Federal prize competition seeks innovative ideas to combat antimicrobial resistance

Source: https://www.nih.gov/news-events/news-releases/federal-prize-competition-seeks-innovative-ideas-combat-antimicrobial-resistance

Contestants will vie for $20 million in prizes to develop new innovative laboratory diagnostic tools that detect and distinguish antibiotic resistant bacteria.

A federal prize competition launched today is calling for innovative ideas for rapid, point-of-care laboratory diagnostic tests to combat the development and spread of drug resistant bacteria, a rising public health threat. Antibiotic resistant bacteria cause at least 2 million infections and 23,000 deaths each year in the United States, according to the Centers for Disease Control and Prevention.

The Antimicrobial Resistance Diagnostic Challenge will award $20 million in prizes over all phases of the competition for new, innovative and novel laboratory diagnostic tests. The diagnostic tests being sought are those that identify and characterize antibiotic resistant bacteria and those that distinguish between viral and bacterial infections to reduce unnecessary uses of antibiotics, a major cause of drug resistance. The prize is sponsored by two U.S. Department of Health and Human Services components, the National Institutes of Health and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) in support of the National Action Plan for Combating Antibiotic Resistant Bacteria(link is external).

“The growing incidence of serious infections from antibiotic resistant bacteria presents a critical risk to the public health of our nation,” said NIH Director Francis S. Collins, M.D., Ph.D. “My hope is that this competition will spur exceptional innovators to rise to the challenge and deliver effective tools to help manage this significant problem.”Scanning electron micrograph of neutrophil ingesting methicillin-  resistant Staphylococcus aureus bacteria.

With real-time detection, healthcare providers would be able to identify infecting pathogens and resistance factors within hours, rather than the two to three days or longer that the standard microbiological culture processes require. Such knowledge would allow tailoring of treatments, minimizing the broad-spectrum antibiotic approach used by many clinicians today.

“This effort even goes beyond public health,” said Nicole Lurie, M.D., M.S.P.H., assistant secretary for preparedness and response. “Combating antibiotic-resistant bacteria is a priority issue for economic and national security.”

Concepts must be submitted by Jan. 9, 2017, for the first phase of the competition. Up to 20 semi-finalists will be selected from the applicant pool, each receiving up to $50,000. In the second phase of the competition, on Dec. 3, 2018, up to 10 finalists will be selected to each receive up to $100,000.  These funds can be used to develop prototypes for evaluation by two CLIA(link is external)-certified independent laboratories, which will be considered when final winners are selected. In the final phase, winners are expected to be announced on July 31, 2020.  The competition specifies that up to three winners can be selected, and winners will share an amount equal to or greater than $18 million.

NIH’s National Institute of Allergy and Infectious Diseases and ASPR’s Biomedical Advanced Research and Development Authority (BARDA) each contributed $10 million to the challenge. The CDC and the U.S. Food and Drug Administration provided technical and regulatory expertise to the design of the challenge competition. Technical criteria, objectives and performance characteristics of laboratory diagnostics that would be considered for the prize were informed by stakeholder input from a public workshop and a request for information.  For more information about the challenge or how to apply, please visit the challenge website(link is external).

About the Biomedical Advanced Research and Development Authority (BARDA): BARDA, within the HHS Office of the Assistant Secretary for Preparedness and Response, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. For more information about BARDA, visit www.phe.gov/about/BARDA/Pages/default.aspx(link is external).

About the Office of the Assistant Secretary for Preparedness and Response (ASPR): ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. For more information about ASPR and for expertise, tools, and resources to help your community prepare, respond and recover from public health emergencies, visitwww.phe.gov(link is external).

