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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

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 see https://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.0000000000001209 and 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 investigator’s 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 NIH’s 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/PI’s 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, and U01and 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 the SF424 R&R) Application Guide and PA-18-591 must followed, the following additions: Application Due Date(s) – Submission dates vary awarding IC. See Table 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 applicant’s 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 See Table 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 Women’s Health ORWH) Division Program Coordination, Planning, Strategic Initiatives DPCPSI) Telephone: 301-496-7853 Email: melissa.ghim@nih.gov

Notice of Special Interest: Administrative Supplements for Existing NIH Countermeasures Against Chemical Threats (CounterACT) Program Research Grants and Cooperative Agreement Awards

Notice of Special Interest
Monday, January 6, 2020
CounterACT
Tuesday, August 4, 2020
333
NOT-NS-20-029

Funding Opportunity Purpose

Notice Special Interest: Administrative Supplements Existing NIH Countermeasures Against Chemical Threats CounterACT) Program Research Grants Cooperative Agreement Awards Notice Number: NOT-NS-20-029 Key Dates Release Date: January 6, 2020 First Available Due Date: August 03, 2020 Expiration Date: August 04, 2020 Related Announcements PA-18-591 NOT-NS-20-030 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) Purpose NIH inviting administrative supplement applications provide additional funds active CounterACT research grants cooperative agreement projects support activities such new collaborations pilot studies were unanticipated the time the new competing continuation application submitted. proposed activities must within original research scope the parent award. Supplemental funding includes direct costs well associated facilities administrative costs. supplement project start any time during budget period must end the last day the budget period. parent award not in terminal no-cost extension going a no-cost extension FY2020. Application budgets limited 75,000 total costs must reflect actual needs the proposed project. Only parent CounterACT research grant cooperative agreement awards funded through following FOAs any reissues these announcements) eligible request supplemental funding under NOSI: PAR-13-208: Countermeasures Against Chemical Threats CounterACT) Cooperative Research Projects U01) PAR-15-146; PAR-16-329; PAR-18-657: Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54 Clinical Trial Optional) PAR-16-330: Countermeasures Against Chemical Threats CounterACT): Identification Therapeutic Lead Compounds U01 Clinical Trial Allowed) PAR-16-331: Countermeasures Against Chemical Threats CounterACT): Optimization Therapeutic Lead Compounds U01 Clinical Trial Optional) PAR-18-721: Countermeasures Against Chemical Threats CounterACT) Exploratory/Developmental Projects Translational Research R21 Clinical Trial Allowed) Scope Interest overall goal the NIH Countermeasures Against Chemical Threats CounterACT) program to support research development therapeutics can reduce mortality morbidity the event the release chemical threat agents. Chemical threat agents toxic compounds could released a deliberate terrorist attack against civilians, by accidental natural disaster causing mass casualties. include chemical warfare agents e.g., sarin, chlorine, sulfur mustard), toxic industrial chemicals e.g., cyanide, hydrogen sulfide, phosgene), pesticides e.g., parathion, brodifacoum), pharmaceutical-based agents e.g., opioids) other chemicals. Applications proposing research chemical threats are of interest the program not considered funding. research related opioid threats being proposed, NOT-NS-18-019 a description research supported the NIH CounterACT program. Examples topics interest include, are limited to: Facilitating collaborations fellow awardees within CounterACT community Identify and/or recruit new resources such investigators additional expertise, industry partner, research tools, systems, assays enhance outcomes the parent award Limited, pilot studies establish proof-of-principle approaches Investigators planning submit application response this NOSI strongly advised contact discuss proposed research/aims the Program Officer their parent CounterACT award well advance the receipt deadline better determine appropriateness relevance the supplement project 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 the SF424 R&R) Application Guide PA-18-591 must followed, the following additions Research Strategy part the application, summarize scope the parent supplemental projects describe proposed aims research strategy the new study. Clearly state the supplemental efforts fit the scope the parent award. research strategy should clearly demonstrate the new collaboration(s), resource(s), and/or studies benefit parent award why those otherwise be feasible either within currently funded efforts by rebudgeting funds. Applicants the program urged consider directly address elements rigor reproducibility described NOT-OD-15-103 their experimental design. Administrative Evaluation Criteria the proposed supplemental project outcomes relevant the NIH CounterACT program mission goals? the work proposed within scope the active parent award? Does proposed research/scientific team possess expertise conduct achieve goals the supplemental study? Does supplemental proposal include well-described, rigorous scientific approach? the project yield significant preliminary data support more advanced drug discovery development efforts? the scope budget reasonable the proposed studies? Letters Support Applicants must include letter appropriate institutional biosafety officials indicating studies deemed safe research personnel the environment. formal letter support must provided all newly proposed collaborative, consultative, and/or contract arrangements. Application Due Date(s) – August 3,2020, 5:00 PM local time applicant organization. funding consideration, applicants must include “NOT-NS-20-029” 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 CounterACT program eligible apply. process Streamlined Submissions using eRA Commons cannot used this initiative. Applicants strongly encouraged notify CounterACT Program Officer the parent award a request been submitted response this FOA order facilitate efficient processing the request. application budget cannot exceed 75,000 total costs must reflect actual needs the project. Inquiries Please direct inquiries related the overall NIH CounterACT Program and/or parent awards managed the National Institutes Neurological Disorders Stroke NINDS) to: David A. Jett, PhD Telephone: 301-496-6035 Email: jettd@nih.gov Shardell M. Spriggs, PhD Telephone: 301-443-8189 Email: shardell.spriggs@nih.gov parent awards managed the National Institute Arthritis Musculoskeletal Skin Diseases NIAMS): Hung Tseng, Ph.D. Telephone: 301-594-5032 Email: tsengh@mail.nih.gov parent awards managed the National Eye Institute NEI): Houmam Araj, Ph.D. Telephone: 301-451-2020 Email: arajh@nei.nih.gov parent awards managed the National Institute Environmental Health Sciences NIEHS): Srikanth S. Nadadur, Ph.D. Telephone: 984-287-3296 Email: nadadurs@niehs.nih.gov parent awards managed the National Institute Drug Abuse NIDA): Kristopher Bough, Ph.D. Telephone: 301-443-9800 Email: boughk@nih.gov

