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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, HHS.

# ACTION:

Request for information.

# SUMMARY:

                        Through this Request for Information (RFI), the Office of AIDS Research (OAR) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), National Institutes of Health (NIH), invites feedback from researchers, health care professionals, advocates and health advocacy organizations, scientific or professional organizations, federal/state/local government agencies, community, and other interested constituents on the development of the fiscal year (FY) 2026-2030 NIH Strategic Plan for HIV and HIV-Related Research (the Plan). The Plan (                        *https://www.oar.nih.gov/​sites/​default/​files/​NIH_​StrategicPlan_​FY2021-2025.pdf*) guides the NIH investment, building on scientific progress and opportunities for advancing HIV research toward an end to the pandemic.                    

# DATES:

Send comments on or before April 1, 2024 to ensure consideration.

# ADDRESSES:

                        Submissions must be submitted electronically via the following website:                         *https://rfi.grants.nih.gov/​?s=​65b25017cf031643470daad2.*

# FOR FURTHER INFORMATION CONTACT:

                        Questions about this request for information should be directed to Rachel I. Anderson, Office of AIDS Research, 5601 Fishers Lane, Rockville, MD 20852,                         *HIVstrategicplan@nih.gov,*                         (301) 496-0357.                    

# SUPPLEMENTARY INFORMATION:

This notice is in accordance with the NIH Revitalization Act of 1993 that requires the Office of AIDS Research to develop a comprehensive plan, reviewed annually and revised as appropriate, that establishes HIV/AIDS research priorities and serves as a guiding framework for allocation of HIV/AIDS funding across NIH. This notice also complies with the 21st Century Cures Act, wherein NIH and its institutes, centers, and offices are required to regularly update their strategic plans.

## Background

                    The most recent global statistics from the Joint United Nations Programme on HIV/AIDS (                    *https://www.unaids.org/​sites/​default/​files/​media_​asset/​UNAIDS_​FactSheet_​en.pdf*) estimate that in 2022, 39 million people were living with HIV, 1.3 million people acquired HIV, and 630,000 people died from AIDS-related illnesses. The Centers for Disease Control and Prevention (                    *https://www.cdc.gov/​hiv/​statistics/​index.html*) estimates that in the United States in 2021, 1.2 million people were living with HIV, with disparities by age, race, gender, and ethnicity. There were over 36,000 new HIV diagnoses documented in the U.S. in 2021, and an estimated 66% of people with diagnosed HIV achieved viral suppression. These statistics point to the need for expanded access and choice among current HIV prevention, testing, and treatment methods, as well as the need for an effective HIV vaccine and a scalable HIV cure. Global patterns of HIV epidemiology underscore the necessity for research and implementation strategies to address the intersectional nature of health disparities and social determinants of health.                

NIH OAR oversees and coordinates all HIV research activities across NIH, including both extramural and intramural research, research training, program evaluation, and HIV research infrastructure and capacity development. NIH supports a comprehensive portfolio of research representing a broad range of basic, clinical, behavioral, social, translational, and implementation science on HIV and associated coinfections and comorbidities. The Plan provides a framework for developing the NIH HIV research budget, articulates HIV research priorities, and provides information about NIH HIV research priorities to the scientific community, Congress, HIV-affected communities, and the public at large.

                    Since 2015, the NIH HIV research portfolio has been framed according to five overarching priority areas (                    *https://grants.nih.gov/​grants/​guide/​notice-files/​NOT-OD-20-018.html*): 1) Reduce the incidence of HIV; 2) Develop next-generation HIV therapies; 3) Conduct research toward HIV cure; 4) Address HIV-associated comorbidities, coinfections, and complications; and 5) Advance cross-cutting areas of research (including basic research, behavioral and social sciences research, health disparities, trainings, capacity-building and infrastructure). To capitalize on advances in HIV science that span multiple areas (                    *e.g.,*                     the use of long-acting injectable ART for both prevention and treatment) and to promote a multidisciplinary and integrative approach, OAR proposes a new framework based on the HIV research-to-practice continuum for priority setting.                

## A New Framework for NIH HIV Research

OAR is adopting a new framework for the next Strategic Plan (FY 2026-2030) that consists of four strategic goals:

Goal 1. Enhance discovery and advance HIV science through fundamental research.

Goal 2: Advance the development and assessment of novel interventions for HIV prevention, treatment, and cure.

