WE THOUGHT IT WOULD BE VERY HELPFUL FOR YOU TO UNDERSTAND THIS, SO YOU UNDERSTAND WHY YOU ARE ASKED TO DISCUSS CONCEPT CLEARANCES. >> THAT WOULD BE NICE. WHY AM I DOING THIS? SO YES. GOOD MORNING. I THINK TOO THERE HAVE BEEN SOME QUESTIONS IN THE PAST WHEN WE HAVE MET ABOUT HOW DO YOU COME UP WITH THIS STUFF? WHERE IS THIS COME FROM SO THAT IS WHAT I WILL TRY TO DO, PROVIDE A LITTLE TRANSPARENCY WITH REGARD TO WHAT I REFER TO AS INITIATIVE PLANNING PROCESS. IT GOES BY OTHER NAMES IN OTHER PLACES, AND I WILL PROBABLY SLIP INTO A VERNACULAR ONE POINT BECAUSE WE CALL IT INTERNALLY OPERATIONAL PLANNING. BUT BASICALLY WHAT WE ARE TALKING ABOUT IS INITIATIVE PLANNING. FIRST TO SET A CONTEXT FOR YOU. WHEN WE ARE TALKING INITIATIVES WE ARE TALKING ABOUT IDEAS THAT WILL MATERIALIZE THEMSELVES IN TO SOME OPPORTUNITY THAT HAS SET ASIDE FUNDING. SO IT COULD BE AN RFA, A CONTRACT, BUT SOMETHING GOING TO TAKE A PIECE OF FUNDING AND GO WITH THIS IDEA. THIS IS DATA FOR THE ALL OF NIH, THIS IS AVAILABLE ON THE NIH WEBSITE, THERE IS A WONDERFUL THING CALLED A DATA BOOK, IF YOU HAVE -- WANT TO GET FACTS AND FIGURE ABOUT THE NIH, THAT'S PLACE TO GO. THIS IS ONE FACT AND FIGURE THEY HAVE OUT THERE. SO THIS IS FOR RESEARCH PROJECT GRANTS. SO THE GENERAL RPGs, TYPE ONE, SO COMPETING. AND THE PERCENTAGE THAT IS DEVOTED TO WHAT NIH REFERS TO IT AS TARGETED RESEARCH. BECAUSE IF WE PUT OUT AN RFA OR RFP THING, THAT'S TARGETED BECAUSE IT'S COMING FROM THE INSTITUTE AND TARGETING AN AREA OF SCIENCE. SO THE RED LINE FOR THOSE WHO ARE CHALLENGED WITH COLOR, IT'S PROBABLY A GRAY LINE, SORT OF BOUNCES AROUND, THAT'S THE PERCENTAGE. YOU WILL SEE IN 2018 IT WAS ROUGHLY 20% OF THE RPG EXPENDITURES FOR ALL OF NIH WENT TOWARDS TARGETED RESEARCH. PUTTING THAT IN CONTEXT FOR YOU BECAUSE SOMETIMES IT LOST AND PEOPLE ARE THINKING IT'S YOUR ENTIRE BUDGET IS GOING TOWARD THESE INITIATIVES. THAT'S NOT THE CASE. THE MAJORITY OF THE BUDGET GOES TO INVESTIGATOR INITIATED RESEARCH. WITH THE HELP OF ALEXIS, WE CAN'T LIVE WITHOUT HER, WE ALSO LOOKED AT THIS INFORMATION FOR NICHD. AND SO THIS IS WHAT WE LOOKED LIKE IN 2018 BACK TO 2013. WITH THE RED OR GRAY LINE INDICATING THE PROPORTION OUR EXTRAMURAL RPG LINE DEVOTED TO TARGETED RESEARCH. WE ARE AT THE LOWER END. MORE AROUND 10%. SO AGAIN, PERSPECTIVE TAKING IS WHAT THAT IS. SO WHAT IS THEN HOW DOES THIS WHOLE THING GET STARTED? FROM YOUR PERSPECTIVE, THIS WHOLE THING GETS STARTED WITH SOMETHING WE ARE GOING TO BE DOING IN ANOTHER HOUR WHICH IS CONCEPT CLEARANCE. YOU GET THESE CONCEPTS AND YOU ARE LIKE OKAY, SOUNDS GOOD OR NO IT DOESN'T SOUND GOOD. N'T LET ME ASK QUESTIONS ABOUT THAT. WHERE DOES THAT COME FROM, BLAH BLAH BLAH KIND OF STUFF. THAT'S WHAT YOU HAVE BEFORE YOU, SORT OF A OVERVIEW OF WHAT IS THE IDEA, WHAT IS THE SCOPE, THE PURPOSE AND WHAT IT IS IS A WAY THAT WE ARE GOING TO BE USING TO TRY TO STIMULATE RESEARCH TO ACCOMPLISH WHATEVER THAT GOAL PURPOSE OBJECTIVE WAS. THIS IS AN EXAMPLE OF WHAT YOU'RE DISCUSSING IN A WHILE, THIS IS ONE. BUT YOU'RE GOING TO HAVE TO HAVE A CONVERSATION IN TERMS OF CONCEPT. WHERE DO THEY COME FROM? AT THE HEART OF WHERE THEY COME FROM ARE PROGRAM OFFICIALS. IN TERMS OF THEIR ABILITY TO CREATE AN IDEA, AND IDENTIFY ESSENTIALLY A NEED IN THE FIELD. WHERE DOES THAT COME FROM? ONE WAY IS THROUGH CONVERSATIONS WE HAVE INTERNALLY ABOUT DIFFERENT AREAS OF SCIENCE, AND STIMULATING EACH OTHER BECAUSE MANY OF US ARE EXPERTS IN OUR GIVEN AREA AND WE WORK NEXT TO ANOTHER EXPERT NOT NECESSARILY IN OUR AREA. SO THAT CAN BE REALLY QUITE SIMILAR STIMULATING IN TERMS OF THESE CONVERSATIONS ABOUT WOW, THIS IS WHAT MY FIELD THINKS ABOUT THIS. AND THEY ARE LIKE MINE DOESN'T. YOU START HAVING THESE COOL CONVERSATIONS TO TRY TO UNDERSTAND WHERE THERE MIGHT BE SPARK POINTS. OBVIOUSLY PROGRAM OFFICIALS ALSO READ. I KNOW THIS IS OLD FASHIONED IN TERMS OF PRINTED DOCUMENT BUT IT'S CLEARLY ALL THE PROGRAM OFFICIALS ARE STAYING ON TOP OF THE LITERATURE. PUBLIC HEALTH NEED. THINGS HAPPEN. EVENTS SITUATIONS, DISEASE HAPPENS. AND WE ARE NOT IMMUNE ESSENTIALLY TO THAT. SO SOMETIMES THOSE NEEDS REALLY DO DRIVE US AND HELP IN THE DEVELOPMENT OF A SET OF INITIATIVES TO TRY TO ACCOMPLISH GOALS. I THINK WE TALKED EARLIER YESTERDAY ABOUT THE HEAL INITIATIVE. THAT'S A GREAT EXAMPLE OF PUBLIC HEALTH NEED AND WHAT DO WE DO TO TRY TO ADDRESS THAT. SO ANOTHER SET OF FACTORS. THERE'S PRIORITIES FOR THE NIH, FOR THE INSTITUTE, THERE'S BRANCH PRIORITIES. ESSENTIALLY IN TERMS OF RESEARCH. ALL THOSE ARE TAKEN INTO ACCOUNT. LOOKING AT THEIR INDIVIDUAL PORTFOLIOS. THIS IS A AREA THAT NIH HAS NOW DEVELOPED A SERIES OF TOOLS ESSENTIALLY FOR PROGRAM OFFICIALS. TO USE TO TRY TO VISUALIZE THEIR PORTFOLIOS, LOOK FOR GAP AREAS, OBVIOUSLY NOTHING REPLACES READING ESSENTIALLY WHAT'S IN THE PORTFOLIO AND STAYING ON TOP OF IT. BUT THERE ARE AIDS TO THAT PROCESS NOW TO TRY TO REALLY UNDERSTAND WHAT'S MISSING, WHAT WILL REALLY HELP TO ACCELERATE A GIVEN AREA OF RESEARCH. THEN THERE'S MEETINGS AND CONFERENCES SOME WHICH WE CONVENE, SOME WE ATTEND IN TERMS OF PROFESSIONAL MEETINGS, ET CETERA, WHERE THERE'S ALWAYS ADVANCES WITH REGARD TO SCIENCE. SO ALL OF THIS MILIEU BASICALLY IS PULLED TOGETHER BY PROGRAM OFFICIALS IN TERMS OF LOOKING FOR WAYS TO STIMULATE THE FIELD. SO THE BASIC ELEMENTS OF AN INITIATIVE AS SAID BEFORE WAS PURPOSE OF THE GOAL, WHAT IS THE GAP? WHAT IS TRYING TO ESTABLISHED THAT ISN'T ALREADY HAPPENING? NO NEED TO STIMULATE RESEARCH IF IT'S ALREADY HAPPENING. THAT'S PART OF THE INVESTIGATOR INITIATED PART OF THE BLUE LINE I SHOWED YOU EARLIER. WHAT IS IT THAT NEEDS TO BE POKED TO GO FURTHER? IF IT IS A RECURRING INITIATIVE, WHY DO WE NEED TO CONTINUE IT AND WHY NOW AND WHY THIS INSTITUTE? SO THIS GOES TO YESTERDAY'S CONVERSATION WITH REGARD TO STRATEGIC PLANNING BECAUSE THERE ARE OTHER -- MANY TOPICS OF HIGH RELEVANCE TO NIH TO THE FIELDS ET CETERA BUT WE'RE NOT NECESSARILY THE ONLY GAME IN TOWN. WHAT IS OUR PERSPECTIVE WHAT INSTITUTE POSITIONING ITSELF TO DO? OF COURSE HOW MUCH DO THEY THINK IT WILL COST? WE CAN'T IGNORE ESSENTIALLY THE AMOUNT OF FUNDING IT MIGHT TAKE TO ESTABLISH SAID GOAL. AND THE KIND OF GRANT MECHANISM NEEDED, GRANT OR CONTRACT MECHANISM THAT MIGHT BE NEEDED. THIS IS A -- SOMETHING THAT VARIES ACROSS THE INSTITUTES BUT AT LEAST IN THE FEW THAT I HAVE BEEN INVOLVED IN, THIS IS PRETTY GOOD. TO DO THE INITIATIVE PLANNING WE ARE TALKING A TWO YEAR WINDOW. FIRST IT TAKES TIME TO CULTIVATE THE IDEA WHICH IS WHAT WE JUST WALKED THROUGH IN TERMS OF CULTIVATING THE IDEA, THOSE IDEAS WILL THEN COME TO A FORUM THAT WE HOLD INTERNALLY CALLED OPERATIONAL PLANNING AND I WILL GO INTO MORE DETAIL ABOUT THAT IN A LITTLE BIT. THOSE THAT ARE APPROVED AT OPERATIONAL PLANNING THEN THE CONCEPTS HAVE TO BE PREPARED AND BE BROUGHT HERE TO COUNCIL. YOU GUYS THINK THIS IS A GOOD IDEA FOR US TO BE PURSUING? ASSUMING THROUGH THOSE GATES THE NEXT IS