Notice of Special Interest: Administrative Supplements to Promote and Expand into the Research and Development of Medical Countermeasures Against Chemical Threats

Notice of Special Interest
Monday, January 6, 2020
CounterACT
Tuesday, August 4, 2020
333
NOT-NS-20-030

Funding Opportunity Purpose

Notice Special Interest: Administrative Supplements Promote Expand the Research Development Medical Countermeasures Against Chemical Threats Notice Number: NOT-NS-20-030 Key Dates Release Date: January 6, 2020 First Available Due Date: February 03, 2020 Expiration Date: August 04, 2020 Related Announcements PA-18-591 NOT-NS-20-029 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) Purpose NIH inviting administrative supplement applications existing awards are currently focused developing medical countermeasures MCMs) against chemical threats allow to expand research focus this critical field. Supplemental funding includes direct costs well associated facilities administrative costs. supplement project start any time during budget period must end the last day the budget period. parent award not in terminal no-cost extension. Application budgets limited no than amount the current award 125,000 total costs whichever lower) must reflect actual needs the proposed project. Scope Interest overall goal the NIH Countermeasures Against Chemical Threats CounterACT) program to support research development therapeutics can reduce mortality morbidity the event the release chemical threat agents. Chemical threat agents toxic compounds could released a deliberate terrorist attack against civilians, by accidental natural disaster causing mass casualties. include chemical warfare agents e.g., sarin, chlorine, sulfur mustard), toxic industrial chemicals e.g., cyanide, hydrogen sulfide, phosgene), pesticides e.g., parathion, brodifacoum), pharmaceutical-based agents e.g., opioids) other chemicals. research related opioid threats being proposed, NOT-NS-18-019 a description research supported the NIH CounterACT program. scope research will supported this NOSI should consistent the following currently published funding opportunity announcements, PAR-18-721, PAR-19-030, PAR-19-040, including basic translational research through preclinical studies. view list currently funded projects, please visit our webpage, CounterACT Research Network Funded Investigators. Examples topics chemical agents interest include, are limited to: Pulmonary Agents Chlorine Phosgene): Development MCMs prevent treat lung damage including pulmonary edema fibrosis) resulting after exposure Pharmaceutical-based Agents Synthetic Opioids): Development MCMs treat life-threatening respiratory depression caused opioid intoxication. post-exposure treatments should quick-acting effective against variety opioids, e.g., fentanyl, carfentanil. NOT-NS-18-019 more details Vesicants Sulfur Mustard Lewisite): Development MCMs mitigate acute and/or long-term injuries resulting exposure the skin, eyes, mucous membranes vesicating agents. Specific areas interest include treating corneal neovascularization, fibrosis, mustard gas keratopathy. Cellular Respiration/Blood Agents Cyanide): Development MCMs treat acute poisoning. Antidotes should rapidly effective easily administered first responders Nerve Agents Organophosphorus OP) Pesticides: Development MCMs treat seizures either before after become refractory treatment benzodiazepines therapeutics promote neuronal survival other persistent effects after seizure termination. the federal monograph, Sarin: Potential Long-term Neurological Effects. are chemicals interest addition those listed above, Investigators planning submit application response this NOSI strongly advised contact discuss proposed research/aims the Program Officer their parent award the CounterACT Program Officer listed below) most relevant the supplement project well advance the receipt deadline determine responsiveness, programmatic interest, relevance. Applications propose research chemical threats are of interest the program not considered funding. 