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SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1 Clinical Trial Required)

PAR
Friday, July 10, 2020
Wednesday, April 6, 2022
SB1
PAR-20-130
Emily Caporello

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R and D) not typically supported through Phase II or Phase IIB grants or contracts. This may include independent replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, manufacturing costs, regulatory assistance, or a combination of services. Although a significant amount of the work in a CRP award may be subcontracted to other institutions, the Small Business Concern (SBC) is expected to maintain oversight and management of the R and D throughout the award. This Funding Opportunity Announcement requires that at least 1 clinical trial be proposed. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed)

PAR
Friday, July 10, 2020
Wednesday, April 6, 2022
SB1
PAR-20-129
Emily Caporello

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R and D) not typically supported through Phase II or Phase IIB grants or contracts. This may include independent replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, manufacturing costs, regulatory assistance, or a combination of services. Although a significant amount of the work in a CRP award may be subcontracted to other institutions, the Small Business Concern (SBC) is expected to maintain oversight and management of the R and D throughout the award. Clinical Trials are not accepted under this FOA.

Notice of Special Interest: Administrative Supplements for the U.S.-Japan Brain Research Cooperative Program (BRCP) - U.S. Entity (Admin Supp)

Notice of Special Interest
Thursday, May 7, 2020
Thursday, September 8, 2022
333
NOT-NS-20-024

