (https://clinicalgenome.org/curation-activities/), Expert Panels are expected to define operating procedures for gene/variant assessment as described by ClinGen, which will include modification of the ACMG variant assessment guidelines, curation and review processes, and policies for resolving differences. Expert Panels' standard operating procedures are expected to follow ClinGen protocols and be shared with ClinGen. Training for use of ClinGen/ClinVar tools is available through ClinGen, via online courses, webinars, or in person. Expert Panels are expected to deposit gene and variant calls and curation tools into the ClinGen/ClinVar interface.
• The chair of the Expert Panel, leaders of specific gene working groups, coordinators, and key curation staff are expected to be trained on ClinGen procedures and tools, participate in ClinGen working groups, participate in monthly ClinGen webinars, and attend the annual ClinGen/DECIPHER Curating the Clinical Genome meeting.
• Prior to submission of applications to this NOFO, applicants are expected to be familiar with the policies and procedures published on the ClinGen website (https://www.clinicalgenome.org/start/).
• Potential applicants are encouraged to submit a Letter of Intent (LOI).

NIH Data Sharing Expectations and Requirements

The NIH Policy for Data Management and Sharing (NOT-OD-21-013) expects researchers to maximize the sharing of scientific data and that data be accessible as soon as possible, but no later than the time of an associated publication or the end of the award period, whichever comes first. NIH requires all applications submitted in response to this NOFO to include a Data Management and Sharing Plan (Plan), in which they will demonstrate their familiarity with ClinGen’s standard operating procedures for gene and variant curation. The scientific data being generated by the Expert Panels are the gene and/or variant curations, and the Plan should demonstrate applicants' knowledge of the rigorous data generation and documentation workflows used in ClinGen and ClinVar. The source(s) of data that will be used for curation, as well as the curation process to be used by proposed panel(s), should be described. Plans should address how curations will be documented and saved/preserved. The Plan is expected to address the Elements as described in Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014). For applications that aim to co-analyze already-shared data with data that have not yet been shared with the broader research community, applicants should describe in the DMS Plans how such primary data will be shared with the broad research community. If the previously unreleased data are subject to the NIH Genomic Data Sharing Policy, then applicants must attach a single Plan that includes elements for both policies. The Plan will be reviewed and approved by NIH Program Staff prior to award. Awardees will be required to comply with their approved Plan and any approved updates. Additional information on the Data Management and Sharing Policy is available on the NIH Scientific Data Sharing and NICHD Office of Data Science and Sharing websites.

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) are not 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 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:

Mollie Minear, PhD
Email: [email protected]

Page Limitations

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

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.

R&R Budget

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

Applicants may use either modular or R&R Budget forms.

Funds can be used to support partial salary of the Expert Panel chair and, if applicable, the co-chair(s). Other panel experts can receive nominal consulting fees. The primary emphasis of the budget should be on supporting a project coordinator, biocurators, and bioinformatics specialists. Both domestic and international Expert Panel members can receive nominal consulting fees. Funds can also be used for meeting support and travel to face-to-face meetings and the annual Curating the Clinical Genome conference (https://clinicalgenome.org/about/events/) by the PI and other appropriate members. There may be additional costs associated with training on ClinGen tools. Regarding budgeting for consultants, if they will not be conducting a substantive portion of the research, their fees will not be considered to be a sub-award, and therefore, no indirect costs would be involved. If they are conducting a substantive portion of the research, a subcontract will be required. All costs, including indirect costs, come from the parent award.

R&R Subaward Budget

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:

Research Strategy:

1. Describe the clinical domain(s) identified within the scope of priorities described by the participating ICs and identify the disease/disorder genes and/or variants selected for curation. Provide a justification for why this area is ready for analysis and why particular genes/variants were selected. Document their potential for clinical actionability.

Applicants can submit a proposal in response to this NOFO to convene Expert Panels that are anywhere along the continuum of curation activities for genes and/or genomic variants, as long as the curation proposed is justified based on what is known about the disease(s) or condition(s) under study. Applicants are allowed to propose Expert Panels that will curate genes only, variants only (germline and/or somatic), or both genes and variants; if curation of both genes and variants is proposed, justification should be provided as to why both types of curation activities are needed and the application should demonstrate that sufficient staff have been proposed to support doing both types of curation.

Applicants are encouraged to clarify the status of their Curation Expert Panel in the application, including:

• The type of Curation Expert Panel (Gene Curation Expert Panel, Variant Curation Expert Panel, and/or Somatic Cancer Variant Curation Expert Panel);
• Whether the Expert Panel has a relationship to an existing ClinGen Clinical Domain Working Group (CDWG); and
• Whether they have already submitted an expert curation application to the ClinGen Clinical Domain Oversight Committee for approval and, if so, the status of their application and, if applicable, their approved curation activities.

