Opportunity Information: Apply for RFA FD 16 047
Apply for RFA FD 16 047
- The HHS-FDA in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) (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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) (U01) funding opportunity (RFA-FD-16-047) is a U.S. Food and Drug Administration (FDA) cooperative agreement designed to build and sustain the core organizational backbone for the ACTTION Initiative. The central purpose is not simply to run a single study, but to create and maintain the infrastructure needed to support a broad, durable public-private partnership focused on improving how clinical trials are designed, conducted, and translated into practice in three closely related areas: analgesics (pain treatments), anesthetics, and addiction-related therapeutics. In practical terms, the award supports the kind of coordinating entity that can convene stakeholders, set shared priorities, develop common methods and tools, and keep multi-party efforts moving efficiently over time.
Because this is a cooperative agreement (U01), the FDA is expected to have substantial involvement in the funded work compared with a typical grant. That generally means the recipient does not operate entirely independently; instead, the work is carried out in close coordination with FDA program staff to ensure the partnership and its outputs align with FDA public health goals. The activity category aligns with health and consumer protection, and the listing is associated with CFDA 93.103. The opportunity emphasizes an infrastructure-first approach: building the administrative, scientific, and operational capacity that makes it possible to identify barriers in clinical development, propose solutions, and coordinate efforts across academia, industry, government, patient groups, and other partners.
While the main thrust is maintaining the partnership infrastructure, the announcement also notes that specific projects under the ACTTION Initiative may be funded. That suggests the award could cover targeted initiatives that advance ACTTION priorities, such as developing trial endpoints, validating outcome measures, improving trial designs, strengthening safety assessment approaches, and creating consensus standards or guidance-like tools that make evidence generation more efficient and reliable. The overall theme is translation and innovation in clinical trials, meaning work that helps move from scientific concepts to practical, usable approaches that can support regulatory-quality evidence and ultimately better treatment options.
Eligibility is broad and includes a wide range of public and private entities: state, county, and local governments; special districts; independent school districts; public housing authorities; federally recognized tribal governments and other tribal organizations; public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); and small businesses. This wide eligibility reflects the public-private partnership model, where the coordinating organization could plausibly sit in academia, a nonprofit, a government-affiliated entity, or even an experienced private organization, as long as it can credibly manage a multi-stakeholder network and deliver neutral, high-quality outputs.
Funding details in the notice indicate an award ceiling of $800,000 and an expectation of a single award. The opportunity was posted on April 19, 2016, with an original and current closing date of June 20, 2016. The sponsoring agency is HHS-FDA. Overall, the grant is best understood as support for an organizing and coordinating hub for ACTTION: an entity responsible for maintaining the partnership framework, enabling collaboration across sectors, and potentially executing selected projects that help modernize and improve clinical trial methods and evidence generation for pain, anesthesia, and addiction therapeutics.
Frequently Asked Questions (FAQs)
What is the ACTTION (U01) funding opportunity (RFA-FD-16-047)?
The Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) (U01) funding opportunity (RFA-FD-16-047) is a U.S. Food and Drug Administration (FDA) cooperative agreement intended to build and sustain the core organizational backbone for the ACTTION Initiative. It is designed to support the infrastructure needed to run an ongoing, multi-stakeholder public-private partnership focused on improving clinical trials in analgesics, anesthetics, and addiction-related therapeutics.
What is the main purpose of this award?
The central purpose is infrastructure-first: creating and maintaining the administrative, scientific, and operational capacity required to support a durable partnership. Rather than funding only a single clinical study, the award supports a coordinating entity that can convene stakeholders, set shared priorities, develop common methods and tools, and keep multi-party efforts moving over time.
Is this grant meant to fund one clinical trial?
No. The opportunity is described as supporting the organizational backbone for the ACTTION Initiative, meaning the focus is on sustaining the partnership infrastructure. The notice also indicates that specific projects under the ACTTION Initiative may be funded, but the overarching emphasis is building and maintaining a coordinating hub rather than running one standalone trial.
What types of activities are supported under this opportunity?
Supported activities are those that enable and improve clinical trial translation and innovation across the ACTTION areas. The award is intended to support functions like convening stakeholders, identifying barriers in clinical development, proposing solutions, coordinating cross-sector efforts, and developing shared methods and tools that improve how clinical trials are designed, conducted, and translated into practice.
What kinds of specific projects could be funded under the ACTTION Initiative?
The announcement notes that specific projects may be funded and gives examples aligned with ACTTION priorities, such as developing trial endpoints, validating outcome measures, improving trial designs, strengthening safety assessment approaches, and creating consensus standards or guidance-like tools intended to make evidence generation more efficient and reliable.
What therapeutic areas does ACTTION focus on?
ACTTION focuses on three closely related areas: analgesics (pain treatments), anesthetics, and addiction-related therapeutics.
Who is the sponsoring agency for this funding opportunity?
The sponsoring agency is HHS-FDA (the U.S. Department of Health and Human Services, Food and Drug Administration).
What does it mean that this is a cooperative agreement (U01)?