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 the SF424 R&R) Application Guide PA-18-591 must followed, the following additions Research Strategy part the application, include abstract the proposed research shows relevance developing chemical medical countermeasures. Summarize scope the parent supplemental projects describe proposed aims research strategy the new study. Clearly state the supplemental efforts fit the scope the parent grant. Applicants the program urged consider directly address elements rigor reproducibility described NOT-OD-15-103 their experimental design. Administrative Evaluation Criteria the proposed supplemental project outcomes relevant the NIH CounterACT program mission goals? the work proposed within scope the active parent award? Does proposed research/scientific team possess expertise conduct achieve goals the supplemental study? Does supplemental proposal include well-described, rigorous scientific approach? the project yield significant preliminary data support more advanced drug discovery development efforts? the scope budget reasonable the proposed studies Letters Support Applicants must include letter appropriate institutional biosafety officials indicating studies deemed safe research personnel the environment. formal letter support must also provided all newly proposed collaborative, consultative, and/or contract arrangements. Application Due Date(s) – February 3, 2020, April 1, 2020, June 1, 2020, August 3, 2020, 5:00 PM local time applicant organization. funding consideration, applicants must include NOT-NS-20-030” 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. process Streamlined Submissions using eRA Commons cannot used this initiative. Applicants strongly encouraged notify program contact the Institute supporting parent award the CounterACT Program Officer listed below) most relevant the supplemental project a request been submitted response this FOA order facilitate efficient processing the request. application budget cannot exceed 125,000 total costs. Inquiries Please direct inquiries related the overall NIH CounterACT Program, neurological injury metabolic/blood research to: David A. Jett, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-6035 Email: jettd@nih.gov Shardell M. Spriggs, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-443-8189 Email: shardell.spriggs@nih.gov questions related dermal/vesicant-induced injuries: Hung Tseng, Ph.D. National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-5032 Email: tsengh@mail.nih.gov questions related ocular injury research: Houmam Araj, Ph.D. National Eye Institute NEI) Telephone: 301-451-2020 Email: arajh@nei.nih.gov questions related pulmonary injury research: Srikanth S. Nadadur, Ph.D. National Institute Environmental Health Sciences NIEHS) Telephone: 919-541-5327 Email: nadadurs@niehs.nih.gov questions related pharmaceutical based agents: Kristopher Bough, Ph.D. National Institute Drug Abuse NIDA) Telephone: 301-443-9800 Email: boughk@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 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 investigator’s 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 Candidate’s 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 applicant’s 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 Announcements 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-20-004 INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Clinical Trial Readiness R21 Clinical Trial Allowed) RFA-OD-20-005 Transformative 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 mechanisms ONLY: R03, R21, R24, P01, P30, P40, P50, P51, U01, U10, U19, U24, U42, U54, UG1, UG3, UL1, U2C, K12, and T32. 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 Project Research Plan, available the INCLUDE 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 Alzheimer’s disease, with onset decade two earlier typical Alzheimer’s 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 the INCLUDE 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 in DS-Connect®: Down Syndrome Registry. INCLUDE website a list of Funding Priorities Institute Center , well list of contacts for 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 to PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) its subsequent reissued equivalent. instructions the SF424 R&R) Application Guide and PA-18-591 must 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 for PA-18-591. the form package the existing NIH Grants and/or Cooperative Agreements. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response to NOT-OD-20-024 in 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 of no 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 the INCLUDE Project website.

