A grantee's failure to comply with the terms and conditions of
award, including confirmed instances of scientific misconduct,
may cause NIH to take one or more enforcement actions, depending
on the severity and duration of the non-compliance. NIH will undertake
any such action in accordance with applicable statutes, regulations,
and policies, and will generally afford the grantee an opportunity
to correct the deficiencies prior to taking enforcement action
unless public health or welfare concerns require immediate action.
However, even if a grantee is taking corrective action, NIH may,
at the same time, take proactive actions to protect the Federal
Government's interests, including placing special conditions on
awards or precluding the grantee from obtaining future awards
for a specified period, or actions designed to prevent future
noncompliance, such as closer monitoring. If NIH imposes sanctions
on a grantee as a result of misconduct in science or will more
closely monitor an award(s) through the use of special conditions
(see below), NIH will share this information with other HHS components.
MODIFICATION OF THE TERMS OF AWARD
During grant performance, the awarding office may impose special
conditions to require correction of identified financial or administrative
deficiencies. At the time the special conditions are imposed,
the awarding office will notify the grantee of the nature of the
conditions; the reason why they are being imposed; the nature
of the corrective action needed; the time allowed for completing
corrective actions; and the method for requesting reconsideration
of the conditions. See 42 CFR 52.9 and 45 CFR 74.14 or 92.12.
The awarding office may also, for reasonable cause, withdraw approval
of the PI or other key personnel for a project. The qualifications
and competence of the PI and other key personnel were evaluated
prior to award, and, if the awarding office has reasonable basis
to conclude that the PI or other key personnel are no longer qualified
to perform in that capacity, the awarding office may withdraw
its approval of those individuals and request that the grantee
designate a new PI or other key personnel.
The decision to modify the terms of an award by imposing special
conditions, by withdrawing approval of the PI or other key personnel,
or otherwise, is discretionary on the part of the IC.
SUSPENSION, TERMINATION, AND WITHHOLDING OF SUPPORT
When a grantee has failed to materially comply with the terms
and conditions of a grant, NIH may suspend the grant, pending
corrective action, or may terminate the grant for cause. The regulatory
procedures that pertain to suspension and termination are specified
in 45 CFR 74.61 and 74.62 and 92.43.
NIH will generally suspend (rather than immediately terminate)
a grant and allow the grantee an opportunity to take appropriate
corrective action prior to NIH's making a termination decision.
NIH may decide to terminate the grant if the grantee does not
take appropriate corrective action during the period of suspension.
However, NIH may terminate without first suspending the grant
if the deficiency is so serious as to warrant immediate termination
or public health or welfare concerns require immediate action.
Termination for cause may be appealed under the NIH/HHS grant
appeals procedures (see "Administrative Requirements
Grant Appeals Procedures"). NIH may
award a replacement grant for
a limited period of time (up to 18 months) without competition
pending the outcome of an appeal or other action by the grantee.
A grant may also be terminated, partially or totally, by the grantee
or by NIH with the consent of the grantee. If the grantee decides
to terminate a portion of a grant, NIH may determine that the
remaining portion of the grant will not accomplish the purposes
for which the grant was originally awarded. In any such case,
NIH will advise the grantee of the possibility of termination
of the entire grant and allow the grantee to withdraw its termination
request. If the grantee does not withdraw its request for partial
termination, NIH may initiate procedures to terminate the entire
grant for cause.
See "Allowability of Costs/Activities
Items of Cost" for the allowability
of termination costs.
Allowability of these costs does not vary whether a grant is terminated
for cause by NIH, terminated by the grantee, or terminated by
Withholding of support is a decision not to make a noncompeting
continuation award within the current competitive segment. Withholding
may occur for one or more of the following reasons:
- A grantee is delinquent in submitting required reports.
- Adequate Federal funds are not available to support the project.
- A grantee fails to show satisfactory progress in achieving
the objectives of the project.
- A grantee failed to meet the terms of a previous award.
- A grantee's management practices fail to provide adequate
stewardship of Federal funds.
