>> THROUGH ELECTRONIC MEANS. WE ANTICIPATE MAKING THE ELECTRONIC OPTION AVAILABLE TO EACH MEMBER FOR ONE OF THREE ANNUAL MEETINGS WITH POSSIBLE REQUESTING VIRTUAL ATTENDANCE WELL IN ADVANCE. WE HAVE THREE COUNCIL MEMBERS NOT ABLE TO JOIN US TODAY, BOB ROUND GORDON CUTLER, RENEE JENKINSCH WE HAVE INVITED GUESTS AND AT THIS POINT I'LL TURN TO DR. MADDOX. >> THANK YOU. I DON'T KNOW IF DR. DEBATER IS HERE YET BUT WE HAVE INVITED GUESTS FROM OUR FRIENDS OF NICHD COALITION, IF THEY'RE NOT HERE YET THEY WILL BE ON THEIR WAY, MAYBE STUCK ON THE BELTWAY WITH OTHER FOLKS I UNDERSTAND HAVEN'T BEEN ABLE TO GET IN TO THE FRONT GATE YET. WE'RE PLEASED MANY ADVOCACY GROUPS PAY A LOT OF ATTENTION TO ACTIVITIES AND SPECIFICALLY OUR COUNCIL AND OF COURSE OUR OPEN SESSION OF COUNCIL WHICH IS OPEN TO THE PUBLIC. AD ALAN MENTIONED WE DOIATE YOUR PARTICIPATION IN THE COUNCIL, PARTICULARLY COUNCIL MEMBERS WHO HAVE A LARGE LOAD OF WORK TO DO, IN PARTICULAR THIS COUNCIL, WE WANT TO THANK YOU FOR BEING HERE AND BEING PART OF THIS. ONE THING I'M CHARGED WITH REMIND U YOU OF ARE ISSUES ASSOCIATED WITH CONFIDENTIALITY AND CONFLICT OF INTEREST, YOU WILL SEE AT YOUR FOLDER -- AT YOUR PLACE A RED FOLDER AND BRING THIS TO THE ATTENTION CERTAINLY OF NEW COUNCIL MEMBERS BECAUSE I THINK THOSE OF YOU WHO SERVED BEFORE ARE FAMILIAR WITH THE RED FOLDER. THAT INCLUDES YOUR INDIVIDUAL CONFLICT OF INTEREST AS WELL AS YOUR CONFLICT OF INTEREST RECUSAL LIST. WE MUST HAVE THOSE LISTS BACK AT THE END OF THE CLOSED SESSION SIGNED BY YOU TESTING TO THE FACT THAT YOU DID NOT PARTICIPATE IN ANY REVIEW OR DISCUSSION OF APPLICATIONS WHICH YOU WERE IN CONFLICT. SO WE WILL BE AROUND TO COLLECT THEM AT THE END OF THE COUNCIL IF YOU DON'T VOLUNTARILY GIVE THEM TO US. WE ALSO WOULD LIKE TO REMIND COUNCIL MEMBERS, THIS IS SPECIFICALLY FOR NEW COUNCIL MEMBERS, THAT YOU ARE NOT ALLOWED TO SERVE ON ANY OTHER ADVISORY BOARD TO THE FEDERAL GOVERNMENT, CERTAINLY TO NIH WHILE SERVING ON COUNCIL. YOU ARE NOT ALLOWED TO SERVE ON BOTH FIRST LEVEL REVIEW AND SECOND LEVEL REVIEW. COUNCIL IS THE SECOND LEVEL REVIEW. THE OTHER THING THAT'S PART OF THE BUSINESS BEFORE I TURN IT BACK OVER TO ALAN TO WELCOME THE NEW MEMBERS AND HAVE THEM TO SAY WHO THEY ARE, I WANT YOU TO TAKE A QUICK LOOK IF YOU HAVEN'T HAD A CHANCE TO DO SO AT THE COUNCIL MINUTES. WE WILL NEED A MOTION FOR THEIR APPROVAL OR FOR YOUR ACCEPT STANCE AS WRITTEN. CAN I HAVE A MOTION ON THE MINUTES? SECOND PLEASE. ALL IN FAVOR PLEASE SAY AYE. ANY OPPOSED? MOTION IS CARRIEDED. COUNCIL MINUTES ARE APPROVED. ALAN, WOULD YOU LIKE TO SAY SOMETHING ABOUT -- FIRST LET ME JUST REMIND PEOPLE TO -- I DON'T ALWAYS DO THIS BUT REMIND YOU OF FUTURE COUNCIL MEETING DATES. PLEASE TAKE A LOOK AT THEM, YOU SHOULD ALREADY HAVE THEM ON YOUR CALENDARS BECAUSE IT IS CRITICAL THAT WE HAVE A QUORUM AT OUR COUNCILS PARTICULARLY FOR CLOSED SESSION ALAN MENTIONED EARLIER ABOUT THE VIRTUAL SESSIONS, WE ALLOW EACH COUNCIL MEMBER TO HAVE AT LEAST ONE. WE DON'T PROMOTE VIRTUAL BUT FROM IS AN OPPORTUNITY FOR YOU TO DO SOMETHING ELSE THAT YOU THINK IS MORE IMPORTANT THAN COUNCIL AND YOU CAN'T ATTEND WE WILL ALLOW YOU TO HAVE AT LEAST ONE VIRTUAL. WE NEED NOTICE EARLY ON ABOUT ABILITY TO PARTICIPATE IN COUNCIL BECAUSE A QUORUM IS CRITICAL. FOR THOSE WHO HAVEN'T FIGURED IT OUT YET WE HAVE THREE COUNCIL AS YEAR, REGULARLY THE JANUARY COUNCIL IS LAST WEEK IN JANUARY, THE SECOND COUNCIL IS JUNE COUNCIL AND THAT'S USUALLY THE FIRST OR SECOND WEEK IN JUNE SO HERE WE ARE AND THE THIRD COUNCIL IS THE SEPTEMBER COUNCIL AND THAT'S USUALLY THE SECOND OR THIRD WEEK IN SEPTEMBER. MARK YOUR CALENDARS NOW SO THAT YOU CAN GIVE US ANY INFORMATION PERTINENT TO YOUR VARIABILITY BEFORE THE DATE ON THE COUNCIL. WE ALSO WOULD LIKE TO SAY ISSUES AROUND CONFLICT DURING CLOSED SESSION IN REVIEW AND STAFF AND MYSELF WILL BE ON ALERT TO MAKE AWARE IN CONFLICT OF SOMETHING WE KNOW ABOUT AND WE'LL ASK YOU TO LEAVE THE ROOM OR REMIND YOU LEAVE THE ROOM BUT FOR CONFLICTS THAT YOU HAVE THAT WE'RE NOT FAMILIAR WITH, WE LEAVE IT UP TO YOU TO LEAVE THE ROOM. >> WOULD YOU LIKE TO INTRODUCE NEW COUNCIL MEMBER? >> I WOULD. THIS IS A FUN PART OF COUNCIL TO INTRODUCE NEW MEMBERS. WE HAVE FOUR JOINING US TODAY. AND A SLIGHT WARNING IF YOU HAVEN'T RECEIVED I'LL GIVE YOU A FEW SECONDS TO THINK ABOUT I'LL INTRODUCE YOU AND THEN ASK YOU TO INTRODUCE YOURSELVES TO TELL COUNCIL SOMETHING ABOUT YOUR PROFESSIONAL BACKGROUND EXPERTISE AND INTEREST SO FOLKS WILL GET A CHANCE TO KNOW YOU. I GUESS I'LL DO THIS IN ALPHABETICAL ORDER. THE FIRST NEW COUNCIL MEMBER IS DR. DIANA BIANCHI, PEDIATRICS OBSTETRICS AND GYNECOLOGY AT TUFTS UNIVERSITY MEDICAL SCHOOL IN BOSTON. DR. BINCHI. >> MICROPHONE IS FLASHING NOW IT'S ON. I'M A BOARD CERTIFIED MEDICAL GENETICIST, NEONATOLOGIST AND PEDIATRICIAN THAT I HAVE BEEN INTEREST IN REPRODUCTIVE GENETICS, PRE-NATAL DIAGNOSIS AND FATAL THERAPY. I HAVE BEEN THE GRATEFUL RECIPIENT OF NICHD SUPPORT WAY BACK TO THE FIRST GROUP OF THE PHYSICIAN SCIENTIST AWARDS, WHEN THEY WERE FIRST CREATED. >> NEXT IS BONNIE DURAN, PROFESSOR OF SCHOOL OF PUBLIC HEALTH AND INDIGENOUS WELLNESS RESEARCH INSTITUTE AT UNIVERSITY OF WASHINGTON SCHOOL OF PUBLIC HEALTH IN SEATTLE. >> GOOD MORNING, EVERYBODY. I AM FACULTY AND SCHOOL PUBLIC HEALTH AND DRETOR OF SENT E PSYCHIATRIC EPIDEMIOLOGY AND ALCOHOL DRUG INTERVENTION RESEARCH WITH TRIBAL COLLEGES AND DO SOME METHODS RESEARCH LOOK AT PROMOTERS AND BARRIER TO ENGAGEMENT AND MEANINGFUL COMMUNITY ENGAGEMENT AND RESEARCH. I'M DELIGHTED TO BE HERE. THANKS. GOOD TO ARE YOU, BONNIE. >> NEXT IS DR. KEN MUNEOKA, PROFESSOR OF CELL BIOLOGY AT TULANE. KEN. >> I ALSO AM DELIGHTED TO BE HERE. I'M PROFESSOR AT TULANE UNIVERSITY AT AN UNDERSTOOD GRADUATE CAMPUS. MY RESEARCH OR MY TRAINING IS IN DEVELOPMENTAL BIOLOGY. MY RESEARCH OVER MY LIFETIME HAS BEEN IN REGENERATIVE BIOLOGY AND USE IN THE INTERFACE BETWEEN DEVELOPMENTAL BIOLOGY AND REGENERATION. I WORK ON MAMMALIAN MODELS AND MY FUNDING HAS BEEN THROUGH NICHD AS WELL AS THROUGH THE MILITARY THROUGH THE DEPARTMENT OF DEFENSE. MY LAB VERY MUCH COMMITTED TO TRYING TO FIGURE OUT WAYS TO ENHANCE REGENERATIVE ENDOGENOUS REGENERATIVE ABILITIES. THE FINAL ONE OF OUR QUARTET IS DR. PAUL WISE, PROFESSOR IN THE DEPARTMENT OF PEDIATRICS AT STANFORD. >> THANKS, ALAN. I'M A PEDIATRICIAN AND EPIDEMIOLOGIST. MY WORK IS PRIMARILY BEEN ON THE IMPACT OF TECHNICAL INNOVATION ON CHILD HEALTH OUTCOMES AND CHILD HEALTH POLICY. THANKS. >> WE DO WELCOME ALL FOUR OF YOU AND AS YOU'LL SEE WE WILL CALL ON YOU FOR LOTS OF DIFFERENT THINGS, SOME FORMAL, SOME INFORMAL. AND YOU SHOULD FEEL FREE TO CALL ON US, PART OF WHAT WE'RE TRYING TO ENCOURAGE COUNCIL MEMBERS TO DO AND THE NUMBER OF TAKING THIS UP WITH GREAT AVIDITY WHICH IS WONDERFUL, IS TO CONTACT US IN BETWEEN MEETINGS AS WELL. WHEN YOU HAVE THOUGHTS ABOUT THE WAY THE INSTITUTE IS FUNCTIONING OR MAYBE THOUGHTS HOW THE INSTITUTE IS NOT FUNCTIONING, THAT YOU THINK WE SHOULD HEAR ABOUT IF YOU HAVE ANY QUESTION AT ALL ABOUT CONTACTING US, PLEASE CONTACT US. PART OF WHAT YOU BRING TO THE COUNCIL IS BEING A KIND OF EYES AN EARS FOR US IN THE EXFERNL WORLD. AMONG THE MANY THINGS THAT WE PROFIT FROM YOUR PARTICIPATION IS THAT KIND OF CONTINUED INVOLVEMENT WITH US. SO PLEASE DO FEEL FREE TO CONTACT US ABOUT ISSUES YOU'RE AWARE OF, THINGS TO CONSIDER FORMALLY AT COUNCIL OR NOT. PLEASE DO THAT. >> JUST AS PEOPLE COME ON TO COUNCIL, PEOPLE AT SOME POINT2su LEAVE COUNCIL, WHICH IS NOT AS MUCH FUN FOR US BUT STILL PART OF THE NATURAL RENEWAL PROCESS AND WE'RE WITH THE DEVELOPMENTAL LENS REALIZE THERE WAS A LIFE CYCLE, ET CETERA, ET CETERA. WHERE THIS WILL HAPPEN. WE HAVE TWO MEMBERS OF THE COUNCIL FOR WHOM THIS IS THE LAST MEETING. THE FIRST IS DR. DAVID HEPPLE, THE EXOFFICIO REPRESENTATIVE FOR US FROM THE HEALTH RESOURCES AN SERVICES ADMINISTRATION OR HRSA. SINCE 1999. BESIDES THANKING US FOR DOING THIS LONG WE SAY GOODBYE TO PART OF THE INSTITUTIONAL MEMORY IN DOING THAT. DAVID, I DON'T KNOW IF YOU HAVE REFLECTIONS ABOUT THAT OVER DECADE ON COUNCIL THAT YOU WOULD LIKE TO SHARE, YOU HAVE TO BUT WE WOULD LOVE TO HEAR THEM. >> I CERTAINLY HAD A WONDERFUL TIME HERE, I HAVE LEARNED A GREAT DEAL BUT I'M EXTREMELY PLEASED THE QUALITY OF REPRESENTATION FROM HRSA WILL BE GOING UP IN SEPTEMBER YOU HAVE AN INDIVIDUAL COMING IN WHO HAS BEEN A GRANT RECIPIENT INVOLVED IN THE CHILD HEALTH STUDY. IT'S VERY NEW BUT HAS DONE A WONDERFUL JOB SO FAR AT THE MATERNAL CHILD HEALTH BUREAU, DR. MICHAEL LU. I REALIZED WHEN I WAS IN MY SECOND YEAR OF MEDICAL SCHOOL I WAS A SENIOR CO-STEP, YOU SEE -- YIEWN YOUR CO-STEP YOU SEE FOLKS IN UNIFORM HERE. THAT WAS THE SOCIAL BEHAVIORAL SCIENCES BRANCH OF NICHD SO IT'S BEEN A LONG CIRCLE. THANK YOU VERY MUCH. (OFF MIC) [APPLAUSE] >> I MIGHT MENTION COUNCIL CONTINUE TO HAVE A SPECIAL PLACE IN OUR HEART AND WE HOPE THAT YOU WILL STAY IN COMMUNICATION WITH US, ET CETERA BECAUSE YOU FORMALLY LEAVE COUNCIL DOES NOT MEAN WE DON'T WANT TO BENEFIT FROM YOUR COUNSEL, ET CETERA. >> WE CERTAINLY DON'T WANT YOU TO LEAVE BEFORE THIS AFTERNOON FOR THE CLOSED SESSION. YOU HAVE A HUGE WORKLOAD. >> OTHER MEMBER OF COUNCIL FOR WHOM THIS IS THE LAST MEETING IS DR. JOHN SHAI WHO HAS BEEN THE LIAISON MEMBER FROM THE NATIONAL ADVISORY BOARD MEDICAL REHABILITATION RESEARCH AND JOHN HAS BEEN THAT LIAISON MEMBER SINCE 2010. YOU'LL HEAR MORE ABOUT SOME OF THE THINGS JOHN IS IS INVOLVED IN LATER THIS MORNING. BUT JOHN, I DON'T KNOW IF YOU HAVE ANY PARTICULAR COMMENTS YOU WOULD LIKE TO SHARE WITH THE GROUP. >> I WANT TO THANK YOU FOR THE OPPORTUNITY, INSIGHTFUL LEARNING EXPERIENCE FOR ME TO SEE WHO WHOLE PROCESS, IT'S HARD WORK AND I WANT TO THANK YOU ALL FOR TAKING THAT ROLE. [APPLAUSE] >> NEXT IS THE DIRECTOR'S REPORT. WHICH I WILL GIVE SOME IDEA OF THINGS HAPPENING AROUND HERE, BASICALLY STARTING WITH NEWS FROM NICHD SPECIFICALLY TALKING A LITTLE BIT ABOUT PARTICULAR ACHIEVEMENTS OF BOTH STAFF AND GRANTEES SINCE WE LAST MET TOGETHER. AN UPDATE ABOUT PROPOSED EXTRAMURAL ORGANIZATION WE DISCUSSED AT THE LAST COUNCIL MEETING, NEWS FROM THE BROADER NIH AND TO CLOSE ON WHAT MAY NOT BE THE MOST UPLIFTING POINT, BUDGET AND LEGISLATIVE UPDATES. NEWS FROM NICHD. ONE CAN GO ON FOREVER WITH THIS PART OF IT BECAUSE THERE'S SO MUCH THAT HAPPENS AROUND HERE. COUPLE OF THINGS WE MIGHT HIGHLIGHT SOME WHICH VARIOUS MEMBERS OF COUNCIL ARE INVOLVED IN IN SOME WAYS. FIRST IS SOMETHING FOR WHICH WE WERE CLEARLY NOT THE PRIMARY INS GATOR OR WHATEVER BUT WE DID PLAY AN ADVISORY ROLE WITH THIS. I THINK WITH SUCH AN IMPORTANT PUBLICATION AND MARCH OF TIME ASF SPOT LIGHTING. THE GLOBAL ACTION REPORT ON PRE-TERM BIRTH CO-AUTHORED BY WHO AND MARCH OF DIMES WITH OTHER PARTNERS PROVIDING INPUT INCLUDING US. IT'S I THINK A VERY USEFUL DOCUMENT THAT GIVES THE LATEST FIGURES COUNTRY BY COUNTRY ON GLOBAL PREMATURITY RATES AS ALL OF YOU KNOW FROM EMERGING FROM OUR SCIENTIFIC VISIONING PROCESS, THOUGH IT WEREN'T EVIDENT ALREADY, PRE-TERM BIRTH IN TERMS OF MORTALITY AND MORBIDITY ASSOCIATED WITH IT, IS CLEARLY AN AREA OF REAL PRIORITIZATION FOR US IN THE COMING YEARS. SO HAVING THIS LAND MARK DOCUMENT THERE TO THINK ABOUT THIS IN A GLOBAL CONTEXT, NOT JUST A DOMESTIC ONE IS VERY HELPFUL. I MIGHT MENTION AS PART OF THAT, THAT WE ARE REGULAR PARTICIPANTS NOW, WE HAVE BASICALLY PUT TOGETHER A TROICA OF INSTITUTIONS PARTICULARLY INVOLVED IN BOTH DOMESTIC AND GLOBAL PREMATURITY ISSUES, VERGE ISSUES AND SOME DEGREE ON THE GROUND APPLICATION ISSUES. THAT IS NICHD THE MARCH OF DIMES AND BILL AND MELINDA GATES FOUNDATION, SOME WILL KNOW THAT THE GATES FOUNDATION HAS -- GIVES SUBSTANTIAL FUNDING TO AN ORGANIZATION CALLED GAPS WHICH IS OPERATED OUT OF SEATTLE CHILDREN'S HOSPITAL. THE PI FOR IT IS CRAIG RUBINS. THE THREE MAJOR OFTEN WITH GAPS PARTICIPATING WE NOW HAVE MONTHLY PHONE CALLS IN WHICH WE REALLY TRY TO COORDINATE OUR EFFORTS. I MUST SAY HOW IMPRESSED I AM THAT THE INSTITUTIONS INVOLVED HAVE BEEN ABLE TO PUT ASIDE INSTITUTIONAL EGOS. TO REALLY THINK BECAUSE CLEARLY THEY'RE DIFFERENT ASSETS THAT EACH GROUPS IN SOMEWHAT DIFFERENT FOCI EACH BRING TO THE QUESTION OF PREMATURITY, CERTAINLY OVERLAPPING ONES AS WELL. THERE'S BEEN A GREAT EFFORT TO TRY TO WORK TOGETHER FOR THE COMMON GOOD OF TRYING TO COORDINATE THINGS WE'RE NOT DUPLICATING SOMEONE ELSE'S EFFORTS BUT UTILIZING ORGANIZATIONAL EFFORTS SO WE'RE LETTING FOLKS KNOW ABOUT WHAT OUR PLANS ARE AS WELL AS WHAT WE HAVE ALREADY DONE KIND OF THING SO WE CAN MOVE FORWARD WITH THESE KINDS OF THINGS TOGETHER. AS PART OF THAT IN JULY IN SEATTLE A MEETING WAS ORIGINALLY CONVENED BY GATES AND GAPS. WE WERE INVITED TO BE CO-ORGANIZERS ALONG WITH MARCH OF DIMES FOR THAT SO ALL FOUR OF US ARE ORGANIZING THE MEETING TOGETHER. OF FUNDERS TO GET BEYOND THESE BOTH CURRENT FUNDERS AND WHAT WE REGARD AS POTENTIAL FUNDERS FOR EFFORTS BOTH IN PREVENTION AN TREATMENT OF PRE-TERM BIRTH IN THE ROOM TOGETHER TO DISCUSS WHAT WE'RE UP TO AND HO WE MIGHT DO A BETTER JOB WITH THIS. SOME RESEARCH PLANS THAT HAVE BEEN DEVELOPED AND/OR UPDATED SINCE WE LAST MET IN APRIL, WE WITH INPUT FROM A NUMBER OF OTHER ICs AT NIH WE PUBLISHED THE NIH RESEARCH PLAN ON VULVA DIDN'TIA. THAT CAME FROM A MEETING WE HELD LAST YEAR. AND HAS BEEN WELL REGARDED BY A NUMBER OF FOLKS BOTH RESEARCHERS AND ADVOCATES INTERESTED IN THE ISSUE OF VULVA DIDN'TIA. WE WILL BE BACK TO YOU ABOUT THIS, SEE HOW WE'RE DOING WITH THIS RESEARCH PLAN. SINCE WE LAST MET IN MAY WE HELD A MEETING TO UPDATE WHAT WAS SEVERALLIER OLD PLAN ON FRAGILE X SYNDROME DISSOCIATED DISORDERS AND THAT'S DEVELOPED, YOU'LL HEAR MORE ABOUT THAT IN COMING MONTHS. THE NATIONAL CHILDREN'S STUDY, LOTS GOING ON WITH THE NATIONAL CHILDREN'S STUDY, AS PROBABLY MANY OF YOU ARE AWARE, COUPLE OF MAJOR THINGS HAVE HAPPENEDDED SINCE—0 WE LAST MET, ONE IS THAT THE VANGUARD SITES A NEW (INAUDIBLE) ISSUED FOR CONTINUATION OF VANGUARD SITES, ORGANIZED SO THE VANGUARD SITES, THE 40 SITES THERE ARE INTO FOUR GEOGRAPHIC REGIONS OF THE U.S. AND ASKING PEOPLE TO BID ON THE CONTRACTS TO FOLLOW THOSE SITES. I WOULD BE HAPPY TO TELL YOU MORE ABOUT THAT AT ANY POINT IN YOU WOULD LIKE -- IF YOU WOULD LIKE. ALSO A KEY DEVELOPMENTAL POINT IN THE HISTORY OF NCS IS IS WE ARE RIGHT NOW COMING TO FINALIZING THE RECRUITMENT DESIGN FOR THE MAIN STUDY. AS YOU KNOW FROM PRIOR DISCUSSIONS, BOTH FOR REASONS OF SCIENCE AND FOR REASONS OF FISCAL RESPONSIBILITY WE HAVE REACHED THE DECISION TO USE HEALTHCARE PLANS AS THE PRIMARY SOURCE FOR RECRUITING PARTICIPANTS. I'LL COME BACK TO THE PRIMARY QUESTION IN A MOMENT. WHAT WE'RE NOW TRYING TO SEE IS WHETHER IT IS POSSIBLE TO HAVE THE BEST OF BOTH WORLDS, SCIENTIFIC FINANCIAL ADVANTAGES OF THAT RECRUITMENT STRATEGY AN OVERLAY THAT WITH A GEOGRAPHIC VIEW OF THE UNITED STATES AND A WAY TO ACHIEVE WITH THAT RECRUITMENT STRATEGY STILL ACHIEVE A TRULY GENERALIZABLE NATIONAL SAMPLE OF THE US. SO EFFORTS ARE ONGOING AND ARE QUITE INTENSIVE AT THE MOMENT, LOTS OF MEETINGS WITH STATISTICIANS, EPIDEMIOLOGIST, OTHER INTERESTED PARTIES ET CETERA, FOLKS UNDER THE CAPABLE LEADER SHP OF STEVE HER,FELD, DIRECTOR OF NCS AND OTHERS ARE HARD AT WORK ON THAT. TO GET BACK TO THIS PRIMARY QUESTION, IT IS STILL VERY MUCH THE IDEA THAT WE KNOW THAT ONE CLEAR ISSUE WITH USING HEALTHCARE PLANS IS THAT THAT IS LIKELY TO INTRODUCE ONE BIAS TO THE SAMPLE. THAT BIAS BEING THAT BY DEFINITION IF YOU'RE GOING TO RECRUIT THROUGH HEALTHCARE PLANS YOU WON'T RECRUIT INDIVIDUALS WHO DON'T HAVE HEALTHCARE. FORTUNATELY IN THE U.S. IT'S A SMALL PERCENTAGE OF CHILD AND PREGNANT POPULATION THAT DOES NOT RECEIVE HEALTHCARE BUT P BOTH LEGISLATIVE FIAT AND OWN PREDILECTION, THIS IS A GROUP THAT IF ANYTHING YOU WANT TO PARTICULARLY FOCUS ON, NOT IGNORE. SO THERE WILL BE SUPPLEMENTAL ENROLLMENT TO UNDER-REPRESENTED POPULATIONS TO BEGIN WITH THOSE THAT DON'T GET HEALTHCARE BUT ONCE WE HAVE THE PRIMARY RECRUITMENT UP AND GOING TO SEE WHAT OTHER POPULATIONS MAYBE UNDER-REPRESENTED FOR ONE REASON OR ANOTHER. AND DO A VERY TARGETED EXPENSIVE BUT WORTH THE TARGETED RECRUITMENT TO MAKE SURE WE DO ACHIEVE A SAMPLE WHICH IS TRULY DIVERSE. DISCUSSIONS ARE ONGOING. THE NEXT MAJOR DISCUSSION ABOUT THIS WILL BE NCS HAS THE OWN FEDERAL ADVISORY COMMITTEE, THE NEXT MEETING IS JULY 24th. ANYONE INTERESTED BASICALLY THE ENTIRE DAY WILL BE DEVOTED TO TALKING ABOUT DESIGN OF THE MAIN STUDY. WITH THE IDEA THAT RFP FOR MAIN STUDY WILL BE ISSUED LATER THIS YEAR. THE SCIENTIFIC ADVANCES FROM INTRAMURAL AND EXTRAMURAL SIDE WHICH WE HAVE BEEN INVOLVED, YOU SEE THE LIST THERE, ONLY A PARTIAL LIST BECAUSE YOU CAN PUT SO MUCH ON THE SLIDE. P IF YOU WOULD LIKE A LONGER LIST IF YOU GO TO OUR WEBSITE WE HAVE A NEWS RELEASE SECTIONND ALL THESE HAVE BEEN FEATURED WITH NEWS RELEASES BUT THERE ARE OTHER ADVANCES AS WELL. FOR THOSE NEW TO COUNCIL I THINK JUST THIS NON-RANDOM ASSORTMENT GIVES YOU SOME SENSE FOR HOW WIDE IS THE MISSION OF NICHD. WHICH IS I THINK BOTH ONE REAL ASSET AND ONE REAL CHALLENGE AT TIMES. FOR MORE NEWS VISIT ON LINE, SUBSCRIBE TO THE MONTHLY E NEWS LETTER NICHD DEVELOPMENTS OR TUNE IN TO OUR NEW MONTHLY BROADCASTS. THIS JUST STARTED LAST MONTH. THERE WILL BE ANOTHER ONE THIS MONTH BECAUSE THEY'RE MONTHLY. AND THESE CONSIST OF MY INTERVIEWING A FEW -- TO BEGIN WITH STAFF EXTRAMURAL AND INTRAMURAL BUT HAPPEN TO BE INVOLVED IN RESEARCH ADVANCES OF PUBLIC INTEREST. THEY GO ACROSS THE WIDE MISSION WE HAVE, WE THINK THIS MATURES AN DEVELOPS WE MAY ADD TO THAT ACTUALLY WELCOMINGa INVESTIGATORS TO BE PART OF THE INTERVIEW TEAM SO MY CHANCE TO ASK QUESTIONS OF FOLKS WHAT DOES THIS MEAN, WHAT ARE THE NEXT STEPS IN THIS LINE OF RESEARCH THAT YOU WOULD SEE, ET CETERA, ET CETERA TO HELP GET THE WORD OUT A LITTLE BIT ABOUT SOME OF THE FASCINATING RESEARCH THAT WE'RE DOING. IT'S AIMED AT A GENERAL AUDIENCE AND WILL BE OF INTEREST OF SORTS TO SCIENTISTS AND OTHERS. BECAUSE WE DO A LOT OF INTERESTING RESEARCH WE LIKE TO MAKE PEOPLE AWARE OF. YOU MAY FOLLOW US ON FACEBOOK, I'M TOO OLD TO KNOW WHETHER TO SAY ABOUT THAT BEYOND YOU CAN FOLLOW US ON FACEBOOK. IF YOU HAVE MORE QUESTIONS WE HAVE PEOPLE MORE SAVVY ABOUT THESE THAN I AM. THAT WILL BE HAPPY TO TELL YOU MORE. THIS IS A HEADS UP TO SAVE THE DATE. THAT IS AS PART OF OUR CELEBRATION OF THE FACT THAT WE TURN 50 YEARS OLD THIS YEAR WE WILL BE HAVING A DAY LONG SCIENTIFIC CLOAK Q3 YUM HERE ON CAMPUS WHICH WE'RE GOING TO CELEBRATE PAST RESEARCH ACCOMPLISHMENTS AND FUTURE ONES, IT'S AN OCCASION BOTH TO THINK ABOUT THE INCREDIBLE SCIENTIFIC STRIDES MADE ACROSS THOSE 50 YEARS IN SO MANY DIFFERENCE AREAS WHICH WE'RE INVOLVED. WE WON'T COVER ANYTHING BUT A SMATTERING OF THOSE. BUT AT THE SAME TIME LOOK AHEAD, THINK ABOUT WHAT ARE THE KINDS OF ADVANCES WE ANTICIPATE WHAT MIGHT THE FUTURE LOOK LIKE AND I'M CONFIDENT WE WILL UNDERESTIMATE HOW MUCH 50 YEARS NOW SOME GROUP WILL BE IN THIS ROOM WILL BE LOOKING BACK ON WHAT WE TALKED ABOUT DOING AND I'M SURE WE WILL LOOK A THOUGH WE WERE INEPT PREDICTING WHAT WILL HAPPEN BUT QUITE AN INTERRING DAY FOR THOSE WHO WILL BE GETTING MORE SPECIFIC INVITATION, ET CETERA TO THIS BUT A PLACE HOLDER ON YOUR SCHEDULES, IF YOU HAVE ANY INTEREST AT ALL, PLEASE MARK THE DAY OFF. FROM GRANTEE AN STAFF ACCOMPLISHMENTS OVER THE LAST FEW DAYS OR FEW MONTHS AS WELL AS OTHER EVENTS PARTICULARLY, A NICE CELEBRATION SOME WAYS GLOBAL NETWORK FOR WOMEN AND CHILDREN'S HEALTH RESEARCH HAD ITS REGULAR MEETING IN WASHINGTON THIS WEEK. BUT WE WILL HAVE AN INTERESTING VISITOR, THE SECRETARY OF HEALTH AND HUMAN SERVICES KATHLEEN SEBELIUS. THE REASON WHY SHE CAME IS SHE MADE A VISIT TO INDIA A COUPLE OF MONTHS AGO, WHILE SHE WAS THERE WENT TO ONE OF OUR SITES, OUR SITE IN BELGIUM, INDIA. AND WAS SO PERSONALLY IMPRESSED WHAT WAS GOING ON THERE, INDIAN PARTICIPANTS IN THE GLOBAL NETWORK INVITED HER, WE'RE GOING TO BE IN WASHINGTON FOR A MEETING WOULD YOU LIKE TO DROP BY? LOTS OF PEOPLE LOTS OF CABINET CONNECTS ASK QUESTIONS AND INCREDIBLY WELL WRITTEN VERY NICE SUITABLE FOR FRAMING LETTERS BACK, EXPRESSING THE SOUL -- THEY CANNOT PARTICIPATE. THIS WAS AN IMPORTANT ENOUGH EVENT TO MAKE TIME IN HER SCHEDULE TO COME, AND SHE GAVE A LOVELY SPEECH ABOUT THE MEANING OF MATERNAL AND CHILD HEALTH RESEARCH ABOUT THE ACCOMPLISHMENTS OF THE GLOBAL NETWORK, ET CETERA. SO REALLY WAS A LOVELY MEETING AND IT WAS NICE, BESIDES ACCOMPLISHING OTHER THINGS TO HAVE THE SECRETARY GET THE SENSE OF WHAT WE'RE UP TO. THIS IS AN AREA OF PERSONAL INTEREST FOR HER GLOBAL HEALTH RESEARCH AND PARTICULAR MATERNAL CHILD HEALTH RESEARCH. VARIOUS STAFF AND GRANTEE AS IS COMMON PRACTICE, RECOGNIZE FOR ALL KINDS OF THINGS. THE ANNUAL NATIONAL ACADEMY OF SCIENCES, FEATURED THESE FOLKS, ONE MEMBER, AS YOU CAN SEE FIVE FOLKS WHO HAVE BEEN HABITUAL OF GRANTEES OF OURS AND WERE DELIGHTED TO HAVE PLAYED A SMALL ROLE IN THE SUCCESS SCIENTIFICALLY WHICH WAS HONORED WITH THIS ELECTION. WE ALSO HAD A COUPLE OF GRANTEES ELECTED AMERICAN ACADEMY OF ARTS AND SCIENCES THIS YEAR AS WELL. AND AGAIN, CONGRATULATE THEM ON THAT. WE'RE GOING TO BRAG ABOUT A STAFF MEMBER SOME OF YOU WILL KNOW BUT MANY MAY NOT KNOW, THERE HAS BEEN NOW FOR ABOUT DECADE I BELIEVE A RECOGNITION FOR PART MER SHIP FOR -- PARTNERSHIP FOR PUBLIC SERVICE FOR A SELECT FEW EMPLOYEES ACROSS THE ENTIRE FEDERAL GOVERNMENT WHO MAKE PARTICULARLY SIGNAL CONTRIBUTIONS. WE'RE HONOR AND PROUD AND UNSURPRISED THAT LYNN (INDISCERNIBLE) CHIEF PEDIATRIC ADOLESCENT MATERNAL AGE HERE AT THE NICHD IS ONE OF FOUR FINALISTS ACROSS THE GOVERNMENT NOMINATED FOR THE 2012 CAREER ACHIEVEMENT MEDAL, THE MEDAL WINNER WILL BE ANNOUNCED THIS FALL BUT TO BE IN THE FINAL FOUR IS QUITE AN ACCOMPLISHMENT. SO