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 2019-2023 Trans-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 2019-2023 Trans-NIH Strategic Plan Women's Health Research "Advancing Science the Health Women" is proposed identified the application. least of three Sex/Gender-based Study Types is proposed: Pre-Clinical Research includes Cell line, Primary culture animals, Animal model, Xenograft, non-human primates Clinical Research includes Human subjects, Human Biospecimens, Primary culture human subjects Both Pre-Clinical Clinical Research includes above mentioned examples both study types, Patients derived xenografts least of three Sex/Gender-based Research Approaches is 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 not eligible apply. Non-domestic non-U.S.) components U.S. Organizations are not eligible apply. Foreign components, as defined the NIH Grants Policy Statement, are allowed. 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 the SF424 R&R) Application Guide and PA-18-591 must 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 Women’s Health ORWH) Telephone: 301-451-7058 Email: Rajeev.Agarwal@nih.gov

Notice of Special Interest: Research on the Health of Women of Understudied, Underrepresented and Underreported (U3) Populations (Admin Supp Clinical Trial Optional)

Notice of Special Interest
Friday, December 13, 2019
Tuesday, January 26, 2021
333
NOT-OD-20-048

Funding Opportunity Purpose

Notice Special Interest: Research the Health Women Understudied, Underrepresented Underreported U3) Populations Admin Supp Clinical Trial Optional) Notice Number: NOT-OD-20-048 Key Dates Release Date: December 13, 2019 First Available Due Date: January 28, 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 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) 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 health disparities among women the US are underrepresented, understudied, underreported U3) biomedical research. proposed research must address least objective the strategic goals 1, 2, 3 the 2019-2023 Trans-NIH Strategic Plan Women's Health Research "Advancing Science the Health Women." Background NIH encourages supports biomedical research serves entirety the population women the US. However, is disproportionate burden disease exists a significant subpopulation women, including racial ethnic minorities, immigrants, those living poverty, those both rural urban areas. subpopulations diverse are mutually exclusive. Women girls these subpopulations bear disproportionate burden health risks conditions compared the general US population are often underrepresented understudied clinical biomedical research underreported surveillance data. Similarly, women physical, intellectual, developmental, sensory disabilities also often underrepresented biomedical research. women not well represented clinical research subsequent interventions not relevant the health women https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6425923/ Understudied underreported subpopulations represent increasing percentage the US population bear disproportionate burden health risk, poorer health, disease prevalence. 2014 ORWH published Women Color Health Data Book, 4th edition" https://orwh.od.nih.gov/sites/orwh/files/docs/WoC-Databook-FINAL.pdf), consists US Government sourced, population-based health disease data highlights health disparities. Additionally, women a sexual minority including not limited transgender intersex women) often underrepresented biomedical research well in data reporting, failing unique opportunities learn about only differences among men women, also effects the hormonal milieu differs that expected based upon biologic sex alone. health women affected a multitude factors acting across life course. complex intersection these internal e.g., genetics) external e.g., social determinates) factors play crucial role the health status, disease presentations, treatment responses women well the effects diseases conditions women's quality life. Thus, consideration a multidimensional framework Schweinhart Clayton, 2018) needed improve quality women's lives, reduce disease burden across life course, address health disparities populations women most considerable risk certain diseases. Interdisciplinary research initiatives integrating perspectives multiple disciplines—as well researchers diverse skills, knowledge, experiences—are crucial capturing complex interplay various factors affecting health all women. Therefore, NOSI encourages research emerging topics include collaborations across range disciplines including not limited economics, medical anthropology, psychology, sociology, demography address areas the fuller context women's lives the underlying common root causes poorer health outcomes. Specific Areas Research Interest NOSI support projects highlight common sources disparities women's health. common pathways the manifestations ill health disease, differential risk, risk exposure, resilience, morbidity, mortality the individual, community, national levels areas particular research interest. NOSI provides following descriptions the applicants consider: Primary secondary data analysis reporting sex gender-based data, race ethnicity data, their intersection clinical research, including subgroup analyses existing data examine clinical differences among women diverse racial ethnic backgrounds, women sexual gender minority, women physical, intellectual developmental, and/or sensory disabilities. Identify evidence-based methods intervention reaching to women girls are