DoD Breast Cancer Breakthrough Award Levels 1 and 2

W81XWH-15-BCRP-BREAKTHROUGH2-FL12
DoD Breast Cancer Breakthrough Award Levels 1 and 2
Department of Defense
Dept. of the Army — USAMRAA

I. FUNDING OPPORTUNITY DESCRIPTION
A. Program Description
Applications to the Fiscal Year 2015 (FY15) Breast Cancer Research Program (BCRP) are being solicited for the Defense Health Agency, Research, Development, and Acquisition (DHA RDA) Directorate, by the U.S. Army Medical Research Acquisition Activity (USAMRAA). As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the DHA RDA Directorate manages and executes the Defense Health Program (DHP) Research, Development, Test, and Evaluation appropriation. The executing agent for this Program Announcement/Funding Opportunity is the Congressionally Directed Medical Research Programs (CDMRP). The BCRP was initiated in fiscal year 1992 (FY92) to support innovative, high-impact research focused on ending breast cancer. Appropriations for the BCRP from FY92 through FY14 totaled $3 billion. The FY15 appropriation is $120 million (M).
The BCRP challenges the scientific community to design research that will address the urgency of ending breast cancer. Specifically, the BCRP seeks to accelerate high-impact research with clinical relevance, encourage innovation and stimulate creativity, and facilitate productive collaborations.
B. Breast Cancer Landscape
The BCRP has prepared a brief overview of the breast cancer landscape that describes what is currently known about incidence, death, recurrence, metastatic disease, risk factors, and treatments. This overview covers the most pertinent topics that are consistent with the BCRP’s vision of ending breast cancer. Applicants are strongly urged to read and consider the landscape before preparing their applications. The landscape may be found at http://cdmrp.army.mil/bcrp/pdfs/bc_landscape.pdf.

General Information

Document Type: Grants Notice
Funding Opportunity Number: W81XWH-15-BCRP-BREAKTHROUGH2-FL12
Funding Opportunity Title: DoD Breast Cancer Breakthrough Award Levels 1 and 2
Opportunity Category: Discretionary
Funding Instrument Type: Cooperative Agreement
Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:
Expected Number of Awards: 25
CFDA Number(s): 12.420 — Military Medical Research and Development
Cost Sharing or Matching Requirement: No
Posted Date: Aug 25, 2015
Creation Date: Aug 25, 2015
Original Closing Date for Applications: Dec 2, 2015  
Current Closing Date for Applications: Dec 2, 2015  
Archive Date: Jan 1, 2016
Estimated Total Program Funding: $25,000,000
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants:
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility:

Additional Information

Agency Name: Dept. of the Army — USAMRAA
Description: The intent of the Breakthrough Award is to support promising research that has high potential to lead to or make breakthroughs in breast cancer. The critical components of this award mechanism are: Impact: Research supported by the Breakthrough Award will have the potential for a major impact and accelerate progress toward ending breast cancer. The impact may be near-term or long-term, but must be significant and move beyond an incremental advancement. Applications must articulate the pathway to making a clinical impact for individuals with, or at risk for, breast cancer, even if clinical impact is not an immediate outcome. Research Scope: Research proposed under this award mechanism may be small- to large-scale projects, at different stages of idea and research development. Two different funding levels, based on the scope of the research, are available under this Program Announcement/Funding Opportunity. An additional funding level, Funding Level 3, is available under a different Program Announcement (W81XWH-15-BCRP-BREAKTHROUGH2_FL3). It is the responsibility of the Principal Investigator (PI) to select the funding level that is most appropriate for the research proposed. The funding level should be selected based on the scope of the research project, rather than the amount of the budget. The following are general descriptions, although not all-inclusive, of the scope of research projects that would be appropriate to propose under each funding level: • Funding Level 1: Innovative, high-risk/high-reward research that is in the earliest stages of idea development. Research with potential to yield new avenues of investigation. Proof of concept. No preliminary data required. • Funding Level 2: Research that is already supported by preliminary data and has potential to make significant advancements toward clinical translation. Demonstration of efficacy in in vivo models, as applicable. Partnering PI Option: The Breakthrough Award encourages applications that include meaningful and productive collaborations between investigators. The Partnering PI Option is structured to accommodate two PIs, called the Initiating PI and the Partnering PI, each of whom will receive a separate award. The Initiating and Partnering PIs have different submission requirements; however, both PIs should contribute significantly to the development of the proposed research project including the Project Narrative, Statement of Work (SOW), and other required components. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application. New collaborations are encouraged, but not required. It is the responsibility of the PIs to describe how their combined expertise will better address the research question and explain why the work should be done together rather than through separate efforts. To meet the intent of the Partnering PI Option, applicants are discouraged from submitting as a Partnering PI on multiple applications unless they are clearly addressing distinct research questions. Applications submitted by a mentor and his/her current postdoctoral fellow or junior investigator as Initiating and Partnering PIs do not meet the intent of the Partnering PI Option.

