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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:

                        The purpose of this Request for Information (RFI) is to invite input on the development of a National Institutes of Health (NIH)-wide strategic plan to advance autoimmune disease research. NIH is seeking input from members of the scientific community,                               ( print page 2627)                            Federal partners, academic institutions, the private sector, health professionals, professional societies, advocacy groups, patient communities, and other interested members of the public.                    

# DATES:

The NIH-wide Strategic Plan for Autoimmune Disease Research Request for Information is open for public comment through March 1, 2024. Comments must be received by March 1, 2024, to ensure consideration. Comments received after the public comment period has closed may be considered by the Office of Autoimmune Disease Research within the Office of Research on Women's Health.

# ADDRESSES:

                        Submissions must be submitted electronically via the following website:                         *https://rfi.grants.nih.gov/​?s=​656f78c997c67a6239036b22*.                    

# FOR FURTHER INFORMATION CONTACT:

                        Questions about this request for information should be directed to Vicki Shanmugam, MBBS, MRCP, FACR, CCD, Director, Office of Autoimmune Disease Research, Office of Research on Women's Health, 6707 Democracy Boulevard, Bethesda, MD 20892, oadr-orwh#                        *rfi@od.nih.gov,*                         301-402-1770.                    

# SUPPLEMENTARY INFORMATION:

                    This notice is in accordance with the 21st Century Cures Act, wherein NIH and its institutes are required to regularly update their strategic plans. In 2022, the National Academies of Sciences, Engineering, and Medicine report, Enhancing NIH Research on Autoimmune Disease                    *https://pubmed.ncbi.nlm.nih.gov/​35593778/​%22%20/​l%20%22:~:text=​Enhancing%20NIH%20Research%20on%20Autoimmune%20Disease%20also%20calls,years%29%20to%20study%20disease%20across%20the%20life%20course,*                     examined NIH research efforts related to autoimmune diseases                    *.*                     Subsequently, Congress, via the Joint Explanatory Statement                     *https://www.appropriations.senate.gov/​imo/​media/​doc/​Division%20H%20-%20LHHS%20Statement%20FY23.pdf*                     accompanying the Fiscal Year 2023 Consolidated Appropriations Act, 2023 directed the establishment of an Office of Autoimmune Disease Research                    *https://orwh.od.nih.gov/​oadr-orwh*                     within the Office of Research on Women's Health (OADR-ORWH)                     *https://orwh.od.nih.gov/​*                     and directed OADR-ORWH to:                
    - Coordinate development of a multi-institute and center (IC) strategic research plan;
    - Identify emerging areas of innovation and research opportunity;
    - Coordinate and foster collaborative research across ICs;
    - Annually evaluate the NIH autoimmune disease research portfolio;
    - Provide resources to support planning, collaboration, and innovation; and
    - Develop a publicly accessible central repository for autoimmune disease research.

Currently, various NIH institutes, centers, and offices (ICOs) support autoimmune disease research in alignment with their individual mission areas. Establishing an NIH-wide Strategic Plan for Autoimmune Disease Research will allow OADR-ORWH to amplify ICO efforts and create opportunities for synergistic innovation focused on areas of autoimmune disease research that will benefit from multi-ICO partnerships and opportunities to implement cross-cutting research.

## Information Requested

NIH is seeking input from internal and external partners throughout the scientific research, advocacy, and clinical practice communities, including those employed by NIH and by institutions receiving NIH support, as well as the public, on the following key areas related to autoimmune disease research:

*Objective 1:*                     Research areas that would benefit from cross-cutting, collaborative research (these areas may include basic or translational research, clinical research, health services research, population science, data science, preventative research, biomedical engineering, and other areas of research).                

*Objective 2:*                     Opportunities to advance collaborative, innovative, or interdisciplinary areas of autoimmune disease research.                

*Objective 3:*                     Opportunities to improve outcomes for individuals living with autoimmune diseases including NIH-designated health disparities populations                     *h**ttp**s**://www.nimhd.nih.gov/​about/​overview/​,*                     populations and individuals with rare diseases, and specific populations that have been historically underrepresented in research and clinical trials.                

*Objective 4:*                     Cross-cutting areas that are integral to advancing autoimmune disease research at NIH including development of a publicly accessible central repository for autoimmune disease research, sex- and gender-intentional research design across all stages of research, and engagement of all populations in research and clinical trials.                

Responses to this RFI are voluntary and are meant for information and planning purposes only. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. Respondents are advised that the responses are reviewed by NIH staff, and the U.S. government is under no obligation to acknowledge receipt of the information provided or provide feedback to the respondents. This RFI is for planning purposes only and should not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the federal government, the NIH, or individual NIH institutes, centers, and offices to provide any kind of support for any ideas identified in response to it.

The government may use the information submitted in response to this RFI at its discretion. The government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding announcements.

The government will not pay for the preparation of any information submitted or for the government's use of such information. No basis for claims against the U.S. government shall arise as a result of a response to this request for information or from the government's use of such information.

NIH looks forward to your input, and we hope that you will share this RFI document with your colleagues.

Dated: January 6, 2024.

Lawrence A. Tabak,

Principal Deputy Director, National Institutes of Health.

[FR Doc. 2024-00695 Filed 1-12-24; 8:45 am]

BILLING CODE 4140-01-P