About the National Institute of Allergy and Infectious Diseases (NIAID): NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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ADVANCE: Increasing the Participation and Advancement of Women in Academic Science and Engineering Careers

16-594
ADVANCE: Increasing the Participation and Advancement of Women in Academic Science and Engineering Careers
National Science FoundationWISE

General Information

Document Type: Grants Notice
Funding Opportunity Number: 16-594
Funding Opportunity Title: ADVANCE: Increasing the Participation and Advancement of Women in Academic Science and Engineering Careers
Opportunity Category: Discretionary
Opportunity Category Explanation:  
Funding Instrument Type: Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:  
Expected Number of Awards: 26
CFDA Number(s): 47.041 — Engineering Grants
47.049 — Mathematical and Physical Sciences
47.050 — Geosciences
47.070 — Computer and Information Science and Engineering
47.074 — Biological Sciences
47.075 — Social, Behavioral, and Economic Sciences
47.076 — Education and Human Resources
47.079 — Office of International Science and Engineering
47.083 — Office of Integrative Activities
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: Aug 27, 2016
Last Updated Date: Aug 27, 2016
Original Closing Date for Applications: Jan 11, 2017  Adaptation Letter of Intent; Adaptation full proposal; Partnerships Letter of Intent; Partnerships Full Proposal; Institutional Transformation Preliminary Proposal; Institutional Transformation full proposal
Current Closing Date for Applications: Jan 11, 2017  Adaptation Letter of Intent; Adaptation full proposal; Partnerships Letter of Intent; Partnerships Full Proposal; Institutional Transformation Preliminary Proposal; Institutional Transformation full proposal
Archive Date: Feb 18, 2022
Estimated Total Program Funding: $22,200,000
Award Ceiling: $3,000,000
Award Floor: $1,000,000

 
Additional Information

Agency Name: National Science Foundation
Description: Despite significant increases in the proportion of women pursuing science, technology, engineering, and mathematics (STEM) doctoral degrees, women are significantly underrepresented as faculty, particularly in upper ranks, and in academic administrative positions, in almost all STEM fields.  The problems of recruitment, retention, and advancement that are the causes of this underrepresentation vary by discipline and across groups of women faculty (e.g., by race/ethnicity, disability status, sexual orientation, foreign-born and foreign-trained status, and faculty appointment type).  The ADVANCE program is designed to foster gender equity through a focus on the identification and elimination of organizational barriers that impede the full participation and advancement of all women faculty in academic institutions.  Organizational barriers that inhibit equity may exist in areas such as policy, practice, culture, and organizational climate.  For example, practices in academic departments that result in the inequitable allocation of service or teaching assignments may impede research productivity, delay advancement and create a culture of differential treatment and rewards.  Policies and procedures that do not mitigate implicit bias in hiring, tenure, and promotion decisions could mean that women and underrepresented minorities are evaluated less favorably, perpetuating their underrepresentation and contributing to a climate that is not inclusive.     The goals of the ADVANCE program are (1) to develop systemic approaches to increase the representation and advancement of women in academic STEM, [1] careers; (2) to develop innovative and sustainable ways to promote gender equity that involve both men and women in the STEM academic workforce; and (3) to contribute to the research knowledge base on gender equity and the intersection of gender and other identities in STEM academic careers.  The ADVANCE program contributes to the development of a more diverse science and engineering workforce because of the focus on equity for STEM academic faculty who are educating, training, and mentoring undergraduate and graduate students and postdoctoral scholars.  There are three program tracks.  All projects are expected to build on prior ADVANCE work and gender equity research and literature to broaden the implementation of organizational and systemic strategies to foster gender equity in STEM academic careers.  All ADVANCE proposals are expected to recognize that gender does not exist in isolation from other characteristics, such as race/ethnicity, disability status, sexual orientation, foreign-born and foreign-trained status, faculty appointment type, etc., and should offer strategies to promote gender equity for all faculty: The Institutional Transformation (IT) track supports the development of innovative organizational change strategies to produce comprehensive change within one non-profit two-year or four-year academic institution across all STEM disciplines.  IT projects are also expected to contribute new research on gender equity in STEM academics.  Projects that do not propose innovative strategies may be more appropriate for the Adaptation track.

