DOE is publishing this notice of proposed rulemaking in order to update and clarify DOE's policies and procedures for processing complaints by employees of DOE contractors alleging retaliation by their employers for:

The current rule was last updated in 2019. 1 Since then, the rule has been applied to numerous investigations, hearings, appeals, and petitions for Secretarial review regarding contractor complaints filed under this rule. The proposed changes are intended to address areas of potential confusion and bring the regulations in line with current practice in order to ensure clarity, consistency, and fairness in DOE's administration of the Contractor Employe Protection Program. The proposed revisions would:

The proposed rule would amend § 708.1, “Scope and purpose,” by updating the descriptions of the types of protected disclosures that are covered by part 708 to match the text of § 708.5, “Protected conduct,” for consistency.

The proposed rule would amend § 708.2, “Definitions,” by deleting “(a)” before “For purposes of this part”.

The proposed rule would amend the definition for “Alternative Dispute Resolution” to “Alternative dispute resolution” to keep the capitalization consistent.

The proposed rule would amend the definition of “Day” by adding several sentences that detail how the deadlines operate in practice to provide clarity to parties.

The proposed rule would replace the term “EC Director” with “ECP Director” here and throughout the following proposed part 708 regulations. The proposed rule would also replace the term “Office of Employee Concerns” with “Employee Concerns Program” to be consistent with the terminology in DOE O 442.1B.

The proposed rule would amend the definition for “Party” by replacing the term “party” with “individual” to avoid confusion that may result from using the same term twice in the definition.

The proposed rule would add a definition for the term “Law, rule, or regulation” and would define the term as “policies or procedures that are government mandates or implement government mandates.” This proposed addition would clarify the types of violations that may constitute protected disclosures under part 708.

The proposed rule would add a definition for the term “Union-negotiated grievance-arbitration procedure” and would define the term as “one that has been negotiated by a labor organization.” This definition is one that is long-established in Office of Hearings and Appeals (OHA) case law.

The proposed rule would also add a definition of “Verified email” and would define the term as “an email sent to the email address provided by a party.” The proposed addition of this definition reflects a proposed change to acceptable methods of notification under § 708.18.

Lastly, the proposed rule would delete subsection (b) in its entirety because the proposed rule would revise part 708 so the provisions are gender neutral. For example, in place of “he,” the proposed rule would use “he or she,” and in place of “his,” the proposed rule would use “his or her.” Such revisions are proposed throughout part 708 and are consistent with the regular practice of DOE and other federal agencies.

The proposed rule would amend § 708.4, “Complaints not covered,” to clarify which other types of complaints bar an employee from filing a complaint under Part 708. Specifically, the reference in § 708.4(c) through § 708.15(a) would refer instead to § 708.16(a) for accuracy. In addition, the words “a regulation, statute, or other law, including” would be added after “chosen to pursue a remedy available under” in § 708.4(c) to clarify the basis upon which a complaint may be excluded if it is based on the same facts for which the employee chose to pursue another remedy. The proposed rule would also revise the list of regulations, statutes, or other laws listed under § 708.4(c) to update the referenced regulations and to add “41 U.S.C. 4712, `Enhancement of contractor protection from reprisal for disclosure of certain information.'”

The proposed rule would amend § 708.9(a), “How to file complaints or other documents,” to state that a complaint or other document is considered filed on the date it is received by the specified official or office.

The proposed rule would add § 708.10, “Informal resolution of complaints.” This section would encourage the use of alternative dispute resolution services to resolve complaints arising under part 708. To facilitate the use of these services, this section would explain where parties can seek these services, allow for the tolling of deadlines under part 708 while using these services, and provide instructions for the steps to take if a complaint is resolved. The addition of this section will reduce costs associated with part 708 complaints, increase processing efficiency, and improve the effectiveness of alternative dispute resolution services for part 708 complaints.

The proposed rule would amend § 708.13, “Requirements for the form and content of a complaint,” so that the term “union-negotiated” is included before “grievance or arbitration procedures” to be consistent with the proposed revisions to § 708.2.

The proposed rule would amend the title to § 708.14 so that it reads “Exhaustion of union-negotiated grievance-arbitration procedures” and would amend § 708.14 so that “union-negotiated” is added to every reference to “grievance-arbitration procedure” to be consistent with the proposed revisions to § 708.2.

The proposed rule would amend § 708.15, “Time to file a complaint,” as follows. In the proposed first sentence of § 708.15(b), the word “any” replaces the word “an” before “internal company grievance-arbitration procedure” to clarify the types of procedures covered under the regulations. In the second sentence, “period” is removed for brevity, the word “internal” is removed for brevity, and the remainder of the sentence is amended to form a proposed third sentence. The proposed third sentence is amended to state, before introducing subparts, “The time begins to run again on the earlier of:” and, in subpart (2), “If a union-negotiated grievance-arbitration procedure, 150 days after the grievance was initiated if a final decision has not been issued.” These changes clarify that use of any internal company grievance-arbitration procedure may toll the deadline to file a complaint even if it was not negotiated by a labor organization. In the proposed § 708.15(d), “not” is removed, “during” is replaced by “on a date later than,” “90 day period” is replaced by “applicable deadline,” and “filing within that period” is replaced by “meeting that deadline” to be consistent with the proposed amended filing deadlines.

The proposed rule would amend § 708.16, “Duplicative actions under State or other law,” as follows. Section 708.16(a)(2) would be amended to include a relevant duplicate proceeding and would add “or 41 U.S.C. 4712” after “48 CFR part 3, subpart 3.9”, and § 708.16(a)(3) would be amended to include “union-negotiated” in front of “grievance-arbitration” to be consistent with the proposed revisions to § 708.2.

The proposed rule would amend § 708.17, “Notification of complaints and opportunities to respond,” as follows. Section 708.17(a) would be amended to add “upon its receipt” to the end of the third sentence after “will provide the complainant with a copy of the employer's response” to clarify when the response must be provided; to add “upon their receipt” after “copy of those additional comments” to clarify when the complainant's additional comments to the employer's response is to be provided; and to add a final sentence that states “The deadline set forth in this subsection may be extended by the Head of Field Element or ECP Director (as applicable) for good reason” to clarify that the Head of Field Element or ECP Director may extend the deadline for good reason. Section 708.17(b) would be amended to add “The Head of Field Element or ECP Director (as applicable) will provide the comments to the complainant and employer upon his or her receipt” to clarify when the comments submitted by a labor organization bargaining unit representative per § 708.17(b) must be provided to the complainant and employer. A proposed § 708.17(c) would be added and states “The Head of Field Element or ECP Director (as applicable) must provide the contact information for the DOE's Alternative Dispute Resolution Office to the parties as soon as is practicable after receiving the complaint” to promote the use of alternative dispute resolution.

The proposed rule would amend § 708.18, “Dismissal for lack of jurisdiction or other good cause,” as follows. Section 708.18(a) would be amended so that the second sentence states “If the employer does not file a response, such decisions are issued by the 20th day after the employer's period to respond under § 708.17(a) has elapsed.” The third sentence would be amended to state “If the employer files a timely response, such decisions are issued by the 20th day after the complainant files additional comments under § 708.17(a), or the 20th day after the period to file additional comments has elapsed, whichever is soonest.” These changes would clarify deadlines and help the Head of Field Element or ECP Director determine when it will be decided if a complaint is dismissed. Section 708.18(b) would be amended by adding “verified email or” before “certified email” to be consistent with the proposed amended § 708.2 definition of verified email. Section 708.18(c)(1) through (c)(4) would be amended to remove the “or” after each semicolon for brevity.

The proposed rule would amend § 708.19, “Appealing the dismissal of a complaint by the Head of Field Element or ECP Director for lack of jurisdiction or other good cause,” by deleting “as evidenced by a receipt for delivery or certified email” after “dismissal” in § 708.19(a) to allow electronic notice.

The proposed rule would amend § 708.20, “Review by the Secretary of Energy of a decision on appeal of a dismissal,” by replacing “any party” with “the complainant” in § 708.20(a) to reflect the reality that only complainants appeal dismissals. The proposed rule would also replace “a petition for Secretarial review of a dismissal” with “a notice indicating he or she is petitioning for Secretarial review” in § 708.20(a) to clarify that the filing required by the 30th day after a decision on an appeal under § 708.19 is a notice of appeal rather than a statement of the issues being raised on appeal.

The proposed rule would amend § 708.21, “Referral to the Office of Hearings and Appeals,” as follows to clarify the deadlines by which the Head of Field Element or ECP Director must transmit the complaint to OHA. Section 708.21(a) would be amended by deleting “the later of” before the colon to be consistent with the amendments in the proposed subparts that follow it. Section 708.21(a)(1) would be amended to read “The 25th day after receipt of the final submission permitted by § 708.17” for consistency. Section 708.21(a)(2) would be added and would state “If the employer does not respond to the complaint, the 25th day after the period for responses permitted by § 708.17 ends.” Section 708.21(a)(3) would be added and would state “If the complainant does not submit additional comments regarding the response, the 25th day after the period for additional comments permitted by § 708.17 ends.” The proposed rule would renumber § 708.21(a)(2) as proposed § 708.21(a)(4). The language from § 708.21(c) would be moved to proposed § 708.21(d), and a new § 708.21(c) would be added and would state “Where the Head of Field Element or ECP Director (as applicable) found the complaint to be untimely filed, but nonetheless accepted the complaint for processing as a matter of discretion in accordance with § 708.15(d), he or she must indicate upon referring the complaint to the Office of Hearings and Appeals that good reason was found to accept the complaint for processing.” The proposed § 708.21(c) would establish a record of the reason why an untimely complaint was accepted for processing. Proposed § 708.21(d) would be composed of the language from the current § 708.21(c) and would be amended to replace “OHA” with “Office of Hearings and Appeals” for consistency. Section 708.21(e) would be composed of the language from the current § 708.21(d) and would amend § 708.21(e)(1) by adding “and” to the end of the phrase and would amend § 708.21(e)(2) by replacing “OHA” with “Office of Hearings and Appeals” for consistency.

The proposed rule would amend § 708.22, “Investigation of complaint,” as follows. Section 708.22(b) would be amended to add “Documents containing trade secrets or confidential commercial or financial information must be marked as such when submitted. A copy of the document with the protected information redacted must be submitted with the original document.” The proposed revision formalizes the requirement for parties to mark confidential information as such when submitted.

The proposed rule would amend § 708.23, “Time to issue a report of investigation,” by replacing “60th” with “90th” and deleting “unless the OHA Director, for good cause, extends the investigation for no more than 30 days” in § 708.23(a) to extend the time to issue a report of investigation from 60 days to 90 days. This proposed revision would reflect the reality that Part 708 investigations very frequently require more than 60 days to complete.

The proposed rule would amend § 708.26, “Time and location of hearings,” by replacing “for a location near the site where the alleged retaliation occurred or the complainant's place of employment” with “at a time and place that is appropriate” in § 708.26(b) to make clear that the location of the hearing is at the Administrative Judge's discretion.

The proposed rule would amend § 708.28, “Hearing procedures,” as follows. Section 708.28(b) would be amended by replacing the period with a colon after “following”. Section 708.28(b)(1) would be amended to add “or defense raised in the contractor's response” at the end of the sentence to clarify that discovery is appropriate to obtain evidence concerning a raised defense. Section 708.28(b)(2) would be amended to replace “may” with “will” before “permit” to clarify that the Administrative Judge must allow the parties to conduct discovery upon request. The proposed rule would add § 708.28(b)(3) and would read “The period for discovery shall be established by the presiding Administrative Judge. A party may seek discovery anytime during the discovery period” to clarify the Administrative Judge's powers in the proceeding. The current § 708.28(b)(3) would be renumbered as proposed § 708.28(b)(4). The proposed rule would add proposed § 708.28(b)(5) and would read “The Administrative Judge may rule on any motions filed by the parties, with or without oral argument. The Administrative Judge may set deadlines for the filing of motions and responses” to clarify the Administrative Judge's power in the proceeding. The proposed rule would renumber the current § 708.28(b)(4) as proposed § 708.28(b)(6) and would be amended so that “motions,” after “direct that written,” and the comma after “documents” are removed to clarify the Administrative Judge's powers in the proceeding. The proposed rule would renumber current § 708.28(b)(5) through (b)(8) to proposed § 708.28(b)(7) through (b)(10). The proposed rule would add § 708.28(c) and would read “The hearing record consists of all documents and exhibits filed with the Office of Hearings and Appeals under the hearing case number; the report of investigation, including any exhibits or attachments to the report of investigation except as ordered by the Administrative Judge; the hearing transcript; and all motions, rulings, and orders.” This proposed revision would create a formal and consistent practice about which documents and exhibits are included in the hearing record.