A cooperative agreement (U01) indicates that FDA is expected to have substantial involvement in the funded work compared with a typical grant. In practice, the recipient does not operate entirely independently; the work is carried out in close coordination with FDA program staff to help ensure the partnership and its outputs align with FDA public health goals.
How involved is FDA expected to be in the funded work?
FDA involvement is expected to be substantial, consistent with the cooperative agreement structure. The recipient is expected to coordinate closely with FDA program staff as the partnership infrastructure is developed and as outputs are produced.
What is meant by a "public-private partnership" in this context?
The opportunity describes a broad collaboration across sectors, including academia, industry, government, patient groups, and other partners. The funded entity serves as a coordinating organization that helps these stakeholders work together around shared priorities and common methods for improving clinical trials and their translation into practice.
What type of organization is this grant trying to support?
The grant is best understood as support for an organizing and coordinating hub for ACTTION: an entity responsible for maintaining the partnership framework, enabling collaboration across multiple sectors, and potentially executing selected projects that advance ACTTION priorities.
What is the activity category associated with this opportunity?
The activity category aligns with health and consumer protection.
What is the CFDA number associated with this opportunity?
The listing is associated with CFDA 93.103.
Who is eligible to apply?
Eligibility is broad and includes public and private entities, including: state, county, and local governments; special districts; independent school districts; public housing authorities; federally recognized tribal governments and other tribal organizations; public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); and small businesses.
Are for-profit organizations allowed to apply?
Yes. For-profit organizations (including those other than small businesses) are included in the eligible applicant types.
Are small businesses eligible?
Yes. Small businesses are listed as eligible applicants.
Are nonprofit organizations required to have 501(c)(3) status to be eligible?
No. The eligibility description includes nonprofit organizations with or without 501(c)(3) status.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized tribal governments and other tribal organizations are included in the eligible applicant categories.
Are universities and colleges eligible to apply?
Yes. Public and private institutions of higher education are listed as eligible applicants.
How many awards does FDA expect to make?
The notice indicates an expectation of a single award.
What is the maximum funding amount (award ceiling)?
The funding details indicate an award ceiling of $800,000.
When was the opportunity posted?
The opportunity was posted on April 19, 2016.
What is the application deadline?
The original and current closing date listed is June 20, 2016.
What is the overall theme of the work supported by this award?
The overall theme is translation and innovation in clinical trials, meaning work that helps move from scientific concepts to practical, usable approaches. The intent is to improve the quality, efficiency, and reliability of evidence generation for pain, anesthesia, and addiction therapeutics, supporting regulatory-quality evidence and ultimately better treatment options.
What kinds of outputs is the coordinating entity expected to produce?
Based on the description, outputs may include shared priorities, common methods and tools, consensus standards, and guidance-like tools that improve clinical trial design, conduct, measurement, and safety assessment across the ACTTION therapeutic areas.
Why does the opportunity emphasize "infrastructure-first"?
The emphasis reflects the goal of creating a durable partnership that can repeatedly identify barriers, develop solutions, and coordinate multi-party efforts over time. The funding is intended to sustain the organizational capacity needed for ongoing collaboration, not just time-limited project execution.
Browse more opportunities from the same category: Consumer Protection, Food and Nutrition, Health
Next opportunity: BLM OR/WA - Rare Care and Plant Conservation
Previous opportunity: Mentored Quantitative Research Development Award (Parent K25)
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA FD 16 047
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 16 047) also looked into and applied for these:
| Funding Opportunity |
|---|
| Pediatric Anesthesia Safety Initiative (PASI) (U01) Apply for RFA FD 16 037 Funding Number: RFA FD 16 037 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $800,000 |
| FDA Drug Residue Prevention Program (U18) Apply for RFA FD 18 006 Funding Number: RFA FD 18 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $175,000 |
| Development, Implementation, and Management of a Funding System to support the Grade “A” Milk Safety Program and National Shellfish Sanitation Program (U18) Apply for RFA FD 19 004 Funding Number: RFA FD 19 004 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $3,000,000 |
| National Project to Support and Promote Consistent Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (U18) Apply for RFA FD 19 023 Funding Number: RFA FD 19 023 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $1,500,000 |
| Revision Applications - FSMA Human Foods Preventive Controls Implementation Expansion Supplement to RFA-FD-18-001 (U18 Clinical Trials Not Allowed) Apply for PAR 20 091 Funding Number: PAR 20 091 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $300,000 |
| CFD Models to aid the development of generic inhalation products Apply for FOR FD 20 023 Funding Number: FOR FD 20 023 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Health Funding Amount: Case Dependent |
| Collaborating Centers of Excellence in Regulatory Science and Innovation (U01) Apply for RFA FD 16 036 Funding Number: RFA FD 16 036 Agency: Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $5,000,000 |
| Renewal - Integrated Food Safety System Online Research and Collaboration Development (U18) Clinical Trials Not Allowed Apply for RFA FD 20 023 Funding Number: RFA FD 20 023 Agency: Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $1,200,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA FD 16 047", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.