ADMINISTRATIVE REQUIREMENTS
Changes in Project and
Budget
NIH grantees are, in general, allowed a certain degree of latitude
to rebudget within and between direct cost budget categories to
meet unanticipated needs and to make other types of postaward
changes. Some changes may be made by the grantee only within limits
established by NIH. Other changes require NIH prior written approval
before modifying the budget or undertaking the activity in question.
The degree of discretion permitted varies by type of grant, grantee,
and coverage by, or participation in, a special initiative. The
changes that may be made under the grantee's authority and the
changes that require NIH approval are outlined below and in Part
III. In addition, individual awards may restrict grantees' authorities
to make budget and project changes without NIH prior approval.
This section deals only with grantee-initiated changes. Changes
in project or budget resulting from NIH-initiated actions are
discussed in later sections of this Part.
If NIH approval is required, it must be requested of, and obtained
from, the NIH awarding office GMO in advance of the change or
obligation of funds as specified below under "
Requests for
Approval".
PRIOR APPROVAL REQUIREMENTS
The following listing of prior approval requirements applies in
its entirety to NIH grants other than those operating under expanded
authorities and construction grants. If an approval requirement
does not apply under expanded authorities, it is noted in this
list. Part III should be reviewed for other prior approval requirements
unique to a type of grant, such as construction grants, or type
of recipient, such as for-profit organizations. Additional prior
approval requirements may be imposed by specific terms of the
NGA, program legislation, regulations, or policies. Therefore,
the following list may not be all-inclusive; however, it is NIH's
implementation of 45 CFR 74.25, Revision of budget and program
plans, and 45 CFR 92.30, Changes. If a prior approval category
specified in those regulations is not included in this list, NIH
has waived the requirement, as permitted by those regulations.
For those categories or types of actions listed below, prior approval
is required whether or not the change has a budgetary impact.
Change in Scope, including Significant Rebudgeting: 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 NIH for changes in scope, direction,
type of 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 include, but
are not limited to, the following:
- Change in the specific aims approved at the time of award.
- Substitution of one animal model for another.
- Any change from the approved use of animals or human subjects.
- Shifting the research emphasis from one disease area to another.
- Applying a new technology; i.e., changing assays from those
approved to a different type of assay.
- Transferring the performance of substantive programmatic work
to a third party through a consortium agreement, by contract,
or any other means. NOTE: This type of action always requires
NIH prior approval for grants not subject to expanded authorities
(see "Expanded Authorities" below).
Once approval is obtained, transferring the same work to a different
third party does not require NIH approval.
- Change in key personnel whose expertise is critical to the
approved project.
(Note: The following section has been revised in accordance with the 12/18/98 NIH Guide Notice)
- Significant rebudgeting, whether or not the particular expenditure(s)
require prior approval under rules governing budget changes.
Significant rebudgeting occurs when expenditures in a single direct cost budget category deviate (increase or decrease) from the categorical commitment level established at the time of the competing award by more than 25 percent of the total costs awarded. For example, if the award budget for total costs is $200,000, NIH prior approval is required for any rebudgeting that would
result in an increase or decrease of more than $50,000 in a budget
category. The baseline used for determining significant rebudgeting
excludes the effects of prior year carryover balances but includes
competing and noncompeting supplements. When the applicable threshold
is reached, the grantee must consult with the GMO for a decision
as to whether the rebudgeting constitutes a change of scope. If
the GMO determines that the significant rebudgeting constitutes
a change of scope, NIH prior approval is required.
- Incurrence of patient care costs if not previously approved
by NIH or if a grantee desires to rebudget additional funds into
or rebudget funds out of the patient care category. NOTE: These
types of actions always require NIH prior approval for grants
not subject to expanded authorities (see "
Expanded Authorities"
below).
Preaward Costs: See "Cost Considerations
Allowability of
Costs/Activities Selected
Items of Cost
Preaward (Preagreement) Costs".
Change in Status, Including Absence, of Principal Investigator
and Other Key Personnel: The grantee is required to notify
NIH if the PI or other key personnel 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 his or her time
devoted to the project by 25 or more percent 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, including any replacement PI
or other key personnel proposed by the grantee.
The request for approval of a substitute PI/key person should
include a justification for the change, the curriculum vitae 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 NIH, the grant may be suspended
and/or terminated. If the grantee wishes to terminate the project
because it cannot make suitable alternate arrangements, it must
notify the awarding office GMO, in writing, of its wish to terminate,
and NIH will forward closeout instructions.
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 date of the approved project
period. Such a change of grantee organization may be accomplished
under most NIH grants, including construction grants, if:
- The grant to be transferred has been terminated in accordance
with 45 CFR 74.61 or 92.43;
- A noncompeting 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"); or
- 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 PI on a research project transferring from one domestic organization
to another domestic organization or from a foreign organization
to a domestic 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 organization may not take place where it will
involve the transfer of a grant to or between foreign institutions
or international organizations. In addition, a grant to an individual
may not be transferred. However, an individual fellowship may
be transferred to a new organization and this would be considered
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 request for a change of grantee organization must include submission
of a Relinquishing Statement and a Final Invention Statement and
Certification from the original grantee as well as submission
of an application (PHS-398) from the proposed grantee. The application
from the proposed grantee should include, at a minimum:
- A face page;
- Budget pages (current and future years);
- An updated biographical sketch;
- A statement indicating whether the overall research plans/aims
have changed from the original submission, and, if so, providing
updated information;
- An updated "other support" page(s), if necessary;
- A resources page;
- A checklist page;
- An approved IRB/IACUC assurance, if applicable; and
- If the change includes the transfer of equipment purchased
with grant funds, the application must include a detailed list.