HRSA-16-074 Substance Abuse Service Expansion

HRSA-16-074
Substance Abuse Service Expansion
Department of Health and Human Services
Health Resources and Services Administration

General Information

Document Type: Grants Notice
Funding Opportunity Number: HRSA-16-074
Funding Opportunity Title: Substance Abuse Service Expansion
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation: https://grants.hrsa.gov/2010/Web2External/Interface/FundingCycle/ExternalView.aspx?fCycleID=5eb8b6e3-6c30-4162-80f9-68fd9d0f56df
Expected Number of Awards: 310
CFDA Number(s): 93.527 — Affordable Care Act (ACA) Grants for New and Expanded Services under the Health Center Program
Cost Sharing or Matching Requirement: No
Posted Date: Jul 30, 2015
Creation Date: Jul 30, 2015
Original Closing Date for Applications: Sep 28, 2015  
Current Closing Date for Applications: Sep 28, 2015  
Archive Date: Nov 27, 2015
Estimated Total Program Funding: $100,000,000
Award Ceiling: $0
Award Floor: $0

Eligibility

Eligible Applicants:
Private institutions of higher education
Public and State controlled institutions of higher education
Independent school districts
Special district governments
County governments
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
City or township governments
State governments
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Additional Information on Eligibility: Eligible applicants must be an existing Health Center Program award recipient funded under section 330(e), (g), (h) and/or (i) of the Public Health Service Act that did not receive initial Health Center Program funding as a new start/new award recipient in FY 2015 (via a New Access Point, Service Area Competition, or Service Area Competition – Additional Area grant award).

Additional Information

Agency Name: Health Resources and Services Administration
Description: This announcement solicits applications for Fiscal Year (FY) 2016 Substance Abuse Service Expansion. The purpose of this Health Center Program supplemental funding opportunity is to improve and expand the delivery of substance abuse services at existing health centers, 1 with a focus on Medication-assisted Treatment (MAT) in opioid use disorders

AHRQ Health Services Research Projects: Making Health Care Safer in Ambulatory Care Settings and Long Term Care Facilities (R01)

PA-15-339Chair-Exercises-Limited-Mobility-Fitness-300x176
AHRQ Health Services Research Projects: Making Health Care Safer in Ambulatory Care
Settings and Long Term Care Facilities (R01)

Department of Health and Human Services
Agency for Health Care Research and Quality

Purpose

The purpose of this FOA is to support patient safety research projects focused on understanding the epidemiology of patient safety in ambulatory and resident safety in long term care settings, gather evidence on strategies that improve patient and resident safety in these settings, and develop evidence-based tools to facilitate implementation of these strategies.  Knowledge gained from these projects will support the development of strategies and tools to deliver quality care that is safe in the ambulatory and long term care settings.

Background

In 1999, the Institute of Medicine (IOM) published a landmark study, “To Err is Human,” which highlighted the magnitude of safety problems in health care. Since the publication of the IOM report, AHRQ has developed, piloted, and refined a robust portfolio of evidence, tools, and measures to improve patient safety.  The most significant investments to date have been made in the hospital setting where a patient stays for one or more nights in an inpatient unit for treatment.  Substantial research has also focused on safety in emergency room settings where a patient is treated but not admitted to an inpatient unit.  A body of research dedicated to patient safety in other settings, including ambulatory and long term care settings, has also emerged, but research and initiatives to improve safety in these settings is more limited than the hospital setting.  Ambulatory care takes place in any non-hospital patient setting and includes, but is not limited to physicians’ and practitioners’ offices and clinics.  Emergency room settings are not considered ambulatory care settings for the purpose of this announcement.  Long term care facilities include nursing homes, assisted living, residential care homes and home care.  Ambulatory care sites and long term care facilities are settings with high patient/resident volume and high potential for harm.  It is vital to leverage and build on the knowledge gained from the inpatient arena while also recognizing the unique challenges and barriers for ensuring patient safety in these settings.  As such, a need exists for more information about the characteristics of patient safety in these settings and the actions that are needed to realize improvements.

To address this issue AHRQ launched a multi-year initiative beginning in fiscal year 2015 to expand the scientific evidence, strategies, and tools that are available for improving patient safety in all health care settings so that people can expect safe care whenever and wherever they receive it (e.g., see http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-15-002.html).  With this FOA, AHRQ will focus on two healthcare settings–ambulatory care and long term care facilities.  As applicable, work should include a focus on issues that are relevant to underserved and vulnerable populations. Additionally, AHRQ has a specific interest in settings that serve vulnerable populations which include Federally Qualified Health Centers (FQHC), Community Health Centers, safety-net hospital outpatient departments, physician offices and long term care facilities.  While disparities in patient safety have been previously documented, studies have been limited with regard to study design and methods needed to generate the evidence regarding factors underlying disparities.

Unique Issues in Patient Safety in Ambulatory Care

The vast majority of healthcare is delivered in ambulatory settings with outpatient visits being more numerous than inpatient stays. There are approximately 1 billion outpatient visits per year in the United States, outnumbering hospital discharges by a factor of more than 30 to 1.  Approximately one in ten Americans has an inpatient stay in a year, but the average number of visits to ambulatory care settings for each American is four per year.  Because of the complex decentralized organization of ambulatory health care, individuals frequently must seek outpatient care from a variety of settings and providers and thus patients assume more responsibility for coordinating their own care, often obtaining and maintaining information about various aspects of their health care and communicating with more types of health care providers than they do in the inpatient setting.  Continuity and coordination of care are spread among an increasing number of providers for episodes of care which may include follow-up of laboratory and other diagnostic tests or referrals to specialists.  All of these factors may contribute to the challenges in ensuring patient safety in the ambulatory setting.

