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Notice Clarification:  Budget Submission Requirement RFA-AI-12-021 U.S. - China Program Biomedical Collaborative Research R01) Notice Number: NOT-AI-12-049 Key Dates Release Date: August 28, 2012 Related Notices RFA-AI-12-021 Issued National Institute Allergy Infectious Diseases NIAID) National Cancer Institute NCI) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to clarify budget submission requirements the U.S. - China Program Biomedical Collaborative Research R01).  Applications submitted response this FOA must the R&R detailed) budget. may receive warning the wrong budget format being used this be ignored the application successfully process. Please check FAQ site http://www.niaid.nih.gov/researchfunding/qa/Pages/revniaid.aspx#indiv) frequently additional information regarding U.S. - China Program Biomedical Collaborative Research FOA. Inquiries Please direct inquiries to: Maggie Wells Grants Management Program National Institute Allergy Infectious Diseases NIAID) 301-594-9847 wellsmaggie@niaid.nih.gov Crystal Wolfrey Deputy Director Office Grants Administration National Cancer Institute NCI) 301-496-8634 Crystal.wolfrey@nih.gov Rebecca Claycamp Chief, Grants Management Officer National Institute Mental Health NIMH) 301-443-2811 Rebecca.claycamp@nih.gov Tijuanna DeCoster National Institute Neurological Disorders Stroke NINDS) 301-496-9231 decostert@ninds.nih.gov

Frequently Asked Questions FAQs) RFA-MH-13-070 - Limited Competition: National NeuroAIDS Tissue Consortium NNTC) Clinical Sites U24) Notice Number: NOT-MH-12-031 Key Dates Release Date: August 17, 2012 Issued National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Mental Health NIMH) the National Institute Neurological Disorders Stroke NINDS) issued RFA-MH-13-070 - Limited Competition: National NeuroAIDS Tissue Consortium NNTC) Clinical Sites U24) July 5, 2012.  a result discussions potential applicants a pre-application teleconference July 17, 2012, are providing list Frequently Asked Questions FAQs) Answers.  FAQs this FOA be found at:  http://www.nimh.nih.gov/research-funding/grants/faqs-for-rfa-mh-13-070…; information be updated periodically without additional notice.  NIMH staff also respond questions submitted potential applicants contact program, grants management, review staff listed the FOA Section VII. Agency Contacts. Inquiries Inquiries regarding Notice be directed to: Dianne Rausch, Ph.D. Division AIDS Research National Institute Mental Health NIMH) 6001 Executive Blvd, Room 6105, MSC 9616 Rockville, MD 20852-9616 Telephone:  301-443-6100 Email:  drausch@mail.nih.gov Website:  http://www.nimh.nih.gov/about/organization/dar/index.shtml Jeymohan Joseph, Ph.D. Division AIDS Research National Institute Mental Health NIMH) 6001 Executive Boulevard, Room 6110, MSC 9619 Rockville, MD  20892-9619 Telephone:  301-443-3012 Email:  jjeymoha@mail.nih.gov Wong, Ph.D. National Institute Neurological Disorders Stroke NINDS) 6001 Executive Boulevard, Room 2113, MSC 9521 Rockville, MD 20892-9521 Telephone:  301-496-1431 Email:  wongm@mail.nih.gov

