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Frequently Asked Questions FAQs) RFA-NS-12-010 - Exploratory Laboratory Analysis Projects Parkinson’s Disease Biomarkers U18) RFA-NS-12-011 - Studies Parkinson's Disease Biomarkers Discovery U01) Notice Number: NOT-NS-12-015 Key Dates Release Date: April 19, 2012   Issued National Institute Neurological Disorders Stroke NINDS)   Purpose March 16th, 2012, NINDS issued Funding Opportunity Announcements FOAs): RFA-NS-12-010 - Exploratory Laboratory Analysis Projects Parkinson's Disease Biomarkers U18) RFA-NS-12-011 - Studies Parkinson's Disease Biomarkers Discovery U01). goal RFA-NS-12-010 to stimulate innovation development technologies reagents will accelerate discovery biological biomarkers Parkinson’s disease PD).  goal RFA-NS-12-011 to support hypothesis driven clinical research discover biomarkers will improve efficiency outcome Phase II clinical trials Parkinson’s Disease PD) to support collection clinical data new biological specimens will used biomarker exploratory efforts under NINDS Parkinson’s Disease Biomarkers Program PDBP). date, several questions these FOAs been submitted various investigators. purpose this Notice to inform potential applicants a list Frequently Asked Questions FAQs) answers available http://www.ninds.nih.gov/pdbp/). FAQs be updated periodically without additional notice.  Inquiries questions further information, contact: Katrina Gwinn MD National Institute Neurological Disorders Stroke 6001 Executive Blvd Room 2143 Bethesda MD 20892 Telephone: 301-496-5745 Fax: 301-502-1501 Email: gwinnk@ninds.nih.gov

Extension Expiration Date PAR-11-294, NINDS Cooperative Program Translational Research Single-Component Research Projects U01) Notice Number:  NOT-NS-12-011 Key Dates Release Date: April 10, 2012 Related Notices NS-12-010 NS-12-012 NOT-NS-12-013 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice extends expiration date Funding Opportunity Announcement FOA) PAR-11-294, NINDS Cooperative Program Translational Research Single-Component Research Projects U01). new expiration date PAR-11-294 January 8, 2013. other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Linda McGavern, Ph.D. Office Translational Research National Institute Neurological Disorders Stroke NINDS) 6001 Executive Blvd., Room 2227 Bethesda, MD 20892 Telephone: 301) 496-1779 Email: mcgavernlm@ninds.nih.gov

Extension Expiration Date PAR-11-295, NINDS Cooperative Program Translational Research Multi-Component Research Projects U54) Notice Number: NOT-NS-12-012 Key Dates Release Date: April 10, 2012 Related Notices NOT-NS-12-010 NOT-NS-12-011 NOT-NS-12-013 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice extends expiration date Funding Opportunity Announcement FOA) PAR-11-295, NINDS Cooperative Program Translational Research Multi-Component Research Projects U54). new expiration date PAR-11-295 January 8, 2013. other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Linda McGavern, Ph.D. Office Translational Research National Institute Neurological Disorders Stroke NINDS) 6001 Executive Blvd., Room 2227 Bethesda, MD 20892 Telephone: 301) 496-1779 Email: mcgavernlm@ninds.nih.gov

Extension Expiration Date PAR-11-293, NINDS Exploratory/Developmental Projects Translational Research R21) Notice Number: NOT-NS-12-010 Key Dates Release Date: April 9, 2012 Related Notices NOT-NS-12-011 NOT-NS-12-012 NOT-NS-12-013 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice extends expiration date Funding Opportunity Announcement FOA) PAR-11-293,   NINDS Exploratory/Developmental Projects Translational Research R21). new expiration date PAR-11-293 January 8, 2013. other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Christina Vert, M.S. Office Translational Research National Institute Neurological Disorders Stroke NINDS) 6001 Executive Blvd., Room 2117 Bethesda, MD 20892 Telephone: 301) 496-1779 Email: vertc@ninds.nih.gov

Extension Expiration Date PAR-11-296, NINDS Cooperative Program Translational Research Small Business Awards U44) Notice Number: NOT-NS-12-013 Key Dates Release Date: April 10, 2012   Related Notices NOT-NS-12-010 NOT-NS-12-011 NOT-NS-12-012   Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice extends expiration date Funding Opportunity Announcement FOA) PAR-11-296, NINDS Cooperative Program Translational Research Small Business Awards U44). new expiration date PAR-11-296 January 8, 2013. other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Linda McGavern, Ph.D. Office Translational Research National Institute Neurological Disorders Stroke NINDS) 6001 Executive Blvd., Room 2227 Bethesda, MD 20892 Telephone: 301) 496-1779 Email: mcgavernlm@ninds.nih.gov