RICHLY DESERVED HONOR. CATHY SPAWN, THIS IS ALSO MY CHANCE VARIOUS STAFF MEMBERS I TAKE MORE DELIGHT THAN I SHOULD, CATHY SPAWN WAS ALUMNA OF THE YEAR FOR UNIVERSITY OF MISSOURI KANSAS CITY AND AGAIN VERY WELL DESERVED CELEBRATION OF HER ACCOMPLISHMENTS. ANOTHER CELEBRATION OF ONE OF HER ACCOMPLISHMENTS IS THAT THE SOCIETY FOR CLINICAL TRIALS SELECTED MANAGEMENT OF AS TRIAL OF THE YEAR. I'M PRETTY CONFIDENT THAT NICHD NEVER HAD ANY CLINICAL TRIAL BEFORE SELECTED AS THE CLINICAL TRIAL OF THE YEAR, SO THAT'S QUITE SOMETHING. THE GOVERNOR OF JAPAN HONORED ANOTHER INTRAMURAL SCIENTIST, (INDISCERNIBLE) WHO HEADS OUR SECTION MOLECULAR GENETICS IMMUNITY NAMING HER, NOW, THIS IS OTHER PEOPLE WIN AWARDS BUT NO ONE AT NICHD HAS WON AWARD WITH BETTER NAMES THAN THIS. IT'S THE DECORATION, THE ORDER OF THE SACRED TRESH HERB GOLD RAY WITH NECK RIBBON IN RECOGNITION OF SIGNIFICANT CONTRIBUTIONS TO SUPPORT JAPANESE RESEARCHERS AN PROMOTING U.S. JAPANESE EXCHANGE IN ACADEMICS. RECENT UPCOMING RETIREMENTS, SOME FROM INTRAMURAL, OFFICE OF DIRECTOR AND SOME FROM EXTRAMURAL WORLD (INDISCERNIBLE) HEAD OF UNION CELLULAR POLARITY AND INTRAMURAL PROGRAM FOR SOME YEARS HAS RETIRED. GEORGE GAINS WHO YOU MAY KNOW HAS BEEN DIRECTOR OF OFFICE OF PROGRAM PUBLIC LIAISON FOR QUITE A LONG TIME WILL BE RETIRING IN THE NEXT COUPLE OF WEEKS. JIM HANSON WHO WAS THE DIRECTOR OF THE CENTER FOR DEVELOPMENTAL BIOLOGY AND PERINATAL MEDICINE RETIRED IN JANUARY. AND FRANCE HAZELTINE DIRECTOR FOR CENTER FOR POPULATION RESEARCH RECENTLY RETIRED BUT NOT EXACTLY. THAT IS WE TALKED FLORENCE TO CONTINUING IN THE ROLE SO SHE WILL CONTINUE TO BE ADVISER FOR US, PARTICULARLY FOCUSED ON ISSUES OF WOMEN'S HEALTH BUT ALSO USE OF NEW TECHNOLOGIES AND RESEARCH AS WELL. SO WE THANK ALL OF THEM FOR BETWEEN THEM THE MANY YEARS OF WISDOM AN WONFUL SCIENCE THEY HAVE BEEN PART OF HERE. UPDATE IN TERMS OF THE PROPOSED EXTRAMURAL REORGANIZATION THAT WE DISCUSSEDDED IN SOME DETAIL LAST COUNCIL MEETING, AS YOU RECALL, THESE WERE THE UNDERLYING PRINCIPLES WE WERE USING TO GUIDE WHAT WE WERE UP TO, WE TOOK THE DISCUSSION THAT WAS HAD AT COUNCIL SERIOUSLY AND OTHER PUBLIC DISCUSSIONS THAT HAVE BEEN HAD AND THERE'S SOME SLIGHT TWEAKING OF NAMES OF SOME OF THE PROPOSED BRANCHES. THE BASIC IDEA SEEMED TO HAVE OVERWHELMING GENERAL SUPPORT. AND SO WE HAVEN'T TWEAKED THAT BUT WE'RE TWEAKING NAMES A BIT. THAT'S THE WAY WE CURRENTLY LOOK AT IT. WE BELIEVE THAT THINGS ARE ON TARGET TO ACTUALLY BRING TO LIFE THIS NEW REORGANIZED STRUCTURE ON THE FEDERAL FISCAL YEAR, MAY NOT HAVE A FEDERAL BUDGET BY THEN BUT WE WILL HAVE A REORGANIZATION BY THEN. YOU WILL BE HEARING MORE ABOUT THE NATIONAL CENTER FOR MEDICAL REHABILITATION RESEARCH, THIS IS THE CURRENT PROGRAM BUT YOU'LL HEAR MORE ABOUT THAT LATER IN THE MORNING. TO HELP MAKE THIS REAL, WE HAVE A RESEARCH PORTFOLIO ANALYSIS COMMITTEE YVONNE MADDOX IS CO-HEADING ALONG WITH -- WE THOUGHT THEY WERE BOTH SCIENTIFIC ISSUES HERE BUT ALSO ADMINISTRATIVE ORGANIZATIONAL ONES TO PUT IT MILDLY. SO WE HAVE DEPUTY DIRECTOR AN EXECUTIVE OFFICER CO-LEADING THIS TASK FORCE. TO REALLY TRY TO MAKE SURE THAT WE GET THIS RIGHT. AND RIGHT NOW IT'S ASING THE OVERALL EVERY PART OF THE RESEARCH PORTFOLIO TO TRY TO FIGURE OUT GRANT BY GRANT ESSENTIALLY WHAT BELONGS IN WHICH OF THE BRANCHES PARTICULARLY SINCE WE'RE POPULATING THE NEW BRANCHES. AND YVONNE AND JOHN JARMON ARE DOING QUITE A GOOD JOB WITH IT. DRAFTING MISSION STATEMENTS, OTHER THINGS WE NEED ADMINISTRATIVELY IN PLACE TO MAKE THIS WORK. SOME OF YOU MAY NOT KNOW WE HAD A SUBCOMMITTEE OF COUNCIL THAT HAD BEEN FUNCTIONING FOR YEARS AS AN EXECUTIVE COMMITTEE OF COUNCIL HELP SOME PREPARE FOR MEETINGS BE AVAILABLE FOR EMERGENCIES IF WE HAVE ANY, ET CETERA, ET CETERA. BUT RECENT YEARS OUR FEELING, WE TALKED WITH THE MEMBERS, THEY SEEM TO FEEL THE SAME WAY, IT HAD COME BECAUSE OF THE WAYS WE'RE ENGAGING COUNCIL CURRENTLY, ET CETERA, THAT THE THE SUBCOMMITTEE WASN'T PERFORMING THAT MUCH OF A USEFUL NEEDED ANY MORE SO PEOPLE WHO HAVE BUSY LIVES ALREADY ASKING TO DO TOO MUCH IN THEIR SERVICE TO COUNCIL, IT DIDN'T MAKE SENSE. SO WE'RE GOING TO SUBSET -- SUN SET THAT COMMITTEE AND CONSTITUTE AD HOC WORKING GROUPS OF COUNCIL AS OUR THOUGHT TO BE NEEDED TO EXPLORE SPECIFIC TOPICS. THOUGHT TO BE NEED WED MIGHT FROM STAFF FEEL PARTICULAR NEED TO HAVE A GROUP FOCUS ON SOME ISSUE FROM COUNCIL OR COULD BE THE COUNSEL PERCEIVED SOMETHING THEY THINK WOULD BE USEFUL TO GET A SMALL GROUP TO GO OFF FOR A WHILE AND FOCUS ON IT. WE THOUGHT THAT MAKES MORE SENSE AND APPOINT FOLKS THAT DEPENDENT UPON THE NEEDS OF SPECIFIC EXPERTISE PERSPECTIVES, WHATEVER, SO WE HAVE NONE OF THOSE PLANNED AT THE MOMENT. BUT DON'T P SURPRISED WHEN SOMETHING COMES UP AND WE APPROACH YOU AND SAY GEOWE'RE ESTABLISHING A WORKING GROUP ON THE FOLLOWING TOPIC. THEY'RE NOT PERMANENT WORKING GROUPS BUT WILL MEET TO DEAL WITH SOME ISSUE AN ONCE THAT'S SUCCESSFULLY DEALT WITH WE'LL ALSO SUN SET. SO WE'RE TRYING TO MAKE SURE WITH ALL THIS AGAIN THAT FORM FOLLOWS FUNCTION. NULL NIH SOME OF YOU HAVE HEARD GOT FAIRLY WELL PUBLICIZED IN THE GENERAL PRESS THAT SECRETARY SEBELIUS AN FRANCIS COLLINS ANNOUNCE THAT THE NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES OR NCATS HAD ITS FIRST PILOT COLLABORATION PROGRAM DISCOVERING THERAPEUTIC USES FOR EXISTING MOLECULES, BASICALLY THIS CAME BECAUSE THROUGH DISCUSSIONS, THREE DIFFERENT REPRESENTATIVES FROM PHARMA THAT WE BELIEVE ARE GOING TO BE OTHERS LIKELY TO JOIN US IN THE NOT TOO DISTANT FUTURE, OFFERED UP 20 MOLECULAR COMPOUNDS TO BEGIN WITH, WE EXPECT TO HAVE MORE. THEY HAVE ABANDONED ONE REASON OR ANOTHER, OFTEN NOT SCIENTIFIC REASONS BUT BUSINESS DECISION REASONS TO MAKE THOSE AVAILABLE. THE NEXT SLIDE TALKS ABOUT THIS, NO. TO MAKE THESE AVAILABLE ACADEMICS ARE ABLE TO APPLY FOR GRANTS TO US TO EXPLORE THE USE OF THESE COMPOUNDS IN VARIOUS DISEASES. SO THE IDEA THE REASON ESTABLISHING NCATS TO SEE ARE THERE CERTAIN PARTS OF THE DRUG DEVELOPMENT PROCESS TO BE REINVENTED, NOT TO REINVENT THE WHOLE THING OR THROW THE WHOLE THING OUT THE WAY IT'S FUNCTIONED FOR DECADES BUT OTHER WAYS COMPLIMENTARY TO EXPLORE. THIS IS ONE. TO LOOK AT COMPOUNDS ABANDONED OFTEN NOT FOR SIGN ACTIVE UK REASONS AN TO OPEN UP THEIR USE TO OTHERS WHO COULD THINK AB VARIOUS WAYS TO EMPLOY THEM, SO THIS IS THE FIRST STEP IN THAT DIRECTION OF WHAT WE THINK WILL BE MANY STEPS. IF YOU HAVE NOT HEARD THE NATIONAL HEART LUNG AND BLOOD INSTITUTE, NHLBI WILL HAVE A NEW DIRECTOR WHO WILL BEGIN I BELIEVE NEXT MONTH, GARY GIVENS I WAS AT BRIGHAM MANY YEARS BEFORE THAT. GARY IS A CARDIOLOGIST WHOSE RESEARCH INTERESTS HAVE GONE FROM FAIRLY BENCH LEVEL RESEARCH, VERY MUCH TO CARDIOVASCULAR DISEASE AND COMMUNITY. SO IT'S REALLY A BREADTH OF INTERESTS, I'M A LITTLE BIASED BECAUSE HE WAS A MEDICAL SCHOOL CLASSMATE FRIEND OF MINE BUT WILL BE A WONDERFUL ADDITION TO LIFE AROUND NIH, VERY MUCH LOOKING FORWARD AS YOU KNOW WE DO A LOT OF WORK TOGETHER WITH NHLBI ALREADY. BUT I WOULD ANTICIPATE THAT WILL INCREASE WITH GARY'S ARRIVAL. BUDGET LEGISLATIVE UPDATES. UPDATES THE PRESIDENT'S BUDGET REQUEST PROPOSAL LEVEL FUNDING FOR NIH APPROXIMATE LEVEL $30.7 BILLION WITH 1.3 BILLION OF THAT FOR NICHD WHICH IS AGAIN ESSENTIALLY LEVEL FUNDING. AND $165 MILLION NATIONAL CHILDREN'S STUDY WHICH REPRESENTS A 15% DECREMENT IN THE NATIONAL CHILDREN'S STUDY, WE HAD A LOT OF QUESTIONS ABOUT THAT. WE ARE VERY COMFORT THABL THAT IS AN APPROPRIATE LEVEL OF FUNDING FOR THE NATIONAL CHILDREN'S STUDY IF ANYONE SHOULD ASK NICHD CUT IN THE NATIONAL CHILDREN'S STUDY. WE THINK THAT'S ABSOLUTELY APPROPRIATE NUMBER FOR GOING FORWARD WITH THE STUDY WITH THE DESIGN THAT WE HAVE CURRENTLY. CURRENTLY PURSUING. THERE WAS TESTIMONY BEFORE THE HOUSE AN SENATE APPROPRIATIONS COMMITTEES BY DR. COLLINS, THAT HAS NOT HAPPENED EVERY YEAR IN RESENT YEARS THAT -- RECENT YEARS THAT NIH TESTIFY THAT HAPPENED. MARKUPS SCHEDULED LATER MONTH IN HOUSE AN SENATE APPROPRIATION COMMITTEES. BUT WHAT HAPPENS AFTER MARK UP IS VERY UNCLEAR THIS YEAR. JUST TO REMINE YOU THE PROCESS THE PRESIDENT IN EARLY FEBRUARY MAKES THIS BUDGET REQUEST FOR THE ENTIRE FEDERAL GOVERNMENT. THE APPROPRIATIONS COMMITTEES, LOOK AT THE BUDGETS FOR AREAS OF THE FEDERAL GOVERNMENT WHICH THEY'RE INVOLVED, THEY EACH DEVELOP THEIR OWN BUDGETS, ET CETERA. WE HAVE CERTAINLY HAD WORD FROM THE SENATE APPROPRIATORS BOTH THE—ÖCHAIR OF THE COMMITTEE AND RANKING MINORITY MEMBER THAT IF ANYTHING WOULD LIKE STEE BUDGET FOR NIH INCREASE OVER THE PRESIDENT'S REQUEST. FROM THE HOUSE A LITTLE BIT LESS CLEAR EXACTLY WHAT THEIR STANCE WILL BE. THERE'S A LOT OF DISCUSSION OF ANYTHING INCREASING IT. BUT WHAT THIS WILL MEAN AT THE END OF THE DAY IN TERMS OF BUDGET NOBODY REALLY KNOWS. AS WE TALKED ABOUT BEFORE THIS YEAR, IS A PARTICULARLY UNCLEAR YEAR BESIDES THE FACT THAT WE HAVE A FEDERAL ELECTION, THOSE NOT AWARE IN NOVEMBER WILL BE A FEDERAL ELECTION. SINCE MANY FOLKS THINK THAT BOTH THE PRESIDENCY AND BOTH HOUSES CONGRESS ARE IN PLAY IN TERMS OF WHO WILL BE IN THE MAJORITY, ET CETERA, THEN AS WELL AS THAT THERE'S A QUESTION OF SEQUESTRATION, THIS LONGER TERM BUDGET DECISION CONSIST NOT BE MADE IN A TIMELY MANNER POTENTIALLY CONGRESS COULD CHANGE BUT COULD KICK IN AUTOMATIC 8% CUT TO FEDERAL FUNDING FOR THINGS LIKE NIH. BECAUSE OF THAT EVERYTHING IS VERY UNCLEAR THIS YEAR. BUT WHAT OUR EVENTUAL BUDGET WILL BE AND WHEN WE GET IT, SOME PEOPLE THINK THAT AFTER THE ELECTIONS ONCE THE DUST SETTLES AND THINGS ARE CLEAR IN THE SO CALLED LAME DUCK SESSION OF CONGRESS PERHAPS AS BUDGET WILL BE PASSED. MANY THINK WELL, ONLY IF THEIR STAR ACE LINE A CERTAIN WAY IT'S LIKELY TO THAT HAPPEN AFTER THE ELECTION. AFTER START OF THE NEW COPG AND TERM THE NEXT PRESIDENT, ET CETERA, IT'S A LITTLE UNCLEAR, WE ARE GOING TO -- AND YOU'RE INVOLVED IN THIS, WE'RE GOING TO HAVE TO START SPENDING OUR BUDGET AS OF OCTOBER 1 THOUGH NOBODY THINKS WE'LL HAVE IT. WE HAVE GOTTEN USED TO THAT IN PAST YEARS BUT WE'RE NOT USED TO I THINK IS DEALING WITH THIS POTENTIAL DELTA ANYBODY FROM MAYBE MODEST INCREASE SOMETHING LIKE 8 OR POSSIBLY 10% DECREASE, THAT'S FROM A MANAGEMENT POINT OF VIEW, NO MATTER WHAT ONE THINKS. A LITTLE BIT DIFFICULT TO GET THROUGH THE YEAR NOT KNOWING WHETHER THE BUDGET IS UP 1% OR DOWN 9% KIND OF THING BUT WE'LL COME UP WITH WAYS ACROSS NIH AND NICHD SPECIFICALLY TO DEAL WITH IT. HOW PRETTY IT WILL BE NOT SURE BUT WE WILL COME UP WITH WAYS TO DO IT. OTHER THINGS IN TERMS OF LEGISLATIVE WORLD, BEST PHARMACEUTICALS FOR CHILDREN ACT BPCA IS EXPIRING THIS YEAR. RE-AUTHORIZATION BILL PASSEDDED THE HOUSE AND THE SENATE AND IS CURRENTLY HEADED TOWARDS A CONFERENCE BETWEEN HOUSE AN SENATE VERSIONS, NOT ALL THAT DIFFERENT FROM EACH OTHER. PARTICULAR INTEREST IS SECTION 409I WHICH AUTHORIZE IT IS NIH PROGRAM AFTER DRUG TESTING FIVE YEARS, $25 MILLION A YEAR. THAT IS THE CURRENT LEVEL THE WAY IT'S FUNDED BASICALLY IS A PRORATED BASIS ACROSS THOSE MANY INSTITUTES AT NIH INVOLVED IN MEDIA TRICK RESEARCH. WE LOOK AT THE SIZE OF THOSE RELATIVE PORTFOLIOS AN APPORTION BASICALLY THE 25 MILLION VARIOUS INSTITUTES TO CONTRIBUTE ACCORDING TO THAT, NICHD WE GIVE A LITTLE MORE THN OUR FAIR SHARE BECAUSE WE THINK THIS IS SO IMPORTANT. AND THIS IS NOT -- THE BILL DOESN'T PROVIDE PERMANENT RE-AUTHORIZATION AN ALLOWS CONGRESS THE REVISIT THE FUNDING LEVEL FUTURE YEARS. OTHER CONGRESSIONAL ACTIVITY, THERE'S RECENT HEARINGS ON TRAUMATIC BRAIN INJURY AND CHRONIC PAIN WHICH WE HAVE BEEN INTERESTED. THERE'S A NUMBER OF BRIEFINGS ON THE HILL FORMAL, INFORMAL OF SORTS PARTICULARLY FOLKS IN THE NATIONAL CHILDREN STUDY SINCE THERE ARE SO MANY THINGS BOTH IN PLAY AB THE NATIONAL CHILDREN'S STUDY INCLUDING QUESTIONS OF FUNDING LEVEL, ET CETERA. AND THERE'S A BRIEFING ON PRE-TERM BIRTH IN THE FEAR WHICH YOU FUTURE ON THE HILL WHICH WE'RE PARTICIPATING. BILL HAS BEEN INTRODUCED, ALSO OF TOPICS RELEVANT TO US, THAT'S JUST A SELECTION OF SOME OF THOSE. ALSO WORTH MENTIONING THE NATIONAL SCIENCE TECHNOLOGY COUNCIL WITH SUPPORT FROM THE HOUSE APPROPRIATION COMMITTEE IS FORMING AN INTERAGENCY WORKING GROUP TO COORDINATE FELLOW EFFORTS ON NEUROSCIENCE TO PARTICULARLY ACCOMPLISH THINGS SHOWN TO YOU HERE. AND WE AGAIN ANTICIPATE BEING INVOLVED PARTICIPATING IN THIS. HERE IS MY CHANCE TO ASK YOU BEFORE WE GO TO OTHER THINGS, ANY QUESTIONS AB THINGS IN YOUR REPORT OR THINGS THAT WEREN'T IN THE REPORT WHEN YOU CAME TODAY TODAY YOU SAID I CAN'T WAIT TOh HEAR ALAN TALK AD BLANK, BECAUSE IT'S SO IMPORTANT AND I FAILED TO MENTION IT COMPLETELY. OKAY. IF NOT NOW, YOU STILL HAVE A CHANCE, YOU CAN GRAB ME DURING THE LUNCH BREAK, OTHER KINDS OF THINGS, WHILE TALKING BREAKS LET ME MENTION YOU HAVE UNDOUBTEDDEDLY NOTICE THERE HAD IS NO COFFEE PROVIDED TO YOU, ET CETERA, ET CETERA. ANY OF YOU UNAWARE THAT'S FOR VARIOUS REASONS THERE HAVE BEEN NEW PRACTICES IN RECENT MONTHS IN THE FEDERAL GOVERNMENT ABOUT SPENDING OF FEDERAL BUDGET ON VARIOUS KINDS OF ACTIVITIES PARTICULARLY QUESTIONS OF COFFEE, SNACKS, OTHER KINDS OF THINGS HAS COME UNDER ATTENTION T GENERAL PRINCIPLE THAT'S NOW BEING PUT INTO EFFECT IS THAT FOLKS WHO ARE BEING PAID FEDERAL EMPLOYEES AND YOU ARE PAID AS FEDERAL EMPLOYEES, INCREDIBLY I'M SURE MANY OF YOU PLANNED YOUR RETIREMENT BASED UPON THIS INCREDIBLE REMUNERATION FOR COMING TO COUNCIL. IT IS INAPPROPRIATE FOR US TO BE PROVIDING USING OTHER FEDERAL FUNDS FOR YOU WHEN YOU'RE ALREADY DOUBLE DIPPING OR SOMETHING. SO WE APOLOGIZE FOR THE FACT WE'RE IN THE ABLE TO PROVIDE SUSTENANCE TO YOU. BUT WE HOPE WILL TAKE CARE OF YOU IN OTHER WAYS, INTELLECTUAL SUSTENANCE. AS FAR AS I KNOW NO PLANS TO CREATE SOME LEVEL WHICH WE'RE NOT ALLOWED TO GO ABOVE IN TERMS OF INTELLECTUAL SUSTENANCE. SOAK. NEXT UP IS A SEGUE TO THE NEXT DISCUSSION WE'LL HAVE THIS MORNING, FOCUSING ON CONCUSSION RESEARCH. WE'RE DOING THIS SEVERAL REASONSCH ONE IS, THIS CAME UP FROM A COUPLE OF MEMBER OF COUNCIL, HOW IS NICHD INVOLVED IN CONCUSSION RESEARCH. IT'S LOGICAL TO ASK THAT QUESTION BECAUSE IT COMBINES TWO, AT LEAST TWO, YOU COULD ARGUE MORE BUT MAJOR INTERESTS. ONE IS THAT WE DO HAVE WITHIN NICHD THE NATIONAL SENOR FOR MEDICAL REHABILITATION RESEARCH. NCMRR, ONE MAJOR FUNDERS, AT NIH OF RESEARCH AB CONCUSSION. SECOND THING IS OBVIOUSLY WE'RE INTERESTED IN CHILD HEALTH AND HUMAN DEVELOPMENT. AND AS RECENT BOTH POPULAR PRESS AND OTHER KINDS OF THINGS MADE QUITE APPARENT, THERE'S GROWING CONCERN AND WITH SOME REASON ABOUT THE LONG TERM CONSEQUENCES AND PREVALENCE REAL CONCUSSIVE INJURY. WE DON'T KNOW THE EPIDEALOLOGY OF THIS POTENTIAL EPIDEMIC NOR PATHOPHYSIOLOGY. WE DON'T KNOW THE EPIDEMIOLOGY IN TERMS WE DONE KNOW HOW MANY KIDS ARE BEING AFFECTED. WE DONE KNOW HOW MANY NFL PLAYERS ARE AFFECTED. BUT IF YOU LOOK MORE BROADLY WHAT ABOUT ALL OF THE YOUNG WOMEN OUT THERE HEADING SOCCER BOWLS, -- SOCCER BALLS, WHAT ABOUT ALL THE YOUNG STUDENT ATHLETES DOING OTHER KINDS OF ACTIVITIES, WE REALLY DON'T KNOW WHAT THE SIZE OF THE PROBLEM IS, AND WE DONE UNDERSTAND VERY WELL THE PATHOPHYSIOLOGY OF IT. THOSE TWO OBVIOUSLY THOSE TWO ARE RELATED TO EACH OTHER. WE DON'T REALLY UNDERSTAND THE DISEASE PROCESS VERY WELL SO WE BOTH DONE UNDERSTAND WHAT ARE THE TRUE INSTIGATORS OF THIS, WHAT ARE THE TRUCE CAUSATIVE FACTOR, NOR DO WE UNDERSTAND THE NATURAL HISTORY OR HISTORIES OF THE DISORDER SO WE DON'T -- HARD TO GIVE CLEAR INDICATION ABOUT WHEN KIDS ARE QUALIFIED TO RETURN TO ACTIVITY RAREIOUS SORTS, ET CETERA. IT MAKES THIS VERY HARD TO COME TO GRIPS P WITH. IN OUR OWN VISIONING PROCESS, PART OF WHAT CAME OUT OF THAT, DETERMINE MAGNITUDE OF RISK AND LONG TERM IMPACT CONCUSSIVE INJURY DESIGN PROTECTIVE AND TREATMENT MEASURES. THE PRESS IS CLEARLY HIGHLIGHTING THIS RECENTLY AND AS AN EXAMPLE OF THAT, I BELIEVE -- >> (INDISCERNIBLE) START FOOL BALL THE UNTIL HE WAS IN 7TH GRADE BECAUSE HE DIDN'T WANT THE TO GET HURT. >> OCTOBER 28, 2010, LAST GAME OF SENIOR YEAR. THE BEST GAME OF HIS CAREER. HE RAN FOR TWO TOUCHDOWNS. 165 YARDS. IN THE FIRST TWO QUARTERS. THEN TWO MINUTES BEFORE HALF TIME HE WALKED OFF THE FIELD, SCREAMED THAT HIS HEAD HURT AND HE COLLAPSED. THAN DIED EARLY THE NEXT MORNING. NATHAN DIED OF SECOND IMPACT SYNDROME. EARLIER IN THE MONTH AT HOMECOMING GAME HE GOT A CONCUSSION. EVERYONE INCLUDING NATHAN'S DOCTOR THOUGHT IT HAD HEALED. >> NO, I JUST -- IT WAS JUST YOU'RE IN SHOCK. >> I COULDN'T LOOK AT THIS FOR A LONG TIME. THE STYLES WOULD FIND MEANENING NATHAN'S TRAGIC DEATH BECAUSE OF THIS WOMAN. >> I THINK A LOT OF TIME WE WERE HERE WE HAD FIVE ROOMS NOW WE'RE UP TO IN THE '90s. >> DR. ANN MCKEY RUNS THE WRL'S LARGEST BRAIN BANK BETWEEN VET REASONS ADMINISTRATION AN BOSTON UNIVERSITY. I FIRST METHOD HER SEVERAL YEARS AGO BEGAN FINDING EVIDENCE IN THE BRAIN OF DECEASED NFL PLAYERS OF UNNATURAL PROTEIN DEPOSITS. THE SAME PROTEINS FOUND IN ALZHEIMER'S PATIENTS. CHRONIC TRAUMATIC ENCEPHALOPATHY, A PROGRESSIVE DEGENERATIVE DISEASE WHICH LEADS DEMENTIA AND ALZHEIMER'S SYMPTOMS. BUT THESE ARE USUALLY FOUND IN PEOPLE IN THEIR 80s, NOT THEIR 40s. BUT WHAT WE'RE SEEING HERE IS THIS DEFINITELY CAUSED BY BLOWS TO THE HEAD? >> IT'S NEVER BEEN REPORTED CASE EXCEPT IN A CASE OF REPEATED BLOWS TO THE HEAD. >> THAT'S WHAT THE STYLES WANTED TO KNOW WHEN THEY DONATED NATHAN'S BRAIN TO MCKEY CENTER. DID REPEATED BLOWS TO THE BRAIN CAUSE THAT KIND OF DAMAGE IN YOUNG NATHAN'S BRAIN? THE ANSWER WAS YES. UNDER THE MICROSCOPE. >> VERY OBVIOUS. >> WE SAW A TELL TELL SIGNS OF TAU PROTEIN. >> DID THIS SURPRISE YOU? >> YES. DEFINITELY DID. >> FOR THE FIRST TIME DR. MCKEY IS ABOUT TO SHOW NATHAN'S PARENTS WHAT SHE FOUND. >> ANN MCKEY. HOW ARE YOU DOING? >> NOTHING ANN MCKEY IS ABOUT TO TELL THEM WILL BRING NATHAN BACK. >> THIS IS LOOKING UNDER THE MICROSCOPE AND SEEING THE DARK BROWN -- >> THE STYLES HOPEDDED THIS RARE GIFT WILL TEACH US MORE ABOUT BRAIN CON CUGS THAN WE HAVE KNOWN BEFORE. >> WE HAVE ALL THE CONFIDENCE IN THE WORLD THERE'S SOMETHING TO BE LEARNED FROM IT, IT'S IN THE RIGHT PLACE HERE TO DO JUST THAT. >> I WANT TO BE MY LIFE'S NOITION MAKE SURE THIS DOESN'T HAPPEN TO OTHER KIDS. >> MCKEY KNOWS HOW MUCH MORE VULNERABLE THESE YOUNG KIDS MAYBE. WITH YOUNG DEVELOPING BRAIN IS HIT DURING FOOTBALL NO MATTER HOW HARD THE BRAIN IS ROCKED. IT'S LIKE AN EGGEN UNSIDE A SHELL, IT STRETCHES, THE DELICATE FIBERS PULLED, FLUIDS SLOSHED AROUND THE BRAIN TRYING TO ABSORB THE BLOW. >> YOUTH ARE AT RISK FOR ANY CHANGES IN THAT FLUID BALANCE, THEY MAY NOT BE ABLE TO HANDLE IT AS WELL. >> SOUND LIKE YOU'RE SAYING THEY'RE MORE AT RISK THAN ADULTS. >> ABSOLUTELY. >> OBVIOUSLY, PART OF THE REASON WE SHOW THAT IS TO GIVE YOU A SENSE HOW MUCH THIS IS OUT THERE IN THE PRESS. I WOULD ALSO LAUD WHAT'S SANJAY GUN TA HAS DONE. HE'S HAD A SERIES. YOU CAN ARGUE FOR INSTANCE THERE'S GOOD SCIENCE ACTIVIC QUESTIONS -- SCIENTIFIC QUESTIONS ABOUT THE LACK OF BLINDED LOOK AT BRAINS REFERRED TO, ET CETERA, BUT HE'S DONE A NICE JOB BECAUSE OF HIS BACKGROUND IN NEURAL SCIENCES AN NEUROSURGEON. AT PRESENTING TO THE PUBLIC SOMETHING THAT MAKES THEM UNDERSTAND THIS ISSUE BETTER. AT THE SAME TIME WITHOUT OVERDRAMATIZING IT, WITHOUT GOING BEYOND WHAT WE KNOW BEING CLEAR ABOUT WHAT WE KNOW AND VERY MUCH THAT WE DON'T KNOW ON THIS. THIS IS PART OF WHAT OUR INTERESTS ARE. IT'S DIFFICULT AS ALWAYS SCIENTIFICALLY TO GIVE GOOD ADVICE TO PARENTSEN OTHERS EAGER HAVING HEARD ABOUT THIS ISSUE TO KNOW WHAT TO DO WHEN WE DOPE KNOW ENOUGH SCIENTIFICALLY TO SAY WITH GREAT CERTAINTY WHAT YOU SHALL DO IN TERMS OF WHAT SHOULD YOU AVOID, IF CONCUSSION HAPPENED WHAT SHOULD YOU DO AFTERWARDS. SO THAT'S THE REASON FOR TALKING SOMEWHAT MORE ABOUT THIS. I DON'T HAVE MY SCRIPT BUT DO I TURN IT OVER TO -- WHAT HAPPEN? >> DR. MADDOX, TELL ME WHAT WE'RE DOING NEXT. I COULD DO THAT OR WALK TO MY CHAIR. >> ONE THING THAT ALAN WANT US TO DO WAS TO REALLY GET A SENSE OF YOUR FEELINGS AROUND THE TOPIC ONCE YOU BECAME INFORMED ABOUT CONCUSSIONS. ONE WAY TO DO THAT IS TO HAVE SOMEONE KNOWLEDGEABLE ABOUT THEM AND PARTICULARLY ABOUT WAYS WHICH WE CAN ADDRESS THEM. THAT IS OUR OWN COUNCIL MEMBER. DR. GREENWALD. SO WITH THAT, RICK, WE ASKED THEM TO GIVE A HALF HOUR PRESENTATION BUT A OVERVIEW OF CONCUSSION RESEARCH GIVING AN OPPORTUNITY TO TALK ABOUT THE WORK THAT HE'S DOING. AND THEN WE ASKED THREE NIH STAFFERS TO PROVIDE SOME COMMENTS AND REACTIONS DONE TO RICK'S REMARKS BUT ALSO THEIR OWN PERSPECTIVE, WHAT THEY KNOW ABOUT THIS AREA AND ITS IMPORTANCE. SO RICK'S PRESENTATION IS FOLLOWED BY FIVE MINUTE REMARKS BY DR. BETH INSEL, DR. -- RAMONE THERE, YES. DR. RAMONE DUAZ AND DR. MICHAEL WINERIDGE, BOTH ARE FROM NICHD THEY'RE PART OF THE NATIONAL CENTER FOR MEDICAL REHABILITATION RESEARCH AND DR. DIAZ IS FROM THE NATIONAL INSTITUTE OF NEUROLOGICAL DISEASES AN STROKE AND ALSO SERVES AS A PRACTICING PHYSICIAN ACROSS THE UNIFORM SERVICES INSTITUTION. SO IN THAT ORDER. THE PLATFORM IS YOURS RICK. I HOPE ONCE THE REMARKS ARE MADE YOU ARE FIELD QUESTIONS AN COMMENTS FROM THE COUNCIL AND FROM THE AUDIENCE. >> THANK YOU TO ALAN. YVONNE ALLOWING US TO SPEN TIME HERE TO DISCUSS THIS IMPORTANT PROBLEM AND THE OPPORTUNITIES SURROUNDING IT. SO I THINK WE'RE RELATIVELY EARLY IN THE RESEARCH OPPORTUNITIES AND UNDERSTANDING OF IT YOCIALTION PATHOPHYSIOLOGY, BIOBEHAVIORAL ASPECTS AND LONG TERM AN SHORT TERM OUTCOMES RELATED TO CONCUSSION INJURY. THIS IS A SIGNIFICANT HEALTHCARE ISSUE AFFECTING AN ESTIMATED ONE AND A HALF TO 4 MILLION SPORTS RELATED CONCUSSIONS, THERE'S OTHER NON-SPORTS RELATED CONCUSSIONS AS WELL. THIS IS A PROBLEM THAT GETS A LOT OF MEDIA ATTENTION RELATED TO PROFESSIONAL ATHLETES, BUT I THINK OUR FOCUS REALLY NEEDS TO BE AND SHOULD BE ON