NIH Grants Policy Statement
Part II: Terms and Conditions of NIH Grant Awards
Subpart A: General -- File 4 of 5
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 B of this
part. 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 from, the awarding office GMO
in advance of the change or obligation of funds as specified below under “Requests for Prior Approval.”
Changes in project or budget resulting from NIH-initiated
actions are discussed in other sections of this subpart.
NIH has waived cost-related and other prior-approval
requirements for many activities and expenditures, and provided authority for
these activities and expenditures to the grantee. These operating authorities
are termed “expanded authorities.” Exhibit 3 presents a summary of expanded
authorities. Certain award instruments, mechanisms, and types of recipients are
excluded from the expanded 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; and awards
Certain grants or grantees also may be excluded from
expanded authorities, including those that require closer project monitoring or
technical assistance, and certain large multi-project grants. If excluded from
some or all expanded authorities, the NGA will indicate this change from the
standard terms and conditions. In addition, one or more of these authorities
may be overridden by a special term or condition of the award. Therefore,
grantees must review the NGA to determine whether and to what extent they are
permitted to use expanded authorities.
When using expanded authorities, grantees must ensure that
they exercise proper stewardship over Federal funds and 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 expanded authorities have specific deadlines for
submission of reports or for timely notification to the NIH awarding office.
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 expanded authorities.
3. Summary of Expanded Authorities
May exercise as expanded authority
Carryover of unobligated balances from one budget period
to the next
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, and awards
to individuals, or if the NGA indicates otherwise.
Cost-related prior approvals, including research patient
care costs and equipment
If the scope would change.
Extension of final budget period of a project period
without additional NIH funds
If the grantee already has given itself one extension of
up to 12 months.
Transfer of performance of substantive programmatic work
to a third party (by consortium agreement)
If the transfer would be to a foreign component or it
would result in a change in scope.
Carryover of Unobligated Balances from One Budget Period
to Another Within an Approved Project Period. Awards routinely excluded
from the automatic carryover of unobligated balances include 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 mechanism), and awards to individuals.
For these mechanisms, carryover of unobligated balances always requires NIH
awarding office prior approval unless that requirement is waived by a term or
condition of the NGA. Other awards may be excluded from use of this authority
through a special term or condition in the NGA.
For awards using 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
its grant progress report, whether its estimated unobligated balance (including
prior-year carryover) is expected to be greater than 25 percent of the current
year’s total approved budget. If so, the grantee must provide an explanation
and indicate plans for expenditure of those funds.
For those awards subject to expanded authorities but
excluded from SNAP, the FSR must specify the amount to be carried over. The
notification must be provided under item 12, “Remarks,” on the FSR. When a
grantee reports a balance of unobligated funds in excess of 25 percent of the
total amount awarded, 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.
Whether or not under SNAP, 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 NGA.
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. This also includes research patient care as described in
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 NGA if
additional funds are required to be obligated by the NIH awarding office,
project’s originally approved scope will not change, and
any one of the following applies:
Additional time beyond the established expiration date is
required to ensure adequate completion of the originally approved project.
Continuity of NIH grant support is required while a competing
continuation application is under review.
The extension is necessary to permit an orderly phase-out of a
project that will not receive continued support.
The fact that funds remain at the expiration of the grant is
not, in itself, sufficient justification for an extension without additional
The grantee must notify the NIH awarding office, in writing,
of the extension 10 days before the expiration date of the project period. Upon
notification, the NIH awarding office will revise the project period ending
date and provide an acknowledgment to the grantee. In extending the final
budget period of the project period through this process, the grantee agrees to
update all required certifications and assurances, including those pertaining
to human subjects and animal welfare, in accordance with applicable regulations
and policies. Grantees may not extend project periods previously extended by
the NIH awarding office. Any additional project period extension beyond the
one-time extension of up to 12 months requires NIH prior approval. (See “Prior-Approval Requirements” in this
section for extensions requiring additional funds.) Grantees are reminded that
all terms and conditions of the award apply during the extended period.