This list, as part of a transfer application, serves as an acceptance
of title by the new organization.
NIH may request additional information necessary to accomplish
its review of the request.
A change of grantee organization request must be made prior to
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 will normally 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 competitive 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
a competitive review or may disapprove the request and, if appropriate,
terminate the award.
As stated above, the original grantee must provide a written statement
relinquishing its interests and rights to the grant in accordance
with instructions from the NIH awarding office. 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, which will reflect 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
direct cost level (plus applicable F&A costs) previously committed.
Change in Grantee Organizational Status: Grantees must
notify NIH, in advance, of certain changes in organizational status.
This notification is required to ensure that the grantee is still
able to meet its legal and administrative obligations to NIH and
that payments are not interrupted.
The following organizational changes must be reported to NIH prior
to the change:
- Successor-in-Interest: A 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 transfer of this type may result from legislative
or other legal actions, such as a merger or other corporate change.
- Name Change: An action whereby the name of an organization
is changed without otherwise affecting the rights and obligations
of that organization as a grantee.
- Merger: A legal action resulting in the unification
of two or more legal entities. When such an action involves the
transfer of assets, the procedures for recognition of a successor-in-interest
will apply. When the action does not involve the transfer of assets,
the procedures for recognition of a name change will normally
apply.
Neither a name change nor a successor-in-interest is considered
a "change of grantee organization" (as described above).
Grantees are encouraged to contact the GMO of the lead IC to explain
the nature of the change and receive guidance on whether it will
be treated as a name change or successor-in-interest. The lead
IC will ordinarily 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 successor-in-interest or name
change 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 successor-in-interest, a letter signed by the appropriate
institutional officials of the current grantee (transferor) and
the successor-in-interest (transferee) must be sent to the affected
NIH ICs, following consultation with the GMO of the lead IC. The
letter must:
- Stipulate that the transfer was properly effected in accordance
with applicable law,
- Indicate that the transferor relinquishes all rights and interests
in all of the affected grants,
- Request that the NIH awarding office(s) modify its records
to reflect the transferee as the grantee of record, and
- State the effective date of the transfer.
The letter should be accompanied by: a list of the grants to be
transferred; a revised completed grant application face page for
the affected grant(s) showing the transferee as the applicant
organization, along with information regarding changes in taxpayer
identification or entity identification numbers, F&A costs
(including a copy of the rate agreement), and the use of human
subjects or animals. Upon receipt 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 IC must include the effective date of the change. Revised
face pages are not required for name changes since name changes
are processed with the next award action and a face page will
be received from the organization as part of that action.
Addition of a Foreign Component: Addition of a substantial
foreign component under a grant to a domestic organization.
Award Terms and Conditions: Deviations from special terms
or conditions stated in the NGA or from the terms and conditions
included in this policy statement.
Restrictions on Notice of Grant Award: Undertaking any
activities disapproved or restricted as a condition of the award.
Carryover of Unobligated Funds from One Budget Period to Another
Within an Approved Project Period: NOTE: This action is
generally allowable without prior approval under expanded authorities
unless restricted (see "Expanded Authorities
" below).
Extension of a Project Period With or Without Additional Funds:
A request for a noncompeting extension of a project period
should be submitted to the IC GMO, in writing, at least 30 days
before the project period is scheduled to expire. Such requests
are usually for a period 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,
and may be made without funds or with a minimal amount of additional
funds. The request must specify the proposed revised ending date
and must include justification for both the extension and any
additional funds requested. Special justification will be required
for an additional extension that would exceed an initial 12-month
extension. NIH will not approve such requests if the primary purpose
of the proposed extension is to permit the use of unobligated
balances of funds. NOTE: These requirements do not generally
apply under expanded authorities with respect to a "no-cost"
extension of the final budget period of a project period (see
"Expanded Authorities" below).
Equipment Purchase: Equipment exceeding $25,000 per unit,
regardless of the amount of NIH funding to be used. NOTE: This
requirement is not generally applicable under expanded authorities
unless the purchase may result in a change in scope (see
"Expanded
Authorities" below).
Retention of Research Grant Funds When an Independent Scientist
Award is Made: Funds budgeted under an NIH grant for an individual's
salary and/or fringe benefits, but available as a result of receiving
an Independent Scientist Award (ISA) for that individual, may
not be used for any other purpose without NIH prior approval.
Alterations and Renovations: NIH prior approval is required
for an A&R project exceeding $300,000 (see
"Construction
Grants" in Part III for documentation requirements).
Transferring Amounts from Trainee Costs: The transfer of
amounts previously awarded for trainee costs (stipends, tuition,
and fees) to other categories of expense. This excludes trainee
travel, which NIH does not consider to be a trainee cost, and
training-related expenses (see "National
Research Service
Awards" in Part III).
Capital Expenditures: Capital expenditures for land or
buildings. Also, 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.
