[Federal Register Volume 89, Number 32 (Thursday, February 15, 2024)]
[Notices]
[Pages 11843-11844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03122]



[[Page 11843]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information (RFI) To Inform Development of the FY 
2026-2030 NIH Strategic Plan for HIV and HIV-Related Research

AGENCY: National Institutes of Health, HHS.

ACTION: Request for information.

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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, 
[email protected], (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.

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    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