GOOD AFTERNOON. THAT IS STEVE GROFT THE DIRECTOR OF THE OFFICE OF RARE DISEASES RESEARCH AT THE NATIONAL CENTER FOR ADVANCING TRANSLATION ALL SCIENCE HERE AT NIH. AND DR. RASHMI GOPAL-SRIVASTAVA FROM OUR OFFICE FOR THE PLACE OF LAST FIVE PLUS YEARS WILL BE LEAVING US TODAY SO RASHMI OVER TO YOU. >> THANK YOU. I'M RASHMI GOPAL-SRIVASTAVA FROM THE OFFICE OF RESEARCH AND CATS. I WOULD LIKE TO THANK YOU ALL FOR JOINING THIS APPLICATION MEETING FOR RARE DISEASES CLINICAL RESEARCH CONSORTIUM FOR RARE DISEASES CLINICAL RESEARCH NETWORK. HERE IS AGENDA FOR TODAY'S MEETING. FIRST WE WILL HAVE INTRODUCTORY REMARKS FROM DR. STEVE GROFT WHO IS FROM THE DIRECTOR OF THE OFFICE OF RARE DISEASES RESEARCH. AND THEN I WILL GIVE AN OVERVIEW OF RDCRR OR CONSORTIUM RFA FOLLOWED WITH A QUESTION AND ANSWER SESSIONS RELATED TO THE APPLICATION. MY REQUEST OF THE AUDIENCE IN THIS ROOM IS TO USE THE MICROPHONE WHICH IS IN THE AISLES AND MY REQUEST TO THE VIDEOCAST VIEWERS IS TO SEND YOUR QUESTIONS BY E-MAIL AT ORDR AT MAIL.NIH.GOV. CHRIS FROM OUR OFFICE IS HERE AND HE WILL BE RECEIVING THOSE AND FOLLOWING IT TO US. I WOULD LIKE TO REQUEST DR. STEVE GROFT TO GIVE INTRODUCTORY REMARKS. PLEASE, WILL YOU COME TO THE PODIUM. >> THANK YOU VERY MUCH RASHMI. THERE ARE A LOT OF SLIDES TO COVER AND A LOT OF INFORMATION TO PROVIDE. ALL OF THE INFORMATION IN THE SLIDES AND THE WHOLE PROCEEDINGS WILL REMAIN AVAILABLE ON THE WEBSITE AS WE MOVE FORWARD SO I WILL TRY TO MOVE THE SLIDES FORWARD. WRONG WAY. SO HERE WE ARE. THE RARE DISEASES CLINICAL RESEARCH NETWORK CAME ABOUT AS A RESULT OF THE RARE DISEASES ACT OF 2002. AND IN THAT LEGISLATION MANDATED THE DEVELOPMENT OF REGIONAL CENTERS OF EXCELLENCE FOR RARE DISEASES. THIS CAME ABOUT AS A RESULT OF SPECIAL EMPHASIS PANEL ON RARE DISEASES BACK IN THE LATE 1909'S AND THE REPORT WAS PUBLISHED IN 2000. ALL OF THIS INFORMATION IS AVAILABLE ON OUR WEBSITE. THE SIMPLE GOALS OF THE RDCRN WERE TO DEMONSTRATE THE ABILITY TO CONDUCT CLINICAL STUDIES AND CLINICAL TRIAL OF RARE DISEASES WITH SMALL POPULATIONS, SMALL PATIENT POPULATIONS UNDER A COMMON PROTOCOL. FOR MANY YEARS THE FEELING WAS WE REALLY COULDN'T OBTAIN SUFFICIENT NUMBER OF PATIENTS AND TO OPEN THE STUDY, TO COMPLETE THE STUDY. SO THAT WAS ONE OF OUR VERY EARLY GOALS OF WHAT WE WERE TRYING TO ACCOMPLISH. WE ALSO WANTED TO DEMONSTRATE THE VALUE AND THE NEED FOR LONGITUDINAL NATURAL HISTORY STUDIES. AGAIN WE THOUGHT THIS WAS VERY IMPORTANT TO USE THIS INFORMATION TO GAIN FROM THESE TYPE OF STUDIES AS PRECURSOR TO CLINICAL STUDY OR CLINICAL TRIAL. THIS IS WHY YOU SEE THE INCLUSION OF THAT REQUIREMENT WITHIN THE RDCRN FOA THAT'S BEEN MADE AVAILABLE. WE ALSO THOUGHT VERY EARLY ON THAT WE NEEDED TO HAVE AN EXPANDED ROLE FOR MEASURES AND PATIENT ADVOCACY GROUPS. THE OPPORTUNITY TO ESTABLISH THE COLLABORATIVE PARTNERSHIPS THAT HAVE BECOME SO FRUITFUL TO MANY OF THE INVESTIGATORS. AND WE FEEL THIS IS ONE OF THE REAL STRENGTHS OF THE CURRENT RESEARCH NETWORK. THEIR PARTNERSHIPS, THE COLLABORATIVE PARTNERSHIPS HAVE BEEN ESTABLISHED A LONG WAY TO INCRUIT THEM INTO THE STUDIES. WE FOSTERED THE DEVELOPMENT OF COLLABORATIVE PARTNERSHIPS WITH INDUSTRY, OTHER ACADEMIC AND AND INSTITUTIONS TO TRY TO GET A CRITICAL MASS OF INVESTIGATORS AND PATIENTS READY TO OPEN AND COMPLETE THE CLINICAL STUDIES IN A TIMELY FASHION WITHOUT EXTRAORDINARY DELAYS WHICH HAS BEEN ONE OF THE PRIMARY DEFICIENCIES OF RARE DISEASES THAT THE PATIENTS ARE SCATTERED OVER WIDE AREAS AND FREQUENTLY NOT ABLE TO OBTAIN A SUFFICIENT NUMBER OF THE PATIENTS TO PARTICIPATE IN A CLINICAL STUDY. FOR THE MOST PART I THINK THAT HAS BEEN CHANGING AND WE CERTAINLY HAVE BEEN VERY VERY OPPORTUNISTIC IN TAKING ADVANTAGE OF THE PATIENT ADVOCACY GROUPS AND THEIR ROLE TO HELP IMPROVE THE RECRUITMENT. OVER THE LAST TEN YEARS, WE'VE NOTICED THE DIFFERENCE WHEN WE HAD TO FIRST RDCRN, IT TOOK US ALMOST TWO AND-A-HALF YEARS FOR OUR VERY FIRST STUDY. IN RDCRN2 AS WE CALL IT, IT TOOK ABOUT SIX MONTHS TO OPEN THE STUDY. WE KNOW THINGS HAVE BEEN FACILITATED. WE'VE GAINED A LOT OF EXPERIENCE DURING THE FIRST SIX YEARS OF THE GRANT AND WE CONTINUE TO EXPAND AND TAKE ADVANTAGE OF THAT KNOWLEDGE. WE RECEIVE PATIENT RECRUITMENT IMPROVE AND INCREASE, AND THE RESEARCH NETWORK AND INDIVIDUAL CONSORTIUM USE A CONTACT REGISTRY TO SOLICIT PARTICIPATION ON THE PART OF PATIENTS AND FAMILY. WE'VE SEEN THE EXPANDED ROLE OF THE PATIENT ADVOCACY GROUPS THAT ARE INVOLVED. THEY CERTAINLY HAVE BEEN A TREMENDOUS FORCE IN GAINING SUFFICIENT NUMBER OF PATIENTS TO START THE STUDIES. IN THE PRESENCE OF RESEARCH ON THE INTERNET AND WEBSITES AVAILABLE, IT WORKS FOR THE DATA COORDINATING CENTER. ORIGINALLY WE THOUGHT WE HAD SUFFICIENT FUNDS TO SUPPORT FOUR CONSORTIA AND SO THE FIRST FIVE YEARS WE WENT FROM FOUR TO TEN AND IN THE RDCRN2 WE WENT FROM 10 TO 17 THAT WE ENDED UP WITH AT THE PRESENT TIME. WE NOW HAVE APPROXIMATELY 10 INSTITUTES AND CENTERS INVOLVED IN THE FUNDING OPPORTUNITY ANNOUNCEMENT THAT YOU'VE LOOKED AT. SO THAT'S BEEN A GREAT GROWTH FOR THE RESEARCH NETWORK. WE'VE ALSO BEEN ABLE TO SEE THAT WE CAN DO CLINICAL TRIALS THAT DO MEET THE REGULATORY REQUIREMENTS OF NEW DRUG APPLICATIONS AT THE FOOD AND DRUG ADMINISTRATION. AND THIS HAS ALWAYS BEEN A MAJOR CONCERN THAT WE ACTUALLY ARE ABLE TO DO THE STUDIES AND THAT INFORMATION CAN BE USED FOR THE REGULATORY REVIEW PURPOSES. SO SEVERAL PRODUCTS HAVE MOVED THROUGH THE MARKETPLACE AND STUDIES HAVE BEEN DONE WITHIN OUR RESOURCE NETWORK AND WE ENCOURAGE THOSE COLLABORATIONS. SO I WILL END IT WITH THAT. JUST GIVE YOU A LITTLE BIT OF BACKGROUND AND TURN IT BACK OVER TO RASHMI WHO WILL GO THROUGH THE MANY ASPECTS OF THE FOA THAT HAS BEEN PUBLISHED. AND WE WILL BE AVAILABLE FOR QUESTIONS. THANK YOU. >> THANK YOU, DR. GROFT. SO, BRIEFLY ABOUT THE GOAL OF RDCRN. THE PRIMARY GOAL IS TO IDENTIFY BIOMARKERS FOR DISEASE RISK, DISEASE SEVERITY ACTIVITY AND TO IDENTIFY MEASURES OF CLINICAL OUT COMES APPROPRIATE FOR APPLICABILITY TO CLINICAL TRIALS. THIS PROGRAM ALSO ENCOURAGES DEVELOPMENT OF NEW APPROACHES FOR DIAGNOSING, PREVENTING AND TREATING RARE DISEASES. SO AFTER READING THE RFA, I'M SURE YOU ARE NOW FAMILIAR THAT THERE ARE TWO COMPONENTS OF THIS PROGRAM. THE CONSORTIA AND THE DNCC. AND TODAY'S MEETING WILL BE FOCUSED ON THE RDCRC RFA. THIS PROGRAM, THE RDCRN THE NETWORK WHICH CONSISTS OF THE CONSORTIA AND THE NCC IS LED BY OUR OFFICE. AND WE HAVE TEN PARTNERS THIS YEAR. THESE ARE THE PARTICIPATING COLLABORATING IC'S. THE FIRST EIGHT IC'S ARE CONTINUING PARTNERS, AND WE HAVE TWO NEW PARTNERS, NATIONAL ALLIANCE INSTITUTE AND OFFICE OF DIETARY SUPPLEMENTS. SO I LIKE TO SHOW PICTORIAL REPRESENTATIONS. SO THIS JUST SHOWS A PICK CHORAL REPRESENTATION OF THE NETWORK. SO THERE'S THIS ONE CONSORTIUM THE DATA MANAGEMENT COORDINATING CENTER. AND THE PATIENT ADVOCACY GROUPS ARE VERY IMPORTANT PART OF THIS NETWORK. THIS PATIENT ADVOCACY GROUPS WILL BE INTERACTING WITH INDIVIDUAL CONSORTIUM. AS YOU KNOW, THAT THESE CONSORTIA AND THE DATA MANAGEMENT AND COORDINATING CENTER WILL BE FUNDED BY A COOPERATIVE AGREEMENT MECHANISM. SO FROM THE PARTICIPATING INSTITUTE, YOU WILL HAVE PROJECT SCIENTISTS WHO WILL BE YOUR COLLABORATORS. SO COOPERATIVE AGREEMENT MECHANISM AS YOU KNOW IS AN ASSISTANCE MECHANISM, IT'S NOT AN ACQUISITION OR A GRANT MECHANISM. SO I'M GOING TO FOCUS ON RARE DISEASES CLINICAL RESEARCH CONSORTIA RFA. I'M GOING TO CALL IT CONSORTIA FOR SHORT. AND BEFORE I GIVE YOU AN OVERVIEW, I WOULD LIKE TO SHOW YOU THE ORGANIZATIONAL STRUCTURE OF NIH AND I SHOW IT FOR A PURPOSE. OUR OFFICE IS NOW LOCATED WITHIN THE NEWLY CREATED CENTER CALLED NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES OR N-CAP. PREVIOUSLY WE WERE LOCATED WITHIN THE OFFICE OF THE NIH DIRECTOR. WE MOVED AS AN OFFICE TO THIS NEW CENTER N-CAP AND WE CONTINUE TO COLLABORATE WITH VARIOUS INSTITUTES OF NIH. SO AGAIN, I WILL MENTION THAT THE NETWORK WILL CONSIST OF ALL THE FUNDED CONSORTIA AND A SINGLE DATA MANAGEMENT COORDINATING CENTER AND THE SUPPORT WILL BE PROVIDED BY COOPERATIVE AGREEMENT MECHANISM. THE DNCC/RFA FOR THIS NETWORK WILL BE PUBLISHED SEPARATELY. AND I SHOW THIS SLIDE SO THAT YOU CAN APPRECIATE HOW WE MANAGE THIS PROGRAM WITHIN NIH. SO OUR OFFICE WHICH IS LOCATED WITHIN N-CATS PROVIDES THE PROGRAM COORDINATION FOR THE WHOLE PROGRAM AND AT LEAST THE PROGRAM AND WE COLLABORATE, WE WILL COLLABORATE WITH 10 INSTITUTES AND ONE OF THEM IS AN OFFICE OF NIH. NOW THESE PARTICIPATING INSTITUTES, THEY WILL NOT ONLY DO THE AWARDS MANAGEMENT BUT THEY WILL ALSO PROVIDE THE SCIENTIFIC EXPERTISE AS THE PRODUCT SCIENTISTS FROM THIS INSTITUTE. AND MOST OF THEM WILL ALSO PROVIDE FINANCIAL SUPPORT FOR THE AWARD. AND WE WILL HAVE A STEERING COMMITTEE AND I'LL TALK ABOUT THE STEERING COMMITTEE IN A FEW MINUTES. SO THESE ARE THE VARIOUS CONSORTIUM. DON'T PAY ATTENTION TO THE NUMBER OF CONSORTIUM JUST TO MAKE IT LOOK PRETTY, WE PUT THESE BOXES THERE. DATA MANAGEMENT COORDINATING CENTER. AND ALL PARTICIPATING PATIENT ADVOCACY GROUPS. ALL PARTICIPATING PATIENT ADVOCACY GROUPS WILL COLLECTIVELY FORM ON COALITION OF PATIENT ADVOCACY GROUPS, AND THE CHAIRPERSON OF C-PACKAGE OUR COLLATION OF PARTICIPATING ADVOCACY GROUP WILL BE COORDINATOR FOR THE STEERING COMMITTEE NETWORK. SO I'M SURE MOST OF YOU HAVE CONTACTED THE PROGRAMS TASK. THEY ARE ALSO CALLED SCIENTIFIC RESEARCH STAFF FROM THE VARIOUS PARTICIPATING IC'S WHICH ARE LISTED HERE. AND I HOPE YOU HAVE ALSO LOOKED AT THE IC'S SPECIFIC RESEARCH AREA OF INTEREST. THIS IS A VERY IMPORTANT STEP BECAUSE YOU WANT TO MAKE SURE THAT THE PROGRAM YOU ARE PROPOSING FOR YOUR CONSORTIUM AND YOUR RESEARCH AREA OF INTEREST OVERLAPS WITH THE RESEARCH AREA OF INTEREST WITH ONE OF THESE PARTICIPATING IC'S. AND MANY OF YOU HAVE ALREADY SENT ME QUESTIONS WHICH ARE RELATED TO BUDGETS. SO I WILL ALSO URGE YOU TO PLEASE TAKE A LOOK AT THE CONTACT FOR THE GRANT AND FINANCIAL MANAGEMENT FOR EACH OF THESE INSTITUTES LISTED HERE. AND TODAY WE HAVE REPRESENTATION OF PROGRAM STAFF FROM SOME OF THE INSTITUTES. I CAN SEE AT LEAST FOUR OR FIVE INSTITUTES AND OFFICE OF DIETARY SUPPLEMENT. AND WE ALSO HAVE A SENIOR GRANTS MANAGEMENT STAFF FROM NIDDK. SO I'M GOING TO BRIEFLY TELL YOU ABOUT THE TIME LINES FOR RDCRC OR THE CONSORTIA RFA. THE LETTER OF INTENT DATE IS OCTOBER 7TH OF THIS YEAR. AND THE DEADLINE FOR APPLICATION RECEIPT IS NOVEMBER 7TH OF THIS YEAR. THE SCIENTIFIC PEER REVIEW WILL TAKE