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Expiration Date: Friday, January 1, 2027 NOFO Number: NOT-HD-12-015 Release Date: Wednesday, February 29, 2012 Notice Type: NOT
Notice Response Date Extension Request Information RFI):  Updating National Institutes Health Research Plan Fragile X Syndrome Associated Disorders NOT-HD-12-012) Notice Number: NOT-HD-12-015 Key Dates Release Date: February 29, 2012 Extended Response Date: March 26, 2012    Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Cancer Institute NCI) National Institute Aging NIA) National Institute Deafness Other Communication Disorders NIDCD) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Fogarty International Center FIC) National Center Advancing Translational Sciences NCATS) Office Rare Diseases ORD) Purpose purpose this Notice to inform potential responders NOT-HD-12-012 the response date submitting information been extended. nbsp;The new response date March 26, 2012.  Responses should limited one two page(s) marked this RFI identifier: NOT-HD-12-012. responses must e-mailed FragileXPlan@mail.nih.gov later March 26, 2012.    Note: you submitted response prior February 21, 2012 ask you resubmit responses the above email address.  Technical difficulties experienced, have since fixed.  other aspects NOT-HD-12-012 remain same.  Inquiries Please direct inquiries to: Tiina K. Urv, Ph.D. Program Director Intellectual Developmental Disabilities Branch IDDB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) 6100 Executive Boulevard, Room 4B09D, MSC 7510 Bethesda, MD 20892-7510 Rockville, Maryland 20852 express/courier service) Phone 301-402-7015 Email: urvtiin@mail.nih.gov   
Expiration Date: Friday, January 1, 2027 NOFO Number: NOT-OD-12-037 Release Date: Tuesday, February 14, 2012 Notice Type: NOT
Notice Change PAR-12-032 R01) PAR-12-033 R21) Notice Number: NOT-OD-12-037 Key Dates Release Date: February 14, 2012 Issued National Institutes Health NIH) Office Research Women’s Health ORWH) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Center Complementary Alternative Medicine NCCAM) Office Behavioral Social Sciences Research OBSSR) Office Dietary Supplements ODS) Purpose purpose this notice to inform applicants the contact information the Letter Intent PAR-12-032 Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Etiology, Diagnosis, Pathophysiology, Treatment R01) PAR-12-033(Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Etiology, Diagnosis, Pathophysiology, Treatment R21)). Current language related Letter Intent within Section IV. 2. Content Form Application Submission: None. New language related Letter Intent within Section IV. 2. Content Form Application Submission: Letter Intent Although letter intent not required, not binding, does enter the review a subsequent application, information it contains allows IC staff estimate potential review workload plan review. the date listed Part 1. Overview Information, prospective applicants asked submit letter intent includes following information: Descriptive title proposed research Name, address, telephone number the PD(s)/PI(s) Names other key personnel Participating institutions Number title this funding opportunity letter intent should sent to: Susan E. Maier, Ph.D. Office Research Women’s Health ORWH) Democracy II, Suite 400 6707 Democracy Blvd Bethesda, MD 20892-5484 Telephone: 301-435-1573 Fax: 301-402-1798 Email: Susan.Maier@nih.gov Inquiries Please direct inquiries to: Susan E. Maier, Ph.D. Office Research Women’s Health ORWH) Democracy II, Suite 400 6707 Democracy Blvd Bethesda, MD 20892-5484 Telephone: 301-435-1573 Fax: 301-402-1798 Email: Susan.Maier@nih.gov
Expiration Date: Friday, January 1, 2027 NOFO Number: NOT-DA-12-007 Release Date: Monday, February 13, 2012 Notice Type: NOT
