Opportunity Information: Apply for PAR 13 202
Apply for PAR 13 202
- The Food Drug Administration in the consumer protection health sector is offering a public funding opportunity titled "Enhancing post market surveillance through developing registries for medical device epidemiology (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 May 29, 2013 and posted on Apr 19, 2013.
- Applicants must submit their applications by Apr 30, 2017 This FOA has multiple receipt dates. The first application due date is June 14, 2013, by 1159 PM Eastern Time. The next application due date(s) are April 30, 2014, 2015, 2016, 2017 by 1159 PM Eastern Time.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $300,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $150,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: State governments Public housing authorities/Indian housing authorities Small businesses Public and State controlled institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Special district governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Private institutions of higher education City or township governments Nonprofits having 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).
- 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 post market surveillance through developing registries for medical device epidemiology (U01)" (Funding Opportunity Number PAR 13 202) is a U.S. Food and Drug Administration (FDA) research funding program designed to strengthen how medical devices are monitored after they reach the market. It is structured as a cooperative agreement (U01), which generally means the FDA expects to have active involvement with awardees rather than operating as a hands-off funder. The overall intent is to improve real-world evidence generation for medical devices by building and advancing patient registries and the methods needed to make registries more useful, more linkable, and more reliable for safety and performance monitoring.
At the center of the opportunity is the goal of closing recognized gaps in the existing postmarket surveillance system. The FDA is looking for projects that either develop new approaches for how registry data are collected and connected to other data sources, or that adapt established methods (often used in other fields like pharmaceuticals, public health surveillance, or outcomes research) specifically to the realities of medical devices. Medical device evaluation has some unique challenges, such as rapidly changing device models, differences in operator technique, variations in device use across clinical sites, and the need to track not only a product type but the exact version implanted or used. This program is meant to push the field toward better solutions for those challenges, especially through improved registry design and better linkage strategies.
A second major purpose is to create or refine methods that let one registry infrastructure support multiple, high-value uses rather than serving a single narrow function. The announcement emphasizes building registry systems that can support postmarket surveillance while also enabling device tracking via Unique Device Identifiers (UDI). In practice, that points to registries that can capture device identifiers in a consistent, standardized way and then use those identifiers to connect device exposure to outcomes over time. The FOA also highlights broader uses like prospective embedded studies (studies conducted within routine care settings using registry infrastructure), quality improvement initiatives, and other secondary uses that can raise the return on investment for registry creation and maintenance. In other words, the FDA is encouraging multipurpose registries that can serve regulators, health systems, clinicians, and researchers without requiring a separate data platform for each objective.
The third major goal is to support the development of registries and consortia in key medical device areas, with an emphasis on implementing these improved methodologies in real-world settings. This reflects an interest not only in theoretical or academic methodological work, but in building practical registry networks and collaborative groups that can operate at scale. The program is framed to strategically broaden the scope of U.S. and international postmarket surveillance, suggesting an interest in approaches that can extend across institutions and potentially across borders, which can be especially important for devices used globally and for detecting less common adverse events that require large populations to identify.
From an administrative standpoint, this is a discretionary grant program under the Consumer Protection and Health activity category and is associated with CFDA number 93.103 (Food and Drug Administration Research). The FDA expected to make two awards under this opportunity. The estimated total funding amount listed is $300,000, with an award ceiling of $150,000, which aligns with two awards at the maximum level. There is no cost sharing or matching requirement stated, so applicants are not required to provide non-federal matching funds as a condition of the award.
The funding opportunity was posted on April 19, 2013, created on May 29, 2013, and used multiple receipt dates across several years. The first application due date was in 2013, and subsequent due dates occurred annually on April 30 in 2014, 2015, 2016, and 2017, with submissions due by 11:59 PM Eastern Time. The current closing date shown is April 30, 2017, and the archive date is May 30, 2017, meaning the opportunity is now closed and archived, but it remains useful as a reference point for the kinds of registry-based surveillance capabilities the FDA has prioritized.
Eligibility is broad and includes many U.S. entity types such as state and local governments, public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits), small businesses and other for-profit organizations (with certain limitations noted), independent school districts, public housing authorities, special district governments, and tribal governments and organizations. Importantly, the FOA also states that non-U.S. entities (foreign institutions) are eligible to apply, and that foreign components of U.S. organizations are allowed consistent with HHS grants policy. This openness supports the program's emphasis on strengthening both U.S. and international postmarket surveillance capacity.
Operationally, the opportunity is geared toward applicants capable of working at the intersection of clinical practice, data infrastructure, epidemiology, and device regulation. Competitive projects would typically involve building or enhancing registry systems, demonstrating robust governance and data quality practices, and showing credible plans for data linkage and UDI capture where relevant. Because the program emphasizes multipurpose infrastructure and consortia development, it implicitly favors collaborations among health systems, professional societies, academic research groups, and potentially industry or international partners, provided conflicts of interest and data integrity are properly managed. The goal is not just to create datasets, but to develop registry-based methods and networks that can be used repeatedly to detect safety signals, evaluate performance, support embedded research, and improve care.
For applicants who needed help accessing the full announcement, the listed grants management contact was Lisa Ko, Grants Management Specialist, reachable at lisa.ko@fda.hhs.gov, and the full announcement was available through the NIH Guide for Grants and Contracts under PAR 13 202.