Need for Additional NIH Funds: 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, noncompeting continuation, or competing
continuation application was submitted, is a noncompeting supplemental
application. Such requests are submitted directly to the GMO,
in writing, and are not required to compete with other applications
for funding.
Closely Related Work: When salaries or other costs
are being supported by two or more scientifically and technically
related NIH grant projects with the same PI and funded by the
same IC, grantees may charge those costs to any one of those projects
or treat multiple projects as a single cost objective only with
NIH prior approval. NIH will not approve such requests if there
is a change in the scope of the individual grants involved, relating
the costs will be detrimental to the conduct of work approved
under each individual award, or the projects are being related
to circumvent the terms and conditions of an individual award.
(See "Cost Considerations
Allocation of Costs and Closely
Related Work".)
Transfer of Funds Between Construction and Nonconstruction:
Under awards that provide for both construction and nonconstruction
work, NIH prior approval is required to transfer funds between
the two types of work.
Program Income: The use of any alternative for disposition
of program income other than that specified in the terms and conditions
of award must have NIH prior approval (see "Administrative
Requirements Management Systems and Procedures
Program
Income").
EXPANDED AUTHORITIES
NIH has waived the requirement for its approval of specified actions
under certain awards and has provided the authorities (hereafter
"expanded authorities") to grantees to take such actions
without NIH prior approval. This subsection describes the authorities
unique to grants subject to expanded authorities. In using these
expanded authorities, grantees must ensure that they exercise
proper stewardship over Federal funds and that costs charged to
the awards are allowable, allocable, reasonable, and consistently
applied regardless of the source of funds. Expanded authorities
apply to the following mechanisms:
- "R" series (Research Project Grants), except R41,
Phase I Small Business Technology Transfer (STTR) Grants, and
R43, Phase I Small Business Innovation Research (SBIR) Grants
- Program Project Grants (P01)
- "K" series (Career Development Awards)
- Minority High School Student Research Apprentice Program Awards
(S03).
NIH ICs may also authorize some or all of the expanded authorities
for additional awards or classes of awards.
Expanded authorities are not provided under awards to individuals.
Certain support mechanisms or grantees may also be excluded from
expanded authorities. If excluded, the NGA will indicate this
change from the standard terms and conditions. This may include
grants or grantees that require closer project monitoring or technical
assistance, such as clinical trials and certain large multi-project
grants. Therefore, grantees must review the NGA to determine whether
they are permitted to use expanded authorities.
When a grant is under expanded authorities, the grantee may take
the following actions without NIH prior approval unless one or
more of these authorities is overridden by a special term or condition
of the award. Several of the 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 shall be grounds for excluding that
grantee from these special authorities. Even where the grantee
is authorized to use expanded authorities, if it is determined,
through audit or otherwise, that costs do not meet the tests of
allowability, allocability, reasonableness, and consistency, the
costs may be disallowed.
Extension of a Project Period Without Additional Funds: The
grantee may extend the final budget period of the project period
one time for a period of up to 12 months beyond the original expiration
date shown in the NGA if no additional funds are required to be
obligated by the awarding office, there will be no change in the
project's originally approved scope or objectives, 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 phaseout 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
funds. The grantee must notify the NIH awarding office, in writing,
of the extension 10 days prior to 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 grant
through this process, the grantee agrees to update all required
certifications, including 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" above
for extensions
requiring additional funds.)
Carryover of Unobligated Balances: Except for funds restricted
in an NGA, grantees are authorized to carry over unobligated funds
remaining at the end of a budget period. For awards under the
Streamlined Noncompeting Award Process (SNAP), funds are automatically
carried over and are available for expenditure during the entire
project period. However, under those awards, the grantee will
be required to indicate, as part of its noncompeting continuation
request, whether its estimated unobligated balance (including
prior year carryover) is expected to be greater than 25 percent
of the current year's total budget. If so, the grantee must provide
an explanation and indicate plans for expenditure of those funds
if carried forward. (See "Administrative Requirements
Noncompeting
Continuation Awards".)
For those awards subject to expanded authorities but excluded
from SNAP; e.g., P01s and R35s, 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 awarding office 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 take one,
or a combination, of the following actions: restrict the grantee's
authority to automatically carry over unobligated balances in
the future or use the balance to reduce or offset NIH funding
for a subsequent budget period. Any amount not identified for
carryover may be used as an offset. A revised NGA will not be
issued to reflect the carryover.
Use of Program Income: The additive costs alternative for
the use of program income will apply to awards subject to expanded
authorities unless program regulations or the NGA specify another
alternative or a combination of alternatives or the grantee is
a for-profit organization other than an SBIR/STTR awardee (see
"Administrative Requirements Management Systems and Procedures
Program
Income").
REQUESTS FOR APPROVAL
All requests for NIH awarding office prior approval must be
made, in writing, to the awarding office GMO no later than 30
days before the proposed change. The request must be signed by
both the PI and the authorized institutional official. Failure
to obtain prior approval, when required, from the appropriate
NIH awarding office may result in the disallowance of costs, termination
of an award, or other enforcement action within NIH's authority.
The GMO will review the request and inform the authorized institutional
official, in writing, of the final disposition of the request.
