1 00:00:04,767 --> 00:00:05,969 Carmen Ufret-Vincenty: 2 00:00:05,969 --> 00:00:08,271 Hello, everyone, and welcome to today's presentation. 3 00:00:08,271 --> 00:00:11,207 We will be discussing the Notice of Special Interest, 4 00:00:11,207 --> 00:00:14,677 highlighting R13 support for conferences 5 00:00:14,677 --> 00:00:18,581 and scientific meetings to support consensus building 6 00:00:18,581 --> 00:00:22,485 for autoimmune disease research- related common data elements. 7 00:00:22,485 --> 00:00:24,621 My name is Carmen Ufret-Vincenty. 8 00:00:24,621 --> 00:00:26,222 I am the program officer 9 00:00:26,222 --> 00:00:27,824 at the Office of Autoimmune Disease 10 00:00:27,824 --> 00:00:30,860 Research in the Office of Research on Women's Health. 11 00:00:30,860 --> 00:00:32,128 During the presentation, 12 00:00:32,128 --> 00:00:35,064 I will refer to our office by its acronym, OADR. 13 00:00:35,598 --> 00:00:38,601 Dr. Vicki Shanmugam is the director of OADR, 14 00:00:38,601 --> 00:00:40,236 and I want you to recognize her name, 15 00:00:40,236 --> 00:00:41,838 both because of the important work 16 00:00:41,838 --> 00:00:43,806 she is championing in this realm, 17 00:00:43,806 --> 00:00:46,442 and because she is the scientific research contact 18 00:00:46,442 --> 00:00:48,978 for the initiative we will be discussing. 19 00:00:48,978 --> 00:00:50,747 I am excited to be here today 20 00:00:50,747 --> 00:00:53,082 to talk about this key funding opportunity 21 00:00:53,082 --> 00:00:55,685 for advancing autoimmune disease research. 22 00:00:55,685 --> 00:00:57,720 The first part of the presentation will focus 23 00:00:57,720 --> 00:00:59,555 on describing the initiative, 24 00:00:59,555 --> 00:01:02,358 and the second part will provide all the information you need 25 00:01:02,358 --> 00:01:04,894 to help with the application submission process. 26 00:01:07,964 --> 00:01:11,934 The objective of this NOSI is to highlight OADR's interest 27 00:01:11,934 --> 00:01:15,238 in receiving applications that stimulate development 28 00:01:15,238 --> 00:01:18,207 of new NIH-endorsed common data elements 29 00:01:18,207 --> 00:01:21,611 applicable to immune diseases by convening members 30 00:01:21,611 --> 00:01:23,946 of the scientific, clinical, patient, 31 00:01:23,946 --> 00:01:26,949 and advocate community to build consensus 32 00:01:26,949 --> 00:01:28,951 on the appropriate common data elements 33 00:01:28,951 --> 00:01:31,454 to move to NIH endorsement. 34 00:01:31,454 --> 00:01:34,891 The QR code you see takes you to the full NOSI. 35 00:01:34,891 --> 00:01:39,462 To help you plan, keep in mind 36 00:01:39,462 --> 00:01:44,367 that this NOSI expires on December 14, 2026. 37 00:01:45,001 --> 00:01:48,137 Funds available -- funding for this NOSI 38 00:01:48,137 --> 00:01:50,940 is going to be dependent on fund availability, 39 00:01:50,940 --> 00:01:52,942 and this represents a collaboration 40 00:01:52,942 --> 00:01:56,045 between different institutes, centers, and offices. 41 00:01:57,246 --> 00:02:01,284 The NOSI is associated to the parent R13 42 00:02:01,284 --> 00:02:03,119 Notice of Funding Opportunity. 43 00:02:03,119 --> 00:02:06,255 The current number for that NOFO is provided here. 44 00:02:06,255 --> 00:02:07,690 But keep in mind that the NOSI 45 00:02:07,690 --> 00:02:10,326 applies to all reissues of this funding opportunity. 46 00:02:11,094 --> 00:02:13,830 As designed, the award period is one year, 47 00:02:13,830 --> 00:02:16,099 but keep in mind that later in the presentation, 48 00:02:16,099 --> 00:02:18,668 I will provide more context on what this award period 49 00:02:18,668 --> 00:02:20,870 means for the specifics of this NOSI. 50 00:02:22,905 --> 00:02:25,675 Before we delve on the initiative itself, 51 00:02:25,675 --> 00:02:29,078 let's discuss the concept behind NIH endorsement 52 00:02:29,078 --> 00:02:31,581 of common data elements. During the presentation, 53 00:02:31,581 --> 00:02:34,250 I may refer to common data elements as CDEs. 54 00:02:35,151 --> 00:02:39,122 A CDE is a standardized, precisely defined question 55 00:02:39,122 --> 00:02:42,191 paired with a set of allowable responses 56 00:02:42,191 --> 00:02:45,428 that is used systematically across sites, 57 00:02:45,428 --> 00:02:49,198 studies, data repositories, or clinical trials. 58 00:02:49,198 --> 00:02:52,034 And as I say this, I am sure you are immediately 59 00:02:52,034 --> 00:02:54,403 realizing how common data elements 60 00:02:54,403 --> 00:02:56,639 ensure consistent and harmonized data 61 00:02:56,639 --> 00:02:59,275 collection within a specific field. 62 00:03:00,843 --> 00:03:04,547 NIH has endorsed a series of common data elements 63 00:03:04,547 --> 00:03:08,284 through a project at the National Library of Medicine. 64 00:03:08,284 --> 00:03:10,620 And the QR code provided on the slide 65 00:03:10,620 --> 00:03:14,657 takes you to the home of the NIH CDE repository, 66 00:03:14,657 --> 00:03:16,759 where you can find the current list 67 00:03:16,759 --> 00:03:20,429 of NIH-endorsed common data elements and information 68 00:03:20,429 --> 00:03:21,898 related to the process 69 00:03:21,898 --> 00:03:24,567 for achieving NIH endorsement of CDEs. 70 00:03:25,134 --> 00:03:29,605 Use of NIH-endorsed CDEs supports the NIH data management 71 00:03:29,605 --> 00:03:30,840 and sharing policy 72 00:03:30,840 --> 00:03:34,644 and ensures harmonization of data across datasets, 73 00:03:34,644 --> 00:03:37,046 an effort that is foundational 74 00:03:37,046 --> 00:03:39,649 to advancing autoimmune disease research. 75 00:03:42,151 --> 00:03:45,421 Now that we have the definition of what the CDE is, 76 00:03:45,421 --> 00:03:46,956 we can talk about what applications 77 00:03:46,956 --> 00:03:49,759 will be considered responsive to this NOSI. 78 00:03:50,526 --> 00:03:53,930 The final product must be endorsable CDEs 79 00:03:53,930 --> 00:03:57,166 that the community has come to consensus on 80 00:03:57,166 --> 00:03:58,935 and that fulfill the requirements 81 00:03:58,935 --> 00:04:01,037 listed in this slide for CDEs, 82 00:04:01,537 --> 00:04:04,407 which will make them eligible to be submitted for endorsement 83 00:04:04,407 --> 00:04:06,976 by the NIH CDE Governance Committee. 84 00:04:06,976 --> 00:04:10,913 In other words, the goal of the NOSI is endorsable CDEs. 85 00:04:13,616 --> 00:04:16,219 And remember, this process is explained in detail 86 00:04:16,219 --> 00:04:18,588 on the NIH CDE repository website 87 00:04:18,588 --> 00:04:20,990 that we provided in the previous slide. 88 00:04:20,990 --> 00:04:23,526 This means that the conference or series of meetings 89 00:04:23,526 --> 00:04:26,896 that you propose should convene experts and partners 90 00:04:26,896 --> 00:04:28,965 to drive consensus building to arrive 91 00:04:28,965 --> 00:04:30,967 at agreed-upon endorsable CDEs. 92 00:04:31,500 --> 00:04:34,804 Successful applicants are expected to work 93 00:04:34,804 --> 00:04:38,040 with program staff at the Administering Institute 94 00:04:38,040 --> 00:04:41,143 to ensure that the CDEs produced by your approach 95 00:04:41,143 --> 00:04:44,247 meet the requirements of the NIH CDE Governance Committee. 