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Request Information: Soliciting Input Current Approaches Developing Integrated Databases Advance Research Parkinson’s Disease Notice Number: NOT-NS-09-010 Update: following update relating this announcement been issued: 26, 2009 - Notice NOT-NS-09-013 Notice Response Date Extension. Key Dates Release Date: April 21, 2009   Response Due By: New Date June 26, 2009 per NOT-NS-09-013; Original Date: 22, 2009 Issued National Institute Neurological Disorders Stroke NINDS) http://www.ninds.nih.gov Purpose is time-sensitive Request Information RFI) issued the National Institute Neurological Disorders Stroke.  information requested meant ascertain needs clinical databases linked biorepositories advance clinical translational research Parkinson’s disease. Institute envisions such effort serving data sharing data integration needs the wider research community including industry, non-profit Parkinson’s disease-related organizations, the research activities other NIH Institutes Federal agencies including Veterans Administration the Department Defense.  responses the RFI be collected various Institute staff assess best meet needs researchers the field will made available the public. Background NINDS committed facilitating collection sharing data biologic samples amongst clinical translational researchers Parkinson’s disease. Given advances technology the increasing types amounts data being collected, are interested implementing efficient methods data sharing.  Additionally, the efforts develop valid biomarkers the risk progression Parkinson’s disease expand, want ensure access biospecimens might facilitate major research advances.  RFI meant solicit input the greater extramural research community, scientific medical organizations, Federal Agencies, other interested parties well-versed establishing managing large databases repositories.  is meant solicit input the greater research community Parkinson’s disease how specific databases linked biorepositories advance effort discover better strategies treat and/or prevent Parkinson’s disease.  Responses this RFI be reviewed NINDS staff will help inform complement assessment the field the identification specific, achievable goals have potential advance transform field overall. RFI for planning purposes only, should be construed a solicitation applications proposals and/or an obligation any on part the United States Federal Government.  Information Requested mission NIH to support biomedical discoveries will improve health save lives. NIH committed data sharing seeks input the optimal approaches establishing managing large databases biospecimen repositories.  NINDS like input the following issues: Large databases: Describe key features enhance value utility a large clinical database use clinical translational researchers. Describe clinical, imaging, biologic/genetic, pathology data be linked most effectively. Identify considerations impact cost effectiveness data collection data sharing.   Identify are most important barriers must overcome enhance data sharing procedures how these barriers overcome. Identify technologies enhance functional utility a large clinical database. Repository biospecimens: Describe advantages a federated versus non-federated repository.  Describe the collection various biosamples Parkinson’s disease should organized optimize utility. General Information: Please identify nature your interest the area databases repositories i.e. you biomedical clinical researcher, member an advocacy community group, other?). you a member a particular advocacy professional organization, please indicate name the organization. you your organization involved Parkinson’s disease clinical research, please indicate features a large integrated database be useful your group organization.  Describe conditions need be met you your organization enter data such database. Within research, please indicate main area interest. Responses Responses must submitted electronically using web-based form http://www.ninds.nih.gov/research/clinical_research/rfi.htm, will accepted through 22, 2009.  Replies individual questions optional, the site permit anonymous responses.  information provided be analyzed may appear various reports.  Inquiries Specific questions this RFI should directed the contact listed below: Wendy R. Galpern, M.D., Ph.D.  Program Director, Office Clinical Research NINDS / NIH 6001 Executive Blvd., Rm 2225 Bethesda, MD 20892 Phone:  301-496-9135 Fax:  301-480-1080 E-mail:  galpernw@ninds.nih.gov

