Opportunity Information: Apply for RFA FD 11 005
Apply for RFA FD 11 005
- The Food Drug Administration in the agriculture business and commerce consumer protection education employment, labor and training environment health information and statistics natural resources regional development science and technology and other research and development sector is offering a public funding opportunity titled "Pediatric Anesthesia Safety Initiative (PASI)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on Apr 6, 2011 and posted on Apr 6, 2011.
- Applicants must submit their applications by May 6, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Small businesses Public and State controlled institutions of higher education.
- The following types of Higher Education Institutions are always encouraged to apply for support as Public or Private Institutions of Higher Education Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Other Organizations Regional Organizations
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Opportunity Summary:
The Pediatric Anesthesia Safety Initiative (PASI) grant opportunity (RFA-FD-11-005) was a U.S. Food and Drug Administration (FDA) discretionary funding announcement designed to strengthen and coordinate research focused on the safety of anesthetics and sedatives used in children. The core purpose of the award was twofold: first, to build the administrative and operational infrastructure needed to organize a broad scientific collaboration, and second, to support the execution of both non-clinical and clinical studies aimed at answering unresolved questions about how anesthetic and sedative agents may affect the pediatric population. The opportunity was explicitly framed within a public-private partnership (PPP) model, emphasizing coordinated participation from multiple stakeholder groups rather than isolated, single-institution research efforts.
This funding used a cooperative agreement mechanism, which typically signals that the FDA expected to be substantially involved in the project beyond simply providing funds. In practical terms, this kind of mechanism is often used when the agency anticipates ongoing collaboration, shared decision-making, or active programmatic oversight during project implementation. The overall intent was to create a structured environment where scientific, regulatory, clinical, and potentially industry perspectives could be brought together efficiently, with the infrastructure serving as the backbone for harmonized study planning, data coordination, and stakeholder communication.
Financially, the opportunity anticipated a single award (ExpectedAwards: 1) with an estimated total funding amount of $1,000,000, and an award ceiling also set at $1,000,000, meaning the program was structured as one main recipient organization leading the effort. There was no cost sharing or matching requirement, so applicants were not required to contribute non-federal funds as a condition of eligibility. The award floor was listed as $0, which generally indicates flexibility in the final award amount depending on the scope and merit of the proposed work, although the stated intent and ceiling suggested a sizable, centralized project.
Eligibility was broad and included a wide range of organization types: nonprofits (including 501(c)(3) organizations and nonprofits without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, private institutions of higher education, and public/state-controlled institutions of higher education. The announcement also emphasized that certain categories of higher education institutions were encouraged to apply, including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, as well as other regional and organizational entities. This broad eligibility aligns with the PPP concept and suggests the FDA was open to a lead applicant that could credibly convene partners and manage complex, multi-stakeholder research coordination.
From an administrative standpoint, the grant was posted and created on April 6, 2011, with an original and current closing date of May 6, 2011, and an archive date of May 13, 2011, indicating a relatively short application window of about one month. The program was associated with CFDA number 93.103 (Food and Drug Administration Research). Applicants seeking full details were directed to an additional information link in the NIH Guide for Grants and Contracts, reflecting how FDA research opportunities are sometimes cross-posted or referenced through NIH grant communication channels for broader visibility in the research community.
For applicants needing assistance accessing the full announcement, the listed point of contact was Vieda Hubbard, Grants Management Specialist at the FDA (5630 Fishers Lane, Rockville, MD 20857; phone 301-827-7177; email Vieda.Hubbard@fda.hhs.gov). Overall, PASI was positioned as a single, coordinated effort to organize stakeholders and generate evidence, with the explicit goal of reducing uncertainty and improving understanding of pediatric exposure to anesthetics and sedatives through targeted non-clinical and clinical research under an FDA-led safety initiative.
Frequently Asked Questions (FAQs): Pediatric Anesthesia Safety Initiative (PASI) - RFA-FD-11-005
What is the Pediatric Anesthesia Safety Initiative (PASI) grant opportunity?
The Pediatric Anesthesia Safety Initiative (PASI) grant opportunity (RFA-FD-11-005) was a U.S. Food and Drug Administration (FDA) discretionary funding announcement intended to strengthen and coordinate research on the safety of anesthetics and sedatives used in children.