ALL THE CHILDREN THAT ARE INVOLVED MANY THESE SPORTS. CONCUSSION EVENT CBS EASILY MISSED. YOU ABSOLUTELY DO NOT NEED TO SEE AN ATHLETE UNCONSCIOUS FOR THEM TO HAVE A CONCUSSION. THE VAST MAJORITY WHO SUFFER CON CUGS DO NOT LOSE CONSCIOUSNESS. THERE IS OFTEN AN OUTCRY TO SIMPLY FIX IT WITH EQUIPMENT. I WANTED TO LET YOU KNOW CURRENT STANDARDS ARE NOT SPECIFICALLY DEVELOPED FOR REDUCING RISK OF CONCUSSIONS BECAUSE WE DON'T HAVE RESEARCH TO DATE TO DO THAT. I PARTICIPATE IN NATIONAL AND INTERNATIONAL STANDARDS COMMITTEE ON EQUIPMENT AND HELMET DESIGN AND THE INDUSTRY IS INTERESTED AND WILLING TO LOOK TO GROUPS LIKE NIH FOR ADVICE AND INFORMATION SO THEY CAN MAKE BETTER TECHNOLOGY FOR OUR ATHLETES. AND IMPORTANTLY, THERE'S LITTLE RESEARCH CURRENTLY GUIDING DEVELOPMENT OF CHILDREN'S HELMETS. SO WHY DO WE STUDY FOOTBALL, HOCKEY AND OTHER SPORTS? NOT BECAUSE THEY'RE SO POPULAR, IT'S BECAUSE YOU USE MILITARY, THIS IS A IMPACT RICH ENVIRONMENT. SO PROVIDES A EXCELLENT LABORATORY FOR THE STUDY OF INJURIES IN HUMANS, AFTER ALL LABORATORY WORK IS COMPLETED. SO CERTAINLY I CAN COVER THE ENTIRE HISTORY AND RAREIOUS RESEARCH FIELDS RELATED TO CONCUSSION INJURY BUT FOCUS A LITTLE ON THE BIOMECHANICAL ASPECTS. RESEARCH IN THIS AREA GOING ON A LOOK TIME, DECADES AT LEAST AN EARLY WORK FOCUSED ON AREAS RELATED TO TRAUMA AND IMPACT O THE HEAD LEADING TO SKULL FRACTURE AND SUB DO YOU RECALL HEMOTOE MA. TOLERANCE RISK CURVE, WAYNE STATE TOLERANCE RISK CURVE TO GUIDE FEDERAL IMPACT STANDARD RELATED TO AUTOMOBILE SAFETY FOR FRONTAL CAR CRASHESCH LABORATORY WORK DONE IN THE '70s FOCUS ON ASPECTS RELATED TO MECHANISMS OF CONCUSSION, LINEAR AN ROTATIONAL ACCELERATION OF THE HEAD AND BRAIN TISSUES AND TRYING TO UNDERSTAND WHICH OF THESE VARIABLES WERE MORE IMPORTANT OR MORE RELATED TO INJURIES THAT WERE SEEN. MOST OF THIS WORK WAS DONE IN ANIMAL MODELS. AS WE MOVE TOWARDS THE 1980s, SEVERAL INJURY MECHANISMS WERE DEFINED, ONE IN PARTICULAR WE SAW IN THAT RECENT VIDEO, SECOND IMPACT SIN DROA, THIS IS VERY RARE, GETS A LOT OF ATTENTION BECAUSE IN THIS CASE MOST CASES THE ATHLETE DOES DIE. BUT IT'S A VERY RARE EVENT. AND SEEMINGLY ONLY HAPPENS IN CHILDREN. NOT TOO MUCH CASES OF THIS HAPPENING IN ADULTS. A LOT ABOUT POST CONCUSSION SYNDROME, THIS WAS A NON-DESCRIPT LONG TERM ONGOING PROBLEMS HEAD IMPACTS AFTER A SINGLE BLOW TO THE THE HEAD WITH CERTAIN LONG TERM OUTCOME THAT AFFECTED NOT JUST WHAT PEOPLE IN THE ATHLETIC COMMUNITY CARE ABOUT GETTING BACK ON THE FIELD BUT AFFECTING PEOPLE'S LIVES. AND IN THE CASE OF KIDS, AND VERY IMPORTANTLY GETTING BACK-TO-SCHOOL. SUBSEQUENT WORK DOVE, WHAT'S GOING ON IN THE BRAIN CHEMICALLY BEFORE DURING AN AFTER IMPACTS AND WHAT ARE THE RELEASE OF DIFFERENT CHEMICALS AN TRANSMITTERS AND HOW THESE ARE MITIGATED IN THAT HAS LONG TERM IMPLICATIONS FOR THERAPEUTICS. A LOT OF WORK HAS GONE TO AREAS RELATED TO NEUROCOGNITION, BALANCE, WAYS OF UNDERSTANDING, MEASURABLE THINGS IN THE SURROUNDING CONCUSSION AND ON THE FIELD AND SUBSEQUENT TO INJURY, THE FIELD EXPLODED AND I'LL TALK MORE ABOUT THAT SHORTLY. THE WORK DONE ON CTE AND BIOMARKERS IS NOW FRONT AND CENTER, OUR APPROACH IS TO USE TO UNDERSTAND MORE ABOUT BIOMECHANICS OF INJURY TO RELATE TO ALL THESE CLINICAL MEASURES THAT ARE ONGOING. THE IMAGING MODALITIES USED FOR EXAMPLE, MRI AND FOR USE IN UNDERSTANDING STRUCTURAL INJURIES BUT MOST MRIs AND CONCUSSIONS ARE NORMAL. SO IN YOU GO TO THE ER AND THEY SAY LET'S GET AN MRI THEY'RE LOOKING FOR A BLOOD BUT WON'T HELP MUCH WITH DIAGNOSIS AND UNDERSTANDING OF CONCUSSION. ADVANCES IN NEWNOLOGIES MAGNETIC RESONANCE IMAGING ALLOWING US TO LOOK AT COGNITIVE STATES AN BRAIN ACTVATION DURING WORKING MEMORY TASKS FOR EXAMPLE, DIFFUSION TENSER IMAGENING THE MIDDLE LOOKING AT WHITE MATTER INJURIES OKAY DURING. AND THEN MORE RECENTLY SOMETHING WE HAVE BEEN DOING WHICH IS COMBINING ENGINEERING TECHNOLOGIES USING FINITE ELEMENT MODELS OF THE BRAIN AND COMBINING THEM WITH DTI MEASURES. WHAT WE'RE DOING SPECIFICALLY IS TO LOOK AT IF STRAIN IN THE BRAIN RELATED TO A SPECIFIC IMPACT DOES ACTUALLY CORRELATE WITH INJURIES TO CERTAIN TISSUES IN THE BRAIN HERE SHOWN IN THE CORPUS COLLOSUM FOR THE INJURED ATHLETE BASED ON THEIR IMAGE. WE HAVE THE IMPACT, WE HAVE STRAIN PREDICTED FROM THE MODEL AND NOW WE LOOK AT THEIR SCAN. WE ARE FINING AS YOU SEE IN THE DIAGRAM IN THE LOWER RIGHT CORRELATIONS BETWEEN THE STRAIN AND INJURY DEFINED BY DTI. CONCUSSION RESEARCH IS INTERAGENCY, IT'S WIDESPREAD. NIH IS A LEADER IN THIS AREA AND CERTAINLY I'M NOT ABLE TO COVER EVERYTHING AT NIH BUT I WANT TO HIGHLIGHT CERTAINLY THIS EFFORT IS LED BY NICHD THROUGH NCMRR, NINDS AND MANY OTHER INSTITUTES AN CENTERS. IT'S IMPORTANT TO RECOGNIZE THAT CDC, VETERANS ADMINISTRATION AND CERTAINLY MORE RECENTLY THE DEPARTMENT OF DEFENSE HAS SPENT A HUGE AMOUNT OF MONEY AT BLAST RELATED INJURY AND RELATION SO BLAST AN BLUNT TRAUMA IN SOLDIERS. THIS IS A SIGNIFICANT PROBLEM WITH RETURNING SOLDIERS, THE INCIDENCE OF EXPOSURE TO BLAST IS IMMENSE. I DID A VERY QUICK SEARCH ON REPORTER JUST TO LOOK AT WHAT'S GOING ON. CERTAINLY MISSING EVERYONE BUT INTO HIGHLIGHT HERE VARIOUS GRANT MECHANISMS, VARIOUS INSTITUTES AND CENTERS, YOU HAVE RO-1 GRANTS, GRANTS FROM NICHD AND NINDS FROM THE CDC, TRAINING GRANTS, SBIR GRANTS PARTNERSHIP AWARD. A LOT OF MECHANISMS AN EFFORT GOING ON THERE'S STILL QUITE A BIT TO BE DONE. WHAT DO WE AND DON'T WE KNOW? DO WE UNDERSTAND THE MECHANISM OF INJURY? I DON'T THINK IT'S AS SIMPLE AND CERTAIN IT'S NOT SIMPLY SAYING ROTATIONAL INJURY OF THE HEAD LEADS TO CONCUSSION. WHAT ABOUT DIFFERENT DIRECTIONS OF IMPACT, WHAT ABOUT DIFFERENCE SEQUENCES OF IMPACTS THAT OCCUR OVER PERIODS OF TIME. OVER THE PAST DECADE IT'S COME TO FOCUS. TRANSIENT ALTERATION AN MENTAL STATUS WITH QUALIFIERS THERE. BUT THE DIAGNOSIS OF CONCUSSION REMAINS INCREDIBLY VARIABLE AT THE CLINICAL LEVEL. IT DEPENDS ON WHERE YOU'RE SEEN. IF YOU'RE SEEN ON THE ATHLETIC FIELD BY A CERTIFIED ATHLETIC TRAINER WHO KNOW IT IS THE ATHLETE. THIS IS A CRITICAL IMPORTANT ASPECT IF YOU UNDERSTAND WHERE THE ATHLETE WAS BEFORE, YOU PROBABLY HAVE A BETTER HANDLE ON WHERE THEY ARE AFTERWARDS. THEY SHOW UP IN THE EMERGENCY DEPARTMENT, IT'S A DIFFERENT SCENE. THEY'RE SEEN BY A NEUROLOGIST, A NEUROSURGEON, A NEUROPSYCHOLOGIST, EVERYONE HAS A DIFFERENT DEFINITION AN UNDERSTANDING OF THESE INJURIES. WE DONE KNOW TREMENDOUSLY ABOUT SHORT, MEDIUM AND LONG TERM SEQUELLA. WE UNDERSTAND SECOND IMPACT SYNDROME S WE DON'T KNOW HOW TO PREVENT IT. WE HAVE A BIG HIT AND A SMALL HIT SUBSEQUENT TO THAT TRIGGERS A BRAIN BLEED AND SOMETIMES CALLEDDED WALK, TALK AND DIE. THE ATHLETE SEEMINGLY IS OKAY AND THEN COLLAPSES ON THE SIDELINE. WE'RE JUST BEGINNING TO LEARN ABOUT RISK FACTOR TORS DEMENTIA AN LONG TERM ISSUES RELATED TO CTE AND WE DONE KNOW HOW YOUNG HOW OFTEN AND WHERE ON THE HEAD YOU CAN GET HIT TO LEAD TO THESE DISEASES. WE'RE BEGINNING REHAB PARADIGMS AND BETTER UNDERSTANDING OF RETURN TO PLAY AN RETURN TO SCHOOL. SO THESE ARE RESEARCH QUESTIONS WE ALL ASK BUT WHAT ABOUT THE PUBLIC? AND WHAT QUESTIONS ARE THEY ASKING? PARENTS? EVEN ATHLETES NOW THEMSELVES MORE THAN EVER? ARE HELMETS SAFE? IS PLAYING CONTACT SPORTS GOING TO CAUSE PERMANENT BRAIN INJURY IN MY CHILD? HOW MANY HITS ARE TOO MANY AND WHEN WITH THEY RETURN PLAY AND IN SCHOOL? ONE THING WE KNOW CLEARLY, PROFESSIONAL ATHLETES AND ADULTS ARE NOT THE SAME AS CHILDREN. IN THIS AREA. I DON'T THINK WE CAN SPLIM SAY CHILDREN ARE MORE OR LESS SUSCEPTIBLE, I THINK THERE'S CAVEATS TO THAT BUT WE HAVE TO STUDY BROAD RANGE OF ATHLETES INCLUSIVE OF ADULTS, BUT FOCUS BECAUSE THAT'S WHERE MOST PEOPLE ARE PLAYING SPORTS IS IN CHILDREN. I THINK IT'S INTERESTING TO REALIZE THE MECHANISM OF INJURY IS PERHAPS SIMILAR, WE NEED TO UNDERSTAND THE SIMILARITIES AN DIFFERENCES WHETHER THE MILITARY ENVIRONMENT, THERE'S OUR FRIEND HOMER SIMPSON DOWN ON LOWER RIGHT. SO OUR WORK IS FOCUSED ON THE BIOMECHANICAL BASIS OF CONCUSSION AN MONITORING HEAD IMPACTS IN SPORTS. I DO HAVE A FINANCIAL INTEREST IN THE TECHNOLOGY WE DEVELOPED WITH SBIR FUNDING HERE SOLD FOR COMMERCIAL USE. WHEN JOHN MAD DON TALKS ABOUT BRAIN ON TV WE KNOW THAT IS AN ISSUE. THE TWO ISSUES AS I SEE IT, THERE'S QUESTIONS ABOUT REPEATED EXPOSURE TO HEAD IMPACT AS SANJAY GUPTA SHOWED AND THIS BIG ISSUE OF UNDERREPORTED. KIDS DON'T TELL YOU ON THE SPORTS FIELD THEY HAVE A HEAD INJURY. THEY WANT THE KEEP PLAYING, THEY WANT TO DO IT FOR THE TEAM, THEY DON'T WANT TO DISAPPOINT THEIR PARENT OR COACHES BUT ESTIMATED MORE THAN HALF CON CUGS GO UNREPORTED. WE TALKED EPIDEMIOLOGY AND I THINK IT'S A PURE GUESS, REALLY DO. OUR APPROACH HAS BEEN TO TRY TO UNDERSTAND BOTH BIOMECHANICS AND CORRELATE THAT WITH THE SIGNS AND SYMPTOMS OF CONCUSSION BUT I HAVE TO TELL YOU WE CAN'T OBSERVE THEM AND THEY OFTEN HAPPEN 24, 48, EVEN 72 HOURS AFTER INJURY. SO PEOPLE SHOW UP LATER AND SAY MY HEAD HURTS OR I HAVE THESE SYMPTOMS AN NOW YOU START WORKING BACKWARDS. WHAT HAPPENED? IT HELPS IN THE PROFESSIONAL LEAGUE AND NCAA WHERE YOU HAVE GREAT VIDEO BUT MOST HIGH SCHOOLS YOU HAVE AT BEST AMATEUR FOOTAGE. OUR APPROACH HAS BEEN TO USE INSTRUMENTED HELL MELTS TO DEFINE HEAD IMPACT EXPOSURE. SEEMINGLY SIMPLE, HOW MUCH, HOW HARD AND WHERE IN THE HEAD YOU GET HIT. WE THOUGHT IT WAS IMPORTANT TO GET AT LABORATORY. I LIKE TO MEASURE THINGS IN THE FIELD SO WE HAD TO DO THAT. TO DO SO, WITH FUNDING FROM NCRR, WE DEVELOPED THE IMPACT MONITORING SYSTEM TO MONITOR IMPACTS IN REAL TIME AND ALL PRACTICING GAME WITNESS THE HELMET. WE P IF WE COULD MONITOR ACTIVITIES WE COULD ANALYZE INJURY MECHANISMS AND ONLY START ON ISSUES RELATED TO EQUIPMENT, RULES AN REGULATIONS, PUBLIC POLICY AND RETURN TO ACTION DECISIONS. THOSE ARE COMING INTO PLAY A DECADE LATER. I APOLOGIZE FOR THIS BUSY SLIDE, I WON'T SPEND TOO MUCH TIME BUT I WANT TO TAKE A SECOND TO SAY I'M A BIG SUPPORTER OF THE SBIR PROGRAM. THIS IS A GREAT CASE WHERE NOR TO ENABLE THE RESEARCH WE NEED TO HAVE THE TECHNOLOGY. I JUST WANT TO SHOW YOU WHAT HAS SPAWNED OFF SBIR THAT WAS DONE ABOUT TEN YEARS AGO LED TO SOMETHING ON THE ORDER OF $10 MILLION OF FUNDED RESEARCH NO LESS THAN 53 PUBLICATIONS, 2 MILLION IMPACTS RECORDED ON THE FIELD, VARIOUS PATENTS, AFFILIATIONS WITH COMPANIES, LOTS OF UNIVERSITY BASED RESEARCH JOBS, EMPLOYMENT AND NOW MOST RECENTLY CHANGES IN POLICY. WHERE POP WARNER FOOTBALL IS LIMITING THE NUMBER OF PRACTICE IMPACTS. IVY LEAGUE LIMITED PRACTICES PARTS WAITION, UNDERSTANDING THEY DON'T KNOW YET WHAT'S GOING ON. THE TECHNOLOGY NEEDED HERE BRIEFLY ARE AIR BAG ACCELEROMETERS. THESE SENSORS THEY USE IN THE CAR, WE USED THE SAME SENSORS FROM ANALOG DEVICES INSIDE OF HELMETS WITH A RADIO TRANSMITTER AND SMALL MICROCONTROLLER TO MEASURE MONITOR THE IMPACTS. THEY GO INSIDE A REGULAR SPORTS HELMET, HERE IS HOCKEY, FOOTBALL, WE HAVE OTHERS. THE INFORMATION IS TRANSMITTED TO A SIDELINE VIA WIRELESS RECEIVER AND STORED IN DATABASE TO LOOK AT IMPACTS LATER AND CORRELATE WITH OTHER THINGS LIKE VIDEO AND CLINICAL DATA. IT'S IMPORTANT TO UNDERSTAND WHAT WE THINK WE NEED TO MEASURE IS HEAD ACCELERATION AND NOT HELMET ACCELERATION. THERE'S A NUMBER OF PRODUCTS THAT ARE NOW COMING OUT ON THE MARKET. THAT SIMPLY WANT TO SLAP A DEVICE ON THE OUTSIDE OF THE HELMET AND IT'S IMPORTANT TO UNDERSTAND THOSE NEED TO BE CORRELATED TO WHAT WE THINK IS IMPORTANT WHICH IS HEAD ACCELERATION. AND IF THEY CAN DO THAT, GREAT. IF THEY CAN'T MAY THAIB GIVING THE WRONG INFORMATION. THE HELMET, THE FORMS QUITE RAPIDLY UNDER IMPACT. THIS WAS ALL ENABLED BY DEVELOPMENT OF ALGORITHM TO ESTIMATE THE LINEAR ROTATIONAL ACCELERATION OF THE BRAIN. OF THE HEAD. THE IMPACT LOCATION, THE TIME OF IMPACT AND THEN TO COMPUTE OTHER VARIABLES USED TIME RELATED ACCELERATION. AND THE KEY WAS TO BE ABLE TO FIT INTO EXISTING HELMET AND ALLOWING THE LAT LEET TO GO -- ATHLETE TO GO ABOUT THEIR BUSINESSCH ONCE THE TECHNOLOGY WAS COMPLETED AND VALIDATED FOR USE IN THE FIELD, WE ENGAGED WITH NIH SUPPORT AND SUBSEQUENTLY WITH CDC SUPPORT AN NOW FROM THE NATIONAL OPERATING COMMITTEE FOR STANDARDS IN ATHLETIC EQUIPMENT, A MULTI-YEAR BIOENGINEERING RESEARCH PARTNERSHIP AWARD WITH DARTMOUTH BROWN, VIRGINIA TECH AND OTHER UNIVERSITIES TO LINK TOGETHER THE HEAD IMPACT EXPOSURE, COGNITIVE ISSUES, THE BRAIN PHYSIOLOGY AS IS BEING SEEN, AND CLINICAL SPORTS MEDICINE PRACTICE. TRULY TRANSLATIONAL RESEARCH IN MY OPINION. SIMILAR PM AS IT MAY SEEM, IT WASN'T EASY HOW OFTEN AN ATHLETE GOT HIT IN THE HEAD. WE WERE SITTING ON THE SIDE I SAID WHI DON'T WE OUT MATE THIS? IT WOULD BE EASIER. WHETHER WE WANT TO KNOW IS HOW MANY IMPACTS IT TOOK IN PRACTICE AN GAMES DIFFERENCE TIME OS YEAR WHERE ON THE HEAD THEY WERE HIT AND MAGNITUDES OF THOSE WERE. WE HAVE DONE THAT AND WORK IS PUBLISHED SIGNIFICANTLY OVER THE PAST BUNCH OF YEARS. SO VERY BRIEFLY, I'LL SKIP IT BECAUSE IT DIDN'T RUN HERE AN I DON'T WANT TO JUMP OUT THE PRESENTATION. YOU HEAR ABOUT IMPACT OF Gs. Gs ARE UNIT OF GRAVITY AND ACCELERATION, ROTATIONAL ACCELERATION DESCRIBED IN UNITS OF GRADIANTS PER SECOND SQUARED. SURE EVERYBODY IS FAMILIAR WITH THAT. WHEN YOU HEAR TALKING 100Gs, IT'S GOOD TO HAVE AN IDEA OF WHAT THEY ARE, WHAT THIS WOULD SHOW IS 100G HIT IN THE LAB COMPRESSING RAPIDLY AGAINST THE HEAD AND NECK DEFORMING VIOLENTLY. WHAT I WILL SHOW YOU INSTEAD IS WHAT IT LOOKS LIKE ON THE FIELD. ASSUME I CAN GET THE GUY TO GO. AND I THINK WHAT YOU'RE SURPRISED WITH IS HOW 100G IMPACT IS SOMETHING THAT YOU MIGHT SEE IN EVERY PLAY OF THE GAME. HERE COME IT IS ATHLETE. SHOW THAT IN SLOW MOTION. THAT DOESN'T LOOK LIKE AN UNUSUAL PLAY, THESE ARE TWO HEAD IMPACTS RECORDED LESS THAN HALF A SECOND APART. THE ATHLETE LOWERS HIS HEAD, CARDINAL NO, NO AND TOOK 128G, 8,900-RADS PER SECOND SQUARED ROTATION A.M. IMPACT TO THE HEAD, SUBSEQUENTLY KNOCKED DOWN AND TOOK A SECOND IMPACT, A 50G TOAS THE SIDE OF THE HEAD AS THEIR HEAD HIT THE GROUND. SO IT SHOULDN'T SURPRISE YOU IF THAT'S WHAT 100G HIT IS, THEN YOU REALIZE HOW MANY IMPACTS ARE OCCURRING DURING A NORMAL GAME. I'LL SHOW YOU THE DISTRIBUTION OF THOSE IN MOMENT. WE COLLECTED MORE THAN 1.8 MILLION IMPACTS IN FOOTBALL, HOCKEY, SOCCER, BOXING, SKIING, OTHER SPORTS, WE STARTED TO STRATIFY ACROSS AGE GROUPS, WE STARTED PRIMARILY IN COLLEGIATE FOOTBALL, MOVED DOWN TO HIGH SCHOOL LEVELS AND NOW MOVING INTO THE YOUTH SPORTS. WE LEARNED DIFFERENT ISSUES RELATE TOTD FREQUENCY MAGNITUDE BY SPORT, PLAYER POSITION, GAMES VERSUS PRACTICE, GENDER, LEVELS OF PLAY AND NOW THAT WE COLLECTEDDED ENOUGH WE'RE STARTING TO LOOK AT ISSUES RELATED TO THOSE WITH DIAGNOSE CONCUSSION BUT I CAN TELL YOU WE HAVE TO CAVEAT THOSE ARE ONLY DIAGNOSED CONCUSSIONS. WHAT ABOUT THE ONES THAT HAD Al CONCUSSION CLINICALLY BUT YOU NEVER KNEW ABOUT. THEY'RE INCLUDED IN THE UNCON CUSSED DATA SET. SO BRIEFLY WHAT ARE ISSUE? WE SEE THE ATHLETES MAY HAVE AS MANY AS 2,000 IMPACTS IN A SINGLE SEASON BUT WIDELY DISTRIBUTED DIFFERENCE BY TEAM, COACHING PHILOSOPHY, LOTS OF IMPACTS. PARTICULARLY HIGH SCHOOL WHERE THEY PLAY OFFENSE SLIF AND DEFENSIVELY. WE FOUND WIDE DIFFERENCES BY PLAYING POSITION. SO FOR THOSE NOT AS FAMILIAR WITH QUARTERBACKS WIDE SEVERS, TURNS TOUT LINE MEN GET MANY, MANY, MANY IMPACTS, EVERY PLAY ALMOST, IF YOU THINK ABOUT HOW MANY PLAYS ON THE GAME, THEY TAKE A RECORD GREATER THAN 10G IMPACT EVERY TIME THEY COME OUT OF STANCE AND HIT THE OPPOSING LINEMEN. WE DON'T KNOW WHETHER THE EFFECT OF THESE ARE OVER TIME. THE VAST MAJORITY ARE LOW LEVEL THAT. 100G IMPACT IS VERY TOP .5% OR HIGHER LEVEL OF IMPACT BUT THEY OCCUR WHEN YOU HAVE 2 MILLION IMPACTS, WE'RE TALKING TENS OF THOUSANDS ABOVE THESE 50G LEVEL IN ALL OF OUR ATHLETES. OVER A THOUSAND ATHLETES SO THE VAST MAJORITY IS AT LOW LEVEL BUT THEY'RE ACCUMULATING OVER TIME. WE HAVE DATA ON MORE THAN 120 CONCUSSIONS RECORDED WITH THIS TECHNOLOGY, THERE ARE A LOT OF DATA, NOT ALL HERE, BUT SOME OF THE STUFF THAT COMES OUT QUICKLY ARE THE NUMBER OF IMPACTS, MUCH HIGHER ON DAYS WHEN AN ATHLETE IS DIAGNOSED WITH CONCUSSION. THEY TEND TO HAVE TAKEN MORE IMPACT THAT DAY, WHERE ON THE HEAD? MANY IMPACTS ARE THE FRONT OF THE HEAD BUT THAT SHOULD BE LOGICAL SINCE MOST IMPACT ARE FRONT OF THE HEAD. WE HAVE TO NORMALIZE AND LOOK AT RELATIVE RISK RELATED TO IMPACT LOCATION. 100G IN THE TOP .5% OF IMPACTS. HERE IS THE PROBLEM. MEASURES ARE SENSITIVE BUT NOT SPECIFIC TO CONCUSSION. WE HAVE MORE THAN 8,000 IMPACTS WITH HIGHER MAGNITUDES THAN 100G WHERE THERE WAS NO ASSOCIATION WITH INJURY. SIMPLY A MISSED DIAGNOSIS OR CAN SOME PEOPLE TAKE THAT? YOU DON'T WANT TO DISQUALIFY ATHLETES BECAUSE THEY TOOK A BIG HIT IF THEY HAVE NO CLINICAL SYMPTOMS. DRAMATICALLY CHANGING THE GAME. IMPORTANTLY WE NEED TO COLLATE THIS WITH CLINICAL RELEVANCE, ONGOING RESEARCH AND SIMILAR TOMOLOGY, BIOMARKERS, PHYSIOLOGIC CHANGES. WE FOUND DATA ALONG THE LINES THAT ATHLETES WHO ARE COMPETING DURING MID SEASON IF WE TAKE -- WHEN WE GET A CON CUSSED ATHLETE WE TAKE A CONTROL SO ATHLETES ARE PARTICIPATING GETTING REPEATED IMPACTS AN UNFORTUNATELY WE FOUND HALF OF THEM ARE SUFFERING ONE OR MORE CHANGE SIGNIFICANT CHANGE IN COGNITIVE PROGRAM THE TEARS USING THE COMPUTERIZED NEUROPSYCH TESTING, PAPER AND PENCIL TESTING AS WELL. WHAT ABOUT THE NON-CON CUSSED OR NON-DIAGNOSED ATHLETES? DR. MECHANICALSER'S WORK AT DARTH MOUTH HERE SHOWING INTERESTING ASPECT OF WORK IS WE'RE ABLE TO DO PRE-SEASON AND END SEASON AND POST SEASON IMAGING, VERY EXPENSIVE, VERY CHALLENGING TO DO, BUT WE ARE FINDING CHANGES IN INCREASED ACTIVATION IN THE BRAIN. FOR HELMET PLAYERS VERSUS CONTROLS. WE SEE SIGNIFICANT CHANGES IN CON CUSSED ATHLETES. PRE-TO POST SEASON. THESE ARE FOR THE ATHLETE WHOSE ARE INJUREDDED AND WITHIN COUPLE OF DAYS AFTER THEIR INJURY THEY'RE RE-IMAGED, SIGNIFICANT CHANGES IN DTI SCORES. I MENTIONED EARLIER WE'RE STARTING TO RELATE THIS, WE HAVE A UNIQUE METHOD WE NOW HAVE A SUBJECT SPECIFIC MRI AND WE CAN MAP THAT INTO A SUBJECT SPECIFIC FINITE ELEMENT MODEL AND SINCE WE HAVE THE IMPACT THAT WAS ASSOCIATED WITH THEIR CONCUSSION DIAGNOSIS WE RUN THAT THROUGH THE MODEL AND OVERLAY THE STRAIN PARAMETERS. I MENTION THIS AT THE FIRST SO I WON'T GO OVER IT AGAIN. THIS TECHNOLOGY HAS BEEN PORTED NOW TO OTHER SPORTS, NOT SO EASY IN PORTS LIKE SOCCER WHERE PEOPLE DON'T WEAR HEAD GEAR. WE HAVE DONE IT PURELY ON RESEARCH MODE. IT'S USED BY USA BOXING, AND WE ARE WORKING AND HAVE BEEN WORKING SOME YEARS WITH THE MILITARY TO TRY TO HELP THEM IMPLEMENT THIS IN MILITARY HELMETs. WHAT WE LEARN SO FAR? YOU GET HIT OFTEN, HARD AND ALL OVER THE HEAD. THESE MEASURES ARE SENSITIVE BUT NOT SPECIFIC TO DIAGNOSIS OF INJURY SO NOT AS SIMPLE AS SAYING WE KNOW HOW HARD OR WHEN YOU GOT HIT WE CAN DIAGNOSE. WE DON'T HAVE A DIAGNOSTIC TOOL. THAT'S FAR AWAY. WE KNOW WE HAVE BEEN WORKING TO TRY TO REFINE AND DEVELOP INJURY TOLL LANCE CURVES TO HEAD IMPACT. IT'S INTERESTING TO SEE PREVIOUSLY ESTABLISHED3cv FIELD DATA THAT'S GREAT. WE HAVE TO REFINE THESE MEASURES. WE HAVE TO CONTINUE TO LOOK AT THE RELATIONSHIPS OF HEAD IMPACTS TO CLINICAL MEASURES AN OUTCOME. WIDE VARIABILITY ACROSS POPULATIONS, AGE AND GENDER. WE HAVE A LOT TO LEARN. SO MY COLLEAGUE TINA DUE HAYNE SAYS CHILDREN ARE NOT JUST SMALL ADULTS. WE HAVE TO MOVE THIS DOWN THE CHAIN HERE. AND WHERE KIDS ARE. THIS FALL AT VIRGINIA TECH THERE WILL BE INSTRUMENTING SIX YOUTH TEAMS WITH 210 KIDS. AND HAVE FUNDING TO DO NEUROIMAGING ON THOSE AS WELL. I WANT TO EMPHASIZE THE AREAS RELATED TO PREVENTION. WE SHOULDN'T BE WARY ABOUT WHAT WE DO WITH ATHLETES ONCE HURT. I DON'T BUY THE ARGUMENT THAT HELMETS, TECHNOLOGY AN EQUIPMENT, THOSE WITH RULES CHANGES, UNDERSTANDING BASIC SCIENCE ARE GOING TO ALLOW US TO IMPROVE THESE INJURIES AND PERHAPS ALLOW US TO CONTINUE THE PLAY THESE GAMES THE WAY EVERYONE ENJOYS. IT'S GREAT TO PARTICIPATE IN THESE SPORTS. I WANT TO ACKNOWLEDGE I COULDN'T POSSIBLY ACKNOWLEDGE EVERYONE WHO WORKEDDED ON THIS OVER THE YEARS. NOW LET'S TAKE COMMENTS FROM OTHER PANEL MEMBERS AND WE CAN CERTAINLY ENTERTAIN AN OPEN DISCUSSION ON THIS TOPIC. THANK YOU. [APPLAUSE] >> IN OUR ROLE IN MILD TRAUMATIC BRAIN INJURY. AS RICK POINTED OUT, I THINK Y'ALL ARE AWARE IF YOU PICK UP A PEOPLE MAGAZINE OR NEWSPAPER OR TURN ON THE RADIO, SPORTS-RELATEDDED HEAD INJURY CONCUSSION RECEIVED A LOT OF RECENT PRESS RELATED TO PROFESSIONAL ATHLETES AND COLLEGE ATHLETES. I THINK IT'S IMPORTANT TO POINT OUT THAT THE TERMINOLOGY MAY CHANGE IN THIS PRESS WE HEAR MORE ABOUT SPORTS CONCUSSION BUT I THINK WE'RE ALL TALKING ABOUT THE SAME THING WHICH IS MILE HEAD INJURY, A HEAD INJURY ON THE CONTINUUM OF SEVERITY. THEY'RE ALL IN MY MIND THE SAME NOTION. SO WITH THAT IN MIND AS RICK BEGAN TO POINT OUT, THE CENTER NCMRR CHILD HEALTH HAS RESEARCH WE HAVE SUPPORTED OVER THE YEARS. FROM BOTH INVESTIGATOR INITIATED AND TARGETED RFAs, REALLY DEALT WITH THIS TOPIC FROM A VARIETY OF PERSPECTIVES AND ARE -- OUR FOCUS REMAINED CONSISTENTENT THROUGHOUT THE YEARS. THAT IS TO LOOK TO EVALUATE THE CAUSES, DIAGNOSIS TREATMENT ACROSS SEVERITY AN AGE SPAN, IT'S IMPORTANT TO TALK ABOUT THE AGE SPAN PIECE. I'LL GIVE A FEW EXAMPLES BECAUSE I HAVE FIVE MINUTES TO BRING IN A RANGE OF HUGE TOPIC. AND GIVE YOU A SENSE OF THE VARIETY OF PROJECTS WHICH ARE QUITE VAST. SO ON ONE END OF THE SPECTRUM WE HAVE THINGS LIKE PHARMACOLOGICAL INTERVENTIONS OF PEDIATRIC TBI, ONE APPROACH, WE HAVE LOOKED AT ISSUED RFAs ON EVALUATION INTERVENTION TO IMPROVE COGNITION IN CHILDREN VIA VARIETY OF STRATEGIES OF COMMUNICATION, COMBINATIONS OF DRUGS AND BEHAVIORAL APPROACHES TO WORK ON THE BEHAVIORAL SEQUELLA OF INDIVIDUALS, CHILDREN AND ADULTS AS WELL WITH HEAD INJURY. WE'VE ALSO SPOKEN IN THE PAST ABOUT TBI CLINICAL TRIAL NETWORK