NIH Grants Policy Statement
Part II: Terms and Conditions of NIH Grant Awards
Subpart A: General – File 6 of 6
8 ADMINISTRATIVE REQUIREMENTS
8.1 Changes in Project and Budget
In general, NIH grantees are allowed a certain degree of
latitude to rebudget within and between budget
categories to meet unanticipated needs and to make other types of post-award
changes. Some changes may be made at the grantee's discretion as long as they
are within the limits established by NIH. In other cases, NIH prior written
approval may be required before a grantee makes certain budget modifications or
undertakes particular activities. The grantee-initiated changes that may be
made under the grantee's authority and the changes that require NIH approval
are outlined below and, with respect to particular types of awards, activities,
or recipients, in Subpart IIB. In addition, individual awards may restrict
grantees' authorities to make budget and project changes without NIH prior
approval. If NIH approval is required, it must be requested of, and obtained in
writing from, the awarding IC GMO in advance of the change or obligation of
funds as specified later in this chapter under Requests
for Prior Approval.
Changes in project or budget resulting from NIH-initiated
actions are discussed in other sections of this chapter.
Standard Terms of Award
Federal administrative requirements allow agencies to waive
certain cost-related and administrative prior approvals; these are known as
expanded authorities. In 2001, NIH extended expanded authorities to all NIH
awards except for the provision to automatically carry over unobligated
balances. Certain award instruments, grant programs, and types of recipients
are routinely excluded from the authority to automatically carry over
unobligated balances. This includes centers (P50, P60, P30, and others);
cooperative agreements (U); Kirschstein-NRSA
institutional research training grants (T); non-Fast Track Phase 1 SBIR and
STTR awards (R43 and R41); clinical trials (regardless of activity code); and
awards to individuals.
One or more of these authorities may be overridden by a
special term or condition of the award. Grantees must review the NoA to determine if a particular authority is withheld for
a specific grant.
Grantees must exercise proper stewardship over Federal funds
and ensure that costs charged to awards are allowable, allocable, reasonable,
necessary, and consistently applied regardless of the source of funds. NIH may
disallow the costs if it determines, through audit or otherwise, that the costs
do not meet the tests of allowability, allocability, reasonableness, necessity, and consistency.
Several authorities have specific deadlines for submission
of reports or for timely notification to the NIH awarding IC. Grantees should
be aware that any consistent pattern of failure to adhere to those deadlines
for reporting or notification will be grounds for excluding that grantee from a
Exhibit 6. Summary of NIH Standard Terms of Award
|Grantee Authorities as NIH Standard Terms of Award
|Carryover of unobligated balances from one
budget period to any subsequent period
||Centers (P50, P60, P30 and others), cooperative agreements
(U), Kirschstein-NRSA institutional research
training grants (T), non-Fast Track Phase I SBIR and STTR awards (R43 and
R41), clinical trials, and awards to individuals, or if the NoA indicates otherwise.
|Cost-related prior approval changes, including research
patient care costs and equipment
||The cost would result in a change of scope.
|Extension of final budget period of a project period
without additional NIH funds (no-cost extension)
||The grantee has already exercised its one-time authority
to extend the award for up to 12 months.
|Transfer of performance of
substantive programmatic work to a third party (by consortium agreement)
||The transfer would be to a foreign component or it would
result in a change in scope.
of Unobligated Balances from One Budget Period to Any Subsequent Budget Period
Grantees should be
aware that there is a difference between unliquidated obligations and unobligated balances. Unliquidated obligations are commitments of the recipient and are considered to be
obligations and, therefore, should not be reported as unobligated balances.
The NoA will include a term and
condition to indicate the disposition of unobligated balances. The term and
condition will state whether the grantee has automatic carryover authority, or if
prior approval is required by the NIH awarding IC. Note the authority to
automatically carry over unobligated balances includes the authority to
carryover from one competitive segment to another.
Automatic carryover of unobligated balances applies to all
awards except centers (P50, P60, P30, other), cooperative agreements (U), Kirschstein-NRSA institutional research training grants
(T), non-Fast Track Phase I SBIR and STTR awards (R43 and R41), clinical trials
(regardless of activity code), and awards to individuals. For these grants,
carryover of unobligated balances requires NIH awarding IC prior approval
unless otherwise noted in the NoA. Other awards may
be excluded from this authority through a special term or condition in the NoA.
For awards under SNAP (see Administrative Requirements—Monitoring—Reporting—Streamlined Non-Competing Award Process for applicability), funds are automatically carried over to the subsequent
budget period. However, the grantee will be required to indicate, as part of
the grant's progress report, whether any estimated unobligated balance
(including prior-year carryover) is expected to be greater than 25 percent of
the current year's total approved budget. The total approved budget amount
includes current year and any carryover from prior years of the project period.
If the unobligated balance is greater than 25 percent of the total approved
budget, the grantee must provide an explanation and indicate plans for
expenditure of those funds within the current budget year.
For awards that require an annual FFR, the amount to be
automatically carried over must be specified under item 12, "Remarks."
For both SNAP and non-SNAP, when a grantee reports a balance
of unobligated funds in excess of 25 percent of the total amount awarded for
the budget period, the GMO will review the circumstances resulting in the
balance to ensure that these funds are necessary to complete the project, and
may request additional information from the grantee, including a revised
budget, as part of the review.
If the GMO determines that some or all of the unobligated
funds are not necessary to complete the project, the GMO may restrict the
grantee's authority to automatically carry over unobligated balances in the
future, use the balance to reduce or offset NIH funding for a subsequent budget
period, or use a combination of these actions. The GMO also may indicate
whether the balance may be carried forward to a budget period other than the
succeeding one. The GMO's decision about the disposition of the reported
unobligated balance will be reflected in the terms and conditions of the NoA.
All Federal agencies are required by PL 101-510 to close
fixed year appropriation accounts and cancel any remaining balances by
September 30 of the fifth fiscal year after the year of availability. In order
for the NIH to meet its obligation to close these accounts and cancel any
remaining balances by September 30, grantees must report disbursements on the
quarterly cash transaction report (using the FFR) no later than June 30 of the
fifth fiscal year after the year of availability. At the end of five years, the
funds are cancelled and returned to the Treasury. This provision limits the
availability of funds for carryover.
184.108.40.206 Cost-Related Prior Approvals
NIH prior approval is not required to rebudget funds for any direct cost item that the
applicable cost principles identify as requiring the Federal awarding agency's
prior approval, unless the incurrence of costs is associated with or is
considered to be a change in scope.
220.127.116.11 Extension of Final Budget Period of a Previously
Approved Project Period without Additional NIH Funds
The grantee may
extend the final budget period of the previously approved project period one
time for a period of up to 12 months beyond the original expiration date shown
in the NoA if
- no term of award specifically prohibits the
- no additional funds are required to be obligated
by the NIH awarding IC, and
- the project's originally approved scope will not
Such an action affirms that additional work remains to be
completed on the project and that resources are available to continue to
support the project, or that additional time is needed to provide for an
orderly closeout. The fact that funds remain at the expiration of the grant is
not, in itself, sufficient justification for an extension without additional
Grantees are encouraged to use the eRA Commons No-Cost Extension feature to electronically notify NIH that they are
exercising their one-time authority to extend without funds the expiration date of an award. This
extension may be up to 12 months beyond the final budget period end date. In
the eRA Commons, this notification can be made up to
the last day of the current project end date. An e-mail notification is
automatically sent to the GMO and no further action is required.
Notifications submitted via e-mail or fax must be received
by the GMO at the NIH awarding IC at least 10 days prior to the project period end
date. Upon receipt of the notification, the GMO will process and acknowledge
the extension. If the no-cost extension notification is submitted late, the
extension notification automatically becomes a request and requires the
approval of the IC Chief GMO. (See Administrative
Requirements—Prior Approval Requirements for extension requiring additional
In extending the final budget period of the project period
through this process, the grantee agrees to update all required certifications
and assurances, including but not limited to those pertaining to human subjects
and animal welfare, in accordance with applicable regulations and policies.
Grantees are reminded that all terms and conditions of the award apply during
the extension period.
Grantees may not extend project periods that were previously
extended by the NIH awarding IC. Any additional project period extension
requires NIH prior approval. (See Administrative
Requirements—Prior Approval Requirements for extensions requiring
of the Performance of Substantive Programmatic Work to a Third Party by Means
of a Consortium Agreement
Prior approval by the NIH awarding IC is not required to
transfer the performance of already peer reviewed programmatic work unless the
activity constitutes a change in scope or results in the transfer of
substantive programmatic work to a foreign component.
8.1.2 Prior Approval Requirements
This section describes the activities and/or expenditures
that require NIH prior approval. NIH prior approval requirements are summarized
in Exhibit 7, which is provided for guidance only. For the prior approval
requirements specified in the exhibit, approval is required whether or not the
change has a budgetary impact. The circumstances under which prior approval is
required also are summarized in the exhibit.
Grantees also should
consult Subpart IIB for prior approval requirements that apply to specific
mechanisms, types of grants, and types of recipients.
Any question about
the need for prior approval for an activity or cost under a specific NIH award
should be directed to the GMO.
Exhibit 7. Summary of Actions Requiring NIH Prior Approval
is required for
|Under the following circumstances
extension, extension greater than 12 months, or late notification of initial
no-cost extension (18.104.22.168)
||Rebudgeting into A&R costs
that would exceed 25 percent of the total approved budget for a budget period.
If rebudgeting would not meet
this threshold but would result in a change in scope.
Any single A&R project exceeding $500,000.
|Capital expenditures (construction, land, or building
||All instances. Also, any proposals to convey, transfer,
assign, mortgage, lease, or in any other manner encumber real property
acquired with NIH grant funds.
unobligated balances (22.214.171.124)
||If the NoA indicates that the
grantee does not have the authority to automatically carry over unobligated
|Change in scope (126.96.36.199)
|Change in status of the
PD/PI or senior/key personnel named in the NoA (188.8.131.52)
||Withdrawal from the project; absence for any continuous
period of 3 months or more; reduction of the level of effort devoted to
project by 25 percent or more from what was approved in the initial competing
|Change of grantee
|Change of grantee
organization status (184.108.40.206)
|Deviation from award
terms and conditions (220.127.116.11)
||All instances. Includes undertaking any activities
disapproved or restricted as a condition of the award.
added to a grant to a domestic organization (18.104.22.168)
|Need for additional
NIH funding (22.214.171.124 and 126.96.36.199)
||All instances, including extension of a final budget
period of a project period with additional funds.
|Pre-award costs (188.8.131.52)
||More than 90 days before effective date of the initial
budget period of a new or competing continuation award; always at the
grantee's own risk.
|Rebudgeting funds from trainee costs (184.108.40.206)
|Rebudgeting of funds between construction and non-construction work (220.127.116.11)
|Retention of research
grant funds when CDA awarded (18.104.22.168)
22.214.171.124 Additional No-cost Extension or Extension
Greater Than 12 Months or Late Notification of Initial No-Cost Extension
The NIH Standard Terms of Award provide the grantee the authority to extend the final budget period of a
previously approved project period one time for a period of up to 12 months
beyond the original expiration date down in the NoA.
Any additional project period extension beyond the initial extension of up to
12 months requires NIH prior approval. The request should include a description
of the project activities that require support during the extension and a
statement about the funds available to support the extension. Further any late
notification of the initial no-cost extension provided by the NIH Standard
Terms of Award also requires prior approval.
126.96.36.199 Alterations and Renovations
NIH prior approval is required if a grantee wishes to rebudget more than 25 percent of the total approved budget
for a budget period into A&R costs. NIH prior approval also is required for
lesser rebudgeting into A &R costs if the rebudgeting would result in a change in scope. If rebudgeting results in an A&R project exceeding
$500,000, NIH always will consider the rebudgeting to
be a change in scope. (See the Construction Grants chapter in IIB for documentation requirements for A&R projects exceeding
188.8.131.52 Capital Expenditures
Capital expenditures for land or buildings require NIH prior
approval. In addition, real property acquired with NIH grant funds may not be
conveyed, transferred, assigned, mortgaged, leased, or in any other manner
encumbered by the grantee without the written prior approval of the NIH
awarding IC or its successor organization.
184.108.40.206 Carryover of Unobligated Balances
The NoA will include a term and
condition to indicate the disposition of unobligated balances. The term and
condition will state whether the grantee has automatic carryover authority or
if prior approval is required by the NIH awarding IC. When NIH prior approval
is required, the AOR should submit a request to the GMO that includes at a
minimum the following information:
- A detailed budget by direct cost category with
the F&A cost information (base and rate) for the proposed use of the
carryover funds. If personnel costs are requested, include a detailed breakdown
of personnel costs, including base salary, salary requested and effort to be
spent on the project during the extension.
