Research Opportunity Announcement

OTA-20-011 

ACTIV Integration of Host-targeting Therapies for COVID191

Introduction

Addressing a crisis of the magnitude and urgency of the COVID-19 pandemic transcends what 

any single entity can accomplish acting in isolation and calls for rapid and efficient mobilization 

and coordination of our nation’s clinical trial infrastructure. In recognition of this, NIH has 

launched the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Initiative

to develop a collaborative framework for streamlining clinical trials, coordinating regulatory 

processes, and leveraging assets among industry, institutional, and government partners to 

rapidly respond to this national public health emergency. NHLBI is a key participant in the 

ACTIV Program, and in this capacity is launching a nimble NHLBI adaptive clinical trial platform 

that integrates its various research networks and resources capable of rapidly and efficiently

executing robust clinical trials of promising host-directed interventions for COVID-19. The 

NHLBI Adaptive Clinical Trial Platform will be aimed at rapid and rigorous testing of 

mechanistically diverse COVID-19 host-directed interventions that are relevant to heart, lung, 

blood, and cardiovascular dimensions of COVID-19 and that target critical points along the 

clinical spectrum, from exposure through development of mild symptoms, development of 

symptoms requiring hospitalization, and extending through convalescence and recovery. This 

will significantly contribute to the evidence base for clinical practice and development of safe 

and effective interventions and implementation strategies as part of the larger ACTIV whole-ofgovernment, whole-of-America response to conquer COVID-19.

Given the remarkable variations in severity of SARS-CoV-2 infection among different groups and 

the striking contributions of lung, cardiac, vascular, and hematologic dysfunction to COVID-19 

morbidity and mortality, it is clear that host- and community-related factors are important 

modulators of COVID-19. It is therefore imperative to test not only antiviral therapies, but also 

host-targeting treatments that seek to ameliorate tissue injury, enhance reparative responses, 

and improve health outcomes related to heart, lung, blood and vasculature by targeting 

pathobiological processes with organ system or risk group specificity. Examples of such 

treatments include, but are not limited to, immunomodulators and as well drugs and biologics 

that target particular pathways such as mTOR, IL-system, coagulation, or the renin-angiotensin 

systems. Host-targeting interventions may be repurposed or novel agents or devices, used 

alone or in combination, or may involve strategies of medical care. 

1 Originally published on 4/28/2020 and titled “Host-targeting Therapies for COVID19," this ROA has been 

retitled as "ACTIV Integration of Host-targeting Therapies for COVID19" and amended to reflect 

anticipated integration with the NIH ACTIV initiative.

No longer receiving applications As of June 18, 2020 NHLBI is no longer receiving applications for this announcement. 
This solicitation:

1. Invites Data and Clinical Coordinating Centers that have appropriate expertise in clinical

trial design and implementation, as well as existing relationships with a

network/consortium of Clinical Centers, to propose inpatient or outpatient trials of

host-targeting interventions in patients infected with SARS-CoV-2, designed

appropriately for the population and intervention being studied. Although the primary

focus of this program is on adaptive design-based testing of interventions in phase II or

III drug or therapeutic trials, it is strongly encouraged that proposed studies also include

complementary aims such as collecting data, images, and biospecimens; identifying

predictive biomarkers; and/or clarifying the pathobiology or the distinctive organ-

/individual-specificity of this disease relevant to the NHLBI mission.

2. Invites Data and Clinical Coordinating Centers with appropriate expertise and capacity

to submit a proposal to serve as the Administrative Coordinating Center (ACC) for the

Network of Networks Platform, outlining the functions, roles, and responsibilities of

such a Coordinating Center in ensuring the efficient and effective operations of the

NHLBI’s host-directed COVID-19 Clinical Trials Platform as an integral component of the

over-arching, trans-NIH ACTIV program. In accordance with the overall objectives of

the ACTIV program, the ACC will assist and support the NHLBI in identifying the most

compelling and strategic scientific opportunities and will enhance the likelihood that all

funded trials are successful in achieving the scientific goals.