Funding Opportunity Purpose

Notice Special Interest: Administrative Supplements the U.S.-Japan Brain Research Cooperative Program BRCP) - U.S. Entity Admin Supp) Notice Number: NOT-NS-20-024 Key Dates Release Date: 05, 2020 First Available Due Date: September 07, 2020 Expiration Date:September 08, 2022 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Institute Aging NIA) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Center Complementary Integrative Health NCCIH) Purpose National Institutes Health NIH) announces continuation the U.S. entity the U.S.-Japan Brain Research Cooperative Program BRCP). administrative supplement program provide funds currently active research grants are currently supported one the participating NIH Institutes Centers. Notice soliciting administrative supplements the following mechanisms ONLY:DP1,DP2,DP5,R01,R03,R21,R33,R34,R37,R61,U01,UH2, andUH3. purpose the BRCP to promote scientist exchange, training, collaborations basic, translational clinical research between neuroscientists the U.S. Japan. U.S. entity the BRCP supports following activities: 1) Visit U.S. scientists conduct collaborative research and/or acquire advanced research skills Japanese institutions, 2) Joint workshops exchange scientific information to foster collaborations. Background agreement ldquo;Cooperation Research Development Science Technology signed the President the United States the Prime Minister Japan May 1, 1980, has subsequently renewed extended. Under umbrella this Agreement, National Institute Neurological Disorders Stroke NINDS) the National Institute Physiological Sciences NIPS), Okazaki National Research Institutes, Japan, signed Memorandum Understanding a Brain Research Cooperative Program BRCP) November 29, 2000. Since inception the U.S. BRCP 2002, NIH successfully supported U.S. neuroscientists collaborative activities Japanese institutions, joint workshops the neurosciences. Japanese entity the BRCP been active since 2001. Details the program available http://www.nips.ac.jp/jusnou/english/. Within funding guidelines the BRCP program, country supports own scientists participate the aforementioned activities. BRCP Activities Supported the NIH A. Collaborative Research Fund Collaborative Research Fund provides support the travel lodging expenses the U.S. scientists visit Japan. visit the institution Japan be performed the PD/PI, collaborators, postdoctoral fellows students work the collaborative project. Support the Collaborative Research Fund be used one multiple trips. duration the supplement one year. supplement be carried over the next fiscal year, prior approval NIH Program staff. B. Workshop Fund U.S. Workshop Fund provides partial support joint workshops. U.S. Japan funding agencies the BRCP provide parallel support joint-workshops. entity support travel lodging expenses the joint-workshop participants their own country. the joint workshop be held the U.S., U.S. entity the BRCP support logistical meeting expenses. the joint workshop be held Japan, Japan entity support logistical meeting expenses. proposed workshop should at least co-organizer the U.S. one Japan. Co-organizers encouraged work together develop workshop applications. U.S. co-organizer must an active grant a participating NIH Institute Center. Workshop applications U.S. co-organizers should submitted response this FOA. Similarly, co-organizers Japan should submit application the NIPS. See:http://www.nips.ac.jp/jusnou/eng/ Applicants encouraged use Workshop Fund compensate travel lodging individuals groups are underrepresented the biomedical, clinical, behavioral social sciences encourage participation, the planning implementation of, well participation in, proposed workshop. NOT-OD--20-031. support junior investigators, postdoctoral fellows, graduate students also encouraged. Areas research interests the participating NIH Institutes Centers NINDS supports basic, translational clinical research understand structure function the nervous system mechanisms underlying neurological disorders stroke. Awardees projects funded the NIH BRAIN Initiative braininitiative.nih.gov/) encouraged submit supplement requests collaborative efforts are within scope this FOA NIHs goals the BRAIN Initiative, defined the strategic planning report, BRAIN 2025: Scientific Vision. Investigators encouraged contact potential collaborators participating related efforts led Japan such the Brain/MINDS project http://brainminds.jp/en/). Collaborations promote interdisciplinary approaches research questions within NINDS mission also strongly encouraged. NIA supports broad spectrum research training aimed a better understanding age-related normal pathological changes the structure function the nervous system how such changes affect behavior. addition, NIA encourages cross-country collaborations research related the etiology, diagnosis, progression, treatment Alzheimers Disease AD). mission includes basic clinical studies the nervous system, clinical trials interventions therapeutic modalities, epidemiological research identify risk factors to establish prevalence incidence estimates pathologic conditions aging AD. mission NIBIB to improve human health leading development accelerating application biomedical technologies. NIBIB encourages submission applications support development bioengineering biomedical imaging technologies. NIDA supports basic, clinical, applied research the causes, consequences, prevention treatment drug abuse addiction. NIDCD encourages collaborative basic clinical biomedical bio-behavioral research the communication sciences hearing, balance, smell, taste, voice, speech language. NIDCR supports wide range basic, clinical translational research painful disorders the orofacial region including temporomandibular joint disorders, trigeminal neuropathies, burning mouth syndrome, oral cancer pain, dental pain, other conditions; well chronic pain conditions co-morbid orofacial pain. NIEHS supports basic mechanistic human based studies the interplay environmental neurotoxicant exposure neuronal dysfunction across life span. includes influence prenatal exposure both childhood adult dysfunction/disease well adult exposures the aging brain. NIMH supports research transform understanding treatment mental illnesses through basic, translational, clinical, services research, paving way prevention, recovery, cure. NIMH encourages innovative thinking ensure a full array novel scientific perspectives used further discovery the evolving science brain, behavior, experience. NIMH now focusing an experimental medicine approach evaluating novel interventions mental illnesses. strategy designed increase value the public investment early clinical trials ensuring informed, data-driven decisions an early stage behavioral, device, pharmacologic studies. NCCIH supports rigorous scientific investigation, usefulness safety complementary integrative health approaches, their roles improving health health care. includes collaborations involving studying neurobiological mechanisms natural products such herbs, prebiotics, probiotics, dietary supplements) mind body interventions such acupuncture, meditation, manual therapy, yoga, Tai Chi, hypnosis, music art therapy, etc) their effects pain, sleep, stress, anxiety, emotional well-being, and/or behavioral changes. NCATS supports development disruptive innovative methods technologies will enhance development, testing implementation diagnostics therapeutics across wide range human diseases conditions. includes translational early stage clinical research rare neurologic brain conditions. Award Project Period be eligible, parent award must active the current fiscal year i.e., parent award received funds the current fiscal year is in extension period), the research proposed the supplement should requested one year should accomplished within currently approved project period the existing parent award. awarding institute consider no-cost extension up an additional year the conclusion the first year. Award Budget