Opportunity Information: Apply for RFA FD 16 037

  • The HHS-FDA in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Pediatric Anesthesia Safety Initiative (PASI) (U01)" 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 Apr 19, 2016 and posted on Apr 19, 2016.
  • Applicants must submit their applications by Jun 20, 2016. (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 $800,000.00 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.
Apply for RFA FD 16 037

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Opportunity Summary:

The Pediatric Anesthesia Safety Initiative (PASI) (U01) funding opportunity (RFA FD 16 037) is a discretionary cooperative agreement offered by the U.S. Department of Health and Human Services, Food and Drug Administration (HHS-FDA). It sits within the broad activity area of consumer protection, food and nutrition, and health (CFDA 93.103), reflecting FDAs role in safeguarding public health and supporting initiatives that improve the safe use of medical products and practices, including those affecting children.

The purpose of this award is to build and sustain the organizational backbone needed to run a wide-reaching public-private partnership under FDAs Pediatric Anesthesia Safety Initiative. In practical terms, the emphasis is less on a single narrow research study and more on creating the infrastructure that allows multiple stakeholders to coordinate effectively over time. That infrastructure can include partnership governance and coordination, meeting and convening capacity, shared processes and workflows, communications and stakeholder engagement, and other operational functions that keep a multi-organization initiative functioning smoothly. The description also notes that specific projects carried out under PASI may be funded through this mechanism, meaning the award can support not only the partnership structure itself but also concrete PASI-related work streams that fit within the initiative.

Because this is a cooperative agreement (U01), the FDA is expected to have substantial involvement in the work compared to a standard grant. Cooperative agreements are typically used when the funding agency anticipates active collaboration, such as participating in planning, providing programmatic guidance, coordinating across federal and non-federal partners, and helping shape milestones and deliverables. The design is well-suited to public-private partnership models where federal scientific, regulatory, or convening expertise is integrated into the project rather than remaining at arm's length.

Eligibility is broad and includes many types of organizations that could credibly host or coordinate a national or multi-institution partnership. Eligible applicants include state, county, and local governments (including special districts and 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 and Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories); for-profit organizations other than small businesses; and small businesses. This wide eligibility suggests the FDA was focused on finding the strongest organizational lead for the partnership function, regardless of sector, rather than restricting the opportunity to one applicant type.

The opportunity anticipated a single award (ExpectedAwards: 1), with an award ceiling of $800,000. With only one expected recipient, the intent appears to be the selection of one coordinating entity to serve as the hub for PASI partnership operations and any associated PASI projects supported through the award. The funding opportunity was created and posted on April 19, 2016, and the application closing date was June 20, 2016 (original and current closing dates are the same), indicating a defined submission window without subsequent extensions noted in the provided data.

In summary, PASI (U01) was designed to fund one lead organization to establish and maintain the coordination and management infrastructure for FDAs Pediatric Anesthesia Safety Initiative, enabling a broad public-private partnership to function effectively and, where appropriate, to carry out specific PASI projects under that umbrella.

Frequently Asked Questions (FAQs) - Pediatric Anesthesia Safety Initiative (PASI) (U01) (RFA FD 16 037)

What is the Pediatric Anesthesia Safety Initiative (PASI) (U01) funding opportunity?

PASI (U01) (RFA FD 16 037) is a discretionary cooperative agreement funding opportunity offered by the U.S. Department of Health and Human Services, Food and Drug Administration (HHS-FDA). It is associated with the broad activity area of consumer protection, food and nutrition, and health, and is listed under CFDA 93.103.

Which federal agency is offering this cooperative agreement?

The opportunity is offered by HHS-FDA (the U.S. Food and Drug Administration within the U.S. Department of Health and Human Services).

What is the main purpose of this award?

The main purpose is to build and sustain the organizational backbone needed to run a wide-reaching public-private partnership under the FDA's Pediatric Anesthesia Safety Initiative. The emphasis is on creating and maintaining infrastructure that enables multiple stakeholders to coordinate effectively over time, rather than supporting only a single narrow research study.

