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Notice New Budget Limitation PAR-16-331 Countermeasures Against Chemical Threats CounterACT): Optimization Therapeutic Lead Compounds U01) Notice Number: NOT-NS-18-071 Key Dates Release Date: June 12, 2018 Related Announcements PAR-16-331 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 purpose this notice to amend award budget PAR-16-331 Countermeasures Against Chemical Threats CounterACT): Optimization Therapeutic Lead Compounds U01)." Section II. Award Information Currently Reads: Award Budget Application budgets not limited, need reflect actual needs the proposed project. most applications within scope this FOA, expected direct cost individual awards 300,000-$500,000 per year. applications not need request maximum budget the size duration the awards vary depending upon nature scope research programs. Modified Read: Award Budget Application Budget not exceed $500,000 in direct costs per year. applications not need request maximum budget the size duration the awards vary because nature scope research programs vary. other aspects this FOA remain same. Inquiries Please direct inquiries to: David A. Jett, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone:  301-496-6035 Email:  jettd@ninds.nih.gov nbsp;

Notice Participation PAR-18-721 Countermeasures Against Chemical Threats CounterACT) Exploratory/Developmental Projects Translational Research R21 Clinical Trial Allowed) Notice Number: NOT-NS-18-053 Key Dates Release Date: March 29, 2018 Related Announcements PAR-18-721 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) Purpose purpose this Notice to inform potential applicants the National Eye Institute NEI),  National Institute Environmental Health Sciences NIEHS), the National Institute Drug Abuse NIDA) participating PAR-18-721 Countermeasures Against Chemical Threats CounterACT) Exploratory/Developmental Projects Translational Research R21 Clinical Trial Allowed). following sections been updated reflect participation NINDS this FOA. Currently Reads: Part 1. Overview Information Components Participating Organizations National Institute Neurological Disorders Stroke NINDS) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.853; 93.846 Modified Read: Part 1. Overview Information Components Participating Organizations National Institute Neurological Disorders Stroke NINDS) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Eye Institute NEI) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS)   Catalog Federal Domestic Assistance CFDA) Number(s) 93.853; 93.846; 93.867; 93.279; 93.113 following contacts been added: Section VII. Agency Contacts Scientific/Research Contact(s) 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 Financial/Grants Management Contact(s) Karen Robinson Smith National Eye Institute NEI) Telephone: 301-451-2020 Email: kyr@nei.nih.gov Lisa A. Edwards, MBA National Institute Environmental Health Sciences NIEHS) Telephone:  919-541-0751 E-mail: archer@niehs.nih.gov Amy Connolly National Institute Drug Abuse NIDA) Telephone: 301-827-4457 Email: connolla@mail.nih.gov other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Shardell Spriggs, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-443-8189 Email: shardell.spriggs@nih.gov

Countermeasures Against Chemical Threats CounterACT): Opportunities Opioid Research Notice Number: NOT-NS-18-019 Key Dates Release Date: November 27, 2017 Related Announcements PAR-15-315 PAR-16-330 PAR-16-331 Issued National Institute Neurological Disorders Stroke NINDS) National Institute Drug Abuse NIDA) Purpose purpose this notice to highlight NIH/NINDS Countermeasures Against Chemical Threats CounterACT) program's interest developing safe effective therapeutics would prevent morbidity mortality following exposure the opioids fentanyl, carfentanil, acetylfentanyl, alfentanil, and/or diacetylmorphine heroin). program concentrates developing therapeutics treat and/or prevent injuries deaths may result exposure chemical threats a variety scenarios. Applications being accepted under three specific Funding Opportuntiy Announcements FOAs) issued the NIH CounterACT program PAR-15-315, PAR-16-330, PAR-16-331). be considered appropriate these FOAs, applications must follow instructions general descriptions found these FOAs well the following requirements related the specialized mission the NIH CounterACT program. Research supported these FOAs must relevant chemical emergencies where general civilian population might exposed opioids. research might include industrial accidents, natural disasters causing casualties, deliberate attacks again civilians. examples research could supported include, are limited to, following: Safety efficacy studies naloxone other FDA-approved drugs use against opioids listed above, especially they relate potential respiratory problems Safety efficacy studies naloxone other FDA-approved drugs use against opioids listed above these opioids administered a method consistent a deliberate attack against civilians, by industrial accidents natural disasters causing mass casualties e.g. aerosolized, food water, etc.) opioid overdose antidotes greater safety efficacy naloxone other FDA- approved drugs match higher potency fentanyl analogues, including naloxone-related antidotes those based new therapeutic targets Antidotes longer half-lives that multiple doses not needed rapid succession, many people be treated once during mass casualty event; includes increases serum half-life well alteration degradative metabolism Single antidotes acceptable activity against least or of opioids listed above NIH CounterACT program support exploratory developmental research PAR-15-315) well the identification PAR-16-330) optimization PAR-16-331) therapeutic lead compounds. Potential applicants should the descriptions scientific scope found these FOAs. Applicants strongly urged contact NIH representatives listed below prior submission. Inquiries Please direct general NIH CounterACT inquiries to: David A. Jett, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-6035 Email: david.jett@nih.gov Please direct specific opioid research inquiries: Kristopher J. Bough, Ph.D. National Institute Drug Abuse NIDA) Telephone: 301-443-9800 Email: boughk@nih.gov nbsp;