General Information

Document Type: Grants Notice
Funding Opportunity Number: PA-15-339
Funding Opportunity Title: AHRQ Health Services Research Projects: Making Health Care Safer in Ambulatory Care Settings and Long Term Care Facilities (R01)
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.226 — Research on Healthcare Costs, Quality and Outcomes
Cost Sharing or Matching Requirement: No
Posted Date: Aug 27, 2015
Creation Date: Aug 27, 2015
Original Closing Date for Applications: Mar 5, 2018  
Current Closing Date for Applications: Mar 5, 2018  
Archive Date: Apr 5, 2018
Estimated Total Program Funding:
Award Ceiling: $500,000
Award Floor:

Eligibility

Eligible Applicants:
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 governments (Federally recognized)
City or township governments
Public and State controlled institutions of higher education
County governments
Special district governments
State governments
Private institutions of higher education
Public housing authorities/Indian housing authorities
Independent school districts
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Small businesses
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)
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.

Additional Information

Agency Name: Agency for Health Care Research and Quality
Description: The purpose of this Funding Opportunity Announcement (FOA) is to support investigative research projects that examine the epidemiology of patient safety in ambulatory care settings and long term care facilities, gather evidence about strategies that can improve safety in these settings, and develop evidence-based tools to facilitate implementation of these strategies.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PA-15-339.html

Ryan White HIV/AIDS Program Part A HIV Emergency Relief Grant Program

HRSA-16-021RWhomepg2
Ryan White HIV/AIDS Program Part A HIV Emergency Relief Grant Program
Department of Health and Human Services
Health Resources and Services Administration

General Information

Document Type: Grants Notice
Funding Opportunity Number: HRSA-16-021
Funding Opportunity Title: Ryan White HIV/AIDS Program Part A HIV Emergency Relief Grant Program
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation: https://grants.hrsa.gov/2010/Web2External/Interface/FundingCycle/ExternalView.aspx?fCycleID=201a99bc-b2b4-4222-9ff7-5a45fb0cef86
Expected Number of Awards: 53
CFDA Number(s): 93.914 — HIV Emergency Relief Project Grants
Cost Sharing or Matching Requirement: No
Posted Date: Aug 27, 2015
Creation Date: Aug 27, 2015
Original Closing Date for Applications: Nov 2, 2015  
Current Closing Date for Applications: Nov 2, 2015  
Archive Date: Jan 1, 2016
Estimated Total Program Funding: $620,079,915
Award Ceiling: $0
Award Floor: $0

Additional Information

Agency Name: Health Resources and Services Administration
Description This announcement solicits applications for the Ryan White HIV/AIDS Program (RWHAP) Part A HIV Emergency Relief Grant Program.  Part A funds provide direct financial assistance to an eligible metropolitan area (EMA) or a transitional grant area (TGA) that has been severely affected by the HIV epidemic.  Grants assist eligible program areas in developing or enhancing access to a comprehensive continuum of high quality, community-based care for low-income individuals and families with HIV through the provision of formula, supplemental, and Minority AIDS Initiative (MAI) funds.  Based on an assessment of the services and gaps in the HIV Care Continuum within a jurisdiction or service area, planning bodies and recipients may identify specific service categories to fund. Funded service categories should facilitate improvements at specific stages of the HIV Care Continuum.  Comprehensive HIV/AIDS care consists of core medical services and supportive services that meet the criteria of enabling individuals and families living with HIV/AIDS to access and remain in primary medical care to improve their medical outcomes. HRSA/HAB recognizes that Part A EMAs and TGAs must use grant funds to support and further develop and/or expand systems of care to meet the needs of PLWH within the EMA/TGA and strengthen strategies to reach minority populations.  HAB requires EMAs/TGAs to collect data to support identification of need, for planning purposes, and to validate the use of RWHAP funding.  A comprehensive application should reflect how those data were used to develop and expand the system of care in EMA/TGA jurisdictions.  Needs assessments conducted by individual jurisdictions should also review/reference relevant needs assessments conducted by other HIV/AIDS programs, such as HRSA’s Bureau of Primary Health Care, Centers for Disease Control and Prevention (CDC), Substance Abuse and Mental Health Services Administration (SAMHSA), and the U.S. Department of Housing and Urban Development (HUD). Ongoing CDC initiatives, as well as HAB’s efforts with recipients to estimate and address unmet need of those aware of their HIV status and the newer requirement to identify and bring into care persons in their jurisdictions who are unaware of their positive HIV status, should result in many more PLWH entering into the EMA/TGA care system.  

The EMA/TGA planning process must ensure that essential core medical services have been adequately funded to meet the needs of those already in care and those being newly linked to care. As of November 2014, the CDC estimates more than 1.2 million people are living with HIV and 1 in 7 (14 percent) are not aware of their HIV status.  The ultimate goal within the United States (U.S.) is to inform all HIV-positive persons of their status and bring them into care in order to improve their health status, prolong their lives, and slow the spread of the epidemic in the U.S. through enhanced prevention efforts.  Important Notes: ·

  •   In accordance with the RWHAP legislation (Sec. 2603 (a)(4)) of the PHS Act hold harmless will not be a factor in the FY 2016 RWHAP Part A awards. · 
  •  Information on Ryan White and the Affordable Care Act, along with Policy Clarification Notices can be found at http://hab.hrsa.gov/affordablecareact/. ·
  •  Greater emphasis has been placed on the HIV Care Continuum.  Applicants are expected to include a graph illustrating the HIV Care Continuum in the EMA/TGA and an explanation of how the HIV Care Continuum is utilized in your jurisdiction.  Refer to the Needs Assessment Section IV.2.ii for requirements. ·      
  •    The Unmet Need requirements in this funding announcement have been updated and included in Section IV.2.ii. Needs Assessment 3) b. Unmet Need. 

