Opportunity Information: Apply for RFA FD 15 036
Apply for RFA FD 15 036
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01)" 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 12, 2015 and posted on May 14, 2015.
- Applicants must submit their applications by Jul 2, 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 $1,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Native American tribal governments (Federally recognized) Small businesses Special district governments Public and State controlled institutions of higher education For profit organizations other than small businesses Public housing authorities/Indian housing authorities County governments Private institutions of higher education City or township governments State governments Native American tribal organizations (other than Federally recognized tribal governments) 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) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts.
- Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply.Non domestic (non U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The grant opportunity "Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01)" (Funding Opportunity Number RFA-FD-15-036) is a Food and Drug Administration (FDA) cooperative agreement focused on strengthening how drug manufacturing quality is monitored across the pharmaceutical industry. The core aim is to evaluate a set of potential quality metrics and determine whether those metrics are genuinely useful for tracking and comparing manufacturing quality performance across firms and facilities. In practical terms, the project is meant to help FDA move quality oversight away from largely qualitative, narrative, or inspector-by-inspector judgments and toward a more quantitative, data-driven approach that relies on measurable indicators and technical expertise. The public health motivation is straightforward: better surveillance and earlier signals of quality risk can help ensure that safe, effective, high-quality drugs remain available to patients in the United States.
A central theme of the opportunity is "risk-based surveillance." Rather than treating all manufacturing sites as if they present the same level of risk, the work supported by this award is intended to inform methods for identifying which establishments may warrant closer attention based on objective signals. The expectation is that validated quality metrics could be used to flag potential quality problems earlier, monitor trends in manufacturing performance over time, and support smarter allocation of inspection and oversight resources. Importantly, the announcement notes that the resulting tools and findings could contribute to the development of a risk-based inspection approach for both domestic and foreign drug establishments, reflecting the global nature of pharmaceutical manufacturing and supply chains.
The funding mechanism is a cooperative agreement (U01), which typically indicates substantial involvement or partnership from the funding agency compared with a standard grant. That structure suggests the FDA expected active collaboration as the research team evaluates candidate metrics, tests their performance, and considers how the outputs could be used in real oversight settings. The activity category is listed under consumer protection, food and nutrition, and health, and the program falls under CFDA 93.103 (Food and Drug Administration Research), reinforcing that this is applied, regulatory-relevant research rather than purely academic work.
In terms of scale, the FDA anticipated making two awards, with an estimated total program funding of $1,000,000 and an award ceiling of $500,000. There was no cost-sharing or matching requirement, which generally lowers barriers for applicants that may not have discretionary funds to contribute. Key dates for the original competition included a posted date of May 14, 2015, with a closing date of July 2, 2015, and an archive date of August 1, 2015, indicating this was a time-limited solicitation that is no longer open.
Eligibility was broad and included many types of organizations: public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), small businesses, for-profit entities (including those other than small businesses), state and local governments, tribal governments and tribal organizations, independent school districts, special district governments, and public housing authorities/Indian housing authorities. The announcement also explicitly allowed non-U.S. entities to apply, including foreign institutions and foreign components of U.S. organizations, which aligns with the grant's interest in approaches that can be applied to foreign drug establishments as well as domestic facilities.
For applicants seeking the full details, the announcement pointed to the complete RFA on the NIH Guide for Grants and Contracts. The listed grants management contact for access issues was Lisa Ko, Grants Management Specialist, reachable at lisa.ko@fda.hhs.gov.
Frequently Asked Questions (FAQs)
1) What is the name of this grant opportunity?
The opportunity is titled "Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01)."
2) What is the Funding Opportunity Number?
The Funding Opportunity Number is RFA-FD-15-036.
3) Which agency is offering this opportunity?
This is a Food and Drug Administration (FDA) funding opportunity.
4) What type of funding mechanism is used?
The mechanism is a cooperative agreement (U01), which indicates FDA expected substantial involvement and collaboration with award recipients compared with a standard grant.
5) What is the main purpose of the project?
