CFAR Progress Report Appendix Instructions & Examples (Rev. 10/24/14)

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CFAR Progress Report Appendix Instructions & Examples (Rev. 10/24/14)

Guidance for Appendices/User Tables All Cores DEFINITIONS CFAR Beneficiary: An individual who receives assistance of any sort from the CFAR. Not all CFAR beneficiaries are counted as CFAR users. CFAR Member: There is no official NIH CFAR definition of a CFAR “member.” Each CFAR should establish its own criteria for membership in the CFAR. CFAR User: A CFAR beneficiary who is eligible to serve as PI on any NIH funding mechanism. Only CFAR Users are counted when filling out Appendix A or sections I.A and I.B in the Director’s Overview. Categories: All CFAR users will fall into one or more of six categories. All CFAR users will fall into Categories 1-4. Some CFAR users may also fall into Categories 5-6 A researcher who is or has ever been PI on an R01 equivalent NIH AIDS PIs Category 1 grant in HIV/AIDS

NIH PIs being A researcher who is or has ever been PI on an R01 equivalent brought into Category 2 grant, but never in HIV/AIDS AIDS research

NIH “New Investigators,” An NIH definition that encompasses Category 3 individuals who have received funding as a PI from NIH*, but not AIDS-research yet at the R01 equivalent level. Pipeline CFAR Users who have not yet received funding from NIH* as PI or Category 4 Co-PI funding on any NIH grant mechanism

Developmental Category 5 Recipients of Core B funding, mentoring, and/or other services Core Special Emphasis Category 6 Recipients of NIH CFAR administrative supplements

*Individuals whose only history of NIH funding at the PI or PD level has come indirectly from NIH, for example through the CFAR via an NIH CFAR Administrative Supplement, fall into Category 4 Funded Research Base (FRB): The total dollar amount of research funding that the NIH CFAR counts when determining, during competitive review, whether a given CFAR will receive funding at the Tier 1, Tier 2, or Tier 3 level. Not all NIH funding mechanisms are included when calculating the FRB and not all projects funded through allowable mechanisms are eligible for inclusion in a given year’s FRB. See the CFAR PA for more details. FRB Project: A project appearing on the “Allow” tab of an FRB Excel spreadsheet. FRB projects are prioritized for attention from the CFAR. FRB Report: An Excel spreadsheet provided annually by the NIH CFAR that contains a list of projects that are counted in a CFAR’s FRB for a given NIH fiscal year. Percent Use: The percent of a Core’s total time spent on a particular Core Usage table entry (see Appendix D). Total percent use for a Core should add up to 100%. Project Period: Five-year increments of funding from NIH. e.g. “3rd” project period.