- A scientific justification for the use of funds.
- The reason for the unobligated balance.
220.127.116.11 Change in Scope
In general, the PD/PI may make changes in the methodology,
approach, or other aspects of the project objectives. However, the grantee must
obtain prior approval from the NIH awarding IC for a change in scope. A change
in scope is a change in the direction, aims, objectives, purposes, or type of
research training, identified in the approved project. The grantee must make
the initial determination of the significance of a change and should consult
with the GMO as necessary.
Potential indicators of a
change in scope include, but are not limited to, the following:
- Change in the specific aims approved at the time
- Substitution of one animal model for another.
- Change from the approved use of live vertebrate
animals or involvement of human subjects.
- Shift of the research emphasis from one disease
area to another.
- A clinical hold by FDA under a study involving
an IND or an IDE.
- Application of a new technology, e.g., changing
assays from those approved to a different type of assay.
- Transfer of the performance of substantive
programmatic work to a third party through a consortium agreement, by contract,
or any other means. If the third party is a foreign component, NIH prior
approval is always required.
- Change in other senior/key personnel not
specifically named in the NoA (see Change in Status, Including
Absence, of PD/PI and Other Senior/Key Personnel Named in the NoA below for requirements for NIH approval of
alternate arrangements for or replacement of named senior/key personnel).
- Significant rebudgeting, whether or not the particular
expenditure(s) require prior approval. Significant rebudgeting occurs when expenditures in a single direct cost budget category deviate
(increase or decrease) from the categorical commitment level established for
the budget period by 25 percent or more of the total costs awarded. For
example, if the award budget for total costs is $200,000, any rebudgeting that would result in an increase or decrease of
more than $50,000 in a budget category is considered significant rebudgeting. The base used for determining significant rebudgeting
excludes the effects of prior-year carryover
balances but includes competing and non-competing supplements. Significant rebudgeting does not apply to modular grants.
- Incurrence of research patient care costs if
costs in that category were not previously approved by NIH or if a grantee
desires to rebudget additional funds beyond those approved into or rebudget funds out of the research patient care category.
- Purchase of a unit of equipment exceeding
18.104.22.168 Change in Status,
Including Absence of PD/PI and Other Senior/Key Personnel Named in the NoA
The grantee is required to submit a prior approval request
to the GMO if the PD/PI or other senior/key personnel specifically named in the NoA will withdraw from the project entirely, be
absent from the project during any continuous period of 3 months or more, or
reduce time devoted to the project by 25 percent or more from the level that
was approved at the time of initial competing year award (for example, a
proposed change from 40 percent effort to 30 percent or less effort or in
calendar months a change from 4.8 to 3.6 calendar months). Once approval has
been given for a significant change in the level of effort, then all subsequent
reductions are measured against the approved, adjusted level. NIH must approve
any alternate arrangement proposed by the grantee, including any replacement of
the PD/PI or senior/key personnel named in the NoA.
The request for approval of a substitute PD/PI or senior/key
person should include a justification for the change, the biographical sketch
of the individual proposed, other sources of support, and any budget changes
resulting from the proposed change. If the arrangements proposed by the
grantee, including the qualifications of any proposed replacement, are not
acceptable to the NIH awarding IC, the grant may be suspended or terminated. If
the grantee wishes to terminate the project because it cannot make suitable alternate
arrangements, it must notify the GMO, in writing, of its wish to terminate, and
NIH will forward closeout instructions.
The requirement to obtain NIH prior approval for a change in
status pertains only to those personnel NIH designates in the NoA regardless of whether the applicant organization
designates others as senior/key personnel for its own purposes.
22.214.171.124 Change of Grantee Organization
NIH prior approval is
required for the transfer of the legal and administrative responsibility for a
grant-supported project or activity from one legal entity to another before the
expiration of the approved project period (competitive segment). A change of
grantee organization may be accomplished under most NIH grants, including
construction grants, if any of the following conditions are met:
- The original grantee has agreed to relinquish
responsibility for an active project before the expiration of the approved
project period. This includes any proposed change of grantee as a result of a
PD/PI on a research project transferring from one organization to another
organization. The project under the same PD/PI may be supported at a new
organization for a period up to the remainder of the previously approved
project period in an amount not to exceed that previously recommended for
direct costs (plus applicable F&A costs) for the remaining period.
- The grant to be transferred has been terminated
in accordance with 45 CFR part 74.61 or 92.43.
- A non-competing continuation award that is
within an approved project period has been withheld because of the grantee's
actions (see Administrative
Requirements—Enforcement Actions—Suspension, Termination, and Withholding of Support).
A change of grantee that involves the transfer of a grant to
or between foreign institutions or international organizations also must be
approved by the IC's Advisory Council or Board.
A grant to an individual may not be transferred.
A successor-in-interest or a name change is not considered a
change of grantee (see Change
in Grantee Organizational Status below).
A change of grantee organization may involve the transfer of
equipment purchased with grant funds. The transfer may be accomplished as part
of the original grantee's relinquishment of the grant; otherwise, NIH reserves
the right to transfer title to equipment to the new organization as indicated
Requirements—Management Systems and Procedures—Property Management System
A change of grantee request normally will be permitted only
when all of the permanent benefits attributable to the original grant can be
transferred, including equipment purchased in whole or in part with grant
funds. In reviewing a request to transfer a grant, NIH will consider whether
there is a continued need for the grant-supported project or activity and the
impact of any proposed changes in the scope of the project. A change may be
made without peer review, provided the PD/PI plans no significant change in
research objectives and the facilities and resources at the new organization
will allow for successful performance of the project. If these conditions or
other programmatic or administrative requirements are not met, the NIH awarding
IC may require peer review or may disapprove the request and, if appropriate,
terminate the award.
A change of grantee organization request must be made before
the anticipated start date at the new organization and preferably several
months in advance. Failure to provide timely notification may result in
disapproval of the request or significant delays in processing.
A request for a change of
grantee organization must be submitted to the GMO and the original institution
must include an Official Statement Relinquishing Interests and Rights in a
Public Health Service Research Grant (PHS 3734) (relinquishing statement). A
final FFR and Final Invention Statement are due to NIH from the relinquishing
organization no later than 90 days after the end of NIH support of the project.
The proposed new grantee must
provide the GMO with a change of institution application. Until such time as
NIH develops the capability to allow electronic submission of these
applications, the applicants should use the PHS 398 application form pages. If
the original award was the result of a modular application, modular procedures
apply to the request for change of grantee. The application from the proposed
grantee should include, at a minimum, the following:
- Face page.
- Budget pages (current and future years). (Under
awards resulting from modular applications, the application should include
narrative budget information, including total direct and F&A costs for the
current budget period and, if future budget periods remain, information about
the number of modules and the basis for computing F&A costs for all future
- Updated biographical sketches for the PD/PI and
existing senior/key personnel and biographical sketches for any proposed new
- If transferring on the anniversary date, include
the progress report for the current year including a statement regarding the
goals for the upcoming year. For all transfer applications include also a
statement indicating whether the overall research plans/aims have changed from
the original submission, and, if so, provide updated information.
- Updated "other support" page(s), if necessary.
- Resources page, including probable effect of the
move on the project.
- Checklist page.
- Certification of IRB/IACUC approval, including
OHRP and OLAW assurance numbers, if applicable.
- Detailed list of any equipment purchased with
grant funds to be transferred to the new organization (inclusion of this list
in the transfer application from the new organization indicates its acceptance
of title to that equipment).
NIH may request additional information necessary to
accomplish its review of the request. Acceptance of a relinquishing statement
by NIH does not guarantee approval of a transfer application for the continued
funding of a project.
NIH will accomplish a change of grantee organization by
issuing a revised NoA to the original grantee
reflecting the revised budget/project period end dates, deletion of any
future-year support, and deobligation of remaining
funds, if applicable. (A deobligation of funds will
be based on the estimated grant expenditures through the relinquishment date,
as determined from the relinquishing statement.) Concurrently, the new grantee
will receive the NoA reflecting the direct cost
balance reported on the relinquishing statement plus applicable F&A costs,
if funds are available. If the change of grantee organization occurs on the
anniversary date of the project, the NoA to the new
grantee will reflect the previously committed direct cost level plus applicable
F&A costs if funds are available. This amount is subject to change as a
result of the closeout of the original grant and may be adjusted downward.
126.96.36.199 Change in Grantee
Grantees must give NIH advance notice of the following types
of change in organizational status (not a change of grantee organization as
- Merger. Legal action resulting in the unification of two or more legal entities. When
such an action involves the transfer of NIH grants, the procedures for
recognizing a successor-in-interest will apply. When the action does not involve
the transfer of NIH grants, the procedures for recognizing a name change
normally will apply.
(SII). Process whereby the rights to and obligations under an NIH grant(s)
are acquired incidental to the transfer of all of the assets of the grantee or
the transfer of that part of the assets involved in the performance of the
grant(s). A SII may result from legislative or other legal action, such as a
merger or other corporate change.
Change. Action whereby the name of an organization is changed without
otherwise affecting the rights and obligations of that organization as a
Advance notification is required to ensure that the grantee
remains able to meet its legal and administrative obligations to NIH, and
payments are not interrupted.
Grantees are encouraged to contact the GMO of the lead NIH
awarding IC to explain the nature of the change in organizational status and
receive guidance on whether it will be treated as a name change or SII. The
lead awarding IC ordinarily will be the IC with which the organization has the
most NIH grants. NIH reserves the right to review the material provided, seek
clarification or additional information, and make an independent determination.
A grantee's formal request for a change in organizational
status should be submitted to NIH as soon as possible so that NIH can determine
whether the organization will continue to meet the grant program's eligibility
requirements and take the necessary action to reflect the change in advance of
the change in status.
For a SII, a letter signed by
the AORs of the current grantee (transferor) and the successor-in-interest
(transferee) must be sent to the lead NIH awarding IC, following consultation
with the GMO of that awarding IC. The letter must include the following:
- Stipulate that the transfer will be properly
affected in accordance with applicable law.
- Indicate that the transferor relinquishes all
rights and interests in all of the affected grants.
- Request that the awarding IC(s) modify its
(their) records to reflect the transferee as the grantee of record.
- State the effective date of the transfer.
- Provide the transferee's EIN. If EIN is new,
include completed Form W-9.
- Include verification of the transferee's
compliance with applicable requirements (e.g., research misconduct assurance of
- Include a list of all affected NIH grants
(active and pending) with the following information for each:
grant number (e.g., 5 R01 GM 12345-04).
budget period and project period.
total direct costs (as originally recommended) plus applicable F&A costs
for each remaining budget period. If the SII will occur during a budget period
rather than on the anniversary date, the transferor also must provide estimated
levels of current-year direct and F&A costs remaining as of the SII
effective date. The estimate may be reported on the PHS 3734 (Official
Statement Relinquishing Interests and Rights in a Public Health Service
Research Grant) or an equivalent relinquishing statement for each affected
grant or may be itemized by grant number as an attachment to the letter.
- Include a complete face page (PHS 398) for each
affected grant showing the transferee as the applicant organization. Each face
page must be signed by an AOR at the transferee organization.
- Include a copy of the current negotiated F&A
rate agreement for the transferee.
In order to be recognized as the SII, the "new" (transferee)
organization must meet each grant program's eligibility requirements; except
for grants awarded under the SBIR/STTR programs. See Small Business Innovation Research and Small
Business Technology Transfer Programs—Eligibility in IIB for additional
guidance. Upon review and acceptance of this information, NIH will revise the NoA(s) to show the transferee as the grantee of record.
For name changes, the grantee's written notification to the
lead NIH awarding IC must include the effective date of the change. Revised
face pages are not required for name changes because name changes are reported
and processed with the next award action (e.g., non-competing continuation
188.8.131.52 Deviation from Award Terms and Conditions, including Restrictions in the NoA
NIH prior approval is required for any deviation from terms
or conditions stated or referenced in the NoA,
including those in the NIHGPS. This includes undertaking any activities
disapproved or restricted as a condition of the award.
184.108.40.206 Foreign Component Added to a Grant to a
Adding a foreign component under a grant to a domestic
organization requires NIH prior approval.
220.127.116.11 Need for
Additional NIH Funding without Extension of Budget and Project Period
A request for additional funding for a current budget period
to meet increased costs that are within the scope of the approved application,
but that were unforeseen when the new or renewal application or grant progress
report for non-competing continuation support was submitted, is a non-competing
supplemental application. Such requests are submitted, in writing, directly to
the GMO and are not required to compete with other applications for funding.
