[Federal Register Volume 88, Number 107 (Monday, June 5, 2023)]
[Notices]
[Pages 36603-36604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11897]



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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 https://rfi.grants.nih.gov/?s=646e6654a8ba09024f09e852.

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: 
[email protected]. 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 https://rfi.grants.nih.gov/?s=646e6654a8ba09024f09e852 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 https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-D/subject-group-ECFR031321e29ac5bbd/section-200.332 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:
     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.
     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 https://grants.nih.gov/grants/policy/nihgps/HTML5/section_9/9_multiple_program_director_principal_investigator_applications_and_awards.htm for additional information.
     Procedures for directing and monitoring the research 
effort.
     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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     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).
     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.
     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.
     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.
     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.
     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.
     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.
     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 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 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.
     Expectations for authorship and co-authorship on 
publications.
     Provisions regarding property (other than intellectual 
property), program income, publications, reporting, and audit necessary 
for the recipient to fulfill its obligations to NIH.
     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  https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.4.1_reporting.htm#Recipient). Note, the recipient 
must provide the Federal Award Identification Number (FAIN) at https://grants.nih.gov/grants/policy/nihgps/HTML5/section_1/1.1_abbreviations.htm#FAIN to all subrecipients to aid in this 
requirement.
     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 https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4_public_policy_requirements__objectives_and_other_appropriation_mandates.htm in IIA).
    See NIH Guide Notice NOT-OD-23-133 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-133.html.

    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