PLACE SOMETIME IN EARLY 2014. AND THE COUNCIL REVIEW BY APPROPRIATE INSTITUTE WILL TAKE PLACE IN MAY OF 2014. AND EARLIEST ANTICIPATED AWARD DATE IS JULY 2014. SO I KNOW YOU ALL KNOW THAT LETTER OF INTENT IS OPTIONAL. IT IS NOT REQUIRED, IT'S NOT BINDING. AND IT WILL NOT BE SUBMITTED WHEN YOUR APPLICATIONS ARE BEING REVIEWED. BUT THE INFORMATION YOU WILL PROVIDE WILL BE VERY HELPFUL FOR SCIENTIFIC REVIEW OFFICER IN THE AUDIENCE DR. CAROL LAMBERT WHEN SHE PLANS TO REVIEW AND WHEN SHE LOOKS AT THE OVERLOAD OFFICE REVIEW. AND SO WHEN YOU SUBMIT THE LETTER OF INTENT, PLEASE INCLUDE THE NAME OF THE PRINCIPAL INVESTIGATOR WITH THE CONTACT INFORMATION. OTHER KEY PERSONNEL PARTICIPATING INSTITUTIONS. THE NAME OF THE RFA AND THE NAME OF THE PROPOSED CONSORTIUM. AND WE WOULD ALSO APPRECIATE IF YOU WILL PROVIDE A BRIEF DESCRIPTION OF THE PROJECT. AGAIN, THIS IS OPTIONAL. IT IS NOT REQUIRED BUT IT WILL HELP OUR SCIENTIFIC REVIEW OFFICER IN PLANNING THE REVIEW. AND WHEN YOU SUBMIT THESE LOI'S, LETTER OF INTENTS, YOU CAN SEND IT DIRECTLY TO ME AT GOPALR@NIH.GOV. SO DR. GROFT COVERED THIS VERY WELL BUT I'LL BRIEFLY MENTION IT. WHATEVER I'M PRESENTING TODAY HAS BEEN TAKEN FROM THE RFA WHICH HAS BEEN PUBLISHED. THERE ARE LOTS OF BULLETS SO I MAY NOT BE COVERING ALL THE BULLETS. SOMETIMES I WILL BE JUST FLASHING THEM. WE CAN ALWAYS GO BACK TO THE RFA AND CHECK ON THOSE. SO THE PURPOSE IS TO FACILITATE CLINICAL RESEARCH IN RARE DISEASES AND THESE WILL BE DONE THROUGH CLINICAL PROJECTS. LONGITUDINAL STUDIES, NATURAL HISTORY STUDIES AND EVEN CLINICAL TRIALS. AND THE OTHER PURPOSE OF THIS RFA'S ALSO TO PROVIDE TRAINING TO THE INVESTIGATORS, PROVIDE SUPPORT FOR PILOT PROJECTS PROGRAM. AND ALSO TO PROVIDE WEBSITE RESOURCE FOR RESEARCH AND EDUCATION IN RARE DISEASES. AND I'M SURE BY NOW YOU HAVE REALIZED THAT THERE ARE SEVERAL REQUIREMENTS. AND REFERRAL REQUIRED COMPONENTS AND ACTIVITIES FOR THIS RFA. AND INITIALLY I'LL GO OVER IT BRIEFLY AND THEN I WILL TRY TO DESCRIBE IT IN A LITTLE BIT MORE DETAIL. AND BEFORE I DO THAT, I WOULD LIKE TO SAY THAT THIS RFA'S OPEN FOR BOTH NEW GROUPS AND RENEWAL APPLICATIONS. AND WHEN YOU PROPOSE THE PROJECT, PLEASE MAKE SURE THAT YOU ARE FOCUSING ON AT LEAST THREE RARE DISEASES CONDITIONS SYNDROMES OR DISORDERS. AND THIS IS THE REASON I WAS EMPHASIZING THAT YOU MAKE SURE THAT YOU GET IN TOUCH WITH ONE OF THE INSTITUTE PROGRAMS STAFF SO THAT YOU WANT TO MAKE SURE THAT YOUR AREA OF INTEREST, SCIENTIFIC INTEREST OVERLAPS WITH THE SCIENTIFIC AREA OF INTEREST OF ONE OF THE PARTICIPATING INSTITUTES. SO I'LL GIVE YOU AN EXAMPLE. IF YOU ARE PROPOSING SOME RARE DISEASES ON AGING, AGING IS NOT RARE BUT THERE ARE SOME CONDITIONS. AND I KNOW NIA IS NOT PARTICIPATING HERE, SO THERE IS NO OVERLAP OF YOUR SCIENTIFIC INTERESTS WITH ONE OF THE PARTICIPATING INSTITUTES. AND ALL THE REQUIRED COMPONENTS AND THE ACTIVITIES ARE LISTED HERE AS BULLETS. SO FOR EACH CONSORTIUM, YOU MUST PROPOSE MINIMUM OF TWO CLINICAL RESEARCH PROJECTS AND ONE OF THEM MUST BE A LONGITUDINAL STUDY. YOU MUST ALSO INCLUDE PILOT PROJECT PROGRAM, TRAINING COMPONENT. THIS INCLUDES THE RESOURCES WHICH WILL BE EDUCATIONAL AND RESEARCH RESOURCES WHICH WILL BE PUT ON THE CONSORTIUM WEBSITE. AND I WILL TALK ABOUT THIS IN LITTLE BIT MORE DETAIL LATER HOW THIS WILL BE DONE. YOU WILL ALSO INCLUDE AN ADMINISTRATIVE UNIT, AND YOU WILL INCLUDE A PLAN HOW YOU ARE GOING TO COLLABORATE WITH PATIENT ADVOCACY GROUP AS RESEARCH PARTNERS. SO IN OTHER WORDS, EACH CONSORTIUM WILL PERFORM COLLABORATIVE CLINICAL RESEARCH FOCUSED ON A GROUP OF AT LEAST THREE RARE DISEASES THAT ARE RELEVANT TO THE INTEREST OF PARTICIPATING NIH INSTITUTE OR INSTITUTES. I'M SAYING THIS FOR THE THIRD TIME FOR A REASON. AND THE CONSORTIUM WILL CONSIST OF MULTIPLE INSTITUTIONS RELEVANT ORGANIZATIONS INCLUDING PATIENT ADVOCACY GROUPS AS RESEARCH PARTNERS. YOU WILL ALSO BE INVOLVED IN TRAINING THE INVESTIGATORS AND AGAIN PROVIDE A CONTENT FOR INTERNET RESOURCE SITE ON RARE DISEASES. SO WHEN YOU ARE PUTTING YOUR APPLICATION TOGETHER, THERE IS A SECTION WHICH IS CALLED OVERALL. SO HERE YOU WILL PROVIDE DESCRIPTION FOR OVERALL CLINICAL RESEARCH PROGRAM, LEADERSHIP AND RESOURCES. AND YOU WILL COVER VARIOUS BULLETS WHICH I MENTION HERE. SO UNDER PROGRAM INTRODUCTION AND STATEMENT OF OBJECTIVES, YOU WILL DESCRIBE THE GROUP OF RARE DISEASES. THE RATIONALE FOR GROUPING THOSE RARE DISEASES AND THE EXPERTISE WHICH IS PRESENT IN THE CONSORTIUM WHICH YOU ARE GOING TO PROPOSE. UNDER SCIENTIFIC AND ADMINISTRATIVE LEADERSHIP EMPHASIZE ON THE QUALIFICATION OF THE PRINCIPAL INVESTIGATOR. FOR THE MULTIDISCIPLINARY TEAM, DO INDICATE HOW YOU ARE GOING TO COLLABORATE WITH THE PATIENT ADVOCACY GROUP AND HOW YOU ARE PLANNING TO FULLY INCORPORATE THEM IN YOUR ACTIVITIES WITHIN THE CONSORTIUM. FOR RARE DISEASES PATIENT POPULATION, DOCUMENT THAT YOU HAVE ACCESS TO THE RARE DISEASES PATIENT. AND FOR WEBSITE FOR EDUCATION AND RESEARCH, I JUST TALKED ABOUT IT A MINUTE AGO. MAKE SURE THAT YOU PROVIDE A RESOURCE SHARING PLAN. AND FOR INSTITUTIONAL COMMITMENT, MAKE SURE THAT YOU PROVIDE A STATEMENT WHICH ADDRESSES HOW THIS WILL BE ESTABLISHED AND SUSTAINED. AND HOW YOUR PROPOSED CONSORTIUM RESEARCH EFFORT WILL BE GIVEN PRIORITY AT YOUR INSTITUTION. AND INSTITUTIONAL COMMITMENT CAN COME IN VARIOUS FORMS. SO YOU MAY RECEIVE A PROVISIONAL, A PROVISION FOR DISCRETIONARY RESOURCES OR YOU MAY GET SUPPORT FOR RECRUITING CLINICAL INVESTIGATOR. OR YOU MAY GET A RESEARCH SPACE OR YOU MAY GET SUPPORT FOR SUPPORTING YOUR TRAINING CANDIDATES OR YOU MAY GET SUPPORT FOR PILOT PROJECTS. IT COMES IN VARIOUS FORMS AND VARIES FROM INSTITUTION TO INSTITUTION. MAKE SURE YOU HAVE INFORMATION FROM PATIENT ADVOCACY GROUPS. IF YOU HAVE RESOURCES AVAILABLE TO YOU LIKE CLINICAL FACILITY, LAB FACILITY INCLUDE THEM ALL. IF YOUR INSTITUTION IS WITHIN AN INSTITUTION WHICH ALSO HAS CLINICAL AND TRANSLATIONAL SCIENCE AWARD, YOU ARE ENCOURAGE TO USE THOSE RESOURCES WHICH ARE AVAILABLE IN CTSA INSTITUTION. SO AS I SAID EARLIER YOU MUST PROPOSE TWO PROJECTS AND ONE OF THEM MUST BE LONGITUDINAL STUDY. PROVIDE A RATIONALE FOR THE PLANNED CLINICAL STUDIES AND INCLUDE THE STRATEGIES FOR RECRUITMENT RETENTION ASSESSMENT AND ANALYSIS. FOR THE CLINICAL STUDIES YOU CAN ALSO PROPOSE CLINICAL TRIALS BUT INCLUDING A CLINICAL TRIAL IS NOT A REQUIREMENT OF THIS RFA. SO AGAIN, WHEN YOU ARE PROPOSING THESE CLINICAL PROJECTS, CAPE IN MIND THAT WHEN YOU PROPOSE A LONGITUDINAL STUDIES THEY CAN CHARACTERIZE AND MOST COMPLETELY DEFINE THE DISEASE AND ITS COURSE FOR THE RARE DISEASES. AND ASK QUESTIONS, WHAT KNOWLEDGE OR TOOLS LIKE OUTCOME MEASURES FEATURES OF DISEASE COURSE, MARKERS OF DISEASE OR SUBPOPULATION OF RARE DISEASE THAT MAY ALTER DISEASE COURSE ARE NEEDED REGARDING THE RARE DISEASE IN ORDER TO DESIGN EFFICIENT EFFICACY TRIALS FOR THESE RARE DISEASES. WHICH MAY BECOME AVAILABLE LATER. SO FOR PILOT DEMONSTRATION PROJECT PROGRAM, I'VE RECEIVED SEVERAL INQUIRIES ABOUT THIS ONE. SO I'LL TRY TO INCLUDE THOSE ANSWERS WITHIN THIS PRESENTATION. IN CONTRAST TO THE CLINICAL RESEARCH PROJECTS COMPONENT, THE PILOT PROJECTS WILL BE FOR A SHORTER DURATION. ONE TO TWO YEARS. AND YOU HAVE TO MAINTAIN THIS PILOT PROJECT PROGRAM THROUGHOUT THE FIVE YEARS ON AN ONGOING BASIS. AND THE START AND END DATE OF A PILOT PROJECT WILL DEPEND ON WHAT AND WHEN YOU ARE GOING TO PROPOSE. SO WHEN YOU ARE SUBMITTING APPLICATION, I WOULD SAY YOU INCLUDE THE EXAMPLES OF THE KINDS OF PILOT PROJECTS YOU PLAN TO DO AND DESCRIPTION OF AT LEAST ONE PILOT PROJECT WHICH YOU WOULD LIKE TO START IN YEAR ONE. REMEMBER, THAT THE REVIEWERS WILL BE LOOKING AT A PLAN WHICH WILL ADDRESS HOW TO ATTRACT NEW IDEAS AND PILOT STUDIES. SO MAKE SURE THAT YOU INCLUDE A PLAN. AND ALSO YOU WILL CONTINUOUSLY REVIEW AND FUND A SPECTRUM OF PILOT PROJECTS. SO IT'S VERY IMPORTANT WHEN YOU ARE WRITING YOUR APPLICATION NOT ONLY LOOK AT THE VARIOUS COMPONENTS AND REQUIREMENTS BUT ALSO CHECK THE REVIEW CRITERIA. WE HAVE TRIED TO WRITE THE REVIEW CRITERIA WHICH WILL COVER WHAT IS COVERED WITHIN THE REQUIRED COMPONENTS WHICH YOU WILL BE PROVIDING IN THE APPLICATION. BUT IT'S IMPORTANT THAT YOU DO TAKE A LOOK AT THE REVIEW CRITERIA. SO TRAINING COMPONENT IS ANOTHER REQUIREMENT FOR THIS RFA. AND WHEN YOU ARE WRITING THIS SECTION, PLEASE INCLUDE A PLAN WITH ELIGIBILITY CRITERIA AND PROCESS FOR SELECTING CANDIDATES. YOU MUST INCLUDE MINIMUM OF 50,000 DIRECT COSTS PER YEAR FROM YOUR CONSORTIUM BUDGET FOR THIS PROGRAM AND AGAIN THIS PROGRAM HAS TO BE MAINTAINED THROUGHOUT THE AWARD FIVE YEARS. SO YOU MUST TRAIN AT LEAST TWO TRAINEES WITHIN THE FIVE YEAR PERIOD. WE ALSO REQUEST YOU TO INCLUDE ON PLAN FOR SELECTION AND FOR THE CRITERIA FOR ELIGIBILITY AS WELL AS MENTION WHAT QUALIFICATIONS OF THE MENTORS WILL BE REQUIRED FOR THESE CANDIDATES. DON'T NAME THE NAMES OF THE MENTORS BUT JUST INCLUDE THE QUALIFICATION AND THE RESEARCH ACTIVITIES OF THE MENTORS. THIS PROGRAM IS MEANT FOR CLINICAL FELLOWS AND JUNIOR FACULTY LIKE ASSISTANT PROFESSOR, RESEARCH FACULTY OR INSTRUCTORS. OR AN ADVANCED LEVEL POST DOCTORATE FELLOW. YOU CAN ALSO INCLUDE A SENIOR PROFESSOR WHO IS TRYING TO REORIENT THEIR RESEARCH COURIER GOING FROM BASIC TO CLINICAL. SO THIS IS AN OPPORTUNITY FOR THEM ALSO. SO AGAIN, I WILL NOT BE GOING OVER ALL THE BULLETS, BUT YOU NEED TO INCLUDE THE RESOURCES FOR RESEARCH AND EDUCATION FOR THE RARE DISEASES WHICH WILL BE PUT ON THE WEBSITE. AND THIS WEBSITE WILL BE CREATED WITH THE HELP OF THE DATA MANAGEMENT AND COORDINATING CENTER. THEY WILL HELP YOU PUTTING ALL THESE RESOURCES ON THE WEBSITE. AND YOU MUST AGREE TO WORK COOPERATIVELY TO DEVELOP THIS WEBSITE RESOURCE. AND YOUR PATIENT ADVOCACY GROUP WILL ALSO BE INVOLVED IN HELPING YOU WITH SETTING UP THIS WEBSITE. SO ADMINISTRATIVE UNIT IS ANOTHER REQUIRED COMPONENT FOR THIS RFA. AND YOU WILL BE, THIS PARTICULAR UNIT WILL BE RESPONSIBLE FOR OVERALL ADMINISTRATION OF THE PROPOSED CONSORTIUM. ALL THE COORDINATING ACTIVITIES WITHIN THE CONSORTIUM AND OUTSIDE THE CONSORTIUM WHICH MEANS WITH THE DATA MANAGEMENT COORDINATING CENTER, OUR OFFICE AND THE PARTICIPATING INSTITUTE AND THE PATIENT ADVOCACY GROUP. SO WHEN YOU ARE WRITING THIS SECTION OF THE APPLICATION, INCLUDE ALL THE CHAIN OF RESPONSIBILITY AND DECISION-MAKING AND ADMINISTRATION. YOU CAN INCLUDE A FLOW DIAGRAM IF IT WORKS FOR YOU. INCLUDE ALL PLANS FOR COMMUNICATION WITH ALL THE MEMBERS OF THE