96 00:04:44,881 --> 00:04:48,851 Therefore, the goal of these awards is bringing the community 97 00:04:48,851 --> 00:04:53,022 to consensus on CDEs to move forward for endorsement. 98 00:04:53,556 --> 00:04:56,592 This is distinct from most R13s, 99 00:04:56,592 --> 00:05:00,029 where the meeting is the final product itself. 100 00:05:02,298 --> 00:05:04,734 You may be wondering what autoimmune diseases 101 00:05:04,734 --> 00:05:06,235 qualify for this NOSI. 102 00:05:06,235 --> 00:05:09,205 The image in this slide gives you a high-level visual 103 00:05:09,205 --> 00:05:12,341 of the 144 autoimmune diseases 104 00:05:12,341 --> 00:05:16,078 and related conditions that are part of our research portfolio. 105 00:05:16,078 --> 00:05:17,413 But this font is too small. 106 00:05:17,413 --> 00:05:19,715 I'm not expecting you to read this -- 107 00:05:19,715 --> 00:05:21,317 to see it in the slide at least. 108 00:05:21,317 --> 00:05:24,253 So, the QR code takes you to the OADR website, 109 00:05:24,253 --> 00:05:27,523 where you can find a high- resolution version of this image 110 00:05:27,523 --> 00:05:29,725 and a Word file with searchable tables 111 00:05:29,725 --> 00:05:31,794 that lists the full research portfolio. 112 00:05:33,796 --> 00:05:36,332 It is important to know that as an applicant, 113 00:05:36,332 --> 00:05:38,834 you're not required to follow a specific format 114 00:05:38,834 --> 00:05:41,037 for a conference or series of meetings. 115 00:05:41,037 --> 00:05:44,106 The design of the approach you propose will be based 116 00:05:44,106 --> 00:05:46,609 on what you think has the highest probability 117 00:05:46,609 --> 00:05:49,312 to lead you to fulfill the objective of this NOSI. 118 00:05:49,312 --> 00:05:51,247 As you design your approach, 119 00:05:51,247 --> 00:05:53,316 keep in mind that it will be very important 120 00:05:53,316 --> 00:05:56,319 to include the perspectives of the whole community 121 00:05:56,319 --> 00:05:57,987 when building consensus. 122 00:05:57,987 --> 00:06:01,057 Clinicians and scientists with varied expertise, 123 00:06:01,057 --> 00:06:04,393 and most importantly, people living with autoimmune diseases, 124 00:06:04,393 --> 00:06:05,995 caregivers, and advocacy groups. 125 00:06:06,495 --> 00:06:08,631 As long as you bring together 126 00:06:08,631 --> 00:06:10,766 all these different crucial perspectives, 127 00:06:10,766 --> 00:06:13,269 you can be creative in the design of your approach. 128 00:06:13,269 --> 00:06:16,005 For example, it can be a series of virtual meetings. 129 00:06:16,005 --> 00:06:17,573 It can be a one-day 130 00:06:17,573 --> 00:06:21,243 consensus-making in-person meeting, 131 00:06:21,243 --> 00:06:23,679 or you can combine those two approaches. 132 00:06:26,148 --> 00:06:28,751 However, a conference that focuses 133 00:06:28,751 --> 00:06:31,620 only on discussing the state of the field 134 00:06:31,620 --> 00:06:34,357 or the importance of developing CDEs 135 00:06:34,357 --> 00:06:36,726 will be considered non-responsive 136 00:06:36,726 --> 00:06:38,327 because, again, the final product 137 00:06:38,327 --> 00:06:40,196 should be endorsable CDEs. 138 00:06:42,431 --> 00:06:46,202 To submit an application to this NOSI in response to the NOSI, 139 00:06:46,202 --> 00:06:49,672 please refer to the R13 Parent NOFO for instructions. 140 00:06:49,672 --> 00:06:53,676 Currently, the number for that NOFO is PA-25-080, 141 00:06:53,676 --> 00:06:56,812 and the QR code on the slide takes you to the full document. 142 00:06:57,646 --> 00:07:00,016 The application will be submitted under this NOFO, 143 00:07:00,016 --> 00:07:01,417 and I'll show you in later slides 144 00:07:01,417 --> 00:07:04,320 how to enter your application 145 00:07:04,320 --> 00:07:05,955 that you're responding to this NOSI. 146 00:07:05,955 --> 00:07:08,758 But for now, let's talk about what you see in this NOFO. 147 00:07:08,758 --> 00:07:10,760 Keep in mind that the objective of the R13 148 00:07:10,760 --> 00:07:13,429 in the context of this NOSI remains aligned 149 00:07:13,429 --> 00:07:16,932 with the final product we have been highlighting, 150 00:07:16,932 --> 00:07:19,835 to support high-quality conferences or meetings 151 00:07:19,835 --> 00:07:23,139 for developing endorsable CDEs for autoimmune disease research. 152 00:07:25,441 --> 00:07:29,211 This NOFO has a key requirement that requires timely planning. 153 00:07:29,211 --> 00:07:31,180 Advanced permission to submit is required 154 00:07:31,180 --> 00:07:34,617 from both the OADR and administering office, 155 00:07:34,617 --> 00:07:37,319 and this permission needs to be requested no later 156 00:07:37,319 --> 00:07:39,855 than six weeks before the application is due. 157 00:07:40,723 --> 00:07:43,059 Most of the submission instructions are the same 158 00:07:43,059 --> 00:07:47,129 as for other research applications like R01s and R21s, 159 00:07:47,129 --> 00:07:48,931 but there are some unique requirements 160 00:07:48,931 --> 00:07:50,966 that are summarized briefly here 161 00:07:50,966 --> 00:07:53,702 and will be explained later in the presentation. 162 00:07:56,005 --> 00:07:59,241 So, one of those requirements is that the cover letter 163 00:07:59,241 --> 00:08:03,245 needs to include both permission-to-submit letters, 164 00:08:03,245 --> 00:08:06,148 one from OADR and one from the administering office. 165 00:08:06,715 --> 00:08:09,718 You also are required to produce a diversity plan and submit 166 00:08:09,718 --> 00:08:11,253 that with your application. 167 00:08:11,253 --> 00:08:13,022 And the research strategy section 168 00:08:13,022 --> 00:08:15,357 will become your conference plan. 169 00:08:17,259 --> 00:08:20,463 This information is all explained in the parent 170 00:08:20,463 --> 00:08:26,335 R13 NOFO PA-25-080 or any reissues after this. 171 00:08:30,239 --> 00:08:32,708 Be aware that NOFOs are many times reissued 172 00:08:32,708 --> 00:08:34,276 for administrative reasons 173 00:08:34,276 --> 00:08:36,745 due to changes in policy or for other reasons. 174 00:08:36,745 --> 00:08:39,949 So, this is a good example of what just happened. 175 00:08:39,949 --> 00:08:44,587 We just had a reissue of the parent R13 NOFO 176 00:08:44,587 --> 00:08:48,824 that was before PA-24-141. 177 00:08:48,824 --> 00:08:51,961 In the future, if you find an expiration banner 178 00:08:51,961 --> 00:08:55,431 like the one flagged here by the orange arrow, 179 00:08:55,431 --> 00:08:57,199 it means that it has been reissued. 180 00:08:57,833 --> 00:09:00,669 Then you can scroll down on that NOFO, 181 00:09:01,270 --> 00:09:04,240 and under that section that is called "Related Notices," 182 00:09:04,240 --> 00:09:06,942 section that are flagged here by the orange boxes, 183 00:09:06,942 --> 00:09:09,078 you will find a link to the new NOFO, 184 00:09:09,078 --> 00:09:12,548 which will be the one to submit under in response to this NOSI. 185 00:09:14,049 --> 00:09:17,186 As an applicant interested in responding to this NOSI, 186 00:09:17,186 --> 00:09:18,921 how would you get started? 