Application budgets Collaborative Research Funds limited 25,000 direct cost. to 2,500 be used research supplies. Funds the BRCP not used salary support the PD/PI, collaborators, postdoctoral fellows, students collaborators. Travel costs associated Collaborative Research Fund requests should exceed U.S. Government Foreign Per Diem Rates Japan. See:http://aoprals.state.gov/content.asp?content_id=184&menu_id=81/ Application budgets Workshop Funds limited 35,000 direct cost. support travel lodging expenses should exceed U.S. Government Per Diem Rates http://www.gsa.gov/portal/content/101518; orhttp://aoprals.state.gov/content.asp?content_id=184&menu_id=81/). honorarium allowed. is recommended investigators secure additional funding support other sources, needed. announcement for supplements existing projects. research proposed the NIH grantee the supplement application must within original scope the NIH-supported grant award. Similarly, scope the proposed collaborative research activities workshops should well aligned the aims the parent award. Eligible Individuals Program Director/Principal Investigator) Individual(s) must hold active grant award one the participating NIH Institutes Centers. supplements parent awards include multiple PDs/PIs, supplement be requested any all the PDs/PIs accordance the existing leadership plan) must submitted the awardee institution the parent award. New early stage investigators encouraged apply, well established neuroscientists. Individuals diverse backgrounds, including underrepresented racial ethnic groups, individuals disabilities, women always encouraged apply NIH support. Application Submission Information Applications this initiative must submitted using following opportunity its subsequent reissued equivalent. PA-18-591- Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) instructions theSF424 R&R) Application GuideandPA-18-591must followed, the following additions: Application Due Date(s) September 7, 2020, September 7, 2021, September 7, 2022, 5:00 PM local time applicant organization. funding consideration, applicants must include ldquo;NOT-IC-20-024 without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Requests be one year support only. Research Strategy section the application limited 6 pages. Only existing awardees a participating Institute Center eligible apply. Administrative supplement applications toPA-18-591must the application form package the Competition ID contains ldquo;FORMS-F-ADMINSUPP. addition, process Streamlined Submissions using eRA Commons cannot used this initiative. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response this FOA order facilitate efficient processing the request. Page Limits: NIH consider supplements a Research Strategy no than 6 pages, addition the abstract. Research Strategies Collaborative Research Fund Submitted applications collaboration/training must include: Description the goals the collaboration/training how will enhance research the NIH-supported parent grant Details the supplement's specific aims, research design, methods data analysis Background significance the proposed research/training its relevance the goals the BRCP the mission the participating NIH Institutes Centers unique opportunities offered this collaboration/training, the reciprocal U.S. Japan) entity the project should clearly delineated Description the qualifications the Japanese host the research facilities resources the host institution Submitted applications collaboration/training must include letter invitation biosketch the Japanese host(s). Workshop Fund Submitted applications joint workshops must include: Description the importance the proposed workshop investigators the field the larger neuroscience community Relevance the workshop the goals the BRCP the mission the participating NIH Institutes Centers Background anticipated outcomes Description the meeting content, including topics, sessions, a tentative agenda Plans foster potential collaborations between U.S. Japanese participants Justification the proposed workshop location duration Composition role the organizing committee, the name credentials key participants i.e., presenters, moderators) Plans disseminate information generated the proposed workshop the larger scientific community. Plans the inclusion junior investigators, women, racial/ethnic minorities, persons disabilities. Review Process: Administrative supplement requests undergo administrative evaluation NIH Program staff the participating Institutes Centers. Reporting:Reporting requirements be specified the terms conditions award applicable the supplemental activities. most non-competing continuation applications, progress report budget the supplement must included with, clearly delineated from, progress report budget the parent award. progress report must include information the activities supported the supplement even support future years not requested. Final Report Within month the completion all collaborative research/training efforts workshops, U.S. BRCP supported investigators required submit final report the NIH, detailing following information: Project objectives Significance Results/findings including list publications, presentations, dissemination material research grant applications resulting the collaboration/training workshop Outcome collaboration/training workshop how benefits NIH supported research plans continued collaboration the Japanese investigator(s) Inquiries Please direct inquiries to: Scientific/Research Contact(s) Stacey D. ChambersNational Institute Neurological Disorders Stroke NINDS)Telephone: 301-496-0690 Email:chambers@ninds.nih.go Coryse St. Hillaire-Clarke, Ph.D.National Institute Aging NIA)Telephone: 301-827-6944Email: sthillaireclacn@mail.nih.gov Shumin Wang, Ph.D.National Institute Biomedical Imaging Bioengineering NIBIB)Telephone: 301-594-9001Email: shumin.wang@nih.gov Da-Yu Wu, Ph.D. National Institute Drug Abuse NIDA) Telephone: 301-443-1887 Email: wudy@nida.nih.gov Susan L. Sullivan, Ph.D.National Institute Deafness amp; Communication Disorders NIDCD)Telephone: 301-451-3841Email: sullivaS@nidcd.nih.gov Yolanda F. Vallejo, Ph.D.National Institute Dental Craniofacial Research NIDCR)Telephone: 301-827-4655Email: Yolanda.Vallejo@nih.gov Jonathan A. Hollander, Ph.D. National Institute Environmental Health Sciences NIEHS) Telephone: 919-541-9467 Email: jonathan.hollander@nih.gov Miri Gitik, Ph.D. National Institute Mental Health NIMH) Telephone: 301-827-3523 Email: miri.gitik@nih.gov Inna Belfer, M.D., Ph.D. National Center Complementary Integrative Health NCCIH) Telephone: 301-435-1573 Email: inna.belfer@nih.gov Danilo A. Tagle, Ph.D., M.S. National Center Advancing Translational Sciences NCATS) Telephone: 301-594-8064 Email: danilo.tagle@nih.gov Financial/Grants Management Contact(s) Chief Grants Management Officer National Institute Neurological Disorders Stroke NINDS) Email: ChiefGrantsManagementOfficer@ninds.nih.gov Jennifer Edwards National Institute Aging NIA) Telephone: 301-827-6689 Email: edwardsj@mail.nih.gov James Huff National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4786 Email: huffj@mail.nih.gov Cheryl Nathaniel National Institute Drug Abuse NIDA) Telephone: 202-526-0108 Email: nathanic@nida.nih.gov Christopher MyersNational Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-402-0909 Email: myersc@mail.nih.gov Dede Rutberg National Institute Dental Craniofacial Research NIDCR) Telephone: 301-594-4798 Email: rutbergd@mail.nih.gov James R. Williams National Institute Environmental Health Sciences NIEHS) Telephone: 919-541-1403 Email: james.williams3@nih.gov Tamara KeesNational Institute Mental Health NIMH)Telephone: 301-443-8811Email: tkees@mail.nih.gov Shelley M. CarowNational Center Complementary Integrative Health NCCIH)Telephone: 301-594-3788Email: carows@mail.nih.gov Karen BrummettNational Center Advancing Translational Sciences NCATS)Telephone: 301-594-6268Email: Karen.Brummett@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
Charles Cywin