under-represented the proposed study describe why selected methodology appropriate the project. Develop new effective statistical methods, sampling techniques small study sample include understudied underreported sub-population groups women, applicable. Identify process novel dissemination implementation approaches currently previously implemented the field identified the scientific literature. Areas scientific interest include are limited the study subjects U3 populations, the comparison their outcomes the following general areas: Sensitivity specificity biomarkers, screening, diagnosis disease risk, prognosis, benefit treatment. effect violence, including intimate partner violence across lifespan, including elder abuse, abuse during pregnancy, its subsequent impact upon infant/child. Evidence-based interventions improve outcomes women have experienced gender-based violence. role limited access health care care-seeking behavior outcomes geographically isolated populations understudied underrepresented women. Factors contributing disparities reproductive health and/or gynecologic conditions, their impact risk factors, diagnosis, treatments, health outcomes. Maternal morbidity mortality including effect maternal morbidities health conditions throughout women’s life course. Chronic diseases demonstrate health disparities specific communities women. Exposure assessments disease outcomes understudied women. Disparities economic hardship e.g., low socioeconomic status) its effect the risk disease e.g., epigenetic), disease development e.g., lack safe open spaces activity the development obesity; mental physical consequences early genital trauma), premature aging, increased morbidity mortality. Interdisciplinary transdisciplinary areas scientific interest include are limited to: Studies explore intersections social determinants such education, socioeconomic status, culture, built environment health outcomes, risk poor health outcomes diverse populations women; women suffering intellectual developmental disabilities. Studies will fill the gap focusing inclusion critical subpopulation women do reside households, e.g., homeless, institutionalized, incarcerated, ensure gaps surveillance addressed through research program. Studies encompass our understanding the mutable causes disparities HIV risk, presentation care, care engagement, linkage care, treatment adherence female, transgender, intersex individuals across lifespan. Studies foster our understanding the influence alone in combination exogenous factors such stigma, racism, classicism, residential segregation, historical trauma examples) risk disease, disease progression, health care engagement, retention, disease morbidity mortality. Eligibility Only PDs/PIs an active P01, P20, P30, P50, P60, P2C, S06, U10, U19, U2C, U54, UC2, UM2, R01, R15, R21, R24, R25, R33, R34, R35, RC4, S11, U01, UM1, UP5 award NIH eligible apply. PDs/PIs encouraged apply electronically. PDs/PIs the activity, mentioned above, must also fulfill the following mandatory requirements; otherwise, applications not responsive this NOSI. should 16 months remaining the project period the parent grant. no-cost extension not eligible. Only U3 Admin. Supp. Award permitted a peer-reviewed NIH funded grant one grant cycle. proposed research must address least objective the strategic goals 1, 2, 3 the 2019-2023 Trans-NIH Strategic Plan Women's Health Research "Advancing Science the Health Women." Foreign Institutions: Non-domestic non-U.S.) Entities Foreign Institutions) are not eligible apply. Non-domestic non-U.S.) components US Organizations are not eligible apply. Foreign components, as defined the NIH Grants Policy Statement, are allowed. Budget 2,000,000 expected be available annually funding program. budget should exceed 140,000 direct costs the administrative supplement per year. addition the direct cost, applicable F&A indirect) cost also requested. application budget limited one year only. 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. Scope Support Administrative supplements be used meet increased costs are within scope the approved award, that unforeseen the new renewal application grant progress report non-competing continuation support submitted. Applicants should propose research that, successful, contribute a greater understanding the health wellbeing underrepresented, understudied, unreported women the US population. IC-Specific Considerations 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. Application Submission Information 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: Application Due Date(s) – January 28, 2020, January 21, 2021, 5:00 PM local time applicant organization. funding consideration, applicants must include NOT-OD-20-048 the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Requests must for year support only. Research Strategy section the application limited 6 pages. process Streamlined Submissions using eRA Commons cannot used this initiative. Continuous submission not permitted. other words, late applications be accepted. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response this NOSI facilitate efficient processing the application.   Inquiries Please direct inquiries to: Rajasri Roy Ph.D., MPH Office Research Women's Health ORWH) Telephone: 301-451-0993 Email: rajasri.roy@nih.gov

Notice of Special Interest: Administrative Supplements for Research on Sexual and Gender Minority (SGM) Populations (Admin Supp Clinical Trial Optional)

Notice of Special Interest
Thursday, December 5, 2019
Tuesday, January 26, 2021
333
NOT-OD-20-032

