Guidance for Appendices/User TablesAll Cores

DEFINITIONSCFAR 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

NIH AIDS PIs Category 1 A researcher who is or has ever been PI on an R01 equivalent grant in HIV/AIDS

NIH PIs being brought into AIDS research

Category 2 A researcher who is or has ever been PI on an R01 equivalent grant, but never in HIV/AIDS

AIDS-research Pipeline

Category 3NIH “New Investigators,” An NIH definition that encompasses individuals who have received funding as a PI from NIH*, but not yet at the R01 equivalent level.

Category 4 CFAR Users who have not yet received funding from NIH* as PI or Co-PI funding on any NIH grant mechanism

Developmental Core Special Emphasis

Category 5 Recipients of Core B funding, mentoring, and/or other services

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.

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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 value2. A concrete description of the action taken / resources provided 3. The outcome resulting from CFAR’s contributionValue Added examples are formatted in this way:

[Situation]

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[Action taken] [Outcome]

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USING THIS GUIDANCEFor 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 X2. Badenov, Boris Urban U 2 CU X X X X3. Banzai, Buckeroo Urban U 1 BDC,CU X X X X X4. Beckett, Sam Urban U 1 CU X X X X5. Boop, Betty Suburban CFAR 3, CU X X6. Bullfrog, Jeremiah W.A. Urban U 1 CU X7. Calvin, Susan Urban U 1 CD,CU,SD X X X X8. Coyote, Wile E. Suburban CFAR 4,5 CU X X X X X9. Croft, Lara Urban U 1,5 CU X X

10. Durga, Devi YRGC, Chennai 4,5,6 CU X X X11. Doolittle, John Urban U 3,5 CU X X X X12. Explorer, Dora T. Urban U 3,5 CU X X X X13. Falken, Stephen Urban U 3 CU X X X X14. Hackwrench, Gadget Urban U 4,5, 6 CU X X X15. Jones, Indiana Urban U 1 BDC,CU X X X16. Mephisto, Alphonse Urban U 2,5 CU,SM X X X X X17. Moreau, N.F.N. Urban U 2,5 CU,SM X X X X18. Neutron, Jimmy Rural CFAR 1 BDC,CU X X19. Omega, Zenith Urban U 1 BDC,CU X X X X X X20. Scully, Dana Area 51 D-CFAR 3 SM X21. Shango, Bumba KwaZulu-Natal 4,5,6 CU X X X22. Stein, Francis N. (Frank) Urban U 2 CU X X23. 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................................................................................2A.2: Other YR[26] NIH-funded projects supported by the CFAR..............................................................

BB.1: External Advisory Board Report........................................................................................................B.2: Internal Advisory Board Report ........................................................................................................

CC.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........................................

DD.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.

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APPENDIX A: Support for NIH-funded ProjectsA.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 CFARPI Roles* Categories Grant Title Grant # CORES THAT PROVIDED SUPPORT

C E/S M S T OBanzai, Buckeroo

CU, BDC 1 Giraffe models of HIV-associated head and neck

cancersP01 CA555121

H D F

Beckett, Sam

CD, CU 1 Quantum leap: Time travel as a novel HIV

prevention strategyR29 MH010101

C F C

Bullfrog, Jeremiah W. A.

CU1

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

DA54321F,H,2 H C,D F,J H 2

* CD=Core Director, CU=Core User, BDC=Big Dogs Council

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A.2PURPOSE: 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.1o 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 CFARName Roles* Categories Grant Title Grant # CORES/SWGs THAT PROVIDED SUPPORT

C E/S M S T OBadenov, Boris

CU, BDC 2 Using moose and squirrel to detect HIV in former

Soviet countriesD43 TW555121 H, C H F J

Baba, Ali 2,5Are 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

1Environmental obstacles to the use of sentient robots to provide HIV care in jungle and dessert settings

Core BB J B

Doolittle, John

CU3,5

Increasing Recruitment of Female Centaurs (“Fe-Mares”) in HIV Research

Core BB, C D C F B

Explorer, Dora

CU3,5

Where in the World is HIV? Core BB, H D H F B

Hackwrench, Gadget

CU4,5,6

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 BB, 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 FindingsThe 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.1Appendix 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.2The 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

PHS 398/2590 (Rev. 06/09) Page Continuation Format Page8

Appendix C.1 – All Core B ActivitiesPURPOSE: 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 AWARDSThe 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 FUNDEDPD(s) Category Mentor Date

AwardedInstitute Title Regulatory

PermissionsBaba, Ail 2,5,6 Banzai

Buckeroo08/01/14 NCI Are open sesames a magic bullet for AIDS-related

cancer control?”IRB

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 FUNDEDApplicant 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, 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) Category Date

AwardedInstitute Title Regulatory Permissions

Shango, Bumba & Devi, Durga

4,5,64,5,6

10/01/13 NIAID South-South partnerships in AIDS vaccine research International clearance

9

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 COMPLETEDPI(s) Category Date