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 (NOSI): Availability of Administrative Supplements for the Rare Disease Clinical Research Network (RDCRN)

Notice of Special Interest
Friday, February 28, 2020
Monday, April 4, 2022
333
NOT-TR-20-006

Funding Opportunity Purpose

Notice Special Interest NOSI): Availability Administrative Supplements the Rare Disease Clinical Research Network RDCRN) Notice Number: NOT-TR-20-006 Key Dates Release Date: February 27, 2020 First Available Due Date: April 01, 2020 Expiration Date: April 04, 2022 Related Announcements RFA-TR-18-020 Rare Diseases Clinical Research Consortia RDCRC) the Rare Diseases Clinical Research Network RDCRN) U54 Clinical Trial Optional) PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued National Center Advancing Translational Sciences ( NCATS) National Heart, Lung, Blood Institute NHLBI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Neurological Disorders Stroke NINDS) Purpose National Center Advancing Translational Sciences NCATS) informs Program Directors/Principal Investigators PDs/PIs) holding active Rare Diseases Clinical Research Consortia RDCRC) the Rare Diseases Clinical Research Network RDCRN) U54) awards the opportunity submit administrative supplement requests through NIH Parent Funding Opportunity Announcement FOA), PA-18-591, ldquo;Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional)”. supplements provide short-term and/or catalytic support projects a significant unmet needs. Applicants the administrative supplements encouraged form new collaborations enhance reach impact the activity. Administrative supplements must add value the science proposed the aims the original project; such, they must within scientific scope the parent grant. Enthusiasm be higher requests describe clear outcome that the potential greatest impact across RDCRN these outcomes be subsequently distributed shared throughout consortium. RDCRN Program also identified specific areas interest accordance its aim to advance diagnosis, management, treatment rare diseases a focus clinical trial readiness. The RDCRN priority research areas would appropriate requests supplemental funding include, are limited to, topics listed here: Methods accelerate diagnosis Genomic analysis/characterization, interpretation e.g., Gene Curation leveraging ClinGen resources) Novel precision personalized approaches treatment Outreach increase research participant diversity Addressing health disparities Expanding focus women’s health Expanding focus mental health issues Expanding age range research participants Evolving technologies e.g., remote data capture, augmented reality) facilitate assessment, management treatment rare diseases. Trans-network research common interests e.g., shared molecular etiologies, research data collections approaches) Administrative supplement requests support clinical trials not accepted and/or considered response this funding opportunity announcement. Applications should demonstrate the supplement be completed within project period. applicable, proposed research effort should supported a strong rationale should contribute advancing translational sciences. Applicants strongly encouraged discuss potential requests their Program Official listed the Notice Grant Award the parent grant. Award Project Period Administrative supplements limited 12 months. Budget Available Funds Supplement budget requests not exceed 150,000 per year direct costs must reflect actual needs the proposed project. is guarantee funds available NCATS for any specific grant. Application Submission Information Eligible Individuals Program Director/Principal Investigator) Applicants must hold active RDCRN award: only parent RDCRN cooperative agreement awards funded through following FOA any reissues this announcement) eligible request supplemental funding under NOSI: RFA-TR-18-020: Rare Diseases Clinical Research Consortia RDCRC) the Rare Diseases Clinical Research Network RDCRN) U54 Clinical Trial Optional) supplements parent awards include multiple PDs/PIs, supplement be requested any all the PDs/PIs accordance the existing leadership plan) must submitted the awardee institution the parent award. Submitting Application Applications this initiative must submitted using following opportunity its subsequent reissued equivalent. PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) instructions the SF424 R&R) Application Guide and PA-18-591 must followed, the following additions: funding consideration, applicants must include ldquo;NOT-TR-20-006” without quotation marks) the Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4b not considered this initiative. facilitate efficient processing the request, applicants strongly encouraged notify Tiina Urv urvtiin@mail.nih.gov), well the assigned IC program officer IC grants management specialist the parent award a request been submitted response this NOSI. Research Strategy section the application limited to 6 pages. Applicant organizations submit only application per fiscal year this NOSI. process Streamlined Submissions using eRA Commons cannot used this initiative. applications must submitted electronically using single-project application form package. Please note, for single multi-project applications applicants must the form package the Competition ID ldquo;FORMS-E-ADMINSUPP-RESEARCH". one the methods described PA-18-591. Paper submissions applications submitted attachments be returned. Application Due Date – April 1, 2020; April 1, 2021; April 1, 2022, 5:00 PM local time applicant organization. Inquiries Please direct inquiries to: Tiina K. Urv, Ph.D. National Center Advancing Translational Sciences NCATS) Telephone: 301-827-2746 Email: urvtiin@mail.nih.gov

Non-Viral Technologies for in vivo Delivery of Genome Editors (R41/R42 Clinical Trial Not Allowed)

PAR
Thursday, February 6, 2020
Thursday, January 6, 2022
R41/R42
PAR-20-109
Emily Caporello

Funding Opportunity Purpose

The purpose of this PAR is to support the development and evaluation of non-viral technologies to deliver genome editors to disease relevant somatic cells and tissues in vivo. The ultimate goal of these technologies is translation into clinical trials of genome editing to treat human disease.