187 00:09:18,921 --> 00:09:21,557 The first thing to do is to write the specific aims. 188 00:09:22,224 --> 00:09:23,726 These are limited to one page 189 00:09:23,726 --> 00:09:25,928 and must include the disease area of focus, 190 00:09:26,896 --> 00:09:29,431 a landscape analysis of the current state of the field, 191 00:09:29,431 --> 00:09:32,601 and specific details about how you will bring the community 192 00:09:32,601 --> 00:09:36,372 to consensus around specific components of CDEs 193 00:09:36,372 --> 00:09:39,074 not currently endorsed by NIH. 194 00:09:39,074 --> 00:09:41,143 There are two important points here 195 00:09:41,143 --> 00:09:44,313 based on what needs to be included in the specific aims. 196 00:09:44,313 --> 00:09:47,116 Please check the list of NIH-endorsed CDEs 197 00:09:47,116 --> 00:09:49,919 to confirm that you will be working on new CDEs 198 00:09:49,919 --> 00:09:53,155 and include specific details of the approach you will use. 199 00:09:53,155 --> 00:09:55,124 For example, explain if you're planning to use 200 00:09:55,124 --> 00:09:57,326 the Delphi exercise or a different approach. 201 00:09:58,961 --> 00:10:00,829 While planning the specific aims, 202 00:10:00,829 --> 00:10:02,398 reach out to the teams of experts 203 00:10:02,398 --> 00:10:04,833 and partners you are planning to include. 204 00:10:07,136 --> 00:10:08,904 Also, reach out to colleagues 205 00:10:08,904 --> 00:10:12,041 who have successfully competed for R13 funding 206 00:10:12,041 --> 00:10:15,377 so that you have an idea of what to plan and what to expect. 207 00:10:17,079 --> 00:10:18,547 When the specific aims are ready, 208 00:10:18,547 --> 00:10:20,349 but remember, no later than six weeks 209 00:10:20,349 --> 00:10:25,120 before the application due date, reach out to oadrinfo@nih.gov 210 00:10:25,120 --> 00:10:27,623 and request a meeting to discuss your application 211 00:10:27,623 --> 00:10:29,725 and request permission to submit. 212 00:10:29,725 --> 00:10:34,096 The meeting will be with OADR and the Administering Institute. 213 00:10:34,096 --> 00:10:37,433 More than one meeting might be required in some cases, 214 00:10:37,433 --> 00:10:39,935 so please plan ahead and remember to include 215 00:10:39,935 --> 00:10:42,538 the specific aims when you email OADR. 216 00:10:44,340 --> 00:10:46,075 To prepare for the meeting, 217 00:10:46,075 --> 00:10:49,211 confirm that all players will be able to attend the meeting. 218 00:10:49,945 --> 00:10:52,815 Have everyone on the team carefully read and understand 219 00:10:52,815 --> 00:10:55,618 the NOSI, background information on CDEs, 220 00:10:55,618 --> 00:10:57,219 and the goal of the initiative. 221 00:10:58,020 --> 00:11:00,522 Make a decision on the PI and organization 222 00:11:00,522 --> 00:11:02,491 that will handle the submission. 223 00:11:02,491 --> 00:11:04,660 If possible, select someone with expertise 224 00:11:04,660 --> 00:11:07,763 to avoid submission errors that result in the application 225 00:11:07,763 --> 00:11:10,099 not being moved forward to NIH review. 226 00:11:11,033 --> 00:11:13,969 If this is the first time your team is submitting an R13, 227 00:11:13,969 --> 00:11:15,771 we recommend you partner with colleagues 228 00:11:15,771 --> 00:11:19,141 who have successfully competed for R13 funding. 229 00:11:21,377 --> 00:11:24,213 Also, have a cohesive plan with your team 230 00:11:24,213 --> 00:11:26,949 to discuss the specific aims at the meeting, 231 00:11:29,118 --> 00:11:32,588 and have a clear idea of your diversity plan 232 00:11:32,588 --> 00:11:34,523 that includes not just representation 233 00:11:34,523 --> 00:11:37,660 but true engagement from all participants. 234 00:11:39,261 --> 00:11:41,030 If permission to submit is granted, 235 00:11:41,030 --> 00:11:42,665 you will receive letters documenting 236 00:11:42,665 --> 00:11:47,303 this permission from both OADR and the Administering Institute. 237 00:11:47,303 --> 00:11:48,837 File these letters carefully 238 00:11:48,837 --> 00:11:52,107 because both of them must be combined with a cover letter 239 00:11:53,042 --> 00:11:55,344 that will be submitted with your application. 240 00:11:55,344 --> 00:12:00,015 The application will not move forward if the cover letter 241 00:12:00,015 --> 00:12:03,752 does not include the two permissions to submit letters. 242 00:12:04,286 --> 00:12:05,554 Before you start writing, 243 00:12:05,554 --> 00:12:08,090 carefully reread the NOSI and NOFO 244 00:12:08,090 --> 00:12:10,492 so that you do not forget any requirements 245 00:12:10,492 --> 00:12:12,528 or do work that is not needed. 246 00:12:12,528 --> 00:12:14,730 All instructions will apply to your submission. 247 00:12:14,730 --> 00:12:17,666 I want to flag two important sections in the NOFO. 248 00:12:17,666 --> 00:12:22,204 Section 5 explains how your application will be reviewed, 249 00:12:22,204 --> 00:12:23,839 so refer to this section for guidance 250 00:12:23,839 --> 00:12:25,541 on how to tailor each section. 251 00:12:26,108 --> 00:12:28,344 Section 7 provides contact information 252 00:12:28,344 --> 00:12:29,611 for who will help you 253 00:12:29,611 --> 00:12:31,814 at different stages of the submission process 254 00:12:31,814 --> 00:12:35,217 if you run into issues. If you need help, please confirm 255 00:12:35,217 --> 00:12:37,619 that you are emailing the correct contact. 256 00:12:37,619 --> 00:12:40,456 And finally, make sure that you follow 257 00:12:40,456 --> 00:12:42,291 all the recommendations and instructions 258 00:12:42,291 --> 00:12:46,528 that you receive from OADR and the Administering Institute. 259 00:12:48,931 --> 00:12:50,999 Now that you know what this NOSI is highlighting 260 00:12:50,999 --> 00:12:52,434 and searching for, 261 00:12:52,434 --> 00:12:54,903 we can discuss logistics and instructions relevant 262 00:12:54,903 --> 00:12:57,539 to the submission process. The link in the slide 263 00:12:57,539 --> 00:13:00,843 takes you to the full application submission guide, 264 00:13:00,843 --> 00:13:03,846 and the next set of slides will provide high-level information 265 00:13:03,846 --> 00:13:06,248 for key sections of the application, 266 00:13:06,248 --> 00:13:09,818 taking into consideration the R13-specific requirements. 267 00:13:10,452 --> 00:13:12,287 The next couple of slides after this 268 00:13:12,287 --> 00:13:13,922 will look a little bit busy, 269 00:13:13,922 --> 00:13:16,291 and we will not read through all of them, 270 00:13:16,291 --> 00:13:17,926 but they're there for your reference. 271 00:13:17,926 --> 00:13:19,928 They're meant as a high-level example 272 00:13:19,928 --> 00:13:22,231 of how your application might look like 273 00:13:22,231 --> 00:13:25,100 and as a source of links to the sections you will need. 274 00:13:26,902 --> 00:13:31,006 Okay, now we're here at the example of the table contents. 275 00:13:31,006 --> 00:13:34,777 And this represents what you would see 276 00:13:34,777 --> 00:13:37,379 if this is a new R13 application. 