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Standard Operating Procedure Table of Contents

 

Purpose

To support a two-phased award in which transition to the second phase, which depends on several factors including the achievement of negotiated milestones, can take place without a break in funding.

Procedure

The R21/R33 Phased Innovation Award has two phases: 1) the R21 for milestone-driven exploratory or feasibility studies with a possible transition to 2) the R33 for expanded development.

Transition to the R33 depends on the applicant completing milestones (which were evaluated in peer review and negotiated with NIAID program staff before the R21 was awarded) as well as program priorities and the availability of funds.

NIAID accepts R21/R33 applications in response to a program announcement (PA) or request for applications (RFA) only.

Applicants

Use the following guidelines to prepare your application, accept your award, and prepare for the transition to an R33.

Preparing the Application

  • Prepare a single application (one face page, one Research Plan, etc.) that includes both the R21 and R33 phases.
  • If possible, provide preliminary data. Otherwise, give enough information to enable reviewers to assess the rationale of your hypothesis. 
  • Prepare a detailed budget for both the R21 and the R33, clearly indicating in the justification pages which phase applies in each fiscal year.
  • In the Research Plan, describe the following:
    • Specific Aims for both the R21 and R33 phases, indicating under which phase each aim belongs.
    • A labeled milestones section describing milestones to be achieved to qualify for the transition to the R33.

The R21/R33 Award

  • After initial peer review, the program officer may contact you to negotiate your R33 transition milestones, which will include recommendations from reviewers, NIAID staff, or possibly both. 
  • The initial R21 award will reflect the budget period for the first two years, although you can apply for the R33 phase at any time; see the next section. 
  • If your application is funded, do the following:
    • Read and keep for future reference the R21/R33 informational letter, which gives you detailed instructions on the R33 transition application and the deadline for applying without a break in funds. You will receive it shortly after getting the R21 award.

Transition to the R33

  • When you believe you have successfully accomplished your milestones, prepare an R33 transition application, which should include the following:
    • PHS 2590 Application Form, including detailed budget pages for current and future years.
    • Progress report, including a summary of the R21 Specific Aims and importance of the work accomplished.
    • A section called “Milestones,” describing the milestones and progress achieved in detail.
    • Revisions to address reviewers’ comments from the initial peer review if you feel that doing so would provide additional information about the R33 phase.
    • Any additional documentation requested by NIAID staff.
  • Follow these additional formatting guidelines:
    • Keep your application to approximately 10 pages (the narrative portion does not conform to standard PHS 2590 page limits). You may include additional materials, including photos, graphs, and unpublished manuscripts in an appendix.
    • Since we may need to print your application for the internal review, use a file format that enables us to print it.
  • Send your R33 transition application electronically to Phased Innovation Award Coordinator Ms. Devon Bumbray-Quarles at dbumbray@niaid.nih.gov.  If the document is too large for an email attachment, send the files on a CD to:

    Devon Bumbray-Quarles
    National Institute of Allergy and Infectious Diseases
    6700B Rockledge Drive, Room 2253
    Bethesda, Maryland  20892-7614

  • We will upload your R33 transition application to your electronic grant file and forward it to your program officer for review.   
  • You may submit an R33 transition application at any time during the R21 funding period for approval by your program officer. Keep in mind that an R33 can begin only at the end of an R21 budget year.
    • To avoid a funding break between the awards, submit an R33 transition application up to two months before the end of an R21 budget year.
    • If you have not successfully completed the R33 transition milestones by the end of the R21 funding period, you have the following choices:
      • Opt out of applying for the R33 transition by closing out your award at the end of the R21 phase. Read File Final Reports at Award End for more information.
      • Request a one-time no-cost extension through your institution for up to 12 months to continue the research so you can meet the milestones. You must submit a transition application within this timeframe.
    • Inform your program officer and grants management specialist of your decision.
  • NIAID will review your R33 transition application.
    • Your program officer may contact you for additional information if he or she cannot assess whether you have met your milestones.
    • We may recruit outside consultants for their scientific expertise to help assess whether you have met your milestones.
    • Everyone involved in this review will be held to NIH standards of confidentiality and conflict of interest.
  • Once NIAID program staff determine that you have met your milestones, they will assess the priority of the project and availability of funds in the NIAID budget. 
  • If approved, your award will make the transition to the R33. 
  • If it is not approved, your program officer and grants management specialist will notify you by email. NIAID will close out your award at the end of the R21 award period.

Program Officers, Scientific Review Officers, and Grants Management Specialists

For internal roles, see the Lock icon: This link will not work for public visitors.R21/R33 Phased Innovation Award Staff Roles SOP.

Contacts

Phased Innovation Award Coordinator, Ms. Devon Bumbray-Quarles at dbumbray@niaid.nih.gov

Applicants with questions should Contact Staff for Help.

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Lock icon: This link will not work for public visitors.R21/R33 Phased Innovation Award Staff Roles SOP

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