The proposed rule would amend § 708.29, “Burdens of proof,” by dividing the current language into paragraphs (a) and (b) and would further amend as follows. Proposed § 708.29(a) would be composed of the first sentence from the original text with the following added language: “A complainant can demonstrate that a protected activity was a contributing factor to an alleged act of retaliation by establishing, among other things: (1) that the person taking the adverse action had actual or constructive knowledge of the protected activity; and (2) that the alleged retaliatory act had sufficient temporal proximity to the protected activity to give rise to a reasonable inference of a causal connection.” Proposed § 708.29(b) would state “Once the complainant has met this burden, the burden shifts to the contractor to prove by clear and convincing evidence that it would have taken the same action without the complainant's disclosure, participation, or refusal.” The proposed amendments clarify how a complainant can meet their burden of proof by using language long-established in OHA case law.

The proposed rule would amend § 708.30, “Timing for issuing an initial agency decision,” by replacing “§ 708.28(b)(7)” with “§ 708.28(b)(9)” in § 708.30(c) to be consistent with the proposed amendments to § 708.28(b).

The proposed rule would amend § 708.31, “Procedure for issuing an initial agency decision,” by replacing the text after “the initial agency decision will” with “as appropriate, order any form of relief as permitted under § 708.36, or the Administrative Judge will initiate a second proceeding for the purpose of determining the appropriate form of relief” in § 708.31(c) to align the regulations with the common OHA practice of holding a second hearing to determine the appropriate form of relief.

The proposed rule would amend § 708.34, “Procedure for issuing an appeal decision,” to include “or remand the matter to the Administrative Judge for further proceedings regarding the appropriate relief” at the end of the sentence in § 708.34(b)(2) to allow flexibility for any case to be remanded back to the Administrative Judge for a determination on appropriate relief.

The proposed rule would amend § 708.36, “Remedies,” to include “incurred in pursuing the complaint” after “reasonable costs and expenses” in § 708.36(a)(4) to clarify the scope of allowable reimbursement for the complainant's cost and expenses.

The proposed rule would amend § 708.40, “Notice of program requirements,” by including “obtain information about filing and” after “the DOE Office where employes can” to clarify that employee notices must also inform employees where they can obtain information about filing a complaint from the appropriate office in addition to where they can file a complaint.

The proposed rule would amend § 708.42, “Extension of deadlines,” by removing “OHA” after “relating to the investigation, hearing, and” for consistency.

Section 6(a) of Executive Order (E.O.) 12866 “Regulatory Planning and Review” 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 because it does not have an annual effect on the economy of $100 million or adversely affect the economy; create an inconsistency or interfere with any action planned or taken by another agency; materially alter the budgetary impact of entitlements, grants, user fees, loan programs, or the rights and obligations of recipients thereof; or raise novel legal or policy issues. Accordingly, this action was not submitted to OIRA for review.

This proposed rule has also been determined to be an “E.O. 14192 deregulatory action” under E.O. 14192, “Unleashing Prosperity Through Deregulation,” 90 FR 9065 (February 6, 2025) because the changes would create a cost savings for the agency. DOE estimates that this proposed rule will save DOE approximately $250,000 annually by encouraging the early resolution of complaints through alternative dispute resolution, with potential additional savings benefits to DOE contractors and contractor-employees.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) requires that an agency prepare an initial regulatory flexibility analysis whenever an agency is required by section 553 of this title, or any other law, to publish a general notice of proposed rulemaking for any proposed rule. This proposed rule would alter procedural rules primarily for the OHA, with little impact on the conduct of or burdens on regulated entities. DOE has determined that the proposed rule, if adopted, would not result in a significant economic impact on a substantial number of small entities because few small entities are involved in part 708 proceedings and because the proposed rule contains few changes in the obligations of the litigants. DOE has therefore determined that the regulatory flexibility analysis is inapplicable.

Proposed part 708 does not contain information collection requirements subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.

DOE has considered this proposed rule in accordance with the National Environmental Policy Act (NEPA), as amended, DOE's NEPA regulations, set forth in 10 CFR part 1021, and DOE's NEPA implementing procedures published outside the Code of Federal Regulations at www.energy.gov/nepa. DOE has determined that NEPA does not apply to this action because this proposed rule is an administrative and routine action excepted from NEPA review. DOE has determined that this rulemaking is a Federal action, but it is not “major” and therefore not subject to NEPA. This action is one in which NEPA does not apply because it does not fall within the definition of “major Federal action” in section 111(10) of NEPA, 42 U.S.C. 4336e(10). See section 2.1(c)(5) of DOE's NEPA implementing procedures. For more information, please see appendix A of 10 CFR part 1021 (“A5, Interpretive rulemakings with no change in environmental effect”) and appendix A of DOE's NEPA implementing procedures, “A5, Interpretive rulemakings with no change in environmental effect.”

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of E.O. 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 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 E.O. 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 Attorney General.

Section 3(c) of E.O. 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 whether 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, the proposed part 708 meets the relevant standards of E.O. 12988.

E.O. 13132, “Federalism,” 64 FR 43255 (Aug. 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.

DOE has examined the proposed part 708 and has determined that it will not preempt State law and will 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 E.O. 13132.

Under E.O. 13175, “Consultation and Coordination with Indian Tribal Governments,” 65 FR 67249 (Nov. 9, 2000), DOE may not issue a discretionary rule that has Tribal implications and imposes substantial direct compliance costs on Indian Tribal governments without prior Tribal consultation. DOE has determined that this proposed rule will not have such effects and has concluded that E.O. 13175 does not apply.

Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) generally requires each Federal agency to provide a written statement assessing the effects of Federal regulatory actions on State, local, and tribal governments and the private sector 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), before promulgating any general notice of proposed rulemaking, and before promulgating any final rule for which a general notice of proposed rulemaking was published.

The proposed rule will not result in 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. Accordingly, no assessment or analysis is required under the Unfunded Mandates Reform Act of 1995.

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 proposed rule that may affect family well-being. The proposed rule will not affect 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.

Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for Federal 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 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). Pursuant to OMB Memorandum M-19-15, “Improving Implementation of the Information Quality Act” (April 24, 2019), DOE published updated guidelines, which are available at: www.energy.gov/sites/prod/files/2019/12/f70/DOE%20Final%20Updated%20IQA%20Guidelines%20Dec%202019.pdf. DOE has reviewed this proposed rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

E.O. 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 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 the promulgation of a final rule or regulation and that “(1)(i) is a significant regulatory action under Executive Order 12866, or any successor order, and (ii) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (2) is designated by the Administrator of the Office of Information and Regulatory Affairs 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 regulatory action is not a significant regulatory action under Executive Order 12866. Moreover, it would 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. Therefore, it is not a significant energy action, and accordingly, DOE has not prepared a Statement of Energy Effects.

DOE will accept all comments, data, and information regarding this proposed rule no later than the date provided in the DATES section at the beginning of this proposed rule. Interested parties may submit comments, data, and other information using any of the methods described in the ADDRESSES section at the beginning of this document.

Submitting comments via www.regulations.gov. The www.regulations.gov web page will require you to provide your name and contact information. Your contact information will be viewable to DOE OHA staff only. Your contact information will not be publicly viewable except for your first and last names, organization name (if any), and submitter representative name (if any). If your comment is not processed properly because of technical difficulties, DOE will use this information to contact you. If DOE cannot read your comment due to technical difficulties and cannot contact you for clarification, DOE may not be able to consider your comment.

However, your contact information will be publicly viewable if you include it in the comment itself or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Otherwise, people viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.

Do not submit to www.regulations.gov information for which disclosure is restricted by statute, such as trade secrets and commercial or financial information (hereinafter referred to as Confidential Business Information [CBI]). Comments submitted through www.regulations.gov cannot be claimed as CBI. Comments received through the website will waive any CBI claims for the information submitted. For information on submitting CBI, see the Confidential Business Information section.

DOE processes submissions made through www.regulations.gov before posting. Normally, comments will be posted within a few days of being submitted. However, if large volumes of comments are being processed simultaneously, your comment may not be viewable for up to several weeks. Please keep the comment tracking number that www.regulations.gov provides after you have successfully uploaded your comment.

Submitting comments via email, hand delivery/courier, or postal mail. Comments and documents submitted via email, hand delivery/courier, or postal mail also will be posted to www.regulations.gov. If you do not want your personal contact information to be publicly viewable, do not include it in your comments or any accompanying documents. Instead, provide your contact information in a cover letter. Include your first and last names, email address, telephone number, and optional mailing address. The cover letter will not be publicly viewable as long as it does not include any comments.

Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via postal mail or hand delivery/courier, please provide all items on a CD, if feasible, in which case it is not necessary to submit printed copies. No telefacsimiles (faxes) will be accepted.

Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, that are written in English, and that are free of any defects or viruses. Documents should not contain special characters or any form of encryption, and, if possible, they should carry the electronic signature of the author.

Campaign form letters. Please submit campaign form letters by the originating organization in batches of between 50 to 500 form letters per PDF or as one form letter with a list of supporters' names compiled into one or more PDFs. This format reduces comment processing and posting time.

Confidential Business Information. Pursuant to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email two well-marked copies: one copy of the document marked “confidential” including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. DOE will make its own determination about the confidential status of the information and treat it according to its determination.

It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).

The Secretary of Energy has approved publication of this notice of proposed rulemaking and request for comments.

This document of the Department of Energy was signed on September 15, 2026, by Chris Wright, Secretary of Energy. That document with the original signature and date is maintained by DOE. 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 the reasons set out in the preamble, DOE proposes to amend part 708 of chapter III of title 10 of the Code of Federal Regulations, as set forth:

The United States has a system of dual banking that allows banks to be chartered by either the States or the Federal Government. Congress has demonstrated a desire to maintain a strong and vibrant dual banking system by periodically enacting legislation to achieve parity between State-chartered banks (State banks) and national banks. 1 The FDIC, as the primary Federal regulator of State banks that are not members of the Federal Reserve System, has likewise long sought to maintain a level playing field between State banks and national banks.

Recent litigation involving an Illinois law concerning payment card transactions has created uncertainty as to the application of the laws of States to State-chartered banks which offer services outside their home State. This uncertainty will negatively affect State banks and may result in substantial disruption and confusion for the merchants relying on payment card transactions and the consumers they serve. This uncertainty also creates a competitive imbalance between national and State banks.

This rulemaking would address this legal uncertainty and recognize parity between out-of-State State banks (State banks that are chartered by their home State but doing business in a host State) and national banks doing business in another State (a host State) without establishing a branch in such host State. The rule would clarify that when host State law does not apply to national banks, then host State law would not apply to out-of-State State banks offering services in the host State with or without a branch. Instead, the chartering State's law would apply to such banks offering services in the host State regardless of whether they branch into the host State.

In addition to achieving parity between out-of-State State banks and national banks, the proposed rule also would enhance consistency in the application of host State law among State banks that offer services outside their chartering States. Under the proposed rule, out-of-State State banks that offer services in a host State without a branch would be treated the same as out-of-State State banks that perform the same services through a branch.

As noted above, recent litigation involving an Illinois law concerning payment card transactions has resulted in uncertainty as to the application of host State laws to out-of-State State banks. The litigation concerns the Illinois Interchange Fee Prohibition Act (IFPA), a law enacted by the State of Illinois in 2024. 2 The IFPA includes provisions that: (1) prohibit card issuer banks, card networks, acquirer banks, and other participants in a payment card transaction from charging or receiving interchange fees on the portion of the transaction that constitutes a tax or gratuity (Interchange Fee Prohibition); and (2) make it unlawful for entities other than the merchant involved in a card transaction to distribute, exchange, transfer, disseminate, or use the associated data, subject to certain exceptions (Data Usage Limitation). By its terms, the IFPA's application is not limited to Illinois-chartered banks.

