Notice2024-27421
Request for Information on Proposed Conflict of Interest Disclosure Policy
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 22, 2024
Issuing agencies
Interior Department
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 226 (Friday, November 22, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 226 (Friday, November 22, 2024)]
[Notices]
[Pages 92714-92716]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27421]
[[Page 92714]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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, <a href="/cdn-cgi/l/email-protection#7d3e1c0f1c222a1514091815181c193d14120e53191214531a120b"><span class="__cf_email__" data-cfemail="0d4e6c7f6c525a6564796865686c694d64627e23696264236a627b">[email protected]</span></a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>, 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\
---------------------------------------------------------------------------
\1\ <a href="https://www.whitehouse.gov/wp-content/uploads/2018/06/a11.pdf">https://www.whitehouse.gov/wp-content/uploads/2018/06/a11.pdf</a>.
---------------------------------------------------------------------------
[[Page 92715]]
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
[[Page 92716]]
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on November 22, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.