NHLBI Pilot Program to Provide Regulatory Support to SBIR/STTR Awardees Developing Medical Devices (Diagnostics and Therapeutics) (Admin Supp)

PA-16-335
NHLBI Pilot Program to Provide Regulatory Support to SBIR/STTR Awardees Developing Medical Devices (Diagnostics and Therapeutics) (Admin Supp)
Department of Health and Human Services
National Institutes of Health

Medical Equipment
Includes a medical mask, syringe, stethoscope, gloves, scissors, and gauze. The selective focus is on the syringe needle.
Section I. Funding Opportunity Description

The National Heart, Lung, and Blood Institute (NHLBI) announces a pilot program to encourage Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awardees that are developing and testing technologically innovative or substantial risk medical devices (diagnostics or therapeutics) to engage in early face to face interactions with the FDA Center for Devices and Radiological Health.

Medical device companies spend significant amounts of time, money, and resources developing new technologies based upon a best-guess approach regarding regulatory requirements. For new types of technologies and for high risk devices, even a development plan that is based upon information from public sources – such as Food and Drug Administration (FDA) databases of approvals and clearances, and from professionals with relevant experience – has the potential for generating delays in product development if it is created in the absence of feedback from the FDA.  An early meeting with FDA to validate their development plans can ensure that companies do the appropriate work at the appropriate time and can minimize or eliminate the need to repeat expensive and time consuming studies which can exhaust their limited resources. Although the FDA is noted for saying “come early, come often,” some medical device developers are wary of interacting with the Center for Devices and Radiological Health (CDRH) too early in their development program due to concerns that the CDRH may impose regulatory requirements early in development that are more stringent than those they would need to meet if their technology were more fully developed. CDRH has recently issued guidance documents describing changes to their regulatory approach, including the Expedited Access Pathway Program, the Early Feasibility Studies program, and Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval. CDRH has also worked collaboratively with early stage technology developers to understand the nuances of developing regulatory strategies that fit small business development budgets and timelines (http://medcitynews.com/2015/09/fogarty-institute-hey-medtech-startups-fda-is-your-friend/). These announcements and activities are evidence of a commitment by CDRH to openly engage with the newest types of technologies – such as those represented in their small business portfolios – and wish to encourage their portfolio companies to take advantage of CDRH’s new programs. Furthermore, due to the unique three dimensional aspects of medical devices, NHLBI perceives great value for their portfolio companies to meet in-person with CDRH so that prototypes or components of their technologies can be handled, manipulated, and examined by all attendees.

Companies selected for supplement awards can anticipate an NHLBI-facilitated introduction to a CDRH Coordinator in the appropriate CDRH review division where their technology will be regulated. The CDRH Coordinator will:

  • Introduce the company to the US regulations relevant to the selected technology
  • Talk with the company to more fully understand the technology under development
  • Describe the process of CDRH regulation for the technology type
  • Frame the conversation for a face-to-face meeting
  • Engage appropriate CDRH Senior managers and review staff members with technology-relevant expertise to participate in a face-to-face meeting

The primary outcomes of the face-to-face meeting will be collaborative drafting of a least-burdensome development plan to guide the technology toward submission for first in human or first in US use under an Investigational Device Exemption (IDE), and the development of a relationship between the development team and the CDRH review team. Final guidance on the Least Burdensome approach can be accessed at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085999.pdf .

It is anticipated that participation in this pilot program will encourage and enable:

  • Increased awareness of CDRH regulatory requirements by SBIR/STTR awardees
  • Increased collaboration between NIH and FDA related to the development of new biomedical therapeutic and diagnostic devices
  • Phase II and Phase IIB SBIR/STTR applications with Research and Commercialization plans that are aligned with regulatory milestones
  • Reduced total time to FDA regulatory clearance or approval for innovative devices as compared to technologies that do not receive early input from the FDA
  • Increased U.S.-based clinical development of highly innovative medical devices (diagnostics and therapeutics)

General Information

Document Type: Grants Notice
Funding Opportunity Number: PA-16-335
Funding Opportunity Title: NHLBI Pilot Program to Provide Regulatory Support to SBIR/STTR Awardees Developing Medical Devices (Diagnostics and Therapeutics) (Admin Supp)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.233 — National Center on Sleep Disorders Research
93.837 — Cardiovascular Diseases Research
93.838 — Lung Diseases Research
93.839 — Blood Diseases and Resources Research
93.840 — Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
Cost Sharing or Matching Requirement: No
Posted Date: Jun 15, 2016
Last Updated Date: Jun 15, 2016
Original Closing Date for Applications: Aug 15, 2016  
Current Closing Date for Applications: Aug 15, 2016  
Archive Date: Sep 15, 2016
Estimated Total Program Funding:
Award Ceiling: $5,000

Eligibility

Eligible Applicants:
Small businesses
Additional Information on Eligibility: Other Eligible Applicants include the following: 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.

