Opportunity Information: Apply for RFA FD 11 001
Apply for RFA FD 11 001
- The Food Drug Administration in the education 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 Nov 8, 2012 and posted on Jul 23, 2010.
- Applicants must submit their applications by Nov 8, 2012 Key Dates Release/Posted Date July 16, 2010 Opening Date December 2, 2010 (Earliest date an application may be submitted to Grants.gov) Letters of Intent Receipt Date(s) Not Applicable Application Due Date(s) February 2, 2011 February 1, 2012 Resubmission Due Date(s) October 14, 2011 and October 15, 2012 Peer Review Date(s) May 2011 and 2012 and November 2011 and 2012 Council Review Date(s) September 2011 and 2012 and February 2012 and 2013 Earliest Anticipated Start Date(s) November 2011 and November 2012 Expiration Dates February 2, 2012, October 16, 2012 resubmission ATTENTION ALL APPLICANTS MUST SUBMMIT ON ADOBE FORM B1 TEMPLATE PACKAGE FOR RECEIPTS DATE AFTER MAY 7, 2011.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,100,000.00 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 12 candidate(s).
- Eligible applicants include: Private institutions of higher education Independent school districts For profit organizations other than small businesses Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Small businesses Special district governments 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 City or township governments.
- Hispanic serving Institutions, Historically Balck Colleges and Universities,(HBCUs) Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, For Profit Organizations (Other than Small Businesses),U.S. Territory or Possession, Regional Organizations, Non domestic(non U.S.) Entities (Foreign Organizations) Other(s) Eligible Agencies of the Federal Government, Faith based or Community based 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 the Department of Health and Human Services (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.
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Opportunity Summary:
The Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) is an FDA Office of Orphan Products Development (OPD) funding opportunity designed to move promising medical products for rare diseases toward FDA marketing approval or licensure. OPD focuses on "orphan products," meaning drugs, biologics, medical devices, and medical foods intended for rare diseases or conditions affecting fewer than 200,000 people in the United States (based on prevalence, not incidence). Vaccines and diagnostics can also qualify, but only when the number of people in the U.S. expected to receive the vaccine or diagnostic is fewer than 200,000 per year. The program is aimed at situations where there is no available therapy or where the proposed product could clearly improve on existing options, and it funds clinical studies that generate safety and/or effectiveness evidence expected to either directly support, or substantially contribute to, an eventual FDA approval decision.
This opportunity uses the R01 research project grant mechanism, meaning awards support a clearly defined, time-limited clinical development project led by a named Project Director/Principal Investigator (PD/PI), who is fully responsible for planning and executing the work. The studies supported are clinical investigations and are expected to align with the regulatory pathways FDA uses to evaluate medical products. In practice, FDA is looking for trials that produce data that can be used in an application for marketing approval for drugs or devices (for example, under sections 505 or 515 of the Federal Food, Drug, and Cosmetic Act) or for biologics licensure (for example, under section 351 of the Public Health Service Act). A key boundary is that, except for certain studies involving medical foods (which generally do not require premarket approval), the program is specifically intended to fund premarket clinical studies rather than postmarket work.
Applications are expected to make a strong case that the target condition meets the orphan threshold and that the proposed trial meaningfully advances the product toward approval. In the Background and Significance section, applicants must document the estimated prevalence of the rare disease or condition, or for vaccines/diagnostics, the expected number of people who would receive the product annually. Beyond just stating rarity, the application must explain how the study results will support product approval or provide essential development data needed to progress the product through the FDA pipeline. The program description also lays out standard clinical trial phase concepts for drugs and biologics (Phase 1, Phase 2, Phase 3), emphasizing early human safety and pharmacology in Phase 1, early controlled effectiveness and short-term risk assessment in Phase 2, and broader evidence of safety and effectiveness to support labeling and risk-benefit conclusions in Phase 3. Devices and medical foods may not map perfectly onto those phases, and applicants are expected to use the framework appropriate to their product type.