CONSORTIUM. YOU MAY BE PLANNING ON WEEKLY MEETINGS OR MONTHLY MEETINGS. PLEASE INCLUDE THE DETAILS. AND I HAVE HAD SEVERAL QUESTIONS ABOUT THIS ADMINISTRATIVE DIRECTOR. IN FACT I RECEIVED A COUPLE TODAY ALSO BEFORE COMING HERE. SO THIS ADMINISTRATIVE DIRECTOR IN THE PREVIOUS VERSION OF THE RFA WAS A CO-PI. BUT THIS TIME THE TEMPLATE WE USED, WE HAVE TO USE TEMPLATES WHEN WE PUBLISHED RFA'S AND TA'S. WE WERE NOT ALLOWED TO USE THE WORD CO-PI BECAUSE THAT'S NOT AN OFFICIAL DESIGNATION FOR NIH. SO THIS ADMINISTRATIVE DIRECTOR IS NOT SUPPOSED TO BE A PROGRAM ANALYST OR JUST AN ADMINISTRATOR. SO IT'S -- PI I CAN SAY. SO THIS PERSON WILL BE INVOLVED IN ASSISTING THE PI OF THE CONSORTIUM ON DAY-TO-DAY BASIS. AND DURING THE PROGRAM COORDINATING PLANNING AND EVALUATION AND WILL ALSO REPRESENT THE PI IN THE ABSENCE OF THE PI. THIS IS THE SECTION WHERE YOU WILL DESCRIBE THE SUPPORT FOR YOUR CONSORTIUM. AND THE BIO STATISTICAL SUPPORT, THE BIO STATISTICIAN IS SUPPOSED TO BE INVOLVED IN DESIGNING THE PROTOCOL AND ALSO ASSISTING IN THE ANALYSIS OF THE STUDIES. AND AGAIN, I CANNOT EMPHASIZE ENOUGH THAT YOU MUST INCLUDE A PLAN TO FULLY INCORPORATE THE RELEVANT PATIENT ADVOCACY GROUP AND INCLUDE THEM AS RESEARCH PARTNERS. MAKE SURE WHEN YOU'RE PROPOSING THE ACTIVITIES FOR THESE PATIENT ADVOCACY GROUP YOU CONSULT WITH THEM AND THOSE ACTIVITIES MAKE SURE THAT THEY ARE APPROPRIATE FOR THE LEVEL OF THE PATIENT ADVOCACY GROUPS. BECAUSE YOU KNOW THERE IS A WAY VARIETY OF AMONG THESE PATIENT ADVOCACY GROUPS. SOME ARE VERY SMALL, SOME ARE HUGE, SOME HAVE LARGE FINANCIAL RESOURCES OTHERS DON'T HAVE. JUST A REMINDER FOR THE RENEWAL APPLICATION THAT ADDITIONAL MATERIAL IS REQUIRED SO MAKE SURE THAT YOU READ THE RFA CAREFULLY AND DOCUMENT ADDITIONAL MATERIAL REQUIRED AND ALSO THERE ARE ADDITIONAL REVIEW CRITERIA IN YOUR APPLICATION. I'M NOT GOING TO GO OVER THE BULLETS. I THINK I'VE SAID THIS ENOUGH TIMES. THIS IS JUST A SUMMARY OF ALL THE REQUIRED COMPONENTS AND THE ACTIVITIES FOR THIS RDCRC APPLICATION. SO REMEMBER, THIS IS THE NETWORK OF CONSORTIA AND YOU AS THE PI OF THIS CONSORTIUM WILL BE PROPOSING THE DIRECTION AND ORGANIZATION. AND ALL FUNDING CONSORTIA AND A SINGLE DATA MANAGEMENT COORDINATING CENTER WILL FORM THE NETWORK. THE OVERSIGHT WILL BE PROVIDED BY THE NETWORK STEERING COMMITTEE. ALL PARTICIPATING PATIENT ADVOCACY GROUPS WILL COLLECTIVELY FORM A COALITION OF PATIENT ADVOCACY GROUP. AND AGAIN, THE LAST BULLET I TRIED TO INCLUDE THIS BECAUSE THERE WERE SEVERAL QUESTIONS ABOUT THE TOTAL BUDGET CONSORTIUM CAN REQUEST. IT'S 1.25 MILLION TOTAL COST PER YEAR, MULTIPLIED BY FIVE FOR FIVE YEARS. SO IT'S NOT 1.25 MILLION TOTAL COST FOR FIVE YEARS. SO THE RDCRN STEERING COMMITTEE, THE AWARDING MEMBER WILL BE THE PI'S OF ALL FUNDING CONSORTIA. THE PI OF DATA MANAGEMENT COORDINATING CENTER. THE PROJECT SCIENTIST OF ALL PARTICIPATING IC'S WILL HAVE COLLECTIVELY ONE VOTE. ONE VOTE FOR THE OVERALL PROGRAM COORDINATOR FOR RDCRN. AND THE C-PAG WILL ALSO HAVE A VOTE. ONE PI WILL BE SELECTED AS A CHAIRPERSON FOR THIS STEERING COMMITTEE FOR THIS NETWORK AND THERE WILL BE OTHER INVITEES NON-VOTING MEMBERS. THE STEERING COMMITTEE WILL BE RESPONSIBLE FOR REVIEWING, FACILITATING AND ESTABLISHING ALL NETWORK PROCEDURES. AND FUNCTIONS. AND THE MEMBERS WILL BE MEETING THROUGH MONTHLY TELEPHONE CONFERENCE CALL AND WE WILL ALSO HAVE TWO FACE-TO-FACE MEETINGS IN WASHINGTON METRO AREA. AGAIN I'M A VISUAL PERSON SO I'LL SHOW YOU THE SAME THING, THE STEERING COMMITTEE ORGANIZATION. ALL THE PI'S OF THE CONSORTIA, C-PAG, SCIENTISTS AND RDCRN COORDINATOR. I WOULD LIKE TO MENTION A LITTLE BIT ABOUT THE REVIEW OF APPLICATION. SO THE REVIEW OF APPLICATION WILL BE DONE THROUGH A SPECIAL EMPHASIS PANEL. THIS WILL NOT BE DONE THROUGH AN EXISTING STUDY SECTION. THE REVIEWERS WILL BE INVITED BY THE SCIENTIFIC REVIEW OFFICER, DR. CAROL LAMBERT. AND THE EXPERTISE WILL DEPEND ON THE APPLICATIONS WE RECEIVE. AND BASED ON THE EXPERTISE NEEDED, THE SPECIAL EMPHASIS PANEL WILL BE CREATED. THIS PANEL WILL REVIEW THE RESPONSES, THE APPLICATIONS WHICH ARE RECEIVED IN RESPONSE TO THIS. AND SPECIAL INSTRUCTIONS WILL BE GIVEN TO THE REVIEWERS BECAUSE THEY ARE SPECIAL REVIEW CRITERIA. SO THE SCIENTIFIC PEER REVIEW PROCESS AGAIN AS I SAID WILL BE DRIVEN BY THE NUMBER OF APPLICATIONS. WE PLAN TO USE AN EXPEDITED REVIEW PROCESS. IT WAS CALLED TRIAGING BASICALLY ALL THE APPLICATIONS WILL UNDERGO A SELECTION PROCESS. AFTER LOOKING AT THE SCIENTIFIC AND TECHNICAL MERIT. AND USUALLY THE TOP HALF WILL RECEIVE A SCORE. AND DR. LAMBERT IS HERE SO LATER ON DURING QUESTION AND ANSWER SESSION SHE CAN ANSWER YOUR QUESTIONS. AND EACH APPLICATION WILL RECEIVE WRITTEN CRITIQUE. NOW, I'M GOING TO FLASH A FEW MORE SLIDES AND REMEMBER I WILL BE SHOWING YOU SOME REVIEW CRITERIA AND THESE ARE NOT INCLUSIVE OF ALL REVIEW CRITERIA TO LOOK AT ALL OF THE REVIEW CRITERIA, PLEASE SEE THE RFA. SO FOR THE CLINICAL RESEARCH PROJECTS, YOU WILL SEE FIVE HEADINGS SIGNIFICANCE APPROACH, INNOVATION INVESTIGATORS AND ENVIRONMENT WHICH ARE USED FOR ALL MECHANISM. BUT THE REVIEW CRITERIA MENTIONED UNDER THESE CATEGORIES ARE SPECIAL REVIEW CRITERIA FOR THIS PARTICULAR RFA. FOR PILOT DEMONSTRATION PROJECTS, I HAVE JUST PUT FEW REVIEW CRITERIAS WHICH THE REVIEWER WILL BE LOOKING AT FOR EXAMPLE DOES THE PROPOSED PLAN ADDRESS ATTRACTING NEW IDEAS AND PILOT STUDIES WITHIN THE CONSORTIA INSTITUTIONS. FOR THE SAKE OF TIME I'M NOT GOING TO REVIEW THESE REVIEW CRITERIA I'M JUST FLASH THEM. YOU HAVE A COPY, HARD COPY OF THESE SLIDES AT THE BACK OF THE ROOM. AND WE WILL ALSO POSE A SOFT COPY OF THESE SLIDES ON OUR OFFICE WEBSITE AND ALSO ON THE VIDEOCAST WEBSITE. AND AGAIN, FOR RENEWAL APPLICATION, THERE ARE SPECIAL ADDITIONAL REVIEW CRITERIAS. SO MAKE SURE THAT YOU TAKE A LOOK AT THEM. FOR ADMINISTRATIVE UNIT, THERE ARE REVIEW CRITERIAS WHICH ARE SPECIFIC FOR DEMONSTRATIVE UNIT. AND IF YOU LOOK AT THE OVERALL, AGAIN THERE ARE THOSE FIVE CATEGORIES SIGNIFICANCE, INNOVATION, INVESTIGATOR APPROACH AND ENVIRONMENT. BUT UNDER THOSE CATEGORIES, THERE ARE SPECIAL REVIEW E, UNDER INVESTIGATORS, THERE'S REVIEW CRITERIA FOR LEADERSHIP WHICH IS MENTIONED HERE. UNDER A PROCESS THE REVIEW CRITERIA FOR RARE DISEASES PATIENT POPULATION. AND SEVERAL REVIEW CRITERIA FOR INSTITUTIONAL COMMITMENT. AND SPECIAL REVIEW CRITERIA FOR INVOLVING PATIENT ADVOCACY GROUP. THERE ARE SOME ADDITIONAL REVIEW CRITERIA WHICH ARE PART OF THE NIH AND MOST OF THE REVIEWS. AND I'M SURE YOU ARE FAMILIAR WITH THOSE. AND I MENTIONED THIS PREVIOUSLY, THERE ARE CRITERIA FOR THE PROGRESS OF RENEWAL APPLICATION, SO PLEASE DO TAKE A LOOK AT THEM. AND THERE ARE ADDITIONAL REVIEW CONSIDERATIONS. AND IF YOU READ THE LAST RFA, THIS IS THE ONLY MINOR CHANGE IN THIS RDCRFA WE'RE ASKING YOU TO PROVIDE A PLAN FOR STREAMLINING MULTISITE PROTOCOL APPROVAL PROCESS. YOU ARE NOT REQUIRED TO HAVE A CENTRAL IRD OR A SHARED IRD. THAT'S THE EVENTUAL GOAL LATER ON, BUT IF YOUR CONSORTIUM CAN DO THAT, THAT WOULD BE GREAT. IF YOU CAN NOT DO THAT, DO PROPOSE A PLAN HOW YOU PLAN TO STREAMLINE THIS MULTISITE PROTOCOL APPROVAL PROCESS TO MAKE IT EFFICIENT AND RAPID. SO THE REVIEW AND SELECTION PROCESS FOR AWARDS WILL DEPEND ON THE SCIENTIFIC MERIT OF THE PROPOSED CONSORTIUM AVAILABLE TO YOUR FUND. RELEVANCE TO THE NIH INSTITUTE AND OUR OFFICE. JUST A FEW REMINDERS. REMEMBER, THIS IS A PAPER SUBMISSION NOT ELECTRONIC SUBMISSION. IT'S ALL MENTIONED IN THE RFA. I'M JUST REMINDING YOU HERE BECAUSE I DID GET QUESTIONS ABOUT THIS. INCLUDING ALL REQUIRED AND RECOMMENDED COMPONENTS AND FOLLOW THE SUGGESTIONS ON PAID RECOMMENDATIONS, THE LIMITS. AND I HAVE A SEPARATE SLIDE FOR THAT AND I'LL SHOW YOU. FOLLOW THE NIH INSTRUCTIONS ON APPENDIX MATERIAL. THERE IS A URL IN THE RFA SO PLEASE CHECK THAT. REMEMBER THESE WILL BE COOPERATIVE AGREEMENT AWARDS, SO THERE ARE TERMS AND CONDITIONS FOR THE COOPERATIVE AGREEMENTS. THERE WILL BE CERTAIN RESPONSIBILITIES FOR THE PI. THERE WILL BE CERTAIN RESPONSIBILITIES AND ROLES OF YOUR COLLABORATORS, THE PROJECT SCIENCE INSTITUTE, AND THERE WILL BE CERTAIN COLLABORATIVE RESPONSIBILITIES. AND THESE ARE ALL MENTIONED IN THE TERMS AND CONDITIONS OF COOPERATIVE AGREEMENT. AND READ THE REVIEW CRITERIA CAREFULLY TO UNDERSTAND THE BASIS FOR THE EVALUATION. NOW FOR PAGE LIMITATIONS. FIRST OF ALL, YOU FOLLOW THE PAGE LIMITATIONS WHICH ARE DESCRIBED IN THE 398 APPLICATION GUIDE. THE FOLLOWING PAGE LIMITATIONS ARE FOR THE RESEARCH STRATEGY SESSION OF EACH COMPONENT OF THE APPLICATION. FOR OVERALL, YOU HAVE 12 PAGES. FOR CLINICAL RESEARCH PROJECT YOU HAVE 12 PAGES FOR EACH PROJECT. FOR THE RESEARCH STRATEGY SECTION. FOR PILOT PROJECT PROGRAM YOU HAVE 12 PAGES. FOR TRAINING COMPONENT YOU HAVE SIX PAGES. AND FOR THE ADMINISTRATIVE UNIT, YOU HAVE SIX PAGES. AGAIN, READ AND FOLLOW THE INSTRUCTIONS IN 398. THIS WAS REVISED IN THE AUGUST OF LAST YEAR. MAKE SURE YOUR APPLICATION IS COMPLETE. IT'S OBVIOUS BUT, AND FOR SUPPLEMENTAL MATERIALS, AFTER THE RECEIVE DATE, THERE ARE TWO NOTICES. TAKE A LOOK AT THEM. AND AGAIN OUR FRO DR. LAMBERT IS HERE, IF YOU HAVE ANY QUESTIONS I'M SURE SHE WILL BE HAPPY TO ANSWER. AND OTHER OBVIOUS THINGS WHICH I MENTIONED IN THE NEXT BULLETS INVOLVED TARGETED PLAN ENROLLMENT TABLES FOR YOUR CLINICAL RESEARCH PROJECTS. AND DATA SAFETY AND MONITORING REQUIREMENTS. AND HAVE A STATISTICIAN ASSESS THE POWER FOR ALL CLINICAL RESEARCH PROJECTS. AGAIN, I'LL SAY THIS AGAIN. THIS NETWORK WILL INCLUDE CONSORTIA AND ONE DNCC. THIS IS A COOPERATIVE AGREEMENT PROGRAM AND THIS REQUIRES COOPERATION AMONGST ALL CONSORTIA, DATA MANAGEMENT COORDINATING CENTER. THE PROGRAM STAFF, PROJECT SCIENTIST AND PROGRAM OFFICERS FROM THE PARTICIPATING INSTITUTE. AND THE RDCRN PROGRAM COORDINATOR FROM OUR OFFICE. AND NUMBER OF ISSUES NEED TO BE ADDRESSED. SO PLEASE PAY ATTENTION TO THAT. I'M SAYING THIS FOR THE FOURTH TIME. PLEASE GET IN TOUCH WITH THE INSTITUTE PROGRAM STAFF. TO DISCUSS YOUR PROJECT, YOUR CONSORTIUM, THE RARE DISEASES YOU ARE PLANNING TO STUDY. AND WHAT I WILL DO IS I WILL MAKE THIS MEETING OPEN FOR THE QUESTIONS. AND WHAT I PLAN TO DO IS I HOPE IT'S OKAY WITH ALL OF YOU TO GO OVER THE QUESTIONS WHICH WE HAVE ALREADY RECEIVED. AND I'LL QUICKLY GO OVER IT AND THEN WE WILL GET QUESTIONS FROM ALL OF YOU WHO ARE IN THE ROOM. AND THEN WE WILL GET THE QUESTIONS FROM THOSE WHO ARE ON VIDEOCAST AND THEY CAN SEND AN E-MAIL TO ORDR@MAIL.NIH.GOV