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SERVING AS ACTING CHAIR OF THIS 

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MIGHT.  WE'D LIKE TO WELCOME THE

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MEMBERS OF THE NATIONAL CANCER 

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00:00:18,189 --> 00:00:23,528
ADVISORY BOARD, EX OFFICIO 

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00:00:23,528 --> 00:00:26,197
MEMBERS, PRESIDENT MEMBERS AND 

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MOST ESPECIALLY A WARM WELCOME 

7
00:00:28,700 --> 00:00:34,539
TO DR. DOUGLAS LOWY, DOUG IS 

8
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GREAT TO HAVE YOU AT THE HELM.  

9
00:00:36,307 --> 00:00:37,909
MEMBERS OF THE PUBLIC WHO WISH 

10
00:00:37,909 --> 00:00:39,944
TO EXPRESS THEIR VIEWS REGARDING

11
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ANY ITEMS DISCUSSED IN THIS 

12
00:00:42,347 --> 00:00:45,583
MEETING MAY DO SO BY WRITING 

13
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DR. PAULETTE GREY WITHIN TEN 

14
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DAYS AFTER THE MEETING.  ANY 

15
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WRITTEN STATEMENTS OR QUESTIONS 

16
00:00:50,555 --> 00:00:52,523
SUBMITTED BY THE PUBLIC WILL 

17
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RECEIVE CAREFUL CONSIDERATION.  

18
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AS BOARD MEMBERS, I WANT TO 

19
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REMIND YOU THAT YOU MUST ABSENT 

20
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YOURSELVES VIRTUALLY WHENEVER 

21
00:01:01,265 --> 00:01:02,567
YOUR PARTICIPATION, 

22
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DELIBERATIONS ON A PARTICULAR 

23
00:01:04,569 --> 00:01:05,636
PRODUCT, PROGRAM OR OTHER 

24
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SPECIFIC MATTER WOULD CONSTITUTE

25
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A CONFLICT OF INTEREST OR CREATE

26
00:01:09,741 --> 00:01:12,043
THE APPEARANCE OF ONE.  IT IS 

27
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INCUMBENT UPON YOU TO ADVISE THE

28
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EXECUTIVE SECRETARY AND ABSTAIN 

29
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FROM ANY PARTICIPATION IN 

30
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DISCUSSION OR ACTION REGARDING 

31
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THAT MATTER.  IN LIGHT OF THE 

32
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CURRENT POLICIES GOVERNING 

33
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CONFLICT OF INTEREST BASED ON 

34
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FINANCIAL HOLDINGS, SPECIAL 

35
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GOVERNMENT EMPLOYEES WHICH 

36
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INCLUDES ALL MEMBERS OF THIS 

37
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BOARD WE MUST DEPEND UPON YOU TO

38
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VOLUNTARILY ABSENT YOURSELF 

39
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DURING ANY AND ALL DISCUSSIONS 

40
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OF MATTERS THAT COULD 

41
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CONCEIVABLY IMPACT THE STATUS OF

42
00:01:38,536 --> 00:01:39,404
THOSE HOLDINGS WE TRUST YOUR 

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JUDGMENT IN THESE INSTANCES.  

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DURING ANY CLOSED SESSION, ANY 

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MATERIALS OR DISCUSSIONS OF A 

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CONFIDENTIAL NATURE DELIBERATED 

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ON TODAY ARE PRIVILEGED 

48
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INFORMATION AND ARE MADE 

49
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AVAILABLE TO YOU ON A NEED TO 

50
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KNOW BASIS.  SUCH DELIBERATIONS 

51
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ARE PRIVATE AND THEIR CONTENT 

52
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SHOULD NOT BE DIVULGED.  FUTURE 

53
00:02:00,158 --> 00:02:04,362
DATES WERE PROVIDED AND LISTED 

54
00:02:04,362 --> 00:02:06,531
IN OUR AGENDA.  A QUORUM OF 

55
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BOARD MEMBERS IS REQUIRED FOR 

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EACH INSTANCE IN WHICH A VOTE 

57
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MAY OCCUR WHETHER IN OPEN OR 

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CLOSED SESSION DURING THIS 

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MEETING A MINIMUM OF NINE 

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APPOINTED MEMBERS MUST BE 

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PRESENT TO VOICE THEIR VOTES 

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SINCE WE CANNOT PREDICT THE TIME

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NOR OCCURRENCE OF ANY MOTION 

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YOUR PRESENCE IN THE VIRTUAL 

65
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ROOM FOR ALL SEGMENTS IN THIS 

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MEETING IS A MUST.  DR. GREY, DO

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WE HAVE A QUORUM?

68
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>> YES, WE DON'T  -- DO.

69
00:02:35,393 --> 00:02:36,961
>> THANK YOU.  PLEASE MAKE
SURE 

70
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YOU ARE RECOGNIZED BY ME, 

71
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DR. GRAY, DR. LOWY OR ANY 

72
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RESPECTIVE SPEAKER.  WE WILL 

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BEGIN WITH THE DEPUTY DIRECTOR'S

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REPORT.  DR. LOWY, THE FLOOR IS 

75
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YOURS.

76
00:02:51,576 --> 00:02:52,243
>> DR. LOWY: THANK YOU SO
MUCH 

77
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FOR THE WONDERFUL INTRODUCTION 

78
00:02:53,978 --> 00:02:57,081
FOR ME BUT MORE IMPORTANTLY FOR 

79
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YOUR SETTING THE SCENE FOR THIS 

80
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REALLY IMPORTANT MEETING OF THE 

81
00:03:00,384 --> 00:03:03,054
NATIONAL CANCER ADVISORY BOARD. 

82
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I AM REALLY GLAD WE ARE ABLE TO 

83
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MEET TOGETHER TODAY.  WE FIRST 

84
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PLAN TO GO OVER SEVERAL TOPICS 

85
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IN OPEN SESSION AND THEN FOR THE

86
00:03:13,030 --> 00:03:15,900
NCAB TO PROVIDE SECOND LEVEL 

87
00:03:15,900 --> 00:03:17,468
REVIEW OF MANY GRANT 

88
00:03:17,468 --> 00:03:19,537
APPLICATIONS WITH THE HOPE THAT 

89
00:03:19,537 --> 00:03:21,706
THE MOST MERITORIOUS OF THEM CAN

90
00:03:21,706 --> 00:03:24,642
BE FUNDED IN THE NEAR FUTURE.  

91
00:03:24,642 --> 00:03:27,678
ONE NOTE ABOUT INDIRECT COST 

92
00:03:27,678 --> 00:03:29,780
RATE.  WE WILL CONTINUE TO USE 

93
00:03:29,780 --> 00:03:32,016
PREVIOUSLY NEGOTIATED AND 

94
00:03:32,016 --> 00:03:34,519
APPROVED RATES EXCEPT FOR AWARDS

95
00:03:34,519 --> 00:03:38,523
UNDER WHICH FACILITIES AND 

96
00:03:38,523 --> 00:03:41,826
ADMINISTRATIVE COST OR FOA COSTS

97
00:03:41,826 --> 00:03:44,462
ARE REIMBURSED AT A FIXED RATE I

98
00:03:44,462 --> 00:03:46,497
ALSO JUST WANT EVERYONE TO KNOW 

99
00:03:46,497 --> 00:03:50,535
THAT OUR EARLY STAGE 

100
00:03:50,535 --> 00:03:51,369
INVESTIGATORS HAVE BEEN GRANTED 

101
00:03:51,369 --> 00:03:53,905
AUTOMATIC EXTENSIONS OF THEIR 

102
00:03:53,905 --> 00:03:55,940
ELIGIBILITY THAT MAY HAVE 

103
00:03:55,940 --> 00:03:58,476
RESULTED FROM DELAYS IN GRANT 

104
00:03:58,476 --> 00:04:00,111
APPLICATIONS, SUBMISSIONS, PEER 

105
00:04:00,111 --> 00:04:03,314
REVIEW, OR AWARD PROCESSING 

106
00:04:03,314 --> 00:04:05,182
BETWEEN THE BEGINNING OF JANUARY

107
00:04:05,182 --> 00:04:07,985
AND THE END OF MAY.  BEFORE 

108
00:04:07,985 --> 00:04:10,087
TURNING TO THE NEXT ORDER OF 

109
00:04:10,087 --> 00:04:12,089
BUSINESS, THE ANNUAL DELEGATION 

110
00:04:12,089 --> 00:04:14,225
OF AUTHORITY, I WOULD LIKE TO 

111
00:04:14,225 --> 00:04:16,794
REMIND ALL OF US THAT THE 

112
00:04:16,794 --> 00:04:19,697
ONGOING THREE DECADE DECREASE IN

113
00:04:19,697 --> 00:04:21,866
CANCER MORTALITY RATES HAS 

114
00:04:21,866 --> 00:04:25,102
CONTINUED FOR 19, I'M SORRY, FOR

115
00:04:25,102 --> 00:04:26,837
2023, THE MOST RECENT YEAR FOR 

116
00:04:26,837 --> 00:04:30,374
WHICH WE HAVE RELIABLE DATA.  

117
00:04:30,374 --> 00:04:34,111
PATIENTS, RESEARCHERS, OUR 

118
00:04:34,111 --> 00:04:35,913
ADVISORY COMMITTEES AND CONGRESS

119
00:04:35,913 --> 00:04:39,116
SHOULD BE APPLAUDED FOR ENABLING

120
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THIS PROGRESS.  YOU CAN FIND THE

121
00:04:43,287 --> 00:04:46,090
2023 DATA IN SEER EXPLORER WHICH

122
00:04:46,090 --> 00:04:47,625
IS AVAILABLE TO EVERYONE.  IN 

123
00:04:47,625 --> 00:04:50,528
THAT YEAR, THE ANNUAL MORTALITY 

124
00:04:50,528 --> 00:04:54,131
RATE DECREASE FOR BOTH SEXES 

125
00:04:54,131 --> 00:04:57,969
COMBINED WAS 1.5%.  THANKFULLY, 

126
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THE 2023 MORTALITY RATES ARE 

127
00:05:01,839 --> 00:05:04,275
MORE THAN 1/3 LOWER THAN WHAT 

128
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THEY WERE IN 1992.  WHAT THAT 

129
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MEANS FOR NOW IS AROUND 300,000 

130
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PEOPLE IN THE UNITED STATES THIS

131
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YEAR WON'T DIE OF CANCER.  

132
00:05:17,221 --> 00:05:18,522
COMPARED WITH THE NUMBER WHO 

133
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WOULD HAVE DIED AT 1992 RATES.  

134
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OF COURSE THERE'LL ALSO BE SIX 

135
00:05:26,998 --> 00:05:28,399
THOUSAND PEOPLE WHO WILL DIE 

136
00:05:28,399 --> 00:05:30,735
FROM CANCER THIS YEAR.  THIS 

137
00:05:30,735 --> 00:05:34,372
NUMBER AND THE PATIENTS, 

138
00:05:34,372 --> 00:05:35,573
FAMILIES AND FRIENDS PUTS IN 

139
00:05:35,573 --> 00:05:37,708
PERSPECTIVE THE IMPORTANCE AND 

140
00:05:37,708 --> 00:05:40,645
THE URGENCY FOR SUPPORTING AS 

141
00:05:40,645 --> 00:05:44,115
MUCH MERITORIOUS CANCER RESEARCH

142
00:05:44,115 --> 00:05:47,284
AS POSSIBLE.  THANKS SO MUCH FOR

143
00:05:47,284 --> 00:05:49,587
YOUR PARTICIPATION.  WE REALLY 

144
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LOOK FORWARD TO BEING ABLE TO 

145
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TRY TO MAKE MORE AWARDS IN THE 

146
00:05:54,492 --> 00:05:57,928
NEAR FUTURE COMPARED TO WHERE WE

147
00:05:57,928 --> 00:06:04,835
HAVE BEEN.

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>> THANK YOU SO MUCH DOUG
AND WE

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APPRECIATE WHAT YOU AND THE TEAM

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ARE DOING IN THESE EXTRAORDINARY

151
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CIRCUMSTANCES AND MY PERSONAL 

152
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DEEP APPRECIATION FOR THE VERY 

153
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HARD WORK TO ACHIEVE THOSE GOALS

154
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THAT YOU OUTLINED.  WE HAVE 

155
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ABOUT NINE MINUTES OR SO FOR 

156
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QUESTIONS.  AGAIN, I ASK NCAB 

157
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MEMBERS IF YOU HAVE A QUESTION 

158
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OR A COMMENT TO PLEASE RAISE 

159
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YOUR HAND TO BE IDENTIFIED.  I 

160
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WILL CALL ON YOU FOR THE SAKE OF

161
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EXPEDIENCY I ASK YOU KEEP YOUR 

162
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QUESTIONS AND COMMENTS AS BRIEF 

163
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AS POSSIBLE SO WE CAN HAVE AS 

164
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MUCH DISCUSSION AS POSSIBLE.  

165
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ISABE

166
00:06:52,817 --> 00:06:53,718
ISABEL?

167
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>> ISABEL: THANK YOU,
CHRIS, 

168
00:06:56,287 --> 00:06:58,022
THANK YOU DR. LOWY, GOOD TO SEE 

169
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YOU THIS MORNING.  ONE QUESTION,

170
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WILL WE BE ABLE TO SEE THAT 

171
00:07:04,161 --> 00:07:04,662
REP

172
00:07:04,662 --> 00:07:06,530
REPORT, A LINK TO THAT REPORT 

173
00:07:06,530 --> 00:07:07,798
AND PERHAPS A DEMOGRAPHIC 

174
00:07:07,798 --> 00:07:13,771
BREAKDOWN OF THE IMPROVEMENT 

175
00:07:13,771 --> 00:07:15,639
IN... IN THE AREA OF MORTALITY? 

176
00:07:15,639 --> 00:07:18,309
THAT IS, WE HAVE LESS DEATH IN A

177
00:07:18,309 --> 00:07:19,877
DIFFERENT COMMUNITIES.  SO THAT 

178
00:07:19,877 --> 00:07:22,346
WE CAN MEASURE IF WE'RE DOING 

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WELL.  SNUG ISABEL, I'M NOT SURE

180
00:07:30,454 --> 00:07:40,164
I UNDERSTOOD YOUR QUESTION.

181
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>> ISABEL.  LOOKING FOR A
REPORT

182
00:07:42,533 --> 00:07:45,803
WITH THE DATA SO WE CAN SEE HOW 

183
00:07:45,803 --> 00:07:46,537
OUR DIFFERENT DEMOGRAPHIC 

184
00:07:46,537 --> 00:07:47,671
BREAKDOWNS WE CAN SEE IF OUR 

185
00:07:47,671 --> 00:07:49,406
DIFFERENT COMMUNITIES ARE IN 

186
00:07:49,406 --> 00:07:52,910
FACT, ALSO, MORE SUCCESSFULLY 

187
00:07:52,910 --> 00:07:54,211
CONQUERING CANCER AND SURVIVING 

188
00:07:54,211 --> 00:07:56,313
RATHER THAN FACING SOME HIGHER 

189
00:07:56,313 --> 00:07:58,382
MORTALITY RATES.

190
00:07:58,382 --> 00:08:04,255
>> YES, THE ANNUAL REVIEW
ON 

191
00:08:04,255 --> 00:08:08,359
CANCER GIVES THOSE, GIVE THOSE 

192
00:08:08,359 --> 00:08:09,093
DATA THEY'RE ACTUALLY PUBLISHED 

193
00:08:09,093 --> 00:08:13,130
THIS YEAR IN CANCER A COUPLE OF 

194
00:08:13,130 --> 00:08:14,365
MONTHS AGO.

195
00:08:14,365 --> 00:08:18,602
>> GREAT.  THANK YOU VERY
MUCH.

196
00:08:18,602 --> 00:08:26,010
>> THANK YOU SO MUCH, DR. 
EM 

197
00:08:26,010 --> 00:08:26,911
MENS, PLEASE.  DOCTOR, YOU'RE 

198
00:08:26,911 --> 00:08:37,454
MUTED.  IF YOU WANT TO PUT YOUR 

199
00:08:41,625 --> 00:08:43,861
QUESTION IN THE CHAT, WE'LL 

200
00:08:43,861 --> 00:08:46,564
FOLLOW UP WITH YOU.  THANK YOU. 

201
00:08:46,564 --> 00:08:47,097
ASHOW 

202
00:08:47,097 --> 00:08:48,666
>> I JUST WANT TO SAY
THANK YOU 

203
00:08:48,666 --> 00:08:50,801
TO DR. LOWY AND ALL OF THE NCI 

204
00:08:50,801 --> 00:08:52,436
STAFF FOR THE AMAZING JOB YOU 

205
00:08:52,436 --> 00:08:54,004
GUYS ARE DOING THIS TRYING TIME 

206
00:08:54,004 --> 00:08:57,408
AND I HOPE YOU'RE ALL HANGING IN

207
00:08:57,408 --> 00:08:57,808
THERE.

208
00:08:57,808 --> 00:09:01,212
>> THANKS SO MUCH FOR YOUR

209
00:09:01,212 --> 00:09:02,613
ENCOURAGEMENT AND SUPPORT.  WE 

210
00:09:02,613 --> 00:09:07,751
LOOK AT THE MISSION OF THE NCI 

211
00:09:07,751 --> 00:09:10,154
AS A SACRED TRUST AND 

212
00:09:10,154 --> 00:09:12,256
RESPONSIBILITY AND IT REALLY 

213
00:09:12,256 --> 00:09:16,126
HELPS KEEP US CENTERED.  IT IS 

214
00:09:16,126 --> 00:09:22,299
OUR NORTH STAR.

215
00:09:22,299 --> 00:09:24,201
>> YOU WANT TO TRY AGAIN. 
I 

216
00:09:24,201 --> 00:09:25,603
THINK I SAW SOME VICTORY.

217
00:09:25,603 --> 00:09:29,006
>> SORRY ABOUT THAT. 
APOLOGIES.

218
00:09:29,006 --> 00:09:30,307
AGAIN, I WANT TO ECHO WHAT 

219
00:09:30,307 --> 00:09:31,175
EVERYONE HAS SAID ABOUT JUST 

220
00:09:31,175 --> 00:09:33,143
THAT AMAZING WORK THAT IS 

221
00:09:33,143 --> 00:09:34,111
HAPPENING TO KIND OF KEEP 

222
00:09:34,111 --> 00:09:35,613
EVERYTHING AFLOAT AND SO 

223
00:09:35,613 --> 00:09:37,448
APPRECIATIVE OF THAT.  I KNOW 

224
00:09:37,448 --> 00:09:40,618
FOR MYSELF THAT WHEN THERE'S A 

225
00:09:40,618 --> 00:09:42,553
LOT OF CHANGES TO PROCESSES ALL 

226
00:09:42,553 --> 00:09:45,489
AT ONCE SOMETIMES IT MAKES ONE 

227
00:09:45,489 --> 00:09:46,957
CHANGE THE WAY BUSINESS IS DONE.

