Chances are that in your search for notices of funding opportunities (NOFOs), you’ve come across some familiar activity codes—e.g., R01, R03, and R21—and perhaps some not so familiar like R21/R33 and R61/R33. The latter two are phased (or “biphasic”) awards, and if they are not well known to you, you can get better acquainted here.
What Are Phased Awards?
Phased awards are a type of grant that consist of the following:
- Phase I for milestone-driven exploratory or feasibility studies (i.e., R21 or R61 period)
- Phase II for expanded development (i.e., R33 period)
- Phased cooperative agreements, e.g., the UG3/UH3 activity code used by Engineering and Preclinical Development of Biological Products that Eliminate HIV-Infected Cells (UG3/UH3, Clinical Trial Not Allowed)
These mechanisms are used to support high-risk research and development of promising and viable candidate products or strategies (e.g., drugs, vaccines). Thus, phased grant award mechanisms are often used for early-stage research and discovery, preclinical development of candidate products, and exploratory projects.
The benefit of phased awards is that they provide support for high-risk projects and a rapid pathway to additional funding for those projects able to meet the high-risk goals within established timelines.
Note that NIH does not have parent announcements for phased awards. That means researchers can apply only to targeted biphasic NOFOs (e.g., requests for applications). As always, it’s important to carefully follow the guidance and requirements of a chosen NOFO.
Be aware that the word “phase” has different meanings in other contexts, particularly for clinical trials and small business awards. Additionally, grant mechanisms like Pathway to Independence Awards (K99/R00) and Fast Track small business awards also use phasing, but do so to accomplish different outcomes than the research grants discussed throughout this article.
How Do Phased Awards Work?
Submitted applications contain plans for both phases, including milestones that the applicant believes will justify continued support in Phase II. Phased awards allow NIH to issue shorter period awards to a larger number of recipients who then have the opportunity to demonstrate that they can accomplish the high-risk portion of the project.
At the end of Phase I, the applicant submits a progress update to NIAID, and staff evaluate the recipient’s research progress to determine if their project has met the pre-determined transition milestones and other requisites that would allow the recipient to continue to the second phase of the award.
Continuing on to Phase II of the award is often referred to as “transitioning to Phase II.” And as you can probably guess, approval to transition to Phase II coincides with additional funding to continue work under a different activity code. In many instances, Phase II award amounts can be substantially more than Phase I amounts.
But transitioning to Phase II is not easy. In fact, under some NOFOs, only half of the recipients that receive a Phase I award meet the milestones and other requirements necessary to progress to Phase II. The estimated odds of transitioning are usually mentioned in the NOFO.
How Are the Milestones Set?
Parameters for setting phased award milestones are provided in each NOFO. Applicants use the parameters listed in the NOFO to propose reasonable and measurable milestones that would be indicative of Phase I success to justify additional funding for Phase II. Applicants submit their proposed transition milestones as part of their initial grant application. Most NOFOs for phased awards stipulate that if you fail to include milestones in your application, NIAID will deem it nonresponsive and not review it.
Next, peer reviewers assess the application, paying special attention to the proposed milestones. As usual, the scored review criteria are most important—significance, investigator(s), innovation, approach, and environment—while the milestones function as an additional review criterion that is not given a separate score. Reviewers consider the quality, rigor, and suitability of the milestones. Their opinions and recommendations are captured in a summary statement and provided to the applicant after review.
NIAID program staff also receive a copy of the summary statement, which they use to consider the reviewers’ recommendations, along with the programmatic objectives. If necessary, prior to issuing an award, program staff will also work with the applicant/recipient to negotiate changes to finalize the milestones.
Once program staff and the applicant come to an agreement, the recipient’s authorized organization representative submits the final approved transition milestones to NIAID, which are then referenced in the Notice of Award. Phase I funding is awarded after all the usual requirements for making an award are satisfied. The applicant (now a “recipient”) can then begin work on Phase I of the project.
Does Meeting Phase I Milestones Mean Automatic Approval to Transition to Phase II?
Not exactly. Here’s where the process can begin to get complicated.
As stated earlier, some phased awards may be constructed so that no more than half of the recipients who receive awards for Phase I will be approved to transition to Phase II. That said, typically all the recipients that were issued an award for Phase I of a project and submit a transition application are evaluated simultaneously as a group at the end of the first phase (e.g., after 2 years). The length of each phase is established in Section II. Award Information of the NOFO through which the phased award was made
A panel of NIH program staff is convened to evaluate and rank the “Phase II Transition Packages” of the recipients. External consultants may also participate. In addition to assessing whether each recipient has met the milestones as originally outlined, other determining factors are also weighed in this review; for instance, whether the recipient’s project fits within the scientific priorities of the program division and whether there is sufficient funding available.
Note that the Phase II Transition Package is distinct from the Research Performance Progress Report. Typically, the transition package is due 3 months before the end of Phase I, though the exact deadline will be established in the Phased Award Informational Letter. Phase II can begin only at the end of a Phase I budget year; Phase I will not be terminated early to fund Phase II.
All the above factors and more are considered when evaluating recipient transition packages. At the conclusion of the panel evaluation, the best ranked recipients may receive additional funding for Phase II of their projects. Recipients that do not transition to Phase II will have their Phase I awards closed, though some may elect to use a no-cost extension to continue working for up to 12 months using previously awarded Phase I funds (refer to our No-Cost Extension SOP). For those who do not transition to Phase II, preliminary data from Phase I could instead support a new research grant application.
Additionally, note that recipients who don't successfully transition to Phase II cannot file an appeal against the evaluation panel’s decision, which is final.
What Happens After Phase II Ends?
At the end of the Phase II project period, if a recipient’s project has been successful and shows promise beyond “proof of principle,” the recipient would then be poised to apply to a different NOFO (e.g., R01, Small Business Innovative Research grant) for additional funding.
Resources
To learn more about phased awards, see our Phased Award SOP. You may also want to check out the R21/R33 Sample Application and Summary Statement on our webpage Sample Applications & More.
For specific questions about your biphasic award, contact the program officer or grants management specialist assigned to your grant.