1 00:00:05,097 --> 00:00:07,366 GOOD MORNING, 2 00:00:07,366 --> 00:00:08,200 GOOD AFTERNOON AND GOOD EVENING 3 00:00:08,200 --> 00:00:12,238 TO EVERYONE. ON BEHALF OF NICHD 4 00:00:12,238 --> 00:00:14,206 DIVISION OF EXTRAMURAL RESEARCH 5 00:00:14,206 --> 00:00:15,841 AND WEB PLANNING COMMITTEE I 6 00:00:15,841 --> 00:00:19,612 WOULD LIKE TO WELCOME YOU TO THE 7 00:00:19,612 --> 00:00:22,214 FIRST WEBINAR FOR IN THE OF 8 00:00:22,214 --> 00:00:26,218 FUNDING OPPORTUNITY PAR-25-311 9 00:00:26,218 --> 00:00:27,853 TITLED MULTI-SITE CLINICAL 10 00:00:27,853 --> 00:00:29,255 RESEARCH LEVERAGING NET 11 00:00:29,255 --> 00:00:30,089 INFRASTRUCTURE TO ADVANCE 12 00:00:30,089 --> 00:00:31,924 RESEARCH FOR WOMEN, CHILDREN, 13 00:00:31,924 --> 00:00:33,959 PREGNANT AND LACTATING WOMEN AND 14 00:00:33,959 --> 00:00:35,327 PERSONS WITH DISABILITY. 15 00:00:35,327 --> 00:00:37,096 WE ARE ALL DELIGHTED TO HAVE 16 00:00:37,096 --> 00:00:38,264 YOUR PRESENCE TODAY. THANK YOU 17 00:00:38,264 --> 00:00:44,470 AGAIN FOR YOUR TIME TO ATTEND. 18 00:00:44,470 --> 00:00:47,973 I'M ABWHY I AND ACTING CLINICAL 19 00:00:47,973 --> 00:00:50,042 DIRECTOR FOR OPERATIONS AROUND 20 00:00:50,042 --> 00:00:52,812 WILL OVERSEE APPLICATIONS 21 00:00:52,812 --> 00:00:59,018 SUBMITTED TO THIS NOFO AFTER 2 22 00:00:59,018 --> 00:01:02,688 YEARS MONITORING THE PROGRESS OF 23 00:01:02,688 --> 00:01:06,625 2307 INITIATIVE NICHD IS MAKING 24 00:01:06,625 --> 00:01:08,194 ADDITIONAL ADJUSTMENTS AND 25 00:01:08,194 --> 00:01:10,696 CLEARLY DELINEATING TIMELINES TO 26 00:01:10,696 --> 00:01:12,198 FACILITATE COLLABORATION AND 27 00:01:12,198 --> 00:01:14,366 UTILIZE EXISTING INFRASTRUCTURE. 28 00:01:14,366 --> 00:01:17,036 LATEST ADJUSTMENTS ALSO ALLOW 29 00:01:17,036 --> 00:01:20,206 ONGOING EFFICIENT ASSESSMENT OF 30 00:01:20,206 --> 00:01:21,907 THE FEASIBILITY AND SCIENTIFIC 31 00:01:21,907 --> 00:01:25,077 SCOPE OF PROPOSED PROJECTS. 32 00:01:25,077 --> 00:01:28,080 THIS IS AN UPDATED VERSION AND 33 00:01:28,080 --> 00:01:32,151 ISSUE OF THAT NOTICE OF FUNDING 34 00:01:32,151 --> 00:01:36,722 OPPORTUNITY. 35 00:01:36,722 --> 00:01:38,858 BEFORE WE DELVE INTO CONTENT OF 36 00:01:38,858 --> 00:01:40,593 THE PRESENTATION I WOULD LIKE TO 37 00:01:40,593 --> 00:01:41,460 ACKNOWLEDGE COLLEAGUES THAT 38 00:01:41,460 --> 00:01:43,996 SUPPORTED ME IN MAKING THIS 39 00:01:43,996 --> 00:01:46,465 WEBINAR POSSIBLE. FOUR NICHD 40 00:01:46,465 --> 00:01:49,168 COLLEAGUES ROBERT TAMBU ARE, RO 41 00:01:49,168 --> 00:01:51,470 A MEDICAL DIRECTOR FOR THE TEAM. 42 00:01:51,470 --> 00:01:55,140 I WANT TO GIVE HIM HIS FLOWERS. 43 00:01:55,140 --> 00:01:58,310 HE STEPPED DOWN TO TAKE OTHER 44 00:01:58,310 --> 00:02:01,447 PROJECTS AT NICHD AND PROGRAM A- 45 00:02:01,447 --> 00:02:04,950 N LIST FOR NEONATAL RESEARCH 46 00:02:04,950 --> 00:02:08,053 STEPHANIE ARCHER AND PROGRAM 47 00:02:08,053 --> 00:02:12,191 ANALYST MEGAN MITCHELL AND 48 00:02:12,191 --> 00:02:14,860 NEWEST MEMBER TO LITH CAL 49 00:02:14,860 --> 00:02:18,764 OPERATION TEAM MARGE ORREE 50 00:02:18,764 --> 00:02:20,866 BANDY. THANK YOU. NEXT, I 51 00:02:20,866 --> 00:02:23,435 WOULD LIKE TO THANK THE INFINITY 52 00:02:23,435 --> 00:02:25,971 CONFERENCE TEAM FOR HELP WITH AV 53 00:02:25,971 --> 00:02:27,306 SUPPORT AND REGISTRATION FOR 54 00:02:27,306 --> 00:02:27,540 TODAY. 55 00:02:27,540 --> 00:02:31,844 THANK YOU, AMY. THANK YOU, 56 00:02:31,844 --> 00:02:32,111 SHANARD. 57 00:02:32,111 --> 00:02:36,215 IN 2016, THE NIH PROPOSED AND 58 00:02:36,215 --> 00:02:37,283 SUBSEQUENTLY IMPLEMENTED A 59 00:02:37,283 --> 00:02:40,119 SERIES OF REFORMS TO ENHANCE 60 00:02:40,119 --> 00:02:43,522 CLINICAL TRIAL STEWARDSHIP AND 61 00:02:43,522 --> 00:02:45,491 TRANSPARENCY AND THEREBY FURTHER 62 00:02:45,491 --> 00:02:48,460 ASSURE SUCCESS OF NIH CLINICAL 63 00:02:48,460 --> 00:02:50,129 TRIAL ENTERPRISE. 64 00:02:50,129 --> 00:02:51,330 FOUR GUIDING PRINCIPLES THAT 65 00:02:51,330 --> 00:02:54,266 WERE EXPRESSED AND EMPHASIZED IN 66 00:02:54,266 --> 00:02:56,835 THESE FORMS INCLUDED, ONE, TO 67 00:02:56,835 --> 00:02:58,938 ENHANCE RIGOR AND 68 00:02:58,938 --> 00:02:59,738 REPRODUCIBILITY OF CLINICAL 69 00:02:59,738 --> 00:03:01,640 TRIAL PROTOCOLS. 70 00:03:01,640 --> 00:03:03,976 TWO, TO PROMOTE GREATER 71 00:03:03,976 --> 00:03:05,311 AVAILABILITY OF MULTI-SITE 72 00:03:05,311 --> 00:03:07,012 CLINICAL TRIAL INFRASTRUCTURE TO 73 00:03:07,012 --> 00:03:09,114 SUPPORT TRIALS FOR A WIDER RANGE 74 00:03:09,114 --> 00:03:11,183 OF INVESTIGATORS. 75 00:03:11,183 --> 00:03:12,785 THREE, TO FACILITATE DATA 76 00:03:12,785 --> 00:03:17,823 SHARING AND ACCESS TO 77 00:03:17,823 --> 00:03:18,891 BIOSPECIMENS TO EFFICIENTLY 78 00:03:18,891 --> 00:03:21,594 EXPAND RESEARCH CAPACITY FOR ALL 79 00:03:21,594 --> 00:03:21,961 INVESTIGATORS. 80 00:03:21,961 --> 00:03:24,964 THE LAST ONE IS TO FACILITATE 81 00:03:24,964 --> 00:03:26,398 GREATER INVOLVEMENT OF DIVERSE 82 00:03:26,398 --> 00:03:29,868 POPULATION, A MULTI-SITE 83 00:03:29,868 --> 00:03:31,537 CLINICAL TRIAL. 84 00:03:31,537 --> 00:03:34,039 WE BELIEVE THAT ADHERING TO 85 00:03:34,039 --> 00:03:35,541 PRINCIPLE ENSURES PROPER 86 00:03:35,541 --> 00:03:38,310 STEWARDSHIP OF PUBLIC FUNDS, 87 00:03:38,310 --> 00:03:40,212 INCREASING ACCOUNTABILITY AND 88 00:03:40,212 --> 00:03:45,818 HELPS NICHD MAINTAIN PUBLIC 89 00:03:45,818 --> 00:03:47,653 TRUST. IT IS OUR GOAL THAT 90 00:03:47,653 --> 00:03:50,155 PROJECTS WILL UTILIZE NICHD 91 00:03:50,155 --> 00:03:53,459 CLINICAL RESEARCH NETWORK 92 00:03:53,459 --> 00:03:54,326 INFRASTRUCTURE TO PROMOTE 93 00:03:54,326 --> 00:03:55,794 FUNDING AND SUPPORT OF BEST 94 00:03:55,794 --> 00:03:58,597 SCIENCE IN A TIMELY, 95 00:03:58,597 --> 00:04:01,100 TRANSPARENT, EQUITABLE AND COST 96 00:04:01,100 --> 00:04:04,203 EFFECTIVE MANNER. INITIAL NICHD 97 00:04:04,203 --> 00:04:07,606 NETWORKS TO BE INCLUDED IN THIS 98 00:04:07,606 --> 00:04:08,774 INITIATIVE INCLUDE MATERNAL 99 00:04:08,774 --> 00:04:14,880 FETAL MEDICINE NETWORK. 100 00:04:14,880 --> 00:04:17,383 NEONATAL RESEARCH NETWORK GLOBAL 101 00:04:17,383 --> 00:04:19,151 NETWORK FOR WOMEN'S AND 102 00:04:19,151 --> 00:04:22,187 CHILDREN'S HEALTH RESEARCH 103 00:04:22,187 --> 00:04:22,988 COLLABORATIVE PEDIATRIC CRITICAL 104 00:04:22,988 --> 00:04:26,291 CARE RESEARCH NETWORK AND PELVIC 105 00:04:26,291 --> 00:04:29,962 FLOOR SDOORDS NETWORK. IF AN 106 00:04:29,962 --> 00:04:31,163 APPLICATION IS CONSIDERING A 107 00:04:31,163 --> 00:04:35,601 PROJECT ALIGNING WITH ANOTHER 108 00:04:35,601 --> 00:04:37,036 NICHD NETWORK OR AREA OF SCIENCE 109 00:04:37,036 --> 00:04:39,638 NOT DIRECTLY ALIGNED WITH FIVE 110 00:04:39,638 --> 00:04:41,340 NETWORKS HERE, THEIR ADVICE TO 111 00:04:41,340 --> 00:04:45,010 CONTACT SCIENTIFIC RESEARCH 112 00:04:45,010 --> 00:04:48,213 CONTACT OR MYSELF. 113 00:04:48,213 --> 00:04:52,785 SO, WE ATTEMPTED TO DESCRIBE THE 114 00:04:52,785 --> 00:04:54,920 PRE-APPLICATION PROCESS OF THIS 115 00:04:54,920 --> 00:04:58,490 NOFO IN A 5-STEP PROCESS FOR 116 00:04:58,490 --> 00:05:00,225 CLARITY. STEP 1, INVESTIGATORS 117 00:05:00,225 --> 00:05:03,195 ARE ENCOURAGED TO SEND A 118 00:05:03,195 --> 00:05:06,131 ONE-PAGE LETTER OF INQUIRY, AT 119 00:05:06,131 --> 00:05:07,933 LEAST FOUR TO EIGHT MONTHS PRIOR 120 00:05:07,933 --> 00:05:10,135 TO APPLICATION RECEIVE DATE TO 121 00:05:10,135 --> 00:05:15,074 GENERAL MAILBOX. 122 00:05:15,074 --> 00:05:16,775 NICHD-NETWORK-CLINICAL 123 00:05:16,775 --> 00:05:17,142 RESEARCH.GOV. 124 00:05:17,142 --> 00:05:20,979 STEP 2, ONCE APPROVED, PI OR 125 00:05:20,979 --> 00:05:22,681 INVESTIGATOR PREPARES AND 126 00:05:22,681 --> 00:05:25,150 SUBMITS A 5-PAGE CONCEPT 127 00:05:25,150 --> 00:05:28,220 PROPOSAL. STEP 3, NICHD AND THE 128 00:05:28,220 --> 00:05:30,389 NETWORK REVIEWS THAT CONCEPT 129 00:05:30,389 --> 00:05:33,559 PROPOSAL AND NICHD RENDERS A 130 00:05:33,559 --> 00:05:36,895 FINAL DECISION ON CONCEPT 131 00:05:36,895 --> 00:05:39,164 PROPOS 132 00:05:39,164 --> 00:05:39,431 PROPOSAL. 133 00:05:39,431 --> 00:05:43,836 ONCE APPROVED BY NICHD, PI OR 134 00:05:43,836 --> 00:05:46,872 RESEARCHER AND NETWORK DEVELOP 135 00:05:46,872 --> 00:05:48,073 THE GRANT APPLICATION. 136 00:05:48,073 --> 00:05:51,977 STEP 5, THE PI AND THE NETWORK 137 00:05:51,977 --> 00:05:54,646 DATA COORDINATING CENTER SUBMIT 138 00:05:54,646 --> 00:05:56,882 JOINTLY DEVELOPED APPLICATION. 139 00:05:56,882 --> 00:05:58,484 ALL OF THE INFORMATION IS 140 00:05:58,484 --> 00:06:02,121 READILY AVAILABLE AT NICHD 141 00:06:02,121 --> 00:06:03,655 CLINICAL RESEARCH WEBSITE. THE 142 00:06:03,655 --> 00:06:05,758 LINK IS DISPLAYED HERE ON THE 143 00:06:05,758 --> 00:06:06,391 SLIDE. 