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USING THIS GUIDANCE
For the purposes of this Appendix Guidance, examples of completed tables are provided as they might have been compiled by a hypothetical “Urban University CFAR” for submission to NIH for their current reporting period, which covers Urban CFAR’s Project Year YR10 (8/1/14 – 7/31/15).
The complete list of YR10 Urban CFAR users who appear in this guidance is provided below. For each individual listed this includes: PI/PD name, where s/he is from, what CFAR User Categories s/he falls into, what roles s/he held within the CFAR, and the CFAR Cores and SWGs that provided support of some sort for him or her during the current reporting period.
All Urban CFAR Users in YR10
Name / Location / Categories / Roles* / CORES / SWGB / C / D / F / H / J / 1 / 2
1. / Baba, Ali / Urban U / 2,5,6 / CU / X / X
2. / Badenov, Boris / Urban U / 2 / CU / X / X / X / X
3. / Banzai, Buckeroo / Urban U / 1 / BDC,CU / X / X / X / X / X
4. / Beckett, Sam / Urban U / 1 / CU / X / X / X / X
5. / Boop, Betty / Suburban CFAR / 3, / CU / X / X
6. / Bullfrog, Jeremiah W.A. / Urban U / 1 / CU / X
7. / Calvin, Susan / Urban U / 1 / CD,CU,SD / X / X / X / X
8. / Coyote, Wile E. / Suburban CFAR / 4,5 / CU / X / X / X / X / X
9. / Croft, Lara / Urban U / 1,5 / CU / X / X
10. / Durga, Devi / YRGC, Chennai / 4,5,6 / CU / X / X / X
11. / Doolittle, John / Urban U / 3,5 / CU / X / X / X / X
12. / Explorer, Dora T. / Urban U / 3,5 / CU / X / X / X / X
13. / Falken, Stephen / Urban U / 3 / CU / X / X / X / X
14. / Hackwrench, Gadget / Urban U / 4,5, 6 / CU / X / X / X
15. / Jones, Indiana / Urban U / 1 / BDC,CU / X / X / X
16. / Mephisto, Alphonse / Urban U / 2,5 / CU,SM / X / X / X / X / X
17. / Moreau, N.F.N. / Urban U / 2,5 / CU,SM / X / X / X / X
18. / Neutron, Jimmy / Rural CFAR / 1 / BDC,CU / X / X
19. / Omega, Zenith / Urban U / 1 / BDC,CU / X / X / X / X / X / X
20. / Scully, Dana / Area 51 D-CFAR / 3 / SM / X
21. / Shango, Bumba / KwaZulu-Natal / 4,5,6 / CU / X / X / X
22. / Stein, Francis N. (Frank) / Urban U / 2 / CU / X / X
23. / Who, Doctor / Urban U / 2,5 / CU / X / X
*CD=Core Director, CU=Core User, SD=SWG Director, SM=SWG Member, BDC=Big Dogs Council
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APPENDICES TABLE OF CONTENTS
The purpose of the Appendices Table of Contents is to help readers navigate to specific sections within the Appendices. When constructing your Table of Contents, follow the format provided below.
Appendix:
A
A.1: [XXXX] FRB projects supported by the CFAR 2
A.2: Other YR[#] NIH-funded projects supported by the CFAR
B
B.1: External Advisory Board Report
B.2: Internal Advisory Board Report
C
C.1: All Core B activities
C.2: New Awards: Abstracts, progress reports
C.3: Active Projects: Progress reports
C.4: Newly Completed Projects: Summary reports
D
D.1: Core [X] ([Name]) Utilization Table and Other Significant Activities
D.2: Core [X] ([Name]) Utilization Table and Other Significant Activities
Note: Each Science Core should appear in its own appendix subsection.
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APPENDIX A: Support for NIH-funded Projects
A.1
PURPOSE: To document the support that CFAR Cores provided to projects appearing on the FRB.
· Label the table with the NIH fiscal year whose FRB information is being reported. (See example below)
· Include one row on the table for each row appearing on the “ALLOW” tab of the most recent FRB report Excel sheet
o include those projects for which no Core assistance was provided
· Do NOT submit the actual FRB Excel spreadsheet with your report
· For each separate project list the Core(s) that provided a specific type of support for the project:
consultation (C), equipment or space (E/S), materials (M), services (S), training (T) or other (O) – for that project.