Additional Information

Agency Name: National Institutes of Health
Description: The purpose of this administrative supplement is to provide support to current SBIR and STTR awardees interested in working collaboratively with the FDA’s Center for Devices and Radiological Health (CDRH) to develop strategies for early stage development so that they may bring innovative products to the marketplace more efficiently.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PA-16-335.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

Advertisements

Nutrigenetics and Nutrigenomics Approaches for Nutrition Research (R01)

PA-16-332
Nutrigenetics and Nutrigenomics Approaches for Nutrition Research (R01)
Department of Health and Human Services
National Institutes of Health

neutrigenomics-10-728

The National Cancer Institute [NCI]

The National Cancer Institute has multiple interests in nutrigenetic and nutrigenomic-based mechanistic studies including vitamins, minerals and other nutritive agents present in food that reduce the risk of cancer.  Genetic variations present in individuals may alter their susceptibility to cancer. Specific interests include strategies to facilitate precision medicine using nutrition-focused interventions to reduce cancer risks in various populations including those mediated by host-microbiome interactions.

National Center for Complementary and Integrative Health [NCCIH]

The National Center for Complementary and Integrative Health (NCCIH) is particularly interested in nutrigenetic and nutigenomic-based mechanistic studies of interaction and competition between nutrient-nutrient, nutrient-drug, dietary supplements, and probiotics/prebiotics on host-microbial metabolism, immunologic/inflammatory signaling, neuro-hormonal pathways and target tissues [including bioavailability, absorption, transport, metabolism and excretion studies] that impact the basic fundamentals that will eventually lead to a better understanding of the gut brain function in health promotion and disease prevention. NCCIH is also interested in the impact of [selected] nutrient, dietary supplements, the ketogenic diet, and probiotic/prebiotic modulation of specific conditions including pain. In addition, NCCIH is interested in studying mechanisms for how botanical products, fish oil and other dietary supplements, and prebiotics in helping to identify their relationship to  pain and inflammation.

General Information

Document Type: Grants Notice
Funding Opportunity Number: PA-16-332
Funding Opportunity Title: Nutrigenetics and Nutrigenomics Approaches for Nutrition Research (R01)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Education
Food and Nutrition
Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.213 — Research and Training in Complementary and Integrative Health
93.321 — Dietary Supplement Research Program
93.393 — Cancer Cause and Prevention Research
93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research
Cost Sharing or Matching Requirement: No
Posted Date: Jun 15, 2016
Last Updated Date: Jun 15, 2016
Original Closing Date for Applications: Sep 07, 2019  
Current Closing Date for Applications: Sep 07, 2019  
Archive Date: Oct 08, 2019

Eligibility

Eligible Applicants:
Small businesses
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Native American tribal governments (Federally recognized)
Special district governments
For profit organizations other than small businesses
State governments
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Independent school districts
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Public housing authorities/Indian housing authorities
Private institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
Public and State controlled institutions of higher education
County governments
Additional Information on Eligibility: 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 eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Additional Information

Agency Name: National Institutes of Health
Description: The purpose of this Funding Opportunity Announcement (FOA) is to promote application of nutrigenetics and/or nutrigenomics approaches to nutrition research through collaborative interaction among nutrition researchers and experts in omics technologies.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PA-16-332.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

Metabolic Contributions to the Neurocognitive Complications of Diabetes: Ancillary Studies (R01)

PAR-16-333
Metabolic Contributions to the Neurocognitive Complications of Diabetes: Ancillary Studies (R01)
Department of Health and Human Services
National Institutes of Health

cognitive-neuroscience-cognitive_neuroscience

Section I. Funding Opportunity Description

The purpose of this Funding Opportunity Announcement (FOA) is to elucidate the etiology and pathogenesis of the neurocognitive complications associated with type 2 diabetes (T2D) with the ultimate goal of informing future strategies to mitigate the risk of these complications. Applications should propose expansions of ongoing human studies of well characterized T2D cohorts or cohorts comparing T2D with non-diabetic populations.  Such expansions might include the addition of comprehensive neurocognitive measures (e.g., cognitive testing, neuroimaging, and biomarkers), clinical measures (e.g., insulin resistance, HbA1c), and/or collection of data on other risk factors (e.g., diet, obesity, micro- and macro-vascular disease, inflammation). It must be clearly explained how the collection of additional data will contribute to elucidation of the basis of neurocognitive sequelae of T2D.

