Frequently Asked Questions about the Serological Sciences Network RFAs

What is the difference between a U01 and a U54?

A U01 is a single discrete research project with direct costs of up to $500,000 per year. A U54 consists of two to three research projects, an administrative core, and up to two optional shared resource cores, with total direct costs of up to $1.5 million per year. Both mechanisms will be required to have a Resource Sharing Plan, abide by Cooperative Agreement terms and conditions, set aside 10% of their total direct costs for post-award collaborative activities, and participate in the SeroNet Steering Committee. They will also both be reviewed in a Special Emphasis Panel convened by NCI.

Are the direct cost limits per year or across the entire project period?

The U54 direct cost limit ($1.5 million) and U01 direct cost limit ($500,000) are per year.

This research is intended to inform assay development. Technology development is in scope for these RFAs. Groups that are particularly interested in developing novel assays and building testing capacity are encouraged to look at the Request for Proposals for the Capacity Building Centers (CBCs). The CBCs are expected to participate in serosurveillance research and will have opportunities to participate in other serological sciences research.

Are clinical trials appropriate for these RFAs?

Clinical trials related to treatment interventions are not appropriate. Clinical trial components for these RFAs are intended to support behavioral and healthcare delivery research.

How many institutes need to be included on the team for a U01 or U54 application?

The applicant team can be from the same institution; there is no minimum.

Are private companies allowed to apply?

Yes, private companies can apply for the U54 or U01 and must comply with the resource sharing requirements.

Are multiple applications from the same institution allowed?

Yes, but they must be scientifically distinct.

Can a research project from a U54 application also be submitted as a U01?

No, as stated in the RFA: "The NIH will not accept duplicate or highly overlapping applications under review at the same time."

What are the page limits for the application?

For the U01, the Research Strategy is limited to 6 pages. For the U54, the Overall component is limited to 12 pages; the Administrative Core is 3 pages; the Shared Resource Cores (optional, up to 2) are 3 pages per core; the Research Projects (2–3) are 6 pages per project. The Specific Aims page is not included in the page limits for the Research Strategy of each component.

No, the Resource Sharing Plan does not count toward the Research Strategy page limit. Use the PHS 398 Research Plan form.

What will be the relationship between the U54 Centers of Excellence and the Frederick National Laboratory for Cancer Research (FNL) Serology Lab?

Collaboration is encouraged across the Network. The FNL Serology Lab will develop qualified assay standards, generate novel reagents, and establish serum panels and will share assays, reagents, and standards with the other components of SeroNet. The FNL Serology Lab is not intended to be used as an experimental or testing core for the research projects.

Is there a minimum level of effort required for the investigators?

For U01s, as described in NOT-CA-20-047, a minimum of 1.8 calendar months/year is required from a single principal investigator (PI) and a minimum of 1.2 calendar months/year is required for each PI on a multi-PI application. Although a minimum level of effort is not provided for U54 investigators, applicants are encouraged to consider the guidance for P01s provided in NOT-CA-20-047.