AND WE WILL TRY TO ANSWER THOSE QUESTIONS. I WOULD LIKE TO REQUEST DR. RANDY STEWART TO PLEASE COME ON THE TABLE. HE'S THE PROGRAM OFFICER FOR THE DATA MANAGEMENT AND COORDINATING CENTER. I WILL ALSO REQUEST PAMELA LOVE TO PLEASE COME. SHE'S A SENIOR GRANTS MANAGEMENT STAFF FROM NIDDK. I HAVE SEVERAL OF MY COLLEAGUES IN THE AUDIENCE SO PLEASE FEEL FREE TO ANSWER THE QUESTIONS IF I HESITATE OR IF YOU HAVE ADDITIONAL INFORMATION. DR. REBECCA -- IS HERE -- KATHY FROM ODS IS HERE AND I MENTIONED CAROL LAMBERT, A COUPLE OF MY COLLEAGUES DR. JOHN FERGUSON AND -- BROOKS JIM -- IS HERE AND CLAUDIA -- IS HERE AND LINDA GRIFFITH IS HERE. AND IF I FORGET SOMEBODY, PLEASE ... AND LAURA -- FROM NINDS IS HERE. SO I'LL TRY TO GO QUICKLY OVER THESE QUESTIONS. SIMPLE ONE BUT WHAT IS THE DEFINITION OF RARE DISEASE. ANY RARE DISEASE OR CONDITION WHICH HAS A PREVALENCE OF FEWER THAN 200,000 AFFECTED INDIVIDUALS IN THE UNITED STATES IS CONSIDERED A RARE DISEASE. CAN WE PROPOSE MULTIPLE PI? ANSWER IS NO. IS RFA OPEN TO THOSE CONSORTIA WHICH WERE PREVIOUSLY FUNDED TO REAPPLY FOR ADDITIONAL FUNDING? YES. YOU CAN APPLY BUT WHEN YOU APPLY, MAKE SURE THAT YOU'RE APPLYING AS A NEW APPLICATION. DO NOT INCLUDE THE COMMENTS FROM REVIEWERS FROM YOUR PREVIOUS SUBMISSION. SO THERE WERE SOME GROUPS WHO APPLIED LAST TIME. THEY MAY WANT TO APPLY THIS TIME AGAIN. APPLY IT AS A NEW APPLICATION. HOW SHOULD I DO THE GROUPING OF RARE DISEASES TO BE PROPOSED IN MY RDCRC APPLICATION. SO AGAIN WITHOUT GOING INTO THE DETAILS, THERE ARE VARIOUS WAYS YOU CAN GROUP YOUR DISEASES BY PARTICULAR DEFECT SUCH AS AMINO ACID METABOLISM DEFECT, BY PARTICULAR ORGAN SYSTEMS. AND VARIOUS OTHER WAYS. AGAIN, GET IN TOUCH WITH THE PROGRAM STAFF OF THE INSTITUTE TO DISCUSS WHICH RARE DISEASES YOU ARE PLANNING. AND I'M USING DISEASES IN A BROAD TERM. THESE COULD BE CONDITIONS OR SYNDROMES. SO GET IN TOUCH WITH THE PROGRAM STAFF OF THE INSTITUTE AND DISCUSS THOSE. SUBMISSIONS FROM AN APPLICATION FROM A FOREIGN INSTITUTION NON-USA INSTITUTIONS. FOREIGN INSTITUTIONS ARE NOT ALLOWED TO SUBMIT AN APPLICATION BUT THEY ARE ALLOWED TO BE A COMPONENT OF THIS APPLICATION. YOU CAN BE A SITE OF THE PROPOSED CONSORTIUM OR YOU CAN BE A PROJECT LEADER. SO THOSE KIND OF COLLABORATIONS ARE ALLOWED. I TALKED ABOUT THE CAP ON THE BUDGET, IT'S 1.25 MILLION TOTAL COST PER YEAR MULTIPLIED BY FIVE YEARS. CAN AN ADMINISTRATIVE PI WHICH I'M CALLING CO-PI BUT OFFICIALLY I CANNOT CALL CO-PI CAN BE FROM A DIFFERENT INSTITUTION. YES, HE OR SHE CAN BE FROM A DIFFERENT INSTITUTION AS LONG AS THEY CAN PERFORM THEIR ROLES AND RESPONSIBILITIES AS THE ADMINISTRATIVE PI. IS INDIVIDUAL DATA MANAGEMENT QUALITY CENTER REQUIRED FOR EACH CONSORTIUM. NO, THERE WILL BE A SINGLE DATA MANAGEMENT COORDINATING CENTER FOR THIS NETWORK. AND YOU ARE EXPECTED TO USE THAT DATA MANAGEMENT COORDINATING CENTER. WILL ORDR HELP US PUTTING OUR RESOURCES ON THE WEBSITE? NO. ORDR WILL NOT HELP. THE DATA MANAGEMENT AND COORDINATING CENTER WILL HELP PUTTING YOUR RESOURCES ON YOUR CONSORTIUM WEBSITE. CAN TWO INSTITUTES FROM THE NIH PROVIDE SCIENTIFIC OVERSIGHT. YES. ONE INSTITUTE WILL BE PRIMARY AND OTHER WILL BECOME SECONDARY. AND EVEN IN THE CURRENT NETWORK, WE DO HAVE SEVERAL CONSORTIA WHERE THERE ARE MORE THAN ONE INSTITUTE OF NIH COLLABORATING WITH THEM. AND ONE OF THE INSTITUTES TAKES THE PRIMARY RESPONSIBILITY AND ANOTHER ONE BECOMES THE SECONDARY. COULD AN INTRAMURAL NIH INTRAMURAL PROGRAM PARTICIPATE IN CONSORTIUM AND RECEIVE FUNDS FROM THE RFA? WE CAN PARTICIPATE AS AN INTRAMURAL INVESTIGATOR FROM NIH BUT YOU CANNOT RECEIVE FUNDS FROM THIS RFA. WHAT IS THE DIFFERENCE BETWEEN -- >> THEY CAN USE THE DMCC. >> YES. >> YES, THANK YOU. >> THERE WERE A LOT OF QUESTIONS ABOUT WHETHER THERE'S A REQUIREMENT FOR THE PI OF THE RDCRC CONSORTIUM TO BE THE PROJECT LEADER FOR ONE OF THE PROJECTS. THERE IS NO REQUIREMENT FOR THE PI OF THE CONSORT ANNUAL -- CONSORTIUM TO BE THE PROJECT LEADER. IN ADDITION TO BEING THE PI OF THE WHOLE CONSORTIUM YOU WILL ALSO BE A PROJECT LEADER. YOU MUST DEVOTE 1.2 MONTHS FOR BEING THE PROJECT LEADER. AND OTHERWISE, IF YOU ARE NOT THE PROJECT LEADER, SOME OTHER INVESTIGATOR IS, THEY MUST PUT 1.8 MONTHS. SOMEBODY ASKED ME IF THIS WAS A TYPO OR MISTAKE. NO THIS IS NOT A TYPO OR MISTAKE, THIS IS WHAT WE MEANT. >> CAROL, DO YOU MIND COMING HERE AND SITTING HERE BECAUSE THERE ARE SEVERAL QUESTIONS FOR YOU ALSO. >> RASHMI, THIS IS RANDY. WHEN YOU TALKED ABOUT THE WEBSITE, SOMETIMES CONSORTIUM PI WILL THINK THAT HE OR SHE WILL HAVE TO ESTABLISH A WEBSITE. THAT'S NOT THE CASE. THE CONSORTIUM WILL SUPPLY THE CONTENT TO AN EXISTING WEBSITE THAT'S RUN BY THE DATA MANAGEMENT COORDINATING CENTER. SO IT'S ALREADY BEEN BUILT AND IT'S BEING MAINTAINED. >> YES. >> YOU JUST AS A CONSORTIUM APPLICANT YOU PROVIDE THE CONTENT THAT'S ALL. >> THROUGH YOUR APPLICATION YOU WILL JUST MENTION THOSE RESOURCES WHICH YOU WILL BE PROVIDING ON THAT WEBSITE. YOU MENTIONED THOSE RESOURCES. I HAVE A FEW QUESTIONS HERE AND THEN WE'LL TAKE THE QUESTIONS FROM YOU GUYS. SO THERE WERE A COUPLE QUESTIONS, CAROL, YOU CAN ANSWER. SO THE FIRST ONE IS WILL REVIEWERS HAVE ACCESS TO COLORED IMAGES, FIGURES, GRAPHS, DIAGRAMS. >> THIS IS A CARRYOVER FROM THE LAST OF THE PAPER APPLICATIONS. AND THE ANSWER IS YOU WILL BE SUBMITTING YOUR IMAGES IN A PAPER APPLICATION. YOU DO HAVE THE OPTION BECAUSE WE WILL SCAN THOSE IMAGES AND THEY WILL END UP IN BLACK AND WHITE FOR REVIEWERS. YOU HAVE THE OPTION AND THERE ARE VERY SPECIFIC GUIDELINES FOR THAT OF SUBMITTING HIGH QUALITY IMAGES WITH RESPECT TO SCIENTIFIC PHOTOGRAPHS AND ITEMS SUCH AS THAT. AND WE CAN MAKE THOSE AVAILABLE TO REVIEWERS SEPARATELY. >> THANK YOU, CAROL. >> THAT WOULD BE PART OF AN APPENDIX. >> AND CAN YOU MENTION SOMETHING ABOUT POST APPLICATION SUBMISSION MATERIALS JUST BRIEFLY. >> BRIEFLY, THE POST APPLICATION MATERIAL POLICY WAS REVISED RELATIVELY RECENTLY. IT'S FAIRLY STRICT. WE CAN UP TO 30 DAYS AHEAD OF THE REVIEW, EXCEPT LIMITED INFORMATION SUCH AS A CHANGE OF PI AND A NEW BIO SKETCH. ADMINISTRATIVE CHANGES THAT WERE NOT KNOWN TO THE APPLICANTS AT THE TIME OF REVIEW. AND YOU FORGOT TO PUT IN A BIO SKETCH, THAT DOES NOT COUNT AS TO TAKE AS CLOSE SUBMISSION MATERIAL. IT'S STRICTLY INFORMATION THAT HAPPENED AFTER YOU SUBMITTED YOUR APPLICATION. >> THANK YOU, CAROL. THERE WAS A QUESTION ON WHETHER ORDR WILL PROVIDE FUNDS FOR, IF A CONSORTIUM IS GOING TO PROPOSE CENTRAL IRB AND THE ANSWER IS NO. AND I HAVE SEVERAL QUESTIONS FOR, WHICH IS RELATED TO BUDGET. AND PAMELA WAS VERY KIND IN RESPONDING BUT SINCE SHE'S HERE, I WOULD REQUEST HER, DO YOU HAVE A COPY OF THE QUESTIONS WITH YOU? OTHERWISE I CAN PROVIDE YOU. SO WOULD YOU PLEASE READ THE QUESTIONS AND THEN GIVE THE ANSWER IN BRIEF. >> OH, SURE. SO ONE OF THE FIRST QUESTIONS WAS RELATED TO INDIRECT COSTS. AND IT SAYS HOW SHOULD PAYMENT TO OUTSIDE INSTITUTIONS BE HANDLED TO AVOID HAVING TO PAY INDIRECT COSTS AT CC, I GUESS THAT'S THE INSTITUTION. AND THE OUTSIDE INSTITUTION. I WAS A LITTLE LEERY HOW I SHOULD RESPOND. SO MY ANSWER BASICALLY PROVIDES BASED ON MY INTERPRETATION. SINCE IT MUST BE APPLIED TO THE SAME BASE THAT WAS USED WHEN THE RATE WAS CALCULATED, THE FIRST 25,000 OF EACH SEPARATE SUBAWARD TO THE SAME SUBAWARDY MUST BE INCLUDED IN THE BASE. IF THERE'S A SEPARATE CONTRACT AGREEMENT FOR EACH SUBAWARD. FOR EXAMPLE, IF THERE ARE TWO SEPARATE PROJECTS BOTH GOING TO THE UNIVERSITY OF SOUTHERN CALIFORNIA, TWO SEPARATE PRINCIPAL INVESTIGATORS CLEAR AND CONCISE DIFFERENT PROJECT GOALS. EACH OF THOSE CONTRACTS ARE SEPARATE ARRANGEMENTS. SO EACH ONE WOULD RECEIVE THAT $25,000 F AND A RATE APPLIED. YES. SO THE NEXT QUESTION, IS THERE A CAP ON INDIRECT COSTS. THERE IS NOT AN NIH SET INDIRECT COST CAP. THE INDIRECT COST RATE IS ESTABLISHED AT THE GRANTEE ORGANIZATION. IF YOUR ORGANIZATION HAS AN INDIRECT COST RATE OF 76%, THEN THAT IS THE CAP SET FOR YOUR ORGANIZATION. AND LET ME BE CLEAR ON GO BACK TO THAT, THE INDIRECT COST RATE IS APPLICABLE FOR THE PROJECT PERIOD. WITH THE U54'S IC'S KIND OF TREAT THIS DIFFERENTLY AS FAR AS THE ANNUAL CHANGES TO THE INDIRECT COST RATES. SO YOU WOULD NEED TO SPEAK WITH THE INDIVIDUAL IC GRANTS MANAGEMENT TO SEE HOW THEY HANDLE THE ANNUAL REVIEW OF THE INDIRECT COST RATES. THE NEXT QUESTION, ARE PATIENT CARE COSTS EXEMPT FROM INDIRECT COSTS. EXEMPTIONS VARY AND AGAIN THAT WOULD BE DELINEATED WITHIN YOUR GRANTEE ORGANIZATIONS F AND A RATE AGREEMENT. YOU WILL FIND THAT AT THE BASE SO I WOULD SUGGEST THAT YOU SPEAKER WITH YOUR SPONSOR PROGRAMS OFFICIAL TO DISCUSS EXEMPTION. ALTHOUGH PROJECTS AND TRAINING CORPS. ARE BEING ADMINISTERED BY THE PRIMARY INSTITUTION, WITH THE PRIMARY INSTITUTIONS OFF CAMPUS INDIRECT COST RATE, THE APPLICABLE FOR ACTIVITIES BEING PERFORMED AT PARTICIPATING INSTITUTIONS. NO. THE PI WILL NOT BE WORKING OFF CAMPUS. AGAIN, THIS WILL BE DELINEATED WITHIN YOUR ORGANIZATION F AND A RATE AGREEMENT. OFF CAMPUS RATE AGREEMENTS ARE APPLICABLE IF THE PROJECT IS STILL WITHIN THE UNIVERSITY'S CONTROL BUT NOT WITHIN THE CAPUS RADIUS. AGAIN THAT WILL BE DELINEATED IN THE ORGANIZATION OR THE GRANTEE ORGANIZATION F AND A RATE AGREEMENT. SOME ORGANIZATION DON'T HAVE OFF CAMPUS SO THEY HAVE ONE RATE THAT'S APPLICABLE FOR ALL. LET'S SEE. THE SECOND QUESTION WITH THAT IS, IF NOT, IF OFF-CAMPUS RATES ARE NOT APPLICABLE, WHICH INDIRECT COST RATES SHOULD BE USED FOR THESE PASS-THROUGH COSTS. MAY RESPONSE TO THAT IS GRANTEES ARE RESPONSIBLE FOR NEGOTIATING F AND A RATES WITH THE CONSORTIA PARTICIPANTS THAT RECEIVE AWARDED FUNDS UNDER THE NIH GRANTS. UNLESS THE CONSORTIUM PARTICIPANT IS A FOREIGN ORGANIZATION AND HAS ENOUGH. I'M NOT SURE YOU'RE AWARE WHEN IT'S A FOREIGN CONSORTIUM, THE MAXIMUM F AND A RATE IS 8%. THAT IS THE NIH SET STANDARD. >> -- THAT'S PART OF THE CONSORTIUM. >> RANDY, WILL YOU GO ON THE MICROPHONE, PLEASE. >> SO THE CONSORTIUM CAN'T COME FROM A FOREIGN SITE BUT THE APPLICANT -- BUT A FOREIGN SITE CAN BE PART OF THE CONSORTIUM AND THAT INDIRECT RATE IS SET AT 8%. >> MAXIMUM 8%. >> THAT'S ONE OF THE QUESTIONS I JUST RECEIVED, SO THAT WILL TAKE CARE OF IT. IF YOU ARE A FOREIGN INSTITUTION, YOU CANNOT SUBMIT U54 APPLICATION AS THE PRIMARY SITE. BUT YOU CAN COLLABORATE WITH SOMEBODY WHO IS SUBMITTING AN APPLICATION FROM US. >> DOMESTIC. THE NEXT QUESTION IS THE BUDGET FOR BIOSTATISTICAL SUPPORT SEPARATE FROM THE 1FTE MAXIMUM ALLOWED FOR ADMINISTRATIVE SUPPORT. MY