Authority

This NHLBI Research Opportunity Announcement (ROA) is issued with the goal of establishing 

an “Other Transactions” (OT) agreement pursuant to 42 U.S.C. § 285b-3.

Objectives

• The NHLBI is soliciting applications for multicentered phase 2 and 3 randomized, controlled

clinical trials of host-targeting strategies to prevent and treat SARS-CoV-2 disease.

Although the primary focus of this program is on adaptive-design-based clinical testing of

interventions as part of the ACTIV program, it is strongly encouraged that proposed studies

also include aims such as identification of prognostic biomarkers, developing or refining

activities that improve the safety or efficacy of the clinical care of COVID-19 patients and/or

that slow or prevent the progression of COVID-19. Taken together, these studies should

establish a sound evidence base for clinical practice and development of safe and effective

interventions in accordance with the goals of the ACTIV program.

• The NHLBI is also soliciting applications from experienced Data and Clinical Coordinating

Centers with an established network or consortium of Clinical Centers to serve as the ACC

for the NHLBI’s network of networks platform, which is as an integral component of the

ACTIV program. The ACC will be established to coordinate the development and

implementation of master protocols focused on host-directed interventions relevant to

heart, lung, blood, and cardiovascular dimensions of COVID-19 across the range of COVID19 populations described above and provide logistics, administrative support, for the

No longer receiving applications As of June 18, 2020 NHLBI is no longer receiving applications for this announcement. 
network of networks and support independent oversight of trial progress. This may include 

in the future the need to develop and support peer review of protocols. This initiative is 

open to experienced Data and Clinical Coordinating Centers with an established network or 

consortium of Clinical Centers with heart, lung, and blood expertise. Organizations or 

institutions submitting applications are required to propose trials of a host-targeting

intervention(s), but changes in the intervention(s) or trial design may be negotiated with 

NHLBI. The rationale for trials should be based on thorough evaluation of other ongoing 

trials and networks. The development and implementation of the ACTIV master protocols 

for adaptive trials for: 1) in-hospital (including ICU) patients, 2) high-risk infected 

outpatients, or 3) convalescing and recovered patients is expected. The overall goal is to

establish an inter-connected, centrally coordinated structure with clinical centers executing 

master protocols for adaptive platform trials to increase the clinical trial bandwidth across 

the country and rapidly scale up and maximize the number of host-directed trials that are

conducted and which complement other ongoing trials.

• Proposals with the following characteristics are strongly encouraged :

o Submitted as a collaborative effort by two or more clinical trial networks/consortia.

o Trial designs implemented leveraging the evolving ACTIV master protocols for adaptive

platform approaches supporting rapid adaptive sequential and/or combination testing

of multiple interventions. Proposals should address adaptive approaches to

randomization, monitoring for safety, futility and efficacy, and sample size adjustment.

Also, where appropriate, seamless transition from phase 2 to phase 3.

o High feasibility to launch trials within the next one to two months and likely to complete

in no more than 9 to 12 months.

o Trial designs in which the test and control interventions are in the context of and

additive to usual care.

o Trial designs and plans capable of facile adaptation to the rapidly evolving clinical

landscape with consideration of the possible different evolutions of the pandemic as

reflected in the diverse models of the rate of disease in the United States in the future.

o Proposals should address adaptive approaches to changes in usual care and

incorporation of emerging promising interventions into the ACTIV master platform

protocols.

o Strategies for leveraging a common comparison group for two or more interventions

being tested in a participant population of interest, including implications for masking.

o Consent processes that address e-consent, use of legally authorized representatives,

and other alternative consent processes, as well as utilization and sharing of EHR data,

as appropriate

o Data, image, and biospecimen collection plans that enable a deeper understanding of

the pathobiology and patient stratification and which include, for example, extensive

phenotyping and genotyping of patients and identification of biomarkers

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o Plans for data harmonization that include adoption of COVID-19 common data elements

(CDEs) and for rapid data, image, and biospecimen sharing

o Recruitment strategies to ensure inclusion of appropriate participant populations to

enhance generalizability of research findings

o Collaborations with industry to gain access to leading-edge technologies and novel

therapeutic agents capable of selectively modulating the immune system and other

host-directed biological systems to ameliorate the course of COVID-19.

o Collaborations with other trial networks in the United States which may have other

sources of funding.