Notice Intent Publish Funding Opportunity Announcement Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54) Notice Number: NOT-NS-18-009 Key Dates Release Date: September 19, 2017 Estimated Publication Date Announcement: December 2017  First Estimated Application Due Date: September 2018 Earliest Estimated Award Date: July 2019  Earliest Estimated Start Date: July 2019  Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS), intends re-issue Program Announcement Special Review Considerations PAR) solicit applications quot;Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54)". goal this initiative to provide support translational research develop therapeutics reducing mortality morbidity caused acute exposures chemical threat agents. Chemical threats toxic chemicals could used a terrorist attack accidentally released industrial production, storage shipping.  scope the research includes target candidate identification characterization, through candidate optimization demonstration in vivo efficacy consistent the product's intended in humans. applicants submitting U54 renewal applications, research under FOA should culminate an optimized lead compound ready advanced development.  www.ninds.nih.gov/counteract a description the NIH CounterACT research program. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  general description the planned FOA provided below. sure follow guidance specific instructions the final published FOA once is released.  Research Initiative Details planned FOA encourage collaborative multidisciplinary investigations, combining expertise toxicology drug discovery development, discover develop new improved therapeutics treating victims acute chemical exposures. NIH CounterACT research program utilize Specialized Center Cooperative Agreements U54) support Research Centers Excellence up 5 years.  Center include several individual research projects scientific administrative cores create interdisciplinary multifaceted research approach. should a unifying well-defined goal problem area research which project relates contributes, thereby producing synergistic research environment allows research effort share resources creative strengths the others. is expectation support inter-related projects collaborating investigators yield results beyond those achievable each project pursued separately without formal interaction among participating investigators. civilian chemical threat spectrum includes chemical warfare agents e.g., sarin), toxic industrial chemicals e.g., cyanide), pesticides e.g., parathion), other chemicals.  agents included the current Department Homeland Security DHS) Chemical Terrorism Risk Assessment CTRA) list, is USG official only will be included the planned FOA.  Therefore, applicants strongly urged contact Scientific/Research staff listed this Notice determine their proposed threat agent(s) of interest the NIH.    Research Center must establish milestones include discrete quantitative goals create or no-go decision points the project. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: David A. Jett, Ph.D. National Institute Neurological Disorders Stroke, NINDS Telephone: 301-496-6035 Email: jettd@ninds.nih.gov

Notice a Webinar Presentation the NINDS Countermeasures Against Chemical Threats CounterACT) Funding Opportunity Announcements Notice Number: NOT-NS-16-037 Key Dates Release Date:   July 28, 2016 Related Announcements PAR-15-315 PAR-16-329 PAR-16-330 PAR-16-331 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to alert community the Countermeasures Against Chemical Threats CounterACT) program posted narrated presentation webinar) describing current Funding Opportunity Announcements supported the program.   After reviewing presentation, potential CounterACT applicants encouraged submit any questions comments may via email the point contact below. Depending the nature specifics the inquiries, may included the list Frequently Asked Questions FAQs) already the CounterACT website inform general community. Participation this webinar, although encouraged, optional is required the submission an application response these FOAs. Inquiries Please direct inquiries to: Shardell M. Spriggs, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone:  301-443-8189 Email:  shardell.spriggs@nih.gov