RESEARCH NETWORK, THAT'S BEEN EVALUATING THE LONG TERM CONSEQUENCES OF TBI ACROSS SEVERITY FROM AGE 18 AND UP. AND RAMONE IS ONE OF THE PIs ON THAT STUDY. A THIRD OF THE COHORT OF THE OVER 1200 PATIENTS WE HAVE FROM 18 ABOVE ARE MILD HEAD INJURY. THIS IS DONE PURPOSEFULLY, WE DESIGN THE NETWORK TO ENROLL PATIENTS IN MILD RANGE TBI. THE TAKE HOME MESSAGE HERE IS THAT ALL THE INFORMATION THAT'S GAINED FROM THIS VAST VARIETY VARIETY OF STUDIES INCLUDING SOME THAT RICK POINTED OUT ARE RELEVANT TO THE ISSUES OF SPORTS CONCUSSION OR MILD TBI. AS RICK POINTED OUT DIAGNOSIS OF CONCUSSION OR MILD TBI WHICHEVER TERMINOLOGY YOU PREFER IS BASED ON HISTORY OF ALTERATION AND ACCELERATION OR CONCUSSION THAT OCCURS IMMEDIATELY AFTER A MECHANICAL IMPACT OR RAPID ACCELERATION DECELERATION. IT'S NOT JUST PEOPLE INVOLVED IN PROFESSIONAL SPORTS OR IN ORGANIZED SPORTS. MOST KIDS CLINICALLY FALL OFF THE PLAYGROUND, WHO RUN INTO EACH OTHER WHEN THEY FALL OFF THE BIKE. THESE ARE THE NATURE OF FOLKS YOU SEE CLINICALLY. SUCH INJURIES ARE INVISIBLE ON CAT SCAN AND THEY ARE SUBTLE. IT'S THE SUBTLE NATURE OF THIS INJURY OF MILD TBR CONCUSSION FRAMES THE CONCERNS THAT WE HAVE AS RESEARCHERS, AS CLINICIANS, AND AS PARENTS. SO WHEN I WORK CLINICALLY ON THE HEAD INJURY UNIT AT KENNEDY CREEGER, PROBABLY THE ONE QUESTION EVERY PARENT WHETHER THEIR CHILD IS SEVERELY INJURED OR MILDLY, WOULD COME BACK ONE MONTH POST, TWO MONTH POST MY CHILD IS DIFFERENCE, THEY'RE NOT THE SAME, WHEN ARE THEY GOING TO BE THE SAME. THE SUBTLETIES YOU DON'T RECOGNIZE IMMEDIATELY. THESE ARE SUBTLE CHANGES SO THAT'S IMPORTANT TO POINT OUT. SO FROM THE PERSPECTIVE I FRAMED MY COMMENTS ABOUT WHAT I BELIEVE ARE FOUR PRINCIPLE AREAS OF RESEARCH NEED. THAT IS FIRST, MOST OF THESE PARALLEL WE TALKED ABOUT THIS IN THE PAST. THE LONG TERM CONSEQUENCES ON EFFECT OF DEVELOPING BRAIN, WE KNOW DIFFERENCE REGIONS OF THE BRAIN MATURE DIFFERENT AGES THE PRE-FRONTAL CORTEX DEVELOPS MORE CLOSE SLOWLY AND IS DEVELOPING TO PERHAPS AGE 16. WE KNOW MYELINATION IS OCCURRING THROUGH AGE 10. AS A POINT OF REFERENCE THE CDC REPORTS THAT SOME 70.5% OF ALL ER VISITS POST RECREATIONAL SPORTS, NOT JUST ORGANIZED SPORTS BUT PLAYGROUND FALLS, THAT SORT OF THING, BIKE ACCIDENT ARE AMONG CHILDREN AGE 10 TO 19. THAT'S IMPORTANT TO KEEP IN MIND. WE NEED TO BE PARTICULARLY SENSITIVE TO THE TIMING OF THE INJURY RELATIVE TO THE BRAIN REGIONS UNDER DEVELOPMENT. THE SPECIAL IMPLICATION OF THE INJURY ON THE DEVELOPING BRAIN. SO WE NEED TO OBVIOUSLY LEARN MORE ABOUT BRAIN BIOLOGY, EFFECT OF THE INJURY AND THE GENETIC MARKERS OF RISK. I WROTE THESE DOWN SO I COULD BE REALLY FAST. THE EFFECT -- SECOND THING THAT'S IMPORTANT IS EFFECT OF INJURY ON COGNITIVE EMOTIONAL BEHAVIORAL AND SOABL FUNCTION, ATTENTION, LEARNING, MEMORY. THESE ARE ALL FACTORS THAT HAVE OBVIOUSLY -- OBVIOUS IMPLICATIONS IN DEVELOPMENT EDUCATION AND LIFE PERFORMANCE OF CHILDREN. THESE ARE TOPICS THAT ARE DEALT WITH NOT JUST NCMRR BUT ACROSS THE CHILD HEALTH INSTITUTE. WE HAVE COLLEAGUES THAT I WORK WITH IN OUR INSTITUTE WHO FOCUS ON DIFFERENT ASPECTS OF THIS ISSUE. ONE EXAMPLE OF A STUDY THAT HAS GOTTEN SOME PRESS AS WELL THAT WE SUPPORT IS KEITH YATES AN COLLEAGUES WHO TO THIS POINT IS SHOWING THAT THE PERSISTENCE OF CONCUSSION SYMPTOMS IN CHILDREN AND ADULTS UP TO 12 MONTHS AFTER EVEN MILD INJURY. AND KEITH AND COLLEAGUES POINT OUT REPEATEDLY THE IMPORTANCE OF EDUCATIONAL INTERVENTION IN SUCH CHILDREN. THE THIRD IS DETERMINING WHEN IT'S SAFE AS RICK POINTED OUT FOR A CHILD OR TEENAGER TO RETURN TO NORMAL ACTIVITIES. NOT EVEN ORGANIZED SPORTS BUT NORMAL ACTIVITIES, BIKE RIDING SO FORTH. WE ALSO NEED TO DETERMINE THE BEST WAY TO PREVENT DIAGNOSE KNOW TREAT AND ASSESS OUTCOME. THERE'S BEEN SOME CONVERSATION ABOUT ESTABLISHING TREATMENT GUIDELINES WITH THIS ISSUE. THERE'S TALK ABOUT EVALUATING EFFECTIVENESS OF BASELINE TESTING IN CHILDREN, SOMETHING INVOLVED IN. AND IMPORTANT TO LINK THE IMPACT WITH CLINICAL OUTCOMES, WORK OVER THE YEARS. STUDIES THAT RELATE TO TREATMENT, JA NEAT (INDISCERNIBLE) HAS DEVELOPED FURTHER DEVELOPMENT OF FANCY, WHICH IS AN INTERVENTION PROGRAM TO IMPROVE EMOTIONAL COG MITIVE AND BEHAVIORAL E SEQUELLA OF TEENAGERS AND YOUNG ADULTS FOLLOWING MILD HEAD INJURY, THIS INVOLVES A LARGE PARENTAL COMPONENT, IT'S A COMBINATION WORKING WITH THE CHILD AS WELL AS FAMILY. CURRENTLY WORKING ON A PROJECT OF ANGER SELF-MANAGEMENT ENTER VENGS ONE OF THE HALLMARKS OF INDIVIDUALS WITH MILD TO SEVERE HEAD INJURY. AS RICK POINTED OUT AS WELL AGENCIES ARE INTERESTED IN THIS AREA, WE COULD COLLABORATE WITH THE GAO, IOM, HRSA DEALING WITH EPIDEMIOLOGY LOOK AT CHANGES IN SCHOOL PERFORMANCE AND LOSS OF SCHOOL GAYS AS MARKER OF INJURY, OUR CENTER HAS BEEN INVOLVE -- SCHOOL DAYS. CDC WITH CONGRESS WITH HEADS UP GUIDANCE THAT'S BEEN PUBLISHED BY THE CDC. CLEARLY IT'S A TOPIC THAT RELEVANT TO ALL PROGRAMS WITH NICHD, ALSO A RECENT EUROPEAN UNION AN CANADIAN INTERNATIONAL COLLABORATION. I SPOKE WITH MY COLLEAGUE AT NINDS YESTERDAY MONA HICKS AND THERE'S A POSSIBILITY AN INITIATIVE COMING OUT THEY'RE ASKING FOR COLLABORATIVE FUNDING LOOKING AT THE TRANSCOUNTRY APPROACH TO GATHER THE DATA NEEDED TO BE ABLE TO ANSWER THE QUESTION. I THINK WE ALL THIS VARIETY OF AGENCIES, TOPICS WITHIN OUR SENOR AND VARIETY OF INDIVIDUALS WITHIN THE INSTITUTE SHARE THE COMMON BELIEF THERE ARE PRIMARY QUESTIONS CLEARLY IN NEED. HOPE THAT WAS FIVE MINUTES. >> DR. DIAZ ARASSIA. Q.THANK YOU TO DR. GREENWALD FOR A FANTASTIC PRESENTATION. I MUST SAY I AGREE DESCRIPTION OF THE MAGNITUDE MAGNITUDE OF THE PROBLEM. SO WHEN I TRAINED IN NEUROLOGY, NOT LONG AGO THE STANDARD TEACHING ABOUT CONCUSSION WAS THEY ALWAYS GOT BETTER, IF THEY DIDN'T GET BETTER THEY WERE MA LINGERING, THEY WERE TRYING TO SUE SOMEBODY OR TRYING TO GET SECONDARY, THIS IS REMARKABLE. STILL THE VIEW BY MANY PHYSICIANS OUT THERE. SO FOLKS THAT DID REALLY BY NOW SHOULD KNOW BETTER. I DON'T THINK THIS IS NEW, IT'S BEEN WITH US SINCE THE TIME OF CAVES. CONCUSSION AN BRAIN INJURY PART OF THE EXPERIENCE FOR A LONG TIME, IF ANYTHING MAYBE A LITTLE LESS NOW THAN USED TO BE. I THINK THERE ARE A COUPLE OF REASONSCH FIRST IS THAT THE PREDOMINANT CONSEQUENCES ARE IN THE REALM OF NEUROPSYCHIATRY. SO THE PROBLEMS FOLKS GET AFTER HAVING BEEN EXPOSED TO MULTIPLE MILD TBI IS THINGS LIKE DEPRESSION, IRRITABILITY, ANGER, PERSONALITY CHANGES, HISTORICALLY AND PLACES IN SOCIETY ARE THOUGHT TO BE DISORDERS OF THE MIND OR SOUL, RATHER THAN DISORDERS OF THE BRAIN. CLEAR THERE ARE DISORDER OF THE BRAIN SITUATION BUT EASY TO STUDY. IT DOES REQUIRE SPECIAL TOOLS JUST DEVELOPED WE HAVE COMPLETED THE WORK WITH IMAGING AND NEUROPHYSIOLOGY, DR. GREENWALD INDICATED I THINK REALLY VERY IMPORTANT. THAT'S NUMBER ONE. SECOND REASON IS THERE'S OFTEN A LATENCY BETWEEN INJURY OR EXPOSURE TO MILD TBIs AND DO CRIPTION AND THE ONSET OF THE SYMPTOMS. PARTICULARLY WITH MORE SEVERE TBI THE PROBLEMS ARE RECOGNIZED RIGHT AWAY, WHICH CASE SOMEBODY EASIER, WHAT DOES HAPPEN, MANY YEARS AS WELL AS OTHERS PARTICULARLY WHEN THIS OCCURS IN CHILDREN, THEY SEEM TO RECOVER VERY WELL. SO WITHIN WITHIN A FEW WEEKS OF INJURY THEY'RE SEEMINGLY BACK TO NORMAL. TEN YEARS LATER THEY'RE DIFFERENT. WE'RE PROBABLY HAPPEN IS THAT CHILDREN HAVE CAPACITY TO RECOVER, THEY ARE -- THE INJURY PUT THEM ON A DIFFERENT DEVELOPMENTAL SLOPE AND WHILE THEY CON TO DEVELOP THEY DON'T DEVELOP AT THE SAME SLOPE THAT UNINJURED COHORT GROUP WOULD BE. BY THE TIME THEY COME AS TEENAGERS OR YOUNG ADULTS HAVING PROBLEMS IN SCHOOL AND BEHAVIOR, MANY TIMES FACT THAT THEY HAD AN INJURY EVEN SOME CASES RELATIVELY SEVERE INJURY EARLIER IN LIFE IS NOT SOMETHING THE FAMILY REMEMBERS. THIS IS DEFINITELY GOING TO BE AN ISSUE. SO WE'RE GOING TO NEED FAIRLY LONGITUDINAL STUDIES TO GET A HANDLE ON THIS. POSITIONED TO REALLY GET THIS DATA. 'S REALLY IMPORTANT. THE THIRD REASON THIS IS SOMEWHAT IGNORED IS BECAUSE IT IS A LIFE LONG CONDITION. THOUGH IT'S OFTEN CONCEPTUALIZED AS A SINGLE EVENT, THAT PEOPLE RECOVER FROM TO VARYING DEGREES, THERE'S GROWING DATA THE BRAIN IS CHANGED AFTER HAVING A BRAIN INJURY. 'S ONGOING INFLAMMATION, ONGOING ONGOING SMAP TICK CHANGES, THIS OCCURS IN A LIFE LONG CONDITION AN RESULTS IN CONSEQUENCES THAT MAY TAKE YEARS TO MANIFEST BUT THEY OFTEN DO. THERE IS A LOT TO KNOW, THIS IS AN IMPORTANT AREA OF RESEARCH, THIS IS AN IMPORTANT PROBLEM THOUGH I AGREE WITH DR. GREENWALD WE DON'T KNOW THE FULL MAGNITUDE OF IT, BETTER TOOLS AN DIAGNOSIS, MY LA COMMENT IS THOUGH THIS IS SOMETHING THAT'S BEEN RELATIVELY UNAPPRECIATED IN THE SCIENTIFIC LITERATURE, IT'S ACTUALLY MORE RECOGNIZED IN THE FICTIONAL LITERATURE. SO BACK TO LITERATURE AFTER WORLD WAR I, THERE IS A LOT OF NOVELS DESCRIBING WHAT WAS HAPPENING IN REAL WORLD. SERVICEMEN COME BACK FROM BATTLEFIELDS IN EUROPE WHO HAD BEEN EXPOSED TO EXPLOSION SHELLS, THIS IS WELL RECOGNIZED. IN THE FICTIONAL LITERATURE, IN SPORTS AS WELL. I LIKE READING FICTION ABOUT SPORTS AND IT IS NOT UNCOMMON PEOPLE JOKE AMONG EACH OTHER SO WELL. HE HE'S HAD HIS BELL RUNG TOOMENT, THIS HAS BEEN -- TOO MANY TIMES, THAT'S NON-FICTIONAL THOUGH NOT RECOGNIZED IN THE SCIENTIFIC LITERATURE UNTIL RECENTLY. SO I THANK YOU FOR THE OPPORTUNITY BRING THIS UP, NICHD IS IN A GOOD POSITION THROUGH THE NATIONAL CHRN'S STUDY TO MAKE KEY CONTRIBUTIONS TO THIS IMPORTANT AREA. >> THANK YOU. WE APPRECIATE THE WORK YOU COAS DIRECTOR OF THE -- DO AS DIRECTOR FOR NEUROSCIENCES REGENERATIVE MEDICINE AT OUR SISTER INSTITUTION SO THANK YOU FOR COMING HERE THIS MORNING. DR. WEINRICH. I DON'T WANT TO REPEAT WHAT THE OTHER SPEAKERS HAVE INDICATED BUT I WOULD LIKE TO PUT ANYTIME A DIFFERENT PERSPECTIVE. WE HAVE BEEN STUDYING BRAIN INJURY 50IERS OR MORE. WHY DO WE KNOW SO LITTLE. THERE'S A BUNCH OF REASONS FOR THAT. ONE IS THAT BY AND LARGE INVESTIGATORS HAVE LARGELY FOCUSED ON SEVERE, MODERATE BRAIN INJURY. GOOD REASONS FOR THAT. DEVASTATING INJURIES THE TERRIBLE SHAPE, THEY HAVE HORRIBLE OUTCOMES AND THE PRESENTATION AS YOU HEARD OF MILD INJURIES IS SO VARIABLE AND CASE REPORTING IS SO BEAR MY TENT O SO A LOT OF PEOPLE NEVER PRESENT THOUGH WE HAD SIGNIFICANT MILD HEAD INJURY. SO A LOT OF REASONS INVESTIGATORS FOCUSED ON MORE SEVERE INJURIES. TO SUMMARIZE THING FROM TO DATE IT'S MISERABLE FAILURE BECAUSE THE FA P&ATHOLOGY IS SO SEVERE THAT WE HAVE BEEN ABLE TO MAKE LITTLE HEADWAY IN TERMS OF IMPROVING OUTCOMES FOR MORE SEVERE HEAD INJURIES SO WE HAVE HAD NOTHING TO GENERALIZE IN TERMS OF THERAPEUTICS TO MILDER INJURIES. THE OTHER PART OF THIS IS OF COURSE IS THE CONSEQUENCE OF THIS VARIABILITY IN OUTCOMES IN REPORTING MILE INJURY IS STUDIES REQUIRES TO OBTAIN ACCURATE INFORMATION ON PATHOPHYSIOLOGY, OUTCOMES IN TREATMENT FOR THIS POPULATION ARE GOING TO BE MUCH LARGER. THAT IS ORDER OF MAGNITUDE LARGER, YOU CAN DO A STUDY SEVERE TO MODERATE BRAIN INJURY WITH A FEW HUNDRED PATIENTS. YOU NEED THOUSANDS AN THOUSANDS OF PATIENTS TO OBTAIN ANY CON CHIEWGS ABOUT MILD INJURY. YOU HEARD IMAGING TOOLS ARE JUST BEING DEVELOPED TO STUDY SWRIRRY. THAT'S BEEN SIGNIFICANT PROBLEM ANOTHER PROBLEM HAS BEEN THAT WE HAD A VERY NEURON-CENTRIC VIEW OF THE BRAIN. I WOULD LIKE TO SAY ALMOST EVERYTHING I LEARNED ABOUT NEUROSCIENCE MEDICAL SCHOOL WAS WRONG. I WEPT TO MEDICAL SCHOOL ONLY SLIGHTLY BEFORE RAMONE. ONE THING THAT'S WRONG THAT WE LEARNED WAS THAT ALL THE NON-NEURAL ELEMENTS OF THE BRAIN ARE THEIR ASK FOLDING AND YOU ONLY HAVE TO BE CONCERNED ABOUT NEURONS. THAT IS CLEARLY WRONG. THESE NON-NEURONAL ELEMENTS PLAY AN IMPORTANT ROLE IN INFORMATION PROCESSING AS WELL AS MEMORY. WE DON'T KNOW MUCH ABOUT THE INTERACTION BETWEEN NEURONS AN GLIA AND THAT'S SOMETHING THAT WE'RE JUST BEGINNING TO INVESTIGATE IN A SERIOUS WAY. LET ME COME BACK TO SOMETHING RICK ALLUDED TO INCORRECTLY, THE NEED FOR DIRECT STUDY OF HUMANS. ONE BIG PROBLEM WITH RESEARCH ON BRAIN INJURY, ANIMAL MODELS HAVE BEEN TERRIBLE. THEY'RE OBVIOUS LITERRABLE FOR LOOKING AT COMPLEX BEHAVIOR, COGNITION, EMOTION, ET CETERA, BUT ALSO TERRIBLE EVEN AT THE LEVEL OF PATHOPHYSIOLOGY OF WHITE AND GRATE MATTER INJURIES. THE ANIMAL MODELS JUST DO NOT REMY KATE INJURIES EITHER AT THE GROSS LEVEL OR CELLULAR LEVEL THAT WE SEE IN HUMAN BRAIN. SO THERE'S -- THAT'S PART OF THE BIG PROBLEM IN DEVELOPING A DEEPER UNDERSTANDING OF BRAIN JR. RAIND THERAPEUTICS IS THAT OUR ANIMAL MODELS ESPECIALLY MILD INJURIES AND WHITE MATTER INJURIES ARE INADEQUATE TO THE TASK. IS >> SO WE HAVE A FEW MINUTES STILL NOW TO ENTERTAIN ANY QUESTIONS FROM COUNCIL OR FROM ANYONE IN THE AUDIENCE TO THIS ISSUE. TO THE THE PANEL, TO MYSELF. >> I HAVE A QUICK QUESTION, FIRST CONGRATULATIONS ON THE FANTASTIC MUCH NEEDED WORK. YOU TALKED ABOUT IVY LEAGUE AND CHANGE IN PATTERN GOING ON THERE, WHAT ABOUT HIGH SCHOOL LEVEL? I CAN GIVE YOU THE EXAMPLE OF MY DAUGHTER WHO HAD THIS INJURY AND WAS TOLD SHE WAS MA LINGERING AND GO RIGHT BACK AND PLAY. SO WHAT HAS BEEN DONE IN TERMS OF TEACHING AND EDUCATION IN THIS AREA? >> THERE'S LEGISLATION IN 30 APPROACHING 40 STATES NOW, LEGISLATION IN EVERY STATE IS DIFFERENT AND HAVING TO DO WITH GUIDELINES FOR APPROPRIATE DIAGNOSIS, TREATMENT, ACROSS THE BOARD WHAT SHOULD BE DONE. SOME GOING AS FAR TO LEGISLATE PRE-SEASON TESTING. SO I THINK THE LEGISLATIVE OR POLICY LEVEL THERE'S A LOT OF EFFORT GOING ON AND THE QUESTION DO WE KNOW ENOUGH TO MAKE THESE RECOMMENDATIONS AND HOW THEY WILL BE EFFECTED AND DO WE HAVE SYSTEMS IN PLACE THE TRACK WHETHER THOSE LEGISLATIONS WILL BE EFFECTIVE OVER TIME. WHEN IT GETS TO THE BOOTS ON THE GROUND LEVEL AT THE HIGH SCHOOL, IT REALLY DEPENDS ON INTEREST OF THE ADMINISTRATION, THE COACHES, THE PARENTS, AND A LITTLE BIT OF EDUCATION OF ATHLETE. I THINK WE REALLY HAVE TO START -- THE KIDS UNDERSTAND, THEY'RE THE ONES PROTECTING EACH OTHER. WHEN YOU NEAR A SPORTS TEAM AND ONE KID ISN'T FEELING WELL IT'S HIS BEST FRIEND WHO H WHO COMES OUT AND SAYS YOU NEED TO GET LOOKED AT. YOU'RE NOT RIGHT. SO I THINK IT'S WIDELY VARYING IN VARIOUS SCHOOLS HOW THEY'RE IMPLEMENTED. A TOP DOWN APPROACH BY PUTTING LEGISLATION IS THAT THE BEST APPROACH? IT'S TART BUT WE HAVE TO UNDERSTAND HOW TO IMPLEMENT THAT WIDELY. >> THANKS, RICK, GREAT PRESENTATION. I ACTUALLY FROM A COMPLETELY SEPARATE LIFE I CHAIRED THE ISLAND COMMITTEE ON LONG TERM CONSEQUENCES OF TRAUMATIC BRAIN INJURY HEAVILY FOCUSED ON IRAQ AND EXPLOSION INJURIES. I THINK PART OF THE AGENDA FOR NICHD MAY WELL BE SOCIAL CONSEQUENCES TO CHILDREN OF THE 180,000 AS OF TWO YEARS AGO RETURNING VETERANS WITH VARIOUS DEGREES OF TRAUMATIC BRAIN INJURY AN OFTEN SERIAL TRAUMATIC BRAIN INJURY CHRONIC TRAUMATIC ENCEPHALOPATHY. THAT'S SERIOUS SOCIAL ISSUES WRAPPED UP IN THIS AND READJUSTMENT ISSUES FOR KIDS OF RETURNING VETERANS. I THINK THAT'S SQUARELY PART OF YOUR AGENDA. >> YES, I JUST WOULD LIKE TO ECHO THE APPLAUSE FOR NICHD FOR TACKLING THIS HEAD ON, NO PUN INTENDED. I THINK THIS IDEA OF THE DEVELOPING BRAIN, HOW IMPORTANT IT IS TO BEGIN TO ASSESS WHAT INJURY DOES AND WHERE THE INJURY IS DIFFERENT STAGES OF BRAIN DEVELOPMENT IS ESSENTIAL, THIS HAPPENS TO THE LIFE SPAN RESEARCH THEME YOU DEVELOPED. I THINK WE KNOW ACTUALLY THAT THE BRAIN DOESN'T FINISH MYELENATING UNTIL YOU'RE INTO YOUR 30s. SO WE HAVE TO THINK OF THE MILITARY AS CHILDREN TOO. AND WE NEED TO BE -- THIS TAPS TO WHAT YOU WERE SAYING, NOT SAME AS GRANDPA HITTING HIS HEAD. THEY HAVE THEIR LIFE SPAN IN FRONT AND OFTEN HAVE SMALL CHILDREN OF THEIR OWN AS YOUR POINTING OUT. SO THERE IS EXTRAORDINARY OPPORTUNITY HERE, A LOT HAS TO BE HUMAN BASED MARKERS INCLUDE NEUROIMAGING. I WOULD ALSO PUT IN A PLUG FOR NEUROPHYSIOLOGY, EEG IS A CHEEP TEST, IT'S INEXPENSIVE, FAST AND YOU GET A LOT OF DIGITAL INFORMATION OUT OF IT AND KNOWING EPILEPSY CAN BE A CONSEQUENCE OF TBI AT ANY AGE, WE MIGHT THINK ABOUT THIS CHEAP BEDSIDE TEST AS BEING ANOTHER OPPORTUNITY FOR BIOMARKER PERHAPS COMBINED WITH MORE SOPHISTICATED NEUROIMAGING TEST. SO THE OTHER THING ON NEUROSCIENTIST NEUROLOGIST MYSELF, YOU WERE TALKING NON-NEURONAL ELEMENTS. WE THINK OF BRAIN NEURONS AND AXONS AN SHARING ALL THAT. SPECIFICALLY THE ROLE OF INFLAMMATION IN THIS ORDER, COGNITIVE AND OTHER BRAIN DISEASES. WHAT THE EFFECT OF THAT IS AT DIFFERENT TIMING OF DEVELOPMENT ON THE BRAIN STRUCTURE AN FUNCTION. SO THERE'S OPPORTUNITY THERE FOR BIOMARKERS BECAUSE SYSTEMIC THERE CAN BE DETECTED SYSTEMICALLY AS WELL AS IMAGING OF COURSE. SO IT'S INCREDIBLY EXCITING FIELD AND I JUST SO SUPPORT NICHD PLAYING A ROLE TO A SIGNIFICANT DEGREE. >> JUST A QUICK COMMENT ON THAT. ONE THING WE HAVE TO REMEMBER WHEN DOING THESE STUDIES ON SO MANY PEOPLE IS COST AND FLEXTY OF DOING THE STUDIES AND ALSO THE PRACTICAL NATURE OF DOING THEM. THERE ARE SO MANY TESTS, AND I AGREE, THERE COULD BE VALUE IN ALL AND WE DONE KNOW WHICH ARE BEST. ONE THING WE HAVE SEEN JUST IN OUR FIVE YEARS ON THE FIELD IS PARTICIPANTS CRITIQUE. ONLY SO MANY WAYS TO POKE AND PROD AND TWIST THE KID AND GET THEM TO COME BACK FOR A THIRD SCAN. AFTER YOU OFFER THEM DONUT AND COOKIES AND $100, ALL THEG THINGS IT GETS -- WE HAVE TO BE COGNIZANT OF THAT IN THIS WORK. THE OTHER PART OF THAT (OFF MIC) >> THAT'S RIGHT. OF THE HEALTHY FOOD OF COURSE. AND NO COFFEE. THE OTHER IMPORTANT ASPECT IS THE NEED FOR NATIONAL LEVEL DATABASES ON THIS TOPIC. I DIDN'T RAISE THAT, I WANT TO MENTION, I KNOW THERE'S THE DATABASE IS COMING ONLINE, THE INTERAGENCY TRAUMATIC INJURY DATABASE. THIS IS A VERY INTERESTING RESOIRS THAT -- RESOURCE COMING ONLINE AND WE HAVE TO UNDERSTAND HOW THAT CAN INTEGRATE WITH THIS TYPE OF WORK AS WELL. >> THIS IS BEING VIDEOCAST, CAN YOU USE THE MIC? >> SINCE YOU MENTIONED DEPARTMENT OF DEFENSE THEY OBVIOUSLY HAVE VESTED INTEREST POSITIVE AND NEGATIVE. CAN YOU FOLK BRIEFLY SAY SOMETHING ABOUT -- THEY HAVE TREMENDOUS RESEARCH RESOURCES SO CAN YOU TALK ABOUT YOUR COORDINATION WITH THEIR EFFORTS AND WHAT THEIR INTERESTS SEEM TO BE. >> DEPARTMENT OF DEFENSE INVESTED HEAVILY ON THIS TOPIC OVER THE LAST SEVERAL YEARS. AND I HAVE JOINED THE DEPARTMENT OF DEFENSE WITHIN THE LAST YEAR SO IT'S BEEN A RAPID LEARNING CURVE FOR ME. BUT THEY HAVE TARGETED RESEARCH RELATED TO IMAGING PORTFOLIO, BIOMARKER PORTFOLIO, INTERESTING STUDIES LOOKING AT EEG COHERENCE AND THE CORRELATION OF THAT WITH IMAGING. SO DR. JANSON'S COMMENTS WERE VERY COGENT OF THAT. I WOULD SAY WE CAN DO A BETTER JOB. THERE HAVE BEEN -- I HAVE BEEN IN A -- TAKING IN 11 MONTH POST GRADUATE COURSE IN FEDERAL BUREAUCRACY. MY JOB IS SOMEWHAT INTERESTING THOUGH I'M A DOD EMPLOYEE, I ALSO HAVE CREDENTIALS AND APPOINTMENT AT NINDS BUT THAT IS A PATHWAY THAT'S NOT REALLY BEEN THAT COMMON BEFORE. I THINK WE DO NEED TO DO A MUCH, MUCH BETTER JOB, THERE IS A LOT OF SILOING WITHIN THE FEDERAL GOVERNMENT EVEN BOTH SIDES OF ROCKVILLE PIKE. THAT'S A BARRIER WHICH I THINK EVERYBODY AT THE UPPER LEVELS OF BOTH AGENCIES RECOGNIZE BUT WHEN BOOTS HIT THE GROUND THERE'S SOME IMPROVEMENTS THAT NEED TO BE MADE. >> I CAN AMPLIFY THAT A LITTLE BIT. WE HAVE BEEN WORKING TOGETHER WITH A VARIETY OF FEDERAL AGENCIES INCLUDING DOD FOR SOME YEARS NOW. AND COMMUNICATION HAS IMPROVED CONSIDERABLY WHEN WHEN WE FIRST START AND TRIED TO GET INFORMATION ON WHAT WAS HAPPENING IN DOD THEY SAID THAT INDEED THEY WOULD TELL US BUT THEN THEY WOULD HAVE TO SHOOT US. NOW WE ACTUALLY HAVE BEEN WORKING TOWARDS A COMMON DATABASE, SPEARHEADED BY NINDS. IT DOES LOOK LIKE WE WILL BE ABLE TO SHARE INFORMATION ABOUT PATIENTS IN DIFFERENT CLINICAL STUDIES AND WE HOPE TO ACTUALLY PORT THE DATA FROM NICHD COBRA TRIAL DONE THROUGH OUR TBI NETWORK INTO FITBER AS SOON AS THAT DATA SYSTEM BECOMES OPERATIONAL, IT WILL BE -- WE HOPE A FIRST TRIAL FOR BEING ABLE TO MOVE DATA ACROSS DIFFERENT STUDIES. LET ME ALSO SAY, I THINK THAT WE STILL HAVE AN AWFULF5% LOT TO UNDERSTAND ABOUT THE MECHANISMS OF THESE DIFFERENT INJURIES, IT'S NOT AT ALL CLEAR I THINK YET THAT THE KIND OF INJURIES THAT ARE SUFFERED IN BLAST ARE THE SAME AS SUFFERED IN TRAUMA. THERE'S SIMILARITIES BUT THERE MAYBE DIFFERENCES WE DONE YET APPRECIATE AT THE FINE LEVEL THAT END UP WITH VERY DIFFERENT BEHAVIORAL AND COGNITIVE OUTCOMES AND THIS NEEDS MORE STUDY. >> I HAD ONE QUICK QUESTION, AS A CLINICAL GENETICIST APPEARS THERE ARE OUTLIERS IN THIS ARENA WITH SOME WHO HAD REPEATED INJURIES AND STILL SEEM SOMEWHAT PROTECTED AND SOME SINGLE INJURY REALLY TAKE A BAD HIT. ARE THERE SUSCEPTIBILITY GENES PROTECTIVE GENES OR IS THAT ASPECT LOOKED AT IN THESE EVALUATION? >> WE'RE BEGINNING, APOE-4 IS A BAD GENE TO HAVE IF YOU HAVE A SEVERE BRAIN INJURY. WE KNOW THAT THAT WILL DELETERIOUSLY AFFECT YOUR OUTCOME. AND PROBABLY METHYL TRANSFERASE POLYMORPHISMS ARE ALSO IMPORTANT. BUT WHAT POLYMORPHISMS ARE IMPORTANT FOR TAU ENACCEPT LOVETHY, I DON'T THINK WE HAVE ANY IDEA. WHETHER THERE IS ANY GENETIC SUSCEPTIBILITYIBILITY. PROBABLY THERE IS BUT I DON'T EVEN KNOW IF WE HAVE GOOD CANDIDATE GENES FOR THAT. RAMONE, DO YOU KNOW? (OFF MIC) >> WE COULD GO ON QUITE A WHILE WHICH IS NOT SURPRISING. REALLY VERY MUCH THANK BETH RAMONE, MIC AND PARTICULARLY RICK FOR LEADING THIS DISCUSSION FOR PUTTING THIS ON THE TABLE. ONE REASON FOR US DOING THIS WAS TO JUST GET EVERYONE AROUND THE TABLE, THINKING ABOUT IT AND IT'S INTERESTING IF YOU THINK ABOUT COUNCIL HOW MANY DIFFERENCE PERSPECTIVES AND DIFFERENT EXPERTISE WE HAVE THAT DO COME TO BEAR ON THIS QUESTION. PART WAS TO GET INFORMAL GAUGE OF COUNCIL ENTHUSIASM FOR NICHD BEING ACTIVELY ENGAGED IN THIS AREA AND I TAKE IT BOTH IN THE DISCUSSION OF THE HEAD NODDING AND FOCUS, ET CETERA THAT PEOPLE DO THINK THIS IS AN AREA VERY APPROPRIATE FOR US TO BE INVOLVED IN. AND PROBABLY GIVEN THAT IT'S AN INTRODUCTION BECAUSE WE SUSPECT WE'LL COME BACK TO YOU WITH