1 Rev 10/24/14 Project Year: An individual CFAR’s fiscal year, counted from its first year of NIH funding. e.g. YR12 = 12th year of NIH funding, aka the second year of the third project period, assuming a 5 year D-CFAR project period. “R01 Equivalent” Grant: NIH considers the following mechanisms to be “R01 equivalents:” R01, R23, R29, R37 and, after 2008, DP2. The NIH CFAR also adds “P” series and “U” series to the list. Reporting Period: The period of time since data for the previous progress report was gathered for submission, without reference to a CFAR’s fiscal year. Roles: The types of participation that CFAR users engage in. “CD” (Core Director) and “CU” (Core User) are standard across all CFARs. For reporting in Appendix A.1 and A.2, each CFAR may define and label additional roles that best describe their CFAR’s users participation. Synergy: A “mutually advantageous collaboration between separate entities.” For the purposes of a CFAR report or application those entities may be two or more separate CFARs (inter-CFAR), two or more Cores and/or SWGs within the same CFAR (intra-CFAR), or your CFAR and another organization(s) at your institution or beyond (extra-CFAR). Value Added: Resources provided by the CFAR that allow an individual or group to accomplish a goal they otherwise might not be able to accomplish, or simply to accomplish it “better” (more rapidly, more cost effectively, more collaboratively etc.) than they otherwise might, given the limitations imposed by other NIH funding mechanisms. Value Added Activities: Consultation: Verbal assistance or feedback in a Core faculty member or staff’s area of expertise. For example, helping to develop or critique a research study design Equipment/Space: Shared Equipment: Access to equipment that a Core user may use on his or her own, assuming the presence of proper training and supervision. For example, handheld data collection devices or lab equipment. Shared Space: Access to research space that a Core user may use to perform studies. For example, access to space for use in recruiting into or performing clinical or behavioral studies. Materials: Portable items given to Core Users. For example, tissue samples, chemicals, labware, and/or documents. Services: Developmental Services: Activities that Core staff undertake in order to develop a greater capacity for assisting Core Users in the future. For example, optimization, standardization, and validation of novel assays. Requested Services: Activities that Core staff undertake at the request of a Core User. For example, performing an already standardized assay. Training: Imparting knowledge or a skill to a Core User that s/he may later use on his or her own. For example, teaching someone how to use a piece of equipment, design a study, perform an assay, or do a power analysis Other: Other value added activities not covered above. For example, community outreach. Value Added Example: A well-written value added example has three components: 1. A brief description of the situation/achievement to which the CFAR added value 2. A concrete description of the action taken / resources provided 3. The outcome resulting from CFAR’s contribution Value Added examples are formatted in this way: [Situation] 2  [Action taken] [Outcome]

3 Rev 10/24/14 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 CORES SWG Name Categories Roles* B C D F H J 1 2 1 Baba, Ali Urban U 2,5,6 CU X X . 2 Badenov Urban U 2 CU X X X X . , Boris 3 Banzai, Urban U 1 BDC,CU X X X X X . Buckero o 4 Beckett, Urban U 1 CU X X X X . Sam 5 Boop, 3, CU X X Suburban CFAR . Betty 6 Bullfrog, Urban U 1 CU X . Jeremia h W.A. 7 Calvin, Urban U 1 CD,CU,SD X X X X . Susan 8 Coyote, Suburban CFAR 4,5 CU X X X X X . Wile E. 9 Croft, Urban U 1,5 CU X X . Lara 1 Durga, YRGC, Chennai 4,5,6 CU X X X 0 Devi . 1 Doolittle, 3,5 CU X X X X 1 John . Urban U 1 Explorer, 3,5 CU X X X X 2 Dora T. . Urban U 1 Falken, 3 CU X X X X 3 Stephen . Urban U 1 Hackwre Urban U 4,5, 6 CU X X X 4 nch, . Gadget 1 Jones, Urban U 1 BDC,CU X X X 5 Indiana . 1 Mephisto Urban U 2,5 CU,SM X X X X X 6 , . Alphons 4 Rev 10/24/14 CORES SWG Name Categories Roles* B C D F H J 1 2 1 Baba, Ali Urban U 2,5,6 CU X X . 2 Badenov Urban U 2 CU X X X X . , Boris 3 Banzai, Urban U 1 BDC,CU X X X X X . Buckero o 4 Beckett, Urban U 1 CU X X X X . Sam 5 Boop, 3, CU X X Suburban CFAR . Betty 6 Bullfrog, Urban U 1 CU X . Jeremia h W.A. 7 Calvin, Urban U 1 CD,CU,SD X X X X . Susan 8 Coyote, Suburban CFAR 4,5 CU X X X X X . Wile E. 9 Croft, Urban U 1,5 CU X X . Lara 1 Durga, YRGC, Chennai 4,5,6 CU X X X 0 Devi . e 1 Moreau, Urban U 2,5 CU,SM X X X X 7 N.F.N. . 1 Neutron, Rural CFAR 1 BDC,CU X X 8 Jimmy . 1 Omega, Urban U 1 BDC,CU X X X X X X 9 Zenith . 2 Scully, Area 51 D-CFAR 3 SM X 0 Dana . 2 Shango, KwaZulu-Natal 4,5,6 CU X X X 1 Bumba . 2 Stein, Urban U 2 CU X X 2 Francis . N. (Frank) 2 Who, Urban U 2,5 CU X X 3 Doctor .