Notice Intent Publish Request Applications Centers Excellence Research Relevant the Family Smoking Prevention Tobacco Control Act P50) Notice Number: NOT-DA-12-007 Key Dates Release Date: February 13, 2012 Estimated Publication Date Announcement: Spring 2012 First Estimated Application Due Date: Fall 2012  Earliest Estimated Award Date: July 2013  Earliest Estimated Start Date: July 2013  Issued National Institute Drug Abuse NIDA) National Cancer Institute NCI) National Institute Environmental Health Sciences NIEHS) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Drug Abuse NIDA), National Cancer Institute NCI), National Institute Environmental Health Sciences NIEHS), Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), National Institute Mental Health NIMH), the National Institute Neurological Disorders Stroke NINDS), conjunction other IC partners, intends publish Funding Opportunity Announcement FOA) establish Centers tobacco regulatory science conduct programs multidisciplinary research will aid development evaluation tobacco product regulations.  Centers program conduct research addresses research priorities related the regulatory authority the Food Drug Administration FDA) Center Tobacco Products CTP). Support the Centers come funds provided NIH through FDA CTP support tobacco regulatory science per Family Smoking Prevention Tobacco Control Act FSPTCA), Public Law 111-31. NIH the FDA formed interagency partnership foster regulatory science.  Within framework the Tobacco Control Act, FDA NIH share interest supporting science can assist FDA the development evaluation tobacco product regulations.  Projects resulting this FOA expected serve FDA generating relevant findings data needed inform regulation the manufacture, distribution, marketing tobacco products protect public health.  Consistent the FDA CTP mission, FOA seeks research centers address such topics as: diversity tobacco products, reducing addiction, reducing toxicity carcinogenicity, adverse health consequences, communications, marketing tobacco products, economics policies.   the NIH Web site additional information http://cancercontrol.cancer.gov/nih-fda Notice provided allow prospective applicants sufficient time develop essential collaborations plans prior submitting application response the published FOA.  FOA expected be published the NIH Guide Grants Contracts Spring 2012 an expected receipt date Fall 2012. FOA utilize Specialized Center P50) funding mechanism research centers.  NIH FDA intend make 8-10 research center awards, a maximum 5 years funding; NIH FDA intend make coordinating center award; coordinating center mechanism to determined. Research Initiative Details Centers resulting this FOA expected demonstrate research excellence leadership accelerate pace science will guide FDA actions reduce public health toll tobacco products the United States.  Center application must propose program multidisciplinary research around unifying well-defined goal targeted area research will aid development evaluation tobacco product regulations.  research Center required have minimum three component research projects are judged have independent scientific merit to contribute the overall research theme the center. goal this FOA to fund research relevant FSPTCA. the passage FSPTCA June 2009, FDA authority regulate manufacture, marketing, distribution tobacco products order protect public health.  Although vast sound science base exists regard numerous areas related the FSPTCA, new research provide additional science FDA consider it implements FSPTCA. Research pilot studies supported this notice be used provide scientific evidence seven areas follows. Diversity Tobacco Products - understanding constituents, components, ingredients, additives, design features; behaviors; perceptions, attitudes beliefs conventional new emerging tobacco products Reducing Addiction - understanding dependence relation nicotine level; reductions nicotine affect behaviors; constituents components beyond nicotine affect addiction combustible non-combustible tobacco products Reducing Toxicity Carcinogenicity - understanding reductions toxicity tobacco products affect behaviors perceptions; level reduction harmful potentially harmful constituents result decreased disease risk; assays best compare toxicity between different tobacco products Adverse Health Consequences - understanding health risks multiple tobacco types; biomarkers disease risk be associated measures tobacco exposure; novel biological physiological markers predictive tobacco-related adverse health outcomes  Communications - understanding to effectively convey information regarding risks associated tobacco product and FDA's regulatory authority over tobacco products nbsp; Marketing Tobacco Products - understanding impact tobacco product marketing use behaviors, perception, attitudes beliefs nbsp;       Economics Policies - estimating economic impact FDA regulatory actions; understanding impact FDA