Opportunity Information: Apply for RFA FD 12 026
Apply for RFA FD 12 026
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Building the Capacity of Food Safety Entities to Protect Public Health in Response to a Notification under Section 1008 of the Federal Food, Drug, and Cosmetic Act or a Recall of Foods (U18)" 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 8, 2012 and posted on Jun 8, 2012.
- Applicants must submit their applications by Jul 12, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $100,000.00 in funding.
- The number of recipients for this funding is limited to 20 candidate(s).
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments City or township governments.
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Opportunity Summary:
This grant opportunity, titled "Building the Capacity of Food Safety Entities to Protect Public Health in Response to a Notification under Section 1008 of the Federal Food, Drug, and Cosmetic Act or a Recall of Foods (U18)," is a Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA) cooperative agreement program designed to strengthen the national food safety system over the long term. The central aim is to help public and nonprofit food safety entities build practical readiness and operational capacity to respond effectively when there is either (1) a formal notification under section 1008 of the Federal Food, Drug, and Cosmetic Act, or (2) a recall of foods under the same Act. In plain terms, the program is about making sure organizations responsible for food protection can plan, prepare, and carry out timely actions that reduce harm to the public when a food safety incident triggers a notification or recall.
The award mechanism is a cooperative agreement (U18), which typically means the federal government expects to have substantial involvement in the project compared with a standard grant. The FOA is described as a limited competition, indicating eligibility may be restricted or the competition is not broadly open in the way many discretionary grants are; applicants generally need to pay attention to the full announcement details for any special limitations or requirements tied to that limited competitive structure.
The funding falls under consumer protection, food and nutrition, and health, and it is administered by the FDA. The program anticipated up to 20 awards, supported by an estimated total funding amount of $2,000,000. Individual awards were expected to range from a floor of $1 up to a ceiling of $100,000. There is no cost-sharing or matching requirement, meaning applicants were not required to contribute non-federal funds as a condition of receiving an award.
Eligible applicants include a wide range of government and nonprofit entities that are commonly involved in food safety functions or public health response. This includes state governments; county governments; city or township governments; special district governments; federally recognized tribal governments; and other Native American tribal organizations. It also includes nonprofits with 501(c)(3) status (excluding institutions of higher education) as well as nonprofits without 501(c)(3) status (also excluding institutions of higher education). Overall, the eligibility list signals an emphasis on organizations that can directly support food safety preparedness and response activities in communities and jurisdictions.
Key timeline details show the announcement was posted and created on June 8, 2012, with an original and current closing date of July 12, 2012, and an archive date of August 11, 2012. The opportunity is associated with Funding Opportunity Number RFA-FD-12-026 and CFDA number 93.103 (Food and Drug Administration). Additional details were referenced as being available through the full announcement posted on the NIH Guide.
For applicants or interested parties who needed help accessing the full announcement, the listed grants management contact was Daniel Lukash, Grants Management Specialist at the FDA, reachable by phone at 301-827-6771 or by email at daniel.lukash@fda.hhs.gov.
Frequently Asked Questions (FAQ)
What is the official title of this grant opportunity?
The opportunity is titled "Building the Capacity of Food Safety Entities to Protect Public Health in Response to a Notification under Section 1008 of the Federal Food, Drug, and Cosmetic Act or a Recall of Foods (U18)."
Which federal agency is offering and administering this program?
This program is administered by the U.S. Food and Drug Administration (FDA), specifically the FDA Office of Regulatory Affairs (ORA).
What is the main purpose of the program?
The central purpose is to strengthen the national food safety system over the long term by helping public and nonprofit food safety entities build practical readiness and operational capacity to respond effectively when there is either (1) a formal notification under section 1008 of the Federal Food, Drug, and Cosmetic Act, or (2) a recall of foods under the same Act.
In plain terms, what is this program trying to help organizations do?
It is meant to help organizations responsible for food protection plan, prepare, and carry out timely actions that reduce harm to the public when a food safety incident triggers a notification or a recall.
What award mechanism is used for this opportunity?
The award mechanism is a cooperative agreement (U18).
What does it mean that this is a cooperative agreement (U18)?
A cooperative agreement (U18) typically means the federal government expects to have substantial involvement in the project compared with a standard grant.
Is this an open competition?
The FOA is described as a limited competition, which indicates eligibility may be restricted or the competition is not broadly open in the way many discretionary grants are. Applicants are expected to pay close attention to the full announcement for any special limitations or requirements tied to the limited competitive structure.
What funding areas does this opportunity fall under?
The funding is described as falling under consumer protection, food and nutrition, and health.
How many awards were anticipated?
Up to 20 awards were anticipated.
What is the estimated total funding amount for all awards?
The estimated total funding amount was $2,000,000.
What is the expected size of individual awards?
Individual awards were expected to range from a floor of $1 up to a ceiling of $100,000.
Is cost sharing or matching required?
No. There is no cost-sharing or matching requirement, meaning applicants were not required to contribute non-federal funds as a condition of receiving an award.
Who is eligible to apply?