144 00:06:06,391 --> 00:06:08,093 WE DEFINITELY WANT TO ENCOURAGE 145 00:06:08,093 --> 00:06:10,629 EVERYONE THAT IS ATTENDING TODAY 146 00:06:10,629 --> 00:06:11,797 TO VISIT THAT PAGE. 147 00:06:11,797 --> 00:06:14,967 BECAUSE NOW WE HAVE PUBLISHED A 148 00:06:14,967 --> 00:06:16,568 NEW FREQUENTLY ASKED QUESTION 149 00:06:16,568 --> 00:06:19,371 SECTION ON OUR NICHD CLINICAL 150 00:06:19,371 --> 00:06:20,839 RESEARCH WEBSITE. 151 00:06:20,839 --> 00:06:22,341 HERE, YOU CAN FIND DETAILS ON 152 00:06:22,341 --> 00:06:24,710 WHAT IS NEEDED ON SOME DOCUMENTS 153 00:06:24,710 --> 00:06:28,213 THAT ARE REQUIRED AS WELL. 154 00:06:28,213 --> 00:06:29,748 THERE ARE SIX KEY CHANGES THAT 155 00:06:29,748 --> 00:06:32,217 WE WOULD LIKE TO HIGHLIGHT IN 156 00:06:32,217 --> 00:06:34,953 THIS WEBINAR. 157 00:06:34,953 --> 00:06:40,359 THESE INCLUDE BIPHASIC UG3/UH3 158 00:06:40,359 --> 00:06:42,861 MECHANISM, APPLICATION BUDGETS, 159 00:06:42,861 --> 00:06:46,165 STRONG PREFERENCES, EARLY-STAGE 160 00:06:46,165 --> 00:06:48,200 INVESTIGATORS, RECEIPT DATES, 161 00:06:48,200 --> 00:06:51,069 AND THE SIMPLIFIED REVIEW 162 00:06:51,069 --> 00:06:52,204 FRAMEWORK. 163 00:06:52,204 --> 00:06:54,807 APPLICATIONS UNDER THIS NOFO 164 00:06:54,807 --> 00:06:56,975 WILL OPERATE UNDER A DIFFERENT 165 00:06:56,975 --> 00:06:58,577 TWO -- PHASE MILESTONE DRIVEN 166 00:06:58,577 --> 00:07:02,381 GRANT MECHANISM KNOWN AS UG3/UH3 167 00:07:02,381 --> 00:07:05,250 THAT CONSISTS OF A 168 00:07:05,250 --> 00:07:07,719 START-UP-PHASE UP TO 2 YEARS, 169 00:07:07,719 --> 00:07:10,589 UG3. AND A FULL IMPLEMENT 170 00:07:10,589 --> 00:07:12,491 ENROLLMENT AND FOLLOW UP PHASE 171 00:07:12,491 --> 00:07:17,429 OF UP TO FIVE YEARS, UH3, FOR A 172 00:07:17,429 --> 00:07:23,535 MAXIMUM OF 7 COMBINED YEARS. 173 00:07:23,535 --> 00:07:25,804 APPLICATIONS ARE EXPECTED TO 174 00:07:25,804 --> 00:07:30,242 PROVIDE CLEAR DESCRIPTIONS OF 175 00:07:30,242 --> 00:07:32,244 OVERALL PROJECT DELIVERABLES AND 176 00:07:32,244 --> 00:07:33,512 TOOIL LINES AND MILESTONES 177 00:07:33,512 --> 00:07:36,148 ALIGNING WITH GOALS OF THE STUDY 178 00:07:36,148 --> 00:07:38,283 AND THE NETWORK. 179 00:07:38,283 --> 00:07:41,887 ANNUAL UG3 MILESTONES MUST BE 180 00:07:41,887 --> 00:07:44,823 MET TO ADVANCE TO UH3 PHASE. 181 00:07:44,823 --> 00:07:46,792 TRANSITIONED TO UH3 PHASE 182 00:07:46,792 --> 00:07:50,495 REQUIRES NICHD APPROVAL AND 183 00:07:50,495 --> 00:07:52,197 CONTINUAL FUNDING OF THE PROJECT 184 00:07:52,197 --> 00:07:54,633 WILL BE DEPENDENT UPON MEETING 185 00:07:54,633 --> 00:07:56,134 MILESTONES TO THE PROJECT 186 00:07:56,134 --> 00:07:58,770 INCLUDING BOTH UG3 AND UH3 187 00:07:58,770 --> 00:08:01,006 PHASES THAT IS EXPECTED THAT THE 188 00:08:01,006 --> 00:08:03,475 STUDY WILL BE COMPLETED WITHIN 189 00:08:03,475 --> 00:08:05,711 THE 7-YEAR PROJECT PERIOD. 190 00:08:05,711 --> 00:08:09,514 ALL CARRYOVER AND NO-COST 191 00:08:09,514 --> 00:08:12,184 EXTENSION REQUESTS DO REQUIRE 192 00:08:12,184 --> 00:08:14,086 PRIOR APPROVAL. 193 00:08:14,086 --> 00:08:16,355 SO HERE IS A SAMPLE MILESTONE 194 00:08:16,355 --> 00:08:18,590 TABLE OF UG3 PHASE THAT WE 195 00:08:18,590 --> 00:08:20,959 RECOMMEND OUR INVESTIGATORS USE 196 00:08:20,959 --> 00:08:21,560 IT. 197 00:08:21,560 --> 00:08:23,161 TO THE RIGHT OF THE TABLE IS 198 00:08:23,161 --> 00:08:26,064 WHERE INVESTIGATORS CAN ENTER AN 199 00:08:26,064 --> 00:08:28,467 ESTIMATED TIMELINE IN MONTHS 200 00:08:28,467 --> 00:08:29,968 FROM GRANT AWARD. 201 00:08:29,968 --> 00:08:32,037 THE TYPE OF SAMPLE MILESTONES 202 00:08:32,037 --> 00:08:36,808 INCLUDE ITEMS SUCH AS FDA, IND, 203 00:08:36,808 --> 00:08:39,811 OR IDE APPROVAL IF APPLICABLE. 204 00:08:39,811 --> 00:08:42,781 TIME TO RECEIVE SINGLE IRB 205 00:08:42,781 --> 00:08:43,882 APPROVAL AND TIME TO HAVE AT 206 00:08:43,882 --> 00:08:48,754 LEAST 50% OF RECUTTING SITES 207 00:08:48,754 --> 00:08:50,455 ENROLLED FOR PARTICIPANT AND 208 00:08:50,455 --> 00:08:51,957 INSTITUTIONAL CERTIFICATION 209 00:08:51,957 --> 00:08:53,959 SUBMITTED VERIFYING THAT STUDY 210 00:08:53,959 --> 00:08:55,928 DATA IS APPROPRIATE FOR SHARING 211 00:08:55,928 --> 00:08:59,898 IS DESCRIBED IN OUR DATA 212 00:08:59,898 --> 00:09:04,870 MANAGEMENT AND SHARING PLAN. 213 00:09:04,870 --> 00:09:07,239 ALTERNATIVELY, THIS SAMPLE TABLE 214 00:09:07,239 --> 00:09:11,143 DEPICTS THE UH3 MILESTONE SUCH 215 00:09:11,143 --> 00:09:15,747 AS 100% OF RECRUITING SITES 216 00:09:15,747 --> 00:09:17,082 ENROLLED FOR PARTICIPATANT. 217 00:09:17,082 --> 00:09:19,284 ANOTHER EXAMPLE INCLUDES 218 00:09:19,284 --> 00:09:20,819 SUBMISSION OF FINAL DATA CODE 219 00:09:20,819 --> 00:09:25,123 BOOK TO NICHD-THAT IS OUR 220 00:09:25,123 --> 00:09:27,993 REPOSITORY HERE AT NICHD. 221 00:09:27,993 --> 00:09:30,028 VARIABLE PERCENT DISTRIBUTION OF 222 00:09:30,028 --> 00:09:34,833 50%, 75%, 100% OF THE STUDY 223 00:09:34,833 --> 00:09:37,169 POPULATION PROPOSED RACIAL, 224 00:09:37,169 --> 00:09:38,971 ETHNIC, AND SEX DISTRIBUTION. 225 00:09:38,971 --> 00:09:41,373 ANOTHER EXAMPLE INCLUDES DATA 226 00:09:41,373 --> 00:09:44,209 COLLECTION AND DATA -- BASE LOCK 227 00:09:44,209 --> 00:09:44,509 COMPLETED. 228 00:09:44,509 --> 00:09:47,045 ALSO, PRIMARY OUTCOME DATA 229 00:09:47,045 --> 00:09:47,980 ANALYSIS COMPLETED. 230 00:09:47,980 --> 00:09:50,449 AGAIN, INVESTIGATORS, THIS IS A 231 00:09:50,449 --> 00:09:52,584 SAMPLE OF THE MILESTONES AND WE 232 00:09:52,584 --> 00:09:54,553 ENCOURAGE YOU TO PROVIDE AN 233 00:09:54,553 --> 00:09:55,721 ESTIMATED TIMELINE IN MONTHS 234 00:09:55,721 --> 00:10:00,192 FROM THE GRANT AWARD TO THE FAR 235 00:10:00,192 --> 00:10:01,226 RIGHT. 236 00:10:01,226 --> 00:10:03,195 APPLICATION BUDGET, THE 237 00:10:03,195 --> 00:10:05,597 APPLICATION BUDGET WILL COMPRISE 238 00:10:05,597 --> 00:10:07,866 OF SALARY FOR NON-NETWORK 239 00:10:07,866 --> 00:10:09,868 INVESTIGATORS AND COORDINATORS 240 00:10:09,868 --> 00:10:13,038 AND OTHER PERSONNEL. IF 241 00:10:13,038 --> 00:10:14,973 ADDITIONAL NETWORK 242 00:10:14,973 --> 00:10:15,841 INFRASTRUCTURE SUPPORT IS NEEDED 243 00:10:15,841 --> 00:10:19,644 FOR STUDY SPECIFIC APPROVAL FOR 244 00:10:19,644 --> 00:10:21,680 NICHD WILL BE REQUIRED. 245 00:10:21,680 --> 00:10:23,782 TRAVEL TO NETWORK STEERING 246 00:10:23,782 --> 00:10:27,719 COMMITTEE MEETINGS FOR NONNET 247 00:10:27,719 --> 00:10:28,053 INVESTIGATOR. 248 00:10:28,053 --> 00:10:29,421 WE HAVE INCLUDED TRAFUL FOR 249 00:10:29,421 --> 00:10:33,158 JUNIOR INVESTIGATOR INVOLVEMENT. 250 00:10:33,158 --> 00:10:34,793 OTHER DIRECT COSTS SUCH AS 251 00:10:34,793 --> 00:10:38,630 SINGLE IRB, BIOSPECIMENS AND 252 00:10:38,630 --> 00:10:39,965 PREPARATION AND SUBMISSION TO 253 00:10:39,965 --> 00:10:42,834 DASH. WE HAVE LASTLY CONSORTIUM 254 00:10:42,834 --> 00:10:44,970 COSTS INCLUDING CAPITATIONS AND 255 00:10:44,970 --> 00:10:47,372 STUDY RELATED COSTS AND INCLUDED 256 00:10:47,372 --> 00:10:49,041 INDIRECTS ON CAPITATION COSTS 257 00:10:49,041 --> 00:10:52,411 AND WE HAVE SUBCONTRASTS TO 258 00:10:52,411 --> 00:10:54,079 NON-NETWORK SITES THERE IS A NEW 259 00:10:54,079 --> 00:10:58,817 NOTICE N OWE. TOD25104 RECENTLY 260 00:10:58,817 --> 00:11:01,186 AVAILABLE ABOUT FOREIGN 261 00:11:01,186 --> 00:11:01,486 SUB-AWARDS. 262 00:11:01,486 --> 00:11:03,155 THERE IS A BUDGET CAP. 263 00:11:03,155 --> 00:11:06,825 THERE IS A BUDGET CAP OF 6.25 264 00:11:06,825 --> 00:11:09,161 MILLION DOLLARS IN DIRECT COSTS 265 00:11:09,161 --> 00:11:14,499 FOR ENTIRE 7 YEAR PROJECT AND 266 00:11:14,499 --> 00:11:17,302 SHOULD BE WITH HIGHEST POTENTIAL 267 00:11:17,302 --> 00:11:19,504 SCIENTIFIC IMPACT. PROJECTS 268 00:11:19,504 --> 00:11:21,006 EXCEEDING THIS MAY BE PROPOSED 269 00:11:21,006 --> 00:11:23,175 BUT REQUIRE ADDITIONAL NICHD 270 00:11:23,175 --> 00:11:26,044 APPROVAL AS PART OF THE 271 00:11:26,044 --> 00:11:27,412 PRE-APPLICATION PROCESS AND MY 272 00:11:27,412 --> 00:11:29,981 ALSO INCLUDE COSTS TO PERFORM 273 00:11:29,981 --> 00:11:32,784 SECONDARY ANALYSIS USING DATA 274 00:11:32,784 --> 00:11:35,020 SUBMITTED THROUGH DASH THROUGH 275 00:11:35,020 --> 00:11:35,687 THE POLICY. 