regulatory actions tobacco and overall morbidity mortality APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Kay Wanke, PhD, MPH Epidemiology Research Branch Division Epidemiology, Services Prevention Research National Institute Drug Abuse 301) 402-0036 Direct) 301) 443-6504 Main) 301) 443-2636 Fax) Email: kay.wanke@nih.gov Stacey Vandor Division Cancer Control Population Sciences National Cancer Institute 301) 594-6786 Direct) 301) 594-6776 Main) 301) 594-6787(Fax) Email: Stacey.vandor@nih.gov Srikanth S Nadadur, M.Sc., Ph.D. Cellular, Organs Systems Pathobiology Branch Division Extramural Research Training National Institute Environmental Health Sciences 919) 541-5327 Direct) 919) 541-1919 Main) 919) 541-0462 Fax) Email: nadadurs@niehs.nih.gov Caroline Signore, MD, MPH Pregnancy Perinatology Branch Eunice Kennedy Shriver National Institute Child Health Human Development 301) 496-5577 Direct) 301) 496-5575 Main) 301) 496-3790 Fax) Email: signorec@mail.nih.gov Denise Juliano-Bult, M.S.W. Division Services Intervention Research National Institute Mental Health 301) 443-1638 Direct) 301) 443-4045 Fax) Email: djuliano@mail.nih.gov Randall R. Stewart, Ph.D. Division Extramural Research National Institute Neurological Disorders Stroke 301) 496-6460 Direct) 301) 496-1917 Main) 301) 402-1501 Fax) E-mail: stewartr@ninds.nih.gov
Expiration Date: Friday, January 1, 2027 NOFO Number: NOT-HD-12-012 Release Date: Tuesday, February 7, 2012 Notice Type: NOT
Request Information RFI): Updating National Institutes Health Research Plan Fragile X Syndrome Associated Disorders Notice Number: NOT-HD-12-012 Update: following update relating this announcement been issued: February 29, 2012 - Notice NOT-HD-12-015. Notice Response Date Extension Request Information RFI): Updating National Institutes Health Research Plan Fragile X Syndrome Associated Disorders. Key Dates Release Date: February 7, 2012              Response Date:  March 2, 2012  (Extended March 26, 2012 per NOT-HD-12-015) Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Cancer Institute NCI) National Institute Aging NIA) National Institute Deafness Other Communication Disorders NIDCD) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Fogarty International Center FIC) National Center Advancing Translational Sciences NCATS) Office Rare Diseases ORD) Purpose 2008 U.S. Department Health Human Services DHHS) the Senate Committee Appropriations requested the National Institutes Health NIH) develop Research Plan Fragile X syndrome Associated Disorders.  accomplish task NIH convened working groups charged developing comprehensive recommendations specific, high-priority research objectives Fragile X syndrome FXS) the associated disorders Fragile X-associated Tremor/Ataxia syndrome FXTAS) Fragile X associated Primary Ovarian Insufficiency FXPOI). working groups composed scientific experts the research clinical communities, along representatives affected individuals family members, pertinent federal agencies invested NIH Institutes Centers ICs). goals designed be used the NIH FXS, FXTAS, FXPOI research communities to shared other federal agencies facilitate coordinated research activities will lead timely detection, diagnosis, treatment, prevention the targeted disorders. entire plan be found at: http://www.nichd.nih.gov/publications/pubs/upload/NIH_Research_Plan_on_…. order maintain momentum discovery further develop research relevant FX associated disorders, NIH, input scientific experts, representatives affected individuals family members, other federal agencies, updating current research plan.  NIH Fragile X Research Coordinating Group invites interested stakeholders comment the current National Institutes Health Research Plan Fragile X syndrome Associated Disorders. Please review list the plan’s goals objectives relevant your interests and/or experience at:  http://www.nichd.nih.gov/RFA/NOT-HD-12-012/NIH-Research-Plan-On-FXS_Sum…. Information Requested NIH interested creative, concrete suggestions response the following questions, updating long term research plan: Status  Please comment your perspective the current status progress towards accomplishment the goals objectives the National Institutes Health Research Plan Fragile X syndrome Associated Disorders it relates FX, FXPOI, and/or FXTAS).  research advances highlight progress general toward meeting specific goals objectives?  