Opportunity Information: Apply for RFA FD 12 003
Apply for RFA FD 12 003
- The Food Drug Administration in the education health information and statistics regional development sector is offering a public funding opportunity titled "Minor Use Minor Species Development Drugs" 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 Jun 7, 2013 and posted on Feb 23, 2012.
- Applicants must submit their applications by Jan 16, 2015 This FOA has Multiple Receipt Dates. First application receipt/due date is 02/17/2012 is CURRENTLY POSTED BY THE NIH GUIDE Second application receipt/due date is 07/20/2012 Third application receipt/due date is 12/07/2012 Fourth application receipt/due date is 08/16/2013 Fifth application receipt/due date is 1/03/2014 Sixth application receipt/due date is 08/15/2014 Seventh application receipt/due date is 1/16/2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $750,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $125,000.00 in funding.
- The number of recipients for this funding is limited to 10 candidate(s).
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) State governments Private institutions of higher education Public housing authorities/Indian housing authorities Small businesses 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 Public and State controlled institutions of higher education City or township governments Independent school districts County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
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Opportunity Summary:
The Food and Drug Administration (FDA) grant opportunity titled "Minor Use Minor Species Development Drugs" (Funding Opportunity Number RFA-FD-12-003; CFDA 93.103) supports research studies that help move new animal drugs toward approval or conditional approval for designated products and designated intended uses, particularly in areas where markets are small or species are less commonly studied. The overall aim is to generate safety and/or effectiveness evidence that can be used in regulatory submissions for these targeted animal drug uses, helping address gaps in veterinary therapeutics for minor species or minor uses in major species.
Funding is offered as discretionary grant awards, with two main budget tiers. Applicants may request up to USD 75,000 per year in total costs (meaning direct plus indirect costs combined) for up to three years, or up to USD 125,000 per year in total costs for up to three years. The smaller award level is intended for any safety or effectiveness study that supports new animal drug approval or conditional approval for a designated product and intended use. The larger award level is reserved for studies that must be unusually complex, long in duration, or large in scope, and the proposal should clearly justify why the work requires the higher funding level. A key budgeting detail is that the cap applies to total costs rather than direct costs, which can affect how institutions structure indirect cost recovery. However, Facilities and Administrative (F&A) costs requested by consortium participants are treated differently: those consortium F&A costs are not included in the direct cost limitation, consistent with the referenced guidance (NOT-OD-05-004).
The FDA anticipated making around 10 awards under this announcement, with an estimated total program funding level of USD 750,000 and an award floor and ceiling of USD 75,000 and USD 125,000, respectively. The funding instrument type is a grant, and the opportunity is categorized under Education, Health, Information and Statistics, and Regional Development. There is no cost-sharing or matching requirement, so applicants are not required to contribute non-federal matching funds as a condition of eligibility.
A wide range of applicants are eligible, reflecting the program's intent to encourage participation from research institutions, governments, nonprofits, and industry. Eligible applicants include public and private institutions of higher education, nonprofits with or without 501(c)(3) status, for-profit organizations (including small businesses and other for-profits), state and local governments (including counties, cities or townships, and independent school districts), public housing authorities/Indian housing authorities, and Native American tribal governments and tribal organizations.
The announcement used multiple receipt (due) dates across several cycles, with application deadlines spanning from 2012 through the final closing date of January 16, 2015, and an archive date of February 15, 2015. The opportunity references FDA grant policies and indicates that awards and administration follow the HHS Grants Policy Statement, which governs requirements such as allowable costs, reporting, and grants management expectations.
For applicants needing assistance accessing the full announcement or handling administrative questions, the listed grants management contact is Oluyemisi (Yemisi) Akinneye, Grants Management Specialist at the FDA, reachable by phone at 301-827-0079 or by email at Oluyemisi.Akinneye@fda.hhs.gov. The announcement also points applicants to the NIH Guide for Grants and Contracts for additional information and the officially posted solicitation details.
Frequently Asked Questions (FAQs)
What is the name of this FDA grant opportunity?
