Opportunity Information: Apply for RFA RM 10 006
Apply for RFA RM 10 006
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Advancing Regulatory Science through Novel Research and Science Based Technologies (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310 Trans NIH Research Support.
- This funding opportunity was created on Feb 24, 2010 and posted on Feb 24, 2010.
- Applicants must submit their applications by Apr 27, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $6,750,000.00 to eligible and selected applicants.
- Eligible applicants include: Small businesses For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Public housing authorities/Indian housing authorities Special district governments Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Independent school districts State governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
Advancing Regulatory Science through Novel Research and Science Based Technologies (U01) is a National Institutes of Health (NIH) funding opportunity designed to push regulatory science forward by supporting research that tests and applies new technologies and modern scientific approaches to the development and regulatory review of medical products. The focus is broad across the medical product spectrum, including drugs, biologics, and medical devices, with the central idea being that better science and better tools lead to better regulatory decisions and, ultimately, safer and more effective products reaching patients sooner and with greater confidence.
The purpose of the program is to close important knowledge gaps in regulatory science by encouraging projects that create, improve, or validate tools, methods, standards, and other forms of applied science that regulators and developers can use throughout the entire product life cycle. That life cycle emphasis matters because it includes everything from early development and testing through manufacturing, quality control, and post-market considerations. The FOA highlights needs such as improving how safety, quality, effectiveness, and manufacturing performance are evaluated, and it frames this work as especially valuable when it can be strategically coordinated between NIH and the Food and Drug Administration (FDA). In practice, that means applicants are expected to propose work that does not just generate academic insight, but also produces evidence and approaches that can realistically inform regulatory review and oversight.
A key theme in the announcement is the incorporation of cutting-edge science and evidence-based knowledge into regulatory decision-making. The FOA positions regulatory science as a bridge between biomedical discovery and real-world public health impact, aiming to accelerate translation so that advances in prevention, diagnosis, and treatment are supported by stronger, more modern evaluation frameworks. Rather than treating regulation as a downstream administrative step, the program treats regulatory science as an active research domain where innovation can directly improve the reliability and efficiency of product evaluation.
The mechanism of support is a Cooperative Agreement under the NIH U01 activity code. A U01 is different from a standard research project grant because it typically involves substantial scientific or programmatic involvement from the funding agency during the project. In other words, funded teams should expect collaboration, coordination, and ongoing engagement with NIH (and, by extension in this initiative, alignment with FDA regulatory science priorities), rather than operating in a completely hands-off funding environment.
Funding for the opportunity was estimated at approximately $6.75 million in total costs across fiscal years 2010 through 2012, contingent on the submission of scientifically strong applications. Of that amount, $750,000 was expected to come from the FDA and $6 million from the NIH Common Fund. The announcement anticipated making two to three awards, with flexibility to make more depending on the budgets and scopes of the selected applications.
Eligibility is broad and intentionally inclusive, covering small businesses, other for-profit organizations, nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities), private and public institutions of higher education, and a wide range of governmental and quasi-governmental entities. This includes state governments, county and city governments, special district governments, independent school districts, and U.S. territories or possessions. It also explicitly includes several institution types and communities often named in federal eligibility language, such as Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and tribal governments and tribal organizations (with distinctions for federally recognized status). The practical takeaway is that NIH was aiming to attract strong, diverse applicants across academia, industry, and public-sector organizations, as long as they could credibly execute research that advances regulatory science tools and approaches.
Administratively, the opportunity is identified as Funding Opportunity Number RFA-RM-10-006, categorized as a discretionary cooperative agreement within the health funding activity area (CFDA 93.310, Trans-NIH Research Support). It did not require cost sharing or matching. The FOA was posted on February 24, 2010, with an application closing date of April 27, 2010, and it was later archived on May 28, 2010. For full details, NIH directed applicants to the full announcement page and provided NIH Office of Extramural Research (OER) webmaster contact information for access or linking issues.
Frequently Asked Questions (FAQs)
What is the "Advancing Regulatory Science through Novel Research and Science Based Technologies (U01)" opportunity?