Frequently Asked Questions FAQs) RFA-MH-13-071 - National NeuroAIDS Tissue Consortium NNTC) Data Coordinating Center DCC) U24) Notice Number: NOT-MH-12-032 Key Dates Release Date: August 17, 2012 Issued National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Mental Health NIMH) the National Institute Neurological Disorders Stroke NINDS) issued RFA-MH-13-071 - National NeuroAIDS Tissue Consortium NNTC) Data Coordinating Center DCC) U24) nbsp;on July 5, 2012.  a result discussions potential applicants a pre-application teleconference July 17, 2012, are providing list Frequently Asked Questions FAQs) Answers.  FAQs this FOA be found at:  http://www.nimh.nih.gov/research-funding/grants/faqs-for-rfa-mh-13-071…; information be updated periodically without additional notice.  NIMH staff also respond questions submitted potential applicants contact program, grants management, review staff listed the FOA Section VII. Agency Contacts. Inquiries Inquiries regarding Notice be directed to: Dianne Rausch, Ph.D. Division AIDS Research National Institute Mental Health NIMH) 6001 Executive Blvd, Room 6105, MSC 9616 Rockville, MD 20852-9616 Telephone:  301-443-6100 Email:  drausch@mail.nih.gov Website:  http://www.nimh.nih.gov/about/organization/dar/index.shtml Jeymohan Joseph, Ph.D. Division AIDS Research National Institute Mental Health NIMH) 6001 Executive Boulevard, Room 6110, MSC 9619 Rockville, MD  20892-9619 Telephone:  301-443-3012 Email:  jjeymoha@mail.nih.gov Wong, Ph.D. National Institute Neurological Disorders Stroke NINDS) 6001 Executive Boulevard, Room 2113, MSC 9521 Rockville, MD 20892-9521 Telephone:  301-496-1431 Email:  wongm@mail.nih.gov

Technical Assistance Webinar RFA-NS-13-004: Specialized Neuroscience Research Program SNRP) U54) Notice Number: NOT-NS-12-020 Key Dates Release Date: August 1, 2012 Webinar Date:  August 13, 2012 Issued National Institutes Health NIH) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform extramural research community the NINDS host technical assistance webinar applicants responding the RFA-NS-13-004 Specialized Neuroscience Research Program SNRP) U54). nbsp;The webinar occur August 13, 2012 10:00 a.m. 11:30 a.m. EDT. Webinar review purpose objectives the FOA, budget preparation peer review. Time be allotted questions answers the end. prospective applicants invited participate. Registration: Reserve seat the webinar sending following information Dr. Courtney Ferrell Aklin cferrell@mail.nih.gov) Name Title Institution Desired number participants Webinar Details: nbsp;Information needed join webinar be provided after registration. nbsp; Date: nbsp;August 13, 2012 Time: nbsp;10:00 ndash; 11:30 a.m. EDT Computer Telephone System Requirements: will need telephone the audio portion this webinar. nbsp;If plan access virtual meeting web, should test computer ensure your configuration support participation this Adobe Connect meeting at: http://webmeeting.nih.gov/common/help/en/support/meeting_test.htm. nbsp;You must pass first three tests. Test 4, Adobe Connect Add-In Test, not required participate this meeting. Frequently Asked Questions website RFA-NS-13-004: Approximately 1-2 weeks after technical assistance meeting, slides the presentations answers the Frequently Asked Questions FAQs) regarding preparation applications response RFA-NS-13-004 be posted the Office Special Programs Diversity website. Inquiries Please direct inquiries to: Courtney Ferrell Aklin, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-3102 Email: cferrell@mail.nih.gov