Eligibility

Organizations

The following entities are eligible to apply under this ROA:

• Higher Education Institutions

• Public/State Controlled Institutions of Higher Education

• Private Institutions of Higher Education

• 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)

Scope

The goal of this ROA is to forge a NHLBI network of networks as an integral element of the 

trans-NIH ACTIV program capable of conducting multiple, multicenter randomized, controlled 

clinical trials of promising host-targeting interventions aimed at mitigating and ameliorating the 

tissue injury/enhancing repair responses in the lung, heart, blood and vasculature and 

improving clinical outcomes for the prevention or treatment of COVID-19 disease relevant to 

the NHLBI mission. Host-targeting interventions should encompass the range of organ systems 

affected during COVID-19 and may be used in combination with anti-viral interventions.

Proposed projects should be for focused, adaptive design-based phase II/III efficacy trials to 

treat or prevent the cardiovascular, pulmonary and hematologic (including thrombotic and 

thrombo-inflammatory) manifestations of COVID-19 disease. This ROA is not intended to 

replace traditional NIH research funding mechanisms (e.g., R01, P01, R34, U01, UG3). 

Examples of research areas of interest include, but are not limited to:

No longer receiving applications As of June 18, 2020 NHLBI is no longer receiving applications for this announcement. 
• Host-targeting therapies known to have immunomodulatory or anti-inflammatory

effects such as Interferon-beta 1, alpha and lambda, IL6 receptor blockade with

monoclonal antibodies (e.g., tocilizumab), IL1 receptor antagonist, anakinra, steroids

and other immunotherapies.

• The Renin-Angiotensin-Aldosterone (RAAS) pathway and angiotensin converting enzyme

(ACE) pathway targets such as ARBs, ACE inhibitors, combination RAAS drugs,

(moexipril), monoclonal antibodies, recombinant human ACE2 (rhACE2), or Ang1-7.

• Treatments targeting alternative biologically plausible mechanisms/pathways (e.g.,

mTOR, platelet hyper-activation, autoimmune vasculitis).

• Treatment trials of convalescent plasma, hyperimmune globulins, and other bloodderived therapeutics.

• Treatment trials of anti-thrombotic/anti-thrombo-inflammatory interventions.

• Treatment trials of GM-CSF and other chemokines.

• Use of immunoadjuvants to prevent progression of COVID-19.

• Testing of immunomodulating intervention (e.g. BCG vaccination) to prevent viral

infection in healthcare or nursing home settings.

• Virus-targeting agents such as remdesivir, Kaletra (lopinavir/ritonavir), and the antimalarial, hydroxychloroquine, used in combination with a host-targeting intervention.

• Combination therapies of multiple agents listed above or others as appropriate.

• Combinations of new agents and changes in way that care is delivered.

What is NOT eligible for funding under this ROA? 

Examples include (but are not limited to) the following:

• Development of animal models

• Pre-clinical studies

• Phase I/IIa studies

• Single-center studies

• Observational studies

Regulatory Approvals for Clinical Trials 

All applicants for clinical trials must have all necessary regulatory approvals, such as an IND 

authorization or IDE approval before award (i.e., pre-IND conversations documented at the 

time of submission and INDs/IDEs before award). Given the urgency to test promising 

interventions, the applicant may provide, in lieu of an IND, communication from FDA indicating 

No longer receiving applications As of June 18, 2020 NHLBI is no longer receiving applications for this announcement. 
it is safe to proceed with the proposed clinical protocol if proposing a new trial under an open 

IND/IDE or compassionate use. 

Special Award Terms

The complete terms and conditions of each Other Transaction award issued under this ROA are 

subject to negotiation and will be contained in the OT Agreement entered between the NHLBI 

and the Awardee. This Special Award Terms section is provided for informational purposes only 

in order to provide prospective applicants with an understanding of key expectations and terms 

that may differ from traditional NIH award mechanisms. 