Only responses signed 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 postaward 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, the prior approval authority is
usually the grantee. However, the grantee may not approve any
action or cost that is inconsistent with the purpose or terms
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 shall obtain that approval from NIH
before giving its approval to the consortium participant.
Noncompeting Continuation
Awards
The "Application for Continuation of a Grant" (PHS-2590)
or equivalent documentation must be submitted to, and be approved
by, NIH to noncompetitively fund each additional budget period
within a previously approved project period. Except for awards
subject to SNAP (see below), the application
includes an updated
budget, progress report, and other required information.
Noncompeting continuation applications must be submitted directly
to the IC GMO 2 months before the beginning date of the next budget
period, unless instructed otherwise. (OPERA will provide the grantee
with a computer-generated face page and necessary mailing labels
approximately 4 months before the end of the current budget period.)
Late submission or receipt of an incomplete noncompeting continuation
application will result in delaying the issuance and funding of
the noncompeting continuation award and may result in a reduced
award amount.
STREAMLINED NONCOMPETING AWARD PROCESS
NIH grantees (including those participating in the Federal Demonstration
Partnership) are expected to follow the streamlined noncompeting
process (SNAP) for mechanisms routinely covered under expanded
authorities except Program Project Grants (P01s) and Outstanding
Investigator Grants (R35s). NIH routinely applies expanded authorities
to Program Project Grants (P01s), Minority High School Research
Apprentice Program Awards (S03s), Research Career Awards (K series),
and all Research Project Grants (R series) except Phase I SBIR
(R43) and STTR (R41) awards.
Any additional activity that has been included under expanded
authorities at the discretion of an IC (e.g., centers, training
grants, or cooperative agreements) will be excluded under SNAP
unless inclusion is specifically footnoted as a term or condition
of the award.
Any award excluded from expanded authorities is routinely excluded
from SNAP unless specifically included in SNAP as a term or condition
of the award. Individual awards may be excluded from routine inclusion
under SNAP (and expanded authorities) on the basis of the following
criteria:
- Grants that require close project monitoring or technical
assistance; e.g., clinical trails, exceptional (high-risk) grantees,
certain large individual or multi-project grants, or grants with
significant unobligated balances.
- Grantees that have a consistent pattern of failure to adhere
to appropriate reporting or notification deadlines.
Under SNAP, the GMO negotiates the direct costs for the entire
competitive segment at the time of the competing award. This eliminates
the need for annual budget submissions and negotiations and reduces
the information NIH requires to review and approve noncompeting
continuation applications and to monitor these awards. As a result,
for awards under SNAP, grantees are required to submit only limited
portions of the PHS-2590, including an annual progress report.
Grantees are also required to submit
a quarterly Federal Cash Transactions Report (FCTR) (SF-272) to
PMS.
As part of the progress report, grantees must answer the following
questions:
- Has there been a change in the "other support" of
key personnel since the last reporting period? If so, the change(s),
including termination of a previously active grant or activation
of a previously pending grant, must be explained. If not, the
grantee must so state.
- Will there be, in the next budget period, significant rebudgeting
of funds from what was approved for the project? If so, the grantee
must explain; if not, the grantee must so state. "Significant
rebudgeting" occurs when expenditures in a single direct
cost budget category deviate (increase or decrease) from the categorical
commitment level established at the time of the competing award
by more than 25 percent of the total amount awarded. The basis
for determining significant rebudgeting in relation to SNAP excludes
the effects of prior year carryover balances but includes competing
and noncompeting supplements.
- Will there be, in the next budget period, a change in the
level of effort for key personnel from what was approved for this
project? A "significant change" is a 25 percent or greater
reduction in time devoted to the project. If so, the grantee must
explain; if not, the grantee must so state.
- Does the grantee anticipate that it will have an estimated
unobligated balance (including prior year carryover) that will
be greater than 25 percent of the current year's total budget?
If so, the grantee will be required to explain why there is a
significant balance and how it will be spent if carried forward
into the next budget period. If not, the grantee should so state.
The IC will rely on the grantee's assessment of whether significant
changes have occurred or will occur in these areas; however, the
GMO may require additional information in order to evaluate the
project for continued funding. Failure to provide this information
will result in a delayed award.
For awards under SNAP, an FSR (SF 269) is required only at the end of a
competitive segment rather than annually. This FSR 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 FSR (see "Administrative Requirements---
Closeout").
Availability of Research
Results: Publications and Intellectual Property Rights, Including
Unique Research Resources
It is NIH policy to make available to the public the results and
accomplishments of the activities that it funds. Therefore, 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. This policy notwithstanding,
NIH recognizes that certain research findings may result in inventions.
Grantees have the prerogative to protect these inventions, as
long as they abide by the provisions of the Bayh-Dole Act of 1980,
as implemented in 37 CFR 401. In general terms, these regulations
require the grantee to utilize patent and licensing processes
to transfer grant-supported technology to industry for development.
Alternatively, technology transfer may take place in the form
of journal articles or other publications or through the availability
of research products or resources.
The importance of each of these outcomes of funded research is
reflected in the specific policies pertaining to rights in data,
unique research resources, and inventions and patents that follow.
