Opportunity Information: Apply for RFA HL 15 016
Apply for RFA HL 15 016
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Network Management Core (NEMO) for the Pulmonary Trials Cooperative (PTC) (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233 National Center on Sleep Disorders Research 93.838 Lung Diseases Research.
- This funding opportunity was created on Aug 14, 2014 and posted on Aug 14, 2014.
- Applicants must submit their applications by Oct 20, 2014. (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 $3,300,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: For profit organizations other than small businesses Public housing authorities/Indian housing authorities Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses State governments Native American tribal governments (Federally recognized) County governments 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 Independent school districts City or township governments Public and State controlled institutions of higher education Special district governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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 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 not allowed.
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Opportunity Summary:
The NIH funding opportunity RFA-HL-15-016 sought a single awardee to serve as the Network Management Core (NEMO) for the Pulmonary Trials Cooperative (PTC) through a U01 cooperative agreement mechanism. In practical terms, this was not a grant to run one specific clinical trial. It was a grant to build and operate the central organizing hub for an entire multi-center clinical trials network. Under this model, the PTC would be made up of multiple Protocol Leadership Groups (PLGs) that develop and lead individual study protocols, while NEMO functions as the shared backbone that coordinates the network and keeps the overall program running smoothly across sites and studies.
The scientific and clinical focus of the PTC was adult chronic pulmonary disease, with an emphasis on running multiple "simple" and pragmatic clinical trials in both inpatient and outpatient settings. The FOA highlighted diseases such as interstitial lung disease (ILD), pulmonary hypertension (PH), chronic obstructive pulmonary disease (COPD), sarcoidosis, and obstructive sleep apnea, while explicitly excluding asthma and excluding acute lung injury and critical care. The intent was to create a nimble platform capable of evaluating promising therapies (new or already in use) through Phase 2 and Phase 3 trials that are designed to be more practical and easier to implement than highly complex traditional trials, supporting real-world effectiveness and feasibility.
NEMO's role, as described, was to have primary responsibility for organizing and operating the cooperative as a multi-center network. That typically implies central coordination functions such as network governance support, communication and meeting logistics, site coordination, standardization of network processes, and ensuring consistent operations across multiple protocols led by different PLGs. Because this is a U01 cooperative agreement, the NIH would be expected to have substantial programmatic involvement, meaning the awardee would work in close partnership with NIH staff rather than operating fully independently as in a standard research project grant.
This FOA was paired with a companion announcement (RFA-HL-15-015) that solicited applications to support the actual clinical trial protocols and their associated data management and analysis activities. In other words, RFA-HL-15-016 funded the central network management core, while the companion FOA funded the protocol-specific teams and the study-level data infrastructure and analytics. Together, the two announcements were designed to create a coordinated system: PLGs propose and execute trials, and NEMO ensures the network functions efficiently as a whole.
Administratively, the opportunity was categorized as a discretionary health funding opportunity using the Cooperative Agreement funding instrument (U01). The NIH expected to make 1 award, with an award ceiling listed as $3,300,000, and there was no cost sharing or matching requirement. It was posted on August 14, 2014, with an original and current closing date of October 20, 2014, and an archive date of November 20, 2014. The CFDA numbers associated with the opportunity were 93.233 (National Center on Sleep Disorders Research) and 93.838 (Lung Diseases Research), reflecting the programmatic areas tied to sleep disorders and lung disease research.
Eligibility was broad and included many types of U.S.-based organizations and governments: public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations other than small businesses, small businesses, state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, and special district governments, among others. The FOA also explicitly included categories such as HBCUs, Hispanic-serving institutions, AANAPISISs, Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, tribally controlled colleges and universities, regional organizations, and eligible federal agencies. Foreign institutions and other non-U.S. entities were not eligible to apply, and foreign components were not allowed under NIH policy, including non-domestic components of U.S. organizations.
Overall, the opportunity was aimed at establishing a single, highly capable coordinating center to support a national pragmatic pulmonary trials enterprise in adults, enabling multiple streamlined Phase 2 and Phase 3 studies across diverse chronic lung diseases, with NEMO providing the operational structure that allows multiple PLGs and participating sites to function as one coherent, efficient clinical trials cooperative.
Frequently Asked Questions (FAQs)
What is the NIH funding opportunity RFA-HL-15-016?
RFA-HL-15-016 was an NIH funding opportunity that sought a single awardee to serve as the Network Management Core (NEMO) for the Pulmonary Trials Cooperative (PTC) using a U01 cooperative agreement mechanism.
What would the awardee actually do under this FOA?
The awardee would build and operate the central organizing hub for a multi-center clinical trials network. Rather than running one specific trial, the awardee would manage the shared backbone that helps the overall program function smoothly across sites and studies.
Is this funding for a single clinical trial?
