1. Guidance for Year 06 Track 1.0 ART Program Continuation Applications Tedd Ellerbrock, MD Team Leader, HIV Care and Treatment, GAP, CDC Barbara Aranda-Naranjo, PhD Director, Global HIV/AIDS Program, HRSA

2. Guidance for Year 06 Track 1.0 ART Program Continuation Applications Class Deviation Waiver to Non-Competitively Extend Project Period beyond 5 Years What Does the Waiver Mean? Guidance for Year 06 Track 1.0 ART Program Continuation Applications The Definition of a Local Partner Information for Preparing a Transition Plan Timeline for Completing the Transition Action Steps – To Explain Who Should Do What and When They Should Do It

3. Guidance for Year 06 Track 1.0 ART Program Continuation Applications Class Deviation Waiver to Non-Competitively Extend Project Period beyond 5 Years What Does the Waiver Mean? Guidance for Year 06 Track 1.0 ART Program Continuation Applications The Definition of a Local Partner Information for Preparing a Transition Plan Timeline for Completing the Transition Action Steps – To Explain Who Should Do What and When They Should Do It

4. Guidance for Year 06 Track 1.0 ART Program Continuation Applications Class Deviation Waiver to Non-Competitively Extend Project Period beyond 5 Years What Does the Waiver Mean? Guidance for Year 06 Track 1.0 ART Program Continuation Applications The Definition of a Local Partner Information for Preparing a Transition Plan Timeline for Completing the Transition Action Steps – To Explain Who Should Do What and When They Should Do It

5. Guidance for Year 06 Track 1.0 ART Program Continuation Applications Class Deviation Waiver to Non-Competitively Extend Project Period beyond 5 Years What Does the Waiver Mean? Guidance for Year 06 Track 1.0 ART Program Continuation Applications The Definition of a Local Partner Information for Preparing a Transition Plan Timeline for Completing the Transition Action Steps – To Explain Who Should Do What and When They Should Do It

6. Guidance for Year 06 Track 1.0 ART Program Continuation Applications Class Deviation Waiver to Non-Competitively Extend Project Period beyond 5 Years What Does the Waiver Mean? Guidance for Year 06 Track 1.0 ART Program Continuation Applications The Definition of a Local Partner Information for Preparing a Transition Plan Timeline for Completing the Transition Action Steps – To Explain Who Should Do What and When They Should Do It

7. Guidance for Year 06 Track 1.0 ART Program Continuation Applications Class Deviation Waiver to Non-Competitively Extend Project Period beyond 5 Years What Does the Waiver Mean? Guidance for Year 06 Track 1.0 ART Program Continuation Applications The Definition of a Local Partner Information for Preparing a Transition Plan Timeline for Completing the Transition Action Steps – To Explain Who Should Do What and When They Should Do It

8. Guidance for Year 06 Track 1.0 ART Program Continuation Applications Class Deviation Waiver to Non-Competitively Extend Project Period beyond 5 Years What Does the Waiver Mean? Guidance for Year 06 Track 1.0 ART Program Continuation Applications The Definition of a Local Partner Information for Preparing a Transition Plan Timeline for Completing the Transition Action Steps – To Explain Who Should Do What and When They Should Do It

9. Guidance for Year 06 Track 1.0 ART Program Continuation Applications Class Deviation Waiver to Non-Competitively Extend Project Period beyond 5 Years What Does the Waiver Mean? Guidance for Year 06 Track 1.0 ART Program Continuation Applications The Definition of a Local Partner Information for Preparing a Transition Plan Timeline for Completing the Transition Action Steps – To Explain Who Should Do What and When They Should Do It

10. Class Deviation Waiver to Non-Competitively Extend Project Period for Track 1.0 ART Program Beyond 5 Years What Does the Waiver Mean?