RIGHTS IN DATA (Publication and
Copyrighting)
In general, grantees own the data generated by or resulting from
a grant-supported project. Special terms and conditions of the
award may specify alternative rights; e.g., under a cooperative
agreement or if there are shared rights to data. Except as otherwise
provided in the terms and conditions of the award, the grantee
is free to copyright without NIH approval when publications,
data7,
or other copyrightable works are developed under, or in the course
of, work under an NIH grant. Copyrighted or copyrightable works
also include materials developed by students, fellows, or trainees
under awards whose primary purpose is to further the education
or training of such individuals. Whenever any work subject to
this copyright policy is developed by a consortium participant
or a contractor (or subcontractor) under a grant, the written
agreement/contract must require the consortium participant/contractor
(subcontractor) to comply with these requirements and can in no
way diminish NIH's rights in that work. NIH must be provided a
royalty-free, nonexclusive, and irrevocable license for the Government
to reproduce, publish, or otherwise use the material and to authorize
others to do so for Federal purposes.
Grantees may arrange for publication of initial reports of original
research, supported in whole or in part by NIH grant funds, in
primary scientific journals and for copyright by the journal unless
the journal's copyright policy would preclude individuals from
making or having made, by any means available to them without
regard to the copyright of the journal and without royalty, a
single copy of any such article for their own use (see 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 Procedures
Program
Income". Grantees are encouraged to assert copyright in scientific
and technical articles based on data produced under the grant
where this is necessary to effect publication in academic, technical,
or professional journals, symposia, proceedings, or similar works.
Grantees are required to place an acknowledgment of NIH grant
support and a disclaimer, as appropriate, on any publication written
or published with such support and, if feasible, on any publication
reporting the results of, or describing, a grant-supported activity.
An acknowledgment shall be to the effect that:
"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."
In the event that the recipient wishes to join with NIH in a simultaneous
news release announcing the results of a project, the action should
be coordinated with the awarding office.
One copy of each publication resulting from work performed under
an NIH grant-supported project must accompany the annual progress
report submitted to the NIH awarding office (see "Administrative
Requirements Noncompeting
Continuation Awards").
UNIQUE RESEARCH RESOURCES
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 and/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.
Restricted availability of unique resources upon which further
studies are dependent can impede the advancement of research and
the delivery of medical care. 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.
This policy applies to grants, cooperative agreements, and contracts.
Investigators who believe they will be unable to implement this
policy should promptly contact the appropriate Program Official
to discuss the circumstances, obtain information that might facilitate
compliance with this policy, and reach an understanding in advance
of the subsequent award. In order 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. In the case of unique biological information, such
as DNA sequences or crystallographic coordinates, investigators
are expected to submit them to the appropriate data banks, because,
otherwise, they are not truly accessible to the scientific community.
When distributing unique resources, investigators are to include
pertinent information on the nature, quality, or characterization
of the materials.
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.
INVENTIONS AND PATENTS
Pursuant to the Bayh-Dole Act and Executive Order 12591 (April
10, 1987), all recipients of NIH research funding (i.e., all NIH
grantees and contractors and consortium participants and other
organizations receiving funds under NIH grants and contracts,
whether small businesses, large businesses, or non-profit organizations)
are subject to the same invention reporting requirements and regulations.
These are included in the regulations issued by the Department
of Commerce, found at 37 CFR Part 401.
Grantees (and, in some cases, employee inventors) have rights
to inventions ("subject inventions") conceived or first
actually reduced to practice in the performance of work under
an NIH award. Grantee organizations must fulfill the following
requirements:
- Establish and implement an employee invention reporting policy
(37 CFR 401.14(f)(2));
- Report all subject inventions within 2 months to OPERA (37
CFR 401.14(c) and (l));
- Elect title (or waive title) within 2 years of reporting to
OPERA (37 CFR 401.14(c)(2) and (l));
- File for patent within 1 year of electing title or public
disclosure, whichever comes first (37 CFR 401.14(c)(3));
- Upon election of title, provide a confirmatory license to
the Government (37 CFR 401.14(b));
- Acknowledge NIH support in any patent application or patent
(37 CFR 401.14(f)(4));
- Notify OPERA of any decision not to pursue patent rights (or
licensing) (37 CFR 401.14(f)(3) and (l));
- Submit an annual utilization report for all inventions where
election of title is made and for unpatented, yet licensed, inventions
(37 CFR 401.14(h));
- Exercise preference for U.S. industry and, if the grantee
is a non-profit organization, preference for small businesses
(37 CFR 401.14(i));
- Provide one copy of each publication resulting from work performed
under an NIH grant-supported project to the NIH awarding office
with the annual progress report; and
- Submit a final invention statement and certification to the
NIH awarding office within 90 days of the end of the project period.
(37 CFR 401.14(f)(5)).
Failure of the grantee to comply with these provisions may result
in the loss of patent rights. If the grantee waives its rights
to the employee-inventor, these requirements apply to the employee-inventor.
As specified in 45 CFR Part 74 and 37 CFR 401.1(b), fellowships,
scholarships, and training grants, which are funded by NIH primarily
for educational purposes, are not subject to invention reporting
requirements. The Federal Government (NIH) has no rights to any
inventions, or any income resulting from inventions conceived
or first actually reduced to practice during the course of such
educational activities.
Invention reporting requirements and the use of the Extramural
Invention Information Management System (Edison) are discussed
under "Administrative Requirements Monitoring
Reporting".
To provide a more complete description of the invention and patent
reporting requirements, the complete text of the standard patent
rights clauses (37 CFR 401.14) is included below and may also
be found on the NIH link to the Interagency
Edison Web site.
Sec. 401.14, Standard Patent Rights
Clauses (Small Business Firms and Non-profit Organizations)
(July 1997) (NOTE: While the title of these clauses refers to
small businesses and non-profit organizations, the provisions
also apply to large for-profit businesses. The term "contractor"
in the text applies equally to grantees.)
401.14(a) Definitions.
(1) Invention means any invention or discovery which is
or may be patentable or otherwise protectable under Title 35 of
the United States Code, or any novel variety of plant which is
or may be protected under the Plant Variety Protection Act (7
U.S.C. 2321 et seq.).
(2) Subject invention means any invention of the contractor
conceived or first actually reduced to practice in the performance
of work under this contract, provided that in the case of a variety
of plant, the date of determination (as defined in section 41(d)
of the Plant Variety Protection Act, 7 U.S.C. 2401(d)) may also
occur during the period of contract performance.
(3) Practical Application means to manufacture in the case
of a composition or product, to practice in the case of a process
or method, or to operate in the case of a machine or system; and,
in each case, under such conditions as to establish that the invention
is being utilized and that its benefits are, to the extent permitted
by law or Government regulations, available to the public on reasonable
terms.
(4) Made when used in relation to any invention means the
conception or first actual reduction to practice of such invention.
(5) Small Business Firm means a small business concern
as defined at section 2 of Pub. L. 85-536 (16 U.S.C. 632) and
implementing regulations of the Administrator of the Small Business
Administration. For the purpose of this clause, the size standards
for small business concerns involved in Government procurement
and subcontracting at 13 CFR 121.3-8 and 13 CFR 121.3-12, respectively,
will be used.
(6) Non-profit Organization means a university or other
institution of higher education or an organization of the type
described in section 501(c)(3) of the Internal Revenue Code of
1954 (26 U.S.C. 501(c)) and exempt from taxation under section
501(a) of the Internal Revenue Code (25 U.S.C. 501(a)) or any
non-profit scientific or educational organization qualified under
a state non-profit organization statute.
401.14(b) Allocation of Principal Rights.
The contractor may retain the entire right, title, and interest
throughout the world to each subject invention subject to the
provisions of this clause and 35 U.S.C. 203. With respect to any
subject invention in which the contractor retains title, the Federal
Government shall have a nonexclusive, nontransferable, irrevocable,
paid-up license to practice or have practiced for or on behalf
of the United States the subject invention throughout the world.
401.14(c) Invention Disclosure, Election of Title
and Filing of
Patent Application by Contractor.
(1) The contractor will disclose each subject invention to the
Federal agency within two months after the inventor discloses
it in writing to contractor personnel responsible for patent matters.
The disclosure to the agency shall be in the form of a written
report and shall identify the contract under which the invention
was made and the inventor(s). It shall be sufficiently complete
in technical detail to convey a clear understanding to the extent
known at the time of the disclosure, of the nature, purpose, operation,
and the physical, chemical, biological or electrical characteristics
of the invention. The disclosure shall also identify any publication,
on sale or public use of the invention and whether a manuscript
describing the invention has been submitted for publication and,
if so, whether it has been accepted for publication at the time
of disclosure. In addition, after disclosure to the agency, the
contractor will promptly notify the agency of the acceptance of
any manuscript describing the invention for publication or of
any on sale or public use planned by the contractor.
(2) The contractor will elect in writing whether or not to retain
title to any such invention by notifying the Federal agency within
two years of disclosure to the Federal agency. However,
in any case where publication, on sale or public use has initiated
the one year statutory period wherein valid patent protection
can still be obtained in the United States, the period for election
of title may be shortened by the agency to a date that is no more
than 60 days prior to the end of the statutory period.
(3) The contractor will file its initial patent application on
a subject invention to which it elects to retain title within
one year after election of title or, if earlier, prior to the
end of any statutory period wherein valid patent protection can
be obtained in the United States after a publication, on sale,
or public use. The contractor will file patent applications in
additional countries or international patent offices within either
ten months of the corresponding initial patent application or
six months from the date permission is granted by the Commissioner
of Patents and Trademarks to file foreign patent applications
where such filing has been prohibited by a Secrecy Order.
(4) Requests for extension of the time for disclosure, election,
and filing under subparagraphs (1), (2), and (3) may, at the discretion
of the agency, be granted.
401.14(d) Conditions When the Government May Obtain Title.
The contractor will convey to the Federal agency, upon written
request, title to any subject invention-
(1) If the contractor fails to disclose or elect title to the
subject invention within the times specified in (c), above, or
elects not to retain title; provided that the agency may only
request title within 60 days after learning of the failure of
the contractor to disclose or elect within the specified times.
(2) In those countries in which the contractor fails to file patent
applications within the times specified in (c) above; provided,
however, that if the contractor has filed a patent application
in a country after the times specified in (c) above, but prior
to its receipt of the written request of the Federal agency, the
contractor shall continue to retain title in that country.
(3) In any country in which the contractor decides not to continue
the prosecution of any application for, to pay the maintenance
fees on, or defend in reexamination or opposition proceeding on,
a patent on a subject invention.