FUTURE DISCUSSIONS ABOUT -- BECAUSE UNFORTUNATELY DUE TO THE COMPLEXITY OF THE ISSUE AND DUE TO AS HAS BEEN REALLY NICELY EMPHASIZED HOW MUCH WE DO NOT KNOW, THIS IS NOT SOMETHING THAT'S QUICKLY FIGURED OUT. SO WE HAVE TO BE IN THIS FOR THE LONG HAUL WORKING VERY CLOSELY WITH NINDS AND OTHER PARTNERS BOTH WITHIN NIH AND BEYOND NIH INCLUDING WE'RE OPTIMISTIC ABOUT POTENTIAL PUBLIC PRIVATE PARTNERSHIPS ON THIS ISSUE,ISH TELL YOU. TO EXPLORE THOSE TOGETHER, ET CETERA, SO WE WILL BE RETURNING TO THIS THEME I'M SURE. THANKS VERY MUCH FOR YOUR INTEREST AN AGAIN OTHER THOUGHTS YOU HAVE AFTER THE MEETING FEEL FREE TO SHARE WITH US ABOUT PARTICULAR OPPORTUNITIES YOU SEE, ET CETERA. WE ARE GOING TO TAKE A BREAK. I WOULD ASK COUNCIL MEMBERS BEFORE YOU RUSH OUT FOR THAT COFFEE THAT WE ARE GAPPING FOR THE ANNUAL COUNCIL PHOTOGRAPHS, FOR THOSE OF US TO SEE HOW MUCH OLDER WE LOOK EACH YEAR SO THAT PLEASE REMAIN FOR THOSE PHOTOGRAPHS. THE REST OF YOU CAN CAN GET COFFEE FIRST IF YOU WOULD LIKE. WE WILL REALIZE IT'S A LITTLE FARTHER TO GO TO GET COFFEE ON BREAKS THE A WING FIRST FLOOR SORK TAKE THE ELEVATOR DOWN AND WE WILL START PROMPTLY AGAIN AT 10:30. THAT WILL ALLOW EVERYONE TIME FOR A GOOD BREAK. SO COUNCIL MEMBER, PLEASE STAY FOR PHOTOS THE REST ARE EXCUSED UNTIL 10:30. WE'LL EXCUSE COUNCIL SHORTLY. >> COUNCIL MEMBERS, THERE WILL BE TWO PHOTO, ONE OF FULL COUNCIL AND ONE FOR NEW MEMBERS. >> YOU LOOK RELATIVELY WELL FED AND CAFFEINATED. OUR NEXT AGENDA ITEM IN SOME WAYS IS NOT UNNATURAL SORT OF CONTINUATION OF WHAT WE HAVE BEEN TALKING ABOUT WHICH IS IT'S NOT ABOUT CONCUSSION SPECIFICALLY BUT IT'S CERTAINLY ABOUT REHABILITATION RESEARCH INCLUDING NEUROLOGIC REHABILITATION RESEARCH, ET CETERA AT NICHD AND MORE WIDELY AT NIH, TRY TO INTRODUCE WITHOUT STEALING TOO MUCH THUNDER OF THE PRESENTERS, EXCUSE ME IF I STEAL YOUR THUNDER WE CALL REP TETION FOR EFFECT. REPETITION FOR EFFECT. AS MANY OF YOU KNOW, NCMRR T NATIONAL CENTER FOR MEDICAL REHABILITATION RESEARCH IS PART OF THE LIFE OF NICHD SINCE FOUNDING EVENT CMRR OVER 20 YEARS AGO NOW. AND IT HAS A SEMI SORT OF AUTONOMOUS REORGANIZATION DISCUSSIONS SORT OF THE ROLE WITHIN NICHD, IT'S CLEARLY INTEGRAL TO WHAT WE ARE. INTEGRATED TO ALL THE WORK OF THE INSTITUTE, YET PARTLY BECAUSE OF CONGRESSIONAL LANGUAGE HAS A KIND OF SEMIAUTONOMOUS ROLE AND IT HAS ITS OWN ADVISORY BOARD. BUT STILL AS PART OF THE INSTITUTE WE HAD MANY YEARS LIAISON FROM THE ADVISORY BOARD NCRR TO COUNCIL BECAUSE WE WANT THEM TO BE INVOLVED IN ACTIVITIES OF NCMRR, ET CETERA. BUT THERE'S BEEN PART OF NCMRR BEING AROUND 20 YEARS AND PARTLY BECAUSE OF CONCERNS AMONK THE REHABILITATION COMMUNITY NOT JUST NCMRR BUT THE NIH APPROACHING THE QUESTION OF REHABILITATION RESEARCH. ASKING MYSELF, DR. COLLINS, OTHERS OPTIMALLY ORGANIZED TO REALLY CARRY OUT THE REHABILITATION RESEARCH OF THE PRESENT DAY. OR ARE THERE MIGHT BE WAYS WE CAN BE EVEN MORE EFFECTIVE THAN WE HAVE BEEN. WE THOUGHT THESE GOOD QUESTIONS. SO AFTER LOTS OF DISCUSSIONS WITH LOTS OF FOLK IN THE REHAB COMMUNITY WE THOUGHT IT MADE SENSE TO APPOINT A BLUE RIBBON PANEL TO LOOK SPECIFICALLY AT NCMRR BUT ALSO MORE BROADLY, REHABILITATION RESEARCH ACROSS NIH BECAUSE AS YOU PROBABLY KNOW, THE CONCUSSION DISCUSSION UNDERSCORED, IT IS NOT -- WE DO NOT WORK ON IN ISOLATION ON THIS TOPIC. THAT IS A REAL STRENGTH OF REHAB RESEARCH ACROSS NIH IS THERE'S SO MANY PARTIES INTERESTED. AT THE SAME TIME YOU CAN'T OBVIOUSLY CREATE CHALLENGE ORGANIZATIONALLY. AND FUNCTIONALLY TO MAKE SURE IT'S WELL COORDINATE SOD WE EMPOWERED A GROUP TO LOOK SPECIFICALLY AT NCMRR BUT MORE BROAD RESEARCH AND TO REPORT BACK TO ME WHAT THEY FOUND. I WILL SHARE THAT REPORT WITH DR. COLLINS, AND OTHER INTEREST INSTITUTES AS WELL. SO THAT WE CAN USE THAT TO INFORM OUR THINKING AS WE MOVE FORWARD. WE THOUGHT IT WOULD BE HELPFUL TO HAVE THAT PRELIMINARY VERSION OF THAT REPORT PRESENTED TO COUNCIL.S!s SO YOU WOULD BE AWARE OF IT, SO WE CAN HEAR YOUR DISCUSSION ABOUT IT. THE BLUE RIBBON PANEL WAS LED BY TWO MEMBERS OF COUNCIL, ONE LIAISON MEMBER, THE OTHER A REGULAR MEMBER OF COUNCIL. BECKY CRAIG, I DON'T KNOW ARE YOU PRESENTING ALONE OR JOHN GOING TO PRESENT IT OR HOT SEAT THERE? BECKY WILL PRESENT TO JOHN WITH HER CO-CONSPIRATOR IN THIS AN DESERVES EQUAL CREDIT AND/OR BLAME DEPENDING HOW YOU FEEL ABOUT WHAT THEY CAME UP WITH. WANT TO THANK THEM AND OTHER MEMBERS OF THIS GROUP AS WELL THAT DID HEAVY LIFTING ON THIS. IT'S BEEN MUCH APPRECIATED RICK GREENWALD COUNCIL MEMBER ALSO IS INVOLVED WITH THIS, SO THAT I REALLY DO WANT TO THANK PEOPLE, EVEN THOUGH I'M SURE I HAVEN'T HEARD PRELIMINARY VERSIONS I HAVE WILL CERTAINLY AGREE WITH EVERYTHING THEY'RE GOING TO SAY THAT'S GREAT. IF THEY OANT TOLD US WHAT WE THOUGHT AND KNEW WHAT'S THE PURPOSE OF DOING THIS. SHAREIOUS THOUGHTS HOW THINGS MIGHT BE CHANGED, SERIOUSLY AND WITH VARIOUS DISCUSSIONS ABOUT THIS SO WE'RE THANKING YOU AND OTHERS FOR THE HEAVY LIFTING INVOLVED. TELL US WHAT YOU FOUND, B BECKY. >> I WILL. THANK YOU VERY MUCH. AS ALAN MENTIONED JOHN AND I WERE CO-CHAIRS WERE A TEAM THAT INVOLVED 11 OTHER PANEL MEMBERS BUT THAT'S NOT ALL. WE WERE REMARKABLY FORT IN THE TO HAVE NICHD STAFF HELP US, ASSIST US, THESE ARE SOME OF THE MANY PEOPLE THAT HELPED US. WITHOUT LISA KEISER NOT SURE WE UNDERSTOOD THE LEGISLATION AS MUCH AS WE HOPE WE DO NOW. AND ALSO HER INFORMATION RELATED TO ORGANIZING BODYINGS IS REALLY VERY IMPORTANT TO US. WITHOUT THEM WE WOULDN'T HAVE DONE ANYTHING. IT WAS ABSOLUTELY AN INCREDIBLE EFFORT THEY PUT FORWARD, WHATEVER WE ASK FOR WRP ABLE TO RECEIVE. THAT INCLUDES MEETING WITH MEMBERS LEADERSHIP WITHIN ICs, THE COORDINATING BODY, HAVING INCREDIBLY WELL ORGANIZED MEETINGS. SO THANK YOU, ELLEN FOR SHARING YOUR STAFF SO OPENLY WITH US. IT WAS VERY EMFUL. AS ALAN SAID, LOOK AT REHABILITATION RESEARCH ACROSS THE NIH AND HE GAVE SPECIFIC QUESTIONS THAT WE'LL ADDRESS IN THIS PRESENTATION. SO HOW DO WE DEFINE REHABILITATION RESEARCH AND WHAT IS THE SCOPE WITHIN THE NIH? IS NCMRR DOING WHAT IT IS SUPPOSED TO BE DOING AND WE'LL TALK CRITERIA WITH THAT. CAN VERY SHOULD THERE BE COORDINATION OF REHAB RESEARCH WITHIN THE NIH? WHAT ARE SCIENTIFIC ?UNTS AND WHAT ARE BARRIERS THAT ARE PREVENTING THE SCIENCE FROM MOVING FORWARD? I WILL SPEND TIME ON THIS SLIDE LOOKING WHAT WE COME UP WITH DEFINITION, WE ARE SO VERY DIFFERENT IN OUR AREAS OF SPECIAL SAILINGS AND -- SPECIALIZATION AND NEED TO MAKE SHORE YOU UNDERSTAND THE BASIS OR INFRASTRUCTURE FOR THIS PRESENTATION. SO I'M TOKING TO READ IT AND I APOLOGIZE. THIS IS THE ONLY ONE I'LL READ. BUT WE DEFINE REHABILITATION RESEARCH AS STUDY OF MECHANISMS AN INTERVENTIONS THAT PREVENT, IMPROVE, RESTORE OR REPLACE LOST, UNDERDEVELOPED OR DETERIORATING FUNCTION SO APPRECIATE HOW BROAD THAT IS. THERE'S NOT A MEDICAL DIAGNOSIS IN THERE. I THINK THE PRESENTATION RICK GAVE WITH TRAUMATIC BRAIN INJURY LETS OW APPRECIATE THE EXTENT OF PREVENTION AS WELL AS IMPROVEMENT RESTLATION, ET CETERA. THE OTHER THING I WANT TO DO IS SPEND TIME ON THE DEFINITION OF FUNCTION. WHEN WE LOOKED AT DISABILITY RESULTING FROM INJURY OR ONE OTHER POSSIBILITY WE LOOKED EWING THE WORLD HEALTH ORGANIZATION INTERNATIONAL CLASS PICATION OF FUNCTIONING, DISABILITY AND HEALTH WHICH WE'LL CALL FROM NOW ON THE ICF. IN LOOKING AT FUNCTION, IT DEE FINED NOT ONLY AT LEVEL OF IMPAIRMENT BUT ALSO LEVEL OF ACTIVITY AND PARTICIPATION. I'LL TRY AN EXAMPLE, IT WILL PROBABLY FAIL BUT WILL TRY. WE TAKE 35-YEAR-OLD MALE WHO IS WELL EDUCATED, AND HAS ACCESS TO HEALTH INSURANCE, AND IS IN AN AUTOMOBILE ACCIDENT AND SUSTAINS A SPINAL CORD INJURY. AT THE LEVEL OF IMPAIRMENT WELCOME LOOK AT, LET'S MAKE IT A TOTAL SPINAL CORD INJURY SO THERE'S NOT AN OPPORTUNITY TO RECONNECT AT THIS POINT AT LEAST. SO IF WE LOOK AT LEVEL OF IMPAIRMENT TOTAL LOSS TO SENSATION, VOLUNTARILY MOVEMENT BELOW LEVEL OF INJURY, AS TIME PROGRESS THERE MAYBE PLASTICITY SO THAT'S IMPAIRMENT. AT THE LEVEL OF ACTIVITY WITH HIS -- THE CAPACITY HE WOULD HAVE WOULD BE IB ABILITY TO WALK ACROSS THE ROOM. AND CERTAINLY IF THAT'S ALL WE LEAVE HIM WITH HE'S NOT ABLE TO PARTICIPATE IN SOCIETY AS ALL. BECAUSE OF ACCESS TO HEALTHCARE AN SUPPORT OF FAMILY AND BECAUSE HE'S EMPLOYED AT UNIVERSITY, HE HAS THE OPPORTUNITY TO GO BEYOND HIS CAPACITY WITH HIS ACTIVITY LEVEL AND ACCESS TO CURRENT HEALTHCARE TO BE GIVEN A POWER CHAIR THAT ALLOWS HIM NOT ONLY TO MOVE I CROSS THE ROOM IN HEARSAY APARTMENT BUT TO TWO -- BUT TO GO TO WORK IN HIS VAN AND RESUME PARTS NATION LIFE. -- PARTICIPATION IN LIFE. WE'RE NOT ONLY LOOKING A IMPAIRMENT LEVEL WE DO SO OFTEN AT NIH BUT ALSO AT THE ACTIVITY AND ACTIVITY AND PARTICIPATION LEVEL. TAKE SAME MAN WITH POOR INSURANCE NO FAMILY AND UNDEREDGE WAITED. THAT PERSON MAY NOT GET OUT OF THEIR APARTMENT AFTER DISCHARGED FROM WHATEVER HEALTHCARE THEY RECEIVE AND MAY NOT BE ABLE TO PARTICIPATE IN SOCIETY. SO OTHER THINGS WE LOOK AT ARE PERM ENVIRONMENTAL FACTORS THAT CAN INFLUENCE THE OUTCOME OF A DISABILITY. I HOPE THAT HELPS WITH THE PRESENTATION. SO THAT'S OUR DEFINITION OF RESEARCH, REHABILITATION RESEARCH. IF WE LOOK AT SCOPE OF REHABILITATION RESEARCH ACROSS THE NIH, AND YOU LOOK AT THE DOTTED LINE ACROSS THE TOP HERE, HERE AND HERE. WHAT WE LOOK AT IS THE OFFICIAL DEFINITION OF REHAB WITHIN THE NIH. SO IN 2008 NIH ADOPTED THE RESEARCH CONDITIONS, DISEASE CATEGORY SYSTEM, SO REHABILITATION IS DEFINED USING 380 TERMS. USING THOSE TERMS THE AMOUNTS OF FUNDING ACROSS THE NIH, I'M GOING TO SAY APPROXIMATELY $500 MILLION. STAFF AT NCMRR LOOKED AT THE TERMS BECAUSE REHABILITATION INCLUDES ALCOHOL AND DRUG REHAB, DENTAL IMPLANTS, CARDIOVASCULAR VALVE, SO ABOUT 80 OF THE P TERMS WERE REMOVED FROM THAT DEFINITION SO THEY COME UP WITH A MORE SPECIFIC MEDICAL REHAB DEFINITION USING THE SEARCH TERMS. WHAT WE END UP WITH IS A FLAT -- ABOUT A FLAT ABOUT $330 MILLION DEDICATED TO REHAB RESEARCH ACROSS THE NIH. THE INTERESTING THING FOR THE PANEL MEMBERS WHEN WE TALK ABOUT NCMRR AS THE EPICENTER FOR REHABILITATION RESEARCH IS THAT NCMRR WITHIN NICHD IS NOT THE INSTITUTE THAT HAS THE MOST MONEY DEDICATED TO REHABILITATION RESEARCH. IN FACT, NEUROLOGIC DISEASE AND STROKE AND DEAFNESS COMMUNICATION DISORDERS INSTITUTES HAVE SUBSTANTIALLY MORE MONEY. IF WE LOOK AT THE AMOUNTS OF MONEY THAT NCMR HAS DEDICATED FOR REHABILITATION RESEARCH, IT HAS 20% OF THE TOTAL AMOUNT OF MONEY ACROSS THE NIH. SO THAT WAS SURPRISING TO PANEL MEMBERS. NOW WE LOOKED AT THE SCOPE AND WE HAVE A DEFINITION. THE OTHER THING WE WERE ASKED TO DO WAS TO ADDRESS THE QUESTION WHETHER OR NOT NCMRR IS DOING WHAT IT'S SUPPOSED TO BE DOING. FOR THOSE WHO DON'T KNOW ALAN IMPLIED THERE'S A PUBLIC LAW THAT MANDATES EXISTENCE OF NCMRR, IT WAS PASSED IN 1990. WE USED THE CRITERIA WITHIN THAT LAW TO SEE WHETHER OR NOT NCMRR IS DOING WHAT IT'S SUPPOSED TO DO. ONE THING IT'S SUPPOSED TO DO IS DEVELOP A COMPREHENSIVE RESEARCH PLAN, A RESEARCH PLAN WAS WRITTEN IN 1993. THE PLAN LOOKS AS PRIORITIES WITHIN RESEARCH AND SUPPOSED TO LOOK AT COORDINATION OF RESEARCH, NOT ONLY WITHIN NIH BUT ALSO FEDERAL AGENCIES. COMPREHENSIVE PLAN WAS DEVELOPED IS THE PLAN PERIODICALLY REVISED AND UPDATED? WE FOUND NO OFFICIAL PERIODIC UPDATES OF THAT PLAN SO THE ANSWER TO THAT QUESTION IS NO. THE LAW ALSO SUGGESTED THERE SHOULD BE A REHABILITATION COORDINATING COMMITTEE DEVELOPED. AGAIN, FOR THE PURPOSE OF COORDINATING, COLLABORATING ACROSS INSTITUTES AND ALSO WITH OTHER FEDERAL AGENCIES. RECOGNIZE THAT 80% OF THE REHABILITATION RESEARCH IS FUNDED OUTSIDE OF NCMRR. SO THERE'S DEFINITELY A NEED FOR SOME SORT OF COORDINATION. THERE IS A COORDINATION COMMITTEE THAT EXISTS WITHIN NCMR. BUT IT MEETS INCONSISTENTLY, THERE'S NO ACTIONABLE RECOMMENDATIONS AND NO RESOURCES ALLOCATED TO THE COORDINATION EFFORT. THAT THE COMMITTEE TRIES TO PUT FORWARD. THERE'S NO QUESTION THAT NCMR STAFF COLLABORATE VERY WELL WITH BOTH NINDS AND THE NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING. BUT RARELY WITH OTHER ICs. SO WE SAY YES THERE IS A COORDINATING COMMITTEE AND THERE'S SOME ACTIVITY BUT THERE ARE SOME LIMITATIONS TO THE COORDINATING EFFORT. THIS WAS ANOTHER INCREDIBLE OPPORTUNITY FOR MEMBERS OF THE RESEARCH PANEL TO UNDERSTAND WHAT COORDINATING WE DON'T UNDERSTAND ALL BUT BE INTRODUCE ED COORDINATING BODIES. ON THE BOTTOM IS NATIONAL CENTER FOR MEDICAL REHABILITATION. IF WE LOOK AT TOTAL STAFF, WE SEE SEVEN AND THE BUDGET ALLOCATION IS ZERO. THEN WE'LL TAKE OUR GOLD STANDARD WHICH IS THE OFFICE OF AIDS RESEARCH WHICH HAS LESS THAN 50 STAFF. $3 BILLION OR 10% OF NIH BUDGET WHICH THEY GIVE -- WHICH IS GIVEN TO OTHER ICs TO CONDUCT AIDS RESEARCH BUT THEY'RE PRESERVED ABOUT $63 MILLION FOR THEIR COORDINATING EFFORT. PLEASE LOOK AT THE COORDINATING BODIES AND THEIR OPPORTUNITIES. THE OTHER MANDATE BY THE LAW WAS THAT THERE IS A NATIONAL ADVISORY BOARD ON RESEARCH AND THAT BOARD HELPS DEVELOP THE INITIAL RESEARCH PLAN. AS DR. GUTTMACHER SAID, JOHN IS THE MOST IMMEDIATE PAST CHAIR OF THAT AD VIEWZRY BOARD AND I WAS ALSO CHAIR OF THAT ADVISORY BOARD. I THINK THE QUESTION IS WHAT IS OUR ROLE? SO YES THERE IS AN ADVISORY BOARD BUT A ROLE IN THE IMPACT OF THAT ADVISORY BOARD ON CHANGE ORGANIZE EFFECTING CHANGE WITHIN NCRR IS UNCLEAR. THE OTHER THING DESCRIBED IN THE LEGISLATION IS THAT REHABILITATION IS ASSOCIATED WITH INDIVIDUALS WHO HAVE PHYSICAL DISABILITIES RESULTING FROM DISEASE DISORDERS OR INJURY THAT ARE NEUROLOGIC MUSCULO SKELETAL, CARDIOVASCULAR, PULMONARY AND I WANT TO EMPHASIZE THE NUMBER OF TYPES OF MEDICAL DIAGNOSES INCLUDED IN THIS CONCEPT OF REHABILITATION. WHEN WE LOOK AT THE NCMR PORTFOLIO THE FILLED IN IS NUMBER OF AWARDS GIVEN AND CLEAR IS NUMBER OF AWARDS SUBMITTED. LOOK AT THE DIFFERENT CATEGORIES LESS THAN 20% RESEARCH THAT IS OR TRAINING THAT IS FUNDED ASSOCIATED WITH NCMR IS NON-NEUROLOGIC SO MOST RESEARCH FUNDED ARE ASSOCIATED WITH NEUROLOGIC CONDITIONS. WE'RE NOT CLAINING ABOUT THAT. THAT'S FANTASTIC RESEARCH BUT WE ALSO THINK REHABILITATION IS BROADER THAN JUST THE NEUROLOGICAL CONDITIONS. UNLESS U THINK THAT OTHER MIGHT HAVE SOME OTHER MUSCULOSKELETAL OR CARDIO PULMONARY SYSTEMS INCLUDED, OTHER INCLUDES MULTIPLE SCLEROSIS, PARKINSON DISEASE, PARALYSIS, ET CETERA. SO AGAIN, ADDITIONAL NEUROLOGIC CONDITIONS. SO WHEN WE LOOK AT NCMR PERFORMANCE ACCORDING TO LAW AND WHAT IS REQUIRED WED SAY THE PORTFOLIOS ARE VERY HEAVILY FOCUSED ON NEUROLOGIC DISEASES. HOW IS THE NCMR PERFORMENING RELATIONSHIP TO OTHER CENTERS WITHIN THE NICHD? EASY THING TO DO SLK AT MONEY THAT, MAY NOT BE THE MOST APPROPRIATE BUT IT'S WHAT WE'RE GOING TO DO. IF I LOOK AT THE CENTER AS AN EXAMPLE, THE CENTER FOR RESEARCH FOR MOTHERS AND CHILDREN THE BLUE NUMBERS ACROSS TOP REPRESENT ABSOLUTE INCREASE OR DECREASE OVER TIME SO FROM LOW TO HIGHEST. THE RED NUMBERS ARE AVERAGE CHANGE PER YEAR SO YOU SEE AN ABSOLUTE CHANGE FROM 7 TO 2011 WAS AVERAGE INCREASE OF 4.1% PR YEAR. WE LOOK AT NCMRR, THE ABSOLUTE DIFFERENCE, 17% INCREASE IS 13% DECREASE OVER THE FIVE YEAR PERIOD. DECREASE FROM BEGINNING TO CURRENTLY OF 7% AND AN AVERAGE DECREASE ROUNDING UP SAY AVERAGE DECREASE OF 2% PER YEAR. IF WE LOOK OVERALL AT NICHD WE SEE AGAIN AN ABSOLUTE INCREASE OF ABOUT 5 1/2% AND INCREASE OF 1.4% PER YEAR. I HOPE THIS MAKES SENSE. LOOK AT THE FUNDING OPPORTUNITY ANNOUNCEMENTS, TOTAL NUMBER OF PROPOSALS WE WERE IMPRESSED WITH TOTAL NUMBER OF PROPOSALS THAT WERE SUBMITTED BY NCMRR. AGAIN, ESPECIALLY WITH REGARD TO THE NUMBER OF STAFF ASSOCIATED WITH NCMRR. BUT THE TOTAL PUBLISHED AND SUCCESS RATE IS NOT AS IMPRESSIVE. SO, WHEN WE COMPARE NCMRR TO OTHER CENTERS WITHIN NICHD WHAT WE SEE IS A DECLINING BUDGET, FEWER PROPOSALS, DECLINING NUMBER PUBLISHED FUNDING OPPORTUNITY ANNOUNCEMENTS AN FEWER STAFF. OTHER COMPONENTS OF THE LAW WE EXAMINED, I'M GOING TO BE QUICK WITH THE SLIDE TO SAY YES, NCMR PROVIDES CLINICAL TRIALS. DOWN TO OTHER ESs, IT SUPPORTS MULTI-DISCIPLINARY RESEARCH CONDUCTED OR SUPPORTED BY MORE THAN ONE AGENCY, PARTICULARLY WITHIN NINDS AND NIBIB. IT HAS ESTABLISHED A PEER GROUP AND HAS SUPPORT FOR RESEARCH AND TRAINING CENTERS. THERE IS NOT FUNDING WE COULD SEE RELATED TO MODEL SYSTEMS OF MEDICAL REHABILITATION NOR IS THERE THIS COORDINATION EFFORT WITHIN NIH OR ACROSS FEDERAL GOVERNMENT AGENCIES THAT IS REMARKABLY IMPRESSIVE. IN LOOKING AT NCMRR'S PERFORMANCE USING LAW AS CRITERIA, WITH ONE EXCEPTION, TO RESEARCH PLAN THE NCMR MEETS MINIMUM LETTER OF THE LAW CRITERIA. AND HAVE TO TAKE THIS OPPORTUNITY BECAUSE THE PANEL REALLY WANTS TO EMPHASIZE TA WITH THE LIMITED NUMBER OF STAFF AND THE RESOURCES ALLOCATED NCMR SHOULD BE COMMENDED FOR WHAT IT HAS ACCOMPLISHED TO DATE. PLEASE HEAR THAT MESSAGE. SO OUR CONCLUSION IS NCMR IS FUNCTION BUG NOT THRIVING AND NICHD WE WOULD GIVE A DIAGNOSIS OF FAILURE THE THRIVE. THAT'S JOHN. THANK YOU JOHN FOR THAT. SO WE&G OPPORTUNITIES THAT ARE OUT THERE. I THINK RICK GREENWALD'S PRESENTATION RELATED TO CONCUSSION IS AN INCREDIBLE EXAMPLE OF INCREDIBLE OPPORTUNITIES AVAILABLE IN AREA OF REHABILITATION RESEARCH. SO ON TO ALAN'S ADDITIONAL QUESTIONS, CAN THERE BE COORDINATION OF REHABILITATION WITHIN THE NIH? ANSWER IS YES. CAN THERE BE? OF COURSE WE CAN SAY YES. THERE'S CERTAINLY HOUR EXPERIENCE IS TO UNDERSTAND THE INCREDIBLE SUCCESS OF COORDINATION ACTIVITIES THAT ARE OCCURRING ACROSS THE NIH PARTICULARLY IN THE PAST TEN YEARS. THE BARRIERS AS MENTIONED EARLIER THIS MORNING THE SILOS, THE IC SILO MENTALITY AND THE NEED TO EXPRESS INDIVIDUALISM AND SHOW WHAT A PARTICULAR IC IS ABLE TO ACCOMPLISH WITHOUT COLLABORATING AND THERE'S REALLY NOT AN APPARENT AWARD -- REWARD OF ANY SORT FOR COLLABORATING. AND BOTTOM LINE, FUNDING ALLOCATIONS DETERMINES BEHAVIOR. WHEN WE TALK FACILITATOR OR OPPORTUNITIES, WE HAVE AN INCREDIBLE GROUP OF PUBLIC ADVOCATES, WE DO HAVE CONGRESSIONAL INFLUENCE. NIH ASKED FOR BLUE RIBBON PANEL TO BE PRODUCED. SO THERE IS A HIGH LEVEL OF BUY-IN TO THE REHABILITATION RESEARCH OPPORTUNITY. IN SPEAKING WITH THE LEADERSHIP OF THE COORDINATING BODIES THEY HAVE EM FA IZ SOD IF WE'RE INTERESTED IN BUILDING BRING ACE CROSS ICs, INTERESTED IN COORDINATING WITH OTHERS, WE HAVE TO PI ATEXT TO THE NEED TO NEGOTIATE, BUILD BRIDGES THE NEED FOR DIPLOMACY AND SOCIAL INTERACTION. WE CAN'T SIT HERE AND SAY WE'RE DOING GREAT RESEARCH, COME PLAY WAS. IT WON'T HAPPEN. WE RECOGNIZE DOLLARS ENCOURAGE COORDINATION TOPPING OFF OR FOR CO-FUNNING. SHOULD THERE BE COORDINATION? I THINK AGAIN, THE ANSWER IS YES. 80% OF REHABILITATION RESEARCH OCCURS OUTSIDE OF NCMRR. THAT IS A PROBLEM. THERE'S HIGH LEVEL REDUNDANCY, MANY SAID REDUNDANCY IS GOOD. WE'RE NOT DISAGREEING WITH THAT BUT LET'S TAKE EXERCISE AS AN EXAMPLE. WE ASKED SEVERAL ICs TO PRESENT THE RESEARCH PORTFOLIOS. ONE SCENE THAT EMERGED FROM EACH WAS SOME INTERVENTION TRIAL ASSOCIATE WITH THE EXERCISE. IF EACH OF THOSE INDIVIDUAL INSTITUTES TAKES ON THIS INTEREST IN EXERCISE THEY MAY BE STARTING FROM SCRATCH, RATHER THAN SAYING WE'RE GOING TO LOOK AT THERAPY EXERCISE, WE'RE GOING TO LOOK AT THIS AND INTERVENTION WHAT IS THE DOSE, WHAT IS THE BEST METHODOLOGY THAT SHOULD BE USED, OR SHOULD THE EXERCISES BE TAILORED FOR DEES FRESK CONDITIONS? IS IF THERE WERE COORDINATION OF EXERCISE INTERVENTIONS SUPPORTED BY EACH CENTER WE MAYBE ABLE TO MOVE FURTHER WITH THE FEW DOLLARS AVAILABLE IN NIH. WHILE REDUNDANCY IS USEFUL WE THINK IT COULD BE MORE COST EFFECTIVE AND MOVE RESEARCH AHEAD IF THERE WAS SOME SORT OF COORDINATION. SOME OF THE RESEARCH WAS CONDUCTED OUTSIDE OF ICS FRAMEWORK. I DON'T THINK THE PARTICULAR PROBLEM BUT IT'S JUST TO BE NOTED. MOST RESEARCH THAT OCCURS WITHIN THE OTHER ICs WAS NOT IN COORDINATION WITH NCMRR, IN FACT, SOME DIDN'T KNOW NCMR EXISTED. SO AGAIN, BACK TO OUR GOAL STANDARD. I APOLOGIZE FOR THE SLIDE BUT P I WANT TO REREAD A COUPLE OF LINE, I WANT TO INSERT REHAB RESEARCH SO CHALLENGES POSED BY REHABILITATION RESEARCH, EXCEED THE NOTION OF ANY INSTITUTE. THE DISABILITY IS RESULT OF MULTI-SYSTEM AND MULTI-ORGAN DISEASE, AND INVOLVE MANY SYSTEMS. AFTERS PEOPLE ACROSS THE LIFE SPAN FROM INFANCY TO OLE AGE. SO WE THINK THESE ARE HEROES. UNDERSTAND HAVE A SIMILAR PROBLEM TO WHAT WE-8) OUR PROBLEM IS. WE'RE LOOKING AT THE OPPORTUNITIES T THE PANEL DID NOT -- WAS NOT QUALIFIED TO IDENTIFY SPECIFIC SCIENTIFIC OPPORTUNITIES, ALAN WAS CONDUCTEDDED -- WE LOOK AT GENERAL CATEGORIES SO I WANT TO EMPHASIZE THE TRANSLATIONAL RESEARCH, THE USE OF THE ICS TO LOOK AT DISABILITY, SPECTRUM OF DISEASES AN PREVALENCE OF DISABILITY. SO AGAIN BACK TO THE PORTFOLIO. P IF WE LOOK AT PATHOPHYSIOLOGY AND THE ICS MODEL FOR DISABILITY INCLUDES IMPAIRMENT, ACTIVITY AND PARTICIPATION, A MAJOR -- MOST OF THE PORTFOLIO IS ASSOCIATED WITH PATHOLOGY AND IMPAIRMENT. SO UNMECHANISMS ASSOCIATED WITH THE COOZ AND LOOKING AT EFFECTS OF THAT DISEASE ON IMPAIRMENT, SUCH AS PAIN, WEAKNESS, LACK OF (INDISCERNIBLE) BUT NOT SO MUCH LOOKING AT THE RELATIONSHIP BETWEEN THE DISEASE, THE IMPAIRMENT AND ACTIVITY AND PARTICIPATION. THE BROADER VIEW OF THE EFFECT OF THE DISABILITY. THEIR WORK IN HEALTH SERVICES RESEARCH AND ALSO SECONDARY CONDITIONS. SO WE SEE THIS AS INCREDIBLE OPPORTUNITIES FOR ADDITIONAL RESEARCH THAT COULD BE DONE ACROSS THE NIH. ALSO LOOKING AT MECHANISM VERSUS INTERVENTION TRIALS, THERE'S A TENDENCY TOWARDS MORE MECHANISM THAT'S NOT A SURPRISE LOOKING AT AGAIN DISEASE -- UNDERSTANDING THE BASIS OF DISEASE AND ITS RELATIONSHIP, NOT AS MUCH LOOKING AT INTERVENTION, INCREDIBLE OPPORTUNITY FROM OUR PERSPECTIVE. AND PROBABLY THIS SLIDE LOOKING AT OPPORTUNITIES, WE'RE ALL FAMILIAR WITH TRANSLATIONAL RESEARCH. SO WE CONDUCTED A BASIC SCIENCE GOING UP TO THE LEVEL OF CHANGING POLICY AND AGAIN I THINK THAT RICK GREENWALD'S PRESENTATION HELPS YOU UNDERSTAND WHAT THE LEVELS OF RESEARCH CAN ACCOMPLISH. THEN ON THE Y AXIS WE LOOK AT DISABILITY SO DISEASE IMPAIRMENT ACTIVITY AND PARTICIPATION. WE SEE BLUE MEAN HIESEST AMOUNT OF ACTIVITY IS SO THE HIGHEST AMOUNT OF ACTIVITY RIGHT NOW WITHIN NCMRR IS ASSOCIATED WITH DISEASE AND IMPAIRMENT. LIGHT BLUE INDICATES SOME ACTIVITY AND WHITE INDICATES NO ACTIVITY. SO AGAIN, LOOK AT THE AMOUNT OF OPPORTUNITY THAT'S AVAILABLE TO EXPLORE REHABILITATION RESEARCH. WE ALSO THINK AGAIN, I DON'T WANT ANYBODY TO GO AWAY FROM THE NEUROLOGIC CONDITION BUT WE ALSO SEE THERE'S AN INCREDIBLE OPPORTUNITY TO EXPAND REHABILITATION BEYOND NEUROLOGIC DISEASE TO MUSCULOSKELETAL DISEASES, TO SUCH AS (INAUDIBLE) FOR EXAMPLE AND PERSONS WITH EDUCATION, WE CAN GO ON AND ON AN ON. SO THE POINT IS THEY'RE MANNING OPPORTUNITIES FOR REHABILITATION RESEARCH BEYOND LIFE DISEASES, MAYBE THIS WILL HELP THE MOST. ONE THE INSTITUTE IN 2007 ONE IN EVERY TEN PERSON HAS A DISABILITY. 