228
00:09:46,957 --> 00:09:48,692
I WAS JUST CURIOUS IF YOU CAN 

229
00:09:48,692 --> 00:09:49,960
SAY A LITTLE BIT ABOUT THE, 

230
00:09:49,960 --> 00:09:52,162
THERE'S SO MUCH COMING AT YOU, 

231
00:09:52,162 --> 00:09:54,465
SO MANY CHANGES AND BUDGETARY 

232
00:09:54,465 --> 00:09:56,200
ISSUES.  HOW ARE YOU MANAGING 

233
00:09:56,200 --> 00:09:57,601
KIND OF THE LEADERSHIP OF 

234
00:09:57,601 --> 00:10:00,704
DECISION-MAKING?  HAS THAT 

235
00:10:00,704 --> 00:10:02,606
CHANGED?  DO YOU STILL HAVE FULL

236
00:10:02,606 --> 00:10:03,240
REPRESENTATION IN YOUR ACTION 

237
00:10:03,240 --> 00:10:05,309
TEAM FROM ALL OF THE AREAS THAT 

238
00:10:05,309 --> 00:10:07,177
NCI REPRESENTS?  I WONDER IF YOU

239
00:10:07,177 --> 00:10:08,779
CAN SAY A LITTLE BIT ABOUT THAT 

240
00:10:08,779 --> 00:10:11,916
STRUCTURE THAT YOU'RE USING 

241
00:10:11,916 --> 00:10:17,454
GOING FORWARD.  NOW IS WE TRY TO

242
00:10:17,454 --> 00:10:21,792
DO A LOT OF DECISION-MAKING BY 

243
00:10:21,792 --> 00:10:31,101
CONSENSUS.  WHEN... BUT THERE 

244
00:10:31,101 --> 00:10:33,404
ARE SOECERTAIN TIMES WHEN I NEEO

245
00:10:33,404 --> 00:10:34,571
BE MAKING THE DECISION.  

246
00:10:34,571 --> 00:10:36,540
HOPEFULLY WE'LL BE DOING A 

247
00:10:36,540 --> 00:10:37,908
USEFUL EXERCISE FOR TRYING TO 

248
00:10:37,908 --> 00:10:39,543
PRIORITIZE WHAT IS MOST 

249
00:10:39,543 --> 00:10:42,579
IMPORTANT AMONG OUR CANCER 

250
00:10:42,579 --> 00:10:45,582
RESEARCH AND REALLY MAKING USE 

251
00:10:45,582 --> 00:10:48,786
OF THE INCREDIBLE LEADERSHIP 

252
00:10:48,786 --> 00:10:50,554
THAT WE HAVEMOST IMPORTANT AMON 

253
00:10:50,554 --> 00:10:51,188
RESEARCH AND REALLY MAKING USE 

254
00:10:51,188 --> 00:10:51,789
OF THE INCREDIBLE LEADERSHIP 

255
00:10:51,789 --> 00:10:54,191
THAT WE HAVE THAT SPANS THE NCI 

256
00:10:54,191 --> 00:10:55,626
AND THEN WE ALSO HAVE WHAT WE 

257
00:10:55,626 --> 00:10:59,697
CALL THE DEPUTIES AND THAT GROUP

258
00:10:59,697 --> 00:11:02,599
HAS CONTINUED TO BE THERE AND I 

259
00:11:02,599 --> 00:11:04,635
JUST WANT TO TELL YOU ABOUT TWO 

260
00:11:04,635 --> 00:11:14,578
NEW APPOINTMENTS BECAUSE THEY, 

261
00:11:14,578 --> 00:11:18,215
WHAT HAPPENED WAS WITH THE LOSS 

262
00:11:18,215 --> 00:11:27,591
OF OUR DIRECTOR, YOU KNOW, AKEEM

263
00:11:27,591 --> 00:11:29,293
HAD A WEALTH OF CLINICAL 

264
00:11:29,293 --> 00:11:32,997
EXPERIENCE BUT WE FELT WE NEEDED

265
00:11:32,997 --> 00:11:36,300
DEPUTIES WHO HAVE THAT KIND OF 

266
00:11:36,300 --> 00:11:38,569
CLINICAL EXPERIENCE.  THE 

267
00:11:38,569 --> 00:11:41,138
DOCTORS BOTH HAVE THAT.  THEY 

268
00:11:41,138 --> 00:11:42,706
ARE NOT OFFICIALLY DEPUTIES.  

269
00:11:42,706 --> 00:11:45,743
THEY'RE SPECIAL ADVISORS BUT 

270
00:11:45,743 --> 00:11:48,445
THEY FUNCTION IN THAT WAY.  LET 

271
00:11:48,445 --> 00:11:54,018
ME TURN TO NCI IN GENERAL.  WE 

272
00:11:54,018 --> 00:11:58,555
HAVE LOST MANY COLLEAGUES, BOTH 

273
00:11:58,555 --> 00:12:02,993
THROUGH VOLUNTARY RETIREMENT AS 

274
00:12:02,993 --> 00:12:06,430
WELL AS INVOLUNTARY SEPARATION. 

275
00:12:06,430 --> 00:12:10,000
WHAT REALLY MATTERS FOR THE NCI 

276
00:12:10,000 --> 00:12:12,636
IS THAT EVERYBODY PLAYS A 

277
00:12:12,636 --> 00:12:16,740
CRITICAL ROLE AND THE NCI 

278
00:12:16,740 --> 00:12:18,542
DIRECTOR'S OFFICE, WE HAVE A 

279
00:12:18,542 --> 00:12:20,878
PHOTOGRAPH OF A STONE BRIDGE.  

280
00:12:20,878 --> 00:12:23,847
AND IT ASKS THE QUESTION, WHICH 

281
00:12:23,847 --> 00:12:25,849
STONE HOLDS UP THE BRIDGE?  AND 

282
00:12:25,849 --> 00:12:30,320
THE ANSWER IS ALL OF THEM.  SO 

283
00:12:30,320 --> 00:12:34,091
WE HAVE A CHALLENGE WITHIN THE 

284
00:12:34,091 --> 00:12:37,461
NCI OF HAVING LOST A LOT OF 

285
00:12:37,461 --> 00:12:40,464
COLLEAGUES AS I SAY FOR VARIOUS 

286
00:12:40,464 --> 00:12:43,167
REASONS.  AND NEEDING TO 

287
00:12:43,167 --> 00:12:45,502
CONTINUE TO PRESS FORWARD.  BUT 

288
00:12:45,502 --> 00:12:48,472
WE ARE DOING THAT TO THE BEST OF

289
00:12:48,472 --> 00:12:50,007
OUR APPRECIATES AND WE HAVE 

290
00:12:50,007 --> 00:12:54,044
TERRIFIC PEOPLE WHO REMAIN HERE.

291
00:12:54,044 --> 00:12:54,812
THANKS SO MUCH FOR YOUR 

292
00:12:54,812 --> 00:12:57,514
QUESTION.  

293
00:12:57,514 --> 00:13:02,086
>> PANEEZ: THE ACTING
CHAIR 

294
00:13:02,086 --> 00:13:06,323
RECOGNIZES THE CHAIR, DOCTOR.

295
00:13:06,323 --> 00:13:16,166
>> THANKS, CHRIS.  GOOD
MORNING,

296
00:13:16,166 --> 00:13:17,935
DOUG, THANKS FOR STAYING THE 

297
00:13:17,935 --> 00:13:19,203
COURSE DURING THESE DIFFICULT 

298
00:13:19,203 --> 00:13:20,604
TIMES OVER THIS TIME OF CHANGE 

299
00:13:20,604 --> 00:13:21,939
AND SO I GUESS FROM MY 

300
00:13:21,939 --> 00:13:23,674
PERSPECTIVE, YOU KNOW, MANY OF 

301
00:13:23,674 --> 00:13:27,444
US HAVE SEEN THAT THE CURRENT 

302
00:13:27,444 --> 00:13:30,547
DRAFT BUDGET COMING OUT OF THE 

303
00:13:30,547 --> 00:13:35,185
WHITE HOUSE.  AND IT'S 

304
00:13:35,185 --> 00:13:37,187
UNPRECEDENTED, RIGHT?  SO I 

305
00:13:37,187 --> 00:13:40,691
GUESS IF WE'RE EVEN CLOSE TO 

306
00:13:40,691 --> 00:13:42,993
THAT, EVEN IF CONGRESS EXPANDS 

307
00:13:42,993 --> 00:13:44,595
IT SOME I DON'T KNOW IF WE'LL 

308
00:13:44,595 --> 00:13:46,563
GET TO THE LEVELS WE REALLY 

309
00:13:46,563 --> 00:13:47,698
NEED.  I KNOW YOU'RE GOING TO 

310
00:13:47,698 --> 00:13:50,801
HAVE TO ALL MAKE SOME CHOICES 

311
00:13:50,801 --> 00:13:52,536
EXTERNALLY.  YOU HAVE SOME 

312
00:13:52,536 --> 00:13:53,470
EXTRAMURAL FUNDING AND A 

313
00:13:53,470 --> 00:13:56,173
BEAUTIFUL INTRAMURAL PROGRAM SO 

314
00:13:56,173 --> 00:13:58,075
WHAT DOES THAT DECISION TRY AND 

315
00:13:58,075 --> 00:13:59,443
PRIORITIZATION LOOK LIKE FROM 

316
00:13:59,443 --> 00:14:02,012
YOUR STANDPOINT IN HOW YOU WOULD

317
00:14:02,012 --> 00:14:05,916
BALANCE US SPENDING EXTRAMURALLY

318
00:14:05,916 --> 00:14:11,188
AND INTRAMURALLY? ? SNOU I DON'T

319
00:14:11,188 --> 00:14:12,022
MEAN TO WAFFLE BUT THIS IS ONE 

320
00:14:12,022 --> 00:14:13,757
OF THE IMPORTANT QUESTIONS THAT 

321
00:14:13,757 --> 00:14:15,459
THE LEADERSHIP GROUP I TALKED 

322
00:14:15,459 --> 00:14:19,796
ABOUT 30 PEOPLE AT NCI ARE 

323
00:14:19,796 --> 00:14:26,036
TRYING TO WORK THROUGH AND WE 

324
00:14:26,036 --> 00:14:29,773
ALSO ANTICIPATE TALKING WITH 

325
00:14:29,773 --> 00:14:30,574
EXTRAMURAL COLLEAGUES BECAUSE 

326
00:14:30,574 --> 00:14:33,477
ULTIMATELY THE VAST MAJORITY OF 

327
00:14:33,477 --> 00:14:38,549
OUR FUNDING GOES TO YOU.  AND WE

328
00:14:38,549 --> 00:14:40,217
WOULD LIKE TO BE CLEAR THAT WHAT

329
00:14:40,217 --> 00:14:45,756
WE ARE TRYING TO DO TO HELP YOU 

330
00:14:45,756 --> 00:14:49,092
ACTUALLY WORKS IN THAT 

331
00:14:49,092 --> 00:14:57,367
DIRECTION.  SNARP THANKS, DOUG, 

332
00:14:57,367 --> 00:15:00,604
WE'RE HAPPY TO HELP AND THEY 

333
00:15:00,604 --> 00:15:02,105
HOPE WE GET AN OPPORTUNITY TO 

334
00:15:02,105 --> 00:15:04,908
PLAY A ROLE IN THOSE 

335
00:15:04,908 --> 00:15:06,410
DISCUSSIONS.  THANK YOU.  

336
00:15:06,410 --> 00:15:09,346
>> DR. FRIESE: I THINK WE
HAVE 

337
00:15:09,346 --> 00:15:14,551
ONE MORE QUESTION PLEASE, 

338
00:15:14,551 --> 00:15:22,326
APOLOGIES.  GO AHEAD WITH YOUR 

339
00:15:22,326 --> 00:15:22,893
QUESTION.  SORRY.  YOU CAN 

340
00:15:22,893 --> 00:15:27,631
UNMUTE.  OKAY, MAYBE IF YOU PUT 

341
00:15:27,631 --> 00:15:29,132
YOUR QUESTION IN THE CHAT WE CAN

342
00:15:29,132 --> 00:15:30,167
GET TO IT DURING THE COURSE OF 

343
00:15:30,167 --> 00:15:32,703
THE MEETING.  THANK YOU SO MUCH.

344
00:15:32,703 --> 00:15:36,740
OUR NEXT TOPIC WILL BE ANNUAL 

345
00:15:36,740 --> 00:15:38,575
DELEGATION OF AUTHORITY.  AND 

346
00:15:38,575 --> 00:15:42,379
DR. SRINIVAS OFFICE OF REVIEW 

347
00:15:42,379 --> 00:15:43,580
AND COORDINATION IS PRESENTING.

348
00:15:43,580 --> 00:15:46,149
>> THANK YOU FOR THE
OPPORTUNITY

349
00:15:46,149 --> 00:15:46,917
I HOPE YOU ALL CAN HEAR ME.  SO 

350
00:15:46,917 --> 00:15:49,953
THIS IS THE DELEGATIONS OF 

351
00:15:49,953 --> 00:15:53,123
AUTHORITY OF NCA BEFORE 2025.  

352
00:15:53,123 --> 00:15:57,794
DELEGATION A, THE NCA BEING DULY

353
00:15:57,794 --> 00:15:59,062
CONSULTED HERE BY THE DIRECTOR 

354
00:15:59,062 --> 00:16:00,597
OF NATIONAL CANCER INSTITUTE 

355
00:16:00,597 --> 00:16:02,566
PERMISSION TO UPDATE AS STATED 

356
00:16:02,566 --> 00:16:05,602
IN SECTION 413B 5 OF THE PUBLIC 

357
00:16:05,602 --> 00:16:07,204
HEALTH SERVICE ACT AND IN 

358
00:16:07,204 --> 00:16:09,473
ACCORDANCE WITH THE SECTION IF 

359
00:16:09,473 --> 00:16:11,308
109 OF TITLE 5 UNITED STATES 

360
00:16:11,308 --> 00:16:13,910
CODE BUT WITHOUT REGARD TO THE 

361
00:16:13,910 --> 00:16:16,113
LIMITATION IN SUBSECTION ON A 

362
00:16:16,113 --> 00:16:18,548
PERIOD OF SERVICE THE SERVICES 

363
00:16:18,548 --> 00:16:22,085
OF NOT MORE THAN 151 SPECIAL 

364
00:16:22,085 --> 00:16:24,054
EXPERTSES OR CONSULTANT WHO IS 

365
00:16:24,054 --> 00:16:26,223
HAVE SCIENTIFIC OR PROFESSIONAL 

366
00:16:26,223 --> 00:16:27,291
QUALIFICATION TO ASSIST IN 

367
00:16:27,291 --> 00:16:29,526
ACCOMPLISHING THE MISSION OF THE

368
00:16:29,526 --> 00:16:29,993
INSTITUTE.  

369
00:16:29,993 --> 00:16:33,997
DELEGATION B, THE NCAB BEING 

370
00:16:33,997 --> 00:16:36,166
DULY CONSULTED BY THE DELEGATE 

371
00:16:36,166 --> 00:16:39,703
TO THE DIRECTOR NCI PERMISSION 

372
00:16:39,703 --> 00:16:42,105
TO ACCESS AUTHORITY AS STATED IN

373
00:16:42,105 --> 00:16:43,874
14B 7 OF THE PUBLIC HEALTH 

374
00:16:43,874 --> 00:16:45,842
SERVICE ACT TO APPOINT ONE OR 

375
00:16:45,842 --> 00:16:47,644
MORE ADVISORY COMMITTEES 

376
00:16:47,644 --> 00:16:50,213
COMPOSED OF SUCH PRIVATE 

377
00:16:50,213 --> 00:16:51,982
CITIZENS AND OFFICIALS OR 

378
00:16:51,982 --> 00:16:53,116
FEDERALS STATED IN LOCAL 

379
00:16:53,116 --> 00:16:54,217
GOVERNMENT TO ADVISE THE 

380
00:16:54,217 --> 00:16:56,386
DIRECTOR WITH RESPECT TO THE THE

381
00:16:56,386 --> 00:16:57,721
DIRECTOR'S FUNCTIONS.  STATEMENT

382
00:16:57,721 --> 00:16:59,289
OF UNDERSTANDING WITH NATIONAL 

383
00:16:59,289 --> 00:17:01,224
CANCER INSTITUTE, STAFF ON 

384
00:17:01,224 --> 00:17:02,326
OPERATING PRINCIPLES IN 

385
00:17:02,326 --> 00:17:03,794
EXTRAMURAL AWARDS.  OPERATIONS 

386
00:17:03,794 --> 00:17:07,130
OF THE NCAB WILL BE CONDUCTED BY

387
00:17:07,130 --> 00:17:09,299
THE NCI IN ACCORDANCE WITH 

388
00:17:09,299 --> 00:17:10,567
MANAGEMENT, INTERVIEW 

389
00:17:10,567 --> 00:17:13,203
PROCEDURES, SET FORTH IN THE NIH

390
00:17:13,203 --> 00:17:16,940
MANUAL ISSUANCE 4513 

391
00:17:16,940 --> 00:17:18,809
SPECIFICALLY CONCURRENCE OF THE 

392
00:17:18,809 --> 00:17:20,210
NCAB WITH RECOMMENDATIONS OF 

393
00:17:20,210 --> 00:17:23,747
INITIAL REVIEW GROUPS WILL BE 

394
00:17:23,747 --> 00:17:26,550
REQUIRED EXCEPT FOR TRAINING 

395
00:17:26,550 --> 00:17:28,485
PLANS, FELLOWSHIPS AND OTHER 

396
00:17:28,485 --> 00:17:30,987
GRANT APPLICATIONS ARE NOT 

397
00:17:30,987 --> 00:17:32,356
PROPOSALS TO CONDUCT OR RESEARCH

398
00:17:32,356 --> 00:17:34,558
AND ARE NOT SUBJECT TO REVIEW 

399
00:17:34,558 --> 00:17:37,327
AND APPROVAL AND WITHOUT OTHER 

400
00:17:37,327 --> 00:17:38,662
CONSTANTS MAY BE AWARDED WE 

401
00:17:38,662 --> 00:17:41,131
THOUGHT PRESENTATION TO THE NCAB

402
00:17:41,131 --> 00:17:44,935
FOR CONCURRENCE.  THAT IS EXCEPT

403
00:17:44,935 --> 00:17:47,871
FOR ROOT OR NATIONAL SERVICE 

404
00:17:47,871 --> 00:17:49,773
AWARDS.  APPLICATIONS OVER THE 

405
00:17:49,773 --> 00:17:51,575
20TH PERCENTILE WILL NOT HAVE 

406
00:17:51,575 --> 00:17:52,409
SOME OF THESE STATEMENTS 

407
00:17:52,409 --> 00:17:56,146
PRESENTED TO THE NCAB UNLESS THE

408
00:17:56,146 --> 00:17:57,814
INSTITUTE IS CONSIDERING THE 

409
00:17:57,814 --> 00:18:01,284
AWARD FOR SUCH AN APPLICATION OR

410
00:18:01,284 --> 00:18:03,153
OTHER SPECIAL CONSIDERATIONS IS 

411
00:18:03,153 --> 00:18:04,688
REQUESTED OR OTHER POLICY OR FOR

412
00:18:04,688 --> 00:18:06,189
SPECIAL CONSIDERATION BY AN 

413
00:18:06,189 --> 00:18:09,860
APPOINTED MEMBER OF THE BOARD.  