277 00:13:38,013 --> 00:13:40,282 Each line will provide links to help you 278 00:13:40,282 --> 00:13:41,583 find the form and instructions 279 00:13:41,583 --> 00:13:44,353 you need to complete each individual section. 280 00:13:44,353 --> 00:13:45,921 We will discuss each of these sections 281 00:13:45,921 --> 00:13:47,189 in the next couple of slides. 282 00:13:47,189 --> 00:13:49,691 But there's one important point I want to make here. 283 00:13:49,691 --> 00:13:52,961 Please make note of the content limits in the abstract, 284 00:13:52,961 --> 00:13:55,898 narrative, diversity plan, and biosketches. 285 00:13:57,399 --> 00:13:59,134 This is the second part of the table of contents, 286 00:13:59,134 --> 00:14:01,103 which is in 51 slide. 287 00:14:02,204 --> 00:14:04,506 So, in here, you can see that the specific aims 288 00:14:04,506 --> 00:14:07,342 and conference plans also have page limits. 289 00:14:07,342 --> 00:14:10,245 Another point, in R13s, the conference plans 290 00:14:10,245 --> 00:14:12,614 take the place of the research strategy. 291 00:14:13,182 --> 00:14:15,984 For all research applications, the different budget sections 292 00:14:15,984 --> 00:14:20,022 are all entered in one form that is linked here at the top. 293 00:14:22,357 --> 00:14:24,793 Again, keep it in mind that this table of contents 294 00:14:24,793 --> 00:14:26,562 is only meant as an example. 295 00:14:26,562 --> 00:14:28,464 Additional requirements may apply 296 00:14:28,464 --> 00:14:30,599 based on your individual situation 297 00:14:30,599 --> 00:14:33,702 or if the application is a resubmission or a revision. 298 00:14:35,237 --> 00:14:37,739 All rules in the NOFO will apply. 299 00:14:37,739 --> 00:14:40,509 So, always confirm that you're following those instructions, 300 00:14:40,509 --> 00:14:43,078 and remember that all required sections 301 00:14:43,078 --> 00:14:46,982 must be completed for your application to move forward. 302 00:14:50,752 --> 00:14:54,423 Now, let me share some details specific to each section. 303 00:14:55,123 --> 00:14:59,495 And first, how to make sure that your application is considered 304 00:14:59,495 --> 00:15:02,164 for this initiative that we're discussing today. 305 00:15:02,164 --> 00:15:04,867 That information is going to be entered on the first page 306 00:15:04,867 --> 00:15:07,069 you see in that table of contents: 307 00:15:07,069 --> 00:15:11,473 the SF-424 Receipt and Referral Application form. 308 00:15:12,541 --> 00:15:17,779 The orange arrows point at the agency routing identifier field. 309 00:15:17,779 --> 00:15:19,481 And this is box 4b. 310 00:15:19,481 --> 00:15:25,454 The NOSI number -- note NOT-OD-24-145, 311 00:15:25,454 --> 00:15:29,958 as written in the slide, no spaces or quotation marks 312 00:15:29,958 --> 00:15:32,661 must be entered in this field. And this is super important 313 00:15:32,661 --> 00:15:35,097 because if this number is missing from this field, 314 00:15:35,097 --> 00:15:38,400 the application will not be considered for this initiative. 315 00:15:40,435 --> 00:15:43,205 How to include the permission to submit letters 316 00:15:43,205 --> 00:15:44,806 that I mentioned so many times? 317 00:15:44,806 --> 00:15:46,441 Well, the two letters documenting permission 318 00:15:46,441 --> 00:15:47,709 to submit, 319 00:15:47,709 --> 00:15:51,480 again, remember, OADR and the Administrative Institute 320 00:15:51,480 --> 00:15:52,748 will send you letters. 321 00:15:52,748 --> 00:15:59,121 They must be combined with one cover letter into one PDF file. 322 00:15:59,121 --> 00:16:01,323 The two letters must be included. 323 00:16:01,323 --> 00:16:03,525 And if one or both are missing, 324 00:16:03,525 --> 00:16:05,427 the application will not move forward. 325 00:16:06,929 --> 00:16:10,432 Permission to submit letters for new application 326 00:16:10,432 --> 00:16:14,136 cannot be recycled for resubmission or a revision. 327 00:16:14,136 --> 00:16:16,371 Rather, a new letter is required 328 00:16:16,371 --> 00:16:19,474 if you have a resubmission or a revision. 329 00:16:19,474 --> 00:16:23,545 So, just make sure that you remember the six-week due date 330 00:16:23,545 --> 00:16:27,282 before the application is due. That still applies. 331 00:16:27,282 --> 00:16:30,052 You need to request a meeting again, receive the letters, 332 00:16:30,052 --> 00:16:32,521 and when you submit a revision or resubmission, 333 00:16:33,121 --> 00:16:34,523 just confirm that you're submitting 334 00:16:34,523 --> 00:16:36,992 the correct version of the letter. 335 00:16:38,627 --> 00:16:40,262 Permission to submit an application 336 00:16:40,262 --> 00:16:42,431 does not guarantee that the application 337 00:16:42,431 --> 00:16:44,399 will be moved forward to NIH review. 338 00:16:44,399 --> 00:16:46,368 That's because only applications 339 00:16:46,368 --> 00:16:49,871 that are deemed responsive to the terms of both the NOSI 340 00:16:49,871 --> 00:16:52,474 and the NOFO will be moved forward 341 00:16:52,474 --> 00:16:54,242 and considered for this initiative. 342 00:16:54,242 --> 00:16:56,211 And finally, permission to submit 343 00:16:56,211 --> 00:17:00,849 does not mean that you're going to be guaranteed funding. 344 00:17:03,285 --> 00:17:08,624 In terms of the format logistics of submitting the cover letter, 345 00:17:08,624 --> 00:17:11,827 this is going to be uploaded as an attachment 346 00:17:11,827 --> 00:17:13,996 in that form we mentioned earlier 347 00:17:13,996 --> 00:17:16,798 that shows up first in the table of contents, right? 348 00:17:16,798 --> 00:17:19,067 That form that is SF-424, 349 00:17:19,635 --> 00:17:21,837 Receipt and Referral Application form. 350 00:17:21,837 --> 00:17:23,572 And you're going to go to page two. 351 00:17:23,572 --> 00:17:25,674 The last field is 21, 352 00:17:25,674 --> 00:17:27,876 and it says "cover letter attachment." 353 00:17:27,876 --> 00:17:29,244 And just so that you know, 354 00:17:29,244 --> 00:17:32,648 there's all these messages in different forums 355 00:17:33,415 --> 00:17:37,919 that say that many times people submit their cover letter, 356 00:17:37,919 --> 00:17:41,056 for some reason, it ends up in field 20. 357 00:17:41,056 --> 00:17:43,492 So, just be mindful of this and make sure that 358 00:17:43,492 --> 00:17:45,394 when you're attaching the cover letter, 359 00:17:45,394 --> 00:17:48,296 it goes to field 21, "cover letter attachment." 360 00:17:49,431 --> 00:17:51,166 For the cover letter, what you want is to have 361 00:17:51,166 --> 00:17:54,269 that first page be the cover letter you're writing, 362 00:17:54,269 --> 00:17:57,039 addressed to the Division of Receipt and Referral. 363 00:17:57,039 --> 00:18:00,475 And that letter should contain the application title, 364 00:18:00,475 --> 00:18:03,478 the title and number of the NOFO and the NOSI, 365 00:18:03,478 --> 00:18:05,280 and a statement that you have attached 366 00:18:05,280 --> 00:18:06,948 the required documentation, 367 00:18:06,948 --> 00:18:10,018 which means these two letters we keep talking about, right? 