DRAFTING WHATEVER THE FUNDING OPPORTUNITIES IS GOING TO BE. THAT'S VERY TIME CONSUMING. THE WORDING IS CAREFULLY CONSIDERED. THERE ARE REQUIREMENTSES WE HAVE IMPOSED NOT IMPOSED BUT REQUIREMENTS FROM NIH ABOUT WHAT HAS TO BE INSIDE FUNDING OPPORTUNITY ANNOUNCEMENT, WE HAVE REGULATORY CONSIDERATIONS THAT HAVE TO BE EXPLAINED IN FUNDING OPPORTUNITY ANNOUNCEMENT. THERE MAYBE SPECIAL TERMS AND CONDITIONS OF AWARD. SO THERE'S LOTS OF STUFF THAT GETS WRAPPED UP INSIDE THAT FUNDING OPPORTUNITY ANNOUNCEMENT. IT DOES TAKE A CONSIDERABLE AMOUNT OF EFFORT AND TIME TO PUT TOGETHER. THOSE FUNDING OPPORTUNITY ANNOUNCEMENTS ARE FUNDED AT MULTIPLE LEVELS OF INSTITUTE BUT GOES OVER TO NIH CENTRAL OFFICE OF EXTRAMURAL RESEARCH, VETTED FROM THEIR PERSPECTIVE THROUGH MULTIPLE POLICY HANDS, FINALLY YOU HAVE A FUNDING OPPORTUNITY ANNOUNCEMENT TO BE PUT ON THE STREET, ALL GOOD. WE ARE REQUIRED FOR FUNDING OPPORTUNITY INVOLVING MONEY ON THE STREET FOR MINIMUM OF 60 DAYS. THERE IS A FEW TIMES IN NIH HISTORY THAT RULE HAS BEEN LESSENED, CHALASIA BUT WE HOLD FIRMLY. PRIMARILY THE REASON WE HOLD TO IT FIRMLY IS, THAT'S SORT OF A MINIMUM AMOUNT OF TIME FOR AN INVESTIGATOR TO READ THE FUNDING OPPORTUNITY ANNOUNCEMENT AND DRAFT DECENT QUALITY FUNDING APPLICATION. YOU CAN'T TURN ON A DIME, NOT TO BE EXPECTED. IN TIMES WHEN NIH HAS PULLED BACK 60 DAY, THAT HAPPENED IN TERMS OF QUALITY OF THE APPLICATIONS THAT CAME IN THE DOOR. SO IT HA Z TO BE OPT STREET 60 DAYS THEN ALLOW ONCE IN ALLOW TIME FOR PEER REVIEW, YOU ALL KNOW VERY WELL. THAT TAKES TIME AN EFFORT ON NUMBER OF PEOPLE'S PARTS. THEN BACK TO Y'ALL AT COUNCIL IN TERMS OF IDEAS HOW WE MIGHT THINK ABOUT THIS IN CLOSED SESSION. AND FINALLY GOES FOR DIRECTOR'S APPROVAL. THAT WHOLE PROCESS BASICALLY IS ABOUT A TWO YEAR PROCESS. TO GET THROUGH. THESE IDEAS AS THEY ARE DEVELOPED HAVE MULTIPLE OPPORTUNITIES FOR INPUT AND MULTIPLE OPPORTUNITIES FOR MODIFICATION. ALL ALONG TIME DOESN'T STAND STILL. OTHER EVENTS HAPPEN. THERE CAN BE BREAK THROUGHS IN PARTICULAR AREAS OF SCIENCE THAT MODIFY ESSENTIAL LE WHAT'S GOING ON HERE. THERE COULD BE MASSIVE CHANGES WHICH WE ARE GOING THROUGH NOW BIG CHANGES WITH REGARD TO GOVERNMENT THAT ALSO CAN DELAY OR EXPEDITE ESSENTIALLY SOME OF THESE ACTIVITIES. DEPENDING WHAT IS GOING ON ON THE NATIONAL SCENE. SO THE INITIATIVES AS I SAID BEFORE, ARE PREPARED BY PROGRAM T. AND THEN WE MEET AS A GROUP, ALL OF US THE WHOLE OF THE DER TOGETHER WITH DR.S BIANCHI AND RODNEY AND OTHERS TO HAVE OPERATIONAL PLANNING. THIS IS THE OPPORTUNITY FOR PROGRAM TO PRESENT THEIR WELL CRAFTED IDEAS ESSENTIALLY, TO EVERYONE. EVERYONE IS ENCOURAGED TO PARTICIPATE IN THE DISCUSSION. BECAUSE AGAIN, THE IDEA THAT SOMETIMES THESE IDEAS ARE IMPORTANT NOT JUST TO ONE PARTICULAR AREA OF SCIENCE BUT TO MULTIPLE AREAS OF SCIENCE. TO MAKE SURE THAT WE ARE HARNESSING ESSENTIALLY ALL OF THAT VALUABLE INPUT AS THIS IDEA IS BEING PREPARED. THIS GENERALLY THERE'S ABOUT 20 TO 30, IT VARIES ON A GIVEN YEAR. IN TERMS OF THESE IDEAS THAT ARE PREPARED, THESE INITIATIVES THAT ARE PREPARED. LEADERSHIP EVALUATES AND DECIDES WHICH TO MOVE FORWARD. ELEMENTS OF EVALUATION GO WITH THE ELEMENTS BEFORE ABOUT WHAT'S IN THE ACTUAL INITIATIVE. THE CLARITY OF GOALS AND OBJECTIVES. DOES IT MAKE SENSE, HAVE THEY THOUGHT THROUGH WHAT STAGE DEVELOPMENT IS THIS IDEA. IS IT FOR EARLY FORMATIVE WORK, ARE THERE TRIALS, WHERE'S THE RIGOR AND REPRODUCIBILITY, CONCEPTS, EXTENT WHICH IT ADDRESSES A VERY IMPORTANT GAP, WHAT IS THE JUSTIFICATION FOR THAT. THEN PRIORITIES AND FUNDING RECOGNIZE. THEN THOSE THAT GET SELECT -- FUNDING NEEDS. THOSE SELECTED COME FORWARD FOR THE CONCEPTS. SO THAT IS IT. THAT WAS THE FULL CYCLE OF TERMS OF INITIATIVE DEVELOPMENT PROCESS. Y'ALL PLAY A CRITICAL ROLE, YOU GET TO LOOK AT THE CONCEPTS TO GIVE YOUR INPUT WITH REGARD TO THOSE. SECOND IN TERMS OF APPLICATION COME IN TO PROVIDE YOUR OPINION WITH REGARD TO ALL OF THAT. THAT'S -- HAPPY TO ANSWER ANY QUESTIONS. YES. I THOUGHT SO. >> THANKS VERY MUCH. I HAVE ONLY BEEN WONDERING ABOUT THIS PROCESS FOR THREE YEARS. SINCE I ARRIVED. THIS IS REALLY HELPFUL. I STILL AM INTERESTED IN WHAT WE DON'T SEE. WE HAVE GOT # 1 COMING NOW -- 11 COMING UP NOW. ONLY FOUR RELATED TO DOWN SYNDROME, TWO RELATED TO HIV. SO HALF ARE RIGHT THERE. I WOULD LOVE TO HAVE AN IDEA OF WHAT THE NINE ARE, THE 29 THAT DON'T MAKE THE LIST. >> SO WHAT HAPPENS SOMETIMES IS, THAT'S A DIFFICULT -- IT'S DIFFICULT TO ANSWER. BECAUSE SOMETIMES WHAT HAPPENS IS STAFF ARE ENCOURAGED TO GO BACK AND RETHINK THE IDEA. LIKE PEER REVIEW PROCESS, IT'S NOT QUITE READY SO IT DOESN'T MEAN IT DIES ON THE VINE. SOMETIMES IT'S DECIDED THAT IT'S NOT TIME NECESSARILY FOR A SET ASIDE OF FUNDS. HOWEVER IT IS AN AREA WE WANT TO ENCOURAGE. SO WE WILL DO PROGRAM ANNOUNCEMENT AS OPPOSED TO HAVING SET ASIDE OF FUNDING. SO RARELY WHAT I SAY THE IDEA IS SORT OF DISSIPATED AND PUT OUT OF PRACTICE ESSENTIALLY. IT COMES BACK, YOU MIGHT GET MORPHED GIVEN FEEDBACK THROUGH THE OPERATIONAL PLANNING IDEA. THAT'S WHAT HAPPENS. IF THERE IS A PASSIONATE IDEA FROM A PROGRAM PERSON THEY ARE NOT GOING TO JUST DROP, THEY WILL FIND ANOTHER WAY TO GET THAT SCIENCE GOING. Q. MAYBE WE CAN DO THIS A BUNCH WITH SOME OF THE PROGRAM OFFICERS BUT I WOULD BE INTERESTED TO NOW WHAT -- HOW ONE FEEDS IN TO THOSE MECHANISMS. HOW OTHER THANH HAVING INTERNALLY GENERATED IN THE MINDS OF THE PROGRAM OFFICERS, CAN CONCEPTS BE GENERATED FROM? >> I TRIED I TRIED TO WALK THROUGH THE GENERAL GUESS AT ALL TIMES THAT WE WALK THROUGH. ONE THING WE ALL TAKE SERIOUSLY AT NIH IS PERCOLATE IDEAS IN INTERNALLY AND THOSE THAT PARTICULARLY THAT ARE GOING TO HAVE SET ASIDE OF FUNDS WE HAVE A STRICT PATHWAY THAT WE FOLLOW IN TERMS OF CONCEPT CLEARANCE. WE WANT TO MAKE SURE IT'S AN EQUAL OPEN OPPORTUNITY KIND OF THING. PROGRAM STAFF, FEEL FREE TO ANXIOUS, GET IDEAS FROM ALL DIFFERENT KINDS OF CONVERSATIONS AND READING THEY PARTICIPATE IN. SOMETIMES COMES FROM LOOKING AT THE PROGRESS REPORTS. YOU HAVE READ SIX PROGRESS REPORTS IN YOUR PORTFOLIO, THEY ARE STUCK OPT SAME THING. THAT'S A PROBLEM. WHAT DO I DO. IT COMES FROM DIFFERENT PLACES. >> COULD I SAY SOMETHING AS WELL? I THINK ONE OF THE REASONS WHY I WANTED THIS DISCUSSED IS THE IMPLICATION IS WE ARE TWO YEARS IN ADVANCE COMMITTING HE CAN PERCENTAGE OF OUR RESEARCH FUNDS THAT ARE AVAILABLE. SO I DON'T THINK I APPRECIATED THAT AS MUCH AS I SHOULD HAVE WHEN I WAS ON THE ADVISORY COUNCIL. THAT IT'S NOT JUST -- I MEAN YES, EVERYTHING THAT YOU SEE HAS GONE THROUGH PREVIOUS VETTING BUT THE COUNCIL IS STILL EMPOWERED TO TAKE THESE ASSIGNMENTS SERIOUSLY INITIATED PROJECTS. I GOAT THAT. ALL RIGHT. THANKS. >> THANK YOU, DELLA. WE WILL GET TO THE CONCEPT CLEARANCES IN A MOMENT BUT BEFORE THEN, I'M HAPPY TO INTRODUCE DR. EUGENE HAYUNGA, DIRECTOR OF THE OFFICE OF EXTRAMURAL POLICY AT NICHD. AND HE IS GOING TO GIVE US A PRESENTATION ON NICHD INCLUSION. DATA. >> THANK