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 grantees to submit a variety of reports which are due at specific times during the
life cycle of a grant award. All reports must be are accurate, complete, and submitted on time.
Progress reports are required at least annually as part of the non-competing continuation award process.
The Non-Competing Continuation Progress Report
(PHS 2590), or equivalent documentation, must be submitted to, and approved by, the NIH to receive funding for
each subsequent budget period (non-competitive segment) within a previously approved project period
The information to be included in the progress report is specified in the PHS 2590 instructions. Progress reports
for awards subject to SNAP (Streamlined Non-Competing Award Process) must be submitted electronically using the
eSNAP module in the eRA Commons, and are due 45 days before the grant anniversary date. For awards not subject to
SNAP, a hard copy of the PHS 2590 forms must be
submitted to the centralized mailing address below two months before the beginning date of the next budget period:
Division of Extramural Activities Support, OER
National Institutes of Health
6705 Rockledge Drive, Room 2207, MSC 7987
Bethesda, MD 20892-7987 (for regular or US Postal Service Express mail)
Bethesda, MD 20817 (for other courier/express mail delivery only)
Phone Number: (301) 594-6584
Progress reports are submitted directly to NIH, and not through the Grants.gov interface.
A limited number of awards are Multi-Year Funded (MYF) which means the project and budget period are
the same and are longer than one year. rogress reports for MYF awards are due on the anniversary date of
the award. See NIH Instructions for Progress Reports
for Multi-year Funded (MYF) Awards.
Other factors related to a project may add additional requirements. For example, if working with human
subjects, a certification of IRB approval must be obtained annually. Likewise, if working with research
animals, a certification of IACUC approval is
required every three years.
See Submiting Your Non-Competing Grant Progress Reports (http://grants.nih.gov/grants/submitapplication.htm#nc)
for additional information.
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 all 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 a subsequent competing segment is not funded, or when a grant is transferred
from one institution to another, a Final Invention Statement and Certification (HHS 568) must be submitted to
the NIH with 90 days. 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, the HHS 568
should be submitted directly to the NIH awarding Institute or Center. A downloadable version of the HHS 568 is
Financial Reporting (Institutional Requirement)
Financial reporting is accomplished using the Federal Financial Report (FFR)
Federal Financial Report (SF425) Cash Transaction Reports.
Cash transaction data is submitted on a quarterly basis directly to PMS. For more information on cash transaction
reports, see the Division of Payment Management's Web site.
Federal Financial Report (SF425) Expenditure Data Reports
Expenditure data is required as documentation of the financial status of grants according to the official
accounting records of the grantee organization.
Except for awards under SNAP and awards that require more frequent reporting, the FFR expenditure data
is required on an annual basis. Annual expenditure data 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 end of the calendar quarter in which the
budget period ended. 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 February 1, 2011 all FFR expenditure data must be submitted electronically through the
(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
- A financial-related audit as defined in, and in accordance with, the
Government Auditing Standardsthe "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).
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 the project period end dateif the grant will not be
extended of if continued funding is not provided. Closeout consists of the 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 FFR Expenditure data
- Final progress report
- Final Invention Statement and Certification
- Final population tracking data when applicable
Instructions for submitting the Final Progress Report are part of the PHS 2590, Section 3. All close out
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 FFR 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,
and access requirements for records.