276 00:11:35,687 --> 00:11:39,624 SOME OF YOU MAY BE ASKING: 277 00:11:39,624 --> 00:11:40,725 WELL, WHAT ARE SOME STRONG 278 00:11:40,725 --> 00:11:43,028 PREFERENCES FOR THIS NOFO? 279 00:11:43,028 --> 00:11:46,364 WE STRONGLY ENCOURAGE 280 00:11:46,364 --> 00:11:47,999 INCORPORATING INNOVATIVE 281 00:11:47,999 --> 00:11:49,601 APPROACHES SUCH AS ADAPTIVE 282 00:11:49,601 --> 00:11:53,538 DESIGNS AND IMBEDDED PRAGMATIC 283 00:11:53,538 --> 00:11:56,808 TRIALS AND [INDISCERNIBLE] 284 00:11:56,808 --> 00:11:58,777 ANALYSIS, MACHINE LEARNING 285 00:11:58,777 --> 00:12:02,814 APPROACHES, REAL-WORLD DATA USE 286 00:12:02,814 --> 00:12:05,350 OR INNOVATIVE FOLLOW-UP 287 00:12:05,350 --> 00:12:08,120 METHODOLOGIES AND ALIGNMENT AND 288 00:12:08,120 --> 00:12:11,490 INTEGRATION OF STUDY PROTOCOL 289 00:12:11,490 --> 00:12:13,391 AND LEVERAGING USE OF ELECTRONIC 290 00:12:13,391 --> 00:12:15,160 HEALTH RECORDS AND HIGH PRIORITY 291 00:12:15,160 --> 00:12:17,562 WILL BE GIVEN TO PROJECTS THAT 292 00:12:17,562 --> 00:12:24,636 INCLUDE JUN INVESTIGATORS AND 293 00:12:24,636 --> 00:12:26,805 ASSISTANT FELLOWS AND 294 00:12:26,805 --> 00:12:28,140 RESEARCHERS PART OF THE TEAM AND 295 00:12:28,140 --> 00:12:30,809 SECONDARY ANALYSIS PERFORMED BY 296 00:12:30,809 --> 00:12:31,743 THE NETWORK STRONG PREFERENCE IS 297 00:12:31,743 --> 00:12:34,079 GIVEN TO JUNIOR INVESTIGATORS 298 00:12:34,079 --> 00:12:36,281 SERVING AS LEAD INVESTIGATOR ON 299 00:12:36,281 --> 00:12:39,184 PROJECTS AND MENTORSHIP PROVIDED 300 00:12:39,184 --> 00:12:40,952 BY MORE QUALIFIED AND 301 00:12:40,952 --> 00:12:44,189 EXPERIENCED INVESTIGATORS. 302 00:12:44,189 --> 00:12:46,057 IN ADDITION TO NETWORKS LISTED 303 00:12:46,057 --> 00:12:48,460 HERE, APPLICATIONS PROPOSING TO 304 00:12:48,460 --> 00:12:54,833 ASSESS MATERNAL AND PEDIATRIC 305 00:12:54,833 --> 00:12:58,003 ONCOLOGY SESSIONS UTILIZED FOR 306 00:12:58,003 --> 00:13:00,639 SOURCES TO MATERNAL AND 307 00:13:00,639 --> 00:13:02,107 PEDIATRIC PRECISION IN 308 00:13:02,107 --> 00:13:08,647 THERAPEUTICS KNOWN AS M PRINT 309 00:13:08,647 --> 00:13:13,919 HUB AND PEDIATRIC TRIALS. 310 00:13:13,919 --> 00:13:15,587 INCLUDE CURATED SUMMARIES OF 311 00:13:15,587 --> 00:13:17,122 PUBLISHED LITERATURE AROUND 312 00:13:17,122 --> 00:13:19,224 SPECIFIC DRUGS, INNOVATIVE 313 00:13:19,224 --> 00:13:21,159 APPROACHES TO PEDIATRIC 314 00:13:21,159 --> 00:13:24,129 REAL-WORLD EVIDENCE AND CLINICAL 315 00:13:24,129 --> 00:13:26,198 FARMICOLOGY AND METRICS AND 316 00:13:26,198 --> 00:13:27,632 CLINICAL TRIAL DESIGN AND 317 00:13:27,632 --> 00:13:30,702 PEDIATRIC TRIALS NETWORK 318 00:13:30,702 --> 00:13:31,403 PROVIDES ENVIRONMENT AND 319 00:13:31,403 --> 00:13:33,405 APPROPRIATE INFRASTRUCTURE 320 00:13:33,405 --> 00:13:36,007 CONDUCTING REGULATORY RIGOROUS 321 00:13:36,007 --> 00:13:37,642 PEDIATRIC AND LACTATION CLINICAL 322 00:13:37,642 --> 00:13:39,411 TRIALS LEADING TO UPDATES AND 323 00:13:39,411 --> 00:13:42,280 DRUG LABELS DIRECTED TO BEST 324 00:13:42,280 --> 00:13:43,815 PHARMACEUTICALS FOR CHILDREN'S 325 00:13:43,815 --> 00:13:44,449 ACT. 326 00:13:44,449 --> 00:13:48,420 EARLY STAGE INVESTIGATORS. 327 00:13:48,420 --> 00:13:52,023 THIS NOFO ENCOURAGES INVOLVEMENT 328 00:13:52,023 --> 00:13:54,459 OF EARLY STAGE INVESTIGATORS FOR 329 00:13:54,459 --> 00:13:55,927 EARLY STAGE CLINICAL CENTERS. 330 00:13:55,927 --> 00:13:57,729 BEAR IN MIND IT IS PART OF THE 331 00:13:57,729 --> 00:13:59,898 REVIEW CRITERIA FOR THIS 332 00:13:59,898 --> 00:14:00,665 PROJECT. 333 00:14:00,665 --> 00:14:02,267 THE JUNIOR INVESTIGATOR MAY 334 00:14:02,267 --> 00:14:04,336 ASSUME A VARIETY OF POTENTIAL 335 00:14:04,336 --> 00:14:06,871 ROLES INCLUDING BEING THE SITE 336 00:14:06,871 --> 00:14:09,474 PI OR SITE CO-PI WITH EMPHASIS 337 00:14:09,474 --> 00:14:11,676 ON BEING MENTORED IN ASPECTS OF 338 00:14:11,676 --> 00:14:14,346 THAT ROLE BY SENIOR 339 00:14:14,346 --> 00:14:15,780 INVESTIGATORS. 340 00:14:15,780 --> 00:14:18,116 THE PROJECT, THE JUNIOR 341 00:14:18,116 --> 00:14:19,551 INVESTIGATOR SHOULD UNDERSTAND 342 00:14:19,551 --> 00:14:21,186 ALL ASPECTS OF THAT PROJECT AND 343 00:14:21,186 --> 00:14:24,689 BE POISED TO PROPOSE SECONDARY 344 00:14:24,689 --> 00:14:25,223 ANALYSIS. 345 00:14:25,223 --> 00:14:27,025 REGARDLESS OF ROLE SLESHTHED, IT 346 00:14:27,025 --> 00:14:31,096 SHOULD BE WELL-DEFINED AND 347 00:14:31,096 --> 00:14:36,201 CLEARLY DESCRIBED. 348 00:14:36,201 --> 00:14:42,007 RECEIPT DATES. 349 00:14:42,007 --> 00:14:42,540 PAR-25-311 INCLUDES NEW 350 00:14:42,540 --> 00:14:43,608 APPLICATION RECEIPT DATES THAT 351 00:14:43,608 --> 00:14:45,443 ARE LISTED HERE ON THIS SLIDE 352 00:14:45,443 --> 00:14:48,179 AND IS ALSO AVAILABLE ON OUR 353 00:14:48,179 --> 00:14:50,448 WEBSITE AND THE NOFO. 354 00:14:50,448 --> 00:14:52,183 THESE CHANGES WERE BASED ON 355 00:14:52,183 --> 00:14:54,552 FEEDBACK WE RECEIVED DURING 356 00:14:54,552 --> 00:14:56,921 INITIAL TWO YEARS OF INITIATIVE 357 00:14:56,921 --> 00:14:59,291 AND IMPLEMENTED WITH HOPE OF 358 00:14:59,291 --> 00:15:01,993 DECREASING TIME FROM APPLICATION 359 00:15:01,993 --> 00:15:06,831 SUBMISSION TO NATIONAL VADVISOR 360 00:15:06,831 --> 00:15:07,332 CHILD HEALTH AND HUMAN 361 00:15:07,332 --> 00:15:08,266 DEVELOPMENT COUNTS REVIEW THAT 362 00:15:08,266 --> 00:15:13,972 IS SET FOR MID-MARCH, MID-JULY 363 00:15:13,972 --> 00:15:16,041 AND MID-NOVEMBER. 364 00:15:16,041 --> 00:15:17,142 FOLLOWING INITIAL PEER REVIEW 365 00:15:17,142 --> 00:15:18,810 RECOMMENDED APPLICATIONS, WE 366 00:15:18,810 --> 00:15:21,046 RECEIVE A SECOND LEVEL OF REVIEW 367 00:15:21,046 --> 00:15:24,382 BY THE APPROPRIATE NATIONAL 368 00:15:24,382 --> 00:15:27,218 ADVISORY COUNCIL. 369 00:15:27,218 --> 00:15:30,188 ANY INVESTIGATOR PLANNING TO 370 00:15:30,188 --> 00:15:31,122 SUBMIT AN APPLICATION IN 371 00:15:31,122 --> 00:15:35,493 RESPONSE TO PAR-25-311 MUST 372 00:15:35,493 --> 00:15:39,164 SUBMIT AN LOI AT LEAST FOUR TO 8 373 00:15:39,164 --> 00:15:40,432 MONTHS BEFORE THE APPLICATION 374 00:15:40,432 --> 00:15:41,099 DUE DATE. 375 00:15:41,099 --> 00:15:43,068 THIS TABLE NICE WILL I PROVIDES 376 00:15:43,068 --> 00:15:45,470 TIMELINES FROM WHICH EACH OF THE 377 00:15:45,470 --> 00:15:47,639 FIVE STEPS I ELUDED TO EARLIER 378 00:15:47,639 --> 00:15:49,708 IN THE PRESENTATION SHOULD BE 379 00:15:49,708 --> 00:15:53,578 FOLLOWED AND ALIGNED WITH A 380 00:15:53,578 --> 00:15:54,879 GRANT APPLICATION RECEIPT DATES. 381 00:15:54,879 --> 00:15:56,715 BEAR IN MIND THAT EACH NETWORK 382 00:15:56,715 --> 00:15:59,250 MAY HAVE OWN INTERNAL PROCESSES 383 00:15:59,250 --> 00:16:03,254 FOR CONCEPT REVIEW PROCESS. IT 384 00:16:03,254 --> 00:16:05,390 MAY INVOLVE DEVELOPMENT OF A 385 00:16:05,390 --> 00:16:08,159 FULL PROTOCOL AND REVIEWS BY A 386 00:16:08,159 --> 00:16:09,661 COMMUNITY ENGAGEMENT BOARD. 387 00:16:09,661 --> 00:16:11,162 AN IMPORTANT POINT THAT I WOULD 388 00:16:11,162 --> 00:16:13,898 LIKE TO HIGHLIGHT IS THAT THE 389 00:16:13,898 --> 00:16:16,201 NETWORK DCC WILL BE THE ONE THAT 390 00:16:16,201 --> 00:16:23,875 IS SUBMITTING THE APPLICATION. 391 00:16:23,875 --> 00:16:25,877 SIMPLIFIED REVIEW FRAMEWORK. 392 00:16:25,877 --> 00:16:28,012 MANY OF YOU MAY BE AWARE THAT 393 00:16:28,012 --> 00:16:30,048 THERE IS A SIMPLIFIED REVIEW 394 00:16:30,048 --> 00:16:32,550 FRAMEWORK FOR APPLICATIONS 395 00:16:32,550 --> 00:16:36,187 SUBMITTED AFTER JANUARY 252025. 396 00:16:36,187 --> 00:16:44,529 PLEASE REFER TO NO TCT-OD-24-01 397 00:16:44,529 --> 00:16:46,398 AND NOTE ADDITION ALE REVIEW 398 00:16:46,398 --> 00:16:51,236 CRITERIA SPECIFIC TO PAR-25-311. 399 00:16:51,236 --> 00:16:53,872 TO ADD, AS OF MAY 2025, 400 00:16:53,872 --> 00:16:57,075 APPLICATIONS SUBMITTED TO THIS 401 00:16:57,075 --> 00:17:00,211 NOFO WILL NO LONGER BE CONVENED 402 00:17:00,211 --> 00:17:04,482 BY SCIENTIFIC REVIEW BRANCH BUT 403 00:17:04,482 --> 00:17:06,551 COMPLETED THROUGH NIH CENTERS 404 00:17:06,551 --> 00:17:08,620 FOR SCIENTIFIC REVIEW ALSO KNOWN 405 00:17:08,620 --> 00:17:09,988 AS CSR. 406 00:17:09,988 --> 00:17:11,956 WHAT ARE OTHER HIGHLIGHTS FOR 407 00:17:11,956 --> 00:17:13,625 THIS NOFO? 408 00:17:13,625 --> 00:17:15,860 ONE, IT IS A REQUIREMENT TO 409 00:17:15,860 --> 00:17:18,296 PROVIDE A LETTER OF SUPPORT 410 00:17:18,296 --> 00:17:20,098 AFFIRMING THAT ALL NETWORK 411 00:17:20,098 --> 00:17:22,167 CENTERS ARE COMMITTED TO 412 00:17:22,167 --> 00:17:23,802 PARTICIPATING IN THE STUDY. 413 00:17:23,802 --> 00:17:28,206 IF ANY SPECIFIC SITE IS NOT 414 00:17:28,206 --> 00:17:29,040 PARTICIPATING, CLEAR RATIONALE 415 00:17:29,040 --> 00:17:32,210 SHOULD BE PROVIDED. 416 00:17:32,210 --> 00:17:35,980 EACH NON-NETWORK INSTITUTION 417 00:17:35,980 --> 00:17:37,615 PARTICIPATING IN THE PROJECT 418 00:17:37,615 --> 00:17:39,217 MUST PROVIDE A SEPARATE LETTER 419 00:17:39,217 --> 00:17:41,486 OF SUPPORT SIGNED BY INSTITUTION 420 00:17:41,486 --> 00:17:43,288 OF SIGNING OFFICIALS. 421 00:17:43,288 --> 00:17:45,223 LAST, PLANS FOR ENHANCING 422 00:17:45,223 --> 00:17:47,625 DIVERSE PERSPECTIVE ALSO KNOWN 423 00:17:47,625 --> 00:17:50,328 AS PEDP HAS THEM REMOVED IN THIS 424 00:17:50,328 --> 00:17:54,966 VERSION OF THE PAR AND IS NO 425 00:17:54,966 --> 00:17:57,635 LONGER REQUIRED. 