For new Expert Panels that are not part of an existing CDWG, applicants should articulate plans to engage with the ClinGen consortium. For new Expert Panels that are being initiated from within an existing CDWG, applicants should describe the need for a new Expert Panel in their broad disease area. For established Expert Panels, applicants should describe how the funding from this mechanism will enable them to expand their scope or scale up their curation efforts.

Additional guidance can be found within ClinGen’s Guidelines for Applying for Variant or Gene Curation Expert Panel Status at: https://www.clinicalgenome.org/docs/guidelines-for-applying-for-variant-or-gene-curation-expert-panel-status/.

There is no minimum or maximum number of genes and/or variants required for a successful Expert Panel application, but rather, such number should be feasible and the nature of the disease(s) and condition(s) and what is known about their genetic basis should dictate the scope of the application. Applicants should justify their proposed scope of work in terms of the clinical importance of the disease area as a whole, the impact that their work is expected to have on clinical diagnosis and management of patients, and the feasibility of completing the proposed curation within the time frame of the grant period. In general, Gene Curation Expert Panels tend to cover a larger number of genes, whereas Variant Curation Expert Panels typically focus on a smaller number of genes due to the need to establish variant classification guidelines and then curate hundreds or thousands of variants within each gene. Proposals that include both Gene Curation and Variant Curation Expert Panel activities should clearly describe the subdivision of these efforts within the grant period.

Innovation is not expected in the methods of curation since each Expert Panel is expected to utilize pre-defined ClinGen tools and procedures. Applicants should describe how innovation in their proposed projects arises from their capacity to make substantial and significant new contributions to publicly available knowledge and understanding of genomic variants.

2. Describe the leadership (including a chair and co-chair, if needed) and membership of the Expert Panel as well as other key group members, including a project coordinator and clinical and informatics curators who will provide support for the Expert Panel. Describe the membership of the Expert Panel that will select and evaluate the clinical relevance of genes/variants to be curated. Include details about how each member will contribute to establishing the clinical actionability of the genes/variants being curated.

Each member of the Expert Panel should be listed under personnel as consultants with an NIH biosketch attached. Consultants do not require an e-commons name and should only be paid nominal fees.

3. ClinGen is committed to enhancing diversity across clinical genomics, as outlined in its Justice, Equity, Diversity, and Inclusion (JEDI) Action Plan (https://clinicalgenome.org/tools/justice-equity-diversity-and-inclusion-jedi-action-plan/). Provide a description of how JEDI principles were considered when defining panel membership. Panel membership should incorporate international disease and genetic expertise. Expert Panels should strive to be as diverse and inclusive as possible across scientific expertise, professional background, race, ethnicity, gender, disability status, career stage, geography, and institutional affiliation.

4. Describe how the Expert Panel will carry out its functions. Based on the number of genes or variants proposed, determine whether individual working groups focused on specific subsets of genes or variants will be established, and how these will be related to the Expert Panel. Describe the work of these subgroups, key members that will provide oversight, and those undertaking the process of curation. Ensure that there is adequate biocuration and operations staffing to support the accomplishment of the outlined goals of the Expert Panel. Include information about staff who will support the group and planned interactions with ClinGen.

5. Describe and demonstrate knowledge of the procedures for gene-disease/gene-variant assessments utilizing the ClinGen/ClinVar procedures and interfaces. Include the gene-disease/variant curation guideline development, curation review process and policies for resolving differences.

Applications proposing to generate new functional data to support curation calls are not allowed under this PAR. Instead, applications should describe how existing functional information may be used to curate genes/variants.

While it is understood that there is limited availability of existing genomic data in understudied populations, especially for rare diseases, the research plan should nevertheless describe how the proposed curation activities will ensure that the genes analyzed reflect and include diverse populations (for Gene Curation Expert Panels) and/or that the data used to make variant assertions come from diverse populations (for Germline or Somatic Cancer Variant Curation Expert Panels). To the extent possible, applicants are encouraged to describe how their proposed curation activities will include underrepresented populations.

6. Describe the ClinGen training to be undertaken by the PI(s), experts, coordinator(s), and curators; the curation summaries to be prepared by curators; the process by which these summaries will be reviewed by the Expert Panel using specification rules; and the process used by the Expert Panel for decision-making. Provide a plan for work flow and timeline.

7. Describe both remote and face-to-face plans for regular Expert Panel meetings. At least one annual in-person meeting is usually recommended, although waived under possible travel restrictions. Scheduling this meeting either at a regularly attended professional meeting or in conjunction with the annual Curating the Clinical Genome meeting (https://www.clinicalgenome.org/about/events/) is encouraged.

8. Describe plans for integration with ClinGen working groups and curation activities.

9. Describe plans for interaction with ClinGen and participation in the relevant working groups, including the Coordinators, Curators, and Bioinformatics ClinGen working groups, monthly ClinGen webinars, and the annual face to face meetings, e.g., Curating the Clinical Genome Conference.

10. If this is an application from an existing Expert Panel, provide a justification for the need for this panel, e.g., different group of genes.