What were the main goals of PASI?
The award had two core goals: (1) build the administrative and operational infrastructure needed to organize a broad scientific collaboration, and (2) support the execution of both non-clinical and clinical studies to address unresolved questions about how anesthetic and sedative agents may affect pediatric populations.
What types of research activities were supported?
The opportunity emphasized support for both non-clinical studies and clinical studies related to pediatric exposure to anesthetics and sedatives, specifically to help answer unanswered safety questions.
Was this opportunity intended for single-institution projects or multi-stakeholder collaboration?
It was explicitly framed within a public-private partnership (PPP) model, emphasizing coordinated participation from multiple stakeholder groups rather than isolated, single-institution research efforts.
What does it mean that PASI was structured as a public-private partnership (PPP)?
Based on the announcement language, the PPP framing indicates the FDA sought a coordinated approach that could bring together scientific, regulatory, clinical, and potentially industry perspectives, supported by shared infrastructure for planning, coordination, and communication.
What funding mechanism was used for PASI?
PASI used a cooperative agreement mechanism, which generally indicates the FDA expected substantial involvement in the project beyond providing funding.
What does a cooperative agreement imply for the FDA's role in the project?
This mechanism typically implies ongoing collaboration, shared decision-making, or active programmatic oversight by the agency during project implementation.
How many awards were expected under this opportunity?
The announcement anticipated a single award (ExpectedAwards: 1).
What was the estimated total funding amount?
The estimated total program funding amount was $1,000,000.
What was the maximum (ceiling) award amount?
The award ceiling was $1,000,000.
Was there a minimum (floor) award amount?
The award floor was listed as $0, which generally signals flexibility in the final award amount depending on the scope and merit of the proposed work.
Was cost sharing or matching required?
No. There was no cost sharing or matching requirement, so applicants were not required to contribute non-federal funds as a condition of eligibility.
Who was eligible to apply?
Eligibility was broad and included nonprofits (including 501(c)(3) organizations and nonprofits without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, private institutions of higher education, and public/state-controlled institutions of higher education.
Were small businesses eligible?
Yes. Small businesses were listed among eligible applicant types.
Were for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) were included, and small businesses were also included as an eligible category.
Were colleges and universities eligible?
Yes. Both private institutions of higher education and public/state-controlled institutions of higher education were eligible to apply.
Were any types of higher education institutions specifically encouraged to apply?
Yes. The announcement emphasized that certain categories were encouraged to apply, including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and other regional and organizational entities.
Why was the program structured as a single award?
The funding structure (one expected award with a $1,000,000 ceiling) indicates the program was designed for one main recipient organization to lead and coordinate the overall effort.
What kinds of capabilities would a lead organization need to demonstrate based on the program description?
The description suggests the lead organization would need to credibly convene partners and manage complex, multi-stakeholder research coordination, including infrastructure for harmonized study planning, data coordination, and stakeholder communication.
When was the opportunity posted?
The grant was posted and created on April 6, 2011.
What was the application closing date?
The original and current closing date was May 6, 2011.
How long was the application window?
Based on the posted date (April 6, 2011) and closing date (May 6, 2011), the application window was approximately one month.
When was the opportunity archived?
The archive date was May 13, 2011.
What CFDA number was associated with this program?
The program was associated with CFDA number 93.103 (Food and Drug Administration Research).
Where were applicants directed to find full details about the announcement?
Applicants were directed to an additional information link in the NIH Guide for Grants and Contracts, which the announcement noted as a place where FDA research opportunities may be referenced for broader visibility.
Who was the point of contact for questions about accessing the full announcement?
The listed point of contact was Vieda Hubbard, Grants Management Specialist at the FDA.
What contact information was provided for the FDA point of contact?
Vieda Hubbard, Grants Management Specialist, FDA; 5630 Fishers Lane, Rockville, MD 20857; phone 301-827-7177; email Vieda.Hubbard@fda.hhs.gov.
What was the overall intent of PASI in practical terms?
Overall, PASI was positioned as a single, coordinated effort to organize stakeholders and generate evidence, with the stated goal of reducing uncertainty and improving understanding of pediatric exposure to anesthetics and sedatives through targeted non-clinical and clinical research under an FDA-led safety initiative.
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