11. Class Deviation to Extend Project Period for Track 1.0 ART Program Beyond 5 Years HRSA and the CDC have received official approval of a “class deviation waiver” for the 4 Track 1.0 ART program grantees As a result of the waiver, the Office of Grants Policy, Oversight, and Evaluation at HHS has approved a 3-year non-competing continuation of the 4 awards beyond the current 5-year period, thereby, extending the current project period to February 28, 2012

12. Class Deviation to Extend Project Period for Track 1.0 ART Program Beyond 5 Years The waiver requires that the Track 1.0 partners transition management of their programs to local partners by February 28, 2012 Additionally, the waiver provides for the possibility of an additional 1-year extension, if the grantees need 1 more year to complete a transition to local partners Any additional funding beyond this 3- or 4-year period would occur only as a result of standard awarding processes

13. Class Deviation to Extend Project Period for Track 1.0 ART Program Beyond 5 Years In the short term, this extension means that the Track 1.0 ART partners will continue to submit yearly non-competing applications with appropriate reporting, as indicated on the Notice of Grant Award However, the grantees will have to include in their Year 06 continuation applications plans to transition the management of each of their country programs to a local partner by February 28, 2012

14. Class Deviation to Extend Project Period for Track 1.0 ART Program Beyond 5 Years During March 2009-February 2012, the Track 1.0 ART partners may receive additional funds, expand to new sites, and provide support for additional patients to assure that the USG effort to support and scale up national programs continues without interruption The intent of the class deviation waiver is to sustain care to existing patients without significant & life-threatening disruptions, until programs can be transitioned to local partners

15. Guidance for Year 06 Track 1.0 ART Program Continuation Applications The Definition of a Local Partner

16. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications For the Track 1.0 ART program, a local partner is an entity that meets the following criteria: 1)Must be incorporated or legally organized under the laws of the country and have its principal place of business in the country served by the PEPFAR program with which the entity is or may become involved; 2)Must be at least 75% beneficially owned by individuals who are citizens or lawfully admitted permanent residents of the country served by the PEPFAR program with which the entity is or may become involved;

17. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications 3)At least 75% of the entity’s staff (senior and mid-level support) must be citizens or lawfully admitted permanent residents of the country served by the PEPFAR program, and at least 75% of the entity’s senior staff (i.e., managerial and professional personnel) must be citizens or lawfully admitted permanent residents of such country. Where an entity has a Board of Directors, at least 51% of the members of the Board must be citizens or lawfully admitted permanent residents of the country; or

18. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications 4)A joint venture, unincorporated association, or other arrangement is considered a local partner, if at least 51% of the members of the joint venture, association or other arrangement are local organizations under the criteria in paragraphs (1) through (3) above.

19. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications 5)Host government ministries (e.g., Ministry of Health), sub-units of government ministries, and parastatal organizations in the country served by the PEPFAR program are considered local organizations. A parastatal organization is defined as a fully or partially state-owned or government-funded organizaion. Such state-run enterprises may function through a board of directors, similar to private corporations, but ultimate control over the board may rest with the government.

20. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications 6)The Office of the Global AIDS Coordinator may modify or waive the above criteria where justified to address the circumstances in a specific case.

21. Guidance for Year 06 Track 1.0 ART Program Continuation Applications Information for Preparing a Transition Plan

22. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications The following information should be used to help prepare the Year 06 continuation applications: 1)If requested through country operational plans (COPs), additional funding may be available to Track 1.0 ART program partners 2)Similar to the formats used in previous years, the application should include a yearly work plan, budget, and budget narrative, as will be described in the Year 06 Track 1.0 ART program award announcements

23. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications 3)Prior to submission of the application, each partner is required to obtain concurrence of the program proposal for each country from the in-country U.S. Government team 4)The FY 2009 application must include a transition plan for each country, with in-country concurrence, for how the partner plans to transition the program to a local partner during the class deviation waiver period

24. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications 5)The transition plan should include a timetable with annual benchmarks that the grantee will achieve to transition the program to the local partner, e.g., a timetable could indicate that the local partner will assume clinical oversight of the program by end of year 01 of the transition, administrative oversight by end of year 02, and fiscal oversight by end of year 03 6)In addition to greater responsibility by local partners, grantees should describe increases in yearly targets that may require additional funding from the country

25. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications 7)Previously, we discussed the possibility of transferring Track 1.0 ART program funds to a Track 1.0 ART partner through another funding mechanism that was the result of an in-country funding announcement. HHS has informed us that this approach can not be used, after the class deviation waiver is in effect. For example, if partner X receives Y funds for Track 1.0 activities and is approved for funding through a new announcement in FY 2009, this partner can not receive all or part of the Track 1.0 funds through the new announcement in subsequent years.

26. Guidance for Year 06 Track 1.0 ART Program Continuation Applications Timeline for Completing the Transition

27. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications After February 2012, the Indigenous Partners Need to Be Funded By Standard Awarding Processes 1)After the plan and the funding have received COP approval, the transition from the Track 1.0 ART grantee to an indigenous partner can occur anytime before February 28, 2012 2)Moreover, the transition process for the Track 1.0 ART country programs can occur over different time periods, if explained and justified

28. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications 3)Prior to February 28, 2012, the transition from the Track 1.0 ART partner to the local partner should occur in a non-competitive process but can include competitively qualified indigenous ART partners 4)However, after February 28, 2012, the local partner needs to have been selected as a treatment partner by standard awarding processes to continue to receive funding

29. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications 5)The FY 2009 application must include a plan for each country for how the grantee plans to transition the program to a local partner prior to February 2013, unless the CDC in-country team and the Track 1.0 partner think that this time period is too short to complete the transition. In these cases, the partner should explain how long the transition will take and why and provide yearly benchmarks for the transition period, even though this period is longer than 4 years.

30. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications 6)For programs with a transition period that is longer than 4 years, i.e., beyond February 2013, the CDC in-country team will have to publish a competitive “funding opportunity announcement” (FOA) to provide support for these programs. However, these FOA’s should be designed to fund partners who have demonstrated the capability to (1) initiate and support ART programs that provide optimal care and treatment and (2) reach annual benchmarks in transitioning ART programs to local partners.

31. Guidance for Year 06 Track 1.0 ART Program Continuation Applications Action Steps – To Explain Who Should Do What and When They Should Do It

32. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications Action Steps 1)In consultation with the CDC in-country PEPFAR team in each country, the Track 1.0 ART partners should develop a transition plan for each program that include a narrative, budget, and timetable with annual benchmarks 2)Following consultation, the Track 1.0 ART partners need to receive written approval for the plan from the CDC in-country team in each country

33. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications Action Steps 3)In each country, the CDC in-country team should obtain approval for the transition plans from the USG in-country team 4)The transition plan should then be incorporated into the FY 2009 Country Operational Plan (COP) 5)The transition plan should be included in the Year 06 Track 1.0 ART program continuation applications that are due at the end of 2008 for the CDC grantees and in early 2009 for the HRSA grantees

34. Guidance for the Year 06 Track 1.0 ART Program Continuation Applications Action Steps 6)CDC and HRSA need to approve the transition plans in the Year 06 continuation applications for all of the partners 7)OGAC then needs to approve the FY 2009 COP’s that include the Track 1.0 ART program transition plans 8)Following CDC, HRSA, and OGAC approval, the Track 1.0 ART program transition plans can be implemented

35. Guidance for Year 06 Track 1.0 ART Program Continuation Applications Concluding Statement

36. Guidance for the FY 2009 Track 1.0 ART Program Continuation Applications We strongly encourage the Track 1.0 ART partners to continue “business as usual” by receiving additional funds, expanding to new sites, and providing support for additional patients during the transition period because we need to assure that the USG effort to support and scale up national programs continues without interruption. Finally, we feel it is important to note that full and successful participation in the current effort provides the best justification for who should be selected to provide support for USG-funded HIV care and treatment programs in the future.