FACACLASSIC

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HHS - 1918 - Office of AIDS Research Advisory Council - Statutory (Congress Created)

GENERAL INFORMATION

Committee Name	Office of AIDS Research Advisory Council	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	1918
Original Establishment Date	6/27/1994	Committee Status	Chartered
Actual Termination Date		Committee URL	https://www.oar.nih.gov/about/oarac
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	18
Terminated This FY	No	Designated Fed Officer Position Title*	Acting Deputy Director, Office of AIDS Research
Merged This FY		Designated Federal Officer Prefix	CAP
Current Charter Date	6/27/2024	Designated Federal Officer First Name*	Mary
Date Of Renewal Charter	6/27/2026	Designated Federal Officer Middle Name
Projected Termination Date		Designated Federal Officer Last Name*	Glenshaw
Exempt From Renewal*	No	Designated Federal Officer Suffix	PHD, MPH
Specific Termination Authority		Designated Federal Officer Phone*	(240) 669-2958
Establishment Authority*	Statutory (Congress Created)	Designated Federal Officer Fax*
Specific Establishment Authority*	42 USC 300cc-40b	Designated Federal Officer Email*	mary.glenshaw@nih.gov
Effective Date Of Authority*	6/10/1993
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not Applicable
How does cmte accomplish its purpose?*	The Office of AIDS Research Advisory Council (OARAC) is composed of highly qualified individuals who possess scientific expertise in HIV/AIDS research and a public commitment to advance the HIV/AIDS scientific agenda. The Council provides a breadth and balance of specialized knowledge necessary to advise the Director of the Office of AIDS Research (OAR) and the Director of the National Institutes of Health. The NIH Revitalization Act of 1993 called for the establishment of OARAC to provide advice on planning, coordination, and evaluating AIDS research supported by the NIH. The OAR depends heavily on the Council's advice in the extensive process of reviewing all NIH HIV/AIDS research and developing long-term research plans. To accomplish its purpose, meetings were held on emerging and relevant topics during FY2025 to seek members’ input and advise on the scientific strategic direction of the OAR. Highlighted topical updates included HIV-relevant presentations with NIH Institutes, Centers, and Offices were shared. In addition, each of the three FY 2025 meetings included information from the five HIV clinical guidelines working groups under OARAC: Adult/Adolescent ARV, Adult/Adolescent Opportunistic Infection; Perinatal; Pediatric ARV and Pediatric Opportunistic infection, as well as the four NIH advisory councils that report to OARAC: the AIDS Research Advisory Committee (ARAC), the National Advisory Mental Health Council, the National Advisory Council on Drug Abuse, and the National Cancer Advisory Board.
How is membership balanced?*	The Committee will consist of not more than 18 members appointed by the Secretary (appointed members) and at least 11 nonvoting ex officio members. The nonvoting ex officio members will include the Secretary of Health and Human Services (Secretary); the Director, NIH; the Director, OAR; the Under Secretary for Health of the Department of Veterans Affairs; the Assistant Secretary of Defense for Health Affairs; the Director, Centers for Disease Control and Prevention; and the Director, Division of AIDS, NIAID; (or their designees). The ex officio members will also include one representative from the National Advisory Allergy and Infectious Diseases Council; one representative from the National Cancer Advisory Board; and a representative from each of the advisory councils of the two national research institutes (excluding NIAID and the National Cancer Institute) that receive the greatest funding for AIDS activities; and such additional officers or employees of the United States as the Secretary determines necessary for the Council to effectively carry out its functions. Two-thirds of the appointed members (including not less than 2 individuals who are leaders in the fields of public health and the behavioral or social sciences relevant to the activities of the OAR) will be appointed from the leading representatives of the health and scientific disciplines in the fields of molecular biology, immunology, virology, neurology, pediatrics, vaccine development, antiviral development, clinical care, animal model research, retrovirology, structural biology, infectious disease, epidemiology, mental health, and substance abuse/addictions sciences. One-third of the public members have expertise in public policy, health policy, economics, and management. Persons with HIV and their advocates will be represented on the Council, either from the general public or from the scientific community.
How frequent & relevant are cmte mtgs?*	The OARAC meets three times a year to provide advice on the direction of the NIH HIV and AIDS research program; the development and annual review of a comprehensive plan for the conduct and support of all AIDS activities of the agencies of NIH; including direct involvement in budget projections for carrying out the plan which includes an estimate of the number and type of personnel needed for OAR. The Committee conducted three meetings on the following dates: 10/24/2024, 06/26/2025, and 09/18/2025.
