Notice Number: NOT-HL-18-660

Key Dates
Release Date: October 23, 2018
Response Date : New Date - March 15, 2019 as per issuance of NOT-HL-19-672 (old response date - January 25, 2019)

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

Background

In 2015, the National Heart, Lung, and Blood Institute (NHLBI) formed the NHLBI Women’s Health Working Group (WHWG) to collaborate with the NIH Office of Research on Women’s Health and other trans-NIH initiatives to pursue a better understanding of the health of women through behavioral and biomedical research. More specifically the NHLBI WHWG goals are to: (1) understand mechanisms of heart (and vascular), lung, hematologic (blood), and sleep (HLBS) diseases that present only in women, or are more prevalent in women than in men, and their interaction with the broader environment; (2) improve the execution of existing policies on women in clinical trials, and strengthen collaborations with other agencies and NIH Institutes who perform clinical trials; (3) support the development of a diverse workforce with increased participation of women throughout the training and career pipeline; (4) increase public awareness of institutional efforts centered on research into women’s health and (5) serve as a resource for information on topics related to women’s health.

Major progress has been made in achieving a balance of men and women in human studies. However, scientific needs persist in understanding the underlying mechanisms that increase women’s risk or resilience for certain HLBS diseases. Also, mechanisms that mediate the almost exclusive or specific manifestation of certain HLBS diseases in women, and/or that could explain sex/gender differences in response to treatment of HLBS diseases and their related adverse events are still not fully understood. Uncovering these mechanisms will set a stronger foundation upon which to build clinical research focused on more effective prevention and treatment strategies for HLBS diseases and disorders in women.

Information Requested

This Request for Information (RFI) seeks input from the research community (academia and industry), health care professionals, patient advocates, representatives of health advocacy organizations, members of scientific or professional organizations, and other interested stakeholders on the following topics regarding mechanisms of sex differences of HLBS diseases and disorders, and specifically women’s susceptibility or resilience to these.

Public comment is sought for, but not limited to the following:

• Specific HLBS diseases or group of diseases/risk factors where underlying mechanisms need to be better understood and prioritized (and a rationale for your proposed priorities). Consider mechanisms of HLBS disease or resilience of the entire spectrum of health/disease topics within the NHLBI mission, and throughout women’s life course (including pregnancy and post-partum) and in women of different races/ethnicities/origins/heritage groups. In addition, consider the interaction of these mechanisms (of disease or resilience) with environmental factors, including psychosocial, socioeconomic and sociocultural determinants of health.
• Scientific gaps or areas with the greatest opportunity to uncover mechanisms of HLBS diseases or resilience in women. Consider sex/gender differences and/or increased risk of women for adverse events related to therapies for HLBS disorders, or therapies affecting HLBS tissues and organs, and non-HLBS diseases or disorders with increased HLBS manifestations in women.
• Resources (e.g. biorepositories, registries, patient-reported outcomes, strategies to enhance or overcome challenges associated with data and/or biospecimen collection) that could be used to advance mechanistic studies of HLBS diseases and disorders in women, including symptoms and/or signs of HLBS diseases and disorders that specifically manifest in women of different ages and from different racial/ethnic/origin/heritage groups. Consider strategies to enhance patient enrollment and community outreach, and bioethical aspects or implications for developing these resources.
• Specific training needs (at any career stage) to promote mechanistic studies that investigate sex/gender differences in health, resilience and pathobiology related to HLBS.
• Any additional comments you would like to offer to NHLBI about the study of mechanisms of sex differences and/or health of women.

All responses to this RFI must be submitted via email to [email protected] by January 25, 2018. Please include the Notice number (NOT-HL-18-660) in the subject line.

Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, or sensitive information in your response. The NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. The collected information will be reviewed by NIH staff, may appear in reports, and may be shared publicly on an NIH website.

The Government reserves the right to use any non-proprietary technical information in summaries of the state of the science, and any resultant solicitation(s). The NIH may use the information gathered by this RFI to inform the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), or individual NIH Institutes and Centers. 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.

Inquiries

Please direct all inquiries to:

Email: [email protected]