Track 1.0 Class Deviation Waiver J OSE “R AFI ” M ORALES, MD, FACOG C HIEF M EDICAL O FFICER Transition Guidance from Health and Human Services (HHS) HRSA, HIV/AIDS B UREAU, G LOBAL HIV/AIDS P ROGRAM August 4, 2009

Class Deviation Waiver What does the waiver mean? Deviation Waiver to Non-Competitively Extend Project Period for Track 1.0 ART Program Beyond 5 Years

Class Deviation Waiver  HRSA and CDC 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 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

Class Deviation Waiver  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 to February 28, 2013, if the grantees demonstrate specific needs in a country for 1 more project year to complete a transition to local partners  Any additional funding beyond this 3-year or 4-year period would occur only as a result of standard awarding procedures

Class Deviation Waiver  In the short term, this extension means that the Track 1.0 ART grantees will continue to submit yearly non- competing applications, with appropriate reporting, as indicated in the notices of grant award  However, the grantees were required to include in their Year 06 continuation applications, plans to transition management of each of their country programs to a local partner by February 28, 2012

Class Deviation Waiver  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”

Transition Guidance from HHS Conference call with the Director/HHS Office of Grants Policy Oversight and Evaluation Date:June 3, 2009 Issue:Clarification on TRACK 1.0 Class Deviation

Transition Guidance from HHS Participants included:  Lluana McCann Director, HHS/Office of Grants Policy Oversight and Evaluation  Jim Kulikowski Acting Director, HHS/Office of Global Health Affairs  Debbie Birx Director, CDC/Global AIDS Program  J. Rafi Morales Chief Medical Officer, HRSA/Global HIV/AIDS Program  Catherine McLean PEPFAR Liaison, HHS/Office of Global Health Affairs.

Transition Guidance from HHS 1. The feasibility of using a noncompetitive replacement award mechanism to transition from TRACK 1.0 grantee to a local partner/sub- grantee in country? 2. Transition Period: When should the transition take place: during or at the end of the Class Deviation period?

Transition Guidance from HHS 3. Transfer of TRACK 1.0 funds to non-local partners: Is the transfer of TRACK 1.0 Care and Treatment funds that is part of the Class Deviation permissible to be transitioned to non-local partners? 4. If an additional country was added after the initial award, do the rules of the Class Deviation apply to the new country?

Transition Guidance from HHS 1. Feasibility of using the noncompetitive replacement award mechanism. No. All transition in accordance to the Class Deviation must be through a competitive process.

Transition Guidance from HHS 2. Transition Period All transition needs to take place within the 3 year extension period. Continuation through the 4th year is for unusual circumstances and will require additional documentation and discussion with OGHA.

Transition Guidance from HHS 3. Transfer of TRACK 1.0 funds to local partners The TRACK 1.0 funds are to be directed to local partners. OGPOE recognized that transfer to local partners might not feasible in every circumstance/country. In those situations, OGHA and OGPOE should be notified to review and approve the transition to a non-local partner; however, these awards will include a pre-drawdown of funds term and condition requiring the submission of a written plan developed by the non-local partner in consultation with country officials setting out how they will work together to ensure the transition to a local partner within a specified amount of time.

Transition Guidance from HHS 3. Transfer of TRACK 1.0 funds to local partners. These plans are subject to HHS Operating Division and OGHA approval prior to the release of funds. This transition can occur at any time during the 3 years of the transition period, provided that the stated requirements are met.

Transition Guidance from HHS 4. New country bound to TRACK 1.0 rules. Even though a new country was added after the initial award, the grantee working in the new country is still bound to the requirements of the original award.