GOOD MORNING,
GOOD AFTERNOON AND GOOD EVENING
TO EVERYONE. ON BEHALF OF NICHD
DIVISION OF EXTRAMURAL RESEARCH
AND WEB PLANNING COMMITTEE I
WOULD LIKE TO WELCOME YOU TO THE
FIRST WEBINAR FOR IN THE OF
FUNDING OPPORTUNITY PAR-25-311
TITLED MULTI-SITE CLINICAL
RESEARCH LEVERAGING NET
INFRASTRUCTURE TO ADVANCE
RESEARCH FOR WOMEN, CHILDREN,
PREGNANT AND LACTATING WOMEN AND
PERSONS WITH DISABILITY.
WE ARE ALL DELIGHTED TO HAVE
YOUR PRESENCE TODAY. THANK YOU
AGAIN FOR YOUR TIME TO ATTEND.
I'M ABWHY I AND ACTING CLINICAL
DIRECTOR FOR OPERATIONS AROUND
WILL OVERSEE APPLICATIONS
SUBMITTED TO THIS NOFO AFTER 2
YEARS MONITORING THE PROGRESS OF
2307 INITIATIVE NICHD IS MAKING
ADDITIONAL ADJUSTMENTS AND
CLEARLY DELINEATING TIMELINES TO
FACILITATE COLLABORATION AND
UTILIZE EXISTING INFRASTRUCTURE.
LATEST ADJUSTMENTS ALSO ALLOW
ONGOING EFFICIENT ASSESSMENT OF
THE FEASIBILITY AND SCIENTIFIC
SCOPE OF PROPOSED PROJECTS.
THIS IS AN UPDATED VERSION AND
ISSUE OF THAT NOTICE OF FUNDING
OPPORTUNITY.
BEFORE WE DELVE INTO CONTENT OF
THE PRESENTATION I WOULD LIKE TO
ACKNOWLEDGE COLLEAGUES THAT
SUPPORTED ME IN MAKING THIS
WEBINAR POSSIBLE. FOUR NICHD
COLLEAGUES ROBERT TAMBU ARE, RO
A MEDICAL DIRECTOR FOR THE TEAM.
I WANT TO GIVE HIM HIS FLOWERS.
HE STEPPED DOWN TO TAKE OTHER
PROJECTS AT NICHD AND PROGRAM A-
N LIST FOR NEONATAL RESEARCH
STEPHANIE ARCHER AND PROGRAM
ANALYST MEGAN MITCHELL AND
NEWEST MEMBER TO LITH CAL
OPERATION TEAM MARGE ORREE
BANDY. THANK YOU. NEXT, I
WOULD LIKE TO THANK THE INFINITY
CONFERENCE TEAM FOR HELP WITH AV
SUPPORT AND REGISTRATION FOR
TODAY.
THANK YOU, AMY. THANK YOU,
SHANARD.
IN 2016, THE NIH PROPOSED AND
SUBSEQUENTLY IMPLEMENTED A
SERIES OF REFORMS TO ENHANCE
CLINICAL TRIAL STEWARDSHIP AND
TRANSPARENCY AND THEREBY FURTHER
ASSURE SUCCESS OF NIH CLINICAL
TRIAL ENTERPRISE.
FOUR GUIDING PRINCIPLES THAT
WERE EXPRESSED AND EMPHASIZED IN
THESE FORMS INCLUDED, ONE, TO
ENHANCE RIGOR AND
REPRODUCIBILITY OF CLINICAL
TRIAL PROTOCOLS.
TWO, TO PROMOTE GREATER
AVAILABILITY OF MULTI-SITE
CLINICAL TRIAL INFRASTRUCTURE TO
SUPPORT TRIALS FOR A WIDER RANGE
OF INVESTIGATORS.
THREE, TO FACILITATE DATA
SHARING AND ACCESS TO
BIOSPECIMENS TO EFFICIENTLY
EXPAND RESEARCH CAPACITY FOR ALL
INVESTIGATORS.
THE LAST ONE IS TO FACILITATE
GREATER INVOLVEMENT OF DIVERSE
POPULATION, A MULTI-SITE
CLINICAL TRIAL.
WE BELIEVE THAT ADHERING TO
PRINCIPLE ENSURES PROPER
STEWARDSHIP OF PUBLIC FUNDS,
INCREASING ACCOUNTABILITY AND
HELPS NICHD MAINTAIN PUBLIC
TRUST. IT IS OUR GOAL THAT
PROJECTS WILL UTILIZE NICHD
CLINICAL RESEARCH NETWORK
INFRASTRUCTURE TO PROMOTE
FUNDING AND SUPPORT OF BEST
SCIENCE IN A TIMELY,
TRANSPARENT, EQUITABLE AND COST
EFFECTIVE MANNER. INITIAL NICHD
NETWORKS TO BE INCLUDED IN THIS
INITIATIVE INCLUDE MATERNAL
FETAL MEDICINE NETWORK.
NEONATAL RESEARCH NETWORK GLOBAL
NETWORK FOR WOMEN'S AND
CHILDREN'S HEALTH RESEARCH
COLLABORATIVE PEDIATRIC CRITICAL
CARE RESEARCH NETWORK AND PELVIC
FLOOR SDOORDS NETWORK. IF AN
APPLICATION IS CONSIDERING A
PROJECT ALIGNING WITH ANOTHER
NICHD NETWORK OR AREA OF SCIENCE
NOT DIRECTLY ALIGNED WITH FIVE
NETWORKS HERE, THEIR ADVICE TO
CONTACT SCIENTIFIC RESEARCH
CONTACT OR MYSELF.
SO, WE ATTEMPTED TO DESCRIBE THE
PRE-APPLICATION PROCESS OF THIS
NOFO IN A 5-STEP PROCESS FOR
CLARITY. STEP 1, INVESTIGATORS
ARE ENCOURAGED TO SEND A
ONE-PAGE LETTER OF INQUIRY, AT
LEAST FOUR TO EIGHT MONTHS PRIOR
TO APPLICATION RECEIVE DATE TO
GENERAL MAILBOX.
NICHD-NETWORK-CLINICAL
RESEARCH.GOV.
STEP 2, ONCE APPROVED, PI OR
INVESTIGATOR PREPARES AND
SUBMITS A 5-PAGE CONCEPT
PROPOSAL. STEP 3, NICHD AND THE
NETWORK REVIEWS THAT CONCEPT
PROPOSAL AND NICHD RENDERS A
FINAL DECISION ON CONCEPT
PROPOS
PROPOSAL.
ONCE APPROVED BY NICHD, PI OR
RESEARCHER AND NETWORK DEVELOP
THE GRANT APPLICATION.
STEP 5, THE PI AND THE NETWORK
DATA COORDINATING CENTER SUBMIT
JOINTLY DEVELOPED APPLICATION.