Shortly after the IFPA's enactment, several trade associations and other parties responded by filing suit against the Illinois Attorney General, arguing that various Federal laws preempted the IFPA. 3 In addition, the Comptroller of the Currency, the regulator of national banks, issued for comment an interim final order concluding that Federal law preempts the IFPA, 4 as well as an interim final rule clarifying that national banks' power to charge non-interest charges and fees includes the power to collect non-interest charges and fees, including interchange fees from credit and debit card operations. 5 The district court has determined that the interim final rule expressly conflicts with the Interchange Fee Prohibition, and thus granted a permanent injunction preventing Illinois from enforcing the Interchange Fee Prohibition against national banks, Federal savings associations, payment card networks, and banks chartered by States other than Illinois “that are subject to Riegle-Neal, 12 U.S.C. 1831a(j)(1).”  6

The parties to the litigation have disagreed as to which State-chartered banks are “subject to Riegle-Neal” ( i.e., subject to section 24(j) of the Federal Deposit Insurance Act (FDI Act)). While the plaintiffs asserted that section 24(j) of the FDI Act extends national bank preemption broadly to out-of-State State banks, 7 the Illinois Attorney General argued that section 24(j) of the FDI Act extends such preemption only to out-of-State State banks' branches “physically located” in Illinois, 8 which would potentially leave aspects of many State banks' operations subject to the IFPA. State banks doing business in Illinois without branches in Illinois therefore face substantial legal uncertainty as to the application of the IFPA to their operations. This proposed rule would remove that uncertainty.

Given the IFPA's significant penalties for non-compliance, 9 banks may consider options for mitigating this risk, including potentially rejecting payment card transactions in Illinois. 10 Such measures would cause substantial disruption and confusion for both merchants and consumers. Moreover, a number of other States are considering legislation similar to the IFPA, 11 meaning that legal uncertainty in the application of State laws to out-of-State State banks may become a more widespread concern.

Congress has granted the FDIC the authority to prescribe rules and regulations as it may deem necessary to carry out the provisions of the FDI Act, as well as to define terms as necessary to carry out the FDI Act, except to the extent that authority to issue such rules and regulations has been expressly and exclusively granted to another regulatory agency. 12 Section 24(j) is a provision of the FDI Act, and no other regulatory agency has been expressly or exclusively granted the authority to issue rules or regulations, or to define terms, with respect to section 24(j) of the FDI Act. Consequently, the FDI Act expressly grants the FDIC the authority to issue rules with respect to section 24(j) of the FDI Act.

Section 24(j) of the FDI Act was added to the statute by the Riegle-Neal Interstate Banking and Branching Efficiency Act of 1994 (Riegle-Neal). 13 While section 24(j) of the FDI Act expressly addresses the application of State laws to a “branch” in a host State of an out-of-State State bank, the FDIC believes the provision must be read in the context of the statutory framework. At the time of Riegle-Neal's enactment, banks generally conducted banking activities, such as receiving deposits and making loans, through branches. Thus, branches were the central mechanism against which State laws could discriminate against out-of-State banks, and were, naturally, expressly referenced in the Act.

In the years since Riegle-Neal's enactment, it has become more common for banks to serve their customers through non-branch channels such as online banking and mobile banking. As a result, many State banks serve customers in other States without branches in those States—and may not even maintain branches at all. If a branch was a prerequisite to protection under Riegle-Neal, State banks would either lose parity with national banks with respect to the application of host State laws or be forced into the costly and counterintuitive exercise of establishing branches in host States in order to gain protection from host States' laws, something not required of national banks. 14 As explained below, this would create an irrational result that cannot be squared with the structure of section 24(j) of the FDI Act or congressional intent.

In 2005, the FDIC proposed a regulation implementing section 24(j) of the FDI Act to clarify the application of host State laws to out-of-State State banks. 15 The 2005 proposal responded to a petition for rulemaking that focused on establishing parity in the application of host State laws to State banks' operating subsidiaries. The scope of the 2005 proposal was limited only to activities conducted at branches of out-of-State banks in the host State and suggested that section 24(j) of the FDI Act only applies to State banks with interstate branches.

The 2005 proposal was never finalized, and importantly, focused on parity in the application of host State laws to operating subsidiaries rather than parity between banks with branches in a host State and those without such branches. Furthermore, the 2005 proposal's interpretation of section 24(j) of the FDI Act does not reflect the broader purpose and structure of the statute, particularly in light of the migration of banking activity away from branches to non-branch channels. Indeed, since 2007 when the first iPhone was released, mobile banking has become commonplace, and banks and other financial institutions commonly provide financial services through mobile applications. The rule now being proposed by the FDIC, discussed in further detail below, adheres to the structure and purpose of section 24(j) of the FDI Act and provides necessary regulatory clarity.

Section 24(j) of the FDI Act expressly addresses the application of host State laws to out-of-State State banks that have branched into a host State. The statute provides that host State laws apply to a branch of an out-of-State State bank to the same extent they apply to a branch in the host State of an out-of-State national bank. In other words, if the host State law has been preempted and does not apply to a national bank, then host State law similarly does not apply to the branch of an out-of-State State bank; instead, the chartering State's law applies.

The statute does not, however, explicitly address the application of host State laws where out-of-State State banks provide services in a host State without the establishment of a branch. But it is clear from the statutory scheme that when host State law would not apply to an out-of-State State bank's branch in the State (because State law has been preempted), host State law should similarly not apply to an out-of-State State bank providing services without a branch. Instead, home State law should apply. This is the only result consistent with the structure of section 24(j) of the FDI Act.

Conversely, requiring an out-of-State State bank to establish a branch in a host State to ensure application of its chartering's State law would run contrary to the structure and apparent intent of the 1997 amendments to Riegle-Neal, which was to reestablish parity between interstate State banks and interstate national banks. 16 Thus, the proposed rule ensures consistency with the structure and purpose of section 24(j) of the FDI Act.

The proposed rule provides that for purposes of section 24(j) of the FDI Act, the laws of a host State, including laws regarding community reinvestment, consumer protection, fair lending, and establishment of intrastate branches, shall apply to any branch in the host State of, or any services provided in the host State by, an out-of-State State bank to the same extent as such State laws apply to a branch in the host State of, or any services provided in the host State by, an out-of-State national bank. Accordingly, host State laws inapplicable to branches of out-of-State national banks or to services provided by out-of-State national banks would not apply to branches of out-of-State State banks or to services provided by an out-of-State State bank in the host State without a branch. In all of these cases, the law of the State bank's chartering State would apply. The proposed rule also includes a conforming edit to the current definition of “host State” to reflect that for purposes of part 331, a host State would be a State, other than a State bank's home State, in which the State bank maintains a branch or provides services.

The proposed rule would not affect the interest rates State banks are permitted to charge with respect to any of their loans, which are governed by section 27 of the FDI Act. 17 The proposed rule would apply section 24(j) of the FDI Act, which was added to the statute by Riegle-Neal. Section 111 of Riegle-Neal expressly disclaimed any effect on the application of section 27, stating:

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments using a method listed under ADDRESSES . Include “Docket No. FAA-2026-11783; Project Identifier MCAI-2025-01775-R” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov , including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to David Enns, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

Transport Canada, which is the aviation authority for Canada, has issued Transport Canada AD CF-2025-64, dated December 1, 2025 (Transport Canada AD CF-2025-64) (also referred to as the MCAI), to correct an unsafe condition on certain Bell Textron Canada Limited Model 429 helicopters. The MCAI states that there have been reports of the sliding doors jamming when opened from the inside of the helicopter. The condition was found to be caused by the aft lower roller assembly, part number (P/N) 429-030-897-101, disengaging from the aft lower rail, P/N 429-030-575-103.

The FAA is proposing this AD to prevent the doors from jamming. The unsafe condition, if not addressed, could result in jamming of the doors in an emergency situation, and obstructing occupant evacuation.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2026-11783.

The FAA reviewed Transport Canada AD CF-2025-64, dated December 1, 2025, which specifies procedures for inspecting the lower aft bracket and rail cavity for contact marks and repairing or replacing any affected part. Transport Canada AD CF-2025-64 also requires modifying the roller configuration for Group 1 and Group 2 helicopters, and inspecting the roller configuration and performing corrective actions for all three groups of helicopters, which includes modifying the roller assembly or support assembly if any conditions are detected.

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

These products have been approved by the civil aviation authority (CAA) of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This proposed AD would require accomplishing the actions specified in Transport Canada AD CF-2025-64, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD. See “Differences Between this Proposed AD and the MCAI” for a discussion of the general differences included in this proposed AD.

Where the material referenced in Transport Canada AD CF-2025-64 specifies to repair or refinish if there are contact marks on the lower aft bracket and the rails, this proposed AD would require corrective actions in accordance with a method approved by the Manager, International Validation Branch, FAA; or Transport Canada; or Bell Textron Canada Limited Transport Canada Design Approval Organization (DAO). If approved by the DAO, the approval must include the DAO-authorized signature.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some CAA ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate Transport Canada AD CF-2025-64 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with Transport Canada AD CF-2025-64 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Material required by Transport Canada AD CF-2025-64 for compliance will be available at regulations.gov under Docket No. FAA-2026-11783 after the FAA final rule is published.

The FAA estimates that this AD, if adopted as proposed, would affect 150 helicopters of U.S. registry.

The FAA estimates the following costs to comply with this proposed AD:

The repairs needed as a result of repairing or replacing an affected part due to the required inspection, or if any of the conditions are detected, could vary significantly from helicopter to helicopter. The FAA has no way of determining the costs to accomplish the repairs or the number of helicopters that may require repair.

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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.

For the reasons discussed above, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Would not affect intrastate aviation in Alaska, and

(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments using a method listed under ADDRESSES . Include “Docket No. FAA-2026-8817; Project Identifier MCAI-2026-00010-R” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend the proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov , including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Anthony Kenward, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA issued AD 2022-02-12, Amendment 39-21909 (87 FR 7687, February 10, 2022) (AD 2022-02-12), for all Leonardo S.p.a. Model AB139 and AW139 helicopters. AD 2022-02-12 was prompted by an MCAI originated by the European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union. EASA issued EASA AD 2018-0132, dated June 21, 2018 (EASA AD 2018-0132), to address the failure of certain parts, which could result in the loss of control of the helicopter.

AD 2022-02-12 requires incorporating into maintenance records required by 14 CFR 91.417(a)(2) or 135.439(a)(2), as applicable to the helicopter, airworthiness limitations as specified in EASA AD 2018-0132.

Since the FAA issued AD 2022-02-12, EASA superseded EASA AD 2018-0132 and issued EASA AD 2026-0003, dated January 12, 2026 (EASA AD 2026-0003) (also referred to as the MCAI). The MCAI states that new and more restrictive airworthiness limitations have been developed. Additionally, the MCAI advises that the airworthiness limitations are identified as mandatory for continued airworthiness and that Leonardo S.p.a. has issued applicable ALS revisions to specify new and more restrictive life limits and maintenance tasks. The FAA is proposing this AD to address the failure of certain parts, which could result in the loss of control of the helicopter.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2026-8817.

The FAA reviewed Air vehicle maintenance planning information, AW139 39-B-AMPI-00-P, Chapter 04, Airworthiness Limitations, Issue 015, dated January 07, 2025. This material also applies to other AW139 variants where the same part numbers have been interchanged, which includes the Model AB139 helicopters. This material specifies the airworthiness limitations for the AW139 helicopter and specifies inspections and other maintenance actions, which are required to be incorporated into the existing maintenance program for the helicopter.

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This proposed AD would require revising the ALS of the existing maintenance manual or ICA and the existing approved maintenance or inspection program, as applicable by accomplishing the actions specified in the material already described.

The FAA estimates that this AD, if adopted as proposed, would affect 156 helicopters of U.S. registry.

The FAA estimates the following costs to comply with this proposed AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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.