YOU, DR. BIANCHI. ONE OF THE PROVISIONS OF THE NIH REQUIREMENTS REVITALIZATION ACT OF 1993 IS REQUIREMENT THAT WOMEN AND MINORITIES MUST BE INCLUDED AS SUBJECTS IN PAUL CLINICAL RESEARCH CONDUCTED OR SUPPORTED BY THE NIH, UNLESS THEY'RE INCLUSION IS INAPPROPRIATE WITH RESPECT TO THE HEALTH OF THE SUBJECTS OR THE PURPOSE OF THE RESEARCH. AND ANOTHER REQUIREMENT IS THAT THE ADVISORY COUNCIL OF EACH NATIONAL RESEARCH INSTITUTE SHALL PREPARE REPORTS DESCRIBING THE MANNER IN WHICH THE INSTITUTE HAS COMPLIED WITH SUCH AD VALOR RUM. IS THE TRY ANNUAL REPORT THIS YEAR WILL FOLLOW UNIFORM FORMAT ACROSS THE NIH, STARTING WITH AN OVERVIEW OF THE INSTITUTE MISSION AND RESEARCH PORTFOLIO. THE SECTION ON STRATEGIES FOR ENSURING COMPLIANCE DESCRIBES THE GENERAL PROCESSES AND RESPONSIBILITIES OF PEER REVIEW, PROGRAM, GRANTS MANAGEMENT, AND OVERSIGHT AND INTRAMURAL RESEARCH AND STAFF TRAINING APPROACHES. THE ENROLLMENT DATA ARE PRESENTED IN SPECIFIC AREAS OF EMPHASIS ARE THEN HIGHLIGHTED. SO THE COMPLETE TRY ANNUAL REPORT IS PROVIDED IN THE COUNCIL MATERIALS FOR YOUR CONSIDERATION. AND WILL BE POSTED AS PART OF THE PUBLIC RECORD FOR THIS ADVISORY COUNCIL MEETING. MY PURPOSE TODAY IS TO GIVE YOU A VERY BRIEF SUMMARY OF THESE MATERIALS PRIOR TO YOUR DISCUSSION AND OUR REQUESTS FOR APPROVAL. SO BASICALLY THE AGGREGATE ENVOLE ROLEMENT DATA ARE PRESENTED IN STANDARDIZED TABLES DEVELOPED BY OFFICE OF EXTRAMURAL RESEARCH AT NIH. AND THESE WILL DEPICT THE OVERALL COMPLIANCE SO THIS -- I'M JUST GIVING A LITTLE BIT OF EXTRACTS FROM WHAT WAS PRESENTED IN THE FULL REPORT. THE FIRST TABLES IN THE REPORT PROVIDE AN OVERVIEW OF THE SCOPE OF NICHD RESEARCH PORTFOLIO. TO SHOW THE NUMBER OF INCLUSION RECORDS, IERs, FOR CLINICAL RESEARCH PROJECTS AND PHASE 3 CLINICAL TRIALS OVER THE THREE YEARS OF THE REPORT PERIOD. SO THE DATABASE SHOWED 1,070 ENROLLMENTS FOR NICHD GRANTS CONTRACTS AND INTRAMURAL PROJECTS IN 2016 FOR EXAMPLE. AND OF THOSE 40 IDENTIFIED ADS PHASE 3 TRIALS. AND THE FULL REPORT SHOWS SIMILAR NUMBERS FOR 2017 AND 2018 AND ANY REPORT NOT SHOWN ON THE SLIDE THERE ARE COLUMNS MARKED IERs WITHOUT ENROLLMENT AND THOSE REPRESENT PROJECTS RECRUITMENT HAS NOT BEGUN OR WHERE THE ENROLLMENT HAS NOT YET BEEN REPORTED. AND WE ALSO SHOW THE NUMBER OF U.S. VERSUS NON-U.S. PROJECTS AS WELL AS THOSE INVOLVING FEMALE ONLY OR MALE ONLY STUDIES. SO LOOKING AT THE AGGREGATE ENROLLMENT DATA, EXTRACT WHAT'S IN THE FULL REPORT, FOR PROJECTS IN 2016 WE SEE THE MAJORITY OF PARTICIPANTS ENROLLED WERE FEMALE. 67.6%. ONLY 1.7 WERE UNIDENTIFIED WITH RESPECT TO SEX AND GENDER. IN 2017 AND 2018 FEMALES REMAINED THE MAJORITY. NOT DEPICTED IN THIS SLIDE BUT FOUND IN THE REPORT IS A COMPARISON OF THE EXTRAMURAL AND INTRAMURAL AGGREGATE ENROLLMENT NUMBERS AND THOSE SHOW A MUCH HIGHER PERCENTAGE OF FEMALES IN INTRAMURAL PROJECTS ALL THREE YEARS AND THIS REFLECTS A LARGE NUMBER OF FEMALE ONLY CLINICAL TRIALS IF WE LOOK AT THE MAJORITY ENROLLMENT IN ROW ARE RESEARCH PROJECTS FROM U.S. SITES, IN 2018 FOR EXAMPLE, 1.3% OF ALL THE FEMALES ENROLLED WERE AMERICAN INDIAN ALASKA NATIVE. ASIAN FEMALES WERE 4 PERCENT, BLACK AFRICAN AMERICAN, 22.2%, NATIVE HAWAII PACIFIC ISLANDER 1.5 AND MORE THAN ONE RACE 4. IF WE LOOK AT ETHNICITY, THE AGGREGATE ENROLLMENT DATA SHOW IN 2018 AS AN EXAMPLE, 13.2% OF THE FEMALES AND 15.1 PERCENT OF THE MALES IDENTIFY ADS HISPANIC. SINCE THESE ARE AGGREGATE ENROLLMENT DATA ANY CONCLUSIONS MUST BE GUARDED. WHEN ASSESSING THESE DATA ENROLLMENT FIGURES SHOULDN'T BE DIRECTLY COMPARED TO THE NATIONAL CENSUS FIGURES BUT INSTEAD DETERMINING WHETHER INCLUSION IS APPROPRIATE WILL DEPEND UPON THE SCIENTIFIC QUESTION BEING ASKED, FOR -- AND THE PARTICULAR STUDY AND THE PREVALENCE OF THE DISEASE DISORDER OR CONDITION UNDER INVESTIGATION. THESE ARE BEST ASSESSED ON A CASE-BY-CASE BASIS. FIRST TARGET ENROLLMENT IS ASSESSED DURING REVIEW. AND THEN ACTUAL ENROLLMENT WHEN THE PROGRESS REPORTS ARE SUBMITTED. FINALLY IT'S IMPORTANT TO REMEMBER THAT THE DATA ON INCLUSION WOMEN AND MINORITIES ARE BASED ON SELF-IDENTIFICATION OF THE PARTICIPANTS. IN ACCOUNTS FOR UNKNOWNS IN THE DATA TABLE. SO THE REPORT DESCRIBES RECENT POLICY CHANGES, IT HIGHLIGHTS NICHD RESEARCH RELATED TO INTELLECTUAL AND -- INTELLECTUAL DEVELOPMENT OR DISABILITIES. WE HIGHLIGHT RESEARCH ADDRESSING HEALTH DISPARITIES, THE REPORT INCLUDES A SAMPLING OF NOTEWORTHY PROJECTS AND PUBLICATIONS ADDRESSING DIFFERENCES BETWEEN SELECTED GROUPS. SO WHAT CAN WE LOOK FORWARD TO IN THE FUTURE? FOLLOWING RECENT POLICY CHANGES, MILESTONES ARE NOW BEING REQUIRED FOR CLINICAL TRIAL APPLICATIONS. AND AWARDS TO MONITOR THEIR PROGRESS INCLUDING THE ENROLLMENT GOALS. NIH RECENT HI DEVELOPED A SYSTEM TO DISPLAY ENROLLMENT DATA ACCORDING TO THE NIH RESEARCH CONDITION DISEASE CATEGORIZATION, RCDC CODE. AND THIS WILL ENABLE FILTERING THE DATABASE TO PULL EPIENROLLMENT DATA FOR CLINICAL RESEARCH PROJECTS BASED ON PARTICULAR CONDITIONS. FINALLY RECENT CHANGES IN THE NIH POLICY ON THE INCLUSION OF CHILDREN, NOW INCLUSION OF INDIVIDUALS ACROSS THE LIFE SPAN, WILL ENABLE NIH IN THE DATA AND ANALYSIS OF CHILDREN DIFFERENT AGES IN THE CLINICAL RESEARCH PROJECTS. IN CONCLUSION, WE HAVE PROCESSES IN PLACE, THE AGGREGATE ENROLLMENT DATA PROVIDE OVERVIEW OF OUR RESEARCH PORTFOLIO AND CLEARLY SHOWED SUBSTANTIAL INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH PROJECTS AND TRIALS SUPPORTED BY NICHD. WHAT IS NOT SHOWN IN THE TABLES IS THE ONGOING OVERSIGHT OF EACH INDIVIDUAL PROJECT BY NICHD STAFF TO MONITOR PROGRESS MADE IN RECRUITMENT AND REACH PLANNED ENROLLMENT GOALS. AND PROVIDE GUIDANCE TO INVESTIGATORS AS NEEDED. EVEN MORE IMPORTANT THAN AGGREGATE DATA ARE NUMEROUS CONTRIBUTIONS TO SCIENTIFIC KNOWLEDGE THAT WILL BE GENERALIZABLE TO DIFFERENT POPULATIONS AND WE ATTEMPTED TO SHOW THAT IN -- IN THE LIST OF GRANTS AND PUBLICATIONS AT THE END. IT IS IMPORTANT TO REMEMBER FROM THE OUTSET 20 YEARS AGO THE NIH INCLUSION POLICY HAS BEEN SCIENCE-DRIVEN. THE PRIMARY FOCUS OF THE POLICY HAS BEEN TO IDENTIFY AND REMEDY GAPS IN SCIENTIFIC KNOWLEDGE IN SUCH A MANNER THAT THE RESULTS WILL BE GENERALIZABLE TO ALL POPULATIONS IN THE UNITED STATES. THE INCLUSION POLICY IS BASED ON THE CLINICAL PRINCIPLES OF JUSTICE AND BENEFICENCE. AS IT STRIVES TO ASSURE ALL GROUPS SHARE IN BOTH THE RISKS AND POTENTIAL BENEFITS OF PARTICIPATING IN A CLINICAL RESEARCH. THE POLICY REPRESENTS PARTNERSHIP BETWEEN RESEARCHERS, NIH STAFF AND MOST IMPORTANTLY THE MILLIONS OF INDIVIDUALS WHO AGREED TO PARTICIPATE IN RESEARCH. PUTTING THIS REPORT TOGETHER IS A TEAM EFFORT, LOT OF PEOPLE HAVE BEEN INVOLVED AND I WANT TO ACKNOWLEDGE SOME OF THE KEY ONES. SANDY DELCORN, THOMPSON WORKED WITH ME TO PREPARE THE REPORT, I PARTICULARLY WANT TO SINGLE OUT SANDY OUR ERA COORDINATOR. ERA STANDS FOR ELECTRONIC RESEARCH ADMINISTRATION. SO YOU KNOW HER BECAUSE OF THE COUNCIL MEMBER WEBSITE. THAT IS ONLY