426 00:17:57,635 --> 00:17:59,938 SO THAT CONCLUDES THE 427 00:17:59,938 --> 00:18:01,372 PRESENTATION PORTION OF THIS 428 00:18:01,372 --> 00:18:01,639 WEBINAR. 429 00:18:01,639 --> 00:18:03,408 AT THIS TIME, I WOULD LIKE TO 430 00:18:03,408 --> 00:18:05,910 BRING ON OUR PLANNING COMMITTEE 431 00:18:05,910 --> 00:18:07,712 PANEL TO HELP US READ OUT THE 432 00:18:07,712 --> 00:18:11,416 QUESTIONS DEDICATED IN THE Q & A 433 00:18:11,416 --> 00:18:11,683 SECTION. 434 00:18:11,683 --> 00:18:13,451 I WILL STOP SHARING NOW. 435 00:18:13,451 --> 00:18:17,322 I WILL ALLOW ALL PANELISTS TO 436 00:18:17,322 --> 00:18:21,960 READ ANY QUESTIONS. 437 00:18:21,960 --> 00:18:23,728 THANK YOU. 438 00:18:23,728 --> 00:18:26,264 >> HEY, ABBY. THERE IS ONLY 439 00:18:26,264 --> 00:18:29,200 ONE QUESTION SO FAR IN THE Q & 440 00:18:29,200 --> 00:18:29,367 A. 441 00:18:29,367 --> 00:18:33,238 THAT IS WILL THE SLIDES BE 442 00:18:33,238 --> 00:18:33,505 SHARED? 443 00:18:33,505 --> 00:18:37,375 >> THERE IS GOING TO BE AN NIH 444 00:18:37,375 --> 00:18:38,676 VIDEO CAST RECORDING WHERE THE 445 00:18:38,676 --> 00:18:40,545 SLIDE WILL BE READILY AVAILABLE 446 00:18:40,545 --> 00:18:42,313 AT THE END OF THE PRESENTATION 447 00:18:42,313 --> 00:18:44,182 AND THAT IS WHERE THE SLIDE WILL 448 00:18:44,182 --> 00:18:48,786 BE AVAILABLE. THANK YOU FOR THE 449 00:18:48,786 --> 00:18:49,053 QUESTION. 450 00:18:49,053 --> 00:18:51,723 >> THAT IS ALL WE HAVE 451 00:18:51,723 --> 00:18:53,525 CURRENTLY. IF YOU WANT TO GO 452 00:18:53,525 --> 00:18:54,692 THROUGH SOME OF THE OTHER 453 00:18:54,692 --> 00:18:55,960 QUESTIONS YOU HAVE PREPARED. 454 00:18:55,960 --> 00:18:58,730 >> OKAY. EVERYONE, DON'T BE 455 00:18:58,730 --> 00:18:58,930 SHY. 456 00:18:58,930 --> 00:19:01,432 WE DO WELCOME YOU TO FEEL FREE 457 00:19:01,432 --> 00:19:04,536 TO USE THE Q & A. PRIOR TO THE 458 00:19:04,536 --> 00:19:06,104 WEBINAR, WE RECEIVED SOME 459 00:19:06,104 --> 00:19:07,505 QUESTIONS IN ADVANCE. 460 00:19:07,505 --> 00:19:09,374 AS STEPHANIE ELUDED TO, I'M 461 00:19:09,374 --> 00:19:11,209 HAPPY TO SHARE THAT. PERHAPS 462 00:19:11,209 --> 00:19:12,677 THAT CAN STIMULATE SOME 463 00:19:12,677 --> 00:19:15,547 ADDITIONAL QUESTIONS FROM 464 00:19:15,547 --> 00:19:15,780 OTHERS. 465 00:19:15,780 --> 00:19:18,783 >> THERE IS A QUESTION: IS 466 00:19:18,783 --> 00:19:23,187 THERE DEDICATED FUNDING FOR THIS 467 00:19:23,187 --> 00:19:24,188 PAR? 468 00:19:24,188 --> 00:19:29,093 > 469 00:19:29,093 --> 00:19:32,730 CAN YOU GUYS HEAR ME? 470 00:19:32,730 --> 00:19:35,600 >> YEAH. I WILL JUMP IN IF 471 00:19:35,600 --> 00:19:38,436 NOBODY ELSE IS. THERE IS. THIS 472 00:19:38,436 --> 00:19:42,173 WILL NOT BE COMING OUT OF THE 473 00:19:42,173 --> 00:19:48,746 STANDARD R01 POOL FUNDS. 474 00:19:48,746 --> 00:19:52,250 >> CAN YOU ALL HEAR ME NOW? 475 00:19:52,250 --> 00:19:52,850 >> YES. 476 00:19:52,850 --> 00:20:00,892 >> THANK YOU FOR THAT QUESTION. 477 00:20:00,892 --> 00:20:02,860 THERE IS A QUESTION WE RECEIVED 478 00:20:02,860 --> 00:20:05,229 FROM INDIVIDUALS ASKING ABOUT 479 00:20:05,229 --> 00:20:08,566 RESUBMISSIONS TO PAR-25-311. 480 00:20:08,566 --> 00:20:10,935 ARE THESE PERMITTED? THE ANSWER 481 00:20:10,935 --> 00:20:16,908 IS YES. PRE-SUBMISSIONS TO 482 00:20:16,908 --> 00:20:19,277 PAR-25-311 ARE PERMITTED AND 483 00:20:19,277 --> 00:20:21,879 TIMEFRAME AND GOAL TO HAVE 484 00:20:21,879 --> 00:20:23,881 SUBMITTED WITHIN 37 MONTHS OF 485 00:20:23,881 --> 00:20:25,817 THE ORIGINAL NEW APPLICATION. 486 00:20:25,817 --> 00:20:26,918 PLEASE NOTE THE RECEIPT DATE FOR 487 00:20:26,918 --> 00:20:29,020 THE A1 APPICATION IS THE SAME 488 00:20:29,020 --> 00:20:31,556 RECEIPT DATE AS FOR THE A0 489 00:20:31,556 --> 00:20:36,094 APPLICATIONS FOR PAR-25-311. 490 00:20:36,094 --> 00:20:39,530 NOT A MONTH LATER AS IS TYPICAL 491 00:20:39,530 --> 00:20:41,699 FOR MANY R ACTIVITY CODES. 492 00:20:41,699 --> 00:20:47,505 I DO WANT TO REFER YOU TO THE 493 00:20:47,505 --> 00:20:50,475 NOT-ODA TEAM 109 POLICY FOR 494 00:20:50,475 --> 00:20:54,012 RESUBMISSIONS OF NIH 495 00:20:54,012 --> 00:20:59,651 APPLICATIONS. 496 00:20:59,651 --> 00:21:03,354 SO TO BUILD ON THE QUESTION THAT 497 00:21:03,354 --> 00:21:06,524 WAS ASKED IN THE Q & A, THERE 498 00:21:06,524 --> 00:21:07,392 WAS ANOTHER QUESTION THAT CAME 499 00:21:07,392 --> 00:21:10,194 UP PRIOR TO THIS WEBINAR THAT 500 00:21:10,194 --> 00:21:12,230 STATES THAT GIVEN THAT 501 00:21:12,230 --> 00:21:13,831 CAPITATION INDIRECT COSTS ARE 502 00:21:13,831 --> 00:21:16,167 DIRECT COSTS WITHIN THE GRANT 503 00:21:16,167 --> 00:21:17,735 APPLICATION, SHOULD THEY BE 504 00:21:17,735 --> 00:21:22,173 CONSIDERED IN THE 6.25 MILLION 505 00:21:22,173 --> 00:21:24,542 TOTAL DIRECT COST CAP? 506 00:21:24,542 --> 00:21:25,543 ABSOLUTELY. 507 00:21:25,543 --> 00:21:27,879 THE ANSWER IS YES. DIRECT COSTS 508 00:21:27,879 --> 00:21:30,948 INCLUDE CAPITATION COSTS TO 509 00:21:30,948 --> 00:21:32,950 CONDUCT RESEARCH AS WELL AS 510 00:21:32,950 --> 00:21:35,687 INDIRECT COSTS ON CAPITATION 511 00:21:35,687 --> 00:21:36,020 COSTS. 512 00:21:36,020 --> 00:21:38,423 YES. INDIRECT COSTS ON 513 00:21:38,423 --> 00:21:41,659 CAPITATIONS ARE APPLICABLE ON 514 00:21:41,659 --> 00:21:44,729 THE DIS CAP. I WILL PAUSE TO 515 00:21:44,729 --> 00:21:46,931 SEE IF THERE ARE Q & A QUESTIONS 516 00:21:46,931 --> 00:21:48,166 BEFORE I PROCEED. 517 00:21:48,166 --> 00:21:54,272 >> YES. TWO FROM KIMBERLY. 518 00:21:54,272 --> 00:21:56,307 ONE IS DO LINKS TO PROVIDE LISTS 519 00:21:56,307 --> 00:21:58,743 WITH STUDIES ARE CURRENTLY 520 00:21:58,743 --> 00:22:01,045 ONGOING WITHIN THE NETWORKS? 521 00:22:01,045 --> 00:22:04,215 >> THANK YOU, MARGE ORREE, FOR 522 00:22:04,215 --> 00:22:06,584 THAT QUESTION, AND KIMBERLY FOR 523 00:22:06,584 --> 00:22:10,221 THAT QUESTION. 524 00:22:10,221 --> 00:22:12,824 PAR-25-311 NO PHONE, WE HAVE THE 525 00:22:12,824 --> 00:22:15,760 LINKS FOR THE FIVE SPECIFIC 526 00:22:15,760 --> 00:22:16,027 NETWORKS. 527 00:22:16,027 --> 00:22:19,297 IF YOU CLICK ON LINKS FOR 528 00:22:19,297 --> 00:22:20,164 SPECIFIC NETWORKS OF INTEREST TO 529 00:22:20,164 --> 00:22:23,000 YOU KIMBERLY, YOU CAN SEE ACTIVE 530 00:22:23,000 --> 00:22:24,268 STUDIES ON THEIR OWN WEBSITES 531 00:22:24,268 --> 00:22:26,504 WHAT IS CURRENTLY ONGOING AND 532 00:22:26,504 --> 00:22:29,240 RECRUITING AND HOPE IT HELPS TO 533 00:22:29,240 --> 00:22:30,074 ANSWER YOUR QUESTION. 534 00:22:30,074 --> 00:22:32,009 >> THEN ALSO WHO IS THE PERSON 535 00:22:32,009 --> 00:22:33,945 TO CONTACT TO DETERMINE IF A 536 00:22:33,945 --> 00:22:37,882 STUDY IDEA FITS WITHIN THE GOALS 537 00:22:37,882 --> 00:22:40,718 OF THE FMNU NETWORK? 538 00:22:40,718 --> 00:22:42,787 >> THANK YOU FOR THAT QUESTION, 539 00:22:42,787 --> 00:22:43,855 MARGE ORREE. 540 00:22:43,855 --> 00:22:46,924 THE FIRST CONTACT WOULD BE TO 541 00:22:46,924 --> 00:22:48,726 OUR GENERAL MAILBOX. I WILL 542 00:22:48,726 --> 00:22:51,362 MAKE SURE WE PUT THAT IN THE Q & 543 00:22:51,362 --> 00:22:53,364 A SO THAT EVERYONE GETS ACCESS 544 00:22:53,364 --> 00:22:54,665 TO THAT. 545 00:22:54,665 --> 00:22:58,035 IN ADDITION, WE ARE MORE THAN 546 00:22:58,035 --> 00:23:00,171 HAPPY AT THAT TIME TO LEVERAGE 547 00:23:00,171 --> 00:23:04,742 AND INTRODUCE YOU TO OUR MFMU 548 00:23:04,742 --> 00:23:07,345 COLLEAGUES WITHIN NICHD AND 549 00:23:07,345 --> 00:23:10,114 PROGRAM ANALYST AND PROGRAM 550 00:23:10,114 --> 00:23:13,918 OFFICIAL AS WELL AS OUR PROJECT 551 00:23:13,918 --> 00:23:15,019 SCIENTISTS TO STIMULATE OR 552 00:23:15,019 --> 00:23:17,021 ANSWER ANY QUESTIONS YOU MAY 553 00:23:17,021 --> 00:23:21,159 HAVE REGARDING TO MFMU RELATED 554 00:23:21,159 --> 00:23:22,560 PROPOSAL AND HOPE IT HELPS 555 00:23:22,560 --> 00:23:24,195 ANSWER YOUR QUESTION. THANK 556 00:23:24,195 --> 00:23:24,395 YOU. 557 00:23:24,395 --> 00:23:26,030 >> I THINK WE HAVE AN 558 00:23:26,030 --> 00:23:27,565 ADDITIONAL QUESTION. FOR 559 00:23:27,565 --> 00:23:29,233 CONCEPTS THAT ARE ALREADY 560 00:23:29,233 --> 00:23:31,402 SUBMITTED ON OR ABOUT APRIL 561 00:23:31,402 --> 00:23:39,377 2025, DO WE NEED TO RESUBMIT? 562 00:23:39,377 --> 00:23:43,247 >> THANK YOU FOR THAT QUESTION. 563 00:23:43,247 --> 00:23:44,816 CONCEPTS SUBMITTED IN APRIL OF 564 00:23:44,816 --> 00:23:46,684 2025, FIRST IT HAS TO GO THROUGH 565 00:23:46,684 --> 00:23:51,055 AND BE APPROVED. IF IT HASN'T 566 00:23:51,055 --> 00:23:53,257 BEEN APPROVED, YES. WE WOULD 567 00:23:53,257 --> 00:23:56,060 ASK YOU TO RESUBMIT THE CONCEPT 568 00:23:56,060 --> 00:23:58,896 PROPOSAL AND GET IT APPROVED BY 569 00:23:58,896 --> 00:23:59,430 NICHD. 