PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

Released Date
Expiration Date
Activity Code
R43/R44
Full Announcement
PA-18-574

View the full NIH Guide Notice

The 2018 Omnibus (Parent) Grant Solicitations of the NIH, CDC, and FDA are now available for the SBIR and STTR (NIH only) programs. This issuance also implements new NIH Clinical Trials Policy and FORMS-E transition, as detailed below.

FORMS-E

With the transition to FORMS-E, applicants can no longer submit directly to www.grants.gov with a single, downloaded PDF form package. Submission options are:

  1. NIH ASSIST (Application Submission System & Interface for Submission Tracking) - recommended
  2. Grants.gov Workspace
  3. Your own System-to-System solution

Clinical Trials

Read the NIH definition of a clinical trial

View a decision tree to assist applicants in determining if their project is a clinical trial.

NIH is launching a series of initiatives that are rolling out in 2017-2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the whole clinical trial lifecycle from concept to results reporting. Learn more about these changes and how they will affect your research.

As a result of these initiatives, ALL applications, including SBIR/STTR, proposing any specific aims that meet NIH's definition of a clinical trial must now be submitted to a Funding Opportunity Announcement (FOA) that specifically states it accepts clinical trials.

Webinars

To assist with this adjustment, two informational webinars will be offered in February. The content of both webinars will be similar, but Webinar 1 will provide specific information about clinical trials and using the New PHS Human Subjects and Clinical Trials Information Form.

1. HHS SBIR/STTR PHS 2018-2 Grant Clinical Trial Parent Webinar

2. HHS SBIR/STTR PHS 2018-2 Grant Non-Clinical Trial Omnibus Webinar

After registering, you will receive a confirmation email containing information about joining the webinar.

Small Business Topics of Special Interest for Fiscal Year 2018

The NHLBI accepts investigator-initiated grant applications relevant to the NHLBI mission through the Department of Health and Human Services Omnibus Grant Solicitations. While NHLBI has identified Topics of Special Interest (see below), the NHLBI also encourages mission-aligned applications for innovative technologies outside these targeted areas.

For important information about NHLBI's participation in the NIH SBIR/STTR program, please see pg. 157 of Program Descriptions and Research Topics.

Total funding support (direct costs, indirect costs, fee) typically cannot exceed a hard cap of $225,000 for Phase I awards, or $1,500,000 for Phase II awards. NIH may provide awards that exceed the standard budget guidelines for specific topics. For the list of topics approved for awards over statutory budget limitations, see Appendix A pg. 250 of Program Descriptions and Research Topics. Projects that fit these topics are not guaranteed to be awarded the requested budget.

Applicants considering requesting a budget greater than the statutory budget limits are strongly encouraged to contact us through our inquiry form before submitting an application.

Topics of Special Interest for Fiscal Year 2018

Topics are listed here to inform potential applicants about areas of special interest to the NHLBI. Applications submitted in response to the Omnibus Grant Solicitations are NOT limited to the research and development areas described below.

Instructions for submitting applications in response to the following areas:

  • At the beginning of the title, please include the following four characters: HLS- (Important: according to the NIH's SF424 (R&R) Application Guide. NIH limits title character length to 200 characters including the spaces between words and punctuation. Titles in excess of 200 characters will be truncated).
  • In the first sentence of the abstract, please include the code shown in the last column of the table below. This coding is for internal NHLBI tracking purposes only.

View Topics of Special Interest for Fiscal Year 2017.

Topic

Contact

Code

Development of high throughput methods to apply microfluidics technology in discovery of molecular profiles (DNAs, RNAs, proteins, or metabolites) in a large number of sputum or exhaled breath condensate samples collected from lung disease patients.