Why advice can't be obtained elsewhere?*	The committee and membership requirements are specifically addressed in the statute. HIV/AIDS research is conducted throughout the NIH, which includes 22/27 Institutes and Centers, along with co-funding HIV/AIDS research with the OD programs. The OARAC is the only council with advisory responsibilities applicable to the entire agency-wide NIH HIV and AIDS research program. Therefore, it is essential to the coordination of the NIH HIV and AIDS scientific effort and research direction of the agency's HIV and AIDS programs.
Why close or partially close meetings?	N/A
Recommendation Remarks	The Committee consists of not more than 18 members appointed by the Secretary and at least 11 nonvoting ex officio members. There are several non-federal ex-officio members also serving on OARAC. These members serve as representatives from other advisory committees, including one representative from the National Advisory Allergy and Infectious Diseases Council; one representative from the National Cancer Advisory Board; and a representative from each of the advisory councils of the two national research institutes (excluding the National Institute of Allergy and Infectious Diseases and the National Cancer Institute) that receive the greatest funding for AIDS activities. In the membership section, these members are labeled as "Ex Officio Member" for "Member Designation" and "Agency" for appointment type because they are non-federal. Their pay plan is also designated as "Hourly or Daily Compensation Plus Travel and Per Diem," but the committees on which they are Special Government Employee (SGE) members pay for their participation on OARAC. They also have fixed terms on OARAC; federal Ex Officio members on OARAC do not have fixed terms. On the Fiscal Year (FY) 2023 report, Robert Eisinger and Bill Kapogiannis were incorrectly reported as having fixed terms. On this report, their records have been corrected to demonstrate that they do not have fixed terms. In FY23, Maureen Goodenow, Bill Kapogiannis, and Robert Eisinger were incorrectly reported as having an "agency" appointment type; they are all Federal Employee Ex Officio Members. In FY23, Monica Gandhi, Marguerita Lightfoot, and Melanie Ott were incorrectly reported as having no fixed term. They are non-federal Ex Officio representatives on OARAC and have fixed terms on the committee. Their terms are correctly reflected on this report. Four members were administratively extended and then rotated off OARAC on 3/29/24: Drs. Veronica Miller, Kathleen Collins, Ricardo Rivero, and John Sleasmen. Four members' regular terms ended on 9/30/2024: Dr. Marguerita Lightfoot, Dr. Victoria Davey, Dr. Carl Diffenbach, and Dr. Jonathan Mermin. Currently, seven members and nine ex officios are serving on OARAC. With eight members rotating off OARAC this FY, there are gaps in expertise in molecular biology, management, economics, mental health, and neurology. Six nominees, who will fill the gaps in expertise, are pending. Also, in FY23, Luis Montaner was incorrectly reported as serving a less-than-one-year term, but Luis Montaner is serving a 2-year term. In FY24, the following members' terms were administratively extended to maximize the expertise represented on OARAC: Dr. Shruti Mehta, Dr. Omar Galarraga, and Dr. Mojgan Naghavi. Dr. Turnbull was reappointed as Chair in FY24 and has extended their term through March 29, 2025. OARAC did not produce a report this fiscal year.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	No
Outcome Trust In Government	No	Action Reallocate Resources	No
Outcome Major Policy Changes	Yes	Action Issued New Regulations	No
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	No
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	Yes
Outcome Increased Customer Satisfaction	No	Action Comment	The Committee makes recommendations to the federal staff on the planning, coordination, and evaluation of research and other activities in respect to AIDS conducted or supported by the NIH. OARAC also advises the Secretary of Health and Human Services, the Assistant Secretary for Health, the Director of NIH, and the Director of OAR, on AIDS research programs, the development and annual review of the comprehensive plan for the conduct and support of all AIDS activities of the agencies of NIH, including research policies and priorities, and the coordination of domestic and international NIH AIDS efforts.
Outcome Implement Laws/Reg Requirements	No	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	NA	Number Of Grants Recommended	0
Cost Savings*	None	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	NIH supported basic and clinical research accomplishments which often take many years to unfold into new diagnostic tests and new ways to treat and prevent diseases.	Grants Review Comment	NA
