Opportunity Information: Apply for RFA HL 12 013
Apply for RFA HL 12 013
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Genomic Research in AAT Deficiency and Sarcoidosis study (GRADS) Cooperative Research Project Grant Clinical Centers (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.838 Lung Diseases Research.
- This funding opportunity was created on Feb 2, 2011 and posted on Feb 2, 2011.
- Applicants must submit their applications by May 17, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $12,000,000.00 to eligible and selected applicants.
- Eligible applicants include: State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) County governments For profit organizations other than small businesses Independent school districts Private institutions of higher education Special district governments Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Public and State controlled institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The Genomic Research in Alpha 1 Antitrypsin Deficiency and Sarcoidosis study (GRADS) Clinical Centers opportunity (Funding Opportunity Number RFA-HL-12-013) is an NHLBI, NIH funding announcement designed to build a coordinated, multi-site research program focused on two serious and relatively understudied lung-related conditions: Alpha 1 Antitrypsin Deficiency (AAT) and sarcoidosis. The central idea is to assemble a multidisciplinary network that can apply state-of-the-art genomics, microbiomics, and deep clinical phenotyping to better understand disease mechanisms, discover meaningful biological signals, and identify predictors of disease development and progression. This particular FOA supports the Clinical Centers that will do the participant-facing and sample-collection work, and it runs alongside a separate companion FOA that funds a Genomics and Informatics Center (GIC) (RFA-HL-12-014), which will serve as the analytic and coordinating hub for genomic and microbiomic assays and related informatics needs.
The award mechanism is a U01 cooperative agreement, which signals that this is not a typical investigator-initiated grant where each site operates largely independently. Instead, NHLBI expects substantial coordination and shared governance across awardees, with common protocols and program-wide milestones. GRADS is structured to include up to eight funded Clinical Centers plus one GIC. The Clinical Centers will collectively implement a study-wide protocol, meaning they will recruit and enroll participants, carry out standardized clinical and immunologic phenotyping, and collect and process biospecimens using harmonized procedures so that data and samples are comparable across sites. Those biospecimens are then shipped to the GIC for centralized genomics and microbiomics analyses, allowing the program to generate consistent, high-quality multi-omic datasets linked to carefully characterized clinical phenotypes.
A defining feature of this FOA is that each funded Clinical Center is expected to contribute in two complementary ways. First, every site participates in the common, program-wide GRADS protocol and cohort-building effort. Second, each Clinical Center develops its own clinic-specific research protocol that is aligned with the GRADS mission, with the goal of identifying pathogenetic mechanisms or predictors related to AAT or sarcoidosis disease onset, severity, or progression. In practice, that means the program combines the advantages of a unified cohort and standardized measurements with the scientific flexibility for individual centers to pursue specialized, hypothesis-driven projects that leverage their local expertise, patient populations, and research strengths.
Across the entire network, the targeted cohort size is substantial for rare or heterogeneous lung diseases: approximately 400 AAT participants and about 200 sarcoidosis participants, along with controls. By pooling recruitment across multiple clinical centers, GRADS aims to achieve enough statistical power and breadth of clinical representation to detect meaningful genomic and microbiomic associations, relate those findings to immune and clinical phenotypes, and support sub-analyses that might not be possible in single-center studies. The FOA emphasizes that the Clinical Centers should be led by investigators with relevant expertise spanning AAT and/or sarcoidosis, pulmonary medicine, immunology, genomics, and cell biology, reflecting the program’s intent to integrate clinical insight with modern molecular approaches.
Program governance is designed to keep the multi-site effort aligned and operationally consistent. A Steering Committee made up of all Clinical Center Principal Investigators is to be organized by the GIC. This committee is responsible for developing the study-wide protocol(s), coordinating scientific and operational decisions, and monitoring study progress and conduct across the network. That structure reinforces the cooperative nature of the award: clinical sites are not just recruitment hubs, but active partners in shaping protocols, ensuring quality control, and sustaining a cohesive program that produces integrated datasets and interpretable outcomes.