ONE OF MANY SYSTEMS SHE'S RESPONSIBLE FOR. THEY RUN SMOOTHLY BECAUSE OF WHAT SHE DOES EVERY DAY. AND SHE MAKES IT LOOK EASY BUT IT ISN'T. AND WE ARE GRATEFUL TO SANDY FOR KEEPING A LOT OF THE EXTRAMURAL OPERATIONS GOING. I WANTED TO THANK MELISSA PERISI AND SHAH REECE LAMAR WHO WROTE SECTIONS OF THE REPORT THAT DESCRIBE INTELLECTUAL DEVELOPMENTAL DISABILITIES AND HEALTH DISPARITIES. AND I WANT TO THANK REBECCA CLARK FOR THE DEMOGRAPHIC DATA AND SINGLE OUT JIM GRIFFIN AND LISA KEISER WHO HAVE BEEN INVOLVED IN DEVELOPMENT OF RELATED POLICY THAT HAS TO DO WITH INCLUSION OF CHILDREN. I ALSO WANT TO GIVE SPECIAL MENTION TO DELLA HANN AND MARY O'CONNER WHO THROUGH PORTIONS OF THEIR CAREERS HAVE BEEN VERY MUCH INVOLVED IN IMPLEMENTING AND COORDINATING THE INCLUSION POLICY ACROSS THE NIH. AND FINALLY NUMEROUS STAFF AT NICHD PROGRAM REVIEW GRANTS MANAGEMENT WHO MAKE THIS HAPPEN EVERY DAY. AND STAFF AND OER THAT PROVIDE OVERSIGHT ON THE NIH BASIS. AND FINALLY, THE OFFICE OF RESEARCH ON WOMEN'S HEALTH WHICH MANY YEARS AGO SPEARHEADED THIS EFFORT. [APPLAUSE] >> THE AGGREGATE DATA LOOKS GOOD AND I UNDERSTAND THE INDIVIDUAL GRANT DATA IS WHERE THE RUBBER MEETS THE ROADS KIND OF. >> EXACTLY. >> SO I THINK IT WOULD FALL INTO THREE CRITERIA, IT'S GREAT YOU HIGHLIGHTED THE STUDIES THAT LOOK AT THAT AS A FOCUS. THAT'S AN IMPRESSIVE LIST OF STUDIES. DO WE HAVE -- THERE ARE SOME STUDIESES THAT ARE STILL FALLING IN THIS REALM OF WE DON'T NEED -- WE CAN'T RECRUIT BECAUSE OF SCIENTIFIC REASONS, WHICH I GUESS IS NOW NOT SUPPOSED TO BE ALLOWED, IT HAS TO BE SAFETY FOR THE INDIVIDUAL. I'M CURIOUS IF THERE IS -- WE HAVE AN UNDERSTANDING HOW MANY STUDIES FALL INTO THAT. THEN OF THOSE STUDIES THAT HAVE A GOAL, AND AREN'T LOOKING AT IT AS A SPECIFIC FOCUS. DO WE HAVE AN IDEA HOW WE ARE DOING FROM -- AS A PERCENTAGE OF STUDIES AMOUNT? THAT WOULD BE AN INTERESTING METRIC TO LOOK AT. >> I DON'T KNOW THAT WE HAVE DATA ON THE LAST PORTION BUT AS FAR AS NOT RECRUITING, NOT INCLUDING PEOPLE THE WAY THEY ARE SUPPOSED TO, THIS OF COURSE IS A KEY FEATURE OF PEER REVIEW, IT IS LOOKED AT AND ANYTHING THAT DOES NOT APPROPRIATELY EXPLAIN WHY SOMEONE MIGHT NOT BE INCLUDED, THE OBVIOUS THINGS, STUDY ON DISEASE WOULD HAVE NO FEMALES BUT THOSE WOULD BE FLAGGED BY PEER REVIEW. THEY'RE ACTUALLY GIVEN PART OF FUNDING WE CANNOT PROCEED WITH AN AWARD UNTIL THAT ISSUE SAW RESOLVED. THOSE CONSIDERATIONS ARE ALSO REFLECT IN THE SCORE. THERE MAY ALSO BE CASES WHERE THE APPLICANT MAKES A COMPELLING CASE THAT WE ALREADY KNOW THAT THERE ARE NO DIFFERENCES BETWEEN ONE GROUP AND ANOTHER WITH REGARD TO SAY A CERTAIN ENZYME. IN THOSE SITUATIONS WHILE YOU MAY NOT FOCUS ON PARTICULAR GROUP, WE ARE STILL ENCOURAGING EVERYONE TO INCLUDE WOMEN AND MINORITIES UNDER THE GENERAL PRINCIPLE OF JUSTICE, THAT EVERYONE NEEDS TO SHARE IN BOTH THE RISKS AND POTENTIAL BENEFITS. LAST QUESTION MOST INTERESTED, BE INTERESTING TO LOOK AT THAT, THE FIRST PART OF THAT IS WHAT HAPPENS IN PEER REVIEW IS OFTEN -- IT WOULD BE GREAT TO SEE THE NEEDLE WAS MOVING. BECAUSE I THINK AT SOME POINT IN THE PEER REVIEW PROCESS MY MEMORY FROM BEING ON COMMITTEE IS IT'S A CHECK BOX AND I THINK NIH IS TRYING TO MOVE THE NEEDLE ON THAT. SOARS PERCENTAGE OF STUDIES GIVEN EXEMPTION TO SAY NO WE DON'T HAVE TO WORRY ABOUT RECRUITING WOULD BE GOING DOWN OVER TIME. THAT'S PROBABLY AN NIH WIDE THING. >> HOW MUCH -- THE NUMBERS WERE NEVER BAD TO BEGIN WITH, EVEN WHEN WE STARTED THIS BACK IN 1994, THERE ARE EDITORIALS SAYING THIS WAS GOING TO SCREECH TO A HALT. AND WOULD BE TOTALLY UNTENABLE. THE DATA AT THAT TIME SHOWED WELL OVER 90% OF THE APPLICATIONS WERE IN COMPLIANCE, VERY FEW WERE NOT. IN IF FACT, THOSE -- WE JUST STOPPED REPORTING NUMBERS ALWAYS 90 SOMETHING PERCENT. YES. >> GENE, IN YOUR 2018 DATA YOU HAD I THINK 14% UNKNOWNS AND SOME DEMOGRAPHIC GROUPS, 14% IS OBVIOUSLY LARGER THAN THE PROPORTION OF SOME OF -- SEVERAL DEMOGRAPHIC GROUPS. I KNOW WE ARE RELYING ON SELF-IDENTIFICATION BUT DO WE HAVE AN UNDERSTANDING WHAT BARRIERS MIGHT BE IF SPECIFIC DEMOGRAPHIC GROUPS THAT MIGHT BE LESS WILLING TO SELF-IDENTIFY THAN OTHERS? WHAT TYPES OF INTERVENTIONS MIGHT BE HELPFUL IN LOWERING THAT PERCENTAGE? >> THAT'S CERTAINLY A GOOD QUESTION. I DON'T THINK WE HAVE A GOOD HANDLE ON IT, IT'S SELF-REPORTING AND YOU HAVE TO LOOK AT INDIVIDUAL STUDIES ARE THERE PARTICULAR PROBLEM AREAS, IS THERE PARTICULAR DISEASE WHERE PEOPLE DON'T WANT TO BE STIGMATIZED WITH A CERTAIN GROUP? >> WE CAN LOOK INTO THAT FURTHER. >> THANK YOU VERY MUCH FOR THE REPORT. THE INCLUSION OF THESE TWO SECTIONS, I'M SORRY EVER I DIDN'T GET A CHANCE THE LOOK BEFORE TODAY BUT INCLUSION OF SECTIONS INTELLECTUAL DISABILITY AND HEALTH DISPARITIES IN ADDITION TO REPORT DIVERSITY INCLUSION CRITERIA, SUGGESTS SOME SIN CROW IN THISTY? I WAS -- SIN CROW IN -- >> REPORT OF EXAMPLES TO HIGHLIGHT. NICHD DOES HAVE AN INTEREST IN THAT KIND OF RESEARCH AND YOU MIGHT LIKE TO SEE WHAT WE'RE DOING ON IT AND PROGRESS MADE. >> RELATIONSHIP BETWEEN THOSE AREAS AND THE OVERALL COMPLIANCE ON INCLUSION. >> SO TO ANSWER THAT QUESTION WE'D HAVE TO DIG DEEPER INTO THE DATA. I MENTIONED A TOOL TO PULL OUT SPECIFIC STUDIES USING THE RCDC CODES. THAT TOOL WAS LITERALLY RELEASED A COUPLE OF DAYS AGO. SO WE NEED TO PLAY WITH IT AND SEE WHAT THE TOOL WILL YIELD US. IT IS PUBLICLY AVAILABLE TO ANYONE WHO WANTS -- >> SORRY, I'M NOT CLEAR. I GUESS WHAT I'M ASKING IS THE OVER EMPHASIS ON INCLUSION GUIDELINES FOCUS ON WOMEN AND MINORITIES. >> CORRECT. >> NOT ON HEALTH DISPARITIES IN PEOPLE WITH INTELLECTUAL DEVELOPMENTAL DISABILITIES? >> IT'S A SEPARATE ISSUE. >> SEPARATE ISSUE. SO I'M -- I GUESS MY PERHAPS OBVIOUS QUESTION IS, WHAT WOULD IT TAKE TO HAVE INTEREST IN INTELLECTUAL DEVELOPMENTAL DISABILITY INCLUDED IN THE BROADER NICHD WIDE OR NIH WIDE, FOCUS ON THESE INCLUSION GUIDELINE? WOULD IT TAKE LEGISLATIVE ACTION? I GATHER THIS IS PROMPTED BY CONGRESSIONAL ACTION. WOULD IT TAKE SOME SCIENTIFIC CONSENSUS? WOULD IT TAKE ADVOCACY OR COMBINATION? OR IS IT NOT DESIRABLE FOR SOME REASON? I'M NOT CLEAR ON IT. >> CERTAINLY, THIS IS A PRIORITY FOR NICHD AND WE CONTINUE TO LOOK AT THOSE GROUPS. AND THAT PARTICULAR AREA OF RESEARCH. THE REPORT I'M PRESENTING IS BASED ON LEGISLATIVE REQUIREMENT. AND THAT LEGISLATIVE REQUIREMENT GREW UP IN THE 1990s FOR A NUMBER OF REASONS. NIH WAS ALREADY PAYING ATTENTION IS TO WOMEN'S HEALTH BUT THERE WAS THIS NEEDED TO BE STRENGTHENED BY LEGISLATION. WHAT YOU ARE SAYING IS BEING HEARD AND OF INTEREST AND NICHD WILL FOLLOW THIS WITH OR WITHOUT LEGISLATION. >> JUST TO ADD, GENE, YOU ALLUDED TO TOO, THE NEW TOOLS. FOR OUR INSTITUTE IT'S INTELLECTUAL DEVELOPMENTAL DISABILITIES FOR OTHER INSTITUTES IT'S OTHER POPULATIONS OF INTEREST. SO THE HOPE IS S WE HAVEN'T HAD A CHANCE TO WORK WITH IT IS THAT FOR THOSE SAID POPULATIONS TO BE ABLE TO USE THIS OTHER TOOL RCDC TOOL, TO SAY GIVING ALL THE STUDIES, GIVEN