Please review carefully when preparing this section of your application. The following information will assist in understanding and completing this year’s grant application: · As an applicant and current recipient, you are required to have implemented the Part A National Monitoring Standards at the grant recipient and provider/subrecipient levels.  HRSA has developed and distributed guidelines outlining the responsibilities of HRSA, the grant recipient, and provider/subrecipient staff.  The National Monitoring Standards can be found at: http://hab.hrsa.gov/manageyourgrant/granteebasics.html. ·Women, Infants, Children and Youth (WICY) waiver requests are no longer part of the application process.  The WICY waiver reporting format was revised to allow recipients to submit a waiver request and provide supporting data with the annual progress report. Part A funds are subject to Section 2604(c) of the PHS Act which requires that not less than 75 percent of the funds remaining after reserving funds for administration and clinical quality management be used to provide core medical services that are needed in the EMA/TGA for individuals with HIV/AIDS who are identified and eligible under the RWHAP.  Core medical services are listed in section 2604(c)(3) of the PHS Act, and support services allowed under Part A are limited to services that are needed for individuals with HIV/AIDS to achieve their medical outcomes, as defined by the RWHAP.  The most recent service definitions can be found in the latest version of the National Monitoring Standards, located at http://hab.hrsa.gov/manageyourgrant/granteebasics.html.  The burden is on the applicant to accurately propose plans and projections using the most recent versions of the Standards and definitions that are posted when an application is submitted. · Applicants seeking a waiver to the core medical services requirement must submit a waiver request either with this grant application, at any time up to the application submission, or up to four months after the start of the grant award for FY 2016.  Submission should be in accordance with the information and criteria published by HRSA in the Federal Register Notice, Vol. 78, No. 101, dated Friday, May 24, 2013, and may be found at

http://www.gpo.gov/fdsys/pkg/FR- 2013-05-24/pdf/2013-12354.pdf

Sample letters may be found at http://hab.hrsa.gov/affordablecareact/samplereqwaiverletters.pdf.  In addition, recipients are advised that an FY 2016 Part A waiver request must include funds awarded under the Minority AIDS Initiative (MAI).  A waiver request that does not include MAI will not be considered.  If submitting with the application, a core medical services waiver request should be included as Attachment 9. ·EMA/TGA Agreements and Compliance Assurances are included (Appendix A) with this funding opportunity announcement (FOA), and require the signature of the CEO, or the CEO’s designee; this document should be included as Attachment 2.

Urinary Stone Disease Research Network: Scientific Data Research Center (USDRN-SDRC) (Collaborative U01)

RFA-DK-15-005
Urinary Stone Disease Research Network: Scientific Data Research Center (USDRN-SDRC) (Collaborative U01) stones--cc--rkramer62
Department of Health and Human Services
National Institutes of Health

Section I. Funding Opportunity Description

This FOA invites collaborative U01 cooperative agreement applications to establish a multi-center, multi-disciplinary group of investigators to be known as the Urinary Stone Disease Research Network (USDRN). The Scientific Data Research Center applications submitted under this FOA are linked to RFA-DK-15-004, which will support the USDRN clinical centers.

Background

Urinary Stone Disease (USD) is an important healthcare problem affecting about 1 out of 11 Americans, causing pain and suffering for the patient and a financial burden for the Nation. The prevalence of USD in the US has nearly doubled in the last 15 years, and is increasing in both adults and children. According to the Urological Diseases in America (UDA) project funded by the NIDDK, the annual cost of USD is estimated at $10 billion making it the most expensive non-malignant urologic condition in the U.S. A recent study estimates that the impact of obesity, diabetes and population rates will increase costs of USD to $1.24 billion/year by 2030. An acute symptomatic episode of USD is generally extremely painful and frequently results in Emergency Department (ED) care. ED visit rates for USD have doubled between 1992 and 2009. Computed tomography use for evaluation of USD in ED has tripled during the same time period and use of drugs has also increased. Cross sectional analyses show that about 10% of ED visits for USD are for repeat encounters. The intangible costs to the affected individual and the family, such as pain, diminished quality of life (QoL), time-off from work or school, and professional risks caused by a renal colic are enormous.

The treatment of USD has advanced over the last 30 years. New endourologic approaches allowed most stones to be treated endoscopically without the need for a skin incision. Technical advances have improved surgical USD treatment strategies. Improved optic lens systems and fiberoptic light sources have enabled better visualization. Increased instrument flexibility and miniaturization along with effective energy sources for stone disintegration led to the development of percutaneous nephrolithotomy and ureteroscopic lithotripsy. Extracorporeal shock wave lithotripsy (SWL) was developed for stone fragmentation without invasive instrumentation of the body. Although SWL and endourologic approaches are commonly used for the treatment of an USD episode, there is a major trend towards more frequent use of ureteroscopy (URS). Medical management has also advanced to a certain extent; however the prevalence of USD continues to increase both in adults and children. Despite these advances the limited state of knowledge for USD is reflected in several clinical management guidelines that have been published by the American Urological Association (AUA), and European Association of Urology (EAU) using systematic reviews and data extraction. Only 1 of 27 and 3 of 17 recommendations were based on Level 1 evidence.