Background: Emerging data have established links between T2D and neurocognitive impairment, including dementia. The current epidemic of dementia is driven, at least in part, by the concurrent epidemics of obesity, insulin resistance, T2D, and metabolic syndrome. Early research sought to elucidate the cause(s) for the apparent role of metabolic dysfunction in the increased prevalence of neurocognitive dysfunction and dementia, tentatively attributed to vascular contributions to cognitive impairment and dementia (VCID) and Alzheimer’s disease (AD). Recent neuropathological research indicates that less than half of the variability in cognitive impairment in the years prior to death may be attributable to AD and other common pathologies, and it is unclear which pathologies are the primary drivers of the association between T2D and neurocognitive impairment and dementia.

Unlike other complications of T2D, neurocognitive complications of T2D have not clearly been demonstrated to correlate with measures of peripheral glycemia (with the exception of very poor glycemic control, HbA1c > 10%) and there is even less evidence for an association with other measures of peripheral glucose regulation (e.g., insulin concentration, insulin action, insulin resistance). The dearth of large-scale studies involving longitudinal assessment of T2D and associated risk factors for complications, neurocognition, and disease management has limited our knowledge of how specific parameters associated with T2D may lead to changes in brain structure and function and deficits in cognition, and how susceptibility to these brain changes may vary across the lifespan.  Moreover, it can be difficult to distinguish the etiology of cognitive impairment since individuals with T2D are at increased risk of other associated complications (e.g., obesity, micro- and macro-vascular disease) that can affect cognition. Recent advances in neuroimaging, computerized neurocognitive assessment, and the availability of large, well-characterized cohorts with T2D could lead to improvements in characterizing brain structure/function, cognition, and clinical parameters and other risk factors associated with T2D.  If specific parameters and other risk factors for adverse neurocognitive outcomes associated with T2D could be defined, treatment protocols could be developed to limit neurocognitive complications associated with T2D.

Types of ancillary studies might include, but are not limited to:

Addition of metabolic and clinical phenotyping in individuals with T2D (e.g., measurement of insulin resistance, HbA1c), including associated factors of relevance to neurocognitive complications of T2D (e.g., diet, obesity, micro- and macro-vascular disease, inflammation), to studies that are already obtaining detailed measurement of neurocognition.

Addition of cohorts with T2D and associated metabolic disease (insulin resistance, prediabetes) to studies that are already obtaining detailed measurement of neurocognition.

Addition of comprehensive neurocognitive measures (e.g., cognitive testing, neuroimaging, and fluid-based biomarkers) to existing studies of T2D cohorts with well-characterized clinical correlates and course of disease.

Regardless of the type of study design, there must be a plan to measure the variables of interest in the same cohort at a minimum of two well justified time points. Cross sectional and purely correlative research is not consistent with the goals of this initiative.

Research that can examine how genetic and environmental factors confer risk or protect against the neurocognitive complications of T2D is encouraged. Research that addresses how neurocognitive complications of T2D impact academic and occupational function (where relevant) and activities of daily living, including the relationship to management of disease and/or treatment adherence is also encouraged.

Research across the lifespan and healthspan is appropriate for this FOA; however, it is possible that due to aging and disease-related factors, isolating mechanisms may be more complex and clinical targets less modifiable as individuals advance in age and disease burden increases. Therefore, there will be a special emphasis on research earlier in the developmental spectrum, especially prior to the development of complex disease (e.g., severe complications of T2D, CVD, dementia).

Strong expertise in T2D and associated disease processes (obesity, insulin resistance, prediabetes) and neuroscience is important for the research teams that will carry out the research supported by this FOA. It is anticipated that many of the funded research studies will involve the analysis and interpretation of complex, high-dimensional datasets. Therefore, it is strongly encouraged to include data scientists with relevant expertise on the research team. Collaborations between basic and clinical scientists are also encouraged but not required.