Transfer of the Performance of Substantive Programmatic
Work to a Third Party by Means of a Consortium Agreement. Prior approval by
the NIH awarding office is not required to transfer the performance of
substantive programmatic work unless the activity constitutes a change in scope
or results in the transfer of substantive programmatic work to a foreign
This subsection describes the activities and/or expenditures
that require NIH prior approval. NIH prior-approval
requirements are summarized in Exhibit 4, 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 and whether or not
the grant also is subject to expanded authorities. The circumstances under
which prior approval is required also are summarized in the exhibit.
Grantees also should consult Subpart B of this part 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.
4. Summary of Actions Requiring NIH Prior Approval
NIH prior approval
is required for
Under the following circumstances
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 $300,000.
Capital expenditures (construction, land, or building
All instances when purchase proposed; any proposal to
convey, transfer, assign, mortgage, lease, or in any other manner encumber
real property acquired with NIH grant funds.
Change in scope
Changes in status of key personnel
Withdrawal from the project; absence for any continuous
period of 3 months or more; reduction of time devoted to project by 25
percent or more from level in approved application.
Change of grantee organization
Carryover of unobligated balances
If the NGA indicates that the grantee does not have the
authority to automatically carry over balances.
Deviation from award terms and conditions
All instances. Includes undertaking any activities
disapproved or restricted as a condition of the award.
Foreign component added to a grant to a domestic
Need for additional NIH funding
All instances, including extension of a final budget
period of a project period with additional funds.
More than 90 days before effective date of the initial
budget period of a new or competing continuation award, at grantee’s own
Retention of research grant funds when K award made
Second no-cost extension or extension greater than 12
Transfer of funds between construction and nonconstruction
Transferring amounts from trainee costs
Alterations and Renovations. NIH prior approval is
required if a grantee rebudgets 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 $300,000, NIH always will consider the rebudgeting to be a change in
scope. (See “Construction
Grants—Administrative Requirements—Prior-Approval Requirements—Alteration and
Renovation Projects under Nonconstruction Grants” in Subpart B of this part
for documentation requirements for A&R projects exceeding $300,000).
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 office or
its successor organization.
Change in Scope. In general, the 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 office
for a change in the direction, type of research or training, or other areas
that constitute a significant change from the aims, objectives, or purposes of
the approved project (hereafter “change in scope”). The grantee must make the
initial determination of the significance of a change and should consult with
the GMO as necessary.
Actions likely to be
considered a change in scope and, therefore, requiring NIH awarding office
prior approval include, but are not limited to, the following:
in the specific aims approved at the time of award.
of one animal model for another.
change from the approved use of animals or human subjects.
of the research emphasis from one disease area to another.
clinical hold by FDA under a study involving an IND or an IDE.
of a new technology, e.g., changing assays from those approved to a different
type of assay.
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, this type of action always requires NIH prior approval.
in key personnel (see “Change
in Status, Including Absence, of Principal Investigator and Other Key Personnel”
for requirements for NIH approval of alternate arrangements for or replacement
of key personnel).
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 more than 25 percent 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
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
of a unit of equipment exceeding $25,000.
in Status, Including Absence, of Principal Investigator and Other Key Personnel.
The grantee is required to notify the GMO in writing if the PI or key personnel
specifically named in the NGA 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 award (for example, a proposed change from 40
percent effort to 30 percent or less effort). NIH must approve any alternate
arrangement proposed by the grantee, including any replacement of the PI or key
personnel named in the NGA.
The request for approval of a substitute PI/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 office, 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 the PI and those key personnel NIH names in the NGA
regardless of whether the applicant organization designates others as key personnel
for its own purposes.
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:
grant to be transferred has been terminated in accordance with 45 CFR
74.61 or 92.43.
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”).
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 PI on a research project
transferring from one organization to another organization. The project under
the same 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.
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. However, an
individual fellowship may be transferred to a new sponsoring organization. The
transfer process will be the same as for a change of grantee organization. A
change in an individual fellow’s department or sponsor within the same
organization is not considered a change of grantee organization. A
successor-in-interest or a name change is not considered a change of grantee
(see “Change in Grantee
Organizational Status” in this section).
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 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 a delay in processing.
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 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
office may require peer review or may disapprove the request and, if
appropriate, terminate the award.