Notice Clarify PAR-15-146 Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54)" Notice Number: NOT-NS-16-026 Key Dates Release Date: 5, 2016 Related Announcements PAR-15-146    Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to amend Award Information section, the Application Submission section PAR-15-146 quot;Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54)". Part 2. Section II. Award Information Award Budget FOA currently reads: Application budgets not limited need reflect actual needs the proposed project. most studies within scope this FOA, anticipated direct cost individual awards 2-3 million per year a total 10-15 million over maximum five-year project period. is modified read: Application budgets not exceed 2.5 million direct costs per year over. applications not need request maximum budget the size duration the awards vary depending upon nature scope research programs. Section IV. Application Submission Information 6. Submission Requirements Information FOA currently reads: Requests 500,000 more direct costs any year Applicants requesting 500,000 more direct costs any year excluding consortium F&A) must contact NIH program staff least 6 weeks before submitting application follow Policy the Acceptance Review Unsolicited Applications Request 500,000 More Direct Costs described the SF424 R&R) Application Guide. is modified read: Applicable nbsp; other aspects this FOA remain same. Inquiries Please direct inquiries to: David A. Jett, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-6035 Email: jettd@ninds.nih.gov

Request Information RFI): NIH Countermeasures Against Chemical Threats CounterACT) Investigator-Industry Partnerships Notice Number: NOT-NS-16-005 Key Dates Release Date: February 3, 2016 Response Date: February 29, 2016 Related Announcements None     Issued National Institute Neurological Disorders Stroke NINDS) Purpose is time sensitive Request Information RFI) solicit feedback pharmaceutical biotechnology companies regarding potential convening a meeting facilitate partnerships between active NIH CounterACT investigators entities the commercial industrial sectors. Background mission the NIH Countermeasures Against Chemical Threats CounterACT) program to develop new improved therapeutics treat and/or prevent injuries resulting exposure chemical threats. Chemical threats toxic chemicals could used a terrorist attack accidentally released industrial production, storage shipping. include traditional chemical warfare agents toxic industrial chemicals materials.  chemical threats a variety effects.  Classes chemicals encompass cholinesterase GABA-inhibitors can induce prolonged uncontrolled excitation the nervous system, metabolic/cellular poisons prevent cellular respiration, vesicating agents cause moderate debilitating ocular, dermal, mucosal injuries, pulmonary compounds corrosively injure, irritate, react the lining the respiratory tract.  NIH CounterACT projects developing candidate therapeutics are poised more advanced development activities, including pre-Investigational New Drug pre-IND)-enabling clinical studies could supported other federal agencies fund advanced development, FDA approval licensure, well procurement activities under Project BioShield medical countermeasures.gov). majority projects supported NIH in academic labs often not possess resources expertise these types advanced studies. address need, is critical the NIH facilitate partnerships between academic laboratories pharmaceutical biotechnology companies typically more experience drug development regulatory approval. Please CounterACT Projects a list active projects.  Note not of projects mature enough engaging industry.  there general interest an Investigator-Industry Partnership meeting, information specific projects are ready engagement industry be provided a method be determined.  Information Requested NIH especially interested identifying facilitating establishment partnerships between funded researchers industrial entities. partnerships aid the successful development approved medical countermeasure products the sustainability the overall research enterprise. NIH seeks input specifically industry stakeholders potential interest attending meeting specific NIH CounterACT investigators ready partnerships. achieve goal this time-sensitive RFI, invite comments any all the following areas: 1.  Interest  attending presentations NIH CounterACT investigators regarding lead candidate therapeutics 2.   The most important characteristics a project would influence interest a product under development. example, is type product, market beyond biodefense, available non-dilutive funding including federal, etc.? 3.  Please provide any comments specific features the meeting would most useful. 4. Please provide any comments this proposed initiative respondents feel relevant. meeting also include presentations federal government officials the various funding programs available support advanced development medical products within mission. to Submit Response Responses this RFI must submitted electronically Dr. Shardell Spriggs shardell.spriggs@nih.gov later February 29, 2016.  Reference Notice number NOT-NS-16-005) the subject line the email. Responses this RFI voluntary. RFI for planning purposes only should be construed a solicitation as obligation the part the Federal Government, National Institutes Health, individual NIH institutes Centers. NIH does intend make any type award based responses this RFI to pay either preparation information submitted the Government’s of such information. NIH use information submitted response the RFI its discretion. Respondents advised the Government under obligation acknowledge receipt the information provided will provide feedback respondents. information submitted be analyzed may shared internally used NIH CounterACT staff planning future Investigator-Industry Partnership meetings, appropriate at Government’s discretion. Proprietary, classified, confidential, sensitive information should be included your response.   Inquiries Please direct inquiries to: David A. Jett, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-6035 Email: david.jett@nih.gov