- Any reason that would indicate that continued funding would
not be in the best interests of the Government.
If a noncompeting continuation award is denied (withheld) because
the grantee failed to comply with the terms and conditions of
award in a previous budget period, the grantee may appeal that
OTHER ENFORCEMENT ACTIONS
Depending on the nature of the deficiency, NIH may use other means
of obtaining grantee compliance. Other options available to NIH
include, but are not limited to, temporary withholding of payment
or other actions specified at 45 CFR 74.62 or 92.43, conversion
from an advance payment method to a reimbursement method, suspension
or debarment under 45 CFR Part 76, and other available legal remedies,
including civil action. Suspension under 45 CFR Part 76 is a distinct
action from "suspension" as a postaward remedy described
under "Suspension, Termination, and Withholding of Support"
above. The subject of debarment and suspension as an eligibility
criterion is addressed in the "Completing the Preaward Process
and "Public Policy Requirements and Objectives Ethical
and Safe Conduct in Science and Organizational Operations
Debarment and Suspension".
RECOVERY OF FUNDS
NIH may administratively recover funds paid to a grantee in excess
of the amount to which the grantee is finally determined to be
entitled under the terms and conditions of the award, including
misspent funds or unallowable costs incurred. If the grantee does
not pay back the funds in accordance with the demand by the IC
within a reasonable period of time after the demand, the IC may
collect the debt by:
- Making an administrative offset against payments that would
be due under other grant awards,
- Withholding advance payments that would otherwise be due,
- Taking any other action permitted by statute.
The Federal Debt Collection Act (Act), 31 U.S.C. 3711, and the
Federal Claims Collection Standards (4 CFR Parts 101-105) require
NIH to collect debts due to the Government and, except where prohibited
by law, to charge interest on all delinquent debts owed to NIH
by grantees (see also HHS claims collection regulations at 45
CFR Part 30). Debts may result from disallowances, recovery of
funds, unobligated balances, or other circumstances.
Unless otherwise specified in law, regulation, or the terms and
conditions of the award, debts are considered delinquent 30 days
after notification to the grantee of the indebtedness. The interest
on delinquent debts will be computed from the original notification
date to the grantee of the indebtedness. The interest rate applied
will be at the higher of the Current Value of Funds Rate or the
private consumer rate of interest fixed by the Department of the
Treasury. A higher rate may be charged if necessary to protect
the interests of the Government. Penalties and administrative
collection costs will also be charged in accordance with the Act
and the implementing HHS regulations, as follows:
- A penalty charge of six percent a year will be assessed on
debts that are more than 90 days overdue. Penalty charges will
accrue from the date the debt became overdue until the indebtedness
- Delinquent debtors will be assessed charges to cover the Government's
administrative costs of collecting overdue debts. From time to
time, HHS will publish a notice in the Federal Register
setting forth the amounts to be assessed for administrative collection
If a grantee appeals a monetary adverse determination under 42
CFR Part 50, Subpart D or 45 CFR Part 16, collection will be suspended
pending a final decision on the appeal. If the determination is
sustained (either fully or partially), interest will be charged
beginning with the date of the original notification to the grantee
of the indebtedness.
NIH will close out grants as soon as possible after expiration
of a grant that will not be extended or after termination of a
grant as provided in 45 CFR 74.71 to 74.73 or 92.50. Closeout
includes 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.
Grantees are required to submit a final Financial Status Report,
Final Invention Statement and Certification, and final progress
report within 90 days of the end of grant support unless an extension
is granted by the GMO. Failure to submit timely final reports
may affect future funding to the organization or awards with the
Final Financial Status Report
A final FSR is required for:
- Any grant that is terminated.
- Any grant that is transferred to a new grantee.
- Awards, including awards under SNAP, that will not be competitively
extended through award of a new competitive segment.
