SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

II. Section-by-Section Analysis

III. Regulatory Review and Procedural Requirements

A. Review Under Executive Orders 12866 and 14192

B. Review Under Executive Order 12988

C. Review Under the Regulatory Flexibility Act

D. Review Under the Paperwork Reduction Act

E. Review Under the National Environmental Policy Act

F. Review Under Executive Order 13132

G. Review Under Executive Order 13175

H. Review Under the Unfunded Mandates Reform Act of 1995

I. Review Under the Treasury and General Government Appropriations Act, 1999

J. Review Under Executive Order 13211

K. Review Under the Treasury and General Government Appropriations Act, 2001

L. Congressional Notification

IV. Approval by the Office of the Secretary of Energy

I. Background

The purpose of this rulemaking is to amend the Department's Financial Assistance Regulations at 2 CFR part 910. Specifically, DOE is amending part 910 to prescribe responsibilities, requirements, and procedures for non-Federal entities to identify, evaluate, resolve, and report conflicts of interest, conflicts of commitment, and organizational conflicts of interest in Federal financial assistance applications and awards, as those terms are defined in this final rule.

This final rule implements Office of Management and Budget (OMB) guidance to Federal agencies regarding the establishment of conflict of interest (COI) policies for Federal awards by codifying existing DOE policy, consistent with National Security Presidential Memorandum 33 (NSPM-33) ^[1] and the CHIPS and Science Act of 2022 (Pub. L. 117-167; August 9, 2022).

DOE is required to establish COI policies for Federal awards pursuant to 2 CFR 200.112, which specifies a non-Federal entity recipient or sub-recipient of a Federal financial assistance award must disclose in writing any potential COI to the Federal awarding agency or pass-through entity in accordance with applicable Federal awarding agency policy.

On December 20, 2021, DOE issued an interim COI policy ^[2] addressing COI and organizational conflicts of interest. The interim COI policy has been incorporated in and made enforceable through the Special Terms and Conditions for DOE financial assistance awards. The standards established in the interim COI policy provide a reasonable expectation that the design, conduct, and reporting of projects funded wholly or in part under DOE financial assistance awards ( e.g., a grant, cooperative agreement, or technology investment agreement) will be free from bias resulting from COI or conflict of commitment (COC).^[3] To minimize the implementation burden on non-Federal entities, the interim COI policy largely aligned with the long-standing COI regulations established by the Public Health Service (PHS) at 42 CFR part 50, subpart F, which are applicable to research and development entities that include R&D funded by Public Health Service grants or cooperative agreements.

On June 18, 2024, DOE published in the Federal Register a notice of proposed rulemaking proposing to codify in regulation the interim COI policy, COC requirements, and organizational conflict of interest requirements. See89 FR 51460 (June 2024 NOPR). Comments were received from the following: ( printed page 43512)

A parenthetical reference at the end of a comment quotation or paraphrase in this final rule provides the location of the item in the public record.^[4]

The requirements adopted in this final rule are codified in subpart C to 2 CFR part 910 (Subpart C). The requirements regarding COI, COC, and organizational conflicts of interest (OCI) ^[5] generally apply to non-Federal entities applying and receiving financial assistance awards from DOE as described in 2 CFR 910.122. Subpart C will not be applicable to applicants to or recipients of financial assistance under the programs of the DOE Office of Indian Energy, given that office's statutory mission to maximize the development and deployment of energy solutions for the benefit of American Indians and Alaska Natives; the unique sovereign status of Tribes; the practical limitations such regulations would present Tribes serving their communities, which in certain instances are small and remote; and consideration of traditional Tribal practices.

DOE program offices may tailor as appropriate the COI, COC, and OCI provisions for individuals applying for or receiving a DOE financial assistance award in their individual capacity. Upon the effective date of this final rule, the regulations at 2 CFR part 910, subpart C will supersede the interim COI policy, FAL No. 2022-02.

II. Section-by-Section Analysis

DOE is amending chapter IX of title 2 of the Code of Federal Regulations to add subpart C. Subpart C provides the general requirement for applicants for and recipients of Federal financial assistance from DOE to maintain a COI and COC policy; definitions relevant to the COI and COC policy requirements; and for the disclosure of certain COI, COC, and OCI, by applicants and recipients. Beginning October 1, 2024, updates to several parts of the OMB Guidance for Grants and Agreements (now called the OMB Guidance for Federal Financial Assistance) located in title 2 of the Code of Federal Regulations went into effect. See89 FR 30046; April 22, 2024. In the June 2024 NOPR, DOE stated that it would consider conforming changes to the regulations proposed in the June 2024 NOPR based on the finalized OMB guidance once effective, as appropriate. See89 FR 51460, 51461. This final rule uses terminology and citations consistent with the OMB Guidance for Federal Financial Assistance.

Generally, commenters supported the codification of COI requirements in regulation to ensure the integrity of projects funded by DOE financial assistance, and stated that precise definitions, clear reporting, investigation, and transparency rules serve only to improve the financial assistance process. (UC, No. 6 at 1; Clean Future, No. 1 at 1; Purdue, No. 20 at 1)

Certain commenters expressed concern that parts of the proposed rule were duplicative and redundant in the face of existing, similar Federal requirements. (UC No. 6 at 1-3; AAU et al., No. 3 ^[6] at 1, 4-5; Purdue, No. 20 at 2; UW-Madison, No. 10 at 1) Commenters requested DOE adopt the interim COI policy with modifications to align it with the PHS standards established by the U.S. Department of Health and Human Services (HHS) already adopted by some organizations. ( Id.) Commenters claimed that complying with DOE's proposed rule would be unreasonably burdensome, and asserted DOE's proposal was inconsistent with other Agency rules contrary to broader goals of Federal alignment of COI policy. ( Id.)