This FOA is NOT intended to fund the following:

  • New clinical trials to test the efficacy of interventions for neurocognitive complications of T2D.
  • Animal studies.
  • Projects that need a new or separate clinical research infrastructure for sample collection and subject recruitment.  Projects that use samples or subjects from restricted clinical studies; such as those for which access to resources is only permitted to consortium members, or those that place restrictions on publications or data access that are inconsistent with NIH policy.
  • Core activities of ongoing clinical studies.

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-16-333
Funding Opportunity Title: Metabolic Contributions to the Neurocognitive Complications of Diabetes: Ancillary Studies (R01)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Food and Nutrition
Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research
Cost Sharing or Matching Requirement: No
Posted Date: Jun 15, 2016
Last Updated Date: Jun 15, 2016
Original Closing Date for Applications: Sep 07, 2019  
Current Closing Date for Applications: Sep 07, 2019  
Archive Date: Oct 08, 2019

Eligibility

Eligible Applicants:
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
City or township governments
For profit organizations other than small businesses
Private institutions of higher education
Native American tribal governments (Federally recognized)
Special district governments
Small businesses
Independent school districts
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Public and State controlled institutions of higher education
State governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Public housing authorities/Indian housing authorities
County governments
Additional Information on Eligibility: 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.

Additional Information

Agency Name: National Institutes of Health
Description: This Funding Opportunity Announcement (FOA) invites applications for human studies to elucidate the etiology and pathogenesis of the increased risk for neurocognitive impairment associated with type 2 diabetes.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-16-333.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

Bold New Bioengineering Methods and Approaches for Heart, Lung, Blood and Sleep Disorders and Diseases (R21)

RFA-HL-17-015
Bold New Bioengineering Methods and Approaches for Heart, Lung, Blood and Sleep Disorders and Diseases (R21)
Department of Health and Human Services
National Institutes of Healthnew lungs

Purpose

The purpose of this funding opportunity announcement (FOA) is to seek innovative, high-risk bioengineering research for which preliminary results have not yet been obtained, explore new approaches or concepts that are important to a substantive heart, lung, blood or sleep disorder or disease, support the translation of research into practice, technologies, or commercial products, and to develop trans-disciplinary projects upon which significant future research may be built.  This  program will allow investigators to enter new fields and apply cutting-edge approaches to improve the Nation’s health through bioengineering research.  In particular, ground-breaking studies aimed towards the development of novel agents, materials or coatings related to medical devices and engineered tissues would be uniquely fostered by this FOA.

Background

Originally conceptualized by the NIH Bioengineering Consortium in 2003, NHLBI Exploratory Bioengineering Research Grants (EBRGs) were submitted under PA-12-284 (reissued as PA-16-040, which is administered by NIBIB).  NHLBI examined its EBRG R21 portfolio and found this funding mechanism as a useful and cost-effective way for established investigators to open new areas of research. Our data suggests that low-cost, short term projects may incentivize research teams, especially those not captured by the traditional R01 mechanism.

Why Bioengineering? The NHLBI bioengineering community has transformed medicine by creating the artificial heart, pacemakers and Implantable Cardioverter Defibrillators, Ventricular Assist Devices, stents, human tissue chip devices and cell/gene/combination product therapies. These examples demonstrate that bioengineering is a synergistic approach that crosses not only all technology-related areas of NHLBI, but also all of our Disease-specific domains. Further, bioengineering is unique because unlike most scientific focuses, such as heart disease, it demands collaboration across disciplines, which looks to be necessary for advancement of needed technologies. Our ability to achieve alternative and more effective therapies is an urgent need for NHLBI. It is envisioned that this targeted RFA will serve as an opportunity to address scientific gaps and to programmatically balance bioengineering projects across the NHLBI. We are seeking only the most unique, highly innovative and groundbreaking approaches with potential for significant impact on reducing the burden of disease. Applicants are advised to query NIH RePORTER to make sure their approach or idea has not been funded before.

