Opportunity Information: Apply for RFA FD 15 001
Apply for RFA FD 15 001
- The Food Drug Administration in the business and commerce community development consumer protection education environment food and nutrition health natural resources science and technology and other research and development sector is offering a public funding opportunity titled "Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)" 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 Oct 22, 2014 and posted on Dec 9, 2014.
- Applicants must submit their applications by Oct 18, 2018 Application Due Date(s) February 4, 2015 February 3, 2016 February 1, 2017 February 7, 2018. Resubmission Due Date(s) October 15, 2015 October 14, 2016 October 16, 2017 October 15, 2018). This FOA uses non standard due dates. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $14,100,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- The number of recipients for this funding is limited to 10 candidate(s).
- Eligible applicants include: Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Private institutions of higher education County governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Small businesses City or township governments Others (see text field entitled Additional Information on Eligibility for clarification).
- Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession Faith based or Community based Organizations Regional Organizations Non domestic (non U.S.) Entities (Foreign Institutions)
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Opportunity Summary:
The Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) (Funding Opportunity Number RFA-FD-15-001) is an FDA Office of Orphan Products Development (OPD) grant program designed to move potential treatments for rare diseases and conditions closer to real-world availability. The central purpose is to support clinical studies that evaluate safety and/or effectiveness of an orphan product in situations where there is no existing therapy, or where the proposed product is expected to be better than what is currently available. A key feature of this program is its strong emphasis on practical regulatory impact: funded studies are expected to either directly lead to, or substantially contribute toward, market approval of the product being studied, or generate essential clinical evidence needed for continued product development.
The opportunity is structured as a discretionary grant using the R01 research project grant mechanism, with an expected 10 awards. FDA projected an estimated total funding level of $14.1 million across awards. Individual awards are expected to fall between an award floor of $250,000 and an award ceiling of $500,000. There is no cost-sharing or matching requirement, which means applicants are not required to contribute non-federal funds as a condition of the award.
This funding announcement uses non-standard due dates and was posted on December 9, 2014 (created October 22, 2014). Application due dates were set annually for February 4, 2015; February 3, 2016; February 1, 2017; and February 7, 2018. Resubmission due dates were October 15, 2015; October 14, 2016; October 16, 2017; and October 15, 2018. The original and current closing date was October 18, 2018, with an archive date of November 17, 2018. The assistance listing/CFDA number associated with the program is 93.103 (Food and Drug Administration).
Eligibility is broad and includes a wide range of public and private organizations. Eligible applicants include state, county, city/township, special district governments, and independent school districts; public and state-controlled institutions of higher education and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses, as well as small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) and other tribal organizations. The opportunity also explicitly notes eligibility-relevant categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, faith-based and community-based organizations, regional organizations, U.S. territories or possessions, and even non-domestic (non-U.S.) entities/foreign institutions.
From an application content standpoint, FDA requires applicants to do more than propose a clinical study. In the Background and Significance section, applicants must document that the disease or condition qualifies as rare (an orphan disease/condition) and provide a clear explanation of how the proposed clinical study will support product approval or generate critical data needed for product development. In other words, the application needs to connect the clinical endpoints and study design to a realistic development and regulatory pathway, demonstrating that the work is not purely exploratory but positioned to meaningfully advance an orphan product toward approval.
Administrative and programmatic oversight sits with the Food and Drug Administration, and applicants needing help accessing the full announcement were directed to contact the grants management specialist listed in the notice: Vieda Hubbard, Phone 240-402-7588, vieda.hubbard@fda.hhs.gov.
Frequently Asked Questions (FAQs)
What is this grant opportunity?
The Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) is an FDA Office of Orphan Products Development (OPD) funding program that supports clinical studies evaluating the safety and/or effectiveness of orphan products intended for rare diseases and conditions.
What is the funding opportunity number?
The Funding Opportunity Number (FON) is RFA-FD-15-001.
Which FDA office runs this program?
The program is administered by the Food and Drug Administration (FDA), specifically the Office of Orphan Products Development (OPD).