UC and AAU et al. requested a one-year lead time to allow institutions sufficient time to update their policies, stated insufficient lead time would make compliance impractical, and the one-year lead time provided by PHS ( printed page 43513) when establishing its COI regulations. (UC, No. 6 at 8; AAU et al., No. 3 at 8)

The regulations adopted in this final rule generally codify DOE's existing requirements applicable to DOE's financial assistance awards since 2022. See FAL No. 2022-02. Additionally, the final rule establishes requirements substantively similar to PHS. Given that this final rule largely reflects existing requirements, the regulations adopted in this final rule are effective 30 days following publication in the Federal Register .

As discussed in the following sections, DOE is adopting the COI, COC, and OCI requirements generally as proposed. The final rule codifies and replaces the interim COI policy, which avoids duplication of requirements. The final rule aligns with the COI, COC, and OCI requirements currently applicable to recipients of DOE financial assistance awards, and provides additional details related to the mitigation and reporting of conflicts. Additionally, the adopted COI, COC, and OCI regulations are based on and do not conflict with the PHS requirements. This final rule aligns with the objectives of Executive Order 14303, “Restoring Gold Standard Science,” specifically for science to be conducted without conflicts of interest. ( See90 FR 22601; May 23, 2025).

New 2 CFR part 910, subpart C as adopted in this final rule consists of §§ 910.200 through 910.270 and appendix A as set forth below:

§ 910.200 Definitions

In the June 2024 NOPR, DOE proposed definitions applicable to the new subpart C. Specifically, DOE proposed to define conflict of commitment (COC), conflict of interest (COI), covered individual, financial interest, other support, principal investigator (PI), project, and significant financial interest. See89 FR 51460, 51464-51466. For the reasons provided in the June 2024 NOPR and provided in the following paragraphs, DOE is adopting the definitions as proposed in the June 2024 NOPR with certain changes as discussed in this section.

AAU et al. requested DOE remove examples from the regulatory definition of conflict of commitment, recommending that examples be reserved for guidance to allow more practical implementation. (AAU et al., No. 3, at 5-6) AAU et al. also requested DOE delete reference to certain examples ( i.e., obligations to improperly share information with, or to withhold information from, an employer or DOE). ( Id. at 6) AAU et al. further requested DOE remove references to pending employment from the definition of conflict of commitment, asserting it is practically impossible for institutions to identify or mitigate COCs in this area, as researchers do not typically share plans to seek other employment with their current employers. ( Id.)

DOE is maintaining the examples in the conflict of commitment definition as proposed. Inclusion of examples in the regulatory text facilitates compliance and avoids the need to consult multiple sources. Obligations to improperly share or withhold information present significant risks to the integrity of DOE funded projects and therefore merit inclusion as an example. The regulations adopted in this final rule specify the criteria required of COC policies adopted by a non-Federal entity. Included in the criteria is a requirement for each covered individual who is participating in a DOE Federal financial assistance award update disclosures on an annual basis and as soon as any new actual, apparent, or potential COI or COC arises. To the extent pending employment results in an actual, apparent, or potential COI or COC, a covered individual would be obligated to report the COI or COC to the non-Federal entity. Accordingly, DOE is including a reference to pending employment in definition of conflict or commitment and is adopting the definition of that term as proposed.

DOE proposed conflict of interest to mean a situation in which a covered individual or the spouse or a child of the covered individual has a significant financial interest or financial relationship, whether with a domestic or foreign entity, that could directly and significantly affect the design, conduct, reporting or funding of a project or other Federal financial assistance award-related activities. See89 FR 51460, 51465. Examples of situations that may give rise to a COI include, but are not limited to, holding an Executive position, director position, or equity over a certain dollar amount in a company that stands to benefit from Federal financial assistance award-related activities, receiving financial compensation in the form of consulting payments or payment for services from a company that stands to benefit from Federal financial assistance award-related activities, or intellectual property rights or royalties from such rights whose value may be affected by the outcome of Federal financial assistance award-related activities. Id.

Commenters objected to the proposed definition of COI, asserting that it does not align with the PHS definition. (UC, No. 6 at 3, 7; AAU et al., No. 3 at 6) UC and AAU et al. stated that such inconsistency would require costly realignment of institutional policies. Commenters also recommended removing examples from the regulatory text and placing them in guidance to allow flexibility for real-world circumstances. ( Id.)

The definition of COI as proposed in the June 2024 NOPR is substantively the same as the PHS term, which is defined as a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research. See 42 CFR 50.603. Both the DOE proposed definitions and the PHS definitions specify which individuals' interests must be considered ( e.g., the spouse or a child of the covered individual in addition to the covered individual)—DOE in the proposed definition of conflict of interest and PHS in the definition of significant financial interest definition.

DOE is maintaining the examples in the definition of conflict of interest. Including examples in the regulations avoids the need for applicants and recipients to consult additional documents when determining the applicability of the requirements.