Request Comments the Proposed of Determination Exceptional Circumstances DEC) the NINDS Medicinal Chemistry Neurotherapeutics Program Notice Number: NOT-NS-09-008 Key Dates Release Date: March 27, 2009 Issued National Institute Neurological Disorders Stroke NINDS) http://www.ninds.nih.gov) Purpose National Institute Neurological Disorders Stroke NINDS) seeking public comment a proposed of Determination Exceptional Circumstances DEC), provided under Bayh-Dole Act, its new Medicinal Chemistry Neurotherapeutics Program MCNP). Background goal the NINDS MCNP to improve public health stimulating development new drugs neurological diseases. NINDS supported high-throughput screens basic research studies have led the discovery many small molecule compounds activity models neurological disease. of compounds might transformed drugs, chemical modifications improve potency pharmacological properties. However, biotechnology pharmaceutical companies hesitant invest the early development compounds rare diseases new targets, given concerns market success, budgets, associated risks. Academic researchers have identified promising compound rarely access medicinal chemistry services. MCNP intended overcome barriers. MCNP provide resources chemistry expertise transform small molecule compounds evidence bioactivity lead compounds sufficient potency, efficacy, drug-likeness begin preclinical studies required an investigational new drug application. Once projects ldquo;graduated” the MCNP, researchers take advantage other NIH resources, such the NINDS Translational Research Cooperative Program, NIH Rapid Access Interventional Development RAID) Pilot Program, funding agreements clinical trials advance drug leads through preclinical clinical testing.  Researchers also engage industry other non-government resources follow-up work. MCNP envisioned a collaborative effort between NINDS-contracted medicinal chemistry service facility academic industry researchers bioassays model neurological disorders bioactive small molecule compounds. Under MCNP, researchers Contributors) provide compounds the NINDS medicinal chemistry service facility Contractors) a starting point chemical optimization. Contractors design generate chemical analogs these starting compounds, the Contributors test chemical analogs their disease bioassays. results inform next round analog design development, so on, potentially dozens rounds. design new chemical analogs under MCNP generate new inventions. Bayh-Dole Act establishes rights obligations grantees contractors Subject Inventions—inventions are conceived first actually reduced practice the performance work under funding agreement the Federal Government. of goals the Bayh-Dole Act to incentivize commercialization Government-supported Subject Inventions. Under Bayh-Dole Act, Government contractors generally retain right elect title inventions by researchers a result their work performed under Government-supported agreement. Determination Exceptional Circumstances DEC) the Bayh-Dole Act directs ownership inventions by funding recipient the Government other party. Thus, without Determination Exceptional Circumstances, NINDS-contracted MCNP medicinal chemists retain right elect title/ownership inventions all new compounds they invent under funding agreement NINDS. Responses a NINDS-issued Request Information RFI) directed potential Contributors Contractors suggest allowing Contractors retain ownership the chemical analog patent rights actually impede further development commercialization new drugs. order develop good lead compounds, MCNP must attract promising, high quality starting compounds. Potential Contributors informed NINDS they participate the MCNP only they be assured full ownership patent rights all analogs generated their starting compounds. Most potential Contractors not express interest retaining ownership Subject Inventions directed the analogs their methods use. potential Contractors indicated their business model these particular circumstances be provide specific services a fee. PROPOSED INTELLECTUAL PROPERTY STRATEGY: the MCNP, NINDS considering Determination Exceptional Circumstances DEC), provided under Bayh-Dole Act.  DEC cover classes Subject Inventions: 1)     Subject Inventions directed analog compounds their methods use, NINDS medicinal chemistry Contractors be required offer first right assignment the Contributor. the Contributor declines offer assignment, NINDS dispose the invention rights NINDS determines be the best interests the program public health e.g., allow Contractor retain invention rights). 2)     Subject Inventions directed the methods manufacturing analog compounds, Contractor retain rights, the DEC require the Contractor grant agree negotiate licenses as enable research and commercialization the compounds. Rights all Subject Inventions be retained the Contractor pursuant the Bayh-Dole Act. Inquiries NINDS invites comments this strategy use a DEC the MCNP. Alternative strategies will encourage contribution chemical compounds the program be considered before final determination made regarding use a DEC. Please submit comments the attention Annette Carter, Contracting Officer the address below 4:00 PM Local Time April 17, 2009. Annette Carter, Contracting Officer National Institutes Health, NINDS R&D Contracts Management Branch 6001 Executive Blvd., Suite 3287 Bethesda, MD   20892-9531 via courier Rockville, MD  20852 Electronic submittal also accepted cartera@mail.nih.gov