*CD=Core Director, CU=Core User, SD=SWG Director, SM=SWG Member, BDC=Big Dogs Council

5 Rev 10/24/14 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[26] 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, and regulatory documents...... C.3: Active Projects: Progress reports and regulatory documents...... C.4: Newly Completed Projects: Summary reports and regulatory documents...... 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. E E.1: SWG [#] ([Name]) Membership Table...... E.2: SWG [#] ([Name]) Membership Table......

Note: Each SWG should appear in its own appendix subsection.

6 Rev 10/24/14 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 CORES THAT PROVIDED SUPPORT PI Roles* Categories Grant Title C E/S M S T O Banzai, CU, Giraffe models of HIV-associated head and neck H D F 1 Buckeroo BDC cancers Beckett, CD, CU Quantum leap: Time travel as a novel HIV C F C 1 Sam prevention strategy Bullfrog, CU Joy to the fishes in the deep blue sea: The H H H Jeremiah 1 development of a Zebrafish dendritic cell model in W. A. HIV Croft, Lara CU 1 Archeological evidence of HIV in Egyptian tombs J J J Omega, CU, Aerosolized delivery of a cure for HIV F,H,2 H C,D F,J H2 1 Zenith BDC * CD=Core Director, CU=Core User, BDC=Big Dogs Council

7 Rev 10/24/14 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 CORES/SWGs THAT PROVIDED SUPPORT Name Roles* Categories Grant Title C E/S M S T O Badenov, CU, Using moose and squirrel to detect HIV in former 2 H, C H F J Boris BDC Soviet countries Baba, Ali Are opened sesames a magic bullet for AIDS-related J 2,5 cancer control? B J Banzai, CU, Innovative research housing for a griffin colony 1 J 1 Buckeroo BDC Calvin, CU, Environmental obstacles to the use of sentient Susan CD, SD 1 robots to provide HIV care in jungle and dessert B J B settings Doolittle, CU Increasing Recruitment of Female Centaurs (“Fe- John 3,5 Mares”) in HIV Research B, C D C F B Explorer, CU Where in the World is HIV? 3,5 B, H D H F B Dora Hackwrenc CU New technologies for a rapid HIV test based on H h, Gadget 4,5,6 measuring aura color B H F Jones, BDC, Arc of the covenant: Histo-religious distinctions in 1 H F J Indiana CU responses to HIV and AIDS Mephisto, CU, SM Nutritional Requirements of Vegan-Carnivore Alphonse 2,5 Chimera B, H F, J B Neutron, BDC, Adapting alien technology for use in cloning CD4+ 1 J H H Jimmy CU effector memory T cells * CD=Core Director, CU=Core User, SD=SWG Director, BDC=Big Dogs Council

8 Rev 10/24/14 9 Rev 10/24/14 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

10PHS 398/2590 (Rev. 06/09) Page Continuation Format Page 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.

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, in Appendix C.2.1, an abstract, progress report, and current copies of regulatory approval letters (IRB, IACUC), as applicable. ADMINISTRATIVE SUPPLEMENTS: NEWLY FUNDED PD(s) Category Mentor Date Institute Title Regulatory Awarded Permissions Baba, Ail 2,5,6 Banzai 08/01/14 NCI Are open sesames a magic bullet for AIDS-related IRB Buckeroo cancer control?”