Other grantee-initiated requests for supplemental funding during a current
budget period are considered to change the scope of the approved project and
may be required to compete for funding with other applications.
for Additional NIH Funding with Extension of the Final Budget Period of a
A request for a non-competing extension of the final budget
period of a project period with a minimal amount of additional funds should be
submitted to the GMO, in writing, at least 30 days before the project period is
scheduled to expire. Such requests usually are for a period of up to 12 months,
based on a need that additional work remains to be completed on the project and
that resources are available to continue to support the project, or to permit
orderly phase-out of project activities for which there will be no further NIH
support. The request must specify the proposed revised ending date and must
include justification for both the extension and the additional funds
requested. Special justification will be required for an extension that would
exceed 12 months. NIH will not approve such requests if the primary purpose of
the proposed extension is to permit the use of unobligated balances of funds.
All terms and conditions of the award apply during the extended period.
18.104.22.168 Pre-Award Costs
Considerations—Selected Items of Cost—Pre-Award (Pre-Agreement) Costs.
22.214.171.124 Rebudgeting of Funds
from Trainee Costs
The rebudgeting of amounts
previously awarded for trainee costs (stipends, tuition, and fees) to other
categories of expense requires NIH prior approval. This excludes trainee
travel, which NIH does not consider to be a trainee cost, and training-related
expenses (see Ruth L. Kirschstein National Research Service Awards—Institutional Research Training Grants—Rebudgeting of Funds in IIB).
126.96.36.199 Rebudgeting of Funds Between Construction and Non-construction Work
Under awards that provide for both construction and
non-construction work, NIH prior approval is required to transfer funds between
the two types of work.
of Research Grant Funds When a Career Development Award is Issued
Funds budgeted under an NIH grant for an individual's salary
and fringe benefits, but available as a result of receiving a K award for that
individual, may not be used for any other purpose without NIH prior approval.
8.1.3 Requests for Prior Approval
All requests for NIH awarding IC prior approval must be made
in writing (including submission by e-mail) to the GMO no later than 30 days
before the proposed change, and signed by the AOR. If the request is e-mailed,
it must provide evidence of the AOR's approval; a cc to the AOR is not
acceptable. Failure to obtain required prior approval from the appropriate
awarding IC may result in the disallowance of costs, termination of the award,
or other enforcement action within NIH's authority.
E-mail requests must be clearly identified as prior approval
requests, must reflect the complete grant number in the subject line, and should
be sent by the AOR to the GMO that signed the NoA.
Contact information is provided on each NoA and is
also available in the eRA Commons. E-mail addresses
for NIH staff can be also obtained from the NIH Enterprise Directory at: https://ned.nih.gov/search/.
E-mail requests must include the name of the grantee, the name of the
initiating PD/PI, the PD/PI's telephone number, fax number, and e-mail address,
and comparable identifying information for the AOR.
The GMO will review the request and provide a response to
the AOR indicating the final disposition of the request, with copies to the
PD/PI and to the cognizant NIH PO. Only responses
provided by the GMO are considered valid. Grantees that proceed on the basis of
actions by unauthorized officials do so at their own risk, and NIH is not bound
by such responses.
Whenever grantees contemplate rebudgeting or other post-award changes and are uncertain about the need for prior
approval, they are strongly encouraged to consult, in advance, with the GMO.
Under a consortium agreement or contract, the prior approval
authority usually is the prime grantee. However, the prime grantee may not
approve any action or cost that is inconsistent with the purpose or terms and
conditions of the NIH grant. If an action by a consortium participant will
result in a change in the overall grant project or budget requiring NIH
approval, the prime grantee must obtain that approval from NIH before giving
its approval to the consortium participant.
8.2 Availability of Research Results:
Publications, Intellectual Property Rights, and Sharing Research Resources
It is NIH policy that the results and accomplishments of the
activities that it funds should be made available to the public. PD/PIs and
grantee organizations are expected to make the results and accomplishments of
their activities available to the research community and to the public at
large. (See also Availability and
Confidentiality of Information—Confidentiality of Information—Access to Research
Data in Part I for policies related to providing access to certain research
data at public request.) If the outcomes of the research result in inventions,
the provisions of the Bayh-Dole Act of 1980, as implemented in 37 CFR part
As long as grantees abide by the provisions of the Bayh-Dole Act, as amended by the Technology Transfer Commercialization Act of 2000 (P.L. 106-404),
and 37 CFR part 401, they have the right to retain title to any invention
conceived or first actually reduced to practice using NIH grant funds. The
principal objectives of these laws and the implementing regulation are to
promote commercialization of federally funded inventions, while ensuring that
inventions are used in a manner that promotes free competition and enterprise
without unduly encumbering future research and discovery.
The regulation requires the grantee to use patent and
licensing processes to transfer grant-supported technology to industry for
development. Alternatively, unpatented research products or resources—“research
tools”—may be made available through licensing to vendors or other
investigators. Sharing of copyrightable outcomes of research may be in the form
of journal articles or other publications.
The importance of each of these outcomes of funded research
is reflected in the specific policies pertaining to rights in data, sharing of
research data and unique research resources, and inventions and patents
described in the following subsections.
in Data (Publication and Copyrighting)
In general, grantees
own the rights in data resulting from a grant-supported project. Special terms
and conditions of the award may indicate alternative rights, e.g., under a
cooperative agreement or based on specific programmatic considerations as stated in the applicable
RFA. Except as otherwise provided in the terms and conditions of the award, any
publications, data, or other copyrightable works developed under an NIH
grant may be copyrighted without NIH approval. For this purpose, “data” means
recorded information, regardless of the form or media on which it may be
recorded, and includes writings, films, sound recordings, pictorial
reproductions, drawings, designs, or other graphic representations, procedural
manuals, forms, diagrams, work flow charts, equipment descriptions, data files,
data processing or computer programs (software), statistical records, and other
Rights in data also extend to students, fellows, or trainees
under awards whose primary purpose is educational, with the authors free to
copyright works without NIH approval. In all cases, NIH must be given a
royalty-free, nonexclusive, and irrevocable license for the Federal government
to reproduce, publish, or otherwise use the material and to authorize others to
do so for Federal purposes. Data developed by a consortium participant also is
subject to this policy.
As a means of sharing knowledge, NIH encourages grantees to
arrange for publication of NIH-supported original research in primary
scientific journals. Grantees also should assert copyright in scientific and
technical articles based on data produced under the grant where necessary to
effect journal publication or inclusion in proceedings associated with
Journal or other copyright practices are acceptable unless
the copyright policy prevents the grantee from making copies for its own use
(as provided in 45 CFR parts 74.36 and 92.34). The disposition of royalties and other
income earned from a copyrighted work is addressed in Administrative
Requirements—Management Systems and Procedures—Program Income.
For each publication that results from NIH grant-supported
research, grantees must include an acknowledgment of NIH grant support and a
disclaimer stating the following:
“This publication was made possible by Grant Number ________
from _________” or “The project described was supported by Grant Number
________ from ________” and “Its contents are solely the responsibility of the
authors and do not necessarily represent the official views of the [name of
awarding office or NIH].”
If the grantee plans to issue a press release concerning the
outcome of NIH grant-supported research, it should notify the NIH awarding IC
in advance to allow for coordination. See also Appropriation Mandates—Acknowledgment of
Federal Funding for additional guidance when issuing statements, press releases,
requests for proposals, bid invitations, and other documents describing
projects or programs funded in whole or in part with Federal money.
Publications resulting from work performed under an NIH
grant-supported project must be included as part of the annual or final
progress report submitted to the NIH awarding IC (see Administrative
Requirements—Monitoring—Reporting—Non-Competing Continuation Progress Reports and Administrative Requirements—Closeout—Final
Reports—Final Progress Report). When publications are available
electronically, the url or the PMCID number must be
provided. If not available electronically, one copy of the publication may be
provided along with the progress report. See also NIH
Public Access Policy below for additional requirements for publications
resulting from NIH funded research.
Public Access Policy
The NIH Public Access Policy implements Division F, Section
217 of PL 111-8 (Omnibus Appropriations Act, 2009). The policy ensures that the
public has access to the published results of NIH funded research at the NIH
NLM PMC, a free digital archive of full-text biomedical and life sciences
journal literature (http://www.pubmedcentral.nih.gov/). Under the policy
NIH-funded investigators are required by Federal law to submit (or have
submitted for them) to PMC an electronic version of the final, peer-reviewed
manuscript upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The author's final
peer-reviewed manuscript is defined as the final version accepted for journal
publication on or after 4/7/2008, and includes all modifications from the
publishing peer review process, and all graphics and supplemental material
associated with the article. Institutions and investigators are responsible for
ensuring that any publishing or copyright agreements concerning submitted
articles reserve adequate right to fully comply with this policy. Applicants
citing articles in NIH applications, proposals, and progress reports that fall
under the policy, were authored or co-authored by the applicant and arose from
NIH support must include the PMCID or NIHMS ID. The NIHMSID may be used to
indicate compliance with the Public Access Policy in applications and progress
reports for up to three months after a paper is published. After that period, a
PMCID must be provided to demonstrate compliance.
This policy applies to all peer-reviewed articles resulting
from research supported in whole or in part with direct costs from NIH,
including research grant and career development awards, cooperative agreements,
contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, SBIR/STTR awards, and NIH intramural research
Additional information can be found at: http://publicaccess.nih.gov/.
8.2.3 Sharing Research Resources
Investigators conducting biomedical research frequently develop unique research resources.
NIH considers the sharing of such unique research resources (also called
research tools) an important means to enhance the value of NIH-sponsored
research. Restricting the availability of unique resources can impede the
advancement of further research. Therefore, when these resources are developed
with NIH funds and the associated research findings have been accepted for
publication, or after they have been provided to NIH, it is important that they
be made readily available for research purposes to qualified individuals within
the scientific community. At the same time NIH recognizes the rights of
grantees and contractors to elect and retain title to subject inventions
developed with federal funding pursuant to the Bayh-Dole
Act. See the Office of Extramural Research, Division of Extramural Inventions
& Technology Resources (DEITR), Intellectual Property Policy page: http://inventions.nih.gov.
staff are responsible for overseeing resource sharing policies and for
assessing the appropriateness and adequacy of any proposed resource sharing
To provide further clarification of the NIH policy on disseminating unique
research resources, NIH published Principles and
Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and
Disseminating Biomedical Research Resources (64 FR 72090, December 23, 1999; http://grants.nih.gov/grants/intell-property_64FR72090.pdf). This document will assist grantees in determining reasonable terms and conditions for disseminating and acquiring research tools.
The terms of those agreements also must reflect the objectives of the Bayh-Dole Act and the Technology
Transfer Commercialization Act of 2000 to ensure that inventions made are used
in a manner to promote free competition and enterprise without unduly
encumbering future research and discovery.
In addition to sharing research resources with the research community, upon
request of the NIH awarding IC, the grantee also must provide a copy of
documents or a sample of any material developed under an NIH grant award. The
grantee may charge a nominal fee to cover shipping costs for providing this
material. Income earned from these charges must be treated as program income
(see Administrative Requirements—Management
Systems and Procedures—Program Income).
To facilitate the availability of unique or novel materials and resources
developed with NIH funds, investigators may distribute the materials through
their own laboratory or organization or submit them, if appropriate, to
entities such as the American Type Culture Collection or other repositories and
should ensure that those entities distribute them in a way that is consistent
with the above referenced Principles and
Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and
Disseminating Biomedical Research Resources. Investigators are expected
to submit unique biological information, such as DNA sequences or
crystallographic coordinates, to the appropriate data banks so that they can be
made available to the broad scientific community. When distributing unique
resources, investigators are to include pertinent information on the nature,
quality, or characterization of the materials.
188.8.131.52 Data Sharing Policy
NIH believes that data sharing is essential for expedited translation of research
results into knowledge, products, and procedures to improve human health. NIH
endorses the sharing of final research data to serve these and other important
scientific goals and expects and supports the timely release and sharing of
final research data from NIH-supported studies for use by other researchers. “Timely release and sharing”
is defined as no later than the acceptance for
publication of the main findings from the final data set. All
investigator-initiated applications with direct costs of $500,000 or more
(excluding consortium F&A costs) in any single year are expected to address
data-sharing in their application. In some cases, FOAs may request data-sharing
plans for applications that are less than $500,000 (excluding consortium
F&A costs) in any single year.
