Opportunity Information: Apply for RFA FD 09 001
Apply for RFA FD 09 001
- The Food Drug Administration in the consumer protection education health other (see text field entitled explanation of other category of funding activity for clarification) 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 18, 2010 and posted on Sep 9, 2010.
- Applicants must submit their applications by Oct 18, 2010 Resubmission Application Due Dates Application Resubmission/Receipt Date October 15, 2009, and October 15, 2010 Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. On time submission requires that applications be successfully submitted to Grants.gov no later than 500 p.m. local time (of the applicant institution/organization).. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $41,400,000.00 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 60 candidate(s).
- Eligible applicants include: Special district governments Small businesses Public and State controlled institutions of higher education County governments State governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education.
- Eligible Organizations The grants are available to any foreign or domestic, public or private, for profit or nonprofit entity (including State and local units of government). Federal agencies that are not part of HHS may apply. Agencies that are part of HHS may not apply. For profit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c) (4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards. The following are also included Public/State Controlled Institution of Higher Education Private Institution of Higher Education Hispanic serving Institution Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education) Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education) Non domestic (non U.S.) Entity Small Business For Profit Organization (Other than Small Business) State Government Regional Organization U.S. Territory or Possession Indian/Native American Tribal Government (Federally Recognized) Indian/Native American Tribal Government (Other than Federally Recognized) Indian/Native American Tribally Designated Organization Other Eligible agencies of the Federal government Faith based or community based organizations.
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Opportunity Summary:
The Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) is a discretionary FDA funding opportunity run through the Office of Orphan Products Development (OPD). It uses the R01 mechanism to support a clearly defined, investigator-led clinical research project that fits within the FDA mission. While the project is written and scientifically led by the named Project Director(s)/Principal Investigator(s), the official applicant is the institution or organization that will carry out the work. The intent is to give applicants flexibility to propose a focused clinical study in an area where they already have expertise, as long as the study directly advances FDA-relevant evidence on a product intended for a rare disease or condition.
The program is centered on “orphan products,” meaning drugs, biologics, medical devices, and foods for medical purposes intended to diagnose, treat, or manage a rare disease or condition. For most products, “rare” is defined by prevalence in the United States of fewer than 200,000 people (prevalence, not incidence). Diagnostic tests and vaccines can also qualify, but only if the intended U.S. use population is fewer than 200,000 people per year. The overarching goal is to accelerate clinical development where there is no satisfactory therapy available or where the proposed product would meaningfully improve existing therapy. In practical terms, FDA is looking to fund clinical studies that generate safety and/or effectiveness data that either leads to market approval or substantially contributes to a future approval package by filling key evidence gaps needed for product development.
A central application requirement is that the proposal clearly establishes the orphan nature of the condition and the regulatory relevance of the study. Applicants are expected to include, in the “Background and Significance” section, documentation supporting the estimated U.S. prevalence of the disease or condition. They also need to explain how the proposed clinical study will help support product approval or provide essential data that advances development toward approval. Because this is an FDA orphan-products program focused on clinical development, the expectation is that the work is not just exploratory science, but clinically meaningful research tied to a plausible path toward marketing authorization, with outcomes and endpoints that can inform regulatory decision-making.
All funded projects must comply with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.), related implementing regulations, and other applicable HHS statutes and regulations. That means studies must be designed and conducted in a way that aligns with the regulatory framework governing product development and evaluation. The opportunity points applicants to additional OPD guidance and tips on the FDA orphan website (www.fda.gov/orphan), and notes that understanding the mission of the relevant FDA Centers can matter because products fall under different Center jurisdictions depending on whether they are drugs, biologics, devices, or specialized foods.
From an administrative and funding standpoint, this opportunity is identified as RFA-FD-09-001 (CFDA 93.103) and was posted by the Food and Drug Administration. It anticipated up to about 60 awards, with an estimated total funding amount of $41.4 million. Individual awards were expected to fall between $200,000 (floor) and $400,000 (ceiling). There is no cost-sharing or matching requirement stated for this program. Applications were required to be submitted through Grants.gov by 5:00 p.m. local time of the applicant organization to be considered on time, and the notice lists receipt dates around October 15, 2009 and October 15, 2010, with additional acceptance of resubmissions at February receipt dates in both fiscal years. The announcement also notes that applications previously deemed non-responsive due to technical or IND-related issues could be resubmitted on the stated dates.
Eligibility is broad. FDA made the grants available to domestic or foreign public or private entities, including for-profit and nonprofit organizations, universities (public and private), state and local governments, tribal governments and tribal organizations, U.S. territories, regional organizations, and certain federal entities. A key restriction is that HHS agencies are not eligible to apply, while federal agencies outside HHS may apply. For-profit applicants must agree to exclude fees or profit from their requested budget in order to receive an award. Organizations engaged in lobbying activities as described under section 501(c)(4) of the Internal Revenue Code are not eligible for grant awards. The listing explicitly includes a wide range of institution types (including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations), signaling an intent to keep the applicant pool inclusive so long as the applicant can conduct a compliant, high-quality clinical study.