Eligible applicants include state governments; county governments; city or township governments; special district governments; federally recognized tribal governments; and other Native American tribal organizations. Eligible applicants also include nonprofits with 501(c)(3) status (excluding institutions of higher education) and nonprofits without 501(c)(3) status (also excluding institutions of higher education).
Are institutions of higher education eligible to apply as nonprofits?
No. The eligibility language explicitly excludes institutions of higher education from the nonprofit categories listed (both 501(c)(3) and non-501(c)(3)).
What kinds of organizations does the eligibility list suggest the program is targeting?
The eligibility list signals an emphasis on government and nonprofit organizations that are commonly involved in food safety functions or public health response and that can directly support food safety preparedness and response activities in communities and jurisdictions.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-FD-12-026.
What is the CFDA number associated with this opportunity?
The CFDA number is 93.103 (Food and Drug Administration).
When was the opportunity posted?
The announcement was posted (and created) on June 8, 2012.
What was the application closing date?
The original and current closing date was July 12, 2012.
When was the opportunity archived?
The archive date was August 11, 2012.
Where were additional details about the full announcement referenced?
Additional details were referenced as being available through the full announcement posted on the NIH Guide.
Who is the grants management contact for questions or help accessing the full announcement?
The listed grants management contact is Daniel Lukash, Grants Management Specialist at the FDA.
How can Daniel Lukash be reached?
He can be reached by phone at 301-827-6771 or by email at daniel.lukash@fda.hhs.gov.
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Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 12 026) also looked into and applied for these:
| Funding Opportunity |
|---|
| Building an Integrated Laboratory System to Advance the Safety of Food and Animal Feed (U18) Apply for RFA FD 12 025 Funding Number: RFA FD 12 025 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,500,000 |
| Postmarketing Surveillance of Generic Drug Usage and Substitution Patterns (U01) Apply for RFA FD 13 022 Funding Number: RFA FD 13 022 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $250,000 |
| Bioequivalence of Generic Bupropion (U01) Apply for RFA FD 13 021 Funding Number: RFA FD 13 021 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $800,000 |
| Development of Bio relevant In vitro Assay to Determine Labile Iron in the Parenteral Iron Complex Product (U01) Apply for RFA FD 13 017 Funding Number: RFA FD 13 017 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Collection of Dose Adjustment and Therapeutic Monitoring Data to Aid Narrow Therapeutic Index Drug Classification (U01) Apply for RFA FD 13 020 Funding Number: RFA FD 13 020 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $250,000 |
| Evaluation of Dissolution Methods for Complex Parenteral Dosage Forms (U01) Apply for RFA FD 13 019 Funding Number: RFA FD 13 019 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Development of an Integrated Mathematical Model for Comparative Characterization of Complex Molecules (U01) Apply for RFA FD 14 082 Funding Number: RFA FD 14 082 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $600,000 |
| Development of Process Simulation and Modeling Tools for Integrated Pharmaceutical Manufacturing Processes (U01) Apply for RFA FD 14 083 Funding Number: RFA FD 14 083 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $200,000 |
| The Use of Polyethylene Glycol in the Pediatric Population (R01) Apply for RFA FD 14 088 Funding Number: RFA FD 14 088 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $325,000 |
| Predictive in vitro Methods for Characterizing Product Performance, Case Study Furosemide (U01) Apply for RFA FD 14 080 Funding Number: RFA FD 14 080 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $100,000 |
| Evaluating Predictive Methods and Product Performance in Healthy Adults for Pediatric Patients, Case Study Furosemide (U01) Apply for RFA FD 14 081 Funding Number: RFA FD 14 081 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $100,000 |
| Kidney Health Initiative (R18) Apply for RFA FD 14 018 Funding Number: RFA FD 14 018 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Dissolution Methods for Long acting Levonorgestrel Intrauterine System (U01) Apply for RFA FD 15 006 Funding Number: RFA FD 15 006 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $125,000 |
| Dissolution Methods for Long acting Periodontal Drug Products (U01) Apply for RFA FD 15 007 Funding Number: RFA FD 15 007 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $125,000 |
| Pharmacometric Modeling and Simulation for Long Acting Injectable Products (U01) Apply for RFA FD 15 008 Funding Number: RFA FD 15 008 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $200,000 |
| Limited Competition for Revision Applications for Evaluation of Formulation Effects of Metered Dose Inhalers on Pharmacokinetics (U01) Apply for RFA FD 15 016 Funding Number: RFA FD 15 016 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $800,000 |
| Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (U01) Apply for RFA FD 15 032 Funding Number: RFA FD 15 032 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $250,000 |
| Post market Surveillance of Generic Modified Release Products (U01) Apply for RFA FD 15 015 Funding Number: RFA FD 15 015 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Building towards Statistically Based Pharmaceutical Quality Standards (U01) Apply for RFA FD 15 031 Funding Number: RFA FD 15 031 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,000,000 |
| Development and Application of Case Control Analysis for Generic Drugs (U01) Apply for RFA FD 15 027 Funding Number: RFA FD 15 027 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $200,000 |
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