The Adaptation track supports the adaptation and implementation of evidence-based organizational change strategies, ideally from among those developed and implemented by ADVANCE projects.  Adaptation awards may support the adaptation and implementation of proven organizational change strategies within a non-profit two-year or four-year academic institution that has not had an ADVANCE IT award.  Adaptation awards may also be made to a STEM organization to implement systemic change strategies focused across all STEM disciplines, several STEM disciplines, or within one STEM discipline.  The Partnership track will support partnerships of two or more non-profit academic institutions and/or STEM organizations to increase gender equity in STEM academics.  Projects should have national or regional impact and result in systemic change within one STEM discipline, several STEM disciplines, or all STEM disciplines.  Partnering STEM organizations can include any entity eligible for NSF support.  Partners may include professional societies, industry, non-profit organizations, publishers, policy and research entities, state systems of higher education, higher education organizations, as well as institutions of higher education.  Partnership proposals must include a final year focused on sustainability and/or scale-up, communication, and evaluation. For all proposals, ADVANCE is interested in supporting a range of non-profit academic institution types including: community colleges, primarily undergraduate institutions, minority-serving institutions (e.g. Tribal Colleges and Universities, Historically Black Colleges and Universities, Hispanic-Serving Institutions, Native Hawaiian Serving Institutions, Alaska Native Institutions, Predominantly Black Institutions and Non-tribal, Native American Serving Institutions), women’s colleges, institutions primarily serving persons with disabilities, and master’s and doctoral level institutions. ADVANCE does not provide fellowships, research grants, or travel grants to individual students, postdocs, or faculty.  Undergraduate STEM opportunities can be found at <a href= http://stemundergrads.science.gov and graduate STEM opportunities at = http://stemgradstudents.science.gov

All STEM fields supported by NSF are included in the ADVANCE program.  STEM includes the learning, social, behavioral, and economic sciences.  The program does not include clinical science faculty. </div> </div>

Link to Additional Information: NSF Publication 16-594
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NSF grants.gov support grantsgovsupport@nsf.gov

If you have any problems linking to this funding announcement, please contact

NLM Grants for Scholarly Works in Biomedicine and Health (G13)

PAR-16-417
NLM Grants for Scholarly Works in Biomedicine and Health (G13)
Department of Health and Human Services
National Institutes of Healthbiomedicine

Section I. Funding Opportunity Description

The National Library of Medicine (NLM) awards Grants for Scholarly Works in Biomedicine and Health for the preparation of book-length manuscripts and other works of academic and/or public health policy value to U.S. health professionals, public health officials, biomedical researchers, and historians of the health sciences. Grants are awarded for major critical reviews, state-of-the-art summaries, historical studies, and other useful organizations of knowledge in clinical medicine, public health, biomedical research, and the informatics/information sciences relating to them. The work of academic and/or public health policy value may be prepared for publication in print or electronic media, or both.

Scholars in biomedical fields face competing demands for their time, including requirements for clinical care services, grant-related research and administrative duties. Scholarly work draws upon original sources that may reside in archives, databases, libraries or human experts around the world, in many different languages and formats. The work of scholarship – discovery, thoughtful analysis, synthesis and lucid presentation of findings from such materials – requires protected time and support for incidental costs, including materials, staff assistance, and travel. The NLM Grant for Scholarly Works in Biomedicine and Health is intended to help defray such expenses.

NLM Grants for Scholarly Works can be used to support several types of projects of academic and/or public health policy value, including but not limited to:

  • Works focusing on the history or philosophy of medicine, public health and the life sciences, the development of medical research and health services, bioethics, and studies on the interrelationship of medicine and society
  • Works focusing on the history or philosophy of biomedical informatics, computational biology, health information sciences, health communications, or health sciences librarianship
  • Analytical and comprehensive critical reviews which identify the present status of research and practice in various health-related fields, addressing advances which have been made, problems requiring examination, and emerging trends