FAQs: Enhancing post market surveillance through developing registries for medical device epidemiology (U01) (PAR 13 202)
What is the title of this grant opportunity?
The opportunity is titled "Enhancing post market surveillance through developing registries for medical device epidemiology (U01)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PAR 13 202.
Which federal agency is offering this program?
This is a U.S. Food and Drug Administration (FDA) research funding program.
What type of award mechanism is used?
The mechanism is a cooperative agreement (U01), meaning the FDA expects active involvement with awardees rather than operating strictly as a hands-off funder.
What is the main purpose of the program?
The program is designed to strengthen postmarket surveillance of medical devices by improving real-world evidence generation through building and advancing patient registries and the methods needed to make registries more useful, more linkable, and more reliable for monitoring device safety and performance after devices reach the market.
What gaps is the FDA trying to address with this funding?
The focus is on closing recognized gaps in the existing postmarket surveillance system, especially by improving how registry data are collected, connected to other data sources, and adapted to the specific realities of medical devices.
Why does the FOA emphasize registries for medical devices specifically?
Medical device evaluation has unique challenges, including rapidly changing device models, differences in operator technique, variations in device use across clinical sites, and the need to track not only a product type but the exact version that was implanted or used. The FOA aims to drive better registry design and linkage strategies that address these issues.
What kinds of projects is the FDA looking for?
The FDA is looking for projects that either (1) develop new approaches for collecting and connecting registry data to other data sources, or (2) adapt established methods from other fields (such as pharmaceuticals, public health surveillance, or outcomes research) to the medical device context.
Is this opportunity focused on theory or real-world implementation?
It emphasizes implementation in real-world settings, supporting practical registry development and consortia that can operate at scale, not only academic or theoretical methodological work.
What does it mean that the FOA wants registries to be "multipurpose"?
The FOA encourages registry infrastructures that can support multiple high-value uses rather than a single narrow function, such as supporting postmarket surveillance while also enabling device tracking and additional secondary uses.
How does the FOA connect registries to Unique Device Identifiers (UDI)?
The FOA highlights registry systems that can support device tracking via UDI, pointing to registries that capture device identifiers in a consistent, standardized way and use those identifiers to connect device exposure to patient outcomes over time.
Besides postmarket surveillance, what additional uses of registry infrastructure does the FOA mention?
The FOA highlights uses such as prospective embedded studies (conducted within routine care settings using registry infrastructure), quality improvement initiatives, and other secondary uses intended to increase the return on investment for registry creation and maintenance.
Does the FOA support collaboration or consortia?
Yes. A major goal is to support the development of registries and consortia in key medical device areas, including collaborative groups that can operate at scale.
Is the program limited to the United States?
No. The FOA suggests interest in broadening U.S. and international postmarket surveillance and states that non-U.S. entities (foreign institutions) are eligible to apply. Foreign components of U.S. organizations are also allowed, consistent with HHS grants policy.
What is the CFDA number associated with this program?
The opportunity is associated with CFDA 93.103 (Food and Drug Administration Research).
What activity category is this grant listed under?
It is described as a discretionary grant program under the Consumer Protection and Health activity category.
How many awards did the FDA expect to make?
The FDA expected to make two awards under this opportunity.
What was the estimated total funding amount?
The estimated total funding amount listed is $300,000.
What was the maximum award amount per award (award ceiling)?
The award ceiling is $150,000.
Was cost sharing or matching required?
No cost sharing or matching requirement is stated, so applicants were not required to provide non-federal matching funds as a condition of the award.
When was the funding opportunity posted and created?
It was posted on April 19, 2013, and created on May 29, 2013.
What were the application due dates mentioned?
The FOA used multiple receipt dates. The first application due date was in 2013, and subsequent due dates occurred annually on April 30 in 2014, 2015, 2016, and 2017.
What time were applications due on the listed due dates?
Submissions were due by 11:59 PM Eastern Time.
Is this funding opportunity still open?
No. The current closing date shown is April 30, 2017, and the archive date is May 30, 2017, meaning the opportunity is closed and archived.
If it is closed, why might it still be useful?
Even though it is archived, it can still be useful as a reference for the kinds of registry-based surveillance capabilities and methodological priorities the FDA has emphasized for improving medical device postmarket surveillance.
Who was eligible to apply?
Eligibility is broad and includes many U.S. entity types, including state and local governments, public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits), small businesses and other for-profit organizations (with certain limitations noted), independent school districts, public housing authorities, special district governments, and tribal governments and organizations. Non-U.S. entities (foreign institutions) were also eligible, and foreign components of U.S. organizations were allowed consistent with HHS grants policy.
What kinds of capabilities would a competitive applicant likely need?
Based on the FOA description, competitive projects would typically involve building or enhancing registry systems, demonstrating robust governance and data quality practices, and presenting credible plans for data linkage and UDI capture where relevant, operating at the intersection of clinical practice, data infrastructure, epidemiology, and device regulation.
Does the FOA suggest any preferred collaboration models?
It implicitly favors collaborations among health systems, professional societies, academic research groups, and potentially industry or international partners, with the understanding that conflicts of interest and data integrity should be properly managed.
Where could applicants find the full announcement?
The full announcement was available through the NIH Guide for Grants and Contracts under PAR 13 202.
Who was the listed grants management contact?
The listed grants management contact was Lisa Ko, Grants Management Specialist, reachable at lisa.ko@fda.hhs.gov.
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