No. This opportunity was not intended to fund one specific clinical trial. It was intended to fund network-wide management and coordination through NEMO for a broader cooperative clinical trials enterprise.
What is NEMO in the context of the Pulmonary Trials Cooperative (PTC)?
NEMO is the Network Management Core. It is the central coordinating entity responsible for organizing and operating the PTC as a multi-center network and providing the operational structure that allows multiple groups and sites to function as a single cooperative.
What are Protocol Leadership Groups (PLGs), and how do they relate to NEMO?
PLGs are Protocol Leadership Groups that develop and lead individual study protocols. NEMO supports the network as a whole by coordinating operations across multiple PLGs and participating sites so that the overall cooperative runs consistently and efficiently.
What is the scientific focus of the Pulmonary Trials Cooperative (PTC)?
The PTC focused on adult chronic pulmonary disease and emphasized running multiple simple and pragmatic clinical trials in both inpatient and outpatient settings.
Which diseases were highlighted as part of the PTC focus?
The FOA highlighted interstitial lung disease (ILD), pulmonary hypertension (PH), chronic obstructive pulmonary disease (COPD), sarcoidosis, and obstructive sleep apnea.
Which conditions were explicitly excluded?
The FOA explicitly excluded asthma. It also excluded acute lung injury and critical care.
What kinds of trials was the network intended to run?
The network was intended to support multiple "simple" and pragmatic Phase 2 and Phase 3 trials designed to be more practical and easier to implement than highly complex traditional trials, with an emphasis on real-world effectiveness and feasibility.
Are both inpatient and outpatient settings included?
Yes. The FOA emphasized trials in both inpatient and outpatient settings.
What does "pragmatic" mean here?
Based on the FOA description, "pragmatic" refers to trials that are designed to be practical and easier to implement than highly complex traditional trials, supporting real-world effectiveness and feasibility.
What does the U01 cooperative agreement mechanism imply for how the project is run?
A U01 cooperative agreement implies substantial NIH programmatic involvement. The awardee would be expected to work in close partnership with NIH staff rather than operating fully independently as in a standard research project grant.
What kinds of responsibilities would NEMO typically handle?
NEMO would have primary responsibility for organizing and operating the cooperative as a multi-center network. This typically implies functions such as network governance support, communication and meeting logistics, site coordination, standardization of network processes, and ensuring consistent operations across multiple protocols led by different PLGs.
Was there a companion funding opportunity connected to this FOA?
Yes. This FOA was paired with a companion announcement, RFA-HL-15-015.
What did the companion FOA (RFA-HL-15-015) fund?
RFA-HL-15-015 solicited applications to support the actual clinical trial protocols and their associated data management and analysis activities. In this structure, RFA-HL-15-016 funded the central network management core, while the companion FOA supported protocol-specific teams and study-level data infrastructure and analytics.
How were RFA-HL-15-016 and RFA-HL-15-015 intended to work together?
Together, the two announcements were designed to create a coordinated system: PLGs propose and execute trials, and NEMO ensures the network functions efficiently as a whole.
How many awards did NIH expect to make?
NIH expected to make one (1) award under this opportunity.
What was the maximum award amount listed for this opportunity?
The award ceiling was listed as $3,300,000.
Was cost sharing or matching required?
No. There was no cost sharing or matching requirement.
What type of funding opportunity was this categorized as?
It was categorized as a discretionary health funding opportunity using the Cooperative Agreement funding instrument (U01).
When was the opportunity posted, and what were the key dates?
It was posted on August 14, 2014. The original and current closing date was October 20, 2014. The archive date was November 20, 2014.
What CFDA numbers were associated with the opportunity?
The CFDA numbers were 93.233 (National Center on Sleep Disorders Research) and 93.838 (Lung Diseases Research).
Who was eligible to apply?
Eligibility was broad and included many types of U.S.-based organizations and governments, including public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations other than small businesses, small businesses, and a variety of government entities.
What types of government entities were listed as eligible?
Eligible entities included state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, and special district governments, among others.
Were specific institution types explicitly mentioned as eligible?
Yes. The FOA explicitly included categories such as HBCUs, Hispanic-serving institutions, AANAPISISs, Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, tribally controlled colleges and universities, regional organizations, and eligible federal agencies.
Were foreign institutions or non-U.S. entities eligible to apply?
No. Foreign institutions and other non-U.S. entities were not eligible to apply.
Were foreign components allowed as part of an application?
No. Foreign components were not allowed under NIH policy, including non-domestic components of U.S. organizations.
At a high level, what was the overall purpose of this opportunity?
The overall purpose was to establish a single, highly capable coordinating center to support a national pragmatic pulmonary trials enterprise in adults, enabling multiple streamlined Phase 2 and Phase 3 studies across diverse chronic lung diseases, with NEMO providing the operational structure that allows multiple PLGs and participating sites to function as one coherent, efficient clinical trials cooperative.
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