ALL OF THE INFORMATION IS
READILY AVAILABLE AT NICHD
CLINICAL RESEARCH WEBSITE. THE
LINK IS DISPLAYED HERE ON THE
SLIDE.
WE DEFINITELY WANT TO ENCOURAGE
EVERYONE THAT IS ATTENDING TODAY
TO VISIT THAT PAGE.
BECAUSE NOW WE HAVE PUBLISHED A
NEW FREQUENTLY ASKED QUESTION
SECTION ON OUR NICHD CLINICAL
RESEARCH WEBSITE.
HERE, YOU CAN FIND DETAILS ON
WHAT IS NEEDED ON SOME DOCUMENTS
THAT ARE REQUIRED AS WELL.
THERE ARE SIX KEY CHANGES THAT
WE WOULD LIKE TO HIGHLIGHT IN
THIS WEBINAR.
THESE INCLUDE BIPHASIC UG3/UH3
MECHANISM, APPLICATION BUDGETS,
STRONG PREFERENCES, EARLY-STAGE
INVESTIGATORS, RECEIPT DATES,
AND THE SIMPLIFIED REVIEW
FRAMEWORK.
APPLICATIONS UNDER THIS NOFO
WILL OPERATE UNDER A DIFFERENT
TWO -- PHASE MILESTONE DRIVEN
GRANT MECHANISM KNOWN AS UG3/UH3
THAT CONSISTS OF A
START-UP-PHASE UP TO 2 YEARS,
UG3. AND A FULL IMPLEMENT
ENROLLMENT AND FOLLOW UP PHASE
OF UP TO FIVE YEARS, UH3, FOR A
MAXIMUM OF 7 COMBINED YEARS.
APPLICATIONS ARE EXPECTED TO
PROVIDE CLEAR DESCRIPTIONS OF
OVERALL PROJECT DELIVERABLES AND
TOOIL LINES AND MILESTONES
ALIGNING WITH GOALS OF THE STUDY
AND THE NETWORK.
ANNUAL UG3 MILESTONES MUST BE
MET TO ADVANCE TO UH3 PHASE.
TRANSITIONED TO UH3 PHASE
REQUIRES NICHD APPROVAL AND
CONTINUAL FUNDING OF THE PROJECT
WILL BE DEPENDENT UPON MEETING
MILESTONES TO THE PROJECT
INCLUDING BOTH UG3 AND UH3
PHASES THAT IS EXPECTED THAT THE
STUDY WILL BE COMPLETED WITHIN
THE 7-YEAR PROJECT PERIOD.
ALL CARRYOVER AND NO-COST
EXTENSION REQUESTS DO REQUIRE
PRIOR APPROVAL.
SO HERE IS A SAMPLE MILESTONE
TABLE OF UG3 PHASE THAT WE
RECOMMEND OUR INVESTIGATORS USE
IT.
TO THE RIGHT OF THE TABLE IS
WHERE INVESTIGATORS CAN ENTER AN
ESTIMATED TIMELINE IN MONTHS
FROM GRANT AWARD.
THE TYPE OF SAMPLE MILESTONES
INCLUDE ITEMS SUCH AS FDA, IND,
OR IDE APPROVAL IF APPLICABLE.
TIME TO RECEIVE SINGLE IRB
APPROVAL AND TIME TO HAVE AT
LEAST 50% OF RECUTTING SITES
ENROLLED FOR PARTICIPANT AND
INSTITUTIONAL CERTIFICATION
SUBMITTED VERIFYING THAT STUDY
DATA IS APPROPRIATE FOR SHARING
IS DESCRIBED IN OUR DATA
MANAGEMENT AND SHARING PLAN.
ALTERNATIVELY, THIS SAMPLE TABLE
DEPICTS THE UH3 MILESTONE SUCH
AS 100% OF RECRUITING SITES
ENROLLED FOR PARTICIPATANT.
ANOTHER EXAMPLE INCLUDES
SUBMISSION OF FINAL DATA CODE
BOOK TO NICHD-THAT IS OUR
REPOSITORY HERE AT NICHD.
VARIABLE PERCENT DISTRIBUTION OF
50%, 75%, 100% OF THE STUDY
POPULATION PROPOSED RACIAL,
ETHNIC, AND SEX DISTRIBUTION.
ANOTHER EXAMPLE INCLUDES DATA
COLLECTION AND DATA -- BASE LOCK
COMPLETED.
ALSO, PRIMARY OUTCOME DATA
ANALYSIS COMPLETED.
AGAIN, INVESTIGATORS, THIS IS A
SAMPLE OF THE MILESTONES AND WE
ENCOURAGE YOU TO PROVIDE AN
ESTIMATED TIMELINE IN MONTHS
FROM THE GRANT AWARD TO THE FAR
RIGHT.
APPLICATION BUDGET, THE
APPLICATION BUDGET WILL COMPRISE
OF SALARY FOR NON-NETWORK
INVESTIGATORS AND COORDINATORS
AND OTHER PERSONNEL. IF
ADDITIONAL NETWORK
INFRASTRUCTURE SUPPORT IS NEEDED
FOR STUDY SPECIFIC APPROVAL FOR
NICHD WILL BE REQUIRED.
TRAVEL TO NETWORK STEERING
COMMITTEE MEETINGS FOR NONNET
INVESTIGATOR.
WE HAVE INCLUDED TRAFUL FOR
JUNIOR INVESTIGATOR INVOLVEMENT.
OTHER DIRECT COSTS SUCH AS
SINGLE IRB, BIOSPECIMENS AND
PREPARATION AND SUBMISSION TO
DASH. WE HAVE LASTLY CONSORTIUM
COSTS INCLUDING CAPITATIONS AND
STUDY RELATED COSTS AND INCLUDED
INDIRECTS ON CAPITATION COSTS
AND WE HAVE SUBCONTRASTS TO
NON-NETWORK SITES THERE IS A NEW
NOTICE N OWE. TOD25104 RECENTLY
AVAILABLE ABOUT FOREIGN
SUB-AWARDS.
THERE IS A BUDGET CAP.
THERE IS A BUDGET CAP OF 6.25
MILLION DOLLARS IN DIRECT COSTS
FOR ENTIRE 7 YEAR PROJECT AND
SHOULD BE WITH HIGHEST POTENTIAL
SCIENTIFIC IMPACT. PROJECTS
EXCEEDING THIS MAY BE PROPOSED
BUT REQUIRE ADDITIONAL NICHD
APPROVAL AS PART OF THE
PRE-APPLICATION PROCESS AND MY
ALSO INCLUDE COSTS TO PERFORM
SECONDARY ANALYSIS USING DATA
SUBMITTED THROUGH DASH THROUGH
THE POLICY.