Non-Viral Technologies for in vivo Delivery of Genome Editors (R43/R44 Clinical Trial Not Allowed)

PAR
Thursday, February 6, 2020
Thursday, January 6, 2022
R43/R44
PAR-20-098
Emily Caporello

Funding Opportunity Purpose

The purpose of this PAR is to support the development and evaluation of non-viral technologies to deliver genome editors to disease relevant somatic cells and tissues in vivo. The ultimate goal of these technologies is translation into clinical trials of genome editing to treat human disease.

Notice of Special Interest (NOSI): Administrative Supplement for Continuity of Biomedical and Behavioral Research Among First-Time Recipients of NIH Research Project Grant Awards

Notice of Special Interest
Friday, January 17, 2020
Monday, March 6, 2023
333
NOT-OD-20-055

Funding Opportunity Purpose

Notice Special Interest NOSI): Administrative Supplement Continuity Biomedical Behavioral Research Among First-Time Recipients NIH Research Project Grant Awards Notice Number: NOT-OD-20-055 Key Dates Release Date: January 17, 2020 First Available Due Date: March 05, 2020 Expiration Date: March 06, 2023 Related Announcements PA-18-591 Issued Office The Director, National Institutes Health OD)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 Insrtitute Arthritis Musculoskeletal Skin Diseases NIAMS)National Institute Biomedical Imaging Bioengineering NIBIB)National Institute Deafness Other Cormmunication 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 Cancer Institute NCI) applications this funding opportunity announcement should fall within mission the Institutes/Centers. following NIH Offices co-fund applications assigned those Institutes/Centers. Office Behavioral Social Sciences Research OBSSR) Purpose overarching goal this pilot program to enhance retention investigators facing critical life events are transitioning the first renewal their first independent research project grant award to second new NIH research project grant award. Retention the first renewal continuous NIH research project grant support crucial sustaining both ongoing research NIH made investment and retaining diversity the biomedical research workforce. program supports at-risk investigators identified the NIH Next Generation Researchers Initiative seehttps://grants.nih.gov/ngri.htm). retention program seeks maintain productivity current first-time recipients eligible independent NIH research project grant awards are dealing a critical life event(s), such they remain competitive the first renewal their award for second research project grant award. retention supplements support transition K award independence, the companion NOSI. Background Investigators, especially women, leave science critical transition stages branching points their career for NIH-supported scientific workforce include transitions post-doctoral training faculty positions Heggeness et al., 2016,Acad Med,doi:10.1097/ACM.0000000000001209and Nikaj et al., 2019, FASEB Journal,doi:10.1096/fj.201800639) prior obtaining first R01 renewal Hechtman et al., 2018, PNAS,doi:10.1073/pnas.1800615115). rate R01/R01-equiv renewals potential impact the longevity an investigators research career Pohlhaus et al., 2011,Acad Med,doi:10.1097/ACM.0b013e31821836ff) remains gender disparity NIH funding should addressed. vulnerable career stages often parallel critical life events commonly contribute faculty attrition. Data NSF demonstrates among racial ethnic groups both biomedical scientists engineers, women far likely men cite family responsibilities a reason leaving work force https://www.nsf.gov/statistics/2017/nsf17310/, especially chart 6B). Pregnancy childbirth particular, appear be significant contributors the underemployment women scientists engineers given pregnancy impact research productivity Cech Blair-Loy 2018, Changing career trajectories new parents STEM;https://www.nsf.gov/statistics/2017/nsf17310/, especially chart 6B). demands childbirth subsequent primary caregiving responsibilities necessitate changes career goals alter researchers career trajectories, depriving scientific workforce an important source talent undermining NIHs investment promising avenues new research. Retaining investigators this critical transition point protect research investment already via parent NIH award enhance diversity the investigator pool. Budget be eligible, parent award must able receive funds the time the award. administrative supplement budget request limited 1 year. Supplement budget requests cannot exceed 50,000/year direct costs, applicable F&A indirect) cost also requested. Budgets not exceed total direct costs the current parent award. Requests must reflect actual needs the proposed project. Categorical budgets permitted. Awards subject availability funds. Flexible of supplemental funds highly encouraged, may include all inclusive)computational services, supplies, equipment, supported effort additional scientific staff sustain PD/PIs research during critical life event. Eligible Individuals Program Director/Principal Investigator) PD/PIs the following activity codes eligible the program:DP1,DP2,DP5,R01,R00,R15,R21,R35,RF1, andU01and have qualifying critical life event. PD/PIs more one independent research project grant award ineligible this supplement. Qualifying Critical Life Events: PD/PI must demonstrate critical life event such childbirth adoption during parent grant project period; primary caregiving responsibilities an ailing spouse, partner, a member the immediate family. circumstances which critical life event pending is expected occur during project period, supplement period be submitted advance the event. supplements parent awards include multiple PDs/PIs, supplement be requested any the PDs/PIs accordance the existing leadership plan on behalf the PD/PI meets eligibility criteria) submitted the grantee institution the parent award. should noted for parent grant for administrative supplement, grantee the institution, the PD/PI. Application Submission Information Supplement requests must submitted accordance the parent program announcement: Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional)PA-18-591or subsequent reissued equivalent. Supplement requests must submitted electronically. process Streamlined Submissions using eRA Commons cannot used this initiative. . instructions theSF424 R&R) Application GuideandPA-18-591must followed, the following additions: Application Due Date(s) Submission dates vary awarding IC.SeeTable IC-Specific Information, Requirements Staff Contactsfor details. funding consideration, applicants must include NOT-OD-20-055 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 6 pages. R&R Project Information form, the Attachments" field: Attach Personal Statement the applicant, including long-term research objectives career goals, justification the supplemental support, a plan return full productivity the end the supplement period. Attach Institutional letter commitment includes details resources mentoring be available the applicant ensure strong productivity the parent grant. letter should also detail institutional commitment the applicants return full productivity research career trajectory the end the supplement period. is strongly recommended the applicants contact respective program officers the Institute supporting parent award confirm ahead time the supplement falls within scope the parent award. Further, applicants strongly encouraged notify program contact the Institute supporting parent award SeeTable IC-Specific Information, Requirements Staff Contacts)that request been submitted response this FOA order facilitate efficient processing the request. Administrative Review Process IC conduct administrative reviews applications submitted their IC. ICs the parent grants support most meritorious applications submitted consideration, pending availability funds. Criteria: the work/activities proposed within scope the parent award? the progress the project prior the life event adequate? the administrative supplement increase preserve likelihood the project succeed, assist candidate complete research project submit timely renewal new research project grant application? there plan the PD/PI return full productivity the end the supplement period? there strong institutional commitment e.g., protected time, policies, programs, other strategies) ensure the PD/PI maintains his/her research project independent research trajectory? Inquiries Please direct inquiries to: Melissa Ghim, PhD Office Research Womens Health ORWH) Division Program Coordination, Planning, Strategic Initiatives DPCPSI) Telephone: 301-496-7853 Email:melissa.ghim@nih.gov