NIH recognizes that data sharing may be complicated or limited, in some cases, by
organizational policies, local IRB rules, and local, State and Federal laws and
regulations, including the HIPAA Privacy Rule (see Public
Policy Requirements and Objectives—Confidentiality of Patient Records: Health
Insurance Portability and Accountability). The rights and privacy of individuals who
participate in NIH-sponsored research must be protected at all times. Thus,
data intended for broader use should be free of identifiers that would permit
linkages to individual research participants and variables that could lead to
deductive disclosure of the identity of individual subjects. When data-sharing
is limited, applicants should explain such limitations in their data-sharing
Investigators must exercise great care to ensure that resources involving human cells or
tissues do not identify original donors or subjects, directly or through
identifiers such as codes linked to the donors or subjects.
Organizations that believe they will be unable to meet these expectations should promptly
contact the GMO to discuss the circumstances, obtain information that might
enable them to share data, and reach an understanding in advance of an award.
184.108.40.206 Sharing Model Organisms
All applications where the development of
model organisms is anticipated are expected to include a description of a
specific plan for sharing and distributing unique model organism research
resources generated using NIH funding so that other researchers can benefit
from these resources, or state appropriate reasons why such sharing is
restricted or not possible. Model organisms include but are not restricted to
mammalian models, such as the mouse and rat; and non-mammalian models, such as
budding yeast, social amoebae, round worm, fruit fly, zebra fish, and frog.
Research resources to be shared include genetically modified or mutant
organisms, sperm, embryos, protocols for genetic and phenotypic screens,
mutagenesis protocols, and genetic and phenotypic data for all mutant strains.
This expectation is for all applications where the development of model
organisms is anticipated, regardless of funding amount.
For additional information on this policy,
see the NIH Model Organism for Biomedical Research Web site at: http://www.nih.gov/science/models/.
220.127.116.11 Policy for Genome-Wide Association Studies (GWAS)
NIH is interested in advancing GWAS to
identify common genetic factors that influence health and disease through a
centralized GWAS data repository. For the purposes of this policy, a genome-wide
association study is defined as any study of genetic variation across the
entire human genome that is designed to identify genetic associations with
observable traits (such as blood pressure or weight), or the presence or
absence of a disease or condition.
All applications, regardless of the amount
requested, proposing a genome-wide association study are expected to provide a
plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. For additional information see: http://grants.nih.gov/grants/gwas/.
8.2.4 Inventions and Patents
The Bayh-Dole Act of 1980 (Public Law 96-517; 35 U.S.C.
200-212) and the related EO 12591 (April 10, 1987) provide incentives for the
practical application of research supported through Federal funding agreements.
To be able to retain rights and title to inventions made with Federal funds,
so-called “subject” inventions, the grantee must comply with a series of
regulations that ensure the timely transfer of the technology to the private
sector, while protecting limited rights of the Federal government.
The regulations apply to any subject invention—defined as
any invention either conceived or first actually reduced to practice in the
performance of work under the Federal award—and to all types of recipients of
Federal funding. This includes non-profit entities and small businesses or
large businesses receiving funding through grants, cooperative agreements, or
contracts as direct recipients of funds, or as consortium participants or
subcontractors under those awards.
Some of the steps required by the regulation to retain
intellectual property rights to subject inventions include:
- Report all subject inventions to NIH.
- Make efforts to commercialize the subject
invention through patent or licensing.
- Formally acknowledge the Federal government’s
support in all patents that arise from the subject invention.
- Formally grant the Federal government a limited
use license to the subject invention.
Exhibit 8 summarizes recipient responsibilities for
invention reporting as specified in the regulations in 37 CFR part 401.
Grantees should refer to 37 CFR part 401 (available on the Interagency Edison
site: https://s-edison.info.nih.gov/iEdison/) for a complete
discussion of the regulations.
Exhibit 8. Extramural Invention Reporting Compliance Responsibilities
|Invention Reporting Requirement
||When Action Must Be Taken
||37 CFR part 401 Reference
|Employee Agreement to Disclose All Inventions
||Grantee employees working under the funding award (e.g.,
PD/PI) must sign an agreement to abide by the terms of the Bayh-Dole Act and the NIHGPS as they relate to
intellectual property rights.
||At time of employment-term of employment.
||Grantee organizations and consortium participants must
have policies in place regarding ownership of intellectual property,
including conflict of interest issues.
|Invention Report and “Disclosure”
||The grantee organization must submit to NIH a report of
any subject invention. This includes a written description (the so-called “invention disclosure”) of the invention that is complete in technical
||Within 2 months of the inventor’s initial report of the
invention to the grantee organization.
||There is no single format for disclosing the invention to
the Federal government. The report must identify inventor(s), NIH grant
number, and date of any public disclosure.
|Rights to Consortium Participant
||Consortium participants under NIH grants retain rights to
any subject inventions they make.
||Within 2 months of the inventor’s initial report of the
invention to the consortium participant. (The consortium participant has the
same invention reporting obligations as the grantee.)
||The grantee cannot require ownership of a consortium
participant’s subject inventions as a term of the consortium agreement.
|Election of Title to Invention
||The grantee must notify NIH of its decision to retain or
waive title to invention and patent rights.
||Within 2 years of the initial reporting of the invention
||For each invention, the grantee must provide a user
license to NIH for each invention.
||When the initial non-provisional patent application is
||The grantee must inform NIH of the filing of any
non-provisional patent application. The patent application must include a
Federal government support clause.
||Within 1 year after election of title, unless there is an
||Initial patent application is defined as a non-provisional
application. The patent application number and filing date must be provided.
The following language is to be used on patent application: “This invention
was made with government support under (identify the funding award) awarded
by (identify the IC and Federal Agency). The government has certain rights in
the invention. All communications for such requests must be sent to OER.”
|Assignment of Rights to Third Party
||If the grantee is a non-profit organization, it must ask
NIH approval to assign invention or U.S.
patent rights to any third party, including the inventor(s).
||As needed. All communication for such requests must be
sent to OER. The NIH Office of Technology Transfer serves in an advisory
capacity to OER for the processing of such assignment requests.
||Grantees that are for-profit entities (including small
businesses) do not need to ask approval, but ongoing reporting remains a
requirement for each invention.
||The grantee must notify NIH that a patent has been issued.
||When the patent is issued.
||The patent issue date, number, and evidence of Federal
government support clause must be provided.
|Extension of Time to Elect Title or
||The grantee may request an extension of up to 2 years for
election of title, or an extension of up to 1 year for filing a patent
||Request for extension of time must be made. Such requests
|Change in Patent Application Status
||The grantee must notify NIH of changes in patent status.
||At least 30 days before any pending patent office
||This notification allows NIH to consider continuing the
|Invention Utilization Report
||The grantee must submit information about the status of
commercialization of any invention for which title has been elected.
||This report gives an indication of whether the objectives
of the law are being met. Specific reporting requirements can be found in iEdison (http://iEdison.gov).
|Annual Invention Statement
||The grantee must indicate any inventions made during the
previous budget period on all grant awards.
||Part of all competing applications and non-competing
continuation progress reports.
||The information is requested as a checklist item on the
PHS 398 application and on the non-competing continuation progress report.
||PHS 398 and
|Final Invention Statement and
||The grantee must submit to the NIH awarding IC GMO a
summary of all inventions made during the entire term of each grant award.
||Within 90 days after the project period (competitive
||Required information is specified on the HHS 568 form. If
no inventions occurred during the project period, a negative report must be
Failure of the grantee to comply with any of these or other
regulations cited in 37 CFR part 401 may result in the loss of patent rights or
a withholding of additional grant funds.
The Bayh-Dole Act includes provisions for the grantee to assign
invention rights to third parties. Grantees that are non-profit organizations
must request NIH approval for the assignment. If the assignment is approved and
the rights are assigned to a third party, invention and patent reporting
requirements apply to the third party. The grantee should review existing
agreements with third parties and revise them, as appropriate, to ensure they
are consistent with the terms and conditions of their NIH grant awards and that
the objectives of the Bayh-Dole Act are adequately
represented in the assignment.
Any invention made using funds awarded for educational
purposes, e.g. fellowships, training grants or certain types of career
development awards, is not considered a subject invention and therefore is not
subject to invention reporting requirements (as provided in 45 CFR part 74 and 37
CFR part 401.1(b)). The grantee should seek the advice of NIH to verify whether any
invention made under a career development award should be considered a subject
Details regarding invention reporting and iEdison are discussed under Administrative
All issues or questions regarding extramural technology
transfer policy and reporting of inventions and their utilization should be
referred to the Division of Extramural
Inventions and Technology Resources Branch, OPERA, OER. See Part III for
8.3 Management Systems and Procedures
Grantee organizations are expected to have systems,
policies, and procedures in place by which they manage funds and activities.
Grantees may use their existing systems to manage NIH grant funds and
activities as long as they are consistently applied regardless of the source of
funds and meet the standards and requirements set forth in 45 CFR part 74 or part 92
and the NIHGPS. NIH may review the adequacy of those systems and may take
appropriate action, as necessary, to protect the Federal government’s
interests, including, but not limited to, the use of special terms and
conditions. NIH also will oversee the grantee’s systems as part of its routine
post-award monitoring. The grantee’s systems also are subject to audit (see Administrative Requirements—Monitoring—Audit).
NIH seeks to foster within grantee organizations an
organizational culture that is committed to compliance, leading to both
exemplary research and exemplary supporting systems and use of resources to
underpin that research. Actions to achieve this result should include a clear
delineation of the roles and responsibilities of the organization’s staff, both
programmatic and administrative; written policies and procedures; training;
management controls and other internal controls; performance assessment;
administrative simplifications; and information sharing.
Management System Standards
Grantees are required to meet the standards and requirements
for financial management systems set forth or referenced in 45 CFR part 74.21 or
92.20, as applicable. The standards and requirements for a financial management
system are essential to the grant relationship. NIH cannot support the research
unless it has assurance that its funds will be used appropriately, adequate
documentation of transactions will be maintained, and assets will be
Grantees must have in place accounting and internal control
systems that provide for appropriate monitoring of grant accounts to ensure
that obligations and expenditures are reasonable, allocable, and allowable. In
addition, the systems must be able to identify large unobligated balances,
accelerated expenditures, inappropriate cost
transfers, and other inappropriate obligation and expenditure of funds.
Grantees must notify NIH when problems are identified.
A grantee’s failure to establish adequate control systems
constitutes a material violation of the terms of the award. Under these
circumstances, NIH may include special conditions on awards or take any of the
range of actions specified in Administrative
Requirements—Enforcement Actions, as necessary and appropriate.
Program income is gross income—earned by a grantee, a
consortium participant, or a contractor under a grant—that was directly
generated by the grant-supported activity or earned as a result of the award.
Program income includes, but is not limited to, income from fees for services
performed; charges for the use or rental of real property, equipment or
supplies acquired under the grant; the sale of commodities or items fabricated
under an award; charges for research resources; registration fees for
grant-supported conferences, and license fees and royalties on patents and
copyrights. (Note: Program income from license fees and royalties from
copyrighted material, patents, and inventions is exempt from reporting
requirements unless otherwise specified in the terms and conditions of award.)
The requirements for accountability for these various types of income under NIH
grants are specified in this subsection. Accountability refers to whether NIH
will specify how the income is to be used and whether the income needs to be
reported to NIH and for what length of time. Unless otherwise specified in the
terms and conditions of the award, NIH grantees are not accountable for program
income accrued after the period of grant support.
NIH applies the additive alternative to all grantees,
including for-profit entities, unless there is a concern with the recipient or
activity and NIH uses special terms and conditions, or the program requires a
different program income alternative. NIH may require a different use of
program income if a grantee has deficient systems; if the PD/PI has a history
of frequent, large annual unobligated balances on previous grants; or if the
PD/PI has requested multiple extensions of the final budget period of the
project period. Regardless of the alternative applied, program income may be
used only for allowable costs in accordance with the applicable cost principles
and the terms and conditions of the award. Each NoA will indicate the allowable treatment of program income. Program income
alternatives and their usage are noted below in Exhibit 9.
Consortium agreements and contracts under grants are subject
to the terms of the agreement or contract with regard to the income generated
by the activities, but the terms specified by the grantee must be consistent
with the requirements of the grant award. Program income must be reported by
the grantee as discussed in this subsection.
18.104.22.168 Reporting Program Income
The amount of program income earned and the amount expended
must be reported on the appropriate annual financial report, currently the FFR.
Any costs associated with the generation of the gross amount of program income
that are not charged to the grant should be deducted from the gross program
income earned, and the net program income should be the amount reported.
Program income must be reported in the Program Income section of the FFR (lines
10 L – O). (See Administrative
Requirements—Monitoring—Reporting—Financial Reporting.) For awards under
SNAP, the amount of program income earned must be reported in the non-competing
continuation progress report.
Income resulting from royalties or licensing fees is
generally exempt from reporting as program income.