The use of the R21 mechanism is intended to support short-term exploratory research projects. Long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Additionally, R21 applications may involve considerable risk, so they should clearly explain the significance of the proposed work and why the potential impact outweighs these risks

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-HL-17-015
Funding Opportunity Title: Bold New Bioengineering Methods and Approaches for Heart, Lung, Blood and Sleep Disorders and Diseases (R21)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.233 — National Center on Sleep Disorders Research
93.837 — Cardiovascular Diseases Research
93.838 — Lung Diseases Research
93.839 — Blood Diseases and Resources Research
93.840 — Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
Cost Sharing or Matching Requirement: No
Posted Date: Jun 13, 2016
Last Updated Date: Jun 13, 2016
Original Closing Date for Applications: May 10, 2019  
Current Closing Date for Applications: May 10, 2019  
Archive Date: Jun 10, 2019
Estimated Total Program Funding: $1,350,000
Award Ceiling: $150,000

Eligibility

Eligible Applicants:
For profit organizations other than small businesses
Special district governments
County governments
City or township governments
State governments
Public and State controlled institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Public housing authorities/Indian housing authorities
Small businesses
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
Independent school districts
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Native American tribal governments (Federally recognized)
Private institutions of higher education
Additional Information on Eligibility: 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 allowed.

Additional Information

Agency Name: National Institutes of Health
Description: The purpose of this Funding Opportunity Announcement (FOA) is to encourage basic, translational, and clinical proof-of-concept research projects that are needed for the advancement of bioengineering approaches for heart, lung, blood and sleep diseases.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-17-015.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

Intervening with Cancer Caregivers to Improve Patient Health Outcomes and Optimize Health Care Utilization (R21)

PAR-16-318
Intervening with Cancer Caregivers to Improve Patient Health Outcomes and Optimize Health Care Utilization (R21)
Department of Health and Human Services
National Institutes of Health

breast-cancer-caregivers
Breast cancer care
Purpose

This purpose of this Funding Opportunity Announcement (FOA) is to promote research on interventions designed to support caregivers of adult cancer patients. Interventions that are appropriate for this FOA may be intended to provide caregivers with care training, promote coping skills, and ultimately help them manage care. Outcomes of such interventions are expected to (1) optimize patient health care utilization, (2) improve caregiver well-being, and (3) improve patient physical health and psychosocial outcomes.

Applications submitted to this FOA should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Whereas this FOA is for pilot/exploratory projects, a companion FOA of identical scientific scope (PAR-16-317) is meant for well-developed projects supported by preliminary data.

Background

Informal/family cancer caregivers are individuals who manage care for cancer patients, usually a friend or family member. The care that they manage is typically uncompensated, delivered at home, involves significant amounts of time and energy, and requires the performance of tasks that may be physically, emotionally, socially, or financially demanding. Caregiving tasks can include monitoring for treatment side effects, helping manage symptom burden, treatment decision-making, administering medication, and performing some technical medical tasks (e.g., managing infusion ports, changing dressings). Cancer treatment is now more frequently provided in outpatient and community-based centers, which increases the day-to-day demands on informal caregivers. As lay supporters, caregivers are often underprepared to perform the many tasks required of them and this can lead to negative health consequences. Given that the prevalence of people, in particular older adults, living with cancer is growing, the number of cancer caregivers can also be expected to grow. This anticipated growth will be accompanied by simultaneous increases in the demands placed on caregivers, compounded by the fact that cancer care continues to move further into the outpatient and home settings. The physical and psychosocial health (e.g., comorbidities, depression) of patients and their caregivers are often related, suggesting a need to intervene to improve outcomes for both caregivers and patients.

Specific Research Objectives

Applications submitted to this FOA should propose intervention studies that target a combination of the cancer caregiving outcomes in the following three areas:

1. Healthcare utilization outcomes (e.g., patient readmission to the hospital, number of emergency room visits, caregiver use of health care services, and caregiver use of cancer support services);

2. Caregiver well-being outcomes (lower burden, higher capacity, and better quality of life), and

3. Patient health outcomes (e.g., physical health, symptom burden, health-related quality of life and functioning).

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-16-318
Funding Opportunity Title: Intervening with Cancer Caregivers to Improve Patient Health Outcomes and Optimize Health Care Utilization (R21)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Education
Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.395 — Cancer Treatment Research
93.399 — Cancer Control
Cost Sharing or Matching Requirement: No
Posted Date: Jun 08, 2016
Last Updated Date: Jun 08, 2016
Original Closing Date for Applications: Apr 11, 2019  
Current Closing Date for Applications: Apr 11, 2019  
Archive Date: May 12, 2019
Estimated Total Program Funding:
Award Ceiling: $200,000

Eligibility

Eligible Applicants:
Independent school districts
Private institutions of higher education
Native American tribal governments (Federally recognized)
City or township governments
Small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
State governments
Public and State controlled institutions of higher education
County governments
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
For profit organizations other than small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Information on Eligibility: 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.