For the reasons discussed above, I certify that the proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Would not affect intrastate aviation in Alaska, and

(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments using a method listed under the ADDRESSES section. Include “Docket No. FAA-2026-8809; Project Identifier MCAI-2025-01312-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov , including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Taylor Stanley, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; phone: 407-852-7677; email: Taylor.Stanley@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2025-0170, dated August 4, 2025 (EASA AD 2025-0170) (also referred to as the MCAI), to correct an unsafe condition for all Airbus SAS Model A300 B4-2C, A300 B4-103, A300 B4-120, A300 B4-203, A300 B4-220, A300 C4-203, A300 F4-203, A300 B4-601, A300 B4-603, A300 B4-622, A300 C4-620, A300 B4-605R, A300 B4-622R, A300 F4-605R, A300 F4-622R, A300 C4-605R Variant F, and A300F4-608ST airplanes. Model A300 B4-120, A300 B4-220, A300 C4-203, A300 F4-203, A300 C4-620, and A300 F4-608ST airplanes are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this proposed AD therefore does not include those airplanes in the applicability. The MCAI states that occurrences were reported of cracks found in the MLG two-piece cages. Subsequent investigation determined that the root cause of the cracking was incorrect machining before installation of the MLG two-piece cage into the MLG eye fitting. This condition, if not corrected, could lead to structural failure of the MLG during takeoff or landing, possibly resulting in damage to the airplane and injury to occupants.

The FAA is proposing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2026-8809.

EASA AD 2025-0170 specifies procedures for replacement of an affected MLG with a serviceable MLG and limits the installation of an affected MLG or overhauled MLG under certain conditions. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This proposed AD would require accomplishing the actions specified in EASA AD 2025-0170 described previously, except for any differences identified as exceptions in the regulatory text of this proposed AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2025-0170 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2025-0170 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2025-0170 does not mean that operators need to comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2025-0170. Material required by EASA AD 2025-0170 for compliance will be available at regulations.gov under Docket No. FAA-2026-8809 after the FAA final rule is published.

The FAA estimates that this AD, if adopted as proposed, would affect 99 airplanes of U.S. registry. The FAA has no definitive data on the number of affected MLGs that may need to be replaced and no way of knowing whether the affected MLGs are installed on all or some of the affected airplanes. Therefore, based on the assumption that one MLG would need to be replaced on all affected airplanes, the FAA estimates the following costs to comply with this proposed AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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.

For the reasons discussed above, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Would not affect intrastate aviation in Alaska, and

(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments using a method listed under the ADDRESSES section. Include “Docket No. FAA-2026-8807; Project Identifier MCAI-2025-01385-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Anthony Decaro, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; phone: 562-627-5374; email: anthony.d.decaro@faa.gov . Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2025-0183, dated August 25, 2025 (EASA AD 2025-0183) (also referred to as the MCAI), to correct an unsafe condition for Airbus SAS Model A350-941 airplanes equipped with Rolls-Royce Trent XWB-84 engines, Trent XWB-84EP engines, or Trent XWB-75 engines. The MCAI states that the EHM identified abnormal HMU behavior via “Fuel Metering Valve position high” alerts, requiring premature removal of HMUs. Root cause analysis traced the issue to wear-induced stiction within the combining spill valve (CSV), where piston-to-housing friction prevented full closure of the CSV. This condition, if not corrected, could result in an unintended internal fuel leak during high power demand, leading to reduced fuel flow and potential thrust shortfalls and, combined with a loss of the second engine, could result in reduced control of the airplane.

The FAA is proposing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2026-8807.

EASA AD 2025-0183 specifies procedures for replacing an HMU having part number (P/N) G5000HMU02 or P/N G5000HMU03 with a serviceable HMU before reaching a reduced life limit. EASA AD 2025-0183 also limits the installation of affected parts under certain conditions. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This proposed AD would require accomplishing the actions specified in EASA AD 2025-0183 described previously, except for any differences identified as exceptions in the regulatory text of this proposed AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2025-0183 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2025-0183 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2025-0183 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2025-0183. Material required by EASA AD 2025-0183 for compliance will be available at regulations.gov under Docket No. FAA-2026-8807 after the FAA final rule is published.

The FAA estimates that this AD, if adopted as proposed, would affect 38 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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.

For the reasons discussed above, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Would not affect intrastate aviation in Alaska, and

(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

FDA recognizes that some provisions of its human drug and biological product safety testing and reporting regulations refer only to the use of animal tests where alternatives may be available. FDA is updating these regulations by replacing the terms “animal test” and “animal study” with “nonclinical test” or “nonclinical study,” terms which are defined to encompass a broad variety of tests or studies in addition to animal testing, including scientifically valid new approach methodologies (NAMs) that do not use animals. NAMs have the potential to improve predictivity while replacing, reducing, or refining the use of animal testing for evaluating medical product safety. For consistency in terminology, we are also substituting the term “nonclinical” for the terms “preclinical” and “in vitro.” We also replace “animal” with “nonclinical” in regulations that use the terms “animal testing,” “animal data,” “animal findings” and “animal models” to refer to testing, data, findings and models that are performed with, derived from, or made using nonclinical tests or studies.

This proposed rule is a companion to the direct final rule published elsewhere in this issue of the Federal Register . This proposed rule provides the procedural framework to finalize the rule in the event the direct final rule receives any significant adverse comment and is withdrawn. The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. Any comments received in response to this companion proposed rule will also be considered as comments regarding the direct final rule.

This proposed rule would substitute the terms “nonclinical test” or “nonclinical study” for the terms “animal test,” “animal study,” “preclinical test,” and “in vitro test,” and make other comparable or conforming changes in sections addressing human drug and biological product safety and reporting within parts 312, 314, 315, 361 and 601 of Title 21 of the Code of Federal Regulations (21 CFR). It would also add a definition for “nonclinical test” and “nonclinical study” to part 312 and a definition for “nonclinical study” to parts 314, 315, 361, and 601. The proposed definitions are adapted from the definition of “nonclinical test” in section 505(z) of the FD&C Act (21 U.S.C. 355(z)). 1

This rulemaking is based on FDA's authority under the FD&C Act (21 U.S.C. 301 et seq. ) and the PHS Act (42 U.S.C. 201 et seq. ). By delegation from the Secretary of the Department of Health and Human Services, FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act (section 701; 21 U.S.C. 371), including provisions addressing the regulation of drug products to ensure their safety and effectiveness, and to regulate biological products to ensure that they are safe, effective, pure, and potent (PHS Act section 351; 42 U.S.C. 262). This proposed rule will help with the efficient enforcement of provisions relating to the following: (1) investigational use of human drugs and biological products and (2) safety of human drugs and biological products.

This proposed rule would substitute “nonclinical” for “animal” in phrases like “animal test” and “animal study;” substitutes “nonclinical” for “preclinical” and “in vitro” for consistency in terminology; and add a definition of “nonclinical test” and “nonclinical study” to the definitions section of several of FDA's drug and biological product regulations. If finalized as proposed, this rule would impose no new requirements on industry and so is expected to generate no costs. The proposed amendments may foster the development and use of scientifically valid new testing methodologies and so may yield benefits, but we do not anticipate being able to quantify these benefits. Since this proposed rule would update terminology to unambiguously allow for a broader range of nonclinical studies to meet current requirements without limiting existing options or imposing new requirements, we conclude this proposed rule is classifiable as an Executive Order 14192 deregulatory action.

This proposed rule is a companion to the direct final rule published elsewhere in this issue of the Federal Register . This companion proposed rule provides the procedural framework to finalize the rule in the event the direct final rule receives any significant adverse comment and is withdrawn. The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. Any comments received in response to this companion proposed rule will also be considered as comments regarding the direct final rule. FDA is publishing the direct final rule because we believe the rule contains noncontroversial changes and there is little likelihood that there will be significant adverse comments on the rule.

A significant adverse comment is defined as a comment that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants terminating a direct final rulemaking, we will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process. Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered significant or adverse under this procedure. A comment recommending a regulation change in addition to those in the direct final rule and proposed in this rule would not be considered a significant adverse comment unless the comment states why the regulatory change would be ineffective without the additional change. In addition, if a significant adverse comment applies to a part of the direct final rule and that part can be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of the significant adverse comment.

If any significant adverse comments to the direct final rule or this proposed rule are received during the comment period, FDA will publish in the Federal Register , within 30 days after the comment period ends, a notice of significant adverse comment and withdraw the direct final rule. If we withdraw the direct final rule, any comments received will be considered comments on the proposed rule and will be considered in developing a final rule using the usual notice-and-comment procedure.

If no significant adverse comment is received in response to the direct final rule of this proposed rule during the comment period, no further action will be taken related to this proposed rule. Instead, we will publish a document confirming the effective date of the final rule within 30 days after the comment period ends. Additional information about direct final rulemaking procedures is set forth in the document entitled “Guidance for FDA and Industry: Direct Final Rule Procedures,” announced and provided in the Federal Register of November 21, 1997 (62 FR 62466). The guidance may be accessed at https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.

If FDA receives no significant adverse comments during the specified comment period, FDA intends to publish a document confirming the effective date within 30 days after the comment period ends.

Currently, some human drug and biological product regulations refer to animal studies or tests. For example, section 312.88 states that safeguards for patient safety “include the review of animal studies prior to initial human testing.” However, the Food and Drug Omnibus Reform Act (FDORA) amended Section 505(i) of the FD&C Act by replacing the term “preclinical tests (including tests on animals)” in paragraph (1)(A) and “animal” in paragraph (2)(B) with the term, “nonclinical tests.” FDORA section 3209(a)(1)-(2). It also added a definition of “nonclinical test” to Section 505(z) of the FD&C Act  2 to mean:

[A] test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug. Such test may include the following:

(1) Cell-based assays.

(2) Organ chips and microphysiological systems.

(3) Computer modeling.

(4) Other nonhuman or human biology-based test methods, such as bioprinting.

(5) Animal tests.

FDORA section 3209(a)(2). FDORA also amended item (bb) of section 351(k)(2)(A)(i)(I) of the PHS Act (42 U.S.C. 262(k)(2)(A)(i)(I)) to replace “animal studies (including assessment of toxicity)” with “an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc)).” The studies described in items (aa) and (cc) include analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components, and clinical studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency under certain conditions of use.

This proposed rule would align the terminology used in FDA's drug and biological product regulations more closely with the FD&C Act amendments made by FDORA and with the growing prevalence and capabilities of NAMs.

FDA's current regulatory framework generally allows and encourages the use of non-animal testing, including NAMs, as communicated through regulations, guidance, recognition of international standards, and participation with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).

In general, drugs and biological products may only be tested in or on humans if their use in this context complies with part 312, which implements section 505(i) of the FD&C Act (21 U.S.C. 355(i)) and section 351(a)(3) of the PHS Act (42 U.S.C. 262(a)(3)). These regulations aim to ensure that these products are reasonably safe for use in or on humans under the conditions described in the proposed clinical investigations. The clinical investigations may in turn serve to provide evidence as to whether the medical product is safe and effective as part of a marketing application to FDA.

Generally, a person seeking to market a new drug must submit to FDA a new drug application (NDA) with full reports of investigations, including clinical investigations that show whether the drug is safe and effective (21 U.S.C. 355(b)). Generally, a person seeking to market a new biological product must submit to FDA a biologics license application (BLA), which generally includes data derived from nonclinical laboratory and clinical studies demonstrating the product meets prescribed requirements of safety, purity, and potency (§ 601.2(a)).

FDA encourages the use of innovative approaches to safety testing that may provide predictive data for medical products in our review process, including through guidance documents. The Agency explains in guidance documents, such as those included as references in this proposed rule (Refs. 1-16), our support for moving away from animal testing—and encourages parties to contact us to discuss alternative testing methods early on in their development plans. FDA guidances may be accessed at https://www.fda.gov/regulatory-information/search-fda-guidance-documents#guidancesearch.

In addition to guidance, FDA has signaled its support for alternatives to animal testing in other contexts. In a 2015 final rule, FDA removed the codified general safety test (GST) requirements for biological products, which required rodent testing, because the regulations were duplicative of safety test requirements set forth in approved BLAs for products that present specific safety concerns. In that rule, we noted that the “elimination of the codified GST regulations would encourage the implementation of the principles of the `3Rs,' to reduce, refine, and replace animal use in testing” while continuing to ensure the safety of biological products using appropriate and specific test methods identified in the product's approved BLA or supplement BLA. (80 FR 37971 at 37972).

In December of 2017, FDA published a roadmap for integrating emerging predictive toxicology methods and new technologies into regulatory safety and risk assessments to potentially reduce the use of animal testing (Ref. 17). This work includes collaborating with ICH, ICCVAM, and the Organisation for Economic Co-operation and Developments (OECD) Test Guidelines Programme.

