Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (UM2) | RFA HL 17 031

FAQs: Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (UM2) (RFA HL 17 031)

1) What is this funding opportunity?

This is an NIH funding opportunity announcement (FOA) for competing revision applications under the UM2 Cooperative Agreement mechanism. It is designed to provide additional, competitively reviewed support to certain existing NIH UM2 awards so they can expand the approved scope or modify and extend an existing research protocol during an active budget period.

2) Is this FOA meant to fund brand-new standalone projects?

No. The FOA is not intended to start brand-new independent projects. It specifically supports competing revisions to certain already-funded UM2 cooperative agreement awards, adding a focused innovation-oriented clinical research component within the existing award structure.

3) Who is the intended applicant?

The practical eligible applicant is an investigator (or team) who already holds an active UM2 Program Project or Center with Complex Structure Cooperative Agreement award and is seeking to revise that existing award. While the FOA lists many eligible organization types, the key constraint is that the application must be a competing revision to an active UM2 award.

4) What does "competing revision application" mean in this context?

Based on the FOA description, a competing revision is a request for additional support that is competitively reviewed and that proposes to expand the currently approved scope of the active UM2 award or to modify and extend an existing research protocol, rather than proposing an unrelated new project.

5) What is the scientific focus of the supported work?

The scientific emphasis is on regenerative medicine approaches that use adult stem cells. Proposed additions are expected to meaningfully advance regenerative medicine development by addressing practical barriers to producing safe and effective therapies.

6) What kinds of problems is the FOA trying to solve?

The FOA prioritizes solutions to widely recognized bottlenecks that slow translation from laboratory research into real-world clinical use. In particular, it targets challenges that often arise as products move toward regulatory review and eventual patient access, such as manufacturing, product characterization, quality attributes, and indicators of safety and effectiveness.

7) Why is FDA mentioned as a participating partner?

The FOA was developed with participation from relevant NIH Institutes and Centers and the U.S. Food and Drug Administration (FDA). A major theme is regulatory relevance, meaning applications are encouraged to produce evidence, tools, or methods that can support or strengthen future regulatory submissions by improving how regenerative medicine products are developed, characterized, manufactured, and evaluated.

8) What does "regulatory relevance" mean for proposed revisions?

Within the FOA framing, regulatory relevance means the work should help reduce uncertainty and improve confidence in how adult stem cell-based products are made and how they perform, especially in ways that could inform future regulatory submissions. The emphasis is on practical outputs that strengthen the development and evaluation pathway.

9) What types of activities or outputs does the FOA encourage?

The FOA points applicants toward innovative, solutions-driven contributions such as improved tools, methods, and standards, and applied science that helps the field better understand and evaluate manufacturing processes, product quality attributes, and clinical or nonclinical indicators of safety and effectiveness.

10) Are purely descriptive projects a good fit?

The FOA indicates that supported projects are expected to be innovative and solutions-driven rather than purely descriptive. The intent is to improve the technical and scientific foundation used to assess regenerative medicine products with greater confidence.

11) What stage of work is this FOA aiming to support?

It is oriented toward clinically relevant regenerative medicine innovation within ongoing UM2-supported programs and centers, particularly work that helps translation toward clinical use and regulatory review by improving development, manufacturing, characterization, and evaluation.

12) What does the FOA mean by improving "reproducibility" and "interpretability"?

As described, the FOA aims to make regenerative medicine products more reproducible and interpretable across development stages by reducing uncertainty about manufacturing and performance. This includes improving how products are characterized, how quality attributes are understood, and how safety and effectiveness are evaluated.

13) What funding instrument is used for this opportunity?

This FOA uses the Cooperative Agreement funding instrument (UM2). NIH anticipates substantial programmatic involvement compared with a standard research project grant.

14) What does "substantial programmatic involvement" imply?

The FOA states that NIH anticipates substantial involvement under the cooperative agreement mechanism compared to a standard research grant, which generally means there is a closer level of NIH program engagement in the supported activities than under typical investigator-initiated grants (as framed by the FOA).

15) What organizations are listed as eligible applicants?

The FOA describes broad eligibility that includes government entities (state, county, city/township, special districts), public and private institutions of higher education, federally recognized tribal governments and certain tribal organizations, public housing authorities/Indian housing authorities, nonprofit organizations (including 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), small businesses, and other applicants as allowed under the announcement’s additional eligibility language.

16) If many organization types are eligible, why does eligibility still feel narrow?

Because the FOA is specifically for competing revisions to certain existing NIH UM2 cooperative agreement awards. In practice, to apply you must already have an active UM2 Program Project or Center with Complex Structure Cooperative Agreement award that can be revised.

17) What is the maximum award amount listed?

The listed award ceiling is $324,500.

18) How many awards did NIH anticipate making?

NIH anticipated making about six awards.

19) When was the opportunity posted and when did it close?

The FOA was posted on April 28, 2017, and the original closing date was June 26, 2017.

20) What is the purpose of associating the FOA with multiple CFDA numbers?

The FOA is associated with multiple CFDA numbers spanning several NIH programs, reflecting multi-institute participation and the cross-cutting nature of regenerative medicine development described in the opportunity summary.

21) What is the core objective of the FOA in plain terms?

It is a targeted, competitively reviewed infusion of additional support for existing UM2 centers and program projects to pursue clinically oriented, adult stem cell-based regenerative medicine innovations that directly address development and regulatory science bottlenecks in manufacturing, quality, safety, and effectiveness evaluation.

22) What kinds of barriers are highlighted as especially important?

The FOA highlights barriers that tend to slow translation into clinical use, especially those that become prominent as products move toward regulatory review and patient access. Emphasis areas include manufacturing processes, product characterization, understanding product quality attributes, and identifying clinical or nonclinical indicators of safety and effectiveness.

23) Does the FOA emphasize standards and methods development?

Yes. It explicitly points toward improved tools, methods, and standards, as well as applied science that strengthens the foundation for evaluating regenerative medicine products.

24) What is the relationship between the proposed revision and the existing UM2 award?

The revision is expected to expand the approved scope of the existing UM2 award or modify and extend an existing research protocol, rather than operating as an unrelated add-on. The FOA frames this as adding a focused, innovation-oriented clinical research component that strengthens regenerative medicine development within the ongoing UM2-supported program or center.