1 IN 1E7B. AROUND THE WORLD, ONE IN FIVE PERSONS HAS A DISABILITY. THE NIH EXPENDITURE IS 1.2%. THERE'S A BIG GAP BETWEEN THE TWO. FROM OUR PERSPECTIVE WE BELIEVE ALL ASPECTS OF REHAB RESEARCH AT NIH SHOULD INCREASE. BARRIERS. I'M PART OF THE RESEARCH SO I CAN SAY THE RESEARCH COMMUNITY REHABILITATION RESEARCH COMMUNITY HAS BEEN WAY TO SELF-FOCUSED AND WHINED. WE DON'T GET ENOUGH MONEY, WE THINK WE HAVEN'T BEEN TRAINED WELL, THERE ARE LOTS OF THINGS THAT WERE SAID AND OUR TEENAGE YEARS BOTH TRYING TO BECOME SCIENTISTS. AND WE DECIDED THAT TIME TO STOP BEING SO FOCUSED AND START TO THINK ABOUT THE PERSONS THAT WE SERVE, THE CONSUMERS OF OUR RESEARCH. SO THAT BARRIER IS A BARRIER. LACK OF UNDERSTANDING ABOUT REHABILITATION WITHIN MY RESOURCE, STAKEHOLDERS. IT'S NOT EASY TE UNDERSTAND REHABILITATION RESEARCH. WE HAVEN'T DONE A GOOD JOB EXPLAINING I. ADS EVERYONE WOULD SAY THE NEED FOR BETTER TOOLS TO LOOK AT ASSOCIATED WITH REHABILITATION RESEARCH. LACK OF COORDINATION REHABILITATION RESEARCH, NOT ONLY WITHIN NIH BUT ACROSS AGENCIES. DEPARTMENT OF GEFNS, VAND -- DEFENSE AND VA WERE ADDITIONAL RESEARCH IS GOING ON AND THERE'S NOT AN EFFORT TO ADDRESS THIS AND CERTAINLY INSTITUTE OF MEDICINE REPORTS HAVE ADDRESSED IT AT LEAST TWO TIMES WITH OUT SUCCESSFUL OUTCOME. THERE'S ALSO WITH A LITTLE BIT OF MONEY, TRAINING AND INVESTIGATORS WANT TO ENSHOWER THEY CONTINUE BECAUSE WE NEED TO BUILD RESEARCH CAPACITY. SO THAT LEAVES US TO THE RECOMMENDATION. WITH RELOCATION RESEARCH I HOPE IT MADE SENSE TO YOU. WE WILL SUGGEST A RESEARCH PLAN BE DEVELOPED AND THAT IT BE PERIODICALLY REVISED AND UPDATED. AND THE RESEARCH PLAN IS TRANS-NIH. AND THAT THE RESEARCH PLAN IN DEVELOPING IT, LOOK AT PRIORITIES, NOT ONLY LOOK WITNESS THE INSTITUTE BUT ALSO LOOKS OUTSIDE TO THE GREATER RESEARCH COMMUNITY AND BRINGS THEM IN TO A TRULY COMPREHENSIVE REHABILITATION RESEARCH PLAN. OBVIOUSLY WE WANT TO INCREASE THE MEANINGFULNESS OF THE RESEARCH BY EXPANDING THE TYPE OF SCOPE OF RESEARCH BEING DONE ACROSS THE SPECTRUM OF TRANSLATIONAL RESEARCH. OF COURSE THIS, SUBSTANTIALLY INCREASE FUNDING FOR ALL ASPECTS OF REHABILITATION RESEARCH. AND CONTINUE TO BUILD RESEARCH CAPACITY WE NEED TO WORRY ABOUT THE FUTURE OF REHABILITATION RESEARCH. AND I THINK IN DEVELOPING THE RESEARCH PLAN AND TRYING TO IMPLEMENT THE RESEARCH PLAN IT'S GOING TO FAIL. AND LASTLY, INVOLVE THE CONSUMER WHICH IS I DON'T THINK WE HAVE DONE A VERY GOOD JOB ACROSS DISABILITIES. WITHIN NCMRR. WE RECOMMEND THAT IT BECOMES A NATIONAL CENTER FOR REHABILITATION RESEARCH RATHER THAN MEDICAL RESEARCH BECAUSE THERE'S A A PROBLEM WITH THAT MEDICAL TERM. THEN WE HAVE FUNCTIONAL STRUCTURAL RECOMMENDATION. FUNCTIONALLY, OUR DREAM IS THAT NCMRR HAS MORE INDEPENDENT CONTROL OVER GRANTING AND HAS MONEY TO COORDINATION WITHIN NIH AND THEN ON TO OTHER FEDERAL AGENCIES. THERE'S A REPORTING MECHANISM SUCH OPPORTUNITY TO NEGOTIATE BUDGETARY CONTROL AND STABILITY, THAT THERE'S CONTINUEDED FOCUS ON CAPACITY BUILDING, NCMR WAS INADEQUATE RATHER THAN SCIENTISTS ASSOCIATED WITH IT. STRUCTURAL RECOMMENDATIONS THERE ARE TWO THAT AT LEAST WE COULD CONSIDER. AGAIN, WE ARE GRATEFUL FOR BEING ALLOWED FOR NICHD ADOPTING IT IN THE BEGINNING, 20 YEARS AGO. AT THIS TIME'SI GOOD HOME FOR INCUBATION BUT WE'RE TEENAGERS NOW AND IT'S TIME THE SPREAD OUR WINGS. SO WE'RE ASKING OTHER FOR INDEPENDENT CENTER OR TO BE HOUSED WITHIN OFFICE OF DIRECTOR. INDEPENDENT CENTER IS SCARY. OUR INSTITUTE WE UNDERSTAND THAT COULD CREATE ANOTHER SILO PROPOSAL WOULD BE THAT THE COORDINATION WOULD BE THE MAJOR OBJECTIVE AND THE PERFORMANCE CRITERIA AND BUDGET ALLOCATION IS BASED ON SUCCESSFUL COORDINATION WITH OTHER ICs. A NEW OFFICE, AGAIN, WE SAW INCREDIBLE COORDINATING BODIES ALL WHICH WERE IMPRESSIVE. SO WE WOULD LIKE THE MODEL OURSELVES AFTER THEIR STRUCTURAL ORGANIZATION AND WHAT THIS OPPORTUNITIES PROVIDES IS FOR THIS TRANS-NIH STRATEGIC PLAN, THAT'S REALLY THE BOTTOM LINE HOW CAN WE WORK EFFECTIVELY ACROSS NIH TO ADVANCE REHABILITATION RESEARCH AND TRAINING. BEING WITHIN THE OFFICE OF DIRECTOR PERHAPS ALOUSES FOR OUTSIDE ORGANIZATION ADVOCATES AND COMMUNITY STAKEHOLDERS TO WORK WITH THIS OFFICE MORE DIRECTLY. WE'RE ASKING TO HAVE FOR THIS OFFICE TO HAVE MONEY TO TOP OFF GRANTS, WE'RE ALSO ASKING TO MAINTAIN THE CURRENT BRAND AUTHORITY THE CURRENT CENTER HAS. SO THANK YOU. QUESTIONS. [APPLAUSE] >> THAT'S A DEMONSTRATION OF HOW HEAVY THE LIFTING WAS AND A VERY IMPRESSIVE AMOUNT OF WORK AND THOUGHT PUT INTO THIS. PRE-ARRANGING QUESTIONS, EITHER MAYBE TO START IF THERE'S ANY QUESTIONS, JUST A CLARIFICATION OR SOMETHING BUT THEN BEYOND THAT WE'D BE VERY INTERESTED TO HEARING YOUR INPUT. NEXT STEPS ARE THAT THE GROUP IS CHARGED TO ACTUALLY GIVE A FORMAL WRITTEN REPORT TO ME WHICH I WILL SHARE WITH OTHER INTERESTED BOTH NIH AND IC LEADERS, ET CETERA. SO HERE IS YOUR CHANCE TO SHAPE THEIR THOUGHTS BEFORE THEY FINAL PEN TO PAPER KIND OF THING, WHATEVER BUT BOTH QUESTIONS CLARIFY CAIRKS OTHER THOUGHTS, INSIGHTS, ET CETERA, DO Y'ALL HAVE OR QUESTIONS? WHY TO WANT YOU GO AHEAD AND NOT LET ME INTERRUPT. BECKY LET ME HAND IT BACK TO YOU. >> I THINK WHAT YOU MADE A COMPELLING CASE FOR IT BECOMING ITS OWN ENTITY, ESPECIALLY WHEN YOU MENTION THE COORDINATING EFFORT AND SETTING STANDARDS AND GUIDELINES SO DATA CAN BE SHARED AND COMMON DATA ELEMENTS AND COMMON OUTCOMES, I GUESS IS REALLY IMPORTANT. LIKE YOU SAID, VERY CROSS CUTTING. DO YOU KNOW ANYTHING ABOUT WHEN OFF FROM ANOTHER ONE, WHAT HAPPENS TO THE HOST INSTITUTE IN TERMS OF ITS FINANCIAL -- DOES A PIECE OF BUDGET GET CUT TYPICALLY OR IS A WHOLE NEW ENTITY CREATED? >> LET ME -- I'LL USE THAT AN TRY TO GIVE MORE CONTEXT. TO BE CLEAR WE TAKE NOT JUST ONE BUT ACTS OF CONGRESS FOR THIS TO HAPPEN. ONE IS ORIGINAL LEGISLATION FROM 1990 WHICH CONSTITUTES NCMRR WITHIN NICHD, ET CETERA SO THAT WOULD HAVE TO BE COUNTER VAILING LEGISLATION. TWO, AND THAT WOULD BE SOMEWHAT AN UPHILL STRUGGLE PERHAPS TOO BUT PROBABLY MUCH LARGER ONE, NIH RE-AUTHORIZATION OF 2006 IF I HAVE THE YEAR CORRECT, CAPS THE NUMBER OF INSTITUTES AND CENTERS THAT NIH 27. SO IF ONE IS GOING TO CREATE A NEW ONE, SOMETHING HAS TO DISAPPEAR. NO INSTITUTES OR CENTERS VOLUNTEER FOR THAT AT THE MOMENT TO THAT WOULD BE QUITE A CHALLENGE. CREATING OFFICE OF DIRECTOR, THE STILL CHANGE THE FIRST LAW, THAT MIGHT NOT CHANGE THE SECOND BUT NO NEW OFFICE CREATED WITHIN THE OFFICE OF DIRECTOR FOR SOMETIME AND MOST OF THE NIH COMMUNITY IS -- APPROVES THIS SUCH THING SO THERET ARE THOSE (INDISCERNIBLE) IF SUCH A THING WERE TO HAPPEN IT'S UP TO CONGRESS WHICH GIVES THE ANNUAL APPROPRIATION WHAT TO DO WITH THE APPROPRIATION AND THEY COULD DO ANYTHING THEY WANTED TO IN TERMS OF APPROPRIATION, MOST PEOPLE WOULD ASSUME WHATEVER THE LAST SUM AVAILABLE THAT THAT ENTITY SPENDING IS TRAVEL WITH THEM BUT IT COULD HAPPEN ANYWAY, COULD BE REDUCED, INCREASED, WHATEVER. IF IT WAS IN OFFICE WITHIN THE OFFICE OF THE DIRECTOR, I'M TRYING TO REMEMBER, YES, THEY DO GET, I'M LOOKING AT LISA, DO THEY GET THEIR OWN LINE ITEM BUDGET -- I GUESS THEY DO WITHIN THE OFFICE OF DIRECTOR STIPULATED BY THE CONGRESS. I HOPE THAT HELPS. >> WERE YOU ABLE TO COME UP WITH ANY UNDERSTANDING AT ALL ABOUT AN EXPLANATION FOR THE MODEST DECREASE IN FUNDING FOR RESEARCH? >> I'LL ASK JOHN IF HE HAS THOUGHT ABOUT IT. WE NEED TO INVOLVE JOHN IN THIS. >> THE QUESTION IS EXPLANATIONS FOR THE MODEST DECLINE IN NUMBERS. SOME OF THEM ARE BECAUSE THERE'S SOME NATURAL HISTORY OF LARGE GRAWNTS GOING OFF LABEL WHEN THAT HAPPENS. SOME OF THEM FROM OUR UNDERSTANDING WITH THE IMMUNITY IS THAT SOME RESEARCHERS HAVE CHOSEN NOT TO GO TO NCMRR, IT WILL GO SOMEWHERE ELSE BECAUSE OPPORTUNITIES. KNOWN AS FOA, FUNDING OPPORTUNITY ANNOUNCEMENTS DECLINE WITHIN NCMRR. SO BOTH PROBABLY INTERACT TOGETHER, THERE'S SOME NATURALLY THAT WENT OFF CYCLE AND OTHERS WHO CHOSE WITH THE OPPORTUNITIES THEY FELT MORE AT NCMRR AND WHEN ON -- WENT TO DIFFERENT INSTITUTES AND THE EPOA NUMBERS GOING DOWN PARALLELS THE PHENOMENON. THAT'S EXPLANATIONS AN THEORIES, WE DIDN'T GO BACK AND AT THIS TIME THE -- TEST THE HYPOTHESES, BUT THOSE ARE POSSIBLE EXPLANATIONS. >> AFTER A BLUE RIBBON PANEL PRESENTS A REPORT WHAT WERE THE NEXT STEPS TO EVALUATE AN IMPLEMENT YOUR RECOMMENDATION? >> INTERESTING QUESTION, I ASKED ALAN WHO EXPECT AD FINAL REPORT TO BE WRITTEN, HE SAID YES. OUR UNDERSTANDING IS WE GIVE ALAN AND ALAN IN TURN PRESENTS TO FRANCIS COLLIN, AT THE SAME TIME THIS BECOMES PUBLIC RECORD. WE ALSO HOPE THE ADVOCATES BEYOND NIH SEE THIS AS AN OPPORTUNITY TO INCREASE THEIR EMPHASIS ON REHAB RESEARCH. I'LL LET ALAN GO FURTHER. >> WE HAVE TO -- SO WE TAKE THE REPORT AND WE HAVE TO BALANCE IT AGAINST REALITIES BE IT LEGISLATIVE, FINANCIAL OR OTHER AN TRY TO COME WITH A WAY FORWARD WE THINK IS BOTH DOABLE AND ADVANCES IN SCIENCE OPTIMALLY. SO WE'LL TAKE EVERYTHING THAT'S SAID QUITE SERIOUSLY AND IT'S GOING TO BE -- AND THIS IS SOMETHING WHICH OBVIOUSLY HAS IMPORTS OF NUMBER AS YOU CAN SEE FROM THE STACKS PRESENTED, IMPORTANCE FOR NUMBER OF DIMP INSTITUTES, ET CETERA, SO THAT'S WHY SHARING THE LEADERSHIP ACROSS, THERE'S NO FORMAL RELY OR RESPONSE, WHATEVER THAT GETS PREDICATED AND NO RESPONSE OR RESPONSE, WHATEVER BUT IT'S SOMETHING THAT WE WOULDN'T HAVE ASKED FOR IF WE DIDN'T TAKE INPUT SERIOUSLY. AGAIN, EXPECTED TO HEAR SUGGESTIONS FOR SOMETHING OTHER THAN JUST STATUS QUO. NOT SAY THERE WON'T BE CONVERSATION BUS THERE WON'T BE A SPECIFIC SET OF FORMAL CONVERSATIONS, MANY, MANY INFORMAL CONVERSATIONS ABOUT WHAT TO DO NEXT. >> SOME GUARD RAIL CONSTRAINT THAT DR. GUTTMACHER SHARED WITH Y'ALL HE SHARED WITH THE PANEL, THE PANEL WRESTLED WITH SO WHAT DID THE SCOPE OF OUR RECOMMENDATIONS, DO WE RECOMMEND ONLY TO EXTENT AS IMPLEMENTABLE OR NOT? AND I THINK DR. GUTTMACHER SAID WE NEED TO JUST VOTE YOUR CONSCIENCE. DO WHAT'S GOOD FOR THE AMERICAN PEOPLE AND NOT BE LIMITED BY WHAT GUARD RAIL THAT MIGHT EXIST AT THE NIH LEVEL, EVEN AT THE CONGRESS LEVEL. SO WE DECIDED TO MAKE THE RECOMMENDATIONS ON WHAT WE THINK WILL MAXIMIZE REHABILITATION RESEARCH THROUGHOUT OUR NATION. HAVING SAID THAT, NCMRR HAS TO FUNCTION, NOT TO SAY THEREFORE THIS -- I THINK A PRACTICAL PERSPECTIVE ADVISORY BOARD COMES TO PLAY. I THINK THEY COULD TAKE A LOOK AT THE RECOMMENDATIONS AND THEN DIVIDE, DEVELOP MORE PRACTICAL IMPLEMENTABLE SOLUTIONS IN THE SHORT TERM. THAT THEY CAN MAKE A RECOMMENDATION TO TO DR. GUTTMACHER AND GO ON FROM THERE. IN OTHER WORDS, THEY'RE CLEARLY OTHER SOLUTIONS INTERMEDIARY TO THIS AN THOSE SHOULDN'T BE DISREGARDED. SO MAYBE THAT'S AN EXPLANATION, PRACTICAL PERSPECTIVE. >> DR. RUTHERFORD. >> POINT OF REFERENCE. THERE'S ABOUT $300 BILLION IN NIH RESEARCH REHABILITATION WHSM'S THE SIZE OF THE BA REHAB RESEARCH BUDGET? 50ISH? >> I DON'T KNOW. >> BUT MIGHT REPRESENT ANOTHER QUARTER ON TOP. >> THERE'S ALSO NYDER, 100 MILLION, DEPARTMENT OF EDUCATION. >> (OFF MIC) >> TURN ON THE MICROPHONE. >> YOU MIGHT GIVE YOURSELF A FULLER INTRODUCTION. >> CHIEF OF REHAB MEDICINE AT THE (INAUDIBLE) PROGRAM. I THINK -- THANK YOU GUYS FOR DOING THIS, THIS IS CRITICAL. I'M A HEALTH SERVICES RESEARCHER AND ONE THING I HAVE COME TO REALIZE IS THAT MEDICARE SPENDS ONE IN 4 OR $5 ON REHABILITATION. IT'S AN ENORMOUS COST TO THE US GOVERNMENT SO WE NEED TO THINK HARD ABOUT HOW MUCH WE SPEND ON THIS ISSUE IN PROBABLY MORE DOLLARS WE CERTAINLY CALLER FOR. THE OTHER ISSUE IS CONGRESS IN IT WISDOM ASSIGN MANY PEEP IT WILL JOB OF COORDINATING RESEARCH. I FINISHED THE DEPARTMENT OF EDUCATION AND THEY HAVE A SIMILAR CHARGE. WONDERING IF YOU TRY TO SORT OF TAKE THAT ON, IDENTIFY WHICH GROUPS ARE CHARGED, WHAT THE CHARGES ARE AND HOW YOU'RE ACTUALLY GOING TO COORD DMAIT ALL THE DOLLARS. BECAUSE YOU'RE TALKING QUARTER FROM THE DEPARTMENT OF EDUCATION, QUARTER FROM NIH AND DOD AND VA. AND THAT NEEDS TO BE SOME COORDINATION OF ALL THAT. >> WE -- REMEMBER THE CHARGE WE HAD TWOWZ LOOK TO BEGIN TO DECIDE REHABILITATION ACROSS THE NIH. ONE WHO CHAIRED THE INSTITUTE OF MEDICINE, LOOK AT REHABILITATION RESEARCH AND CAME OUT WITH REALLY STRONG RECOMMENDATIONS ABOUT!." HOW THE WORK ACROSS ALL THOSE AGENCIES. I THINK THERE ARE BLUEPRINTS AVAILABLE THAT CAN ASSIST IN THE FUTURE. BUT JOHN CAN DISAGREE BUT IT WAS BEYOND THE SCOPE OF THIS BLUE RIBBON PANEL. >> I WOULD AGREE, WE LOVE WHAT WE'RE DOING BUT WE ALSO WANT TO BECOME ADVOCATES AND FIGURE OUT -- I HAVE TO ADMIT THAT ONCE IN A WHILE WE TOY AROUND WITH IDEA I WONDER IF THIS -- IF WE ELIMINATE NYDER, TAKE THE MONEY OUT OF THE VA FOR REHAB RESEARCH AND PUT ALL THE NIH THAT WOULD BE GREAT BUT THAT WAS VERY SELF-SERVING. WE KNEW THE TASK WAS SO DIFFICULT. SO WE CHOSE TO ACCEPT THOSE GUARD RAILS IN OUR DEALINGS. >> ONE OF THE ISSUES THOUGH IS THAT NONE OF THOSE COMMITTEES HAS FUNDS OR TEETH. AND I THINK IF ONE WERE GIVEN THAT IT WOULD BE MORE ABILITY TO COORDINATE. SOMETHING TO THINK ABOUT. >> THANK YOU. ALAN, YOU WERE GOING TO SAY SOMETHING? >> WE HAVE TIME FOR ONE MORE QUESTION OR COMMENT I THINK. P THE IF NOT, -- RICK. >> JUST A SECOND, I WANT TO THANK JOHN AND BECKY, I WAS MEMBER OF THIS ECONOMY AND MORE THAN HEAVY LIFTINGFUL THIS WAS MASSIVE AMOUNT OF WORK INVOLVED, MEETING WITH DIRECTORS OF OFFICES, 6 OR 7 TRIPS TO D.C., HUGE AMOUNT OF WORK AND YOU GUYS DID THE BULK OF IT SO WE OWE YOU A DEBT OF GRATITUDE. >> THANK YOU. [APPLAUSE] >> I THINK THAT WAS WHAT I WAS ABOUT TO SAY, I WAS -- IT WAS A SEGUE BECAUSE I WAS GOING TO SAY THAT VERY MUCH ABOUT WHAT BECKY AND JOHN DID BUT OTHER MEMBERS OF THE COMMITTEE. IF YOU CAN THINK, THIS WAS A VERY NEBULOUS ASSIGNMENT WHICH MADE IT THAT MUCH MORE CHALLENGING SO THEY PRESENT IT WITH A STRUCTURE, IT'S NOT THOUGH IT HAD THE STRUCTURE GOING IN PURPOSEFULLY, THE CHARGE WAS A SOMEWHAT NEBULOUS ONE. WE DIDN'T WANT TO PREORDAIN THE OUTCOME AND TO GIVE IT STRUCTURE WOULD HAVE DONE THAT SO THEY CREATED STRUCTURE FROM CHAOS ALONG WITH EVERYTHING ELSE THAT HAD TO BE DONE SO IT IS A PARTICULAR -- I THINK ADMIRABLE JOB. I WOULD REMIND YOU WE'LL PREPARE THE FINAL REPORTS, IF YOU HAVE ANY FINAL THOUGHTS YOU MIGHT HOLD THEM TO LATER TODAY. NOT BUTTON HOLE THEM, WHATEVER, GRAB THEM. AND GIVE THEM YOUR THOUGHTS LATER TODAY. I KNOW WE PROBABLY ARE TRYING TO WORK ON THIS SOON SO THEY CAN GO ON ABOUT THEIR LIVES. THANKS FOR THAT. NEXT I HAND IT OVER TO YOU TO INTRODUCE THE NEXT OR DO IT MYSELF? ALL RIGHT. SO PARTLY BECAUSE YOU ASKED FOR THIS, PARTLY BECAUSE THIS IS SOMETHING WE SHOULD BE DOING ON A REGULAR BASIS, WE ARE GOING TO PRESENT A UP ABOUT NICHD RESEARCH TRAINING. WHICH OBVIOUSLY IS MAJOR PART OF WHAT WE'RE INVOLVED IN AND SOMETHING WE TAKE GREAT PRIDE IN. AND TRY TO LOOK AT QUITE SERIOUSLY AND AGAIN, I THINK YOU CAN GET LOTS OF GOOD ADVICE TO US ABOUT IT. DR. DENNIS TWOMBLY WHO COORDINATES OUR EFFORTS IN RESEARCH TRAINING, WE HE'S GOT A PRESENTATION TO GIVE US. ALSO THE SLIDES ARE IN THE MEMBER FOALERS AND THEY'RE POSTED ON PUBLIC AND INTERNET WEB SITES AFTER THIS. >> Y'ALL MAY RECALL THIS IS SOMETHING THE COUNCIL HAS BEEN ASKING FOR, THE SUBCOMMITTEE ON PLANNING HAS BEEN MAYBE TWO YEARS NOW THAT WE HAVE BEEN TRYING TO GET AROUND TO PUTTING THIS PRESENTATION TOGETHER FOR YOU. THANKS, DENNIS. >> THANK YOU VERY MUCH, IT'S MY PLEASURE TO GIVE PRESENTATION ON ONE OF OUR MOST IMPORTANT ELEMENTS OF TRAINING PROGRAMS AT NICHD, THOSE ARE INSTITUTIONAL TRAINING GRANTS OR THE T-32 GRANTS. THESE ARE PART OF THE RUTH KERSCHTEIN NRSA PROGRAMS BEEN IN EXISTENCE SINCE 1974, THIS IS OUR LARGEST INVESTMENT AND TRAINING AT NICHD. I'LL FOCUS ON T-32 PROGRAMS BUT YOU NEED TO KNOW THE T-32s ARE PART OF A LARGER CONTEXT OF TRAINING AT OUR INSTITUTE. WE PROVIDE FELLOWSHIP, CAREER DEVELOPMENT AWARDS, INSTITUTIONAL K-12 PROGRAMS THAT ARE IMPORTANT. AND COMPLIMENT THE PROGRAMS AS FAR AS THE PIPELINE THAT WE HAVE FOR INDIVIDUALS AND HOW THEY START FROM STATUS AND MOVE TOWARD SEARCH INVESTIGATORS AND AREAS OF REINTERESTX' RESEARCH INSTITUTE. START FELLOWSHIP AND SECOND ARE INSTITUTIONAL TRAINING GRANTS. BEGINNING WITH FELLOWSHIP WE HAVE INDIVIDUAL PRE-DOCTORAL FELLOWSHIPS, THERE ARE TWO FLAVORS OF THAT AT NIH, THERE IS THE DIVERSITY F-31 SCHOLARSHIPS FOR INDIVIDUALS FROM RACIAL AND ETHNIC MINORITIES. SPHRIEWNTS DISADVANTAGED BACKGROUNDS AND DISABILITIES. NICHD ONLY SUPPORTS THE DIVERSITY CATEGORY OF F-31 AWARDS. OTHER INSTITUTES AT NIH HAVE THE MORE GENERIC F-31 AND WE DON'T PARTICIPATE IN THAT. THE INDIVIDUAL POST-DOCTORAL FELLOW P SHIPS ARE FUNDEDDED THROUGH THE F-32 MECHANISM, THE NUMBERS YOU PROBABLY HAVE SEEN BUT THEY HAVEN'T MADE SENSE TO YOU, HOPEFULLY IT WILL BE CLEAR BY THE TIME WE'RE DONE. THESE ARE AWARDED TO VICTIM, INDIVIDUAL GRADUATE STIEWNS, POST-DOCTORAL FELLOWS WRITE THE APPLICATIONS. THEY WERE SUBMITTED BY THE INSTITUTION BUT SUPPORT IS FOR THAT PRE-DOCTORAL OR POST-DOCTORAL FELLOW. IN CONTRAST WE HAVE THE INSTITUTIONAL TRAINING GRANT, P-32 GRANTS AWARDED TO THE INSTITUTION IN SUPPORT OF GROUPS OF PRE-DOCTORAL AND/OR POST-DOCTORAL FELLOW. DIFFERENT TRAINING PROGRAMS HAVE DIFFERENT SLOTS, PRES DOCTORAL SLOTS, POST-DOCTORAL SLOTS EXCLUSIVELY OR A COMBINATION OF BOTH. WE TEND TO HAVE APPROXIMATELY AVERAGE OF FIVE SLOTS PER TRAINING PROGRAM. THE RANGE THREE SLOTS AND 13 SLOTS I BELIEVE. TO PUT IN PERSPECTIVE IN ANY GIVEN FISCAL YEAR WE HAVE 30 F-31 PRE-DOCTORAL FELLOWSHIPS WE SUPPORT AND 70 POST-DOCTORAL FELLOWSHIPS. INDIVIDUAL POST-DOCTORAL FELLOWSHIPS. THESE T-32 PROGRAMS ARE ADMINISTERED UNDER THE DIRECTION OF A PDPI WHO SCHMITZ THE APPLICATION. THIS IS ALMOST BY DEFINITION NATIONALLY OR INTERNATIONALLY RENOUNCED SCIENTISTS. THE ADMINISTRATION SELECTS THE CANDIDATES FOR THESE SLOTS AND APPOINT THEM AND MAKES THE APPOINTMENTS YEAR-TO-YEAR. MOST TRAINING PROGRAMS LAST TWO TO THREE YEARS IN DURATION. AS YOU POINT -- I SHOULD POINT OUT THE LIMITS OF SUPPORT FOR THE NRSA PROGRAMS, A COMBINATION OF F OR T-32 PROGRAMS ARE FIVE YEARS PRE-DOCTORAL FELLOWS AND THREE YEARS FOR POST-DOCTORAL FELLOWS. THESE ARE EXCLUSIVE SO SOMEBODY CONCEIVABLY SUPPORTED FOR 8 YEARS THROUGH BOTH TYPES OF PROGRAMS. IN THIS SCHEMATIC I SHOW PROGRESSION OF RESEARCH TRAINING AT GRADUATE MEDICAL SCHOOL TRAINING DOWN THROUGH FACULTY STATUS. WE HAVE A VARIETY OF FELLOWSHIPS AN CAREER DEVELOPMENT AWARDS TO SUPPORT PEOPLE THROUGH THAT PIPELINE. THERE ARE FELLOWSHIPS THE INDIVIDUAL FELLOWSHIPS PRES DOCTORAL SLOTS ON P-32 PROGRAMS. POST DOCS THERE ARE THE F-32 AWARDS AND THEN THE POST-DOCTORAL SLOTS ON THE P-32 PROGRAMS. SUPPORT MECHANISMS TRAINING AND EDUCATION THROUGH THE INTRAMURAL PROGRAM, THEY HAVE MANY PROGRAMS THERE THAT EEX EXCLUSIVE TO THE INTRAMURAL LABORATORIES, AND YOU SHOULD ASK SOMEBODY ABOUT THOSE, I'LL FOCUS ON THE EXTRAMURAL PROGRAMS. FOLLOWING POST-DOCTORAL TRAINING HISTORICALLY BEEN A BARRIER, A BRICK WALL FROM POST-DOCTORAL STATUS TO FACULTY TA STATUS. FIVE YEARS AGO NIH IMPLEMENTED TWO PROGRAMS TO BRIDGE THAT GAP. THE K-99 ROO PROGRAM, THE PATHWAY TO INDEPENDENCE AWARD. SOME PEOPLE REFERRED TO THIS AS THE KANGAROO AWARD. THAT'S THE K PLUS THE R FROM POST-DOCTORAL PHASE TO FACULTY PHASE. WE HAVE A K-22 AWARD FOR EXISTENCE LONGER THAN THAT. MANY INSTITUTES HAVE THAT, IT SERVES THE SAME PURPOSE HELPING BRIDGE FROM POST-DOC TO FACULTY PHASES OF CAREER. NOW, MANY INSTITUTES INCLUDING OURS DECIDED TO DROP OUR K-THE 22 PROGRAM WHEN SIGNED ON TO THE K-99 PROGRAM IN 2007. EARLY STAGE FACULTY WE HAVE A NUMBER OF MENTORED CAREER DEVELOPMENT AWARDS, THE K AWARDS, TARGETED TO SPECIFIC TYPES OF INDIVIDUALS, MDs, Ph.D.s OR PARTICULAR AREAS OF OF RESEARCH, SOME BASIC SCIENTIST, CLINICAL PATIENT ORIENTED RESEARCH. IN THE CASE OF CAN KO-1 NICHD ONLY SPONSORS AWARDS IN THREE SPECIFIC AREAS OF RESEARCH. SOME INSTITUTES BUT NOT OURS USED THE KO-1 FOR DIVERSITY APPLICANTS. FINALLY WE HAVE THE K-12 INSTITUTIONAL RA CAREER DEVELOPMENT AWARD PROGRAMS. THESE ARE SIMILAR TO T-32s IN THAT IT'S AWARDED TO THE INSTITUTION AND SUPPORT AS CERTAIN NUMBER OF TRAINING SLOTS. THESE ARE MORE SENIOR PEOPLE THAN ON POST-DOC F-32 PROGRAMS. WE HAVE QUITE A NUMBER OF THESE AT NICHD AND IN FACT WE HAVE MORE K-12 AT NICHD THAN ANY OTHER INSTITUTE. FOR ESTABLISHED INVESTIGATORS WE HAVE TWO CAREER DEVELOPMENT AWARDS, WE HAVE THE KO-2 INDEPENDENT SIGN TUS AWARD, THESE ARE FOR PEOPLE WHO ARE ALREADY FUNDED, K-24 MID CAREER AWARD PATIENT ORIENTED RESEARCH HAS RESEARCH COMPONENT AND MENTORING COMPONENT. COUPLE OF PEOPLE HAD THE K-24 RAY WARD AND POSSIBLY KO-2 AWARD AS WELL. THE AWARDS GIVE ADDITIONAL RELEASE TIME TO LAUNCH TO DIFFERENT RESEARCH DIRECTIONS AND IN THE CASE OF K-24 TO SUPPORT MENTORING ACTIVITY. THE OBJECTIVE OF THESE PROGRAMS IS TO IDENTIFY AND SPORE PEOPLE ALL THROUGH THIS PIPELINE WHO HAVE GREAT PROMISE BECOMING