ALL RESEARCH CODIFIED ESSENTIALLY FOR THAT PARTICULAR GROUP OF PEOPLE AND THEN LET US BE ABLE TO DRILL INTO AND LOOK AT HOW IT'S FARING WITH REGARD TO INCLUSION OF FEMALES AND DIFFERENT RACIAL ETHNIC GROUPS. SO THAT WAS -- BECAUSE OTHERWISE WE WOULD BE TRYING TO GATHER POTENTIALLY IF YOU LOOK ACROSS THE NIH TREMENDOUS NUMBERS OF INDIVIDUAL CATEGORIES THAT WILL BECOME DIFFICULT. FROM >> YES. >> SO I -- MY UNDERSTANDING THESE NUMBERS, THESE ARE FOR FORWARD RECRUITMENTS, RIGHT, FOR RECRUITMENTS IN THE STUDY YOU MENTION PHASE 3. YOU SAW SAMPLES BIOBANKS SAMPLES OR DATA ALREADY ACCUMULATED, RIGHT? >> THAT'S RIGHT. THESE ARE PROSPECTIVE STUDIES. YES. >> RIGHT. SO SINCE -- SO I'M GOING TO BRING UP THE SAME POINT OTHERS HAVE BROUGHT UP. IS THIS FRAMEWORK STILL THE RIGHT FRAMEWORK FOR NICHD WITH REGARD TO SCOPE HERE, WE DO KEEP SEEING REVIEW ARTICLE AFTER REVIEW ARTICLE TALKING ABOUT FOR EXAMPLE GWAS, IN VERY SPECIFIC POPULATIONS, NOT VERY INCLUSIVE. THE FUTURES PROGRAM IS TAKING ON ITS OWN APPROACH LOOKING FOR UNDER-REPRESENTED RESEARCH COMMUNITIES THROUGH IN A MORE VERY TARGETED INTERVENTIONAL WAY GO AFTER THOSE POPULATIONS THAT ARE CHRONICALLY UNDER-REPRESENTED IN RESEARCH. IT IS JUST REPORTING THIS WAY ENOUGH TODAY? >> I THINK THE IMPORTANT THING TO REMEMBER IS THAT NIH IS ABOUT SCIENTIFIC DISCOVERY AND TO DOVE TAIL IN WITH THE PRESENTATION YOU JUST HEARD FROM DR. HANN, OUR INTEREST IS IDENTIFYING GAPS IN SCIENTIFIC KNOWLEDGE, THE KIND OF THING YOU MENTION COULD BE A GAP AND AS WE HEARD IN OUR PRESENTATION FROM ONE OF THE PARTICIPANTS, WE ARE SENSITIVE TO INTEREST OF VARIOUS GROUPS. THIS IS WHY INCLUSION POLICY WAS FIRST PROMULGATED. AND WE OPERATE WITHIN THE CONTEXT OF THAT REQUIREMENT. SO A PART FROM WHAT THE REQUIREMENT IS, THESE ARE THINGS THAT WE ARE GOING TO PAY ATTENTION TO. >> WANT TO CONTINUALLY UPDATE THIS PROCESS. THIS IS THE FIRST TIME I HAVE HEARD ABOUT THIS. BUT IT'S. IS THERE A FRAMEWORK NIH WIDE TO CONTINUOUSLY UPDATE HOW WE DO IS THIS THIS? >> DELLA. >> THERE IS THROUGH THE NIH AND OFFICE OF EXTRAMURAL RESEARCH AND OFFICE OF WOMEN'S HEALTH LEAD AND NATIONAL INSTITUTE OF HEALTH MINORITY AND HEALTH DISPARITIES IS INVOLVED. THEY RUN A COORDINATING COMMITTEE AND TALK ABOUT THESE ISSUES AND TRY TO ADDITIONAL TOOLS, METHODS WE CAN EMPLOY, ET CETERA BUT THE FUNDAMENTAL PIECE OF THAT TOOL IS THE LEGISLATION. SO THE LEGISLATION WAS UPDATED THROUGH THE 21st CENTURY CURES ACT. SO THAT WILL NOW SUPERSEDE WHAT WAS THERE BEFORE. THAT'S WHAT NIH IS TRYING TO DO IS TO COME INTO COMPLIANCE WITH CONGRESSIONAL MANDATES. >> OKAY. THANK YOU, GENE. WE NEED A MOTION TO APPROVE. >> I MOVE WE APPROVE. >> SECOND? (OFF MIC) >> ALL THOSE IN FAVOR. ANYONE OPPOSED? MOTION CARRIES. THANK YOU. NOW LAST ITEM IN OUR AGENDA BEFORE BREAKING FOR LUNCH, DELLA WILL PRESENT THE CONCEPT CLEARANCE REVIEW, WHICH ARE NOW PREPARED FOR. WE HAVE LEFT EXTRA TIME FOR DISCUSSION. >> THANK YOU VERY MUCH. WE DO. WE DO HAVE 11. HOWEVER YOU WILL SEE AT LEAST A GROUP OF THEM THAT WILL BE A LITTLE BIT MORE CONDENSED. FOR EACH CONCEPT I WILL ASK THE STAFF JOIN AT THE TABLE RIGHT NEXT TO DR. SEWN IS A GOOD SPOT AND PROVIDE AN OVERVIEW OF THE INITIATIVE THEN ASK THE COUNSEL FOR ANY DISCUSSION WITH REGARD TO THE CONCEPT. AT THE CONCLUSION OF THE DISCUSSION OF EACH, I WILL ASK COUNCIL MEMBERS WHETHER OR NOT THEY CONCUR. DR. PERISI IS OUR FIRST PROGRAM PERSON TO JOIN AT THE TABLE. SHE'S ACTUALLY IN TOTAL GOING TO BE PRESENTING FIVE OF THESE, THE FIRST OF WHICH IS ON THE REPOSITORY OF MOUSE MODELS FOR CYTOGENIC DISORDERS. >> GOOD MORNING. PROGRAM SEEKS COUNCIL APPROVAL FOR INITIATIVE TITLED REPOSITORY OF MOUSE MODELS FOR CYTOGENIC DISORDERS. THE GOAL OF THIS INITIATIVE IS TO ENSURE MOUSE MODELS DOWN SYNDROME AND OTHER RELEVANT CHROMOSOMAL DISORDERS ARE AVAILABLE TO NIH APPROVED SCIENTIFIC INVESTIGATORS IN A TIMELY MANNER. THIS INITIATIVE WILL SUPPORT REPOSITORY FOR THE PRODUCTION MAINTENANCE AND DISTRIBUTION OF MICE WITH PRIMARY EMPHASIS ON THOSE THAT MODEL HUMAN TRISOMY 21, IT IS TIMELY AND NECESSARY BECAUSE IT IS DIFFICULT TO DEVELOP THESE MODELS THAT FAITHFULLY REPLICATE THE HUMAN CONDITION GIVEN CHALLENGE OF DEVELOPING A MOUSE WITH TRISOMY FOR 250 GENES THAT RESIDE ON HUMAN CHROMOSOME 21. THESE MICE ARE DIFFICULT TO BREED AND MAINTAIN REQUIRING DEDICATED FACILITY DEVOTED TO THEIR HUSBANDRY AND DISTRIBUTION AND NEW MODELS ARE BEING DEVELOPED THAT REQUIRE SIMILAR PRODUCTION STRATEGY. IN ADDITION YOU HEARD THE DOWN SYNDROME INCLUDE INITIATIVE FROM DR. BIANCHI'S REPORT YESTERDAY AND WE ANTICIPATE INCREASED DEMAND FROM INVESTIGATORS PROPOSING PROJECTS RELATED SPECIFICALLY TO COMPONENT ONE OF INCLUDE WHICH FOCUSES ON TARGETED BASIC SCIENCE STUDIES IN DOWN SYNDROME THAT MAY INCLUDE EXPLORE RAYINGS OF CHROMOSOME SILENCING, IMMUNE SYSTEM DISREGULATION AND EPIGENETIC METABALOMIC TRANSCRIPT OMIC PROFILING IN MODEL ORISM SYSTEMS. IN ADDITION TO PROVIDING A CENTRAL REPOSITORY OF MOUSE STALKS, THIS RESOURCE WILL PROVIDE COMPREHENSIVE PHENOTYPING OF EXISTING AND NEW STRAINS AND WILL HELP DEVELOP HIGH THROUGH PUT DRUG TESTING PIPELINE FOR DOWN SYNDROME THERAPEUTIC. THIS CONCEPT ALIGNS WITH NICHD VISION AREAS AND IDD PRIORITY AREAS OF UNDERSTANDING THE ETIOLOGY OF IDD INCLUDING DOWN SYNDROME AND DEVELOPING PRE-CLINICAL OUTCOME MEASURES. >> THANK YOU, MELISSA. COUNCIL. ANY DISCUSSION ON THIS TOPIC? >> REALLY EXCITED TO SEE THIS, THIS IS FANTASTIC FOR DOWN IDEA OF HOW MANY MICE GOING TO HAVE TO HAVE AND MAINTAINED, SEEMS LIKE A VERY LONG TERM PROJECT AND ALSO WILL BE RESTRICTED TO DOWN SYNDROME OR CAN IT BE EXPANDED TO OTHER VERY IMPORTANT DISORDERS FOR IDDs? >> THOSE ARE GREAT QUESTIONS. IN FACT, THIS REPOSITORY ALREADY EXISTS. AND HAS BEEN FUNDED FOR ABOUT 20 YEARS. CURRENTLY THE NUMBER OF STRAINS THAT IT CARRIES IS ON THE ORDER OF SIX, THAT ARE AVAILABLE FOR DOWN SYNDROME, THREE OR FOUR WHICH ARE ACTIVE PRODUCTION AND ARE BEING DISTRIBUTED ON A REGULAR BASIS TO INVESTIGATORS IN THE COMMUNITY WITH AN EMPHASIS ON INVESTIGATOR WHOSE ARE NIH FUNDED WHO GET THE MICE FOR FREE. WITH REGARD TO WHETHER OR NOT IT COULD BE EXPANDED OTHER CHROMOSOMAL DISORDERS, THAT'S CERTAINLY A CONSIDERATION. RIGHT NOW WE HAVE LIMITED TO DOWN SYNDROME BECAUSE OF THE DEMAND FOR THE MICE AND THE LARGE INVESTIGATOR COMMUNITY THAT FOCUSES ON DOWN SYNDROME. THAT COULD BE CONSIDERED IN THE FUTURE. I WOULD ALSO POINT OUT THAT THERE ARE SOME NEW STRAINS THAT HAVE RECENTLY BEEN DEVELOPED THAT MAY PROVE TO BE BETTER MODELS FOR SPECIFIC DOWN SYNDROME RELATED PROJECTS UNDER DEVELOPMENT. ANY ADDITIONAL DISCUSSION POINTS? OKAY. COUNCIL DO YOU CONCUR WITH US MOVING FORWARD ON THIS CONCEPT? YES? ANYONE WHO DOES NOT? OKAY. GOOD. THANK YOU. MELISSA IS ALSO GOING TO BE TALKING TO US ABOUT THE NEXT FOUR CONCEPTS WHICH INVOLVE INCLUDE PROJECT OVERALL SO WE WILL DO THIS ONE A LITTLE DIFFERENTLY. MELISSA WILL PROVIDE AFTEROWE VIEW OF THE ENTIRETY