A request for a change of
grantee organization must be submitted to the GMO and must include an Official
Statement Relinquishing Interests and Rights in a Public Health Service
Research Grant (PHS 3734) (relinquishing statement) and a Final Invention
Statement and Certification from the original grantee as well as an application
(PHS 398 or 416-1) from the proposed grantee or sponsoring organization. (A
final FSR is due to NIH from the relinquishing organization no later than 90
days after the end of NIH support of the project.) If the original award was
the result of a modular application, modular procedures apply to the request
for change of grantee. For awards using the PHS 398, the application from the
proposed grantee should include, at a minimum, the following:
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 years)
biographical sketches for the PI and existing key personnel and biographical
sketches for any proposed new key personnel
indicating whether the overall research plans/aims have changed from the
original submission, and, if so, providing updated information
“other support” page(s), if necessary
of IRB/IACUC approval, if applicable
list of any equipment purchased with grant funds being 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 NGA 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 an NGA reflecting the balance reported on the relinquishing
statement or, if the change of grantee organization occurs on the anniversary
date of the project, the NGA to the new grantee will reflect the previously
committed direct cost level plus applicable F&A costs). This amount is
subject to change as a result of the closeout of the original grant and may be
in Grantee Organizational Status. Grantees must give NIH advance
notice of the following types of change in organizational status (that are not considered to be a change
of grantee organization as described in this subsection):
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
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). An 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
still is 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
awarding office 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 office ordinarily will be the IC with which the organization has
the most NIH grants. If there is no advance consultation, 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 an SII, a letter signed
by the AOOs of the current grantee (transferor) and the successor-in-interest
(transferee) must be sent to the lead NIH awarding office, following
consultation with the GMO of that awarding office. The letter must do the
that the transfer will be properly effected in accordance with applicable law.
that the transferor relinquishes all rights and interests in all of the
that the NIH awarding office(s) modify its (their) records to reflect the
transferee as the grantee of record.
the effective date of the transfer.
the transferee’s Entity Identification Number.
verification of the transferee’s compliance with applicable requirements (e.g.,
a list of all affected NIH grants (active and pending) with the following
information for each:
Complete grant number (e.g., 5 R01 GM 12345-04).
Name of PI.
Current budget period and project period.
The 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.
a complete face page (PHS 398) for each affected grant showing the transferee
as the applicant organization. Each face page must be signed by both the PI and
the AOO at the transferee organization.
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. Upon
review and acceptance of this information, NIH will revise the NGA(s) to show
the transferee as the grantee of record.
For name changes, the grantee’s written notification to the
lead NIH awarding office must include the effective date of the change. Revised
face pages are not required for name changes because name changes are processed
with the next award action (e.g., non-competing continuation award) and the
organization will submit a face page with the new information as part of that
Deviation from Award Terms and Conditions, including
Restrictions on the NGA. NIH prior approval is required for any deviation
from terms or conditions stated or referenced in the NGA, including those in
the NIHGPS. This includes undertaking any activities disapproved or restricted
as a condition of the award.
Foreign Component Added to a Grant to a Domestic
Organization. Adding a foreign component under a grant to a domestic
organization requires NIH prior approval.
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 competing continuation 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.
Need for Additional NIH Funding with Extension of the
Final Budget Period of a Project Period. 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 to provide continuity of
project activities while a competing continuation application is being reviewed
or to permit orderly phaseout 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.
Pre-Award Costs. See “Cost Considerations—Selected Items of
Cost—Pre-Award (Pre-Agreement) Costs.”
Retention of Research Grant Funds When a K Award is Made.
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.
Transfer of Amounts from Trainee Costs. The transfer
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 Subpart B of this part).
Transfer of Funds Between Construction and
Nonconstruction Work. Under awards that provide for both construction and
nonconstruction work, NIH prior approval is required to transfer funds between
the two types of work.
Requests for Prior Approval
All requests for NIH awarding office prior approval must be
made in writing (which includes submission by e-mail) to the GMO no later than
30 days before the proposed change. The request must be signed by both the PI
and the AOO. Failure to obtain required prior approval, from the appropriate
NIH awarding office may result in the disallowance of costs, termination of the
award, or other enforcement action within 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 AOO to the GMO that signed the NGA. (E-mail addresses for
NIH staff can be obtained from the NIH Directory and E-Mail Forwarding Services
E-mail requests must include the name of the grantee, the name of the
initiating PI, the PI’s telephone number, fax number, and e-mail address, and
comparable identifying information for the AOO. If the entire message of the
request cannot be included in the body of the e-mail, the request should be
submitted to NIH in hard copy.
