Opportunity Information: Apply for RFA HG 16 012

  • The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Clinical Sequencing Evidence-Generating Research (CSER2) - Coordinating Center (U24)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172,.
  • This funding opportunity was created on May 06, 2016 and posted on May 06, 2016.
  • Applicants must submit their applications by Aug 05, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $645,000.00 in funding.
  • The number of recipients for this funding is limited to 1 candidate(s).
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
Apply for RFA HG 16 012

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Opportunity Summary:

The Clinical Sequencing Evidence-Generating Research (CSER2) - Coordinating Center (U24) opportunity (Funding Opportunity Number RFA-HG-16-012) is a discretionary federal grant issued by the U.S. Department of Health and Human Services, National Institutes of Health (listed as HHS-NIH11). It uses a cooperative agreement mechanism, which generally means the NIH expects to have substantial involvement in the project compared with a standard grant. The overall aim is not to fund new clinical sequencing research projects directly, but to fund a single Coordinating Center that provides centralized organization, operational support, and cross-project integration for the broader CSER2 Consortium, specifically the projects supported under companion announcements RFA-HG-16-010 and RFA-HG-16-011. In practical terms, the Coordinating Center serves as the shared hub that helps multiple CSER2 research sites function like a coherent consortium rather than a collection of disconnected studies.

The core purpose of the award is to coordinate consortium-wide activities in “clinical sequencing evidence-generating research,” which refers to producing usable evidence about how genomic and sequencing-based tests perform and are implemented in real clinical settings. Because CSER2 is a consortium model, the Coordinating Center is expected to support common processes that benefit all participating studies, such as organizing regular meetings and communications, aligning approaches across sites where appropriate, facilitating shared resources, and helping to standardize or harmonize elements like data submission practices, common measures, reporting formats, and collaborative publications. The emphasis is on enabling coordination, comparability, and collective output across funded projects, helping ensure that the consortium produces a body of evidence that is easier to interpret and apply than if each project operated entirely independently.

The opportunity is categorized under the Health funding activity area and references CFDA numbers 93.172 (and also lists 93.172 again, likely indicating the same program catalog entry). It is open to an unusually wide range of eligible applicants, reflecting the operational nature of a Coordinating Center and the fact that the NIH may want to draw from institutions experienced in multi-site coordination, data management, clinical research operations, and consortium administration. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); and small businesses, with “others” potentially eligible as clarified in the full announcement’s additional eligibility language.

Administratively, the opportunity was created and posted on May 6, 2016, with an application closing date of August 5, 2016 (original and current closing dates are the same, indicating no extension in the record provided). The expected number of awards was one, reinforcing that this is meant to fund a single centralized Coordinating Center for the CSER2 Consortium. The listed award ceiling was $645,000, which indicates the maximum anticipated annual or total funding level as presented in the notice (the exact budget period structure would be defined in the full funding announcement). Overall, the award is designed to pay for the infrastructure and staffing needed to keep consortium work moving smoothly: the project management, communications, scheduling, coordination of working groups, documentation, and other shared functions that allow multiple NIH-funded CSER2 projects to collaborate, share lessons learned, and deliver integrated consortium-wide outcomes.

Frequently Asked Questions (FAQs)

What is the name of this grant opportunity?

This opportunity is titled Clinical Sequencing Evidence-Generating Research (CSER2) - Coordinating Center (U24).

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is RFA-HG-16-012.

Which federal agency is offering this grant?

This is a discretionary federal grant issued by the U.S. Department of Health and Human Services (HHS) through the National Institutes of Health (NIH) (listed as HHS-NIH11).

What funding mechanism does this opportunity use?

It uses a cooperative agreement mechanism (U24). This generally means NIH expects to have substantial involvement in the project compared with a standard grant.

What is the main purpose of this award?

The award is intended to fund a single Coordinating Center that provides centralized organization, operational support, and cross-project integration for the broader CSER2 Consortium.

Is this opportunity intended to fund new clinical sequencing research projects?

No. The stated aim is not to directly fund new clinical sequencing research projects. Instead, it funds the shared hub (the Coordinating Center) that helps the consortium function as an integrated program.

What is CSER2, based on the information provided?

CSER2 is described as a consortium model focused on “clinical sequencing evidence-generating research,” meaning work that produces usable evidence about how genomic and sequencing-based tests perform and are implemented in real clinical settings.

What does “clinical sequencing evidence-generating research” mean in this context?

It refers to generating practical evidence about how genomic and sequencing-based tests work and how they are used in real clinical settings, including issues of performance and implementation.

How many awards does NIH expect to make under this announcement?

The expected number of awards is one (1), indicating NIH intends to support a single centralized Coordinating Center for CSER2.

What is the award ceiling listed for this opportunity?

The listed award ceiling is $645,000. The specific budget period structure would be defined in the full funding announcement.

What kinds of activities is the Coordinating Center expected to support?

Based on the description provided, the Coordinating Center is expected to support consortium-wide coordination such as:

  • Centralized organization and operational support for the CSER2 Consortium
  • Organizing regular meetings and communications across sites
  • Facilitating shared resources and cross-project integration
  • Helping standardize or harmonize consortium elements (as appropriate)
  • Supporting alignment of approaches across sites where appropriate
  • Facilitating common processes that benefit all participating studies

What are examples of “standardization” or “harmonization” mentioned for consortium work?

The information provided gives examples that may include harmonizing:

  • Data submission practices
  • Common measures
  • Reporting formats
  • Collaborative publications

What companion announcements are connected to this Coordinating Center?

This Coordinating Center supports projects funded under companion announcements RFA-HG-16-010 and RFA-HG-16-011.

What funding activity area is this opportunity categorized under?

The opportunity is categorized under the Health funding activity area.

What CFDA number is associated with this opportunity?

The opportunity references CFDA number 93.172 (listed twice in the provided information, likely indicating the same program entry).

Who is eligible to apply?

The eligibility is described as unusually broad and includes the following types of applicants:

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and state-controlled institutions of higher education
  • Private institutions of higher education
  • Federally recognized Native American tribal governments
  • Other tribal organizations
  • Public housing authorities / Indian housing authorities
  • Nonprofit organizations with or without 501(c)(3) status (other than higher education institutions)
  • For-profit organizations (other than small businesses)
  • Small businesses
  • Others, as may be clarified in the full announcement’s additional eligibility language

Why might the eligibility be so broad for this opportunity?

The description suggests the eligibility reflects the operational nature of a Coordinating Center and NIH’s interest in organizations experienced in areas like multi-site coordination, data management, clinical research operations, and consortium administration.

When was this opportunity posted?

The opportunity was created and posted on May 6, 2016.

What was the application closing date?

The application closing date was August 5, 2016.

Was the closing date extended?

Based on the record provided, the original and current closing dates are the same (August 5, 2016), which indicates no extension in the provided information.

What does it mean that the Coordinating Center is a “shared hub”?

It means the Coordinating Center is intended to help multiple CSER2 research sites operate as a coordinated consortium rather than as disconnected studies, by providing central support functions and cross-project integration.

What kinds of infrastructure and staffing costs is this award designed to support?

The award is described as supporting the infrastructure and staffing needed for consortium operations, including items such as:

  • Project management
  • Communications
  • Scheduling
  • Coordination of working groups
  • Documentation
  • Other shared functions that enable cross-site collaboration and integrated outcomes

What is the intended benefit of having a Coordinating Center for CSER2?

The Coordinating Center is meant to enable coordination, comparability, and collective output across funded projects, helping ensure the consortium produces a body of evidence that is easier to interpret and apply than if each project operated independently.

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