Opportunity Information: Apply for PAR 15 187
Apply for PAR 15 187
- The Food Drug Administration in the consumer protection food and nutrition health science and technology and other research and development sector is offering a public funding opportunity titled "Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (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 Apr 20, 2015.
- Applicants must submit their applications by Apr 30, 2019 This announcement has multiple deadline dates.June 30, 2015, by 1159 PM Eastern Time. April 29, 2016, by 800 PM Eastern Time.April 28, 2017, by 800 PM Eastern Time.April 30, 2018, by 800 PM Eastern Time.April 30, 2019, by 800 PM Eastern Time.Applicants are encouraged to apply early to allow adequate time to make any corrections by the due date to errors found in the application during the submission process.For the June 30, 2015 application due date, Applicants should be aware that on time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 1159 PM Eastern Time on the application due date. For all subsequent application due dates, Applicants should be aware that on time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 800 PM Eastern Time on the application due date. Late applications will not be accepted for this FOA.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $6,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $3,000,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: County governments Special district 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 Public and State controlled institutions of higher education Small businesses City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) State governments For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities 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.
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Opportunity Summary:
The grant opportunity titled "Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (U01)" (Funding Opportunity Number PAR 15 187) is a Food and Drug Administration (FDA) cooperative agreement program designed to strengthen the scientific foundation FDA and industry use to evaluate and adopt new pharmaceutical manufacturing approaches. The core focus is regulatory science, meaning practical, evidence-based research that improves how manufacturing innovations are assessed for quality, safety, and reliability, especially when those innovations are new enough that FDA reviewers and inspectors have limited direct experience with them.
The program specifically targets "emerging manufacturing technologies" in the pharmaceutical sector. In this context, emerging technologies are those that could modernize the existing pharmaceutical manufacturing knowledge base by making processes more robust, more predictable, and/or more cost-effective. A key reason these technologies need targeted regulatory science support is that their novelty can create uncertainty during development, scale-up, commercialization, and regulatory review. The opportunity highlights three broad areas where novelty may appear: innovative or novel product manufacturing technologies (including new dosage forms), new or advanced manufacturing processes (covering design, scale-up, and commercial-scale production), and novel testing technologies used to assess products or processes. In practical terms, projects funded under this program would be expected to generate data, tools, frameworks, or methodologies that help enable risk-based assessment and smoother implementation of these advanced approaches in real-world pharmaceutical manufacturing.
From an administrative standpoint, this is a discretionary funding opportunity using a cooperative agreement mechanism (U01). A cooperative agreement generally implies substantial involvement or collaboration with the funding agency compared with a standard grant, which aligns with the program's goal of producing research that directly informs regulatory assessment and inspectional confidence for new manufacturing technologies. The funding activity categories are listed broadly, including consumer protection and multiple research and development domains related to health science and technology.
The opportunity anticipated making about 2 awards, with an estimated total funding amount of $6,000,000 and an award ceiling of $3,000,000. No cost sharing or matching requirement was listed, meaning applicants were not required to commit their own funds as a condition of the award (though applicants could still propose leveraged resources if relevant to their projects).
Eligibility was wide and included many types of domestic and non-domestic organizations. Eligible applicants included federal-recognized tribal governments and other tribal organizations, state and local governments (including counties, cities or townships, special district governments, and independent school districts), public housing authorities/Indian housing authorities, public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (including 501(c)(3) and those without 501(c)(3) status), and for-profit organizations (including small businesses and other for-profit entities). Importantly, foreign institutions were eligible to apply, non-U.S. components of U.S. organizations were eligible, and foreign components were allowed as defined under HHS policy, which signals FDA’s openness to globally relevant expertise in advanced manufacturing and testing.
The posting timeline shows it was originally posted on April 20, 2015, with multiple application due dates across several years. The first deadline was June 30, 2015 (with an 11:59 PM Eastern submission cutoff), and subsequent deadlines were April 29, 2016; April 28, 2017; April 30, 2018; and April 30, 2019 (each with an 8:00 PM Eastern cutoff). The notice emphasizes that applications had to be submitted error-free in both Grants.gov and eRA Commons by the deadline, and late applications would not be accepted. The opportunity ultimately closed April 30, 2019 and was archived May 30, 2019.