The GMO will review the request and provide a response to
the AOO indicating the final disposition of the request. The GMO will provide
copies of the response to the PI and to the cognizant NIH PO. Only responses
provided by the GMO are to be 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 grantee. However, the 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 grantee must
obtain that approval from NIH before giving its approval to the consortium
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. 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 “Public Policy Requirements and
Objectives—Availability of Information—Access to Research Data” 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 401, apply.
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.
Rights 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,
or other copyrightable works developed under an NIH grant may be copyrighted
without NIH approval. 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 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
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
office in advance to allow for coordination.
One copy of each publication resulting from work performed
under an NIH grant-supported project must accompany the annual or final
progress report submitted to the NIH awarding office (see “Administrative
Requirements—Monitoring—Reporting—Non-Competing Grant Progress Reports” and
Reports—Final Progress Report”).
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.
Effective with the October 1, 2003 receipt date, investigators submitting an
NIH application seeking $500,000 or more in direct costs in any single budget
period are expected to include a plan for data sharing or state why data
sharing is not possible.
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 “Privacy Rule” (See “Public Policy Requirements and
Objectives—Requirements Affecting the Rights and Welfare of Individuals as
Research Subjects, Patients, or Recipients of
Services—Confidentiality—Standards for Privacy of Individually Identifiable
Health Information”). 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.
Investigators conducting biomedical research frequently
develop unique research resources. Categories of these resources include
synthetic compounds, organisms, cell lines, viruses, cell products, and cloned
DNA, as well as DNA sequences, mapping information, crystallographic
coordinates, and spectroscopic data. Specific examples include specialized or
genetically defined cells, including normal and diseased human cells;
monoclonal antibodies; hybridoma cell lines; microbial cells and products;
viruses and viral products; recombinant nucleic acid molecules; DNA probes;
nucleic acid and protein sequences; certain types of animals, such as
transgenic mice; and intellectual property, such as computer programs.
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
developed with NIH funds and the associated research findings have been
published 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.
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), which is available on the NIH website (http://www.ott.nih.gov/policy/rt_guide_final.html).
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 office, 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 biological
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. 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
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
Organizations that believe they will be unable to comply
with these requirements should promptly contact the GMO to discuss the
circumstances, obtain information that might enable compliance, and reach an
understanding in advance of an award.
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
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.
grantees may retain intellectual property rights to subject inventions provided
they do the following:
all subject inventions to NIH.
efforts to commercialize the subject invention through patent or licensing.
acknowledge the Federal government’s support in all patents that arise from the
grant the Federal government a limited use license to the subject invention.
Exhibit 5 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 5. Extramural
Invention Reporting Compliance Responsibilities
must be taken
37 CFR 401 reference
Agreement to Disclose All Inventions
The PI (employee) must sign an agreement to abide by the
terms of the Bayh-Dole Act and the NIHGPS as they relate to intellectual
At time of employment.
Grantee organizations and consortium participants must
have policies in place regarding ownership of intellectual property.
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.
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 Inventions
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 use 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
U.S. application. The patent application number and filing date must be
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. 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.
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 File Patent
The grantee may request an extension of up to 2 years for
election of title, or 1 year for filing a patent application.
Request for extension of time must be made. Such requests
Change in Patent Application Status
The grantee must notify NIH of changes in patent
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
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 grant
The information is requested as a checklist item on the
PHS 398 application and on the non-competing grant progress report.
PHS 398 and PHS 2590
Final Invention Statement and Certification
The grantee must submit to the NIH awarding office 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 74. and
37 CFR 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 invention.
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 following address:
and Technology Resources Branch
Division of Grants Policy
Office of Policy for Extramural Research Administration
Office of Extramural Research
6705 Rockledge Drive, MSC 7980
Bethesda, MD 20892-7980
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 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 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
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.
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