For the reasons provided in the preceding paragraphs, DOE is adopting the definition of conflict of interest as proposed in the June 2024 NOPR.

In the June 2024 NOPR, DOE proposed covered individual to mean any individual, regardless of title or position, who: (1) Contributes in a substantive, meaningful way to the development or execution ( e.g., purpose, design, conduct, or reporting) of a project funded by DOE or proposed for funding by DOE; and, (2) Is designated as a covered individual by DOE. See89 FR 51460, 51465. DOE proposed specifically designating any principal investigator (PI), project director (PD), co-principal investigator (Co-PI), co-project director (Co-PD), or project manager; and any individual (including an individual at the masters or baccalaureate level) that contributes in a substantive, meaningful way to the development or execution of a subject project that is listed by the non-Federal entity in the application for Federal financial assistance, approved budget, progress report, or any other report submitted to DOE by the non-Federal entity regarding the subject project. Id.

Several commenters urged narrowing the definition of covered individual to focus on individuals with significant influence over project design or execution. (UC, No. 6 at 4, 7-8; Washington University, No. 11, 1-2; AAU et al., No. 3, at 7-8; UW-Madison, No. 10 at 1). Commenters asserted that including all participants, regardless of ( printed page 43514) role, creates unnecessary administrative burden. ( Id.)

Under the proposed definition, a covered individual would be an individual with significant influence over project design or execution. To clarify further that the covered individual definition requires project level control, DOE is defining covered individual as an individual who contributes in a substantive, meaningful way to the development or execution of the scope of work of a project. The adopted definition also specifies DOE designation applies to individuals for whom a current and pending support disclosure and/or biosketch/resume is submitted with an application for financial assistance. Submission of these forms indicates an individual has sufficient involvement to warrant inclusion as a covered individual.

As adopted in this final rule, covered individual means any individual, regardless of title or position, who: (1) Contributes in a substantive, meaningful way to the development or execution of the scope of work of a project funded by DOE or proposed for funding by DOE; and, (2) is designated as a covered individual by DOE. Additionally, the final rule designates as covered individuals any principal investigator (PI), project director (PD), co-principal investigator (Co-PI), co-project director (Co-PD), project manager, and any individual regardless of title that is functionally performing as a PI, PD, Co-PI, Co-PD, or project manager; and persons designated in the applicable Notice of Funding Opportunity (NOFO) or terms and conditions of the Federal financial assistance award. Submission of a current and pending support disclosure and/or biosketch/resume for a particular person serves as an acknowledgement that DOE designates that person as a covered individual.

The adopted definition remains consistent with consideration of an individual's responsibilities in the PHS definition of investigator, which covers individuals responsible for the design, conduct, or reporting of research funded by PHS. See, 42 CFR 50.603. Additionally, the definition adopted in this final rule is consistent with the use of covered individual under the implementation of NPSM-33 and reflects applicants and recipients of DOE funding may use different titles and terminology than those under PHS funding. The adopted definition also provides DOE flexibility to designate additional individuals depending on the sensitivity of a project and potential research security concerns.

The prime applicant is responsible for assessing the applicability of the covered individual definition against each person listed on an application for financial assistance from DOE. Further, the prime applicant is responsible for identifying any such individual to DOE for designation as a covered individual, if not already designated by DOE as described above.

Regarding the definition of significant financial interest, commenters recommended a de minimis disclosure threshold of $5,000 for certain categories ( e.g., intellectual property interests, reimbursed travel), noting that requiring disclosure of smaller amounts diverts resources from higher risk oversight. (UC, No. 6 at 4-5, 7; Washington University, No. 11 at 2; AAU et al., No. 3 at 10)

As explained by HHS when establishing a comparable definition of significant financial interest, requiring the disclosure of the value of travel reimbursements could be difficult, particularly in the case of sponsored travel, which is paid on behalf of the covered individual and not reimbursed by the covered individual, so that the exact monetary value may not be readily available. See76 FR 53256, 53265 (September 26, 2011). HHS identified similar difficulties in determining the precise value of intellectual property interests. Id.

Because of the difficulty in determining the monetary value of sponsored travel and intellectual property interests, a de minimis threshold would risk creating uncertainty when determining compliance. Moreover, applying a de minimis threshold could potentially lead to additional burden in determining whether the threshold is exceeded ( e.g., covered individuals would need to obtain estimates or appraisals to determine whether a significant financial interest existed).

For the reasons discussed in the preceding paragraphs, DOE adopts the definition of significant financial interest as proposed and consistent with the definition established by HHS.

The proposed definition of significant financial interest includes consideration of other support, for which DOE separately proposed a definition. DOE proposed other support to mean all resources made available to a covered individual in support of and/or related to all of their professional research (including basic and fundamental research), development, demonstration, and/or deployment efforts, including resources provided directly to the covered individual rather than through the research organization, and regardless of whether or not they have monetary value ( e.g., even if the support received is only in-kind, such as office/laboratory space, equipment, supplies, or employees). See89 FR 51460, 51465. The proposed definition further provided the term includes resource and/or financial support from all foreign and domestic entities, including but not limited to, gifts provided with terms or conditions, financial support for laboratory personnel, and participation of student and visiting researchers and visiting scholars supported by other sources of funding. Id.