The final FSR must cover the period of time since the previous
FSR submission or, for awards under SNAP, the entire competitive
segment or as much of the competitive segment as has been funded
prior to termination. Final FSRs must have no unliquidated obligations,
and must indicate the exact balance of unobligated funds. Unobligated
funds must be returned to NIH or must be reflected by an appropriate
accounting adjustment in accordance with instructions from the
GMO or from the payment office. For those organizations receiving
their funds through PMS, final reports, as specified by PMS, must
be submitted to that office. It is the responsibility of the grantee
to reconcile reports submitted to PMS and to the NIH awarding
office. Withdrawal of the unobligated balance following expiration
or termination of a grant is not considered an adverse action
and may not be appealed (see "Administrative Requirements
Actions Recovery of Funds").
Where the submission of a revised final FSR results in additional
claims by the grantee, NIH will consider the approval of such
claims subject to the following minimum criteria:
- The charges must represent allowable costs under the provisions
of the grant.
- There must have been an unobligated balance for the given
budget period that is sufficient to cover the additional claim.
Such a claim may be considered regardless of whether the unobligated
balance was moved forward to offset the award for a subsequent
- Funds must be available from the applicable appropriation.
Final Progress Report
The final progress report should include, at a minimum, a summary
of progress toward the achievement of the originally stated aims,
a list of the results (positive or negative) considered significant,
and a list of publications. An original and one copy of this report
should be submitted to the GMO.
Final Invention Statement and
The grantee must submit a Final Invention Statement and Certification
(HHS-568), whether or not an invention(s) results from work under
the grant. The final invention statement/certification must be
signed by the PI and an authorized institutional official and
must list all inventions that were conceived or first actually
reduced to practice during the course of work under the project,
from the original effective date of support through the date of
expiration or termination, whether or not previously reported.
If there were no inventions, the statement should indicate "None."
Grant Appeals Procedures
HHS permits grantees to appeal certain postaward adverse administrative
decisions made by HHS officials to an HHS Grant Appeals Board
(see 45 CFR Part 16). NIH has established a first-level grant
appeal procedure for discretionary grants and cooperative agreements
that must be exhausted before an appeal may be filed with the
HHS Departmental Appeals Board (see 42 CFR Part 50, Subpart D).
NIH will assume jurisdiction for the following adverse determinations:
- Termination, in whole or in part, of a grant for failure of
the grantee to carry out its approved project in accordance with
the applicable law and the terms and conditions of such assistance
or for failure of the grantee otherwise to comply with any law,
regulation, assurance, term, or condition applicable to the grant.
- Determination that an expenditure not allowable under the
grant has been charged to the grant or that the grantee has otherwise
failed to discharge its obligation to account for grant funds.
- Denial (withholding) of a noncompeting continuation award
under the project period system of funding for failure to comply
with the terms of a previous award.
- Determination that a grant is void (i.e., a decision that
an award is invalid because it was not authorized by statute or
regulation or because it was fraudulently obtained).
The formal notification of an adverse determination will contain
a statement of the grantee's appeal rights. As the first level
in appealing an adverse determination, the grantee must submit
a request for review to the NIH official specified in the adverse
determination letter, detailing the nature of the disagreement
with the adverse determination and providing supporting documents
in accordance with the procedures contained in the notification.
The grantee's request to NIH for review must be postmarked no
later than 30 days after receipt of the written notification of
the adverse determination except that, if the grantee can show
good cause why an extension is warranted, an extension may be
granted (42 CFR 50.406).
If the NIH decision on the appeal is adverse to the grantee or
if a grantee's request for review is rejected on jurisdictional
grounds, the grantee then has the option of submitting a request
to the Departmental Appeals Board (DAB) for a further review of
the case in accordance with the provisions of 45 CFR Part 16.
A grantee may not submit an appeal directly to the DAB, as it
will review only appeals that have been reviewed and acted on
In addition to the adverse determinations cited above, the DAB
is the single level of appeal for disputes related to the establishment
of F&A rates, research patient care rates, and certain other
cost allocations used in determining amounts to be reimbursed
under NIH grants (e.g., cost allocation plans negotiated with
State or local governments), and computer, fringe benefit, and
other negotiated special rates10.The grantee will be
advised of any adverse determinations in these areas by the Division
of Cost Allocation.