Request Information RFI): Priorities Outsourcing Laboratory Procedures Notice Number: NOT-GM-12-108 Update: following update relating this announcement been issued: 9, 2012 - Notice NOT-GM-12-110. purpose this Notice to announce extension the deadline the Request Input RFI). Key Dates Release Date: March 30, 2012 Response Date COB:  Extended COB 15, 2012 per NOT-GM-12-110), Original Date 1, 2012 Issued National Institute General Medical Sciences NIGMS) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Alternative Medicine NCCAM) Purpose purpose this Request Information RFI) to seek input researchers regarding current research laboratory procedures could developed outsourced services.  development such services potentially facilitate broad access state-of-the-art technologies methodologies research areas high significance the mission the NIH, particularly the participating Institutes NIGMS, NINDS, NCCAM, NIEHS, NIAMS) not limited them. Clinical services expressly excluded. information be used develop funding initiatives through Small Business Innovation Research SBIR/STTR) Program. RFI for planning purposes only should be construed a funding opportunity grant program. Background Recent technological advances opened new doors solving biomedical problems.  However, access the newest technologies procedures present major expense, especially institutions lacking extensive core facilities.  possibility make such technologies procedures accessible a much wider range investigators to promote outsourcing supporting research development commercially viable pipelines such procedures.   efforts result multiple advantages the biomedical enterprise companies provide appropriate assays, measurements, data, bioinformatics other types research services.  advantages include reduced overall costs research grants, enhanced quality control, timely access.  general concept not novel e.g., oligonucleotide synthesis, expression array services, knockout mice generation) there be unexplored opportunities further outsourcing. Benefits increased outsourcing research services have recognized include enhancing access the acceleration progress Science 334, 1154-1156, Nov 2011), well for establishment broad method data validation standards Science 334, 1230-32; Dec 2011). Therefore, stimulating establishment expansion small business outsourcing services further both mission the NIH general, those the SBIR program particular i.e., stimulation technological innovation, support federal R&D goals). untested proposition that market exists services would justify investment small businesses research development costs.  assumption rests the hypothesis there lab-based, non-clinical technologies procedures are amenable scale-up, not already being provided, which be attractive investigators hitherto not used such services could convinced otherwise their quality lower costs.  purpose this RFI to obtain data evaluate proposition. Information Requested request include is limited concerns such as: 1. Research services which see unmet demand outsourcing the perspective your own research the broader scientific area. 2. likely market such services, including research areas be affected beyond own interests. 3. Special obstacles technological, logistical, costs) currently impede development the services identify. 4. Services sense particularly sensitive obsolescence, any. 5. Services may already on market where access quality limited unsatisfactory. 6. comments, suggestions, considerations relevance this RFI. Indicate primary affiliation optional). to Submit Response Response this RFI voluntary.  Extramural investigators other interested parties invited respond. Responders free address any all the above items. comments must submitted electronically to: http://public.nigms.nih.gov/sbir/.  Please respond COB 1, 2012. Any personal identifiers be removed responses compiled. Proprietary, classified, confidential, sensitive information should be included your response. information provided be analyzed may appear various reports. Request Information RFI) for planning purposes only is a solicitation application 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: James J. Anderson, Ph.D. Program Director, Division Genetics Developmental Biology Center Bioinformatics Computational Biology National Institute General Medical Sciences NIGMS) Tel: 301-594-0943 E-mail: andersj@mail.nih.gov Stefan Maas, Ph.D. Program Director, Division Genetics Developmental Biology National Institute General Medical Sciences NIGMS) Tel: 301-594-0943 E-mail: stefan.maas@nih.gov Xibin Wang, Ph.D. Research Program Analyst Division Musculoskeletal Diseases National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Tel: 301-451-3884 Email: wangx1@mail.nih.gov Daniel Shaughnessy, PhD National Institute Environmental Health Sciences NIEHS) Tel: 919-541-2506 Email: shaughn1@niehs.nih.gov Stephanie Fertig, MBA Small Business Program National Institute of Neurological Disorders Stroke NINDS) Tel: 301- 496-1779 E-mail: fertigs@ninds.nih.gov D. Craig Hopp, Ph.D. Program Officer National Center Complementary Alternative Medicine National Institutes Health NCCAM) Tel: 301-496-5825 E-mail: hoppdc@mail.nih.gov

NSF-NIH Interagency Initiative: Core Techniques Technologies Advancing Big Data Science Engineering BIGDATA) Notice Number: NOT-GM-12-109 Key Dates Release Date:  March 29, 2012          Issued National Institute General Medical Sciences NIGMS), http://www.nigms.nih.gov/) National Cancer Institute NCI), http://www.nci.nih.gov/) National Human Genome Research Institute, http://www.nhgri.nih.gov) National Institute Biomedical Imaging Bioengineering NIBIB), http://www.nibib.nih.gov/) National Institute Drug Abuse NIDA), http://www.nida.nih.gov/) National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov/) National Library Medicine NLM), http://www.nlm.nih.gov/) Purpose Institutes Centers the National Institutes Health NIH) the National Science Foundation NSF) identified Big Data a program focus.  particular, present initiative covers needs core techniques technologies advancing big data science engineering. Full details the programmatic goals application process described the NSF Program Solicitation NSF-12-499). Description:  BIGDATA seeks applications develop evaluate core technologies tools take advantage available collections large data sets accelerate progress science, biomedical research, engineering. addition, applications must also include description how project build capacity.  Also, project choose focus science engineering big data project an area national priority, this optional. small project receive NIH support to 150,000 direct funds to 3 years, while mid-scale projects receive NIH support ranging 150,000 650,000 direct funds to 5 years.  all, participating NIH Institutes committed to 2.75M FY 2012 and/or 2013.   It anticipated NIH pay 4 6 small projects 1 2 mid-scale projects through program fiscal years 2012 and/or 2013, subject availability funds.  Application submission through National Science Foundation. Following jointly conducted initial peer review these applications, likely NIH awardees be asked reformat application resubmit application NIH processing. Detailed information this program be obtained the Internet www.nsf.gov/funding/pgm_summ.jsp?pims_id=504767 Inquiries Potential applicants send inquiries NIH Program Contacts well NSF contacts named the solicitation NSF-12-499). Karin Remington PhD Director, Division Biomedical Technology, Bioinformatics, Computational Biology National Institute General Medical Sciences  (301) 451-6446 remingka@nigms.nih.gov

