Funding News Edition: December 01, 2021 See more articles in this edition
Chances are that in your search for funding opportunity announcements (FOAs), you’ve come across those with activity codes that are familiar—e.g., R01, R03, and R21—and perhaps not so familiar like R21/R33 and R61/R33. Those two are phased (or “biphasic”) awards, and since they might not be as well known, 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)
They 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 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, which means researchers can apply only to targeted biphasic FOAs, e.g., request for applications. As always, it’s important to carefully follow the guidance and requirements of a chosen FOA.
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 grantees who then 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 will evaluate the grantee’s research progress to determine if his or her project has met the pre-determined transition milestones and other requisites that would allow the grantee to continue to the R33 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 the grantee's receiving additional funding to continue work on his or her project. In some instances, Phase II award amounts can be substantially more than the grant amount awarded in Phase I.
But transitioning to Phase II is not easy. In fact, under some FOAs, only half of the grantees 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 FOA.
How Are the Milestones Set?
Parameters for setting phased award milestones are provided in the FOA. Applicants use the parameters listed in the FOA to propose reasonable and measurable milestones that they’d consider 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.
Next, peer reviewers assess the applicant’s grant application, paying special attention to the proposed milestones. The reviewers consider the quality, rigor, and suitability of the milestones and capture their opinions and recommendations in a summary statement that is 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, program staff will also work with the applicant to negotiate changes to the proposed milestones before funding.
Once program staff and the applicant come to an agreement, the authorized organization representative submits the final approved transition milestones to NIAID, which are then referenced in the Notice of Award, and Phase I funding is awarded after all the usual requirements for making an award are satisfied. The applicant (now a “grantee”) can then begin work on Phase I of his or her 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 grantees who receive awards for Phase I will be approved to transition to Phase II. That said, all of the grantees that were issued an award for Phase I of a project are evaluated, sometimes simultaneously as a group, at the end of the first phase (Phase I can be one, two, or three years).
A panel of NIH program staff is convened to evaluate and rank the “Phase II Transition Packages” of the grantees. External consultants may also participate. In addition to assessing whether each grantee has met the milestones as originally outlined, other determining factors are also weighed heavily in this review; for instance, whether or not the grantee’s project still fits within the scientific priorities of the program division and whether there is sufficient funding available.
All of the above factors and more are considered when evaluating grantee transition packages. At the conclusion of the panel evaluation, promising grantees may receive additional funding for Phase II of their projects. Grantees who 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 might instead support a new research grant application.
Additionally, note that grantees 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 grantee’s project has been successful and shows promise beyond “proof of principle,” the grantee would then be poised to apply to subsequent FOAs (e.g., R01s, Small Business Innovative Research grants) for additional funding.
For specific questions about your biphasic award, contact the program officer or the grants management specialist assigned to your grant.