570 00:23:59,430 --> 00:24:03,134 HOPE IT HELPS TO ANSWER YOUR 571 00:24:03,134 --> 00:24:05,036 QUESTION. 572 00:24:05,036 --> 00:24:07,772 >> THOSE SUBMISSIONS, YOU ARE 573 00:24:07,772 --> 00:24:09,140 TALKING ABOUT THE GRANT 574 00:24:09,140 --> 00:24:10,274 SUBMISSION NOT JUST SOMETHING 575 00:24:10,274 --> 00:24:13,477 THAT HAS NOT BEEN SUBMITTED AS 576 00:24:13,477 --> 00:24:19,417 AN APPLICATION, CORRECT? 577 00:24:19,417 --> 00:24:20,818 >> CORRECT. 578 00:24:20,818 --> 00:24:22,220 >> WE HAVE ANOTHER QUESTION. 579 00:24:22,220 --> 00:24:24,222 CAN YOU EXPAND A BIT MORE ON HOW 580 00:24:24,222 --> 00:24:27,058 MUCH DETAIL YOU WANT FOR THE 581 00:24:27,058 --> 00:24:28,326 JUNIOR INVESTIGATORS INVOLVED IN 582 00:24:28,326 --> 00:24:30,461 RESEARCH STRATEGY SECTIONS OF 583 00:24:30,461 --> 00:24:32,230 THE GRANTS. 584 00:24:32,230 --> 00:24:34,098 I THOUGHT IT -- THE TRAVEL 585 00:24:34,098 --> 00:24:35,933 BUDGET WAS MOSTLY FOR EACH OF 586 00:24:35,933 --> 00:24:37,568 THEM TO ATTEND THE MEETING 587 00:24:37,568 --> 00:24:39,337 UNLESS THEY ARE SPECIFICALLY 588 00:24:39,337 --> 00:24:43,341 GOING TO LEAD A PORTION OF THE 589 00:24:43,341 --> 00:24:45,076 STUDY. 590 00:24:45,076 --> 00:24:47,912 >> THANK YOU STEPHANIE, FOR 591 00:24:47,912 --> 00:24:49,380 THAT ANSWER. 592 00:24:49,380 --> 00:24:54,886 TO BUILD ON THAT, I THINK, ONE, 593 00:24:54,886 --> 00:25:00,224 TO HIGHLIGHT FACT THAT JUNIOR 594 00:25:00,224 --> 00:25:01,792 INVESTIGATORS -- TRAINER 595 00:25:01,792 --> 00:25:03,461 INVESTIGATORS AND USE IT TO 596 00:25:03,461 --> 00:25:05,029 TRAIN NEXT GENERATION SCIENTISTS 597 00:25:05,029 --> 00:25:07,331 AND TO STEPHANIE'S POINT 598 00:25:07,331 --> 00:25:08,966 ATTENDING STEERING COMMITTEE 599 00:25:08,966 --> 00:25:10,902 MEETINGS AND TRIAL TO THEM IS 600 00:25:10,902 --> 00:25:12,236 IMPORTANT AND GIVING THEM 601 00:25:12,236 --> 00:25:13,704 OPPORTUNITY AND TIME AND 602 00:25:13,704 --> 00:25:17,608 INTEGRATING THEM MORE INTO A 603 00:25:17,608 --> 00:25:20,544 PRIMARY STUDY IS IMPORTANT. 604 00:25:20,544 --> 00:25:22,480 EXAMPLES I CAN THINK OF IS 605 00:25:22,480 --> 00:25:25,049 SOMETIMES NETWORKS THAT PROPOSED 606 00:25:25,049 --> 00:25:28,386 THAT JAUNOR INVESTIGATORS CAN BE 607 00:25:28,386 --> 00:25:31,188 INVOLVED IN SURGICAL TECHNIQUE 608 00:25:31,188 --> 00:25:32,723 AND HELP RE-KWON SENT SUBJECTS 609 00:25:32,723 --> 00:25:35,760 AND STUDY PROCEDURES THEY CAN 610 00:25:35,760 --> 00:25:38,362 LEAD SECONDARY MANUSCRIPTS AND 611 00:25:38,362 --> 00:25:40,631 TO STEPHANIE'S POINT, THERE IS A 612 00:25:40,631 --> 00:25:42,066 GREAT OPPORTUNITY FOR THEM AND 613 00:25:42,066 --> 00:25:48,239 HOPE IT HELPS TO ANSWER YOUR 614 00:25:48,239 --> 00:25:50,741 QUESTION. 615 00:25:50,741 --> 00:25:53,144 >> I WILL PUSH ON TO ANOTHER 616 00:25:53,144 --> 00:25:56,314 QUESTION THAT WE RECEIVED PRIOR 617 00:25:56,314 --> 00:26:01,319 TO THIS THAT WAS AROUND JUNIOR 618 00:26:01,319 --> 00:26:02,420 INVESTIGATORS TO BUILD ON THAT. 619 00:26:02,420 --> 00:26:05,256 CAN JUNIOR INVESTIGATORS INCLUDE 620 00:26:05,256 --> 00:26:07,425 NETWORK PARTICIPATION ON K-AWARD 621 00:26:07,425 --> 00:26:08,125 DEVELOPMENT PLAN? 622 00:26:08,125 --> 00:26:10,528 ANSWER IS POSSIBLY. IF 623 00:26:10,528 --> 00:26:11,762 PARTICIPATION IN THE NETWORK 624 00:26:11,762 --> 00:26:14,265 PROJECT ALIGNS WELL WITH THEIR 625 00:26:14,265 --> 00:26:16,500 CAREER GOALS AND RESEARCH 626 00:26:16,500 --> 00:26:19,303 INTERESTS, RECIPIENTS K-AWARD 627 00:26:19,303 --> 00:26:21,138 AND NETWORK PARTICIPATION MAY BE 628 00:26:21,138 --> 00:26:24,108 INCLUDED AS PART OF K-AWARD 629 00:26:24,108 --> 00:26:25,743 DEVELOPMENT PLAN ON A CASE BY 630 00:26:25,743 --> 00:26:28,212 CASE BASIS AND ROLES IN THE 631 00:26:28,212 --> 00:26:29,480 NETWORK PROJECT SHOULD BE 632 00:26:29,480 --> 00:26:32,249 CLEARLY DESCRIBED IN BOTH 633 00:26:32,249 --> 00:26:34,285 NETWORK APPLICATIONS AND K AWARD 634 00:26:34,285 --> 00:26:35,152 DEVELOPMENT PLAN AND 635 00:26:35,152 --> 00:26:36,954 PARTICIPATION IN THE NETWORK 636 00:26:36,954 --> 00:26:38,656 PROJECT MUST BE CONSISTENT WITH 637 00:26:38,656 --> 00:26:40,958 OUR CURRENT NIH GUIDANCE AND 638 00:26:40,958 --> 00:26:44,829 LINKS ARE PROVIDED HERE ON THE 639 00:26:44,829 --> 00:26:54,972 SLIDE. 640 00:26:55,706 --> 00:26:57,475 ANOTHER QUESTION WE RECEIVED IS 641 00:26:57,475 --> 00:27:00,177 INDIRECT COSTS PROVIDED ON 642 00:27:00,177 --> 00:27:01,946 CAPITATION FUNDING PROVIDED TO 643 00:27:01,946 --> 00:27:03,481 ENROLLING CLINICAL RESEARCH 644 00:27:03,481 --> 00:27:06,751 CENTERS AND SITES? 645 00:27:06,751 --> 00:27:07,118 ANSWER IS YES. 646 00:27:07,118 --> 00:27:13,224 APRIL APPLICANTS ARE TO CONSULT 647 00:27:13,224 --> 00:27:15,059 WITH OFFICES WITHIN OUR OWN 648 00:27:15,059 --> 00:27:17,094 INSTITUTION TO ENSURE COSTS FOR 649 00:27:17,094 --> 00:27:20,431 YOUR OWN INSTITUTION OR 650 00:27:20,431 --> 00:27:22,533 SUBCONTRACTS OR SUBINSTITUTIONS 651 00:27:22,533 --> 00:27:25,336 PROPOSED IN ACCORDANCE WITH 652 00:27:25,336 --> 00:27:28,205 APPLICABLE COST PRINCIPLES AND 653 00:27:28,205 --> 00:27:29,240 PROVIDED GRANT POLICY STATEMENT 654 00:27:29,240 --> 00:27:31,242 SECTION 7.2 TO HIGHLIGHT THAT 655 00:27:31,242 --> 00:27:34,345 AND IS IMPORTANT TO CONFORM TO 656 00:27:34,345 --> 00:27:36,981 YOUR ORGANIZATION'S NEGOTIATED 657 00:27:36,981 --> 00:27:40,785 FNA INDIRECT COST RATE 658 00:27:40,785 --> 00:27:41,886 AGREEMENT. 659 00:27:41,886 --> 00:27:43,821 ARE THERE ANY OTHER Q & A 660 00:27:43,821 --> 00:27:51,462 QUESTIONS OR PANELISTS? NOT 661 00:27:51,462 --> 00:27:55,332 HEARING ANY, I WILL PROCEED WITH 662 00:27:55,332 --> 00:27:59,003 OTHER QUESTIONS WE RECEIVED IN 663 00:27:59,003 --> 00:28:00,438 ADVANCE. THE NEXT QUESTION IS 664 00:28:00,438 --> 00:28:03,240 CAN APPLICATIONS REQUEST A 665 00:28:03,240 --> 00:28:08,212 BUDGET IN EXCESS OF THE 6.25 666 00:28:08,212 --> 00:28:10,014 MILLION TOTAL DIRECT COST CAP. 667 00:28:10,014 --> 00:28:12,450 THE ANSWER IS YES. HOWEVER, AS 668 00:28:12,450 --> 00:28:16,220 DESCRIBED IN PAR-25-311, 669 00:28:16,220 --> 00:28:18,122 PROJECTS REQUIRING DIRECT COSTS 670 00:28:18,122 --> 00:28:23,627 EXCEEDING 6.25 MILLION MAY BE 671 00:28:23,627 --> 00:28:26,363 PROPOSED AND REQUIRE ADDITIONAL 672 00:28:26,363 --> 00:28:28,199 NICHD APPROVAL AS PART OF THE 673 00:28:28,199 --> 00:28:29,667 PRE-APPLICATION PROCESS AND WE 674 00:28:29,667 --> 00:28:32,103 DO ASK THAT BUDGETS NEED TO BE 675 00:28:32,103 --> 00:28:36,240 SUBMITTED AND APPROVED BY NICHD 676 00:28:36,240 --> 00:28:38,109 AT LEAST ONE MONTH PRIOR TO 677 00:28:38,109 --> 00:28:40,244 GRANT RECEIVED DATE AS DESCRIBED 678 00:28:40,244 --> 00:28:42,780 ON NICHD CLINICAL RESEARCH 679 00:28:42,780 --> 00:28:45,015 WEBSITE AND WE HAVE IT UNDER THE 680 00:28:45,015 --> 00:28:55,493 SECTION TITLED TIMELINES. 681 00:28:55,493 --> 00:28:57,061 >> WE DID RECEIVE ANOTHER ONE. 682 00:28:57,061 --> 00:28:58,762 DOES INSTITUTION NEED TO BE PART 683 00:28:58,762 --> 00:29:03,000 OF THESE NETWORKS OR CAN YOU 684 00:29:03,000 --> 00:29:06,170 COLLABORATE WITH SOMEONE IN THE 685 00:29:06,170 --> 00:29:06,470 NETWORK? 686 00:29:06,470 --> 00:29:08,506 >> EXCELLENT QUESTION. THANK 687 00:29:08,506 --> 00:29:09,206 YOU, MARGE ORREE. 688 00:29:09,206 --> 00:29:14,845 RIGHT NOW, WE ARE AND DO ALLOW 689 00:29:14,845 --> 00:29:17,181 THAT INSTITUTIONS THAT ARE NOT 690 00:29:17,181 --> 00:29:19,316 PART OF THE NETWORK CAN BE ADDED 691 00:29:19,316 --> 00:29:21,152 IN TO THE NETWORK. 692 00:29:21,152 --> 00:29:22,453 THIS, AGAIN, IT IS IMPORTANT TO 693 00:29:22,453 --> 00:29:25,089 NOTE THAT WE DO HAVE TO VET THAT 694 00:29:25,089 --> 00:29:27,091 INSTITUTION THAT YOU PLAN TO ADD 695 00:29:27,091 --> 00:29:29,994 ON INTO THE NETWORK. 696 00:29:29,994 --> 00:29:32,062 WE WELCOMED COLLABORATION AND 697 00:29:32,062 --> 00:29:34,165 NICHD WILL VET THAT IN THE 698 00:29:34,165 --> 00:29:35,099 PRE-APPLICATION PROCESS. 