· Edit the standard “Roles” legend to include roles that are specific to your CFAR
[Example from Urban CFAR’s appendix A
2013 FRB “Allow” Tab Projects Supported by the CFAR
PI / Roles* / Categories / Grant Title / Grant # / CORES THAT PROVIDED SUPPORTC / E/S / M / S / T / O
Banzai, Buckeroo / CU, BDC / 1 / Giraffe models of HIV-associated head and neck cancers / P01 CA555121 / H / D / F
Beckett, Sam / CD, CU / 1 / Quantum leap: Time travel as a novel HIV prevention strategy / R29 MH010101 / C / F / C
Bullfrog, Jeremiah W. A. / CU / 1 / Joy to the fishes in the deep blue sea: The development of a Zebrafish dendritic cell model in HIV / R37 CA010000 / H / H / H
Croft, Lara / CU / 1 / Archeological evidence of HIV in Egyptian tombs / R23 AI555555 / J / J / J
Omega, Zenith / CU, BDC / 1 / Aerosolized delivery of a cure for HIV / R01 DA54321 / F,H,2 / H / C,D / F,J / H / 2
* CD=Core Director, CU=Core User, BDC=Big Dogs Council
A.2
PURPOSE: To document the support that CFAR Cores provided to projects NOT appearing on the most recent FRB.
· Include a row for each NIH-funded project supported by the CFAR in the current reporting period, that does not appear in Appendix A.1
o Do NOT include NIH-funded projects for which no CFAR Core assistance was provided
· For each separate project list the Core(s) that provided a specific type of support for the project:
consultation (C), equipment or space (E/S), materials (M), services (S), training (T) or other (O) – for that project.
· Edit the standard “Roles” legend to include roles that are specific to your CFAR (see example below)
[The example table below is not comprehensive for the Urban CFAR’s Y10 reporting period]
Other NIH-funded Projects Supported by the CFAR
Name / Roles* / Categories / Grant Title / Grant # / CORES/SWGs THAT PROVIDED SUPPORTC / E/S / M / S / T / O
Badenov, Boris / CU, BDC / 2 / Using moose and squirrel to detect HIV in former Soviet countries / D43 TW555121 / H, C / H / F / J
Baba, Ali / 2,5 / Are opened sesames a magic bullet for AIDS-related cancer control? / NCI Admin Supplement / B / J / J
Banzai, Buckeroo / CU, BDC / 1 / Innovative research housing for a griffin colony / C06 0D018248 / J / 1
Calvin, Susan / CU, CD, SD / 1 / Environmental obstacles to the use of sentient robots to provide HIV care in jungle and dessert settings / Core B / B / J / B
Doolittle, John / CU / 3,5 / Increasing Recruitment of Female Centaurs (“Fe-Mares”) in HIV Research / Core B / B, C / D / C / F / B
Explorer, Dora / CU / 3,5 / Where in the World is HIV? / Core B / B, H / D / H / F / B
Hackwrench, Gadget / CU / 4,5,6 / New technologies for a rapid HIV test based on measuring aura color / NCCAM Admin Sup. / B / H / F / H
Jones, Indiana / BDC, CU / 1 / Arc of the covenant: Histo-religious distinctions in responses to HIV and AIDS / R36 MD200002 / H / F / J
Mephisto, Alphonse / CU, SM / 2,5 / Nutritional Requirements of Vegan-Carnivore Chimera / Core B / B, H / F, J / B
Neutron, Jimmy / BDC, CU / 1 / Adapting alien technology for use in cloning CD4+ effector memory T cells / R21 AI989898 / J / H / H
* CD=Core Director, CU=Core User, SD=SWG Director, BDC=Big Dogs Council
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Program Director/Principal Investigator (Last, First, Middle): Curran, James W.
Appendix B: Advisory Committee Findings
The purpose of Appendix B is to describe the strategic planning recommendations that have been provided to your CFAR by committees established specifically for that purpose.
Appendix B.1
Appendix B.1 should include the report from the most recent meeting of your External Advisory Board, if one has been held since the last progress report was submitted.
If no meeting of the External Advisory Board was held in the current reporting period say so here.
Do not include meeting agendas or materials provided to Advisory Board members
Appendix B.2
The purpose of Appendix B.2 is to describe the recommendations and actions arising from any major meetings of your Internal Advisory Board (IAB) or other internal CFAR committees that were established specifically to provide scientific review and advice to the CFAR.
If no IAB meetings were held in the current reporting period say so here.
Do not include meeting agendas or materials provided to advisory committee members
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Appendix C.1 – All Core B Activities
PURPOSE: To provide the specifics for each funding application received by Core B in response to the mechanisms described in the “Application Summary Table” contained in the Core B narrative.
