Notice2023-11897
Notice To Announce NIH Updated Policy Guidance for Subaward/Consortium Written Agreements
Primary source
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Published
June 5, 2023
Effective
October 1, 2023
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Institutes of Health (NIH) is seeking public comment on updates to the NIH Grants Policy Statement (GPS), Section 15.2, which outlines the requirements for consortium/subaward agreements on NIH-funded grants.
Full Text
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<title>Federal Register, Volume 88 Issue 107 (Monday, June 5, 2023)</title>
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[Federal Register Volume 88, Number 107 (Monday, June 5, 2023)]
[Notices]
[Pages 36603-36604]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-11897]
[[Page 36603]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notice To Announce NIH Updated Policy Guidance for Subaward/
Consortium Written Agreements
AGENCY: National Institutes of Health, HHS.
ACTION: Request for comments.
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SUMMARY: The National Institutes of Health (NIH) is seeking public
comment on updates to the NIH Grants Policy Statement (GPS), Section
15.2, which outlines the requirements for consortium/subaward
agreements on NIH-funded grants.
DATES: To ensure that your comments will be considered, please submit
your response to this Request for Comments no later than July 5, 2023
to ensure consideration. The planned effective date of this guidance is
October 1, 2023, and updated language will be incorporated into the GPS
in the FY24 publication.
ADDRESSES: Comments may be submitted online at <a href="https://rfi.grants.nih.gov/?s=646e6654a8ba09024f09e852">https://rfi.grants.nih.gov/?s=646e6654a8ba09024f09e852</a>.
FOR FURTHER INFORMATION CONTACT: Xanthia James, Director, Division of
Grants Policy, Office of Policy for Extramural Research Administration,
NIH, Rockledge I, Suite 350, Bethesda, MD 20817. Email:
<a href="/cdn-cgi/l/email-protection#742c151a001c1d155a3e15191107341a1d1c5a131b02"><span class="__cf_email__" data-cfemail="d981b8b7adb1b0b8f793b8b4bcaa99b7b0b1f7beb6af">[email protected]</span></a>. Phone number (301) 435-0949.
SUPPLEMENTARY INFORMATION:
Request for Comments
NIH encourages the public to provide comments on any aspect of the
updated guidance outlined below.
Submitting a Response
Comments should be submitted electronically to the following web
page <a href="https://rfi.grants.nih.gov/?s=646e6654a8ba09024f09e852">https://rfi.grants.nih.gov/?s=646e6654a8ba09024f09e852</a> by the
comment due date. Unedited comments will be compiled and may be posted,
along with the submitter's name and affiliation, on the NIH Office of
Extramural Research website after the public comment period closes.
Submitted comments are considered public information. Please do not
include any proprietary, classified, confidential, or sensitive
information in your response.
Updated Guidance
2 CFR 200.332(a)(5) at <a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-D/subject-group-ECFR031321e29ac5bbd/section-200.332">https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-D/subject-group-ECFR031321e29ac5bbd/section-200.332</a> states that subaward agreements
must include, ``a requirement that the subrecipient permit the pass-
through entity and auditors to have access to the subrecipient's
records and financial statements as necessary for the pass-through
entity to meet the requirements of this part.'' In response to the
Department of Health and Human Services (HHS), Office of Inspector
General and Government Accountability Office audits, NIH has determined
that to assure that this requirement is met, NIH finds it necessary to
impose a requirement that foreign subrecipients turn over all records
to the primary recipient at an agreed upon frequency (e.g., once a
quarter, once a month). Therefore, section 15.2 is updated as follows
(changes are bold and italicized).
15.2 ADMINISTRATIVE AND OTHER REQUIREMENTS
The following highlights several areas within the consortium
relationship that the recipient needs to address with consortium
organizations receiving subawards under a grant to ensure compliance
with NIH requirements. The requirement for a written agreement
addressing these and other areas is specified in this section. NIH will
not support any agreement that does not meet the minimum requirements
outlined in the written agreement section below (15.2.1). NIH reserves
the right to request copies of the written agreement and relevant
supporting documentation as needed, as part of its oversight
responsibilities. Failure to provide requested documentation may lead
to remedies for noncompliance and potential enforcement actions (see
8.5, Specific award conditions and remedies for noncompliance).
NIH encourages recipients to ask potential subrecipients, at the
application stage, to submit language in their letters of support
indicating their awareness of these requirements and the subrecipient's
willingness to abide by all requirements should an award be issued.
Note that most of these requirements only apply to a recipient's
consortium relationships with sub-recipients. When the relationship is
with a vendor that is providing routine goods and services within
normal business operations that are ancillary to the operation of the
research program, the public policy requirements listed below do not
apply. The vendor must also be providing similar goods and services to
many different purchasers and provide them in a competitive
environment.
15.2.1 Written Agreement
The recipient must enter into a formal written agreement , signed,
and agreed to by both parties, with each consortium participant/
subrecipient that addresses the negotiated arrangements for meeting the
scientific, administrative, financial, and reporting requirements of
the grant, including those necessary to ensure compliance with all
applicable Federal regulations and policies and facilitate an efficient
collaborative venture. If a subrecipient is unwilling to accept the
requirements outlined in this section, by signing a written agreement,
then an agreement cannot be issued. At a minimum, this agreement must
include the following:
<bullet> Identification of the individual who will serve as the
consortium lead investigator and other individuals responsible for the
research activity at each consortium participant along with their roles
and responsibilities.