Because this is a clinical-investigation-focused grant, the compliance expectations are extensive. Awards are governed by Public Health Service (PHS) and HHS grants policies (referencing the HHS Grants Policy Statement and applicable federal regulations), and all funded work must meet human subject protection requirements and the regulatory requirements tied to clinical investigations. The announcement highlights that an active IND (Investigational New Drug) or IDE (Investigational Device Exemption) is required where applicable, and that institutions must have appropriate Office for Human Research Protections (OHRP) assurances on file. Before an award can be made, documentation of IRB approval and a Federalwide Assurance (FWA) for the IRB of record must be in place for all performance sites. This requirement is framed as a way to avoid funding delays caused by missing or late IRB approvals. Grantees may also be asked for additional documentation for review by FDA's IRB processes after award.
The funding profile described in the source material indicates an estimated total funding amount of about $4.1 million with roughly 12 expected awards. Award sizes are shown with a floor of $200,000 and a ceiling of $400,000 (with the note that actual size and duration can vary depending on the project scope), and there is no cost-sharing or matching requirement. Funding is discretionary and contingent on the availability of appropriated funds, meaning even strong proposals depend on the program's final budget and award decisions in a given year. The program is listed under CFDA 93.103 (Food and Drug Administration Research) and falls under broad activity categories that include health and research and development.
Eligibility is intentionally broad and includes domestic and foreign, public and private entities, for-profit and nonprofit organizations, and various government units. Federal agencies may apply only if they are not part of HHS (HHS components are not eligible). For-profit applicants must agree to request support without fees or profit, and organizations engaged in certain lobbying activities (as described for 501(c)(4) organizations) are not eligible for awards. The opportunity also explicitly notes inclusivity across institution types, including minority-serving institutions and faith-based or community-based organizations, as well as regional organizations and U.S. territories or possessions.
Administrative and timing details in the record show the funding opportunity number as RFA-FD-11-001, posted in 2010 and later archived in 2012, with multiple receipt and resubmission dates across 2011 and 2012 and a requirement for Adobe form submission templates for applications after a specified date in 2011. While those specific deadlines are historical for this particular notice, they illustrate the typical multi-cycle structure: application receipt dates, peer review windows, council review timing, and an anticipated start date. The notice also points to a grants management contact at FDA for applicants needing help accessing the full announcement or navigating submission and administrative requirements.
FAQs: Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)
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 opportunity intended to move promising medical products for rare diseases toward FDA marketing approval or licensure by supporting clinical studies that generate safety and/or effectiveness evidence.
Which FDA office runs the program?
The program is offered by the FDA Office of Orphan Products Development (OPD).
What does FDA mean by "orphan products" in this program?
In this opportunity, "orphan products" refers to drugs, biologics, medical devices, and medical foods intended for rare diseases or conditions affecting fewer than 200,000 people in the United States (based on prevalence, not incidence).
Can vaccines or diagnostics qualify as orphan products under this opportunity?
Yes. Vaccines and diagnostics can qualify, but only when the number of people in the U.S. expected to receive the vaccine or diagnostic is fewer than 200,000 per year.
How is "rare" determined for eligibility in the application?
Applicants are expected to document an estimated prevalence for the rare disease or condition (fewer than 200,000 people in the U.S.). For vaccines and diagnostics, applicants should document the expected number of people who would receive the product annually (fewer than 200,000 per year).
What is the main purpose of the funded work?
The intent is to fund clinical studies that generate safety and/or effectiveness evidence expected to either directly support, or substantially contribute to, an eventual FDA approval decision for the product.
What kinds of situations is the program aimed at?
The program targets situations where there is no available therapy or where the proposed product could clearly improve on existing options.
What grant mechanism is used?
This opportunity uses the NIH-style R01 research project grant mechanism, supporting a clearly defined, time-limited clinical development project led by a named Project Director/Principal Investigator (PD/PI), who is responsible for planning and executing the work.
What types of studies does OPD expect to fund?
The studies supported are clinical investigations and are expected to align with the regulatory pathways FDA uses to evaluate medical products.
Is the program focused on premarket or postmarket studies?
It is specifically intended to fund premarket clinical studies rather than postmarket work, except for certain studies involving medical foods (which generally do not require premarket approval).