Pre-Application Meeting RFA-DA-13-003: Tobacco Centers Regulatory Science Research Relevant the Family Smoking Prevention Tobacco Control Act Notice Number: NOT-DA-12-018 Key Dates Release Date: August 1, 2012 Related Notices RFA-DA-13-003 Issued National Cancer Institute NCI) National Heart, Lung, Blood Institute NHLBI) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Center Tobacco Products CTP) FDA) Purpose notice to inform potential applicants a pre-application web-based seminar RFA-DA-13-003, which prospective applicants invited. webinar intended explain goals objectives this initiative answer questions prospective applicants. Meeting Details Title: Pre-application meeting RFA-DA-13-003 When: Thursday, August 23, 2012, 3:00–4:30 PM Time Zone: GMT - 05:00) Eastern Time US Canada) Information the webinar be found this web site: http://cancercontrol.cancer.gov/nih-fda/funding.htm.  Instructions be provided how join web-based meeting, well participation guidelines the meeting agenda. Frequently Asked Questions submitted potential applicants also posted this website. Questions be submitted advance the following email:  NIHFDATobaccoScience@mail.nih.gov.  deadline submission questions Monday, August 20th, 5:00 p.m. Eastern Time.  While effort be to include questions the webinar presentations discussion, is possible not will addressed during meeting due time constraints. Potential applicants the FOA not required attend pre-application meeting. archive the meeting be posted http://cancercontrol.cancer.gov/nih-fda/funding.htm a public resource soon possible after meeting, provide applicants unable attend meeting access the proceedings. applicants strongly encouraged discuss applications the appropriate NIH IC Scientific/Research Contact and/or Financial/Grants Management Contact listed the FOA early possible the process.  complete text the FOA available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-13-003.html. Inquiries Inquiries be directed to: Kay Wanke, PhD, MPH Epidemiology Research Branch Division Epidemiology, Services Prevention Research National Institute Drug Abuse NIDA) 301) 402-0036 Direct) 301) 443-6504 Main) 301) 443-2636 Fax) Email: kay.wanke@nih.gov Elizabeth M. Ginexi, PhD Tobacco Control Research Branch Division Cancer Control Population Sciences National Cancer Institute NCI) 301) 435-6387 Direct) 301) 496-8675 Fax) Email: LGinexi@mail.nih.gov Antonello Punturieri, M.D., Ph.D. Program Director Division Lung Diseases National Heart, Lung, Blood Institute NHLBI) 2 Rockledge Centre Suite 10018 6701 Rockledge Drive Bethesda, MD 20892 301) 435-0230 Direct) 301) 480-3557 Fax) Email: punturieria@nhlbi.nih.gov Abraham P. Bautista, Ph.D. Office Extramural Activities National Institute Alcohol Abuse Alcoholism NIAAA) 301) 443-9737 Alt 3013663942 Fax 3014436077 Email:bautista@mail.nih.gov Caroline Signore, MD, MPH Pregnancy Perinatology Branch Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) 301) 496-5577 Direct) 301) 496-5575 Main) 301) 496-3790 Fax) Email: signorec@mail.nih.gov Srikanth S Nadadur, M.Sc., Ph.D. Cellular, Organs Systems Pathobiology Branch Division Extramural Research Training National Institute Environmental Health Sciences NIEHS) 919) 541-5327 Direct) 919) 541-1919 Main) 919) 541-0462 Fax) Email: nadadurs@niehs.nih.gov Amy Goldstein, PhD Child Adolescent Treatment Preventive Intervention Research Branch National Institute Mental Health NIMH) 301) 496-7227 Direct) 301) 443-4045 Fax) Email: goldsteinam@mail.nih.gov Randall R. Stewart, Ph.D. Division Extramural Research National Institute Neurological Disorders Stroke NINDS) 301) 496-6460 Direct) 301) 496-1917 Main) 301) 402-1501 Fax) Email: stewartr@ninds.nih.gov

Sharing Data via Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System Notice Number: NOT-NS-12-016 Update: following update relating this announcement been issued: NOT-NS-17-029 March 27, 2014 - Notice NOT-NS-14-022. Notice Modification the Data Sharing Policy the Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System. March 21, 2013 - Notice NOT-NS-13-018. Notice Modification the Data Sharing Policy the Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System. Key Dates Release Date: June 4, 2012   Issued National Institute Neurological Disorders Stroke NINDS) Purpose further accelerate pace discovery advance research, National Institutes Health NIH) the Department Defense DoD) collaborating develop Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System.  FITBIR Informatics System provide traumatic brain injury TBI) research community a common platform exchanging data, protocols, research-related information.  Moreover, architecture FITBIR supports federation other data resources. FITBIR begin accepting clinical data July 16, 2012 a variety phenotypic assessments, including image genomic data, a variety formats details, FITBIR, Contributing Data).  TBI researchers are collecting clinical phenotypic, genomic imaging data expected share data via FITBIR, to this national resource advance projects.  is expected all investigators regardless the size the budget their research projects, regardless the source support their TBI research, including investigators supported NIH grants awarded under focused funding opportunity announcements FOAs) those under parent mechanism FOAs (“unsolicited” applications). TBI researchers supported non-federal sources also encouraged utilize FITBIR Informatics System.  Inquiries Inquiries regarding notice be directed to: FITBIR Operations Team Email: FITBIR-ops@mail.nih.gov

