1. New NIH HIV/AIDS Research Priorities Judy Auerbach ARI Faculty Meeting October 21, 2015

2. Established in 1988 by Assistant Secretary of Health, Dr. Robert Windom, to coordinate trans-NIH AIDS research Legislatively established in the Health Omnibus Programs Extension Act (HOPE) 1988 (P.L. 100-607) Specific mandates and authorities established in the NIH Revitalization Act of 1993 (P.L. 103-43) Establishment and Role of OAR

3. The NIH Revitalization Act of 1993 mandates that OAR: Develops a comprehensive strategic plan that identifies and establishes objectives, priorities, and policy statements governing the conduct and support of all NIH AIDS research activities Develops and presents to OMB and the President an annual scientifically justified budget estimate for NIH AIDS-related research activities Submits an alternate AIDS budget to the Secretary, DHHS, and the Director, NIH, in accordance with the strategic plan Receives and disburses all appropriated funds for NIH AIDS research activities to the NIH Institutes and Centers (ICs) in accordance with the strategic plan Directs the planning, coordination, and integration of all AIDS research activities across and throughout the NIH ICs Has a 3% transfer authority: within any Fiscal Year, the OAR Director may move money from one IC to another Evaluates NIH HIV/AIDS research programs developed for the strategic plan and carried out by the ICs Administers a discretionary fund for the support, through the ICs, of AIDS research Key Office of AIDS Research Legislative Mandates & Authorities

4. Current Context

7. Guidelines for High-, Medium-, and Low- Priorities for Use of AIDS-designated Funds Developed by NIH Director, based on: OAR Advisory Council HIV/AIDS Research Portfolio Review Working Group Report (May 2014) FY 2015 Trans-NIH Plan for HIV-Related Research – reflecting input from scientific and academic community, scientific foundations, and community constituency groups NIH Leadership Applicable to determining priority for receiving AIDS funding not scientific merit of grants, contracts, and intramural projects

8. High Priority AIDS Research (From 8/12 NIH NOT) High Priority topics of research for support using AIDS-designated funds Reducing incidence of HIV/AIDS including: developing and testing promising vaccines, developing and testing microbicide and pre-exposure prophylaxis candidates and methods of delivery, especially those that mitigate adherence issues; and developing, testing, and implementing strategies to improve HIV testing and entry into prevention services. Next generation of HIV therapies with better safety and ease of use including: developing and testing HIV treatments that are less toxic, longer acting, have fewer side effects and complications, and easier to take and adhere to than current regimens. Additionally, implementation research to ensure initiation of treatment as soon as diagnosis has been made, retention and engagement in these services, and achievement and maintenance of optimal prevention and treatment responses. Research toward a cure including: developing novel approaches and strategies to identify and eliminate viral reservoirs that could lead toward a cure or lifelong remission of HIV infection, including studies of viral persistence, latency, reactivation, and eradication. HIV-associated comorbidities, coinfections, and complications including: addressing the impact of HIV-associated comorbidities, including tuberculosis, malignancies, cardiovascular, neurological, and metabolic complications, and premature aging associated with long-term HIV disease and antiretroviral therapy.

9. High Priority AIDS Research (continued) Cross cutting areas: Basic research, health disparities, and training including: o Basic Research: understanding the basic biology of HIV transmission and pathogenesis; immune dysfunction and chronic inflammation; host microbiome and genetic determinants; and other fundamental issues that underpin the development of high priority HIV prevention, cure, co-morbidities, and treatment strategies. o Research to Reduce Health Disparities in the incidence of new HIV infections or in treatment outcomes of those living with HIV/AIDS. o Research Training of the workforce required to conduct High Priority HIV/AIDS or HIV/AIDS-related research.

10. Medium Priority AIDS Research Medium Priority topics of research for support using AIDS-designated funds include projects that demonstrate HIV/AIDS is a meaningful component of the project and/or knowledge about HIV will be enhanced by the project, as evidenced in the specific aims. Several examples of research that could be considered as Medium Priority include: The project examines a fundamental scientific question (or questions) that has a clear or potential link to HIV/AIDS; The project includes people (or biological specimens from people) who are living with HIV, are HIV exposed, and/or are at elevated risk for HIV infection as part of a broader sample or as a comparative cohort; The project addresses health and social issues that are clearly linked with HIV (transmission/acquisition, pathogenesis, morbidity and mortality, stigma) and examines them in the context of HIV (i.e., in populations or settings with high HIV prevalence or incidence), such as other infectious pathogens and diseases, non-infectious pathogens and diseases, substance use/addiction, and mental health disorders; The project meaningfully includes HIV/AIDS (or SIV) outcomes/endpoints; or The results of the project will advance HIV treatment or prevention and/or provide tools/techniques and/or capacity beneficial to HIV research (including training and infrastructure development). The project meaningfully includes HIV/AIDS (or SIV) outcomes/endpoints; or The project results will advance HIV treatment or prevention and/or provide tools/techniques and/or capacity beneficial to HIV research (including training and infrastructure development).