AAU et al. opposed inclusion of a definition for other support, describing it as redundant and a source of compliance uncertainty. (AAU et al., No. 3 at 8) DOE proposed a definition of other support recognizing certain resources made available to a covered individual may not readily be characterized as current or pending support, and that such support has the potential to create a conflict. There may be instances in which support could be characterized as either other support or as current and pending support. This potential overlap does not impact the reporting required by a covered individual as reporting does not require further categorization of a significant financial interest.

DOE is adopting language to clarify other support includes gifts provided without terms or conditions. This clarification is consistent with what is required to be reported under the Current and Pending Financial Assistance Letter 2022-04. Accordingly, DOE is establishing a definition for other support as proposed.

§ 910.210 Applicability

Section 910.210 establishes the applicability of the COI and COC policy and reporting requirements in new subpart C as proposed. In general, the requirements are applicable to non-Federal entities that are applicants to or recipients of a DOE Federal financial assistance award.

Washington University recommended removing the proposed provision allowing the requirements to be tailored for individuals receiving financial assistance. Washington University, No. 11 at 3. Washington University stated that permitting such tailoring would defeat the purpose of a unifying set of requirements and significantly increase the administrative burden on institutions to comply with varying application of the same regulation. ( Id.)

DOE clarifies that the tailoring provision at § 910.210(a)(2) applies to individuals applying for or receiving financial assistance in their individual capacity. DOE would not tailor the requirements of this subpart when the ( printed page 43515) non-Federal entity is a university or research facility.

§ 910.220

Reserved.

§ 910.230 Required Conflict of Interest (COI) and Conflict of Commitment (COC) Policies

As proposed in the June 2024 NOPR, § 910.230 would require non-Federal entities that are applicants to or recipients of DOE Federal financial assistance to establish and maintain written and enforced policies addressing actual, apparent, and potential COI and COC. See89 FR 51460, 51466-51467. Proposed § 910.230 would also establish requirements COI and COC policy requirements for subrecipients. Under the proposed regulations, COI and COC policies would be required to mandate certain reporting by covered individuals to the non-Federal entity, as well as required training.

Per the June 2024 NOPR, any non-Federal entity that is an applicant to or recipient of a DOE Federal financial assistance award must maintain a written and enforced policy addressing actual, apparent, and potential COI and COC, both foreign and domestic.

Washington University commented inclusion of “actual, apparent, or potential” does not align with, nor is included in, the definition of a COI, and that inclusion of the terms creates ambiguity in what institutions should identify as a COI or COC. (Washington University, No. 11 at 4.) AAU et al. recommended deletion of the term “apparent” from the phrase “actual, apparent, or potential” COI in proposed § 910.230(a), stating that absent a precise regulatory definition use of the term risks uncertainty and redundancy. (AAU et al., No. 3 at 9)

“Actual, apparent, or potential” describe the relevant types of COIs and COCs. An actual COI occurs when a significant financial interest or financial relationship exists that could directly and significantly affect the design, conduct, reporting or funding of a project or other Federal financial assistance award-related activities. A potential COI occurs when there is the possibility such a significant or financial relationship will arise in the future ( e.g., when an individual applies for employment). Under FAL 2022-02, apparent conflicts are included in the definition of potential conflicts. However, an apparent conflict may be distinct from a potential conflict. An apparent conflict occurs when a conflict may appear to exist to a reasonable outside observer even if there is no actual or potential conflict. To clarify the distinction between an apparent conflict and a potential conflict, DOE proposed to separately specify the terms. Use of apparent and potential are consistent with the common understanding of those terms and regulatory definitions are not necessary. DOE is adopting the use of “actual, potential, and apparent” as proposed.

Commenters recommended removing the COC policy requirements, asserting that institutions cannot reasonably monitor individual commitments. (AAU et al., No. 3 at 10; Washington University, No. 11 at 4) Washington University stated that requirements extending a recipient's COC policy to a subrecipient are impractical as they would require the recipient institution to have knowledge of both external commitments and the institutional obligations of each covered individual for a subrecipient. (Washington University, No. 11 at 4) AAU et al. commented COC concerns are already addressed though FAL 2022-02 and the common disclosure forms contain an individual certification statement that each senior/key person must complete regarding current and pending support. (AAU et al., No. 3)

The proposed regulations would require a subrecipient to certify it has COI and COC policies that comply with the DOE regulations, or if a subrecipient cannot provide such certification, the subrecipient's covered individuals would be subject to the COI and COC policy of the recipient. Under either option, a covered individual would be required to report an actual, apparent, and potential COC to the subrecipient or recipient comparable to the requirement to reporting required for a COI. An implemented COC policy and COI policy both rely on the reporting of the covered individuals. As proposed, applicability of the COI and COC policies to a subrecipient must be established in a written agreement between the recipient and subrecipient. Such a written agreement would establish the reporting, timing, and compliance obligations of the subrecipient to the recipient.

Common forms and use of tools such as digital persistent identifiers provide means for tracking and demonstrating compliance, but in and of themselves, do not establish a transparent requirement and process for ensuring any such conflicts are identified and appropriately mitigated. As noted, adoption of this final rule will supersede FAL 2022-02.