OF THE INCLUDE PROJECT AND THEN WE WILL WALK THROUGH EACH OF THE FOUR INDIVIDUALLY. >> SO PROGRAM SEEKS COUNCIL APPROVAL FOR INITIATIVE ENTITLED THE INCLUDE PROJECT TRANSFORMATIVE RESEARCH AWARD. THISES THE FIRST OF FOUR. AS IN DR. BIANCHI'S REPORT YESTERDAY DOWN SYNDROME IS THE MOST COMMON GENETIC CAUSE OF INTELLECTUAL AND DEVELOPMENTAL DISABILITIES AND IN THE PAST 25 YEARS AVERAGE LIFE SPAN HAS DOUBLED FROM 30 TO 60 YEARS. HOWEVER, INDIVIDUALS WITH DOWN SYNDROME FACE SIGNIFICANT AND CHANGING HEALTH CHALLENGES AND HAVE BEEN EXCLUDED FROM PARTICIPATION IN RESEARCH THAT COULD IMPROVE THEIR HEALTH OUTCOMES AND QUALITY OF LIFE. THE FISCAL YEAR 18 BUDGET APPROPRIATION REQUIRED NEW TRANS-NIH DOWN SYNDROME INITIATIVE TO STUDY TRISOMY 21 AND IMPROVE HEALTH AND DEVELOPMENT OF DOWN SYNDROME IN TYPICAL INDIVIDUALS AT RISK FOR MANY SAME CONDITIONS. THE NIH INCLUDE INITIATIVE WHICH STANDS FOR INVESTIGATION OF CO-OCCURRING CONDITIONS ACROSS THE LIFE SPAN TO UNDERSTAND DOWN SYNDROME AIMS TO ADDRESS ISSUES BY ADVANCING RESEARCH IN THREE DOMAINS. THE FIRST IS TARGETED HIGH RISK HIGH REWARD BASIC SCIENCE STUDY IT IS OF TRISOMY 21. SECOND IS ASSEMBLY OF LARGE CLINICAL COHORT OF INDIVIDUALS WITH DOWN SYNDROME ACROSS THE LIFE SPAN. AND THE THIRD IS INCLUSIVE CLINICAL TRIALS RESEARCH OF CURRENT FUTURE THERAPIES FOR CO-OCCURRING CONDITIONS IN DOWN SYNDROME. AS DR. HANN MENTIONED THIS PROGRAM IS DEVELOPED BY OFFICE OF THE DIRECTOR OF NIH WHICH IS COORDINATING AND FUNDING THE FORE PLANNED INCLUDE INITIATIVES IN 2019. DUE TO THE LARGE NUMBER OF PARTICIPATING NIH INSTITUTES AND CENTERS INVOLVED WHICH RIGHT NOW COUNTS AT LEAST 18, THE NIH OFFICE OF EXTRAMURAL RESEARCH INDICATED CONCEPT CLEARANCE WILL ONLY BE REQUIRED AT A SINGLE INSTITUTE, WHEREAS OTHERWISE REQUIRED BY ALL 18 INSTITUTES. THEREFORE NICHD IS SERVING AS THE INSTITUTE OF RECORD FOR CLEARANCE WITH THIS INITIATIVE AND THREE ADDITIONAL ONES THAT WILL BE PROPOSED AS PART OF INCLUDE. SO THAT'S MY INTRODUCTORY COMMENTARY FOR THE FOUR FOLLOWING INITIATIVES. THIS FIRST OF FOUR INITIATIVES WILL FOCUS ON RESEARCH IN THE FIRST DOMAIN OF INCLUDE AND WILL SUPPORT UNUSUALLY INNOVATIVE RESEARCH PROJECTS WHICH IF SUCCESSFUL WILL HAVE A MAJOR IMPACT IN UNDERSTANDING THE BIOLOGY OF DOWN SYNDROME, DEVELOPMENT OF TREATMENTS FOR HEALTH CONDITIONS EXPERIENCED BY THOSE WITH DOWN'S SYNDROME. TO BE CONSIDERED TRANSFORMATIVE PROJECTS WOULD NEED TO HAVE POTENTIAL TO CREATE OR OVERTURN FUNDAMENTAL SCIENTIFIC PARADIGMS THROUGH NOVEL APPROACHES TRANSFORM THE WAY RESEARCH IS CONDUCTED THROUGH THE DEVELOPMENT OF NOVEL TOOLS OR TECHNOLOGIES OR LEAD TO MAJOR IMPROVEMENTS IN HEALTH THROUGH THE DEVELOPMENT OF HIGHLY INNOVATIVE THERAPIES DIAGNOSTIC TOOLS OR PREVENTED STRATEGIES. >> THANK YOU, MELISSA, FOR THE OVERVIEW. DO I HAVE ANY COUNCIL DISCUSSION WITH REGARD TO THIS PARTICULAR INITIATIVE? >> I HAVE A QUESTION MORE IN GENERAL, I'M SORRY IF I MISSED IT IN THE PRESENTATION YESTERDAY BUT GIVEN NICHD ACTING AS INSTITUTE OF RECORD FOR THESE CONCEPTS AND CLEARLY IS GOING TO BE TAKING LEADERSHIP ROLE, OFFICE OF DIRECTOR ALSO PROVIDING ADDITIONAL RESOURCES TO YOUR TEAM TO SUPPORT THIS? OKAY ANSWER IS YES. THANK YOU. >> ANY ADDITIONAL DISCUSSION? THOSE THAT CONCUR THOSE THAT DON'T. THANK YOU, DICK FOR TWO VOTES. ALL RIGHT MELISSA TAKE US TO THE NEXT ONE. SECOND INITIATIVE PROGRAM SEEKS APPROVAL THIS ENTITLED IMPROVE PROJECT CLINICAL TRIALS READINESS AWARDS. THIS INITIATIVE FOCUS ON RESEARCH IN THIRD DOMAIN OF THE INCLUDE PROJECT AND WILL SUPPORT CLINICAL PROJECTS THAT ADDRESS CRITICAL NEEDS FOR CLINICAL TRIAL READINESS IN DOWN'S SYNDROME. PROJECTS MAY FACILITATE DOWN SYNDROME RESEARCH BY ENABLING EFFICIENT AND EFFECTIVE MOVEMENT OF CANDIDATE THERAPEUTICS OR DIAGNOSTICS TOWARDS CLINICAL TRIALS FOR DOWN SYNDROME AND CO-OCCURRING CONDITIONS OR MAY INCREASE SUCCESS THROUGH DEVELOPMENT AND TESTING OF BIOMARKERS AND CLINICAL OUTCOME ASSESSMENT MEASURES. DEVELOPMENT AND TESTING OF NOVEL TRIAL METHODS AND RECRUITMENT STRATEGIES FOR THE DOWN SYNDROME POPULATION, OR BY DEFINING THE PRESENTATION AND COURSE OF THE CO-OCCURRING CONDITIONS AND INDIVIDUALS WITH DOWN SYNDROME TO ENABLE THE DESIGN OF FUTURE CLINICAL TRIALS. >> THANK YOU. COUNCIL DISCUSSION. THOSE IN CONCURRENCE. THOSE NOT. PERFECT. THANK YOU. NEXT. OOPS. SORRY. HANG ON. MICROPHONE, THANK YOU. PROGRAM SEEKS COUNCIL APPROVAL FOR INITIATIVE TITLED INCLUDE PROJECT CLINICAL TRIALS FOR CO-OCCURRING CONDITIONS IN DOWN SYNDROME, THE THIRD INITIATIVE FOCUSES ON RESEARCH IN THE THIRD DOMAIN OF INCLUDE PROJECT AND WILL SUPPORT DEVELOPMENT OF CLINICAL TRIALS TO TREAT CO-OCCURRING HEALTH CONDITIONS IN INDIVIDUALS WITH DOWN SYNDROME. RESEARCH IS NEEDED TO TRANSLATE AMEND DEVELOP OR TEST NEW INNOVATIVE ADAPTATIONS OF CURRENT DRUGS INTERVENTION THERAPIES, FOR THE TREATMENT AND MANAGEMENT OF CO-OCCURRING CONDITIONS IN DOWN SYNDROME. PROJECTS ENCOURAGE FOCUS ON DELIVERING BETTER HEALTHCARE OUTCOMES AND HEALTH SERVICE RESEARCH AND SEEK SOLUTIONS THAT ARE EFFECTIVE DELIVERABLE AND SUSTAINABLE IN CLINICAL SETTINGS BEYOND THE RESEARCH ENVIRONMENT. PROJECTS MAY ADDRESS A PARTICULAR CO-OCCURRING CONDITION AT PARTICULAR STAGE OF DEVELOPMENT OR ACROSS THE LIFE SPAN PEOPLE WITH DOWN SYNDROME. BECAUSE SOME ASPECT OF THIS RESEARCH AREA MAYBE NEW FOR THE TRANS-NIH SCIENTIFIC COMMUNITY, THERE WILL LIKELY BE A NEED TO OBTAIN PRELIMINARY DATA OR CONDUCT EARLY STAGE CLINICAL TRIAL PREPARATORY ACTIVITIES BEFORE MOVING TO A FULL SCALE PROJECT IN THIS ARENA. >> THANK YOU. COUNCIL DISCUSSION. THOSE IN CONCURRENCE. SORRY, GO AHEAD. >> THIS IS MASSIVE ENTERPRISE, CLINICAL TRIALS, I PROBABLY -- ANY OR ALL THIS DATA GOING TO ANY ONE PLACE? (INDISCERNIBLE) BE ABLE TO LEARN FROM EXPERIENCE? OPEN DATA, ALL THAT? >> GREAT QUESTION. WE ARE MODELING THE INCLUDE PROJECT OFF CANCER MOON SHOT AND REQUIREMENTS FOR ANY SUCCESSFUL APPLICATIONS WILL INCLUDE BROAD EXTENSIVE EARLY DATA SHARING. IN TERMS OF WAYS WE FACILITATE THIS DATA SHARING WE ARE DEVELOPING THOSE PROCESSES, WE ARE WORKING ON FOAs WE ANTICIPATE FOR THE FUTURE, THAT WOULD INCLUDE SPECIFIC TARGETED INITIATIVES RELATED TO DATA COORDINATION. BUT WE DON'T WANT TO REINVENT THE WHEEL AS WELL SO OUR REAL INTEREST IS TO TRY TO BUILD AND LEVERAGE OFF EXISTING NIH RESOURCES FOR DATA COORDINATION, DATA HARMONIZATION AN DATA SHARING, AND THE GOAL IS TO ACTUALLY BASICALLY SUPPLEMENT EXPAND EXISTING RESOURCES. WE ARE PLANNING SEVERAL WORKSHOPS THIS YEAR TIN COLLUDING ONE FOCUS ON COHORT PARTICIPANTS ACROSS THE LIFE SPAN AND ISSUES OF DATA SHARING AND COORDINATION HARMONIZATION IS AN IMPORTANT FOCUS FOR THAT WORKSHOP. >> AS YOU KNOW MOST CLINICAL TRIALS FAIL AND IN THIS PARTICULAR CASE WE WANT TO LEARN SCIENCE BEHIND WHEN THEY FAIL, OF COURSE WE WANT THEM TO SUCCEED BUT DON'T WANT THAT DATA TO BE IN THE WAY FOR FAILING TRIALS HERE, IN ALL SCIENCE. >> >> IF I CAN MAKE A COMMENT, THANK YOU FOR