414
00:18:09,860 --> 00:18:12,195
FOR APPLICATIONS ASSIGNED THAT 

415
00:18:12,195 --> 00:18:14,097
ARE NOT PERCENTILE THE CUTOFF 

416
00:18:14,097 --> 00:18:17,033
WILL BE AN IMPACT SCORE OF 50 

417
00:18:17,033 --> 00:18:25,609
MORE ALL MECHANISMS EXCEPT FOR R

418
00:18:25,609 --> 00:18:25,909
4

419
00:18:25,909 --> 00:18:26,209
4

420
00:18:26,209 --> 00:18:28,245
41-44 AWARDS.  ALL OTHER 

421
00:18:28,245 --> 00:18:29,446
APPLICATIONS LISTINGS AND SOME 

422
00:18:29,446 --> 00:18:31,148
OF THESE OTHER STATEMENTS 

423
00:18:31,148 --> 00:18:32,649
PRESENTED FOR PURPOSE OF 

424
00:18:32,649 --> 00:18:33,316
CONCURRENCE WILL BE CONSIDERED 

425
00:18:33,316 --> 00:18:34,885
ON BLOCK BY THE MEMBERS OF THE 

426
00:18:34,885 --> 00:18:38,255
BOARD.  IN THE CASE OF EXPEDITED

427
00:18:38,255 --> 00:18:41,792
CONCURRENTS, FOR R 01 AND R 21 

428
00:18:41,792 --> 00:18:42,526
APPLICATIONS EXCLUDING THOSE 

429
00:18:42,526 --> 00:18:46,563
FROM FOREIGN ORGANIZATIONS, WITH

430
00:18:46,563 --> 00:18:47,631
PERCENTILE SCORES THAT FALL 

431
00:18:47,631 --> 00:18:50,567
WITHIN PAY LINES FOR THAT 

432
00:18:50,567 --> 00:18:52,469
MECHANISM THAT HAVE NO CONSTANTS

433
00:18:52,469 --> 00:18:54,704
NOTED THAT WILL REPRESENT AN 

434
00:18:54,704 --> 00:18:56,706
ADMINISTRATIVE BARTER AWARD 

435
00:18:56,706 --> 00:18:58,542
EXAMPLE WILL BE HUMAN SUBJECTS, 

436
00:18:58,542 --> 00:19:01,344
ANIMAL WELFARE, BIOHAZARDS OR 

437
00:19:01,344 --> 00:19:02,646
INCLUSION OF WOMEN INDIVIDUALS 

438
00:19:02,646 --> 00:19:04,514
ACROSS THE LIFE SPAN AND 

439
00:19:04,514 --> 00:19:05,415
APPROPRIATE MINORITY 

440
00:19:05,415 --> 00:19:08,819
DISTRIBUTION, A PROCESS OF 

441
00:19:08,819 --> 00:19:09,453
EXPEDITED CONCURRENTS WILL BE 

442
00:19:09,453 --> 00:19:12,289
USED WHEREBY THE REVIEW 

443
00:19:12,289 --> 00:19:13,390
APPLICATIONS IS DELEGATED BY THE

444
00:19:13,390 --> 00:19:14,491
CHAIR SPECIFICALLY DESIGNATED 

445
00:19:14,491 --> 00:19:16,793
MEMBERS OF THE BOARD ACTING ON 

446
00:19:16,793 --> 00:19:18,562
BEHALF OF THE BOARD AS A WHOLE. 

447
00:19:18,562 --> 00:19:21,331
THE REVIEWERS WILL CONSIST OF 

448
00:19:21,331 --> 00:19:23,066
THE CHAIR, SUBCOMMITTEE ON 

449
00:19:23,066 --> 00:19:24,401
SPECIAL ACTIONS AND THREE 

450
00:19:24,401 --> 00:19:25,902
ADDITIONAL MEMBERS AS APPOINTED 

451
00:19:25,902 --> 00:19:29,039
BY THE CHAIR IN NCAB IN CASES OF

452
00:19:29,039 --> 00:19:30,574
EMERGENT NEED AS DETERMINED BY 

453
00:19:30,574 --> 00:19:33,944
THE DIRECTOR OF NCI WITH THE 

454
00:19:33,944 --> 00:19:35,912
CONCURRENCE OF THE CHAIR, 

455
00:19:35,912 --> 00:19:38,949
EXPEDITED CONCURRENCE MAY BE 

456
00:19:38,949 --> 00:19:41,251
UTILIZED BY SINGLE CASE 

457
00:19:41,251 --> 00:19:42,419
COMPETITIVE APPLICATIONS WHEN 

458
00:19:42,419 --> 00:19:44,221
TIME IS OF ESSENCE IN ISSUING 

459
00:19:44,221 --> 00:19:46,556
THE AWARD THE EXECUTIVE 

460
00:19:46,556 --> 00:19:48,625
SECRETARY WILL ALERT THE BOARD 

461
00:19:48,625 --> 00:19:49,292
MEMBERS WITH THE RESPONSIBILITY 

462
00:19:49,292 --> 00:19:52,229
FOR EXPEDITED CONCURRENCE WITH 

463
00:19:52,229 --> 00:19:54,798
THE REVIEW OUTCOMES FOR ELIGIBLE

464
00:19:54,798 --> 00:19:57,067
APPLICATIONS THAT ARE AVAILABLE 

465
00:19:57,067 --> 00:19:59,336
ON THE ELECTRONIC PORTION OF THE

466
00:19:59,336 --> 00:20:01,137
ELECTRONIC COUNCIL BOOK THE 

467
00:20:01,137 --> 00:20:02,339
EXECUTIVE SECRETARY WILL PROVIDE

468
00:20:02,339 --> 00:20:04,307
THE FOLLOWING INFORMATION TO THE

469
00:20:04,307 --> 00:20:04,941
MEMBERS, APPLICATION NUMBER, 

470
00:20:04,941 --> 00:20:07,544
NAME OF THE PI, PROJECT TITLE, 

471
00:20:07,544 --> 00:20:09,846
AND PERCENTILE AND ALL IMPACT 

472
00:20:09,846 --> 00:20:12,148
SCORE.  ELECTRONIC CONCURRENCE 

473
00:20:12,148 --> 00:20:13,884
BY THE MINIMUM OF TWO MEMBERS 

474
00:20:13,884 --> 00:20:16,253
WITH NO AWARDS FOR NON-CON 

475
00:20:16,253 --> 00:20:18,488
CURVES WITHIN SEVEN DAYS OF 

476
00:20:18,488 --> 00:20:20,490
NOTIFICATION OF POSTING IS 

477
00:20:20,490 --> 00:20:22,492
REQUIRED FOR APROVEN ANY MEMBER 

478
00:20:22,492 --> 00:20:24,494
MAY BRING AN APPLICATION TO FULL

479
00:20:24,494 --> 00:20:25,595
BOARD CONSIDERATION WITHOUT THE 

480
00:20:25,595 --> 00:20:29,332
NEED FOR JUSTIFICATION.  ANY 

481
00:20:29,332 --> 00:20:30,567
SINGLE BOARD FOR NON-CON CURVES 

482
00:20:30,567 --> 00:20:33,203
WITHIN THAT ALLOTTED TIME PERIOD

483
00:20:33,203 --> 00:20:34,571
WILL RESULT IN THAT APPLICATION 

484
00:20:34,571 --> 00:20:37,874
FOR REGULAR CONSIDERATION TO THE

485
00:20:37,874 --> 00:20:39,476
BOARD UNDER ITS STANDARD 

486
00:20:39,476 --> 00:20:41,778
PROCEDURES FOR ANY NON-EXPEDITED

487
00:20:41,778 --> 00:20:42,812
APPLICATION.  MEMBERS NOT ACTING

488
00:20:42,812 --> 00:20:44,614
UPON AN APPLICATION WITHIN THE 

489
00:20:44,614 --> 00:20:45,949
ALLOTTED TIME PERIOD AFTER 

490
00:20:45,949 --> 00:20:47,584
POSTING WILL BE CONSIDERED TO 

491
00:20:47,584 --> 00:20:50,353
HAVE ABSTAINED FROM VOTE ON THAT

492
00:20:50,353 --> 00:20:53,456
APPLICATION.  EXPEDITED LISTINGS

493
00:20:53,456 --> 00:20:54,558
LACK ENOUGH WORDS FOR FINAL 

494
00:20:54,558 --> 00:20:57,527
ACTION WILL BE PRESENTED TO THE 

495
00:20:57,527 --> 00:20:58,962
FULL NCAB ADDED TO THE MEETING. 

496
00:20:58,962 --> 00:21:01,398
A FULL NCAB WILL BE PROVIDED 

497
00:21:01,398 --> 00:21:04,100
WITH A LIST OF ALL APPLICATIONS,

498
00:21:04,100 --> 00:21:06,369
ELIGIBLE FOR EXPEDITED 

499
00:21:06,369 --> 00:21:07,170
CONCURRENCE AS WELL AS THE 

500
00:21:07,170 --> 00:21:09,639
OUTCOME OF THE VOTE BY THE 

501
00:21:09,639 --> 00:21:10,540
DELEGATED MEMBERS ON THOSE 

502
00:21:10,540 --> 00:21:13,143
APPLICATIONS.  A REPORT OF THE 

503
00:21:13,143 --> 00:21:14,077
EXPEDITED RECOMMENDATIONS WILL 

504
00:21:14,077 --> 00:21:17,180
BE POSTED ELECTRONICALLY FOR 

505
00:21:17,180 --> 00:21:18,315
EACH MEETING WHERE APPLICATIONS 

506
00:21:18,315 --> 00:21:20,617
ARE REVIEWED A BOARD MAY 

507
00:21:20,617 --> 00:21:22,385
CONSIDER THE PARAMETERS FOR 

508
00:21:22,385 --> 00:21:23,920
EXPEDITED ELIGIBILITY AT ANY 

509
00:21:23,920 --> 00:21:26,556
TIME BUT NO LESS THAN ONCE PER 

510
00:21:26,556 --> 00:21:28,325
YEAR.  ADMINISTRATIVE 

511
00:21:28,325 --> 00:21:31,962
ADJUSTMENTS THE NCAB BEING NEWLY

512
00:21:31,962 --> 00:21:33,430
CONSULTED HEREBY DELEGATES TO 

513
00:21:33,430 --> 00:21:35,165
THE DIRECTOR OF THE NATIONAL 

514
00:21:35,165 --> 00:21:37,367
CANCER INSTITUTE.  PERMISSION TO

515
00:21:37,367 --> 00:21:38,902
ALLOW STAFF TO NEGOTIATE 

516
00:21:38,902 --> 00:21:40,971
APPROPRIATE ADJUSTMENTS IN THE 

517
00:21:40,971 --> 00:21:43,239
DOLLARS OR OTHER GRANTS OR 

518
00:21:43,239 --> 00:21:45,008
COOPERATIVE AGREEMENT AWARDS 

519
00:21:45,008 --> 00:21:46,977
RECOMMENDED BY THE BOARD.  THESE

520
00:21:46,977 --> 00:21:48,178
GUIDELINES HAVE BEEN DEVELOPED 

521
00:21:48,178 --> 00:21:50,313
TO MAINTAIN THE SMOOTH EFFECT 

522
00:21:50,313 --> 00:21:53,717
ANDIVE OPERATION THAT HAS 

523
00:21:53,717 --> 00:21:54,417
CHARACTERIZED THE DEBUT OF GRANT

524
00:21:54,417 --> 00:21:55,318
APPLICATIONS OF THE BOARD AND 

525
00:21:55,318 --> 00:21:57,120
THE ADMINISTRATION OF GRANTS BY 

526
00:21:57,120 --> 00:21:59,923
THE INSTITUTE.  STAFF OF THE NC 

527
00:21:59,923 --> 00:22:01,858
ANALYZES AND REVIEWS ALL 

528
00:22:01,858 --> 00:22:03,193
APPLICATIONS THAT IS 

529
00:22:03,193 --> 00:22:05,795
NON-COMPETING NON CONTINUATION 

530
00:22:05,795 --> 00:22:07,364
APPLICATIONS.  THE NEW 

531
00:22:07,364 --> 00:22:08,732
SUPPLEMENT COMPETING 

532
00:22:08,732 --> 00:22:09,299
APPLICATIONS BEFORE ISSUING 

533
00:22:09,299 --> 00:22:11,501
GRANT AWARD.  STAFF WILL 

534
00:22:11,501 --> 00:22:13,737
NEGOTIATE APPROPRIATE 

535
00:22:13,737 --> 00:22:14,671
ADJUSTMENTS WHEN APPLICABLE FOR 

536
00:22:14,671 --> 00:22:18,108
CHANGES AS THE BASE USED FOR THE

537
00:22:18,108 --> 00:22:19,209
FACILITIES AND ADMINISTRATIVE 

538
00:22:19,209 --> 00:22:21,344
COSTS AND ON LEGISLATIVE IMPOSE 

539
00:22:21,344 --> 00:22:25,582
SALARY OR OTHER LIMITS ON THE 

540
00:22:25,582 --> 00:22:26,216
COSTS, ET CETERA.  ALSO STAFF 

541
00:22:26,216 --> 00:22:30,086
WILL MAKE ADJUSTMENTS TO 

542
00:22:30,086 --> 00:22:31,521
RECONCILE INCONSISTENCIES 

543
00:22:31,521 --> 00:22:32,288
BETWEEN THE RECOMMENDED BUDGET 

544
00:22:32,288 --> 00:22:34,557
AND AIMS AND ACTIVITIES.  

545
00:22:34,557 --> 00:22:36,393
ADMINISTRATIVE REQUESTS FOR 

546
00:22:36,393 --> 00:22:37,727
INCREASE IN DIRECT COSTS WHICH 

547
00:22:37,727 --> 00:22:40,397
ARE RESULT OF MARKED EXPANSION 

548
00:22:40,397 --> 00:22:42,198
OR SIGNIFICANT CHANGE IN 

549
00:22:42,198 --> 00:22:44,434
SCIENTIFIC CONTENT OF THE 

550
00:22:44,434 --> 00:22:45,001
PROGRAM, AFTER FORMAL PEER 

551
00:22:45,001 --> 00:22:46,236
REVIEW WILL BE REFERRED TO THE 

552
00:22:46,236 --> 00:22:47,937
BOARD FOR ADVICE AND 

553
00:22:47,937 --> 00:22:49,873
RECOMMENDATION.  THE DIRECTOR OF

554
00:22:49,873 --> 00:22:51,274
NCI WILL DETERMINE WHETHER THE 

555
00:22:51,274 --> 00:22:54,444
SCOPE AND URGENCY ARE SUFFICIENT

556
00:22:54,444 --> 00:22:57,280
TO WARRANT CONSULTATION WITH THE

557
00:22:57,280 --> 00:22:58,848
BOARD BY MAIL OR TELEPHONE 

558
00:22:58,848 --> 00:23:00,483
INSTEAD OF DELAYING ACTIONS 

559
00:23:00,483 --> 00:23:01,818
UNTIL THE NEXT BOARD MEETING OR 

560
00:23:01,818 --> 00:23:03,620
THE MUTUAL AGREEMENT WITH THE 

561
00:23:03,620 --> 00:23:06,322
DIRECTOR, THE CHAIR MAY ACT ON 

562
00:23:06,322 --> 00:23:08,858
BEHALF OF THE BOARD AS A WHOLE. 