Section 507 of the FD&C Act requires establishment of a process for the qualification, based on scientific merit, of drug development tools for a proposed context of use; once qualified, any sponsor can then use the tool(s) in the development and evaluation of their products within the qualified context of use. FDA is making use of the Drug Development Tools (DDT) and Innovative Science and Technology Approaches for New Drugs (ISTAND) programs to evaluate, validate, and qualify various tools, including NAMs. DDT and ISTAND submissions include new biomarkers, clinical assessments, animal models for use with the Animal Rule, and other novel approaches or methodologies of potential benefit to drug development and evaluation. These programs support innovation and regulatory science and foster early communication and collaboration with FDA and sponsors helping to bridge the gap between the research of medical products and their delivery to patients.

Sponsors may contact the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) to request feedback on their development programs, the use of nonclinical tests, and feedback on the use of a NAM for a particular development program, such as through a Type D meeting. 3 Alternatively, if a sponsor seeks feedback on the use of a novel manufacturing method that incorporates use of a NAM to support multiple products, the sponsor could consider engaging the CBER Advanced Technologies Team.

A 2024 report to the Science Board to FDA from its New Alternative Methods Subcommittee, entitled “Potential Approaches to Drive Future Integration of New Alternative Methods for Regulatory Decision-Making” (Ref. 19), noted that FDA has accepted approaches that reduce the number of animals used in test protocols, including by adopting and issuing ICH guidances that recommend testing of relevant species (ICH S6), that reduce or eliminate animal testing recommendations for reproductive toxicology (ICH S5(R3)) and carcinogenicity testing (ICH S1B(R1)), and that reduce the duration of recommended chronic toxicology studies for oncology indications (ICH S9). The report also noted that FDA has explored options like the use of virtual control groups to support a reduction of animals in studies, and that newer methods are largely already available at FDA to produce scientifically valid data to meet FDA's regulatory needs, including those using systems biology, engineered biologically active tissues, in silico methods, alternative organisms such as Zebrafish and C. elegans, and microphysiological systems, including organs-on-chips.

FDA, along with a number of other federal regulatory agencies and research laboratories, participated in the development of the 2024 ICCVAM report entitled “Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies” (Ref 20). ICCVAM developed the report to help developers and end users build confidence in NAMs. It recommends the implementation of flexible, fit-for-purpose validation strategies that consider the intended application of the NAM, and describes concepts such as context of use, biological relevance, and technical characterization of NAMs.

In April 2025, FDA announced a roadmap to reduce animal testing in safety studies by replacing them in a stepwise approach with scientifically valid NAMs (Ref. 21). The approach outlined in the roadmap is designed to improve drug safety and identify more efficient methods to inform the evaluation process while reducing animal experimentation. The roadmap provided an overview of key NAM categories and their applicability to drug development and laid out a stepwise list of specific actions FDA is considering for validation and integration of NAMs into its regulatory process, initially focusing on safety testing of monoclonal antibodies.

Although the Agency is optimistic that fostering the use of scientifically valid NAMs will lead to a reduced need for animal testing and to the use of fewer animals and of animals lower on the phylogenetic scale, it is also important to recognize that there remain areas where animal testing is important and necessary. For example, for a product inhibiting a novel molecular target, animal studies may enable the evaluation of toxicities that occur through complex physiologic interactions such as the release of hormones, neurotransmitters, cytokines, and other internally secreted chemicals that maintain homeostasis within an organism and communication between organ systems. However, we also recognize that NAMs using human-derived cells may be able to assess additional or more relevant endpoints for clinical drug development. Thus, it is important that developers consult with FDA about their use of NAMs, including providing information about the technical characterization of the NAM and its biological relevance for particular contexts of use. As is its general practice, FDA also will develop guidance to support specific recommendations to sponsors about study design, conduct, and interpretation of NAMs as it gains experience with their use and as data and information become available.

In sum, we believe the changes to the terminology used in FDA regulations described in this proposed rule should foster the development and use of new alternative research methods where feasible while ensuring that nonclinical test methods used in drug and biological product development generate data appropriate for demonstrating the safety of the drug product.

The rule proposes to amend certain provisions of FDA's drug and biological product regulations addressing the collection, analysis, submission, reporting, and surveillance of safety and toxicological data. 4 Specifically, this rule proposes to:

• Amend § 312.3(b) by adding a definition of the terms “nonclinical test” and “nonclinical study” and §§ 314.3, 315.2 and 601.31 by adding a definition of the term “nonclinical study.” The definitions are adapted from the definition of “nonclinical test” in section 3209(a) of FDORA. This proposed change aligns the regulations that use the terms “nonclinical test” and “nonclinical study”  5 with the amendments made to the FD&C Act and the PHS Act by FDORA. Like the statutory definition, the regulatory definitions we are proposing to add include an illustrative, non-exhaustive list of examples of nonclinical tests and studies. The proposed definition is broader than the statutory definition to include “study” because part 312 refers to both tests and studies and parts 314, 315, and 601 generally refer to studies instead of tests. Further, FDA considers nonclinical tests and nonclinical studies to be equivalent for purposes of these requirements and does not believe that these changes result in any substantive differences compared to the definition in section 505(z) of the FD&C Act because both definitions describe the same types of nonclinical data that can be used to satisfy the underlying requirement. The definitions we are proposing in this rule also omit reference to when the nonclinical test or study occurs because the regulations being revised focus on the type of data needed to address the requirement, not on when the nonclinical test or study to generate the data occurs. To include the temporal part of the statutory definition (“a test . . . that occurs before or during the clinical trial phase”) would change the meaning of some of the regulatory provisions being revised under this proposal to use “nonclinical study” or “nonclinical test”.

• Amend the other regulations specified below by substituting the term “nonclinical test” or “nonclinical study” for the terms “animal test,” “animal study,” “preclinical test,” and “in vitro test,” and making other comparable or conforming changes. These proposed changes result in more consistent and updated terminology that is not unduly focused on animal testing and that encompasses the use of scientifically valid NAMs.

• Where FDA's existing regulations that are being revised under this rule use “animal” and “in vitro” together to describe the scope of nonclinical testing (such as “animal or in vitro studies”), FDA has historically treated these paired terms here to encompass all nonclinical testing conducted outside of humans. When these regulations were originally developed, in chemico and in silico methodologies were not widely used and the pairing of “animal” and “in vitro” reflected the available testing methods that were in common use at the time. As in chemico and in silico methods evolved and became scientifically established, they became more widely used in drug development, results from these nonclinical tests were submitted to the Agency under these same provisions, and FDA accepted such data under these provisions when appropriate. Substituting “nonclinical” in instances where “animal” and “in vitro” are used in conjunction as proposed in this rule does not in practice expand the scope of data that must be reviewed, submitted, or reported under the affected provisions because the existing regulatory requirements, in these specific instances, generally focus on the significance or relevance of the information to human safety ( e.g., “all information relevant to the safety of the drug,” “findings that suggest a significant risk in humans”), not on the specific methodology used to generate that information. Sponsors have submitted data from in silico, in chemico, and other nonclinical methodologies conducted outside a living organism under the current regulations, consistent with this position.

Part 312 lists requirements for an investigational new drug application (IND).

Section 312.3(b) lists definitions in alphabetical order that apply to part 312. We are proposing to amend § 312.3(b) by adding, after the definition of “Marketing application,” the following definition  6 of the terms “nonclinical test” and “nonclinical study”:

Nonclinical test and nonclinical study mean a test or study conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test or study. Such test or study may include the following:

(1) Cell-based assays.

(2) Organ chips and microphysiological systems.

(3) Computer modeling.

(4) Other nonhuman or human biology-based test methods, such as bioprinting.

(5) Animal tests or studies.

Section 312.22 provides general principles of the IND submission. Paragraph 312.22(c) notes that amendments to INDs “should build logically on previous submissions and should be supported by additional information, including the results of animal toxicology studies or other human studies as appropriate.” We are proposing to amend the paragraph by replacing “animal” with “nonclinical.” This proposed change clarifies that the types of supportive toxicology studies that may be appropriate can include nonanimal studies, highlighting the flexibility inherent in this provision. As with toxicology data from animal studies or other human studies, FDA will examine any toxicological data from nonanimal nonclinical studies to determine whether they adequately support the clinical studies identified in the IND if the proposed changes are finalized.

Section 312.23 lists requirements for IND content and format, and paragraph (a) lists the elements that the IND must contain and in what order. Paragraph (a)(3) describes what is included in the IND's introductory statement and general investigational plan. Paragraph (a)(3)(iv)( f ) provides that the plan should include “any risks of particular severity or seriousness anticipated on the basis of the toxicological data in animals or prior studies in humans with the drug or related drugs.” We are proposing to amend the paragraph by replacing the word “animals” with the phrase “nonclinical studies.” While this change would expand the types of studies or tests that may be used to provide the basis for a sponsor to identify “any risks of particular severity or seriousness” that a sponsor should anticipate, and thus should be included in the investigational plan, this proposed change does not increase the amount of information needed to meet current requirements because the regulatory change does not impose any requirement to conduct additional tests or studies to identify such risks. This proposed change reflects how there is flexibility in the types of toxicological data that can be used to identify risks to be addressed in the general investigational plan. As with toxicological data from animal studies or prior human studies, FDA will examine any toxicological data from nonanimal nonclinical studies to determine whether they adequately support the clinical studies identified in the IND if the proposed changes are finalized.

Section 312.23(a)(5) describes what must be included in the IND's investigator's brochure, when such brochure is required by § 312.55. Section 312.23(a)(5)(ii) requires that there be a “summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans.” We are proposing to amend the regulation by replacing the word “animals” with the phrase “nonclinical studies.” This change would add flexibility and clarify that the pharmacological and toxicological effects of the drug that must be included in the IND submission may be derived from a broader range of studies than animal studies. This change would not expand the scope of the submission requirement. The investigator's brochure is intended to inform investigators of information relevant to the safe conduct of the clinical investigation, and the obligation to summarize pharmacological and toxicological effects is grounded in that goal rather than in the methodology used to generate the data. Consistent with this, data from nonclinical studies other than animal studies would be included in the brochure to the extent they are relevant to the safe conduct of the proposed investigation. This change would not impose any new testing requirements. As with pharmacological and toxicological effects derived from animal studies or prior human studies, FDA will examine any pharmacological and toxicological data from nonanimal nonclinical studies to determine whether they adequately support the clinical studies identified in the IND if the proposed changes are finalized.

Section 312.23(a)(5) describes what must be included in the IND's investigator's brochure, when such brochure is required by § 312.55. Section 312.23(a)(5)(iii) requires that there be a “summary of the pharmacokinetics and biological disposition of the drug in animals and, if known, in humans.” As above, we are proposing to amend the regulation by replacing the word “animals” with the phrase “nonclinical studies.” This proposed change would provide flexibility and clarify that the pharmacokinetics and biological disposition of the drug may be derived from a broader range of studies than animal studies. This change would not expand the scope of the submission requirement. The investigator's brochure is intended to inform investigators of information relevant to the safe conduct of the clinical investigation, and the obligation to summarize pharmacological and toxicological effects is grounded in that goal rather than in the methodology used to generate the data. Consistent with this, data from nonclinical studies other than animal studies would be included in the brochure to the extent they are relevant to the safe conduct of the proposed investigation. This change would not impose any new testing requirements. As with pharmacokinetics and biological disposition of the drug derived from animal studies or prior human studies, FDA will examine data from nonanimal nonclinical studies to determine whether they adequately support the clinical studies identified in the IND if the proposed changes are finalized.