<bullet> When multiple Program Directors/Principal Investigators
(PDs/PIs) are involved at different organizations, only the Contact PD/
PI is required to have the official relationship with the applicant
organization. PDs/PIs in the leadership team at other organizations
must have a documented relationship with a consortium organization but
need not be employees. Any consortium agreement must address the unique
aspects to these individuals holding the PD/PI role including the
requirement for the prime institution to secure and retain all PD/PI
signatures for all applications, progress reports, and post-award prior
approval requests. Further, such signatures must be made available to
NIH or other authorized HHS or Federal officials upon request. See
Multiple Program Director/Principal Investigator Applications and
Awards at <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_9/9_multiple_program_director_principal_investigator_applications_and_awards.htm">https://grants.nih.gov/grants/policy/nihgps/HTML5/section_9/9_multiple_program_director_principal_investigator_applications_and_awards.htm</a> for additional information.
<bullet> Procedures for directing and monitoring the research
effort.
<bullet> Procedures to be followed in reimbursing each consortium
participant for its effort, including dollar ceiling, method and
schedule of reimbursement, type of supporting documentation required,
procedures for review and approval of expenditures of grant funds at
each organization and timing of applicable reporting requirements. This
includes provisions on access to core facilities and resources and
whether access will be provided as a fee-for-service.
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<bullet> If different from those of the recipient, a determination
of policies to be followed in such areas as travel reimbursement and
salaries and fringe benefits (the policies of the consortium
participant may be used as long as they meet NIH requirements).
<bullet> Terms that establish whether the Financial Conflict of
Interest (FCOI) policy of the prime Institution or that of the
subrecipient will apply to the subrecipient's Investigators.
<bullet> If the subrecipient's Investigators must comply with the
prime Institution's FCOI policy, the subrecipient shall certify as part
of the written agreement that its policy complies with the 2011 revised
FCOI regulation (42 CFR part 50 Subpart F). If the subrecipient cannot
provide such certification, the agreement shall state that subrecipient
Investigators are subject to the FCOI policy of the prime Institution
for disclosing Significant Financial Interests that are directly
related to the subrecipient's work for the prime Institution.
<bullet> If the subrecipient's Investigators must comply with the
subrecipient's FCOI policy, the written agreement shall specify time
period(s) for the subrecipient to report all identified FCOI to the
prime Institution. Such time period(s) shall be sufficient to enable
the prime Institution to provide timely FCOI reports, as necessary, to
the Public Health Service (PHS) as required by the regulation.
<bullet> Alternatively, if the subrecipient's Investigators must
comply with the prime Institution's FCOI policy, the written agreement
shall specify time period(s) for the subrecipient to submit all
Investigator disclosures of Significant Financial Interests to the
prime Institution. Such time period(s) shall be sufficient to enable
the prime Institution to comply timely with its review, management, and
reporting obligations under the 2011 revised FCOI regulation.
<bullet> A provision addressing ownership and disposition of data
produced under the consortium agreement. This includes whether cell
lines, samples or other resources will be freely available to other
investigators in the scientific community or will be provided to
particular investigators only.
<bullet> For foreign subrecipients, a provision requiring the
foreign subrecipient to provide copies of all lab notebooks, all data,
and all documentation that supports the research outcomes as described
in the progress report. These supporting materials must be provided to
prime recipient with each scientific update (no less than once every
six months, or more frequently based on risks) in line with the
timelines outlined in the agreement.
<bullet> A provision making NIH data sharing and inventions and
patent policy, including a requirement to report inventions to the
recipient (see Administrative Requirements-Availability of Research
Results: Publications, Intellectual Property Rights, and Sharing
Research Resources at <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.2_availability_of_research_results_publications__intellectual_property_rights__and_sharing_research_resources.htm">https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.2_availability_of_research_results_publications__intellectual_property_rights__and_sharing_research_resources.htm</a> in IIA), applicable to each
consortium participant and its employees in order to ensure that the
rights of the parties to the consortium agreement are protected and
that the recipient can fulfill its responsibilities to NIH.
<bullet> Expectations for authorship and co-authorship on
publications.
<bullet> Provisions regarding property (other than intellectual
property), program income, publications, reporting, and audit necessary
for the recipient to fulfill its obligations to NIH.
<bullet> Provisions regarding compliance with requirements for a
Unique Entity Identifier (UEI) and subrecipient reporting under the
Federal Funding Accountability and Transparency Act (FFATA) (see
Recipient Reporting of Subrecipient Data and Executive Compensation
Information for FFATA at <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.4.1_reporting.htm#Recipient">https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.4.1_reporting.htm#Recipient</a>). Note, the recipient
must provide the Federal Award Identification Number (FAIN) at <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_1/1.1_abbreviations.htm#FAIN">https://grants.nih.gov/grants/policy/nihgps/HTML5/section_1/1.1_abbreviations.htm#FAIN</a> to all subrecipients to aid in this
requirement.
<bullet> Incorporation of applicable public policy requirements and
provisions indicating the intent of each consortium participant to
comply, including submission of applicable assurances and
certifications (see Public Policy Requirements, Objectives, and Other
Appropriation Mandates at <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4_public_policy_requirements__objectives_and_other_appropriation_mandates.htm">https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4_public_policy_requirements__objectives_and_other_appropriation_mandates.htm</a> in IIA).
See NIH Guide Notice NOT-OD-23-133 at <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-133.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-133.html</a>.
Dated: May 30, 2023.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2023-11897 Filed 6-2-23; 8:45 am]
BILLING CODE 4140-01-P
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