Opportunity Information: Apply for RFA FD 23 035

This funding opportunity (RFA-FD-23-035) is a cooperative agreement (U01) from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), focused on improving how postoperative pain is managed after diagnostic and procedural laparoscopic abdominal surgeries. The core purpose is to support the development, dissemination, implementation, and evaluation of an evidence-based Clinical Practice Guideline (CPG) that specifically advances safer opioid prescribing for patients experiencing postoperative pain following these laparoscopic procedures. Clinical trials are not allowed under this opportunity, so the work is centered on guideline creation and real-world uptake and assessment rather than testing new interventions in a trial framework.

The FDA is looking for a comprehensive, evidence-based plan that results in practical guidance clinicians can use to make better, safer prescribing decisions. The emphasis is on postoperative pain management in the laparoscopic abdominal surgery context, where prescribing practices can vary widely and where there is a strong public health interest in reducing unnecessary opioid exposure while still ensuring patients have adequate pain control. Because the mechanism is a cooperative agreement, the funded recipient should expect substantial federal involvement and collaboration during the project, meaning the FDA will likely play an active role in shaping deliverables, aligning methods with agency priorities, and supporting dissemination expectations.

Only one award is expected, indicating the FDA intends to fund a single, coordinated effort rather than multiple smaller projects. The award ceiling is $2,000,000, which signals a relatively large, national-scope project that can support the full lifecycle of guideline development: assembling expert stakeholders, conducting or updating systematic evidence reviews as needed, translating evidence into recommendations, creating clinician- and patient-facing materials, rolling out the guideline through dissemination channels, encouraging adoption in practice settings, and evaluating how well the guideline is implemented and what effects it has on prescribing patterns and postoperative pain management practices.

Eligibility is broad and includes many types of organizations that can credibly lead a guideline effort and national dissemination work. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those specific categories); for-profit organizations other than small businesses; and small businesses. The breadth of eligibility suggests the FDA is open to applicants with strong clinical guideline expertise, implementation science capacity, health services research skills, and established relationships with surgical, anesthesia, pain management, and healthcare quality communities.

Administratively, the opportunity was created on June 28, 2023, with an original application closing date of August 15, 2023. It is categorized as a discretionary grant using the cooperative agreement funding instrument, and it falls under the funding activity category listed as Agriculture, Consumer Protection, Food and Nutrition, with CFDA number 93.103. In practical terms, applicants were expected to propose a structured, evidence-driven approach that produces a credible clinical guideline and then demonstrates a serious plan for getting that guidance used in real clinical environments, including measuring uptake and outcomes related to safe opioid prescribing in the laparoscopic abdominal surgery postoperative setting.

  • The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Cooperative Agreement to Support an Evidence-Based Clinical Practice Guideline for the Management of Laparoscopic Abdominal Surgeries (U01) Clinical Trials Not Allowed" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
  • This funding opportunity was created on Jun 28, 2023.
  • Applicants must submit their applications by Aug 15, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $2,000,000.00 in funding.
  • The number of recipients for this funding is limited to 1 candidate(s).
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
Apply for RFA FD 23 035

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