How should applicants explain the regulatory relevance of their study?
Applications are expected to explain how the study results will support product approval or provide essential development data needed to progress the product through the FDA pipeline, not just that the condition is rare.
What FDA approval or licensure pathways are referenced as examples?
The opportunity notes that FDA is looking for trials that produce data usable in a marketing application for drugs or devices (for example, under sections 505 or 515 of the Federal Food, Drug, and Cosmetic Act) or for biologics licensure (for example, under section 351 of the Public Health Service Act).
Does this opportunity define clinical trial phases?
Yes. It summarizes common phase concepts for drugs and biologics: Phase 1 (early human safety and pharmacology), Phase 2 (early controlled effectiveness and short-term risk assessment), and Phase 3 (broader evidence of safety and effectiveness to support labeling and risk-benefit conclusions).
Do device and medical food studies need to match Phase 1/2/3 exactly?
Not necessarily. The notice indicates devices and medical foods may not map perfectly to those phases, and applicants should use the framework appropriate to their product type.
Are IND or IDE requirements mentioned?
Yes. The announcement highlights that an active IND (Investigational New Drug) or IDE (Investigational Device Exemption) is required where applicable.
What human subjects protections and assurances are expected?
Funded work must meet human subject protection requirements and regulatory requirements tied to clinical investigations. Institutions must have appropriate Office for Human Research Protections (OHRP) assurances on file.
What documentation is required before an award can be made?
Before an award can be made, documentation of IRB approval and a Federalwide Assurance (FWA) for the IRB of record must be in place for all performance sites.
Why is IRB documentation emphasized?
The requirement is framed as a way to avoid funding delays caused by missing or late IRB approvals.
Can FDA request additional documentation after award?
Yes. Grantees may be asked for additional documentation for review by FDA's IRB processes after award.
What policies govern awards under this program?
Awards are governed by Public Health Service (PHS) and HHS grants policies, referencing the HHS Grants Policy Statement and applicable federal regulations.
How much funding is available and how many awards are expected?
The source material indicates an estimated total funding amount of about $4.1 million with roughly 12 expected awards.
What is the expected award size range?
Award sizes are shown with a floor of $200,000 and a ceiling of $400,000, with the note that actual size and duration can vary depending on project scope.
Is cost-sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement.
Is funding guaranteed if an application is strong?
No. Funding is described as discretionary and contingent on the availability of appropriated funds, so awards depend on the program's final budget and award decisions in a given year.
What CFDA program number is associated with this opportunity?
The program is listed under CFDA 93.103 (Food and Drug Administration Research).
Who is eligible to apply?
Eligibility is broad and includes domestic and foreign, public and private entities, for-profit and nonprofit organizations, and various government units.
Can federal agencies apply?
Federal agencies may apply only if they are not part of HHS. HHS components are not eligible.
Are for-profit organizations allowed to apply?
Yes, for-profit entities are included, but for-profit applicants must agree to request support without fees or profit.
Are any organizations specifically described as not eligible?
Organizations engaged in certain lobbying activities (as described for 501(c)(4) organizations) are not eligible for awards.
Does the opportunity mention inclusion of specific institution types?
Yes. The notice explicitly notes inclusivity across institution types, including minority-serving institutions, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.
What is the funding opportunity number?
The funding opportunity number is RFA-FD-11-001.
When was this notice posted and what is its current status?
The record shows it was posted in 2010 and later archived in 2012.
Are the listed submission deadlines current?
The notice references multiple receipt and resubmission dates across 2011 and 2012, and indicates these dates are historical for this particular notice.
What submission format detail is mentioned?
The record mentions a requirement for Adobe form submission templates for applications after a specified date in 2011.
What does the timing information suggest about how the program runs?
It illustrates a typical multi-cycle structure that can include application receipt dates, peer review windows, council review timing, and an anticipated start date.
Is there a point of contact mentioned for administrative help?
Yes. The notice points to a grants management contact at FDA for applicants who need help accessing the full announcement or navigating submission and administrative requirements.
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