The example tables below are provided to illustrate the type of information you would provide for some of the mechanisms that were used in the examples provided in the Core B narrative Guidance. It is not expected that CFARs will provide these exact funding mechanisms.
The regulatory column is to ensure regulatory approvals (IRB, IACUC, HS/IRB Exemptions, and etc.) are current and up to date for supplement and pilot awards. Include the type of regulatory permission and the date of expiration for each. If a study has multiple institutions and/or sites, each applicable IRB expiration date must be listed.
If a study required clinical and/or international clearance, note yes and the type, or none required in the column “Clinical and/or Int’l Clearance Required”
Do not include paper copies of the regulatory documents.
Regulatory permission types include, but not restricted to:
· Domestic IRB Approvals
· International IRB Approvals
· IACUC Approval
· IBC Approvals
· HS/IRB Exemptions
· IRB Authorization Agreement Date
IRB approvals must be one year approvals or acknowledgement of a yearly review. IRB approvals must cover the duration of the study in which human subjects research was conducted.
ADMINISTRATIVE SUPPLEMENT APPLICATIONS AND AWARDS
The table below should list administrative supplements received since the last progress report was submitted. For each project listed below provide and abstract and progress report, as applicable, in Appendix C.2.1.
ADMINISTRATIVE SUPPLEMENTS: NEWLY FUNDED
PD(s) / Category / Mentor / Date Awarded / Institute / Title / Clinical and/or Int’l Clearance Required? (Y/N) / Regulatory Permission Type(s) and Expiration DateBaba, Ail / 2,5,6 / Banzai Buckeroo / 08/01/14 / NCI / Are open sesames a magic bullet for AIDS-related cancer control?” / Yes, Clinical / Urban U. IRB Exp. 12/6/2016
The table below should list administrative supplement applications submitted to NIH that were not funded and describe what actions were subsequently taken.
ADMINISTRATIVE SUPPLEMENT APPLICATIONS: NOT FUNDED
Applicant / Category / Applied / Title / OutcomeFalken, Stephen / 3 / 11/1/14 / The use of artificial intelligence in HIV prevention / Research hypothesis is being rethought under mentor’s supervision (Alan Turing)
The table below should list administrative supplements that have already been reported in a previous progress report and are still active. For each project listed below provide a progress report in Appendix C.3.1. Also provide, in Appendix C.5, updated outcomes to date via the NIH’s Cumulative Outcomes Summary.
ADMINISTRATIVE SUPPLEMENTS: ACTIVE
PI(s) / Category / Date Awarded / Institute / Title / Clinical and/or Int’l Clearance Required? (Y/N) / Regulatory Permission Type(s) and Expiration DateShango, Bumba & Devi, Durga / 4,5,6
4,5,6 / 10/01/13 / NIAID / South-South partnerships in AIDS vaccine research / Yes, International and Clinical / Urban U. IRB Exp. 7/7/2016
South African IRB Exp. 9/2/2016
The table below should list administrative supplements that finished their funded activities after the last progress report was submitted. For each project include a progress report in Appendix C.4.1. Also provide, in Appendix C.5, updated outcomes to date via the NIH’s Cumulative Outcomes Summary.
ADMINISTRATIVE SUPPLEMENTS: NEWLY COMPLETED
PI(s) / Category / Date Completed / Institute / Title / Clinical and/or Int’l Clearance Required? (Y/N) / Regulatory Permission Type(s) and Expiration DateHackwrench, Gadget / 4,5,6 / 07/15/14 / NCCAM / New technologies for a rapid HIV test based on measuring aura color / None required / None required
INTERNAL FUNDING APPLICATIONS AND AWARDS
The table below should list internal awards given since the last progress report was submitted. For each project listed below provide and abstract and progress report, as applicable, in Appendix C.2.[#].
INTERNAL AWARDS: NEWLY FUNDED
PI(s) / Category / Mentor / Date Awarded / Mechanism / Title / Clinical and/or Int’l Clearance Required? (Y/N) / Regulatory Permission Type(s) and Expiration DateDoolittle, John / 3,5 / Buckeroo Banzai / 08/08/14 / Microgrant / Increasing Recruitment of Female Centaurs (“Fe-Mares”) in HIV Research / Yes, Clinical / City U. IRB Pending, IACUC Exp. 6/17/2017
Moreau, N.F.N. / 2,5 / N/A (Category 2 applicant) / 01/15/15 / CFAR03 (Y10A) / Mouse/Macaque Models for AIDS Vaccine Studies / None required / IACUC Exp. 5/27/2016
The table below should list applications received since the last progress report was submitted that were not funded and describe what actions were subsequently taken.