Codifying the requirements for COI and COC upholds NSPM-33 through clearly articulated requirements and processes for appropriate disclosure of information related to both COIs and COCs. Effective implementation across recipients and subrecipients of DOE financial assistance will make it more difficult for individuals to conceal materially important support, obligations, conflicts of interest, and/or relationships that, when concealed, could lead to DOE making inadequately informed funding decisions. Effective implementation will also make it easier for recipients to identify and address noncompliance in a timely and fair manner. For these reasons, DOE is adopting the COC provisions in 2 CFR 200.201 as proposed.

DOE proposed covered individuals update required disclosures to the non-Federal entity on an annual basis and as soon as any new actual, apparent, or potential COI or COC arises. See89 FR 51460, 51466. AAU et al. and UC requested aligning the timing of ongoing reporting requirements with existing PHS rules and inclusion of a clear compliance timeline, noting that the proposed rule would increase administrative burden. (AAU et al., No. 3 at 9; UC No. 6 at 8-9) Strikland requested DOE define “as soon as.” (Strikland, No. 2 at 1) AAU et al. and UC requested specifying a 30-day period to report new conflicts, stating that a defined time would provide more regulatory certainty and be better understood by researchers. (AAU et al., No. 3 at 9; UC No. 6 at 8-9)

DOE is generally adopting the reporting criteria as proposed. The reporting criteria reflects DOE's general requirement that applicants for financial assistance as well as recipients comply with the COI and COC policies and generally align with the requirements applicable under FAL 2022-02. DOE acknowledges that requiring reporting “as soon as possible” is less certain than specifying a timeframe. To reduce this uncertainty, the final rule specifies that a new COI or COC must be reported as soon as practicable, but not later than 15 days, after it arises.

DOE proposed requiring COI and COC policies to mandate each covered individual to complete COI and COC training prior to engaging in projects funded under a DOE Federal financial assistance award and complete refresher training least every two years. See89 FR 51460, 51466. Commenters recommended increasing required training intervals to four years to align with PHS regulations and minimize administrative impact. (AAU et al., No. 3 at 10; Purdue, No. 20 at 2-3; Washington University, No. 11 at 3)

DOE is adopting the training frequency as proposed. Covered ( printed page 43516) individuals are required to update their disclosures annually and periodically as COIs and COCs arise. Training more frequently than every four years helps ensure the annual and periodic updates are completed correctly and completely. The two-year training cycle reflects the focus on increased training under the CHIPS and Science Act of 2022 and NPSM-33. Further, the final rule does not prohibit non-federal entities from aligning the two-year cycle with longer training cycles as may be adopted by other agencies. Additionally, the research security training developed for compliance with CHIPs and Science Act of 2022 ^[7] addresses COIs and COCs and therefore could be relied upon to meet this requirement.

§ 910.240 Reporting Conflicts of Interest (COIs) and Conflicts of Commitment (COCs)

As proposed, § 910.240 would establish requirements for non-Federal entities to report to DOE certain identified COIs and COCs and mitigation measures. See89 FR 51460, 51467. In general, proposed § 910.240(a) would require applicants and recipients of DOE financial assistance to disclose to DOE any actual, apparent, or potential COI or COC if such conflict cannot be eliminated or appropriately managed or reduced in accordance with the non-Federal entity's policy. In addition, the proposed subsection would require disclosure of any actual, apparent, or potential COI or COC involving any foreign governments, their instrumentalities, or any other entities owned, funded, or otherwise controlled by a foreign government, as well as any measures the entity has taken to eliminate or, where appropriate, manage or reduce the COI or COC.

UC requested removal of the reference to 2 CFR 200.112, stating that the referenced CFR section is limited to conflicts that might arise when a non-federal entity expends funds under a Federal award, such as decisions about subrecipient selection or procurement, and the reference may lead to confusion. (UC, No. 6 at 9).

The language of 2 CFR 200.112 is not as narrow as suggested by UC. That section requires Federal agencies to establish COI policies for Federal awards and a recipient or subrecipient to disclose in writing any potential COI to the Federal agency in accordance with the established Federal agency policies. 2 CFR 200.112. Reference to section 2 CFR 200.112 explicitly identifies the requirements in proposed 2 CFR 910.240 as DOE's implementation of the regulatory direction in the OMB Guidance for Federal Financial Assistance at 2 CFR part 200. DOE is including the reference to 2 CFR 200.112 in the adopted § 910.240.

Commenters opposed requiring COI and COC reporting as part of an application for DOE financial assistance stating the costs of such reviews would be unreasonable, absent assurance of award. (AAU et al., No. 3 at 10; UC, No. 6 at 6-7; Washington University, No. 11 at 5) Commenters further stated that it would be overly burdensome to require reviews prior to submission as such reporting would require institutions to complete reviews, identify potential conflicts, and design and implement management plans for projects that may not be funded, and that there is not sufficient time between receipt of completed proposals from investigators, and submission deadlines. ( Id.)