RESPONSE TO THAT, THE ROLE OF THE BIOSTATISTICIAN SHOULD BE CLEARLY DELINEATED WITHIN THE BUDGET. YOU HAVE TO AVOID BEING DETERMINED AS ADMINISTRATIVE SUPPORT. SO IF THE NIH REVIEWERS OR THE GRANTS MANAGEMENT SPECIALIST DISCOVER AN ALLOWABLE COST IN YOUR BUDGET, GENERALLY WE WOULD DISCOUNT THAT COST FROM YOUR TOTAL AWARD AMOUNT. SO IT'S BEST TO MAKE THOSE POSITIONS REALLY CLEAR. IN YOUR BUDGET JUSTIFICATION. PLEASE CONFIRM THE INDIRECT COST RATE FOR CLINICAL RESEARCH PROJECTS AND PILOT DEMONSTRATION CLINICAL RESEARCH PROJECT PROGRAM BEING CONDUCTED BY A FOREIGN INSTITUTION. SO I THINK WE'VE PRETTY MUCH ANSWERED THAT QUESTION. THERE IS A LIMITED F AND A COST, 8% TOTAL DIRECT COST LESS EQUIPMENT TO FOREIGN INSTITUTIONS AND INTERNATIONAL ORGANIZATIONS TO SUPPORT THE COST OF THE RESEARCH PROJECT. THE RFA STATES THAT COST ESCALATION SHOULD NOT USE COST ESCALATION FOR OUTUSE DURING BUDGET DEVELOPMENT. DOES THIS APPLY TO NON-CONSUMABLE BUDGET LINE ITEMS OR ALL BUDGET CATEGORIES. THIS IS APPLICABLE TO ALL CATEGORIES. WE OFTEN TERM THAT AS COST OF LIVING INCREASE OR INFLATIONARY INCREASE CAN BE A GRADUATE 1% INCREASE, 2%, 4, 5 BUT IF WE NOTICE IT IS A CONSISTENT INCREASE THAT WILL BE REMOVED. IN MOST CASES ALL BUDGETS ARE FLAT LINED UNLESS THERE'S ADEQUATE JUSTIFICATION AS TO YAW THERE ARE INCREASES IN THE FUTURE YEAR. WE NEED CLEAR AND CONCISE DETAIL REASONS WHY THE BUDGET IN ANY CATEGORY IS INCREASED. WITH RESPECT TO THE PERSONNEL. OF COURSE INCREASES ARE ACCESSIBLE IF YOU HAVE SOMEONE WHO MAY BE AT ONE POINT CALENDAR MONTH IN YEAR ONE AND TWO AND INCREASE THEIR EFFORT IN YEARS THREE THROUGH FIVE. THAT IS ACCEPTABLE BUT IT MUST ALSO BE JUSTIFIED. BESIDES OVERALL, IS THE PHS .3998 FACE PAGE REQUIRED FOR REMAINING COMPONENTS IN ADDITION TO THE BUDGET PAGE. AND WITH THAT, THE COMPONENTS WITHIN THE APPLICATION ITSELF, RESEARCH PROJECT PILOT PROJECTS, TRAINING, ADMINISTRATIVE UNIT, THEY ALL NEED THEIR OWN INDIVIDUAL COVER PAGES. THIS IS CLEARLY BEEN DELINEATED IN THE RFA. AS FAR AS THE CONSORTIUM PARTICIPANTS, THIS IS A PAPER APPLICATION. EIGHT PAGES ARE REQUIRED FOR EACH SUBAWARDEE OR SUBCOURT ANNUAL SITE. IT MUST BE A COUNTERSIGNED FACE PAGE AND INCLUDES THE RESOURCE PAGES AND A DETAILED BUDGET PAGE WITH BUDGET JUSTIFICATION. SO THAT IS REQUIRED FOR EVERY CONSORTIUM SUBAWARDEE SITE. THAT'S IT. >> ALL RIGHT, THANK YOU PAMELA. I THINK ALL THESE QUESTIONS CAME FROM TWO GROUPS. A LOT OF QUESTIONS BUT I'M GLAD YOU WERE HERE AND YOU COULD ANSWER THEM. SO I THINK WE'LL TAKE THE QUESTIONS FROM THE AUDIENCE WHO ARE IN THE ROOM, AND THEN I'VE RECEIVED SEVERAL INQUIRIES ABOUT E-MAIL SO WE WILL TRY TO ANSWER THOSE AFTER WE TAKEN CARE OF AUDIENCE OVER HERE. PLEASE GO IN THE I'LL AISLE AND USE THE MICROPHONE. >> THERE'S A FACE PAGE AT THE BEGINNING OF THE APPLICATION AND THEN THERE'S A PAGE AT THE BEGINNING OF EACH PROJECT WHERE YOU LIST THE NAME OF THE PROJECT AND WHATNOT. I DIDN'T SEE ANYTHING IN THE RFA ABOUT GETTING FACE PAGES FROM EACH I'LL CONSORTIUM MEMBER. >> THAT'S A NORMAL PSH 398 REQUIREMENT. THAT IS PART OF THE APPLICATION PROCESS. IN ORDER FOR US TO PROCESS THAT SUBAWARD AND TO REVIEW IT AND MAKE SURE IT'S COMPLIANT, IT IS LIKE A MINI SET APPLICATION WITHIN THE APPLICATION ITSELF. SO WE'LL NEED TO KNOW THE SUBAWARDEE NAME, MAKE SURE THIS SUBAWARD ARRANGEMENT HAS BEEN AGREED. THAT SIGNATURE AND THAT COMPLETED FACE PAGE IS WHAT WE USE TO JUSTIFY THIS. THIS IS AN ARRANGEMENT BETWEEN TWO ORGANIZATIONS, AND THAT SIGNATURE IS STATING THAT THIS PERSON ADHERES TO THE NIH REQUIREMENTS SET FORTH AND PASS THROUGH THAT PRIMARY AWARD RECIPIENTS. >> WHERE DOES THAT GO IN THE APPLICATION? >> IS IT SEPARATE FROM THE PROJECT. >> IS IT SEPARATE IN IF YOU HAVE THE ADMIN UNIT, WITHIN THAT ADMIN UNIT, YOU HAVE A SUBAWARDEE ARRANGEMENT WITHIN THAT ADMIN UNIT. LIKE FOR INSTANCE SHE SAID THAT THE CO-PI, CO-PI CAN BE AT ANOTHER ORGANIZATION. AT THAT POINT, THERE WILL BE A FACE PAGE FROM THE BUSINESS OFFICE WITHIN THAT CO-PI'S INSTITUTION. AND THEN AT THAT POINT, THAT'S WHERE THAT FACE PAGE GOES. >> SO IF I HAVE A RESEARCH PROJECT THAT'S BEING DONE AT ANOTHER INSTITUTION OR THEN IN THAT CLINICAL RESEARCH PROJECT AFTER THE FACE PAGE THERE WOULD BE ANOTHER FACE PAGE FROM THAT OTHER INSTITUTION SAYING THAT THEY COMPLY. >> UH-HUH. SO YOU WOULD INCLUDE THEIR BUDGET AT THAT POINT. SO SAY IF YOU HAVE THE MAIN INSTITUTION'S BUDGET JUSTIFICATION AND IN THAT YOU INCLUDE THE BUDGET WITH THE PERSONNEL, EQUIPMENT, CONSULTING COSTS, SUPPLIES, AT THE BOTTOM OF THE PHS 398 DETAIL BUDGET PAGE THERE ARE TWO SECTIONS THAT SAYS CONSORTIUM. THERE'S A LINE ITEM THAT SAYS CONSORTIUM IN THAT YOU PUT A VALUE. THAT VALUE WOULD MATCH UP WITH THE DETAILED BUDGET PAGE THAT YOU WOULD PUT IN AFTER THE PRIMARY BUDGET PAGE. BUDGET PAGES. >> OKAY. >> I WOULD SUGGEST THAT YOU TALK TO THE GRANTS MANAGEMENT STAFF OF THE PARTICULAR INSTITUTE ALSO. BUT WHAT SHE'S MENTIONING IS MENTIONED IN PHS 398. THAT DOES NOT SEE THE COVER PAGE FOR YOUR PROJECT. YOU WILL SEE MENTIONED THE TITLE OF THE PROJECT AND THE PROJECT LEADER AND THINGS LIKE THAT. BUT THESE ARE GENERAL REQUIREMENTS FOR PHS 398. >> OKAY. >> THOSE THINGS WHICH ARE GENERAL WE DID NOT INCLUDE IN THE RFA. WE JUST SAID FOLLOW PHS 298. >> YOU KNOW, OUR CONSORTIUM IS PROPOSING HAVING A TRAINING PROGRAM AT ONLY INSTITUTION WHICH IS DIFFERENT THAN THE GRANTEE INSTITUTION SIMPLY BECAUSE THE RESOURCES ARE MUCH BETTER AT ANOTHER INSTITUTION. AND THAT INSTITUTION IS WILLING TO MAKE AN INSTITUTIONAL COMMITMENT TO THAT. THAT'S ACCEPTABLE. >> THAT IS ACCEPTABLE. AND WHEN YOU HAVE THEIR AGREEMENT LETTER, INCLUDE THAT INSTITUTIONAL COMMITMENT. >> THERE'S A RESOURCE SHARING COMPONENT OF THE GRANT APPLICATION. SO THERE'S A RESOURCE SHARING PLAN AT THE END OF THE OVERALL SECTION, TEND OF EACH OF THE PROJECTS, AT THE END OF THE ADMINISTRATIVE UNIT. SO THAT WILL GET SOMEWHAT REDUNDANT. >> YES, IT IS BECAUSE IT'S A MULTIUNIT. THAT'S A TEMPLATE CREATED FOR MULTICOMPONENT. NO, I AGREE WITH YOU. >> I'M SURE I CAN PUT PLEASE SEE PAGE SUCH AND SUCH TO SEE. >> WELL YOU CAN, OR YOU COULD JUST COPY IT AS WELL. >> COPY IT, ARE YES. >> IT'S NOT PAGE LIMITED. GENERALLY ---WE DON'T LIKE TO SKIP AROUND APPLICATIONS. EVEN IF IT'S REPETITIVE IF YOU PUT IT WHERE THEY NEED TO SEE. SOME OF THE COMPONENTS LIKE SAY THE ADMINISTRATIVE UNIT ARE NOT REALLY WELL DESIGNED USING THE SIGNIFICANT INNOVATION APPROACH PARADIGM THAT'S IN PHS 398 WHEREAS SAY THE CLINICAL RESEARCH PROJECTS CLEARLY ARE. SO WE CAN ADDRESS THE ISSUES THAT ARE IN THE RFA. >> EXACTLY. THOSE WHICH ARE MENTIONED IN THE RFA. AS YOU MUST HAVE NOTICED FOR ADMINISTRATIVE UNITS WE DON'T HAVE THOSE CRITERIA. FROM NIH, WHAT WE ARE ASKED IS TO PUT OUR SPECIAL REVIEW CRITERIA AND THOSE CRITERIA MUST FIT WITHIN THOSE FIVE. ONE OF THOSE FIVE OR ALL OF FIVE OR WHICHEVER RATE'S APPLICABLE. THAT'S HOW WE DID IT. >> AND THE DUE DATE IS THE RECEIPT DATE AND NOT THE MAILING DATE. >> NO, THAT IS THE RECEIVED DATE NOT THE MAILING DATE. >> AND JUST ABOUT THE PAGE, ONE ISSUE ON PAGE LIMITS I COULD NOT FIND ANYWHERE AND THAT IS FOR THE RESOURCES SECTION, THERE IS NO PAGE LIMIT TO THAT? THAT'S NOT IN THE TABLE OF PAGE LIMITS IN EITHER -- >> IF IT'S NOT IN THE TABLE OF PAGE LIMITS, THEN IF I LOOKED IN THE 398, I COULD PROBABLY FIND SOMETHING THAT SAYS IT'S NOT PAGE-LIMITED BECAUSE THEY'RE FAIRLY SPECIFIC ABOUT THING THAT ARE PATIENT LIMITED. >> I HAVE A COPY OF THE PHS 398 IF ANYONE WANTS TO TAKE A LOOK AT IT. >> OKAY. >> I CAME PREPARED. >> JUST A QUICK QUESTION ON THE F AND A COSTS AGAIN, AND THAT IS THAT SO SAY I'M AT THE GRANTEE INSTITUTION AND ANOTHER INSTITUTION IS DOING COMPONENT OF THE RESEARCH SO THEY OBVIOUSLY ARE GOING TO NEED SOME OF THE MONEY TO DO THAT RESEARCH. SO THAT'S I GUESS WHAT YOU WOULD CALL PASS-THROUGH FUNDS. >> RIGHT. >> RIGHT. THAT'S THROUGH THE CONSORTIUM ARRANGEMENT UNLESS THIS IS A FEE FOR SERVICE AND THAT'S A TOTALLY DIFFERENT ARRANGEMENT. >> OKAY. SO IN THAT PARTICULAR CIRCUMSTANCE, THEY HAVE A DIFFERENT F AND A RATE THAN MY INSTITUTION HAS WHICH F AND A RATE DO WE USE. IS IT SOMETHING I NEGOTIATE WITH THEM. >> RIGHT. IN MOST CASES IF THEY HAVE A RATE, THEN THEY HAVE TO APPLY THAT RATE BASED ON THE BUDGET THAT THEY ARE USING. FOR INSTANCE, IF THEY ARE REQUESTING $30,000 IN DIRECT COSTS AND HAVE A RATE OF 76, THEY ARE REQUIRED TO TRACK AND APPLY THAT 76% TO THAT $30,000 DIRECT COST. AND THEN FROM THAT, THAT GIVES THEIR TOTAL COSTS AND YOU USE THEIR TOTAL COSTS IN YOUR DIRECT COST BUDGET. >> RIGHT, YES, OKAY. YOU ANSWERED THIS LITTLE BIT BEFORE IN THE PILOT PROGRAM AT LEAST ONE OF THE IDEAS HAS TO BE VERY WELL DEVELOPED AND THE OTHERS ARE JUST BRIEFLY DESCRIBED OR IS IT -- >> YES, YOU CAN BRIEFLY DESCRIBE -- >> -- MORE THAN ONE PROJECT THAT IS VERY WELL DEVELOPED. >> YOU WOULD LIKE TO INCLUDE A DESCRIPTION OF AT LEAST ONE PROJECT BECAUSE AS SOON AS YOU'RE AWARDED, YOU WOULD LIKE TO START ON THAT. AND THEN UNLESS YOU CAN DESCRIBE OR INCLUDE EXAMPLES WHAT KIND OF PILOT PROJECTS YOU WILL BE SOLICITING. >> OKAY. IF WE'RE NOT GOING TO DESCRIBE IT IN DETAIL, WE WON'T BE ABLE TO BUDGET FOR IT. IF I HAVE A PROJECT IN YEARS THREE THROUGH FIVE AND IF IT'S AN IDEA UNLESS THAT IDEA'S VERY WELL DEVELOPED, WE WON'T BE ABLE TO BUDGET FOR IT. I'M GOING TO BUDGET FOR SOMETHING IN THE PILOT PROJECT PROGRAM, IT SHOULD BE WELL DEVELOPED AND PRESENTED THEN. >> YES. SO THE FIRST ONE YOU WILL PUT AND THERE IS A FLEXIBILITY IN THIS PROGRAM. YOU HAVE TO MAINTAIN THE PILOT PROJECTS AND PILOT PROJECTS WILL VARY. SOME MAY REQUIRE -- IF YOU ARE READY TO PROPOSE THREE PILOT PROJECTS YOU KNOW WHAT YOU'RE DOING, YOU CAN PROPOSE. >> OKAY. BUT WE DON'T SEE THAT BECAUSE WE'RE LOOKING FOR A PROGRAM WITH EXAMPLES. AND RIPTION OF ONE. BECAUSE YOU WILL BE SOLICITING PILOT PROJECTS. IF YOU ARE ALREADY PRESENTED, YOU HAVE -- IF YOU ARE ALREADY PREPARED AND YOU HAVE ALREADY DONE, THAT'S ALL RIGHT. DO YOU HAVE A COMMENT. >> IF I RECALL THE REVIEW CRITERIA FOR THE PILOT PROGRAM ARE BASED ON A PROGRAM NOT ON A SPECIFIC INDIVIDUAL PROJECT. SO YOU MAY WELL HAVE THREE WELL-DEVELOPED PROJECTS. I WOULD NOT SUBMIT THEM THE WAY THAT I WOULD FOR THE CLINICAL PROJECTS WHICH ARE CLEARLY SOMETHING YOUR PROPOSING. I WOULD SUBMIT THEM BUT MAKE SURE THAT I HAD ENOUGH ROOM WITHIN MY PAGE LIMITS TO TALK ABOUT THE PROGRAM AS A WHOLE. AND HOW THEY WERE BEING SELECTED AND HOW THEY WERE GOING TO BE SUPPORTED AND THING