Request Information RFI) the Development a Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System Notice Number: NOT-NS-12-017 Update: following update relating this announcement been issued: March 27, 2014 - Notice NOT-NS-14-022. Notice Modification the Data Sharing Policy the Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System. March 21, 2013 - Notice NOT-NS-13-018. Notice Modification the Data Sharing Policy the Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System. Key Dates Release Date: June 4, 2012 Response Date: June 30, 2012 Related Notices NOT-NS-12-016 Issued National Institute Neurological Disorders Stroke NINDS) Center Information Technology CIT) Purpose stated the recent Notice NOT-NS-12-016, National Institutes Health NIH), collaboration the Department Defense DoD), developing Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System further accelerate pace discovery advance research. FITBIR Informatics System provide traumatic brain injury TBI) research community a common platform exchanging data, protocols, research-related information.  goal this RFI to seek public comment considerations the development implementation the FITBIR Informatics System.  Information obtained via RFI help improve design policies the FITBIR Informatics System optimize utility productivity, overall value the scientific community the public health. Background TBI a major medical problem lacks sensitive, predictive diagnostic tools proven effective treatments.   Developing effective diagnostics treatments challenging because the heterogeneity TBI, spans ages, evolves over time, includes wide variety causes injury severities.  address challenges, FITBIR Informatics System aims provide high quality, highly granular contemporary data can accessed analyzed scientific experts.  FITBIR Informatics System enable central archiving data both prospective retrospective studies, thereby prevent data sets being lost off-line, long-term storage a multitude distributed databases institutions.  large, rich clinical data set is stored a secure, centralized database the potential address critical questions fundamental needs TBI diagnosis treatment. Functionality include storage, query, retrieval, off-site backup, optionally pre-processing, post-processing, collaboration between approved researchers federal agencies.  Sharing phenotypic, imaging, functional outcome, pathology, genomic data a central secure repository greatly accelerate ability researchers to: a) validate research results; b) pool standardized information improve statistical significance; c) analyze data collected others explore new hypotheses well the variability different treatment protocols, an effort improve TBI treatments all; d) sophisticated analysis tools gain better understanding risk mitigating factors outcome after TBI. Information Requested RFI invites input potential FITBIR users well the broader biomedical research community other interested parties the following other matters relating the FITBIR Informatics System:  1.  FITBIR Data Sharing Policies, including timelines uploading sharing data, requirements   for accessing data.    2.  Strategies incentives promoting collaboration use the FITBIR Informatics System. 3.  Issues regarding informed consent re-consent data sharing. 4.  Research priorities the FITBIR Informatics System. 5. Strategies tools increasing availability aggregate data publications the broad   TBI community, e.g. patients families, healthcare providers, policy makers, other stakeholders. Responses Responses due June 30, 2012 may directed to: FITBIR Operations Team Email: FITBIR-ops@mail.nih.gov Any personal identifiers e.g., names, addresses, email addresses, etc.) be removed responses compiled.  Proprietary, classified, confidential, sensitive information should be included your response. Replies individual topics optional, anonymous responses permitted.  information provided be analyzed may appear various reports. 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 further information contact: FITBIR Operations Team Email: FITBIR-ops@mail.nih.gov

Introduction the NeuroNEXT Network New Academic Investigators Disease Study Groups Notice Number:  NOT-NS-12-019 Key Dates Release Date:   June 4, 2012 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Network Excellence Neuroscience Clinical Trials NeuroNEXT) designed increase efficiency clinical trials, facilitate patient recruitment retention, increase quality neuroscience clinical trials, to enable public-private partnerships. network includes multiple Clinical Sites, Clinical Coordinating Center CCC), one Data Coordinating Center DCC); listing the sites more information the network be found the NeuroNEXT website www.neuronext.org). clinical research network provide robust, standardized, accessible infrastructure facilitate rapid development implementation protocols neurological disorders affecting adult and/or pediatric populations. webinar intended introduce new Academic Investigators existing Neurological Disease Study Groups the NeuroNEXT network. will give overview the network including scope, purpose available resources. Discussions opportunities disease study groups apply collaborate NeuroNEXT occur. application process NeuroNEXT be explained. Time be allotted questions answers. Thursday, August 2, 2012 1:00 PM – 2:00 PM EST) Teleconference number toll-free: 1-877-739-5903 Access Code: 669-891-429 Audio PIN: Shown after joining Webinar Weblink:  Reserve Webinar seat at https://www1.gotomeeting.com/register/306886344 Title:    Introduction the NeuroNEXT Network New Academic Investigators Disease Study Groups Date:    Thursday. August 2, 2012 Time:   1:00 PM - 2:00 PM EST After registering will receive confirmation email containing information joining Webinar. Inquiries Please direct inquiries to: D. Elizabeth McNeil, MD MSc NINDS Telephone: 301-496-9135 mcneilde@ninds.nih.gov www.ninds.nih.gov/NeuroNEXT