Funding Opportunity Purpose

Notice Special Interest: Administrative Supplements Research Sexual Gender Minority SGM) Populations Admin Supp Clinical Trial Optional) Notice Number: NOT-OD-20-032 Key Dates Release Date: December 6, 2019 First Available Due Date: January 31, 2020 Expiration Date: January 26, 2021 nbsp; Related Announcements PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued National Institutes Health NIH) Sexual amp; Gender Minority Research Office SGMRO) National Center Complementary Integrative Health NCCIH) National Cancer Institute NCI) National Human Genome Research Institute NHGRI) National Heart, Lung, Blood Institute NHLBI) 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 Drug Abuse NIDA) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Mental Health NIMH) National Institute Minority Health Health Disparities NIMHD) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) Additionally, following NIH Offices co-fund applications assigned these Institutes Centers: Office Behavioral Social Sciences Research OBSSR) Office Research Women’s Health ORWH) Purpose mission the NIH to seek fundamental knowledge the nature behavior living systems the application that knowledge enhance health, lengthen life, reduce illness disability. NIH committed supporting research will increase scientific understanding the health wellbeing various population subpopulation groups that help establish effectiveness evidence-based health interventions services individuals within groups. NIH places high priority research populations appear have distinctive health risk profiles who also received insufficient attention investigators. this end, Notice Special Interest NOSI) announces availability administrative supplements provide funding the expansion existing research projects incorporate sexual gender minority SGM) populations, include, are limited to, those populations described Notice NOT-OD-19-139. Basic, social, behavioral, clinical, translational, health services research relevant the missions the sponsoring NIH Institutes Centers ICs) be proposed response this solicitation. Potential applicants also encouraged review the FY 2017 Portfolio Analysis of NIH-funded SGM research identify potential research gaps may relevant this NOSI. Background Although collective knowledge base SGM health grown substantially since release the 2011 Institute Medicine the National Academy Medicine) report on health lesbian, gay, bisexual, transgender people, continually growing body evidence indicates SGM individuals still suffer disproportionately numerous conditions, diseases, health issues compared the general population. October 2016, the National Institute Minority Health Health Disparities, collaboration the Agency Healthcare Research Quality, announced that SGMs been officially designated health disparity population. designation facilitated creation tailored research projects, programs, activities, funding opportunities tackle unique health-related issues encountered SGM individuals. addition, ascertainment SGM status ongoing planned population studies been enhanced. However, SGM-specific health disparities persist today, there still urgent need novel strategies understand, measure, address, prevent them. of August 28, 2019, NIH definition sexual gender minorities" includes, is limited to, individuals identify lesbian, gay, bisexual, asexual, transgender, two-spirit, queer, and/or intersex. Individuals same-sex gender attractions behaviors those a difference sex development also included. populations also encompass those do self-identify one these terms whose sexual orientation, gender identity expression, reproductive development characterized non-binary constructs sexual orientation, gender, and/or sex. Applicants this administrative supplement propose study relevant SGM subpopulations explicitly identified this definition and/or adopt classification frameworks terminologies appropriate. Specific Areas Research Interest NOSI calls research will enrich scientific understanding how sexual orientation, gender identity, and/or being born disorders/differences sex development intersex conditions relate health outcomes, health risks, health behaviors, perceptions expectations health, access health-related services associated barriers. Appropriate topics studies these supplements include, are limited to, those listed below: Addition SGM participants an ongoing study either not originally include or not enrolled enough SGM participants make meaningful comparisons between groups; proposed studies must sufficiently powered allow meaningful comparisons Expansion an ongoing study focused one SGM group add another; proposed studies must sufficiently powered allow meaningful comparisons Expansion surveys questionnaires add items related sexual attraction, sexual behavior, sexual identity, gender identity, gender expression, and/or non-binary sex relevant appropriate Assessment reliability and/or validity measures relevant sexual attraction, sexual behavior, sexual identity, gender identity, gender expression, and/or non-binary sex Methodological strategic innovations improve recruitment retention SGM individuals any research activity Ethical, legal, social science research the implications data collection and/or research findings SGM populations Scope Support Administrative supplements be used meet increased