Notice2024-03122
Request for Information (RFI) To Inform Development of the FY 2026-2030 NIH Strategic Plan for HIV and HIV-Related Research
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Published
February 15, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 32 (Thursday, February 15, 2024)</title>
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[Federal Register Volume 89, Number 32 (Thursday, February 15, 2024)]
[Notices]
[Pages 11843-11844]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-03122]
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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 (<a href="https://www.oar.nih.gov/sites/default/files/NIH_StrategicPlan_FY2021-2025.pdf">https://www.oar.nih.gov/sites/default/files/NIH_StrategicPlan_FY2021-2025.pdf</a>) 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: <a href="https://rfi.grants.nih.gov/?s=65b25017cf031643470daad2">https://rfi.grants.nih.gov/?s=65b25017cf031643470daad2</a>.
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,
<a href="/cdn-cgi/l/email-protection#dc94958aafa8aebda8b9bbb5bfacb0bdb29cb2b5b4f2bbb3aa"><span class="__cf_email__" data-cfemail="94dcddc2e7e0e6f5e0f1f3fdf7e4f8f5fad4fafdfcbaf3fbe2">[email protected]</span></a>, (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 (<a href="https://www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf">https://www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf</a>) 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 (<a href="https://www.cdc.gov/hiv/statistics/index.html">https://www.cdc.gov/hiv/statistics/index.html</a>) 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 (<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-018.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-018.html</a>): 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:
<bullet> 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.
<bullet> 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.
<bullet> 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.
[[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
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