Additional Information

Agency Name: National Institutes of Health
Description: This Funding Opportunity Announcement (FOA) invites applications for intervention research designed to support caregivers of adult cancer patients. Interventions supported by this FOA are intended to provide caregivers with care training, promote coping skills, and ultimately help them manage care. Outcomes of such interventions are expected to (1) optimize patient health care utilization, (2) improve caregiver well-being, and (3) improve patient physical health and psychosocial outcomes.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-16-318.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

Biophysical and Biomechanical Aspects of Embryonic Development (R01)

PAR-16-325
Biophysical and Biomechanical Aspects of Embryonic Development (R01)
Department of Health and Human ServicesebryoCapture

National Institutes of Health

Research Objectives

Research funded through this FOA will advance our knowledge of the biophysical and biomechanical factors that are critical for various aspects of morphogenesis during normal and abnormal embryonic development. Aberrations in morphogenesis result in a variety of structural birth defects. The purpose of this announcement is to invite applications designed to exploit innovative ideas for studying biophysical and mechanical processes contributing to embryonic development. This includes quantitative measurement of temporal changes in physical and mechanical properties of cells and tissues in living organisms, in relation to changes in their microenvironment.

Applicants should propose hypothesis-driven research in developmental biology. It should be noted that applications submitted to this R01 FOA should have sufficient preliminary data to substantiate the validity of the proposed research and use of new technologies. It is important to note that the goal of this FOA is to promote studies conducted in vivo, as emphasized below.

Background

The term ‘developmental mechanics’ refers to and emphasizes the importance of an orderly sequence of physical, chemical, and physiological mechanisms essential for normal embryonic development (His, 1874). In the past, research on developmental biomechanics was focused on developing theoretical models and using in vitro experimental approaches for model validation. However, it is now well recognized that morphogenesis occurs through interactions between multiple tissue layers, and physical parameters contributing to these processes are not displayed appropriately when studying individual cells in culture. The challenge is to match theoretical models to experimental data and integrate the analyses across time and space so that cellular mechanisms can be linked to tissue-level behavior. Consequently, to better understand the role of the physical and mechanical forces exerted during development, the focus of this FOA is to promote studies aimed at understanding biomechanics of morphogenesis in vivo.

In recent years, there has been considerable progress in understanding the genetic control of morphogenesis. It is evident that regulated gene expression determines the chemical environment of cells and tissues and thereby regulates biophysical processes. In turn, changes in physical forces feed back to regulate gene function and cell fate. Advancing our knowledge of the physical aspects of development will thus provide a broader view on how the genome of multicellular organisms functions in association with physical forces to specify final shape and architecture of an organ and/or an entire organism.

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-16-325
Funding Opportunity Title: Biophysical and Biomechanical Aspects of Embryonic Development (R01)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Health
Income Security and Social Services
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.865 — Child Health and Human Development Extramural Research
Cost Sharing or Matching Requirement: No
Posted Date: Jun 10, 2016
Last Updated Date: Jun 10, 2016
Original Closing Date for Applications: Sep 19, 2018  
Current Closing Date for Applications: Sep 19, 2018  
Archive Date: Oct 20, 2018
Estimated Total Program Funding:
Award Ceiling: $500,000

Eligibility

Eligible Applicants:
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Private institutions of higher education
State governments
County governments
Public housing authorities/Indian housing authorities
Public and State controlled institutions of higher education
Small businesses
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
Native American tribal organizations (other than Federally recognized tribal governments)
Native American tribal governments (Federally recognized)
City or township governments
For profit organizations other than small businesses
Independent school districts
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Information on Eligibility: 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.

