An official website of the United States government
          Here’s how you know
        Here’s how you know**Official websites use .gov**A
              **.gov** website belongs to an official government
              organization in the United States.
        **Secure .gov websites use HTTPS**A
              **lock** (
              Locked padlock icon) or **https://** means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.
 Top Utility Nav
        
        
        Asian-Language Resources
        
        Portal en español


Site search Mega Menu
  

        

        Home
                  Health Topics
                                      
    
  Health Topics

    Arthritis and Rheumatic Diseases
          
    Muscle and Bone Diseases
          
    Skin Diseases
          
    All Diseases and Conditions
          
    Publication Catalog
                  Grants & Funding
                                      
    
  Grants & Funding

    Current Funding Opportunities
          
    Supported Scientific Programs
          
    NIAMS-Supported Programs
          
    Applying for a Grant
          
    NIH Policies and Guidance
          
    Peer Review and Grants Administration Resources
          
    Types of Funding Mechanisms (Activity Codes)
                  Labs @ NIAMS
                                      
    
  Labs @ NIAMS

    NIAMS Labs and Core Facilities
          
    Research Faculty
          
    Research Areas
          
    NIAMS Scientific Advances
          
    Training and Career Development
                  Clinical Trials
                                      
    
  Clinical Trials
      
            For Principal Investigators

    Clinical Trial Policies, Guidelines, and Templates
          
    Conducting Clinical Trials
          
    Register with ClinicalTrials.gov

For Patients

What is a Clinical Trial?
	Clinical Trials at NIAMS
	Clinical Trials in the Spotlight
                  News & Events
                                      
    
  Newsroom

    All NIAMS News
          
    NIAMS Newsletters
          
    Meetings & Events
                  About NIAMS
                                      
    
  About NIAMS

    Director's Page
          
    NIAMS Organization
          
    Strategic Plan Fiscal Years 2020-2024
          
    Staff Directory
          
    NIAMS Budget
          
    Partnerships
          
    Contact NIAMS
                  Community Outreach
                                      
    
  Community Outreach

    Bone Health
          
    Joint Health
          
    Muscle, Tendon, and Ligament Health
          
    Skin Health
          
    Health Information For Kids And Young Adults
          
    Health Information For Older Adults/Seniors
          
    Printable Materials for Community Events
          
    Resources in Other Languages
          
    Annual Health Observances
          
    Social Media Resources Breadcrumb
    Home
          Grants & Funding: The NIAMS Extramural Program
          Applying for a Grant
          NIAMS Large Grant Policy for Applications








NIAMS Large Grant Policy for Applications


(Grants with Budgets of $500,000 or More in Any Grant Year) FacebookEmailPrintFacebookEmail     
    NIAMS Policy for Acceptance of Letters of Request (LORs) for Large Grants

*Grants with Budgets of $500,000 Direct Costs or More in any One Budget Period within a Competitive Segment*

NIH policy requires Letters of Request (LORs) for acceptance of grant applications that request $500,000 or more in direct costs (excluding consortium F&A costs) in any one-year budget period within a competitive segment. This policy is in place to help Institutes and Centers with budgetary planning. This procedure requires use of the NIH Prior Approval Module in the eRA Commons, which is the first step in the process of applying for support.

Applicants are required to seek agreement to accept assignment from Institute/Center staff at least 6 weeks prior to the receipt date of the application. For clinical trials with proposed budgets of $500,000 or more for any one year, NIAMS policy states that applicants should request the agreement at least 10 weeks in advance.

The NIAMS will consider acceptance of LORs for all three grant cycles. All applicants interested in submitting an application with $500,000 or more in direct costs for any year should contact the appropriate NIAMS Program Director well in advance of submitting the application and the formal LOR.

This policy applies to every investigator-initiated new, resubmission (amended), renewal (competing continuation), and revision (competing supplement) application.
	The submission cycle requested by the applicant in the LOR does not obligate the NIAMS to accept an application for that cycle. NIAMS staff may determine that the application should be submitted for a different receipt date, and should this be the case, it will be communicated to the applicant in the NIAMS decision letter.Although applicants can ask for up to $499,999 without prior approval, they should contact the Program Officer if the anticipated request comes anywhere close to that level for the following reasons:

A future year may exceed $500,000.
	The system may round up dollar figures which could cause the budget to go over $500,000.
	The Institute may not have funds available for applications close to $500,000. NIAMS funds only a small number of large grants each year because they strain the budget and may necessitate reducing the total number of grants that can be awarded.EXCEPTIONS

This policy does not apply to applications submitted in response to Requests for Applications (RFAs) nor to applications submitted in response to the Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) Solicitations.