368 00:18:10,018 --> 00:18:12,220 And then apart from that, 369 00:18:12,220 --> 00:18:15,724 just combine the two permission letters you receive. 370 00:18:16,358 --> 00:18:20,095 And just so that you know, the cover letter will not become 371 00:18:20,095 --> 00:18:23,098 part of your assembled application. 372 00:18:23,098 --> 00:18:26,735 So, when you go to see your assembled application 373 00:18:26,735 --> 00:18:28,070 in eRA commons, 374 00:18:28,070 --> 00:18:31,339 just don't be worried if you don't see the letters there. 375 00:18:31,339 --> 00:18:32,874 They're not there because they're not shared 376 00:18:32,874 --> 00:18:34,142 with peer reviewers. 377 00:18:34,142 --> 00:18:36,712 They're only used for administrative purposes. 378 00:18:39,214 --> 00:18:43,018 So, another R13 requirement we mentioned in that table 379 00:18:43,018 --> 00:18:45,187 of contents, right, was the diversity plan. 380 00:18:45,687 --> 00:18:47,222 Since it is a unique requirement, 381 00:18:47,222 --> 00:18:50,692 let's go through some important points related to this section. 382 00:18:50,692 --> 00:18:54,563 The biggest reminder is if the diversity plan is missing, 383 00:18:55,097 --> 00:18:56,965 your application will not be reviewed. 384 00:18:56,965 --> 00:19:00,702 There's all these requirements for the system to understand 385 00:19:00,702 --> 00:19:03,271 that the diversity plan is a diversity plan. 386 00:19:03,271 --> 00:19:06,641 So, remember to use the correct required file name that is here, 387 00:19:07,442 --> 00:19:08,744 no spaces. 388 00:19:08,744 --> 00:19:15,050 And if the file name is changed, grants.gov might not interpret 389 00:19:15,050 --> 00:19:17,586 that you submitted your diversity plan, 390 00:19:17,586 --> 00:19:20,088 and it's going to flag an error. 391 00:19:20,088 --> 00:19:22,023 And that will result in the application 392 00:19:22,023 --> 00:19:23,425 not being moved forward 393 00:19:23,425 --> 00:19:27,763 to receipt and referral for further attention. 394 00:19:27,763 --> 00:19:31,366 So, make sure that you submit the diversity plan 395 00:19:31,366 --> 00:19:35,604 using field 12 that is called "Other Attachments" 396 00:19:35,604 --> 00:19:37,205 in the Research 397 00:19:38,840 --> 00:19:41,243 and Other Project Information form, 398 00:19:41,243 --> 00:19:43,178 and that form is linked here for you. 399 00:19:43,845 --> 00:19:47,349 The limit of this plan is one page in length. 400 00:19:47,349 --> 00:19:50,786 And during the review, remember that section that I told you, 401 00:19:50,786 --> 00:19:54,422 Section 5 of the NOFO explains this information in more detail. 402 00:19:54,422 --> 00:19:57,526 During review, the diversity plan will be evaluated 403 00:19:57,526 --> 00:20:00,162 based on how it demonstrates your efforts 404 00:20:00,162 --> 00:20:01,429 to enhance diversity 405 00:20:01,429 --> 00:20:03,999 and increase participation of individuals 406 00:20:03,999 --> 00:20:05,901 from diverse backgrounds, 407 00:20:05,901 --> 00:20:08,036 including underrepresented groups, 408 00:20:08,036 --> 00:20:10,672 in the planning, implementation, and engagement. 409 00:20:10,672 --> 00:20:12,574 Always remember that word, engagement, 410 00:20:12,574 --> 00:20:14,576 in the proposed conference and meetings. 411 00:20:15,911 --> 00:20:17,345 In terms of content, 412 00:20:17,345 --> 00:20:21,016 what is expected to be included in the diversity plan? 413 00:20:21,783 --> 00:20:24,553 You can reference this slide for that information. 414 00:20:25,187 --> 00:20:27,222 In summary, it provides specific information 415 00:20:27,222 --> 00:20:29,357 for how you plan to enhance diversity 416 00:20:29,357 --> 00:20:31,459 by increasing participation of individuals 417 00:20:31,459 --> 00:20:34,062 from diverse backgrounds, like we mentioned before, 418 00:20:34,062 --> 00:20:36,798 and that includes the organizing committee, 419 00:20:36,798 --> 00:20:39,568 speakers, and other participants. 420 00:20:39,568 --> 00:20:41,770 Also, demonstrate how you will create mechanisms 421 00:20:41,770 --> 00:20:43,905 to support not only the representation, 422 00:20:43,905 --> 00:20:46,007 but that word, engagement, comes up again. 423 00:20:47,108 --> 00:20:48,643 Demonstrate, you know, 424 00:20:48,643 --> 00:20:52,147 think about childcare, lactation spaces, 425 00:20:52,147 --> 00:20:54,282 and when you describe your diversity plan, 426 00:20:54,282 --> 00:20:57,152 always consider the geographical conference area 427 00:20:57,686 --> 00:20:59,654 of the participants 428 00:20:59,654 --> 00:21:02,757 and the people who will be part of this effort, 429 00:21:02,757 --> 00:21:05,427 the expected size, the composition, 430 00:21:07,028 --> 00:21:10,298 and how your efforts will be assessed after the fact. 431 00:21:12,567 --> 00:21:14,135 Due to the nature of this effort, 432 00:21:14,135 --> 00:21:17,205 it is important to give strong consideration 433 00:21:17,205 --> 00:21:19,040 to who will be your key personnel. 434 00:21:19,040 --> 00:21:20,375 And why is this? 435 00:21:20,375 --> 00:21:22,944 Because you will need a wide range of expertise 436 00:21:22,944 --> 00:21:26,381 and experiences to come up with endorsable CDEs 437 00:21:26,381 --> 00:21:29,551 that move autoimmune disease research forward. 438 00:21:29,551 --> 00:21:31,386 And remember, part of this effort 439 00:21:31,386 --> 00:21:33,922 is reaching consensus on the CDEs. 440 00:21:33,922 --> 00:21:37,225 So, carefully consider the different types of expertise 441 00:21:37,225 --> 00:21:40,095 needed in the context of the disease area of focus. 442 00:21:40,095 --> 00:21:42,931 For example, clinicians, scientists, 443 00:21:42,931 --> 00:21:44,799 clinical research coordinators, 444 00:21:44,799 --> 00:21:47,636 epidemiologists, data scientists, statisticians, 445 00:21:47,636 --> 00:21:50,872 and other people from the research community 446 00:21:50,872 --> 00:21:52,607 or the clinical community. 447 00:21:52,607 --> 00:21:54,809 And then, also remember the people living 448 00:21:54,809 --> 00:21:58,747 with autoimmune diseases, advocacy groups, and caregivers. 449 00:22:00,048 --> 00:22:03,151 Ensure that there is balanced and adequate representation 450 00:22:03,151 --> 00:22:06,321 of different perspectives in the field, again, 451 00:22:06,321 --> 00:22:07,589 including the voice of people 452 00:22:07,589 --> 00:22:09,958 living with autoimmune diseases and caregivers. 453 00:22:10,892 --> 00:22:13,295 Grants.gov requires a valid 454 00:22:13,295 --> 00:22:17,832 Commons ID for each key person in the application, 455 00:22:17,832 --> 00:22:20,936 and this can become a rate-limiting factor 456 00:22:20,936 --> 00:22:22,470 if you don't have that ahead of time. 457 00:22:22,470 --> 00:22:24,506 So always, when you're going to consider 458 00:22:24,506 --> 00:22:27,842 and ask a person to be part of your key personnel, 459 00:22:27,842 --> 00:22:30,545 ask them if they already have a valid Commons ID. 460 00:22:30,545 --> 00:22:33,448 And if they don't, ask them to take care of it right away. 461 00:22:34,549 --> 00:22:37,652 For key participants who are not key personnel, 462 00:22:37,652 --> 00:22:40,255 provide letters of support documenting 463 00:22:40,255 --> 00:22:41,489 that they want to participate, 464 00:22:41,489 --> 00:22:45,126 that they will support this effort when it is appropriate. 