When applicable, income earned from the sale of equipment
must be reported on the FFR for the period in which the proceeds are received
in accordance with the reporting requirements for the program income
alternative specified. Amounts due NIH for unused supplies must be reflected as
a credit to the grant on the FFR using line 10 m.
Reporting requirements for accountable income accrued after
grant support ends will be specified in the NoA.
Exhibit 9. Use and Applicability of Program Income Alternatives
|Program Income Alternative
||Use of Program Income
||Added to funds committed to
the project or program and used to further eligible project or program
||Applies to all NIH awards
unless there is a concern with the recipient or activity or the program
requires a different alternative.
||Deducted from total
allowable costs of the project or program to determine the net allowable
costs on which the Federal share of costs will be based.
||Available for use by NIH
programs on an exception basis.
||Uses all program income up
to (and including) $25,000 as specified under the additive alternative and
any amount of program income exceeding $25,000 under the deductive
||Available for use by NIH
programs on an exception basis.
||Used to satisfy all or part of the non-Federal share of a
project or program.
||Available for use by NIH programs that require matching.
of Real Property, Equipment, and Supplies
The requirements that apply to the sale of real property are
addressed in the Construction Grants chapter. For equipment and supplies purchased under NIH grants for basic or
applied research by non-profit institutions of higher education or non-profit
organizations whose principal purpose is the conduct of scientific research,
the grantee is exempt from any requirement to account to NIH for proceeds from
the sale of the equipment or supplies; however, NIH has certain rights with
respect to such property as specified in Administrative
Requirements—Management Systems and Procedures—Property Management System
All other types of grants and grantees are subject to the
requirements in 45 CFR part 74.34 or 92.32 if title to the equipment vests in the
grantee rather than in NIH. If the grant-supported project or program for which
equipment was acquired is still receiving NIH funding at the time of sale, the
grantee must credit the NIH share of the proceeds to the grant and use that
amount under the deductive alternative for program income. If the grantee is no
longer receiving NIH grant support, the amount due should be paid in accordance
with instructions from NIH. These grants and grantees also are subject to the
requirements in 45 CFR part 74.35 or 92.33 with respect to the use or sale of unused
supplies. If the grantee retains the supplies for use on other than federally
sponsored activities, an amount is due NIH as if they were sold.
22.214.171.124 Royalties and Licensing Fees from Copyrights, Inventions, and
NIH grantees do not have to report program income resulting
from royalties or licensing fees from sale of copyrighted material unless
specific terms and conditions of the award provide otherwise. The NoA may include special terms and conditions if
commercialization of an invention is an anticipated outcome of a research
However, the regulations implementing the Bayh-Dole Act (37 CFR part 401.14(h)) require reporting of income
resulting from NIH-funded inventions and patents. Specifically, as part of the
annual invention utilization report, grantees must report income generated by
all subject inventions to which title has been elected and by inventions such
as research tools that have been licensed but not patented (see Administrative Requirements—Availability of
Research Results: Publications, Intellectual Property Rights, and Sharing
Research Resources and Administrative
Management System Standards
Generally, grantees may use their own property management
policies and procedures for property purchased, constructed, or fabricated as a
direct cost using NIH grant funds, provided they observe the requirements in 45
CFR parts 74.30 through 74.37 or parts 92.31 through 92.34, as applicable, and the
following. State governments will use, manage, and dispose of equipment
acquired under a grant in accordance with state laws and procedures as
specified in 45 CFR part 92.32.
The dollar threshold for determining the applicability of
several of the requirements in those regulations is based on the unit
acquisition cost of an item of equipment. As defined in 45 CFR part 74.2, the acquisition cost of an item of equipment to the grantee includes
necessary modifications and attachments that make it usable for the purpose for
which it was acquired or fabricated. When such accessories or attachments are
acquired separately and serve to replace, enhance, supplement, or otherwise
modify the equipment’s capacity and they individually meet the definition of equipment (see Glossary in Part I), any required NIH
prior approval for equipment must be observed for each item. However, the
aggregate acquisition cost of an operating piece of equipment will be used to
determine the applicable provisions of 45 CFR part 74.34 or 92.32. If property is
fabricated from individual component parts, each component must itself be
classified as equipment if it meets the definition of equipment. In this case,
the aggregate acquisition cost of the resulting piece of equipment will
determine the appropriate accountability requirements in 45 CFR part 74.34 or 92.32.
Grantees are required to be prudent in the acquisition of
property under a grant-supported project. It is the grantee’s responsibility to
conduct a prior review of each proposed property acquisition to ensure that the
property is needed and that the need cannot be met with property already in the
possession of the organization. If prior approval is required for the
acquisition, the grantee must ensure that appropriate approval is obtained in
advance of the acquisition. The grantee also must follow appropriate
procurement procedures in acquiring property as specified in Administrative Requirements—Management
Systems and Procedures—Procurement System Standards and Requirements.
Recipients of NIH grants other than Federal institutions
cannot be authorized to use Federal supply sources.
126.96.36.199 Real Property
Grants—Real Property Management Standards in IIB for requirements that
apply to the acquisition, use, and disposition of real property. Fixed
equipment that is part of a construction grant is subject to those
188.8.131.52 Equipment and Supplies
In general, title to equipment and supplies acquired by a
grantee with NIH funds vests in the grantee upon acquisition, subject to the
property management requirements of 45 CFR parts 74.31, 74.34, 74.35, and 74.37, or
parts 92.32 and 92.33. Limited exceptions to these general rules are States, which
may use, manage, and dispose of equipment acquired under a grant in accordance
with State laws and procedures, and certain research grant recipients with
exempt property. These requirements do not apply to equipment for which only
depreciation or use allowances are charged, donated equipment, or equipment
acquired primarily for sale or rental rather than for use.
184.108.40.206.1 Exempt Property
Under the Federal Grant and Cooperative Agreement Act, 31
U.S.C. 6306, NIH may permit non-profit institutions of higher education and
non-profit organizations whose primary purpose is the conduct of scientific
research to obtain title to equipment and supplies acquired under grants for
support of basic or applied scientific research without further obligation to
the Federal government. However, there is one exception: NIH has the right to
require transfer of title to equipment with an acquisition cost of $5,000 or
more to the Federal government or to an eligible third party named by the NIH
awarding IC under the conditions specified in 45 CFR part 74.34(h). NIH may exercise
this right within 120 days of the completion or termination of an award or
within 120 days of receipt of an inventory, as provided in 45 CFR part 74.34(h)(2),
whichever is later.
220.127.116.11.2 Nonexempt Property
All other equipment and supplies acquired under all other
NIH grant-supported projects by any other type of grantee are subject to the
full range of acquisition, use, management, and disposition requirements of 45
CFR parts 74.34 and 74.35, or 45 CFR parts 92.32 and 92.33. Property acquired or used under
an NIH grant-supported project, including any federally owned property, also is
subject to the requirements for internal control specified in 45 CFR part 74.21 or
92.20. Pursuant to 45 CFR part 74.37, equipment (and intangible property and debt
instruments) acquired with, or improved with, NIH funds must not be encumbered
without NIH approval.
The grantee’s management system for equipment must meet the
requirements of 45 CFR part 74.34(f) or 92.32, which include the following:
- Records that adequately identify (according to
the criteria specified in the regulations) items of equipment owned or held by
the grantee and state the current location of each item.
- A physical inventory of the equipment, at least
once every 2 years, to verify that the items in the records exist and either
are usable and needed or are surplus (a statistical sampling basis is
- Control procedures and safeguards to prevent
loss, damage, and theft.
- Adequate maintenance procedures to keep the
equipment in good condition.
- Proper sales procedures when the grantee is authorized
to sell the equipment.
For items of equipment having a unit acquisition cost of
$5,000 or more, NIH has the right to require transfer title to the equipment to
the Federal government or to an eligible third party named by the NIH awarding
IC under the conditions specified in 45 CFR parts 74.34(h) and 92.32, respectively.
This right applies to nonexempt property acquired by all types of grantees,
including Federal institutions, under all types of grants under the stipulated
If there is a residual inventory of unused supplies
exceeding $5,000 in aggregate fair market value upon termination or completion
of the grant and if the supplies are not needed for other federally sponsored
programs or projects, the grantee may either retain them for use on other than
federally sponsored activities or sell them, but, in either case, the grantee
must compensate the NIH awarding IC for its share as a credit to the grant.
Recipients of NIH grants must not use equipment acquired
with grant funds to provide services for a fee to compete unfairly with private
companies that provide equivalent services, unless the terms and conditions of
the award provide otherwise.
18.104.22.168.3 Revocable License
As permitted under Federal
property management statutes and regulations and NIH property management
policies, federally owned tangible personal property may be made available to
grantees under a revocable license agreement. The revocable license agreement
between NIH and the grantee provides for the transfer of the equipment for the
period of grant support under the following conditions:
- Title to the property remains with the Federal
- NIH reserves the right to require the property
to be returned to the Federal government should it be determined to be in the
best interests of the Federal government to do so.
- The use to which the grantee puts the property
does not permanently damage it for Federal government use.
- The property is controlled and maintained in
accordance with the requirements of 48 CFR part 45.5 (the FAR).
System Standards and Requirements
Grantees may acquire a variety of goods or services in
connection with a grant-supported project, ranging from those that are
routinely purchased goods or services to those that involve substantive
programmatic work. States may follow the same policies and procedures they use
for procurements from non-Federal funds. All other grantees must follow the
requirements in 45 CFR parts 74.40 through 74.48 or 92.36, as applicable, for the purchase of goods
or services through contracts under grants. The requirements for third-party
activities involving programmatic work are addressed under Consortium Agreements chapter in IIB.
A contract under a grant must be a written agreement between
the grantee and the third party. The contract must, as appropriate, state the
activities to be performed; the time schedule; the policies and requirements
that apply to the contractor, including those required by 45 CFR part 74.48 or
92.36(i) and other terms and conditions of the grant
(these may be incorporated by reference where feasible); the maximum amount of
money for which the grantee may become liable to the third party under the agreement;
and the cost principles to be used in determining allowable costs in the case
of cost-type contracts. The contract must not affect the grantee’s overall
responsibility for the direction of the project and accountability to the
Federal government. Therefore, the agreement must reserve sufficient rights and
control to the grantee to enable it to fulfill its responsibilities.
When a grantee enters into a service-type contract in which
the term is not concurrent with the budget period of the award, the grantee may
charge the costs of the contract to the budget period in which the contract is
executed even though some of the services will be performed in a succeeding
period if the following conditions are met:
- The NIH awarding IC has been made aware of this
situation either at the time of application or through post-award notification.
- The project has been recommended for a project
period extending beyond the current year of support.
- The grantee has a legal commitment to continue
the contract for its full term.
However, costs will be allowable only to the extent that
they are for services provided during the period of NIH support. To limit
liability if continued NIH funding is not forthcoming, it is recommended that
grantees insert a clause in such contracts of $100,000 or less stipulating that
payment beyond the end of the current budget period is contingent on continued
Federal funding. The contract provisions prescribed by 45 CFR parts 74.48 and 92.36(i)(2) specify termination provisions for contracts in excess
22.214.171.124 Approval Requirements
The procurement standards in
45 CFR parts 74.44 and 92.36(g) allow NIH to require approval of specific procurement
transactions under the following circumstances (and provide a mechanism for
governmental grantees to be exempt from this type of review):
- A grantee’s procurement procedures or operations
do not comply with the procurement standards required by those regulations.
- The procurement is expected to exceed the “simplified acquisition threshold” (currently $100,000) (formerly the “small
purchase threshold”) established by the Federal Property and Administrative
Services Act, as amended, and is to be awarded without competition or only one
bid or proposal is received in response to a solicitation.
- A procurement that will exceed the simplified
acquisition threshold specifies a “brand name” product.
- A proposed award over the simplified acquisition
threshold is to be awarded to other than the apparent low bidder under a
- A proposed contract modification changes the
scope of a contract or increases the contract amount by more than the amount
considered to be a simplified acquisition.
When NIH prior approval is required, the grantee must make
available sufficient information to enable review. This may include, at NIH
discretion, presolicitation technical specifications
or documents, such as requests for proposals or invitations for bids, or
independent cost estimates. Approval may be deferred pending submission of
additional information by the applicant or grantee or may be conditioned on the
receipt of additional information. Any resulting NIH approval does not
constitute a legal endorsement of the business arrangement by the Federal
government nor does such approval establish NIH as a party to the contract or
any of its provisions.