563
00:23:08,858 --> 00:23:10,326
ACTIONS NOT REQUIRING BOARD 

564
00:23:10,326 --> 00:23:11,761
REVIEW AND CHANGE OF 

565
00:23:11,761 --> 00:23:14,564
INSTITUTION, CHANGE OF PRINCIPLE

566
00:23:14,564 --> 00:23:16,499
INVESTIGATOR, PHASE OUT OF 

567
00:23:16,499 --> 00:23:17,133
SUPPORT OR ADDITIONAL SUPPORT 

568
00:23:17,133 --> 00:23:18,568
EITHER TO MEET THE INCREASED 

569
00:23:18,568 --> 00:23:21,337
COST OF MAINTAINING THE LEVEL OF

570
00:23:21,337 --> 00:23:22,539
RESEARCH PREVIOUSLY RECOMMENDED 

571
00:23:22,539 --> 00:23:25,508
OR TO ACCOMMODATE ACTIVITIES, 

572
00:23:25,508 --> 00:23:26,543
JUDGED BY STAFF TO BE WITHIN THE

573
00:23:26,543 --> 00:23:28,745
SCOPE OF THE PREVIOUSLY REVIEWED

574
00:23:28,745 --> 00:23:29,979
RESEARCH NEED NOT BE REPORTED TO

575
00:23:29,979 --> 00:23:31,681
THE BOARD.  THE BOARD WILL BE 

576
00:23:31,681 --> 00:23:35,485
PROVIDE WITH NOTICE OF GENERAL 

577
00:23:35,485 --> 00:23:36,786
SOLICITATIONS FOR ADMINISTRATIVE

578
00:23:36,786 --> 00:23:39,489
SUPPLEMENTS IF THEY APPLY TO THE

579
00:23:39,489 --> 00:23:41,191
APPLICATIONS.  IN ADDITION, NCI 

580
00:23:41,191 --> 00:23:44,694
STAFF MAY RESTORE REQUESTED TIME

581
00:23:44,694 --> 00:23:46,563
AND SUPPORT WHICH ARE DELETED BY

582
00:23:46,563 --> 00:23:47,997
THE INITIAL REVIEW GROUP WHEN 

583
00:23:47,997 --> 00:23:50,500
THE PI HAS PROVIDED 

584
00:23:50,500 --> 00:23:53,336
JUSTIFICATION IN AN APPEAL 

585
00:23:53,336 --> 00:23:56,239
LETTER THE RESTORE RATION IS IN 

586
00:23:56,239 --> 00:23:57,841
THE BEST INTEREST.  AS 

587
00:23:57,841 --> 00:23:59,976
CIRCUMSTANCES REQUIRED, BASED ON

588
00:23:59,976 --> 00:24:01,144
PROGRAMMATIC CONSIDERATION, THE 

589
00:24:01,144 --> 00:24:03,713
DIRECTOR OF NCI AFTER 

590
00:24:03,713 --> 00:24:05,882
CONSULTATION WITH NCI CHAIR MAY 

591
00:24:05,882 --> 00:24:07,684
MAKE EXCEPTION TO THESE 

592
00:24:07,684 --> 00:24:08,318
GUIDELINES REGARDING THE SPECIAL

593
00:24:08,318 --> 00:24:10,553
COUNCIL REVIEW OF PIS WITH 

594
00:24:10,553 --> 00:24:11,955
GREATER THAN TWO MILLION DOLLARS

595
00:24:11,955 --> 00:24:16,259
TOTAL COST IN THE RPG AWARDS IN 

596
00:24:16,259 --> 00:24:17,060
AN EFFORT TO CONTINUE 

597
00:24:17,060 --> 00:24:18,795
RESPONSIBLE STEWARDSHIP OF 

598
00:24:18,795 --> 00:24:21,264
PUBLIC FUNDS AND TO SUPPORT 

599
00:24:21,264 --> 00:24:24,467
RESEARCH, NIH HAS INSTITUTED A 

600
00:24:24,467 --> 00:24:26,569
POLICY OF SPECIAL CONSIDERATE 

601
00:24:26,569 --> 00:24:29,973
REVIEW FOR SCR OF APPLICATION OF

602
00:24:29,973 --> 00:24:30,540
WELL-FUNDED INVESTIGATORS 

603
00:24:30,540 --> 00:24:31,841
PENDING GRANTS GOING TO THE 

604
00:24:31,841 --> 00:24:34,511
BOARD FROM PIS THAT HAVE MORE 

605
00:24:34,511 --> 00:24:35,945
THAN TWO ADMINISTER MILLION OR 

606
00:24:35,945 --> 00:24:39,482
MORE IN TOTAL COST FROM ACTIVE 

607
00:24:39,482 --> 00:24:42,552
RESEARCH PROJECT GRANTSES OR 

608
00:24:42,552 --> 00:24:44,354
RPGS MUST BE GIVEN ADDITIONAL 

609
00:24:44,354 --> 00:24:45,155
CONSIDERATION IT IS IMPORTANT TO

610
00:24:45,155 --> 00:24:46,556
RECOGNIZE THAT THIS IS A 

611
00:24:46,556 --> 00:24:49,125
THRESHOLD ONLY.  INVESTIGATORS 

612
00:24:49,125 --> 00:24:51,761
WHO HAVE MORE ACCESS SUPPORT MAY

613
00:24:51,761 --> 00:24:54,531
STILL RECEIVE ADDITIONAL REWARDS

614
00:24:54,531 --> 00:25:02,739
AS WARRANTED.  THANK YOU.  

615
00:25:02,739 --> 00:25:04,274
>> DR. FRIESE: THANK YOU
VERY 

616
00:25:04,274 --> 00:25:07,744
MUCH DRA SRINIVAS, ARE THERE ANY

617
00:25:07,744 --> 00:25:09,312
QUESTIONS, FROM THE BOARD?  

618
00:25:09,312 --> 00:25:12,749
HEARING NONE, THE NEXT AGENDA 

619
00:25:12,749 --> 00:25:14,951
ITEM IS THE TRIENNIAL REPORT ON 

620
00:25:14,951 --> 00:25:17,487
THE INCLUSION OF WOMEN AND 

621
00:25:17,487 --> 00:25:20,957
MINORITIES IN CLINICAL RESEARCH.

622
00:25:20,957 --> 00:25:24,394
DR. MOONEY, TCDT IS PRESENTING. 

623
00:25:24,394 --> 00:25:25,728
DR. MOONEY, WELCOME AND WE LOOK 

624
00:25:25,728 --> 00:25:27,096
FORWARD TO YOUR REPORT.

625
00:25:27,096 --> 00:25:28,998
>> THANK YOU VERY MUCH. 
I'M 

626
00:25:28,998 --> 00:25:30,533
VERY HAPPY THIS MORNING TO ON 

627
00:25:30,533 --> 00:25:33,903
BEHALF OF EVERYONE AT THE NCI 

628
00:25:33,903 --> 00:25:38,374
ALL THE NCI STAFF AS WELL AS ALL

629
00:25:38,374 --> 00:25:41,544
THE INVESTIGATORS THAT HAVE 

630
00:25:41,544 --> 00:25:43,947
COMPLETED RESEARCH TO SHOW THE 

631
00:25:43,947 --> 00:25:45,481
REPORT THAT MONITORS OUR 

632
00:25:45,481 --> 00:25:47,116
ADHERENCE TO THE POLICY ON THE 

633
00:25:47,116 --> 00:25:48,451
INCLUSION OF WOMEN AND 

634
00:25:48,451 --> 00:25:49,786
MINORITIES IN CLINICAL RESEARCH.

635
00:25:49,786 --> 00:25:51,387
WE DO THIS OBVIOUSLY EVERY THREE

636
00:25:51,387 --> 00:25:52,922
YEARS AND SO THIS WILL BE A 

637
00:25:52,922 --> 00:25:54,357
REPORT FOR EVERYONE R EVERYTHING

638
00:25:54,357 --> 00:25:56,726
FROM FISCAL YEAR 2022 THROUGH 

639
00:25:56,726 --> 00:26:02,565
FISCAL YEAR 2024.  NEXT SLIDE, 

640
00:26:02,565 --> 00:26:08,571
PLEAS

641
00:26:08,571 --> 00:26:11,608
PLEASE.  NIH IS LOOKED AT IN ALL

642
00:26:11,608 --> 00:26:13,509
CLINICAL RESEARCH IN A MANNER 

643
00:26:13,509 --> 00:26:15,478
APPROPRIATE TO THE SCIENTIFIC 

644
00:26:15,478 --> 00:26:17,347
QUESTION UNDER STUDY.  THE 

645
00:26:17,347 --> 00:26:18,982
PRIMARY GOAL OF THIS ALL WAS TO 

646
00:26:18,982 --> 00:26:21,317
ENSURE THAT A RESEARCH FINDINGS 

647
00:26:21,317 --> 00:26:24,387
CAN BE GENERALIZABLE TO THE 

648
00:26:24,387 --> 00:26:27,724
ENTIRE POPULATION.  THERE WAS 

649
00:26:27,724 --> 00:26:30,560
ALSO SOMETHING THAT WAS AMENDED.

650
00:26:30,560 --> 00:26:32,695
THE REVITALIZATION ACT AMENDED 

651
00:26:32,695 --> 00:26:39,802
BY THE CURES ACT TO PREPARE A 

652
00:26:39,802 --> 00:26:41,804
TRIENNIAL REPORT DESCRIBING HOW 

653
00:26:41,804 --> 00:26:43,640
THE INSTITUTE HAS COMPLIED WITH 

654
00:26:43,640 --> 00:26:47,877
THE GUIDELINES AND TRACKING 

655
00:26:47,877 --> 00:26:49,846
REQUIREMENTS.  HENCE THIS IS A 

656
00:26:49,846 --> 00:26:50,546
RESPONSE TO THAT REQUIREMENT ON 

657
00:26:50,546 --> 00:26:54,050
THE DATA INCLUDED.  NEXT SLIDE. 

658
00:26:54,050 --> 00:26:55,551
THE SOURCE JUST TO GIVE YOU SOME

659
00:26:55,551 --> 00:26:58,154
BACKGROUND OF THE NIH INCLUSION 

660
00:26:58,154 --> 00:27:02,025
DATA FOR NIH DEFINED CLINICAL 

661
00:27:02,025 --> 00:27:03,192
RESEARCH STUDIES THEY HAVE TO 

662
00:27:03,192 --> 00:27:05,595
MEET THE DEFINITION PROVIDED BY 

663
00:27:05,595 --> 00:27:07,697
THE NIH OF CLINICAL RESEARCH AND

664
00:27:07,697 --> 00:27:08,231
COLLECT INFORMATION ON 

665
00:27:08,231 --> 00:27:11,267
PARTICIPANT SEX, RACE AND 

666
00:27:11,267 --> 00:27:12,135
ETHNICITY.  AND OBVIOUSLY THE 

667
00:27:12,135 --> 00:27:13,870
CLINICAL RESEARCH THE IS 

668
00:27:13,870 --> 00:27:16,072
RESEARCH THAT INVOLVES HUMAN 

669
00:27:16,072 --> 00:27:16,606
SUBJECTS. 

670
00:27:16,606 --> 00:27:18,541
IT CAN BE PATIENT ORIENTED SO IT

671
00:27:18,541 --> 00:27:20,710
COULD BE A CLINICAL TRIAL ITSELF

672
00:27:20,710 --> 00:27:23,346
BUT IT ALSO CAN BE WHEN AN 

673
00:27:23,346 --> 00:27:24,480
INVESTIGATOR INTERACTS IN ANY 

674
00:27:24,480 --> 00:27:27,750
WAY WITH HUMAN SUBJECTS AND 

675
00:27:27,750 --> 00:27:28,384
EXAMPLES ARE GIVEN UNDER POINT 

676
00:27:28,384 --> 00:27:31,154
NUMBER ONE.  IT ALSO INCLUDES 

677
00:27:31,154 --> 00:27:33,056
EPIDEMIOLOGICAL AND BEHAVIORAL 

678
00:27:33,056 --> 00:27:34,223
STUDIES AS WELL AS OUTCOMES 

679
00:27:34,223 --> 00:27:35,558
RESEARCH AND HEALTH SERVICES 

680
00:27:35,558 --> 00:27:37,360
RESEARCH AND ALSO INCLUDES 

681
00:27:37,360 --> 00:27:39,929
INFORMATION FROM CLINICAL 

682
00:27:39,929 --> 00:27:40,596
RESEARCH WHERE THEY'RE CONDUCTED

683
00:27:40,596 --> 00:27:42,198
EITHER BY GRANTEE WHO IS REPORT 

684
00:27:42,198 --> 00:27:44,334
IT ANNUALLY IN THEIR ANNUAL 

685
00:27:44,334 --> 00:27:46,536
RESEARCH PERFORMANCE PROGRESS 

686
00:27:46,536 --> 00:27:47,003
REPORT.  

687
00:27:47,003 --> 00:27:48,771
OR CONTRACTS IN THE INTERMURAL 

688
00:27:48,771 --> 00:27:52,108
PROGRAM RESEARCHERS WHO REPORT 

689
00:27:52,108 --> 00:27:53,409
ANNUALLY THROUGH THEIR 

690
00:27:53,409 --> 00:27:55,778
MECHANISMS.  NCI'S PORTFOLIO FOR

691
00:27:55,778 --> 00:27:57,513
THIS REPORT INCLUDES STUDY 

692
00:27:57,513 --> 00:27:59,549
SUPPORTED BY THE FOLLOWING NCI 

693
00:27:59,549 --> 00:28:01,951
DIVISIONS AND CENTERS AS LISTED 

694
00:28:01,951 --> 00:28:04,954
ON THE SLIDE.  SO OBVIOUSLY WE 

695
00:28:04,954 --> 00:28:07,490
REPORT EVERYTHING RELATED TO 

696
00:28:07,490 --> 00:28:08,958
INTRAMURAL RESEARCH AS WELL AS 

697
00:28:08,958 --> 00:28:10,493
EXTRAMURAL RESEARCH DONE BY THE 

698
00:28:10,493 --> 00:28:12,528
MAJOR, FOUR MAJOR DIVISIONS OF 

699
00:28:12,528 --> 00:28:14,564
CLINICAL RESEARCH AT THE NCI BUT

700
00:28:14,564 --> 00:28:16,733
ALSO FROM ALL THE CENTERS AT THE

701
00:28:16,733 --> 00:28:18,434
NCI AS WELL AND YOU SEE ALL 

702
00:28:18,434 --> 00:28:22,038
THOSE LISTED ON THE RIGHT-HAND 

703
00:28:22,038 --> 00:28:26,542
SIDE OF THE SLIDE.  NEXT SLIDE, 

704
00:28:26,542 --> 00:28:28,378
WE DO HAVE SOME STRATEGIES FOR 

705
00:28:28,378 --> 00:28:29,112
ENSURING COMPLIANCE AND THERE'S 

706
00:28:29,112 --> 00:28:30,713
A LOT OF TRAINING THAT GOES WITH

707
00:28:30,713 --> 00:28:32,315
THE STAFF HERE, THE PROGRAM 

708
00:28:32,315 --> 00:28:36,052
STAFF AS WELL AS WITH THE 

709
00:28:36,052 --> 00:28:36,753
INVESTIGATORS TO MAKE SURE THAT 

710
00:28:36,753 --> 00:28:39,055
WE CAN PROVIDE AS ACCURATE 

711
00:28:39,055 --> 00:28:40,390
INFORMATION AS POSSIBLE PER THE 

712
00:28:40,390 --> 00:28:43,059
SYSTEM THAT IS IN PLACE.  SO 

713
00:28:43,059 --> 00:28:44,460
THAT'S DONE THROUGH PEER REVIEW 

714
00:28:44,460 --> 00:28:46,562
FIRST WHERE REVIEWERS ACTUALLY 

715
00:28:46,562 --> 00:28:49,365
EVALUATE THE APPLICATIONS FOR 

716
00:28:49,365 --> 00:28:50,033
APPROPRIATENESS OF THE INCLUSION

717
00:28:50,033 --> 00:28:52,101
PLANS AND ANALYSES AND THE 

718
00:28:52,101 --> 00:28:53,603
PROGRAM STAFF WORK WITH TIN VEST

719
00:28:53,603 --> 00:28:56,372
GATORS TO RESOLVE ANY ISSUES 

720
00:28:56,372 --> 00:28:58,207
BEFORE ANY GRANT IN CASE OF 

721
00:28:58,207 --> 00:28:58,541
CONTRACTS. 

722
00:28:58,541 --> 00:29:02,512
ARE FUNDED.  WE ALSO WANT TO 

723
00:29:02,512 --> 00:29:03,679
CONTINUING BASIS WITH THE 

724
00:29:03,679 --> 00:29:05,214
PROGRAM STAFF, MONITOR 

725
00:29:05,214 --> 00:29:05,882
ENROLLMENT AND PROGRESS FOR ALL 

726
00:29:05,882 --> 00:29:07,884
THE CLINICAL RESEARCH AS 

727
00:29:07,884 --> 00:29:09,952
NECESSARY.  AND THEN THE GRANTS 

728
00:29:09,952 --> 00:29:10,553
MANAGEMENT STAFF ALSO ENSURE 

729
00:29:10,553 --> 00:29:14,557
TERMS AND CONDITIONS ARE 

730
00:29:14,557 --> 00:29:16,192
INCLUDED.  IN THE AWARD FOR THE 

731
00:29:16,192 --> 00:29:17,794
FUNDING OF A GRANT.  FOR THE 

732
00:29:17,794 --> 00:29:18,561
INTRAMURAL PROGRAM, THE 

733
00:29:18,561 --> 00:29:21,064
INTRAMURAL INVESTIGATORS PROVIDE

734
00:29:21,064 --> 00:29:23,666
THEIR INCLUSION PLANS DURING 

735
00:29:23,666 --> 00:29:25,802
SCIENTIFIC REVIEW AT THE CCR AND

736
00:29:25,802 --> 00:29:27,670
THEN THE ENROLLMENT PROGRESS IS 

737
00:29:27,670 --> 00:29:30,473
ALSO REVIEWED AS PART OF THEIR 

738
00:29:30,473 --> 00:29:33,976
INTERNAL IRB REVIEW WITH ANY 

739
00:29:33,976 --> 00:29:36,279
ISSUES RESOLVED LAST BUT NOT 

740
00:29:36,279 --> 00:29:37,080
LEAST THERE'S REGULAR INCLUSION 

741
00:29:37,080 --> 00:29:38,548
TRAINING PROVIDE TO ALL PROGRAM 

742
00:29:38,548 --> 00:29:42,085
AND REVIEW STAFF AT THE NCI.  

743
00:29:42,085 --> 00:29:44,420
NEXT SLIDE.  THERE ARE HOWEVER 

744
00:29:44,420 --> 00:29:46,389
SOME KEY LIMITATIONS WITH THE 

745
00:29:46,389 --> 00:29:48,057
DATA THAT WE'LL PRESENT THIS 

746
00:29:48,057 --> 00:29:50,093
MORNING FROM THE TRIENNIAL 

747
00:29:50,093 --> 00:29:51,027
REPORT THIS PRESENTATION DOES 

748
00:29:51,027 --> 00:29:53,629
COVER JUST THE ENROLLMENT DATA 

749
00:29:53,629 --> 00:29:56,966
FOR THE FISCAL YEARS FY 2022-24 

750
00:29:56,966 --> 00:30:01,204
AS I SAID, THERE ARE SOME 

751
00:30:01,204 --> 00:30:04,740
LIMITATIONS SO I AM JUST GOING 

752
00:30:04,740 --> 00:30:06,542
TO EXPLAIN SOME AS WE PRESENT 

753
00:30:06,542 --> 00:30:08,411
THE DATA.  THE WHOLE REPORT IN 

754
00:30:08,411 --> 00:30:10,546
THE SYSTEM IS INTENDED TO GIVE A

755
00:30:10,546 --> 00:30:12,248
BROAD OVERVIEW OF THE GENERAL 

756
00:30:12,248 --> 00:30:14,550
INCLUSION TRENDS.  BUT IT'S NOT 

757
00:30:14,550 --> 00:30:17,420
A PRECISE COUNT OF THE ACTUAL 

758
00:30:17,420 --> 00:30:18,554
TRIALS OR PARTICIPANTS PER SE.  