SOME OF YOU MAY BE ASKING:
WELL, WHAT ARE SOME STRONG
PREFERENCES FOR THIS NOFO?
WE STRONGLY ENCOURAGE
INCORPORATING INNOVATIVE
APPROACHES SUCH AS ADAPTIVE
DESIGNS AND IMBEDDED PRAGMATIC
TRIALS AND [INDISCERNIBLE]
ANALYSIS, MACHINE LEARNING
APPROACHES, REAL-WORLD DATA USE
OR INNOVATIVE FOLLOW-UP
METHODOLOGIES AND ALIGNMENT AND
INTEGRATION OF STUDY PROTOCOL
AND LEVERAGING USE OF ELECTRONIC
HEALTH RECORDS AND HIGH PRIORITY
WILL BE GIVEN TO PROJECTS THAT
INCLUDE JUN INVESTIGATORS AND
ASSISTANT FELLOWS AND
RESEARCHERS PART OF THE TEAM AND
SECONDARY ANALYSIS PERFORMED BY
THE NETWORK STRONG PREFERENCE IS
GIVEN TO JUNIOR INVESTIGATORS
SERVING AS LEAD INVESTIGATOR ON
PROJECTS AND MENTORSHIP PROVIDED
BY MORE QUALIFIED AND
EXPERIENCED INVESTIGATORS.
IN ADDITION TO NETWORKS LISTED
HERE, APPLICATIONS PROPOSING TO
ASSESS MATERNAL AND PEDIATRIC
ONCOLOGY SESSIONS UTILIZED FOR
SOURCES TO MATERNAL AND
PEDIATRIC PRECISION IN
THERAPEUTICS KNOWN AS M PRINT
HUB AND PEDIATRIC TRIALS.
INCLUDE CURATED SUMMARIES OF
PUBLISHED LITERATURE AROUND
SPECIFIC DRUGS, INNOVATIVE
APPROACHES TO PEDIATRIC
REAL-WORLD EVIDENCE AND CLINICAL
FARMICOLOGY AND METRICS AND
CLINICAL TRIAL DESIGN AND
PEDIATRIC TRIALS NETWORK
PROVIDES ENVIRONMENT AND
APPROPRIATE INFRASTRUCTURE
CONDUCTING REGULATORY RIGOROUS
PEDIATRIC AND LACTATION CLINICAL
TRIALS LEADING TO UPDATES AND
DRUG LABELS DIRECTED TO BEST
PHARMACEUTICALS FOR CHILDREN'S
ACT.
EARLY STAGE INVESTIGATORS.
THIS NOFO ENCOURAGES INVOLVEMENT
OF EARLY STAGE INVESTIGATORS FOR
EARLY STAGE CLINICAL CENTERS.
BEAR IN MIND IT IS PART OF THE
REVIEW CRITERIA FOR THIS
PROJECT.
THE JUNIOR INVESTIGATOR MAY
ASSUME A VARIETY OF POTENTIAL
ROLES INCLUDING BEING THE SITE
PI OR SITE CO-PI WITH EMPHASIS
ON BEING MENTORED IN ASPECTS OF
THAT ROLE BY SENIOR
INVESTIGATORS.
THE PROJECT, THE JUNIOR
INVESTIGATOR SHOULD UNDERSTAND
ALL ASPECTS OF THAT PROJECT AND
BE POISED TO PROPOSE SECONDARY
ANALYSIS.
REGARDLESS OF ROLE SLESHTHED, IT
SHOULD BE WELL-DEFINED AND
CLEARLY DESCRIBED.
RECEIPT DATES.
PAR-25-311 INCLUDES NEW
APPLICATION RECEIPT DATES THAT
ARE LISTED HERE ON THIS SLIDE
AND IS ALSO AVAILABLE ON OUR
WEBSITE AND THE NOFO.
THESE CHANGES WERE BASED ON
FEEDBACK WE RECEIVED DURING
INITIAL TWO YEARS OF INITIATIVE
AND IMPLEMENTED WITH HOPE OF
DECREASING TIME FROM APPLICATION
SUBMISSION TO NATIONAL VADVISOR
CHILD HEALTH AND HUMAN
DEVELOPMENT COUNTS REVIEW THAT
IS SET FOR MID-MARCH, MID-JULY
AND MID-NOVEMBER.
FOLLOWING INITIAL PEER REVIEW
RECOMMENDED APPLICATIONS, WE
RECEIVE A SECOND LEVEL OF REVIEW
BY THE APPROPRIATE NATIONAL
ADVISORY COUNCIL.
ANY INVESTIGATOR PLANNING TO
SUBMIT AN APPLICATION IN
RESPONSE TO PAR-25-311 MUST
SUBMIT AN LOI AT LEAST FOUR TO 8
MONTHS BEFORE THE APPLICATION
DUE DATE.
THIS TABLE NICE WILL I PROVIDES
TIMELINES FROM WHICH EACH OF THE
FIVE STEPS I ELUDED TO EARLIER
IN THE PRESENTATION SHOULD BE
FOLLOWED AND ALIGNED WITH A
GRANT APPLICATION RECEIPT DATES.
BEAR IN MIND THAT EACH NETWORK
MAY HAVE OWN INTERNAL PROCESSES
FOR CONCEPT REVIEW PROCESS. IT
MAY INVOLVE DEVELOPMENT OF A
FULL PROTOCOL AND REVIEWS BY A
COMMUNITY ENGAGEMENT BOARD.
AN IMPORTANT POINT THAT I WOULD
LIKE TO HIGHLIGHT IS THAT THE
NETWORK DCC WILL BE THE ONE THAT
IS SUBMITTING THE APPLICATION.
SIMPLIFIED REVIEW FRAMEWORK.
MANY OF YOU MAY BE AWARE THAT
THERE IS A SIMPLIFIED REVIEW
FRAMEWORK FOR APPLICATIONS
SUBMITTED AFTER JANUARY 252025.
PLEASE REFER TO NO TCT-OD-24-01
AND NOTE ADDITION ALE REVIEW
CRITERIA SPECIFIC TO PAR-25-311.
TO ADD, AS OF MAY 2025,
APPLICATIONS SUBMITTED TO THIS
NOFO WILL NO LONGER BE CONVENED
BY SCIENTIFIC REVIEW BRANCH BUT
COMPLETED THROUGH NIH CENTERS
FOR SCIENTIFIC REVIEW ALSO KNOWN
AS CSR.
WHAT ARE OTHER HIGHLIGHTS FOR
THIS NOFO?
ONE, IT IS A REQUIREMENT TO
PROVIDE A LETTER OF SUPPORT
AFFIRMING THAT ALL NETWORK
CENTERS ARE COMMITTED TO
PARTICIPATING IN THE STUDY.
IF ANY SPECIFIC SITE IS NOT
PARTICIPATING, CLEAR RATIONALE
SHOULD BE PROVIDED.
