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Provides avenues to advance the methodological sciences that support clinical research within and across the NIAMS’ portfolio of diseases.

These FAQs apply to the following funding opportunity:
                        - Core Centers for Clinical Research (CCCR) (P30 Clinical Trial Not Allowed):  RFA-AR-24-003

## Core Design

### Is it a requirement for the Methodology Core to charge for core services? Do I need to charge user fees for the services and resources offered by the Resource Cores?

Typically, P30s do charge fees for core services both within and outside the institution. It is expected that the Methodologic and/or Resource Core(s) will recover at least a portion of the cost of providing services or other resources in the form of user fees that are charged to the funds of the users. The Administrative Core component, with the assistance of the External Advisory Committee, should “describe how these Core(s) will set user fees, taking into account applicable Federal cost principles as discussed in NOT-OD-13-053.” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-053.html).

### Can I include Resource Cores and core users outside the grantee organization?

Yes.

### Can my P30 application focus on a single disease?

Yes.

### Can genetic or biochemical biomarkers be generated as an activity of a CCCR?

This funding opportunity does not allow support of core centers that genetic data except for when such data are being used for patient phenotyping. 

### Can I include large equipment in my application budget?

This grant mechanism is not intended for acquisition of high-cost equipment. Equipment purchases in excess of $25,000 for any year of the grant would require special justification. Under unusual circumstances, where costly items of equipment are requested, the application must document available equipment within the institution and provide clear justification in terms of core service to be provided by the CCCR. Costly items of equipment should be funded through other sources.

### Would extending/expanding an existing longitudinal cohort fall into the type of core resource the CCCR budget could support?

That should be fine.  Keep in mind, the goal of the CCCR is to leverage existing resources to stimulate clinical research for clinical care.

### How do I handle Human Subjects and Vertebrate Animals in my application?

If no work is done in the Core that goes beyond approved protocols of other projects in the research community OR there is no human or animal activity involved, answer NO to human and animal involvement.  If a Core involves stand-alone human and/or animal activity, you must answer YES to human and/or animal involvement and the required sections must be completed. Any Pilot and Feasibility project that includes human subjects or vertebrate animals will need to be addressed by the NIAMS prior to funding.

### Should I include names of proposed Advisory Committee members?

No. Describe the expected composition of the Advisory Committee (number of members, types of expertise, etc.), but do NOT name the members of the committee who are not from the Center Institution in the application so as not to limit the pool of potential reviewers.

### What is envisioned for interactions of the Core Research Centers within and external to the institution?

While research within the mission of NIAMS may be carried out in separate departments and even schools, the goals of Core Resource Centers is to provide services and resources to serve institutional, local and national clinical research efforts.

### Does the research community need to be funded by NIAMS?

Not necessarily. However, the proposed Center should be serving a research community that will use Center resources for research within the NIAMS mission.

### Will there be an attempt to split the review based on diseases?

All of the applications are reviewed in one meeting.  The meeting will cover all research areas within the NIAMS mission and relevant to the applications received.  The results from the peer review will be assessed and evaluated by the NIAMS leadership.

## Previous Cores

### Does this funding opportunity allow for renewal application?

Yes.

### I have previously applied for a NIAMS CCCR. Can I re-submit the unsuccessful application as an A1?

No, resubmissions are not allowed. However, you may submit a New Application that does not refer to the previous application or review of the previous application.

### Is it permissible to apply for this if you already have a P30?

Yes, it is permissible to apply to this funding opportunity even if you already have an existing P30. Keep in mind this funding opportunity encourages leveraging existing resources.  There should be no overlap between the two applications, but synergy is encouraged.

### Can I include a progress report if I have/had a NIAMS CCCR?

If the application is a Renewal Application, all applicants must provide a progress report. The progress report must provide information for the impact of the previous center on the institution(s) and research community.

## PI

### If the PI of a core within a CCCR is a new investigator, will the person lose new investigator status if the CCCR is awarded? 

According to the NIH early stage investigator (ESI) policy, if the lead of a project or core in a multi-component application is a new investigator, but not the PI/PD for the overall application, the individual will retain ESI status when the award is made.

### Can a foreign investigator be the PI of a core within a CCCR application?  

Yes, but the need for the foreign component must be well justified.

### Are multi-PI applications accepted?

Yes, but NIAMS strongly discourages multiple PI applications for the CCCR P30. However, if there are multi PIs, one should be listed as Director and one as Associate Director and the decision-making process should be well described.

## P&F

### What is allowable for the optional Pilot and Feasibility projects if providing this opportunity is part of the Administrative Core?

The Administrative Core can offer opportunities for CCCR funded Pilot and Feasibility projects in years 2, 3, and 4 of the funded grants as a component of the CCCR enrichment program. A CCCR can fund up to 2 P&F projects/year with budgets between $20,000 and $50,000/year/project. If P&F projects are included as part of the enrichment plan, funds up to $100,000/year can designated in the budget of the Administrative Core. The P&F projects may be funded for 1, 2, or 3 years in length, depending on the year funded and the nature of the research.

### If I choose to have a Pilot and Feasibility Program, can I include specific projects within the application?

No. Descriptions of projects or individuals named for support should NOT be included in the application. However, plans for soliciting, reviewing, selecting, managing and reporting on the results of projects during the tenure of the Center should be included in the application.

### The funding opportunity states " Up to two Pilot and Feasibility Projects per year can be supported beginning in year two of the CCCR funding. Pilot and Feasibility Projects may be 1-3 years in length." If a Pilot and Feasibility Program is proposed, is it required that a solicitation is done every year?  

No. A CCCR could solicit P&Fs as few or as many times as desired, but support will be provided only for a maximum of two new or continuing P&F projects per year, with no single P&F being more than three years.

### If a Pilot and Feasibility Program is proposed, do solicitation and review of projects need to occur during a certain time of year? 

Solicitation and review can occur at any time, however Pilot and Feasibility Projects that will be supported in a given project year must be submitted to NIAMS for approval in conjunction with the previous year’s Research Performance Progress Report (RPPR).  It is recommended that grantees time their proposed plans for soliciting, review, and selection to align with this requirement.

### Can a foreign investigator be awarded a Pilot and Feasibility award? 

Yes, foreign components are allowed as part of the CCCR P30, however, the need for the foreign component would need to be well justified.

## Sustainability Plan

### Is a sustainability plan required for a new or renewal CCCR application?  

It is required for both new and renewal applications.

### Do I need to provide evidence that my CCCR is sustainable at the time of the application?   

No, the applicant should describe steps that will occur over the course of the award that will increase the likelihood that the center can be sustained in some form at the conclusion of NIAMS support.

May 2023

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