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 Outcome Falken, 3 11/1/14 The use of artificial intelligence in HIV prevention Research hypothesis is being rethought Stephen 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, in Appendix C.3.1, a progress report and current copies of regulatory approval letters (IRB, IACUC), as applicable. Also provide, in Appendix C.5, updated outcomes to date via the NIH’s Cumulative Outcomes Summary. ADMINISTRATIVE SUPPLEMENTS: ACTIVE PI(s) Cat Date Institute Title Regulatory Permissions ego Awarded ry Shango, Bumba & 4,5, 10/01/13 NIAID South-South International clearance Devi, Durga 6 partnerships in 4,5, AIDS vaccine 6 research

11 The table below should list administrative supplements that finished their funded activities after the last progress report was submitted. For each project include, in Appendix C.4.1, a progress report and copies of any necessary regulatory approvals (IRB, IACUC) that were current at the time funded activities finished. Also provide, in Appendix C.5, updated outcomes to date via the NIH’s Cumulative Outcomes Summary. ADMINISTRATIVE SUPPLEMENTS: NEWLY COMPLETED PI(s) C Date Institute Title Regulatory Permissions at Completed e g or y New technologies None required 4, for a rapid HIV test Hackwrench, Gadget 5, 07/15/14 NCCAM based on 6 measuring aura color

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, in Appendix C.2.[#], an abstract, progress report, and current copies of regulatory approval letters (IRB, IACUC), as applicable. INTERNAL AWARDS: NEWLY FUNDED PI(s) Category Mentor Date Mechanism Title Regulatory Awarded Permissions Doolittle, Buckeroo Increasing Recruitment of Female Centaurs (“Fe- 3,5 08/08/14 Microgrant IRB, IACUC John Banzai Mares”) in HIV Research Moreau, N/A (Category CFAR03 2,5 01/15/15 Mouse/Macaque Models for AIDS Vaccine Studies IACUC N.F.N. 2 applicant) (Y10A)

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. INTERNAL APPLICATIONS: NOT FUNDED Applicant C Date Applied Mechanism Title Outcome at e g or y Hound, Basset 2 11/1/14 Opportunity Award Development of a Revising for resubmission Robust, Sensitive 12 Microsphere- based Assay to Quantify FIV in Transgenic Cats Futurama: Cloning People as Old as Farnsworth,Hubert J. No resubmission of this 4 11/1/14 SWG 2 Seed Grant Me who have the (Mars U) proposal will be accepted letters “H” “I” and “V” in their Name

The table below should list projects that have already been reported in a previous progress report and are still active. For each project listed below provide, in Appendix C.3.[#], a progress report and current copies of regulatory approval letters (IRB, IACUC), as applicable. Also provide, in Appendix C.5, updated outcomes to date via the NIH’s Cumulative Outcomes Summary. INTERNAL AWARDS: ACTIVE PI(s) Category Mechanism Title Regulatory Permissions Explorer, CFAR03 3,5 Where in the World is HIV? International clearance Dora T (Y09B)

The table below should list projects that finished their funded activities after the last progress report was submitted. For each project include, in Appendix C.4.[#], a progress report and copies of any necessary regulatory approvals (IRB, IACUC) that were current at the time funded activities finished. Also provide, in Appendix C.5, updated outcomes to date via the NIH’s Cumulative Outcomes Summary. INTERNAL AWARDS: NEWLY COMPLETED PI(s) C Date Completed Mechanism Title Regulatory Permissions at e g or y 10/01/14 Nutritional 2, Requirements of Mephisto, Alphonse CFAR03 (Y08A) IACUC, IRB 5 Vegan-Carnivore Chimera

OTHER CORE B ACTIVITIES The purpose of this subsection is to summarize any other significant activities that Core B engaged in since the last report. The table or tables used to report the information may be formatted in any way that will help you summarize those Core B activities that provided the most value added. Do not attach flyers or RFA announcements

Conference Support Name Category Activity 13 Baba, Ali 2,5,6 Travel award; arranged for feedback on APHA conference oral presentation by members of SWG 2 Croft, Laura: 1,5 Travel award; arranged for internal review of CROI abstract prior to (successful) submission Explorer, Dora T: 3,5 Travel award: poster design tutorial and printing for presentation at APHA (Poster: “Where in the World is HIV?”)