For practical questions about accessing the full announcement, the listed grants management contact is Marc Pitts, Senior Grants Management Specialist (301-827-7162, Marc.Pitts@FDA.HHS.GOV).
Frequently Asked Questions (FAQs)
What is the Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)?
It is a discretionary U.S. Food and Drug Administration (FDA) funding opportunity run through the Office of Orphan Products Development (OPD) that uses the R01 mechanism to support a clearly defined, investigator-led clinical research project that fits within the FDA mission. The emphasis is on generating clinical safety and/or effectiveness evidence for products intended for rare diseases or conditions.
Which FDA office administers this grant program?
The program is administered by the FDA Office of Orphan Products Development (OPD).
What does "orphan products" mean in this program?
"Orphan products" refers to drugs, biologics, medical devices, and foods for medical purposes intended to diagnose, treat, or manage a rare disease or condition.
How is a "rare disease or condition" defined for most products?
For most products, "rare" is defined by U.S. prevalence of fewer than 200,000 people. The definition is based on prevalence (how many people have the condition), not incidence (new cases).
Can diagnostic tests and vaccines qualify as orphan products under this opportunity?
Yes, diagnostic tests and vaccines can qualify, but only if the intended U.S. use population is fewer than 200,000 people per year.
What types of studies is FDA trying to fund through this opportunity?
FDA is looking to fund clinical studies that generate safety and/or effectiveness data that either leads to market approval or substantially contributes to a future approval package by filling key evidence gaps needed for product development.
Is this program focused on exploratory research or clinical development?
The expectation is clinical development-focused research rather than purely exploratory science. The study should be clinically meaningful and tied to a plausible path toward marketing authorization, with outcomes and endpoints that can inform regulatory decision-making.
Who leads the scientific work for an application?
The project is written and scientifically led by the named Project Director(s)/Principal Investigator(s) (PD(s)/PI(s)).
Who is the official applicant for the grant?
The official applicant is the institution or organization that will carry out the work, not the individual investigator.
What is a central application requirement related to orphan status?
A central requirement is that the proposal clearly establishes the orphan nature of the condition. Applicants are expected to include documentation supporting the estimated U.S. prevalence of the disease or condition in the "Background and Significance" section.
What must applicants explain about the regulatory relevance of the study?
Applicants must explain how the proposed clinical study will help support product approval or provide essential data that advances development toward approval.
What laws and regulations must funded projects comply with?
All funded projects must comply with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.), related implementing regulations, and other applicable HHS statutes and regulations.
Where can applicants find additional OPD guidance mentioned in the announcement?
The opportunity points applicants to OPD guidance and tips on the FDA orphan website: www.fda.gov/orphan.
Why does the relevant FDA Center matter for this program?
The announcement notes that understanding the mission of the relevant FDA Centers can matter because products fall under different Center jurisdictions depending on whether they are drugs, biologics, devices, or specialized foods.
What is the opportunity identifier and CFDA number?
The opportunity is identified as RFA-FD-09-001 and CFDA 93.103.
How many awards were anticipated, and what was the estimated total funding amount?
The announcement anticipated up to about 60 awards, with an estimated total funding amount of $41.4 million.
What was the expected funding range per individual award?
Individual awards were expected to range from $200,000 (floor) to $400,000 (ceiling).
Is cost sharing or matching required?
No cost-sharing or matching requirement is stated for this program.
How and where were applications required to be submitted?
Applications were required to be submitted through Grants.gov.
What was the application submission deadline time?
Applications had to be submitted by 5:00 p.m. local time of the applicant organization to be considered on time.
What receipt dates were listed in the announcement?
The notice lists receipt dates around October 15, 2009 and October 15, 2010, and also notes acceptance of resubmissions at February receipt dates in both fiscal years.
Were resubmissions allowed if an application was previously deemed non-responsive?
Yes. The announcement notes that applications previously deemed non-responsive due to technical or IND-related issues could be resubmitted on the stated receipt dates.
Who was eligible to apply?
Eligibility was broad and included domestic or foreign public or private entities, including for-profit and nonprofit organizations; public and private universities; state and local governments; tribal governments and tribal organizations; U.S. territories; regional organizations; and certain federal entities.
Are HHS agencies eligible to apply?
No. HHS agencies are not eligible to apply under this opportunity.
Can federal agencies outside HHS apply?
Yes. Federal agencies outside HHS may apply.
Are for-profit organizations allowed to apply, and are there special budget rules?
Yes, for-profit organizations are eligible. However, for-profit applicants must agree to exclude fees or profit from their requested budget in order to receive an award.
Are organizations engaged in lobbying eligible?
No. Organizations engaged in lobbying activities as described under section 501(c)(4) of the Internal Revenue Code are not eligible for grant awards.
Does the announcement indicate that minority-serving, faith-based, or community-based organizations can apply?
Yes. The listing explicitly includes a wide range of institution types (including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations), indicating an inclusive applicant pool as long as the applicant can conduct a compliant, high-quality clinical study.
Who is the listed grants management contact for questions about accessing the full announcement?
The listed contact is Marc Pitts, Senior Grants Management Specialist, at 301-827-7162 or Marc.Pitts@FDA.HHS.GOV.
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