Section 312.23(a)(8) describes what pharmacology and toxicology information must be provided in an IND and the first two sentences of the paragraph state that “[a]dequate information about pharmacological and toxicological studies of the drug involving laboratory animals or in vitro, on the basis of which the sponsor has concluded that it is reasonably safe to conduct the proposed clinical investigations. The kind, duration, and scope of animal and other tests required varies with the duration and nature of the proposed clinical investigations.” We are proposing to amend these two sentences in the regulation by replacing the phrase “pharmacological and toxicological studies of the drug involving laboratory animals or in vitro” with the phrase “nonclinical pharmacological and toxicological studies of the drug” and replacing “animal and other tests” with “nonclinical tests.” This proposed change would provide flexibility and clarify that the pharmacological and toxicological studies of the drug may be derived from a broader range of studies than laboratory animal and in vitro studies. As discussed above, FDA has treated the paired terms “animal” and “in vitro” to encompass all nonclinical testing conducted outside of humans and this change is consistent with that position. Additionally, this change would not mandate what types of studies are performed to generate this information; rather, it would require disclosure in the IND of information about the pharmacological and toxicological studies, regardless of the type of non-clinical study that has generated the information. This is not an increase in burden because FDA already permits the use of non-animal studies to satisfy these requirements where appropriate, this proposed change would not preclude sponsors from using any types of studies that are currently permitted to meet these requirements, and this change would not increase the amount of information required to meet these existing requirements. As with pharmacological and toxicological studies of the drug derived from laboratory animal or in vitro studies, FDA will examine data from other types of nonclinical studies to determine whether they adequately support the clinical studies identified in the IND if the proposed changes are finalized. The remainder of this paragraph, describing FDA guidance documents and more detail about the required information to be submitted, is not being amended.

Section 312.23(a)(8)(i) requires that each IND contain a “section describing the pharmacological effects and mechanism(s) of action of the drug in animals, and information on the absorption, distribution, metabolism, and excretion of the drug, if known.” We are proposing to amend the regulation by replacing the word “animals” with the phrase “nonclinical tests.” This proposed change would provide flexibility and clarify that the pharmacological effects and mechanism(s) of action of the drug, and information on the absorption, distribution, metabolism, and excretion of the drug, if known, may be derived from a broader range of studies than animal studies. The change would not mandate what types of studies are performed to generate this information but will require submission in the IND of this information regardless of the type of nonclinical study generating the data. This would not increase burden on regulated entities because FDA already permits the use of non-animal studies to satisfy these requirements where appropriate, this change will not preclude sponsors from using any types of studies that are currently permitted to meet these requirements, and this change would not increase the amount of information required to meet these requirements. As with such information derived from animal studies, FDA will examine information from nonanimal nonclinical studies to determine whether they adequately support the clinical studies identified in the IND if the proposed changes are finalized.

Section 312.23(a)(8)(ii)(a) requires that the toxicology information in the IND contain an “integrated summary of the toxicological effects of the drug in animals and in vitro. Depending on the nature of the drug and the phase of the investigation, the description is to include the results of acute, subacute, and chronic toxicity tests; tests of the drug's effects on reproduction and the developing fetus; any special toxicity test related to the drug's particular mode of administration or conditions of use ( e.g., inhalation, dermal, or ocular toxicology); and any in vitro studies intended to evaluate drug toxicity.” We are proposing to amend the regulation by replacing the phrase “in animals and in vitro” with the phrase “based on nonclinical studies” and replacing the phrase “and any in vitro studies” with the phrase “and any nonclinical studies.” This proposed change would provide flexibility and clarify that the “integrated summary of the toxicological effects of the drug” may be derived from a broader range of studies than animal and in vitro studies. As discussed above, FDA has treated the paired terms “animal” and “in vitro” in the regulations being amended in this proposed rule to encompass all nonclinical testing conducted outside of humans and this change is consistent with that position. The proposed change does not mandate what types of studies are performed to generate this information but would continue to require submission in the IND of this information regardless of the type of nonclinical study generating the data. This would not be an increase in burden because FDA already permits the use of non-animal studies to satisfy these requirements where appropriate, this change would not preclude sponsors from using any types of studies that are currently permitted to meet these requirements, and this change does not increase the amount of information required to meet these requirements. As with such information derived from animal and in vitro studies, FDA will examine information from other types of nonclinical studies to determine whether they adequately support the clinical studies identified in the IND if the proposed changes are finalized.

Section 312.23(a)(10)(i) provides that “[i]f the drug is a psychotropic substance or otherwise has abuse potential,” then the IND must include “a section describing relevant clinical studies and experience and studies in test animals.” We are proposing to amend the regulation by replacing the phrase “clinical studies and experience and studies in test animals” with the phrase “clinical and nonclinical studies and experience.” This change would provide flexibility and clarify that the relevant experience and studies do not have to be limited to that which occurred in humans and test animals, but may include studies and experience using nonclinical tests. The proposed change does not mandate what types of studies are performed to generate this information but would continue to require submission in the IND of this information regardless of the type of nonclinical study generating the data. This would not be an increase in burden because FDA already permits the use of non-animal studies to satisfy these requirements where appropriate, this change would not preclude sponsors from using any types of studies that are currently permitted to meet these requirements, and this change would not increase the amount of information required to meet these requirements. As with clinical studies and experience and studies in test animals, FDA will examine studies and experience from nonanimal nonclinical studies to determine their relevance to support an IND for a drug that is a psychotropic substance or otherwise has abuse potential if the proposed changes are finalized.

Section 312.23(a)(10)(ii) provides that if the drug is a radioactive drug, then the IND must include “sufficient data from animal or human studies to allow a reasonable calculation of radiation-absorbed dose to the whole body and critical organs upon administration to a human subject.” We are proposing to amend the regulation by replacing the word “animal” with the word “nonclinical.” This proposed change would add flexibility and clarify that the data sufficient to allow a reasonable calculation of radiation-absorbed dose to the whole body and critical organs upon administration to a human subject may be obtained from a broader range of studies than animal studies. The change would not mandate what types of studies are performed to generate this information but would continue to require submission in the IND of this information regardless of the type of nonclinical study generating the data. We believe that this is not an increase in burden because FDA already permits the use of non-animal studies to satisfy these requirements where appropriate, this change will not preclude sponsors from using any types of studies that are currently permitted to meet these requirements, and this change does not increase the amount of information required to meet these requirements. As with data obtained from animal studies or human studies, FDA will examine any data from nonanimal nonclinical studies to determine whether they allow a reasonable calculation of radiation-absorbed dose to the whole body and critical organs of a human subject if the proposed changes are finalized.

Section 312.32 describes what must be contained in IND safety reporting. Paragraph 312.32(b) requires the sponsor to “promptly review all information relevant to the safety of the drug obtained or otherwise received by the sponsor from foreign or domestic sources, including information derived from any clinical or epidemiological investigations, animal or in vitro studies, reports in the scientific literature, and unpublished scientific papers, as well as reports from foreign regulatory authorities and reports of foreign commercial marketing experience for drugs that are not marketed in the United States.” We are proposing to amend the regulation by replacing the phrase “animal or in vitro studies” with the phrase “nonclinical studies.” This proposed change clarifies that “all information relevant to the safety of the drug obtained or otherwise received by the sponsor from foreign or domestic sources” includes information from nonclinical studies. This proposed change would not expand the scope of information sponsors must review under this provision; rather, it clarifies FDA's longstanding position that sponsors are required to review all information relevant to the safety of the drug that the sponsor received or obtained from foreign or domestic sources. The list of specific sources of information to be reviewed is a list of examples and has never been intended to be an exhaustive list of potentially relevant sources of information that should be reviewed by a sponsor. The proposed change from “animal or in vitro studies” to the broader term “nonclinical studies” better captures that intent by explicitly including modern technologies such as computer modeling and organ chips. This proposed change would not impose any new testing requirements.

Section 312.32(c) requires a sponsor to notify FDA and all participating investigators “of potential serious risks, from clinical trials or any other source” in a safety report provided as soon as possible (but not later than 15 calendar days after the sponsor determines that the information qualifies for reporting under the regulation). Section 312.32(c)(1)(iii) is headed “Findings from animal or in vitro testing.” The first sentence of the paragraph states: “The sponsor must report any findings from animal or in vitro testing, whether or not conducted by the sponsor, that suggest a significant risk in humans exposed to the drug, such as reports of mutagenicity, teratogenicity, or carcinogenicity, or reports of significant organ toxicity at or near the expected human exposure.” We are proposing to amend the regulation by replacing the phrase “animal or in vitro” with the word “nonclinical” in both the heading and first sentence. This change would clarify FDA's longstanding position that any findings “from clinical trials or any other source” (21 CFR 312.32(c)(1)), including non-clinical studies, that suggest a significant risk to humans from exposure to the drug must be reported to FDA, including from modern technologies like computer modeling and organ chips that were not commonly used when the regulation was originally written. The information covered by this provision is critical to FDA's ability to protect human subjects in clinical investigations, as it encompasses data that would “[o]rdinarily . . . result in a safety-related change in the protocol, informed consent, investigator brochure (excluding routine updates of these documents), or other aspects of the overall conduct of the clinical investigation.” This proposed change brings the language up-to-date, consistent with scientific progress and the modernization of testing methods; it would not impose any additional testing requirements.

Section 312.32(c)(1)(v) describes the format in which sponsors must submit IND safety reports and contains the statement “Reports of overall findings or pooled analyses from published and unpublished in vitro, animal, epidemiological, or clinical studies must be submitted in a narrative format.” We are proposing to amend the regulation by replacing the phrase “in vitro, animal” with “nonclinical” in this sentence. This proposed change clarifies FDA's longstanding position that any findings “from clinical trials or any other source,” including non-clinical studies, that suggest a significant risk to humans from exposure to the drug must be reported to FDA (and participating investigators) (21 CFR 312.32(c)(1)). Further, this revision would conform section 312.32(c)(1)(v) with the changes made to sections 312.32(b) and 312.32(c)(1)(iii) in describing the format for the IND safety reports required by the remainder of section 312.32(c)(1). It would not impose any additional testing requirements.

Section 312.33(b)(6) requires, as part of annual reports, a summary of information “obtained during the previous year's clinical and nonclinical investigations,” including “[a] list of the preclinical studies (including animal studies) completed or in progress during the past year and a summary of the major preclinical findings.” We are proposing to amend the regulation by replacing the phrase “preclinical studies (including animal studies)” with “nonclinical studies” and replacing “preclinical findings” with “nonclinical findings.” This proposed change would conform the terminology in this regulation with that used in the rest of part 312, as amended in this rule. Paragraphs (b)(1) through (b)(6) of section 312.33 identify the type and scope of information to be included but the proposed change to paragraph (b)(6) does not change the purpose of the summary section of the annual report to “bring together data from individual studies and briefly communicate what was learned during the past year about the investigational drug's safety and effectiveness” (75 FR 8819 [emphasis added]). The proposed change would not expand the requirements, because section 312.33(b) already specifies that the summary of information covers both clinical and non-clinical information. Although paragraph (b)(6) specifies “preclinical” studies and findings (meaning studies and tests before clinical, that is testing or use in humans), the proposed revision to refer to nonclinical studies and findings leaves out that temporal component because some nonclinical studies may take place after the start of clinical studies. Nonetheless, this section of the annual report is intended to be brief and does not require extensive discussion of all activities during the year. Otherwise, the scope of tests and studies described in this provision is the same. Based on these points, we believe that the change to section 312.33(b) and the scope of the required summary of information in the annual report would not increase burden.

Section 312.82 provides that for “products intended to treat life-threatening or severely-debilitating illnesses, sponsors may request to meet with FDA-reviewing officials early in the drug development process to review and reach agreement on the design of necessary preclinical and clinical studies.” We are proposing to amend the regulation by replacing “preclinical” with “nonclinical.” This proposed change would conform the terminology in this regulation with that used in the rest of part 312, as amended in this rule, and reflects the fact that some nonclinical studies may take place after the start of clinical studies. This proposed change also reflects that scientific and regulatory recommendations provided during drug development meetings with sponsors may result in more efficient and robust development programs and that engagement with FDA may occur and be fruitful at multiple stages in drug development.

Section 312.82(a) provides that the “primary purpose of this meeting is to review and reach agreement on the design of animal studies needed to initiate human testing.” We are proposing to amend the regulation by replacing “animal” with “nonclinical.” This change would provide flexibility and clarify that the meeting may also be used to review and reach agreement on the design of any nonclinical studies needed to initiate human testing, which is consistent with FDA's support for moving away from animal testing.

Section 312.86 states that “FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical, chemical/manufacturing, and clinical phases of drug development and evaluation.” We are proposing to amend this paragraph by replacing “preclinical” with “nonclinical.” This proposed change would conform this regulation with the changes we are making in the rest of part 312 and better reflect the potential scope of FDA regulatory research.

Section 312.88 states that the safeguards for patient safety incorporated within parts 50, 56, 312, 314 and 600 “include the review of animal studies prior to initial human testing (§ 312.23).” We are proposing to amend the regulation by replacing “animal” with “nonclinical” to conform to the changes we are proposing in section 312.23 and to be more consistent with FDA's support for moving away from animal testing.