EACH NON-NETWORK INSTITUTION
PARTICIPATING IN THE PROJECT
MUST PROVIDE A SEPARATE LETTER
OF SUPPORT SIGNED BY INSTITUTION
OF SIGNING OFFICIALS.
LAST, PLANS FOR ENHANCING
DIVERSE PERSPECTIVE ALSO KNOWN
AS PEDP HAS THEM REMOVED IN THIS
VERSION OF THE PAR AND IS NO
LONGER REQUIRED.
SO THAT CONCLUDES THE
PRESENTATION PORTION OF THIS
WEBINAR.
AT THIS TIME, I WOULD LIKE TO
BRING ON OUR PLANNING COMMITTEE
PANEL TO HELP US READ OUT THE
QUESTIONS DEDICATED IN THE Q & A
SECTION.
I WILL STOP SHARING NOW.
I WILL ALLOW ALL PANELISTS TO
READ ANY QUESTIONS.
THANK YOU.
>> HEY, ABBY. THERE IS ONLY
ONE QUESTION SO FAR IN THE Q &
A.
THAT IS WILL THE SLIDES BE
SHARED?
>> THERE IS GOING TO BE AN NIH
VIDEO CAST RECORDING WHERE THE
SLIDE WILL BE READILY AVAILABLE
AT THE END OF THE PRESENTATION
AND THAT IS WHERE THE SLIDE WILL
BE AVAILABLE. THANK YOU FOR THE
QUESTION.
>> THAT IS ALL WE HAVE
CURRENTLY. IF YOU WANT TO GO
THROUGH SOME OF THE OTHER
QUESTIONS YOU HAVE PREPARED.
>> OKAY. EVERYONE, DON'T BE
SHY.
WE DO WELCOME YOU TO FEEL FREE
TO USE THE Q & A. PRIOR TO THE
WEBINAR, WE RECEIVED SOME
QUESTIONS IN ADVANCE.
AS STEPHANIE ELUDED TO, I'M
HAPPY TO SHARE THAT. PERHAPS
THAT CAN STIMULATE SOME
ADDITIONAL QUESTIONS FROM
OTHERS.
>> THERE IS A QUESTION: IS
THERE DEDICATED FUNDING FOR THIS
PAR?
>
CAN YOU GUYS HEAR ME?
>> YEAH. I WILL JUMP IN IF
NOBODY ELSE IS. THERE IS. THIS
WILL NOT BE COMING OUT OF THE
STANDARD R01 POOL FUNDS.
>> CAN YOU ALL HEAR ME NOW?
>> YES.
>> THANK YOU FOR THAT QUESTION.
THERE IS A QUESTION WE RECEIVED
FROM INDIVIDUALS ASKING ABOUT
RESUBMISSIONS TO PAR-25-311.
ARE THESE PERMITTED? THE ANSWER
IS YES. PRE-SUBMISSIONS TO
PAR-25-311 ARE PERMITTED AND
TIMEFRAME AND GOAL TO HAVE
SUBMITTED WITHIN 37 MONTHS OF
THE ORIGINAL NEW APPLICATION.
PLEASE NOTE THE RECEIPT DATE FOR
THE A1 APPICATION IS THE SAME
RECEIPT DATE AS FOR THE A0
APPLICATIONS FOR PAR-25-311.
NOT A MONTH LATER AS IS TYPICAL
FOR MANY R ACTIVITY CODES.
I DO WANT TO REFER YOU TO THE
NOT-ODA TEAM 109 POLICY FOR
RESUBMISSIONS OF NIH
APPLICATIONS.
SO TO BUILD ON THE QUESTION THAT
WAS ASKED IN THE Q & A, THERE
WAS ANOTHER QUESTION THAT CAME
UP PRIOR TO THIS WEBINAR THAT
STATES THAT GIVEN THAT
CAPITATION INDIRECT COSTS ARE
DIRECT COSTS WITHIN THE GRANT
APPLICATION, SHOULD THEY BE
CONSIDERED IN THE 6.25 MILLION
TOTAL DIRECT COST CAP?
ABSOLUTELY.
THE ANSWER IS YES. DIRECT COSTS
INCLUDE CAPITATION COSTS TO
CONDUCT RESEARCH AS WELL AS
INDIRECT COSTS ON CAPITATION
COSTS.
YES. INDIRECT COSTS ON
CAPITATIONS ARE APPLICABLE ON
THE DIS CAP. I WILL PAUSE TO
SEE IF THERE ARE Q & A QUESTIONS
BEFORE I PROCEED.
>> YES. TWO FROM KIMBERLY.
ONE IS DO LINKS TO PROVIDE LISTS
WITH STUDIES ARE CURRENTLY
ONGOING WITHIN THE NETWORKS?
>> THANK YOU, MARGE ORREE, FOR
THAT QUESTION, AND KIMBERLY FOR
THAT QUESTION.
PAR-25-311 NO PHONE, WE HAVE THE
LINKS FOR THE FIVE SPECIFIC
NETWORKS.
IF YOU CLICK ON LINKS FOR
SPECIFIC NETWORKS OF INTEREST TO
YOU KIMBERLY, YOU CAN SEE ACTIVE
STUDIES ON THEIR OWN WEBSITES
WHAT IS CURRENTLY ONGOING AND
RECRUITING AND HOPE IT HELPS TO
ANSWER YOUR QUESTION.
>> THEN ALSO WHO IS THE PERSON
TO CONTACT TO DETERMINE IF A
STUDY IDEA FITS WITHIN THE GOALS
OF THE FMNU NETWORK?
>> THANK YOU FOR THAT QUESTION,
MARGE ORREE.
THE FIRST CONTACT WOULD BE TO
OUR GENERAL MAILBOX. I WILL
MAKE SURE WE PUT THAT IN THE Q &
A SO THAT EVERYONE GETS ACCESS
TO THAT.
IN ADDITION, WE ARE MORE THAN
HAPPY AT THAT TIME TO LEVERAGE
AND INTRODUCE YOU TO OUR MFMU
COLLEAGUES WITHIN NICHD AND
PROGRAM ANALYST AND PROGRAM
OFFICIAL AS WELL AS OUR PROJECT
SCIENTISTS TO STIMULATE OR
ANSWER ANY QUESTIONS YOU MAY
HAVE REGARDING TO MFMU RELATED
PROPOSAL AND HOPE IT HELPS
ANSWER YOUR QUESTION. THANK
YOU.
>> I THINK WE HAVE AN
ADDITIONAL QUESTION. FOR
CONCEPTS THAT ARE ALREADY
SUBMITTED ON OR ABOUT APRIL
2025, DO WE NEED TO RESUBMIT?
>> THANK YOU FOR THAT QUESTION.