Notice Changes Key Dates PAR-11-030, quot;Limited Competition: Brain Disorders the Developing World: Research across Lifespan R01)" Notice Number: NOT-TW-12-014 Key Dates Release Date: 30, 2012 Issued Fogarty International Center FIC) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Office Dietary Supplements ODS) Purpose Notice being provided alert grantees the change Key Dates Non-AIDS related applications being submitted response the Funding Opportunity Announcement FOA), PAR-11-030 issued the Fogarty International Center FIC), invites applications the Limited Competition: Brain Disorders the Developing World: Research Across Lifespan R01) Program. nbsp;The changes the Key Dates for non-AIDS related applications only appear follows bold text: _____________________________________________________________________________ CURRENT LANGUAGE: Key Dates:  Letter Intent Receipt Date(s): Non-AIDS Related Applications: nbsp;December 10, 2012 AIDS Related Applications: March 11, 2013 Application Due Date(s): Non-AIDS Related Applications: January 10, 2013 AIDS Related Applications: April 11, 2013 Peer Review Date(s): June/July 2013 Council Review Date(s): October 2013 Early Anticipated Start Date(s): December 2013 Expiration Date: April 12, 2013 _______________________________________________________________________________ NEW LANGUAGE: Key Dates:  Letter Intent Receipt Date(s): Non-AIDS Related Applications: January 14, 2013 AIDS Related Applications: March 11, 2013 Application Due Date(s): Non-AIDS Related Applications: February 14, 2013 AIDS Related Applications: April 11, 2013 Peer Review Date(s): June/July 2013 Council Review Date(s): October 2013 Early Anticipated Start Date(s): December 2013 Expiration Date: April 12, 2013 other aspects the FOA remain unchanged. Inquiries Please direct inquiries to:   Kathleen Michels, Ph.D. 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: brainfic@nih.gov

Notice Changes Key Dates PAR-11-031, quot;Brain Disorders the Developing World: Research across Lifespan R21)" Notice Number: NOT-TW-12-015 Key Dates Release Date: 30, 2012   Issued Fogarty International Center FIC) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Office Dietary Supplements ODS) Purpose Notice being provided alert grantees the change Key Dates Non-AIDS related applications being submitted response the Funding Opportunity Announcement FOA), PAR-11-031 issued the Fogarty International Center FIC), invites applications the Brain Disorders the Developing World: Research Across Lifespan R21) Program. nbsp;The changes the Key Dates for non-AIDS related applications only appear follows bold text: _____________________________________________________________________________ CURRENT LANGUAGE: Key Dates:  Letter Intent Receipt Date(s): Non-AIDS Related Applications: December 10, 2012 AIDS Related Applications: March 11, 2013 Application Due Date(s): Non-AIDS Related Applications: January 10, 2013 AIDS Related Applications: April 11, 2013 Peer Review Date(s): June/July 2013 Council Review Date(s): October 2013 Early Anticipated Start Date(s): December 2013 Expiration Date: April 12, 2013 _________________________________________________________________________________ NEW LANGUAGE: Key Dates:  Letter Intent Receipt Date(s): Non-AIDS Related Applications: nbsp;January 14, 2013 AIDS Related Applications: nbsp;March 11, 2013 Application Due Date(s): Non-AIDS Related Applications: February 14, 2013 AIDS Related Applications:  April 11, 2013 Peer Review Date(s): June/July 2013 Council Review Date(s): October 2013 Early Anticipated Start Date(s): December 2013 Expiration Date: April 12, 2013 other aspects the FOA remain unchanged. Inquiries Please direct inquiries to:   Kathleen Michels, Ph.D. 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: brainfic@nih.gov