NINDS Policy Submission Applications Containing Clinical Trials Notice Number: NOT-NS-12-007 Update: following update relating this announcement been issued: February 6, 2013 - Notice been replaced with, NOT-NS-13-006; NINDS Policy Submission Applications Containing Clinical Trials. Key Dates Release Date: March 13, 2012 Related Notices NOT-NS-11-018 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform NINDS grant applicants that, beginning applications submitted the June 5, 2012 submission date, NINDS not accept unsolicited R01 applications include clinical trials potential therapies under NIH parent R01 Funding Opportunity Announcement FOA) PA-11-260 subsequent revisions this FOA.  clinical trial a prospective biomedical behavioral research study human subjects is designed answer specific questions pharmacologic, behavioral, biologic, surgical, device interventions. Applicants submitting unsolicited applications NINDS contain clinical trial such interventions must submit one the following NINDS FOAs specifically designed clinical trials: NINDS Exploratory Clinical Trials R01) PAR-10-199 NINDS PHASE III Investigator-Initiated Multi-Site Clinical Trials U01) PAR-11-173 Clinical trial applications also be submitted NINDS response other NINDS-specific announcements specifically solicit clinical trials.  policy applies only the NIH parent FOA PA-11-260 unsolicited R01 applications subsequent revisions.  application submitted response the NIH parent R01 not include clinical trial within aims; such applications not accepted NINDS. Inquiries Please direct inquiries concerning policy to: Crina Frincu, PhD Office Clinical Research National Institute Neurological Disorders Stroke Neuroscience Center, Room 2210 6001 Executive Boulevard Bethesda, MD 20892 Telephone: 301) 496-9135 Fax: 301) 410-1080 Email:  CRLiaison@ninds.nih.gov inquiries review issues contact: Chief, Scientific Review Branch National Institute Neurological Disorders Stroke Room 3201, MSC 9529 6001 Executive Blvd. Bethesda, MD 20892-9529 Telephone: 301) 496-9223 Fax: 301) 402-0182 Email: nindsreview@ninds.nih.gov

Notice Change Funding Mechanism Brain Banks Notice Number: NOT-MH-12-020 Update: following update relating this announcement been issued: April 12, 2013 - Notice NOT-NS-13-024. Notice Clarification Responsive Projects. Key Dates Release Date: March 1, 2012 Issued National Institute Mental Health NIMH) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to alert community a change funding strategy support biobanking neuropsychiatric neurodevelopmental disorders.  NIMH, NICHD NINDS no longer fund applications individual brain collection facilities via research grant R) cooperative agreement U) mechanisms the exception NeuroAIDS banking efforts).  NIMH, NICHD NINDS intend fund such activities via competitive contract mechanism solicitations intend issue request proposals FY2013.  Access high quality brain related biospecimens serves a critical research tool discovery mechanisms underlying diseases neurobiological origin, well identification potential therapeutic targets. change funding strategy intended broaden access and improve quality valuable biospecimens collected NIH funds. Currently supported research grants brain banks continue be funded through current competitive cycle; however, grants not renewed.  Rather, investigators encouraged compete subsequent funding via competitive contract mechanisms the close their budget periods. intent this change funding stream to allow linked facilities via IT system database infrastructure a federated model integrated brain banking. federated approach encourage foster access, standard practices, quality control methods, partnership disease advocacy organizations. Solicitations contract proposals be advertised the Federal Business Opportunities website www.fedbizopps.gov). Inquiries Inquiries regarding Notice be directed to: Michelle Freund, Ph.D. National Institute Mental Health 6001 Executive Boulevard, MSC 9667 Rockville, MD  20892-9667 Telephone:  301-443-1815 Email:  freundm@mail.nih.gov Melissa Parisi, Ph.D. National Institute Child Health Human Development 6100 Executive Boulevard, MSC 7510 Rockville, MD  20892-7510 Telephone:  301-496-1383 Email:  parisima@mail.nih.gov Anna Taylor, Ph.D. National Institute Neurological Disorders Stroke 6001 Executive Boulevard, Room 3303, MSC 9631 Rockville, MD  20892-9631 Telephone:  301-496-9248 Email:  taylorann@mail.nih.gov

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