699 00:29:35,099 --> 00:29:37,034 I HOPE THAT HELPS TO ANSWER YOUR 700 00:29:37,034 --> 00:29:40,938 QUESTION OR IF ANYONE WANTS TO 701 00:29:40,938 --> 00:29:45,576 ADD ANYTHING ELSE. 702 00:29:45,576 --> 00:29:47,811 >> ONLY THING I ADD IS 703 00:29:47,811 --> 00:29:49,980 REITERATING WHAT YOU SAID WHICH 704 00:29:49,980 --> 00:29:53,651 IS GOAL OF THIS INITIATIVE IS TO 705 00:29:53,651 --> 00:29:54,952 ALLOW INVESTIGATORS NOT PART OF 706 00:29:54,952 --> 00:29:56,787 NETWORKS OR AFFILIATED WITH 707 00:29:56,787 --> 00:29:58,122 NETWORK INSTITUTIONS TO HAVE 708 00:29:58,122 --> 00:29:59,823 OPPORTUNITY TO LEVERAGE NETWORK 709 00:29:59,823 --> 00:30:01,725 RESOURCES AS YOU SAID. 710 00:30:01,725 --> 00:30:04,461 SO AS ABBY MENTIONED, WE WOULD 711 00:30:04,461 --> 00:30:05,696 DEFINITELY ENCOURAGE THAT. 712 00:30:05,696 --> 00:30:08,799 >> THANK YOU, BOB. WELL SAID. 713 00:30:08,799 --> 00:30:10,534 >> WE HAVE AN ADDITIONAL 714 00:30:10,534 --> 00:30:13,737 QUESTION ASKING ABOUT 715 00:30:13,737 --> 00:30:17,041 COMPOSITION OF THE FINAL GRANT 716 00:30:17,041 --> 00:30:20,177 REVIEW AND ANY ASKING IF 717 00:30:20,177 --> 00:30:21,011 SPECIFIC STUDY SECTION 718 00:30:21,011 --> 00:30:22,513 ESPECIALLY AS THERE IS A MOVE 719 00:30:22,513 --> 00:30:24,515 AWAY FROM SETS. 720 00:30:24,515 --> 00:30:27,551 >> THAT IS AN EXCELLENT 721 00:30:27,551 --> 00:30:30,354 QUEST 722 00:30:30,354 --> 00:30:30,621 QUESTION. 723 00:30:30,621 --> 00:30:32,856 RIGHT NOW, THESE APPLICATIONS 724 00:30:32,856 --> 00:30:36,160 REVIEWED BY NIH CENTER OF 725 00:30:36,160 --> 00:30:37,795 SCIENTIFIC REVIEW THAT CAME 726 00:30:37,795 --> 00:30:40,497 AFTER ANNOUNCEMENT IN MARCH. 727 00:30:40,497 --> 00:30:42,233 APPLICATIONS RESPONDING TO PAR 728 00:30:42,233 --> 00:30:44,702 WOULD BE ASSIGNED TO A STUDY 729 00:30:44,702 --> 00:30:46,537 SECTION OR SPECIAL EMPHASIS 730 00:30:46,537 --> 00:30:49,039 PANEL OF BEST SCIENTIFIC FIT. 731 00:30:49,039 --> 00:30:50,908 PLEASE BEAR IN MIND THIS IS NEW 732 00:30:50,908 --> 00:30:51,308 FOR US. 733 00:30:51,308 --> 00:30:53,043 WE ARE ALL LEARNING AND WILL DO 734 00:30:53,043 --> 00:30:56,947 OUR BEST TO MAKE SURE THAT YOUR 735 00:30:56,947 --> 00:31:00,651 APPLICATION GETS ASSIGNED TO THE 736 00:31:00,651 --> 00:31:05,289 RIGHT STUDY SECTION. I WANT TO 737 00:31:05,289 --> 00:31:07,091 HIGHLIGHT IF REQUESTS FOR 738 00:31:07,091 --> 00:31:08,492 REASSIGNMENT TO THAT SECTION, 739 00:31:08,492 --> 00:31:10,060 THEY NEED TO COME SPECIFICALLY 740 00:31:10,060 --> 00:31:15,332 FROM THE PI THAT WE ASSOCIATED 741 00:31:15,332 --> 00:31:20,804 SCIENTIFIC JUSTIFICATION. 742 00:31:20,804 --> 00:31:24,642 THANK YOU FOR THE QUESTION. 743 00:31:24,642 --> 00:31:26,143 >> IF I COULD ADD SOMETHING 744 00:31:26,143 --> 00:31:30,714 ELSE TO THAT, I TOLD ABBEY I 745 00:31:30,714 --> 00:31:33,651 WOULDN'T TALK MUCH. COMES FROM 746 00:31:33,651 --> 00:31:37,187 BRAIN STEM IT IS COURTIC COL. 747 00:31:37,187 --> 00:31:39,723 THAT ASIDE, EMPHASIZING EFFORTS 748 00:31:39,723 --> 00:31:41,825 THAT ABBY AND TEAM MAEM TO 749 00:31:41,825 --> 00:31:43,694 ENSURE WITH THIS TRANSITION HOW 750 00:31:43,694 --> 00:31:44,795 APPLICATIONS ARE BEING REVIEWED 751 00:31:44,795 --> 00:31:46,830 AND THAT THEY END UP IN THE 752 00:31:46,830 --> 00:31:48,332 RIGHT STUDY SECTION AND MORE 753 00:31:48,332 --> 00:31:49,700 IMPORTANTLY THAT THE STUDY 754 00:31:49,700 --> 00:31:51,702 SECTION HAS SPECIFIC CONTENT 755 00:31:51,702 --> 00:31:55,572 EXPERTISE TO PROVIDE AN INFORMED 756 00:31:55,572 --> 00:31:56,307 REVIEW. 757 00:31:56,307 --> 00:31:58,742 WITHOUT THAT, THE PROCESS CAN'T 758 00:31:58,742 --> 00:32:00,511 BE SUCCESSFUL AND REALLY WANT TO 759 00:32:00,511 --> 00:32:02,579 THANK HER FOR GOING ABOVE AND 760 00:32:02,579 --> 00:32:04,181 BEYOND TRYING TO MAKE THAT 761 00:32:04,181 --> 00:32:06,483 HAPPEN DURING A VERY CHALLENGING 762 00:32:06,483 --> 00:32:06,684 TIME. 763 00:32:06,684 --> 00:32:11,989 >> THANK YOU, BOB. 764 00:32:11,989 --> 00:32:13,357 OKAY. WE WILL PROCEED WITH SOME 765 00:32:13,357 --> 00:32:15,459 -- ARE THERE QUESTIONS THAT WE 766 00:32:15,459 --> 00:32:17,661 RECEIVED PRIOR TO THIS WEBINAR? 767 00:32:17,661 --> 00:32:21,065 PERHAPS WE CAN TAKE ANOTHER ONE 768 00:32:21,065 --> 00:32:23,400 FROM THE Q & A. 769 00:32:23,400 --> 00:32:26,970 NEXT QUESTION READS CAN K-AWARD 770 00:32:26,970 --> 00:32:28,205 RECIPIENT PART IN AND BE PAID 771 00:32:28,205 --> 00:32:30,207 FOR ACTIVITIES ON GRANT 772 00:32:30,207 --> 00:32:33,110 APPLICATIONS SUBMITTED IN 773 00:32:33,110 --> 00:32:36,413 RESPONSE TO PAR-25-311? ANSWER 774 00:32:36,413 --> 00:32:39,416 IS YES K AWARD RECIPIENTS CAN 775 00:32:39,416 --> 00:32:42,453 ENGAGE AND BE COMPENSATED FOR 776 00:32:42,453 --> 00:32:44,788 ACTIVITY ON OTHER GRANTS 777 00:32:44,788 --> 00:32:47,925 INCLUDING PAR-25-311 AND MUST 778 00:32:47,925 --> 00:32:51,095 MAINTAIN MINIMUM OF 75% EFFORT 779 00:32:51,095 --> 00:32:53,330 ON K AWARD ENSURING CAREER 780 00:32:53,330 --> 00:32:54,932 DEVELOPMENT REMAINS THEIR MAIN 781 00:32:54,932 --> 00:32:57,134 FOCUS AND REMAINING UP TO 25 P 782 00:32:57,134 --> 00:32:59,670 RS CAN BE ALLOCATED TO OTHER 783 00:32:59,670 --> 00:33:03,140 PROFESSIONAL ACTIVITIES THAT 784 00:33:03,140 --> 00:33:07,411 CAN'T EXCEED 100% TOTAL EFFORT. 785 00:33:07,411 --> 00:33:09,179 ADDITIONALLY MUST BE NO OVERLAP 786 00:33:09,179 --> 00:33:11,915 IN COSTS OR ACTIVITIES BETWEEN K 787 00:33:11,915 --> 00:33:14,351 AWARD OR OTHER GRANTS AND ANY 788 00:33:14,351 --> 00:33:15,919 ADDITIONAL INVOLVEMENT IN OTHER 789 00:33:15,919 --> 00:33:17,654 PROJECTS SHOULD BE APPROPRIATELY 790 00:33:17,654 --> 00:33:20,224 DOCUMENTED AND JUSTIFIED TO 791 00:33:20,224 --> 00:33:24,728 AVOID CONFLICTS WITH K-AWARD 792 00:33:24,728 --> 00:33:25,062 REQUIREMENTS. 793 00:33:25,062 --> 00:33:26,730 IF UNCERTAINTY REGARDING 794 00:33:26,730 --> 00:33:30,434 SPECIFIC SITUATION, K-AWARD 795 00:33:30,434 --> 00:33:31,802 RECIPIENTS SHOULD REFER TO GUIDE 796 00:33:31,802 --> 00:33:36,740 NOTICE OTOD1709084 AND AGAIN 797 00:33:36,740 --> 00:33:39,276 FEEL FREE TO CONTACT NIH PROGRAM 798 00:33:39,276 --> 00:33:43,180 OFFICER AND GRANT MANAGEMENT 799 00:33:43,180 --> 00:33:44,515 SPECIALIST FOR FURTHER 800 00:33:44,515 --> 00:33:45,682 CLARIFICATION. 801 00:33:45,682 --> 00:33:48,819 >> WE RECEIVED ANOTHER ONE FOR 802 00:33:48,819 --> 00:33:49,953 INVESTIGATORS WHO ARE NOT 803 00:33:49,953 --> 00:33:52,389 CURRENTLY PART OF NICHD 804 00:33:52,389 --> 00:33:54,324 SUPPORTED NETWORK, WHAT IS THE 805 00:33:54,324 --> 00:33:56,126 RECOMMENDED PROCESS FOR 806 00:33:56,126 --> 00:33:57,694 INITIATING A COLLABORATION AND 807 00:33:57,694 --> 00:33:59,296 REACHING OUT DIRECTLY TO 808 00:33:59,296 --> 00:34:00,564 LEADERSHIP OF SPECIFIC NETWORK 809 00:34:00,564 --> 00:34:03,100 OR IS IT PREFERABLE TO FIRST 810 00:34:03,100 --> 00:34:05,035 CONTACT NETWORK'S COORDINATING 811 00:34:05,035 --> 00:34:08,205 CENTER OR NICHD PROGRAM STAFF TO 812 00:34:08,205 --> 00:34:10,941 FACILITATE AN INTRODUCTION? 813 00:34:10,941 --> 00:34:13,243 >> THANK YOU, MARGE ORREE, FOR 814 00:34:13,243 --> 00:34:14,711 THE QUESTION AND PERSON THAT 815 00:34:14,711 --> 00:34:15,679 ASKED THAT QUESTION. 816 00:34:15,679 --> 00:34:18,949 FIRST STEP, WE ENCOURAGE YOU TO 817 00:34:18,949 --> 00:34:20,517 E-MAIL US AND SUBMIT WHAT YOU 818 00:34:20,517 --> 00:34:27,624 CALL A LETTER OF INQUIRY TO 819 00:34:27,624 --> 00:34:28,992 NICHD-NETWORK-CLINICAL RESEARCH 820 00:34:28,992 --> 00:34:31,662 AND MALE.RESEARCH.GOV THAT IS IN 821 00:34:31,662 --> 00:34:33,063 OUR CHAT BOX AND WHAT IS 822 00:34:33,063 --> 00:34:34,198 IMPORTANT TO US IS ONCE YOU 823 00:34:34,198 --> 00:34:36,433 REACH OUT TO US WE DO OUR BEST 824 00:34:36,433 --> 00:34:39,403 TO RESPOND VERY QUICKLY AND GOAL 825 00:34:39,403 --> 00:34:41,505 THERE IS TO REVIEW THAT LETTER 826 00:34:41,505 --> 00:34:44,007 OF INQUIRY THAT YOU SEND AND 827 00:34:44,007 --> 00:34:48,178 THEN ONCE THAT IS APPROVED, WE 828 00:34:48,178 --> 00:34:50,147 DO ALLOW YOU TO PROCEED TO WHAT 829 00:34:50,147 --> 00:34:53,484 YOU CALL IN SUBMITTING A CONCEPT 830 00:34:53,484 --> 00:34:53,784 PROPOSALS. 831 00:34:53,784 --> 00:34:57,554 NOW, IN TERMS OF ENGAGING WITH 832 00:34:57,554 --> 00:34:59,523 DCC OR COORDINATING CENTER THAT 833 00:34:59,523 --> 00:35:01,525 YOU ASK, THAT WOULD HAVE BEEN AT 834 00:35:01,525 --> 00:35:02,559 A LATER POINT. 835 00:35:02,559 --> 00:35:04,194 I THINK THAT THE FIRST STEP IS 836 00:35:04,194 --> 00:35:06,463 TO MAKE SURE THAT YOU PUT 837 00:35:06,463 --> 00:35:08,198 TOGETHER THIS LETTER OF INQUIRY 838 00:35:08,198 --> 00:35:10,567 AND E-MAIL US AND LETTER OF 839 00:35:10,567 --> 00:35:11,768 INQUIRY IS RELATIVELY 840 00:35:11,768 --> 00:35:13,170 STRAIGHTFORWARD THAT WE ASK FOR 841 00:35:13,170 --> 00:35:15,672 THINGS SUCH AS PROJECT TITLE AND 842 00:35:15,672 --> 00:35:17,941 SPECIFIC AIMS AND STUDY 843 00:35:17,941 --> 00:35:19,843 POPULATION OR ESTIMATED SAMPLE 844 00:35:19,843 --> 00:35:20,410 SIZE. 845 00:35:20,410 --> 00:35:22,246 IT IS A ONE-PAGER. 846 00:35:22,246 --> 00:35:24,214 WE HAVE A ROBUST DISCUSSION 847 00:35:24,214 --> 00:35:26,283 INCLUDING FOLKS WITHIN THAT 848 00:35:26,283 --> 00:35:27,751 NETWORK OF INTEREST THAT YOU MAY 849 00:35:27,751 --> 00:35:31,321 HAVE. HOPE IT HELPS YOU TO 850 00:35:31,321 --> 00:35:32,389 ANSWER YOUR QUESTION. 