CONCEPTS SUBMITTED IN APRIL OF
2025, FIRST IT HAS TO GO THROUGH
AND BE APPROVED. IF IT HASN'T
BEEN APPROVED, YES. WE WOULD
ASK YOU TO RESUBMIT THE CONCEPT
PROPOSAL AND GET IT APPROVED BY
NICHD.
HOPE IT HELPS TO ANSWER YOUR
QUESTION.
>> THOSE SUBMISSIONS, YOU ARE
TALKING ABOUT THE GRANT
SUBMISSION NOT JUST SOMETHING
THAT HAS NOT BEEN SUBMITTED AS
AN APPLICATION, CORRECT?
>> CORRECT.
>> WE HAVE ANOTHER QUESTION.
CAN YOU EXPAND A BIT MORE ON HOW
MUCH DETAIL YOU WANT FOR THE
JUNIOR INVESTIGATORS INVOLVED IN
RESEARCH STRATEGY SECTIONS OF
THE GRANTS.
I THOUGHT IT -- THE TRAVEL
BUDGET WAS MOSTLY FOR EACH OF
THEM TO ATTEND THE MEETING
UNLESS THEY ARE SPECIFICALLY
GOING TO LEAD A PORTION OF THE
STUDY.
>> THANK YOU STEPHANIE, FOR
THAT ANSWER.
TO BUILD ON THAT, I THINK, ONE,
TO HIGHLIGHT FACT THAT JUNIOR
INVESTIGATORS -- TRAINER
INVESTIGATORS AND USE IT TO
TRAIN NEXT GENERATION SCIENTISTS
AND TO STEPHANIE'S POINT
ATTENDING STEERING COMMITTEE
MEETINGS AND TRIAL TO THEM IS
IMPORTANT AND GIVING THEM
OPPORTUNITY AND TIME AND
INTEGRATING THEM MORE INTO A
PRIMARY STUDY IS IMPORTANT.
EXAMPLES I CAN THINK OF IS
SOMETIMES NETWORKS THAT PROPOSED
THAT JAUNOR INVESTIGATORS CAN BE
INVOLVED IN SURGICAL TECHNIQUE
AND HELP RE-KWON SENT SUBJECTS
AND STUDY PROCEDURES THEY CAN
LEAD SECONDARY MANUSCRIPTS AND
TO STEPHANIE'S POINT, THERE IS A
GREAT OPPORTUNITY FOR THEM AND
HOPE IT HELPS TO ANSWER YOUR
QUESTION.
>> I WILL PUSH ON TO ANOTHER
QUESTION THAT WE RECEIVED PRIOR
TO THIS THAT WAS AROUND JUNIOR
INVESTIGATORS TO BUILD ON THAT.
CAN JUNIOR INVESTIGATORS INCLUDE
NETWORK PARTICIPATION ON K-AWARD
DEVELOPMENT PLAN?
ANSWER IS POSSIBLY. IF
PARTICIPATION IN THE NETWORK
PROJECT ALIGNS WELL WITH THEIR
CAREER GOALS AND RESEARCH
INTERESTS, RECIPIENTS K-AWARD
AND NETWORK PARTICIPATION MAY BE
INCLUDED AS PART OF K-AWARD
DEVELOPMENT PLAN ON A CASE BY
CASE BASIS AND ROLES IN THE
NETWORK PROJECT SHOULD BE
CLEARLY DESCRIBED IN BOTH
NETWORK APPLICATIONS AND K AWARD
DEVELOPMENT PLAN AND
PARTICIPATION IN THE NETWORK
PROJECT MUST BE CONSISTENT WITH
OUR CURRENT NIH GUIDANCE AND
LINKS ARE PROVIDED HERE ON THE
SLIDE.
ANOTHER QUESTION WE RECEIVED IS
INDIRECT COSTS PROVIDED ON
CAPITATION FUNDING PROVIDED TO
ENROLLING CLINICAL RESEARCH
CENTERS AND SITES?
ANSWER IS YES.
APRIL APPLICANTS ARE TO CONSULT
WITH OFFICES WITHIN OUR OWN
INSTITUTION TO ENSURE COSTS FOR
YOUR OWN INSTITUTION OR
SUBCONTRACTS OR SUBINSTITUTIONS
PROPOSED IN ACCORDANCE WITH
APPLICABLE COST PRINCIPLES AND
PROVIDED GRANT POLICY STATEMENT
SECTION 7.2 TO HIGHLIGHT THAT
AND IS IMPORTANT TO CONFORM TO
YOUR ORGANIZATION'S NEGOTIATED
FNA INDIRECT COST RATE
AGREEMENT.
ARE THERE ANY OTHER Q & A
QUESTIONS OR PANELISTS? NOT
HEARING ANY, I WILL PROCEED WITH
OTHER QUESTIONS WE RECEIVED IN
ADVANCE. THE NEXT QUESTION IS
CAN APPLICATIONS REQUEST A
BUDGET IN EXCESS OF THE 6.25
MILLION TOTAL DIRECT COST CAP.
THE ANSWER IS YES. HOWEVER, AS
DESCRIBED IN PAR-25-311,
PROJECTS REQUIRING DIRECT COSTS
EXCEEDING 6.25 MILLION MAY BE
PROPOSED AND REQUIRE ADDITIONAL
NICHD APPROVAL AS PART OF THE
PRE-APPLICATION PROCESS AND WE
DO ASK THAT BUDGETS NEED TO BE
SUBMITTED AND APPROVED BY NICHD
AT LEAST ONE MONTH PRIOR TO
GRANT RECEIVED DATE AS DESCRIBED
ON NICHD CLINICAL RESEARCH
WEBSITE AND WE HAVE IT UNDER THE
SECTION TITLED TIMELINES.
>> WE DID RECEIVE ANOTHER ONE.
DOES INSTITUTION NEED TO BE PART
OF THESE NETWORKS OR CAN YOU
COLLABORATE WITH SOMEONE IN THE
NETWORK?
>> EXCELLENT QUESTION. THANK
YOU, MARGE ORREE.
RIGHT NOW, WE ARE AND DO ALLOW
THAT INSTITUTIONS THAT ARE NOT
PART OF THE NETWORK CAN BE ADDED
IN TO THE NETWORK.
THIS, AGAIN, IT IS IMPORTANT TO
NOTE THAT WE DO HAVE TO VET THAT
INSTITUTION THAT YOU PLAN TO ADD
ON INTO THE NETWORK.
WE WELCOMED COLLABORATION AND
NICHD WILL VET THAT IN THE
PRE-APPLICATION PROCESS.
I HOPE THAT HELPS TO ANSWER YOUR
QUESTION OR IF ANYONE WANTS TO
ADD ANYTHING ELSE.