126.96.36.199 Contracting with Small Businesses,
Minority-Owned Firms, and Women’s Business Enterprises
Grantees must make positive
efforts to use small businesses, minority-owned firms, and women’s business
enterprises as sources of goods and services whenever possible. Grantees should
take the steps outlined in the applicable administrative requirements (45
CFR part 74.44(b) or 45 CFR part 92.36(e)) to implement this policy.
Grantees are responsible for managing the day-to-day
operations of grant-supported activities using their established controls and
policies, as long as they are consistent with NIH requirements. However, to
fulfill their role in regard to the stewardship of Federal funds, NIH awarding
ICs monitor their 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. The names and telephone
numbers of the individuals responsible for monitoring the programmatic and
business management aspects of a project or activity will be provided to the
grantee at the time of award.
Monitoring of a project or activity will continue for as
long as NIH retains a financial interest in the project or activity as a result
of property accountability, audit, and other requirements that may continue for
a period of time after the grant is administratively closed out and NIH is no
longer providing active grant support (see Administrative
NIH requires that grantees periodically submit financial and
progress reports. Other required reports may include annual invention
utilization reports, lobbying disclosures, conflict of interest reports, audit
reports, reports to the appropriate payment points (in accordance with
instructions received from the payment office), and specialized programmatic
reports. Grantees also are expected to publish the results of research in
peer-reviewed journals and to provide information to the public on the
objectives, methodology, and findings of their NIH-supported research
activities, as specified in Administrative
Requirements—Availability of Research Results: Publications, Intellectual
Property Rights, and Sharing Research Resources.
The GMO is the official receipt point for most required
reports. However, NIH has centralized the submission of annual progress
reports; details are provided below. In addition, electronic submission through
the eRA Commons is required for some annual progress
reports (SNAPs) and available for all closeout documents (final grant progress
reports, final invention statements and certifications, and final financial
status reports). When a paper (non-SNAP) non-competing continuation progress
report is submitted, only a signed original is required; no copies are
required. Submission of these reports to an address other than the centralized
one may result in delays in processing of the non-competing continuation award
or the submission being considered delinquent. FFRs must be electronically
submitted to OFM (see Financial Reports below) through the eRA Commons eFFR feature unless otherwise indicated in the award’s terms and conditions.
Grantees are allowed a specified period of time in which to
submit required financial and final progress reports (see 45 CFR parts 74.51 and
74.52, 92.40 and 92.41, and the discussion in this subsection). Failure to
submit complete, accurate, and timely reports may indicate the need for closer
monitoring by NIH or may result in possible award delays or enforcement actions,
including withholding, removal of certain NIH Standard Terms of Award, or
conversion to a reimbursement payment method (also see Administrative
Requirements—Enforcement Actions). The schedule for submission of
the non-competing continuation progress report is discussed in the next
188.8.131.52 Non-Competing Continuation Progress Reports
Progress reports usually are required
annually as part of the non-competing continuation award process. NIH may
require these reports more frequently. The “Non-Competing Continuation Progress
Report” (PHS 2590) or equivalent documentation must be submitted to, and
approved by, NIH to non-competitively fund each additional budget period within
a previously approved project period (competitive segment). Except for awards
subject to SNAP, the progress report includes an updated budget in addition to
other required information.
The information to be included in the
progress report is specified in the PHS 2590 instructions, which also include
alternate instructions for awards under SNAP (as described in the next
subsection). Forms for paper non-competing continuation progress reports are
available at http://grants.nih.gov/grants/funding/2590/2590.htm.
The non-competing Progress Report includes
an All Personnel Report on which the grantee must report all individuals who
devoted one person month or more effort to the project. The eRA Commons ID must be provided on this report for those who worked on the project
in a postdoctoral role.
NIH has centralized the mailing of paper annual
non-competing continuation grant progress reports submitted for all NIH ICs. The
centralized mailing address is found in Part III.
Note paper progress reports are only accepted for the non-SNAP progress
reports. All SNAP progress reports must be submitted electronically (see Submitting SNAP Progress Reports below).
Grantees should routinely query and review
the list of pending grant progress reports and due dates available at the NIH
Web site (http://era.nih.gov/commons/quick_queries/index.cfm#progress).
Late submission or receipt of an incomplete grant progress report will result
in delaying the issuance and funding of the non-competing continuation award
and may result in a reduced award amount.
The progress report for the final budget period
of a competitive segment for which a competing continuation application is
submitted will be part of that application; however, if an award is not made or
the grantee does not submit an application for continued support, a final
progress report is required (see Administrative Requirements—Closeout—Final
Reports—Final Progress Report).
The NIH awarding IC will specify the
requirements for progress reporting under construction grants or grants
supporting both construction activities, including acquisition or
modernization, major alteration and renovation, and non-construction
184.108.40.206 Streamlined Non-Competing Award Process
SNAP includes a number of provisions that
modify annual progress reports, NoAs, and financial
The NoA will
specify whether an award is subject to SNAP. Awards routinely included in SNAP
are "K" awards and "R" awards, except R35. Awards excluded from SNAP are those
that generally do not have the authority to automatically carry over
unobligated balances (centers; cooperative agreements, Kirschstein-NRSA
institutional research training grants, non-Fast Track Phase I SBIR and STTR
awards), clinical trials (regardless of activity code), P01, R35, and awards to
individuals. In addition, specific awards may be excluded from SNAP if:
- they require close project monitoring or
technical assistance, e.g., high-risk grantees, certain large individual or multi-project
grants, or grants with significant unobligated balances, or
- the grantee has a consistent pattern of failure
to adhere to appropriate reporting or notification deadlines.
220.127.116.11.1 Modified Annual Progress Reports
A SNAP progress report is a streamlined version
of the annual progress report requirements. Only limited information is
required for each submission.
- IRB and IACUC approval dates are not required as
part of each submission. It remains an institutional responsibility to ensure
that these reviews are conducted in accordance with all Federal requirements.
The Federalwide (human subjects) and Animal Welfare
Assurance numbers for the grantee organization are maintained in the
Institutional Profile section of the eRA Commons.
Actual approval dates must be submitted to NIH upon request.
- No detailed budget information is required;
instead, grantees provide answers to the following key questions:
there been a change in the “other support” of senior/key personnel since the
last reporting period? If yes, explain the change(s); if no, so state.
Specific information is to be provided only if active support has changed. If a
previously active grant has terminated and/or if a previously pending grant is
now active, the grantee must submit complete Other Support information using the
suggested format and instructions found in the PHS 398 application (http://grants.nih.gov/grants/funding/phs398/phs398.html).
Annotate this information so it is clear what has changed from the previous
submission. Submission of other support information is not necessary if support
is pending or for changes in the level of effort for active support reported
Other support information should be submitted only for the PD/PI and all other
individuals considered by the PD/PI to be scientifically key to the project.
Senior/key personnel are defined as individuals who contribute in a substantive
measurable way to the scientific development or execution of the project,
whether or not a salary is requested. Do not routinely include Other Support
information for Other
e.g., those that may contribute to the scientific development or execution of
the project, but are not committing any specified measurable effort to the
project. However, if the level of involvement for an individual previously
listed in this category has changed such that they are now considered senior/key personnel,
this change should be indicated in this section and Other Support information
there be, in the next budget period, a significant change in the level of
effort for the PD/PI(s) or other senior/key personnel named in the NoA from what was approved for this project? If
yes, explain the change(s) (e.g., decreased level of effort from 4.8 CY months
to 3.6 CY months); if no, so state. A “significant change” in level of effort
is defined in Federal regulations as a 25 percent or greater reduction in time
devoted to the project.
it anticipated that an estimated unobligated balance (including prior-year
carryover) will be greater than 25 percent of the current year’s total approved
budget? If yes, the grantee is required to explain why there is a
significant balance and how it will be spent if carried forward into the next
budget period. If no, so state. The “total approved budget” equals the current
fiscal year award authorization plus any carryover of funds from a prior year.
The numerator equals the total amount available for carryover and the
denominator equals the current year’s total approved budget.
- If there is a change in performance site or
anticipated program income, grantees also must submit the PHS 2590 checklist.
If program income is anticipated, the progress report should reflect the
estimated amount and source of the income.
Specific instructions for answering the SNAP
questions as well as modified requirements of SNAP progress reports are in the
PHS 2590 Instructions, http://grants.nih.gov/grants/funding/2590/2590.htm.
The NIH awarding IC will rely on the
grantee’s assessment of whether significant changes have occurred or will occur
in these areas. NIH program or grants management staff may require additional
information to evaluate the project for continued funding. Failure to provide
this information will result in a delayed award. Incomplete or inadequate progress
reports may be returned for revision and may result in a delay of continued
18.104.22.168.2 Modified NoAs
Under SNAP, the GMO negotiates the direct
costs for the entire competitive segment at the time of the competing award or,
in the case of modular awards, determines the applicable number of modules for
each budget period within the competitive segment. This eliminates the need for
annual budget submissions and any negotiations, and reduces the information NIH
requires to review and approve non-competing continuation awards and to monitor
these awards. SNAP NoAs are issued with only total
direct and F&A costs awarded for the budget period. While direct costs
categorical breakdowns are not awarded, grantees are required to allocate and
account for costs by category in accordance with applicable cost principles.
Future year commitments on SNAP awards reflect total cost commitments (direct
plus F&A costs).
22.214.171.124.3 Modified Financial Reporting Requirements
For awards under SNAP (other than awards to
foreign organizations or Federal institutions), an FFR is required only at the
end of a competitive segment rather than annually. The FFR must be submitted
within 90 days after the end of the competitive segment and must report on the
cumulative support awarded for the entire segment. An FSR must be submitted at
this time whether or not a competing continuation award is made. If no further
award is made, this report will serve as the final FFR (see Administrative Requirements—Closeout).
For awards under SNAP, grantees (other than foreign grantees and Federal
institutions) also are required to submit a quarterly FFR to PMS. Foreign
organizations and Federal institutions must submit an annual FFR even if an
award is under SNAP. (Also see Administrative
126.96.36.199.4 Submitting SNAP Progress Reports
All SNAP progress reports are due no later
than 45 days before the next budget start date and must be submitted
electronically. Paper submissions are not acceptable, will not be used for
consideration for funding, and will not become part of the official file. If a
paper SNAP progress report is submitted, grantees will be required to resubmit
the information electronically.
The electronic Streamlined Non-Competing
Award Process (eSNAP) is a module in the eRA Commons that allows
grantees to electronically prepare and submit SNAP progress reports and supporting
documentation. eSNAP provides the user with dedicated
screens to collect the required SNAP progress report information, including
appropriate uploads for text documents. Data submitted through eSNAP for Performance Sites and All Personnel is retained
in the system for easy update in the future year submission.
When using eSNAP to electronically prepare and submit the SNAP progress report, do not use the
PHS 2590 fillable form pages for any file uploads. (Text
inserted into the fillable form pages is not saved.)
Electronic routing of eSNAP information to authorizing officials at the applicant institution for review
and approval prior to submission to NIH is also a feature of the eSNAP system. In addition, eSNAP provides grantees with the option to delegate to the PD/PI the authority to
submit the progress report directly to NIH. This optional authority is managed
on a PD/PI basis in the eSNAP system; such authority
can be rescinded at any time.
Guidance on eSNAP submission is documented in the eSNAP User Guide
found at: http://era.nih.gov/commons/index.cfm.
For more information on eSNAP, see https://commons.era.nih.gov/ commons/index.jsp.
188.8.131.52 Final Progress Reports
A final progress report is required for any
grant that is terminated and any award that will not be extended through award
of a new competitive segment. Instructions for the final progress report are
found in the PHS 2590. Grantees should also review the information found in Administrative Requirements—Closeout—Final
184.108.40.206 Financial Reports
Two types of financial reports are typically used. Cash
transaction data is submitted on a quarterly basis directly to PMS. Expenditure
data is submitted directly to the NIH. Historically this data was submitted
using 2 separate forms, the SF272 and the SF269. A new form, the SF425 called
the Federal Financial Form (FFR), is now used for collecting both types of financial
data. For NIH grantees, it is important to note that while the data is now
submitted using the same form, there is no change in the actual receipt and
processing of data. Cash transaction data continues to be submitted directly to
and processed by PMS. Expenditure data continues to be
submitted directly to and processed by NIH.
220.127.116.11.1 Cash Transaction Reports
The FFR has a dedicated section to report Federal cash
receipts and disbursements. This information is submitted quarterly directly to
the PMS using the web-based tool. Quarterly reports are due 30 days the end of
each calendar quarter. The reporting period for this report continues to be
based on the calendar quarter. Questions concerning the requirements for this
quarterly financial report should be directed to the PMS.