Number Of Recommendations*	14	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	Sessions on specific topics that are timely and of relevance were presented during FY25 to update the OARAC with recommendations. October 2024: Recommendation to (1) enhance public-private partnerships to ensure that pharmaceutical discoveries and new drugs are implemented rapidly; (2) emphasize the importance of industry-academic engagement for scientific innovation and new discoveries; (3) consider recommendations for 4 funding priorities: (3A) Enhance discovery and advance HIV science through fundamental research, (3B) Advance the development and assessment of novel interventions for HIV prevention, treatment, comorbidities, and cure through preclinical, translational, and applied research pipelines; (3C) Optimize public health impact of HIV discoveries through implementation science and dissemination of research findings; (3D) Build research workforce and infrastructure capacity to enhance sustainability of HIV scientific discovery; (4) utilize OAR portfolio analysis to identify how funding has mapped to previous strategic plans: (5) review input from each strategic plan task force regarding capacity community-engaged research and capacity building goals, and consider these especially in global and resource limited settings; (6) optimize pediatric antiretroviral therapy development and work with partners to implement discoveries at scale and across the lifespan, importantly including people with perinatally acquired HIV; (7) consider addition of sections on metabolic and cardiovascular complications in people with HIV in the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. December 2024: Unanimous notational vote to endorse HIV Strategic Plan Task Force recommendations for the FY 2026-FY2030 NIH Plan for HIV and HIV-Related Research. OARAC members reviewed and endorsed goals, objectives, strategies, and Task Force recommendations for priorities, presented at the October 2024 OARAC meeting by the HIV Strategic Plan Task Forces Chairs and documented in an OARAC report to the OAR Director in December 2024. June 2025: Recommendation to (1) consider the HIV clinical guidelines as central to the OAR mission to coordinate the NIH HIV research program and the broader NIH mission to foster fundamental discoveries and their applications; (2) solicit feedback from the larger community regarding potential transition of the HIV clinical guidelines; conduct small-group discussions with each of the guideline panels to explore ways to improve and gather input about areas to maintain, change, or initiate within the guidelines to ensure relevance across settings; (3) consider the benefit of OAR support to the guidelines in terms of rigor, timeliness, accessibility, trust, and reputation; recommendation to examine cost of supporting the HIV clinical guidelines relative to their effectiveness and impact; (4) encourage transparency regarding costs to produce and maintain HIV clinical guidelines when discussing efficiency enhancements; (5) expand outreach to encourage early career and future scientists and physician-scientists early in their training, including medical schools, professional organizations such as the HIV Medicine Association, the Infectious Diseases Society of America, the Association of Nurses in HIV Care, university research offices, and biomedical libraries; expand dissemination opportunities with conference presenters and attendees; (6) to help quantify high risk, high reward research investment impact, consider alternate metrics (e.g. use of award applications or membership in honor societies) to measure output as interim indicators.	Access Agency Website	Yes
% of Recs Fully Implemented*	0.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	Due to the complexity of the recommendations made by this committee, staff is unable to determine which recommendations have been fully or partially implemented solely in response to this committee's activities.	Access GSA FACA Website	Yes
% of Recs Partially Implemented*	0.00%	Access Publications	No
% of Recs Partially Implemented Comment	Due to the complexity of the recommendations made by this committee, staff is unable to determine which recommendations have been fully or partially implemented solely in response to this committee's activities.	Access Other	No
Agency Feedback*	Yes	Access Comment	N/A
Agency Feedback Comment*	Information is provided to the public at each meeting. The public can view information related to the Committee through the committee’s official website.	Narrative Description*	NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. NIH works toward that mission by supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad. Section 492 of the PHS Act states that The Secretary ...shall by regulation require appropriate technical and scientific peer review of (A) applications...; and (B) biomedical and behavioral research and development contracts...

COSTS

1. Payments to Non-Federal Members*		1. Est Paymnts to Non-Fed Membrs Nxt FY*
2. Payments to Federal Members*		2. Est. Payments to Fed Members Next FY*
3. Payments to Federal Staff*		3. Estimated Payments to Federal Staff*
4. Payments to Consultants*		4. Est. Payments to Consultants Next FY*
5. Travel Reimb. For Non-Federal Membrs*		5. Est Travel Reimb Non-Fed Membr nxtFY*
6. Travel Reimb. For Federal Members*		6. Est Travel Reimb For Fed Members*
7. Travel Reimb. For Federal Staff*		7. Est. Travel Reimb to Fed Staf Nxt FY*
8. Travel Reimb. For Consultants*		8. Est Travel Reimb to Consltnts Nxt FY*
10. Other Costs		10. Est. Other Costs Next FY*
11. Total Costs	$0.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	3/14/2025 9:35 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Health Health Care Medicine Health and Health Research

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