Renewal applications from an existing Expert Panel are allowed. Applicants should justify the continued need for this panel under this funding mechanism, such as curation activities focused on a different group of genes or different class of variants, and/or extending the scope of curation of variants in a given group of genes. Past productivity of the existing Expert Panel should be provided, including metrics such as described here: https://search.clinicalgenome.org/kb/reports/stats.

Letters of support from ClinGen:

Letters of support from Expert Panel members who are not listed as key personnel should be included in the Letters of Support Section.

Applicants are strongly encouraged to submit a letter of support from ClinGen with the type and status of their curation panel clearly defined:

• New Expert Panel that is not part of an existing CDWG: applicants should articulate plans to engage with the ClinGen consortium and the need for a new Expert Panel in their broad disease area.
• New Expert Panel that is being initiated from within an existing CDWG: applicants should describe the need for a new Expert Panel in their broad disease area.
• Established Curation Expert Panel: applicants should describe how the funding from this mechanism will enable them to expand their scope or scale their curation efforts.

To request a letter of support from ClinGen, please email [email protected] with the subject line: Request for LOS for NIH GCEP/VCEP application, in response to PAR-23-199 .

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:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

All Expert Panels are required to collaborate with ClinGen and ClinVar utilizing the ClinGen suite of curation interfaces and tools to submit their underlying data to these resources in order to share data with the field. Applicants must describe their plans for doing so in the Data Management and Sharing Plan.

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.

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.

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 U24 mechanism invites applications to support research projects contributing to improvement of the capability of resources to serve biomedical research. The Genomic Expert Curation Panels provide an infrastructure within which panel members are able to utilize the tools developed by ClinGen and ClinVar to determine the clinical significance of individual genes and genomic variants to diseases or disorders of high priority to the participating ICs. Accordingly, the review will emphasize whether the Expert Panels have the breadth of expertise and institutional representation to assess the clinical actionability of the genes and/or variants they have selected. Reviewers should also assess how well the Expert Panels will utilize the ClinGen/ClinVar curation resources in their determination of clinical significance. Prioritization and funding decisions will be made at the discretion of the individual ICs participating in this NOFO.

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 Center for Scientific Review (CSR), 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 may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. 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.
• Compliance with data management and sharing policies.

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR 200 and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Accept close coordination, cooperation, and participation of the NIH staff in the aspects of scientific and technical management of the project as described below.
• Ensure that all goals of the Expert Panel are met.
• Ensure effective interaction and coordination among Expert Panel Members, ClinGen, ClinVar staff and the NIH staff.
• Adhere to the NIH policies regarding intellectual property, data release, and other applicable resource sharing policies as appropriate.
• Accept and participate in the cooperative nature of the ClinGen and ClinVar programs.
• Deposit gene and variant calls to ClinGen/ClinVar as appropriate and consistent with achieving the goals of the program.
• Recipients will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Project Scientist(s) -- NIH staff will have the role of Project Scientist(s) through technical assistance, advice, and coordination. The Project Scientists' responsibilities are defined as follows:

• Participate in the group process of setting project priorities and making decisions on joint activities and standard practices within each Expert Panel. The Project Scientist(s) will assist and facilitate the group process but not direct it.
• Negotiate goals and timelines with the recipients , as necessary.
• Serve as liaisons between the recipients , ClinGen, NIH, and the larger scientific community in helping the Expert Panels to achieve their goals.
• Coordinate the efforts of the Expert Panel with ClinGen, ClinVar and others engaged in similar and related activities.
• Serve on subgroups of the Expert Panels as appropriate.
• Where warranted, co-author publications about the goals of this NOFO, and of results of studies funded under this NOFO.Program Official -- Additionally, an Institute Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Official will:
• Approve progress of award.
• Retain the option of recommending termination of project activities if they cannot be effectively pursued in a timely manner.
• Retain the option to recommend additional project activities by the Expert Panel within the constraints of the approved research and negotiated budget.

Areas of Joint Responsibility include:

None; all responsibilities are divided between recipients and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Expert Panel chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient . This special dispute resolution procedure does not alter recipients right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

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

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

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]

Jonathan Pevsner, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-728-5618
Email: [email protected]

Mollie Minear, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: [email protected]

Grace L Shen
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8169
E-mail: [email protected]

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

Vicky Whittemore, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1917
Email: [email protected]

Tiina K Urv
NCATS - NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
Phone: (301) 402-7015
E-mail: [email protected]

Bracie Watson, Jr., Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: [email protected]

Marjorie Lindhurst, PhD
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-451-8484
E-mail: [email protected]

Elena Smirnova, PhD
Center for Scientific Review (CSR)
Telephone: 301-357-9112
Email: [email protected]

Heather Weiss
National Institute of Mental Health (NIMH)
Telephone: 301-443-4415
Email: [email protected]

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

Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

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

Juliana Pina Desantis
NCATS - NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
Phone: none
E-mail: [email protected]

Samantha Tempchin
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-1404
Email: [email protected]

Eik Edgerton
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-7760
E-mail: [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.