The opportunity is titled "Minor Use Minor Species Development Drugs".
What is the Funding Opportunity Number (FON) and CFDA number?
The Funding Opportunity Number is RFA-FD-12-003 and the CFDA number is 93.103.
What is the main purpose of this grant program?
This program supports research studies intended to help move new animal drugs toward approval or conditional approval for designated products and designated intended uses, especially where markets are small or species are less commonly studied.
What kinds of evidence is the FDA looking for projects to generate?
The goal is to generate safety and/or effectiveness evidence that can be used in regulatory submissions for targeted animal drug uses.
Who is this funding meant to help in veterinary medicine?
The program aims to address gaps in veterinary therapeutics for minor species or minor uses in major species, where fewer approved options may exist.
What type of funding instrument is used?
The funding instrument type is a grant, and awards are made as discretionary grant awards.
How much funding can an applicant request?
Applicants may request either:
- Up to USD 75,000 per year in total costs for up to three years, or
- Up to USD 125,000 per year in total costs for up to three years.
How long can projects be funded?
Projects may be funded for up to three years.
What is the difference between the USD 75,000/year tier and the USD 125,000/year tier?
The USD 75,000/year level is intended for any safety or effectiveness study supporting approval or conditional approval for a designated product and intended use. The USD 125,000/year level is reserved for studies that must be unusually complex, long in duration, or large in scope, and proposals should clearly justify why the higher level is needed.
Do the funding caps apply to direct costs only, or to total costs?
The caps apply to total costs (direct plus indirect costs combined), not just direct costs.
How are Facilities and Administrative (F&A) costs treated under this opportunity?
Because the cap applies to total costs, applicants need to consider how their indirect costs fit within the yearly limit. However, consortium participants' F&A costs are treated differently: those consortium F&A costs are not included in the direct cost limitation, consistent with the referenced guidance (NOT-OD-05-004).
Is cost sharing or matching required?
No. There is no cost-sharing or matching requirement. Applicants are not required to provide non-federal matching funds as a condition of eligibility.
How many awards did the FDA anticipate making under this announcement?
The FDA anticipated making about 10 awards under this announcement.
What was the estimated total funding level for the program?
The estimated total program funding level was USD 750,000.
What are the minimum and maximum award amounts?
The award floor is USD 75,000 and the award ceiling is USD 125,000 (per year in total costs, as described in the budget tiers).
What types of organizations are eligible to apply?
A wide range of applicants are eligible, including:
- Public and private institutions of higher education
- Nonprofits with or without 501(c)(3) status
- For-profit organizations (including small businesses and other for-profits)
- State governments
- Local governments (including counties, cities or townships, and independent school districts)
- Public housing authorities/Indian housing authorities
- Native American tribal governments
- Native American tribal organizations
What topical categories is this opportunity listed under?
The opportunity is categorized under Education, Health, Information and Statistics, and Regional Development.
When were applications due for this opportunity?
The announcement used multiple receipt (due) dates across several cycles, with deadlines spanning from 2012 through the final closing date of January 16, 2015.
When was this opportunity archived?
The archive date was February 15, 2015.
What policies govern awards and administration for this grant?
The announcement indicates awards and administration follow the HHS Grants Policy Statement, which governs requirements such as allowable costs, reporting, and grants management expectations.
Where can applicants find the official solicitation details and related information?
The announcement points applicants to the NIH Guide for Grants and Contracts for additional information and the officially posted solicitation details.
Who is the grants management contact for administrative questions?
The listed grants management contact is Oluyemisi (Yemisi) Akinneye, Grants Management Specialist at the FDA.
How can someone reach the grants management contact?
Phone: 301-827-0079
Email: Oluyemisi.Akinneye@fda.hhs.gov
What kinds of studies are specifically encouraged by this program?
Research studies that help move a new animal drug toward approval or conditional approval for designated products and designated intended uses, particularly where the market is small or the species is less commonly studied, are the focus of this opportunity.
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