Section 314.3(b) lists definitions of terms in alphabetical order that apply to parts 314 and 320. We are proposing to amend the section by adding, after the definition of “Newly acquired information,” the following definition of “nonclinical study” adapted from the definition of “nonclinical test” added to section 505 of the FD&C Act by section 3209(a) of FDORA:

Nonclinical study means a test or study conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test or study. Such a test or study may include the following:

(1) Cell-based assays.

(2) Organ chips and microphysiological systems.

(3) Computer modeling.

(4) Other nonhuman or human biology-based test methods, such as bioprinting.

(5) Animal tests or studies.

This proposed definition varies from the definition added to § 312.3(b) in that it only defines “nonclinical study” rather than both “nonclinical test” and “nonclinical study.” This is because part 314 generally uses the term “study” rather than “test.” To be consistent in terminology across the provisions in this proposed rule, all proposed definitions list “animal tests and studies” as an example of non-clinical studies whether the definition is for “nonclinical studies” or “nonclinical test” and “nonclinical study.”

Section 314.50 establishes the content and format of an application, new drug application or NDA. It provides that the NDA is required to contain reports of all investigations of the drug product sponsored by the applicant, and “all other information about the drug pertinent to an evaluation of the NDA that is received or otherwise obtained by the applicant from any source.” Section 314.50(d)(2) requires that an NDA contain a “section describing, with the aid of graphs and tables, animal and in vitro studies with drug, . . .” We are proposing to amend the regulation by replacing “animal and in vitro” with “nonclinical” and correcting the typographical error “with drug” so that the relevant part of the sentence will read “nonclinical studies with the drug.” This change would provide flexibility and clarify that nonclinical studies other than animal or in vitro studies may be used to support the pharmacology and toxicology section of an NDA. As discussed above, FDA has treated the paired terms “animal” and “in vitro” to encompass all nonclinical testing conducted outside of humans and this change is consistent with that position. Furthermore, the proposed changes does not specify which types of nonclinical studies must be used and thus does not broaden the testing requirement or impose any additional testing requirements. As with such data and information derived from animal studies, if FDA receives data and information from other types of nonclinical studies, FDA will examine it to determine whether it adequately supports the NDA if the proposed changes are finalized.

Section 314.50(d)(2)(iv) requires that the NDA's nonclinical pharmacology and toxicology section include “Any studies of the absorption, distribution, metabolism, and excretion of the drug in animals.” We are proposing to amend this sentence to read: “Any nonclinical studies of the absorption, distribution, metabolism, and excretion of the drug.” This change would provide flexibility and clarify that nonclinical studies other than animal studies may be used to provide data and information on the absorption, distribution, metabolism, and excretion of the drug. The proposed change would not impose any additional testing requirements. As with such data and information derived from animal studies, if FDA receives data and information from other types of nonclinical studies, FDA will examine it to determine whether it adequately supports the NDA if the proposed changes are finalized.

Section 314.50(d)(4)(ii) requires that the microbiology section of an NDA for an anti-infective drug include a “description of the antimicrobial spectra of the drug, including results of in vitro preclinical studies to demonstrate concentrations of the drug required for effective use.” We are proposing to amend the regulation by replacing the phrase “in vitro preclinical” with “nonclinical.” This change would provide flexibility and clarify that we will accept additional types of nonclinical studies to support the microbiology section of an NDA for an anti-infective drug. The proposal does not add any testing requirements. As with such information derived from in vitro preclinical studies, if FDA receives data and information from other types of nonclinical studies, FDA will examine it to determine whether it adequately supports the microbiology section of the NDA if the proposed changes are finalized. We also are proposing to correct a typographical error by replacing “antimicrobial spectra” with “antimicrobial spectrum.”

Section 314.50(d)(5)(i) requires that the clinical data section of the NDA include “[a] description and analysis of each clinical pharmacology study of the drug, including a brief comparison of the results of the human studies with the animal pharmacology and toxicology data.” We are proposing to amend the regulation by replacing the word “animal” with “nonclinical”. This change would provide flexibility and clarify that we will accept comparison of the results of the human studies with pharmacology and toxicology data from nonanimal nonclinical studies to support the clinical data section of an NDA. The proposed change does not add any testing requirements. As with animal pharmacology and toxicology data, if FDA receives pharmacology and toxicology data from nonanimal nonclinical studies, FDA will examine it to determine whether it adequately supports the NDA if the proposed changes are finalized.

The first sentence of section 314.50(d)(5)(vi)( a ) requires the applicant to “submit an integrated summary of all available information about the safety of the drug product, including pertinent animal data, demonstrated or potential adverse effects of the drug, clinically significant drug/drug interactions, and other safety considerations, such as data from epidemiological studies of related drugs.” We are proposing to amend the regulation by replacing the word “animal” with “nonclinical.” This proposed change clarifies that “all available information about the safety of the drug product” includes pertinent nonclinical data not obtained from animals. The proposal does not require that applicants conduct additional studies. The proposal recognizes that there are newer methods of assessing safety and brings the requirements up-to-date, consistent with scientific progress and the modernization of testing methods.

The second sentence of section 314.50(d)(5)(vi)( b ) requires that an applicant's safety update reports “include the same kinds of information (from clinical studies, animal studies, and other sources) . . .” We are proposing to amend the regulation by replacing the word “animal” with “nonclinical” to conform to the amendment we are making to section 314.50(d)(5)(vi)( a ). This proposed change would not expand the requirements because this provision already contemplates including information from sources outside of animal studies through the use of the phrase “and other sources.” The proposal recognizes that there are newer methods of assessing safety and brings the requirements up-to-date, consistent with scientific progress and the modernization of testing methods.

Section 314.81(b)(2)(v) requires that the postmarketing annual report of an NDA holder include “[c]opies of unpublished reports and summaries of published reports of new toxicological findings in animal studies and in vitro studies ( e.g., mutagenicity) conducted by, or otherwise obtained by, the applicant concerning the ingredients in the drug product.” The paragraph heading reads, “Nonclinical laboratory studies.” We are proposing to amend the regulation by replacing the phrase “toxicological findings in animal studies and in vitro studies ( e.g., mutagenicity)” with “nonclinical toxicological findings, including, for example, from mutagenicity studies.” As discussed above, FDA has treated the paired terms “animal” and “in vitro” to encompass all nonclinical testing conducted outside of humans and this change is consistent with that position. This proposed change does not require NDA holders to conduct new or additional studies. The proposal simply brings the reporting requirements up to date, to capture newer methods of generating toxicological findings, consistent with scientific progress and the modernization of testing methods.

Section 314.81(b)(2)(vii)( a )( 7 ) specifies that the status report of the schedule for completion and reporting of the postmarketing study commitment “should include the actual or projected dates for submission of the study protocol to FDA, completion of patient accrual or initiation of an animal study, completion of the study, submission of the final study report to FDA, and any additional milestones or submissions for which projected dates were specified as part of the commitment.” We are proposing to amend the regulation by replacing the phrase “an animal” with “a nonclinical.” This proposed change would provide flexibility by recognizing that a postmarketing study commitment may include nonanimal nonclinical studies, and therefore, the status report should include the date for initiation of a nonanimal nonclinical study that is part of a postmarketing study commitment. We note that the obligation to include information in the status report required under section 314.81(b)(2)(vii)( a ) is limited to postmarketing study commitments and this proposed amendment would not require additional reporting of nonclinical studies that are outside of such commitments.

Section 314.93 describes conditions under which FDA will or will not approve a petition to submit an ANDA for a drug product that is not identical to a listed drug in route of administration, dosage form, and strength, or in which one active ingredient is substituted for one active ingredient in a listed combination drug. Paragraph (e)(1) of section 314.93 lists a series of conditions under which FDA will not approve such a petition, one of which is if it finds that “[i]nvestigations must be conducted to show the safety and effectiveness of the drug product . . .” The first sentence of paragraph 314.93(e)(2) states that “[f]or purposes of this paragraph, `investigations must be conducted' means that information derived from animal or clinical studies is necessary to show that the drug product is safe or effective.” We are proposing to amend § 314.93(e)(2) by replacing “animal” with “nonclinical.” This proposed change in terminology would not alter FDA's implementation through regulation of the requirement articulated in section 505(j)(2)(C)(i) that if the Agency finds investigations must be conducted to show safety and effectiveness of the petitioned drug product then it will not approve a petition to submit such an ANDA. The proposal would bring the regulation up-to-date, consistent with scientific progress and the modernization of testing methods, by recognizing that when studies are necessary to determine that a drug product is safe or effective, nonclinical methods other than animal studies might be used to make that determination.

Section 314.200 addresses the procedures for issuing a notice of opportunity for a hearing on CDER's proposal to refuse to approve an application or to withdraw the approval of an application or abbreviated application under section 505(e) of the FD&C Act, filing a notice of participation and request for a hearing, and submitting studies and comments. Section 314.200(d) provides that the person requesting a hearing is required to submit certain information on which the person relies to justify a hearing with respect to the drug product and paragraph (d)(3) specifies FDA's preferred format for such submissions. Roman numeral heading I, letter A of that format identifies “Animal safety data” as a component of such submissions. FDA is amending the regulation by replacing “Animal” with “Nonclinical.” This change would provide flexibility and clarify that the safety data in support of the submission may come from nonclinical tests other than animal tests. To the extent that such tests have not been performed or the submitter does not rely on the data to justify a hearing with respect to the drug product, the regulation, including as amended under this proposal, does not require such tests to be performed or data submitted.

Section 314.430(a) specifies that the safety and effectiveness data for which FDA will determine public availability include “all studies and tests of a drug on animals and humans” as well as studies and tests to establish identity, stability, purity, potency, and bioavailability. FDA is proposing to amend the regulation by replacing the phrase “all studies and tests of a drug on animals and humans” with “all nonclinical and clinical studies and tests of a drug.” This proposed change conforms the regulation to the scope of data that may be submitted to support the safety and effectiveness of a drug.

Section 315.2 is the definition section of part 315, with paragraphs (a) and (b) currently defining two types of diagnostic radiopharmaceuticals. We are proposing to amend the section by first redesignating the introductory text as paragraph (a) and redesignating current paragraphs (a) and (b) as paragraphs (a)(1) and (a)(2) such that the two types of diagnostic radiopharmaceuticals are defined in paragraph (a); our amendments include minor revisions to refer to “paragraph (a)(1)” rather than “paragraph (a)” in the cross-reference in the definition of nonradioactive reagent kit. We are also proposing to add, as a new paragraph (b), the definition of “nonclinical study” adapted from the definition of “nonclinical test” added to section 505 of the FD&C Act by section 3209(a) of FDORA as follows: (b) For purposes of this part, nonclinical study means a test or study conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test or study. Such test or study may include the following:

(1) Cell-based assays.

(2) Organ chips and microphysiological systems.

(3) Computer modeling.

(4) Other nonhuman or human biology-based test methods, such as bioprinting.

(5) Animal tests or studies.

This proposed definition varies from the definition added to § 312.3(b) in that it only defines “nonclinical study” rather than both “nonclinical test” and “nonclinical study”. This is because part 315 generally uses the term “study” rather than “test.” To be consistent in terminology, all proposed definitions list “animal tests or studies” as an example of non-clinical studies, whether the definition is for “nonclinical studies” or “nonclinical test” and “nonclinical study”.

Section 315.6(c)(2) states that safety data required by FDA for diagnostic radiopharmaceuticals “may include, but is not limited to, the dose, route of administration, frequency of use, half-life of the ligand or carrier, half-life of the radionuclide, and results of clinical and preclinical studies.” We are proposing to amend the regulation by replacing “preclinical” with “nonclinical.” This proposed change conforms the terminology in this regulation with the other regulations in this rule; as noted earlier, part of the intent of this rule is to bring more consistency to these regulations in referring to non-clinical tests. This proposed revision would not expand the requirements because the revision is to an example of the type of information that the regulation requires.