465 00:22:45,126 --> 00:22:47,228 For example, think of everybody who's telling you, 466 00:22:47,228 --> 00:22:49,030 "Okay, I'm going to be part of this effort," 467 00:22:49,030 --> 00:22:52,033 speakers, presenters, moderators, 468 00:22:52,033 --> 00:22:54,536 and always remember the advocacy groups, 469 00:22:54,536 --> 00:22:57,339 the people living with this disease, and the caregivers. 470 00:22:59,774 --> 00:23:03,278 Biosketches are required for each senior key person 471 00:23:03,278 --> 00:23:04,546 in your application, 472 00:23:04,546 --> 00:23:07,916 so please make sure that they're using the correct format, 473 00:23:07,916 --> 00:23:10,919 and remember that they need to use a non-fellowship template. 474 00:23:13,388 --> 00:23:15,857 The QR code in the slide links 475 00:23:15,857 --> 00:23:19,594 to the current instructions for biosketches. 476 00:23:20,929 --> 00:23:23,198 Confirm that the personal statements 477 00:23:23,198 --> 00:23:28,303 reflect the R13 submission and that part of the biosketch 478 00:23:28,303 --> 00:23:30,572 is not talking about a different application. 479 00:23:31,139 --> 00:23:32,841 For the purposes of R13, 480 00:23:32,841 --> 00:23:35,310 they must describe how past experiences, training, 481 00:23:35,310 --> 00:23:38,446 and expertise will contribute to consensus building, 482 00:23:38,446 --> 00:23:40,749 increasing the participation of individuals 483 00:23:40,749 --> 00:23:43,251 from diverse backgrounds, and remember always, 484 00:23:43,251 --> 00:23:46,154 to think of people from underrepresented groups 485 00:23:46,154 --> 00:23:48,423 and development of endorsable CDEs 486 00:23:48,423 --> 00:23:50,992 in the disease area of focus. 487 00:23:52,093 --> 00:23:55,897 So, also remember that all of the attachments 488 00:23:55,897 --> 00:23:57,165 in the application, 489 00:23:57,165 --> 00:24:00,435 and this is also relevant to the diversity plan, 490 00:24:00,435 --> 00:24:02,937 they have to follow the formatting requirements 491 00:24:02,937 --> 00:24:04,472 for attachments. 492 00:24:04,472 --> 00:24:07,175 And that information is linked in the slide, 493 00:24:07,776 --> 00:24:09,177 where you can find instructions 494 00:24:09,177 --> 00:24:11,112 for formatting all the PDF documents 495 00:24:11,112 --> 00:24:13,515 that are going to be attached to the submission. 496 00:24:16,851 --> 00:24:19,220 So, what is allowable in the budget? 497 00:24:19,220 --> 00:24:23,925 You might remember that in the slide talking about the NOSI, 498 00:24:23,925 --> 00:24:26,461 I said the award period is one year, 499 00:24:26,461 --> 00:24:29,297 but let me give you a bit more context about that. 500 00:24:29,297 --> 00:24:31,766 If you're doing this type of project for the first time 501 00:24:31,766 --> 00:24:34,569 and are unsure of how it will evolve, 502 00:24:34,569 --> 00:24:36,771 you can initially request one year of funding 503 00:24:36,771 --> 00:24:40,008 for a set of CDEs 504 00:24:40,008 --> 00:24:43,311 and then submit future applications for additional CDEs 505 00:24:43,311 --> 00:24:44,913 if that is appropriate. 506 00:24:45,914 --> 00:24:47,382 Another option is if you're considering 507 00:24:47,382 --> 00:24:49,217 requesting multiple years of funding. 508 00:24:49,217 --> 00:24:51,753 Just keep in mind, this needs to be discussed 509 00:24:51,753 --> 00:24:54,089 during the meeting with OADR 510 00:24:54,089 --> 00:24:57,926 and the Administering Institute, and if you do that, 511 00:24:57,926 --> 00:24:59,527 we're going to ask that a clear plan 512 00:24:59,527 --> 00:25:04,799 with concrete milestones of CDEs for each year must be specified. 513 00:25:06,301 --> 00:25:09,304 The funds can be applied to salary, conference facilities, 514 00:25:09,304 --> 00:25:13,241 online conference platforms, publications, as appropriate, 515 00:25:13,241 --> 00:25:16,945 as you think is needed. Indirect costs are not allowed. 516 00:25:17,445 --> 00:25:20,515 The NOFO Section 4 will give you all the details 517 00:25:20,515 --> 00:25:23,284 about what can be considered under funding. 518 00:25:23,284 --> 00:25:26,821 The award budget is $75,000 total cost 519 00:25:26,821 --> 00:25:28,423 for one year of funding. 520 00:25:28,990 --> 00:25:30,825 Provide a narrative justification 521 00:25:30,825 --> 00:25:32,861 for each proposed personnel addition, 522 00:25:32,861 --> 00:25:35,663 including the role they will play in the conference 523 00:25:35,663 --> 00:25:37,365 and the proposed level of effort. 524 00:25:37,866 --> 00:25:41,436 Include information regarding efforts to obtain funding 525 00:25:41,436 --> 00:25:43,838 for this conference from other sources. 526 00:25:43,838 --> 00:25:46,674 We include that information there, too. 527 00:25:46,674 --> 00:25:50,912 Reminder, as you write this budget and put it together, 528 00:25:50,912 --> 00:25:53,882 the final product must be endorsable CDEs 529 00:25:53,882 --> 00:25:56,584 that the community has come to consensus on. 530 00:25:58,286 --> 00:26:00,255 How to write the specific aims? 531 00:26:00,255 --> 00:26:02,223 Well, consider if the specific aims 532 00:26:02,223 --> 00:26:06,694 that you originally sent to OADR and the Administering Institute 533 00:26:06,694 --> 00:26:09,631 for that meeting to request permission to submit. 534 00:26:10,565 --> 00:26:12,200 At this point, 535 00:26:12,200 --> 00:26:15,870 by the point of receiving the permission to submit 536 00:26:15,870 --> 00:26:19,007 and putting together your application, there might be -- 537 00:26:19,007 --> 00:26:21,843 it might be needed to change some parts of this. 538 00:26:21,843 --> 00:26:24,746 So, always confirm that all of these 539 00:26:24,746 --> 00:26:26,614 are appropriately described, 540 00:26:26,614 --> 00:26:29,117 and also take into account all the guidance 541 00:26:29,117 --> 00:26:33,021 you receive from OADR and the Administering Institute. 542 00:26:33,922 --> 00:26:35,723 Revisit the disease area of focus, 543 00:26:36,257 --> 00:26:39,427 the landscape analysis of the current state of the field, 544 00:26:39,427 --> 00:26:41,996 and again, look at the list of NIH-endorsed CDEs. 545 00:26:41,996 --> 00:26:44,499 Confirm that you're working on new ones, 546 00:26:44,499 --> 00:26:47,001 and provide specific details. This is key. 547 00:26:47,001 --> 00:26:48,836 You need specific details of the approach 548 00:26:48,836 --> 00:26:51,673 you're going to use for that consensus-building exercise 549 00:26:53,541 --> 00:26:58,079 to show that you have a plan to bring the community 550 00:26:58,079 --> 00:27:01,482 to consensus around the specific components of CDE development 551 00:27:01,482 --> 00:27:03,351 that you're proposing. 