Application Support Name Category Activity CTSI N/A Review Committee for Core B helped review CTSI pilot project applications. Coyote, Wile E. 4,5 Solicited external reviews of draft R21 application.

Mentoring Activities Other Mentee Mentor Frequency of Contact Activities Cores/SWGs Outcome Involved Baba, Ali Angelika Pickes, Once a month Provided advice on Virology Core Introduced to the Virology assays Core for development of new assay Explorer, Dora T Christopher Met weekly during Introduced to research Clinical and Supplement application Columbus application development, mentor and proposed Immunology Cores submitted (funded), monthly since then foreign collaborators Devi, Durga & Shango, Indiana Jones Bi-monthly, via Skype Ongoing research Biostatistics and South-South partnership Bumba mentoring for NIH Virology Cores established; All Urban administrative University-based training supplement award complete; enrollment targets met

Appendix C.2 – New Awards The purpose of this appendix is to succinctly describe each newly-funded project reported in Appendix C.1. Follow the required format provided below. Organization:  Group reports by funding mechanism, with NIH supplements listed first (C.2.1).  Provide a separate subsection (C.2.2; C.2.3 etc) for each internal mechanism.  Within subsections, alpha order by contact PI’s last name. Header: Follow the format provided in the examples below  Not every project may have a mentor (e.g. senior faculty being brought into AIDS)  Regulatory permission choices are: None, IRB, IACUC, NIH (Medical and/or International) 14 Abstract: Follow the same rules as for an NIH application abstract/project summary. Specifically:  Limit length to 30 lines or less of text  Include the project’s broad, long-term objectives and specific aims  Include a description of the research design and methods for achieving the stated goals  Do NOT include proprietary or confidential information, or trade secrets  Write in plain language, so even a non-scientists can understand the importance of the project Progress Report section:  Limit length to amount of page remaining below completed header and abstract  Include any information not being collected in the online NIH Cumulative Outcomes Summary – e.g. oral and poster conference presentations Regulatory Permissions section:  After the progress report, attach current copies of all permission letters listed in the report header (IRB, IACUC) that have been received by time of report submission.  Indicate regulatory permissions that have not yet been received.

C.2.1: Newly Funded NIH Administrative Supplements Ali Baba, PhD Are Open Sesames a Magic Bullet for AIDS-related Cancer Control? Funded Activities Completed: N/A Award: $75,000 Mechanism: NCI Administrative Supplement Mentor(s): Buckeroo Bonzai Project Period: 08/01/14 – 07/31/15 Regulatory Permissions Required: IRB, NIH Medical Approval Date Report Received: 11/01/14

Abstract: [see instructions above] Progress Report: This study is still in the preparation period. Regulatory Approvals: See attached IRB approval. NIH medical approval is still in process

[Imagine attached copy of IRB approval letter here] 15 NOTE: Although NIH medical approval is required do not attach copies of NIH medical checklist, protocol, emails between CFAR and NIH, or any other materials including targeted/planned enrollment tables.

16 C.2.2: Newly Funded CFAR03 Pilot Projects N.F.N. Moreau, MD, PhD Mouse-Macaque Models for AIDS Vaccine Studies Funded Activities Completed: N/A Award: $40,000 Mechanism: standard CFAR03 (Y10A) Mentor(s): None (Category 2) Project Period: 01/15/15 – 01/14/16 Regulatory Permissions Required: IACUC Date Report Received: 02/15/15

Abstract: [see instructions above]

Progress Report: This study is still in the preparation phase.

Regulatory Approvals: None to attach. IACUC approval In still in process.

C.2.3: Newly Funded Microgrants John Doolittle, MD Increasing Recruitment of Female Centaurs (“Fe-Mares”) in HIV Research Funded Activities Completed: N/A Award: $2,000 Mechanism: Microgrant Mentor(s): Buckeroo Banzai Project Period: 08/08/14 – 02/07/15 Regulatory Permissions Required: IRB, IACUC Date Report Received: 10/15/14

Abstract: [see instructions above]

Progress Report: This study is still in the preparation phase. 17 Regulatory Approvals: See attached IRB approval. IACUC approval is still in process

[Imagine copy of IRB approval letter attached here]

18 Appendix C.3 – Active Awards The purpose of Appendix C.3 is to provide a succinct update on progress made by active projects (including those operating under no cost extensions) since submission of the last progress report.

