Request for Information on Proposed Conflict of Interest Disclosure Policy, 92714-92716 [2024-27421]

Agencies

• DEPARTMENT OF THE INTERIOR
• Office of the Secretary

[Federal Register Volume 89, Number 226 (Friday, November 22, 2024)]
[Notices]
[Pages 92714-92716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27421]



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DEPARTMENT OF THE INTERIOR

Office of the Secretary

[Docket No. DOI-2024-0009; 245D0102DM, DS600000, 
DLSN00000.000000.DX6CS25]


Request for Information on Proposed Conflict of Interest 
Disclosure Policy

AGENCY: Office of the Secretary, Interior.

ACTION: Notice of request for public comments.

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SUMMARY: The Department of the Interior (DOI) is developing a conflict 
of interest (COI) disclosure policy and corresponding term and 
condition for financial assistance awards (i.e., grants and cooperative 
agreements) to address undue foreign influence in DOI-supported 
research and development (R&D). DOI is soliciting public comment on its 
proposed policy and accompanying award term and condition to ensure 
government resources are managed with integrity to the greatest public 
benefit.

DATES: Submit comments on or before January 21, 2025.

ADDRESSES:  Comments may be submitted through the Federal eRulemaking 
Portal at https://www.regulations.gov. Type in DOI-2024-0009 in the 
search bar. Follow the instructions on the website for submitting 
comments.

FOR FURTHER INFORMATION CONTACT: Cara Whitehead, Director, Office of 
Grants Management, (202) 603-5735, [email protected]. Mailing 
address: Department of the Interior, 1849 C Street NW, Mail Stop 3023 
MIB, Washington, DC 20240.

SUPPLEMENTARY INFORMATION: On December 17, 2020, the U.S. Government 
Accountability Office (GAO) published GAO-21-130, Federal Research: 
Agencies Need to Enhance Policies to Address Foreign Influence in 
Research. The report alerted agencies of the need to develop conflict 
of interest policies to assess risks and protect U.S. investments in 
scientific research from undue foreign influences.
    DOI plans to develop a conflict-of-interest policy to define core 
terms, require financial assistance award recipients to maintain 
written and enforceable policies, and mandate covered individuals to 
identify, disclose, manage, reduce, or eliminate COI. The policy will 
address required actions by DOI in instances where the covered 
individual intentionally fails to disclose COI information and will 
include a term and condition which will be incorporated into the DOI 
financial assistance award terms and conditions. The DOI Office of 
Grants Management intends to implement the policy for all R&D 
competitive and non-competitive grant and cooperative agreements after 
obtaining and considering public comment.
    Before including your address, phone number, email address, or 
other personal identifying information in your comment, you should be 
aware that your entire comment, including your personal identifying 
information, may be made publicly available at any time. If you submit 
a comment at https://www.regulations.gov, your entire comment, 
including any personal identifying information, will be posted on the 
website. If you submit a hardcopy comment that includes personal 
identifying information, such as your address, phone number, or email 
address, you may request at the top of your document that we withhold 
this information from public review. However, we cannot guarantee that 
we will be able to do so.

Definitions

    Conflict of interest is a situation in which an individual, or the 
individual's spouse or dependent children, has a significant financial 
interest or financial relationship that could directly and 
significantly affect the design, conduct, reporting, or funding of 
research or other award-related activities.
    Conflict of commitment is a situation in which an individual 
accepts or incurs conflicting obligations between or among multiple 
employers or other entities. Conflict of commitment includes 
conflicting commitments of time and effort, including obligations to 
dedicate time in excess of one organization's funding, policies, or 
commitments in favor of another organization's priorities. Conflict of 
commitment also includes obligations to improperly share information 
with, or to withhold information from, an employer or DOI, as well as 
other conflicting obligations that threaten research security and 
integrity. Such conflicts are also described as an organizational 
conflict of interest.
    Covered individual or senior/key person is an individual who (a) 
contributes in a substantive, meaningful way to the scientific 
development or execution of a research and development project proposed 
to be carried out with a research and development award from a Federal 
research agency or (b) is designated as a covered individual by the 
Federal research agency concerned. As defined by the National Security 
Presidential Memorandum--33 (NSPM-33) Implementation Guidance, this 
means principal investigators (Pis) and other senior/key persons 
seeking or receiving Federal research and development funding (i.e., 
extramural funding) and researchers at Federal agency laboratories and 
facilities (i.e., intramural researchers, whether or not federally 
employed), including Government-owned, contractor-operated laboratories 
and facilities. A covered individual may also include a current or 
former DOI employee.
    Financial Interest can be anything of monetary value, whether or 
not the value is easily measurable.
    Intramural Researcher is an agency employee who conducts research 
supported by the agency in which they are employed.
    Investigator is a principal investigator (PI) and any other person, 
regardless of title or position, who is responsible for the purpose, 
design, funding, conduct or reporting of a project funded or proposed 
to be funded by DOI.
    Principal Investigator (PI) means a principal investigator of a 
project funded under a DOI financial assistance award; PI is included 
in the definitions of senior/key personnel and Investigator.
    Research and development (R&D) includes basic research, applied 
research, and experimental development. Basic research is experimental 
or theoretical work undertaken primarily to acquire new knowledge of 
the underlying foundations of phenomena and observable facts. Applied 
research is original investigation undertaken in order to acquire new 
knowledge and directed primarily towards a specific practical aim or 
objective. Experimental development is creative and systematic work, 
drawing on knowledge gained from research and practical experience, 
which is directed at producing new products or processes or improving 
existing products or processes. Like research, experimental development 
will result in gaining additional knowledge. Experimental development 
includes the production of materials, devices, and systems or methods, 
including the design, construction, and testing of experimental 
prototypes. Experimental development also includes technology 
demonstrations in cases where a system or component is being 
demonstrated at scale for the first time, and it is realistic to expect 
additional refinements to the design (feedback R&D) following the 
demonstration.\1\
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    \1\ https://www.whitehouse.gov/wp-content/uploads/2018/06/a11.pdf.