What is the main purpose of the program?
The central purpose is to move potential treatments for rare diseases and conditions closer to real-world availability by funding clinical studies that evaluate safety and/or effectiveness of an orphan product, especially when there is no existing therapy or when the proposed product is expected to be better than currently available options.
What kinds of studies does the program support?
The program supports clinical studies that evaluate safety and/or effectiveness of an orphan product. The opportunity emphasizes studies with practical regulatory impact, meaning the study should be positioned to support market approval or generate essential clinical evidence needed for continued development.
Does the FDA expect funded projects to have regulatory impact?
Yes. A key feature of this program is that funded studies are expected to either directly lead to, or substantially contribute toward, market approval of the product being studied, or generate essential clinical evidence needed for continued product development.
Is this a discretionary grant?
Yes. The opportunity is structured as a discretionary grant.
What grant mechanism is used?
This funding opportunity uses the R01 research project grant mechanism.
How many awards were expected?
FDA projected an expected 10 awards under this opportunity.
What was the estimated total funding level?
FDA projected an estimated total funding level of $14.1 million across awards.
What is the expected award size per project?
Individual awards were expected to fall between an award floor of $250,000 and an award ceiling of $500,000.
Is cost sharing or matching required?
No. There is no cost-sharing or matching requirement, so applicants are not required to contribute non-federal funds as a condition of the award.
Does the announcement use standard due dates?
No. This funding announcement uses non-standard due dates.
When was the opportunity posted and created?
The opportunity was posted on December 9, 2014 and was created on October 22, 2014.
What were the application due dates?
Application due dates were set annually for February 4, 2015; February 3, 2016; February 1, 2017; and February 7, 2018.
What were the resubmission due dates?
Resubmission due dates were October 15, 2015; October 14, 2016; October 16, 2017; and October 15, 2018.
When did the opportunity close?
The original and current closing date was October 18, 2018.
When was the opportunity archived?
The archive date was November 17, 2018.
What is the assistance listing (CFDA) number for this program?
The assistance listing/CFDA number is 93.103 (Food and Drug Administration).
Who is eligible to apply?
Eligibility is broad and includes many types of public and private organizations, including government entities, higher education institutions, nonprofits, and for-profit organizations (including small businesses), as well as certain housing authorities and tribal entities. The opportunity also allows applications from non-domestic (non-U.S.) entities/foreign institutions.
Which government entities are eligible?
Eligible government applicants include state governments; county governments; city or township governments; special district governments; and independent school districts.
Are colleges and universities eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.
Are nonprofit organizations eligible?
Yes. Nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education) are eligible.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses, as well as small businesses, are eligible.
Are tribal organizations eligible?
Yes. Eligible applicants include Native American tribal governments (federally recognized) and other tribal organizations.
Are U.S. territories or possessions eligible?
Yes. The opportunity notes U.S. territories or possessions among eligibility-relevant categories.
Are non-U.S. (foreign) institutions eligible?
Yes. The opportunity explicitly includes non-domestic (non-U.S.) entities/foreign institutions as eligible.
Are specific types of institutions or organizations highlighted as eligible?
Yes. The announcement explicitly notes eligibility-relevant categories including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, faith-based and community-based organizations, regional organizations, and other similar categories.
What must be included in the Background and Significance section of the application?
Applicants must document that the disease or condition qualifies as rare (an orphan disease/condition) and clearly explain how the proposed clinical study will support product approval or generate critical data needed for product development.
Does the application need to connect the study design to product approval?
Yes. FDA requires applicants to connect clinical endpoints and study design to a realistic development and regulatory pathway, showing the work is positioned to meaningfully advance an orphan product toward approval rather than being purely exploratory.
Who provides administrative and programmatic oversight?
Administrative and programmatic oversight is with the Food and Drug Administration (FDA).
Who can applicants contact for help accessing the full announcement?
Applicants needing help accessing the full announcement were directed to contact the grants management specialist listed in the notice: Vieda Hubbard, Phone 240-402-7588, Email vieda.hubbard@fda.hhs.gov.
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