Additional Information

Agency Name: National Institutes of Health
Description: This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations that propose to advance our knowledge in the area of the physics and mechanics of embryonic development. Applicants should propose hypothesis-driven developmental research with the prospect of gaining new and critical information about tissue mechanics relevant to vertebrate development and understanding the basis for developmental disorders. Investigators are encouraged to explore approaches and concepts new to the area of developmental tissue mechanics, and use newly developed techniques superior to the ones currently used in the field. It should be noted that applications submitted to this R01 FOA should have sufficient preliminary data to substantiate the validity of the proposed research and feasibility of new technologies or tools.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-16-325.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

Small Research Grants for Establishing Basic Science-Clinical Collaborations to Understand Structural Birth Defects (R03)

PAR-16-323
Small Research Grants for Establishing Basic Science-Clinical Collaborations to Understand Structural Birth Defects (R03)
Department of Health and Human Services
National Institutes of Health

R03

Scope

The intent of this FOA is to support basic scientists, physician scientists (including individuals with DVM/VMD degrees), and/or clinicians in a collaborative effort to develop a multi-pronged research program focused on the etiology of a structural birth defect.  The R03 funding will specifically support formulation of the overall collaborative experimental approaches as well as the collection of preliminary data to support a future, larger grant application such as an R01.

The first aspect of developing an interdisciplinary collaboration is often time spent breaking down barriers between differing disciplines and establishing effective lines of communication.  For example, it is anticipated that pediatricians might need to learn more about developmental biology and genomics while developmental biologists might need to learn more about human genetics or epidemiology.  Therefore, part of the R03 should be devoted to the cross-disciplinary discussions necessary to build the foundation for the experimental approaches to tackle the problem at hand.

Depending on the combination of experimental approaches to be undertaken, the areas of expertise required are expected to vary.  For birth defects research to succeed in the long run, it is clear that interdisciplinary teams including but not limited to the following are necessary:  developmental biologists, cell biologists, geneticists, genomicists, clinicians, veterinarians with animal modeling and comparative medicine expertise, epidemiologists, biostatisticians, and/or bioinformaticists.  Therefore, the collaborative R03 should minimally include at least two PD/PIs with differing expertise.  Expertise from both the basic science side of the spectrum as well as the clinical side should be engaged in the R03 research.  The multiple PD/PI model is strongly encouraged but not required.

The scope of the research proposed is expected to vary as well.  The proposed studies should develop, adapt, and use approaches to identify genetic contributions as well as environmental interactions and other non-genetic determinants that contribute to various structural birth defects.  It is clear that genetic factors can be the primary cause of structural birth defects and/or may act in concert with environmental exposures.  Genetic and epigenetic factors provide a basis for functional studies in animal models or cell culture systems such as patient-derived induced pluripotent stem cells.  Introducing genetic variants into animal model systems can bolster the causative role of the variant as well as provide insight into the embryological mechanisms underlying structural birth defects.  Depending on the birth defect in question, the most appropriate model(s) will vary.  Examples of research areas that are appropriate for this FOA are described below.  This is not intended to be all-inclusive, but is designed merely to provide guidance and direction for applicants.

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-16-323
Funding Opportunity Title: Small Research Grants for Establishing Basic Science-Clinical Collaborations to Understand Structural Birth Defects (R03)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Education
Environment
Health
Income Security and Social Services
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.113 — Environmental Health
93.121 — Oral Diseases and Disorders Research
93.273 — Alcohol Research Programs
93.279 — Drug Abuse and Addiction Research Programs
93.351 — Research Infrastructure Programs
93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders
93.865 — Child Health and Human Development Extramural Research
Cost Sharing or Matching Requirement: No
Posted Date: Jun 10, 2016
Last Updated Date: Jun 10, 2016
Original Closing Date for Applications: Sep 07, 2019  
Current Closing Date for Applications: Sep 07, 2019  
Archive Date: Oct 08, 2019
Estimated Total Program Funding:
Award Ceiling: $75,000

Eligibility

Eligible Applicants:
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Private institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Public housing authorities/Indian housing authorities
County governments
State governments
Public and State controlled institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Independent school districts
Small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
Special district governments
Native American tribal governments (Federally recognized)
For profit organizations other than small businesses
City or township governments
Additional Information on Eligibility: 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.

Additional Information

Agency Name: National Institutes of Health
Description: The purpose of this funding opportunity announcement (FOA) is to promote initial establishment of basic science-clinical collaborations by providing small grants to teams of basic scientists, physician scientists, and/or clinicians. These interdisciplinary teams may include but are not limited to the following: developmental biologists, cell biologists, geneticists, genomicists, physician scientists including individuals with DVM/VMD degrees, clinicians, epidemiologists, biostatisticians, and/or bioinformaticists.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-16-323.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster