Opportunity Information: Apply for RFA FD 16 004
Apply for RFA FD 16 004
- 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 Jul 31, 2015 and posted on Jul 31, 2015.
- Applicants must submit their applications by Oct 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 $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) Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Special district governments Small businesses Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Independent school districts County governments State governments For profit organizations other than small businesses.
- 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.
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Opportunity Summary:
The grant opportunity "Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01)" (Funding Opportunity Number RFA-FD-16-004) is a Food and Drug Administration (FDA) cooperative agreement aimed at strengthening how drug manufacturing quality is monitored across the pharmaceutical industry. The core purpose is to evaluate a set of proposed quality metrics and determine how useful they are for ongoing, sector-wide surveillance of manufacturing performance and product quality. In practice, this means identifying which measurable indicators of manufacturing quality actually help distinguish well-performing facilities from those at higher risk of producing quality problems, and then assessing whether those indicators can be applied consistently across different companies, products, and manufacturing sites.
A major theme of the opportunity is supporting the FDA's broader shift in quality oversight from largely qualitative judgments toward more quantitative, data-driven, expertise-based assessment. Rather than relying primarily on narrative evaluations or periodic snapshots from inspections, the work funded under this announcement is intended to help establish whether routinely collected, standardized metrics can provide earlier and clearer insight into a facility's state of control and its likelihood of quality failures. The public health motivation is direct: better surveillance and smarter prioritization should help ensure that safe, effective, high-quality drugs remain available to patients in the United States, including by reducing disruptions that can contribute to shortages and by identifying potential problems before they lead to widespread impact.
The outcomes are also intended to inform the development or refinement of a risk-based inspection model for drug establishments, both domestic and foreign. That focus reflects the reality that the pharmaceutical supply chain is global and that inspection resources are finite. If quality metrics can reliably signal risk, they can help regulators target inspections where they are most needed, adjust inspection frequency based on evidence, and improve consistency in oversight across a diverse set of manufacturing operations and facilities. In effect, the project sits at the intersection of regulatory science, quality management systems, and operational analytics: it is about testing whether specific metrics can serve as practical, defensible inputs into risk-based surveillance and inspection planning.
Administratively, this is a discretionary funding opportunity using a cooperative agreement mechanism (U01). A cooperative agreement implies substantial involvement by the FDA during the project, meaning recipients should expect active collaboration, coordination, and potentially iterative feedback on approach, data interpretation, and deliverables, rather than operating with minimal federal interaction. The activity is categorized under consumer protection, food and nutrition, and health, and it falls under CFDA number 93.103 (Food and Drug Administration Research).
The total estimated funding listed is $1,000,000, with an anticipated two awards and an award ceiling of $500,000. There is no cost-sharing or matching requirement, which lowers barriers for organizations that may not have discretionary funds to contribute. Key dates in the posted announcement indicate it was posted on July 31, 2015, with an original and current closing date of October 16, 2015, and an archive date of November 15, 2015.
Eligibility is broad and includes many types of domestic applicants, such as state and local governments, tribal governments and organizations, public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and certain non-501(c)(3) entities), public housing authorities, independent school districts, special district governments, small businesses, and other for-profit organizations (with small businesses explicitly called out). Importantly, foreign participation is allowed: non-U.S. entities may apply, and foreign components of U.S. organizations are eligible as well. This aligns with the opportunity's explicit interest in supporting a risk-based approach that is applicable to both domestic and foreign drug manufacturing sites.
For applicants or interested parties seeking the full official announcement and detailed requirements, the FDA pointed to the complete listing on the NIH Guide for Grants and Contracts under the "Full Announcement of RFA-FD-16-004." The named grants management contact for access issues was Lisa Ko, Grants Management Specialist, reachable at lisa.ko@fda.hhs.gov.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01)" and the Funding Opportunity Number is RFA-FD-16-004.
Which federal agency is offering this opportunity?
This is a Food and Drug Administration (FDA) funding opportunity.
What type of funding mechanism is used?
The award mechanism is a cooperative agreement (U01). This is a discretionary funding opportunity.
What does a U01 cooperative agreement imply for how the project will be run?
A cooperative agreement implies substantial involvement by the FDA during the project. Recipients should expect active collaboration and coordination with FDA, and potentially iterative feedback related to the project approach, interpretation of data, and deliverables, rather than minimal federal interaction.
What is the main purpose of this grant?
The core purpose is to evaluate a set of proposed drug manufacturing quality metrics and determine how useful they are for ongoing, sector-wide surveillance of manufacturing performance and product quality across the pharmaceutical industry.
What does "evaluating quality metrics" mean in practical terms for this project?
It means identifying which measurable indicators of manufacturing quality help distinguish facilities that are performing well from facilities that appear to be at higher risk for producing quality problems, and assessing whether those indicators can be applied consistently across companies, products, and manufacturing sites.
How does this opportunity relate to FDA's oversight approach?
The opportunity supports FDA's broader shift from largely qualitative judgments toward more quantitative, data-driven, expertise-based assessment of manufacturing quality.
Why is FDA interested in routinely collected, standardized metrics?
The intent is to test whether standardized metrics can provide earlier and clearer insight into a facility's state of control and likelihood of quality failures than relying primarily on narrative evaluations or periodic inspection snapshots.
What public health outcomes is this work intended to support?
The work is motivated by improving surveillance and prioritization so that safe, effective, high-quality drugs remain available to patients in the United States, including by reducing disruptions that can contribute to shortages and by identifying potential problems before they lead to widespread impact.
How could the results influence FDA inspections?
The outcomes are intended to inform development or refinement of a risk-based inspection model for drug establishments (domestic and foreign). If metrics can reliably signal risk, they can help target inspections where they are most needed, adjust inspection frequency based on evidence, and improve consistency in oversight.
Does the opportunity address both U.S. and international manufacturing facilities?
Yes. The opportunity explicitly reflects a global pharmaceutical supply chain and aims to support a risk-based approach applicable to both domestic and foreign drug manufacturing sites.
What program or topic areas does this activity fall under?
The activity is categorized under consumer protection, food and nutrition, and health.
What is the CFDA number for this opportunity?
The CFDA number listed is 93.103 (Food and Drug Administration Research).
How much funding is available in total under this announcement?
The total estimated funding listed is $1,000,000.
How many awards does FDA anticipate making?
The announcement indicates an anticipated two awards.
What is the maximum award size (award ceiling)?
The award ceiling is $500,000.
Is cost sharing or matching required?
No. The announcement specifies there is no cost-sharing or matching requirement.
When was this funding opportunity posted?
The opportunity was posted on July 31, 2015.
What was the application closing date?
The original and current closing date listed is October 16, 2015.
When was the opportunity archived?
The archive date is November 15, 2015.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic applicants, such as state and local governments, tribal governments and organizations, public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and certain non-501(c)(3) entities), public housing authorities, independent school districts, special district governments, small businesses, and other for-profit organizations.
Are small businesses eligible?
Yes. Small businesses are explicitly included among eligible applicants.
Are for-profit organizations eligible?
Yes. The eligibility list includes other for-profit organizations, with small businesses specifically called out.
Are non-U.S. (foreign) organizations allowed to apply?
Yes. The opportunity allows foreign participation; non-U.S. entities may apply.
Can a U.S. organization include a foreign component?
Yes. Foreign components of U.S. organizations are eligible as well.
Where can applicants find the full official announcement?
The FDA pointed to the complete listing on the NIH Guide for Grants and Contracts under the "Full Announcement of RFA-FD-16-004."
Who should be contacted for access issues related to the full announcement?
The grants management contact listed for access issues is Lisa Ko, Grants Management Specialist, at lisa.ko@fda.hhs.gov.
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