Notice Correct Submission Instructions the Number Scientific Cores Allowed PAR-15-146 Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54)" Notice Number: NOT-NS-16-002 Key Dates Release Date:   January 8, 2016 Related Announcements PAR-15-146     Issued National Institute Neurological Disorders Stroke NINDS)  Purpose purpose this notice to correct information the number Scientific Cores allowed PAR-15-146 quot;Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54)". Section IV. 2. Content Form Application Submission Currently FOA reads: application should consist the following components: Overall: required Administrative Core: required Scientific Core: optional; Maximum 2 Research Education Core: required Project: Minimum 3 required; Maximum 5 nbsp; FOA modified read: application should consist the following components: Overall: required Administrative Core: required Scientific Core: optional; Maximum 3 Research Education Core: required Project: Minimum 3 required; Maximum 5 nbsp; other aspects the FOA remain unchanged Inquiries Please direct inquiries to: David A. Jett, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-6035 Email: jettd@ninds.nih.gov

Notice Pre-application Informational Webinar PAR-15-146 Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54)" Notice Number: NOT-NS-15-030 Key Dates Release Date:   June 12, 2015 Related Announcements PAR-15-146 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice to inform potential applicants PAR-15-146 quot;Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54)" a pre-application webinar provide submission information this FOA. NIH CounterACT program supports research the development new improved medical countermeasures designed prevent treat conditions caused acute exposure chemical agents www.ninds.nih/counteract). NIH CounterACT research network includes Research Centers Excellence, individual research projects, contracts, other programs. Currently NIH soliciting proposals new renewal U54 Research Centers Excellence. webinar provide information preparing research proposals will include information eligibility, scientific scope, Center structure, application instructions, grants management, well time questions the audience answers the NIH staff. intent the webinar to provide overview the initiative to address questions pertinent preparing applications. webinar optional not required application submission. Webinar Information Date:                            Friday, July 17, 2015 Time:                           1:00 pm ET Meeting URL:               CounterACT Center Webinar Questions be submitted email sarah.norring@nih.gov before webinar; Please include quot;U54 Webinar Question" the subject line. While every effort be to answer questions during webinar itself, due time constraints responses be sent afterwards. applicants strongly encouraged discuss applications the Scientific/Research contact early the application development process. complete text the FOA available http://grants.nih.gov/grants/guide/pa-files/PAR-15-146.html. Inquiries Please direct inquiries to: Sarah A. Norring, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-443-8189 Email: sarah.norring@nih.gov

Notice Participation Additional NIH Institutes Centers PAR-13-208 Countermeasures Against Chemical Threats CounterACT) Cooperative Research Projects U01) Notice Number: NOT-NS-13-029 Key Dates Release Date: 14, 2013 Related Announcements PAR-13-208 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the participation additional NIH Institutes, effective immediately, Funding Opportunity Announcement FOA) PAR-13-208. following sections PAR-13-208 been updated reflect participation NEI, NIAID, NIAMS, NIEHS this FOA. Part 1. Overview Information Components Participating Organizations National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.853; 93.867; 93.855; 93.856; 93.846; 93.113; 93.859  Part 2. Section VII. Agency Contacts Scientific/Research Contact(s)       Houman Araj, Ph.D. National Eye Institute NEI) Telephone: 301-451-2020 Email: arajh@nei.nih.gov Gennady E. Platoff Jr., Ph.D. National Institute Allergy amp; Infectious Diseases NIAID) Telephone: 301-451-4418 Email: platoffg@niaid.nih.gov Hung Tseng, Ph.D. National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-5032 Email: tsengh@mail.nih.gov Srikanth S. Nadadur, Ph.D. National Institute Environmental Health Sciences NIEHS) Telephone: 919-541-5327 Email: nadadurs@niehs.nih.gov Financial/Grants Management Contact(s) William W. Darby Grants Management Branch National Eye Institute NEI) Telephone: 301-451-2020 Email: darbyw@mail.nih.gov Victoria Connors Grants Management Branch National Institute Allergy amp; Infectious Diseases NIAID) Telephone: 301-402-5065 Email: connorssv@niaid.nih.gov Melinda B. Nelson Grants Management Branch National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-435-5278 Email: nelson@mail.nih.gov Lisa Archer Edwards, MBA Grants Management Branch National Institute Environmental Health Sciences NIEHS) Telephone: 919-541-0751  Email:  archer@niehs.nih.gov Inquiries Please direct inquiries to: David A. Jett, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-6035  Email: jettd@ninds.nih.gov