goals objectives the 2008 plan shown less progress? Priorities:  of objectives considered important 2008, we recognize the field constantly advancing.  Therefore, is important periodically reassess prioritize needs opportunities Fragile X research.   Please comment the relative priorities the current goals objectives the National Institutes Health Research Plan Fragile X syndrome Associated Disorders they relate FX, FXPOI, and/or FXTAS).  New Areas Please suggest new areas research FX, FXPOI, FXTAS) may emerged since National Institutes Health Research Plan Fragile X syndrome Associated Disorders plan developed. to Submit Response Responses be accepted through March 2, 2012.   Responses should limited one two page(s) marked this RFI identifier: NOT-HD-12-012. responses must e-mailed FragileXPlan@mail.nih.gov.    Request Information RFI) for planning purposes only is a solicitation applications an obligation the part the United States U.S.) Government, the Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) provide support any ideas identified response it.  Please note the U.S. Government not pay the preparation any information submitted for use that information. individual responses remain confidential. Any identifiers e.g., names, institutions, e-mail addresses, etc.) be removed responses compiled. Only processed, anonymized results be shared internally NIH staff members any member scientific working groups convened the NICHD, appropriate. NICHD use information submitted response this RFI its discretion will provide comments any responder’s submission. However, responses the RFI submitted be reflected future solicitation(s). NICHD contact any responder the sole purpose enhancing NICHD’s understanding your RFI submission. information provided be analyzed may appear reports. Respondents advised the Government under obligation acknowledge receipt the information received provide feedback respondents respect any information submitted.  proprietary, classified, confidential, sensitive information should included your response. Government reserves right use any non-proprietary technical information any resultant solicitation(s). Inquiries Please direct inquiries to: Tiina K. Urv, Ph.D. Program Director Intellectual Developmental Disabilities Branch IDDB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) 6100 Executive Boulevard, Room 4B09D, MSC 7510 Bethesda, MD 20892-7510 Rockville, Maryland 20852 express/courier service) Phone 301-402-7015 Email: urvtiin@mail.nih.gov
Expiration Date: Friday, January 1, 2027 NOFO Number: NOT-AR-13-002 Release Date: Monday, February 6, 2012 Notice Type: NOT
Notice Intent Publish Request Applications Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers U54) Notice Number: NOT-AR-13-002 Key Dates Release Date: February 6, 2012 Estimated Publication Date Announcement: 4, 2012 First Estimated Application Due Date: November 19, 2012 Earliest Estimated Award Date: July 1, 2013 Earliest Estimated Start Date: July 1, 2013 Issued National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Heart, Lung, Blood Institute NHLBI) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Arthritis Musculoskeletal Skin Diseases NIAMS), the National Heart, Lung, Blood Institute NHLBI), Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) the National Institute Neurological Disorders Stroke NINDS), intend promote ongoing initiative publishing Request Applications RFA) solicit new renewal applications Wellstone Muscular Dystrophy Cooperative Research Centers.  NIH established Centers Excellence program 2003 part an ongoing effort enhance intensify research the muscular dystrophies. Centers described the MD-CARE Act Public Law 107-84 2001 110-361 2008), were named honor the late Senator Paul D. Wellstone.  theme each Center must focus one more the muscular dystrophies, include Duchenne, Becker, myotonic, facioscapulohumeral, limb-girdle, congenital, oculopharyngeal, Emery-Dreifuss others.  Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published the Spring 2012 an expected receipt date the Fall 2012. FOA utilize U54 activity code. Details the planned Funding Opportunity Announcement FOA) provided below. Research Initiative Details Notice encourages investigators expertise insights translational clinical muscular dystrophy research consider organizing collaborative group prepare application this new FOA.  nbsp;Successful applicants foster translation new scientific findings technological developments novel treatments other strategies improving lives muscular dystrophy patients. Center should involve clinical research direct interactions between researchers muscular dystrophy patients.  