SUCCESSFUL INDEPENDENT INVESTIGATORS, THE OBJECTIVE IS TO APPLY FOR RESEARCH PROJECT GRANTS LISTED THERE ON THE LEFT SIDE. I'LL FOCUS ON THE T-32 AWARDS, AT NICHD WE HAVE IN FISCAL YEAR 201295 PROGRAMS. THOSE PROGRAMS SUPPORT 267 PRES DOCTORAL FELLOWS, 235 POST-DOCTORAL FELLOWS. THE APPLICATIONS CAME IN IN RESPONSE TO 7 PROGRAM ANNOUNCEMENTS OR PARs, 80% ARE IN RESPONSE TO PARENT PA. PA-184. THE OTHER ONE, THE OTHER SIX WERE SPECIFIC PARs PUBLISHED TO PROMOTE TRAINING IN SPECIFIC AREAS OF RESEARCH. TOTAL COST FOR T-32 PROGRAMS IN 2012 IS 24.2 MILLION, ABOUT 40% RESEARCH TRAINING BUDGET. A LITTLE CONTEXT THE INSTITUTIONAL K-12 PROGRAMS ARE NEXT IN LINE, WE DEVOTE 18 MILLION TO THOSE. THE INDIVIDUAL K AWARDS RECEIVE 12 MILLION IN SUPPORT AND THE INDIVIDUAL F AWARDS, F-31 AND 32, RECEIVE ABOUT 6 MILLION. SO THIS IS THE T-32s LARGEST INVESTMENT. SO WHAT ARE THE ELEMENTS OF A T-32 PROGRAM? MOST IMPORTANTLY THESE TRAINING PROGRAMS PROVIDE AN OPPORTUNITY FOR THE TRAINEES TO SPEND TIME IN THE LABORATORIES OR WITH THE RESEARCH PROGRAM OF WELL ESTABLISHED MENTORS. WHO PROVIDE THE TRAINEES WITH HANDS ON TRAINING AND RESEARCH. THERE MAYBE A CHOICE OF LABORATORIES FOR POST DOCS, THAT GENERALLY STAY IN ONE LABORATORY BUT PRE-DOCKS DO LAB LOWATIONS BEFORE SELECTING A LABORATORY FOR Ph.D.. MOST PROGRAMS HAVE DIFFERENT COURSES AN METHODOLOGIES THEY'RE EXPOSED TO. AND MORE RECENTLY IN THE LAST FIVE OR SO YEARS THERE'S REQUIREMENTS FOR THE T-32 PROGRAMS TO PROVIDE TRAINING AND RESEARCH AN ETHICS AND ANIMAL SUBJECT PROTECTIONS REQUIRED WITHIN THE PROGRAM ANNOUNCEMENT PART OF THE REVIEW CRITERIA OR CONSIDERATION. SOME PROGRAMS ADDED BELLS AN WHISTLES AS THEY COME FR FOR RENEWAL AND THEY HAVE ADDED ADDITIONAL TYPES OF TRAINING, RESEARCH TRAINING THAT THE TRAINEES GET. FOR EXAMPLE, THERE'S TRAINENING MANUSCRIPT PREPARATION, GRANT WRITING SKILLS, ORAL PRESENTATIONS, PROGRAMS HAVE PUBLIC OUTREACH ACTIVITY WHERE IS TRAINEES GO TOUT THE COMMUNITY AND TALK TO K-12 STUDENTS, TEACHERS, ADVOCACY GROUPS. THESE ARE ALL IMPORTANT COMPONENTS OF THE PROGRAM. OVER TIME BECOME MORE ENRICHING AN INDEED ESTABLISHED REALLY HIGH STAN DAD FOR TRAINING ACROSS NIH. MOST INSTITUTIONS INDIVIDUALS SUPPORTED ON RO-1 GRANTS HAVE THE OPPORTUNITY TO PARTICIPATE IN MANY OF THESE FUNDD THROUGH THE T-32 PROGRAM BUS THE EXPECTATION FOR ALL TRAINEES ARE NOW FOLLOWING STANDARDS THE T-32 PROGRAMS HAVE SET. SUPPORT THROUGH THE PROGRAM FOR NRSA TRAINEES PRES DOCK AND POST-DOCS CONSIST OF STIPENDS. TUITION AN FIE, NOW NIH REIMBURSES 60% OF THE COST FOR TUITION AN FEES FOR PRE-DOCS AND POT DOCS THERE'S A COP OF 16,000 FOR PRE-DOCKS, IN MOST CASES CAP OF $4,500 FOR POST DOCS. TRAINING RELATED EXPENSES, THE AMOUNTS ARE AROUND $7,000 OR SO, THIS IS TO PAY FOR RESEARCH SUPPLIES MOSTLY BUT MORE RECENTLY MANY PROGRAMS HAVE BEEN ALLOWING TRAINEES TO USE THOSE FUNDS FOR HEALTH INSURANCE FOR THE TRAINING. ADMINISTRATIVE COSTS FNA IS 8% ON ALL NRSA AWARDS. THE AMOUNT CURRENTLY FOR FISCAL YEAR 2012 ARE SHOWN ON THIS TABLE, THESE LIMITS ARE SETTLE OFTEN YEAR-TO-YEAR AND UPDATED OCCASIONALLY EVERY OTHER YEAR, YOU SEE THE BEGINNING STIPEND IS $22,000, FOR POST DOC IT BEGINS WITH 0 YEARS OF EXPERIENCE AT $39,000 AND GOES UP EVERY YEAR WITH EVERY YEAR RESEARCH EXPERIENCE FOR THE POST-DOCTORAL FELLOW CAPPING AT $54,000 FOR SOMEONE WITH 7 YEARS OF EXPERIENCE. TRAINING RELATED EXPENSES ARE $4,200 HERE. PRE-DOCKS AND 78.50 FOR POST DOCS. I WOULD LICK TO SHOW YOU NOW THE RELATIVE DISTRIBUTION WE HAVE FOR P-32 FUNDS FOR DIFFERENT DISCIPLINES WITHIN OUR MISSION. THE THREE HERE WITHIN THE BRANCHES NICHD T PERCENTAGES ARE THE OF -- I DIVIDED BY BRANCH BECAUSE REASONABLE APPROXIMATION FOR DIFFERENT DISCIPLINES KEEPING IN MIND A LOT OF T-32 PROGRAM VERSUS FOLLOWS IN MANY DIFFERENT DISCIPLINES SO IT'S MULTI-DISCIPLINARY TRAINING IT'S A ROUGH AWAY TO DIVIDE UP T. TAKE HOME MESSAGE IS WE USE THESE PROGRAMS IN EVERY BRANCH AT NICHD. SOME ARE LARGER, SOME SMALLER, SOME PROGRAMS HERE REPRODUCTIVE SCIENCES, REHAB, ALSO HAVE K-12 PROGRAM, INSTITUTIONAL K-12 PROGRAMS T T-32 INVESTMENT INVESTMENT FITS INTO A LARGE PORTFOLIO FOR EACH BRANCH. INDIVIDUAL K AWARDS, THEY ALSO HAVE INDIVIDUAL FELLOWSHIPS. DON'T GET THE TOO WORRIED ABOUT LARGE OR SMALL SLICES TESTIMONY NEXT PIE CHRT SHOWS RELATIVE DISTRIBUTION OF PRES DOC VERSUS POST DOCS. ON THE RIGHT SIDE OF THE PIE CHART HERE YOU SEE PRE-DOCS, T-32 PRE-DOCS CONSTITUTE 45% OF THE FULL TIME TRAINING POSITIONS SUPPORTED THROUGH THE NRSA PROGRAMS. THIS IS LARGE MAJORITY OF PRES DOCS A SMALL SLICE ARE SMALL BECAUSE OF THE DIVERSITY F-31s AND THE ELIGIBILITY IS RESTRICTED. PRE-DOCS CONSTITUTE ABOUT HALF OF THE OVERALL FULL TIME TRAINING POSITION. ON THE LEFT SIDE YOU SEE THE POST DOCS, AGAIN, THOSE ON PRES DOCTORAL -- POST-DOCTORAL SLOTS REPRESENT 38% TOTAL. ABOUT THREE TIMES BIGGER THAN POST-DOCS ON INDIVIDUAL F-32 AWARDS. MANY T-32 PROGRAMS START POST DOCS OFF ON TO SLIDES IN FACT THOSE FOLK WHOSE GET BOTH TYPES OF AWARDS HAVE THE BEST LONG TERM OUTCOMES IN TERMS OF THEIR SUCCESS FOR OBTAINING FACULTY POSITIONS AN SUCCESS IN GETTING FUNDING. WE LIKE A COMBINATION OF BOTH AWARDS USED. AT NIH WE DO LOTS OF EVALUATIONS FOR SUCCESSIVE PROGRAMS, THE OFFICE OF EXTRAMURAL RESEARCH OER, MOST SHOULD BE FAMILIAR WITH CONDUCTS EVALUATIONS FOR K AWARDS, NRSA PROGRAMS ALL KINDS OF PROGRAMS, THIS IS AN EVALUATION RECENTLY FOR NICHD SUPPORTED T-32 TRAINEES. THE CATEGORY WERE PRE-DOCTORAL TRA KNEE, POST DOCS WITH Ps, POST DOCS WITH MDs AN COMBINED M.D. Ph.D. DEGREES. THESE WERE INDIVIDUALS WHO WERE POINTED BETWEEN YEARS 1985 AND 1995. MIGHT THINK THIS IS OLD COHORT BUT THE REASON WE PICKED THAT COHORT IS SO THAT WE COULD TRACK THEM FOR 15 YEARS. SO IF ANY OF YOU WORKED WITH INSTITUTIONAL T-32s O K-12 PROGRAMS AND YOU HAD THE CHALLENGE OF FOLLOWING SOMEBODY AN TRYING TO DETERMINE DID THEY GO INTO SCIENCE, APPLY FOR GRANTS, SUCCESSFUL ON GETTING GRANTS YOU KNOW YOU NEED TO FOLLOW THEM FOR A LONG PERIOD OF TIME. THE 15 YEAR CHOICE DICTATED THE PERIOD OF APPOINTMENT THE ANALYSIS WAS DONE. SO THESE COLUMNS HERE WITH FIGURES, YOU SEE THE PROPORTION OF INDIVIDUALS WHO APPLY FOR AN NIH RESEARCH BUDGET GRANT. THE PROPORTION THAT ACTUALLY RECEIVED A RESEARCH PROJECT GRANT. THE RESEARCH PROJECT GRANTS I DON'T KNOW IF YOU CAN SEE AT THE BOTTOM BUT R TYPE AWARDS FOR THE MOST PART THE HIGHEST REPRESENTATION R-3, R-21s AN RO-1s, THE AMILLIONSIS DIDN'T INCLUDE K AWARDS, DIDN'T INCLUDE SUBSEQUENT APPLICATIONS OR LOAN REPAYMENT PROGRAMS. WE WANT TO KNOW WERE THESE PEOPLE BECOMING ACTIVE INVESTIGATORS AND WERE THEY APLOOING -- APPLYING FOR RESEARCH PROJECT GRANTS. PERCENTAGE HERE FOR PRE-DOCS, 53% WITHIN 15 YEARS OF APPOINTMENT APPLIED FOR RESEARCH PROJECT GRANT. 32% WERE SUCCESSFUL IN OBTAINING A GRANT. THESE NUMBERS ARE AMAZING, HIGHER THAN NIH NUMBERS APPROXIMATE WE HAVEN'T FIGURED OUT WHAT WHY THAT'S THE CASE BUT QUITE PLEASED WITH THAT. POST DOCS WITH Ph.D. DEGREES, 34% APPLIED, 23% WERE SUCCESSFUL, THOSE WITH M.D. Ph.D. DEGREES, 36% APPLIED, 22% WERE SUCCESSFUL AND BOTTOM POST DOCS WITH M.D. DEGREE, 19% APPLIED, A LORE NUMBER CATEGORIES HERE, AND ONLY 12% WERE SUCCESSFUL. WE CAN SPECULATE ABOUT THE REASONS FOR THAT, PERSONALLY I THINK THE SITUATION FOR THE M.D. IS AFTER THE T-32 PROGRAMS THEY THEN TRY TO AAPPLY FOR KO-8 OR K-23, IF YOU CAN SESESFUL THEY CONTINUE THE RESEARCH TRACK, IF NOT THEY GO TOWARD THE CLINICAL TRACK. THERE'S A LOT OF PRESSURE FROM CHAIRMEN AND OTHER FACTORS THAT FORCE THEM IN THAT DIRECTION. >> CLARIFICATION ON NUMBERS. WHEN YOU SAY PRE-DOCTORAL TRAINING, 53.2%, OF THOSE INDIVIDUALS PRES DOCTORAL TRAINING, YOU SAID 32.4% RECEIVED, IS THAT 3 # .4% OF THE 53.2? >> >> NO, 34% OF APPOINTEES. >> SO SUCCESS RATE IS 60%, IS THAT CORRECT? >> SUCCESS RATE IS 32%. 32% OF PRES DOCS WHO WERE TRAINED WITHIN THAT -- >> ONLY 53.2% ACTUALLY APPLIED AND 32% ORIGINAL GOT IT, THAT SUCCESS RATE, IS THAT WHAT YOU'RE SAY SOMETHING >> OKAY. >> YES, NO? CLARIFICATION. >> I THINK THAT WOULD BE THE CASE. >> THAT'S A VERY HIGH RATE. >> VERY HIGH. HIGHER THAN NIH AND WHEN THEY SENT ME THESE NUMBERS THEY HAD CORRESPONDING SLIDE THAT LOOKED MORE LIKE THESE FOR THE POST DOCS. I ASKED THEM DO YOU HAVE THOUGHTS ON WHY THIS IS THE CASE AND THEY DIDN'T KNOW. THEY ASKED ONE OF THEIR SPECIAL PROGRAMS AT NICHD HAD BECOME THEN AND IF YOU FIND IT YOU MIGHT COMMENT BUT NOT AWARE OF ANYTHING. SO WE'LL LOOK INTO IT BUT IT WAS HIGHER THAN EXPECTED FOR SURE. OKAY. SWITCHING GEARS NOW TO TALK ABOUT REVIEW OF T-32 APPLICATIONS, IT'S VERY IMPORTANT BECAUSE WE HAVE A LARGE INVESTMENT BUT ALSO BECAUSE THE T-32s SPAN DIFFERENT DISCIPLINES. WE NEED TO MAKE THE TOUGH CHOICE DECIDE WIG TO FUND SO HAVEN'T AN EFFECTIVE REVIEW PROCESS REALLY IMPORTANT. BEFORE I SHOW YOU SOME -- THE NEXT FEW SLIDES I WOULD LIKE TO POINT OUT WE USE ONE RECEIPT DATE PER YEAR, MANY OTHER INSTITUTES DO THE SAME THING. SO ALL THOSE APPLICATIONS THAT COME IN MAY 25th REVIEW IN LATE OCTOBER, EARLY NOVEMBER. AND WE NORMALLY HAD ANYWHERE FROM 65 TO 85 APPLICATIONS EACH YEAR. UNTIL 2011 WE REVIEWD APPLICATIONS IN THE DIFFERENT STANDING SUBCOMMITTEES OF OUR DIVISION OF SCIENTIFIC REVIEW. YOU SEE SUBCOMMITTEES HERE, YOU'RE PROBABLY FAMILIAR WITH THEM, THE MAJORITY OF APPLICATIONS WERE REVIEWED IN COMMITTEES, DIFFERENT NUMBERS OF APPLICATIONS FOR DIFFERENT COMMITTEES. BUT ALSO A SPRINKLING OF APPLICATIONS REVIEWED IN SPECIAL EMPHASIS PANELS BECAUSE OF CONFLICTS AND OTHER SPECIFIC REASONS. FOR 2011 THERE WERE 17 SPECIAL EMPHASIS PANELS. THOSE PANELS REVIEWED ANYWHERE FROM ONE TO THREE APPLICATIONS ONLY. WE WENT BACK AND DID ANALYSIS OF THE NUMBERS OF APPLICATIONS PER GROUP AS WELL AS THE PRIORITY SCORES, SUCCESS RATES FOR FUNDING AND IT WAS CLEAR THERE WERE SEG CAINT DIFFERENCES FROM GROUP TO GROUP. THE DIFFERENCE INTENDED TO WASH OUT OVER TIME ONE BRANCH DOING WELL ONE YEAR, T NOT SO WELL ANOTHER YEAR BUT FLUCTUATED BACK AND FORTH BUT FOR ANY GIVEN FISCAL YEAR, SOME COULD BE DISADVANTAGED SOME ADVANTAGED DEPENDING WHO WAS ON THAT COMMITTEE, APPLICATIONS OR SCORING METRICS. SO WE WERE CONCERNED AND DECIDED WE WOULD TRY A NEW FORMAT FOR 2012 WHICH YOU'LL SEE ON THE SLIDE. THE KEY ELEMENT OF THE NEW FORMAT WAS THAT WE USED A SINGLE REVIEW COMMITTEE. I NEED TO PINT OUT SEVERAL OTHER NIH INSTITUTES DO THE SAME WAY RATHER THAN TOPIC SPECIFIC REVIEW COMMITTEE, A SINGLE COMMITTEE DEDICATEDDED TO T-32 APPLICATION. WE DID THIS WAY, THE LEAD WAS TAKEN BY THE DIVISION OF SCIENTIFIC REVIEW UNDER LEADERSHIP OF SHERRY DOES PAIR, IT WAS A HEROIC EFFORT TO ORGANIZE, PLAN AND INVITE REVIEWERS AND SO FORTH TO IMPLEMENT THE REVIEW. LET ME EXPLAIN HOW IT WORKS. SET A HIGH BAR WHO THEY CHOSE FOR THE COMMITTEE 40 INDIVIDUALS EACH INDIVIDUAL HAD BEEN PDPI TRAINING DIRECTORS ON T-32 PROGRAMS. THOSE INDIVIDUAL VERSUS EXPERTISE IN THE DISCIPLINES OF THE APPLICATIONS THAT WE WERE REVIEWING. THE REASON FOR PICKING PDPI P-32 PROGRAMS IS THEY KNOW HOW THEY WORK. THEY KNOW HOW THEY'RE ORGANIZED, WHEES EFFECTIVE, THE PROGRAMATIC ELEMENTS, BETTER EXPECTATION HOW LONG IT TAKES TRAINEES TO GET FACULTY APPOINTMENTS FOR EXAMPLE, CERTAIN NUMBERS OF APPLICATIONS, SUCCESS IN APPLYING FOR RESEARCH GRANTS THAT, SORT OF THING. SO IT WAS DIFFICULT TO FIND ENOUGH PEOPLE, IT WAS A CHALLENGE BUT WE DID HIT THAT MARK. ALL THE REVIEW IRS PDPIs, THE WAY THE FORMAT WORKED WAS A TWO DAY REVIEW, FIRST DAY ALL THE INDIVIDUALS WORKED TOGETHER AS A SINGLE GROUP. THAT WAS HELPFUL BECAUSE IT ALLOWED THE SIGNTIVIC OFFICERS TO PROVIDE STANDARD INSTRUCTIONS TO THE REVIEWERS. ALLOWED EVERYBODY HEAR AND DISCUSS SCORING METRICS AN EVERYBODY WAS GOING TO BE ON THE SAME SCORING SCALE BEST WE COULD DETERMINE. SO FIRST DAY THEY REVIEWED THE PARENT APPLICATIONS, ONES COMING IN UNDER PARENT ANNOUNCEMENT. DAY TWO, TWO SUBGROUPS WERE FORMED TESTIMONY FIRST SUBGROUP, A LARGER SUBGROUP CONTINUED REVIEWING THE PARENT T-32 APPLICATION, A SMALLER SUB GROAT REVIEWED APPROXIMATELY 12 APPLICATIONS THAT HAD BEEN SUBMITTED IN RESPONSE TO SPECIFIC PARs SO IN PARALLEL. BY THE TIME IT WAS FINISHED I THINK REVIEW STAFF AS WELL AS MANY REVIEWERS FELT REALLY GOOD ABOUT THE CONSISTENCY THAT WE HAD ACROSS THE REVIEWS FOR ALL THE DIFFERENCE DISCIPLINES. YOU WERE QUITE PLEASED WITH THAT. HOW DID THAT TRANSLATE INTO SUCCESS RATE AT THE END. FOR FUNDING CONSIDERINGS, NICHD USES THE SAME CONSIDERATION THAT OTHER INSTITUTES DO. WE LOOK AT STRENGTH AND WEAKNESS AND CRITIQUES, AVAILABILITY OF FUNDS, RELEVANCE TO PROGRAM PRIORITIES, THAT SORT OF THING IS ALL PUBLISHED IN THE PA. IN OUR CASE SINGLE ECONOMY WE -- COMMITTEE WE RANKED ORDEREDDED BY PRIORITY SCORE BECAUSE APPLICATIONS WERE ON THE SAME SCALE. DIFFICULT TO DO IF WE ONLY HAVE ONE OR TWO APPLICATIONS IN ONE COMMITTEE AND IS THE 12 IN ANOTHER COMMITTEE SO THIS HELPED US GET A FEEL FOR THE RANKING OF THE INDIVIDUAL APPLICATIONS. SO THIS TABLE SHOWS YOU MANY HOW APPLICATIONS DID. NUMBERS WE RECEIVED HERE, NUMBER AWARDS MADE THWARTING WITH -- STARTING WITH FISCAL 2008, DOWN TO 2012, THIS YEAR TALKING ABOUT WITH A NEW REVIEW PROCESS. NUMBER OF APPLICATIONS, WE DID 75 THIS YEAR, WHICH IS NOT FAR FROM THE TYPICAL RANGE. WE ENDED UP MAKING 24 AWARDS. IN THE P SCORE THIS IS PRIORITY SCORE COLUMN YOU SEE 3 TWENTIES, THESE WERE PAY LINES WE PAID TO FOR THE P-32s. YOU DON'T SEE NUMBERS HERE BECAUSE THAT WAS A DIFFERENT SCORING SCALE, THE SCORING SCALE CHANGED ABOUT THREE YEARS AGO SO SO THE PAY LINE STAYED THE SAME. IN TERMS OF SUCCESS RATE, AWARDS DIVIDED BY APPLICATIONS, YOU SEE THE TRADITIONAL SUCCESS RATE FOR T-32 HAS BEEN AROUND 30%. AND FOR 2012 THE LAST ROUND IT WAS 32 AND 2011, 32% WHICH IS REALLY GOOD. YVONNE WILL SHOW YOU THE SLIDE SETS IN OTHER TYPES OF MECHANISMS AND IT'S NOWHERE NEAR THIS GOOD. WE WANTED TO MAKE SURE THERE WASN'T SOME UNRECOGNIZED QUIRK IN THE REVIEW PROCESS THAT WOULD THROW OFF THE DISTRIBUTION, THROW OFF HOW WE HAVE BEEN FUNDING THINGS SO WE WERE PLEASED THIS IS HOW IT WORKED OUT. LET ME MAKE CLIEWNGS BASED ON WHAT I HAVE SHOWN YOU ALREADY. FIRST WE SUPPORT 95 INSTITUTIONAL TRAINING GRANTS, OUR LARGEST INVESTMENT. SUPPORTS ABOUT 500 TRAINEES PRES DOCTORAL AND POST-DOCTORAL TRAINEES. 83% OF FULL TIME TRAINING POSITIONS THROUGH THE NRSA PROGRAMS. THE AWARDS ARE DISTRIBUTED ACROSS ALL OF OUR BRANCHES AND DISCIPLINES. BY VIR DHIEW OF THE REQUIRED TRAINING, DIFFERENT TYPES OF THINGS LIKE RESPONSIBLE CONDUCT OF RESEARCH AND HUMAN AND ANIMAL SUBJECT PROTECTIONS AS WELL AS PROGRAMATIC PARTS OF APPLICATIONS, T-32 PROGRAMS RAISED STANDARDS FOR TRAINING OF PRETS DOCS AND POST DOCS ACROSS NIH, IT'S DEFINITELY THE CASE FOR NICHD AS WELL. IF WE LOOK AT OUTCOMES, T-32 TRAINEES HAVE BETTER LONG TERM OUTCOMES IN TERMS OF NUMBERS OF APPLICATIONS AN NUMBERS OF AWARDS. WHAT I DIDN'T SHOW YOU WERE NIH WIDE COMPARISONS OF T-32 VERSUS THOSE WHO WERE IN LABORATORIES WORKING ON RO-1s OR PRIVATE FOUNDATION SUPPORT AND SUCCESS RATE FOR T-32 TRAINEES IS SIGNIFICANTLY BETTER. THE BEST SUCCESS RATE ARE THOSE WHO HAVE FELLOWSHIP SUPPORT, INDIVIDUAL FELLOWSHIP SUPPORT BECAUSE THAW EAR WRITING THEIR OWN APPLICATIONS AND MORE VESTED TO THE PROJECT. THE ONE WHOSE HAVE THE ABSOLUTE BEST OUTCOMES ARE THE ONES WHO HAVE BOTH TYPES OF SUPPORT. SO THEY HAVE THE STRUCTURAL SUPPORT OF THE APPLICATIONS THEY SUBMIT. THE E VIEW FOR MAT WAS AN UNDERTAKING BUT IT IMPROVED THE SCORING CONSISTENCY ACROSS DISCIPLINES. AS YOU SAW THE LAST TABLE THE SUCCESS RATE IS STABLE PRETTY MUCH FOR THE LAST FIVE YEARS. SO I'LL STOP THERE, THANK YOU VERY MUCH FOR THIS OPPORTUNITY TO PRESENT THIS. BE HAPPY TO ANSWER ANY QUESTIONS ON T-32s OR K-99s, ANY OF THE TRAINING MECHANISMS. THANK YOU. [APPLAUSE] >> THANK YOU, DENNIS. WE'LL HAVE TIME FOR ONE QUESTION. YOU HAVE THE POWERPOINT PRESENTATION THERE AND WE MIGHT BE ABLE TO GET BACK TO THIS QUESTION MAYBE AFTER MY PRESENTATION. GO AHEAD. (OFF MIC) -- OPPORTUNITY AMONG MANY PEOPLE THAT T-32s ARE HHARD TO GET. WHAT YOU SHOWED IS THAT THE PERCENTILE SCORES 20 AND BETTER WOULD NORMALLY BE FUNDED BUT YOU ALSO SHOWED LARGE NUMBER OF APPLICATION HAVE BEEN SUCKSISFULLY FUND WID MEANS I PREDICT THEREFORE THAT MOST OF THE -- THERE'S A CLUSTERING OF GOOD SCORES BETWEEN 10 AND 20. >> ABSOLUTELY. >> WHICH ALSO MEANS NOW THIS ALSO INTERTWINED WITH EFFECT IT'S VERY DIFFICULT TO DIFFERENTIATE A GOOD T-32 PROGRAM FROM A LESS GOOD ONE BECAUSE THEY'RE STRUCTURED. AND IT'S HARD FOR THIS INVESTIGATORS PIs THE TO WRITE A GOOD ONE BECAUSE HOW DO YOU DIFFERENTIATE THIS FROM ANOTHER ONE. THERE'S TWO ISSUES OF CLUSTERING OF SCORES VERY HIGH END, ALSO THE STRUCTURED APPLICATION THAT I -- MAKES ME WONDER IS IT WORTHWHILE FOR YOU TO ACTUALLY CHANGE SOME OF THE RFAs AND INTRODUCE SOME LANGUAGE THAT WILL BETTER HELP P RKs TO REALLY DEFINE ASPECTS OF THE PROGRAM, BETTER DIFFERENTIATION OF SCORES, THEREFORE, MORE I WOULD SAY ADEQUATE SELECTION OF THE BETTER APPLICATIONS. >> RIGHT. SPHAIRS DISTRIBUTION IS CONCERNED WE SEE THE BIGGEST HUMP BETWEEN 20 AND 25. THERE AREN'T SO MANY BELOW 20 THERE ARE A LOT OF SCORES BETWEEN 20 AND 25 T. NEW SCORING SYSTEM OF 10 TO 90 IS IT ONE OR TWO, SO WE HAVE TIES AT 20. THAT'S LAST YEAR AND THIS YEAR, THIS WAS A BIG PROBLEM AND TRYING TO PICK WELL WHICH ONES -- GIVEN THAT WAS WHERE FUNDING LYNN BY VIRTUE HOW MUCH MONEY WE HAD, WE HAD TO DO PICKING AND CHOOSING AND THIS YEAR WE HADED TO DO FLAT TRIMMING TO PICK UP THE 20s. BASICALLY WE WERE ABLE TO DO IT. EXPERIENCE, CERTAINLY INDIVIDUALS WHO HAVE DONE THIS HAVE A BIG ADVANTAGE THEY KNOW HOW TO WRITE APPLICATIONS YOU HEARD ABOUT THE TERRIBLE DATA THAT DESCRIBE MENTORS AND TRAINEES, THE YOU COMES FOR THOSE TRAINEES. THESE APPLICATIONS RUN HUNDREDS OF PAGES, COMPILING DATA IS A REALLY IMPORTANT THING. THERE IS A TENDENCY FOR RENEWAL APPLICATIONS TO DO BETTER BECAUSE THEY HAVE A TRACK HISTORY. FOR BRAND NEW APPLICATIONINGS. WE HOPE APPLICANTS PUT THEIR BEST FOOT FORWARD AND DESCRIBE THE PROGRAMS, LIMITED GUIDANCE WE CAN PROVIDE IN THE PARENT T-32 ANNOUNCEMENT. I'M THE CONTACT FOR THIS. CERTAINLY APPLICANTS CALL PROGRAM PEOPLE AND TALK ABOUT IT AND WE'RE MORE THAN HAPPY TO TRY TO EXPLAIN WHAT WE THINK ARE IMPORTANT CONSIDERATIONS. BUT REALLY, IT'S THE QUALITY OF MENTOR, THE EXPERIENCE OF THE PI PD AND PROBABLY MOST IMPORTANTLY IN MY MIND LISTENING TO HOW REVIEWERS THINK THE TRAINING DID ULTIMATELY. SO HOW -- WHAT KINDS OF POSITIONS DID THEY GET, SUCCESSFUL WITH PUBLICATIONS AND THAT KIND OF THING. THANK YOU VERY MUCH. >> THANK YOU, DENNIS. WEAL HAVE A CHANCE PERHAPS TO DISCUSS THE TRAINING GRANT PROGRAM AT OUR NEXT COUNCIL, ONE OF THE THINGS WE WANTED TO DO MORE FREAKILY WITH OUR COUNCIL IS TO BRING TO YOUR ATTENTION VARIOUS MECHANISMS THAT WE USE TO SUPPORT OUR RESEARCH AND GIVE YOU PERIODIC UPDATES. AS ALAN MENTIONED EARLIER WE PUT TOGETHER RESEARCH PORTFOLIO ANALYSISIOMAN'S JOB TO LOOK AT NOT ONLY THE SCIENCE PORTFOLIO THAT NICHD SUPPORTS BUT ALSO TO LOOK AT THE VARIOUS MECHANISMS THAT WE USE TO SUPPORT OUR RESEARCH. AS WE LOOK TO HOW WE MIGHT PROCEED TO ANALYZE MECHANISMS, IT BECOMES CLEAR THAT PERHAPS ONE OF THE FIRST AREAS OF MECHANISM UTILIZATION THAT WE SHOULD LOOK AT WOULD BE THE RESEARCH PROJECT GRANT OR THE RPG WHICH IS THE MAIN STAY OF THE BIOMEDICAL RESEARCH ENTERPRISE, NOT JUST NICHD BUT REALLY AT THE NIH, WHEN YOU THINK NICHD WE PUT ABOUT 53% TO PUT EXTRAMURAL RESEARCH DOLLARS INTO RESEARCH PROJECT GRANTS. AS YOU SAW FROM DENNIS'S SLIDE SEVERAL MECHANISMS FALL UNDER RESEARCH PROJECT GRANT MODE. BUT THE RESEARCH PROJECT GRANTS MOST UTILIZED WOULD BE THE RO-1 OR TRADITIONAL RESEARCH PROJECT GRANT, THE RO-1. THE RO-3, THE R-21, THE R-15. THESE ARE THE BASIC RESEARCH PROJECT GRANTS THAT MOST OF OUR RESEARCHERS AND SCIENTISTS USE. OTHER THING TO BRING TO BEAR, WHEN IT COMES TO RESEARCH PROJECT GRANTS THEY ARE REVIEWED IN TWO PLACES IN MOST INSTITUTES WHO HAVE PRIMARY ASSIGNMENTS FOR THEM. ONE PLACE WOULD BE CENTER FOR SCIENTIFIC REVIEW WHICH REVIEWS MOST APPLICATIONS AN MOST RESEARCH PROJECT GRANTS BUT MANY ARE ALSO REVIEWED WITHIN THE INSTITUTES. THOSE REVIEWED IN NICHD ARE THOSE IN RESPONSE TO RFAs OR REQUEST FOR APPLICATIONS. AND SPECIAL PROJECTS THAT ARE RELATED TO CLINICAL TRIALS WE SEE AS UO-1s AND MECHANISM AND ALSO ARE COOPERATIVE AGREEMENTS BUT RELY HEAVILY ON THAT INDIVIDUAL INVESTIGATOR OR THAT INDIVIDUAL PROJECT. ONE THING I WANTED TO DO IN WORKING WITH OUR STAFF IS TO TAKE A QUICK LOOK, I THINK I CAN DO THIS IN TEN MINUTES TO TAKE A QUICK LOOK AT RPGs, UTILIZATION OF RESEARCH PROJECT GRANTS OVER THE LAST FIVE YEARS. WE HAD SEVERAL QUESTIONS TO ASK. FIRST, WHAT REALLY HAVE BEEN THE RESEARCH PROJECT GRANTS SUCCESS RATES, YOU HER DENNIS TALK SUCCESS RATE, IT WILL YOU AB WHAT SUCCESS RATE IS. HAS THERE BEEN INCREASE IN OWM OF RESEARCH PROJECT GRANTS REVIEWED? HOW MANY COMPETING RESEARCH PROJECT GRANTS WERE AWARDED? AND WHAT WAS THE COST OF THESE GRANTS? DID THE RESEARCH PROJECT GRANTS THAT CAME IN UNDER SET ASIDES OR RFAs DID THEY HAVE IMPACT ON PAY LINE OR ON PARTICULAR RESEARCH AREAS? AND WHAT OTHER FACTORS OTHER THAN PERHAPS RFA SET ASIDE TO AFFECT THE OVERALL RPG PAY LINES. SO THIS IS -- I WANT TO GET RIGHT TO THE CHASE AND GIVE YOU AN EXAMPLE OF WHAT THE NICHD SUCCESS RATES HAVE BEEN FROM 2007 THROUGH 2011. WE DON'T HAVE 2012 YET BUT WE CAN WORK ON IT BECAUSE ONCE THE COUNCIL IS DONE AND WE'RE TO THE END OF FISCAL YEAR WE'LL GET A BETTER HANDLE BUT OUR SUCCESS RATE IN 2007 WAS 20.6%, IN 2008, 16.8, OF COURSE IN 2011 YOU'RE SEEING A SUCCESS RATE OF 12.4. THIS IS FOR OUR NEW COUNCIL MEMBERS GET IRTHEIR FEET WET IN THIS PROCESS, MANY PEOPLE CONFUSE SUCCESS RATES WITH PERCENTILES. AS YOU CAN SEE FROM THIS, WE DEFINE SUCCESS