>> ONLY THING I ADD IS
REITERATING WHAT YOU SAID WHICH
IS GOAL OF THIS INITIATIVE IS TO
ALLOW INVESTIGATORS NOT PART OF
NETWORKS OR AFFILIATED WITH
NETWORK INSTITUTIONS TO HAVE
OPPORTUNITY TO LEVERAGE NETWORK
RESOURCES AS YOU SAID.
SO AS ABBY MENTIONED, WE WOULD
DEFINITELY ENCOURAGE THAT.
>> THANK YOU, BOB. WELL SAID.
>> WE HAVE AN ADDITIONAL
QUESTION ASKING ABOUT
COMPOSITION OF THE FINAL GRANT
REVIEW AND ANY ASKING IF
SPECIFIC STUDY SECTION
ESPECIALLY AS THERE IS A MOVE
AWAY FROM SETS.
>> THAT IS AN EXCELLENT
QUEST
QUESTION.
RIGHT NOW, THESE APPLICATIONS
REVIEWED BY NIH CENTER OF
SCIENTIFIC REVIEW THAT CAME
AFTER ANNOUNCEMENT IN MARCH.
APPLICATIONS RESPONDING TO PAR
WOULD BE ASSIGNED TO A STUDY
SECTION OR SPECIAL EMPHASIS
PANEL OF BEST SCIENTIFIC FIT.
PLEASE BEAR IN MIND THIS IS NEW
FOR US.
WE ARE ALL LEARNING AND WILL DO
OUR BEST TO MAKE SURE THAT YOUR
APPLICATION GETS ASSIGNED TO THE
RIGHT STUDY SECTION. I WANT TO
HIGHLIGHT IF REQUESTS FOR
REASSIGNMENT TO THAT SECTION,
THEY NEED TO COME SPECIFICALLY
FROM THE PI THAT WE ASSOCIATED
SCIENTIFIC JUSTIFICATION.
THANK YOU FOR THE QUESTION.
>> IF I COULD ADD SOMETHING
ELSE TO THAT, I TOLD ABBEY I
WOULDN'T TALK MUCH. COMES FROM
BRAIN STEM IT IS COURTIC COL.
THAT ASIDE, EMPHASIZING EFFORTS
THAT ABBY AND TEAM MAEM TO
ENSURE WITH THIS TRANSITION HOW
APPLICATIONS ARE BEING REVIEWED
AND THAT THEY END UP IN THE
RIGHT STUDY SECTION AND MORE
IMPORTANTLY THAT THE STUDY
SECTION HAS SPECIFIC CONTENT
EXPERTISE TO PROVIDE AN INFORMED
REVIEW.
WITHOUT THAT, THE PROCESS CAN'T
BE SUCCESSFUL AND REALLY WANT TO
THANK HER FOR GOING ABOVE AND
BEYOND TRYING TO MAKE THAT
HAPPEN DURING A VERY CHALLENGING
TIME.
>> THANK YOU, BOB.
OKAY. WE WILL PROCEED WITH SOME
-- ARE THERE QUESTIONS THAT WE
RECEIVED PRIOR TO THIS WEBINAR?
PERHAPS WE CAN TAKE ANOTHER ONE
FROM THE Q & A.
NEXT QUESTION READS CAN K-AWARD
RECIPIENT PART IN AND BE PAID
FOR ACTIVITIES ON GRANT
APPLICATIONS SUBMITTED IN
RESPONSE TO PAR-25-311? ANSWER
IS YES K AWARD RECIPIENTS CAN
ENGAGE AND BE COMPENSATED FOR
ACTIVITY ON OTHER GRANTS
INCLUDING PAR-25-311 AND MUST
MAINTAIN MINIMUM OF 75% EFFORT
ON K AWARD ENSURING CAREER
DEVELOPMENT REMAINS THEIR MAIN
FOCUS AND REMAINING UP TO 25 P
RS CAN BE ALLOCATED TO OTHER
PROFESSIONAL ACTIVITIES THAT
CAN'T EXCEED 100% TOTAL EFFORT.
ADDITIONALLY MUST BE NO OVERLAP
IN COSTS OR ACTIVITIES BETWEEN K
AWARD OR OTHER GRANTS AND ANY
ADDITIONAL INVOLVEMENT IN OTHER
PROJECTS SHOULD BE APPROPRIATELY
DOCUMENTED AND JUSTIFIED TO
AVOID CONFLICTS WITH K-AWARD
REQUIREMENTS.
IF UNCERTAINTY REGARDING
SPECIFIC SITUATION, K-AWARD
RECIPIENTS SHOULD REFER TO GUIDE
NOTICE OTOD1709084 AND AGAIN
FEEL FREE TO CONTACT NIH PROGRAM
OFFICER AND GRANT MANAGEMENT
SPECIALIST FOR FURTHER
CLARIFICATION.
>> WE RECEIVED ANOTHER ONE FOR
INVESTIGATORS WHO ARE NOT
CURRENTLY PART OF NICHD
SUPPORTED NETWORK, WHAT IS THE
RECOMMENDED PROCESS FOR
INITIATING A COLLABORATION AND
REACHING OUT DIRECTLY TO
LEADERSHIP OF SPECIFIC NETWORK
OR IS IT PREFERABLE TO FIRST
CONTACT NETWORK'S COORDINATING
CENTER OR NICHD PROGRAM STAFF TO
FACILITATE AN INTRODUCTION?
>> THANK YOU, MARGE ORREE, FOR
THE QUESTION AND PERSON THAT
ASKED THAT QUESTION.
FIRST STEP, WE ENCOURAGE YOU TO
E-MAIL US AND SUBMIT WHAT YOU
CALL A LETTER OF INQUIRY TO
NICHD-NETWORK-CLINICAL RESEARCH
AND MALE.RESEARCH.GOV THAT IS IN
OUR CHAT BOX AND WHAT IS
IMPORTANT TO US IS ONCE YOU
REACH OUT TO US WE DO OUR BEST
TO RESPOND VERY QUICKLY AND GOAL
THERE IS TO REVIEW THAT LETTER
OF INQUIRY THAT YOU SEND AND
THEN ONCE THAT IS APPROVED, WE
DO ALLOW YOU TO PROCEED TO WHAT
YOU CALL IN SUBMITTING A CONCEPT
PROPOSALS.
NOW, IN TERMS OF ENGAGING WITH
DCC OR COORDINATING CENTER THAT
YOU ASK, THAT WOULD HAVE BEEN AT
A LATER POINT.
I THINK THAT THE FIRST STEP IS
TO MAKE SURE THAT YOU PUT
TOGETHER THIS LETTER OF INQUIRY
AND E-MAIL US AND LETTER OF
INQUIRY IS RELATIVELY
STRAIGHTFORWARD THAT WE ASK FOR
THINGS SUCH AS PROJECT TITLE AND
SPECIFIC AIMS AND STUDY
POPULATION OR ESTIMATED SAMPLE
SIZE.