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-16-417
Funding Opportunity Title: NLM Grants for Scholarly Works in Biomedicine and Health (G13)
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): 93.879 — Medical Library Assistance
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: Aug 26, 2016
Last Updated Date: Aug 26, 2016
Original Closing Date for Applications: Feb 23, 2018  
Current Closing Date for Applications: Feb 23, 2018  
Archive Date: Mar 26, 2018
Estimated Total Program Funding:  
Award Ceiling: $50,000
Award Floor:  

Eligibility

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

Additional Information

Agency Name: National Institutes of Health
Description: NLM Grants for Scholarly Works in Biomedicine and Health are awarded for the preparation of book-length manuscripts and other works of academic and/or public health policy value to U.S. health professionals, public health officials, biomedical researchers and historians of the health sciences.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-16-417.html
Grantor 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

Limited Competition for the Continuation of the Hepatitis B Research Network Clinical Centers (U01)

RFA-DK-16-512
Limited Competition for the Continuation of the Hepatitis B Research Network Clinical Centers (U01)
Department of Health and Human Services
National Institutes of Healthhepatitis-b

Section I. Funding Opportunity Description

In prior funding cycles, the HBRN has developed and initiated the following protocols: an Adult and a Pediatric Cohort studies; the Adult Immune Active study; an Adult and a Pediatric Immune Tolerant studies.  Additional ancillary studies have been developed and implemented that focus on specific aspects of various clinical scenarios, approaches to assessment, or complications that are associated with hepatitis B.  In addition to the clinical studies in progress noted above, the HBRN has developed a biospecimen repository consisting of over 340,600 adult and 10,700 pediatric plasma and sera samples; and 1372 adult and 182 pediatric DNA specimens; along with detailed clinical database.

The HBRN is currently composed of 15 adult and 7 pediatric clinical sites throughout North America and a Data Coordination Center through 10 individual U01 Cooperative Agreements.

The HBRN Clinical Centers, which will be supported through this FOA, are  primarily charged with completing and analyzing the various clinical studies currently underway and for the future, to consider novel treatment trials for chronic hepatitis B and delta hepatitis; and to exploit translational research opportunities with the vast collection of biospecimens in the repository .

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-DK-16-512
Funding Opportunity Title: Limited Competition for the Continuation of the Hepatitis B Research Network Clinical Centers (U01)
Opportunity Category: Discretionary
Opportunity Category Explanation:  
Funding Instrument Type: Cooperative Agreement
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
Version: Synopsis 1
Posted Date: Aug 18, 2016
Last Updated Date: Aug 18, 2016
Original Closing Date for Applications: Dec 19, 2016  
Current Closing Date for Applications: Dec 19, 2016  
Archive Date: Jan 19, 2017
Estimated Total Program Funding: $7,000,000
Award Ceiling:  
Award Floor:

Eligibility

Eligible Applicants: Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: Other Eligible Applicants include the following: Faith-based or Community-based Organizations; Only the current HBRN awardees are eligible to apply to this FOA. Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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. See FOA for Eligibility Details

Additional Information

Agency Name: National Institutes of Health
Description: The purpose of this Funding Opportunity Announcement (FOA) is to continue the Hepatitis B Research Network Clinical Centers with a focus on the promotion of translational research on hepatitis B focusing upon elucidating the pathogenesis and natural history and developing means of treatment and control.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-16-512.html
Grantor 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

Kidney Precision Medicine Project Tissue Interrogation Sites (UG3/UH3)

RFA-DK-16-027
Kidney Precision Medicine Project Tissue Interrogation Sites (UG3/UH3)
Department of Health and Human Services
National Institutes of HealthDigital-Health-Infographic-08-636x412

Background

AKI and CKD impose a significant global health burden. Yet, no effective therapies currently exist for AKI, and only a few are available for CKD. Community feedback indicates that—despite significant effort from industry and academia—development of pharmacologic therapies for AKI and CKD has been hampered by non-predictive animal models, the inability to identify and prioritize human targets, the limited availability of human kidney biopsy tissue, and a poor understanding of AKI and CKD heterogeneity [Kidney Research National Dialogue 2014; AKI Outcomes Meeting 2015; Kidney Precision Medicine Meeting 2016]. Historically, AKI and CKD have been described as single, uniform diseases; however, growing consensus suggests that different disease pathways lead to different subgroups of AKI and CKD (AKIs and CKDs). Access to human kidney biopsy tissue is a critical first step to define disease heterogeneity and determine the precise molecular pathways that will facilitate identification of specific drug targets and ultimately enable individualized care for people with AKI and CKD.

