Opportunity Information: Apply for RFA FD 13 001
Apply for RFA FD 13 001
- The Food Drug Administration in the business and commerce community development consumer protection education environment food and nutrition health information and statistics natural resources regional development 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 Jan 9, 2014 and posted on Dec 10, 2012.
- Applicants must submit their applications by Oct 16, 2014 Regular Submission Dates February 6, 2013 and February 5, 2014 Resubmission Dates October 15, 2013 and October 15, 2014. (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 $400,000.00 in funding.
- The number of recipients for this funding is limited to 40 candidate(s).
- Eligible applicants include: For profit organizations other than small businesses Public and State controlled institutions of higher education County governments Private institutions of higher education 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 Native American tribal governments (Federally recognized) Special district governments City or township governments Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments.
- Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving 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-13-001) is a discretionary grant program run by the Food and Drug Administration (FDA) through its Orphan Products Development (OPD) program. Its central purpose is to move promising medical products forward for rare diseases or conditions, especially in situations where no adequate therapy exists today or where a new product is expected to be meaningfully better than what is currently available. The program is specifically aimed at supporting clinical studies that generate safety and/or effectiveness evidence strong enough to either directly lead to marketing approval or to materially advance a product toward approval by filling key evidence gaps in development.
The opportunity focuses on clinical development rather than basic discovery work. In practical terms, it funds studies that test a product in people and that are designed to produce interpretable, decision-ready data. The FDA frames the program around outcomes that matter for regulatory advancement: studies should be built in a way that they will either support an application for market approval or produce essential data that substantially contributes to that endpoint. Applicants are expected to connect the study design to the regulatory path, clarifying how the trial results would be used to support approval or de-risk the next development step (for example, by establishing dosing, demonstrating a clinically meaningful effect, or characterizing safety in the target population).
A key application requirement is the justification that the disease or condition being studied qualifies as rare (an orphan condition). In the application "Background and Significance" section, applicants must provide documentation supporting the assertion that the target indication is a rare disease or condition, and they must explain clearly how the proposed study will support product approval or provide critical data needed for product development. This requirement is not just a formality; it is central to the program's mission and to how proposals are evaluated for alignment with OPD goals.
The award mechanism is an R01 research project grant. The program anticipated making about 40 awards, with an estimated total funding level of $14.1 million. Individual awards were expected to fall within a range: an award floor of $200,000 and an award ceiling of $400,000. The listing is associated with CFDA number 93.103 (Food and Drug Administration). 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.
Eligibility is broad and includes many organizational types. Eligible applicants include for-profit organizations (including small businesses and other for-profits), nonprofits (including 501(c)(3) organizations and nonprofits without 501(c)(3) status), public and private institutions of higher education, and a variety of government entities such as state, county, city or township, and special district governments. The eligibility information also highlights institutional categories such as Hispanic Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions, indicating that these institution types are explicitly recognized within the opportunity's eligibility framework.
From an administrative standpoint, the opportunity was posted on December 10, 2012, with a creation date of January 9, 2014. The regular submission dates were February 6, 2013 and February 5, 2014, with resubmission dates on October 15, 2013 and October 15, 2014. The current closing date listed is October 16, 2014, and the archive date is November 15, 2014. For applicants seeking additional official guidance, the announcement points to the NIH Guide for Grants and Contracts as an additional information link, reflecting the common practice of publishing detailed funding announcements and related instructions in that venue.
For questions or issues accessing the full announcement electronically, the contact listed is Vieda Hubbard, Grants Management Specialist, at vieda.hubbard@fda.hhs.gov.
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity and its funding opportunity number?
The opportunity is titled "Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)." The Funding Opportunity Number (FON) is RFA-FD-13-001.
Which federal agency runs this program?
This is a discretionary grant program run by the U.S. Food and Drug Administration (FDA) through the Orphan Products Development (OPD) program.
What is the central purpose of the program?
The program is designed to move promising medical products forward for rare diseases or conditions (orphan conditions), especially when there is no adequate therapy available or when a new product is expected to be meaningfully better than what is currently available.
What type of work does this grant primarily support?
The focus is on clinical development rather than basic discovery work. In practical terms, it supports clinical studies that test a product in people and are intended to generate interpretable, decision-ready safety and/or effectiveness data.
What kinds of study outcomes is FDA looking for under this opportunity?
FDA emphasizes outcomes that matter for regulatory advancement. Supported studies should be structured to either directly support a marketing approval application or substantially advance a product toward approval by filling key evidence gaps.
How should applicants connect the study design to regulatory advancement?
Applicants are expected to explain how the proposed trial results would be used to support approval or to de-risk the next development step. Examples noted include establishing dosing, demonstrating a clinically meaningful effect, or characterizing safety in the target population.
Does the program support studies intended to lead to marketing approval?
Yes. A central intent is to fund studies that generate evidence strong enough to either directly lead to marketing approval or materially advance a product toward approval by addressing critical evidence gaps.
Is this opportunity limited to orphan (rare) diseases or conditions?
Yes. The program is specifically aligned to rare diseases or conditions, and the application must justify that the target indication qualifies as a rare (orphan) condition.
Where in the application must the rare disease (orphan condition) status be justified?
Applicants must include documentation supporting the assertion that the indication is rare in the "Background and Significance" section of the application.
Beyond documenting rarity, what else is required in the "Background and Significance" section?
Applicants must clearly explain how the proposed study will support product approval or provide critical data needed for product development.
What grant mechanism is used for awards under this program?
The award mechanism is an R01 research project grant.
How many awards were anticipated and what was the estimated total funding?
The program anticipated making about 40 awards, with an estimated total funding level of $14.1 million.
What is the expected funding range per award?
Individual awards were expected to fall within an award floor of $200,000 and an award ceiling of $400,000.
Is there a cost-sharing or matching requirement?
No. There is no cost sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of receiving an award.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.103 (Food and Drug Administration).
Who is eligible to apply?
Eligibility is broad and includes for-profit organizations (including small businesses and other for-profits), nonprofits (including 501(c)(3) organizations and nonprofits without 501(c)(3) status), public and private institutions of higher education, and a variety of government entities.
Which types of government entities are listed as eligible applicants?
Eligible government applicants include state, county, city or township, and special district governments.
Are specific institution categories explicitly recognized in the eligibility description?
Yes. The eligibility information highlights categories such as Hispanic Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions.
When was the opportunity posted and when was it created?
The opportunity was posted on December 10, 2012, and the creation date listed is January 9, 2014.
What were the regular submission dates?
The regular submission dates were February 6, 2013 and February 5, 2014.
Were resubmission dates provided?
Yes. The resubmission dates were October 15, 2013 and October 15, 2014.
What is the closing date and archive date shown for this opportunity?
The current closing date listed is October 16, 2014, and the archive date is November 15, 2014.
Where can applicants find additional official guidance referenced by the announcement?
The announcement points to the NIH Guide for Grants and Contracts as an additional information link for official guidance and related instructions.
Who should be contacted for issues accessing the full announcement electronically?
The listed contact is Vieda Hubbard, Grants Management Specialist. The email provided is vieda.hubbard@fda.hhs.gov.
What is the program trying to accomplish in terms of evidence generation?
It aims to support clinical studies that produce safety and/or effectiveness evidence that is interpretable and strong enough to support regulatory decision-making, including supporting an approval application or substantially advancing a product toward that endpoint.
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