Lower Tier Agreements

With mutual consent of the Awardee and the NHLBI, successful Data and Clinical Coordinating 

Centers will be expected to issue sub-awards to entities identified and approved by the NHLBI

as a result of this or future ROAs that solicit ideas for new and novel agents targeting

understudied areas or interventions. The Awardee will therefore need to dedicate a sufficient 

level of qualified professional services to develop and implement the systems, processes, and 

management techniques to effectively and efficiently execute and manage clinical sub-awards 

at the direction of the NHLBI. As a future extension to this capability and with the mutual 

consent of the Awardee, the NHLBI may require the successful Data and Clinical Coordinating 

Centers to develop and maintain an internal proposal solicitation, receipt, and peer review

function. 

Milestone-Based Payment Schedule

NHLBI funds issued under the OT Agreement will be disbursed based upon achievement of 

specific Operational Milestones, as proposed by the Awardee in its application and 

subsequently approved by NHLBI.

An “Operational Milestone” is an objective, measurable event that is indicative of project 

progress occurring as proposed in the application. NHLBI establishes Operational Milestones in 

the OT Agreement based upon information provided in the application. Except for the first 

payment issued upon the execution of the OT Agreement, payments will be obligated and 

disbursed upon completion of specific Operational Milestones.

With mutual consent of the Awardee and the NHLBI, adjustments may be made to the timeline 

for inclusion in the OT Agreement to ensure that funds are appropriately dispersed across 

Operational Milestones. If NHLBI determines, in its sole discretion, that an awardee has failed 

to satisfy one or more Operational Milestone(s), NHLBI may terminate the OT Agreement.

Award Criteria and Selection Information

Awardees will be selected through an objective review process. Multiple awards are 

anticipated. The level of funding for awards made under this ROA has not been predetermined 

but will depend on (1) the objectives proposed by the applicant and how well they fit with the 

goals of the host targeting therapies initiative, (2) quality of the proposals received, and (3) 

No longer receiving applications As of June 18, 2020 NHLBI is no longer receiving applications for this announcement. 
availability of funds. Agreements for all awards will be negotiated with eligible entities whose 

proposals are determined to be the most meritorious and provide the best value to the NHLBI 

toward achieving the goals of the host targeting therapies initiative and in accordance with the 

NHLBI priorities.

The NHLBI reserves the right to:

• Select for negotiation all, some, one, or none of the proposals received in response to 

this ROA;

• Segregate portions of resulting awards into components and their associated budget 

and/or milestones that differ from those that have been proposed;

• Accept proposals in their entirety or to select only portions of proposals for award;

• Fund proposals in increments and/or with options for continued work at the end of one 

or more phases, which can consist of more than one milestone;

• Fund proposals of two or more applicant entities as part of a reorganized, consolidated 

consortium operating under an article of collaboration, teaming arrangement, or other 

means acceptable to the NHLBI;

• Fund proposers as sub-awardees of a separate Coordinating Center entity to be 

established by the NHLBI;

• Request additional documentation (certifications, etc.); and

• Remove proposers from award consideration should the parties fail to reach a finalized, 

fully executed agreement, or the proposer fails to provide requested additional 

information in a timely manner.

Proposal Process

Submission in response to this ROA occurs in two stages. Stage 1 requires submitting a Letter of 

Request; if approved to proceed by NHLBI (see >$500k process on NHLBI web site), proceed to 

Stage 2, which requires submitting a full proposal using eRA ASSIST. In its sole discretion, NHLBI 

may invite applicants to skip Stage 1 and proceed to Stage 2 directly, if deemed ready to submit 

a full proposal.

STAGE 1 - NHLBI Host-targeting Therapies Initial Eligibility and Preliminary Review

NHLBI will review and determine whether the applicant should proceed with completing the full 

proposal submission. The NHLBI may request additional information be provided by the 

applicant to complete their initial eligibility and preliminary review. These requests will be sent 

to the applicant via email. Applicants are strongly encouraged to provide the requested 

information in a timely manner to prevent any potential delays in the review process. Proposals 

that do not meet the initial Host Targeting Therapies ROA program and eligibility criteria will be 

rejected.

