81 FR 33680 - Request for Information on the Development of the FY 2018 Trans-NIH Plan for HIV-Related Research

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 103 (May 27, 2016)

Through this Request for Information (RFI), the Office of AIDS Research (OAR) in the Division of Program Coordination, Planning, and Strategic Initiatives, National Institutes of Health (NIH) invites feedback from investigators in academia, industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, federal agencies, and other interested constituents and the community on the development of the fiscal year 2018 Trans-NIH Plan for HIV-Related Research. This plan is designed to identify and articulate possible future directions to maximize benefits of investments in HIV/AIDS research.

[Federal Register Volume 81, Number 103 (Friday, May 27, 2016)]
[Notices]
[Pages 33680-33681]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12578]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information on the Development of the FY 2018 Trans-
NIH Plan for HIV-Related Research

SUMMARY: Through this Request for Information (RFI), the Office of AIDS 
Research (OAR) in the Division of Program Coordination, Planning, and 
Strategic Initiatives, National Institutes of Health (NIH) invites 
feedback from investigators in academia, industry, health care 
professionals, patient advocates and health advocacy organizations, 
scientific or professional organizations, federal agencies, and other 
interested constituents and the community on the development of the 
fiscal year 2018 Trans-NIH Plan for HIV-Related Research. This plan is 
designed to identify and articulate possible future directions to 
maximize benefits of investments in HIV/AIDS research.

DATES: The Office of AIDS Research Request for Information is open for 
public comment for a period of 30 days. Comments must be received by 
June 27, 2016 to ensure consideration. After the public comment period 
has closed, the comments received will be considered in a timely manner 
by the Office of AIDS Research in the Division of Program Coordination, 
Planning, and Strategic Initiatives.

ADDRESSES: Submissions may be electronically to [email protected].

FOR FURTHER INFORMATION CONTACT: Questions about this request for 
information should be directed to Shoshana Kahana, Ph.D., Office of 
AIDS Research, Division of Program Coordination, Planning, and 
Strategic Initiatives, Office of the Director, National Institutes of 
Health, 5601 Fishers Lane, Bethesda, MD 20892, [email protected], 
301-496-0357.

SUPPLEMENTARY INFORMATION: OAR oversees and coordinates the conduct and 
support of all HIV/AIDS research activities at the NIH. The NIH-
sponsored HIV/AIDS research program includes both extramural and 
intramural research, buildings and facilities, research training, and 
program evaluation and supports a comprehensive portfolio of research 
representing a broad range of basic, clinical, behavioral, social 
science, and translational research on HIV/AIDS and its associated 
coinfections. The NIH HIV/AIDS research program is conducted and 
supported by nearly all of the NIH Institutes and Centers (ICs).
    OAR plans and coordinates research through the development of an 
annual Trans-NIH Plan for HIV-Related Research (the ``Plan'') that 
articulates the overarching HIV/AIDS research priorities and serves as 
the framework for developing the trans-NIH AIDS research budget. The 
Plan provides information about the NIH's HIV/AIDS research priorities 
to the scientific community, Congress, community stakeholders, HIV-
affected communities, and the broad public at large. The fiscal year 
2017 Plan was recently distributed on the OAR Web site: (http://www.oar.nih.gov/strategic_plan/fy2017/OARStrategicPlan2017.pdf).
    New overarching priorities for HIV/AIDS research for the next three 
to five years were defined in the NIH Director's Statement of August 
12, 2015 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html).
    High Priority topics of research for support include:
    (1) Reducing the incidence of HIV/AIDS (including the development 
of a safe and effective vaccine, microbicides, and pre-exposure 
prophylaxis candidates);
    (2) Developing the next generation of HIV therapies with less 
toxicity, better safety, and ease of use;
    (3) Identifying strategies to cure AIDS; and
    (4) Improving the prevention and treatment of HIV-associated 
comorbidities, coinfections, and complications.
    There also are three cross-cutting areas associated with these 
overarching priorities which include:
    (1) Basic research underlying the basic biology of HIV (e.g., 
transmission and pathogenesis; immune dysfunction and chronic 
inflammation; host microbiome and genetic determinants);
    (2) Research to reduce health disparities in the incidence of new 
HIV infections or in treatment outcomes of those living with HIV/AIDS; 
and
    (3) Research training of the workforce required to conduct high 
priority HIV/AIDS research.

Information Requested

    OAR is seeking input on the inclusion of important new and/or 
emerging areas of scientific investigation to inform the development of 
the fiscal year 2018 Trans-NIH Plan for HIV-Related Research. The 
overarching high-priority areas of research as delineated in NOT-15-137 
will remain unchanged. OAR would like feedback on those scientific and 
research opportunities that refine the NIH HIV/AIDS research agenda and 
optimize the investment of HIV/AIDS research resources to search for 
critical strategies to prevent, treat, and cure AIDS.
    Please provide your perspective on any of the following topics as 
they relate to the development of the fiscal year 2018 Trans-NIH Plan 
for HIV-Related Research. Comments can include but are not limited to 
the following areas:
    1. Emerging strategies and technologies related to the development, 
testing, and production of promising HIV vaccine candidates (active and

[[Page 33681]]

passive), and novel adjuvants, including the coordinated role that 
mucosal and systemic immunity play in protection from viral acquisition 
and infection.
    2. Emerging topics related to the development, testing, and 
formulation of microbicides, pre-exposure prophylaxis candidates, long 
acting/and/or injectable formulations of antiretroviral treatment 
candidates (and related methods of delivery for HIV treatments) that 
are less toxic, longer acting, have fewer side effects and 
complications, and easier to take and adhere to than current regimens.
    3. Emerging topics that relate to the research toward a cure, 
including the development of novel approaches and strategies that could 
lead to sustained HIV remission or viral eradication without the 
continuing need for combination antiretroviral therapy, including 
studies of HIV persistence, latency, and reservoir formation.
    4. Emerging topics that relate to the HIV cascade of care, 
including the development, testing, and implementation of integrated 
biomedical, behavioral, and social science strategies to improve HIV 
testing and entry into prevention and treatment services, including 
linkage, engagement, and retention in these services for optimal 
treatment response.
    5. Emerging topics that relate to basic research underlying the 
basic biology of HIV, (e.g., acquisition, transmission and 
pathogenesis; viral persistence; immune dysfunction and chronic 
inflammation; host microbiome and genetic determinants; and 
pathogenesis of opportunistic infections, coinfections, comorbidities, 
and HIV-related mortalities.
    6. Emerging topics that relate to reducing health disparities in 
the incidence of new HIV infections or in treatment outcomes of those 
living with HIV/AIDS, with a specific focus on structural, 
environmental, and community-level determinants of health and the 
interplay of these determinants in developing strategies to mitigate 
the disparities in HIV incidence and access to HIV preventive and 
treatment services,
    7. Emerging topics that relate to the challenges and opportunities 
that should be considered for research training and career development 
programs targeting researchers conducting high priority HIV/AIDS 
research.
    Please limit responses to <1500 characters. 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: May 20, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-12578 Filed 5-26-16; 8:45 am]
BILLING CODE 4140-01-P