759
00:30:18,554 --> 00:30:20,189
THAT'S DONE AT THE MORE DETAILED

760
00:30:20,189 --> 00:30:23,059
LEVEL WITHIN THE PROGRAMS, SO IF

761
00:30:23,059 --> 00:30:25,027
WE'RE ON THE PARTICULAR CLINICAL

762
00:30:25,027 --> 00:30:26,395
RESEARCH GRANTS OR CONTRACTS SO 

763
00:30:26,395 --> 00:30:29,232
WHAT YOU WILL SEE IS A MANDATED 

764
00:30:29,232 --> 00:30:30,733
SERIES OF TABLES THAT WERE 

765
00:30:30,733 --> 00:30:33,636
REQUIRED TO REPORT TO THE NIH 

766
00:30:33,636 --> 00:30:34,570
THOSE INCLUDE SOMETHING WE 

767
00:30:34,570 --> 00:30:37,306
CALLED INCLUSION DATA RECORDS.  

768
00:30:37,306 --> 00:30:38,541
THEY DON'T REALLY REPRESENT AN 

769
00:30:38,541 --> 00:30:40,943
ACCOUNT OF TOTAL STUDIES OR 

770
00:30:40,943 --> 00:30:42,545
TRIALS.  SO MULTIPLE RECORDS 

771
00:30:42,545 --> 00:30:44,113
COULD BE SUBMITTED FOR A SINGLE 

772
00:30:44,113 --> 00:30:46,549
TRIAL THAT USUALLY OCCURS WHEN A

773
00:30:46,549 --> 00:30:48,251
TRIAL IS CONDUCTED BOTH IN THE 

774
00:30:48,251 --> 00:30:51,888
U.S. AND INTERNATIONALLY.  

775
00:30:51,888 --> 00:30:53,055
BECAUSE WE HAVE TO REPORT ON 

776
00:30:53,055 --> 00:30:54,223
INCLUSION SEPARATED FROM 

777
00:30:54,223 --> 00:30:55,825
DOMESTIC ENROLLMENT AND 

778
00:30:55,825 --> 00:30:57,126
INTERNATIONAL ENROLLMENT.  SAME 

779
00:30:57,126 --> 00:30:59,061
THING CAN HAPPEN IN TERMS OF THE

780
00:30:59,061 --> 00:31:00,530
INCLUSION DATA, DON'T 

781
00:31:00,530 --> 00:31:01,464
NECESSARILY REPRESENT THE 

782
00:31:01,464 --> 00:31:06,536
ENROLLMENT FOR A SINGLE  YEAR.  

783
00:31:06,536 --> 00:31:08,771
THE DATA ACTUALLY REPRESENT 

784
00:31:08,771 --> 00:31:10,139
CUMULATIVE REPORTS ON THAT 

785
00:31:10,139 --> 00:31:13,409
RESEARCH PROJECT OR TRIAL BY THE

786
00:31:13,409 --> 00:31:14,544
GRANTEES AND CONTRACTORS IN 

787
00:31:14,544 --> 00:31:17,613
INTRAMURAL INVESTIGATORS THAT 

788
00:31:17,613 --> 00:31:19,549
DURING THE ENTIRE SPAN OF THEIR 

789
00:31:19,549 --> 00:31:20,683
PROJECT RATHER THAN IN A SINGLE 

790
00:31:20,683 --> 00:31:22,084
YEAR WHAT WE'RE ACCOUNTING IS 

791
00:31:22,084 --> 00:31:24,320
FOR ALL ACTIVE CLINICAL RESEARCH

792
00:31:24,320 --> 00:31:27,523
PROJECTS WE'RE LOOKING AT THE 

793
00:31:27,523 --> 00:31:29,992
CUMULATIVE ENROLLMENTS TO THAT 

794
00:31:29,992 --> 00:31:30,593
PROJECT WITHIN EACH OF THOSE 

795
00:31:30,593 --> 00:31:32,495
FISCAL YEARS.  THE LAST ITEM 

796
00:31:32,495 --> 00:31:34,530
THAT PROBABLY IS NOT AS RELEVANT

797
00:31:34,530 --> 00:31:36,499
IN THIS TRIENNIAL REPORT IS THAT

798
00:31:36,499 --> 00:31:40,036
GRANTS ARE RECOMPETED IN A 

799
00:31:40,036 --> 00:31:41,804
FISCAL YEAR, THEY'RE NOT 

800
00:31:41,804 --> 00:31:43,639
INCLUDED IN THE DATA FOR THAT 

801
00:31:43,639 --> 00:31:43,839
YEAR. 

802
00:31:43,839 --> 00:31:45,241
SO IF WE HAVE VERY LARGE 

803
00:31:45,241 --> 00:31:46,542
CLINICAL TRIALS NETWORK 

804
00:31:46,542 --> 00:31:48,978
PROGRAMS, FOR EXAMPLE, THAT ARE 

805
00:31:48,978 --> 00:31:50,279
BEING RECOMPETED IN A PARTICULAR

806
00:31:50,279 --> 00:31:51,914
FISCAL YEAR BECAUSE THEY'RE 

807
00:31:51,914 --> 00:31:53,049
BEING RECOMPETED AND WE DON'T 

808
00:31:53,049 --> 00:31:55,418
ACTUALLY KNOW WHAT THE DATA 

809
00:31:55,418 --> 00:31:56,485
ENROLLMENT WILL BE FOR THAT 

810
00:31:56,485 --> 00:31:56,686
YEAR. 

811
00:31:56,686 --> 00:31:58,221
THEY'RE NOT INCLUDED IN THE 

812
00:31:58,221 --> 00:32:00,423
REPORT.  THAT HAPPENED IN OUR 

813
00:32:00,423 --> 00:32:02,458
LAST TRIENNIAL REPORT BUT WE 

814
00:32:02,458 --> 00:32:05,561
DON'T HAVE ANY LARGE PROGRAMS 

815
00:32:05,561 --> 00:32:08,531
PER SE THAT ARE NOT BEING RE -- 

816
00:32:08,531 --> 00:32:10,533
ARE BEING RECOMPETED BETWEEN FY 

817
00:32:10,533 --> 00:32:12,735
22-24 SO WE DON'T HAVE THAT 

818
00:32:12,735 --> 00:32:15,638
DEFICIENCY IN THIS TRIENNIAL 

819
00:32:15,638 --> 00:32:18,341
REPORT AND LAST BUT NOT LEAST, 

820
00:32:18,341 --> 00:32:20,943
CHARTS THAT YOU MAY SEE IN THE 

821
00:32:20,943 --> 00:32:22,245
SEPARATE REPORT OR IN THE SLIDES

822
00:32:22,245 --> 00:32:24,981
MAY NOT EXACTLY ADD UP TO 100% 

823
00:32:24,981 --> 00:32:26,515
BUT THAT'S DUE TO NORMAL 

824
00:32:26,515 --> 00:32:28,985
ROUNDING ERROR.  NEXT SLIDE, 

825
00:32:28,985 --> 00:32:31,821
PLEASE.  SO TO START WITH IF WE 

826
00:32:31,821 --> 00:32:33,122
LOOK AT THE INCLUSION RECORDS 

827
00:32:33,122 --> 00:32:34,423
AND ENROLLMENT NUMBERS FOR ALL 

828
00:32:34,423 --> 00:32:36,025
CLINICAL RESEARCH YOU CAN SEE 

829
00:32:36,025 --> 00:32:38,728
THOSE LAID OUT BY FISCAL YEAR.  

830
00:32:38,728 --> 00:32:40,529
THERE WAS A SLIGHT INCREASE IN 

831
00:32:40,529 --> 00:32:42,231
THE NUMBER OF I.E.R RECORDS, 

832
00:32:42,231 --> 00:32:43,933
AGAIN, THAT'S NOT THE NUMBER OF 

833
00:32:43,933 --> 00:32:45,835
STUDIES PER SE. 

834
00:32:45,835 --> 00:32:48,504
IT'S THE NUMBER OF RECORDS WE 

835
00:32:48,504 --> 00:32:49,739
GOT FROM THEIR VARIOUS STUDIES 

836
00:32:49,739 --> 00:32:52,208
DEPENDING ON HOW THEY WERE 

837
00:32:52,208 --> 00:32:53,809
COMPOSED.  YOU ALSO SEE THE 

838
00:32:53,809 --> 00:32:55,444
TREND IN TOTAL ENROLLMENT.  AND 

839
00:32:55,444 --> 00:32:57,880
JUST TO POINT OUT THAT WENT DOWN

840
00:32:57,880 --> 00:33:00,216
SLIGHTLY IN FY24 AND THE REASON 

841
00:33:00,216 --> 00:33:02,018
FOR THAT WAS THAT THERE WERE 

842
00:33:02,018 --> 00:33:04,320
SEVERAL LARGE STUDIES THAT WERE 

843
00:33:04,320 --> 00:33:08,024
COHORT STUDIES.  AND IN ONE CASE

844
00:33:08,024 --> 00:33:10,526
AN INTRAMURAL PROGRAM THAT HAD 

845
00:33:10,526 --> 00:33:12,128
MORE THAN 500,000 PARTICIPANTS 

846
00:33:12,128 --> 00:33:15,164
THAT CLOSED IN FY 23 SO THAT'S 

847
00:33:15,164 --> 00:33:17,867
NOT REPRESENTED IN FY24 SO 

848
00:33:17,867 --> 00:33:21,971
WITHIN THAT SHORT SHAME OF -- 

849
00:33:21,971 --> 00:33:23,339
FRAME OF FOUR YEARS YOU'LL SEE 

850
00:33:23,339 --> 00:33:25,374
THE INCREASES AND DECREASES THAT

851
00:33:25,374 --> 00:33:27,510
ARE RELATED TO ONE LARGE TRIAL 

852
00:33:27,510 --> 00:33:28,411
HAVING CHANGED THE COMPOSITION 

853
00:33:28,411 --> 00:33:29,545
WITHIN THAT THREE YEAR PERIOD. 

854
00:33:29,545 --> 00:33:31,213
YOU ALSO SEE THE BREAKDOWN BY 

855
00:33:31,213 --> 00:33:33,883
U.S. ONLY ENROLLMENT.  AND 

856
00:33:33,883 --> 00:33:35,618
APPROXIMATELY FOR ALL OUR 

857
00:33:35,618 --> 00:33:40,956
CLINICAL RESEARCH ANYWHERE FROM 

858
00:33:40,956 --> 00:33:42,091
85-86% OF PATIENTS DO COME FROM 

859
00:33:42,091 --> 00:33:44,727
THE UNITED STATES.  NEXT SLIDE, 

860
00:33:44,727 --> 00:33:45,761
PLEASE.  SO WHEN WE FIRST LOOK 

861
00:33:45,761 --> 00:33:47,897
AT THE INCLUSION DATA FOR ALL 

862
00:33:47,897 --> 00:33:49,732
CLINICAL RESEARCH STUDIES, IF WE

863
00:33:49,732 --> 00:33:51,100
BREAK THAT DOWN BY SEX, YOU CAN 

864
00:33:51,100 --> 00:33:54,103
SEE IT FOR THE THREE INDIVIDUAL 

865
00:33:54,103 --> 00:33:56,439
FISCAL YEARS HERE.  IT'S BEEN 

866
00:33:56,439 --> 00:33:58,507
FAIRLY STABLE.  OVER THIS THREE 

867
00:33:58,507 --> 00:34:02,011
YEAR PERIOD OF TIME AND REFLECTS

868
00:34:02,011 --> 00:34:03,646
THE NUMBER OF PATIENTS OF A 

869
00:34:03,646 --> 00:34:05,414
PARTICULAR SEX WHO ARE ENROLLED 

870
00:34:05,414 --> 00:34:07,683
IN THE VARIOUS CLINICAL RESEARCH

871
00:34:07,683 --> 00:34:12,021
STUDIES.  NEXT SLIDE, PLEASE.  

872
00:34:12,021 --> 00:34:13,889
DO THE SAME THING WHEN WE BREAK 

873
00:34:13,889 --> 00:34:16,425
DOWN BY SEX BUT WE TRY TO 

874
00:34:16,425 --> 00:34:18,461
EXCLUDE SINGLE SEX STUDIES.  

875
00:34:18,461 --> 00:34:19,428
HOWEVER, THE WAY SINGLE SEX 

876
00:34:19,428 --> 00:34:23,165
STUDIES ARE DEFINED IT'S ANY 

877
00:34:23,165 --> 00:34:25,801
STUDY THAT DOES NOT HAVE SIMPLY 

878
00:34:25,801 --> 00:34:27,536
ALL WOMEN OR ALL MEN IN THE 

879
00:34:27,536 --> 00:34:29,071
TRIAL OR THE CLINICAL RESEARCH 

880
00:34:29,071 --> 00:34:30,473
PROJECT AT THE TIME OF 

881
00:34:30,473 --> 00:34:32,341
REPORTING.  SO YOU CAN SEE IT'S 

882
00:34:32,341 --> 00:34:34,810
A FAIRLY EVEN SPLIT ABOUT 50/50 

883
00:34:34,810 --> 00:34:36,579
WITH A LITTLE BIT OF UNKNOWN OR 

884
00:34:36,579 --> 00:34:39,382
NON REPORTED FOR SOME SMALLER 

885
00:34:39,382 --> 00:34:42,251
STUDIES ACROSS THE THREE FISCAL 

886
00:34:42,251 --> 00:34:45,087
YEARS.  NEXT SLIDE, PLEASE.  

887
00:34:45,087 --> 00:34:47,623
WE ALSO LOOK AT THE INCLUSION 

888
00:34:47,623 --> 00:34:50,092
DATA FOR ALL CLINICAL RESEARCH 

889
00:34:50,092 --> 00:34:53,162
BY ETHNICITY AND YOU SEE THIS 

890
00:34:53,162 --> 00:34:56,565
BROKEN DOWN BY HISPANIC OR 

891
00:34:56,565 --> 00:34:58,534
LATINO.  VERSUS NON-HISPANIC OR 

892
00:34:58,534 --> 00:35:00,369
LATINO OR OTHER UNKNOWN OR NON 

893
00:35:00,369 --> 00:35:02,238
REPORT AND WHAT THIS REALLY 

894
00:35:02,238 --> 00:35:04,340
REFLECTS IS WE DID HAVE A BIG 

895
00:35:04,340 --> 00:35:06,542
CHANGE WHERE A LARGE INTRAMURAL 

896
00:35:06,542 --> 00:35:08,544
COHORT STUDY CONTRIBUTED 

897
00:35:08,544 --> 00:35:11,514
SIGNIFICANTLY TO THE CHANGES IN 

898
00:35:11,514 --> 00:35:12,481
OVERALL ETHNICITY PARTICULARLY 

899
00:35:12,481 --> 00:35:15,117
IN FISCAL YEAR 2024 WHEN IT WAS 

900
00:35:15,117 --> 00:35:18,554
A VERY LARGE STUDY THAT WAS 

901
00:35:18,554 --> 00:35:21,190
MOSTLY NON-HISPANIC AND LATINO 

902
00:35:21,190 --> 00:35:23,192
THAT LARGE INTRAMURAL STUDY THAT

903
00:35:23,192 --> 00:35:25,628
WAS OVER 500,000 PATIENTS IT WAS

904
00:35:25,628 --> 00:35:27,129
AN ELDERLY POPULATION MOSTLY IN 

905
00:35:27,129 --> 00:35:28,531
THE UNITED STATES AND IT WAS 

906
00:35:28,531 --> 00:35:30,466
PRIMARILY WHITE.  SO ONCE THAT 

907
00:35:30,466 --> 00:35:33,235
STUDY WAS NO LONGER PART OF THE 

908
00:35:33,235 --> 00:35:36,338
REPORTING IN THESE THREE YEAR 

909
00:35:36,338 --> 00:35:39,074
PERIOD, YOU CAN SEE THAT OUR 

910
00:35:39,074 --> 00:35:42,211
NUMBER OF NON-HISPANIC AND 

911
00:35:42,211 --> 00:35:42,978
LATINOS DECREASED ONCE THAT 

912
00:35:42,978 --> 00:35:46,382
TRIAL CLOSED AT THE END OF FY 23

913
00:35:46,382 --> 00:35:51,654
AND WAS NOT REPORTED IN FY24.  

914
00:35:51,654 --> 00:35:55,090
NEXT SLIDE, PLEASE.  WE ALSO 

915
00:35:55,090 --> 00:35:57,259
BREAK DOWN THE INCLUSION DATA BY

916
00:35:57,259 --> 00:35:59,462
RACE.  YOU SEE THE VARIOUS OMB 

917
00:35:59,462 --> 00:36:01,430
CATEGORIES OF RACE LISTED ON THE

918
00:36:01,430 --> 00:36:02,565
RIGHT-HAND SIDE OF THE SLIDE AND

919
00:36:02,565 --> 00:36:05,801
THEN IN ALL THREE FISCAL YEARS, 

920
00:36:05,801 --> 00:36:07,837
YOU SEE THE BREAKDOWN IN EACH OF

921
00:36:07,837 --> 00:36:09,638
THOSE PERCENTAGES PER THE 

922
00:36:09,638 --> 00:36:12,608
DEFINITIONS THAT ARE PROVIDED BY

923
00:36:12,608 --> 00:36:14,910
OMB FOR THIS INCLUSION REPORT.  

924
00:36:14,910 --> 00:36:16,579
AGAIN, WE FOUND THAT WHEN WE 

925
00:36:16,579 --> 00:36:21,717
TOOK, WE SAW THAT THIS LARGE 

926
00:36:21,717 --> 00:36:22,852
INTRAMURAL COHORT STUDY 

927
00:36:22,852 --> 00:36:24,253
CONTRIBUTED SIGNIFICANTLY TO THE

928
00:36:24,253 --> 00:36:26,755
CHANGES IN OVERALL RACE IN FY 

929
00:36:26,755 --> 00:36:29,091
2024 WHEN IT CLOSED SO THAT THE 

930
00:36:29,091 --> 00:36:30,526
NUMBER OF WHITE PATIENTS 

931
00:36:30,526 --> 00:36:32,161
ACTUALLY DID DECREASE THERE 

932
00:36:32,161 --> 00:36:36,065
BECAUSE THAT WAS A LARGE ELDERLY

933
00:36:36,065 --> 00:36:37,099
POPULATION MOSTLY WHITE WHO, 

934
00:36:37,099 --> 00:36:41,170
THAT WAS CLOSED AT THE END OF FY

935
00:36:41,170 --> 00:36:46,775
2023.  NEXT SLIDE, PLEASE.  HERE

936
00:36:46,775 --> 00:36:48,310
YOU SEE THE INCLUSION DATA WHERE

937
00:36:48,310 --> 00:36:51,347
WE COMBINED RACE AND ETHNICITY 

938
00:36:51,347 --> 00:36:54,250
AND, AGAIN, THE TREND IS USUALLY

939
00:36:54,250 --> 00:36:58,020
FAIRLY STABLE BETWEEN FY 22 AND 

940
00:36:58,020 --> 00:37:03,325
FY 23 THE BIG JUMP UP IN FY 24 

941
00:37:03,325 --> 00:37:04,760
DOES REFLECT THE LARGE 

942
00:37:04,760 --> 00:37:07,029
INTRAMURAL STUDY THAT CLOSED.  