Stage 1 will be patterned after the NHLBI >$500K process that includes a Letter of Request 

addressed to the appropriate NHLBI division (heart, lung or blood) outlining major elements of 

research, budget, feasibility, and specific elements related to COVID-19 studies (see process on 

No longer receiving applications As of June 18, 2020 NHLBI is no longer receiving applications for this announcement. 
NHLBI website: https://www.nhlbi.nih.gov/grants-and-training/policies-andguidelines/applications-with-direct-costs-of-500000-or-more-in-any-one-year). 

In order for the NHLBI to make an informed decision about whether to accept a proposed 

application for review, the Letter of Request (https://www.nhlbi.nih.gov/grants-andtraining/policies-and-guidelines/applications-with-direct-costs-of-500000-or-more-in-any-oneyear) should not exceed 5 pages and should include:

o The proposed project title

o The anticipated solicitation (Funding Opportunity Announcement/Research Opportunity

Announcement

o The anticipated application receipt date

o The expected start date to launch the study

o The status of regulatory consultation and any requisite regulatory approvals (e.g., IND

authorization or IDE approval as appropriate and IRB review) or communications from

the FDA related to the agent being tested. This approval will be needed at the time of

award

o The key personnel (the eRA Commons userid must be included for the PI or contact PI)

o The submitting organization or institution

o Demonstrated ability of the group or history of the investigators in conducting clinical

research

o Succinct summary of the specific research question(s) to be addressed

o Brief description of the rationale for and importance of the research question(s),

particularly from a public health perspective, describing what the study will contribute

to advancing the diagnosis, consequences, treatment, and/or prevention of COVID-19

and COVID-19 related conditions and how the proposed study will complement other

ongoing trials

o Summary of the study -- sample size, methods, primary and secondary outcomes,

description of interventions, key measurements to be obtained, duration of study, very

brief description of statistical methods, very brief description of power focusing on the

primary question or major hypotheses, and impact of different feasible projections of

future disease rates

o Brief description of any preliminary work, including pilot testing of interventions

o Brief summary of the safety profile, evidence for efficacy, drug availability now and on a

large scale in the future, drug administration, storage, and dosing requirements of

intervention(s)

o Evidence for the appropriateness of the trial design, equipoise among the trial arms, and

how the trial interventions compare to usual or standard care; briefly address how the

trial will address and adapt to a very dynamic clinical landscape in which “usual care” is

rapidly evolving; and whether co-enrollment of research participants in other clinical

trials is permissible

o Brief description of commitment to and experience with development and

implementation of a master protocol for an adaptive platform trial

o Flexibility to adapt to changing environment, including for example, evolution of

standard of care and treatment modalities

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o Efforts to standardize and collaborate with other studies including utilization, as 

appropriate, of COVID-19 CDEs, harmonized endpoints and outcome measures, and 

leveraging multiple existing networks, cohorts, or other relevant infrastructure and 

studies

o Brief summary of evidence in support of ability to meet accrual targets 

o Planned organizational structure for the study, including the sites and coordinating 

center; include brief information about key investigators

o Description of the planned demographics of study participants, including plans to 

comply with:

o NHLBI Policy for Inclusion of Women and Minorities as Subjects in Clinical 

Research

o NIH Policy and Guidelines on the Inclusion of Women and Minorities as 

Subjects in Clinical Research

o NIH Policy and Guidelines on the Inclusion of Children as Participants in 

Research Involving Human Subjects

o NIH Policy and Guidelines on the Inclusion of Individuals Across the 

Lifespan as Participants in Research Involving Human Subjects

o Monitoring plan for clinical studies, including a Data and Safety Monitoring 

Board/Observational Study Monitoring Board, if required

o Direct and total costs by year, and for the entire duration of the study – generally a oneparagraph description of major sources of costs in the study using one of the two tables 

provided via the following link. Specify (1) any funding provided by other entities 

(federal agencies, foundations, companies), and (2) any goods or services (and their 

value) provided by any of these parties, including drugs/placebo, equipment, 

procedures, etc. 