Extension Expiration Date PA-07-085 R01) PA-06-392 R21) - Research Autism Autism Spectrum Disorders Notice Number: NOT-MH-09-003 Key Dates Release Date: January 16, 2009 Expiration Date: September 8, 2009 Issued National Institute Mental Health NIMH), http://www.nimh.nih.gov) National Institute Deafness Other Communication Disorders NIDCD), http://www.nidcd.nih.gov) National Institute Child Health Human Development NICHD), http://www.nichd.nih.gov) National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov) National Institute Environmental Health Sciences NIEHS), http://www.niehs.nih.gov) National Institute Nursing Research NINR), http://www.ninr.nih.gov) Office Dietary Supplements ODS), http://ods.od.nih.gov) purpose this notice to extend expiration dates PA-07-085 R01) PA-06-392 R21) - Research Autism Autism Spectrum Disorders until September 8, 2009. extension being at time allow approval adoption the Strategic Plan Autism Spectrum Disorders ASD) Research, was mandated the Combating Autism Act 2006 P.L. 109-416).  Through Act, Congress intended rapidly increase, accelerate pace, improve coordination scientific discovery ASD research.  Once new Strategic Plan adopted, goals it be incorporated updated FOAs ASD research.  FOAs be updated reissued ensure they reflect most current priorities ASD research.  Extending Funding Opportunity Announcements FOAs) until September 8, 2009 also coincide the expiration dates the R03 PA-06-391) FOA the same title.  After September 8, 2009, applicants must apply response the updated FOAs, issued. Inquiries Inquiries regarding Research Autism Autism Spectrum Disorders FOAs be directed to: Lisa Gilotty, Ph.D. Division Developmental Translational Research National Institute Mental Health 6001 Executive Boulevard, Room 6179, MSC 9617 Bethesda, MD 20892-9617 Telephone: 301) 443-3825 Fax: 301) 480-4415 Email: gilottyl@mail.nih.gov

Addendum NOT-NS-09-005, NINDS Administrative Supplements Collaborative Activities Promote Translational Research CAPTR)” Notice Number: NOT-NS-09-006 Key Dates Release Date:  January 13, 2009 Issued National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov/) purpose this Notice to add R00 Pathway Independence mechanism the list grants eligible CAPTR administrative supplements previously restricted R01s, R37s, P01s).  original K99/R00 grantee to transitioned the Research Phase R00) the award prior the submission date March 23, 2009) the CAPTR administrative supplement request.  other career development K) awardees eligible apply a CAPTR supplement.   other aspects NOT-NS-09-005 remain unchanged.  full text the Notice, was published December 29, 2008, be accessed http://grants.nih.gov/grants/guide/notice-files/NOT-NS-09-005.html. Inquiries Inquiries regarding Notice be directed the NINDS Program staff listed NOT-NS-09-005. 

Guidance Submitting Applications the Roadmap Molecular Libraries Assay Development High-Throughput Screening Program: PAR-08-024 Notice Number: NOT-RM-09-008 Key Dates Release Date: January 2, 2009 Issued The National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov/), behalf the Roadmap Molecular Libraries Initiative. purpose this notice to provide additional guidance investigators preparing applications the Assay Development High-Throughput Screening Program PAR-08-024 http://grants.nih.gov/grants/guide/pa-files/PAR-08-024.html). Background: Roadmap Assay Development High Throughput Screening HTS) Program serves a key incubator funding development assay projects HTS will eligible advance the Molecular Libraries Probe Production Centers Network MLPCN; https://mli.nih.gov/mli/mlpcn/mlpcn-probe-production-centers/) completed. HTS-ready assays then screened a Network Center against Molecular Libraries Small Molecule Repository MLSMR; http://mli.nih.gov/mlsmr/index.php), promising small molecule hits further developed molecular probes. present, projects funded the Assay Development HTS Program eligible rapid entry the MLPCN Year 2 the R21 award. year 2 Investigators asked submit Fast Track request screening the Program Director is based their progress report the end Year 1 the award. Roadmap Molecular Libraries Project Team provides technical review these requests a monthly basis, placing emphasis project readiness the need probes the proposed target. Upon approval this Project Team projects immediately assigned a Network Screening Center implementation, the investigator awarded 25,000 direct costs) be used facilitating effective collaboration between assay provider the assigned Center the HTS probe development project. CLARIFICATION: the present notice, NIH advising applicants the PAR-08-024 Program they not need request Year 2 funding the R21 application order enter MLPCN their assay project after preparation completed funded Year 1 the award). R21 applications be limited a Year 1 request funding assay development to 100,000 direct costs), will still able enter MLPCN the assays HTS-ready using Fast Track request process described the preceding section. Upon approval this request the Project Team, investigators funded the R21 receive 25,000 direct costs) via Roadmap Supplement, be used previously described) establishing effective Investigator:Center collaboration. Inquiries Further information regarding eligibility the PAR-08-024 Program, information preparing Fast Track requests MLPCN entry, be obtained contacting Mark Scheideler, Ph.D., Program Director the Roadmap Assay Development HTS Fast Track Programs, the following email address: scheidelerm@ninds.nih.gov