Limited Competition: Molecular Transducers of Physical Activity Consortium Coordinating Center (U24 Clinical Trial Not Allowed) | RFA RM 23 011

FAQs: NIH MoTrPAC Consortium Coordinating Center (CCC) - RFA-RM-23-011 (U24)

1) What is this funding opportunity?

This is a National Institutes of Health (NIH) limited competition announcement soliciting applications to support a Consortium Coordinating Center (CCC) for the Molecular Transducers of Physical Activity Consortium (MoTrPAC). The notice of funding opportunity (NOFO) is RFA-RM-23-011.

2) What is the purpose of the MoTrPAC Consortium Coordinating Center (CCC)?

The CCC is intended to serve as the operational backbone of MoTrPAC. Its role is to coordinate consortium components so multi-site activities run consistently and efficiently, monitor implementation of the uniform protocol across sites, and coordinate the collection, management, and distribution of MoTrPAC data and biological samples. The CCC is also expected to help ensure MoTrPAC outputs become a lasting, well-documented research resource for future use.

3) What funding mechanism is being used?

The opportunity uses the cooperative agreement mechanism (U24). This indicates the awardee will work in close partnership with NIH staff and the broader MoTrPAC program, with substantial NIH involvement in coordinating priorities, oversight, and consortium-level decision-making.

4) What does it mean that this is a cooperative agreement (U24) rather than a typical grant?

Under a U24 cooperative agreement, the funded coordinating center is expected to operate collaboratively with NIH and the consortium. The project is not described as a fully independent, investigator-initiated effort; instead, it is designed to support and coordinate the existing consortium framework and activities.

5) Is this a limited competition? Who is eligible to apply?

Yes. Eligibility is tightly restricted. Only current MoTrPAC clinical coordinating center awardees are eligible to apply, which limits applications to organizations already holding the relevant MoTrPAC coordinating center awards.

6) The listing mentions small businesses. Can a small business apply?

The source listing references "Small businesses" as eligible applicants, but the decisive eligibility language provided for this NOFO is that only current MoTrPAC clinical coordinating center awardees may apply. Based on the information provided, an organization would need to already be a current MoTrPAC clinical coordinating center awardee to be responsive, regardless of business type.

7) Are foreign institutions eligible to apply?

No. Non-U.S. (foreign) institutions cannot apply under this opportunity.

8) Can a U.S. organization include a foreign component or non-domestic component?

No. Non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed. Participation must be fully domestic under NIH definitions, with no foreign components.

9) What is the activity area and CFDA number?

The activity area is health, and the CFDA listing provided is 93.310.

10) When was this NOFO created and what was the application due date?

The announcement was created on March 22, 2023. The original application due date was May 15, 2023.

11) Are clinical trials allowed under this opportunity?

No. The NOFO is labeled "Clinical Trial Not Allowed." Applicants should not propose a new clinical trial under this award.

12) If clinical trials are not allowed, what work is the CCC expected to support?

The CCC is meant to coordinate and support the consortium's existing, IRB-approved, protocol-driven work. The center is expected to operate within MoTrPAC's established uniform protocol rather than introducing a separate protocol.

13) What does "uniform IRB-approved protocol" imply for the CCC's scope of work?

It implies MoTrPAC already operates under an established consortium-wide protocol that has IRB approval. The CCC is expected to work within that existing framework, focusing on consistent implementation across sites and coordination functions rather than creating a new protocol.

14) What are the CCC's responsibilities related to protocol implementation?

A major responsibility is monitoring implementation of the study protocol across participating sites. This includes tracking whether sites are following the uniform protocol and maintaining alignment with required procedures and timelines across the consortium.

15) What are the CCC's responsibilities related to data and biospecimens?

The CCC is responsible for coordinating the collection, management, and distribution of data and biological samples generated through MoTrPAC studies. This typically involves establishing and maintaining standardized workflows for data intake, quality control, harmonization, secure storage, access governance, and fulfillment processes for distribution to approved users.

16) What does "distribution to approved users" mean in this context?

Based on the description provided, the CCC is expected to manage governed processes that control access and fulfillment for MoTrPAC data and biospecimens, ensuring distribution occurs through an access governance approach and only to users who are approved under the consortium's processes.

17) What is meant by creating a "lasting research resource"?

The CCC is expected to contribute to the creation of durable MoTrPAC outputs by ensuring they are curated, well-documented, and usable by future researchers beyond the original study teams, consistent with NIH expectations for data sharing, stewardship, and long-term value.

18) Does the CCC analyze data from clinical trial-like activities even though no new trial can be proposed?

Yes. The description indicates that while the U24 does not allow proposing a new clinical trial, the CCC will work with data arising from clinical trial-like activities within MoTrPAC, and NIH sets expectations that analyses, monitoring, and reporting practices align with established oversight standards.

19) What is the role of the Data and Safety Monitoring Board (DSMB) in this NOFO?

The announcement emphasizes that research approaches should align with guidance from the consortium's Data and Safety Monitoring Board (DSMB) for the analysis of clinical trial data. The CCC is expected to follow DSMB direction and oversight expectations when working with MoTrPAC clinical trial data.

20) How closely will NIH be involved in the work of the CCC?

The cooperative agreement structure indicates substantial NIH involvement. NIH expects to be engaged in coordinating priorities, oversight, and consortium-level decision-making as the coordinating center carries out its responsibilities.

21) What is the main outcome NIH appears to be seeking with this award?

Based on the description, NIH aims to sustain and strengthen MoTrPAC by funding a central coordinating entity that keeps the consortium aligned on protocol execution, ensures high-quality and consistent data and biospecimen handling across sites, and supports the creation of a durable, well-governed research resource for broader future scientific use.