IT IS A ONE-PAGER.
WE HAVE A ROBUST DISCUSSION
INCLUDING FOLKS WITHIN THAT
NETWORK OF INTEREST THAT YOU MAY
HAVE. HOPE IT HELPS YOU TO
ANSWER YOUR QUESTION.
>> THERE WAS A QUESTION
RECEIVED IN ADVANCE REGARDING
BIOSKETCHES.
I'M HAPPY TO READ THAT BEFORE WE
TAKE OTHER QUESTIONS FROM THE Q
& A.
ARE BIOSKETCHES REQUIRED IN THE
GRANT APPLICATION SUBMITTED IN
RESPONSE TO PAR-25-311 FOR ALL
JUNIOR INVESTIGATORS OR JUST
THOSE PARTICIPATING TO A
SIGNIFICANT DEGREE?
BIOSKETCHES ARE ONLY REQUIRED
FOR THOSE JUNIOR INVESTIGATORS
WHO ARE BEING PROPOSED TO SERVE
AS A SENIOR OR KEY PERSONNEL
JUNIOR INVEST GAFRORS ATTEND
COMMITTEE STEERING MEETINGS AND
PROJECT DO NOT NEED BIOSKETCH.
ALL REQUIRED BIOSKETCHES MUST BE
PROVIDED IN ACCORDANCE TO
NOTD241063 AND IF YOU NEED MORE
GUIDANCE THERE IS A LINK
PROVIDED THERE AS WELL.
ANOTHER QUESTION WE RECEIVED IN
ADVANCE TO THIS WEBINAR IS DOES
EACH ENROLLING SITE NEED TO
PROVIDE A JUNIOR INVESTIGATOR TO
PARTICIPATE IN THE PROPOSED
STUDY OR SIMPLY A FUNDED
CLINICAL RESEARCH CENTER?
ANSWER IS ONE JUNIOR
INVESTIGATOR NEEDS TO BE
IDENTIFIED FROM EACH OF THE
CLINICAL RESEARCH CENTERS FROM
THE NETWORK. THAT IS CENTERS
RECEIVING PRIMARY NOTICE OF
GRANT AWARD AND NOT FROM EACH OF
THE SATELLITES OR ENROLLING
SITES.
JUN INVESTIGATOR MAY BE
IDENTIFIED FROM THE PRIMARY
CLINICAL RESEARCH CENTER OR ANY
SATELLITE SITES FROM THE PRIMARY
CLINICAL RESEARCH CENTER AND
ONLY ONE JUNIOR INVESTIGATOR
NEEDS TO BE IDENTIFIED FROM
PRIMARY CLINICAL RESEARCH
CENTER.
JUNIOR INVESTIGATOR MAY TAKE ON
ANY NUMBER OF ROLES IN THE
PROJECT BUT THE ROLE MUST BE
CLEARLY DEFINED.
THOSE ARE ALL QUESTIONS WE
RECEIVED IN ADVANCE AND WILL
PAUSE AGAIN TO GIVE OTHERS A
CHANCE TO PERHAPS READ ANY OTHER
QUESTIONS WE RECEIVED IN OUR Q &
A.
WE WELCOME ADDITIONAL QUESTIONS
IF NOW OR AT A LATER TIME.
HERE IS THE GENERAL MAILBOX FOR
EVERYONE TO REFER TO IF YOU DO
HAVE INTERESTS OR HAVE QUESTIONS
REGARDING THIS NO PHONE.
>> ABBY, WE HAVE A QUESTION IN
THE CHAT ABOUT INDIRECT COSTS
AND WHETHER THE INDIRECT COSTS
ON CAPITATION THAT GO TO THE
CLINICAL CENTERS ARE CONSIDERED
PART OF THE DIRECT COSTS UNDER
THE (62) 500-0000 CAP THAT
APPLIES. THE ANSWER TO THAT IS,
YES. THOSE INDIRECT COSTS TO
THE CLINICAL CENTERS ARE PART OF
THAT CAP BECAUSE THAT -- IT IS
ALL INCLUDED AS DIRECT COSTS
UNDER THE DCC GRANT APPLICATION.
>> I WILL TAKE THIS ONE. IT
SEEMS I CREATED THE CONFUSION.
I APOLOGIZE FOR THAT.
INDIRECT COSTS ON CAPITATIONS
WILL BE CONSIDERED AS PART OF
DIRECT COSTS CAP.
IF IT PUTS YOU OVER 6.25
MILLION, THAT IS SOMETHING WE
WILL TAKE TO OUR LEADERSHIP IN
EXPLAINING THIS IS THE RATIONALE
FOR GOING AHEAD OF THAT.
TO BE CLEAR, INDIRECT COSTS ON
CAPITATIONS ARE CONSIDERED AS
DIRECT COSTS AS PART OF 6.25
MILLION AND, AGAIN, I APOLOGIZE
FOR CONFUSION.
>> THANK YOU, BOB, AND
STEPHANIE, FOR THAT ANSWER.
>> THEN THERE IS ANOTHER
QUESTION IN LIGHT OF NIH POLICY
ON FOREIGN SUB AWARDS AND WHAT
YOUR GUIDANCE ON NEW SUBMISSION
OF CONCEPTS IN RESPONSE TO
PAR-25-311.
>> THANK YOU, STEPHANIE.
THANKS FOR THAT QUESTION.
AGAIN, WE DID RECEIVE, AND I'M
SURE YOU ALL HEARD, ABOUT THE
NOTICE THAT CAME OUT.
NOT-OD-25-104 IS UPDATED POLICY
THAT CAME OUT ON FOREIGN SUB
AWARDS AND RECOGNIZE THAT THINGS
ARE CHANGING AND WANT TO
HIGHLIGHT OUR CURRENT PAR-25-311
STATE FOREIGN COMPONENTS ARE
ALLOWED.
AGAIN, FOR RIGHT NOW, ANSWER
WOULD BE TO REFER TO THAT
NOTICE.
AGAIN, YOU ARE WELCOME TO E-MAIL
US AT NICHD NETWORK CLINICAL
RESEARCH AT NIH.GOV AND IF YOU
HAVE FURTHER QUESTIONS WE WILL
MAKE SURE TO ANSWER THAT FOR
YOU.
THANK YOU.
>> >> THERE IS ANOTHER
QUESTION THEN.
THANK YOU FOR HOSTING THE
WEBINAR.
I UNDERSTAND THERE ARE REVIEWS
ABOUT I NICHD AND ALSO BY THE
NETWORK WITH WHICH THE STUDY IS
BEING PROPOSED AND CONCEPT
APPROVAL AND DEADLINE FOR REVIEW
BY NETWORK BEFORE THE REVIEW BY
NICHD?
