The Elm

The Food and Drug Administration (FDA) Office of Women’s Health (OWH) requests 1-page proposals from Centers of Excellence in Regulatory Science and Innovation (CERSIs) for potential regulatory science research funding. OWH provides leadership on women’s health topics within the FDA through policy, scientific, and outreach initiatives. The OWH research program aims to improve the health and safety of women through yearly calls for research, which seeks to fill critical knowledge gaps. 

Priority topics include:

Research addressing maternal morbidity and mortality with the goal of improving care and outcomes for diverse populations of women (especially in high-risk women by race, ethnicity, comorbid conditions, and age). Use of real-world data and other innovative data sources/approaches is encouraged. Potential research areas include, but are not limited to, commonly cited causes of maternal morbidity and mortality such as:

• Maternal mental health conditions including substance use disorders
• Hyperemesis gravidarum
• Excessive bleeding (hemorrhage)
• Cardiovascular complications, including hypertensive conditions (eclampsia/preeclampsia, cardiomyopathy, thromboembolic conditions)
• Infection

Improving diagnostics, therapeutics, and treatment utilization and identifying barriers for addressing chronic debilitating conditions in women, including, but not limited to:    

• Female-specific conditions such as cancers of the female reproductive tract, uterine fibroids, endometriosis, polycystic ovary syndrome
• Conditions with high morbidity in women such as mood disorders, neuroinflammation disorders, and migraines
• Understudied conditions in women such as osteoarthritis, osteoporosis, autoimmune disorders (such as lupus, celiac disease, inflammatory bowel disease, and thyroid disease), HIV, and rare conditions
• Mechanisms underlying sex differences in pain sensitivity and analgesic response

For additional information, prospective research applicants are encouraged to read OWH’s Women’s Health Research Roadmap, which provides a framework for women’s health research priorities. Proposals with a potential for high regulatory impact will be given highest priority. 

OWH requests that the following information be included in the 1-page proposal:

1. Names and titles of key personnel
2. Objective of the research
3. Relevance to FDA OWH scientific interest areas and potential for regulatory impact
4. Brief description of the proposed approach and scientific methodology that includes:

• Hypothesis and specific aims of the proposed project and overview of study design
• Anticipated challenges to the proposed project and approaches to overcome these challenges

5. Major project milestones and anticipated outcomes
6. Proposed budget and anticipated timeline. Indirect cost rate is 20%, and pre-proposal only needs to list total direct cost, total indirect cost, and total cost amounts.

Investigators should propose a budget that is sufficient to complete the proposed work within the ~$150,000 - $350,000 range. OWH will review the one-page proposals and determine whether to invite investigators to submit a full CERSI research proposal. 

Please direct any questions and submit one-page proposals to Dr. Joyce Obidi (Joyce.Obidi@fda.hhs.gov) and cc to ORSI-CERSI-Team@fda.hhs.gov by Sept. 8, 2023.

More information about CERSI can be found at www.fda.gov/science-research/advancing-regulatory-science/centers-excellence-regulatory-science-and-innovation-cersis