LIKE THAT. >> BECAUSE YOU HAVE JUST SIX PAGES. >> I UNDERSTAND THAT. SO IF THERE'S MATERIALS THAT I NEED FOR THIS IDEA, HOW DO I BUDGET FOR THAT IF I DON'T DESCRIBE. >> SO WHATEVER YOU BUDGET APPROXIMATELY YOU CAN BUDGET FOR REST OF THE YEAR, THAT'S HOW IT HAS BEEN DONE. >> SO IT'S BEEN DONE IN MY INITIAL PILOT PROJECT AND MY BUDGET FOR EACH YEAR. >> YES. >> SO IT LOOKS LIKE 12 PAGES. >> NO, FOR PILOT PROJECT YOU JUST KEPT SIX PAGES. >> THAT IS 12. >> IT SAYS 12 IN ARE TALKING WHAT PILOT PROJECT OR TRAINING? >> PILOT PROJECT. >> OKAY. SO IT SAYS 12 IS 12. THEN I STAND CORRECTED. IN OUR TRAINING PROGRAM, WE WERE GOING TO HAVE A COMPONENT, OBVIOUSLY IT'S VERY RESEARCH ORIENTED BUT THERE WAS ALSO GOING TO BE A COMPONENT OF CLINICAL MANAGEMENT OF RARE DISEASE PATIENTS. THAT'S APPROPRIATE AS WELL? IN THE TRAINING PROGRAM. >> SAY IT AGAIN. CAN YOU REPEAT THIS PLEASE. >> SO IN THE TRAINING PROGRAM THAT WE'RE DESIGNING, YOU KNOW, OBVIOUSLY THE MAJORITY OF THIS IS RESEARCH ORIENTED TO TRAIN FOLKS ON HOW TO INVESTIGATE RARE DISEASES BUT THERE'S ALSO, YOU KNOW, A CLINICAL MANAGEMENT PORTION TO MANAGE PATIENTS WITH RARE DISEASES AS WELL. IS THAT OKAY? >> THAT'S SOMETHING NEW BUT IF IT IS EVENTUALLY GOING TO HELP THEM GET TRAINED DURING CLINICAL RESEARCH, THEN I THINK IT WILL BE A GOOD OPTION. >> LEARN HOW TO -- >> REBECCA, RANDY? >> IT SOUNDS FINE. >> I THINK ONE PERSON AT A TIME. I CAN'T HEAR YOU. ARE YOU DONE? >> YES. >> WE WILL BE HERE AND WE CAN ALWAYS SET UP A FOLLOW UP AND A PHONE CALL WITH YOU. SO THIS IS NOT THE LAST OPPORTUNITY. AND THANK YOU. AND I'LL STAY ON EVEN AFTER THIS MEETING IS OVER SINCE YOU ARE HERE SO I WILL BE HAPPY -- YES, REBECCA? >> IT LOOKS LIKE YOU ARE TO PROVIDE CARE TO A PATIENT IN A HOSPITAL OR CLINIC. NO MATTER HOW THAT WAS COUCHED OR TRAINING THAT'S PART OF THEIR MEDICAL RESPONSIBILITY. NOW IF THERE'S SOMETHING SPECIAL GOING ON THERE, THAT'S SOMETHING ELSE. BUT THAT IS NOT, THE ORDINARY JOB THAT THEY'RE DOING DAY TO DAY WOULD NOT BE CONSIDERED ELIGIBLE GRANT EXPENSE. THERE'S NO RESEARCH REALLY ASSOCIATED WITH IT. OBVIOUSLY THERE ARE JUDGMENT ISSUES HERE BUT THAT'S PRETTY MUCH SOMETHING TO KEEP IN MIND. >> IF THEY ARE LEARNING INNOVATIVE. AT THIS POINT -- I CAN'T FOR REVIEWER BUT FOR AN NIH ALLOWABLE COST POINT OF VIEW WE'RE NOT GOING TO PAY FOR REGULAR CLINICAL CARE OF REGULAR PATIENTS. SO SORT OF AS THE CONTINUATION OF THIS THOUGHT, DR. GROFT STARTED OUT BY SPEAKING ABOUT ESTABLISHING CLINICAL CENTERS OF EXCELLENCE. AND SO THE QUESTION WAS, YOU KNOW, THIS IS CERTAINLY SOMETHING WE CAN DO, WE CAN DEVELOP A TEMPLATE, WE CAN TEACH PEOPLE HOW TO DO THAT BUT IS THAT AN ALLOWABLE EXPENSE EITHER UNDER A PROJECT OR PART OF THE TRAINING? >> I THINK THE CLINICAL CENTER OF EXCELLENCE I REFERRED TO, THAT WAS THE MANDATE IN THE LEGISLATION. WE INTERPRETED THAT AS BEING THESE RESEARCH NETWORK CONSORTIA. SO RATHER THAN ON TWO OR THREE RESEARCH CENTERS IN THE COUNTRY WE OPTED FOR THIS RESEARCH CONSORTIA INSTEAD. AND WE THINK THAT WHAT WILL FLOW FROM THE INDIVIDUAL CONSORTIA WILL BE A CERTAIN LEVEL OF EXCELLENCE IN PROVIDING CLINICAL CARE AND WE WILL GAIN THAT EXPERIENCE THROUGH THE TRAINING PROGRAMS AND ACTUALLY SEEING ALL OF THE INCREASED NUMBER OF PATIENTS THAT WILL COME THROUGH THE ENTIRE RESEARCH NETWORK. WE WILL GAIN THAT EXPERIENCE AND KNOWLEDGE FOR BETTER CARE FOR PATIENTS. THAT WILL BE ONE OF THE OUT COMES. >> SO WE MIGHT BE ABLE TO DEVELOP SOMETHING, HAVE IT ON THE WEBSITE ETCETERA BUT IT'S NOT AN EXPENSE. >> ALSO YOU HAVE PRESUMABLY A NATURAL HISTORY STUDY GOING ON WHERE THE PATIENTS ARE COMING IN AND BEING EVALUATED. AS A QUICK KIND OF CHECK ON YOURSELF, I THINK FOR FIRST APPROXIMATION, IF THE PATIENT IS NOT BEING ENROLLED IN ANY ASPECT OF THE RESEARCH PROBABLY CARE FOR THAT PATIENT IS NOT AN ELIGIBLE EXPENSE. I IMAGINE THAT THERE WOULD BE EXCEPTIONS BUT IT'S HARD TO KNOW WHAT THEY WOULD LOOK LIKE. >> I WOULD JUST LIKE TO ADD -- FROM NICHD THAT WITHIN SOME OF OUR TRAINING PROGRAMS, ESPECIALLY IF THEY ARE CLINICIANS AND YOU WANT TO BRING A CLINICIAN INTO ESSENTIALLY A NEW FIELD SERIES OF COMPLEX DISEASES, PART OF THEIR TRAINING IS ALSO BEING ABLE TO DIAGNOSE TO IDENTIFY DIFFERENT ASPECTS OF THE DISEASE SO IT'S NOT CLINICAL CARE PER SE BUT AT THE SAME TIME IT'S BECOMING FAMILIAR WITH THIS PARTICULAR I WOULD SAY PHENOTYPE. BUT LOOKING AT IT FROM THAT PERSPECTIVE SO THAT THEN ONE CAN DO SOME CLINICAL STUDIES ON THE INDIVIDUAL THAT BECOME PART OF SOME VERY VERY SMALL PILOT STUDIES ASSOCIATED WITH THE TRAINING. IT'S NOT CLINICAL CARE PER SE BUT THERE'S THE -- OF THE INDIVIDUAL. >> I JUST WANTED TO ASK A COUPLE CLARIFICATION QUESTIONS WHEN THE QUESTIONS ARE ASKED PREVIOUSLY. TO TRAINING. THERE'S THE QUESTION WITHIN THE RFA STATES THE TRAINING MUST ALLOW THREE CALENDAR MONTHS PER YEAR THROUGH THE ACTIVITIES. HOW DOES THAT RELATIVE TO THESE QUESTIONS OF NOT HAVING THEM DO OTHER THINGS THAT ARE NOT ALLOWABLE. I JUST HAVE NOT ARE THEY ONLY SUPPOSED TO BE FUNDED THEN FOR THOSE THREE MONTHS OR ARE THEY SUPPOSED TO BE FUNDED FOR THE ENTIRE YEAR AND ONLY -- >> TOTAL MINIMUM EFFORT THEY SHOULD BE PUTTING IN. >> OKAY. >> IT USED TO BE -- EFFORTS NOW YOU HAVE TO PUT IT IN CALENDAR MONTHS. >> THANK YOU FOR THAT CLARIFICATION. I HAVE ANOTHER CLARIFICATION ON THE BUDGETS OF THE PILOT PROGRAMS. SO IT IS ALLOWABLE AND OTHER -- JUST WROTE TO SAY A LUMP SUM WILL BE DEDICATED EVERY YEAR. >> THERE'S FLEXIBILITY. >> HOW DO YOU PROVIDE BUDGET UNDER YOUR BUDGET JUSTIFICATION, DO YOU JUST SAY THIS WILL BE ATTRIBUTED EVERY YEAR TO PILOT FUNDS. >> AND MY LAST QUESTION HAS TO DO WITH -- >> IF YOU HAVE A TIME LINE YOU CAN MENTION A TIME LINE. IF YOU ARE VERY WELL PREPARED YOU KNOW WHICH PILOT YOU CAN INCLUDE A TIME LINE. >> OKAY. AND THEN MY LAST QUESTION HAS TO DO WITH THE WEBSITE. I'M A LITTLE BIT CONFUSED BECAUSE IT'S PUT AS ONE OF THE REQUIREMENTS OF THE WEBSITE BUT THEN IT'S STATED THAT WON'T BE AN INDIVIDUAL GROUP WEBSITE BUT A GENERALIZED WEBSITE SO WE ACTUALLY WENT AHEAD AND GENERATED A WEBSITE FOR OUR CONSORTIUM. IS THAT SOMETHING THAT THEN SHOULD BE MENTIONED IN THE APPLICATION AS A STRENGTH OR NOT OR SHOULD IT BE -- >> SO IF YOU READ IT CAREFULLY IT SAYS YOU SHOULD MENTION THE RESOURCES AVAILABLE TO YOUR CONSORTIA AND MEMBERS WHICH YOU WILL MAKE AVAILABLE ON THE WEBSITE. AND THE WEBSITE RIGHT NOW WE DO HAVE A WEBSITE WHICH IS MAINTAINED BY DATA MANAGEMENT COORDINATING CENTER. THERE'S THIS RDCR WEBSITE AND THEN IT'S CONNECTED TO INDIVIDUAL CONSORTIUM. SO THEY WILL HELP YOU. IF YOU HAVE ALREADY DEVELOPED, I'M SURE THERE IS A WAY TO MAKE IT COMPATIBLE AND ONCE YOU GET THE AWARD. >> YES. >> BEFORE YOU DEVELOP ANYTHING, PLEASE ASK US QUESTIONS. THIS IS OUR JOB TO RESPOND TO YOUR INQUIRIES SO FEEL FREE TO DO THAT. >> PETER -- FROM WASHINGTON DC I'M REPRESENTING RSDSA -- SYNDROME INFORMATION AN INTERNATIONAL CONSORTIUM. WE HAVE SEVERAL PROJECTS ONGOING THAT WOULD QUALIFY UNDER THE CRITERIA OF THE RFA. BUT IF OUR NEW DEVELOPMENT, NEW PROJECT DEVELOPMENT IS NOT SUFFICIENTLY READY, WILL THIS RFA BE REPEATED IN THE FORESEEABLE FUTURE AND CAN YOU DECLARE THE INTERVAL. >> I'LL ASK DR. GROFT TO COMMENT. IF IT IS REISSUED RFA, IT WILL BE OFFER FIVE YEARS. AND USUALLY FOR RFA'S THERE'S ONE APPLICATION RECEIVE DATES. SO PREVIOUS RFA WAS REISSUED IN 2008. AND AFTER THIS YEAR, IT'S ANOTHER FIVE YEARS. >> DO YOU HAVE MORE. >> THAT IS CORRECT. >> GOT IT. A FEW OTHERS, PLEASE. EXCUSE ME FOR JUST A SECOND. IF ANY OF THE GROUPS DO NOT MEET THE DEADLINE OR DECIDE THEY DON'T WANT TO BRING IN AN APPLICATION, THE OFFICE WILL BE HAPPY TO TALK WITH THEM ABOUT OTHER ACTIVITIES WE COULD ENGAGE WITH YOU TO SORT OF GET READY FOR THE NEXT GO ROUND. EVEN IF IT'S FIVE YEARS WE FOUND THAT SOME OF THE GROUPS WERE EITHER NOT SUCCESSFUL OR DECIDE NOT TO COME IN WITHIN APPLICATION THAT WE WERE ABLE TO WORK WITH THEM AND DEVELOP PROGRAMS OR ACTIVIES THAT WOULD LEND THEMSELVES THEN TO A STRONG APPLICATION COMING DOWN THE ROAD AS WE ALL KNOW FIVE YEARS CAN GO BY VERY QUICKLY. SO ANYONE WHO OPTS, ANY OF THOSE OPTIONS, THE OFFICE WILL BE HAPPY TO WORK WITH YOU. >> THANK YOU VERY MUCH. >> IN ADDITION, THIS IS NOT RELATED TO RDCD-RFA BUT IN RESPONDING TO YOUR QUESTIONS. THERE ARE OTHER PROGRAMS WHICH MAY BE OF INTEREST TO YOU NOT ONLY WITHIN OUR OFFICE OR N-CATS BUT WITHIN OTHER INSTITUTES WHICH ARE PARTICIPATING OR EVEN NOT. THERE ARE MANY OTHER TRANSLATIONAL AND CLINICAL RESEARCH PROGRAMS WHICH MAY BE OF INTEREST TO YOU AND WE CAN GET YOU CONNECTED. >> THOSE RESOURCES DO INCLUDE THE INSTITUTES THAT ARE OUR PARTNERS IN WHATEVER WE DO WITH RARE DISEASES AS WELL AS THE OTHER RESOURCES THAT MIGHT BE AVAILABLE IN DIFFERENT PROGRAMS WE FIND WITH THE RARE DISEASES. THERE ARE SO MANY ACTIVITIES ONGOING WE HAVE TO POINT AT SPECIFIC PROGRAMS THAT MIGHT BE OF ASSISTANCE. THAT'S WHY IT'S GOOD TO COME IN AND TALK AND TAKE ADVANTAGE OF THOSE RESOURCES. >> THANK YOU. I INTEND TO CORNER ONE OF THE REPRESENTATIVES FROM THE APPROPRIATE INSTITUTE. YOU TALKED ABOUT FOREIGN RESOURCES AND INSTITUTIONS. IS THERE ANY CAP ON THE PROPORTION OF FOREIGN INSTITUTIONS PERSONNEL AND CLINICAL MATERIAL TO BE INCLUDED IN THE WORK OF THE CONSORTIUM. >> THERE IS NO CAP OTHER THAN WHAT PAM WAS MENTIONING ABOUT INDIRECT COSTS AND OTHER THINGS. DO YOU HAVE A COMMENT? >> NO. IT'S ENCOURAGED. IN SOME CASES, IT'S BEEN THE FOREIGN SITES THAT ARE MADE AT CLINICAL TRIAL FOR EXAMPLE. >> THE PREPONDERANCANCE OF OUR COLLABORATORS ARE UK, EUROPE AND OCEANA AND OTHER PLACES. >> IN THE CURRENT NETWORK WE HAVE 13 COUNTRIES WE ARE COLLABORATING WITH. >> GIVEN THAT OUR FOCUS OF INTEREST IS COMPLEX REGIONAL PAIN SYNDROME, CAN YOU DECLARE THE RATIONALE FOR REQUIRING A MINIMUM OF THREE RARE DISEASES AS THE FOCUS OF INTEREST FOR THE CONSORTIUM. >> WE CAN FIGURE OUT TWO IF WE FUDGE A LITTLE BIT, BUT THREE IS GOING TO BE HARD FOR US. >> AGAIN I THINK WE WANT TO SET UP A SEPARATE CALL WITH INDS AND BOTH LAURA AND RANDY ARE HERE SO THEY CAN ADVISE YOU ON THAT ABOUT THE THIRD ONE. THAT WAS IT? >> THANK YOU VERY MUCH. >> ANYMORE QUESTIONS FROM THE AUDIENCE IN THIS ROOM? MAYBE YOU WILL HAVE MORE AFTER A FEW MINUTES SO I'LL GO AHEAD AND START ANSWERING THE QUESTIONS WHICH WE HAVE RECEIVED VIA E-MAIL. AND THE FIRST ONE IS CAN PILOT PROJECTS RUN SEQUENTIALLY IE PILOT ONE IN YEAR ONE AND YEAR TWO THREE AND THE ANSWER IS YES. AND THE SECOND QUESTION FROM THE SAME PERSON IS ABOUT ANOTHER