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    Significant financial interest is anything of monetary value, 
including, but not limited to, salary or other payments for services 
(e.g., consulting fees or honoraria); an existing loan; equity interest 
(e.g., stocks, stock options or other ownership interests); and 
intellectual property rights (e.g., patents, copyrights, and royalties 
from such rights), but does not include the following:
    1. Salaries, royalties or other remuneration from the applicant 
organization;
    2. Any ownership interests in the applicant organization if the 
organization is a commercial or for-profit entity;
    3. Income from investment portfolio such as mutual funds and 
retirement account if the investigator does have direct control of the 
investment decisions in the portfolio;
    4. Income from seminars, lectures, or teaching engagements 
sponsored by a public or non-profit entity;
    5. Income from service on advisory committees or review panels for 
a public or nonprofit entity;
    6. An equity interest that, when aggregated for the covered 
individual and the covered individual's spouse and dependent children, 
meets both of the following tests: does not exceed $10,000 in value as 
determined through reference to public prices or other reasonable 
measures of fair market value, and does not represent more than a 5 
percent ownership interest in any single entity;
    7. An existing or offered loan or other financing to the covered 
individual or covered individual or covered individual's spouse and 
dependent children not exceeding $10,000 in the aggregate; or
    8. Salaries, royalties or other payments that, when aggregated for 
the covered individual and the covered individual's spouse and 
dependent children, are not expected to exceed $10,000 during the prior 
12-month period.

Responsibilities of Non-Federal Entities Regarding Conflict of Interest

    Each non-Federal Entity shall:
    1. Maintain a current, written, enforced policy addressing COI 
which aligns with the DOI COI policy.
    2. Ensure that each subrecipient develops and implements a policy 
which corresponds with the DOI COI policy if the non-Federal entity 
implements the DOI award through one or more subrecipients.
    3. Designate a non-Federal entity official to solicit and review 
disclosures of significant financial interests from each covered 
individual who is planning to participate in, or is participating in, 
the project funded under a DOI award, including disclosures of 
subrecipient investigators.
    4. Disclose to DOI any potential or actual conflict of interest and 
submit common disclosure forms for the Biographical Sketch Common Form 
and the Current and Pending (Other) Support Common Form for PIs and 
other senior/key personnel, program officers, and intramural 
researchers with the application for competitive and non-competitive 
DOI grant and cooperative agreement awards, per NSPM-disclosure 
requirements indicated in the NSPM-33 Implementation Guidance.
    5. Require each investigator who is planning to participate in the 
DOI award to disclose to the non-Federal entity's designated official 
the investigator's significant financial interests (and those of the 
investigator's spouse and dependent children) no later than the time of 
application for the DOI award. Disclosures must be updated during the 
period of the award, either annually or upon learning of new reportable 
significant financial interests.
    6. Require investigators engaged in subaward activities to comply 
with the COI policies of the pass-through entity.

Management of Conflict of Interest

    Prior to the non-Federal entity's expenditure of any funds under a 
DOI award, the designated official of a non-Federal entity shall review 
all investigator disclosures of significant financial interests, 
identify whether any of the disclosures relate to the project funded 
under the DOI award, and determine whether an actual or potential COI 
exists. In instances where a COI may exist, the non-Federal entity must 
develop and implement a management plan which manages, reduces, or 
eliminates the COI. Conditions or restrictions of which one or more may 
be imposed to eliminate an actual or potential COI include but are not 
limited to:
    1. Public disclosure of any COI (e.g., when presenting or 
publishing the project);
    2. For projects involving human subjects, disclosure of any COI 
directly to participants;
    3. Appointment of an independent monitor or oversight committee 
capable of taking measures to protect the purpose, design, conduct, and 
reporting of the project against bias resulting from any COI;
    4. Modification of the project plan;
    5. Change of personnel or personnel responsibilities, or 
disqualification of personnel from participation in all or a portion of 
the project;
    6. Reduction or elimination of the financial interest (e.g., sale 
of an equity interest) creating the COI; or
    7. Severance of relationship(s) that create the COI.
    DOI will review the Biographical Sketch Common Form and the Current 
and Pending (Other) Support Common submitted by the non-Federal entity 
to assess qualifications and any conflict of interest or commitment 
which may impact the proposed project activities.

Reporting of Financial Conflict of Interest

    Prior to the non-Federal entity's expenditure of any funds under a 
DOI-funded project, the non-Federal entity must inform the DOI 
financial assistance officer identified in the award(s), in writing, of 
any COI which cannot be satisfactorily managed, mitigated, or 
eliminated in accordance with the non-Federal entity's policy.
    Any conflict of interest identified by the non-Federal entity 
during the course of an ongoing project funded under a DOI award must 
be reported to DOI by the non-Federal entity within 60 days of the 
identified COI that cannot be managed, mitigated, or eliminated.
    Notifications must include sufficient information to enable DOI to 
understand the nature and extent of the COI and assess the 
appropriateness of the non-Federal entity's management plan. The 
notification shall include, but is not limited to, the following 
information: (a) DOI award number; (b) Name of PI or contact PI; (c) 
Name of the investigator with the COI; (d) Name of the entity in which 
the investigator's interest has created a COI; (e) Nature of any 
applicable financial interest (e.g., equity, loan, consulting fee, 
travel reimbursement, honorarium) and/or applicable external 
relationships or activities; (f) Value of any applicable financial 
interest or a statement that the interest is one whose value cannot be 
readily determined through reference to public prices or other 
reasonable measures of fair market value; and (g) A description of how 
the financial interest relates to the project funded under a DOI award 
and the basis for the non-Federal entity's determination that there is 
a conflict with such project.

Remedies

    Upon notification to DOI of a COI which cannot be managed, 
mitigated, or eliminated by the non-Federal entity or upon DOI 
independently learning of this, the DOI financial assistance officer 
must report the COI to the DOI Office of the Solicitor, Branch of 
Acquisitions

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and Intellectual Property, to review and take appropriate action, as 
necessary.
    DOI will consider and take appropriate actions, as necessary, such 
as requiring and enforcing a corrective action plan and imposing 
specific award conditions under 2 CFR 200.208 as necessary. As 
appropriate, DOI will also utilize available remedies for non-
compliance and terminations provisions pursuant to 2 CFR 200.339 
through 200.343, as appropriate under the circumstances. Available 
remedies include but are not limited to: (a) temporarily withholding 
payment; (b) disallowing all or part of the cost of an award activity; 
(c) wholly or partly suspending or terminating the award; (d) 
initiating referrals for consideration of suspension or debarment 
proceedings, and (e) withholding further Federal awards for the project 
or program.

Conflict of Interest Award Term and Conditions

    DOI's COI financial assistance award term and condition will be 
revised as follows:
    The DOI COI policy for financial assistance can be found at the 
Office of Grants Management website. This policy is applicable to all 
non-Federal entities applying for, or that receive, DOI funding by 
means of a financial assistance award (e.g., a grant or cooperative 
agreement) and, through the implementation of this policy by the 
entity, to each investigator who is planning to participate in, or is 
participating in, the project funded wholly or in part under the DOI 
financial assistance award.
    The DOI COI policy establishes standards that provide a reasonable 
expectation that the design, conduct, and reporting of projects funded 
wholly or in part under DOI financial assistance awards will be free 
from bias resulting from financial conflict of interest or conflict of 
commitment. The recipient is subject to the requirements of the DOI COI 
policy and within each award for financial assistance, the recipient 
must certify that it is, compliant with all requirements in the DOI COI 
policy. The recipient must pass-through the requirements of the DOI COI 
policy to any subrecipient non-Federal entity.

Authority

    The authority for this action is the Department's Financial 
Assistance Regulations at 2 CFR part 1402.

Cara Whitehead,
Director, Office of Grants Management, Department of the Interior.
[FR Doc. 2024-27421 Filed 11-21-24; 8:45 am]
BILLING CODE 4334-63-P