Lisa Postow, lisa.postow@nih.gov

HLS18-01

Development of novel diagnostics to evaluate the efficacy of therapeutics and interventions for the treatment of pulmonary diseases. Examples include, but are not limited to:

  • Microfluidic technologies

  • Point-of-care devices (i.e. rapid diagnostic tests)

  • Mobile technologies to monitor in home therapies

John Sheridan, john.sheridan@nih.gov

HLS18-02

Development of novel tools, reagents, and methods to enhance the targeting and delivery of gene therapies to the airway epithelium for the treatment of cystic fibrosis.

John Sheridan, john.sheridan@nih.gov

HLS18-03

Sleep and Circadian Biomarkers

  • Development of sleep and circadian biological markers in accessible blood, urine, saliva is needed to stratify sleep related risks to health and public safety, the diagnosis of disease, and the prediction of disease outcomes. Areas of emphasis include both candidate discovery and verification and the development of assays. Proposals leading to the development of assays suitable for deployment by researchers in field studies, point-of-care health care providers, and public health/safety-related screenings are highly encouraged.

Marishka Brown, marishka.brown@nih.gov

HLS18-04

Development of unique and innovative mobile health tools, technologies, and health IT platforms to improve case finding, access to care, disease management, and treatment adherence in COPD and asthma patients from hard to reach areas (i.e. rural settings) and socially and economically disadvantaged communities.

Tony Punturieri, punturieria@nhlbi.nih.gov

HLS18-05

Development and validation of techniques (or algorithms) to study the microbiome in situ, including, but not limited to:

  • Sampling the microbiome of different lung or gut segments while minimizing contaminations from other locations.

  • Development of an analytical system to study the metabolic products of the lung and gut microbiome from breath condensate.

Lis Caler, lis.caler@nih.gov

HLS18-06

High-definition, conformal, biocompatible mesh technologies made from nanoscale materials are revolutionizing electronic-tissue interfaces. Applications that leverage this technology should expand or enhance the ability of present systems to monitor and treat cardiovascular and pulmonary disorders such as arrhythmias, sleep apnea, asthma, and COPD.

David Lathrop, lathropd@nhlbi.nih.gov

HLS18-07

Develop new and improved methods to assess, monitor, or predict cardiovascular toxicity of therapeutic agents. Methods or assay platforms that utilize in vitro (e.g., re-programmed cells and engineered 3D-tissue constructs) and in silico approaches are encouraged.

Bishow Adhikari, adhikarb@mail.nih.gov

HLS18-08

For citizens returning to an urban environment after release from prison or jail, develop and validate mobile app solutions they can use to improve their health outcomes related to cardiovascular diseases including but not limited to hypertension. For example, these solutions should use evidence-based guidelines for the management of cardiovascular disease such as care planning, medication management, assessment or monitoring of cardiovascular disease and decision support that includes multi-level (health systems, provider, and patient) facets. Solutions should also include user support documentation for all potential users of the technology, including but not limited to patients, family/caregivers, and providers.

Erin Iturriaga, iturriae@mail.nih.gov

HLS18-09

New animal models for the study of chronic venous insufficiency (CVI) and post-thrombotic syndrome, and innovative approaches for their prevention and treatment.

Cheryl McDonald, mcdonalc@mail.nih.gov

HLS18-10

Development of mechanical circulatory support devices for individuals with congenital heart disease and single ventricle physiology after Fontan surgical palliation.

Kristin Burns, kristin.burns@nih.gov

HLS18-11

Novel non-invasive strategies that detect early subclinical changes in cardiac structure, function, and /or tissue are needed to improve detection and monitoring of chemotherapy-induced cardiac injury in order to improve cardioprotection and effectiveness of cancer therapeutics. Strategies that increase sensitivity and precision of existing or enhance imaging technologies with respect to normal and altered cardiac structure, function, energetics, and metabolism are sought. Pre-clinical or patient studies using molecular changes or biomarkers to enhance early detection of cardiac derangements are also responsive.