Under the proposed reporting requirements, individuals that would qualify as covered individuals under a funding opportunity would be required to identify any actual, apparent, or potential COI or COC were the non-Federal entity awarded financial assistance under that opportunity. See89 FR 51460, 51467. As a result of annual COI and COC reporting and periodic training, it is expected that individuals participating in an application for financial assistance will be able to readily ascertain whether an award would create an actual, apparent, or potential COI or COC. DOE recognizes that changes may occur after application. However, in evaluating potential selections for award, it is crucial for DOE to be aware of possible COIs and COCs that would arise under the award and that could not be mitigated. For example, identifying a COI or COC that cannot be mitigated for the primary investigator listed on an application weighs into DOE's evaluation of the personnel on a proposed project. Identifying such COIs and COCs as part of the application process will facilitate submission of applications that are more representative of a project were it awarded. Additionally, as part of DOE's on-going research security responsibilities it is crucial to be aware of possible COIs and COCs involving any foreign governments, their instrumentalities, or any other entities owned, funded, or otherwise controlled by a foreign government, were DOE to award the applicant project. Identification of COIs and COCs that cannot be mitigated and COIs and COCs related to foreign governments at the application process reduces the likelihood of selected projects not proceeding to award because of such conflicts. DOE is adopting the reporting requirements applicable to applicants and recipients as proposed.

UC recommended limiting the reporting of COIs and COCs related to foreign governments “if known” and “where appropriate,” and stated it can be complicated to determine if an entity is connected to a foreign government as the information may not be publicly available or accessible. (UC, No. 6 at 9)

DOE is not adopting language as suggested by UC. If a covered individual is listed on an application for or participating in a project receiving DOE financial assistance, it is incumbent on the individual have a reasonable understanding of whom that individual is conducting business and exercise due diligence to determine whether such interest presents an actual, apparent, or potential COI or COC.

Washington University asserted that the proposed rule required four different reporting scenarios, (unmanageable COI/COC, all foreign COI/COC, all COI/COC as required by the funding opportunity, and all COI/COC per the terms and conditions of an award) and that the multiple reporting matrices overcomplicates reporting by requiring award specific reporting requirements and increases the risk for failure to report. (Washington University, No. 11 at 4; see also AAU et al., No. 3 at 10) AAU et al. recommended removal of the “case-specific” reporting requirements and instead adoption of a uniform reporting requirement that aligns with the PHS standards. (AAU et al., No. 3 at 12)

As explained, the proposed rule would require reporting of all COIs and COCs that are unmanageable and all COIs and COCs related to foreign governments. Based on the sensitivity of the funded subject area or an awarded project, DOE proposed that reporting of additional conflicts could be required. It is not uncommon for DOE to specify tailored application and award requirements in order to address concerns and/or circumstances specific to a funding opportunity or an award. Any such tailored reporting requirements would be explicitly delineated in the relevant notice of funding opportunity or award, as may be applicable. DOE strives for consistency across Federal agencies to the extent such consistency is consistent with DOE's mission and responsibilities. DOE is adopting the provisions which provide DOE flexibility that make application/award specific modifications to the COI and COC reporting requirements ( printed page 43517) commensurate with sensitives and risks particular to a funding opportunity or award, as proposed.

Proposed § 910.240(d) provided that in addition to the annual COI/COC report, DOE may require a non-Federal entity to routinely, or upon request, submit all or some covered individuals' disclosures. See89 FR 51460, 51467. AAU et al. objected to routine reporting requirements in addition to the annual reporting, stating mandating disclosures “routinely” would make it extremely difficult for institutions to establish and maintain efficient processes for collecting and reviewing disclosures and making required reports. (AAU et al., No. 3 at 12)

Proposed § 910.240(d) addresses instances in which reporting more than on an annual basis may be necessary. Such instances, as specified in the proposed regulation: as part of monitoring the non-Federal entity's compliance with this subpart; bankruptcy of the non-Federal entity; other legal winding down of the non-Federal entity; acquisition of the non-Federal entity by a foreign entity, where “acquisition” includes a foreign entity obtaining a controlling interest in the non-Federal entity; or as otherwise set forth in 2 CFR part 200 and this part. As illustrated by the specified circumstances, routine submission of covered individuals' disclosures would be required in circumstances that may warrant a heightened degree of oversight. DOE does not anticipate such routine reporting to be typical. DOE is establishing § 910.240(d) as proposed.

Proposed § 200.240(e) provided if a non-Federal entity becomes aware that a covered individual failed to comply with the non-Federal entity's COI and COC policy or a management plan, the non-Federal entity must promptly notify DOE in writing of the failure to comply and of the corrective action taken or to be taken. See89 FR 51460, 51467.

AAU et al. requested a non-Federal entity be provided 60 days to report such failures, stating 60 days would provide time to take any necessary corrective action and would align with the NASA and PHS requirements, and FAL 2022-02. (AAU et al., No. 3 at 12)

DOE is not adopting a 60-day period for reporting non-compliance as suggested by AAU et al. DOE notes that FAL 2022-02 establishes a requirement to “promptly” report noncompliance. See FAL 2022-02, Remedies. Receiving prompt notification allows DOE to take corrective action in a timely manner. DOE also notes that the proposal would not require the non-Federal entity to have taken corrective action prior to reporting, explicitly stating that report may include corrective action the non-Federal entity will take.

For the reasons discussed in the preceding paragraphs, DOE is adopting § 910.240, Reporting conflicts of interest (COIs) and conflicts of commitment (COCs), as proposed.

§ 910.250 Organizational Conflicts

Consistent with 2 CFR 200.318, DOE proposed requirements regarding non-Federal entities with a parent, affiliate, or subsidiary organization that is not a state government, local government, or Indian tribe, the non-Federal entity must maintain written standards of conduct covering organizational conflicts of interest (OCIs) as that term is defined in 2 CFR 200.318(c)(2). See89 FR 51460, 51467. DOE notes that in the context of the Federal Acquisition Regulations, the head of an agency or their designee may waive the organizational conflicts of interest requirement by determining that its application in a particular situation would not be in the Government's interest. 48 CFR 9.503.