PROCEDURES

The Principal Investigator (PI) initiates the process by sending a request to the Program Officer (PO) listed in the Funding Opportunity Announcement (FOA) under Scientific/Research Contacts; the PO can advise the PI on the feasibility of successfully competing for an award.  NIAMS will then initiate the request electronically in the eRA Commons, after which the PI will receive an invitation to submit the required material through the Prior Approval Module. Please consult the eRA Commons User Guide (Prior Approval) for additional information about the Prior Approval Module.

WHAT TO INCLUDE IN THE LOR:

The intended application submission date.
	A descriptive title of the proposed research.
	Name, institutional affiliation, email address, and telephone number of the Principal Investigator.
	Names of all key personnel and participating institutions.
	A description of the proposed research or training program (one page or less).
	For clinical studies, include a brief description of the plans for considering gender, minority status and inclusion across the lifespan in the enrollment.
	A table that details the requested budget—include major budget categories (key/senior and other personnel, equipment, travel, trainee support, other direct costs), F&A (indirect costs), and total costs for each year of the requested application.
	A brief narrative justification for each budget category.Investigators who are considering applying for a Clinical Trial with a budget of $500,000 or more in direct costs in any year should also include the following:

Any refinements or changes in the Principal Investigator(s), rationale, objectives, protocol, study sites, and industry partners for the proposed trial, from that outlined in the R34/U34 application (if applicable).
	A table that details the requested budget—include major budget categories (key/senior and other personnel, equipment, travel, trainee support, other direct costs), F&A (indirect costs), and total costs for each year of the requested application.
	A separate page with the title of the proposed research and a one-page synopsis of the likely impact of the proposed study on disease prevention, diagnosis, or treatment.
	A separate document that summarizes each of the planning Milestones and provides a status of each task. Any tasks that remain to be completed must be detailed and justified before the trial can open for recruitment. Please use the Clinical Trial Planning Milestone Checklistto submit this information.All LORs should address:

The relevance of the proposed research to the NIAMS mission.
	Why the information gained through this research will provide a valuable addition to the existing knowledge base.CRITERIA FOR ACCEPTANCE

The following general criteria will factor into the consideration of all LORs subject to this policy:

The proposed research or training program is relevant to the NIAMS mission.
	The results of the proposed research or training program will provide a valuable addition to the existing knowledge base or will address needs in the research workforce.
	The proposed research or training program complements ongoing program activities of the NIAMS and is likely to have a positive impact on program balance.
	For all proposed research involving human subjects, the outcome is likely to have public health applicability.
	The annual costs for each year of support for the proposed research are reasonable to complete the proposed work.
	For clinical research, study population plans comply with the NIH Policy on Inclusion of Women and Minorities as Subjects in Clinical Research and the NIH Policy on Inclusion Across the Lifespan.
	The NIAMS budget has sufficient funds to support the project or training program, taking into consideration other financial obligations.ADDITIONAL GUIDANCE

The Institute recognizes that a request will often be preceded by informal discussions with NIAMS scientific staff regarding the proposed research; however, no official action will be taken until a formal request, in the form of the complete LOR described above, is received and reviewed by the Institute.

Following NIAMS review and a final decision, a notification of the decision will be provided in writing. If the LOR is approved, this notification will include the approved receipt date, the Council date, and the following statement: “Any application submitted over the LOR approved budget will be withdrawn prior to peer review.” NOTE: We will withdraw applications that are submitted over the LOR-approved budget level.

Following peer review for technical/scientific merit and impact, and subsequent consideration by the NIAMS Advisory Council, funding decisions are made by Institute leadership on a case-by-case basis.  NOTE: NIAMS policy states that funding decisions on grants requesting $500,000 or more will be made on a case-by-case basis and that posted RPG paylines DO NOT APPLY to these applications.

If you have any questions about this policy, please contact the appropriate NIAMS Program Officer.  If you have questions about this policy as it relates to clinical trials, please contact NIAMSclinicaltrials@mail.nih.gov.


Last Updated: September 2021


Back to Top
 About NIAMS
                    Clinical Trials
                    Grants & Funding
                    Health Topics
                    Labs @ NIAMS
              News Room
                    NIAMS Multimedia Library
                    Disclaimer
                    FOIA
                    Contact us
              Privacy Statement
                    Accessibility
                    HHS Vulnerability Disclosure
                    Social Media Moderation Policy
                    NIAMS Archives
        Subscribe to Our E-Newsletters
            Click the button to see different options to sign up for newsletters.
            Click Here to Subscribe
          Follow us on
  
  About NIH
                  Accessibility Support
            FOIA requests
                  No FEAR Act data
            Office of the Inspector General
                  Performance reports
            Privacy Policy