RATES THIS WAY. THAT IS, IT'S A RELATIONSHIP BETWEEN APPLICATIONS REVIEWED AND APPLICATIONS THAT ARE AWARDED. SO IT REALLY DOES CORRESPOND TO APPLICATIONS RECEIVED BECAUSE THE ONES RECEIVED MOST ARE REVIEWED BUT SOME ARE INELIGIBLE REVIEWED AS COMPARED THE APPLICATIONS AWARDED. OVER THE. LAST FIVE YEARS W E HAVE SEEN A DIMINUTION IN NUMBER OF APPLICATIONS WE HAVE AWARDED, WE ALSO SEEM DIMINUTION IN SUNG SES RATE BUT -- SUCCESS RATE BUT WE CAN ALSO SUGGEST THAT IT'S NOT JUST AVAILABILITY OF FUNDS THAT MAYBE CONTRIBUTING TO THE NUMBER OF AWARDS MADE BUT COULD REALLY BE RELATED ALSO TO THE NUMBER OF APPLICATIONS THAT WE'RE RECEIVING. IT'S CLEAR NICHD IS RECEIVING A LARGER NUMBER OF APPLICATIONS. IF WE WERE TO GO INTO THE NIH WEBSITE AND PULL UP THE SUCCESS RATES FROM ALL INSTITUTES YOU SEE NICHD IS ONE OF THE LOWEST IF NOT THE LOWEST SUCCESS RATE NICHD ARE THE TWO LOWER INSTITUTES WITH THE LOWEST SUCCESS RATES. WHEN WE LOOK AT THE DATA RELATING TO NUMBER OF APPLICATIONS COMING IN, IT'S VERY CLEAR WITH THE EXCEPTION OF GENOME WE'RE SEEING APPLICATIONS COMING IN THAN OTHER INSTITUTES TO OUR PORTION, TO OUR OVERALL BUDGET AND HISTORICAL PERCEPTION ONE THING THE RPGs OR RESEARCH PROJECT GRANTS AND THINK ABOUT THE SUCCESS RATE, I MENTION THE NUMBER OF GRANTS WE AWARD, IT'S THE NUMBER BASED ON RELATIONSHIP BETWEEN THE NUMBER OF AWARDED TO THE NUMBER RECEIVED. WE ALSO HAVE TO RECOGNIZE EACH OF THOSE APPLICATIONS THAT COME IN HAVE A BUDGET PROJECTED ON BASED OFTENTIMES RELATED TO TYPE OF SCIENCE BUT MOST IMPORTANTLY FOR THIS EXERCISE, IS ALSO RELATED TO THE NUMBER, TYPE OF APPLICATION. YOU HEARD ME SAY THE RPGs REPRESENT RO-3, R-21, RO-1s SO THEY VARY IN SIZE BUT IF YOU LOOK AT 2007 TO 2011, AND DISREGARD THE AMERICAN REINVENTION REINVESTMENT AND REINVENTION ACT OR THE ARRA GRANTS AWARDED THROUGH THE PRESIDENT REINVENTION PROGRAM YOU SEE THAT THE NUMBER INDEED HAS GONE UP IN TERMS OF AVERAGE COST BECAUSE WE DONE NOTICE TIME, WE'RE GOING TO DO MORE DRILLING DOWN TO SEE IF THE AVERAGE COST IS TOTALLY RELATED TO THE SIZE SAY OF AN RO-1 AS OPPOSED TO THE MIX WE'RE SEEING OF RO-1s, R-21s, RO-3s AND THE LIKE. SO THIS GIVES YOU OVERALL PERSPECTIVE WHERE WE HAVE BEEN AND I SHOULD ADD HERE THAT THESE NUMBERS IN CONCERT WITH THE UNDERSTANDING THAT OUR BUDGET HAS BEEN VERY FLAT. IN 2007 THE NICHD OVERALL BUDGET WAS $1.25 BILLION. WE WENT UP TO 1.3 BILLION IN 2008 AND ALAN SHOWED YOU THIS MORNING BASICALLY STAYED THE SAME. IN 2011 WE HAD $100 MILLION LESS THAN IN 2010. SO THIS TABLE IS REFLECTIVE OF NOT ONLY CHANGES IN NUMBER OF GRANTS WE GET BUT CHANGES IN THEIR SIZE AND OBVIOUSLY THE NUMBERS THAT WE CAN AWARD ARE ALSO REFLECTIVE OF THE FACT THAT THE BUDGET HAS ALSO STAYED FLAT. TO GIVE YOU A SENSE OF RFA SET ASIDES, IN MANY SPECIAL AREAS, YOU HEARD DR. CHANGE MENTION THIS MORNING ALONG ALONG WITH DR. CRAIG, WE HAVE REQUEST FOR APPLICATIONS THAT OUR PROGRAM STAFF SCHMITZ TO US FOR SPECIAL AREAS OF SCIENCE, IF YOU WANT TO MOBILIZE SPECIAL AREA OF SCIENCE OR CALL SPECIAL ATTENTION TO A PARTICULAR THERAPY TO ADVANCE BUT YOU WANT TO SET ASIDE MONEY TO DO SO, WE DO RFAs, AS MOST INSTITUTES DO, FUNDING OPPORTUNITY ANNOUNCEMENTS IS ONE TYPE OF FUNDING OPPORTUNITY ANNOUNCEMENT. IN 2007 WE SET ASIDE $13.9 MILLION FOR SPECIAL INITIATIVES. IN 2011 WE SET ASIDE ABOUT 41 MILLION FOR SPECIAL INITIATIVES. VERY INTERESTING AS YOU SEE THE NUMBERS VARY FROM 13.9 MILLION TO 2009 WHERE WE HAD 51.9 MILLION IN SET ASIDES FOR SPECIAL INITIATIVES. THESE ARE RPG SPECIAL INITIATIVES NOT COB FUSED WITH CENTER GRANTS OR NETWORKS. THESE ARE APPLICATION THAT'S CAME IN UNDER RFAs, THAT ARE MEETING THE DEFINITION FOR RPG, SUCCESS RATE FOR 2009 YOU RECALL IN YOUR HAHN OUT THAT I THINK YOU HAVE THE SLIDE THERE, THAT WAS ONE OF THE YEARS IN WHICH WE BEGAN TO THE SEE THE FLUCTUATION INU THE SUCCESS RATE IS LOW. IF YOU WERE TO SAY HOW MANY RPGs ARE REFLECTIVE OF THOSE DOLLARS SAY FOR 2007, OF THE 13 -- THAT 13.9 MILLION ACTUALLY SUPPORTED ABOUT 17 RPGs. AGAIN, WE NEED TO DRILL DOWN TO FINE OUT HOW MANY WERE RO-3, RO-1, ET CETERA. 2008, THAT WAS REFLECTIVE OF 20 RPGs, 2009, 88 RPGs CAME IN AND WERE FUNDED. WERE AWARDED. IN 2009. THAT'S WHERE THE $51 MILLION SHOWS UP. IN 2010, 25 RPGs WERE AWARDED AND IN 2011, 40 RPGS AWARDED. SO WE'RE SEEING THE SET ASIDES, WHEN Y'ALL REVIEW THE RFAs, WE ALWAYS ARE COG MY SANT THAT THE RFAs DO STIFLE MONEY AWAY FROM BUDGET USE FORD INVESTIGATOR INITIATED RESEARCH PROJECT GRANTS BUT AGAIN, IT'S TARGETED, THESE RFAs ARE TARGETED TO THE HIGH PROGRAM RELEVANT NEEDS OF THE INSTITUTE. THEN LAST BUT NOT LEAST I WANT TO DO A QUICK OVERVIEW FOR YOU IN TERMS OF HOW ALL -- WE HAD ALL THE DYNAMICS OF THE VARIOUS RPGs THAT WE SUPPORT BUT I WANT TO FOCUS ON THE RO-1 PAY LINES AS AN EXAMPLE OF HOW THE PAY LINES ALSO HAVE FLUCTUATED OVER THIS PERIOD OF TIME AND HOW PAY LINES AND SUCCESS RATES ARE INTERTWINED. THE ONE THING WE ALL KNOW IS THAT THE RO-1 IS THE GOLD STANDARD FOR INVESTIGATORS. WE HAVE HEARD THAT IT TAKES THEM MUCH LONGER TO GET AN RO-1 NOW, THE AVERAGE AGE FOR RO-1 INVESTIGATOR WHEN THEY CONSIDER THEMSELVES INDEPENDENT AT 42 YEARS OLD AND GROWING. OUR PERCENTILE INDEED HAS CHANGED FROM 2007 HERE ON THE BOTTOM, WE WERE AT A 15th PERCENTILE, THE PERCENTILE IS REFLECTIVE OF THE RANKING OF A PARTICULAR APPLICATION. IN A PARTICULAR STUDY SECTION. SO HOW DID A PARTICULAR APPLICATION RANK ANY PARTICULAR STUDY SECTION? NOT TO BE CONFUSED WITH SUCCESS RATE WHICH IS A REFLECTION OF THE APPLICATIONS RECEIVED AND NUMBER AWARDED. IN FACT, IT WAS IN 2007 WE DID NOT HAVE A DIFFERENTIAL PAY LINE FOR NEW INVESTIGATORS OR EARLY CAREER INVESTIGATORS. BUT WE WERE WORKINGJGr HARD TO BE REFLECTIVE OF THE FACT THAT AS LONG AS WE WERE KEEPING A PAY LINE THAT WERE SO LOW AND SEEING SUCCESS RATE AS WELL AS IT WAS WE NEED TO DO SOMETHING TO INCREASE THE NUMBER OF SCIENTISTS IN OUR FIELDS. SO IN 2008 WE WENT TO A DIFFERENTIAL PAY LINE APPROACH P WHICH THE PERCENTILE FOR ESTABLISHED INVESTIGATORS WAS THE 15th PERCENTILE, 20 PERCENTILE FOR NEW OR EARLY STAGE INVESTIGATORS, IN 2009 WE HAD TO GO BACK TO THE THE 10TH PERCENTILE OR GO TO THE 10TH PERCENTILE BECAUSE THE FUNDING DID NOT ALLOW US, THAT'S THE YEAR, REMEMBER WE GOT MORE APPLICATIONS IN AND WE ALSO HAD MORE SET ASIDE MONEY FOR RFAs. 2010 PERCENTILE WAS ESTABLISHED INVESTIGATORS, 15 PERCENTILE FOR EARLY STAGE INVESTIGATORS. ALAN HAS BEEN PERSISTENT WITH US IN THE SENSE THAT WE -- EVEN IN BAD FUNDING TIMES OR TIMES IN WHICH FUNDS ARE CONSTRAINED THAT WE DO MAINTAIN THAT DIFFERENTIAL FOR NEW INVESTIGATORS. SO IN 2011, FISCAL YEAR 2011, THE MAY COUNCIL, WE REALIZE THE PAY LINE FOR ESTABLISHED INVESTIGATORS AT THE 10TH PERCENTILE AND FOR NEW INVESTIGATORS AT THE 13th PERCENTILE. WE BEGAN THAT FISCAL YEAR AS YOU RECALL, FISCAL YEAR BEGINS IN OKAY SO OCTOBER 2010, THAT WE BEGAN THAT FISCAL YEAR, OCTOBER 2010 WE HAD A PERCENTILE OF ESTABLISH 13 NEW INVESTIGATORS AND WE CARRIED THAT THROUGH IN JANUARY. AND IN MAY WE WERE ABLE TO KEEP A DIFFERENTIAL BUT WE HAD TO DROP BACK TO THE 10TH PERCENTILE FOR ESTABLISHED INVESTIGATORS. I THINK THAT GOES BACK TO MAYBE SOME OF THE DISCUSSION EARLIER RELATE ODD THE SIZE OF THE GRANT, OFTEN TIMES WE CAN DO BETTER WHEN IT COMES TO PICKING UP A GNAW NU INVESTIGATOR BECAUSE OFTENTIMES THE SIZE OF THE GRANT IS SMALLER. SO WHAT HAVE WE LEARNED BRIEFLY WITH THIS EXERCISE WE PLAN TO DO WITH OTHER MECHANISMS AS WELL? THE NUMBER OF RPGs WE AWARDED HAS DECREASED. THE AVERAGE COST OF THE RPG HAS INCREASED. THE NUMBER OF RPGs WE RECEIVED AND HENCE REVIEWED, HAS INCREASED. THE RFAs SOLICITING RPGs ARE CONTRIBUTING WE THINK TO THE NUMBERS, IN PARTICULAR TO THE NUMBER OF APPLICATIONS BECAUSE I FORGOT TO MENTION IT'S NOT ONLY CONTRIBUTING TO THE DOLLARS BECAUSE WE'RE AWARDING SO MANY RPGs THROUGH THE RFA BUT IF YOU LOOK AT THE NUMBERS THAT COME INTO RFAs, WE'RE SEEING HUGE INCREASE IN NUMBER OF APPLICATIONS THAT TOM COM IN RESPONSE TO R FXA. WHEN YOU LOOK AT STAFF RECOMMENDATIONS IN CLOSED SESSION WE CAN HAVE AN RFA WHICH WE'RE GOING TO SUPPORT MAYBE FOUR GRANTS. BUT THAT RFA STIMULATED THE FIELD IN SUCH A WAY THAT YOU GET 90 APPLICATIONS IN, THAT CONTRIBUTES TO THE NUMBER OF APPLICATIONS AND HENCE CONTRIBUTES TO THE SUCCESS RATE. ANOTHER REASON TO MAKE THIS DISTINCTION AND MAKE THIS CLEAR, IS BECAUSE OFTENTIMES YOU HEAR PEOPLE TALKING ABOUT THE VARIOUS INSTITUTES AND THEIR SUCCESS RATES. IT DOESN'T FEEL GOOD TO SAY YOU HAVE ONE OF THE LOWEST SUCCESS RATES. BUT I THINK IF PEOPLE UNDERSTAND AND APPRECIATE SOME OF THE DYNAMICS AN SOME OF THE FACTORS THAT CONTRIBUTE TO THE SUCCESS RATE WE'LL HAVE A BETTER UNDERSTANDING. ALSO WE DO NEED TO LOOK AT OTHER FACTORS THAT CONTRIBUTE TO PAY LINE. NOT ONLY HAWAII YOURTY SET ASIDES AND AVERAGE COST OF GRANTS BUT WE DO NEED TO LOOK AT OREGON FUNDING MECHANISMS AND CENTERS PROGRAM, CORPORATE AGREEMENTS, NETWORK PROGRAMS, TO SEE THE BALANCE THERE AND HOW IT MAY CONTRIBUTE TO RPGs AND VICE VERSA. WE PUT 53% OF THE INSTITUTES BUDGET IN RPGs COMPETING AN NON-COMPETING BY THE WAY, THOUGH I HAVE BEEN SPEAKING MAINLY TODAY OF COMPETING. AS YOU THINK ABOUT THIS NEW GRANTS WE PUT ABOUT 12% BUDGET INTO NEW APPLICATIONS. SO DO WE NEED TO BE LOOKING AT A BALANCE THERE. AND LOOKING AT A BALANCE WITH OTHER FUNDING MECHANISMS SO WITH THAT I'LL STOP. I MAY HAVE A MINUTE FOR ONE QUESTION BUT AFTER THAT WE'RE GOING TO HAVE TO MOVE FORWARD. HOPING THAT WE CAN DO THIS EVERY COUNCIL, MAYBE AT LEAST BRING UP ONE MECHANISM TO SPARK YOUR THOUGHTS AND YOUR JUICES AND WHEN ALAN ASKS QUESTIONS ABOUT ANYTHING YOU CAN SAY I REMEMBER THAT PRESENTATION THAT SOMEONE GAVE SOMETIME AGO ON RPGs AND I WANT TO TELL YOU, I WANT TO OFFER SOME COMMENTS AB HOW YOU MIGHT BE ABLE TO IMPROVE THAT SUCCESS RATE. ONE QUESTION MAYBE IF ANYBODY HAD A COMMENT OR A QUESTION. ALL CLEAR. ALAN WE CAN MOVE TO THE NEXT ONE. WE WILL HAVE SOMEg# DISCUSSION AROUND MANY ISSUES DURING CLOSED SESSION. >> THE NEXT ONE, THANK YOU VERY MUCH, YVONNE, IS GENE HAYUNGA TALKING ABOUT NEW NIH AND THEREFORE NICHD POLICIES, ABOUT SPECIAL COUNCIL REVIEW FOR APPLICATIONS TAKE INVESTIGATOR OVER THE MAGIC $1.5 MILLION TOTAL POST IMPORTANCE OF SO GENE TAKE AWAY. >> I WOULD LIKE TO DESCRIBE A NEW POLICY THAT'S GOING TO BE IMPLEMENTED ACROSS THE NIH IN THE NEXT FEW MONTHS FOR GRANT APPLICATIONS THAT WOULD BE PAID IN FISCAL YEAR 2013. BEGINNING WITH THE SEPTEMBER, OCTOBER COUNCIL ROUND GRANT APPLICATIONS FROM INVESTIGATORS WHO HAVE ALREADY RECEIVED NIH GRANTS OF $1.5 MILLION TOTAL COST OR MORE, WILL BE BROUGHT TO YOUR ATTENTION FOR SPECIAL COUNSEL REVIEW. NOW, IT'S IMPORTANT TO REMEMBER THAT THIS IS NOT A TAP ON THE AMOUNT OF FUNDS THAT AN INVESTIGATOR CAN RECEIVE FROM THE NIH. INSTEAD, IT'S A TRIGGER FOR ADDITIONAL CONSIDERATION TO DETERMINE WHETHER SUCH -- THE NEXT GRANT SHOULD BE AWARDED TO A WELL-FUNDED INVESTIGATOR. THIS APPLIES TO RESEARCH PROJECT GRANTS ONLY. YOU JUST HEARD WHAT THEY ARE. WITH LIMITED EXCEPTIONS, IT WOULD NOT APPLY TO MULTI-COMPONENT OR MULTI-PI APPLICATIONS UNLESS ALL PIs EXCEED THE THRESHOLD. AND IT WOULDN'T APPLY TO PENDING APPLICATIONS THAT HAVE BEEN RECEIVED IN RESPONSE TO RFAs. IN DETERMINING WHICH APPLICATIONS REQUIRE SPECIAL COUNSEL REVIEW WE LOOK AT ALL THE PIs EXISTING RESEARCH SUPPORT RPG AWARDS AT THE TIME OF THE NEXT AWARD TO COUNCIL. THIS INCLUDES MULTI-YEAR AWARDS ACTIVE IN THE CURRENT FISCAL YEAR. FOR PO-1s AN MULTI-COMPONENT RPG WE CONSIDER ONLY THOSE FUNDS ATTRIBUTED TO THE PI PROJECT EXCLUDING THE PORES. FOR MULTIPLE PI APPLICATIONS, THE TOTAL COST OF EXISTING AWARDS WOULD BE APPROPRIATELY DIVIDED AMONG THE DIFFERENT PIs AND MULTI-YEAR SUPPLEMENTS THE COSTS INCLUDED IN THE OUT-YEAR BUDGETS WOULD COUNT TOWARDS TOTAL FOR THAT YEAR. BUDDY VERSETY SUPPLEMENTS AND ENTRY SUPPLEMENTS WOULD NOT COUNT. IN CONDUCTING THE SPECIAL REVIEW, THE NIH INSTITUTES AND CENTERS AND THEIR ADVISORY COUNCILS WILL HAVE THE FLEXIBILITY TO DETERMINE EXACTLY HOW THEY WILL CONSIDER DIFFERENT FACTORS SUCH AS TYPE OF RESEARCH PERFORMED OR SPECIALIZED PURPOSES OF GRANT MECHANISM OR COMPLEXITY OF WHAT THE RESEARCHERS ARE TRYING TO DO. CHARGED TO DEVELOP DETAILS OF IMPLEMENTING THIS POLICY. NOW, WHEN WE RECONVENE THIS AFTERNOON CLOSED SESSION COUNCIL MEMBERS WILL SEE SPECIFIC EXAMPLES OF THE KINDS OF APPLICATIONS TRIGGERED BY THIS POLICY AND DISCUSS WHAT ADDITIONAL INFORMATION YOU WILL NEED TO MAKE YOUR SPECIAL COUNCIL REVIEW. AT THIS TIME I'LL TAKE ANY GENERAL QUESTIONS ABOUT THE POLICY. >> I THINK GENE MADE IT CLEAR THAT WE ARE REQUIRED TO DO A OVERVIEW TODAY AND DO A PILOT TO GET SENSE FROM YOU WHAT ARE THE THINGIOUS NEED TO HELP YOU WITH THIS PROCESS. >> YES, SIR. >> SO WHEN YOU SAY 1 PONTIUS PILATE 5 MILLION TOTAL COSTS DO YOU MEAN FOR THE TOTAL FUTURE OF EXISTING GRANTS? >> PER FISCAL YEAR. TOTAL COST SO FOR EXAMPLE, IN YOUR CONSIDERATIONS YOU MIGHT LOOK AT THE INDIRECT RATE OF A PARTICULAR INSTITUTE AND CONSIDER THAT TO BE A FACTOR IN EXPLAINING WHY AN INVESTIGATOR RECEIVES THAT MUCH MONEY. YES. >> I'M WONDERING IF THIS SPECIAL WORKING GROUP THOUGHT ABOUT POSSIBLY PUBLISHING SOME INFORMATION FOR INVESTIGATORS WHO MIGHT FALL INTO THAT CATEGORY TO UNDERSTAND BETTER WHAT WOULD PUSH THEM OVER THE TOP. WHAT ARE THE PRIORITIES TO EXTENUATING CIRCUMSTANCES, IS IT THE GREAT TRACK RECORD, THE NURTURING OF K PEOPLE IN THEIR LAB, OTHERS -- THINGS THAT WOULD HELP AN INVESTIGATOR DEMONSTRATE THAT THAT FOURTH RO-1 OR WHATEVER WE'RE TALKING ABOUT HERE IS GOING TO BE MORE LIKELY TO BE APPROVED. I THINK IT WOULD BE FAIR THAT THAT -- SOMETHING BE PUT OUT HOW IT WOULD BE PRIORITIZED. AS IT STARTS THE TAKE PLACE. >> NIH PUBLISHED A NOTICE ABOUT THE POLICY. AS WE IMPLEMENT THE FINER DETAIL ALSO COME OUT AND THERE MAYBE SUBSEQUENT INSTRUCTIONS IF NOT A NOTICE, PERHAPS SOMETHING ON THE WEBSITE AN EACH COUNCIL WILL DEVELOP INTERNAL WORKING RULES HOW TO MEET THAT REQUIREMENT. >> I WANT TO EMPHASIZE THE POINT GENE MADE. THE CALL FOR REALLY MAKING THIS VERY CLEAR TO FOLKS IS ABSOLUTELY APPROPRIATE. ON THE OTHER HAND, WHAT WAS WE'RE TRYING TO DO HERE HAVE AN OVERARCHING NIH POLICY. PARENTHETICALLY NOTE WE'RE TRYING TO DO IT MORE. NOT JUST TOUGH BUDGET TIME BUT IN GENERAL TO MAKE POLICIES AS MUCH AS WE CAN CONSISTENT ACROSS NIH. AT THE SAME TIME REALIZING DIFFERENT CONTENT AREAS REQUIRES DIFFERENCE APPLICATION. YOU CAN IMAGINE THE DIFFERENT INSTITUTES THAT FUND HUGE PROJECTS. FOR INSTANCE NHGRI, ET CETERA, ET CETERA VERSUS OTHERS SO THAT'S RECOGNITION TO SOME DEGREE WITH AREA DIFFERENT COUNCILS MIGHT ACTUALLY NEED TO DEVELOP DIFFERENT WAYS TO LOOK THAT THE. WE'RE REQUIRING THAT ALL COUNCILS LOOK. AND THAT BECAUSE OF THE DIFFERENCE IN THE SCIENCE WE ASSUME COUNCILS APPRECIATE BETTER THAT THE COUNCILS WILL DEVELOP INDIVIDUAL CRITERIA WITH THIS. WE WANT SOME CONSISTENCY BUT LOCAL CONTROL THE TO TO MAKE SURE WE ADMINISTER THIS IN THE BEST WAY WHAT WE'RE TRYING TO AT THE END OF THE DAY ADVANCE THE SCIENCE. >> JUST A BRIEF QUESTION. WOULD YOU ALLOW INVESTIGATORS TO SUBMIT ADDITIONAL LETTER OR ADDENDUM TO EXPLAIN TO COUNCIL WHY IT MAY EXCEED 1.5 MILLION? >> THAT WOULD NOT EXCEED THE PROCESS, THE PROCESS WOULD INVOLVE ORDINARILY ACTIONS TAKEN DURING CLOSED SESSION AND THAT TIME THERE WOULD BE INPUT FROM THE PROGRAM STAFF. AS WE DEVELOP INTERNAL PROCESSES SOME WILL INCLUDE PROGRAM STAFF EITHER KNOWING THEIR PORTFOLIOS WELL ENOUGH TO ANSWER THOSE QUESTIONS OFF THE TOP OF THEIR HEAD OR BACK TO THE APPLICANT AND SAYING THIS LOOKS FUNNY. CAN YOU EXPLAIN IT? THIS LOOKS TO NEED MORE DETAIL SO THERE WOULD BE THAT BACK AND FORTH EXCHANGE BUT NOT FORMAL HERE IS A LETTER TO THE COUNCIL TYPE OF THING. YES. >> CAN YOU EXPLAIN THE REASON WHY THEY DECIDE TO LOOK AT TOTAL DOLLARS AS OPPOSED TO DIRECT DOLLARS? THERE'S A BIAS THEN THAT MAYBE OUT OF INVESTIGATORS CONTROL. >> UNDERSTOOD. THAT'S THE LANGUAGE IN THE PRESIDENT'S BUDGET WE'RE REQUIRED TO FOLLOW AND AGAIN, THESE ARE DOLLARS SPENT SO FROM TAXPAYER THAT'S WHAT'S IMPORTANT FROM INVESTIGATORS POINT OF VIEW HOW MUCH MONEY I HAVE IN MY DIRECT COST SO WE HAVE TO CONSIDER THAT. BUT WE ARE FOLLOWING THE LANGUAGE OF THE BUDGET. >> IF COUNCIL DID MUCH BEYOND REVIEW THE SITUATION, THIS WOULD BE SORT OF A CHANGE IN PHILOSOPHY WHERE WE WOULD BE COUNT TORE WHAT STUDY SECTIONS RECOMMENDING MORE THAN WHAT WE NORMALLY DO. IF PEOPLE WERE REALLY SERIOUS ABOUT THIS, HAS THERE BEEN THOUGHT OF THIS BEING A CONSIDERATION STUDY SECTION? >> I THINK YOU HAVE TO VIEW THESE AS TWO SEPARATE ISSUES AND STUDY SECTION FOCUSES ON SCIENTIFIC MERIT WHAT WE'RE DOING IS WITHIN THE CONTEXT OF WHAT WE ALREADY DO. WHENEVER SOMEONE HAS MORE THAN ONE GRANT THE INSTITUTES LOOK AT OVERLAP, AT PERCENT EFFORT, AND THE LIKE AND WE'RE JUST ASKING FOR YOUR INPUT FOR THIS SUBGROUP OF APPLICATIONS. FURTHER CONTEXT, ACROSS THE NIH FOR MAY COUNCIL, ONLY 70 APPLICATIONS FROM PIs WHO WOULD BE AFFECTED BY THIS POLICY, WHO ALREADY WELL FUNDED, ONLY 70 OF THOSE ACROSS THE NIH WERE IN THE RANGE OF 0 TO -- 1 TO 25th PERCENTILE. YOU'LL SEE THIS AFTERNOON THIS IS A SMALL COHORT. >> I THINK WHEN THIS LANGUAGE WAS PUT IN THE PRESIDENT'S BUDGET IT WAS REALLY THOUGHT THERE WERE MORE INVESTIGATORS OUT THERE THAN THERE ARE AND THIS LEVEL AND COULD BE SOME SAVINGS AND CONTRIBUTIONS BUDGET THAT WASN'T GOING TO GROW. BUT WE DIDN'T SEE THAT. >> ITEM ON AGENDA. IS THE MEMBER RAN DUMB OF UNDERSTANDING WITH OUR COUNCIL MEMBERS. AND MR. BRIAN CLARK, WHO IS CHIEF OF OUR GRANTS MANAGEMENT BRANCH WILL PRESENT THE STATEMENT OF UNDERSTANDING TO YOU. WE PRESENT IT EVERY JUNE. >> THANK YOU, MADDOX. THIS REQUIRES AN ANNUAL REVIEW AND I THINK IT'S IN MY BEST INTEREST TO GO THROUGH IT QUICKLY BECAUSE I'M THE LAST ONE STANDING BETWEEN YOU AND LUNCH. STATEMENT OF UNDERSTANDING IS PROVIDED TO YOU, VIA THE COUNCIL MEMBER WEBSITE SO HOPEFULLY YOU HAVE BEEN ABLE TO REVIEW IT THERE. WHAT IS THE STATEMENT OF UNDERSTANDING? IT'S AN AGREEMENT BETWEEN THE COUNCIL AND THE NICHD BASICALLY ABOUT THE COUNCIL'S ROLE AND RESPONSIBILITIES. PRIMARILY AS BEING ADVISORY AND MAKING RECOMMENDATIONS TO DR. GUTTMACHER AS DIRECTOR OF THE INSTITUTE. AND ALSO AS PROVIDING SECOND LEVEL REVIEW FOR ALL APPLICATIONS COMING TO COUNCIL. SO I'LL GO OVER BRIEFLY SECTIONS OF THE STATEMENT OF UNDERSTANDING AND TALK TWO CHANGES, THOSE CHANGES ARE IN THE FIRST AN SECOND SECTION. FIRST SECTION TALKS COUNCIL MEMBERSHIP AND STRUCTURE. Z AS WAS MENTIONED EARLIER, THE SUBCOMMITTEE ON PLANNING AND POLICY IS BEING SUN SETTED. I DON'T KNOW IF YOU HAVE TO WAIT UNTIL THE EVENING TO SUN SET THAT. I DON'T KNOW HOW THAT WORKS BUT SO THAT'S SUN SET. THE SECOND SECTION IS ON SECONDARY REVIEW OF GRANT APPLICATIONS. AND WITHIN THIS SECTION, IT COVERS SPECIAL ACTIONS THAT COME TO COUNCIL AND THOSE ARE MERIT AWARDS, MERIT EXTENSIONS, CO-FUNDING RFAs, FOREIGN, FOREIGN TRANSFERS AND THE LIKE. ONE WE OTHER ADDING TO THIS IS WHAT DR. HAYUNGA JUST REVIEWED. -- PRESENTED, THAT IS APPLICATIONS FROM PIs WITH THE TOLL NIH GRANT SUPPORT ALREADY IN EXCESS OF 1.5 MILLION PER YEAR TOTAL COST. THAT'S ADDED TO THIS LISTING, THAT'S THE SECOND CHANGE TO STATEMENT OF UNDERSTANDING. THIRD SECTION IS ADMINISTRATIVE DECISIONS AN ACTIONS THAT DO NOT REQUIRE COUNCIL, RECOMMENDATION, THESE ARE THINGS LIKE CHANGE PI, CHANGE OF INSTITUTION, APPLICATIONS DEFERRED FROM REVIEW PRIOR TO COUNCIL MEETING. THOSE ARE THINGS NOT RESPONSIBILITY OF COUNCIL. THEN SECTION 4 IS OPTIONS AVAILABLE TO COUNCIL, THESE ARE CONCURRENCE, NON-CONCURRENCE, RECOMMENDATION OF HIGH PROGRAM PRIORITY, LOW PRIORITY AND ALSO DEFERRAL -- DEFERRAL TO OBTAIN ADDITIONAL INFORMATION FOR COUNCIL CONSIDERATION SUBSEQUENT MEETING. THERE'S A SECTION ON EXPEDITED REVIEW. WE HAVEN'T USED THIS BUT KEPT IN A STATEMENT OF UNDERSTANDING IF THERE'S A POINT WE DECIDE TO USE EXPEDITED REVIEW. INTERIM REVIEWS THE NEXT SECTION. THIS IS USED IF THERE'S NEED FOR A COUNCIL REVIEW OF APPLICATIONS, A SPECIAL RFA OR CASE OF REREVIEW OF RFA, BETWEEN COUNCIL ROUNDS. SO THAT'S WHAT INTERIM REVIEW IS. CONCEPT REVIEW, THAT'S THE 6TH SECTION, THAT IS WHAT WOULD BE COVERED THAT IS OPEN SESSION. RECOMMENDATION FOR SPECIFIC MODIFICATIONS. AND THE FINAL SECTION IS EMERGENCY PROCEDURES. SO WE INCLUDE THAT AS WELL THINGS IF WE NEED TO HAVE A TELECONFERENCE FOR COUNCIL PROCEEDINGS. THAT'S WHERE THE REMOTE COUNCIL HAS HELPED TO PILOT THAT IF WE NEED TO DO THAT IN LARGER SCALE. THAT'S IT. ARE THERE ANY QUESTIONS? IF NOT, I BELIEVE WE NEED A VOTE. WE'VE DONE THAT IN THE PAST. >> YOU WANT US TO TAKE A VOTE? OKAY. LET ME ASK YOU GUYS, ARE THERE ANY QUESTIONS AN COMMENTS? YOU'LL SEE A LOT OF MECHANISMS AND YOU'LL SEE A LOT OF THE ISSUES THAT ARE PRESENTED IN THE STATEMENT OF UNDERSTANDING THIS AFTERNOON. YOU'LL SEE THEM IN REALITY, CO-FUNDING ISSUES WITH MERIT NOMINATIONS, ET CETERA F. THERE ARE NO QUESTIONS YOU HAD IT IN YOUR ELECTRONIC COUNCIL BOOK DOCUMENTATION SO YOU HAD A CHANCE TO READ IT. SO MAY I HAVE A MOTION TO ACCEPT THE STATEMENT OF UNDERSTANDING BETWEEN NICHD AND THE COUNCIL? SECOND? ALL IN FAVOR PLEASE SAY -- SHOW HANDS, PLEASE. ANY OPPOSED? THANK YOU. THANKS, BRIAN. OKAY. THAT TAKES CARE OF THE BUSINESS OF THE CLOSE -- OF THE OPEN SESSION OF COUNCIL. AND I WANT TO THANK ALL OF OUR GUESTS AND VISITORS WHO CAME AND TO HEAR OUR PUBLIC SESSION. NOW I LIKE TO INVITE ALL OF THOSE WHO WANT TO HAVE LUNCH TO GET SOME. AND THEN WE'LL BE COMING BACK AT 1:30, 1:30 SHARP FOR THE CLOSED SESSION. ALAN, ANYTHING ELSE TO ADD HERE? >> USUALLY ASK ME TO BANG THE GAVEL BECAUSE YOU GET A KICK OUT OF THAT. I'M CLOSING THE OPEN SESSION AN NOW OPEN THE CLOSED SESSION. THANKS TO YOU FOR COMING THOSE WHO WERE HERE SIMPLY FOR THE OPEN SESSION. >> THANK YOU VERY MUCH.