2009 CTSA Rollout:
Questions and Answers

Last updated July 14, 2009

Budget Guidelines

Q: If a CTSA application was unsuccessful, what can the applicant do?
A: An unsuccessful CTSA applicant may amend their application and resubmit it in response to RFA-RM-09-004. Applications are due by October 14, 2009. Amended applications must address the comments provided in the Summary Statement developed by the peer reviewers. Based on NIH policy (see NOT-OD-09-003 and NOT-OD-09-016), applicants may only submit one amended application. After submission of the original and an amended application, only a new application, with significantly different goals and methodologies, may be submitted.

Q: How do the FY 2009 CTSA awards increase the diversity and geographic distribution of the CTSA program?
A: Three of new CTSA awards are to institutions in states that did not previously have a CTSA award: Arkansas, Florida and South Carolina. Of the three, Arkansas and South Carolina are participants in NCRR's Institutional Development Award (IDeA) program, which fosters health-related research at institutions located in states in which the aggregate success rate for applications to NIH has historically been low.

Q: Why were there two cycles of review in FY 2009?
A: Because of the substantial time commitment to participate on a CTSA application review panel, NCRR decided to divide the review into two cycles in an effort to reduce the burden on the reviewers. Thus, for 2009, NCRR arranged two review cycles for the applications, and therefore announced grants at two separate times.

Q: Why did the first cycle only result in one CTSA award versus seven CTSA awards after the second cycle?
A: The number of applications submitted for the first review was substantially smaller than the number submitted for the second review. NCRR decided to fund only one of the applications from the first review, and carry over the few remaining applications to be considered with the applications from the second review.

Q: Were applicants disadvantaged by the two cycle review process?
A: No. NCRR monitors the review process closely to ensure that the same criteria, standards and rigor are applied to each review panel session. Applications from both cycles were considered before final funding decisions were made.

Q: Will NCRR be continuing with a two cycle per year review process?
A: The purpose of two review cycles per year was to alleviate the burden on the external reviewers who spend many hours - in addition to several days away from their home institutions - in reviewing complex CTSA grant applications. However, since the vast majority of applicants submitted their grant proposals for the second review cycle, NCRR determined that there is no benefit to the reviewers by holding two separate review cycles. Therefore, NCRR will return to one review cycle for FY 2010.

Q: Why are there only a total of eight new CTSAs awarded in FY 2009, when there were 12, 12 and 14 awarded in FY 2006, 2007 and 2008, respectively?
A: The number of CTSA awards depends on the size of each CTSA award and the funds available. Awards vary in size due to the consolidation of multiple programs at the applicant institution(s) into the CTSA program proposal.

Q: Why wasn't Recovery Act funding used to increase the number of CTSA awards in FY 2009?
A: The American Recovery and Reinvestment Act (also known as "Recovery Act" or "ARRA") funding is only available for obligation until September 30, 2010. Since CTSA awards are generally five-year commitments, the funding provided by ARRA would not be able to fully support CTSAs within this timeframe. However, ARRA funds may be used by existing CTSAs to supplement their existing activities. In addition, other NIH-supported investigators may apply for ARRA funds to facilitate their access to the resources provided by the CTSAs.

Q: Could NCRR delay funding of new CTSA sites until the ability of smaller and larger centers to collaborate in meeting the goals of the CTSA program has been evaluated?
A: The CTSA consortium provides resources that clinical and translational researchers have identified as urgently needed. By continuing to expand the consortium, researchers will have increased access to resources and expertise through national and regional collaborations. Newly funded CTSAs bring great energy and opportunities for additional collaborations and partnerships to the consortium. NCRR is working with external evaluators and advisors to carefully evaluate the national CTSA program.

Q: How do you envision the CTSA consortium functioning with variation in the size and scope of the CTSA institutions?
A: Since the inception of the CTSA program, NCRR envisioned and encouraged diversity in their size and scope. With a total funding level of $4 million per year, CTSAs are expected to leverage a diversity of resources from federal and nonfederal partners. The CTSA identity attracts additional collaborations and resources to accomplish their goals. Finally, through participation in consortium-wide activities, CTSAs will benefit from each others' expertise and best practices.