USD is often recurrent.  Data from the National Health and Nutrition Examination Survey (NHANES) show that 35% of participants had experienced 2 or more distinct episodes of urinary stones. Other epidemiologic data show that recurrence rates of first time stone formers at 2, 5, 10, and 15 years were 11%, 20%, 31%, and 39%, respectively. Thus prevention of USD recurrence could substantially reduce its public health burden.

Ureteral stenting is a common prophylactic procedure after URS to mitigate peri-operative complications. Stenting the ureter is also performed in conjunction with SWL, and after complicated percutaneous nephrolithotomy (PCNL). Ureteral stenting is also used for therapeutic purposes such as obstructive pyelonephritis, bilateral obstructing stones or an obstructing stone in a solitary kidney. However; ureteral stents cause considerable patient discomfort such as pain, dysuria, urinary frequency, incontinence and hematuria.

The goals outlined in this FOA were developed in part, from the NIDDK sponsored workshop “Urinary Stone Disease: Research Challenges and Opportunities” held on April 1-2, 2015.

Research Objectives

This FOA will establish a network of investigators to design and conduct clinical research studies in adults and children with USD. The network is expected to include a wide range of expertise including but not limited to adult and pediatric urologists, adult and pediatric nephrologists, pediatricians, ED physicians, clinical trialists, nutritionists, behavioral scientists and radiologists. All studies proposed in the applications will be a starting point for discussions regarding the research undertaken by the network. USDRN investigators will devise studies that will be reviewed by a Protocol Review Committee (PRC) and approved by the NIDDK, then recruit stone forming patients for the collaborative studies. The final study protocol will be designed by the Clinical Center, and Scientific Data Research Center Program Directors/Principal Investigators and approved by the Steering Committee. Network study results are expected to provide evidence for management approaches to USD.

USD has different causes, and there have been many studies to understand the mechanisms of stone formation and prevention of new episodes of USD. In contrast, there is scant information about recurrent episodes of USD.  Available evidence suggests a high (about 35%) and unchanging rate of recurrence. Most urinary stones are primarily composed of calcium. There is a need to identify the underlying causes and to improve methods to prevent calcium USD recurrences. Increasing fluid intake and urinary volume, and medical therapies with potassium citrate and/or thiazide or thiazide analog diuretics are the recommended measures for recurrent calcium stone prevention based on moderate quality of evidence.

Although increasing fluid intake is generally recommended for stone-forming patients, a Cochrane review found no studies of increased fluid intake for the primary prevention of USD, and only one study for secondary prevention (to reduce recurrence). A more recent systematic review and meta-analysis including observational studies demonstrated that increased fluid intake significantly reduced incident and recurrent stones. Adherence and safety data were limited. Thus there is a need for a definitive randomized clinical trial (RCT) to evaluate the impact of increased fluid intake on urinary stone recurrence. However, increasing fluid intake and maintaining a daily urine volume of at least 2.5 liters is very challenging in children and adults. There are no reliable recommendations on fluid intake in children. Reluctance to drink increased amounts of water, urinary symptoms due to higher urine volumes, environmental circumstances for bathroom breaks, potential hyponatremia causing altered mental status, confusion, and even seizures, and difficulties in behavior change are some of the impediments for uninterrupted and sustained high fluid intake. The use of wearable devices, smartphone applications and incentives to encourage fluid intake, methods to monitor urine volume, pH and specific gravity are some of the new methods that can be used to facilitate fluid intake. A RCT with sufficient power is needed to determine how to maintain high fluid intake, and then show whether increasing and maintaining urinary volume decreases the urinary stone recurrences in adults and children. Investigators are encouraged to think broadly on incorporating mobile health technology, behavioral economics and/or other innovative strategies to maintain long-term fluid intake. Applicants are also encouraged to propose innovative trial methodologies such as adaptive and pragmatic trial designs, and use of surrogates for stone recurrence.

Ureteral stents are commonly used for therapeutic or prophylactic purposes. Their use is frequently based on clinical judgment of the surgeon to improve stone passage and/or prevent complications rather than evidence. Despite their clinically utility, ureteral stents can cause significant patient pain and discomfort. Years of research by academia and industry to reduce patient discomfort by different stent designs, developing drug-coated stents, and using different stent materials, have not completely eliminated stent related symptoms. Some of the pain and stent related symptoms can be controlled or reduced by medications. Studies are needed to provide evidence for appropriate stent use of ureteral stents during common procedures for stones (SWL, URS, and PCNL), identify patients who will likely experience stent related pain and symptoms, and to mitigate those symptoms. These questions may be answered by establishing new patient cohorts, randomized clinical trials, pragmatic clinical trials or by using other novel clinical study methodologies. Applicants may propose integrated approaches such as an observational study for event rate and risk identification, and a RCT to reduce ureteral stent use and/or mitigate stent pain and symptoms.

The long-term goal of USDRN is to inform clinical practice by a) providing evidence on the effects of fluid intake on urinary stone recurrence, b) understanding and reducing pain and suffering from the use of ureteral stents in USD patients, and c) to create data and biological specimen resources for USDRN investigators and other future researchers.