Do not provide progress reports for any project completely external to the CFAR. For example, projects funded by another organization for which Core B provided study section assistance may be described as a community outreach initiative in “Other Core B Activities” or “Other Key Achievements” but reports for those projects should not be included here. Organization:  As in Appendix C.2, group reports by funding mechanism, with NIH supplements listed first (C.3.1).  Provide a separate subsection (C.3.2; C.3.3 etc) for each internal mechanism.  Within subsections, alpha order by contact PI’s last name. Header: Follow the format provided in the examples below  Not every project may have a mentor (e.g. senior faculty being brought into AIDS)  If project is operating under a No Cost Extension, use Project Period format as in Shango & Devi example below  Regulatory permission choices are: None, IRB, IACUC, NIH (Medical and/or International) Progress Report section:  Limit length to amount of page remaining below completed header (i.e., no report to exceed one page)  Tables are permitted but do not include graphs, pictures, or articles in reports.  Only include information that is new since the last progress report was submitted  Include any information not being collected in the online NIH Cumulative Outcomes Summary – e.g. information about oral and poster conference presentations Regulatory Permissions section:  After the progress report, attach current copies of permission letters listed in the report header (IRB, IACUC)

C.3.1: Active NIH Administrative Supplements Bumba Shango, PhD & Durga Devi MD South-South Partnerships in AIDS Vaccine Research (NIAID) Funded Activities Completed: N/A Award: $125,000 Mechanism: NIAID Administrative Supplement Mentor(s): Indiana Jones Project Period: Original: 10/01/13 – 9/30/14 NCE: 10/01/13 – 9/30/15 Regulatory Permissions Required: NIH International Clearance Date Report Submitted: 9/15/14

Progress Report: This project has just received international clearance. We are awaiting receipt of a revised NGA from the NIH CFAR to begin funded activities. Regulatory Approvals: N/A Note: There are no attached regulatory approvals as neither IRB nor IACUC is required for this study. Although NIH international clearance is required do not attach copies of international checklist, emails between CFAR and NIH, revised NOA, or any other materials including targeted/planned enrollment tables. C.3.2: Active CFAR03 Pilot Projects Dora T. Explorer, PhD Where in the World is HIV? Date Funded Activities Completed: N/A Award: $40,000 Mechanism: Co-funded CFAR03 (Urban University Dept. of Global Health) Mentor(s): Christopher Columbus Project Period: 08/15/14 – 08/14/15 Regulatory Permissions Required: NIH International Clearance Date report received: 8/15/14

Progress Report: [Insert here]

Regulatory Approvals: International clearance documents on file at NIH Appendix C.4 – Newly Completed Projects The purpose of Appendix C.4 is to provide a summary report for projects that have completed funded activities since submission of the last progress report.