18.104.22.168.2 Financial Expenditure Reports
Reports of expenditures are required as documentation of the
financial status of grants according to the official accounting records of the
grantee organization. NIH is transitioning the reporting of expenditure from
the FSR to the FFR. NIH requires all financial expenditure reports to be
submitted using the eFSR/FFR system located in the eRA Commons. This includes all initial FSR/FFRs being
prepared for submission and any revised FSR/FFRs being submitted or
re-submitted to NIH. The eRA Commons eFSR/FFR system allows participants to view information on
currently due and late expenditure reports and to submit these reports
electronically to NIH. Paper expenditure reports are not accepted. Expenditure
data submitted to NIH is initially reviewed and accepted by OFM. NIH IC grants
management staff also review these expenditure reports.
Except for awards under SNAP and awards that require more
frequent reporting, the FSR/FFR is required on an annual basis. An annual
FSR/FFR 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 reporting period for an annual FSR/FFR will continue to be that of the
budget period for the particular grant; however, the actual submission date is
now based on the calendar quarter. Failure to submit timely reports may affect
future funding. 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.
For domestic awards under SNAP, in lieu of the annual
FSR/FFR, NIH will monitor the financial aspects of grants by using the
quarterly cash transaction information submitted directly to PMS using the FFR.
The GMO may review the report for patterns of cash expenditures, including
accelerated or delayed drawdowns, and to assess
whether performance or financial management problems exist. For these awards,
an FSR/FFR is required only at the end of a competitive segment. It must be
submitted within 90 days after the end of the competitive segment and must
report on the cumulative support awarded for the entire segment. An FSR/FFR
must be submitted at this time whether or not a competing continuation award is
made. If no further award is made, this report will serve as the final FSR/FFR
(see Administrative Requirements—Closeout).
Before submitting FSR/FFRs to NIH, grantees must ensure that
the information submitted is accurate, complete, and consistent with the
grantee’s accounting system. When submitting the FSR/FFR through the eRA Commons, the AOR or the individual designated to submit
this report on behalf of their institution, certifies that the information in
the FSR/FFR is correct and complete and that all outlays and obligations are
for the purposes set forth in grant documents, and represents a claim to the
Federal government. Filing a false claim may result in the imposition of civil
or criminal penalties.
Revised Expenditure Reports. NIH requires all financial expenditure reports
(domestic and foreign) to be submitted using the electronic FSR/FFR system
located in eRA Commons. This includes the initial FFR
and any FSR/FFR revisions being submitted or re-submitted to NIH. In some cases
the grantee may have to revise or amend a previously submitted FSR/FFR. The
revised report should be submitted in the same format as the original; e.g., if
the original was an FSR, the revision will also be submitted using the FSR
format. When the revision results in a balance due to NIH, the grantee must
submit a revised report whenever the overcharge is discovered, no matter how
long the lapse of time since the original due date of the report. Revised
expenditure reports representing additional expenditures by the grantee that
were not reported to NIH within the 90-day time frame may be submitted
electronically through the eFSR/FFR system to OFM
with an explanation for the revision. The explanation also should indicate why
the revision is necessary and describe what action is being taken by the
grantee to preclude similar situations in the future. This should be done as
promptly as possible, but no later than 1 year from the due date of the
original report, i.e., 15 months following the end of the budget period (or
competitive segment for awards under SNAP). If an adjustment is to be made, the
NIH awarding IC will advise the grantee of actions it will take to reflect the
22.214.171.124.3 Unobligated Balances and Actual Expenditures
Disposition of unobligated balances is determined in
accordance with the terms and conditions of the award. (See Administrative Requirements—Changes in Project
and Budget for NIH approval authorities for unobligated balances.) Using the
principle of “first in-first out,” unobligated funds carried over are expected
to be used before newly awarded funds.
Upon receipt of the annual
FSR/FFR for awards other than those with authority for the automatic carryover
of unobligated balances, the GMO will compare the total of any unobligated
balance shown and the funds awarded for the current budget period with the NIH
share of the approved budget for the current budget period. If the funds
available exceed the NIH share of the approved budget for the current budget
period, the GMO may select one of the following options:
- In response to a written request from the
grantee, revise the current NoA to authorize the
grantee to spend the excess funds for additional approved purposes.
- Offset the current award or a subsequent award
by an amount representing some or all of the excess.
126.96.36.199.4 Recipient Reporting of Subrecipient Data and Executive Compensation Information for Federal Funding Accountability and Transparency Act (FFATA)
A component of Public Law 109-282, the Federal
Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires
most recipients of new Federal funds awarded on or after October 1, 2010 to report
on subawards/subcontracts/consortiums equal to or
greater than $25,000. This includes awards that are initially below $25,000 but subsequent grant modifications
result in an award equal to or greater than $25,000.
The FFATA Subaward Reporting
System (FSRS) tool can be accessed directly at www.fsrs.gov, and will serve as the collection tool for subaward data which will ultimately be distributed for
publication and display on www.USASpending.gov.
Grantees are required to register with FSRS, collect the necessary data from subawardees, and file subaward reports by the end of the month following the month in which the prime grantee
awards any subaward greater than $25,000.
FFATA specifies the data that should be captured for each prime
recipient and first-tier subrecipient of Federal
awards, regardless of award type. To promote data consistency and reduce
reporting burdens, existing agency data sources will be leveraged to pre-populate
reports for prime awardees as well as for subawardees when available. Recipients are responsible for confirming the pre-populated
data and providing any additional required information.
Included in these requirements is the need to report the names and total compensation of the five most highly compensated officers of the entity if the entity as part of their registration profile in CCR in the preceding fiscal year: 1) received 80 percent or more of its annual gross revenues in Federal grants, subawards, contracts, and subcontracts; and 2) received $25,000,000 or more in annual gross revenues from Federal grants, subawards, contracts, and subcontracts; and 3) had gross income, from all sources, of $300,000 or more; and 4) the public does not have access to this information about the compensation of the senior executives of the entity through periodic reports filed under section section 13(a) or 15(d) of the
Securities Exchange Act of 1934 (15 U.S.C. §§ 78m(a), 78o(d)) or section 6104
of the Internal Revenue Code of 1986. See FFATA § 2(b)(1). Additionally, recipient organizations may be required to verify the following information in FSRS:
- Organization DUNS number
- Name and Address of organization
- Parent DUNS number
- CFDA number
- Federal Award Identification Number (FAIN)
- Federal Awarding Agency of the grant
188.8.131.52 Invention Reporting
A complete list of the reporting requirements under the Bayh-Dole Act can be found at 37 CFR part 401.14. The
requirements also are specified in Administrative
Requirements—Availability of Research Results: Publications, Intellectual
Property Rights, and Sharing Research Resources.
In addition to complying with Bayh-Dole-related
regulations, each NIH competing grant application and non-competing
continuation progress report must indicate whether or not any subject
inventions were made during the preceding budget period. If inventions were
made, the grantee must also indicate whether they were reported.
The grantee also must submit an annual invention utilization
report for all subject inventions to which title has been elected and
inventions that have been licensed but not patented (research tools). The
utilization report provides a way to evaluate the extent of commercialization
of subject inventions, consistent with the objectives of the Bayh-Dole Act.
A grantee’s failure to comply with invention reporting
requirements and/or associated NIH policies on intellectual property and
resource sharing may result in the loss of patent rights or a withholding of
grant funds or other enforcement actions, including the imposition of special
terms and conditions.
Bayh-Dole regulations allow
grantees to report inventions electronically (37 CFR part 401.16). NIH strongly
supports electronic reporting through an Internet-based system, Interagency
Edison (http://iEdison.gov). To meet
the objectives of the Federal Financial Assistance Management Improvement Act
of 1999 (P.L. 106-107), grantees should make all reasonable efforts to submit
invention reports using iEdison. The system supports
confidential transmission of required information and provides a utility for
generating reports and reminders of pending reporting deadlines. Further
information about the system, including instructions for creating an account
needed to submit reports electronically, are on the iEdison site. Grantees also may contact the Division
of Extramural Inventions and Technology Resources Branch, OPERA, OER. See
Part III for contact information.
Retention and Access
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 under SNAP (other than those to foreign organizations and Federal institutions),
the 3-year retention period will be calculated from the date the FFR for the
entire competitive segment is submitted. Those grantees must retain the records
pertinent to the entire competitive segment for 3 years from the date the FFR
is submitted to NIH. Foreign organizations and Federal institutions must retain
records for 3 years from the date of submission of the annual FSR to NIH. See
45 CFR parts 74.53 and 92.42 for exceptions and qualifications to the 3-year
retention requirement (e.g., if any litigation, claim, financial management
review, or audit is started before the expiration of the 3-year period, the
records must be retained until all litigation, claims, or audit findings
involving the records have been resolved and final action taken). Those
sections also specify the retention period for other types of grant-related
records, including F&A cost proposals and property records. See 45 CFR
parts 74.48 and 92.36 for record retention and access requirements for contracts
These record retention policies apply to both paper and
electronic storage of applicable information, including electronic storage of
faxes, copies of paper document, images, and other electronic media.
Institutions that rely on an electronic storage system must be able to assure
such a system is stable, reliable, and maintains the integrity of the
information. When storing electronic images of paper documents, the system must
also assure a full, complete, and accurate representation of the original,
including all official approvals.
An audit is a systematic
review or appraisal made to determine whether internal accounting and other
control systems provide reasonable assurance of the following:
- Financial operations are properly conducted.
- Financial reports are timely, fair, and
- The entity has complied with applicable laws,
regulations, and other grant terms.
- Resources are managed and used economically and
- Desired results and objectives are being
NIH grantees (other than Federal institutions) are subject
to the audit requirements of OMB Circular A-133, as implemented by 45 CFR parts 74.26
and 92.26, or the audit requirements stated in 45 CFR part 74.26(d) and in the
NIHGPS (for types of organizations to which OMB Circular A-133 does not
directly apply). In general, OMB Circular A-133 requires a State government,
local government, or non-profit organization (including institutions of higher
education) that expends $500,000 or more per year under Federal grants,
cooperative agreements, and/or procurement contracts to have an annual audit by
a public accountant or a Federal, State, or local governmental audit
organization. The audit must meet the standards specified in generally accepted
government auditing standards (GAGAS). The audit requirements for foreign
grantees and for-profit grantees are addressed in the chapters of this NIHGPS
that provide specific requirements for those types of grantees.
When a grantee procures audit services, the procurement must
comply with the procurement standards of 45 CFR part 74 or 92, as applicable, including
obtaining competition and making positive efforts to use small businesses,
minority-owned firms, and women’s business enterprises. Grantees should ensure
that comprehensive solicitations made available to interested firms include all
audit requirements and specify the criteria to be used for selection of the
firm. Grantees’ written agreements with auditors must specify the rights and
responsibilities of each party.
OMB Circular A-133 explains
in detail the scope, frequency, and other aspects of the audit. Some highlights
of this Circular are as follows:
- Covered organizations expending $500,000 or more
per year in Federal awards are required to have an audit performed in
accordance with the Circular. However, if the awards are under one program, the
organization can have either a single organization-wide audit or a
program-specific audit of the single program, subject to the provisions of
section 235 of the Circular. NIH’s research awards may not be considered a
single program for this purpose. Covered organizations expending less than
$500,000 in any year are exempt from these audit requirements in that year but
must have their records available for review as required by Administrative Requirements—Monitoring—Record
Retention and Access.
- The reporting package must contain the
statements and schedule of expenditures of Federal awards.
auditor’s report, including an opinion on the financial statements and the
schedule of expenditures of Federal awards, a report on compliance and internal
control over financial reporting, and a report on compliance with requirements
applicable to each major program and on internal control over such compliance
- A schedule of findings and questioned costs.
- If applicable, a summary of prior audit findings and a corrective action plan.
- An audit under OMB Circular A-133 is in lieu of
a financial audit of individual Federal awards. However, Federal agencies may
request additional audits necessary to carry out their responsibilities under
Federal law or regulation. Any additional audits will build upon work performed
by the independent auditor.
- The data collection form and copies of the
reporting package must be submitted to the FAC at the address provided in Part
If the schedule of findings and questioned costs discloses
an audit finding related to an HHS or NIH award or if the schedule of prior
audit findings reports the status of any audit finding relating to an HHS or
NIH award, the FAC will provide copies of the audit report to NEARC, OIG, HHS.
NEARC will, in turn, distribute them within HHS for further action, as
necessary. Audit reports should not be sent directly to the GMO.