Goal 3: Optimize public health impact of HIV discoveries through translation, dissemination, and implementation of research findings.

Goal 4: Build research workforce and infrastructure capacity to enhance sustainability of HIV scientific discovery.

The Goals in this new framework are inclusive of scientific disciplines, individuals, communities, and populations—including women and minoritized populations experiencing health disparities. Within each Goal, specific funding priorities will be informed by public input. Priorities will be reviewed annually and updated as developments in science, the epidemic, funding, and/or policy emerge.

The FY 2026-2030 Plan will be developed in accordance with the following foundational principles:
    - Research to identify and address HIV-related health disparities will be essential to ensure that the benefits of scientific advances reach all people and communities affected by HIV, including groups that have historically been underrepresented and underserved.
    - Research must address the unique needs of people with HIV across the lifespan, particularly as people, including those born with HIV, age with the virus.
    - Engagement and partnership with communities affected by HIV are essential at every stage of HIV research, from developing research questions and planning and conducting research to disseminating results and health information and implementing new practices.

## Information Requested

                    Respondents are invited to propose research priorities within each Goal as described below. This feedback will assist in informing the FY 2026-2030 Plan. Please note that response fields are limited to 200 words. Professional societies, advocacy organizations, and other groups are encouraged to submit a single collective response that reflects the views of their membership.                          ( print page 11844)    

*Goal 1: Enhance discovery and advance HIV science through fundamental research.*

*Description:*                     Fundamental research seeks to expand understanding of the biological, physiological, interpersonal, and social-structural mechanisms of HIV—                    *i.e.,*                     how it operates as a virus and as an infectious disease pandemic—at the molecular, cellular, individual, community, and population level. This understanding provides the foundation for the development of safe, effective, and scalable tools to prevent, treat, and ultimately cure HIV infection, as well as reduce the risk and impact of comorbid conditions and co-occurring infections. Fundamental research includes theoretical, pre-clinical, and methodological research across scientific disciplines.                

*Goal 2: Advance the development and assessment of novel interventions for HIV prevention, treatment, and cure.*

*Description:*                     Knowledge gleaned from fundamental, pre-clinical, and translational research to inform clinical trials and other intervention studies to test the most promising products, tools, or strategies for HIV prevention, treatment, and cure and management of its complications. Rigorous randomized control trials, observational studies, and other methodologies assess biological, behavioral, and social outcomes of novel interventions, as well as their feasibility, acceptability, effectiveness, and scalability in differing populations and across the lifespan.                

*Goal 3: Optimize public health impact of HIV discoveries through translation, dissemination, and implementation of research findings.*

*Description:*                     As HIV prevention, treatment, and cure interventions are shown to be efficacious, their findings must be translated to inform practice and to connect with communities and the general public in order to maximize their public health impact. Implementation research can identify how best to facilitate effective adaptation, uptake, integration, and scale-up of evidence-based HIV interventions. Information-sharing through community partnerships, research collaborations, and dissemination activities can amplify the impact of research and promote health equity.                

*Goal 4: Build research workforce and infrastructure capacity to enhance sustainability of HIV scientific discovery.*

*Description:*                     Continued progress in HIV science and its application requires robust support for research tools, computational resources, instrumentation, data and physical infrastructure, and workforce development, particularly in institutions that serve underrepresented or high HIV burden populations or that historically have been underfunded in the United States and globally. Such enhanced capacity-strengthening efforts will promote diversity and inclusion in the HIV research workforce.                

*Respondents are also invited to share comments on the new framework.*

*Responses to this RFI Notice are voluntary.*                     The submitted information will be reviewed by NIH staff and may be made available to the public. Submitted information will not be considered confidential. This request is for information and planning purposes and should not be construed as a solicitation or as an obligation of the federal government or the NIH. No awards will be made based on responses to this Request for Information. The information submitted will be analyzed and may be used in reports or presentations. Those who respond are advised that the NIH is under no obligation to acknowledge receipt of your comments or provide comments on your submission. No proprietary, classified, confidential and/or sensitive information should be included in your response. The NIH and the government reserve the right to use any non-proprietary technical information in any future solicitation(s).                

Dated: February 5, 2024.

Lawrence A. Tabak,

Principal Deputy Director, National Institutes of Health. 

[FR Doc. 2024-03122 Filed 2-14-24; 8:45 am]

BILLING CODE 4140-01-P