PROJECT WE SUPPORT ABOUT PATIENT REGISTRY SINCE IT IS NOT RELEVANT TO RDCRFA, I WILL NOT AN OVER HERE AND I WILL DO A FOLLOW UP WITH AN E-MAIL. >> AND ALSO WHATEVER ANSWER WE PROVIDE WILL BE ALSO PROVIDED TO EVERYONE, ACCORDING TO RASHMI. >> YES, AS I SAID EARLIER. >> AND THE ANSWERS THAT WE DON'T PROVIDE TODAY TO QUESTIONS IF WE RUN OUT OF TIME, WE ALSO MAKE THOSE ANSWERS AVAILABLE. >> THIS MAKES SURE EACH AND EVERY QUESTION IS ANSWERED IF NOT TODAY, WE'LL DO A FOLLOW UP. AND WE ARE DEVELOPING A FREQUENTLY ASKED QUESTIONS. AND HOPE THREE -- HOPEFULLY BY THE END OF THIS WEEK OR EARLY NEXT WEEK WE WILL PUT IT ON THE WEBSITE. THIS WILL BE ANONYMOUS, YOUR NAMES WILL NOT BE THERE. WE WILL DO SOME CLEANING AND PUT IT ON THE WEBSITE. THE NEXT QUESTION IS CAN NIC INTRAMURAL INVESTIGATORS PARTICIPATE AND AS I SAID EARLIER, YES, THEY CAN PARTICIPATE. BUT THEY CANNOT RECEIVE FUNDS FROM THIS RFA. CAN SUCH AN INVESTIGATOR BE THE PI ON A PROJECT AND THE ANSWER IS YES, YOU CAN BE A PI ON A PROJECT. AND I'LL TAKE THREE OR FOUR MORE QUESTIONS AND I'LL COME BACK TO YOU. SO THIS IS A QUESTION ABOUT DSMB. WHEN THE DSMB BE REMANDED CENTRALLY BY DATA MANAGEMENT AND COORDINATING CENTERS. SO I CAN TELL YOU HOW IT IS BEING DONE RIGHT NOW IN THE NETWORK. THE DATA SAFETY MONITORING BOARDS ARE BEING RUN BY MOST OF THE CASES BY THE INSTITUTE. NIH INSTITUTE. AND THE LOGISTICAL SUPPORT IN MOST OF THE CASES, MOST OF THE CASES IS BEING PROVIDED BY THE DATA MANAGEMENT COORDINATING CENTER. BUT INSTITUTE TAKES THE MAJOR ROLE THERE. IN ONE CASE, DSMB'S BEING PROVIDED BY THE INSTITUTION, NOT THE NIH INSTITUTE. SO THERE IS A VARIETY THERE. ARE FOREIGN COLLABORATIONS ALLOWED. YES. IS THERE A CALENDAR MONTH REQUIREMENT FOR THE ADMINISTRATIVE DIRECTOR. NO, WE HAVE NOT PUT ANY REQUIREMENT THERE. THE BUDGET PRESENTATION IS QUITE COMPLEX. CAN YOU SUMMARIZE HOW THE OVERALL BUDGET AND BUDGET OF INDIVIDUAL SECTIONS SHOULD BE PRESENTED? I THINK IT WAS COVERED IN DETAIL BY PAM AND I WOULD SUGGEST TO THIS INVESTIGATOR IN THIS QUESTION IS TO GET IN TOUCH, IN THIS CASE IT'S NI PH.D. SO I'LL FORWARD THIS TO YOU AND YOU CAN GET THIS PERSON CONNECTED TO THE GRANTS MANAGEMENT STAFF. FOR THE QUESTIONS PILOT PROJECT 12 PAGES TOTAL OR 12 PAGE PER PILOT PROJECT. 12 PAGES TOTAL. FOR THE PILOT PROJECT PROGRAM. DOES EACH COMPONENT PILOTS TRAINING REQUIRE PI WITH EFFORT. YOU DO NEED A PERSON IN CHARGE FOR EACH COMPONENT AND REQUIREMENT FOR TH E EFFORT. I'LL STOP HERE AND TAKE A QUESTION. >> I HAVE A QUESTION ABOUT THE ROLE OF THE PATIENT ADVOCACY GROUP IN THE APPLICATION. IS THAT SORT OF, ARE THEY SUPPOSED TO BE PART OF THE APPLICATION OR IS IT JUST THAT THERE'S A WAY TO BRING THEM IN TOGETHER WITH OTHER ADVOCACY GROUPS AFTER THE APPLICATION IS IN AS PART OF THE -- >> SO I WILL SAY YOU WILL DO IT BEFORE YOU PUT IN THE APPLICATION. WE DO REQUIRE THAT YOU INCLUDE A LETTER OF SUPPORT FROM THE PATIENT ADVOCACY GROUP, OUR GROUPS AND ALSO PROVIDE WE ARE ASKING YOU TO PUT IT WITHIN THE BIO GRAPHICAL SKETCH. SO IT SHOULD BE BEFORE NOT AFTER. WE ARE TELLING YOU FROM EXPERIENCE. IF YOU INCLUDE THEM BEFOREHAND YOU WILL HAVE A BETTER APPLICATION. >> I THINK IT WOULD BE ADVISABLE TOO TO SHARE THE APPLICATION WITH THE LEADERSHIP OF THE ORGANIZATION, NOT EVERYONE BUT THE KEY LEADERS JUST TO TALK TO THEM ABOUT WHAT YOU'RE PLANNING TO DO AND YOUR EXPECTATION, TYPES OF STUDIES AND HOW YOU MIGHT BE ABLE TO RECRUIT PATIENTS. I THINK THAT WOULD BE HELPFUL. >> SO THIS QUESTION IS FROM A PATIENT ADVOCACY GROUP. WE ARE A SMALL PATIENT ADVOCACY GROUP, DO WE NEED TO HAVE DONE REGISTRATION. ONLY PI MAIN APPLICANT. >> ONLY THE MAIN PI APPLICANT ORGANIZATION WHO SUBMITS THE APPLICATION IS SUPPOSED TO HAVE DONE REGISTRATION AND I WILL STRONGLY ENCOURAGE YOU TO GET IN TOUCH WITH PROPOSED CONSORTIUM PI YOU ARE PLANNING TO WORK WITH. I THINK THERE ARE SEVEN QUESTIONS OR ONE QUESTION. THE FACE PAGE ISSUE IS STILL NOT CLEAR TO ME. IF INSTITUTION X IS THE PI INSTITUTION AND THE CONSORTIUM HAS THREE PROJECTS AND ON ALL THREE PROJECTS INSTITUTION Y HAS A ROLE DO WE JUST NEED THREE SEPARATE FIND FACE PAGES FROM INSTITUTION Y. I DO REALIZE WE NEED THREE BUDGETS AND THREE JUSTIFICATIONS FOR INSTITUTION Y. FACE PAGE CONFIRMS THAT THIS IS A REVIEWED AND APPROVED CONSORTIUM ARRANGEMENT BETWEEN BOTH ORGAINIZATIONS. THAT SIGNATURE FROM THE AUTHORIZED OFFICIAL FROM THE CONSORTIUM SITE IS CONFIRMATION THAT THEY WILL ADHERE TO THE REGULATION OF THE NIH PROJECT THAT THEY ARE AGREEING TO PLAY A ROLE IN. >> ONE INSTITUTION, ONE FACE PAGE. >> THANK YOU. SO THIS IS ANOTHER E-MAIL. I HAVEN'T HEARD AN ANSWER YET TO DR. X'S QUESTION THAT HE E-MAILED TO ME YESTERDAY. I THOUGHT I TOOK CARE OF IT BUT I'LL REPEAT IT. THE PROJECT LEADERS SHOULD DEVOTE AT LEAST 1.8 CALENDAR MONTHS TO THE RESEARCH. THIS IS RISKING THE BUDGET BECAUSE OF THE NUMBER OF STUDIES WE HAVE CAN BE SPLIT 15% -- AMONG ALL THE SITE PI'S. FIRST OF ALL THIS IS NOT A NEW REQUIREMENT AND THIS IS COMING FROM A COMPETING RENEWAL. 1.8 CALENDAR MONTHS WAS REQUIRED EARLIER ALSO IS STILL THE SAME. IF YOU WANT TO SPLIT IT, IF YOU HAVE PROJECT LEADER AND THEN ANOTHER INVESTIGATOR SHARING THE RESPONSIBILITY CAN BE SPLIT. THAT'S THE BRIEF ANSWER I CAN GIVE YOU RIGHT NOW. AND WE CAN ALWAYS DO A FOLLOW UP. DID I MISS ANY QUESTION? I THINK THERE WERE A COUPLE MORE. IF I MISSED IT, CHRIS? DO YOU HAVE ANY I DID NOT ANSWER? I THINK, I DON'T WANT TO SAY THE A GROUP WHICH IS PUTTING IN COMPETING RENEWAL. I KNOW THERE WERE SEVERAL QUESTIONS AND I CAN'T FIND IT ON MY iPHONE. I WILL FOLLOW UP WITH AN E-MAIL OR PHONE CALL. >> JUST GETTING BACK TO THE FACE PAGE ISSUE AGAIN, AND THAT IS THAT SOME OF THE INSTITUTIONS POLICY AND GRANTS ADMINISTRATION OFFICES WILL TAKE WEEKS IF NOT MONTHS TO GO THROUGH THE ENTIRE PROPOSAL, AND FOR US TO GET A COMPLETED GRANT APPLICATION TO THEM AND THEN PUT IT INTO THEIR SYSTEM FOR THEM TO GO THROUGH THE ENTIRE GRANT APPLICATION BEFORE THEY'LL SIGN OFF ON THE FACE PAGE. IT'S GOING TO BE DIFFICULT. MY IMPRESSION WAS WE DIDN'T HAVE TO HAVE A SIGNED CONTRACT AT THE TIME WE SUBMITTED THE PROPOSAL BUT APPARENTLY WE DO. >> SO I HAVE HEARD DIFFERENT ANSWERS FROM SOME OF MY COLLEAGUES AND INSTITUTES AND I'VE HEARD THAT THEY CAN GET A SIGNED SUBCONTRACT LATER ON. BUT THEY SHOULD HAVE -- >> -- WE'RE GOING TO HAVE TO DO TO PARTICIPATE. >> THERE'S AN INTENT BUT IF YOU HAVE A JUSTIFIED BUDGET, THEN THAT NEGOTIATION PROCESS TO CREATE A DETAILED BUDGET SHOULD TAKE JUST AS LONG AS IT WOULD TO OBTAIN A FACE PAGE. IF YOU'RE AGREEING, IF THAT CONSORTIUM SITE IS TAKING THE TIME TO CREATE A DETAILED BUDGET TO JUSTIFY THIS BUDGET, THAT SHOULD BE THE SAME AMOUNT OF TIME FOR THEM TO OBTAIN A SIGNED FACE PAGE. IN ORDER FOR NIH TO PASS DOWN THAT MONEY AND KNOW THAT MONEY IS BEING USED APPROPRIATELY WITHIN THE NIH SET GUIDELINES THEN THAT FACE PAGE IS DEFINITELY REQUIRED. >> SO IS THE FACE PAGE THEN A BINDING. >> THAT SIGNATURE FROM THAT SUN COURT ANNUAL FROM THE AUTHORIZED INSTITUTION PERSONNEL OFFICER SPONSORED PROJECT WHATEVER THE EQUIVALENT MAY BE IS. >> BOUND TO PARTICIPATE IN THE CONSORTIUM AT THAT POINT. >> YES. AND THEN I HAVE RECEIVED NOTIFICATION SAYING WE NO LONGER WISH TO HAVE A CONSORTIUM ARRANGEMENT WITH THIS ORGANIZATION. THAT HAS HAPPEN. YOU'RE NOT REQUIRED TO NOW FUNNEL THAT MONEY TO THAT CONSORTIUM SITE. IF YOU HAVE AN ALTER -- ALTERNATE PLAN, YOU NEED TO SAY NOW WE WISH TO USE AND DETAIL WHAT YOU PLAN TO DO. AND THEN AT THAT TIME UCLA WILL NOW NEED TO CONTACT YOU ALL AND CREATE A CONSORTIUM ARRANGEMENT. >> SO I HAVE TWO, THREE COMMENTS. FIRST OF ALL I WOULD LIKE TO HEAR FROM RANDY, MAYBE YOU MAY HAVE SOME COMMENTS WITH YOUR EXPERIENCE. AND WE'LL DEFINITELY TOUCH BASE WITH SPECIFIC INSTITUTES. AND. >> SO I'VE DONE THAT AND THEY DON'T GIVE ME THAT ANSWER TO THE ISSUE. >> NO, YOU SHOULD BE GETTING AN ANSWER. WE WILL MAKE SURE THAT YOU GET AN ANSWER. AND I'M REALLY GLAD THAT PAMELA'S HERE AND SHE'S SHARING HER EXPERIENCE FROM HER INSTITUTE WHICH IS VERY USEFUL. I ALSO WANT TO MENTION FOLLOW UP TO WHAT PAM WAS SAYING. IF YOU ARE PROPOSING SOME SITES AND FOR SOME REASON THEY WILL NOT BE PARTICIPATING OR YOU WANT TO ADD A SITE LATER ON, WE DO HAVE AN INTERNAL PROCESS TO DO IT. >> RIGHT. I GUESS MY QUESTION IS, BECAUSE PAMELA, YOU'RE TALKING ABOUT AT THE TIME OF THE AWARD, YOU HAPPEN TO HAVE THIS. BUT I THINK YOU'RE ASKING AT TIME OF APPLICATION. >> SUBMISSION OF APPLICATION. >> AT THE TIME OF SUBMISSION OF APPLICATION, I'M JUST TRYING TO SEE WHETHER THERE IS A DIFFERENCE IN THE AMOUNT OF DETAIL OR IN THE CONSORTIA AGREEMENTS DO THEY ALL NEED TO BE IN PLACE, FINALIZED AT THAT TIME. BECAUSE YOU KNOW, SO THAT'S THE QUESTION THAT I HAVE. >> I CAN'T MAKE THAT ANSWER BECAUSE I'M NOT A REVIEWER BUT AT THE TIME THAT IT LANDS ON MY DESK. >> THAT'S RIGHT. >> YES, THAT'S A LITTLE DIFFERENT THAN SUBMITTING THE APPLICATION. >> RANDY, DO YOU HAVE EXPERIENCE WITH THAT. >> I DO NOT. >> I THINK IT'S A QUESTION THAT WE NEED TO FIND AN ANSWER FOR. >> WE WILL FIND AN ANSWER FOR YOU, SPECIFIC ANSWER FOR YOU. DR. GROFT. >> I HAD A SITUATION WHERE ONE GRANT, WHERE THEY STATED THAT THEY WOULD ESTABLISH, THEY PLANNED IN THEIR BUDGET JUSTIFICATION THEY'RE PLANNING TO ESTABLISH A CONSORTIUM ARRANGEMENT AT THAT TIME I FULLLY RESTRICTED THAT BUDGET LINE ITEM, EXCUSE ME, AND ALERTED THE GRANTEE I WOULD NOT RELEASE THOSE FUNDS TO THEM UNTIL THEY SUBMIT. >> YES. BUT THAT COMES AFTER THE AWARD. >> THAT COMES AFTER THE GRANT IS SCORED AND EVERYTHING. >> WE ARE TALKING ABOUT DURING THE SUBMISSION OF APPLICATION. >> NOVEMBER 7TH DO I HAVE TO HAVE -- >> THAT'S A QUESTION THAT THEY'LL DEFINITELY HAVE TO FIND OUT. >> IT'S MY UNDERSTANDING THAT YOU DON'T HAVE TO AND I HAVE A DISCLAIMER, I'VE BEEN THERE FOR EIGHT YEARS BUT I HAVE NOT DONE AWARDS MANAGEMENT. WHEN I WAS AT NCI I DID THAT THAT'S WHY I DEPEND ON MY COLLEAGUES FROM OTHER INSTITUTES. EVEN IN THE CURRENT RECORD THERE ARE CONSORTIA AND HOW IT WAS DONE. SO I'M GOING TO TOUCH BASE WITH MY COLLEAGUES, AND THIS IS ONE FOR ALL OF YOU WHO ARE HERE OR WHO ARE NOT HERE. AND WE WILL HAVE A DEFINITIVE ANSWER FOR YOU, AND FOR OTHERS WHO HAVE SIMILAR QUESTIONS AND WHO ARE WATCHING US ON THE VIDEOCAST. IT'S MY UNDERSTANDING THAT YOU DO NOT NEED DURING THE TIME OF SUBMISSION BUT DURING THE TIME OF AWARD PAMELA IS CORRECT YOU NEED THOSE DOCUMENTS OTHERWISE YOUR AWARD WILL BE RESTRICTED. ANYMORE QUESTIONS FROM HERE IN THE