EACH HAS OWN PROCESSES AND IN
GENERAL SUBMIT CONCEPT AND
PRESENT IT TO RELEVANT NETWORK'S
STEERING COMMITTEE MEETINGS AND
IN FOLLOWING THAT MEETING THE
STEERING COMMITTEE WOULD PROVIDE
COMMENTS AND VOTE ON THAT THAT
WOULD GO TO NICHD AS PART OF
THEIR REVIEW OF KONT CREPT
ITS
ITSELF.
>> YEAH.
>> DIFFERENCES IN HOW NETWORKS
HANDLE CONCEPTS BUT THAT IS IT
IN GENERAL.
>> WELL-SAID, STEPHANIE. THANK
YOU FOR THAT.
BUILDING ON THAT, PERHAPS WHAT I
HEARD IN THE QUESTION PERHAPS
WHAT ARE THEY ASSESSING FOR?
CONCEPT THAT WE ASSESS THEMES
SUCH AS FEASIBILITY AND
IMPORTANCE AND RELEVANCE OF
SCIENCE AND MISSION OF THE
NETWORK AND NICHD, WE ALSO
ASSESS BUDGET. TO STEPHANIE'S
POINT, PRESENTING AT THE
STEERING COMMITTEE MEETINGS IS
IMPORTANT TO GET THAT NETWORK
FEEDBACK.
GO ELIS TO HOPEFULLY GET THAT
FEEDBACK IN A TIMELY MANNER.
WE TRY TO SET TIMELINE OF AROUND
OR WITHIN 2 MONTHS OF OBTAINING
INITIAL ACCESS OF SUBMISSION OF
CONCEPT PROPOSAL.
TO STEPHANIE'S POINT, NICHD
RENDERS FINAL DECISION WHEN WE
RECEIVE NETWORK FEEDBACK OR
WHETHER OR NOT CONCEPT PROPOSAL
CAN PROCEED TO BECOME A FULL
GRANT APPLICATION AND HOPE IT
HELPS TO ANSWER YOUR QUESTION.
THANK YOU.
>> WE HAVE AN ADDITIONAL
QUESTION ASKING ABOUT INDIRECTS
FOR EXTERNAL NON-NETWORK
CLINICAL CENTERS TRYING TO
UNDERSTAND IF THOSE WILL BE
INCLUDED IN THE 6.25 DIRECT COST
CAP.
SUB-AWARDS TO CENTERS.
>> YES. ALL APPLICABLE
INDIRECT COSTS FOR CAPITATION
WOULD BE CONSIDERED PART OF THE
DIRECT COST BUDGET AND THEIR
APPLICABLE TO THAT CAP.
THANK YOU FOR THAT QUESTION.
>> I JUST MAYBE TO KEEP IT
SIMPLE ANYTHING THAT IS
CONSIDERED A DIRECT COST ON
APPLICATION WILL BE CONSIDERED
PART OF THE 6.25 MILLION DIRECT
COST CAPS AND INDIRECT COSTS
PUTTING YOU OVER THE LIMIT IS
SOMETHING WE SHOULD DISCUSS AND
TRY TO WORK OUT ON THE FRONT END
AND WHY AS ABBY SAID WE TRY TO
GET BUDGETS IN AT LEAST A MONTH
PRIOR TO GRANT DUE DATE SO ANY
CONCERNS CAN BE ADDRESSED.
>> THANK YOU, BOB.
>> WE DO HAVE ANOTHER QUESTION
FOR PRESENTATIONS THAT HAVE BEEN
IN THE LAST MONTH OF -- LAST
MONTH'S STEERING COMMITTEE TO BE
SUBMITTED WILL WE GET FEEDBACK
FROM SUBMISSIONS?
>> THANK YOU FOR THAT QUESTION.
WE DO IDEALLY DO OUR BEST TO SET
UP AN ADDITIONAL CALL, IF
NEEDED, WITH INVESTIGATORS THAT
PRESENTED AT STEERING COMMITTEE
MEETING AND GOAL IS TO BE
COLLABORATIVE AND HELP PRODUCE
THE BEST SCIENCE.
WE ABSOLUTELY ENCOURAGE YOU TO
E-MAIL US AT THIS GENERAL
MAILBOX. WE ARE MORE THAN HAPPY
TO SHARE WITH YOU SOME TIPS OR
STRATEGIES TO POSSIBLY HELP YOU
TO GET THAT FEEDBACK THAT YOU
NEED TO RESUBMIT. WE WELCOME IT
AS WELL. THANK YOU FOR THE
QUESTION.
>> ABBY, RELATED I THINK TO
THIS QUESTION IS SORT OF THE
CONCEPTS THAT HAVE BEEN OR COME
IN IN THE MEANTIME AND ARE IN
DEVELOPMENT.
I DON'T THINK THAT THEY NEED TO
RESUBMIT CONCEPTS AT THIS TIME.
IT IS ONLY IF THEY HAVE
SUBMITTED A GRANT APPLICATION
UNDER THE PRIOR PAR THAT THERE
NEEDS TO BE REVISION THAT IT
WOULD COME IN UNDER THE NEW PAR
AND NEW MECHANISM STRUCTURE.
ONES THAT ARE CURRENTLY IN
DEVELOPMENT WILL PROCEED AS-IS.
YOU WOULD ONLY NEED TO RESUBMIT
THE CONCEPT IF -- BASED ON
FEEDBACK YOU MIGHT RECEIVE FROM
STEERING COMMITTEES.
>> ABSOLUTELY.
WELL SAID.
>> WE DON'T HAVE OTHER
QUESTIONS IN THE Q & A AND WANT
TO SAY WITH THAT, WE ARE HAPPY
TO STAY ON. THIS WEBCAST IS
GOING TO 2 O'CLOCK EASTERN
STANDARD TIME BUT SAYING
RECORDING OF THIS WEBINAR WILL
BE MADE ON NIH ARCHIVE SITE AND
FEEL FREE TO REACH OUT TO US.
WE WELCOME QUESTIONS YOU HAVE TO
OUR PROGRAM OFFICIALS AND
SCIENTISTS AND TO ANALYSTS AND
ANYONE YOU SEE TODAY AT THE
PRESENTATION.
WE WELCOME YOU ALSO TO USE THIS
EMILL ADDRESS PRESENTED ON THE
SLIDE THAT IS THE SAME AS ONE
THAT IS LISTED ON PAR AND ON
BEHALF OF WEBINAR PLANNING
COMMITTEE THANKS SO MUCH. THIS
IS A LONG TIME COMING TO HAVE
THE WEBINAR AND THANKS FOR
PATIENCE AND ENGAGING QUESTIONS
YOU HAD PRIOR TO THE WEBINAR AND
THOSE THAT ASKED DURING THE
WEBINAR.
THANKS SO MUCH. ENJOY THE REST
OF YOUR DAY.