Patrice Desvigne-Nickens, patrice.desvignenickens@nih.gov

HLS18-12

Stimulate the development of new technologies (e.g., integration into EMR) for use by clinicians and health care professionals to enhance their lifestyle behavioral counseling skills (i.e., nutrition and physical activity) using evidence-based approaches to promote cardiovascular health, and to test the efficacy and effectiveness of the newly developed technologies in enhancing patient care, lifestyle behaviors, and in promoting cardiovascular health.

Charlotte Pratt, prattc@nhlbi.nih.gov

 

HLS18-13

Develop innovative technology and/or service delivery models or designs to increase the adoption, uptake, and sustainability of evidence-based guideline recommendations for the management of heart, lung, blood, and sleep disorders. These should include multi-level (health systems, provider, and patient) facets and benefit ethnic/racial minority groups, rural populations, and low socioeconomic status groups.

Uche Sampson, uchechukwu.sampson@nih.gov

HLS18-14

Development and validation of tools that study disease-microbiota relationship allowing to generate new diagnostic, prognostic, and therapeutic approaches for hematologic disorders.

Malgorzata Klauzinska, malgorzata.klauzinska@nih.gov

HLS18-15

Development and validation of data science methodologies to link data standards such as MedDRA and CDISC with other standard measures and common data elements to enable the transition of clinical trials study populations to longitudinal cohort studies. 

Ellen Werner, ellen.Werner@nih.gov

 

HLS18-16

Digitization of prevalence and/or incidence maps for HLBS-related health conditions, environmental exposures, social and geographic patterns, health care and transportation networks to characterize population and community health, and health disparities or resilience.

Ellen Werner, ellen.Werner@nih.gov

 

HLS18-17

Development of vascular-based (e.g. endothelial cell-based) tools for assessment of permeability and transport across the blood-brain interface.

Margaret Ochocinska, margaret.ochocinska@nih.gov

HLS18-18

Development and adaptation of circulating (i.e. liquid biopsy) exosome-based diagnostic and therapeutic tools for heart, lung, and blood diseases. Some specific examples may include, but are not limited to:

  • Exosome-based assays for donor/recipient screening, patient stratification and monitoring to assess the risk for developing graft-versus-host disease (GVHD) pre- and post-transplant.

  • Development of exosome-based assays to assess quality of blood products, recipient safety, risk for transfusion complications, and/or to monitor effectiveness of transfused blood products.

  • Development of exosome-based assays for patient stratification and monitoring in pulmonary and sleep disorders.

  • Exosome-based liquid biopsy assays for diagnosis of cardiovascular disease. 

Margaret Ochocinska, margaret.ochocinska@nih.gov

HLS18-19

Adaptation of microfluidic technology platform to address needs in the following areas:

  • Small volume blood sampling and testing in pediatric/neonatal setting. Monitoring of blood values in pediatric intensive care units is dependent on obtaining sufficient blood volumes for testing. Since neonates may provide only small volume samples, there is a pressing clinical need for the development of devices capable of performing blood tests on samples sizes of <100 uL.

  • Evaluation of the peripheral blood for biomarkers linked to the microbiome and their predictive value in identifying disease risk factors. The microbiome may significantly impact human health, both in health and disease. Interactions of the body with these microbial organisms may yield biomarkers with predictive value in determining risk of disease and subsequent prognosis.

Ron Warren, ronald.warren@nih.gov

 

HLS18-20

Studies confirm that iron deficiency occurs in blood donors and that frequent donors and premenopausal women are at increased risk. Scientific evidence supports the need for routine monitoring of iron stores by testing ferritin, preferably prior to blood donation. Reliable point of care ferritin testing would expedite the process of identifying iron deficiency and would in turn, protect individuals from potentially damaging further donations and/or indicate the need for iron supplementation. Applicants are encouraged to develop an innovative, inexpensive, point of care device that would accurately and reproducibly measure ferritin levels in humans.

Norma Lerner, norma.lerner@nih.gov

 

HLS18-21