943
00:37:07,029 --> 00:37:08,397
NEXT SLIDE, PLEASE.  HERE WE 

944
00:37:08,397 --> 00:37:10,633
WERE ASKED LAST TIME WHEN WE 

945
00:37:10,633 --> 00:37:13,335
PRESENTED THE TRIENNIAL REPORT 

946
00:37:13,335 --> 00:37:16,739
TO MAYBE COMPARE WHAT WE HAD IN 

947
00:37:16,739 --> 00:37:19,074
THE TRIENNIAL REPORT AGAINST AT 

948
00:37:19,074 --> 00:37:21,110
LEAST THE DATA, THE ESTIMATED 

949
00:37:21,110 --> 00:37:23,746
NUMBER OF CASES PER ETHNICITY 

950
00:37:23,746 --> 00:37:25,814
AND RACE AT THE TIME OF 

951
00:37:25,814 --> 00:37:28,951
DIAGNOSIS.  SO WE HAVE PROVIDED 

952
00:37:28,951 --> 00:37:31,220
THAT HERE.  IT IS AN IMPERFECT 

953
00:37:31,220 --> 00:37:32,988
COMPARISON IN A SENSE THAT THE 

954
00:37:32,988 --> 00:37:34,523
INCLUSION DATA YOU'RE SEEING IS 

955
00:37:34,523 --> 00:37:37,326
GOING TO INCLUDE U.S. AND 

956
00:37:37,326 --> 00:37:38,527
INTERNATIONAL PATIENTS WHO 

957
00:37:38,527 --> 00:37:39,328
PARTICIPATED -- OR PARTICIPANTS 

958
00:37:39,328 --> 00:37:41,330
WHO PARTICIPATED IN CLINICAL 

959
00:37:41,330 --> 00:37:45,401
RESEARCH OR TRIALS.  BUT 

960
00:37:45,401 --> 00:37:47,403
OBVIOUSLY ABOUT, ALMOST 90% OF 

961
00:37:47,403 --> 00:37:49,471
THOSE PARTICIPANTS AND PATIENTS 

962
00:37:49,471 --> 00:37:51,206
WILL ACTUALLY HAVE BEEN FROM THE

963
00:37:51,206 --> 00:37:56,579
U.S. COMPARED TO WHAT YOU SEE IN

964
00:37:57,179 --> 00:37:58,380
SEER WHICH IS FAIRLY COMPARABLE.

965
00:37:58,380 --> 00:38:01,383
WE ALSO DO IT NOT JUST BY RACE, 

966
00:38:01,383 --> 00:38:04,453
BUT ALSO BY ETHNICITY.  IN TERMS

967
00:38:04,453 --> 00:38:06,288
OF WHETHER PATIENTS WHO ARE 

968
00:38:06,288 --> 00:38:08,123
HERETO DEEMED, OR REPORTED 

969
00:38:08,123 --> 00:38:09,325
THEMSELVES TO BE HISPANIC OR 

970
00:38:09,325 --> 00:38:17,166
LATINO.  NEXT SLIDE, PLEASE.  

971
00:38:17,166 --> 00:38:18,367
THERE ARE ALSO SPECIAL 

972
00:38:18,367 --> 00:38:20,336
CONSIDERATIONS IN THE ACT THAT 

973
00:38:20,336 --> 00:38:21,337
DRIVES THE REQUIREMENT FOR 

974
00:38:21,337 --> 00:38:22,738
MONITORING AND REPORTING ON 

975
00:38:22,738 --> 00:38:26,208
ADHERENCE TO THIS POLICY.  FOR 

976
00:38:26,208 --> 00:38:28,544
PHASE THREE CLINICAL TRIALS.  

977
00:38:28,544 --> 00:38:30,546
AND SO WHAT THAT PART OF THE ACT

978
00:38:30,546 --> 00:38:32,014
WANTED TO MAKE CONGRESSIONAL ACT

979
00:38:32,014 --> 00:38:33,415
WANTED TO MAKE SURE IS THAT OUR 

980
00:38:33,415 --> 00:38:35,584
TRIALS ARE DESIGNED TO PERMIT 

981
00:38:35,584 --> 00:38:37,553
VALID ANALYSIS OF GROUP 

982
00:38:37,553 --> 00:38:39,455
DIFFERENCES BASED ON RACE, SEX, 

983
00:38:39,455 --> 00:38:41,724
AND ETHNICITY UNLESS THERE WAS 

984
00:38:41,724 --> 00:38:42,558
CLEAR REASON THAT SUCH 

985
00:38:42,558 --> 00:38:44,827
DIFFERENCES WERE UNLIKELY TO BE 

986
00:38:44,827 --> 00:38:45,794
SEEN.  SO I WON'T READ THE 

987
00:38:45,794 --> 00:38:48,564
DIFFERENT IN ADDITION HERE OF 

988
00:38:48,564 --> 00:38:50,332
NIH DEFINED PHASE THREE CLINICAL

989
00:38:50,332 --> 00:38:51,934
TRIAL BUT IT DOES INCLUDE ANY 

990
00:38:51,934 --> 00:38:55,170
KIND OF CLINICAL TRIAL THAT IS 

991
00:38:55,170 --> 00:38:56,472
TRYING TO, THAT OBVIOUSLY 

992
00:38:56,472 --> 00:38:58,540
INVOLVES HUMAN SUBJECTS AND IS 

993
00:38:58,540 --> 00:39:00,376
REALLY EVALUATING AN 

994
00:39:00,376 --> 00:39:01,777
EXPERIMENTAL INTERVENTION AND 

995
00:39:01,777 --> 00:39:02,578
USUALLY IN COMPARISON WITH A 

996
00:39:02,578 --> 00:39:04,079
STANDARD OR CONTROLLED 

997
00:39:04,079 --> 00:39:08,350
INTERVENTION, MAY OR MAY NOT BE 

998
00:39:08,350 --> 00:39:09,952
RANDOMIZED BUT IT WOULD COMPARE 

999
00:39:09,952 --> 00:39:13,222
AT LEAST TWO OR MORE EXISTING 

1000
00:39:13,222 --> 00:39:14,356
TREATMENTS.  THE AIM OF SUCH 

1001
00:39:14,356 --> 00:39:17,559
INVESTIGATION IS TO PROVIDE THE 

1002
00:39:17,559 --> 00:39:19,528
EVIDENCE FOR CONSIDERATION AND 

1003
00:39:19,528 --> 00:39:20,629
CHANGING STANDARD OF CARE FOR 

1004
00:39:20,629 --> 00:39:21,630
PARTICIPANTS AND SO WE WANT TO 

1005
00:39:21,630 --> 00:39:23,499
MAKE SURE IT'S AS 

1006
00:39:23,499 --> 00:39:24,533
GENERALIZABILITY AS POSSIBLE.  

1007
00:39:24,533 --> 00:39:26,535
AND SO BECAUSE OF THESE 

1008
00:39:26,535 --> 00:39:28,937
ADDITIONAL REQUIREMENTS, NCI AND

1009
00:39:28,937 --> 00:39:36,879
NIH DO CONDUCT ANALYSES ON THE 

1010
00:39:36,879 --> 00:39:37,813
INCLUSION DATA FROM THESE 

1011
00:39:37,813 --> 00:39:38,814
TRIALS.  WHAT WE'RE REPORTING 

1012
00:39:38,814 --> 00:39:39,615
HERE IS THE SAME INFORMATION 

1013
00:39:39,615 --> 00:39:41,884
THAT WE JUST REPORTED FOR ALL 

1014
00:39:41,884 --> 00:39:43,619
CLINICAL RESEARCH AND NOW IT'S 

1015
00:39:43,619 --> 00:39:45,721
JUST FOR THE, THOSE STUDIES AND 

1016
00:39:45,721 --> 00:39:48,524
PROJECTS THAT FIT THE DEFINITION

1017
00:39:48,524 --> 00:39:50,859
OF NIH DEFINED PHASE THREE 

1018
00:39:50,859 --> 00:39:53,629
CLINICAL TRIALS.  SO YOU SEE THE

1019
00:39:53,629 --> 00:39:55,631
SAME ISSUES IN TERMS OF THE 

1020
00:39:55,631 --> 00:39:57,366
RECORDS THAT ARE REPORTED, THE 

1021
00:39:57,366 --> 00:39:59,535
TOTAL ENROLLMENT, THE U.S. 

1022
00:39:59,535 --> 00:40:01,570
ENROLLMENT AND YOU CAN SEE THAT 

1023
00:40:01,570 --> 00:40:03,772
THE PERCENTAGE OF U.S. 

1024
00:40:03,772 --> 00:40:08,110
ENROLLMENT RANGE FROM 76.5% IN 

1025
00:40:08,110 --> 00:40:11,380
2024 BUT STARTED AT 82.2% IN 

1026
00:40:11,380 --> 00:40:13,449
2022.  WE DO WANT TO POINT OUT 

1027
00:40:13,449 --> 00:40:16,919
THAT THE HIGHER PROPORTION OF 

1028
00:40:16,919 --> 00:40:18,187
NON-U.S. PARTICIPANTS LARGELY 

1029
00:40:18,187 --> 00:40:19,822
DROVE THE DECREASE IN U.S. 

1030
00:40:19,822 --> 00:40:21,490
ENROLLMENT BECAUSE OF THE LARGE 

1031
00:40:21,490 --> 00:40:23,058
SCREENING CANCER STUDY.  MUCH OF

1032
00:40:23,058 --> 00:40:30,399
WHICH WAS DONE INTERNATIONALLY. 

1033
00:40:30,399 --> 00:40:31,767
NEXT SLIDE, PLEASE, HOWEVER 

1034
00:40:31,767 --> 00:40:37,906
WE'VE -- HERE WE'VE TAKEN THE 

1035
00:40:37,906 --> 00:40:39,842
TRIALS AND DONE THE ANALYSIS BY 

1036
00:40:39,842 --> 00:40:40,109
SEX. 

1037
00:40:40,109 --> 00:40:44,680
YOU SEE THE LARGE NUMBER OF 

1038
00:40:44,680 --> 00:40:46,548
FEMALE PARTICIPANTS THAT YOU SEE

1039
00:40:46,548 --> 00:40:48,751
INCREASING UP TO 81% IS DRIVEN 

1040
00:40:48,751 --> 00:40:51,053
LARGELY BY SIGNIFICANT 

1041
00:40:51,053 --> 00:40:52,221
ENROLLMENT TO A VERY LARGE 

1042
00:40:52,221 --> 00:40:55,124
BREAST CANCER SCREENING STUDY.  

1043
00:40:55,124 --> 00:40:56,959
NEXT SLIDE, PLEASE.  WE HAVE 

1044
00:40:56,959 --> 00:40:58,727
DONE IT HERE AS WELL.  LOOKED AT

1045
00:40:58,727 --> 00:41:02,564
SEX BUT WE'VE TRIED TO EXCLUDE 

1046
00:41:02,564 --> 00:41:04,099
THOSE STUDIES THAT WERE JUST 

1047
00:41:04,099 --> 00:41:06,568
SINGLE SEX STUDIES.  THE 

1048
00:41:06,568 --> 00:41:08,637
DIFFICULTY WITH THIS ANALYSIS IN

1049
00:41:08,637 --> 00:41:09,838
THE PARTICULAR SYSTEM THAT IF WE

1050
00:41:09,838 --> 00:41:12,141
HAVE A LARGE BREAST CANCER TRIAL

1051
00:41:12,141 --> 00:41:14,443
AND IT DOES ALLOW MALE 

1052
00:41:14,443 --> 00:41:15,477
PARTICIPANTS BECAUSE THERE IS A 

1053
00:41:15,477 --> 00:41:18,747
SMALL PERCENTAGE OF MEN WHO DO 

1054
00:41:18,747 --> 00:41:19,515
GET BREAST CANCER AND THEY 

1055
00:41:19,515 --> 00:41:20,916
ACTUALLY ENROLL IN THAT TRIAL 

1056
00:41:20,916 --> 00:41:22,851
THEY'LL STILL BE INCLUDED THAT 

1057
00:41:22,851 --> 00:41:24,553
BREAST STUDY WILL STILL BE 

1058
00:41:24,553 --> 00:41:25,854
INCLUDED IN THIS ANALYSIS SO 

1059
00:41:25,854 --> 00:41:27,990
THAT'S WHY YOU DO SEE SUCH A 

1060
00:41:27,990 --> 00:41:31,660
LARGE PERCENTAGE OF WOMEN IN 

1061
00:41:31,660 --> 00:41:36,965
FY24 AGAIN BECAUSE WE HAD LARGE 

1062
00:41:36,965 --> 00:41:37,800
BREAST CANCER TRIALS BUT THEY 

1063
00:41:37,800 --> 00:41:39,835
DID INCLUDE SOME MEN.  NEXT 

1064
00:41:39,835 --> 00:41:42,037
SLIDE, PLEASE.  THIS IS BY 

1065
00:41:42,037 --> 00:41:43,872
ETHNICITY AND AGAIN, YOU SEE A 

1066
00:41:43,872 --> 00:41:46,875
DIFFERENCE BETWEEN FY 2022 AND 

1067
00:41:46,875 --> 00:41:50,512
FY 2024 THERE IS A HIGHER 

1068
00:41:50,512 --> 00:41:52,881
PERCENTAGE OF HISPANIC OR LATINO

1069
00:41:52,881 --> 00:41:54,516
PATIENTS.  AGAIN, LARGELY DRIVEN

1070
00:41:54,516 --> 00:41:57,553
BY SIGNIFICANT LATIN AMERICAN 

1071
00:41:57,553 --> 00:41:59,421
ENROLLMENT TO LARGE CANCER 

1072
00:41:59,421 --> 00:42:00,155
SCREENING TRIAL THAT HAPPENED 

1073
00:42:00,155 --> 00:42:03,792
DURING THIS PERIOD.  NEXT SLIDE,

1074
00:42:03,792 --> 00:42:08,497
PLEASE.  WE HAVE TAKEN THE 

1075
00:42:08,497 --> 00:42:09,998
INFORMATION FROM THE CLINICAL 

1076
00:42:09,998 --> 00:42:13,135
TRIALS AND BROKEN IT DOWN HERE 

1077
00:42:13,135 --> 00:42:16,939
BY RACE AND SO YOU CAN SEE THE 

1078
00:42:16,939 --> 00:42:19,308
INFORMATION AGAIN AND IT'S BEEN 

1079
00:42:19,308 --> 00:42:20,175
FAIRLY STABLE OVER THESE YEARS 

1080
00:42:20,175 --> 00:42:22,344
ALTHOUGH WE TRIED TO DO A BETTER

1081
00:42:22,344 --> 00:42:24,146
JOB PARTICULARLY IN CLINICAL 

1082
00:42:24,146 --> 00:42:25,514
TRIALS MAKING SURE THAT TUN 

1083
00:42:25,514 --> 00:42:28,917
KNOWN AND NON REPORTED CATEGORY 

1084
00:42:28,917 --> 00:42:31,420
IS AS SMALL AS POSSIBLE BUT 

1085
00:42:31,420 --> 00:42:32,387
OCCASIONALLY IT'S A CONSTANT 

1086
00:42:32,387 --> 00:42:34,523
PROCESS OF TRYING TO TRAIN 

1087
00:42:34,523 --> 00:42:36,859
PATIENTS AND PARTICIPANTS AS 

1088
00:42:36,859 --> 00:42:38,927
WELL AS THE CLINICAL STAFF WHO 

1089
00:42:38,927 --> 00:42:40,028
ARE PARTICIPATING IN COLLECTING 

1090
00:42:40,028 --> 00:42:42,965
THE DATA TO MAKE SURE AS MUCH AS

1091
00:42:42,965 --> 00:42:44,766
POSSIBLE WE CAN GET THIS 

1092
00:42:44,766 --> 00:42:47,369
INFORMATION.  