Notice of Special Interest: Administrative Supplements to Promote Research Continuity and Retention of NIH Mentored Career Development (K) Award Recipients and Scholars

Notice of Special Interest
Thursday, January 2, 2020
Monday, March 6, 2023
333
NOT-OD-20-054

Funding Opportunity Purpose

Notice Special Interest: Administrative Supplements Promote Research Continuity Retention NIH Mentored Career Development K) Award Recipients Scholars Notice Number: NOT-OD-20-054 Key Dates Release Date: January 2, 2020 First Available Due Date: March 05, 2020 Expiration Date: March 06, 2023 Related Announcements PA-18-591 RFA-AG-21-020 Issued Office The Director, National Institutes Health OD) 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) 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) Fogarty International Center FIC) National Center Complementary Integrative Health NCCIH) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) National Cancer Institute NCI) Purpose overarching goal this program to support transition retention investigators mentored career development research independence to minimize departures biomedical research workforce this critical juncture. supplement program intended ensure continuity research among recipients mentored career development K) awards providing supplemental research support help sustain investigators research during critical life events. supplement be used support additional personnel, computational services, supplies, equipment will promote continuity the career development research project during period which PD/PI experiences critical life events have potential impact research progress potential productivity. Administrative supplements must support work within scope the original project. the purposes this program, childbirth, adoption, primary caregiving responsibilities an ailing spouse, child, partner, a member the immediate family during project period critical life events would qualify consideration. Evidence the circumstance affect advancement the mentored career development award productivity must provided. circumstances which critical life event pending is expected occur during project period, supplement request be submitted advance the event. K awardees are late stage postdoctoral scientists, instructors, early stage faculty recipients the K awards referenced above encouraged apply. retention supplements support first-time NIH R01-Equivalent Awards, companion FOA Budget be eligible, parent award must able receive funds the time the award. administrative supplement budget limited 1 year. application budget cannot exceed maximum direct cost 50,000, applicable F & indirect) cost also requested. Flexible of supplemental funds highly encouraged support successful research within scope the parent project, including supported effort additional personnel, computational services, supplies equipment sustain research the PD/PI the individual K award during critical life event. Eligible Individuals Program Director/Principal Investigator) PD/PIs the following activity codes eligible the award: K01, K07, K08, K22, K23, K25, K38, K43, K76, K99/R00 the mentored K99 portion the K99/R00). Individual(s) must hold active grant, the research proposed the supplement must accomplished within competitive segment the active award. Individuals encouraged work their organizations develop applications support. Application Submission Information Supplement requests must submitted accordance the parent program announcement: Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-591or subsequent reissued equivalent. Supplement requests should submitted electronically. process Streamlined Submissions using eRA Commons cannot used this initiative. instructions the SF424 R&R) Application Guide PA-18-591 must followed, the following additions: Application Due Date(s) Submission dates vary awarding IC. Table IC-Specific Information Requirements more details. funding consideration, applicants must include NOT-OD-20-054 without quotation marks) the Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4bwill be considered this initiative. PHS 398 Career Development Award Supplemental Form Candidate Information Goals Career Development attachment: Personal Statement the applicant, including long-term research objectives career goals, justification the supplemental support, a plan return full productivity the end the supplement period. Institutional Commitment Candidates Research Career Development attachment: Institutional letter commitment includes details resources mentoring be available the applicant ensure strong productivity the parent grant. letter should also detail institutional commitment the applicants return full productivity research career trajectory the end the supplement period. is strongly recommended the applicants contact respective program officers the NIH Institute/Center IC) supporting parent award confirm ahead time the supplement falls within scope the parent award. Further, applicants strongly encouraged notify program contact the IC supporting parent award Table IC-Specific Information Requirements)that request been submitted response this FOA order facilitate efficient processing the request. Administrative Review Process: IC conduct administrative reviews applications submitted their IC separately, will support most meritorious applications submitted consideration, based upon availability funds. Criteria: the work proposed within scope the parent mentored career development award? is progress date the parent mentored career development award? the administrative supplement increase preserve likelihood the project succeed assist K awardee appointee completing research project, transitioning the next career stage? there plan the PD/PI return full productivity the end the supplement period? there strong institutional commitment e.g., protected time, policies, programs, other strategies) ensure the PD/PI maintains his/her research project independent research trajectory? Inquiries Please direct inquiries to: Division Biomedical Research Workforce Office Extramural Research Website: https://researchtraining.nih.gov Email: NIHTrain@mail.nih.gov