The core aim is to evaluate a set of potential drug manufacturing quality metrics and determine whether those metrics are genuinely useful for tracking and comparing manufacturing quality performance across firms and facilities.
6) What does "risk-based surveillance" mean in this opportunity?
Risk-based surveillance means using objective signals to identify which manufacturing establishments may warrant closer attention, rather than treating all sites as having the same level of risk. The intent is to help focus oversight and inspections more strategically.
7) How would quality metrics be used in practice?
Based on the opportunity description, validated metrics could be used to flag potential quality problems earlier, monitor manufacturing performance trends over time, and support smarter allocation of inspection and oversight resources.
8) Why is FDA interested in moving toward quantitative quality metrics?
The opportunity emphasizes shifting quality oversight away from largely qualitative or narrative judgments and toward a more quantitative, data-driven approach that relies on measurable indicators and technical expertise.
9) What is the public health motivation behind this grant?
The public health motivation is to strengthen surveillance and provide earlier signals of quality risk so that safe, effective, high-quality drugs remain available to patients in the United States.
10) Does the opportunity relate to inspections of manufacturing facilities?
Yes. The announcement notes that tools and findings could contribute to developing a risk-based inspection approach for both domestic and foreign drug establishments.
11) Does this opportunity consider global pharmaceutical manufacturing?
Yes. The description explicitly references the ability to support a risk-based inspection approach for both domestic and foreign establishments, reflecting the global nature of manufacturing and supply chains.
12) What program area or category does this fall under?
The activity category is listed under consumer protection, food and nutrition, and health.
13) What CFDA program is associated with this grant?
The program falls under CFDA 93.103 (Food and Drug Administration Research).
14) How many awards did FDA anticipate making?
FDA anticipated making two awards.
15) What was the estimated total funding amount for the program?
The estimated total program funding was $1,000,000.
16) What was the maximum award amount (award ceiling)?
The award ceiling was $500,000.
17) Was cost-sharing or matching required?
No. The opportunity stated there was no cost-sharing or matching requirement.
18) When was the opportunity posted?
The posted date was May 14, 2015.
19) What was the application closing date?
The closing date was July 2, 2015.
20) Is this opportunity still open?
No. The archive date was August 1, 2015, indicating it was a time-limited solicitation that is no longer open.
21) Who was eligible to apply?
Eligibility was broad and included public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); small businesses; for-profit entities (including those other than small businesses); state and local governments; tribal governments and tribal organizations; independent school districts; special district governments; and public housing authorities/Indian housing authorities.
22) Were non-U.S. entities allowed to apply?
Yes. The announcement explicitly allowed non-U.S. entities to apply, including foreign institutions and foreign components of U.S. organizations.
23) Where were applicants directed to find the full announcement details?
The opportunity pointed applicants to the complete RFA on the NIH Guide for Grants and Contracts.
24) Who was the grants management contact listed for access issues?
The listed contact was Lisa Ko, Grants Management Specialist.
25) What email address was provided for the grants management contact?
The email address provided was lisa.ko@fda.hhs.gov.
Browse more opportunities from the same agency: Food Drug Administration
Browse more opportunities from the same category: Consumer Protection Food and Nutrition Health
Next opportunity: Fuel Tax Evasion Intergovernmental Grants 2015
Previous opportunity: DoD Gulf War Illness Investigator Initiated Research Award
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA FD 15 036
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 15 036) also looked into and applied for these:
| Funding Opportunity |
|---|
| Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01) Apply for RFA FD 15 014 Funding Number: RFA FD 15 014 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Smokeless Tobacco Reference Products (UC2) Apply for RFA FD 15 026 Funding Number: RFA FD 15 026 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $3,000,000 |
| Building towards Statistically Based Pharmaceutical Quality Standards (U01) Apply for RFA FD 16 003 Funding Number: RFA FD 16 003 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,000,000 |
| Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01) Apply for RFA FD 16 004 Funding Number: RFA FD 16 004 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA FD 15 036", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.