Do not provide reports for any project completely external to the CFAR. For example, projects funded by another organization for which Core B provided a poster design tutorial may be described in “Other Core B Activities” but should not be included here. Organization:  As in Appendix C.2, group reports by funding mechanism, with NIH supplements listed first (C.4.1).  Provide a separate subsection (C.4.2; C.4.3 etc) for each internal mechanism.  Within subsections, alpha order by contact PI’s last name. Header: Follow the format provided in the examples below  Not every project may have a mentor (e.g. senior faculty being brought into AIDS)  If project included a No Cost Extension, use Project Period format as in Mephisto example below  Regulatory permission choices are: None, IRB, IACUC, NIH (Medical and/or International) Summary Report section:  Limit length to amount of page remaining below completed header (i.e., no report to exceed one page)  Tables are permitted but do not include graphs, pictures, or articles in reports.  Briefly summarize project activities and outcomes  Include any information not being collected in the online NIH Cumulative Outcomes Summary – e.g. information about oral and poster conference presentations Future Plans section  Limit length of “Future Plans” section plus “Value Added” section plus “Regulatory Permissions” header and descriptive text to one page total  Describe the PI’s next steps for use of the findings and how this project will lead to future NIH funding Value Added by the CFAR section  See comment about Value Added section length in “Future Plans” instructions above  Describe why the PI is happy to have received the money – i.e. what she or he was able to accomplish that they wouldn't have been able to had it not been for the award. For example, "Because of the Developmental Core award Dr. X …. " or "If it hadn't been for the Developmental Core award Dr. X would not have been able to …." Regulatory Permissions:  At the end of the report attach copies of permission letters listed in the report header (IRB, IACUC) documenting that regulatory permissions were current at the time funded activities completed

C.4.1: Newly Completed NIH Administrative Supplements Gadget Hackwrench, PhD New technologies for a rapid HIV test based on measuring aura color Funded Activities Completed: 07/15/14 Award: $50,000 Mechanism: NCCAM Administrative Supplement Mentor(s): Zenith Omega Project Period: 08/01/13 – 07/31/14 Regulatory Permissions Required: None Date report received: 09/01/13 Summary Report: [insert report here] Future Plans: [insert report here] Value Added by the CFAR: [insert report here] Regulatory Permissions: N/A

C.4.2: Newly Completed CFAR03 Pilot Projects Alphonse Mephisto, MD, PhD Mouse/Macaque Chimeras: The Next Generation Model Funded Activities Completed: 10/01/14 Award: $40,000 Mechanism: Standard CFAR03 Mentor(s): None (Category 2) Project Period: Original: 11/01/12 – 10/31/13 NCE: 11/01/12 – 10/31/14 Regulatory Permissions Required: IACUC Date report received: 11/15/14

Summary Report: [insert report here] Future Plans: [insert report here] Value Added by the CFAR: [insert report here] Regulatory Permissions: See attached IACUC letter [Imagine IACUC letter attached here]