From an administrative standpoint, this is a discretionary health research opportunity under CFDA 93.838 (Lung Diseases Research), with no cost sharing or matching requirement. The FOA was posted February 2, 2011, with an original and current closing date of May 17, 2011, and an archive date of June 17, 2011. The estimated total funding level listed is $12,000,000. Eligibility is broad and includes many applicant types commonly seen in NIH programs: public and private institutions of higher education, nonprofits (including 501(c)(3) organizations), for-profit organizations, small businesses, state and local governments, tribal governments and organizations, U.S. territories or possessions, and various mission-specific institutional categories such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities. The eligibility list also notes that non-U.S. (foreign) entities and regional organizations may be eligible, and that additional clarifications may appear in the full FOA text.
Overall, this funding opportunity is best understood as an effort to stand up a coordinated national (and potentially broader) clinical research network that can recruit well-characterized AAT and sarcoidosis cohorts, collect high-quality biospecimens, and link deep phenotyping with centralized genomic and microbiomic analyses. The expected end product is not just a collection of separate projects, but a shared resource and integrated body of findings that can clarify disease biology, improve risk or progression prediction, and set the stage for future diagnostics or targeted interventions in AAT deficiency and sarcoidosis.
Frequently Asked Questions (FAQs)
What is the GRADS Clinical Centers funding opportunity?
The Genomic Research in Alpha 1 Antitrypsin Deficiency and Sarcoidosis study (GRADS) Clinical Centers opportunity (Funding Opportunity Number RFA-HL-12-013) is an NHLBI (NIH) funding announcement to build a coordinated, multi-site research program focused on two serious and relatively understudied lung-related conditions: Alpha 1 Antitrypsin Deficiency (AAT) and sarcoidosis.
Which diseases and research areas does this program focus on?
GRADS focuses on Alpha 1 Antitrypsin Deficiency (AAT) and sarcoidosis. The program emphasizes state-of-the-art genomics, microbiomics, and deep clinical phenotyping to better understand disease mechanisms, discover meaningful biological signals, and identify predictors of disease development and progression.
Who is sponsoring this opportunity?
This funding opportunity is sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).
What is the funding mechanism for this opportunity?
The award mechanism is a U01 cooperative agreement. This structure indicates that NHLBI expects substantial coordination, shared governance, and common protocols across awardees rather than largely independent site-by-site projects.
How is a U01 cooperative agreement different from a typical research grant?
Under a U01 cooperative agreement, the program is designed to operate as a coordinated network with shared decision-making, common protocols, and program-wide milestones. Clinical Centers are expected to work together and with the coordinating hub rather than running fully independent studies.
What is the role of the Clinical Centers funded under RFA-HL-12-013?
The Clinical Centers are responsible for participant-facing activities and sample-collection work. Collectively, they recruit and enroll participants, carry out standardized clinical and immunologic phenotyping, and collect and process biospecimens using harmonized procedures so data and samples are comparable across sites.
Is there a companion funding opportunity associated with this program?
Yes. A separate companion FOA funds the Genomics and Informatics Center (GIC) (RFA-HL-12-014), which serves as the analytic and coordinating hub for genomic and microbiomic assays and related informatics needs.
What does the Genomics and Informatics Center (GIC) do in GRADS?
The GIC serves as the centralized analytic and coordinating hub. Biospecimens collected by Clinical Centers are shipped to the GIC for centralized genomics and microbiomics analyses, supporting consistent, high-quality multi-omic datasets linked to deeply characterized clinical phenotypes.
How many awards are expected under GRADS?
GRADS is structured to include up to eight funded Clinical Centers plus one Genomics and Informatics Center (GIC).
What is meant by a "study-wide protocol" in this FOA?
