When an agency awards a grant, it is formalizing its partnership with the recipient (grantee) to ensure compliance with federal laws, regulations and policies. This protects the integrity of the overall scientific endeavor. Timely and effective communication between a grantee and the NIH is critical throughout the pre-award process, award process and post-award process.
At this stage in the grants process, the roles and responsibilities of NIH participants are summarized as follows:
- Grants Management Officer (GMO): The GMO signs the Notice of Award (NoA) and is the NIH official who is responsible for the business management and other non-programmatic aspects of the award. GMOs ensure that the NIH and grantee staffs fulfill requirements of laws, regulations, and administrative policies.
- Grants Management Specialist (GMS): The GMS works with the GMO on the day-to-day management of the grant. The name and contact information of the GMS assigned to a particular grant appears on the NoA.
- Program Official (PO): The PO is responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. The PO’s responsibilities include, but are not limited to, developing research initiatives and research training programs to meet the Institute/Center’s (IC) mission; coordinating with Center for Scientific Review and IC Scientific Review Officers and working in partnership with grants management on post-award administration, including review of progress reports, participation in site visits, and other activities.
A summary of Grantee participants’ roles and responsibilities appears below:
- Authorized Organizational Representative (AOR): The AOR, also known as Signing Official (SO) in the eRA Commons, is the designated representative of the grantee organization in matters related to the award and administration of its NIH grants, including those that require NIH approval. In signing a grant application, this individual certifies that the applicant organization will comply with all applicable assurances and certifications referenced in the application. This individual’s signature further certifies that the applicant organization will be accountable both for the appropriate use of funds awarded and for the performance of the grant-supported project or activities resulting from the application.
- Project Director(s)/ Principal Investigator(s) (PD/PI): The PD/PIs are the individual(s) designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award. The applicant organization may designate multiple individuals as PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PI is responsible and accountable to the grantee organization, or as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of all required reports.
The PD/PIs are core members of the grantee team responsible for ensuring compliance with the financial and administrative aspects of the award. These individuals work closely within the grantee organization to create and maintain necessary documentation, such as technical and administrative reports, preparing justifications, appropriately acknowledging federal support of research findings in publications, announcements, news programs, and other media, and ensuring compliance with other federal and organizational requirements.
NIH encourages the PD/PIs to maintain contact with the NIH program officer with respect to the scientific aspects of the project and the grants management officer concerning the business and administrative aspects of the award.
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Pre-Award Process - Competing Applications
IC Preliminary Review
Following the peer review process, applications that an IC may fund are reviewed for a number of other considerations. These include alignment with NIH’s funding principles, review of the project budget, assessment of the applicant’s management systems, determination of applicant eligibility, and compliance with public policy requirements.
In anticipation of an award being made, the applicant may be asked to submit additional information, such as
Note: Such requests by NIH do not guarantee that an award will be made.
Collection of Just in Time (JIT) Information
After the priority scores are released, NIH sends an e-mail requesting Just-in-Time (JIT) information for grants within the competitive range for possible funding. This notification, sent to the PD/PI, is NOT a Notice of Award, nor should it be construed as an indicator of possible award. JIT information requested includes other support, certification of Institutional Review Board (IRB) approval, certification of IACUC approval, and human subjects training certification for all key personnel. JIT information must be submitted for review and evaluation PRIOR to making an award. This information may be submitted via the Just-In-Time function within the eRA Commons.
If you have questions about the JIT process, contact your assigned grants management specialist.
Negotiation of Competing Award
Following the IC’s review and evaluation of the application, peer review results, and all applicable material, the IC will determine whether an award can be made, if special conditions are required, and what level of funding is appropriate.
The pre-award process involves communication between the NIH and the applicant organization, and includes negotiation if significant adjustments are required prior to award.
- Initial peer review recommendations: Peer reviewers may recommend changes to the specific aims and/or modifications to the requested budget. These recommendations are provided in the summary statement. Under these circumstances, NIH staff will include these recommendations in consideration of a potential award.
- Overlap: Program and grants management staff will review the other support information before an award to ensure the following:
- Sufficient levels of effort are committed to support the approved project.
- There is no scientific, budgetary, or commitment overlap.
- Budget/programmatic modification: NIH may reduce the project’s budget if sufficient funds are not available to support the application at 100 percent of the recommended level.
- Determination of Facilities and Administrative (F&A) Costs:
Grants Management staff will utilize the negotiated F&A costs (also known as indirect costs) for each grant. More information on the reimbursement of F&A costs can be found in the NIH Grants Policy Statement.
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Pre-Award Process - Non-Competing Awards
The pre-award process for non-competing continuation awards is a streamlined version of this process, including an assessment of progress (see “Administrative Requirements—Monitoring—Reporting—Non-Competing Grant Progress Reports”).
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Following review of all applicable information, the IC will determine whether an award will be made, if special conditions are required, and what level of funding is appropriate.
Notice of Award (NoA)
The NoA is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office. An NoA is issued for the initial budget period. If subsequent budget periods are also approved, the NoA will include a reference to those budgetary commitments. Funding for subsequent budget periods are generally provided in annual increments following the annual assessment of progress. This funding is also contingent on the availability of funds. The NoA includes all applicable terms of award either by reference or specific statements. It provides contact information for the assigned program officer and grants management specialist.