Q: Will the emphasis on pediatric research continue?
A: Yes. Under the NIH Multi-PI initiative, an institution may still propose a Pediatric PI with direct authority over a separate budget and infrastructure for pediatric clinical research.

Q: How will CTSAs provide clinical research support that was previously provided by GCRCs?
A: The CTSA program is providing substantially more funding for clinical research than was available under the GCRC program. The CTSA award allows the institution to continue activities that were conducted in the GCRC and add new activities.

Beyond Fiscal Year 2009

Q: The President's Budget Request for FY 2010 shows a decrease in funding for the CTSA program for that year. Will any new CTSA awards be made in FY 2010?
A: The decrease in funding for the CTSA program in FY 2010 is due to the decrease in support from the NIH Common Fund. The decrease in support was larger than the increase in funding for the CTSA program by the NCRR.

Q: How can NCRR fund new awards if there is an overall decrease in funding?
A: Funding for the CTSA program includes funding to the existing General Clinical Research Centers (GCRCs). As some of these centers are phased out, funding is freed up for additional CTSAs.

Q: What is the funding plan for 2011, given that the initial cohort will be seeking CTSA renewal funds, and there will be new applicants?
A: The initial 12 CTSAs from 2006 are eligible to re-compete; however, they must comply with the CTSA funding guidelines established in 2007. In addition, NCRR expects to fund new awards.

Q: Will the re-competing or renewal-seeking applicants be reviewed along with the new applicants?
A: There will be two separate announcements: one for those seeking renewal of funding, and one for new applicants. The renewal applications will be reviewed together as a group, and the new applications will be reviewed together as a group. The Draft Review Criteria for Competing Renewal Applications are posted on this site, and the current review criteria for new applications are available at RFA-RM-08-002.html#SectionV.

Q: Will CTSAs be allowed to hold unexpended funds and carry them over to future years?
A: Requests for carry forward of funds will continue to be handled in accordance with NIH and NCRR policy. NCRR funds several grant mechanisms, among which are the CTSA Us, Ks, and Ts, that do not have automatic carryover authority. CTSA grantees may continue to submit carryover requests which will be reviewed on a case by case basis taking into account the scientific justification, the plan for the use of funds, the scope of the activity proposed, as well as other factors as described in NCRR Review of Carryover Requests.

Q: Is NIH still on track to fund 60 CTSA sites? If so, what is the funding strategy to reach this goal?
A: To reach the critical mass necessary to transform clinical and translational research, NCRR projects that 60 CTSAs are needed throughout the United States. NCRR expects to fulfill the charge to transform clinical and translational research within the current overall budget for the program through a significant increase in the infrastructure support for clinical research that exceeds the $340 million allocated to pre-existing NIH clinical research resources (i.e., NCRR K12, M01, NIH K30 and Roadmap T32 and K12 programs). Diversity in the size, scope and geographic location of participating institutions will not only strengthen the CTSA consortium, it will enhance its national and regional collaborations. The optimal balance within the CTSA consortium will include a few large centers, with the majority being small- to medium-sized centers across the country. CTSAs have been able to attract funding outside of NIH support, both from within their institutions and from other, external sources.

Contact Information

Please contact your NCRR Grants Management Specialist or your Program Officer if you have questions regarding this information.

For general questions about the CTSA program, contact:

Anthony R. Hayward, M.D., Ph.D.
Director
Division of Clinical Research Resources
National Center for Research Resources
National Institutes of Health
One Democracy Plaza, Room 906
6701 Democracy Boulevard, MSC 4874
Bethesda, Maryland 20892-4874 (20817 for express mail)
Telephone: 301-435-0790
Fax: 301-480-3661
HaywardA@mail.nih.gov