Recent advances in multi-scale interrogation of human tissue and single cells have set the stage for precision medicine to be applied to AKI and CKD. The objectives of the KPMP are to ethically obtain and evaluate human kidney biopsies from participants with AKI or CKD, create a kidney tissue atlas, define disease subgroups, and identify critical cells, pathways and targets for novel therapies. The KPMP will be made up of three distinct, but highly interactive activities:

1.  Recruitment Sites: recruit people with AKI or CKD for longitudinal cohort studies that include a research kidney biopsy.

2.  Tissue Interrogation Sites: use and develop innovative technologies to analyze human kidney tissue (this FOA).

3.  Central Hub: aggregate, analyze and visualize all data and samples, and provide scientific, infrastructure and administrative support for the entire KPMP.

All data and samples from the RS and TIS will go to the CH. In addition to an Administrative Core (AC), the CH will have a Data and samples Coordinating Center (DCC) and a Data Visualization Center (DVC). The DCC will perform standard clinical data assessments (e.g., patient data reports, recruitment tables, observational study reports), whereas the DVC will perform digital pathological assessments and create a kidney tissue atlas (incorporating data and images generated by the RS and TIS) to help define disease subgroups and identify critical cells, pathways and targets for novel therapies. The DVC will also manage a KPMP website to facilitate the sharing of all de-identified data and samples with the broader research community.

While kidney tissue from transplant, nephrectomy, and autopsy will be used to optimize tissue interrogation methods, these do not provide the quality and diversity of tissue to meet all of the KPMP objectives. The KPMP requires research kidney biopsies (or clinical biopsies with research core(s); collectively called research kidney biopsies throughout this document) linked to longitudinal clinical phenotypic data and biosamples.

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-DK-16-027
Funding Opportunity Title: Kidney Precision Medicine Project Tissue Interrogation Sites (UG3/UH3)
Opportunity Category: Discretionary
Opportunity Category Explanation:  
Funding Instrument Type: Cooperative Agreement
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
Version: Synopsis 1
Posted Date: Aug 17, 2016
Last Updated Date: Aug 17, 2016
Original Closing Date for Applications: Dec 06, 2016  
Current Closing Date for Applications: Dec 06, 2016  
Archive Date: Jan 06, 2017
Estimated Total Program Funding:  
Award Ceiling:  
Award Floor:

Eligibility

Eligible Applicants: Independent school districts
Public and State controlled institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Native American tribal governments (Federally recognized)
Others (see text field entitled “Additional Information on Eligibility” for clarification)
City or township governments
Special district governments
For profit organizations other than small businesses
Public housing authorities/Indian housing authorities
Small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
County governments
State 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) requests applications for the  (KPMP) Tissue Interrogation Sites (TIS) to use and develop innovative technologies to analyze human kidney tissue. The TIS will collaborate with the KPMP Recruitment Sites and Central Hub to obtain and evaluate kidney biopsies from participants with acute kidney injury and chronic kidney disease, create a kidney tissue atlas, define disease subgroups, and identify critical cells, pathways and targets for novel therapies. Applicant teams should have documented experience with a current state-of-the-art method that can be used or adapted to interrogate human kidney tissue. The initial UG3 exploratory phase will be used to demonstrate that the site can interrogate existing tissue samples and small numbers of new biopsies. The UG3 phase will also encourage the development of next generation tissue interrogation technologies that probe the structural, functional and molecular complexities of kidney tissue. UG3 projects that have met their milestones will be administratively considered by the NIDDK and prioritized for transition to the UH3 implementation phase. UH3 awards will support further validation, scale-up and technology development. Applicants must address both the UG3 and UH3 phases. This FOA is intended to support only human studies and applications that include animal or model systems are not responsive.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-16-027.html
Grantor 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