Recipients must follow a systematic method for ensuring
timely and appropriate resolution of audit findings and recommendations,
whether discovered as a result of a Federal audit or a recipient-initiated
audit. Grantees usually are allowed 30 days from the date of request to respond
to the responsible audit resolution official (Action Official) concerning audit
findings. Failure to submit timely responses may result in cost disallowance or
other actions by NIH or HHS. At the completion of the audit resolution process,
the grantee will be notified of the Action Official’s final decision. The
grantee may appeal this decision if the adverse determination is of a type covered by the NIH or HHS grant
appeals procedures (see Administrative
Requirements—Grant Appeals Procedures). Refunds owed to the Federal
government as a result of audit disallowances must be made in accordance with
instructions issued by the Action Official or OFM.
It is imperative that grantees submit required OMB Circular
A-133 audits within the time limits specified in the Circular. If grantees are
delinquent in complying with the provisions of the Circular, HHS or NIH will
impose sanctions that may result in the loss of Federal funds. No audit costs
will be allowed either as F&A costs or direct costs to Federal awards if
the required audits have not been completed or have not been conducted in
accordance with the provisions of OMB Circular A-133.
See Cost Considerations—Allowability of Costs/Activities—Selected Items of Cost for the allowability of audit costs.
8.5 Enforcement Actions
A grantee’s failure to comply with the terms and conditions
of award, including confirmed instances of research 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. NIH generally will afford the
grantee an opportunity to correct the deficiencies before taking enforcement
action unless public health or welfare concerns require immediate action.
However, even if a grantee is taking corrective action, NIH may take proactive
action 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 may take action designed to prevent future
non-compliance, such as closer monitoring.
8.5.1 Modification of the Terms of Award
During grant performance, the GMO may include special
conditions in the award to require correction of identified financial or
administrative deficiencies. When the special conditions are imposed, the GMO
will notify the grantee of the nature of the conditions, the reason why they
are being imposed, the type of corrective action needed, the time allowed for
completing corrective actions, and the method for requesting reconsideration of
the conditions. See 42 CFR part 52.9 and 45 CFR part 74.14 or 92.12.
The NIH awarding IC also may withdraw approval of the PD/PI
or other senior/key personnel specifically referenced in the NoA if there is a reasonable basis to conclude that the
PD/PI and other such named senior/key personnel are no longer qualified or
competent to perform. In that case, the awarding IC may request that the
grantee designate a new PD/PI or other named senior/key personnel.
The decision to modify the terms of an award—by imposing
special conditions, by withdrawing approval of the PD/PI or other named
senior/key personnel, or otherwise—is discretionary on the part of the NIH
Termination, and Withholding of Support
If a grantee has failed to materially comply with the terms
and conditions of award, 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 parts 74.61 and 74.62, and in
NIH generally will suspend (rather than immediately
terminate) a grant and allow the grantee an opportunity to take appropriate
corrective action before NIH makes a termination decision. NIH may decide to
terminate the grant if the grantee does not take appropriate corrective action
during the period of suspension. 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 and HHS grant appeals procedures (see Administrative Requirements—Grant Appeals
Procedures). Pending the outcome of an appeal or other action by the
grantee, NIH may award a replacement grant for a limited period of time (up to
18 months) without competition.
A grant also may 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
See Cost Considerations—Allowability of Costs/Activities—Selected 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 at the request of the grantee, or
terminated by mutual agreement.
Withholding of support is a decision not to make a
non-competing continuation award within the current competitive segment.
Support may be withheld for one or more of the following reasons:
- Adequate Federal funds are not available to
support the project.
- A grantee failed to show satisfactory progress
in achieving the objectives of the project.
- A grantee failed to meet the terms and
conditions of a previous award.
- For whatever reason, continued funding would not
be in the best interests of the Federal government.
If a non-competing continuation award is denied (withheld)
because the grantee failed to comply with the terms and conditions of a
previous award, the grantee may appeal that determination.
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 part 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, such as civil action. Suspension under 45 CFR
part 76, implementing E.O.s 12549 and 12689, “Debarment and Suspension,” is a
separate action from the “suspension” of an award as a post-award remedy, as
described in Suspension, Termination,
and Withholding of Support above. The subject of debarment and suspension
as an eligibility criterion is addressed in Completing the Pre-Award Process—Determining
Eligibility of Individuals and Public Policy Requirements
and Objectives—Debarment and Suspension.
8.5.4 Recovery of Funds
NIH may identify and administratively recover funds paid to
a grantee at any time during the life cycle of a grant. Debts may result from
cost disallowances, recovery of funds, unobligated balances, unpaid share of
any required matching or cost sharing, funds in the recipient’s account that
exceed the final amount determined to be allowable,
or other circumstances. NIH may identify and initiate debt collection
activities at any time during the life cycle of a grant.
8.5.5 Debt Collection
The debt collection
process is governed by the Federal Claims Collection Act, as amended (Public
Law [P.L.] 89-508, 80 Stat. 308, July 19, 1966); the Federal Debt Collection
Act of 1982 (P.L. 97-365, 96 Stat. 1749, October 25, 1982); the Debt Collection
Improvement Act (P. L.104-134, 110 Stat. 1321, April 26, 1996); and, the
Federal Claims Collection Standards (31 CFR
parts 900-904), which are implemented for HHS in 45 CFR part 30. NIH is
required to collect debts due to the Federal government and, except where
prohibited by law, to charge interest on all delinquent debts owed to NIH by
When NIH determines
the existence of a debt under a grant, written debt notification will be
provided to the grantee. Unless otherwise specified in law, regulation, or the
terms and conditions of the award, debts are considered delinquent if they are
not paid within 30 days from the date the debt notification is mailed to the
grantee. Delinquent debts are subject to the assessment of interest,
administrative cost charges, and penalties. The interest on delinquent debts
accrues on the amount due beginning on the date the debt notification is mailed
to the grantee.
If a grantee appeals
an adverse monetary determination under 42 CFR part 50, Subpart D, or 45 CFR
part 16, interest will accrue but assessment will be deferred pending a final
decision on the appeal. If the appeal is not successful, interest will be
charged beginning with the date the debt notification was mailed to the
grantee, not the date of the appeal decision. Interest charges will be computed
using the prevailing rate in effect on the date the debt notification is
mailed, as specified by the Department of the Treasury and 45 CFR part 30.13(a)(2). See http://www.hhs.gov/of/library/policy/debt/debtcoll.html.
The requirement for timely closeout is a grantee responsibility.
Failure to submit timely and accurate closeout documents may affect future
funding to the organization. NIH may impose sanctions on institutions that fail
to correct recurring reporting problems. Such sanctions may include, but are
not limited to, corrective actions, removal of authorities, and/or delay or
withholding of further awards to the project or program. NIH will close out a
grant as soon as possible after expiration if the grant will not be extended or
after termination as provided in 45 CFR parts 74.71 through 74.73 and in 45 CFR
part 92.50. Closeout includes ensuring timely and accurate 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 must submit a final
FSR, final progress report, and Final Invention Statement and Certification
within 90 calendar days of the end of grant support.
8.6.1 Final Federal Financial Report
A final FFR is required for
- any grant that is terminated,
- any grant that is transferred to a new grantee,
- any award, including awards under SNAP, which
will not be extended through award of a new competitive segment.
Grantees are required to electronically submit the final FFR
through the eRA Commons (https://commons.era.nih.gov/commons).
The final FFR must cover the period of time since the previous FSR/FFR
submission or, for awards under SNAP, the entire competitive segment or as much
of the competitive segment as has been funded before termination. Final FFRs
must indicate the exact balance of unobligated funds and may not reflect any unliquidated obligations. There must be no discrepancies
between the Federal share of net outlays reported on the final FFR and the net
cash disbursements reported to PMS on the Federal cash section on the FFR.
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 grantee’s responsibility to reconcile reports submitted to
PMS and to the NIH awarding IC. Withdrawal of the unobligated balance following
expiration or termination of a grant is not considered an adverse action and is
not subject to appeal (see Administrative Requirements—Enforcement
Actions—Recovery of Funds).
When the submission of a
revised final FFR results in additional claims by the grantee, NIH will
consider the approval of such claims subject to the following minimum criteria:
- The grantee must indicate why the revision is
necessary and explain and implement internal controls that will preclude
similar occurrences in the future.
- The charge must represent otherwise allowable
costs under the provisions of the grant.
- There must be an unobligated balance for the
budget period sufficient to cover the claim.
- The funds must still be available for use.
- NIH must receive the revised FSR within 15
months of its original due date.
8.6.2 Final Progress Report
A final progress report is required for any grant that is
terminated and any award that will not be extended through award of a new
competitive segment. If a competitive renewal (Type 2) application has been
submitted, whether funded or not, the progress report contained in that
application may serve in lieu of a separate final progress report. Otherwise, a
final progress report should be prepared in accordance with the requirements in
the PHS 2590 instructions and any specific requirements set forth in the terms
and conditions of the award. At a minimum, the final progress report should
include a summary of progress made toward the achievement of the originally
stated aims, a list of significant results (positive or negative), and a list
of publications. Grantees should also report additional information required by
the awarding IC in program-specific final progress report instructions. The
final progress report also should address the following when applicable:
- Report on the inclusion of gender and minority
study subjects (using the gender and minority inclusion table as provided in
the PHS 2590).
- Where appropriate, indicate whether children
were involved in the study or how the study was relevant for conditions
affecting children (see Public Policy Requirements
and Objectives—Inclusion of Children as Subjects in Clinical Research).
- Describe any data, research materials (such as
cell lines, DNA probes, animal models), protocols, software, or other information
resulting from the research that is available to be shared with other
investigators and how it may be accessed.
- Publications that were authored or co-authored
by the PD/PI and arose from the award must include the NIH Manuscript
Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. If the
PMCID is not yet available because the Journal submits articles directly to PMC
on behalf of their authors, indicate "PMC Journal - In Process." A
list of these Journals is posted at: http://publicaccess.nih.gov/submit_process_journals.htm.
- If there are any other specific requirements set
forth in the terms and conditions of the award, they must be addressed in the
final progress report as well.
8.6.3 Final Invention Statement and
The grantee must submit a Final Invention Statement and
Certification (HHS 568), whether or not the funded project results in any
subject inventions, and whether or not inventions were previously reported. The
HHS 568 must list all inventions that were conceived or first actually reduced
to practice during the course of work under the project, and it must be signed
by an AOR. The completed form should cover the period from the original
effective date of support through the date of expiration or termination or the
award, and it should be submitted to the NIH awarding IC. If there were no inventions,
the form must indicate “None.” For certain programs (activity codes = C06, R13,
R25, S15, Ts, and Fs), the Final Invention Statement and Certification is not
currently required. For questions, the grantee should contact NIH awarding IC
for specific instructions.
When invention reporting is required, the HHS 568 does not
relieve the responsible party of the obligation to assure that all inventions
are promptly and fully reported directly to the NIH, as required by terms of
the award. Copies of the HHS 568 form are available on the iEdison Web site at http://iEdison.gov and at http://grants.nih.gov/grants/forms.htm.
of Closeout Documents
Use of the Closeout feature in the eRA Commons is strongly encouraged. Submission of non-financial closeout documents
(such as the final progress report and HHS 568 Final Invention Statement and
Certification) not submitted through the eRA Commons
may be e-mailed as PDF attachments to the NIH
Central Closeout Center. Paper copies of the final progress report and HHS
568 may be faxed or mailed to the NIH Central
Closeout Center at the contact information provided in Part III.
HHS permits grantees to
appeal to the DAB certain post-award adverse administrative decisions made by
HHS officials (see 45 CFR part 16). NIH has established a first-level grant
appeal procedure that must be exhausted before an appeal may be filed with the
DAB (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 award 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 non-competing
continuation award 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 notification, detailing the nature
of the disagreement with the adverse determination and providing supporting
documents in accordance with the procedures contained in the notification. The
request for review must include a copy of the adverse determination, must
identify the issue(s) in dispute, and must contain a full statement of the
grantee’s position with respect to such issue(s) and the pertinent facts and
reasons in support of the grantee’s position. In addition to the required
written statement, the grantee shall provide copies of any documents supporting
its claim. The grantee’s request to NIH for review must be submitted no later
than 30 days after the written notification of the adverse determination is
received; however, an extension may be
granted if the grantee can show good cause why an extension is warranted (42
CFR part 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 DAB for a further
review of the case in accordance with the provisions of 45 CFR part 16. A
prospective appellant must submit a notice of appeal to the DAB within 30 days
after receiving the final NIH decision.
A grantee may not submit an appeal directly to the DAB
because the DAB will review only those appeals that have been reviewed and
acted on by NIH.
In addition to the adverse determinations indicated, the DAB
is the single level of appeal for disputes related to the establishment of
F&A cost 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 special rates). The determination leading
to such disputes may be made by an HHS official other than the GMO and may
affect NIH grants as well as other HHS grants.