Appropriate clinical studies include early stage clinical trials, patient-oriented studies facilitate future trials, natural history studies, biomarker identification validation, biopsychosocial studies, etc. Center also contain basic and/or preclinical translational research, long efforts directed toward steps required therapeutic development, including therapeutic target identification, characterization, validation, development diagnostics biomarkers characterize stratify patient populations, vitro assay development, animal model development characterization, candidate therapeutic efficacy screening, preclinical therapeutic optimization FDA-required activities leading an investigational new drug IND) application. Applicants should propose multi-disciplinary collaborative studies will significantly accelerate progress toward effective treatments other improvements patients' lives. Research problems should require substantial collaborative efforts solve, thus best carried in center setting.  Center should at least core facility shares services resources the national international muscular dystrophy research community another core promotes training, education outreach activities.  Centers supported through FOA participate annual meetings the existing Centers the program promote communication collaborations.  APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Glen H. Nuckolls, Ph.D. Director, Muscle Disorders and Therapies Program Division Musculoskeletal Diseases National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institutes Health NIH) U.S. Department Health Human Services Democracy Plaza, Suite 800 6701 Democracy Blvd. Bethesda, MD 20892-4872 couriers 20817) 301-594-4974 nuckollg@mail.nih.gov John D. Porter, Ph.D. Program Director, Neuromuscular Disease National Institute Neurological Disorders Stroke NINDS) National Institutes Health 6001 Executive Boulevard, Room 2142 Bethesda, MD 20892-9523 courier services, Rockville, MD 20852) Telephone: 301) 496-5739 FAX: 301) 402-1501 Email: porterjo@ninds.nih.gov Ljubisa Vitkovic, Ph.D. Program Director Intellectual Developmental Disabilities Branch Center Developmental Biology Perinatal Medicine Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), NIH 6100 Executive Boulevard Room 4B09E, MSC 7510 Bethesda, MD 20892 Phone: 301) 402-1822 Fax:     301) 496-3791 Email: vitkovil@mail.nih.gov Jonathan R. Kaltman, M.D.  Heart Development Structural Diseases Branch Division Cardiovascular Diseases  National Heart, Lung, Blood Institute NHLBI) Rockledge Center  6701 Rockledge Drive, Room 8104  Bethesda, MD 20892-7940 (use Zip Code 20817 express/courier service)  Telephone: 301) 435-0510  FAX: 301-480-1454  Email: kaltmanj@nhlbi.nih.gov
Expiration Date: Friday, January 1, 2027 NOFO Number: NOT-NS-12-002 Release Date: Wednesday, December 21, 2011 Notice Type: NOT
Withdrawal NINDS Participation PAR-09-251, quot;Optimization Small Molecule Probes the Nervous System R21)" Notice Number: NOT-NS-12-002 Key Dates Release Date: December 21, 2011   Related Notices PAR-09-251; PAR-12-060   Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice informs potential applicants the National Institute Neurological Disorders Stroke NINDS) no longer accept applications under PAR-09-251, quot;Optimization Small Molecule Probes the Nervous System R21)," beginning the February 16, 2012 receipt date. Researchers seeking support chemical optimization small molecules probes preclinical, vivo proof-of-concept experiments the purposes drug discovery should consider PAR-12-060, quot;Solicitation Validated Hits the Discovery in vivo Chemical Probes R01)." following Institutes continue participate PAR-09-251: National Institute Drug Abuse NIDA) National Institute Aging NIA) National Institute Mental Health NIMH) National Eye Institute NEI) National Institute Alcohol Abuse Alcoholism NIAAA) other aspects PAR-09-251 remain unchanged. Inquiries Please direct inquiries to: Rebecca Farkas, PhD Office Translational Research National Institute Neurological Disorders Stroke 6001 Executive Boulevard Neuroscience Center/Room 2109 Bethesda, MD 20892 Telephone: 301) 496-1779 Fax: 301-402-1501 Email: farkasr@ninds.nih.gov