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-DK-15-005
Funding Opportunity Title: Urinary Stone Disease Research Network: Scientific Data Research Center (USDRN-SDRC) (Collaborative U01)
Opportunity Category: Discretionary
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Food and Nutrition
Health
Category Explanation:
Expected Number of Awards: 2
CFDA Number(s): 93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research
Cost Sharing or Matching Requirement: No
Posted Date: Aug 24, 2015
Creation Date: Aug 24, 2015
Original Closing Date for Applications: Nov 18, 2015  
Current Closing Date for Applications: Nov 18, 2015  
Archive Date: Dec 19, 2015
Estimated Total Program Funding: $4,000,000
Award Ceiling: $700,000
Award Floor:

Eligibility

Eligible Applicants:
Native American tribal governments (Federally recognized)
City or township governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
Public and State controlled institutions of higher education
Private institutions of higher education
Independent school districts
Small businesses
Special district governments
County governments
State governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
For profit organizations other than small businesses
Public housing authorities/Indian housing authorities
Others (see text field entitled “Additional Information on Eligibility” for clarification)
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 cooperative agreement applications to establish a multi-center, multi-disciplinary group of investigators to be known as the Urinary Stone Disease Research Network (USDRN). This FOA solicits applications for the Scientific Data Research Center (SDRC) and runs in parallel with a separate FOA that invites applications for the Clinical Centers (CCs) (RFA-DK-15-004). The USDRN will a) design and conduct a randomized clinical trial (RCT) to investigate the impact of increased fluid intake and increased urine output on the rate of recurrence of urinary stones in adults and children, b) conduct clinical research to understand and mitigate ureteral stent-related pain and symptoms, and c) provide data and collect biological samples from the studies to create a resource for future researchers. RFA-DK-15-004 will support USDRN Clinical Centers.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-15-005.html

BRAIN Initiative: Technology Sharing and Propagation (R03)

RFA-MH-16-725brain
BRAIN Initiative: Technology Sharing and Propagation (R03)
Department of Health and Human Services
National Institutes of Health

Section I. Funding Opportunity Description

Background

The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) InitiativeSM is aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, shows how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to treat, cure, and even prevent brain disorders.

NIH is one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH component of the BRAIN Initiative is guided by the long-term scientific plan, “BRAIN 2025: A Scientific Vision,” which details seven high-priority research areas and calls for a sustained federal commitment of $4.5 billion over 12 years. This FOA and other BRAIN Initiative FOAs are based on careful consideration by the NIH of the recommendations of the BRAIN 2025 Report, and input from the NIH BRAIN Multi-Council Working Group (MCWG, Roster).  Information about MCWG meetings is available at http://www.braininitiative.nih.gov/index.htm.

In addition to the national BRAIN Initiative, the NIH continues to have a substantial annual investment in neuroscience research. The Institutes and Centers contributing to the NIH BRAIN Initiative support those research efforts through applications received via parent announcements as well as through specific FOAs. Potential applicants to this FOA are strongly encouraged to contact the Scientific/Research Contact if they have any questions about the best FOA for their research.

To promote progress in development of new technologies as well as in theory and data analysis, the BRAIN Initiative encourages collaborations between neurobiologists and researchers with expertise in statistics, physics, mathematics, engineering, and computer science, and NIH welcomes applications from investigators in these disciplines.

Research Objectives

This FOA seeks applications from investigators who can identify new technologies which, if introduced into their laboratory, will enable or promote new research activities that further the aims of the BRAIN initiative as described in the BRAIN 2025 Report.  Injection of these new technologies, whether experimental, theoretical or data analytical, into the applicant’s research program must newly enable experimentation in areas that are relevant to the NIH BRAIN Initiative.  Projects that are successful will result in a publication or other concrete deliverable that will allow the awardee to apply that technology or method in future research, and thus enhance research infrastructure.  This FOA is meant to support work on a particular research project that will illustrate that the technology has been mastered by the receiving laboratory.

NIH also supports dissemination activities between tool developers and the research community in other ways such as the dissemination activities of the BD2K Centers, the collaboration, service, and dissemination activities of the Biomedical Technology Research Resources and various NIH Career Development Awards.  This funding opportunity is distinct in its focus on the dissemination of tools related to the goals of the BRAIN Initiative.

The primary intent of this FOA is to inject technology into a particular laboratory that does not have experience with that technology, with the potential for sustained enhancement of the research conducted by that laboratory.  In some cases, effort may be needed by the developer of the technology to fit the needs of the recipient laboratory.  Such collaborations are welcome since a major purpose of the BRAIN Initiative is to support the development of new tools.  Although the new technology is transferred to a single research group, subsequent dissemination to other groups, performing research related to the aims of the BRAIN initiative, is welcomed.  While it is not required that the awardee have plans to re-distribute their newly gained expertise, groups with the intent and capability to more broadly disseminate their new expertise should briefly describe their plans.

Examples of supported activities include, but are not limited to:

  • Sending a faculty member, graduate student, postdoctoral fellow or technical staff to a company or academic laboratory that has developed a new technology, to collaborate on applying the technology to a problem of interest to the BRAIN initiative.
  • Bringing a member of a company or academic laboratory with a new technology to a research laboratory to establish or train members of the awardee laboratory, in applying the new tool in the context of a specific research project.
  • Establishing a collaboration whereby experts in theory, modeling, computer science, or statistics (TMCS) can introduce newly developed data analytics into the research program of the recipient laboratory. Such collaborations are likely to be most valuable early in the design of an experiment.  As with the tool development examples, the TMCS expert could either host a member of the academic laboratory or could visit that laboratory to disseminate expertise.