CompletedInstitute Title Regulatory Permissions

Hackwrench, Gadget 4,5,6 07/15/14 NCCAM New technologies for a rapid HIV test based on measuring aura

colorNone required

INTERNAL FUNDING APPLICATIONS AND AWARDSThe 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 FUNDEDPI(s) Category Mentor Date

AwardedMechanism Title Regulatory

PermissionsDoolittle, John 3,5 Buckeroo

Banzai 08/08/14 Microgrant Increasing Recruitment of Female Centaurs (“Fe-Mares”) in HIV Research IRB, IACUC

Moreau, N.F.N. 2,5 N/A (Category

2 applicant) 01/15/15 CFAR03 (Y10A) Mouse/Macaque Models for AIDS Vaccine Studies IACUC

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 FUNDEDApplicant Category Date Applied Mechanism Title OutcomeHound, Basset 2 11/1/14 Opportunity

AwardDevelopment of a Robust, Sensitive Microsphere-based Assay to Quantify FIV in Transgenic Cats Revising for resubmission

Farnsworth,Hubert J. (Mars U)

4 11/1/14 SWG 2 Seed Grant

Futurama: Cloning People as Old as Me who have the letters “H” “I” and “V” in their Name

No resubmission of this proposal will be accepted

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: ACTIVEPI(s) Category Mechanism Title Regulatory PermissionsExplorer, Dora T 3,5 CFAR03

(Y09B) Where in the World is HIV? International clearance

10

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 COMPLETEDPI(s) Category Date Completed Mechanism Title Regulatory PermissionsMephisto, Alphonse 2,5 10/01/14 CFAR03

(Y08A) Nutritional Requirements of Vegan-Carnivore Chimera IACUC, IRB

OTHER CORE B ACTIVITIESThe 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 SupportName Category ActivityBaba, Ali 2,5,6 Travel award; arranged for feedback on APHA conference oral presentation by members of SWG 2Croft, Laura: 1,5 Travel award; arranged for internal review of CROI abstract prior to (successful) submissionExplorer, Dora T: 3,5 Travel award: poster design tutorial and printing for presentation at APHA (Poster: “Where in the World is HIV?”)

Application SupportName Category ActivityCTSI 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

Mentee Mentor Frequency of Contact Activities Other Cores/SWGs Involved Outcome

Baba, Ali Angelika Pickes, Once a month Provided advice on assays

Virology Core Introduced to the Virology Core for development of new assay

Explorer, Dora T Christopher Columbus

Met weekly during application development, monthly since then

Introduced to research mentor and proposed foreign collaborators

Clinical and Immunology Cores

Supplement application submitted (funded),

Devi, Durga & Shango, Bumba

Indiana Jones Bi-monthly, via Skype Ongoing research mentoring for NIH administrative supplement award

Biostatistics and Virology Cores

South-South partnership established; All Urban University-based training complete; enrollment targets met

11

Appendix C.2 – New AwardsThe 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)

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 SupplementsAli Baba, PhDAre Open Sesames a Magic Bullet for AIDS-related Cancer Control?Funded Activities Completed: N/AAward: $75,000Mechanism: NCI Administrative SupplementMentor(s): Buckeroo BonzaiProject 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] 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.

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C.2.2: Newly Funded CFAR03 Pilot ProjectsN.F.N. Moreau, MD, PhDMouse-Macaque Models for AIDS Vaccine StudiesFunded Activities Completed: N/AAward: $40,000Mechanism: standard CFAR03 (Y10A)Mentor(s): None (Category 2)Project Period: 01/15/15 – 01/14/16Regulatory Permissions Required: IACUCDate 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 MicrograntsJohn Doolittle, MDIncreasing Recruitment of Female Centaurs (“Fe-Mares”) in HIV ResearchFunded Activities Completed: N/AAward: $2,000Mechanism: MicrograntMentor(s): Buckeroo BanzaiProject Period: 08/08/14 – 02/07/15 Regulatory Permissions Required: IRB, IACUCDate Report Received: 10/15/14

Abstract:[see instructions above]

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

Regulatory Approvals:See attached IRB approval. IACUC approval is still in process

[Imagine copy of IRB approval letter attached here]

13

Appendix C.3 – Active AwardsThe 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 SupplementsBumba Shango, PhD & Durga Devi MDSouth-South Partnerships in AIDS Vaccine Research (NIAID)Funded Activities Completed: N/AAward: $125,000Mechanism: NIAID Administrative SupplementMentor(s): Indiana JonesProject Period:

Original: 10/01/13 – 9/30/14NCE: 10/01/13 – 9/30/15

Regulatory Permissions Required: NIH International ClearanceDate 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.