AUDIENCE? CHRIS, DID YOU FORWARD ME SOMETHING IN THE E-MAIL. >> RASHMI, I DID TALK TO JEFF WHO RUNS THE DATA MANAGEMENT COORDINATING CENTER AND HE HAD SENT OUT A DOCUMENT ON WHAT CAPABILITIES AND HE'S FINE WITH SENDING THAT TO ANYONE WHO WANTS IT. >> OKAY. >> THAT IS ANY APPLICANT WHO WANTS IT. >> DID YOU HEAR. SO OUR CURRENT DATA MANAGEMENT COORDINATING CENTER, THE PI'S DR. JEFF CUSHER AND HE HAS DEVELOPED A DOCUMENT WHICH DESCRIBES THE CAPABILITIES OF THE DATA MANAGEMENT COORDINATING CENTER AND HE HAS AGREED THAT WE CAN GO AHEAD AND FORWARD IT TO ANYBODY IN CASE YOU ARE WONDERING THE DETAILS ABOUT THE CAPABILITIES OF THE CURRENT DNCC. SO WE WILL TRY TO SEND IT TO ALL POTENTIAL PI'S AND IF YOU DON'T RECEIVE IT IN A DAY OR TWO, SEND ME AN E-MAIL AND WE WILL ALSO POST IT ON OUR WEBSITE WHERE WE PUT THE FREQUENTLY ASKED QUESTIONS AND WHERE WE HAVE PUT THE LINK FOR THE RDCR. WE WILL DO THAT. >> I WANT TO ASK ONE MORE RELATED QUESTION TO THAT POINT. IS IT ADVISABLE TO MAKE CONTACT WITH THE DMCC TO DESCRIBE THE STATISTICAL CONSIDERATION AND HOW THAT COLLABORATION WILL OCCUR. >> THIS IS MY UNDERSTANDING THAT DR. JEFF CUSHER DOES NOT MIND. HE HAS BEEN HELPFUL TO MANY GROUPS. BIOSTATISTICAL SUPPORT IS TO BE PROVIDED BY THE CONSORTIUM. BUT YOUR BIOSTATISTICIAN WILL NEED TO WORK WITH THE DATA MANAGEMENT COORDINATING CENTER, YES. AND HIS CONTACT INFORMATION IS ON OUR WEBSITE. SO THERE IS A QUESTION AGAIN ABOUT PILOT PROJECT PROGRAM. DO YOU RECOMMEND APPLYING WITH ONE SPECIFIC PROJECT AND A PLAN FOR HOW WE WILL SELECT ADDITIONAL PILOT PROJECTS? YES. THE ANSWER IS THE FIRST ONE, YES. PROPOSE A PLAN AND DESCRIBE A PILOT PROJECT. MORE CAME IN. YES. SO IT'S THE SAME PERSON AND HE SAYS RASHMI DID NOT ANSWER MY OTHER QUESTIONS. HERE I AM AGAIN. DO YOU WANT ME TO TELL YOUR NAME? NO, I WON'T. SO CAN THE ADMINISTRATIVE DIRECTOR POSITION BE SPLIT AMONG MORE THAN ONE PERSON? IF NOT, WHY NOT. SO IF YOU WANT TO HAVE TWO ADMINISTRATIVE DIRECTOR IT'S DOABLE AND IF THEY HAVE THE EXPERTISE TO DO IT. FOR EACH PROJECT DO WE HAVE A SPECIFIC FOR SPECIFIC GAINS AND 12 PAGES FOR PLAN 13 PAGES OR 12 PAGES TOTAL. >> THIS IS RHS398 AND I DON'T DO THIS ON A DAY-TO-DAY BASIS BUT THIS IS PIE UNDERSTANDING THAT WITHIN THE RESEARCH STRATEGY SECTION, THERE IS AN APPROACH -- SORRY, I JUMPED AHEAD. I STARTED ANSWERING HIS THIRD QUESTION. SO FOR THE SECOND QUESTION, YES, YOU HAVE 12 PAGES FOR THE RESEARCH STRATEGY WHICH WAS PREVIOUSLY CALLED RESEARCH PLAN. AND YOU HAVE ONE PAGE FOR SPECIFIC AIM. AND THE THIRD QUESTION IS FOR RENEWAL APPLICATIONS, DO WE GET TO HAVE EXTRA PAGES. NO, YOU DON'T GET ANY EXTRA PAGES AND YOU HAVE TO FOLLOW PHS 398. THAT'S WHAT I WAS TRYING TO SAY EARLIER. I THINK IT'S MENTION THAT UNDER RESEARCH STRATEGY THERE IS A SECTION CALLED APPROACH, AND THAT'S WHERE YOU ARE SUPPOSED TO PUT YOUR PROGRESS SUPPORT AND I THINK IT'S ONE PAGE. AGAIN MY COLLEAGUES FROM THE INSTITUTE OR ANY OF THE INVESTIGATOR. I HAVE PAGES 398 HERE BUT I'M NOT GOING TO FLIP THROUGH PAGES. SO I'LL GO TO THE NEXT ONE. CAN GRANTS MANAGER ADMINISTRATIVE STAFF BE LISTED WITH THE EFFORT ON THE ADMINISTRATIVE UNIT. SO, I'M NOT SURE WHAT IS MEANT BY GRANT MANAGERS HERE. YES. DO YOU HAVE ANY COMMENTS? SO THE PERSON WHO SENT ME THIS QUESTION, CAN YOU PLEASE SPECIFY WHAT DO YOU MEAN BY GRANTS MANAGERS? CAN A LETTER OF INTENT BE USED IN LIEU OF AN NIH FACE PAGE. I'M NOT SURE I UNDERSTAND THAT BUT I THINK THE ANSWER IS NO. >> IN IT'S TALKING ABOUT A CONSORTIUM ARRANGEMENT, YES. >> OKAY. SO MAYBE THIS WAS A FOLLOW UP ON YOUR COMMENTS, YES. OKAY. >> AND THEN AT THE TIME OF THE AWARD THEN I COULD REQUEST IT. >> OKAY. SO IF THE QUESTION WAS REGARDING THE CONSORTIUM ARRANGEMENT WITH OTHER INSTITUTIONS, THEN YES YOU CAN PUT IN A LETTER OF INTENT AND THEN LATER ON YOU WILL HAVE TO HAVE A FORMAL AGREEMENT WITH THE SIGNATURES. SO ONE MORE QUESTION AND I THINK IT'S COMING FROM -- FOR THE CURRENT DMCC WEBSITE THE CURRENT DMCC IS MANAGING ALL THE DATA. THE DMCC HOUSES ALL DATA FOR RDCRN CENTRALLY WE ARE IN HOUSE -- CUSTOMIZE ELECTRONIC DATA CATTLE SYSTEM. SHOULD WE BE INCLUDING COSTS FOR DEVELOPMENT AND MAINTAINING OF ELECTRONIC DATA CAPTURE SYSTEM OR IS THIS THE ROLE OF DATA MANAGEMENT AND COORDINATING CENTER. RANDY, DO YOU WANT TO COMMENT ON THIS ONE? >> IT'S HAPPENED IN THE MOST. I DON'T KNOW WHETHER YOU EXCLUDED IT IN THIS CONCURRENT IN THE PAST PEOPLE HAVE IN SOME CASES SET UP DUAL STRUCTURES. ONE, THEIR OWN IN-HOUSE DATA CAPTURER AND THEN MONTHLY TRANSFER TO THE DATA MANAGEMENT COORDINATING CENTER. WAS THAT EXCLUDED? >> YOU WERE INVOLVED IN WRITING OF THIS RFA BUT I WILL REPEAT IT. IT IS THE EXPECTATION THAT IF YOU WANT TO BE PART OF THIS NETWORK, YOU WILL BE USING THE DATA MANAGEMENT COORDINATING CENTER FOR THIS NETWORK. IN ADDITION, IF YOU HAVE SOME PLACE ELSE TO SEND YOUR DATA, YOU CAN DO THAT BUT THIS WILL BE YOUR PRIMARY MANAGEMENT COORDINATING CENTER. DOES THAT ANSWER? >> THAT WAS REQUIRED LAST TIME. EVERYTHING HAS TO BE SENT TO DATA MANAGEMENT COORDINATING CENTER AT SOME POINT. >> THIS IS YOUR PRIMARY DATA MANAGEMENT COORDINATING CENTER IF YOU WANT TO BE PART OF THIS NETWORK. >> SO WE HAVE AN EXISTING DATA MANAGEMENT SYSTEM AND COLLECTION WAS THINKING OF DOING WAS JIBING THAT WITH THE DMCC, THAT'S ALL. >> YES, YOU CAN DO THAT. YOU CAN ESTABLISH THE HAPPENED SHAKE AND SEND ON A MONTHLY OR EVERY TWO WEEKS OR HOWEVER YOU WANT TO DO IT. SEND THE DATA TO THEM. >> BUT MAKE SURE THAT YOU DON'T USE DMCC AS YOUR SECONDARY. IT SHOULD BE YOUR PRIMARY. AND I'M SURE COMPATIBILITY IS NOT MY AREA, THOSE WILL COME LATER AND THEN WE CAN ALSO -- LOOK A LITTLE BIT MORE LATER TO A PHONE CALL. >> I HAVE A CALL SET UP WITH JEFFREY CUSHER ABOUT THIS BUT OUR DATA CAPTURE SYSTEM IS PRETTY SOPHISTICATED. SO IT CAPTURES NOT ONLY DATA BUT IMAGING, OKAY AND SOME FAIRLY SOPHISTICATED PIECES OF DOTTED. AND I GUESS I WOULD NEED TO DISCUSS WITH HIM WHETHER OR NOT HOW HAD TRANSFER IS GOING TO TAKE PLACE AND IF THEY'RE CAPABLE OF RECEIVING SOME OF THIS DATA. >> YES. MY IMAGES, YES. ANYTHING ELSE, IF NOT, HE CAN FIGURE OUT HOW TO DO IT. >> THEY RECEIVE IMAGES. IT'S A CAPABLE GROUP. >> OKAY. >> THAT'S ALL I CAN COMMENT. GO AHEAD, LINDA. >> I HAVE A QUESTION IN THE SECTION RDCRC INVESTIGATIVE UNIT. >> YOU HAVE A QUESTION. >> YES. I HAVE A QUESTION. >> OKAY MY COLLEAGUE FROM NIAID. >> FROM LISTENING TO THE DISCUSSION THAT'S JUST TAKEN PLACE HERE I WANT TO MAKE SURE I UNDERSTAND. YOU SAY RDCRC ADMINISTRATIVE UNITS PERSONNEL MAY BE BUDGETED AT NO MORE THAN 12 CALENDAR MONTHS. BY RDCRC AND AU SUPPORT PERSONNEL ARE YOU INCLUDING PEOPLE LIKE PROJECT MANAGER, BUSINESS OFFICE STAFF. SO FOR EXAMPLE, IF YOU WANT TO DESIGNATE PEOPLE IN THOSE SLOTS, THOSE SLOTS CAN ONLY ADD UP TO 1.0 FTE. >> THIS IS AGAIN NOT A NEW REQUIREMENT. SO DO YOU REMEMBER HOW IT IS BEING DONE IN ONE OF YOUR CURRENT CONSORTIUM. >> I DO AND IT'S BEING DONE DIFFERENTLY. THERE'S ADDITIONAL STAFF HOURS DUE TO THE AMOUNT OF WORK NEEDED. IT WAS NOT POSSIBLE TO ACCOMPLISH THE WORK NEEDED. >> SO YOU ADDED. >> SO WE CURRENTLY HAVE ACTUALLY ABOUT 2.5 FTE. >> SHE'S TALKING ABOUT A COMPETING RENEWAL AND THAT PARTICULAR CONSORTIUM IS COMPLETELY SUPPORTED. THE FINANCIAL SUPPORT COMES FROM NIAID SO I DID NOT KNOW THE DETAILS. >> BUT WE'VE DONE THAT. I THINK THE ORIGINAL APPLICATION HAD 1.0 FTE. AS TIME PROGRESSED IT BECAME OBVIOUS THAT THE FUNCTIONING OF THE ADMINISTRATIVE UNIT FOR EFFICIENT FUNCTION ARE NEEDED TO BE MORE STAFF. AND THERE NEEDED TO BE A SENIOR STAFF IN THE BUSINESS OFFICE DUE TO THE NUMBER OF SITES THAT WE HAVE AND THE COMPLEXITY. >> SO IN THE RFA, IT IS ONE FULL TIME ACTIVITY. >> I WANT TO BE CLEAR SO IN THE NEED TO SPECIFY ONLY ONE FTE. >> THIS IS JUST A THANK YOU WHICH MAKES ME SMILE. NO I DID NOT DELETE YOUR E-MAIL, I JUST COULD NOT FIND IT. I ALWAYS APPRECIATE A THANK YOU. I THINK AS WE ALL DO. SO CAN ANY ADMINISTRATIVE STAFF BE LISTED WITH EFFORT ON AN ADMINISTRATIVE GOALS. I THINK SHE MEANT UNIT. YES. IF YOU CAN. OTHER QUESTIONS? WE HAVE EIGHT MORE MINUTES TO GO. >> I'LL JUST MAKE A COMMENT THAT IN YOUR APPLICATION, IF YOU'RE TALKING ABOUT HOW YOU'RE GOING TO COMMUNICATE WITH MONTHLY CONFERENCE CALLS, IT WOULD BE A GOOD IDEA TO MENTION THAT YOU'RE GOING TO INCLUDE THE SCIENTIFIC PROGRAM OFFICER FROM THE INSTITUTE ON THOSE CALLS. IT'S WORTHWHILE MENTIONING. YOU'RE THINKING ABOUT YOUR ADVOCATE AT THE INSTITUTE BEING INCLUDED ON THE CALL. >> YES. SO THIS WAS SAID THE FIFTH TIME. SO IT'S GOOD TO HEAR. SOMEBODY'S ENJOYING THE SESSION AND THEY ARE PLANNING TO PAY THEIR SUBCONTRACT SITE BY PAYING PER SUBJECT VISIT AS IT OCCURS. IS IT ALLOWED IF WE ESTIMATE THE MINIMUM NUMBER OF SUBJECT VISITS AT EACH SITE. MY ANSWER IS YES. AND THERE'S ONE MORE QUESTION. I UNDERSTAND THAT THE FIRST CLINICAL PROJECT NEEDS TO BE A LONGITUDINAL STUDY. WHAT CONSTITUTES CLINICAL RESEARCH FOR THE PURPOSE OF THE SECOND STUDY? SPECIFICALLY DOES STUDYING MATERIALS OBTAINED DIRECTLY FROM PATIENTS COUNT AS CLINICAL RESEARCH. AND BASED ON THE VERY LIMITED INFORMATION HERE, MY INITIAL ANSWER WOULD BE YES. SO YOUR SECOND STUDY CAN ALSO BE A LONGITUDINAL STUDY OR WE CAN USE HUMAN SUBJECT MATERIALS. AGAIN, I WOULD URGE YOU TO SEND LITTLE BIT MORE DETAIL ABOUT THIS PROJECT, SO THAT WE CAN GIVE YOU MORE INPUT AND TELL YOU WHETHER THIS WILL BE RESPONSIVE TO THIS PROGRAM OR NOT. ONE MORE. CHRIS KEEPS FORWARDING ME. SO WE HAVE SIX MORE MINUTES TO GO. I THINK I ANSWERED THESE QUESTIONS. OKAY. IT'S JUST THANK YOU. ANYMORE QUESTIONS FROM THE AUDIENCE WHO ARE HERE OR WHO ARE WATCHING THROUGH VIDEOCAST OR ANY OF MY COLLEAGUES FROM THE INSTITUTE ORDR, THE REVIEW OFFICER, GRANTS MANAGEMENT, DR. GROFT. IF NOT, THEN I WOULD AGAIN LIKE TO THANK YOU ALL. THOSE WHO ARE HERE IN THE ROOM AND THOSE WHO TOOK TRAIN OR CARS OR FLEW HERE OR THOSE WHO ARE WATCHING ON THE WEBCAST. AGAIN IT'S MY RESPONSIBILITY, IT'S THE RESPONSIBILITY OF MY COLLEAGUES TO RESPOND TO YOUR QUESTIONS BEFORE YOU SUBMIT. SO PLEASE FEEL FREE TO CONTACT ME OR ANY OF MY COLLEAGUES. AND MAKE SURE THAT YOU TALK TO AN INSTITUTE PROGRAM STAFF. I'LL BE HAPPY TO ANSWER ANY OF EARLIER CORRECTIONS. WE WILL TRY TO SET UP PHONE CALLS AND SET UP THE PROGRAM STAFF IN CASE YOU WANT TO SENT A SHORT DESCRIPTION OF YOUR PROJECT SO WE CAN COMMENT ABOUT THE RESPONSIVENESS OF THOSE PROJECTS. SO WE WOULD LIKE TO END HERE AND THANK YOU ALL AGAIN. AND IF YOU ARE FLYING OR TAKING A TRAIN, HAVE A SAFE TRIP. AND THANK YOU.