DOE is adopting § 910.250 as proposed.

§ 910.260 Reporting Organizational Conflicts of Interest (OCIs)

DOE proposed reporting requirements relevant to any potential or actual OCI to DOE. See89 FR 51460, 51467. Proposed section 910.260 would establish the timing and content required of such reports. As proposed, non-Federal entities would be required to report any potential or actual OCI within five business days of learning of the conflict. Washington University recommended extending reporting timelines from five days to 60 days to align with PHS standards and reduce administrative burden. (Washington University, No. 11 at 5-6).

Identifying and mitigating OCIs is necessary to ensure the integrity of procurement activities under a Federally funded award. A failure or delay in identifying an OCI can make mitigation more difficult and risks costs associated with the subject procurement being unallowable, which can increase the administrative burden and costs to recipients when addressing identified OCIs. As proposed, the non-Federal entity would not be required to have implemented mitigation measures prior to reporting. The recipient would be required to report plans to avoid, eliminate, or mitigate the OCI. Timely reporting of an OCI allows DOE to coordinate and undertake necessary measures. DOE recognizes that five business days may not be sufficient time for a non-Federal entity to report an OCI. DOE is adopting a 15-day period for reporting consistent with historical practice for the terms and conditions of DOE awards.

DOE is adopting § 910.260 as proposed, but with a 15-day period required for reporting.

§ 910.270 Remedies, Penalties, and Enforcement

Proposed § 910.270 would specify actions DOE may take if a non-Federal entity fails to disclose a COI or COC or fails to sufficiently manage or mitigate such a conflict. See89 FR 51460, 51467-51468. Proposed section 910.270 would also specify the remedies for failure to disclose an OCI. See89 FR 51460, 51468.

AAU et al. expressed concern with language requiring a disclosure or mitigation to “ensure the integrity of the DOE-supported project” and “protect the government's interests,” asserting that the meaning of these terms is not defined and not readily ascertainable by non-Federal entities. (AAU et al., No. 3 at 13-14) Similarly, AAU et al. expressed concern with DOE's evaluation of whether a COI or COC would “adversely impact the project.” (AAU et al., No. 3 at 14)

In exercising appropriate stewardship over Federal funding, DOE has the responsibility of ensuring funding is spent in a manner consistent with the Department's programmatic objectives, that safeguards the security of federally funded projects, and that maintains the integrity of science produced using Federal funds. Recipients of Federal funds accept such funding subject to Federal oversight. As proposed, § 910.270(a) specifies the actions DOE may take in response to a failure to disclose or adequately manage, or mitigate a COI or COC, including providing the non-Federal entity an opportunity to take additional action.

AAU et al. further requested limiting § 910.270 to procurement activities as opposed to “procurement or transaction” activities as proposed. (AAU et al., No. 3 at 14)

Non-Federal entities may undertake transactions to acquire goods and services similar to procurement transactions, but that rely on different mechanisms and/or authorities. These other transactions have the potential to raise OCI concerns in the same manner as procurement transactions. DOE is clarifying the applicability of § 910.270 extends to such other transactions.

To provide for the appropriate exercise of Federal stewardship over federally funded projects, DOE is adopting § 910.270 as proposed, but clarifying its applicability to other ( printed page 43518) transactions similar to procurement transactions.

Appendix A

AAU et al. and Washington University requested replacing appendix certification statements with institution-specific attestation statements to reduce administrative burden. (AAU et al., No. 3 at 10; Washington University, No. 11 at 3)

DOE is adopting the specific certification statement as proposed. Appendix A provides uniform language that avoids the need for non-Federal entities to separately develop statements and ensures the legal enforceability of such statements.

III. Regulatory Review and Procedural Requirements

A. Review under Executive Orders 12866 and 14192

Executive Order (E.O.) 12866, “Regulatory Planning and Review,” requires agencies, to the extent permitted by law to: (1) propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fee or profit or marketable permits, or providing information upon which choices can be made by the public. DOE has determined that this final rule is consistent with these principles, including the requirement that, to the extent permitted by law, agencies adopt a regulation only upon a reasoned determination that its benefits justify its costs and, in choosing among alternative regulatory approaches, those approaches maximize net benefits.

Section 6(a) of E.O. 12866 also requires agencies to submit “significant regulatory actions” to the Office of Information and Regulatory Affairs (OIRA) for review. OIRA has determined that this regulatory action does not constitute a “significant regulatory action” under section 3(f) of E.O. 12866. Accordingly, this action was not submitted to OIRA for review under E.O. 12866.

DOE has examined this rulemaking and has determined that it is consistent with the policies and directives outlined in E.O. 14192, “Unleashing Prosperity Through Deregulation.” This final rule is considered an E.O. 14192 deregulatory action. The final rule will not impose additional costs to applicants and recipients of financial assistance. The regulations codify and streamline the Department's policies and requirements currently addressed through financial assistance letters, notice of funding opportunity announcements, and award terms and conditions. Moreover, the rule streamlines the financial assistance process by facilitating the use of common forms and improve consistency in the disclosure requirements across Federal agencies, consistent with NSPM-33. DOE did not estimate the cost savings of this final rule.