Accepting the Award
The grantee accepts an NIH award and its associated terms and conditions by drawing or requesting funds from the Payment Management System, or upon the endorsement of a check from the US Treasury for foreign awardees.
Compliance with Terms and Conditions of Award
An NoA includes two sections (Sections III & IV) where terms of award are described.
Section III of awards lists standard terms such as:
The NIH Grants Policy Statement, NIHGPS, as a term and condition for all awards contains the legally binding requirements for all grant recipients (See Part II Terms of Award).
- Grant program legislation and program regulation cited in this NoA.
- Restrictions on the expenditure of federal funds in appropriation acts, to the extent those restrictions are pertinent to the award.
- Code of Federal Regulations/Regulatory Requirements - 45 CFR Part 74 or 45 CFR Part 92 as applicable.
- The National Institutes of Health Grants Policy Statement (NIHGPS) in effect at the beginning date of the budget period.
- The award notice including any special terms and conditions….”
- A reference to carryover authority when applicable
- A reference to inclusion or exclusion to SNAP as applicable
- A reference on the treatment of Program Income
- A reference to participation in the Federal Demonstration Partnership as applicable.
Section IV of awards contains Special Terms and Conditions specific to the particular NIH Institute/Center and/or specific to the particular grant. It is important that you pay careful attention to the terms and conditions of an award, particularly any specific to the grant. Unless these terms are carefully reviewed and addressed, grantees may unknowingly violate the terms and conditions of the award. In those cases, NIH may place a restriction on the award, institute special monitoring procedures, or potentially terminate an award.
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If you are the recipient of a grant from the NIH, there is a great deal of information that your organization will need in order to be successful steward of federal funds. The NIH Welcome Wagon Letter provides information and resources for new grantee organizations on how to manage the award.
NIH publishes policy updates in the NIH Guide for Grants and Contracts. Individuals may subscribe for weekly e-mail updates.
The information provided below is just a brief overview of selected post-award processes and requirements. For full details on any of these topics, see the NIH Grants Policy Statement. In addition, for specific questions, consult first with the administrative officials within your organization. The assigned NIH program officials and grants management specialists are also available to answer any remaining questions.
Monitoring Your Award
Grantees are responsible for managing the day-to-day operations of their grant. To fulfill their role in regard to the stewardship of federal funds, NIH awarding offices monitor grants to identify potential problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the grantee, audit reports, site visits, and other information available to NIH.
HHS grant payments may be made by one of several advance payment methods, including SMARTLINK II/ACH, CASHLINE/ACH, or cash request, or by cash request on a reimbursement basis. The Office of Financial Management (OFM) makes payments under grants to foreign or international organizations, awards to individuals, and awards to agencies of the federal government. Additional information on payment is in the NIH Grants Policy Statement.
Applicant organizations are required to have financial systems in place to monitor their grant expenditures. NIH monitors grantee expenditures under individual grants within each budget period and within the overall project period. The funding that NIH provides for each budget period is based on an assessment of the effort to be performed during that period and the grantee’s associated budget, including the availability of “un-obligated” balances. Although NIH allows its grantees flexibilities with respect to re-budgeting (see “Administrative Requirements—Changes in Project and Budget” in the NIH Grants Policy Statement), NIH expects the rate and types of expenditures to be consistent with the approved project and budget and may question or restrict expenditures that appear inconsistent with these expectations.
The Grants Management Specialist (GMS) reviews grantee cash expenditure reports to determine whether they indicate a pattern of accelerated or delayed expenditures. Expenditure patterns are of particular concern because they may indicate a deficiency in the grantee’s financial management system or internal controls. Accelerated or delayed expenditures may result in a grantee’s inability to complete the approved project within the approved budget and period of performance. In these situations, the GMS may seek additional information from the grantee and may make any necessary and appropriate actions.
Prior Approval Requests
All requests that require prior NIH approval must be made in writing (e-mail is acceptable) to the Grants Management Officer at least 30 days before the proposed change. The request must be endorsed by the Authorized Organization Representative. Failure to obtain required prior approval from the appropriate NIH awarding office may result in the disallowance of costs, termination of the award, or other enforcement action within the NIH’s authority.
See the NIH Grants Policy Statement on Prior Approval Requirements.
If you have questions, contact the grants management specialist or the program official named in your NoA.
NIH requires that grantees periodically submit reports. For all of the reports discussed in this section, grantees are reminded that they are due at specific times during the life cycle of a grant award. It is important that all reports are accurate, complete, and submitted on time.
Progress reports are usually required annually as part of the non-competing continuation award process. The “Grant Progress Report” (PHS 2590) or equivalent documentation must be submitted to (and approved by) the NIH to non-competitively fund each additional budget period within a previously approved project period (competitive segment).
The information to be included in the progress report is specified in the PHS 2590 instructions, which also include alternate instructions for awards under Streamlined Non-competing Award Process (SNAP). Non-competing progress reports are submitted directly to NIH. Forms for non-competing grant progress reports are available at http://grants.nih.gov/grants/funding/2590/2590.htm.