552 00:27:03,351 --> 00:27:07,055 The applicants are expected to work in consultation with OADR 553 00:27:07,055 --> 00:27:09,924 and the Administering Institute program staff 554 00:27:09,924 --> 00:27:14,495 to ensure that the CDEs developed in this process 555 00:27:14,495 --> 00:27:18,099 meet the requirements of the NIH CDE Governance Committee. 556 00:27:18,700 --> 00:27:20,335 Keep in mind that reviewers will evaluate 557 00:27:20,335 --> 00:27:23,338 if the conference or meetings or approach 558 00:27:23,338 --> 00:27:26,441 that you're going to use addresses an important point, 559 00:27:26,441 --> 00:27:28,843 and how scientific knowledge or clinical practice 560 00:27:28,843 --> 00:27:31,746 will be advanced. Keep this in mind as you write 561 00:27:31,746 --> 00:27:35,416 because it is important that this is clear to the reviewers 562 00:27:35,416 --> 00:27:38,286 when they read your specific aims and the conference plan. 563 00:27:39,120 --> 00:27:41,923 Since the final product must be endorsed with CDEs, 564 00:27:41,923 --> 00:27:45,026 it is expected that the specific aims will focus 565 00:27:45,026 --> 00:27:46,894 on bringing the community together 566 00:27:46,894 --> 00:27:50,131 to build consensus and deliver those CDEs. 567 00:27:50,131 --> 00:27:52,767 It is up to the applicants to strategize 568 00:27:52,767 --> 00:27:55,136 which CDEs to target and when. 569 00:27:57,405 --> 00:27:59,874 What information is needed for the conference plan? 570 00:27:59,874 --> 00:28:02,110 So, this is very clearly explained. 571 00:28:02,110 --> 00:28:05,013 I have the slides here as reference, 572 00:28:05,013 --> 00:28:06,414 but always look at the NOFO 573 00:28:06,414 --> 00:28:10,451 because this part is very clearly explained in the NOFO. 574 00:28:10,451 --> 00:28:12,787 But also remember that you need to think 575 00:28:12,787 --> 00:28:14,956 in the context of these NOSIs. 576 00:28:14,956 --> 00:28:17,692 So, start with describing the approach that you propose 577 00:28:17,692 --> 00:28:20,061 to use to achieve those endorsable CDEs. 578 00:28:20,061 --> 00:28:23,398 And remember, you can decide what approach to use. 579 00:28:23,398 --> 00:28:26,434 And also, think of the pre-work leading up to the conference 580 00:28:26,434 --> 00:28:28,036 or meeting you propose, 581 00:28:28,036 --> 00:28:30,672 and describe that clearly in the application. 582 00:28:31,472 --> 00:28:34,008 Describe the objectives, the specific problem, 583 00:28:34,008 --> 00:28:36,344 and all the logistical arrangements 584 00:28:36,344 --> 00:28:37,945 that you plan to use. 585 00:28:38,813 --> 00:28:42,283 Outline the proposed agenda and the timeline, 586 00:28:42,283 --> 00:28:44,585 and in the timeline, include concrete, 587 00:28:44,585 --> 00:28:46,387 achievable milestones 588 00:28:46,387 --> 00:28:49,490 for building the consensus towards endorsable CDEs. 589 00:28:49,490 --> 00:28:52,493 And this needs to be covered during the period of the award. 590 00:28:53,394 --> 00:28:55,997 Provide a detailed justification for the approach 591 00:28:55,997 --> 00:29:00,435 that you have chosen to take to build that consensus. 592 00:29:00,435 --> 00:29:03,938 And remember to include in that justification 593 00:29:03,938 --> 00:29:06,207 the scientific and clinical need, 594 00:29:06,207 --> 00:29:09,143 the timeliness of the effort, 595 00:29:09,143 --> 00:29:11,879 and the usefulness to the scientific community 596 00:29:11,879 --> 00:29:14,882 and to people living with autoimmune diseases. 597 00:29:15,750 --> 00:29:19,387 Additional information needed for the conference plan. 598 00:29:19,387 --> 00:29:22,357 For in-person meeting attendance for some individuals 599 00:29:22,357 --> 00:29:25,727 will be dependent on family situations 600 00:29:25,727 --> 00:29:29,831 or other situations that may affect their ability to come 601 00:29:31,766 --> 00:29:35,036 to whatever effort you're choosing to move forward with. 602 00:29:35,803 --> 00:29:39,707 So, describe in the application the plans to identify resources 603 00:29:39,707 --> 00:29:42,276 for childcare and other types of family care 604 00:29:42,810 --> 00:29:45,480 at or near the conference and meeting site, 605 00:29:45,480 --> 00:29:50,284 so that when individuals have family care responsibilities, 606 00:29:50,284 --> 00:29:53,788 that does not stop them from being part of this effort. 607 00:29:54,555 --> 00:29:57,158 The information should allow attendees to arrange 608 00:29:57,158 --> 00:29:59,427 as needed for their specific situation. 609 00:29:59,961 --> 00:30:03,431 And we strongly encourage that a hybrid option is always 610 00:30:03,431 --> 00:30:06,901 available to account for unexpected events 611 00:30:06,901 --> 00:30:10,338 like getting sick or having a family member get sick. 612 00:30:11,139 --> 00:30:12,607 Describe the composition and role 613 00:30:12,607 --> 00:30:13,875 of the organizing committee 614 00:30:13,875 --> 00:30:16,244 and provide the names and credentials 615 00:30:16,244 --> 00:30:17,812 of the key participants. 616 00:30:17,812 --> 00:30:21,616 And again, I want to remind everybody 617 00:30:21,616 --> 00:30:24,218 to think of everybody that is included there, 618 00:30:24,218 --> 00:30:26,487 speakers, presenters, moderators, 619 00:30:26,487 --> 00:30:29,023 the advocacy group representatives, 620 00:30:29,023 --> 00:30:31,726 people living with autoimmune diseases, and caregiver. 621 00:30:32,260 --> 00:30:36,264 And include the basis for why these people were selected. 622 00:30:37,932 --> 00:30:40,168 Describe how advocacy groups, caregivers, 623 00:30:40,168 --> 00:30:42,170 and people living with autoimmune diseases 624 00:30:42,170 --> 00:30:44,639 will be part of this effort. 625 00:30:44,639 --> 00:30:47,408 It is so important to garner their input 626 00:30:48,075 --> 00:30:50,144 when completing the CDE questionnaires. 627 00:30:50,144 --> 00:30:52,046 And some questions that come to mind, 628 00:30:52,046 --> 00:30:54,182 but there are many others, are: 629 00:30:54,182 --> 00:30:56,951 Are the questionnaires too burdensome? 630 00:30:57,885 --> 00:31:02,089 Do they measure things that matter to them? 631 00:31:02,089 --> 00:31:06,794 And do the new CDEs will measure things that matter to them? 632 00:31:07,995 --> 00:31:10,465 Estimate anticipated geographic conference area 633 00:31:10,465 --> 00:31:12,166 where participants will come from, 634 00:31:12,166 --> 00:31:15,203 the expected size and composition of the audience, 635 00:31:15,203 --> 00:31:17,171 as well as a method of selection. 636 00:31:18,406 --> 00:31:22,210 Publicity and dissemination of the panel public 637 00:31:22,210 --> 00:31:24,545 are also part of the conference plan. 638 00:31:24,545 --> 00:31:27,148 So, please don't forget to address this 639 00:31:27,148 --> 00:31:30,117 in those six-page limit that is the conference plan. 640 00:31:30,618 --> 00:31:33,221 Describe the plans for publicizing the conference 641 00:31:33,754 --> 00:31:35,490 to all interested participants. 642 00:31:35,490 --> 00:31:37,792 How are you going to raise awareness 643 00:31:37,792 --> 00:31:40,561 of what's happening so that people who are interested 644 00:31:40,561 --> 00:31:43,898 in being part of the effort can be part of the effort? 645 00:31:43,898 --> 00:31:47,435 And keep in mind, publishing the proceedings. 646 00:31:48,269 --> 00:31:50,071 I know that that's not required, 647 00:31:50,071 --> 00:31:52,640 but it's strongly, strongly encouraged. 648 00:31:52,640 --> 00:31:54,041 Publishing costs, by the way, 649 00:31:54,041 --> 00:31:56,277 are an allowable cost under the budget. 650 00:31:57,144 --> 00:32:00,414 Include specifics on groups, associations, institutions, 651 00:32:00,414 --> 00:32:03,417 among others, that will be contacted in efforts 652 00:32:03,417 --> 00:32:06,354 to expand diverse participation 653 00:32:06,354 --> 00:32:10,525 in every role of conference or meeting 654 00:32:10,525 --> 00:32:12,393 or approach you're going to use. 655 00:32:12,393 --> 00:32:16,898 Identify related conference that have been held in the past 656 00:32:16,898 --> 00:32:18,966 within the last three years 657 00:32:18,966 --> 00:32:24,472 and explain how this conference is unique or similar 658 00:32:24,472 --> 00:32:28,609 and how this conference can move the field forward. 659 00:32:30,912 --> 00:32:34,949 So now, we can talk about common pitfalls and solutions. 660 00:32:34,949 --> 00:32:37,852 We want to remind everybody, if this is your first time 661 00:32:37,852 --> 00:32:40,488 submitting an R13, partner with an institution 662 00:32:40,488 --> 00:32:43,824 that has successfully competed for R13 funding. 663 00:32:44,358 --> 00:32:46,928 They're going to be able to tell you things about what to do, 664 00:32:46,928 --> 00:32:49,463 what not to do, what to expect, et cetera. 665 00:32:50,431 --> 00:32:54,335 Attachments must comply with formatting requirements 666 00:32:54,335 --> 00:32:57,405 for the system to upload the PDF document 667 00:32:57,405 --> 00:32:59,507 you are trying to attach. 668 00:32:59,507 --> 00:33:01,642 If you don't use the correct format, 669 00:33:02,209 --> 00:33:04,946 the system is not going to recognize the attachment, 670 00:33:04,946 --> 00:33:08,849 and it will not compile it with the assembled application. 671 00:33:08,849 --> 00:33:10,985 I have some examples here, but there are others. 672 00:33:10,985 --> 00:33:12,920 Some examples to keep in mind 673 00:33:12,920 --> 00:33:16,223 are that the file name has character limits. 674 00:33:16,223 --> 00:33:18,626 Remember, the hyperlinks are not allowed 675 00:33:18,626 --> 00:33:20,861 in any part of the application 676 00:33:20,861 --> 00:33:24,198 except they are allowed in the biosketch, 677 00:33:24,198 --> 00:33:28,603 but only for you to provide the publication list 678 00:33:28,603 --> 00:33:31,539 in the biosketch. Those are two examples. 679 00:33:31,539 --> 00:33:33,541 So, go to the formatting requirements 680 00:33:33,541 --> 00:33:36,110 to know what is important to keep in mind 681 00:33:36,110 --> 00:33:38,379 so that the grants.gov 682 00:33:38,379 --> 00:33:40,881 recognizes the attachment you're trying to upload. 683 00:33:42,783 --> 00:33:49,590 And the biggest solution to problems 684 00:33:49,590 --> 00:33:53,094 that people encounter is to submit early 685 00:33:53,094 --> 00:33:56,998 and view your application before the due date. 686 00:33:56,998 --> 00:33:59,033 When you view your assembled application 687 00:33:59,033 --> 00:34:02,436 and related documents using the eRA Commons Status, 688 00:34:02,436 --> 00:34:05,272 you can confirm that nothing is missing 689 00:34:05,272 --> 00:34:08,242 or that the application was not corrupted 690 00:34:08,242 --> 00:34:11,445 when grants.gov uploaded that PDF document. 691 00:34:11,445 --> 00:34:13,948 This has been known to happen to other people. 692 00:34:14,682 --> 00:34:17,718 If you submit at least two days prior to the deadline, 693 00:34:17,718 --> 00:34:21,722 that allows you time to make corrections before the deadline. 694 00:34:21,722 --> 00:34:24,625 Keep in mind that that two-day viewing window 695 00:34:24,625 --> 00:34:27,862 allows corrections but does not extend the deadline. 696 00:34:27,862 --> 00:34:30,264 That's why it's important to do it early. 697 00:34:30,264 --> 00:34:34,268 If you receive emails from grants.gov notifying you 698 00:34:34,268 --> 00:34:36,170 that there were submission errors, 699 00:34:36,170 --> 00:34:38,639 these submission errors must be resolved 700 00:34:38,639 --> 00:34:41,142 before the application moves forward 701 00:34:41,142 --> 00:34:45,713 from the grants.gov platform to receipt and referral. 702 00:34:45,713 --> 00:34:49,383 If you do not see your application in eRA Commons, 703 00:34:49,383 --> 00:34:52,286 that means your application was not moved forward 704 00:34:52,286 --> 00:34:55,022 from grants.gov to receipt and referral. 705 00:34:55,022 --> 00:34:58,426 Remember that the NOFO has contact information 706 00:34:58,426 --> 00:35:01,362 for when you run into issues during the submission process. 707 00:35:02,363 --> 00:35:06,367 This slide is here just so that you know to raise awareness 708 00:35:06,367 --> 00:35:11,639 that CSR has published guidance for NIH grant applicants, 709 00:35:11,639 --> 00:35:13,607 and it addresses a lot of the topics 710 00:35:13,607 --> 00:35:16,343 that we've discussed today and others. 711 00:35:16,343 --> 00:35:19,280 So, here's an example of how that infographics look like, 712 00:35:19,280 --> 00:35:21,949 but you also have the link and the QR code 713 00:35:21,949 --> 00:35:23,517 that will take you there. 714 00:35:25,152 --> 00:35:28,089 And finally, I wanted to leave you with the due dates 715 00:35:28,089 --> 00:35:30,057 so that you keep in mind -- 716 00:35:30,057 --> 00:35:34,462 if you're submitting for whichever due date you choose -- 717 00:35:35,329 --> 00:35:38,099 you know when is the due date to reach out to OADR 718 00:35:38,099 --> 00:35:40,534 so that you can request permission to submit, 719 00:35:40,534 --> 00:35:41,736 have the meeting done, 720 00:35:41,736 --> 00:35:45,372 and receive the letters on time so that your submission goes in. 721 00:35:47,274 --> 00:35:50,311 And finally, I want to say thank you. 722 00:35:50,311 --> 00:35:54,982 Thank you for your interest in this funding opportunity. 723 00:35:54,982 --> 00:35:57,218 Thank you for your attention today, 724 00:35:57,218 --> 00:36:02,123 and thank you for your interest in the work being done by OADR. 725 00:36:02,123 --> 00:36:04,225 Here are -- if you have questions, 726 00:36:04,225 --> 00:36:07,628 here are contact information so that you can reach out to us. 727 00:36:08,496 --> 00:36:13,067 Very soon, when you see this video on the website, 728 00:36:13,067 --> 00:36:17,271 you will also have access to the slides so that you have -- 729 00:36:17,905 --> 00:36:20,374 so you can use all the links that are provided 730 00:36:21,075 --> 00:36:23,110 when you are submitting your application. 731 00:36:23,878 --> 00:36:25,446 Thank you again.