What kinds of activities can the award support?

Based on the description provided, the award can support operational and coordination functions such as partnership governance and coordination, meeting and convening capacity, shared processes and workflows, communications and stakeholder engagement, and other functions needed to keep a multi-organization initiative operating smoothly. The description also notes that specific PASI projects may be funded through this mechanism, meaning the award may support both partnership infrastructure and concrete PASI-related work streams aligned with the initiative.

Is this opportunity focused on research, infrastructure, or both?

It is primarily focused on infrastructure for a public-private partnership (the organizational backbone). However, the description indicates that specific PASI projects may also be supported under the award, so both partnership operations and PASI-related projects may fit within the scope as described.

What does "U01 cooperative agreement" mean for how the project will be run?

A U01 is a cooperative agreement, which typically means the FDA is expected to have substantial involvement compared to a standard grant. The provided description suggests FDA involvement may include active collaboration in planning, programmatic guidance, coordination across federal and non-federal partners, and helping shape milestones and deliverables.

Why is a cooperative agreement model used for PASI?

The cooperative agreement model is described as well-suited to public-private partnership approaches where federal scientific, regulatory, or convening expertise is integrated into the work rather than remaining at arm's length.

Who is eligible to apply?

Eligibility is broad and includes the following types of applicants:

  • State, county, and local governments (including special districts and 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 and Indian housing authorities
  • Nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories)
  • For-profit organizations other than small businesses
  • Small businesses

Does eligibility limit applicants to a particular sector (academic, nonprofit, government, or industry)?

No. The eligibility list includes government entities, higher education institutions (public and private), tribal governments and organizations, housing authorities, nonprofits (with or without 501(c)(3) status), and for-profit organizations (including small businesses). This suggests the opportunity was designed to select the strongest organization to lead and coordinate the partnership, regardless of sector.

How many awards were expected to be made?

The opportunity anticipated a single award (ExpectedAwards: 1).

What is the maximum (ceiling) award amount?

The award ceiling is $800,000.

What does it mean that only one award was expected?

With only one expected recipient, the intent appears to be selecting one coordinating entity to serve as the central hub for PASI partnership operations and any associated PASI projects supported through the cooperative agreement.

When was the opportunity posted?

The funding opportunity was created and posted on April 19, 2016.

What was the application closing date?

The application closing date was June 20, 2016. The information provided indicates the original and current closing dates are the same, suggesting no extensions are noted in the provided data.

What is CFDA 93.103 and how does it relate to this opportunity?

The opportunity is associated with CFDA 93.103 and described as sitting within the broad activity area of consumer protection, food and nutrition, and health. In this context, it reflects the FDA's role in safeguarding public health and supporting initiatives that improve the safe use of medical products and practices, including those affecting children.

What kind of partnership is this award intended to support?

The award is intended to support a wide-reaching public-private partnership operating under the FDA's Pediatric Anesthesia Safety Initiative, with an emphasis on long-term coordination among multiple stakeholders.

What types of "backbone" functions are specifically mentioned?

The description explicitly mentions infrastructure such as partnership governance and coordination, meeting and convening capacity, shared processes and workflows, communications and stakeholder engagement, and other operational functions needed to keep a multi-organization initiative functioning smoothly.

Can the funded work include convening stakeholders and running meetings?

Yes. "Meeting and convening capacity" is specifically mentioned as part of the partnership infrastructure that may be supported.

Is the FDA expected to participate in project planning and deliverables?

Yes. The opportunity description indicates that, as a cooperative agreement, the FDA is expected to have substantial involvement, which may include participating in planning, providing programmatic guidance, coordinating across partners, and helping shape milestones and deliverables.

Is this funding opportunity ongoing?

The provided information shows a defined submission window with a closing date of June 20, 2016. No later dates or extensions are noted in the provided data.

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