For applicants seeking the complete requirements and expectations, the listing points to the full announcement in the NIH Guide for Grants and Contracts. A grants management contact was provided for access issues: Lisa Ko, Grants Management Specialist, at lisa.ko@fda.hhs.gov. Overall, the program was structured to fund a small number of sizable, collaborative research efforts aimed at reducing uncertainty and improving confidence in the risk-based regulatory evaluation of novel pharmaceutical manufacturing and testing technologies.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (U01)" and the Funding Opportunity Number is PAR 15 187.
Which agency is offering this opportunity?
This is a Food and Drug Administration (FDA) funding opportunity offered as a cooperative agreement program.
What is the purpose of this cooperative agreement program?
The purpose is to strengthen the scientific foundation that FDA and industry rely on to evaluate and adopt new pharmaceutical manufacturing approaches. The emphasis is on generating practical, evidence-based regulatory science that improves how manufacturing innovations are assessed for quality, safety, and reliability.
What does "regulatory science" mean in this program?
In this program, regulatory science refers to practical, evidence-based research that improves regulatory evaluation. The goal is to reduce uncertainty and increase confidence in the assessment and inspection of new manufacturing technologies, especially when FDA reviewers and inspectors have limited direct experience with them.
What types of technologies does the program consider "emerging manufacturing technologies"?
Emerging manufacturing technologies are those in the pharmaceutical sector that could modernize current manufacturing knowledge and practice by making processes more robust, more predictable, and/or more cost-effective.
Why does FDA target emerging manufacturing technologies for regulatory science support?
Because the novelty of these technologies can create uncertainty during development, scale-up, commercialization, and regulatory review. The program aims to generate the data, tools, frameworks, or methodologies needed for risk-based assessment and smoother implementation.
What are the main novelty areas highlighted by the opportunity?
The opportunity highlights three broad areas where novelty may appear: (1) innovative or novel product manufacturing technologies (including new dosage forms), (2) new or advanced manufacturing processes (covering design, scale-up, and commercial-scale production), and (3) novel testing technologies used to assess products or processes.
What kinds of outputs or deliverables are projects expected to produce?
Funded projects would be expected to generate data, tools, frameworks, or methodologies that enable risk-based assessment and support real-world implementation of advanced pharmaceutical manufacturing and testing approaches.
What funding mechanism is used for this opportunity?
The mechanism is a cooperative agreement (U01).
What does a U01 cooperative agreement imply for the relationship with FDA?
A cooperative agreement generally implies substantial involvement or collaboration with the funding agency compared with a standard grant. This aligns with the program goal of producing research that directly informs regulatory assessment and inspectional confidence for new manufacturing technologies.
How many awards were anticipated?
The opportunity anticipated making about 2 awards.
What was the estimated total funding amount and the maximum award size?
The estimated total funding amount was $6,000,000, and the award ceiling was $3,000,000.
Is cost sharing or matching required?
No cost sharing or matching requirement was listed. Applicants were not required to commit their own funds as a condition of the award.
Who was eligible to apply?
Eligibility was broad and included many domestic and non-domestic organization types, including tribal governments and other tribal organizations; state and local governments (including counties, cities or townships, special districts, and independent school districts); public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits (including 501(c)(3) and those without 501(c)(3) status); and for-profit organizations (including small businesses and other for-profit entities).
Are foreign (non-U.S.) organizations eligible to apply?
Yes. Foreign institutions were eligible to apply.
Are non-U.S. components of U.S. organizations allowed?
Yes. Non-U.S. components of U.S. organizations were eligible.
Are foreign components permitted under this opportunity?
Yes. Foreign components were allowed as defined under HHS policy.
What were the application due dates and submission cutoffs?
The first deadline was June 30, 2015 with an 11:59 PM Eastern cutoff. Subsequent deadlines were April 29, 2016; April 28, 2017; April 30, 2018; and April 30, 2019, each with an 8:00 PM Eastern cutoff.
What submission systems were required?
Applications had to be submitted error-free in both Grants.gov and eRA Commons by the deadline.
Were late applications accepted?
No. The notice emphasizes that late applications would not be accepted.
When did the opportunity close and when was it archived?
The opportunity closed on April 30, 2019 and was archived on May 30, 2019.
Where can applicants find the complete requirements and expectations?
The listing points applicants to the full announcement in the NIH Guide for Grants and Contracts for complete requirements and expectations.
Who is the contact for grants management or access issues?
The grants management contact listed is Lisa Ko, Grants Management Specialist. Email: lisa.ko@fda.hhs.gov.
What broad activity categories were associated with this opportunity?
The funding activity categories were described broadly, including consumer protection and multiple research and development domains related to health science and technology.
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