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-MH-16-725
Funding Opportunity Title: BRAIN Initiative: Technology Sharing and Propagation (R03)
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Education
Health
Income Security and Social Services
Category Explanation:
Expected Number of Awards: 10
CFDA Number(s): 93.173 — Research Related to Deafness and Communication Disorders
93.213 — Research and Training in Complementary and Integrative Health
93.242 — Mental Health Research Grants
93.273 — Alcohol Research Programs
93.279 — Drug Abuse and Addiction Research Programs
93.286 — Discovery and Applied Research for Technological Innovations to Improve Human Health
93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders
93.865 — Child Health and Human Development Extramural Research
93.866 — Aging Research
93.867 — Vision Research
Cost Sharing or Matching Requirement: No

Posted Date:Aug 24, 2015

Creation Date:Aug 24, 2015

Original Closing Date for Applications:Jan 6, 2016

  Current Closing Date for Applications:Jan 6, 2016  

Archive Date:Feb 6, 2016

Estimated Total Program Funding:$1,000,000

Award Ceiling:$100,000

Award Floor:

Eligibility

Eligible Applicants:
Special district governments
City or township governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
State governments
Independent school districts
Public housing authorities/Indian housing authorities
Small businesses
County governments
Native American tribal governments (Federally recognized)
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
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Private institutions of higher education
Public and State controlled institutions of higher education
For profit organizations other than small businesses
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 Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative Funding Opportunity Announcement (FOA) is to encourage the transfer of new technologies and new data analysis techniques into a research laboratory. One of the key goals of the BRAIN Initiative is to develop new technologies to improve our understanding of the brain. In order for those technologies to be useful, they need to be broadly disseminated beyond the laboratory or company where they originated. This FOA promotes this goal by providing funds to enable the incorporation of new technologies or data analysis techniques into research programs that further the aims of the BRAIN initiative.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-16-725.html

Limited Competition: Alzheimer’s Disease Neuroimaging Initiative, ADNI (U19)

Limited Competition: Alzheimer’s Disease Neuroimaging Initiative, ADNI (U19)
Department of Health and Human Servicesalzheimers
National Institutes of Health – RFA-AG-16-019

Document Type: Grants Notice
Funding Opportunity Number: RFA-AG-16-019
Funding Opportunity Title: Limited Competition: Alzheimer’s Disease Neuroimaging Initiative, ADNI (U19)
Opportunity Category: Discretionary
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards: 1
CFDA Number(s): 93.866 — Aging Research
Cost Sharing or Matching Requirement: No
osted Date: Aug 17, 2015
Creation Date: Aug 17, 2015
Original Closing Date for Applications: Oct 27, 2015  
Current Closing Date for Applications: Oct 27, 2015  
Archive Date: Nov 27, 2015
Estimated Total Program Funding: $8,000,000
Award Ceiling: $12,000,000
Award Floor:
Background

The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is a landmark, public-private partnership that has made major contributions to our understanding of Alzheimer’s Disease and to the ability of industry and non-industry sponsors to carry out registration trials of disease modifying interventions.  ADNI has also been a pioneer in scientific transparency and data-sharing: putting all of its (de-identified) data online and available to all qualified investigators.

ADNI began October, 2004, as a cooperative agreement between the National Institute on Aging (NIA) and the Northern California Institute for Research and Education (NCIRE) to “develop a multi-site, longitudinal, prospective, naturalistic study of normal cognitive aging, mild cognitive impairment (MCI), and early Alzheimer’s disease (AD) as a public domain research resource”.  Substantial additional support was provided by a consortium of 21 industry and foundation partners through the Foundation for NIH (FNIH).

ADNI subjects were followed longitudinally with repeated clinical and neuropsychological evaluations, MRI imaging, FDG-PET scans, and plasma and CSF biomarkers.  During the initial 5 year support period, revisions to the project added Genetics and Neuropathology Cores, and PiB PET imaging in a subset of sites.  The American Recovery and Reinvestment Act (ARRA) of 2009 funded ADNI-GO, expanding the cohort to include milder MCI subjects and adding PET amyloid imaging at all sites.  In 2010, NCIRE submitted a competitive renewal application for the cooperative agreement, extending follow-up, replacing dropouts, and focusing on earlier detection.   ADNI2 was funded by NIA and the FNIH consortium of private partners in 2011.  A cohort of subjects with subjective memory complaints but normal testing was also added.  A competitive revision to pilot tau PET imaging was awarded in early 2015.  ADNI2 is currently funded through July 2016.

ADNI1, ADNI-GO, and ADNI2 are natural history studies in a cohort representative of subjects who participate in AD randomized clinical trials (RCTs).   ADNI2 involves 55 clinical sites across the United States and Canada, and follows more than 1000 subjects: ranging from healthy, elderly controls with normal cognition, to cognitively and functionally impaired patients with early AD, as well as patients with intermediate levels of impairment or subjective memory complaints.  The FNIH consortium of private partners now includes 32 members.