costs are within scope the approved parent award, that unforeseen the new renewal application grant progress report non-competing continuation support submitted. Applicants this NOSI should propose research that, successful, contribute a greater understanding the health wellbeing SGM communities. Clinical trials cannot proposed be added grants do include clinical trial since would constitute change scope. IC-Specific Considerations applications submitted response this NOSI should fall within mission the IC the awarded parent grant. Applicants strongly encouraged discuss proposed supplement project the IC Program Officer the funded parent award prior submission a supplement application order ensure the proposed activity aligns the scientific priorities the IC is within scope the parent award. Scientific inquiries also addressed the contacts listed the Inquiries section below. Information   Recently issued trans-NIH policy notices may affect application submission. full list policy notices published NIH provided the NIH Guide Grants Contracts. awards subject the terms conditions, cost principles, other considerations described the NIH Grants Policy Statement. Authority Regulations Awards made under authorization Sections 301 405 the Public Health Service Act amended 42 USC 241 284) under Federal Regulations 42 CFR Part 52 45 CFR Part 75. 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 the SF424 R&R) Application Guide and PA-18-591 must followed the following additions: Application Due Dates – January 31, 2020 FY 2020, January 25, 2021 FY 2021, 5:00 PM local time applicant organization. expiration date January 26, 2021. project budget periods must within currently approved project period the existing parent award. funding consideration, applicants must include ldquo;NOT-OD-20-032” 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. project budget cannot exceed 100,000 total costs. Research Strategy section the application limited 6 pages. process Streamlined Submissions using eRA Commons cannot used this initiative. Applicants strongly encouraged notify Program Officer the IC supporting parent award a request been submitted response this NOSI order facilitate efficient processing the application. Applications do comply these instructions be delayed not accepted review. Applications nonresponsive terms this NOSI be be considered the NOSI initiative. Inquiries Please direct inquiries the Program Officer associated the parent award and/or designated contact the IC supporting parent award listed below: Scientific/Research Contact(s) Della White, PhD National Center Complementary Integrative Health NCCIH) Telephone: 301-827-6358 whitede@mail.nih.gov Liz Perruccio, PhD National Cancer Institute NCI) Telephone: 240-276-6178 Email: perruccioem@mail.nih.gov Tina Gatlin, PhD National Human Genome Research Institute NHGRI) Telephone: 301-?480-2280 Email: gatlincl@mail.nih.gov Brad Newsome, PhD National Heart, Lung, Blood Institute NHLBI) Telephone: 301-827-8170 Email: brad.newsome@nih.gov Melissa Gerald, PhD National Institute Aging NIA) Telephone: 301-?496-3136 Email: melissa.gerald@nih.gov Robert Freeman, PhD National Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301-443-8820 Email: rfreeman@mail.nih.gov Philip Renzullo, PhD, MPH National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3041 Email: prenzullo@mail.nih.gov Heiyoung Park, PhD National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-5032 Email: parkh1@mail.nih.gov Jeffrey Schulden, MD National Institute Drug Abuse NIDA) Telephone: 301-402-1526 Email: schuldenj@mail.nih.gov Alberto Rivera-Rentas, PhD National Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-496-1804 Email: riverara@mail.nih.gov Elise Rice, PhD National Institute Dental Craniofacial Research NIDCR) Telephone: 301-594-4814 Email: elise.rice@nih.gov Tamara Bavendam, MD, MS National Institute Diabetes Digestive Kidney Diseases NIDDK) Telephone: 301-594-4733 Email: bavendamtg@mail.nih.gov Tamara Lewis Johnson, MPH, MBA National Institute Mental Health NIMH) Telephone: 301-594-7963 Email: tl247e@nih.gov Jennifer Alvidrez, PhD National Institute Minority Health Health Disparities NIMHD) Telephone: 301-594-9567 Email: alvidrezjl@mail.nih.gov Richard Benson, MD, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9135 Email: richard.benson@nih.gov Rebecca Henry, PhD, BSN, RN National Institute Nursing Research NINR) Telephone: 301-594-5976 Email: rebecca.henry@nih.gov Rajasri Roy, PhD, MPH Office Research Women’s Health ORWH) Telephone: 301-451-0993 Email: royr2@mail.nih.gov nbsp;

HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed)

RFA
Friday, October 4, 2019
Friday, September 9, 2022
R41/R42
RFA-NS-20-009

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) aims to speed scientific solutions to stem the national opioid public health crisis by supporting the development of therapies and technologies directed at enhanced pain management through the Small Business Technology Transfer (STTR) program. This FOA is focused on applications directed at improving pain treatment, including the development of new non-addictive medications and devices and objective pain measurement. In addition, NIH is interested in new screening tools and models focused specifically on pain and development of pain therapies.

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