A study-wide protocol means all Clinical Centers collectively implement a common GRADS protocol for cohort-building and standardized measurements. This includes harmonized recruitment, phenotyping, and biospecimen collection/processing procedures across sites.
Do Clinical Centers only participate in the common protocol, or can they pursue their own research?
Each funded Clinical Center is expected to contribute in two ways: (1) participate in the common, program-wide GRADS protocol and cohort-building effort, and (2) develop a clinic-specific research protocol aligned with the GRADS mission to identify pathogenetic mechanisms or predictors related to AAT or sarcoidosis onset, severity, or progression.
What types of data and samples will Clinical Centers collect?
Clinical Centers will conduct standardized clinical and immunologic phenotyping and will collect and process biospecimens using harmonized procedures. Those biospecimens are then shipped to the GIC for centralized genomics and microbiomics analyses.
What are the targeted cohort sizes for AAT and sarcoidosis?
The targeted cohort across the network is approximately 400 AAT participants and about 200 sarcoidosis participants, along with controls.
Why does GRADS use a multi-site network for these conditions?
By pooling recruitment across multiple Clinical Centers, GRADS aims to assemble substantial cohorts for rare or heterogeneous lung diseases, improve statistical power, broaden clinical representation, and enable sub-analyses that may not be feasible in single-center studies.
What kinds of scientific outcomes is GRADS aiming to produce?
The program aims to clarify disease biology by relating genomic and microbiomic findings to immune and clinical phenotypes, discover meaningful biological signals, and identify predictors of disease development and progression. The expected end product is an integrated body of findings and a shared resource rather than a set of disconnected projects.
What expertise is expected for Clinical Center leadership?
The FOA emphasizes that Clinical Centers should be led by investigators with relevant expertise spanning AAT and/or sarcoidosis, pulmonary medicine, immunology, genomics, and cell biology, reflecting the goal of integrating clinical insight with modern molecular approaches.
How will the GRADS network be governed and coordinated?
Program governance includes a Steering Committee made up of all Clinical Center Principal Investigators, organized by the GIC. The Steering Committee is responsible for developing the study-wide protocol(s), coordinating scientific and operational decisions, and monitoring study progress and conduct across the network.
What is the CFDA number and program area for this opportunity?
This is a discretionary health research opportunity under CFDA 93.838 (Lung Diseases Research).
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
What is the estimated total funding level for this FOA?
The estimated total funding level listed is $12,000,000.
When was the FOA posted, and what are the closing and archive dates?
The FOA was posted February 2, 2011. The original and current closing date is May 17, 2011, and the archive date is June 17, 2011.
Who is eligible to apply for this opportunity?
Eligibility is broad and includes: public and private institutions of higher education; nonprofits (including 501(c)(3) organizations); for-profit organizations; small businesses; state and local governments; tribal governments and organizations; U.S. territories or possessions; and mission-specific institutional categories such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities.
Are non-U.S. (foreign) entities eligible?
The eligibility list notes that non-U.S. (foreign) entities and regional organizations may be eligible, and that additional clarifications may appear in the full FOA text.
Is this opportunity intended to support independent projects at each site?
No. While each Clinical Center proposes a clinic-specific protocol aligned with the GRADS mission, the program is designed as a coordinated network with a shared cohort, standardized procedures, and centralized omics analysis through the GIC.
What makes this FOA "participant-facing"?
The Clinical Centers handle the on-the-ground clinical research activities: recruiting and enrolling participants, performing standardized phenotyping, and collecting/processing biospecimens that feed into centralized genomic and microbiomic analyses.
What is the relationship between deep phenotyping and genomics/microbiomics in GRADS?
GRADS is designed to link high-quality genomic and microbiomic datasets to carefully characterized clinical and immune phenotypes. The Clinical Centers generate standardized clinical and immunologic data and collect biospecimens, while the GIC performs centralized assays and informatics so results can be interpreted in the context of comparable phenotypes across the full cohort.
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