THAT. ONE MAJOR REASON PRIOR CLINICAL TRIALS IN THE DOWN SYNDROME COMMUNITY HAVE NOT BEEN SUCCESSFUL IS BECAUSE THEY HAVE BEEN SMALL. MAY HAVE THEY HAVE NOT HAD ADEQUATE SAMPLE SIZE. THERE ARE CERTAINLY A NUMBER OF REASONS FOR THAT. THERE ARE ADDITIONAL REASONS FOR THE FAILURE OF CLINICAL TRIALS INCLUDING THE SIGNIFICANT IMPACT OF PLACEBO EFFECT WHICH HAVE ACTUALLY IN SOME CASES MASKED POTENTIAL SUBPOPULATION RESPONSES TO GIVEN DRUGS. THAT'S ANOTHER PLANNED WORKSHOP FOR THE END OF THIS YEAR THAT WE ARE PLANNING TO REALLY EXPLORE CLINICAL TRIALS DOWN SYNDROME AND TRY TO IDENTIFY STRATEGIES SUCCESSFUL. THERE ARE A COUPLE OF RESOURCES AVAILABLE TO THE NIH COMMUNITY THAT WILL BE BENEFICIAL TO INCLUDE, THIS INCLUDES NCATS SUPPORTED RECRUITMENT INNOVATION CENTERS AND TRIAL INNOVATION CENTERS THAT ARE PART OF THE CTSA PROGRAM. WE HAVE A REGISTRY KNOWN AS DS CONNECT THAT WE ARE ALSO GEARING UP TO HELP BOTH RECRUITMENT AND ALSO REPOSITORY FOR DATA FOR SUBJECTS THAT PARTICIPATE IN INCLUDE. >> GREAT. ANY ADDITIONAL DISCUSSION? ALL RIGHT. THOSE IN CONCURRENCE. OOPS SORRY. GO AHEAD. >> MAYBE NOT FOR NOW AND I CAN ASK AFTERWARDS. I MAYBE MISSED THIS BECAUSE I MISSED YOUR REPORT, HOW DID INCLUDE HAPPEN? DOES EVERYBODY ELSE KNOW THIS? WHICH CASE WE SHOULD MOVE ON. EVEN ELSE DOES. YOU TELL ME LATER. OKAY. >> THOSE IN CONCURRENCE. ALL RIGHT. ANY PERSON NOT IN CONCURRENCE? GREAT. LAST ONE, MELISSA. >> PROGRAM SEEKS COUNCIL APPROVAL FOR THE FOURTH INITIATIVE TITLED INCLUDE PROJECT COMPETITIVE SUPPLEMENTS FOR RESEARCH IN DOWN SYNDROME. THIS INITIATIVE WILL ENCOMPASS RESEARCH ON ALL THREE DOMAINS OF INCLUDE AND WILL SUPPORT COMPETITIVE SUPPLEMENT APPLICATIONS, ALSO KNOWN AS REVISION TO EXISTING FUNDED NIH PROJECTS THAT PROPOSED TO ADD A NEW COMPONENT RELATED TO GOALS OF INCLUDE INITIATIVE. THE GOAL IS TO SUPPORT NEW BUT RELATED PROJECTS OR AIMS TO ADD DOWN SYNDROME ELEMENT TO SUPPORT SCIENTIFIC PROGRESS ON THE INCLUDE PROJECT. IT IS ANTICIPATED MULTIPLE INSTITUTES PARTICIPATE IN ORDER TO ENCOURAGE INNOVATIVE RESEARCH IN MANY BASIC AND CLINICAL ARENAS TO ADDRESS CO-OCCURRING CONDITIONS IN DOWN SYNDROME. >> THANK YOU. ANY DISCUSSION? THOSE IN CONCURRENCE? THOSE NOT? THANK YOU. THAT INCLUDES INCLUDE. >> NEXT WE HAVE DR. REBECCA CLARK PRESENTING ON THE DATA SHARING DEMOGRAPHIC RESEARCH INFRASTRUCTURE PROGRAM. >> DATA SHARING IS MY FAVORITE TOPIC AFTER LONGITUDINAL RESEARCH PROGRAM SEEKS COUNCIL APPROVAL FOR RECOMPETING IN RAFA DATA CHAIRING DEMOGRAPHIC RESEARCH DSDR, THE PURPOSE OF THE RFA IS TWO FOLD. FIRST, PROVIDE RESOURCE FOR INVESTIGATORS SHOULD DEPOSIT DATA ONCE GRANT ENDED AND PASSES -- SHARING PASSING DATA SHARING DUTIES TO DATA SHARING EXPERTS. SECOND ALLOW RESEARCHERS OUTSIDE RESEARCH ACCESS TO HAVE ACCESS TO EXISTING DATA WELL DOCUMENTED INEXPENSIVE TO ACCESS AND EASY TO USE. THIS RFA WILL REQUIRE THE GRANTEE PROCESSING CLEAN DATA DOCUMENTING ANY OTHERS, PROVIDE DATA AND METADATA DOCUMENTATION THAT MEETS INTERNATIONAL STANDARDS. THIRD, THIS IS VERY IMPORTANT. IDENTIFY DATA SETS THAT REQUIRE RESTRICTED ACCESS AND IMPLEMENT AND ENFORCE APPROPRIATE DATA USE AGREEMENTS AND FINALLY, PROVIDE TECHNICAL ASSISTANCE PLUS TRAINING AND OUTREACH ON BEST PRACTICES. APPLICANTS MUST BE ABLE DEMONSTRATE EXPERTISE AND CAPACITY TO, THESE ARE PER YEAR, CURE RATE UP TO 20 COMPLEX DATA SETS, DOWNLOAD DATA SETS UP TO 8,000 TIMES OVER THE COURSE OF THAT YEAR AND PROVIDE DAY TO DAY USERS FOR SUPPORT TO APPROXIMATELY 20,000 USERS. >> COUNCIL DISCUSSION. >> REISSUE SO THERE IS A PARTICULAR GROUP THAT HAS THIS ALREADY? >> THERE IS BUT IT'S AN OPEN COMPETITION AND WE HAD MORE THAN ONE COMPETITOR LAST TIME. >> WHY WOULDN'T DASH DO THIS? >> THANK YOU FOR ASKING THAT. I DIDN'T HAVE TIME TO GET INTO THIS. FIRST, ALL DSDR HOLDINGS ARE CROSS POSTED ON THE DASH PORTAL. SECOND OF ALL, AT THIS POINT AND I HAVE CONFERRED WITH THE CHAIR OF DASH, DASH DOES NOT HAVE THE CAPACITY TO PROVIDE THE TYPES OF SERVICES REQUIRED FOR DSDR BUT IF THE CURRENT DASH CONTRACTOR IS INTERESTED IN APPLYING FOR THE RFA, THEY ARE VERY WELCOME TO DO SO. A LOT HAS TO DO WITH HUMAN SUBJECTS PROTECTIONS AND PRIVACY, WHICH IS THAT IF NIH, NICHD IN PARTICULAR, NICHD CONTRACTOR, HELD THESE DATA, THEY WOULD BE SUBJECT TO PROVIDING DATA IN RESPONSE TO FREEDOM OF INFORMATION ACT REQUESTS THAT'S BEEN ESTABLISHED AND THE ORIGINAL INVESTIGATORS AND IRBs WILL NOT ALLOW THEIR -- THESE HIGHLY COMPLEX HIGHLY SENSITIVE DATA, LOTS OF DRUG USE, UNDOCUMENTED ALIENS, SEXUAL ACTIVITIES AMONG ADOLESCENTS, ET CETERA. THEY WILL NOT ALLOW THESE DATA TO BE STORED IN AN AREA, IN REPOSITORY THAT IS SUBJECT TO FREEDOM OF INFORMATION ACT REQUESTS. DID THAT ANSWER YOUR QUESTION? >> PERFECTLY. >> I KNEW YOU WERE GOING TO ASK THAT. >> WE CAME PREPARED. ANY ADDITIONAL DISCUSSION ON THIS TOPIC? >> I HAVE A QUESTION BECAUSE I'M NOT FAMILIAR WITH CONCEPT HERE. IS THIS AN NIH WIDE INITIATIVE, DOES IT EXIST IN OTHER INSTITUTES? >> OTHER INSTITUTES HAVE THEIR OPEN REPOSITORIES, WHICH IS CURRENTLY ICPSR. DON'T ASK WHAT THE ACRONYM IS. MASSIVE REPOSITORY UNIVERSITY OF MICHIGAN. AGING HAS THEIR OWN ARCHIVE, THERE'S A LITTLE ARCHIVE JUST FOR NCMRR, THIS ARCHIVE FOR US MOSTLY DEMOGRAPHIC RESEARCH BUT WE HAVE IN THE PAST WRITTEN RFA, SO IT INCLUDES PRETTY GENERALLY ANYBODY FROM NICHD WHO WANTS TO DEPOSIT NICHD RELATED DATA. AND CHILD DEVELOPMENT AND BEHAVIOR BRANCH ACTUALLY DEPOSITS A LOT OF DATA THERE TOO. DID THAT ANSWER YOUR QUESTION? >> MORE GOING FOR BEST PRACTICES THEY HAD, DO YOU INTENT TO USE THE SAME, ARE YOU TALKING TO EACH OTHER ABOUT HOW TO POTENTIALLY OVERCOME SOME OF THESE CONTRACTOR ISSUES? >> SO YES, WE DO. IN PARTICULAR, AGING WITH AGING. WE TALKED CONSTANTLY WITH HIM ABOUT THIS. AND THIS IS AN RFA FOR A GRANT, R 24, NO T THAT IT MATTERS. SO BY THE GRANT MECHANISM SOME OF THOSE PROTECTIONS ARE BUILT IN. WE TALK -- AND WE -- THE CURRENT HOLDER OF THE GRANT DOES AMAZING WORK ON DEDUCTIVE DISCLOSURE AND MITIGATING AGAINST THAT RISK. THEY ALSO HAVE REAL TEETH IN THEIR DATA USE AGREEMENTS. SO THAT PEOPLE CANNOT IF THEY LEAK PRIVATE DATA THEY'RE TOAST, THEIR CAREERS ARE OVER AND INSTITUTIONS ARE BANKRUPT. AND THEIR CHILDREN ARE WEEPING. THE FEDERAL GOVERNMENT ENTITY CAN'T WRITE A DATA USE PROTECTION LIKE THAT. >> IN ADDITIONAL DISCUSSION ON THIS CONCEPT? THOSE IN CONCURRENCE. THOSE NOT? TERRIFIC. THANK YOU VERY MUCH, REBECCA. NEXT DR. EDWINA YOUNG WILL PRESENT ON STUDY OF PREGNANCY AND NEONATAL HEALTH. >> HELLO, GOOD AFTERNOON. I'M PRESENTING STUDY OF PREGNANT AND NEONATAL HEALTH ON BEHALF OF OUR STUDY TEAM INCLUDING MY CO-PI DR.S KATHERINE GRANT AND (INDISCERNIBLE). THIS INITIATIVE WILL ADDRESS CRITICAL DATA GAPS IN ORIGIN HEALTH DISEASE RESEARCH WITHIN THE MISSION OF THE INSTITUTE. THE FIRST ADDRESSES IMPORTANT GAP IN THE FIELD BY SEEKING PATERNAL CARDIOVASCULAR RISK FACTORS ASSOCIATED WITH NEONATAL OUTCOMES AND NOVEL EPIGENETIC MECHANISMS THAT