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Administrative Supplements to Promote Diversity in Small Businesses-SBIR/STTR (Admin Supp Clinical Trial Not Allowed)

PA
Friday, September 10, 2021
Workforce Diversity
Tuesday, September 10, 2024
333
PA-21-345

Funding Opportunity Purpose

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) hereby notify Small Business Concerns (SBCs) holding Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants that funds are available for administrative supplements to improve the diversity of the research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from groups that have been shown to be nationally underrepresented in health-related research or in the SBIR and STTR programs. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project. Administrative supplements must support work within the scope of the original project. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

Notice of Special Interest to Encourage Eligible NIH BRAIN Initiative Awardees to Apply for PA-21-071 Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)

Notice of Special Interest
Thursday, August 26, 2021
Monday, September 30, 2024
333
NOT-NS-22-012

Funding Opportunity Purpose

This Notice encourages eligible awardees in the BRAIN Initiative community to apply for administrative supplements in response to PA-21-071, Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed). The NIH has a strong interest in the diversity of the NIH-funded workforce (see NOT-OD-18-210) and encourages institutions to diversify their populations by enhancing the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral, and social sciences.

HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Advance the Study of Chronic Overlapping Pain Conditions (COPCs)

Notice of Special Interest
Wednesday, August 25, 2021
Saturday, November 6, 2021
333
NOT-NS-21-068

Funding Opportunity Purpose

The purpose of this request for administrative supplements to current NIH-fundedstudies is to encourage clinical and translational research that will increase our understanding of the prevalence, psychological variables, and response to therapy in those individuals with multiple chronic overlapping pain conditions (COPCs). Recent clinical findings suggest that substantial overlap may exist between chronic pain conditions. Individuals diagnosed with one pain disorder often exhibit characteristics of additional chronic painful conditions or transition to other diagnostic categories. A better understanding is needed of the characteristics of overlapping pain conditions, the progression of these conditions, and therapeutic approaches best suited for treating individuals with COPCs. Research efforts in chronic pain conditions have focused on single disorders or types of pain such as neuropathic and inflammatory pain. These research efforts have generated a substantial body of information advancing our understanding of the underlying mechanisms of pain onset and development, the transition from acute to chronic pain, and therapeutic targets for treating acute and chronic pain. Over the past twenty years reports have documented the presence of more than one chronic pain condition in subjects with pain. Studies have identified overlap between a number of chronic pain conditions, including lower back pain, fibromyalgia (FM), vulvodynia, endometriosis, functional gastrointestinal disorders such as irritable bowel syndrome (IBS), temporomandibular joint disorder (TMD), migraine, tension headache, low back pain, and urologic chronic pelvic pain syndromes (UCPPS). These results suggest that chronic pain conditions may not be localized conditions but may share symptoms and mechanisms that involve a general central nervous system dysfunction as well as disorder-specific symptoms.

Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)

PAR
Friday, August 20, 2021
Friday, June 21, 2024
U44
PAR-21-282

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from Small Business Concerns (SBCs) to pursue translational activities and limited-size clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and effectivenesting, design verification and validation activities leading to submission of an Investigational Device Exemption (IDE) to the FDA or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also augment their project with NIH contract research organizations that specialize in large animal testing, sterilization testing, biocompatibility assessment, manufacturing, and medical monitoring. SBCs developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or any of the companion opportunities. For more information see: https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-medtech

Notice of Special Interest: Adding TBI Assessments to AD/ADRD Cohorts

Notice of Special Interest
Thursday, July 29, 2021
Tuesday, November 16, 2021
333
NOT-NS-22-002

Funding Opportunity Purpose

These administrative supplements will provide funding to existing AD/ADRD cohort studies to support the inclusion/addition of NINDS Common Data Elements (CDEs) for life-time exposure to Traumatic Brain Injury (TBI) and other relevant TBI-related CDEs to current clinical assessment batteries. Data will be available to better understand the prevalence of TBI history in these populations and could be hypothesis generating for studying the pathophysiology underlying TBI as a risk factor for AD/ADRDs.

Notice of Special Interest (NOSI): Research Supplements to Promote Re-Entry and Re-integration into Health-Related Research Careers (Admin Supp - Clinical Trial Not Allowed)

Notice of Special Interest
Friday, July 23, 2021
Saturday, October 7, 2023
333
NOT-OD-21-134

Funding Opportunity Purpose

The goal of this program is to provide support for a mentored research training experience for individuals with high potential to re-enter or re-integrate into an active research career, after an interruption for family responsibilities or other qualifying circumstances described below. This program encourages re-entry and re-integration administrative supplement applications to existing NIH research grants to support full or part-time mentored research experiences by these individuals. The supplement grants are intended to provide these scientists an opportunity to update or extend their research skills and knowledge and prepare them to re-establish their careers in basic biomedical, behavioral, clinical, translational, or social science research. It is anticipated that by the completion of the supplement support period, the re-entry/re-integration scientist will be prepared to apply for a fellowship (F), career development (K) award, a research award (R), or other types of independent research support.

NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)

PAR
Friday, July 16, 2021
Heal
Saturday, April 6, 2024
R41/R42
PAR-21-267
Emily Caporello

Funding Opportunity Purpose

(Reissue of PAR-18-617) The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Technology Transfer (STTR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only STTR Phase II and Fast-Track applications are supported under this program. STTR Phase I applications are only accepted as part of a Fast-track application.

NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)

PAR
Thursday, July 15, 2021
Saturday, April 6, 2024
R43/R44
PAR-21-266

Funding Opportunity Purpose

(Reissue of PAR-18-618) The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only SBIR Phase II and Fast-Track applications are supported under this program. SBIR Phase I applications are only accepted as part of a Fast-track application.

NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional)

PAR
Thursday, July 15, 2021
Translational Research, Clinical Trials Research, Clinical Research
Saturday, April 6, 2024
R44
PAR-21-265
Emily Caporello

Funding Opportunity Purpose

(Reissue of PAR-18-665) This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that seek additional funding to support clinical trials for projects that were previously funded by NIH SBIR and STTR Phase II awards. The projects must focus on products related to the mission and goals of the National Institute of Neurological Disorders and Stroke (NINDS) and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Since conducting the clinical trials needed for commercialization may be capital-intensive, the FOA aims to facilitate the transition of SBIR Phase II projects to the commercialization stage by promoting partnerships between NIH's SBIR/STTR awardees and third-party investors and/or strategic partners. Consistent with the goals of this funding initiative and as required by the SF424 instructions for all SBIR Phase II applications, applicants must submit a Commercialization Plan, which should include details on any independent third-party investor funding that has already been secured or is anticipated during the project period. It is expected that the level of this independent third-party funding will equal or exceed the NINDS funds being requested throughout the SBIR Phase IIB project period.

PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

PA
Thursday, July 8, 2021
Wednesday, April 6, 2022
R41/R42
PA-21-262

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institutes of Health (NIH) invites eligible United States small businesses to submit Small Business Technology Transfer (STTR) grant applications. United States small businesses that have the research capabilities and technological expertise to contribute to the R and D mission(s) of the NIH awarding components identified in this FOA are encouraged to submit STTR grant applications in response to identified topics (see PHS 2021-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA). This Parent Funding Opportunity Announcement does not accept clinical trials.

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