Expiration Date: Friday, January 1, 2027 NOFO Number: NOT-NS-12-008 Release Date: Wednesday, December 21, 2011 Notice Type: NOT
Withdrawal NINDS Participation PAR-10-001, quot;Drug Discovery Nervous System Disorders R01)" Notice Number: NOT-NS-12-008 Key Dates Release Date: December 21, 2011 Related Notices PAR-10-001; PAR-12-060   Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice informs potential applicants that, effective immediately, National Institute Neurological Disorders Stroke NINDS) no longer accept applications under PAR-10-001, quot;Drug Discovery Nervous System Disorders R01)," beginning the February 5, 2012 receipt date. Researchers seeking support chemical optimization small molecules probes preclinical, vivo proof-of-concept experiments the purposes drug discovery should consider PAR-12-060, quot;Solicitation Validated Hits the Discovery in vivo Chemical Probes R01)." following Institutes continue participate PAR-10-001: National Institute Mental Health NIMH) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Drug Abuse NIDA) other aspects PAR-10-001 remain unchanged. Inquiries Please direct inquiries to: Rebecca Farkas, PhD Office Translational Research National Institute Neurological Disorders Stroke 6001 Executive Boulevard Neuroscience Center/Room 2109 Bethesda, MD 20892 Telephone: 301) 496-1779 Fax: 301-402-1501 Email: farkasr@ninds.nih.gov
Expiration Date: Friday, January 1, 2027 NOFO Number: NOT-NS-12-006 Release Date: Tuesday, December 20, 2011 Notice Type: NOT
Notice Technical Assistance Workshop RFA-NS-12-007, quot;Stroke Prevention/Intervention Research Program SPIRP)" Notice Number: NOT-NS-12-006 Key Dates Release Date: December 19, 2011 Date Workshop: February 3, 2012   Related Notices RFA-NS-12-007   Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke sponsoring technical assistance workshop RFA-NS-12-007, Stroke Prevention/Intervention Research Program SPIRP) U54) Friday, February 3, 2012 1:30 pm 4 pm at: Hilton New Orleans Riverside, Room HEC-A Poydras Street New Orleans, LA nbsp;70130 Phone: 1-504-561-0500 purpose this technical assistance workshop to highlight recent changes NINDS are relevant stroke disparities to facilitate understanding the SPIRP funding opportunity announcement was released December 6, 2011.  Those interested applying this announcement should attend meeting.  Presenters this meeting include representatives the NINDS Office Clinical Research other NINDS staff.  event free charge requires registration.  However, email intent attend Technical Assistance Workshop encouraged planning purposes.  Emails the subject line SPIRP Technical Assistance Workshop” should sent waddysp@mail.nih.gov. Inquiries Please direct inquiries to: Salina Waddy, MD National Institute Neurological Disorders Stroke Telephone: 301-496-9135 waddysp@mail.nih.gov
Expiration Date: Friday, January 1, 2027 NOFO Number: NOT-NS-12-004 Release Date: Monday, December 12, 2011 Notice Type: NOT
Request Information: Scientific Regulatory Issues be Explored an Upcoming Pluripotent Stem Cell Workshop involving NIH FDA Notice Number: NOT-NS-12-004 Key Dates Release Date: December 12, 2011 Response Due Date: February 9, 2012 Related Notices NOT-NS-10-016   Issued National Institutes Health NIH) Purpose National Institutes Health NIH) the Food Drug Administration FDA) organizing series workshops will engage broader research community regarding requirements necessary translation pluripotent stem cell-derived products the clinic. purpose this RFI to solicit information pertinent developing second workshop, will focus preclinical safety proof-of-concept evaluation including, among topics: clinical relevance the animal models disease, translation cell dose levels animal human, assessment cell engraftment/survival animals, effect delivery site cell behavior, cell disposition post-administration. Background Human pluripotent stem cells the potential both self-renew differentiate specialized cell populations can used repair, replace, regenerate damaged tissue.  characteristics offer substantial promise development therapeutic products address unmet medical needs.  state stem cell science advancing rapidly research activities this area, including those directed clinical application, expected multiply the next few years.  