NOTE Core B Awards Outcome Summary, 2000 – current

The NIH Google Document (Excel template) is no longer available and is being replaced by a secure website interface that will be used to directly input information. Information in that website will be available online to NIH CFAR readers. No outcome summary report needs to be printed and included here. Appendix D – CFAR Science Core Activities The purpose of this appendix is to describe the support provided for CFAR- and NIH-funded projects and other key activities of the Core. . Report information for each Science Core in a separate Appendix (D.1, D.2, D.3, etc). . Divide information into two tables: 1) Support for NIH-Funded Projects; 2) Other Significant Activities. . The “% Use” column for the two tables should cumulatively equal 100% . List Core B projects first, followed by NIH Admin Supplements, followed by NIH awards . Put the names of first time core users in italicized font; put NIH grant numbers appearing on FRB in bold face font . Under “Core Services Provided” Label the Value Added Activity by type and then provide enough detail to make it clear how the user benefitted from their interaction with the Core (see Core Support legend beneath example Table #1 below) Appendix D.6 – Core H Core H Utilization Table: Support for Core B- and NIH-Funded Projects Investigator “Core B” or NIH Title of Project Core Services Provided (location) Grant Number Category % Use Collaborator (location) Calvin, Susan (Urban Core B Environmental obstacles to the use of Space: Provided use of BSL2 facility 3 U) & sentient robots to provide HIV care in 1 Boop, Betty (Suburban jungle and dessert settings CFAR) Explorer, Dora T. Consulting: Advice on study design 3,5 Core B Where in the World is HIV? 3 (Urban Univ) Services: cell sorting Mephisto, Alphonse Core B Nutritional Requirements of Consulting: Advice on study design <1 2,5 (Urban Univ) Vegan-Carnivore Chimera Hackwrench, Gadget NIH Admin Supp New technologies for a rapid HIV test Training: Use of flow cytometer 4 4,5,6 (Urban Univ) based on measuring aura color Equipment: Access to flow cytometer Badenov, Boris D43 TW555121 Using moose and squirrel to detect Materials: Provided assays and 12 2 (Urban Univ) HIV in former Soviet Block countries specimens Banzai, Buckeroo P01 CA555121 Giraffe models of HIV-associated Consulting: Advice on study design 10 1 (Urban Univ.) head and neck cancers Beckett, Sam R29 MH010101 Quantum leap: Time travel as a novel Training: Use of flow cytometer <1 1 (Urban Univ) HIV prevention strategy Bullfrog, Jeremiah W.A. R37 CA010000 Joy to the fishes in the deep blue sea: Services: Dendritic cell sorting 13 (Urban Univ) 1 The development of a Zebrafish dendritic cell model in HIV Jones, Indiana R36 MD200002 Arc of the covenant: Histo-religious Consulting: Advice on study design <1 (Urban Univ) 1 distinctions in responses to HIV and AIDS Neutron, Jimmy R21 AI989898 Adapting alien technology for use in Training: BSL2 protocols 10 1 (Rural CFAR) cloning CD4+ effector memory T cells Services: Provided tetramer staining Omega, Zenith R01 DA54321 Aerosolized delivery of a cure for HIV Space: Access to a BSL3 facility 9 1 (Urban Univ) Services: Use of BSL3 staff Core H: Other Significant Activities Type Activity % Use Training Provided training for 10 labs on flow cytometer use and training for 5 labs on BSL3 protocols 15 Services Developed 18 novel assays to increase capacity of the Core 20 Performed flow assays for CDC-funded project (Disease Surveillance in Parallel Universes; Dr. Who, PI) that enabled first ever Other <1 research collaboration between Urban University CFAR scientists and CDC scientists The purpose of the table above is to describe other activities that EITHER took significant amounts of Core time OR provided significant value added. Format table as needed to present the information as succinctly and quantitatively as possible

The “% Use” column for Tables 1 and 2 should cumulatively equal 100% Appendix E The purpose of Appendix E is to describe the individuals who belong to each of the CFAR’s Scientific Working Groups (SWGs).

Bear in mind that a central purpose of the SWG concept is to turbocharge HIV/AIDS research by including investigators who can contribute expertise from other fields, to support junior and NIH New Investigators, and to bring together a broad array of expertise and interests. Use this roster to document progress in achieving this purpose.

 Use column 2 (“New to SWG”) to identify members who have joined the SWG since the previous year  Use column 3 (“Outside Expertise”) to identify members who are primarily contributing expertise that is outside of the field of HIV/AIDS  Use column 4 (“Categories”) to identify unfunded (Category 4) or NIH new investigators (Category 3)  Provide enough detail on research interests to make it clear how their research will facilitate the work of the SWG Appendix E.1

SWG 1: Artificial, Mythic, and Extraterrestrial Life Forms First established: 11/01/2013 Membership roster as of: 05/25/14

Name N Outside Categories Involvement with the SWG (Location) e Expertise w

t o

S W G Susan Calvin SWG Director. Helping to identify potential (DIRECTOR) 1 co-investigators for P30 application currently (Urban U) under discussion Alphonse Mephisto Organizing activities of the SCREAM journal (Urban U) club to assist in locating pertinent literature; 2,5 will serve as Co-investigator on R01 application under development N.F.N. Moreau Providing SCREAM Center research field site X 2,5 (Urban U) (at his undisclosed island location) Dana Scully X X 3 Gave research presentation at SWG (Area 51 D-CFAR) meeting; serving as a co-investigator in upcoming R01 application being organized by the SWG Frank Stein Applying for CFAR03 seed grant funding (Urban U) through the SWG to expand current research X X 2 on STDs (Sea-transmitted Diseases) to include AIDS-associated malignancies

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