Notice of Special Interest (NOSI): Availability of Administrative Supplements for the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project

Notice of Special Interest
Wednesday, December 18, 2019
Thursday, March 24, 2022
333
NOT-OD-20-024

Funding Opportunity Purpose

Notice Special Interest NOSI): Availability Administrative Supplements the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project Notice Number: NOT-OD-20-024 Key Dates Release Date: December 18, 2019 First Available Due Date: March 23, 2020 Expiration Date: March 24, 2022 Related AnnouncementsNOT-OD-20-129 - Notice Special Interest NOSI) regarding Availability Urgent Competitive Revisions Administrative Supplements Research Coronavirus Disease 2019 COVID-19) Individuals Down Syndrome the INCLUDE Project NOT-OD-20-022 NOT-OD-20-012, Notice Intent Publish Funding Opportunity Announcements Fiscal Year 2020 the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project PA-18-591,Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) NOT-OD-20-017,Notice Special Interest Encourage Development Animal Models Related Biological Materials Research Related Down Syndrome NOT-OD-20-020 Notice Special Interest NOSI): Ruth L. Kirschstein National Research Service Award NRSA) Fellowship Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-021 Notice Special Interest NOSI): Mentored Career Development Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-022 Notice Special Interest: Administrative Supplements the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project NIH-funded K12 KL2 Institutional Career Development Awards NOT-OD-20-023 Notice Special Interest: Availability Competitive Supplements/Revisions the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Competitive Supplement/Revision Clinical Trial Optional) NOT-OD-20-025 Notice Special Interest: NIH Research Project Grants Down Syndrome R01) RFA-OD-20-003 Clinical Trials Development Co-Occurring Conditions Individuals Down syndrome: Phased Awards INCLUDE R61/R33 Clinical Trial Required) RFA-OD-20-004INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Clinical Trial Readiness R21 Clinical Trial Allowed) RFA-OD-20-005Transformative Research Award the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project R01 Clinical Trial Allowed) RFA-OD-20-006 Small Research Grants Analyses Down Syndrome-related Research Data the INCLUDE Project R03 Clinical Trial Allowed) RFA-OD-20-007 Development the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Data Coordinating Center U2C) Issued Office The Director, National Institutes Health OD) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Institute Aging NIA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) 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 Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Center Advancing Translational Sciences NCATS) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) National Cancer Institute NCI) Purpose Office the Director the National Institutes Health NIH) announces opportunity investigators relevant active NIH-supported grants the participating Institutes listed above submit administrative supplement applications funded projects meet new NIH Down syndrome research objectives related the NIH INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Project. Notice soliciting administrative supplements the following mechanismsONLY:R03,R21,R24,P01,P30,P40,P50,P51,U01,U10,U19,U24,U42,U54,UG1,UG3,UL1,U2C,K12, andT32. Background INCLUDE Project developed response Fiscal Year 2018 2019 Omnibus Appropriations Reports, encouraged NIH expand current efforts Down syndrome DS) common co-occurring conditions also seen the general population while increasing pipeline DS investigators. Information projects were funded 2018 2019, well the INCLUDE ProjectResearch Plan, available theINCLUDE Project website. Individuals DS face significant changing health challenges have often excluded participation research could improve health outcomes quality life. population understudied even though DS the most common genetic cause intellectual developmental disabilities IDD) and, the past 25 years, average lifespan doubled 30 60 years. addition intellectual disability, DS associated an increased prevalence autism epilepsy. 75% individuals DS experience cognitive decline a syndrome resembles Alzheimers disease, with onset decade two earlier typical Alzheimers disease. Individuals DS also high rates hearing loss, eye abnormalities, congenital heart defects, sleep apnea, pulmonary hypertension, gastrointestinal malformations, thyroid disease, leukemia, other autoimmune immune dysregulation disorders including celiac disease. However, people DS infrequently develop solid tumors such breast prostate cancer. Despite multiple risk factors coronary artery disease high rates obesity, sleep apnea, type 1 diabetes, people DS rarely develop atherosclerosis have myocardial infarctions. Understanding unique combination risk resiliencies inform medical advances individuals DS for individuals do have DS who share co-occurring conditions. Research Objectives Notice Special Interest NOSI) announces NIH support the professional development early career scientists aiming establish career DS-related research. providing scientists training, resources, mentorship, NIH intends foster pipeline investigators DS other intellectual disabilities will lead future research improve understanding the biology DS support development new treatments health conditions experienced those DS. Sharing