401.14(e) Minimum Rights to Contractor and Protection of the Contractor
Right to File.
(1) The contractor will retain a nonexclusive royalty-free license
throughout the world in each subject invention to which the Government
obtains title, except if the contractor fails to disclose the
invention within the times specified in (c), above. The contractor's
license extends to its domestic subsidiary and affiliates, if
any, within the corporate structure of which the contractor is
a party and includes the right to grant sublicenses of the same
scope to the extent the contractor was legally obligated to do
so at the time the contract was awarded. The license is transferable
only with the approval of the Federal agency except when transferred
to the successor of that party of the contractor's business to
which the invention pertains.
(2) The contractor's domestic license may be revoked or modified
by the funding Federal agency to the extent necessary to achieve
expeditious practical application of the subject invention pursuant
to an application for an exclusive license submitted in accordance
with applicable provisions at 37 CFR part 404 and agency licensing
regulations, if any. This license will not be revoked in that
field of use or the geographical areas in which the contractor
has achieved practical application and continues to make the benefits
of the invention reasonably accessible to the public. The license
in any foreign country may be revoked or modified at the discretion
of the funding Federal agency to the extent the contractor, its
licensees, or the domestic subsidiaries or affiliates have failed
to achieve practical application in that foreign country.
(3) Before revocation or modification of the license, the funding
Federal agency will furnish the contractor a written notice of
its intention to revoke or modify the license, and the contractor
will be allowed thirty days (or such other time as may be authorized
by the funding Federal agency for good cause shown by the contractor)
after the notice to show cause why the license should not be revoked
or modified. The contractor has the right to appeal, in accordance
with applicable regulations in 37 CFR part 404 and agency regulations,
if any, concerning the licensing of Government-owned inventions,
any decision concerning the revocation or modification of the
license.
401.14(f) Contractor Action to Protect the Government's Interest.
(1) The contractor agrees to execute or to have executed and promptly
deliver to the Federal agency all instruments necessary to:
(i) establish or confirm the rights the Government has throughout
the world in those subject inventions to which the contractor
elects to retain title, and
(ii) convey title to the Federal agency when requested under para-graph
(d) above and to enable the Government to obtain patent protection
throughout the world in that subject invention.
(2) The contractor agrees to require, by written agreement, its
employees, other than clerical and non-technical employees, to
disclose promptly in writing to personnel identified as responsible
for the administration of patent matters and in a format suggested
by the contractor each subject invention made under contract in
order that the contractor can comply with the disclosure provisions
of paragraph (c), above, and to execute all papers necessary to
file patent applications on subject inventions and to establish
the Government's rights in the subject inventions. This disclosure
format should require, as a minimum, the information required
by (c)(1), above. The contractor shall instruct such employees
through employee agreements or other suitable educational programs
on the importance of reporting inventions in sufficient time to
permit the filing of patent applications prior to U.S. or foreign
statutory bars.
(3) The contractor will notify the Federal agency of any decisions
not to continue the prosecution of a patent application, pay maintenance
fees, or defend in a reexamination or opposition proceeding on
a patent, in any country, not less than thirty days before the
expiration of the response period required by the relevant patent
office.
(4) The contractor agrees to include, within the specification
of any United States patent applications and any patent issuing
thereon covering a subject invention, the following statement,
"This invention was made with Government support under (identify
the contract) awarded by (identify the Federal agency). The Government
has certain rights in the invention."
(5) The contractor agrees to provide a final invention statement
and certification prior to close-out listing all subject inventions
or stating that there were none.
(6) The contractor will provide the patent application filing
date, serial number and title; copy of the page of the patent
application with the statement identified in (4) above (and, upon
request, a copy of the patent application); and patent number
and is due date for any subject invention in any country in which
the contractor has applied for patent.
401.14(g) Subcontracts.
(1) The contractor will include this clause, suitably modified
to identify the parties, in all subcontracts, regardless of tier,
for experimental, developmental or research work to be performed
by a small business firm or domestic non-profit organization.
The subcontractor will retain all rights provided for the contractor
in this clause, and the contractor will not, as part of the consideration
for awarding the subcontract, obtain rights in the subcontractor's
subject inventions.
(2) The contractor will include in all other subcontracts, regardless
of tier, for experimental developmental or research work the patent
rights clause required by (cite section of agency implementing
regulations or FAR).
(3) In the case of subcontracts, at any tier, when the prime award
with the Federal agency was a contract (but not a grant or cooperative
agreement), the agency, subcontractor, and the contractor agree
that the mutual obligations of the parties created by this clause
constitute a contract between the subcontractor and the Federal
agency with respect to the matters covered by the clause; provided,
however, that nothing in this paragraph is intended to confer
any jurisdiction under the Contract Disputes Act in connection
with any proceedings under paragraph (j) of this clause.
401.14(h) Reporting on Utilization of Subject Inventions.
The contractor agrees to submit on request periodic reports no
more frequently than annually on the utilization of a subject
invention or on efforts at obtaining such utilization that are
being made by the contractor or its licensees or assignees. Such
reports shall include information regarding the status of development,
date of first commercial sale or use, gross royalties received
by the contractor, and such other data and information as the
agency may reasonably specify. The contractor also agrees to provide
additional reports as may be requested by the agency in connection
with any march-in proceeding undertaken by the agency in accordance
with paragraph (j) of this clause. As required by 35 U.S.C. 202(c)(5),
the agency agrees it will not disclose such information to persons
outside the Government without permission of the contractor.