11. Low-Priority AIDS Research Low Priority topics of research will not be supported with AIDS-designated funds; however, highly meritorious projects could be eligible for support with non-AIDS funds by an NIH Institute or Center. Several examples of research that will be considered Low Priority include: Natural history and epidemiology that is entirely focused on a co-morbidity and does not have any focus on or inclusion of HIV (e.g., malaria, TB, and drug abuse) Basic virology on pathogens that are co-infecting, but not in the context of HIV infection; and basic immunology studies of general relevance, but not specific to HIV. Examples of these include: Basic virology and neurobiology research of co-infecting pathogens not in the context of HIV infection (e.g., Herpesviruses, HPV, TB, Malaria, hepatitis C and B, syphilis, Cryptococcus, flaviviruses, JC virus, etc.) Basic cancer-related immunology studies not in the context of HIV infection Studies of co-morbidities of general relevance, but not in the context of HIV (e.g., diabetes, lipid defects, endocrinology) Data analysis and systems tools that are not HIV-related, e.g., genomics studies of little or no relevance to HIV Studies of behaviors (e.g., sexual activities, drug use activities) or social conditions (e.g., economic distress) that have multiple negative outcomes where HIV/AIDS is only one of many outcomes being studied without a focus on how HIV/AIDS is unique in that context (i.e., it is just mentioned as potentially relevant)

12. Emerging Issues Priorities are “apples and oranges” Whole areas of research are not mentioned Behavioral and social research How much room for interpretation is there? ICs saying different things

13. FY14 AIDS Portfolio Review Purpose: OAR and a small panel of IC scientific staff are conducting an AIDS portfolio review of all grants, contracts, and intramural projects scheduled to recompete in FY16 Outcome - Identify projects that are “low priority” research; these projects will not be supported with AIDS dollars when they recompete in FY16 -- or are considered for funding after most recent BSC review for intramural projects. Funds identified will go into a common high AIDS relevance pool. Results of portfolio review will be presented at ACD meeting on December 10-11, 2015 Approximately 25% of all projects will be reviewed this year and annually until the entire portfolio is realigned with the highest priorities

14. ProjectLowNo 100 X$Medium Maybe/ Pro-rating High Yes/ Pro-rating 0-100X$ Priority Ranking AIDS Dollars % AIDS $ Recouped Total $ Recouped/ Available for Reprogramming FY 2014 HIV/AIDS Project Review and Decision Flow Chart

15. Pro-rating Grants with AIDS and non-AIDS Components Scientific/Programmatic FocusProration of AIDS Dollars <10% AIDS0% AIDS 10-25% AIDS 25% AIDS 26-50% AIDS50% AIDS 51-75% AIDS75% AIDS 76-100% AIDS100% AIDS

16. Actions to Be Taken in FY16 FY16 - Funds made available from an IC that shows a decrease in AIDS project funding will go into a common high AIDS relevance pool. FY16 - In consultation with the NIH Director, OAR will exercise, as necessary, its 3% transfer authority to transfer funds between ICs after the Appropriation. At least for FY16, expectation is that total funds for HIV/AIDS will likely remain about the same. Except.... 16

17. Senate LHHS Appropriations Hearing October 7, 2015....... COLLINS: So I'm not totally familiar with the detailed numbers you present but I will certainly look at those. Certainly we are in the process Senator of trying to right size the way in which our HIV research budget is being allocated. And the office of aids research has the potential to move dollars around between institutes and between program... CASSIDY: But can we move it out of HIV? So for example, I have a study here, there's been a million dollars that has gone to study, behaviors of Chinese men having sex with men in some city in China. A million dollars over the last four years. It would've have been great to put that to Alzheimer's or to Oregon, where the guy -- where Markley's researcher would find -- I don't -- one of your predecessors or honies said that we're not the International Institute of Health, we're the National Institute of Health. Why are we spending a million bucks on a behavioral health study in China? COLLINS: Again, we have now identified I think the four areas of high priority and frankly I do not think that that study would necessarily fit those priorities...

18. NIH AIDS Research Budget by Area of Emphasis and by IC (from FY 2016 CJ)

19. New OAR Processes in FY 2016 Revision of CSR Referral Guidelines and restructuring of AIDS IRG study sections Review of FOAs – OAR will review draft FOAs and RFPs to ensure that these are properly aligned to priorities OAR will require that all new and competing renewal projects (grants, contracts, intramural projects) are aligned with the highest overarching AIDS priorities All new and competing renewal projects will be pro-rated on the basis of their AIDS-related proportion

20. Thank You!