It is a National Institutes of Health (NIH) funding opportunity designed to advance regulatory science by supporting research that tests and applies new technologies and modern scientific approaches to the development and regulatory review of medical products.
What is the main goal of this funding opportunity?
The main goal is to close important knowledge gaps in regulatory science by encouraging projects that create, improve, or validate tools, methods, standards, and other applied approaches that regulators and developers can use across the medical product life cycle.
What types of medical products are included in the scope?
The scope is broad and spans the medical product spectrum, including drugs, biologics, and medical devices.
What does the FOA mean by "regulatory science" in this context?
In this announcement, regulatory science is treated as an active research domain that bridges biomedical discovery and public health impact by strengthening the scientific tools and evidence base used in regulatory decision-making. The emphasis is on better science and better tools leading to better regulatory decisions and safer, more effective products reaching patients sooner and with greater confidence.
What kinds of projects does the program aim to support?
The program emphasizes applied projects that produce practical outputs, such as tools, methods, standards, and validated approaches that can realistically inform regulatory review and oversight, rather than projects that only generate academic insight.
What parts of the medical product life cycle can proposed projects address?
Projects can address the entire product life cycle, including early development and testing, manufacturing, quality control, and post-market considerations.
What specific needs or evaluation areas are highlighted?
The FOA highlights needs such as improving how safety, quality, effectiveness, and manufacturing performance are evaluated.
How is this opportunity connected to the Food and Drug Administration (FDA)?
The FOA describes work as especially valuable when it can be strategically coordinated between NIH and the FDA, and it notes that applicants should expect alignment with FDA regulatory science priorities as part of the overall initiative.
What funding mechanism is used for this program?
The mechanism is a Cooperative Agreement under the NIH U01 activity code.
How is a U01 cooperative agreement different from a standard research project grant?
A U01 typically involves substantial scientific or programmatic involvement from the funding agency during the project. Funded teams should expect collaboration, coordination, and ongoing engagement with NIH (and alignment with FDA regulatory science priorities), rather than a fully hands-off funding arrangement.
How much funding was expected to be available?
Total funding was estimated at approximately $6.75 million in total costs across fiscal years 2010 through 2012, contingent on the submission of scientifically strong applications.
How was the funding expected to be split between NIH and FDA?
Of the estimated total, $750,000 was expected to come from the FDA and $6 million from the NIH Common Fund.
How many awards were anticipated?
The announcement anticipated making two to three awards, with flexibility to make more depending on the budgets and scopes of selected applications.
Is eligibility limited to universities and nonprofits?
No. Eligibility is broad and includes small businesses, other for-profit organizations, nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities), private and public institutions of higher education, and various governmental and quasi-governmental entities.
What government entities are eligible to apply?
Eligible entities include state governments, county and city governments, special district governments, independent school districts, and U.S. territories or possessions.
Are minority-serving institutions and tribal entities included in the eligibility language?
Yes. The eligibility language explicitly includes institution types and communities commonly named in federal eligibility descriptions, including Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, tribal governments (with distinctions for federally recognized status), and tribal organizations.
Is cost sharing or matching required?
No. The FOA did not require cost sharing or matching.
What is the Funding Opportunity Number?
The Funding Opportunity Number is RFA-RM-10-006.
What is the CFDA number and program area listed?
The opportunity is categorized under CFDA 93.310, Trans-NIH Research Support.
When was the FOA posted, and what was the application closing date?
The FOA was posted on February 24, 2010, and the application closing date was April 27, 2010.
Is this funding opportunity still active?
No. The FOA was later archived on May 28, 2010.
Who was listed as the contact for access or linking issues related to the announcement?
NIH directed applicants to the full announcement page and provided NIH Office of Extramural Research (OER) webmaster contact information for access or linking issues.
What type of federal award category was it listed under?
It was categorized as a discretionary cooperative agreement within the health funding activity area.
What is the overall emphasis of the FOA regarding scientific approach?
The FOA emphasizes incorporating cutting-edge science and evidence-based knowledge into regulatory decision-making, with the aim of accelerating translation so that advances in prevention, diagnosis, and treatment are supported by stronger, more modern evaluation frameworks.
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