401.14(i) Preference for United States Industry.
Notwithstanding any other provision of this clause, the contractor
agrees that neither it nor any assignee will grant to any person
the exclusive right to use or sell any subject inventions in the
United States unless such person agrees that any products embodying
the subject invention or produced through the use of the subject
invention will be manufactured substantially in the United States.
However, in individual cases, the requirement for such an agreement
may be waived by the Federal agency upon a showing by the contractor
or its assignee that reasonable but unsuccessful efforts have
been made to grant licenses on similar terms to potential licensees
that would be likely to manufacture substantially in the United
States or that under the circumstances domestic manufacture is
not commercially feasible.
401.14(j) March-in Rights.
The contractor agrees that with respect to any subject invention
in which it has acquired title, the Federal agency has the right
in accordance with the procedures in 37 CFR 401.6 and any supplemental
regulations of the agency to require the contractor, an assignee
or exclusive licensee of a subject invention to grant a nonexclusive,
partially exclusive, or exclusive license in any field of use
to a responsible applicant or applicants, upon terms that are
reasonable under the circumstances, and if the contractor, assignee,
or exclusive licensee refuses such a request the Federal agency
has the right to grant such a license itself if the Federal agency
determines that:
(1) Such action is necessary because the contractor or assignee
has not taken, or is not expected to take within a reasonable
time, effective steps to achieve practical application of the
subject invention in such field of use.
(2) Such action is necessary to alleviate health or safety needs
which are not reasonably satisfied by the contractor, assignee
or their licensees;
(3) Such action is necessary to meet requirements for public use
specified by Federal regulations and such requirements are not
reasonably satisfied by the contractor, assignee or licensees;
or
(4) Such action is necessary because the agreement required by
paragraph (i) of this clause has not been obtained or waived or
because a licensee of the exclusive right to use or sell any subject
invention in the United States is in breach of such agreement.
401.14(k) Special Provisions for Contracts with Non-profit Organizations.
If the contractor is a non-profit organization, it agrees that:
(1) Rights to a subject invention in the United States may not
be assigned without the approval of the Federal agency, except
where such assignment is made to an organization which has as
one of its primary functions the management of inventions, provided
that such assignee will be subject to the same provisions as the
contractor;
(2) The contractor will share royalties collected on a subject
invention with the inventor, including Federal employee co-inventors
(when the agency deems it appropriate) when the subject invention
is assigned in accordance with 35 U.S.C. 202(e) and 37 CFR 401.10;
(3) The balance of any royalties or income earned by the contractor
with respect to subject inventions, after payment of expenses
(including payments to inventors) incidental to the administration
of subject inventions, will be utilized for the support of scientific
research or education; and
(4) It will make efforts that are reasonable under the circumstances
to attract licensees of subject invention that are small business
firms and that it will give a preference to a small business firm
when licensing a subject invention if the contractor determines
that the small business firm has a plan or proposal for marketing
the invention which, if executed, is equally as likely to bring
the invention to practical application as any plans or proposals
from applicants that are not small business firms; provided, that
the contractor is also satisfied that the small business firm
has the capability and resources to carry out its plan or proposal.
The decision whether to give a preference in any specific case
will be at the discretion of the contractor. However, the contractor
agrees that the Secretary may review the contractor's licensing
program and decisions regarding small business applicants, and
the contractor will negotiate changes to its licensing policies,
procedures, or practices with the Secretary when the Secretary's
review discloses that the contractor could take reasonable steps
to implement more effectively the requirements of this paragraph
(k)(4).
401.14(l) Communication.
All NIH-related disclosures, elections, confirmatory licenses
to the Government, face page of a patent application, waivers
and other routine communications should be sent to the following
address:
Inventions and Extramural Reporting Branch
Division of Grants Policy, OPERA/OER/NIH
Rockledge II, Room 3190, MSC 7750
Bethesda, MD 20892-7750
(301) 435-1986
FAX: (301) 480-0272
For other awarding agencies, please follow their instructions.
In most cases, invention information and communications should
be sent to the cognizant GMO.
The NIH link to the electronic Interagency Edison extramural invention
reporting system can be accessed through the Web at
http://www.iedison.gov.
This electronic reporting system was designed to facilitate reporting
compliance and timeliness, and to reduce paperwork. Edison also
has an e-mail address (Edison@od.nih.gov).
(End of clause)
In the most recent revision of 37 CFR 401, grantees are provided
the option of meeting reporting requirements through electronic
filing. Section 401.16, as stated below, describes changes in
provisions to accommodate electronic filing.
401.16 Electronic Filing.
Unless otherwise requested or directed by the agency:
- The written report required in (c)(1) of the standard clause
in sec. 401.14 may be electronically filed;
- The written election required in (c)(2) of the standard clause
in sec. 401.14 may be electronically filed; and
- The closeout report in (f)(5) of the standard clause in sec.
401.14 and the information identified in (f)(2) and (f)(3) of
sec. 401.5 may be electronically filed.
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