ADNI’s major accomplishments include:

  • Validating biomarkers to be used in selecting subjects for interventional RCTs during the earliest stages of AD: demonstrating changes in CSF ß-amyloid 42 and tau, and amyloid PET, that presumably reflect initial steps in AD pathology in mildly symptomatic, and even some asymptomatic subjects.
  • Standardizing methods for magnetic resonance imaging (MRI), positron emission tomography (PET), and cerebrospinal fluid (CSF) biomarkers, enabling multicenter AD studies.  ADNI methods have become a standard for industry and academia.
  • Demonstrating the feasibility and value of multicenter PET amyloid imaging.
  • Demonstrating that a significant portion of healthy, elderly controls have beta amyloid in their brains, and may be at increased risk for cognitive decline and AD.
  • Demonstrating that decreased hippocampal volume on MRI is associated with disease progression.
  • Creating an online database and sharing de-identified study data with almost 2,500 non-ADNI investigators, who have used the data to publish more than 350 papers
  • Fostering the establishment of ADNI-like programs in many other countries, leading to worldwide collaborations between academic, government and industry investigators.
Objectives
  • Understand and characterize clinical AD pathobiology
  • Identify biomarkers to detect AD at its earliest stages
  • Identify biomarkers associated with disease progression, including potential surrogate endpoints.
  • Work in a precompetitive space to develop biomarkers to facilitate multicenter RCTs of disease modifying interventions for AD
  • Share de-identified clinical and biomarker data as they are gathered, without embargo

ADNI helped establish the value of PET amyloid imaging in a precompetitive, research use only setting.  Subsequent to this, PET amyloid radio-tracers from three different industry sponsors (Avid/Lilly – Amyvid, Piramal – Neuraceq, and GE – Vizamyl) were approved by the Food and Drug Administration (FDA) and are now commercially available in the US.  While ADNI had an important role in establishing the scientific and clinical utility of PET amyloid imaging, it had no role in the regulatory approval of any particular radio-tracer.  It is essential for ADNI to continue working in the precompetitive space, where transparency, data sharing, and unfettered access to results have paramount importance.  Industry support remains crucial for ADNI, but this collaboration, and ADNI’s work must take place in the public domain.

In recent years, PET tau imaging radio-tracers have been developed by groups in industry and academia.  Tau PET imaging is only beginning to be applied in clinical settings (ADNI2 has initiated a tau PET pilot).  Preliminary results appear promising: but remain, preliminary.  One goal for ADNI3 should be to explore the role of tau PET imaging in clinical AD research.  Baseline and longitudinal tau PET imaging in the ADNI cohort of healthy controls, subjects with MCI, and AD, combined with correlation to clinical outcomes and changes in other biomarkers can establish the value of this new biomarker.

ADNI is a unique, shared scientific endeavor.  It has not been, and should not be devoted  to testing any particular hypothesis about AD, but should provide the clinical data and biosamples needed by academic and industry investigators to generate and test models of AD onset and progression.  The project, by itself, will not conquer AD, but ADNI will provide the scientific ammunition needed by the field to understand the pathobiology of AD and to find a disease modifying intervention.

ADNI has 9 different Cores, whose functions should continue to be provided in any renewal.  Their duties include:

  • Administrative Core: leads and coordinates the entire project
  • Clinical Core: collects clinical data, interfaces with and monitors the clinical sites; curates clinical data before transfer to Informatics Core
  • MRI Core: oversees collection of anatomical and functional MRI data by clinical sites; establishes scanning protocols; ensures data quality; manages and curates MRI data before transfer to Informatics Core
  • PET Core: oversees collection of PET data (FDG, amyloid, tau, and any other tracers) by clinical sites; establishes scanning protocols, ensures data quality; manages and curates PET data before transfer to Informatics Core
  • Biomarker Core: collects, stores, and curates CSF and blood samples collected by clinical sites; transfers samples to investigators approved by an independent Resource Allocation Review Committee (RARC) to use ADNI biosamples; performs standardized assays for specific analytes in CSF and/or plasma from all subjects and transfers data to Informatics Core
  • Genetics Core: collects, stores, and curates genetic materials collected by clinical sites; transfers samples to investigators approved by an independent Resource Allocation Review Committee (RARC) to use ADNI genetic materials; performs specific standardized genetic analyses on all subjects and transfers data to Informatics Core
  • Neuropathology: collects, stores, and curates the ADNI brain bank; coordinates post-mortem collection of brains by clinical sites; transfers brain samples to investigators approved by an independent Resource Allocation Review Committee (RARC) to study ADNI brain materials; provides standardized post-mortem neuropathological evaluations and transfers data to Informatics Core
  • Biostatistics: provides biostatistical consultation and support to other Cores and to ADNI, overall
  • Informatics: maintains the ADNI database; manages and shares ADNI data with qualified investigators, maintaining subject anonymity and ensuring data integrity

Eligibility

Eligible Applicants:
Private institutions of higher education
State governments
Independent school districts
Public housing authorities/Indian housing authorities
Small businesses
City or township governments
Special district governments
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
County governments
For profit organizations other than small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Public and State controlled 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: This limited competition FOA invites a renewal application for the next 5-year cycle of the Alzheimer’s Disease Neuroimaging Initiative (ADNI). ADNI’s purpose is to develop a multisite, longitudinal, prospective, naturalistic study of normal cognitive aging, mild cognitive impairment (MCI), and early Alzheimer’s disease as a public domain research resource to facilitate the scientific evaluation of neuroimaging and other biomarkers for the onset and progression of MCI and Alzheimer’s disease.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-AG-16-019.html