14

C.3.2: Active CFAR03 Pilot ProjectsDora T. Explorer, PhDWhere in the World is HIV?Date Funded Activities Completed: N/AAward: $40,000Mechanism: Co-funded CFAR03 (Urban University Dept. of Global Health)Mentor(s): Christopher ColumbusProject Period: 08/15/14 – 08/14/15 Regulatory Permissions Required: NIH International ClearanceDate report received: 8/15/14

Progress Report:[Insert here]

Regulatory Approvals:International clearance documents on file at NIH

Appendix C.4 – Newly Completed ProjectsThe 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:15

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 SupplementsGadget Hackwrench, PhDNew technologies for a rapid HIV test based on measuring aura color Funded Activities Completed: 07/15/14Award: $50,000Mechanism: NCCAM Administrative SupplementMentor(s): Zenith OmegaProject Period: 08/01/13 – 07/31/14Regulatory Permissions Required: NoneDate 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 ProjectsAlphonse Mephisto, MD, PhDMouse/Macaque Chimeras: The Next Generation Model Funded Activities Completed: 10/01/14Award: $40,000Mechanism: Standard CFAR03 Mentor(s): None (Category 2)Project Period:

Original: 11/01/12 – 10/31/13NCE: 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]

16

NOTECore 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.

17

Appendix D – CFAR Science Core ActivitiesThe 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 HCore H Utilization Table: Support for Core B- and NIH-Funded ProjectsInvestigator (location)Collaborator (location) Category “Core B” or NIH

Grant NumberTitle of Project Core Services Provided % Use

Calvin, Susan (Urban U) &Boop, Betty (Suburban CFAR)

1Core B Environmental obstacles to the use of

sentient robots to provide HIV care in jungle and dessert settings

Space: Provided use of BSL2 facility 3

Explorer, Dora T. (Urban Univ) 3,5 Core B Where in the World is HIV? Consulting: Advice on study design

Services: cell sorting 3

Mephisto, Alphonse (Urban Univ) 2,5 Core B Nutritional Requirements of

Vegan-Carnivore ChimeraConsulting: Advice on study design <1

Hackwrench, Gadget (Urban Univ) 4,5,6 NIH Admin Supp New technologies for a rapid HIV test

based on measuring aura colorTraining: Use of flow cytometerEquipment: Access to flow cytometer

4

Badenov, Boris (Urban Univ) 2 D43 TW555121 Using moose and squirrel to detect

HIV in former Soviet Block countriesMaterials: Provided assays and specimens

12

Banzai, Buckeroo (Urban Univ.) 1 P01 CA555121 Giraffe models of HIV-associated

head and neck cancersConsulting: Advice on study design 10

Beckett, Sam (Urban Univ) 1 R29 MH010101 Quantum leap: Time travel as a novel

HIV prevention strategyTraining: Use of flow cytometer <1

Bullfrog, Jeremiah W.A. (Urban Univ) 1

R37 CA010000 Joy to the fishes in the deep blue sea: The development of a Zebrafish

dendritic cell model in HIV

Services: Dendritic cell sorting 13

Jones, Indiana (Urban Univ) 1

R36 MD200002 Arc of the covenant: Histo-religious distinctions in responses to HIV and

AIDS

Consulting: Advice on study design <1

Neutron, Jimmy (Rural CFAR) 1 R21 AI989898 Adapting alien technology for use in

cloning CD4+ effector memory T cellsTraining: BSL2 protocolsServices: Provided tetramer staining

10

Omega, Zenith (Urban Univ) 1 R01 DA54321 Aerosolized delivery of a cure for HIV Space: Access to a BSL3 facility

Services: Use of BSL3 staff9

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Core H: Other Significant ActivitiesType Activity % UseTraining Provided training for 10 labs on flow cytometer use and training for 5 labs on BSL3 protocols 15Services Developed 18 novel assays to increase capacity of the Core 20

Other Performed flow assays for CDC-funded project (Disease Surveillance in Parallel Universes; Dr. Who, PI) that enabled first ever research collaboration between Urban University CFAR scientists and CDC scientists <1

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%

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Appendix EThe 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.1SWG 1: Artificial, Mythic, and Extraterrestrial Life Forms

First established: 11/01/2013Membership roster as of: 05/25/14

Name(Location)

New to SWG

Outside Expertise

Categories Primary Research Area Involvement with the SWG

Susan Calvin(DIRECTOR)(Urban U)

1Application of HIV immunology to artificial life forms

SWG Director. Helping to identify potential co-investigators for P30 application currently under discussion

Alphonse Mephisto(Urban U) 2,5

The use of genetic engineering to increase innate and acquired resistance to HIV infection

Organizing activities of the SCREAM journal club to assist in locating pertinent literature; will serve as Co-investigator on R01 application under development

N.F.N. Moreau(Urban U)

X 2,5Development and use of Human-Animal chimera in clinical research

Providing SCREAM Center research field site (at his undisclosed island location)

Dana Scully(Area 51 D-CFAR)

X X 3Clinical care of extraterrestrials Gave research presentation at SWG meeting;

serving as a co-investigator in upcoming R01 application being organized by the SWG

Frank Stein(Urban U) X X 2

Communicable diseases in mermaids

Applying for CFAR03 seed grant funding through the SWG to expand current research on STDs (Sea-transmitted Diseases) to include AIDS-associated malignancies

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