Peer Reviewed Orthopaedic Clinical Trial Award

W81XWH-16-PRORP-CTA
Peer Reviewed Orthopaedic Clinical Trial Award
Department of Defense
Dept. of the Army — USAMRAAorthomap

All applications must address one, and only one, of the following FY16 PRORP Focus Areas. The Focus Area addressed should be one from either the Surgical Care category or Rehabilitation category. Selection of the appropriate Focus Area is the responsibility of the applicant. Studies that propose nominal or iterative advancements are not encouraged.
Surgical Care Focus Areas:
Peripheral Nerve Injuries: Treatment strategies to improve outcomes from segmental peripheral nerve defects of motor and mixed (motor and sensory) peripheral nerve damage from crush or complete injury.
Prevention of Heterotopic Ossification: Techniques to retard or prevent the development of human post-traumatic heterotopic ossification in the upper extremity.
Volumetric Muscle Loss: Techniques to regenerate functional, innervated muscle units in treatment of volumetric muscle loss.
Extremity Fractures: Strategies to optimize patient outcomes after extremity fracture (i.e., time to begin rehabilitation, weight-bearing strategy, etc.).
Pelvic Ring Injuries: Treatment strategies to improve outcomes of complex pelvic ring injuries.

Compartment Syndrome: Strategies to improve current diagnoses for compartment
syndrome.
Gaps in Clinical Practice Guidelines: Address gaps in current orthopaedic clinical
practice guidelines (CPG) and recommendations (http://www.usaisr.amedd.army.mil/
cpgs.html). Applications under this Focus Area must specify which orthopaedically
relevant CPG their application is intended to support. Applicants should also highlight
the expected impact of their research on orthopaedic clinical practice.
Surgical Techniques to Optimize Gait: Validation of surgical techniques to optimize
gait efficiency and outcomes for patients with amputation or limb salvage.
Soft Tissue Trauma: Strategies to develop and/or identify musculoskeletal extremity
soft tissue trauma treatments optimizing return to duty, work, or reintegration.

General Information

Document Type: Grants Notice
Funding Opportunity Number: W81XWH-16-PRORP-CTA
Funding Opportunity Title: Peer Reviewed Orthopaedic Clinical Trial Award
Opportunity Category: Discretionary
Opportunity Category Explanation:  
Funding Instrument Type: Cooperative Agreement
Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:  
Expected Number of Awards: 3
CFDA Number(s): 12.420 — Military Medical Research and Development
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: Aug 02, 2016
Last Updated Date: Aug 02, 2016
Original Closing Date for Applications: Dec 07, 2016  
Current Closing Date for Applications: Dec 07, 2016  
Archive Date: Jan 06, 2017
Estimated Total Program Funding: $9,000,000
Award Ceiling: $0
Award Floor: $0