B. Review Under Executive Order 12988

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” (61 FR 4729, February 7, 1996), imposes on Executive agencies the general duty to adhere to the following requirements: (1) eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction.

With regard to the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the United States Attorney General.

Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or if it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this rule meets the relevant standards of Executive Order 12988.

C. Review Under the Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires preparation of an initial regulatory flexibility analysis for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. As required by Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” (67 FR 53461, August 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the rulemaking process (68 FR 7990). DOE has made its procedures and policies available on the Office of General Counsel's website at www.energy.gov/​gc/​office-general-counsel.

DOE has reviewed this rule under the provisions of the Regulatory Flexibility Act and the procedures and policies published on February 19, 2003. DOE certifies that this rule will not have significant economic impact on a substantial number of small entities. The factual basis for this certification is set forth below.

The final rule is applicable to non-Federal entities that are applicants to or recipients of financial assistance awards from the Department. Non-Federal entities, including small entities, are currently subject to the Department's interim policies implementing the conflicts provisions at 2 CFR 200.112 and the requirements regarding OCI at 2 CFR 200.318(c). This final rule codifies the existing policies applicable to financial assistance awards from the Department. Additionally, the applicable DOE program office may tailor as appropriate the COI, COC, and OCI provisions for individuals that are applicants to or recipients of a DOE financial assistance award.

Accordingly, DOE certifies that this rule will not have a significant economic impact on a substantial number of small entities, and, therefore, no regulatory flexibility analysis is required. DOE will transmit a certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the Small Business Administration for review under 5 U.S.C. 605(b). ( printed page 43519)

D. Review Under the Paperwork Reduction Act

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Ch. 3506; 5 CFR part 1320, appendix A.1) (PRA), DOE reviewed this rule and determined that there are no new collections of information contained therein. DOE's financial assistance reporting and recordkeeping burdens have been approved under OMB Control No. 1910-0400.

E. Review Under the National Environmental Policy Act.

DOE has determined that promulgation of this rule falls into a class of actions that would not individually or cumulatively have a significant impact on the human environment, as determined by DOE's regulations implementing the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) (NEPA). Specifically, DOE determined that this rule is covered under the categorical exclusion found in DOE's NEPA regulations at paragraph A6 of appendix A to subpart D, 10 CFR part 1021.

Categorical exclusion A6 applies to rulemakings that are strictly procedural. Additionally, DOE has preliminarily determined that this rule is covered under the Categorical Exclusion found in DOE's NEPA regulations at paragraph A5 of appendix A to subpart D, 10 CFR part 1021, which applies to a rulemaking that amends an existing rule or regulation and that does not change the environmental effect of the rule or regulation being amended. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

F. Review Under Executive Order 13132

Executive Order 13132, “Federalism” (64 FR 43255, August 4, 1999), imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and carefully assess the necessity for such actions. The Executive order requires agencies to have an accountability process to ensure meaningful and timely input by state and local officials in the development of regulatory policies that have federalism implications.

On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations (65 FR 13735). DOE has examined the rule and has determined that it does not preempt State law and does not have a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. No further action is required by Executive Order 13132.

G. Review Under Executive Order 13175

Under Executive Order 13175 (65 FR 67249, November 6, 2000) on “Consultation and Coordination with Indian Tribal Governments,” DOE may not issue a discretionary rule that has “Tribal” implications and imposes substantial direct compliance costs on Indian Tribal governments. DOE has determined that the final rule would not have such effects and concludes that Executive Order 13175 does not apply to this rulemaking.

H. Review Under the Unfunded Mandates Reform Act of 1995

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect them. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820. DOE's policy statement is also available at https://energy.gov/​sites/​prod/​files/​gcprod/​documents/​umra_​97.pdf. This rule does not contain a Federal intergovernmental mandate, nor is it expected to require expenditures of $100 million or more in any one year by the private sector. As a result, the analytical requirements of UMRA do not apply.

I. Review Under the Treasury and General Government Appropriations Act, 1999

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277), requires Federal agencies to issue a Family Policymaking Assessment for any rulemaking or policy that may affect family well-being. This rulemaking will have no impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

J. Review Under Executive Order 13211

Executive Order 13211, “Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use,” (66 FR 28355, May 22, 2001), requires Federal agencies to prepare and submit to OIRA, of the Office of Management and Budget (OMB), a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1) is a significant regulatory action under Executive Order 12866, or any successor order, (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution and use. This rule is not a significant energy action. Moreover, it will not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Accordingly, DOE has not prepared a Statement of Energy Effects.

K. Review Under the Treasury and General Government Appropriations Act, 2001

The Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516, note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (February 22, 2002), and ( printed page 43520) DOE's guidelines were published at 67 FR 62446 (October 7, 2002). DOE has reviewed this rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

L. Congressional Notification

As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of this rule before its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).

IV. Approval by the Office of the Secretary of Energy

The Secretary of Energy has approved publication of this final rule.

Signing Authority

This document of the Department of Energy was signed on July 10, 2026, by Derek Passarelli, Director of the Golden Field Office and Senior Procurement Executive, and William J. Quigley, Deputy Associate Administrator for Office of Partnership and Acquisition Services and Senior Procurement Executive, National Nuclear Security Administration, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE/NNSA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register.

For reasons set out in the preamble, DOE amends chapter IX of title 2 of the Code of Federal Regulations as set forth below: