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Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

PAR
Thursday, November 19, 2020
Friday, September 8, 2023
U44
PAR-21-057

Funding Opportunity Purpose

The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

PAR
Thursday, November 19, 2020
Friday, September 8, 2023
U44
PAR-21-059

Funding Opportunity Purpose

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

Notice of Special Interest (NOSI): Availability of Urgent Competitive Revisions and Administrative Supplements For Research on Biological Effects of the 2019 Novel Coronavirus on the Nervous System

Notice of Special Interest
Thursday, April 30, 2020
Thursday, April 15, 2021
333
NOT-NS-20-051

Funding Opportunity Purpose

Notice Special Interest NOSI): Availability Urgent Competitive Revisions Administrative Supplements Research Biological Effects the 2019 Novel Coronavirus the Nervous System Notice Number: NOT-NS-20-051 Key Dates Release Date: April 30, 2020 First Available Due Date: 01, 2020 Expiration Date: April 15, 2021 Related Announcements NOT-NS-20-074 Notice Change Eligible Activity Codes NOT-NS-20-051 PA-18-935 Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional) PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) NOT-OD-20-026 New NIH FORMS-F" Grant Application Forms Instructions Coming Due Dates or after 25, 2020 Issued National Institute Neurological Disorders Stroke NINDS) National Institute Alcohol Abuse Alcoholism NIAAA) - New participating organization of 05/08/2020 due dates on/after 05/08/2020 Purpose NINDS issuing Notice Special Interest NOSI) highlight urgent need research Coronavirus Disease 2019 COVID-19) on biological effects the nervous system its causative agent, severe acute respiratory syndrome coronavirus 2 SARS-CoV-2). Research interest must fall within NINDS’s scientific mission, is support basic, translational, clinical neuroscience research expand fundamental knowledge the brain nervous system to that knowledge reduce burden neurological disease. Research Objectives order rapidly improve our understanding the neurological consequences infection SARS-CoV-2 of COVID-19, NINDS encouraging submission applications supplements address biology, pathophysiology, prevention, diagnosis, sequelae, treatment the 2019 Novel Coronovirus are directly related the NINDS mission. National Institute Alcohol Abuse Alcoholism NIAAA) accept supplements NIAAA-supported projects fall within scope the NOT-NS-20-051 are relevant the mission the NIAAA. Specifically, NIAAA interested studies integrate alcohol exposure research topics outlined the announcement better understand, prevent, mitigate of neurobiological consequences SARS-CoV-2 infection COVID-19 individuals have Alcohol Disorders AUD). NIAAA encourages supplements be collaborative nature include appropriate neurological expertise the proposed projects. Application Submission Information Applications this initiative must submitted using of following opportunity announcements the subsequent reissued equivalent. PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-935 - Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional) Applications research fall within scope an existing NINDS award should submitted through PA-18-591 (Parent Admin Supp Clinical Trial Optional). Eligible activity codes fare limited the mechanisms listed in PA-18-591. Applications research involve change the original scope an active award, still falls within mission the NINDS must apply through PA-18-935 Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional). Eligible activity codes applications to PA-18-935 are limited the following mechanisms: P01, P50, R00, R01, R03, R15, R21, R33, R35, R41, R42, R43, R44, R61, U01, U19, U24, U44, U54, UG3, UH3). Scope defined the original specific aims, objectives, purposes a grant, methodology, approach, analyses other activities, the tools, technologies, timeframes needed meet grant's objectives. Changes include shifting research emphasis one disease area another, changing any aspects research involving vertebrate animals human subjects. you unsure whether application involve change scope, contact NINDS program director. instructions the SF424 R&R) Application Guide and PA-18-591 or PA-18-935 must followed, the following additions: funding consideration, applicants must include “NOT-NS-20-051"(without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. project period the supplement must exceed year. Application budgets not exceed 200,000 direct costs. Exceptions this budget limit be only NINDS pre-approval will only approved under very rare circumstances where work immediately impact public health. Research Strategy section the application limited 6 pages parent award must active the supplement application submitted e.g. within originally reviewed approved project period), regardless the time remaining the current project. Grants multi-year funding RF1) have additional constraints. Applicants these grants should contact program official determine eligibility. applications including those multi-project activity codes) must submitted electronically using single-project application form package Administrative supplement applications to PA-18-591 must the application form package the Competition ID contains FORMS-E-ADMINSUPP”. FOA be reissued application form packages containing FORMS-F-ADMINSUPP” May 25, 2020. Submissions to PA-18-591 must completed June 25, 2020 see NOT-OD-20-026 for details.) Submissions the reissued FOA be accepted or after 25, 2020 through expiration date this Notice. addition, process Streamlined Submissions using eRA Commons cannot used this initiative. Competitive revision applications to PA-18-935 must the application form package the Competition ID NOT-NS-20-051-FORMS-E." FOA be reissued a NOT-NS-20-051-FORMS-F” package May 25, 2020. Submissions to PA-18-935 must completed June 25, 2020. Submissions the reissued FOA be accepted or after 25, 2020 through expiration date this Notice. Applications be accepted a rolling basis from April 15, 2020 April 14, 2021 5:00 PM local time of applicant organization. NOSI expires on April 15, 2021. application submitted response this NOSI is received after expiration date be withdrawn Applications must specifically address issues potential biohazards, all research must conducted compliance the health safety requirements found the NIH Grants Policy Statement. Applications are responsive the terms this Notice not considered. Investigators planning apply response this NOSI strongly encouraged contact discuss proposed research/aims the Program Official the Parent Award advance better determine appropriateness interest the NINDS.   Inquiries Please direct inquiries the contacts Section VII the listed funding opportunity announcements the following additions/substitutions: Scientific/Research Contact(s) Please contact program officer your active award. NIAAA grantees, please direct inquiries Dr. Changhai Cui changhai.cui@nih.gov).

Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)

PAR
Tuesday, March 3, 2020
Monday, May 8, 2023
U44
PAR-20-111

Funding Opportunity Purpose

Reissue of PAR-18-541. The Blueprint Neurotherapeutics Network (BPN) encourages applications from small businesses seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry to the Development stage, to advance a single development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Alternatively, projects can enter at the Development stage and progress in a shorter period to IND enabling toxicology studies and phase I clinical testing. Projects that enter at the Discovery stage and meet their milestones may continue on through Development. BPN awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

Notice of Special Interest: Administrative Supplements for Research on Sex/Gender Influences (Admin Supp Clinical Trial Optional)

Notice of Special Interest
Friday, December 13, 2019
Tuesday, January 26, 2021
333
NOT-OD-20-049

Funding Opportunity Purpose

Notice Special Interest: Administrative Supplements Research Sex/Gender Influences Admin Supp Clinical Trial Optional) Notice Number: NOT-OD-20-049 Key Dates Release Date: December 12, 2019 First Available Due Date:January 31, 2020 Expiration Date: January 26, 2021 Related Announcements PA-18-591: Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued Office Research Women's Health ORWH) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Library Medicine NLM) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) Sexual Gender Minority Research Office SGMRO) Office The Director, National Institutes Health OD) National Cancer Institute NCI) Purpose Office Research Women's Health ORWH) announces availability administrative supplements support research highlighting impact sex gender influences human health illness. Sex gender important considerations many areas research, including basic biological, psychological, social, behavioral studies. continuous interaction between sex gender, human health determined both biology expression gender. most robust experimental designs include consideration both sex gender; therefore, applications proposing investigate influence both sex gender factors highly encouraged. proposed research must address least objective the five strategic goals the 2019-2023Trans-NIH Strategic Plan Women's Health Research"Advancing Science the Health Women". Background Women men characterized both sex gender, highlighted the Institute Medicine IOM) report, Exploring Biological Contributions Human Health: Does Sex Matter?"(IOM Report, 2001). this initiative, ORWH use IOM definitions describe sex gender-based studies: Sex-based studies:Sex the classification living things, generally male female according their reproductive organs functions assigned chromosomal complement. Gender-based studies:Gender refers a person's self-representation male female, how person responded by social institutions based the individual's gender presentation. Gender rooted biology shaped environment experience. Consideration these variables comparisons males females be critical the accurate interpretation, validation, generalization research findings. Sex gender also determine health disease processes differ among women, between women men, inform development testing preventive therapeutic interventions both sexes. Sex-based comparisons research also ensure findings applicable both women men. Specific Areas Research Interest broad range research be appropriate this initiative. Areas interest include study both male female subjects, the comparison their outcomes the following general areas: Preclinical research projects aimed increasing mechanistic understanding sex differences Comparative studies male female cells including stem cells), tissues, organs physiological systems Systems biology e.g., omics") approaches outcomes Bioengineering imaging studies structural and/or functional differences; medical device development implementation, including body armor, assistive exoskeletons, organs tissues chips vivo methods techniques identify fetal sex prior visualization gonads Computational models disease progression, transmission, prevention, treatment, relapse Prenatal, perinatal, postnatal development, both normal abnormal Assessment differences phenotypic characterization risk factors mental disorders; neurobehavioral mechanisms psychopathology; trajectories risk resilience. Neurobiological mechanisms relating alcohol other addictive drugs Sensitivity specificity biomarkers e.g. screening, predisposition/risk assessment, diagnostic, prognostic, predictive, therapeutic) Therapeutic interventions treatment prevention; development drugs/identification targets; Pharmacokinetic/Pharmacodynamic PK/PD) profiles. Examples Pain; Depression; Prescription drug abuse, addictive drugs; Atherothrombosis including coronary, cerebrovascular, peripheral artery diseases; Heart failure; Asthma; Myelodysplasia/myeloproliferative disorders; Insomnia- sleep-related fatigue, depression, stress, suicide; Sleep-disordered breathing. ORWH specifically interested supporting studies related the influence gender human health. Topics interest include, are limited to: influence gender disease incidence, prevention, treatment, relapse Gender roles influencing caretaking responsibilities, effects health, resilience, disease Research considering roles sex gender together the outcome human health Population study examining role gender different cultural, social, ethnic populations Eligibility Only PDs/PIs an active DP1, DP2, DP4, DP5, K08, K23, K76, P01, P20, P30, P40, P41, P50, P51, P60, PM1, R01, R03, R21, R21/R33, R24, R35, R37, R41, R41/R42, R42, R43, R43/R44, R44, RM1, U01, U10, U19, U42, U44, U54, U56, UG1, UG3/UH3, UH2, UH2/UH3, UH3, UM1, UM2 award NIH eligible apply. PDs/PIs encouraged apply electronically. PDs/PIs above-mentioned activity codes must also fulfill the following mandatory requirements, otherwise applications be deemed non-responsive this NOSI. parent peer-reviewed NIH funded grant must at least 16 months active grant support remaining the due date specified this NOSI. No-cost-extension not eligible. Only Sex/Gender Admin. Supp. award permitted a peer-reviewed NIH funded grant one grant cycle. least objective the five strategic goals the 2019-2023Trans-NIH Strategic Plan Women's Health Research"Advancing Science the Health Women"is proposed identified the application. least of threeSex/Gender-basedStudy Typesis proposed: Pre-Clinical ResearchincludesCell line, Primary culture animals, Animal model, Xenograft, non-human primates Clinical ResearchincludesHuman subjects, Human Biospecimens, Primary culture human subjects Both Pre-Clinical Clinical Researchincludesabove mentioned examples both study types, Patients derived xenografts least of threeSex/Gender-based ResearchApproachesis proposed: Add Opposite Sex/Gender:The addition animal human subjects, tissues cells the sex opposite those used the parent grant allow sex/gender-based comparisons.Applicants should discuss measures ensure comparability new data data already collected under parent grant. Increase Sample Size:The addition more animal human subjects, tissues cells a sample already includes both males females increase power a study analyze a sex/gender difference.Applicants should discuss methods used ensure control potential cohort differences related the new data compared data already collected. Analyze Existing Data:Comparative analyses existing samples/datasets/databases and/or data-mining investigate role sex/gender.Applicants should explain the proposed experiments analyses complement, without expanding scope the funded grant. Foreign Institutions: Non-domestic non-U.S.) Entities Foreign Institutions)are noteligible apply. Non-domestic non-U.S.) components U.S. Organizationsare noteligible apply. Foreign components, asdefined the NIH Grants Policy Statement,areallowed. Budget ORWH intends commit to 1 million per year award to 10 applications. Application budget limited one year only. Application budget cannot exceed maximum direct cost 100,000. addition the direct cost, applicable F&A indirect) cost also requested. Supplements provide support above dollar limits the funding opportunity announcement the parent grant award. Earliest start date July/August 2020 July/August 2021 Scientific Review Process NIH program staff conduct administrative reviews submitted applications will support most meritorious applications submitted consideration, pending availability funds. Application Submission Information process streamlined submissions using eRA Commons cannot used this initiative. Applications this initiative must submitted using following opportunity:PA-18-591- Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Continuous Submission not permitted. other words, late applications be accepted. instructions theSF424 R&R) Application GuideandPA-18-591must followed, the following additions: Application Due Date(s) - January 31, 2020 January 25, 2021, 5:00 PM local time applicant organization funding consideration, applicants must include NOT-OD-20-049 without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Research Strategy section the application limited parent application pages. is strongly recommended the applicant contact respective program officers the Institute supporting parent award confirm ahead time the supplement falls within scope the parent award. Following submission, applicants strongly encouraged notify program contact the IC supporting parent award a request been submitted response this FOA order facilitate efficient processing the request. Inquiries Please direct inquiries to: Rajeev K. Agarwal, Ph.D. Office Research Womens Health ORWH) Telephone: 301-451-7058 Email:Rajeev.Agarwal@nih.gov

NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)

PAR
Monday, February 5, 2018
Clinical Trials Research
Tuesday, April 6, 2021
U44
PAR-18-628

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm).

NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44 - Clinical Trials Optional)

PAR
Tuesday, January 9, 2018
Clinical Trials Research
Tuesday, April 6, 2021
U44
PAR-18-563

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. The program will utilize the cooperative agreement mechanism to enable milestone-drive projects. Successful applicants will collaborate and conduct the trial within the NIH StrokeNet. Following peer review, NINDS will prioritize trials among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. The NIH StrokeNet network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for stroke treatment, prevention, and recovery.

BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44 Clinical Trial Required)

RFA
Thursday, December 21, 2017
Translational Research, Clinical Trials Research
Tuesday, February 23, 2021
U44
RFA-NS-18-022

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue translational non-clinical studies and clinical studies for recording and/or stimulating devices to treat nervous system disorders and thereby better understand the human brain. The program will utilize a cooperative agreement mechanism to support the non-clinical studies necessary for the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or to obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and the subsequent small clinical trial (e.g., Early Feasibility Study). Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical trial. The small clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information 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.

CREATE Bio Development Track: Preclinical and Early-Phase Clinical Development for Biologics (U44 SBIR- Clinical Trial Optional)

PAR
Wednesday, December 20, 2017
Translational Research, Clinical Trials Research
Saturday, May 8, 2021
U44
PAR-18-543
Chris Boshoff

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA).

Translational Neural Devices (U44 - Clinical Trial Required)

RFA
Wednesday, November 8, 2017
Translational Research, Clinical Trials Research
Tuesday, February 23, 2021
U44
RFA-NS-18-012

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 small clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. The translational device activities, including translational bench and animal studies, are expected to lead to submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study. This cooperative agreement will also support the subsequent small clinical study to collect safety and effectiveness data required to support a marketing application or to inform final device design.

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