If your award is eligible for the eSNAP, you may file an electronic progress report 45 days before the grant anniversary date. Non-SNAP awards should be submitted 60 days before the grant anniversary date.
Other factors related to your project might add additional requirements. For example, if you are working with human subjects, you need to get your certification of IRB approval re-approved every year of your award. Likewise, if you're working with research animals, you need to get your certification of IACUC approval re-approved every three years.
Regulations require that grantee organizations report all inventions to the awarding agency (see NIH Grants Policy Statement), as well as include an acknowledgement of federal support in any patents. Grantee organizations are expected to use the Web-based Interagency Edison system (iEdison). NIH funding recipients are expected to use this system to comply with the Bayh-Dole Act (P.L. 96-517) and related intellectual property reporting requirements.
For more information on the policies that govern Invention Reporting, see the iEdison Web site.
Final Invention Statement
When a grant is completed and no more funding is provided, or when a grant is transferred from one institution to another, then a Final Invention Statement and Certification (HHS 568) is one of the required forms submitted to the NIH. For grants that are closing out, the Final Invention Statement and Certification can be submitted along with the other required closeout documents through the eRA Commons. For transfers, this document should be submitted directly to the NIH awarding Institute or Center. A downloadable version of the HHS 568 is at: http://grants.nih.gov/grants/hhs568.pdf or: https://s-edison.info.nih.gov/iEdison/hhs568.pdf.
Financial Reporting (Institutional Requirement)
Quarterly Cash Transaction Reports (PSC 272)
Quarterly Federal Cash Transaction Report, PSC 272 covers the financial information related to your project. For more information on 272 reports, see the Division of Payment Management's Web site
Financial Status Reports (SF269)
A Financial Status Report (FSR) is required as documentation of the financial status of grants according to the official accounting records of the grantee organization. Financial reporting is accomplished using the FSR (SF-269 or SF-269 A); the grantee must use the long form (SF 269) to report program income earned and used.
Except for awards under SNAP and awards that require more frequent reporting, the FSR is required on an annual basis. An annual FSR is required for awards to foreign organizations and federal institutions, whether or not they are under SNAP. When required on an annual basis, the report must be submitted for each budget period no later than 90 days after the close of the budget period. The report also must cover any authorized extension in time of the budget period. If more frequent reporting is required, the NoA will specify both the frequency and due date.
Beginning October 1, 2007 all FSRs must be submitted electronically through the eRA Commons. (NIH Guide Notice)
For fiscal years ending after 12/31/2003, NIH grantees or sub-recipients that expend $500,000 or more in federal awards during the fiscal year are subject to an audit requirement. Organizations expending less than $500,000 during the fiscal year are not required to have an annual audit for that year, but must make their grant-related records available to NIH or other designated officials for review or audit.
- Educational institutions and nonprofit organizations, including hospitals, are subject to the requirements of OMB Circular A-133.
- For-profit organizations , including for-profit hospitals, and foreign organizations can satisfy audit requirements with either of two audit types, according to 45 CFR 74.26(d):
- A financial-related audit as defined in, and in accordance with, the Government Auditing Standards (the "Yellow Book").
- An audit that meets the requirements of OMB Circular A-133.
These audits are required annually. Audits shall be completed and submitted to the designated offices shown below within a period that is either the earlier of (1) 30 days after receipt of the auditor’s report(s), or (2) nine months after the end of the audit period (i.e., the organization’s fiscal year).
Educational institutions and non-profit institutions should submit their audit report directly to:
Federal Audit Clearinghouse
Bureau of the Census
1201 East 10th Street
Jeffersonville, IN 47132
For-profit organizations, including for-profit hospitals, and foreign organizations should submit their audit report directly to:
National External Audit Review Center
HHS Office of Audit Services
1100 Walnut Street, Suite 850
Kansas City, MO 64106-2197
If your organization has expended less than $500,000 in federal funds in a year, it is exempt from the audit requirements, but must keep grant-related records available to NIH or other designated officials for review or audit.
NIH closes out a grant as soon as possible after expiration if the grant will not be extended of if continued funding is not provided. Closeout includes ensuring timely submission of all required reports and adjustments for amounts due the grantee or NIH. Closeout of a grant does not automatically cancel any requirements for property accountability, record retention, or financial accountability. Following closeout, the grantee remains obligated to return funds due as a result of later refunds, corrections, or other transactions, and the federal government may recover amounts based on the results of an audit covering any part of the period of grant support.
Required closeout reports include:
- Final FSR
- Final progress report
- Final Invention Statement and Certification
- Final population tracking data when applicable
These reports are due within 90 days of the end of grant support. Failure to submit timely and accurate final reports may affect future funding to the organization or awards with the same PD/PI.
Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the annual FSR is submitted. For awards issued under the SNAP authorities, the three-year retention period is calculated from the date the FSR is submitted for the entire competitive segment.
Closeout may also affect the time period for retention of records by the grantee, because the three-year record retention period begins with the submission of the final FSR. See 45 CFR Part 74.53 and 45 CFR Part 92.42, Retention and access requirements for records.