resources effective communication outputs the broader communities a high priority theINCLUDE Project. Applicants responding this NOSI strongly encouraged describe plans rapid sharing data results well innovative data analytics approaches Goal 3,NIH Strategic Plan Data Science). Supplement applications be eligible funding they address or of following components related the INCLUDE Project research objectives: Component 1: Targeted, high risk-high reward, basic science studies areas highly relevant Down syndrome Component 2: Cohort Study connect existing resources expand inclusion individuals Down Syndrome Component 3: Inclusive clinical trials research co-occurring conditions individuals Down syndrome Applications be considered eligible funding they: within scope the active parent award focused DS Propose address of three components listed above likely stimulate additional activity leading progress DS Address priority the IC issued parent award below more information) Supplements existing clinical trials allowed. proposed research must within scope the parent clinical trial the parent clinical trial award must two more budget years remaining the current project period. addition a new clinical trial was a part the parent award not allowed. Supplement requests addressing INCLUDE Components 2 3 should encourage participants DS their caregivers register inDS-Connect: Down Syndrome Registry. INCLUDE website a list ofFunding Priorities Institute Center, well list ofcontactsfor participating NIH Institute Center. Before submitting supplement request, applicants strongly encouraged contact program officer the program contact the Institute Center IC) supporting parent award any questions to discuss whether proposed supplement within scope the parent award, focused the goals the INCLUDE Project consistent IC priorities. Award Project Period be eligible, parent award must active the current fiscal year i.e., parent award received funds the current fiscal year is in extension period), the research proposed the supplement should requested one year. awarding institute consider no-cost extension up an additional year the conclusion the first year. earliest anticipated start date August 2020, August 2021, August 2022. Budget Requests must reflect actual needs the proposed project. Supplement budget requests exceed 500,000 direct costs 50% the direct costs the current year the parent award exclusive Facilities Administrative costs sub-contracts) must receive permission the project officer IC Contact prior submission. Eligible Individuals Program Director/Principal Investigator) Individual(s) must hold active grant cooperative agreement. supplements parent awards include multiple PDs/PIs, supplement be requested any all the PDs/PIs accordance the existing leadership plan) submitted the awardee institution the parent award. Application Submission Information: Applications response this NOSI must submitted toPA-18-591Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) its subsequent reissued equivalent. instructions theSF424 R&R) Application GuideandPA-18-591must followed, the following additions: order ensure identification, tracking, appropriate review their applications, applicants MUST follow special instructions: Application Due Date(s) March 23, 2020, March 23, 2021, March 23, 2022 5:00 PM local time applicant organization. Applications must include NOT-OD-20-024 the Agency Routing Identifier field Box 4b) the SF424 R&R form. Applications without identifier NOT-OD-20-024) Box 4b not considered this initiative. process Streamlined Submissions using eRA Commons cannot used forPA-18-591. the form package theexistingNIH Grants and/or Cooperative Agreements. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response toNOT-OD-20-024in order facilitate efficient processing the request. Applicant organizations submit than application this NOSI. unique project titles each application ensure our systems treat application a distinct submission. Application budgets must reflect actual needs the proposed project. Supplement budget requests exceed 500,000 direct costs 50% the direct costs the current year the parent award exclusive Facilities Administrative costs sub-contracts) must receive permission the project officer IC Contact prior submission. application Abstract section should describe proposed supplement, the Research Strategy section should include summary abstract the funded parent award project. Research Strategy should state relevance the parent award the INCLUDE project, articulate component(s) any IC-specific priorities the supplement addressing. Page Limits:NIH consider supplements a Research Strategy ofno than 6 pages, addition the abstract. part the application investigators should submit abstract the proposed research shows relevance DS. Place abstract the Project Summary/Abstract section the SF424 R&R) Form. work include pilot projects resource development. Review Process:Each IC conduct administrative reviews applications their IC separately. Inquiries Please direct inquiries to: Investigators planning submit application response this NOSI strongly encouraged contact discuss proposed research/aims a Program Officer the appropriate Institute Center listed this NOSI well advance the grant receipt date better determine appropriateness interest the awarding ICO. Please direct inquiries the contact the Institute, Center Office supporting parent award indicated the funding page theINCLUDE Project website.

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