851 00:35:32,389 --> 00:35:42,833 >> THERE WAS A QUESTION 852 00:35:44,034 --> 00:35:46,270 RECEIVED IN ADVANCE REGARDING 853 00:35:46,270 --> 00:35:46,870 BIOSKETCHES. 854 00:35:46,870 --> 00:35:48,205 I'M HAPPY TO READ THAT BEFORE WE 855 00:35:48,205 --> 00:35:51,875 TAKE OTHER QUESTIONS FROM THE Q 856 00:35:51,875 --> 00:35:53,710 & A. 857 00:35:53,710 --> 00:35:56,146 ARE BIOSKETCHES REQUIRED IN THE 858 00:35:56,146 --> 00:35:58,448 GRANT APPLICATION SUBMITTED IN 859 00:35:58,448 --> 00:36:02,319 RESPONSE TO PAR-25-311 FOR ALL 860 00:36:02,319 --> 00:36:02,953 JUNIOR INVESTIGATORS OR JUST 861 00:36:02,953 --> 00:36:04,855 THOSE PARTICIPATING TO A 862 00:36:04,855 --> 00:36:06,156 SIGNIFICANT DEGREE? 863 00:36:06,156 --> 00:36:08,091 BIOSKETCHES ARE ONLY REQUIRED 864 00:36:08,091 --> 00:36:09,760 FOR THOSE JUNIOR INVESTIGATORS 865 00:36:09,760 --> 00:36:12,596 WHO ARE BEING PROPOSED TO SERVE 866 00:36:12,596 --> 00:36:17,968 AS A SENIOR OR KEY PERSONNEL 867 00:36:17,968 --> 00:36:21,772 JUNIOR INVEST GAFRORS ATTEND 868 00:36:21,772 --> 00:36:23,240 COMMITTEE STEERING MEETINGS AND 869 00:36:23,240 --> 00:36:25,175 PROJECT DO NOT NEED BIOSKETCH. 870 00:36:25,175 --> 00:36:28,178 ALL REQUIRED BIOSKETCHES MUST BE 871 00:36:28,178 --> 00:36:34,184 PROVIDED IN ACCORDANCE TO 872 00:36:34,184 --> 00:36:36,687 NOTD241063 AND IF YOU NEED MORE 873 00:36:36,687 --> 00:36:40,023 GUIDANCE THERE IS A LINK 874 00:36:40,023 --> 00:36:46,730 PROVIDED THERE AS WELL. 875 00:36:46,730 --> 00:36:48,231 ANOTHER QUESTION WE RECEIVED IN 876 00:36:48,231 --> 00:36:51,401 ADVANCE TO THIS WEBINAR IS DOES 877 00:36:51,401 --> 00:36:52,669 EACH ENROLLING SITE NEED TO 878 00:36:52,669 --> 00:36:55,005 PROVIDE A JUNIOR INVESTIGATOR TO 879 00:36:55,005 --> 00:36:57,240 PARTICIPATE IN THE PROPOSED 880 00:36:57,240 --> 00:36:59,476 STUDY OR SIMPLY A FUNDED 881 00:36:59,476 --> 00:37:01,845 CLINICAL RESEARCH CENTER? 882 00:37:01,845 --> 00:37:03,246 ANSWER IS ONE JUNIOR 883 00:37:03,246 --> 00:37:04,314 INVESTIGATOR NEEDS TO BE 884 00:37:04,314 --> 00:37:06,049 IDENTIFIED FROM EACH OF THE 885 00:37:06,049 --> 00:37:08,051 CLINICAL RESEARCH CENTERS FROM 886 00:37:08,051 --> 00:37:10,153 THE NETWORK. THAT IS CENTERS 887 00:37:10,153 --> 00:37:11,655 RECEIVING PRIMARY NOTICE OF 888 00:37:11,655 --> 00:37:13,857 GRANT AWARD AND NOT FROM EACH OF 889 00:37:13,857 --> 00:37:16,059 THE SATELLITES OR ENROLLING 890 00:37:16,059 --> 00:37:17,527 SITES. 891 00:37:17,527 --> 00:37:18,395 JUN INVESTIGATOR MAY BE 892 00:37:18,395 --> 00:37:19,997 IDENTIFIED FROM THE PRIMARY 893 00:37:19,997 --> 00:37:22,933 CLINICAL RESEARCH CENTER OR ANY 894 00:37:22,933 --> 00:37:26,069 SATELLITE SITES FROM THE PRIMARY 895 00:37:26,069 --> 00:37:27,504 CLINICAL RESEARCH CENTER AND 896 00:37:27,504 --> 00:37:29,773 ONLY ONE JUNIOR INVESTIGATOR 897 00:37:29,773 --> 00:37:32,009 NEEDS TO BE IDENTIFIED FROM 898 00:37:32,009 --> 00:37:33,744 PRIMARY CLINICAL RESEARCH 899 00:37:33,744 --> 00:37:35,178 CENTER. 900 00:37:35,178 --> 00:37:36,079 JUNIOR INVESTIGATOR MAY TAKE ON 901 00:37:36,079 --> 00:37:38,348 ANY NUMBER OF ROLES IN THE 902 00:37:38,348 --> 00:37:41,518 PROJECT BUT THE ROLE MUST BE 903 00:37:41,518 --> 00:37:45,589 CLEARLY DEFINED. 904 00:37:45,589 --> 00:37:47,024 THOSE ARE ALL QUESTIONS WE 905 00:37:47,024 --> 00:37:48,659 RECEIVED IN ADVANCE AND WILL 906 00:37:48,659 --> 00:37:51,762 PAUSE AGAIN TO GIVE OTHERS A 907 00:37:51,762 --> 00:37:52,863 CHANCE TO PERHAPS READ ANY OTHER 908 00:37:52,863 --> 00:37:55,899 QUESTIONS WE RECEIVED IN OUR Q & 909 00:37:55,899 --> 00:37:56,199 A. 910 00:37:56,199 --> 00:37:59,036 WE WELCOME ADDITIONAL QUESTIONS 911 00:37:59,036 --> 00:38:03,907 IF NOW OR AT A LATER TIME. 912 00:38:03,907 --> 00:38:05,776 HERE IS THE GENERAL MAILBOX FOR 913 00:38:05,776 --> 00:38:07,811 EVERYONE TO REFER TO IF YOU DO 914 00:38:07,811 --> 00:38:12,149 HAVE INTERESTS OR HAVE QUESTIONS 915 00:38:12,149 --> 00:38:14,885 REGARDING THIS NO PHONE. 916 00:38:14,885 --> 00:38:17,087 >> ABBY, WE HAVE A QUESTION IN 917 00:38:17,087 --> 00:38:19,890 THE CHAT ABOUT INDIRECT COSTS 918 00:38:19,890 --> 00:38:22,392 AND WHETHER THE INDIRECT COSTS 919 00:38:22,392 --> 00:38:25,529 ON CAPITATION THAT GO TO THE 920 00:38:25,529 --> 00:38:28,198 CLINICAL CENTERS ARE CONSIDERED 921 00:38:28,198 --> 00:38:30,600 PART OF THE DIRECT COSTS UNDER 922 00:38:30,600 --> 00:38:34,905 THE (62) 500-0000 CAP THAT 923 00:38:34,905 --> 00:38:37,574 APPLIES. THE ANSWER TO THAT IS, 924 00:38:37,574 --> 00:38:38,909 YES. THOSE INDIRECT COSTS TO 925 00:38:38,909 --> 00:38:42,446 THE CLINICAL CENTERS ARE PART OF 926 00:38:42,446 --> 00:38:45,082 THAT CAP BECAUSE THAT -- IT IS 927 00:38:45,082 --> 00:38:47,584 ALL INCLUDED AS DIRECT COSTS 928 00:38:47,584 --> 00:38:52,956 UNDER THE DCC GRANT APPLICATION. 929 00:38:52,956 --> 00:38:54,825 >> I WILL TAKE THIS ONE. IT 930 00:38:54,825 --> 00:38:57,761 SEEMS I CREATED THE CONFUSION. 931 00:38:57,761 --> 00:38:59,429 I APOLOGIZE FOR THAT. 932 00:38:59,429 --> 00:39:01,431 INDIRECT COSTS ON CAPITATIONS 933 00:39:01,431 --> 00:39:03,133 WILL BE CONSIDERED AS PART OF 934 00:39:03,133 --> 00:39:04,201 DIRECT COSTS CAP. 935 00:39:04,201 --> 00:39:07,404 IF IT PUTS YOU OVER 6.25 936 00:39:07,404 --> 00:39:08,772 MILLION, THAT IS SOMETHING WE 937 00:39:08,772 --> 00:39:11,074 WILL TAKE TO OUR LEADERSHIP IN 938 00:39:11,074 --> 00:39:12,209 EXPLAINING THIS IS THE RATIONALE 939 00:39:12,209 --> 00:39:14,678 FOR GOING AHEAD OF THAT. 940 00:39:14,678 --> 00:39:18,615 TO BE CLEAR, INDIRECT COSTS ON 941 00:39:18,615 --> 00:39:19,950 CAPITATIONS ARE CONSIDERED AS 942 00:39:19,950 --> 00:39:22,552 DIRECT COSTS AS PART OF 6.25 943 00:39:22,552 --> 00:39:26,089 MILLION AND, AGAIN, I APOLOGIZE 944 00:39:26,089 --> 00:39:27,791 FOR CONFUSION. 945 00:39:27,791 --> 00:39:30,961 >> THANK YOU, BOB, AND 946 00:39:30,961 --> 00:39:35,866 STEPHANIE, FOR THAT ANSWER. 947 00:39:35,866 --> 00:39:36,433 >> THEN THERE IS ANOTHER 948 00:39:36,433 --> 00:39:38,735 QUESTION IN LIGHT OF NIH POLICY 949 00:39:38,735 --> 00:39:40,437 ON FOREIGN SUB AWARDS AND WHAT 950 00:39:40,437 --> 00:39:43,874 YOUR GUIDANCE ON NEW SUBMISSION 951 00:39:43,874 --> 00:39:47,611 OF CONCEPTS IN RESPONSE TO 952 00:39:47,611 --> 00:39:47,911 PAR-25-311. 953 00:39:47,911 --> 00:39:49,546 >> THANK YOU, STEPHANIE. 954 00:39:49,546 --> 00:39:51,848 THANKS FOR THAT QUESTION. 955 00:39:51,848 --> 00:39:54,451 AGAIN, WE DID RECEIVE, AND I'M 956 00:39:54,451 --> 00:39:56,486 SURE YOU ALL HEARD, ABOUT THE 957 00:39:56,486 --> 00:40:02,192 NOTICE THAT CAME OUT. 958 00:40:02,192 --> 00:40:03,727 NOT-OD-25-104 IS UPDATED POLICY 959 00:40:03,727 --> 00:40:06,997 THAT CAME OUT ON FOREIGN SUB 960 00:40:06,997 --> 00:40:09,866 AWARDS AND RECOGNIZE THAT THINGS 961 00:40:09,866 --> 00:40:12,836 ARE CHANGING AND WANT TO 962 00:40:12,836 --> 00:40:16,339 HIGHLIGHT OUR CURRENT PAR-25-311 963 00:40:16,339 --> 00:40:18,241 STATE FOREIGN COMPONENTS ARE 964 00:40:18,241 --> 00:40:18,642 ALLOWED. 965 00:40:18,642 --> 00:40:20,043 AGAIN, FOR RIGHT NOW, ANSWER 966 00:40:20,043 --> 00:40:21,878 WOULD BE TO REFER TO THAT 967 00:40:21,878 --> 00:40:22,212 NOTICE. 968 00:40:22,212 --> 00:40:24,681 AGAIN, YOU ARE WELCOME TO E-MAIL 969 00:40:24,681 --> 00:40:27,918 US AT NICHD NETWORK CLINICAL 970 00:40:27,918 --> 00:40:30,420 RESEARCH AT NIH.GOV AND IF YOU 971 00:40:30,420 --> 00:40:32,189 HAVE FURTHER QUESTIONS WE WILL 972 00:40:32,189 --> 00:40:36,026 MAKE SURE TO ANSWER THAT FOR 973 00:40:36,026 --> 00:40:36,226 YOU. 974 00:40:36,226 --> 00:40:36,593 THANK YOU. 975 00:40:36,593 --> 00:40:40,764 >> >> THERE IS ANOTHER 976 00:40:40,764 --> 00:40:41,131 QUESTION THEN. 977 00:40:41,131 --> 00:40:43,500 THANK YOU FOR HOSTING THE 978 00:40:43,500 --> 00:40:43,767 WEBINAR. 979 00:40:43,767 --> 00:40:45,068 I UNDERSTAND THERE ARE REVIEWS 980 00:40:45,068 --> 00:40:49,606 ABOUT I NICHD AND ALSO BY THE 981 00:40:49,606 --> 00:40:53,877 NETWORK WITH WHICH THE STUDY IS 982 00:40:53,877 --> 00:40:56,213 BEING PROPOSED AND CONCEPT 983 00:40:56,213 --> 00:40:57,848 APPROVAL AND DEADLINE FOR REVIEW 984 00:40:57,848 --> 00:41:03,854 BY NETWORK BEFORE THE REVIEW BY 985 00:41:03,854 --> 00:41:07,057 NICHD? 