Notice Number: NOT-AR-15-018

Key Dates
Release Date: July 23, 2015
Response Date: September 11, 2015

Issued by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

In July 2014, the Congressional Lupus Caucus requested that the NIAMS, as convener of the Lupus Federal Working Group (LFWG), develop a new coordinated action plan for lupus research on behalf of the NIH. In response, the NIAMS has led NIH efforts to develop the Action Plan for Lupus Research over the past year, and is now requesting comments and feedback on the draft.

Background
NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The National Institute of Arthritis and Musculoskeletal and Skin Diseases, and a number of other Institutes and Centers support lupus-related research at the NIH. The NIAMS facilitates collaboration among the NIH Institutes, other Federal agencies, and voluntary and professional organizations with shared interests in lupus by leading the LFWG.

Systemic lupus erythematosus (SLE, or lupus) is a complex, heterogeneous, multisystem autoimmune disease that predominantly affects women of childbearing age. Lupus severity ranges on a spectrum from mild to severe, and in its most severe forms lupus can cause significant morbidity and mortality. No effective targeted therapies exist for the most severe forms of the disease, including lupus nephritis, and lupus affecting the central nervous system. A major challenge remains to find new targeted therapies that can achieve a high degree of disease activity reduction (i.e., remission) or disease cure, and therapies that have fewer immunosuppressive side effects.

The fiscal year 2005 House Appropriations Committee Report Language directed the NIH to develop a plan to guide the nation's investment in lupus research. To identify the opportunities, priorities and needs in lupus research that should be considered for inclusion in the research plan, a workshop consisting of scientific experts in the field of lupus was organized for two days of presentations and discussion. The highlights of their conclusions were reported in The Future Directions of Lupus Research, released in 2007. Through the individual and collaborative activities of researchers, clinicians, and stakeholders in the lupus community, there have been significant advances in understanding of disease mechanisms, evolution of new partnerships, and advances in drug discovery and development that have fostered candidate therapeutics, FDA approval of a new therapeutic, and improvements in the care and quality of life for affected individuals. At this time, there are new challenges and opportunities that would benefit from an assessment of progress and current needs, as requested by the Congressional Lupus Caucus.

Over the past year, NIAMS has led the efforts to develop the draft Action Plan for Lupus Research (action plan). The structure of the draft action plan is similar to the 2007 report on the Future Directions of Lupus Research, with chapters focusing on etiology, disease mechanisms, development of new treatments, diagnosis and clinical care, special populations, and health services research. In addition, new chapters have been added focusing on behavioral and biopsychosocial research, and research training and collaborations. NIAMS solicited input on information to be included in the action plan via a data call in December 2014 to other NIH Institutes and Centers, issuance of a Request for Information (RFI) on the Future Directions of Lupus Research (NOT-AR-15-007) in December 2014, and a webinar held in May 2015. NIAMS also provided regular updates to the LFWG, NIAMS Advisory Council, and Congressional Lupus Caucus staff. NIAMS staff have considered all of the feedback collected through the NIH data call, the previous RFI, and the webinar in drafting the action plan.

Information Requested
Through this RFI, NIAMS invites feedback on the draft Action Plan for Lupus Research from researchers in academia and industry, health care professionals, patient advocates, representatives of health advocacy organizations, members of scientific or professional organizations, and other interested members of the public. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and membership as a whole.

Please provide your comments and feedback. The final Action Plan for Lupus Research will be presented to the NIAMS Advisory Council and Lupus Federal Working Group, provided to the Congressional Lupus Caucus, and posted on the NIAMS website in Fall/Winter 2015.

How to Submit a Response

Responses to this RFI must be submitted electronically by email to the following address: niamslupusplanupdate@mail.nih.gov. Responses will be accepted until September 11, 2015.

Responses to this RFI are voluntary. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response.

This request is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States Government. The NIAMS or the NIH will not make any awards based on responses to this RFI, nor will the NIAMS or the NIH otherwise pay for the preparation of any information submitted or for the Government's use of such information.

The NIAMS will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Inquiries

Please direct all inquiries to:

Stephanie Burrows, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-496-8271
Email: burrowss@mail.nih.gov

Katy Marron, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email: marronk@mail.nih.gov