UNDERLINE ASSOCIATIONS. THE SECOND AIM WILL ESTABLISH FUNCTIONAL MECHANISMS THAT LINK FATAL GROWTH USEK STATE-OF-THE-ART GENETICS AND EPIGENETICS APPROACHES. ALL RACE ETHNIC GROUPS ARE INVOLVED IN FIRST PHASE ANALYSIS CONDUCTED IN AFRICAN AMERICANS. FOR THE THIRD AIM WE WILL BE CONDUCTING AN INNOVATIVE TRIAL USING ATAPTIVE DESIGN TO DETERMINE OPTIMAL DELIVERY TIME FOR JUSSATIONAL DIABETES COMPLICATED DELIVERIES BETWEEN 38 AND 39 WEEKS. NEONATAL MORBIDITY AND MORTALITY IS LOWEST. THIS EVIDENCE HAS THE POTENTIAL TO CHANGE MANAGEMENT OF GESTATIONAL DIABETES AND IMPROVE CHILD HEALTH. THANK YOU. >> DISCUSSION FROM COUNCIL? THOSE IN CONCURRENCE. THOSE NOT. THANK YOU VERY MUCH. NEXT DR. WREN WILL PRESENT ON OBSTETRIC FETAL PHARMACOLOGY RESEARCH CENTERS. >> GOOD MORNING T. PROGRAM SEEKS COUNCIL APPROVAL FOR RENEWED RFA TITLED OBSTETRIC FETAL PHARMACOLOGY RESEARCH CENTERS. THE OBJECTIVE OF THIS INITIATIVE IS TO SUPPORT MULTI-DISCIPLINARY TEAMS OF BASIC TRANSLATIONAL AND CLINICAL SCIENTIST TO IDENTIFY INNOVATIVE RESEARCH STRATEGIES IN OBSTETRIC FETAL PHARMACOLOGY WITH ULTIMATE GOAL OF IMPROVING THE SAFETY AND EFFECTIVENESS OF THE DRUG TREATMENT IN PREGNANT AND LACTATING WOMAN. THIS PROPOSED CONCEPT IS HIGHLY RELEVANT TO NICHD MISSION AND IS ALSO ALLIES WITH THE TATSK FORCE RECOMMENDATION INCREASING THE QUALITYAND QUALITY AND QUANTITY AND TIMELINESS OF RESEARCH SAFETY AND EFFICACY OF THERAPEUTIC PRODUCTS USED BY PREGNANT WOMEN AND LACTATING WOMEN. >> THANK YOU FOR YOUR PRESENTATION, I WANTED TO KNOW HOW DO YOU CHOOSE WHICH DRUGS YOU STUDY? >> IN THE PAST, AS YOU SEE, THIS IS RENEWED INITIATIVE IN THE PAST SO WE HAVE GIVEN THE GUIDELINES ARE PROGRAM PRIORITIES. SO THE APPLICANTS ARE PROPOSED CONCEPT IN -- ALIGN WITH OUR OUR PROGRAM PRIORITY AND ALSO TO IDENTIFY THERE IS PA CRITICAL NEED IN TERMS OF SCIENCE AND CLINICAL SIGNIFICANCE. >> ANY ADDITIONAL DISCUSSION? THOSE IN CONCURRENCE. THOSE NOT. THANK YOU. NEXT, DR. DIANA WILL PRESENT ON CONTRACEPTIVE CLINICAL TRIALS NETWORK. THIS CONCEPT PROPOSAL IS FOR RECOMPETITION TO ALLOW CLINICAL INVESTIGATORS TO HAVE AN OPPORTUNITY TO PARTICIPATE IN THE CONTRACEPTIVE CLINICAL TRIALS NETWORK. CONGRESS DIRECTS NICHD TO CONDUCT CLINICAL TRIALS OF NEW OR IMPROVED DRUGS AND DEVICES FOR CONTRACEPTIVE USE BY MALES AND FEMALES. THE CCTN FULFILLS THIS DIRECTIVE. THE INVESTIGATORS IN THE NETWORK ARE LEADERS IN THE FIELD OF CONTRACEPTIVE RESEARCH AND THE CCTN SERVES AS A TRAINING RESOURCE FOR NEW INVESTIGATORS IN CONTRACEPTIVE CLINICAL EVALUATION. THIS RECOMPETITION PROVIDES AN OPPORTUNITY FOR NEW INVESTIGATORS TO BE CONSIDERED FOR INCLUSION IN THE NETWORK ADS PRINCIPLE SAY -- AS PRINCIPLE INVESTIGATORS. IN PARTICULAR, CONGRESS URGES NICHD TO STRENGTHEN ITS SUPPORT FOR CONTRACEPTIVE DEVELOPMENT OF METHODS FOR MEN AND TO IMPROVE EFFICACY AND SAFETY OF METHODS FOR OBESE WOMEN. PRODUCTS MOVING THROUGH THE PROGRAMMATIC PIPELINE ARE RESPONSIVE TO THAT DIRECTIVE. THUS THE GOAL OF THIS INITIATIVE IS TO ENABLE THE CONTRACEPTIVE DEVELOPMENT PROGRAM TO CONTINUE VALUE EVALUATION FOR NEW METHODS FOR MEN AND WOMEN. >> THANK YOU, DIANA. YES. >> I HAVE A QUICK QUESTION T. WAS THIS PART OF THE CURES ACT, THIS CONGRESSIONAL INTENT? OR DID IT COME OUT YEARS AGO BEFORE CONGRESS CHANGED? THANK YOU. ANY ADDITIONAL DISCUSSION? THOSE IN CONCURRENCE. THOSE NOT. THANK YOU, DIANA. NEXT DR. BILL (INDISCERNIBLE) WILL PRESENT ON THE U.S. CHILDREN WITH PERINATAL HIV THAT WERE BORN INTERNATIONALLY. I BELIEVE IT'S GOOD AFTERNOON OFFICIALLY. PROGRAM SEEKS COUNCIL APPROVAL FOR NEW INITIATIVE ENTITLED U.S. CHILDREN WITH PERINATAL HIV BORN INTERNATIONALLY. DESPITE THE DECLINING RATES OF DOMESTIC MOTHER TO CHILD TRANSMISSION OF HIV THERE'S INCREASING NUMBERS OF DIAGNOSED HIV INFECTIONS AMONG CHILDREN WHO ACQUIRE HIV FROM THEIR MOTHERS AND LIVE IN BUT WERE BORN OUTSIDE OF THE US. THERE ARE UNIQUE CHARACTERISTICS AND PRESENTATIONS OF ILLNESSES, THAT MAKE CARING FOR THESE FOREIGN BORN CHILDREN AD AND ADOLESCENTS CHALLENGE INCLUDING EPIDEMIOLOGIC DIAGNOSTIC MANAGEMENT KNOWLEDGE GAPS, CLINICAL CARE AND TREATMENT NOT ONLY OF HIV BUT ALSO OF ITS CO-OCCURRING ILLNESSES AND CONDITIONS. THE GOAL OF THIS INITIATIVE IS TO STIMULATE RESEARCH ON THIS AREA OF EMERGING PUBLIC HEALTH SIGNIFICANCE AND IMPROVE THE UNDERSTANDING NATURAL HISTORY DIAGNOSIS MANAGEMENT AND CO-MORBID CONDITIONS AMONG THESE CHILDREN. >> THANK YOU. YES. >> I WANTED TO ASK -- THANK YOU FOR THE CONCEPT, WITH REGARDS TO THE STRUCTURAL FACTORS THAT COULD IMPACT OUTCOMES ARE YOU INCLUDING ISSUES SUCH AS OPPORTUNITY DOCUMENTED FAMILIES AND DELAYS IN ACCESS TO CARE? >> I THINK THAT IS A VERY IMPORTANT QUESTION AND YES. THIS WOULD INCLUDE POPULATIONS WITH CHALLENGES WITH STATUS. >> ANY ADDITIONAL DISCUSSION? THOSE IN CONCURRENCE? THOSE NOT? THANK YOU, THANK YOU, BILL. THE FINAL CONCEPT WILL BE FROM DR. DENISE RUSSO, PRESENTING ON THE PEDIATRIC HIV AIDS COHORT STUDY. >> GREETINGS, EVERYBODY, MATERNAL PEDIATRIC INFECTIOUS DISEASE BRANCH IS PROPOSING AN FY 20 INITIATIVE ENTITLED THE PEDIATRIC HIV AIDS COHORT STUDY FACTS FOR APPROVAL BY COUNCIL. THE FACT STUDY ADDRESSES TWO CRITICAL PEDIATRIC HIV RESEARCH QUESTIONS. WHAT IS THE LONG TERM SAFETY OF FETAL INFANT EXPOSURE TO ANTIRETROVIRAL THERAPY ART. WHAT ARE THE AFFECTS OF PERINATALLY ACQUIRED HIV INFECTION IN ADOLESCENCE. NICHD BEGAN STUDYING THE FACTS COHORTS IN 2005. THIS INITIATIVE WOULD CONTINUE THE ONGOING FACT STUDIES OF PERINATALLY INFECTED AND EXPOSED BE BUT UNINFECTED INFANTS FROM BIRTH THROUGH ADOLESCENTS AND THE EFFECT OF HIV DISEASE AND ITS TREATMENT ON SEXUAL MATURATION AND OTHER OUTCOMES IN PRE-ADOLESCENTS, ADOLESCENTS AND YOUNG ADULTS AGED 8 TO 24. THE STUDY PROVIDES INVALUABLE INFORMATION ON THE HEALTH AND WELL BEING OF THESE POPULATIONS AND INFORM DEVELOPMENT OF ADDITIONAL INTERVENTIONS FOR ENSURING HEALTHY DEVELOPMENT OF CHILDREN WHO ARE INFECTED PERINAY IT WILY AND HIV EXPOSED BUT UNINFECTED. THIS PROPOSED CONCEPT ALIGNS WITH THE NICHD RESEARCH AREAS OF DEVELOPMENTAL ORIGINS OF HEALTH AND DISEASE IN REPRODUCTION. THE PROPOSED CONCEPT ALSO ALIGNS WITH THE BRANCH HIV AIDS PRIORITIES REDUCING INCIDENCE OF HIV AIDS AND NEXT GENERATION THERAPEUTICS. >> THANK YOU, DENISE. COUNCIL DISCUSSION. >> THOSE IN CONCURRENCE. THOSE NOT. THANK YOU VERY MUCH. THANK YOU, DENISE. NOW TURN IT BACK TO DR. BIANCHI. >> THANK YOU, DELLA, WE'RE DOING VERY WELL. IT'S TIME FOR LUNCH AND YOU HAVE A FOOD MAP OF NEARBY EATING PLACES IN YOUR MATERIALS FOLDER. ALSO YOUR COUNCIL BUDDY IS AVAILABLE TO HELP YOU, SHOULD YOU REQUIRE MORE ASSISTANCE. I WOULD LIKE TO REMIND EVERYONE TO BE BACK IN THIS ROOM BY 1:10 SO WE CAN GATHER FOR OUR COUNCIL PHOTOGRAPH AT 1:15 AND WE WILL THEN BE ABLE TO ACCELERATE OUR AGENDA BY HALF AN HOUR SO I'M SURE EVERYBODY IS A LITTLE CONCERNED ABOUT THE AIRPORT SITUATION. WE WILL DO WHAT WE CAN TO GET YOU OUT OF HERE AS EFFICIENTLY AS POSSIBLE. BON APPETITE.