1093
00:42:47,369 --> 00:42:49,238
NEXT SLIDE, PLEASE.  HERE WE 

1094
00:42:49,238 --> 00:42:50,539
HAVE SHOWN THE POPULATION FOR 

1095
00:42:50,539 --> 00:42:52,975
THE PHASE THREE CLINICAL TRIALS 

1096
00:42:52,975 --> 00:42:55,878
BY RACE AND ETHNICITY COMBINED 

1097
00:42:55,878 --> 00:42:58,013
AGAIN THE BIG JUMP UP IN MORE 

1098
00:42:58,013 --> 00:42:59,748
MINORITY PARTICIPANTS BY RACE 

1099
00:42:59,748 --> 00:43:02,551
AND ETHNICITY IN FY 23 AND THEN 

1100
00:43:02,551 --> 00:43:12,794
FY24 IS REALLY LARGE LY DRIVEN Y

1101
00:43:12,794 --> 00:43:13,962
A LARGE BREAST CANCER SCREENING 

1102
00:43:13,962 --> 00:43:16,098
TRIAL.  THERE ARE ALSO OTHER 

1103
00:43:16,098 --> 00:43:18,000
SCREENING TRIALS THAT EFFECT 

1104
00:43:18,000 --> 00:43:20,869
THIS IN THAT REGARD AS WELL BUT 

1105
00:43:20,869 --> 00:43:22,537
IT WAS MAINLY IN THIS THREE YEAR

1106
00:43:22,537 --> 00:43:25,073
PERIOD DRIVEN BY THAT LARGE 

1107
00:43:25,073 --> 00:43:26,541
CANCER SCREENING TRIAL.  NEXT 

1108
00:43:26,541 --> 00:43:30,345
SLIDE.  THIS IS BROKEN DOWN WITH

1109
00:43:30,345 --> 00:43:32,981
THE COMPARISON TO SEER CENSUS 

1110
00:43:32,981 --> 00:43:34,116
POPULATION ESTIMATES.  AND SO 

1111
00:43:34,116 --> 00:43:37,085
YOU CAN SEE THE COMPARISON 

1112
00:43:37,085 --> 00:43:38,520
BETWEEN THE PHASE THREE CLINICAL

1113
00:43:38,520 --> 00:43:42,524
TRIALS INCLUSION DATA.  BY RACE 

1114
00:43:42,524 --> 00:43:44,626
ON THE LEFT-HAND SIDE OF THE 

1115
00:43:44,626 --> 00:43:48,597
SLIDE.  AND ON THE RIGHT HAND 

1116
00:43:48,597 --> 00:43:55,270
SIDE YOU SEE IT BROKEN  DOWN BY 

1117
00:43:55,270 --> 00:43:57,105
HISPANIC ETHNICITY.  AND YOU SEE

1118
00:43:57,105 --> 00:43:57,773
THE LARGE INTERNATIONAL BREAST 

1119
00:43:57,773 --> 00:44:00,142
CANCER SCREENING TRIAL WE HAD A 

1120
00:44:00,142 --> 00:44:01,576
HIGHER PROPORTION OF HISPANIC 

1121
00:44:01,576 --> 00:44:04,947
AND LATINOS BECAUSE IT WAS 

1122
00:44:04,947 --> 00:44:06,548
LARGELY DRIVEN BY THAT.  NEXT 

1123
00:44:06,548 --> 00:44:08,750
SLIDE.  SO WE JUST LIKE TO SAY 

1124
00:44:08,750 --> 00:44:11,119
THANK YOU TO ALL THE NCI STAFF 

1125
00:44:11,119 --> 00:44:12,955
AND PARTICULARLY TO GRACE 

1126
00:44:12,955 --> 00:44:14,523
MICHIGAN WHO HEADS UP THE TEAM 

1127
00:44:14,523 --> 00:44:17,059
THAT PUTS ALL THIS INFORMATION 

1128
00:44:17,059 --> 00:44:19,194
TOGETHER TO THE STAFF AND 

1129
00:44:19,194 --> 00:44:21,330
SUPPORT INVESTIGATORS WHO 

1130
00:44:21,330 --> 00:44:22,631
ENSURED THE ACCURACY OF THE 

1131
00:44:22,631 --> 00:44:26,268
INCLUSION DATA THAT IS PRESENTED

1132
00:44:26,268 --> 00:44:30,572
IN THE TRIENNIAL REPORT.  THANK 

1133
00:44:30,572 --> 00:44:30,839
YOU.  

1134
00:44:30,839 --> 00:44:31,340
>> DR. FRIESE: SO MUCH 

1135
00:44:31,340 --> 00:44:32,908
DR. MOONEY, WE APPRECIATE THE 

1136
00:44:32,908 --> 00:44:34,209
WORK OF YOUR TEAM AND THANK YOU 

1137
00:44:34,209 --> 00:44:35,477
FOR YOUR RESPONSIVENESS AND 

1138
00:44:35,477 --> 00:44:39,514
COMPARING THE DATA TO THE SEER 

1139
00:44:39,514 --> 00:44:40,182
DATA.  WE'RE A LITTLE BIT BEHIND

1140
00:44:40,182 --> 00:44:41,650
SCHEDULE SO I WILL SAY, WE'LL 

1141
00:44:41,650 --> 00:44:42,651
TAKE ONE QUESTION AT THIS POINT 

1142
00:44:42,651 --> 00:44:43,552
SO WE CAN KEEP THE AGENDA MO

1143
00:44:43,552 --> 00:44:50,959
MOVING.  FRED, PLEASE?

1144
00:44:50,959 --> 00:44:52,494
>> FRED: THANK YOU DR.
MOONEY 

1145
00:44:52,494 --> 00:44:54,029
FOR PRESENTING THESE VERY 

1146
00:44:54,029 --> 00:44:57,065
HELPFUL DATA.  I AM GLAD TO SEE 

1147
00:44:57,065 --> 00:45:00,268
THAT THE INCLUSION REPORTING IS 

1148
00:45:00,268 --> 00:45:03,238
MANDATED BY LAW AND WE CANNOT 

1149
00:45:03,238 --> 00:45:05,173
OVEREMPHASIZE THE IMPORTANCE OF 

1150
00:45:05,173 --> 00:45:06,341
INCLUSION DATA FOR THE 

1151
00:45:06,341 --> 00:45:08,443
EFFECTIVENESS OF THE THERAPIES 

1152
00:45:08,443 --> 00:45:11,446
THAT COME OUT OF THESE CLINICAL 

1153
00:45:11,446 --> 00:45:12,848
TRIALS AND THE PREVENTIVE 

1154
00:45:12,848 --> 00:45:16,785
MEASURES THAT ARE DESIGNED FROM,

1155
00:45:16,785 --> 00:45:20,222
FROM THIS.  THE QUESTION THAT I 

1156
00:45:20,222 --> 00:45:26,528
HAVE IS HOW IS, HOW IS THIS 

1157
00:45:26,528 --> 00:45:30,232
COMPLIANCE EVALUATED IN THE 

1158
00:45:30,232 --> 00:45:32,034
NEWER FRAMEWORK OF PEER REVIEW 

1159
00:45:32,034 --> 00:45:35,370
THAT HAS BEEN REORGANIZED TO THE

1160
00:45:35,370 --> 00:45:38,540
THREE FACTORS?  SNOON IT'S STILL

1161
00:45:38,540 --> 00:45:45,280
PART OF THAT REVIEW AND THE I 

1162
00:45:45,280 --> 00:45:46,548
FORGET THE THREE FACTORS OFF THE

1163
00:45:46,548 --> 00:45:50,085
TOP OF MY HEAD.  IT USED TO BE 

1164
00:45:50,085 --> 00:45:51,620
SEPARATE CRITERIA FOR THE, WHEN 

1165
00:45:51,620 --> 00:45:53,221
WE HAD THE FIVE FACTORS AND WE 

1166
00:45:53,221 --> 00:45:54,523
HAD ADDITIONAL INFORMATION THAT 

1167
00:45:54,523 --> 00:45:57,626
WAS INCLUSION BUT NOW IN THE 

1168
00:45:57,626 --> 00:45:59,628
THREE FACTORS, DATA ON INCLUSION

1169
00:45:59,628 --> 00:46:01,630
IS INCLUDED AS I UNDERSTAND IT, 

1170
00:46:01,630 --> 00:46:04,066
WITHIN ONE OF THOSE THREE 

1171
00:46:04,066 --> 00:46:05,734
FACTORS.  AND SO IT'S NOT THAT 

1172
00:46:05,734 --> 00:46:08,170
IT HAS DISAPPEARED AT ALL, IT'S 

1173
00:46:08,170 --> 00:46:10,172
STILL PART OF PEER REVIEW AND IT

1174
00:46:10,172 --> 00:46:16,244
SHOULD STILL BE INCLUDED.  

1175
00:46:16,244 --> 00:46:18,580
>> DR. FRIESE: VERY
BRIEFLY.  I 

1176
00:46:18,580 --> 00:46:21,149
SEE YOUR QUESTION, WE'LL LET HER

1177
00:46:21,149 --> 00:46:22,250
ANSWER THAT OFFLINE.

1178
00:46:22,250 --> 00:46:25,087
>> I THINK ONE THING TO
START 

1179
00:46:25,087 --> 00:46:26,121
CONTEMPLATING IS HOW WE'RE 

1180
00:46:26,121 --> 00:46:26,922
ACTUALLY GOING TO DO SOMETHING 

1181
00:46:26,922 --> 00:46:30,525
LIKE THIS MOVING FORWARD.  I 

1182
00:46:30,525 --> 00:46:32,861
THINK IT'S INEVITABLE THAT WE'RE

1183
00:46:32,861 --> 00:46:34,329
LOOKING AT PRIVATIZATION OF MANY

1184
00:46:34,329 --> 00:46:36,298
OF THESE TYPES OF CLINICAL 

1185
00:46:36,298 --> 00:46:37,732
TRIALS AND MANY, MANY MORE 

1186
00:46:37,732 --> 00:46:38,500
INDUSTRY SPONSORED CLINICAL 

1187
00:46:38,500 --> 00:46:40,135
TRIALS AND YOU'RE NOT GOING TO 

1188
00:46:40,135 --> 00:46:42,437
HAVE A MECHANISM FOR ACCOUNTING 

1189
00:46:42,437 --> 00:46:43,772
WHERE THESE PATIENTS ARE COMING 

1190
00:46:43,772 --> 00:46:45,240
FROM, THEIR BACKGROUND, ET 

1191
00:46:45,240 --> 00:46:46,341
CETERA, BECAUSE THEY'RE NOT 

1192
00:46:46,341 --> 00:46:48,310
GOING TO BE NECESSARILY NCI AND 

1193
00:46:48,310 --> 00:46:49,411
THAT'S OBVIOUSLY A LIMITATION OF

1194
00:46:49,411 --> 00:46:52,047
THE DATASET THAT YOU HAVE AT 

1195
00:46:52,047 --> 00:46:54,783
HAND SO HAS THERE BEEN ANY 

1196
00:46:54,783 --> 00:46:55,684
DISCUSSION WITH REGARDS TO HOW 

1197
00:46:55,684 --> 00:47:00,655
THIS MANDATE IS GOING TO WORK 

1198
00:47:00,655 --> 00:47:01,890
MOVING FORWARD?  BECAUSE AGAIN 

1199
00:47:01,890 --> 00:47:03,525
THE VAST MAJORITY IS GOING TO 

1200
00:47:03,525 --> 00:47:06,328
SHIFT TO PRIVATE.

1201
00:47:06,328 --> 00:47:08,096
>> I THINK OBVIOUSLY THE
MANDATE

1202
00:47:08,096 --> 00:47:10,332
HERE FROM THE NIH IS FOR 

1203
00:47:10,332 --> 00:47:13,702
PUBLICLY FUNDED NIH TRIALS SO IN

1204
00:47:13,702 --> 00:47:16,138
THAT SENSE, OBVIOUSLY WHATEVER 

1205
00:47:16,138 --> 00:47:20,876
WE DO AT THE NCR OR NIH WILL 

1206
00:47:20,876 --> 00:47:21,510
STILL REPORT THIS INFORMATION IN

1207
00:47:21,510 --> 00:47:23,812
TERMS OF PRIVATE CLINICAL TRIALS

1208
00:47:23,812 --> 00:47:28,783
I CERTAINLY KNOW THE FDA IS VERY

1209
00:47:28,783 --> 00:47:29,417
INTERESTED IN THIS INFORMATION 

1210
00:47:29,417 --> 00:47:30,051
AND DOES ASK COMPANIES FOR THIS 

1211
00:47:30,051 --> 00:47:30,652
INFORMATION IN PART OF THEIR 

1212
00:47:30,652 --> 00:47:31,286
REVIEW AND DECISION-MAKING 

1213
00:47:31,286 --> 00:47:33,421
PROCESS, EVEN IF THE TRIAL WAS 

1214
00:47:33,421 --> 00:47:34,523
DONE COMPLETELY PRIVATELY.  SO 

1215
00:47:34,523 --> 00:47:37,058
THE EXTENT OF THAT, I AM NOT 

1216
00:47:37,058 --> 00:47:39,628
BEING AT THE FDA I DON'T KNOW 

1217
00:47:39,628 --> 00:47:41,530
THE EXTENT TO WHICH THEY REQUIRE

1218
00:47:41,530 --> 00:47:43,131
CERTAIN CATEGORIES BUT THEY 

1219
00:47:43,131 --> 00:47:44,399
CERTAINLY ARE VERY INTERESTED IN

1220
00:47:44,399 --> 00:47:47,402
WHERE THE PATIENTS COME FROM AND

1221
00:47:47,402 --> 00:47:49,237
OBVIOUSLY THE SEX, RACE AND 

1222
00:47:49,237 --> 00:47:54,543
ETHNICITY.  THAT'S WHAT I CAN 

1223
00:47:54,543 --> 00:47:56,511
SAY ABOUT THE PRIVATE SECTOR 

1224
00:47:56,511 --> 00:47:58,513
SINCE I'M IN THE PUBLIC SECTOR.

1225
00:47:58,513 --> 00:47:59,814
>> YEAH, BUT THEY'RE
PROBABLY 

1226
00:47:59,814 --> 00:48:01,116
GOING TO HAVE TO PAY FOR THAT 

1227
00:48:01,116 --> 00:48:02,584
MOVING FORWARD BECAUSE I CAN'T 

1228
00:48:02,584 --> 00:48:04,686
SEE A COMPANY THAT IS PRIVATE 

1229
00:48:04,686 --> 00:48:05,754
TURNING THAT OVER.  THEY'RE 

1230
00:48:05,754 --> 00:48:07,522
GOING TO HAVE TO COME UP WITH 

1231
00:48:07,522 --> 00:48:10,525
SOME KIND OF FUNDING MECHANISM 

1232
00:48:10,525 --> 00:48:13,261
TO SUPPORT COMPANIES DOING THAT.

1233
00:48:13,261 --> 00:48:14,229
>> DR. MOONEY: I WOULD
HAVE TO 

1234
00:48:14,229 --> 00:48:17,666
REFER TO THE REST OF HHS 

1235
00:48:17,666 --> 00:48:18,533
REGARDING THAT AND STUDIES THAT 

1236
00:48:18,533 --> 00:48:20,135
ARE IN THE PRIVATE SECTOR THAT 

1237
00:48:20,135 --> 00:48:27,142
THEY HAVE TO REVIEW AND ASSESS. 

1238
00:48:27,142 --> 00:48:27,809
>> DR. FRIESE: DR. MOONEY
THANK 

1239
00:48:27,809 --> 00:48:29,244
YOU AGAIN SO MUCH AND A FEW 

1240
00:48:29,244 --> 00:48:31,079
QUESTIONS FOR YOU IN THE CHAT 

1241
00:48:31,079 --> 00:48:34,015
THAT WILL BE HELPFUL FOR YOU AS 

1242
00:48:34,015 --> 00:48:35,250
WELL.  SO THE BOARD WILL NOW 

1243
00:48:35,250 --> 00:48:35,784
CONSIDER ONGOING AND NEW 

1244
00:48:35,784 --> 00:48:38,553
BUSINESS AND THE FIRST NEW 

1245
00:48:38,553 --> 00:48:42,490
BUSINESS ITEM WE HAVE, OH, 

1246
00:48:42,490 --> 00:48:43,124
EXCUSE ME, I HAVE TO BACK UP AND

1247
00:48:43,124 --> 00:48:44,292
WE HAVE TO VOTE ON DR. MOONEY'S 

1248
00:48:44,292 --> 00:48:46,895
REPORT, APOLOGIES.  SO I WOULD 

1249
00:48:46,895 --> 00:48:50,532
LIKE TO ASK A BOARD MEMBER TO 

1250
00:48:50,532 --> 00:48:53,668
MAKE A MOTION TO ACCEPT 

1251
00:48:53,668 --> 00:48:54,135
DR. MOONEY'S REPORT.

1252
00:48:54,135 --> 00:48:58,340
>> I'LL MAKE A MOTION. 
SNEEZE 

1253
00:48:58,340 --> 00:49:00,408
>> DR. FRIESE: MOVED AND 

1254
00:49:00,408 --> 00:49:02,244
SECONDED.  ANY DISCUSSION?  

1255
00:49:02,244 --> 00:49:06,414
OKAY.  THANK YOU.  ANY NAYS TO 

1256
00:49:06,414 --> 00:49:10,452
ACCEPTING THE REPORT?  ANY 

1257
00:49:10,452 --> 00:49:14,589
ABSTENTIONS?  PAULETTE.

1258
00:49:14,589 --> 00:49:17,359
>> YOU'RE GOOD TO GO, IT'S

1259
00:49:17,359 --> 00:49:17,659
UNANIMOUS.  

1260
00:49:17,659 --> 00:49:18,426
>> DR. FRIESE: THANK YOU. 

1261
00:49:18,426 --> 00:49:21,029
THANKS SO MUCH.  SO NOW THE 

1262
00:49:21,029 --> 00:49:23,531
BOARD WILL CONSIDER ONGOING NEW 

1263
00:49:23,531 --> 00:49:26,735
BUSINESS AND THE FIRST ITEM IS 

1264
00:49:26,735 --> 00:49:32,007
TO ACCOMPESTABLISH THE AD HOC W 

1265
00:49:32,007 --> 00:49:33,608
GROUP.  THIS WAS SENT A DOCUMENT

1266
00:49:33,608 --> 00:49:34,476
FOR YOUR CONSIDERATION ON 

1267
00:49:34,476 --> 00:49:36,278
ESTABLISH AING WORKING GROUP TO 

1268
00:49:36,278 --> 00:49:39,314
ADVISE THE NCI IN ITS 

1269
00:49:39,314 --> 00:49:40,482
CONSIDERATION OF CONCEPTS AND 

1270
00:49:40,482 --> 00:49:41,850
OTHER RELATED PROGRAMS.  I WILL 

1271
00:49:41,850 --> 00:49:45,620
PAUSE HERE TO SEE IF ANY 

1272
00:49:45,620 --> 00:49:46,488
QUESTIONS TO THAT DOCUMENT THAT 

1273
00:49:46,488 --> 00:49:50,025
YOU RECEIVED PRIOR TO THE 

1274
00:49:50,025 --> 00:49:54,529
MEETING.  OKAY HEARING NONE, WE 

1275
00:49:54,529 --> 00:49:59,467
MUST VOTE AS A BOARD TO APPROVE,

1276
00:49:59,467 --> 00:49:59,934
DISAPPROVE --

1277
00:49:59,934 --> 00:50:02,370
>> SORRY, CHRIS.  I JUST
DIDN'T 

1278
00:50:02,370 --> 00:50:04,406
GET MYSELF TURNED ON FAST 

1279
00:50:04,406 --> 00:50:07,676
ENOUGH.  SORRY I HAD SOME 

1280
00:50:07,676 --> 00:50:08,877
QUESTIONS ABOUT WHAT, LIKE WHAT 

1281
00:50:08,877 --> 00:50:11,980
THIS IS REPLACING.  WHAT IS, I 

1282
00:50:11,980 --> 00:50:13,248
NEED TO UNDERSTAND A LITTLE BIT 

1283
00:50:13,248 --> 00:50:16,151
MORE BEHIND THIS IT FEELS LIKE 

1284
00:50:16,151 --> 00:50:17,018
IT'S PERHAPS FIXING AN ISSUE BUT

1285
00:50:17,018 --> 00:50:19,054
I'M NOT SURE WHAT IT IS.  CAN 

1286
00:50:19,054 --> 00:50:21,890
SOMEONE SAY MORE ABOUT THE 

1287
00:50:21,890 --> 00:50:32,167
GENESIS OF THIS.