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 PRORP Clinical Trial Award mechanism was first offered in FY09. Since then, 191 Clinical Trial Award applications have been received, and 18 have been recommended for funding. The PRORP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a major impact on military combat-related orthopaedic injuries or non-battle injuries that significantly impact unit readiness and return-to-duty/work rates. Funding from this award mechanism must support a clinical trial and may not be used for preclinical research studies. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. The term “human subjects” is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. All applications are required to articulate the relevance of the proposed project to military and/or Veteran populations affected by orthopaedic injury. Collaboration with military and VA researchers and/or clinicians is encouraged. Studies that include active duty military or Veteran participants as all or a portion of the study population are encouraged. Proposed projects may range from small proof-of-concept trials to demonstrate feasibility or inform the design of more advanced trials (i.e., pilot, first in human, or Phase 0), through large-scale trials to determine efficacy in relevant patient populations. All funding amounts requested should be well-justified and appropriate to the scope of work proposed. If the clinical trial involves the use of a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) may be required and must be submitted to the FDA within 6 months of the award date. If the investigational product is a device, evidence that an Investigational Device Exemption (IDE) application that meets all requirements under 21 CFR 812 has been submitted to the FDA within 6 months of the award date, or that the device is exempt from an IDE, is required. The Government reserves the right to withdraw funding if an IND or IDE is necessary but has not been submitted to the FDA within 6 months of the award date, or if documented status of the IND or IDE has not been obtained within 12 months of the award date. This award is intended to support clinical trial studies that have potential to develop novel interventions in either surgical care or rehabilitation. Animal research is not allowed under the FY16 PRORP Clinical Trial Award. The following are important aspects of submission for the Clinical Trial Award:  The proposed clinical trial is expected to begin no later than 12 months after the award date, or 18 months for FDA-regulated studies.  The proposed intervention to be tested should offer significant potential impact for military personnel and Veterans with combat-related orthopaedic injuries or non-battle orthopaedic injuries that impact unit readiness and return-to-duty/work.  Inclusion of preliminary data relevant to the proposed clinical trial is required.  The proposed clinical trial must be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature.  The application should describe the planned indication for the product label, if appropriate. Likewise, it should include an outline of the development plan and regulatory strategy required to support that indication.  The application should demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study. The applicant should discuss how accrual goals will be achieved and how standards of care may impact the study enrollment.  The application should demonstrate documented availability of and access to the drug/ compound, device, and/or other materials needed, as appropriate. The quality of the product should be commensurate with FDA manufacturing standards applicable to the type and phase of product being developed (i.e., Quality System Regulation, Good Manufacturing Practices).  The application should demonstrate the study team has experience interacting with the FDA, to include previous FDA submissions, if applicable.  The proposed clinical trial design should include clearly defined and appropriate endpoints, and follow Good Clinical Practice (GCP) guidelines.  The application should include a clearly articulated statistical analysis plan, appropriate statistical expertise on the research team, and a power analysis reflecting sample size projections that will clearly answer the objectives of the study.  The application should include a clearly articulated data management plan and use of an appropriate database to safeguard and maintain the integrity of the data. For FDA-regulated studies, compliance with 21 CFR 11 is required.  The application should include a clearly articulated safety management plan outlining how safety and pharmacovigilance will be conducted, as applicable.  The application should include a clearly articulated clinical monitoring plan outlining how the study will be monitored for GCP compliance.  The application should include a study coordinator(s) who will guide the clinical protocol through the local Institutional Review Board (IRB) of record and other Federal agency regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual.  For studies determined to be greater than minimal risk to human subjects by the local IRB of record, the Department of Defense (DoD) requires an independent research monitor with expertise consistent with the nature of risk(s) identified within the research project. If applicable, refer to the General Application Instructions, Appendix 6, for more information on study reporting authorities and responsibilities of the research monitor.  The application should include a Transition Plan (including potential funding and resources) showing how the product will progress to the next clinical trial phase and/or delivery to the market after the successful completion of the FY16 PRORP CTA.  The application should clearly demonstrate strong institutional support (refer to Section II.C., Full Application Submission Content, Supporting Documentation).  Funded studies are required to file the study in the National Institutes of Health (NIH) clinical trials registry, http://www.clinicaltrials.gov. Refer to the General Application Instructions, Appendix 6, Section C, for further details. Multi-Institutional Clinical Trials: If the proposed clinical trial is multi-institutional, plans for communication and data transfer among the collaborating institutions, as well as how specimens and/or imaging products obtained during the study will be handled, should be included in the appropriate sections of the application. A separate intellectual and material property plan agreed upon by all participating institutions is also required for multi-institutional clinical trials.
Link to Additional Information:  
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

CDMRP Help Desk 301-682-5507

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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