pluripotent stem cells pose additional challenges therapeutic development beyond those encountered other types somatic cellular products? enable effective translation clinical research increase coordination between research regulatory communities, National Institutes Health the Food Drug Administration planning workshop series engage broader research community regarding prerequisites necessary translation investigational pluripotent stem cell-derived products the clinic. first workshop, held March 21-22, 2011, focused establishment stem cell lines banks, covering safety regulatory issues related how original cell line derivation done the case embryonic stem cells, how cells reprogrammed the case iPS cells Day 1: http://videocast.nih.gov/Summary.asp?File=16558; Day 2: http://videocast.nih.gov/Summary.asp?File=16557). second workshop focus preclinical safety proof concept assessment, including, among topics, clinical relevance the animal models disease, translation cell dose levels animal human, assessment cell engraftment/survival animals, effect delivery site cell behavior, cell disposition post-administration,.  third, final, workshop expected focus clinical trial design, including safety monitoring, immunogenicity, immunosuppressant and immune monitoring. Information Requested NIH seeking information will useful developing second workshop the series. Specifically, NIH seeking comment the following five items: 1.  Describe challenges exist the preclinical evaluation pluripotent stem cell-derived products enable translation the laboratory clinical trials. 2.  Present key questions posed pluripotent stem cell biology should addressed using animal models assess safety potential clinical effectiveness.  3.  Identify any laboratories, research institutions, companies countries have experience translational stem cell research can serve models discussion. 4.  Describe can learned our experience other cell therapies is applicable products derived pluripotent stem cells. 5.  Present questions should addressed the workshop. Note: Responses this RFI voluntary. information provided be analyzed may appear various reports.  Any personal identifiers e.g., names, addresses, email addresses, etc.) be removed responses compiled.  Proprietary, classified, confidential, sensitive information should be included your response.  Responses Responses should submitted via email nindsstemcell@mail.nih.gov, will accepted through February 9, 2012.   Request Information RFI) for planning purposes only is a solicitation applications an obligation the part the United States U.S.) Government provide support any ideas identified response it.  Please note the U.S. Government not pay the preparation any comment submitted for use that comment. Inquiries Please direct inquiries to: Susan Marino, Ph.D., Office the Director National Institute Neurological Disorders Stroke National Institutes Health Phone: 301-594-4470 FAX: 301-496-0296 Email: marinosw@ninds/nih.gov
Expiration Date: Friday, January 1, 2027 NOFO Number: NOT-TW-12-004 Release Date: Friday, December 9, 2011 Notice Type: NOT
Notice Termination PAR-11-037, quot;Limited Competition: Fogarty International Research Collaboration - Basic Biomedical FIRCA-BB) Research Award R03)" Notice Number: NOT-TW-12-004 Key Dates Release Date: December 9, 2011 Issued Fogarty International Center FIC) National Cancer Institute NCI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform prospective applicants the Fogarty International Center FIC) terminate Funding Opportunity Announcement FOA) PAR-11-037 effective January 11, 2012. Therefore, NIH not accept applications submitted after January 10, 2012 response the Limited Competition: Fogarty International Research Collaboration - Basic Biomedical FIRCA-BB) Research Award R03) originally the final submission date January 10, 2013. Please note this NOTICE only pertains the Basic Biomedical program not the FIRCA Behavioral Social Sciences program. Inquiries Please direct inquiries to: Xingzhu Liu, M.D., Ph.D. FIRCA-BSS Program Officer Division International Training Research Fogarty International Center FIC) National Institutes Health Building 31, Room B2C39 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: 301-496-1653 Fax: 301-402-0779 Email:   Xingzhu.Liu@nih.gov
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