1288
00:50:38,106 --> 00:50:40,241
>> AS YOU MAY BE AWARE THE

1289
00:50:40,241 --> 00:50:42,043
ADMINISTRATION HAS WANTED TO 

1290
00:50:42,043 --> 00:50:43,845
DECREASE THE NUMBER OF 

1291
00:50:43,845 --> 00:50:47,449
COMMITTEES AND SO TO THAT END, 

1292
00:50:47,449 --> 00:50:53,822
THEY HAVE ELIM LILIM LILIMIT  - 

1293
00:50:53,822 --> 00:50:57,926
THREE OF OUR COMMITTEES AND WE 

1294
00:50:57,926 --> 00:50:59,427
CLEARLY APPRECIATE THE ABILITY 

1295
00:50:59,427 --> 00:51:04,499
OF THE NCAB TO LOOK AT NEW 

1296
00:51:04,499 --> 00:51:07,535
CONCEPTS AND CONSIDER THEM.  BUT

1297
00:51:07,535 --> 00:51:09,971
THE, YOU KNOW, ESSENTIALLY, THE 

1298
00:51:09,971 --> 00:51:12,374
BOARD OF SCIENTIFIC ADVISORS 

1299
00:51:12,374 --> 00:51:17,379
USED TO HAVE THAT AS PART OF ITS

1300
00:51:17,379 --> 00:51:27,922
REMIT.  SO WE THOUGHT IT COULD 

1301
00:51:30,425 --> 00:51:32,994
BE USEFUL TO HAVE A LARGER GROUP

1302
00:51:32,994 --> 00:51:37,232
AVAILABLE FOR REVIEWING NEW 

1303
00:51:37,232 --> 00:51:40,568
CONCEPTS.  AND JUST AS AN 

1304
00:51:40,568 --> 00:51:44,606
EXAMPLE, WE STILL HAVE THE 

1305
00:51:44,606 --> 00:51:46,908
TRANSITIONAL ADVISORY COMMITTEE.

1306
00:51:46,908 --> 00:51:48,943
SO IT MIGHT BE REASONABLE TO 

1307
00:51:48,943 --> 00:51:52,981
CONSIDER APPOINTING SOME MEMBERS

1308
00:51:52,981 --> 00:51:54,916
OF THAT GROUP OBVIOUSLY PEOPLE 

1309
00:51:54,916 --> 00:51:56,985
FROM THE NCAB IF THEY WANTED TO 

1310
00:51:56,985 --> 00:52:00,522
BE PART OF THIS WORKING GROUP 

1311
00:52:00,522 --> 00:52:01,589
TOTALLY APPROPRIATE.  BUT IT 

1312
00:52:01,589 --> 00:52:04,659
GIVES IN PRINCIPLE MORE 

1313
00:52:04,659 --> 00:52:09,531
FLEXIBILITY TO HAVE A WIDER 

1314
00:52:09,531 --> 00:52:12,767
RANGE OF REPRESENTED EXPERTISE.

1315
00:52:12,767 --> 00:52:17,572
>> THANK YOU.  

1316
00:52:17,572 --> 00:52:18,273
>> DR. FRIESE: THANKS SO
MUCH 

1317
00:52:18,273 --> 00:52:19,474
FOR THE QUESTION AND ANSWER 

1318
00:52:19,474 --> 00:52:22,544
KAREN AND DOUG, ANY OTHER 

1319
00:52:22,544 --> 00:52:33,021
QUESTIONS ON THIS PROPOSAL?

1320
00:52:35,457 --> 00:52:37,392
>> I HAVE ONE QUESTION ON
THIS, 

1321
00:52:37,392 --> 00:52:38,193
DOES THIS GROUP HAVE A THE 

1322
00:52:38,193 --> 00:52:43,097
ABILITY TO VOTE ON CONCEPTS FOR 

1323
00:52:43,097 --> 00:52:45,934
ACCEPTING THEM?  AS WE HAVE SEEN

1324
00:52:45,934 --> 00:52:49,137
WITH DSA OR WOULD THE REVIEW BE 

1325
00:52:49,137 --> 00:52:53,608
DIFFERENT, WITH THE REVIEW IN 

1326
00:52:53,608 --> 00:52:54,542
RECOMMENDATION VERSUS IN VOTING 

1327
00:52:54,542 --> 00:52:57,946
TO ACCEPT.

1328
00:52:57,946 --> 00:53:01,716
>> THE VOTE WOULD BE DONE
BY THE

1329
00:53:01,716 --> 00:53:03,485
NCAB.  THE PERSON ON THE WORKING

1330
00:53:03,485 --> 00:53:07,455
GROUP WILL BRING FORWARD THEIR 

1331
00:53:07,455 --> 00:53:07,856
RECOMMENDATIONS.  

1332
00:53:07,856 --> 00:53:08,490
>> DR. CARPTEN THE 

1333
00:53:08,490 --> 00:53:12,026
RECOMMENDATIONS, OKAY, GREAT, 

1334
00:53:12,026 --> 00:53:18,166
THANKS, PAULA.  

1335
00:53:18,166 --> 00:53:19,467
>> DR. LOWY: THIS WOULD
REST 

1336
00:53:19,467 --> 00:53:21,836
WITH THE NCAB BASED ON THE 

1337
00:53:21,836 --> 00:53:22,971
ADVISE IF YOU WILL OF THE 

1338
00:53:22,971 --> 00:53:26,474
WORKING GROUP.  DOES THAT SOUND 

1339
00:53:26,474 --> 00:53:26,674
OKAY?

1340
00:53:26,674 --> 00:53:28,910
>> YOU'RE GOOD TO GO,
DOUG.  

1341
00:53:28,910 --> 00:53:29,644
>> DR. FRIESE: OKAY WE
HAVE KIM 

1342
00:53:29,644 --> 00:53:30,545
AND WE HAVE KAREN AND THEN I'M 

1343
00:53:30,545 --> 00:53:32,013
GOING TO ASK TO CALL THE 

1344
00:53:32,013 --> 00:53:33,214
QUESTION IF I MAY.  SO KIM, 

1345
00:53:33,214 --> 00:53:34,549
PLEASE, BE BRIEF IF YOU CAN, 

1346
00:53:34,549 --> 00:53:39,420
THANK YOU.

1347
00:53:39,420 --> 00:53:41,122
>> IF I TALK ABOUT HOW
MEMBERS 

1348
00:53:41,122 --> 00:53:43,124
WILL BE SELECTED WHAT WOULD THE 

1349
00:53:43,124 --> 00:53:43,758
PROCESS BE FOR THAT?

1350
00:53:43,758 --> 00:53:46,528
>> THE PROCESS WILL BE THE
SAME 

1351
00:53:46,528 --> 00:53:53,201
AS WITH ANY OTHER WORKING GROUPS

1352
00:53:53,201 --> 00:53:56,304
THE NCI LEADERSHIP WILL COME UP 

1353
00:53:56,304 --> 00:53:57,939
WITH RECOMMENDATIONS AND ET 

1354
00:53:57,939 --> 00:54:00,575
CETERA.  AND THOSE INDIVIDUALS 

1355
00:54:00,575 --> 00:54:02,610
THAT THEY RECOMMEND WILL 

1356
00:54:02,610 --> 00:54:05,513
APPROACHED TO ASCERTAIN THE 

1357
00:54:05,513 --> 00:54:08,850
INTEREST IN PARTICIPATING.

1358
00:54:08,850 --> 00:54:12,820
>> THANK YOU.  

1359
00:54:12,820 --> 00:54:13,721
>> DR. FRIESE: KAREN?

1360
00:54:13,721 --> 00:54:16,324
>> CHRIS, THAT WAS MY
QUESTION. 

1361
00:54:16,324 --> 00:54:16,958
>> DR. FRIESE: THANK YOU
SO 

1362
00:54:16,958 --> 00:54:18,826
MUCH.  COULD I HAVE A MOTION, 

1363
00:54:18,826 --> 00:54:22,530
PLEASE TO ESTABLISH A WORKING 

1364
00:54:22,530 --> 00:54:25,066
GROUP?

1365
00:54:25,066 --> 00:54:25,867
>> SO MOVED.  

1366
00:54:25,867 --> 00:54:27,068
>> DR. FRIESE: JOHN, THANK
YOU.

1367
00:54:27,068 --> 00:54:27,502
>> SECOND.

1368
00:54:27,502 --> 00:54:28,836
>> SECOND, KAREN, THANK
YOU.  

1369
00:54:28,836 --> 00:54:34,375
ANY FURTHER DISCUSSION?  OKAY 

1370
00:54:34,375 --> 00:54:38,546
I'LL ASK FOR THE NAYS.  ANY N

1371
00:54:38,546 --> 00:54:44,919
NAYS?  ANY ABSTENTIONS?

1372
00:54:44,919 --> 00:54:45,620
>> IT'S UNANIMOUS.

1373
00:54:45,620 --> 00:54:50,425
>> THANKS PAULA.  THANK
YOU, 

1374
00:54:50,425 --> 00:54:51,926
ALL, WE'RE IN THE LIGHTNING 

1375
00:54:51,926 --> 00:54:53,161
ROUND HERE BEFORE WE ADJOURN THE

1376
00:54:53,161 --> 00:54:54,529
OPEN SESSION I, IF WE CAN GO 

1377
00:54:54,529 --> 00:54:56,230
VERY, VERY QUICKLY, IF YOU HAVE 

1378
00:54:56,230 --> 00:54:58,433
AN AGENDA ITEM FOR A FUTURE 

1379
00:54:58,433 --> 00:54:59,934
MEETING.  IF YOU COULD JUST LIST

1380
00:54:59,934 --> 00:55:02,537
IT, SPEAK UP AND LIST IT.  WE 

1381
00:55:02,537 --> 00:55:04,606
WILL RECORD THOSE AND IF TOPICS 

1382
00:55:04,606 --> 00:55:07,375
COME TO YOU LATER, PLEASE SEND 

1383
00:55:07,375 --> 00:55:09,644
THEM TO MYSELF OR PAULETTE FOR 

1384
00:55:09,644 --> 00:55:10,545
FURTHER CONSIDERATION.  BUT ANY 

1385
00:55:10,545 --> 00:55:14,048
AGENDA ITEMS YOU'D LIKE TO PUT 

1386
00:55:14,048 --> 00:55:22,423
ON THE LIST RIGHT NOW?  

1387
00:55:22,423 --> 00:55:23,257
>> DR. CARPTEN IT'D BE
GREAT TO 

1388
00:55:23,257 --> 00:55:25,426
GET A BETTER UNDERSTANDING OF 

1389
00:55:25,426 --> 00:55:28,029
SORT OF THE INTERNAL PROCESSES 

1390
00:55:28,029 --> 00:55:30,164
THAT ARE IN PLAY NOW FOR 

1391
00:55:30,164 --> 00:55:32,033
REVIEWING MECHANISMS AND NOTICES

1392
00:55:32,033 --> 00:55:34,535
OF FUNDING OPPORTUNITY THAT MAY 

1393
00:55:34,535 --> 00:55:36,337
BE PULLED DOWN.  

1394
00:55:36,337 --> 00:55:37,472
I MEAN, WE'RE SEEING IT AND 

1395
00:55:37,472 --> 00:55:40,108
WE'RE HEARING ABOUT IT BUT IT 

1396
00:55:40,108 --> 00:55:41,209
WOULD BE GREAT TO UNDERSTAND 

1397
00:55:41,209 --> 00:55:49,684
THAT PROCESS A BIT BETTER.  

1398
00:55:49,684 --> 00:56:00,228
>> DR. FRIESE: THANK YOU. 
OTHER

1399
00:56:02,030 --> 00:56:03,998
TOPIC ITEMS?  OKAY WELL, AGAIN, 

1400
00:56:03,998 --> 00:56:06,100
IF YOU HAVE ITEMS FOR FUTURE 

1401
00:56:06,100 --> 00:56:07,735
AGENDA, FEEL FREE TO PASS THEM 

1402
00:56:07,735 --> 00:56:09,671
ONTO PAULETTE OR TO MYSELF.  AND

1403
00:56:09,671 --> 00:56:15,610
WE'RE HAPPY TO ADDRESS THOSE.  

1404
00:56:15,610 --> 00:56:17,278
THERE BEING NO -- 

1405
00:56:17,278 --> 00:56:18,246
>> DR. CARPTEN ONE MORE 

1406
00:56:18,246 --> 00:56:21,049
QUESTION, CHRIS, I APOLOGIZE, I 

1407
00:56:21,049 --> 00:56:23,117
WAS WONDERING IF WE WILL SORT 

1408
00:56:23,117 --> 00:56:25,820
OF, WHEN WE CONVENE AGAIN LATER 

1409
00:56:25,820 --> 00:56:27,822
WILL WE HAVE THE LEGISLATIVE 

1410
00:56:27,822 --> 00:56:28,756
REPORT?  WILL THAT CONTINUE SORT

1411
00:56:28,756 --> 00:56:31,459
OF THE, IN FUTURE MEETINGS WILL 

1412
00:56:31,459 --> 00:56:33,528
THE AGENDA BE SIMILAR TO WHAT 

1413
00:56:33,528 --> 00:56:36,464
IT'S BEEN PREVIOUSLY?  I KNOW 

1414
00:56:36,464 --> 00:56:39,167
WE'RE HAVING SORT OF A, SORT OF 

1415
00:56:39,167 --> 00:56:41,302
ABBREVIATED MEETINGS TODAY BUT I

1416
00:56:41,302 --> 00:56:43,071
AM WONDERING, MEETINGS LATER 

1417
00:56:43,071 --> 00:56:45,940
THIS YEAR, WILL WE HAVE A 

1418
00:56:45,940 --> 00:56:47,341
LEGISLATIVE REPORT IN WILL WE GO

1419
00:56:47,341 --> 00:56:49,377
BACK TO THE STANDARD AGENDA OR 

1420
00:56:49,377 --> 00:56:50,812
DO WE HAVE AN IDEA OF WHAT THE 

1421
00:56:50,812 --> 00:56:54,082
AGENDAS WILL LOOK LIKE GOING 

1422
00:56:54,082 --> 00:56:59,687
FORWARD?  

1423
00:56:59,687 --> 00:57:01,723
>> DR. LOWY: TO ME THIS IS
TBD. 

1424
00:57:01,723 --> 00:57:05,326
TA MEANS TO BE DETERMINED.  

1425
00:57:05,326 --> 00:57:05,727
AND -- 

1426
00:57:05,727 --> 00:57:08,329
>> DR. CARPTEN I HAVE TO
ASK.  

1427
00:57:08,329 --> 00:57:10,531
>> DR. LOWY: YOU'RE SO FAR

1428
00:57:10,531 --> 00:57:12,467
OUTSIDE THE BELTWAY, EXCUSE ME. 

1429
00:57:12,467 --> 00:57:16,437
WHAT YOU MAY NOT BE AWARE OF IS 

1430
00:57:16,437 --> 00:57:23,945
THAT THE NIH IS TRYING TO REALLY

1431
00:57:23,945 --> 00:57:26,280
BRING TOGETHER THE LEGISLATIVE 

1432
00:57:26,280 --> 00:57:36,824
ACTIVITIES UNDER THE NIH, THIS 

1433
00:57:40,495 --> 00:57:42,563
IS CALLED CENTRALIZATION, HOW 

1434
00:57:42,563 --> 00:57:44,432
THAT WILL PLAY OUT AND WHAT IT 

1435
00:57:44,432 --> 00:57:48,836
WILL LOOK LIKE REMAINS TO BE 

1436
00:57:48,836 --> 00:57:51,572
DETERMINED.  THEY'RE STILL HERE 

1437
00:57:51,572 --> 00:57:54,942
WITH US.  BUT WE'RE JUST NOT 

1438
00:57:54,942 --> 00:57:57,411
QUITE SURE OF WHAT THE GROUND 

1439
00:57:57,411 --> 00:58:01,249
RULES ARE GOING TO BE, OKAY?  

1440
00:58:01,249 --> 00:58:03,518
>> DR. CARPTEN THANKS. 
I'M 

1441
00:58:03,518 --> 00:58:04,852
SORRY TO BE THAT GUY.  I 

1442
00:58:04,852 --> 00:58:05,353
APPRECIATE IT.  

1443
00:58:05,353 --> 00:58:07,455
>> DR. LOWY: I LIKE TO
GIVE 

1444
00:58:07,455 --> 00:58:10,825
PEOPLE AS UP-TO-DATE INFORMATION

1445
00:58:10,825 --> 00:58:12,293
AS WE HAVE BUT REALLY THIS IS 

1446
00:58:12,293 --> 00:58:14,529
WHAT WE OFTEN REFER TO AS A WORK

1447
00:58:14,529 --> 00:58:19,400
IN PROGRESS.  

1448
00:58:19,400 --> 00:58:20,568
>> DR. CARPTEN THANKS,
DOUG 

1449
00:58:20,568 --> 00:58:21,702
>> DR. FRIESE: THANK YOU
ALL 

1450
00:58:21,702 --> 00:58:24,338
VERY MUCH.  SO THERE BEING NO 

1451
00:58:24,338 --> 00:58:25,773
FURTHER BUSINESS, THE OPEN 

1452
00:58:25,773 --> 00:58:28,009
MEETING IS ADJOURNED.  THIS 

1453
00:58:28,009 --> 00:58:29,177
CONCLUDES THE OPEN SESSION.  

1454
00:58:29,177 --> 00:58:31,712
THERE WILL BE A BRIEF BREAK ONLY

1455
00:58:31,712 --> 00:58:36,184
BOARD MEMBERS AND DESIGNATED NCI

1456
00:58:36,184 --> 00:58:39,220
STAFF SHOULD REMAIN.  ALL OTHERS

1457
00:58:39,220 --> 00:58:41,355
SHOULD SIGN OFF NOW AND THOSE 

1458
00:58:41,355 --> 00:58:42,890
USING THE CLOSED SESSION SHOULD 

1459
00:58:42,890 --> 00:58:44,926
SIGN ON IN THE NEXT FIVE 

1460
00:58:44,926 --> 00:58:45,760
MINUTES.  THE CLOSED SESSION 

1461
00:58:45,760 --> 00:58:49,363
WILL BEGIN PROMPTLY AT 12:05.  

1462
00:58:49,363 --> 00:58:50,531
THANK YOU, ALL, FOR JOINING US 

1463
00:58:50,531 --> 00:58:53,367
TODAY AND I WILL SEE THE NCAB 

1464
00:58:53,367 --> 00:59:03,678
MEMBERS SHORTLY.