986 00:41:07,057 --> 00:41:10,060 EACH HAS OWN PROCESSES AND IN 987 00:41:10,060 --> 00:41:11,595 GENERAL SUBMIT CONCEPT AND 988 00:41:11,595 --> 00:41:14,731 PRESENT IT TO RELEVANT NETWORK'S 989 00:41:14,731 --> 00:41:15,498 STEERING COMMITTEE MEETINGS AND 990 00:41:15,498 --> 00:41:20,203 IN FOLLOWING THAT MEETING THE 991 00:41:20,203 --> 00:41:22,239 STEERING COMMITTEE WOULD PROVIDE 992 00:41:22,239 --> 00:41:23,840 COMMENTS AND VOTE ON THAT THAT 993 00:41:23,840 --> 00:41:28,879 WOULD GO TO NICHD AS PART OF 994 00:41:28,879 --> 00:41:33,850 THEIR REVIEW OF KONT CREPT 995 00:41:33,850 --> 00:41:34,584 ITS 996 00:41:34,584 --> 00:41:34,818 ITSELF. 997 00:41:34,818 --> 00:41:35,252 >> YEAH. 998 00:41:35,252 --> 00:41:37,754 >> DIFFERENCES IN HOW NETWORKS 999 00:41:37,754 --> 00:41:40,223 HANDLE CONCEPTS BUT THAT IS IT 1000 00:41:40,223 --> 00:41:41,224 IN GENERAL. 1001 00:41:41,224 --> 00:41:43,360 >> WELL-SAID, STEPHANIE. THANK 1002 00:41:43,360 --> 00:41:45,328 YOU FOR THAT. 1003 00:41:45,328 --> 00:41:46,396 BUILDING ON THAT, PERHAPS WHAT I 1004 00:41:46,396 --> 00:41:47,364 HEARD IN THE QUESTION PERHAPS 1005 00:41:47,364 --> 00:41:50,066 WHAT ARE THEY ASSESSING FOR? 1006 00:41:50,066 --> 00:41:51,968 CONCEPT THAT WE ASSESS THEMES 1007 00:41:51,968 --> 00:41:53,570 SUCH AS FEASIBILITY AND 1008 00:41:53,570 --> 00:41:54,738 IMPORTANCE AND RELEVANCE OF 1009 00:41:54,738 --> 00:41:56,239 SCIENCE AND MISSION OF THE 1010 00:41:56,239 --> 00:41:58,875 NETWORK AND NICHD, WE ALSO 1011 00:41:58,875 --> 00:42:01,878 ASSESS BUDGET. TO STEPHANIE'S 1012 00:42:01,878 --> 00:42:03,346 POINT, PRESENTING AT THE 1013 00:42:03,346 --> 00:42:04,447 STEERING COMMITTEE MEETINGS IS 1014 00:42:04,447 --> 00:42:08,151 IMPORTANT TO GET THAT NETWORK 1015 00:42:08,151 --> 00:42:08,418 FEEDBACK. 1016 00:42:08,418 --> 00:42:10,921 GO ELIS TO HOPEFULLY GET THAT 1017 00:42:10,921 --> 00:42:12,923 FEEDBACK IN A TIMELY MANNER. 1018 00:42:12,923 --> 00:42:15,492 WE TRY TO SET TIMELINE OF AROUND 1019 00:42:15,492 --> 00:42:18,595 OR WITHIN 2 MONTHS OF OBTAINING 1020 00:42:18,595 --> 00:42:21,464 INITIAL ACCESS OF SUBMISSION OF 1021 00:42:21,464 --> 00:42:21,865 CONCEPT PROPOSAL. 1022 00:42:21,865 --> 00:42:26,369 TO STEPHANIE'S POINT, NICHD 1023 00:42:26,369 --> 00:42:27,470 RENDERS FINAL DECISION WHEN WE 1024 00:42:27,470 --> 00:42:28,939 RECEIVE NETWORK FEEDBACK OR 1025 00:42:28,939 --> 00:42:31,241 WHETHER OR NOT CONCEPT PROPOSAL 1026 00:42:31,241 --> 00:42:33,076 CAN PROCEED TO BECOME A FULL 1027 00:42:33,076 --> 00:42:34,945 GRANT APPLICATION AND HOPE IT 1028 00:42:34,945 --> 00:42:38,181 HELPS TO ANSWER YOUR QUESTION. 1029 00:42:38,181 --> 00:42:45,188 THANK YOU. 1030 00:42:45,188 --> 00:42:46,489 >> WE HAVE AN ADDITIONAL 1031 00:42:46,489 --> 00:42:48,825 QUESTION ASKING ABOUT INDIRECTS 1032 00:42:48,825 --> 00:42:50,427 FOR EXTERNAL NON-NETWORK 1033 00:42:50,427 --> 00:42:51,594 CLINICAL CENTERS TRYING TO 1034 00:42:51,594 --> 00:42:53,830 UNDERSTAND IF THOSE WILL BE 1035 00:42:53,830 --> 00:42:58,134 INCLUDED IN THE 6.25 DIRECT COST 1036 00:42:58,134 --> 00:43:00,603 CAP. 1037 00:43:00,603 --> 00:43:02,405 SUB-AWARDS TO CENTERS. 1038 00:43:02,405 --> 00:43:05,976 >> YES. ALL APPLICABLE 1039 00:43:05,976 --> 00:43:07,344 INDIRECT COSTS FOR CAPITATION 1040 00:43:07,344 --> 00:43:09,646 WOULD BE CONSIDERED PART OF THE 1041 00:43:09,646 --> 00:43:12,215 DIRECT COST BUDGET AND THEIR 1042 00:43:12,215 --> 00:43:15,352 APPLICABLE TO THAT CAP. 1043 00:43:15,352 --> 00:43:17,020 THANK YOU FOR THAT QUESTION. 1044 00:43:17,020 --> 00:43:20,223 >> I JUST MAYBE TO KEEP IT 1045 00:43:20,223 --> 00:43:21,925 SIMPLE ANYTHING THAT IS 1046 00:43:21,925 --> 00:43:23,960 CONSIDERED A DIRECT COST ON 1047 00:43:23,960 --> 00:43:25,028 APPLICATION WILL BE CONSIDERED 1048 00:43:25,028 --> 00:43:28,898 PART OF THE 6.25 MILLION DIRECT 1049 00:43:28,898 --> 00:43:31,034 COST CAPS AND INDIRECT COSTS 1050 00:43:31,034 --> 00:43:33,370 PUTTING YOU OVER THE LIMIT IS 1051 00:43:33,370 --> 00:43:34,404 SOMETHING WE SHOULD DISCUSS AND 1052 00:43:34,404 --> 00:43:36,706 TRY TO WORK OUT ON THE FRONT END 1053 00:43:36,706 --> 00:43:39,476 AND WHY AS ABBY SAID WE TRY TO 1054 00:43:39,476 --> 00:43:41,745 GET BUDGETS IN AT LEAST A MONTH 1055 00:43:41,745 --> 00:43:44,047 PRIOR TO GRANT DUE DATE SO ANY 1056 00:43:44,047 --> 00:43:46,783 CONCERNS CAN BE ADDRESSED. 1057 00:43:46,783 --> 00:43:48,218 >> THANK YOU, BOB. 1058 00:43:48,218 --> 00:43:49,886 >> WE DO HAVE ANOTHER QUESTION 1059 00:43:49,886 --> 00:43:53,556 FOR PRESENTATIONS THAT HAVE BEEN 1060 00:43:53,556 --> 00:43:57,894 IN THE LAST MONTH OF -- LAST 1061 00:43:57,894 --> 00:44:00,897 MONTH'S STEERING COMMITTEE TO BE 1062 00:44:00,897 --> 00:44:04,567 SUBMITTED WILL WE GET FEEDBACK 1063 00:44:04,567 --> 00:44:06,703 FROM SUBMISSIONS? 1064 00:44:06,703 --> 00:44:09,339 >> THANK YOU FOR THAT QUESTION. 1065 00:44:09,339 --> 00:44:11,608 WE DO IDEALLY DO OUR BEST TO SET 1066 00:44:11,608 --> 00:44:14,110 UP AN ADDITIONAL CALL, IF 1067 00:44:14,110 --> 00:44:16,546 NEEDED, WITH INVESTIGATORS THAT 1068 00:44:16,546 --> 00:44:18,548 PRESENTED AT STEERING COMMITTEE 1069 00:44:18,548 --> 00:44:20,216 MEETING AND GOAL IS TO BE 1070 00:44:20,216 --> 00:44:21,885 COLLABORATIVE AND HELP PRODUCE 1071 00:44:21,885 --> 00:44:22,752 THE BEST SCIENCE. 1072 00:44:22,752 --> 00:44:25,855 WE ABSOLUTELY ENCOURAGE YOU TO 1073 00:44:25,855 --> 00:44:27,590 E-MAIL US AT THIS GENERAL 1074 00:44:27,590 --> 00:44:30,994 MAILBOX. WE ARE MORE THAN HAPPY 1075 00:44:30,994 --> 00:44:34,230 TO SHARE WITH YOU SOME TIPS OR 1076 00:44:34,230 --> 00:44:35,698 STRATEGIES TO POSSIBLY HELP YOU 1077 00:44:35,698 --> 00:44:38,001 TO GET THAT FEEDBACK THAT YOU 1078 00:44:38,001 --> 00:44:40,770 NEED TO RESUBMIT. WE WELCOME IT 1079 00:44:40,770 --> 00:44:42,906 AS WELL. THANK YOU FOR THE 1080 00:44:42,906 --> 00:44:43,173 QUESTION. 1081 00:44:43,173 --> 00:44:44,908 >> ABBY, RELATED I THINK TO 1082 00:44:44,908 --> 00:44:49,579 THIS QUESTION IS SORT OF THE 1083 00:44:49,579 --> 00:44:51,247 CONCEPTS THAT HAVE BEEN OR COME 1084 00:44:51,247 --> 00:44:53,383 IN IN THE MEANTIME AND ARE IN 1085 00:44:53,383 --> 00:44:53,817 DEVELOPMENT. 1086 00:44:53,817 --> 00:44:55,985 I DON'T THINK THAT THEY NEED TO 1087 00:44:55,985 --> 00:44:57,720 RESUBMIT CONCEPTS AT THIS TIME. 1088 00:44:57,720 --> 00:45:00,056 IT IS ONLY IF THEY HAVE 1089 00:45:00,056 --> 00:45:02,358 SUBMITTED A GRANT APPLICATION 1090 00:45:02,358 --> 00:45:08,865 UNDER THE PRIOR PAR THAT THERE 1091 00:45:08,865 --> 00:45:11,468 NEEDS TO BE REVISION THAT IT 1092 00:45:11,468 --> 00:45:13,903 WOULD COME IN UNDER THE NEW PAR 1093 00:45:13,903 --> 00:45:15,805 AND NEW MECHANISM STRUCTURE. 1094 00:45:15,805 --> 00:45:17,941 ONES THAT ARE CURRENTLY IN 1095 00:45:17,941 --> 00:45:20,944 DEVELOPMENT WILL PROCEED AS-IS. 1096 00:45:20,944 --> 00:45:25,248 YOU WOULD ONLY NEED TO RESUBMIT 1097 00:45:25,248 --> 00:45:27,784 THE CONCEPT IF -- BASED ON 1098 00:45:27,784 --> 00:45:30,520 FEEDBACK YOU MIGHT RECEIVE FROM 1099 00:45:30,520 --> 00:45:31,488 STEERING COMMITTEES. 1100 00:45:31,488 --> 00:45:34,824 >> ABSOLUTELY. 1101 00:45:34,824 --> 00:45:45,034 WELL SAID. 1102 00:45:46,836 --> 00:45:48,004 >> WE DON'T HAVE OTHER 1103 00:45:48,004 --> 00:45:51,040 QUESTIONS IN THE Q & A AND WANT 1104 00:45:51,040 --> 00:45:58,148 TO SAY WITH THAT, WE ARE HAPPY 1105 00:45:58,148 --> 00:46:00,817 TO STAY ON. THIS WEBCAST IS 1106 00:46:00,817 --> 00:46:03,319 GOING TO 2 O'CLOCK EASTERN 1107 00:46:03,319 --> 00:46:05,054 STANDARD TIME BUT SAYING 1108 00:46:05,054 --> 00:46:07,457 RECORDING OF THIS WEBINAR WILL 1109 00:46:07,457 --> 00:46:11,528 BE MADE ON NIH ARCHIVE SITE AND 1110 00:46:11,528 --> 00:46:14,030 FEEL FREE TO REACH OUT TO US. 1111 00:46:14,030 --> 00:46:15,798 WE WELCOME QUESTIONS YOU HAVE TO 1112 00:46:15,798 --> 00:46:17,600 OUR PROGRAM OFFICIALS AND 1113 00:46:17,600 --> 00:46:20,370 SCIENTISTS AND TO ANALYSTS AND 1114 00:46:20,370 --> 00:46:22,505 ANYONE YOU SEE TODAY AT THE 1115 00:46:22,505 --> 00:46:23,072 PRESENTATION. 1116 00:46:23,072 --> 00:46:25,608 WE WELCOME YOU ALSO TO USE THIS 1117 00:46:25,608 --> 00:46:27,110 EMILL ADDRESS PRESENTED ON THE 1118 00:46:27,110 --> 00:46:29,245 SLIDE THAT IS THE SAME AS ONE 1119 00:46:29,245 --> 00:46:32,916 THAT IS LISTED ON PAR AND ON 1120 00:46:32,916 --> 00:46:34,450 BEHALF OF WEBINAR PLANNING 1121 00:46:34,450 --> 00:46:36,219 COMMITTEE THANKS SO MUCH. THIS 1122 00:46:36,219 --> 00:46:38,888 IS A LONG TIME COMING TO HAVE 1123 00:46:38,888 --> 00:46:39,989 THE WEBINAR AND THANKS FOR 1124 00:46:39,989 --> 00:46:41,524 PATIENCE AND ENGAGING QUESTIONS 1125 00:46:41,524 --> 00:46:44,194 YOU HAD PRIOR TO THE WEBINAR AND 1126 00:46:44,194 --> 00:46:47,030 THOSE THAT ASKED DURING THE 1127 00:46:47,030 --> 00:46:47,297 WEBINAR. 1128 00:46:47,297 --> 00:46:51,000 THANKS SO MUCH. ENJOY THE REST 1129 00:46:51,000 --> 00:47:01,244 OF YOUR DAY.