o A description of any anticipated agreements with third-parties relevant to the proposed 

project, including details about any provisions or restrictions related to intellectual 

property, publication, data and specimen sharing, and dissemination of results

o Given the context of current COVID-19 public health emergency:

Plan for expedited data, images and biospecimen sharing and facilitating data and 

biospecimen sharing through: usage of COVID-19 CDEs; plans for the use and 

sharing of EHR data as applicable; plans, including timelines, for making data 

and biospecimens available rapidly through NHLBI-designated repositories; 

and sharing data and biospecimens, as available, with public health agencies

Plan for interim analyses and rapidly disseminating the results for clinical or public 

health practice, including a brief description of the intended audience, 

approaches designed to reach that audience, and a timeline

o Brief description of the consent process and justification, if applicable, for Waiver of 

Informed Consent (WIC) or Exception from Informed Consent (EFIC), with plans for 

community consultation in the case of EFIC

o Statement indicating willingness to collaborate as part of the overarching trans-NIH 

ACTIV program as it evolves, including adaptation to ACTIV master protocols as 

appropriate

No longer receiving applications As of June 18, 2020 NHLBI is no longer receiving applications for this announcement. 
STAGE 2 - Full Proposal 

If upon review of the Letter of Request the NHLBI determines the proposed research to be in 

scope and hold significant promise for achieving the objectives of this ROA, the applicant will be 

invited to submit a full proposal. The full proposal will be submitted via eRA ASSIST following 

instructions that will be provided to the applicant. 

The full proposal should include information in the following areas:

• Additional administrative information about the applicant and institution or organization 

(name, address, entity and Principal Investigator NIH Commons Registration information), 

including SAM information and DUN and Bradstreet number, human and animal assurance 

approvals as appropriate.

• Project Plan uploaded as searchable PDF format in a font size of 11 or 12 point and font type 

of Arial or Times New Romans. Margins must be 1-inch wide (top, bottom, left, and right). The 

project plan must not exceed 50 pages in length. Biosketches must not exceed 4 pages in length 

and are not counted in the page limit. Also excluded from the page limitation are cover sheets, 

letters from collaborators and consultants, and representation and certification documents.

• Budget reflecting the proposed milestone-based payment schedule and total cost proposed, 

accounting for cost share amounts offered by the applicant. (If proposing F&A include a 

negotiated federal rate approval.)

o Statement indicating willingness to collaborate as part of the overarching trans-NIH ACTIV 

program as it evolves, including adaptation to ACTIV master protocols as appropriate

Project Plan

The precise contents of the Project Plan will depend on the nature of the proposed clinical trial. 

The Project Plan should generally include the following elements:

• Project Summary: Description of the project.

• How the proposed intervention will improve patient outcomes and/or quality of life. 

Discussion of the scientific rationale and data, including the therapeutic candidate, that 

support its use in COVID19 disease and in the patient population in which testing will occur.

• Risk/Benefit Profile: Risk/benefit profile and draft of the Investigator’s Brochure (IB), if 

available.

• Operational Milestone Based Plan: The plan should describe all proposed Operational 

Milestones. Each Operational Milestone should include objective completion criteria and an 

anticipated completion date, as well as a 9-12 month timeline showing each milestone in a 

Gantt chart like format. Pricing for each milestone should be separately identified in the 

Budget.

No longer receiving applications As of June 18, 2020 NHLBI is no longer receiving applications for this announcement. 
• Food and Drug Administration (FDA) Correspondence: Relevant FDA comments and plan for

addressing any issues raised by FDA and official FDA meeting minutes and/or FDA

correspondence relevant to the proposed project.

• Adaptive-design clinical protocols synopsis and draft of clinical protocols in the framework

of a master protocol for an adaptive platform trial.

• Data and Safety Monitoring Information: The proposal should include a description of how

clinical trial research activities will be monitored consistent with the NIH Policy for Data and

Safety Monitoring. A Data and Safety Monitoring Plan should be submitted as part of a

proposal. The NHLBI reserves the right to establish an NHLBI Data and Safety Monitoring

Board (DSMB) for any clinical trial project funded under this ROA.

• Financial Contingency Plan: Potential risks, mitigation strategies, and associated costs,

including a description of a viable source to cover these costs (other than NHLBI and not

including co-funding). The plan must address how obligations to patients, including ethical

ones, will be financed by the applicant, should milestones not be met and/or upon

termination of the award due to lack of progress.

• Team Organization: Team structure, leadership and communications plan, including

biosketches of individuals identified as the principal investigator and all key personnel.

• Resources and Environment: Resources available to the project and environment in which

the activities will be performed.

• References

Budget

The Budget section of the application must provide a realistic, fully justified budget and cost 

proposal for performing the work over a specified period of performance needed to accomplish 

project objectives. In particular, the budget must include a proposed Operational Milestonebased payment schedule, including objective completion criteria and anticipated completion 

date for each Operational Milestone. Except for the first payment issued upon the execution of 

the OT Agreement, payments will be obligated and disbursed upon completion of specific 

Operational Milestones subject to the availability of funds. Costs resulting from a delay or 

failure to meet an Operational Milestone will be the sole responsibility of the Awardee. 

Successful applicants will therefore have thoughtfully accounted for foreseeable project risks 

and developed contingency plans that do not involve the need for additional funding from 

NHLBI. (see “Financial Contingency Plan” under Project Plan elements).

Provide the overall expected cost for each of the following categories:

• Personnel

• Equipment

• Travel

• Subawards/subcontracts/consultants

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• Other direct costs

• Total cost (with indirect costs included)

• Proposed Cost Share contribution

Submission and Contact Information

For best consideration, initial Stage 1 Letters of Request should be submitted via email by

Friday, May 15, 2020, by 5 PM EDT to NHLBI_OTA@mail.nih.gov. Additional letters of request 

will be considered on a monthly basis (June 15, July 15, August 15). Letters from each of these 

submission dates may be batched to evaluate multiple proposals together. This mailbox will 

also be used to answer questions. If invited to submit a Stage 2 full proposal, the applicant will 

be provided specific instructions for how to submit via eRA ASSIST. 

Financial and administrative questions should be addressed to Benjamin Sakovich, NHLBI 

Agreements Officer. 

Technical questions should be addressed to the NHLBI Division that best aligns with the study: 

James Kiley, Division of Lung Diseases, David Goff, Division of Heart and Vascular Diseases and 

Keith Hoots, Division of Blood Diseases and Resources.

A note about eRA Registration 

NHLBI uses the eRA Commons system to administer OT awards. If you are invited to submit a 

full proposal in eRA ASSIST, you will need to be registered in eRA Commons, which can take 

some time to complete – as many as several weeks in some cases. Therefore, if you are 

considering submitting a proposal and are not yet registered in eRA, it is highly recommended 

that you begin the process of registering your organization, Program Director/Principal 

Investigator (PD/PI) and Signing Official (SO) in eRA Commons as soon as possible to avoid 

possible award processing delays. To register, please follow the instructions via this website: 

https://public.era.nih.gov/commons/public/registration/registrationInstructions.jsp.

1. Complete the online Institution Registration Form and click Submit.

2. The NIH database will send you an email with the link to confirm your email address.

3. Once your email address is verified, the NIH will review your request and let you

know of the result via email.

4. If your request is denied, you will get an email notifying you of the reason.

5. If your request is approved, you will get an email with your Commons User ID and

temporary password.

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6. Log into Commons with the temporary password and the system will prompt you to

change temporary password to a permanent one. Your SO will be prompted to

electronically sign your registration request. (Please review your registration

information carefully.)

7. Once your SO has electronically signed the request, your organization will be active in

Commons and you may create and maintain additional accounts for your institution

staff.

To complete the registration above, you may need to register for the following if you haven’t 

done so already: 

Dun & Bradstreet Number (DUNS) - https://fedgov.dnb.com/webform/ 

Employer Identification Number (EIN)- https://www.irs.gov/businesses/smallbusinesses-self-employed/apply-for-an-employer-identification-number-ein-online

Small Business Administration (SBA) - https://www.sbir.gov/registration 

System for Award Management (SAM) - https://www.sam.gov/SAM/ 

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