Section 315.6(d) states that “[t]he radiation safety assessment must establish the radiation dose of a diagnostic radiopharmaceutical by radiation dosimetry evaluations in humans and appropriate animal models.” We are proposing to amend the regulation by replacing the phrase “animal” with “nonclinical.” This change would provide flexibility and clarify that radiation dosimetry evaluations may be conducted in appropriate nonclinical models other than animal models. As with data obtained from animal models and human studies, FDA will examine data from nonanimal nonclinical models to determine whether they support the establishment of a safe radiation dose if the proposed changes are finalized.

Section CFR 361.1(d)(7) states in the second sentence after the heading that a protocol for determining the safety of radioactive drugs to be used for human research “shall be based upon a sound rationale derived from appropriate animal studies or published literature and shall be of sound design such that information of scientific value may result.” We are proposing to amend the regulation by replacing “animal studies” with “nonclinical studies, as defined in § 312.3(b) of this chapter.” This change would add flexibility and clarify that the sound rationale may be derived from appropriate nonclinical studies other than animal studies. As with animal studies, FDA will examine information from nonanimal nonclinical studies to determine if it supports a sound rationale for the use of the radioactive drugs in human research if the proposed changes are finalized.

Section 601.31 establishes definitions for certain terms used in part 601, with paragraphs (a) and (b) currently defining two types of diagnostic radiopharmaceuticals. We are proposing to amend the section by first redesignating the introductory text as paragraph (a) and redesignating current paragraphs (a) and (b) as paragraph (a)(1) and (a)(2) such that the two types of diagnostic radiopharmaceuticals are defined in paragraph (a); our amendments include minor revisions to refer to “paragraph (a)(1)” rather than “paragraph (a)” in the cross-reference in the definition of nonradioactive reagent kit. We are proposing to add, as a new paragraph (b), the proposed definition of “nonclinical study” adapted from the definition of “nonclinical test” added to section 505 of the FD&C Act by section 3209(a) of FDORA as follows:

(b) For purposes of this part, nonclinical study means a test or study conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test or study. Such test or study may include the following:

(1) Cell-based assays.

(2) Organ chips and microphysiological systems.

(3) Computer modeling.

(4) Other nonhuman or human biology-based test methods, such as bioprinting.

(5) Animal tests or studies.

This proposed definition varies from the definition added to § 312.3(b) in that it only defines “nonclinical study” rather than both “nonclinical test” and “nonclinical study.” This is because part 601 generally uses the term “study” rather than “test.” To be consistent in terminology, all proposed definitions list “animal tests or studies” as an example of non-clinical studies, whether the definition is for “nonclinical studies” or “nonclinical test” and “nonclinical study.”

Section 601.35(c)(2) states that safety data required by FDA for diagnostic radiopharmaceuticals “may include, but is not limited to, the dose, route of administration, frequency of use, half-life of the ligand or carrier, half-life of the radionuclide, and results of clinical and preclinical studies.” We are proposing to amend the regulation by replacing “preclinical” with “nonclinical.” This change would conform the terminology in this regulation with that used in its counterpart regulation section 315.6(c)(2); as noted earlier, part of the intent of this rule is to bring more consistency to these regulations in referring to non-clinical tests.

Section 601.35(d) states that “[t]he radiation safety assessment must establish the radiation dose of a diagnostic radiopharmaceutical by radiation dosimetry evaluations in humans and appropriate animal models.” We are proposing to amend the regulation by replacing “animal” with “nonclinical.” This change would conform the terminology in this regulation with that used in its counterpart regulation section 315.6(d) and is being proposed for the same reasons; as noted earlier, part of the intent of this rule is to bring more consistency to these regulations in referring to non-clinical tests.

Section 601.70(b)(7) states that the schedule of a BLA holder's completion and reporting of a postmarketing study commitment in the holder's annual progress report “should include the actual or projected dates for submission of the study protocol to FDA, completion of patient accrual or initiation of an animal study, completion of the study, submission of the final study report to FDA, and any additional milestones or submissions for which projected dates were specified as part of the commitment.” We are proposing to amend the regulation by replacing the phrase “an animal” with “a nonclinical” in this provision. This change would provide flexibility by recognizing that a postmarketing study commitment may include nonanimal nonclinical studies, and therefore, the status report should include the date for initiation of a nonanimal nonclinical study that is part of a postmarketing study commitment. We note that this obligation to include information in the status report required under section 601.70(b)(8) is limited to postmarketing studies described in 21 CFR 601.70(a) and this amendment would not require additional reporting of nonclinical studies that are outside of such commitments.

We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, Executive Order 14192, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

Executive Orders 12866 and 13563 direct us to assess all benefits and costs of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits. The Office of Information and Regulatory Affairs (OIRA) has determined that this proposed rule is a significant regulatory action under section 3(f) of Executive Order 12866.

Executive Order 14192 requires that any new incremental costs associated with certain significant regulatory actions “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations.” This proposed rule is classifiable as an Executive Order 14192 deregulatory action.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because we estimate that this proposed rule would produce no quantifiable costs, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes estimates of anticipated impacts, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $193 million, using the most current (2025) Implicit Price Deflator for the Gross Domestic Product. If finalized as proposed, this proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

This proposed rule would substitute “nonclinical” for “animal” in phrases like “animal test,” substitutes “nonclinical” for “preclinical” and “in vitro” for consistency in terminology, and add a definition of “nonclinical test” and “nonclinical study” to the definitions section of FDA's drug and biological product regulations. Nonclinical tests and studies include but are not limited to the following: cell-based assays, organ chips and microphysiological systems, computer modeling, other nonhuman or human biology-based test methods ( e.g., bioprinting), and animal tests or studies. FDA already permits the use of nonanimal studies and this rule will not preclude sponsors from using any types of studies that are currently permitted; industry will continue to provide information on the nonanimal studies that they use and rely on. The terminology changes in this rule also address existing obligations to submit and report information on nonclinical testing to FDA. Where the proposed rule would substitute the term “nonclinical” for the paired terms “animal” and “in vitro,” this proposed change does not expand the scope of data that must be reviewed, submitted, or reported, because FDA has historically treated those paired terms in the context of the regulations being amended in this proposed rule to encompass all nonclinical testing conducted outside of humans. These regulatory requirements generally focus on the significance or relevance of the information to human safety rather than on the methodology used to generate it. As described in section V of this rule, sponsors have submitted data from in silico, in chemico, and other nonclinical methodologies under the current regulations consistent with this position and FDA has accepted such data under these provisions when appropriate. In short, the proposed regulatory changes in rule would impose no new requirements on industry and so are expected to generate no costs. Hence, we estimate that this proposed rule will produce no quantifiable savings, costs, or transfers. We do not expect any loss of public health benefits as a result of this rule. In fact, the proposed changes in this rule may foster the development and use of scientifically valid non-animal methods and so may yield benefits from this added flexibility.

Table 1 summarizes the estimated benefits and costs of the proposed rule using a 10-year time horizon. We estimate that annualized benefits would be $0 million per year using either a 3 or 7 percent discount rate and that annualized costs would be $0 million per year using either a 3 or 7 percent discount rate.

We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required.

We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We tentatively determine that this proposed rule does not contain policies that have substantial direct effects 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. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.

We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175. We tentatively determine that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.

The following references are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR parts 312, 314, 315, 361, and 601 be amended as follows:

On July 13, 2026, an organization notified the Coast Guard that they will be hosting an aerobatic air show on the Neuse River, New Bern, NC on November 28, 2026. The Captain of the Port, Sector North Carolina (COTP) has determined that potential hazards associated with air shows, such as the risk of being hit by aircraft doing low altitude maneuvers, are a safety concern for anyone within the aerobatic display area. Therefore, the COTP is proposing this rule under the authority in 46 U.S.C. 70034, which is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone.

This proposed rule would establish a safety zone from 2 p.m. until 7:30 p.m. on November 28, 2026. The safety zone would cover all navigable waters within the aerobatic display area, which is approximately one square mile large on the Neuse River adjacent to Union Point Park. No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP or their designated representative. The regulatory text we are proposing appears at the end of this document.

We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended (RFA), requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities for the following reasons.

Vessel traffic will be able to safely transit around this regulated area. In addition, the Coast Guard will issue a Broadcast Notice to Marines via VHF FM marine channel 16, which will allow small entities to adjust their transit plans, and the rule allows vessels to request permission to enter the regulated area from the COTP.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this proposed rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), if this proposed rule will affect your small business, organization, or governmental jurisdiction and you have questions, contact the person listed in the FOR FURTHER INFORMATION CONTACT section. Small businesses may send comments to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards by calling 1-888-REG-FAIR (1-888-734-3247).

This proposed rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

We have analyzed this proposed rule under Executive Order 13132, Federalism, and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in that Order.

Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

As required by The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Coast Guard certifies that this proposed rule will not result in an annual expenditure of $100,000,000 or more (adjusted for inflation) by a State, local, or tribal government, in the aggregate, or by the private sector.

We have analyzed this proposed rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment.

This proposed rule is a safety zone. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A record of environmental consideration is available in the docket.

We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

Submitting comments. We encourage you to submit comments at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2026-1024 in the search box and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER INFORMATION CONTACT section of this proposed rule for alternate instructions.

Viewing material in the docket. To view available documents, find the docket as described in the previous paragraph, and then select “Supporting & Related Material” in the Document Type column. We will post public comments in our online docket. Additional information is on the https://www.regulations.gov Frequently Asked Questions web page.

Personal information. We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have provided. For more about privacy and submissions to the docket in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).

For the reasons discussed in the preamble, the Coast Guard is proposing to amend 33 CFR part 165 as follows:

On September 16, 2026, the Postal Service filed a petition pursuant to 39 CFR 3050.11 requesting that the Commission initiate a rulemaking proceeding to consider changes to analytical principles relating to periodic reports. 1 The Petition presents a proposal to update the methodology for developing labor productivity data for selected mail processing operations using Management Operating Data System (MODS) data. Petition at 1.

Background. The Postal Service states that MODS-based labor productivities are “important inputs” into the mailflow models for letter-, flat-, and parcel-shaped products that are used to develop cost avoidances for workshare discounts. Petition, Proposal at 1. MODS classifies Postal Service work activities, including, but not limited to, mail processing activities, using a system of standardized operation numbers. Id. The Postal Service states that “MODS collects workhours associated with the operations and, as applicable, workload data from data systems such as the Time and Attendance Collection System (TACS) and [the Web End-of-Run system (webEOR)].” Id.

For automated mail processing, workloads are passively obtained using machine counts of processed articles that are automatically transmitted to MODS. Id. The Postal Service asserts that, accordingly, these automated workloads “generally are measured reliably.” Id. at 1-2. The Postal Service states that accurate workhour measurement requires employees to “clock into the appropriate operation number(s) for their work activities and to re-clock during shifts, as needed, to reflect changes of work activities during the workday.” Id. at 2. The Postal Service states that labor productivity methodology “must balance needs for sufficiently detailed productivities to reflect materially different costs among mailflows, while ensuring that workhour and workload data are well aligned given data generation processes.” Id. The Postal Service states that the currently accepted methodology “mitigates data issues by aggregation over time, facilities, and/or operations as well as by outlier screening.” Id. According to the Postal Service, the Proposal retains these methodologies with certain changes discussed below. See id.

Proposal. The Proposal updates the methodology for developing MODS-based labor productivity data for selected mail processing operations based on certain operational, facility, and time aggregation changes. Id. The Proposal reflects, among other things, “the discontinuation of certain flats operations, including the Flats Sequencing System (FSS) and the UFSM 1000; the supplanting of Sack Sorting Machine (SSM) processing with universal sorters; and [the] incorporat[ion of] additional operations related to the processing of undeliverable-as-addressed (UAA) letters and flats.” Id. (internal footnotes omitted). Additionally, the Proposal updates the role of network distribution centers (NDCs) in mail processing operations to reflect that NDCs provide significant processing, particularly for parcels, but “no longer have a distinct network role.” Id. The Proposal combines data for NDCs with other MODS plants in order to provide “more comprehensive coverage of operations” carried out by both types of facilities. Id. at 2, 6. The Proposal also increases the frequency of MODS data inputs from monthly to weekly. Id. at 7. The Postal Service contends that “[t]he increased frequency would improve data quality by requiring workload and workhour data to be aligned at the weekly level and . . . reject data from periods where workhours and workloads are not both recorded.” Id. at 8. The Proposal provides detail on these and other proposed changes to labor productivities to reflect operational, network, and equipment changes. Id. at 6-20. The Postal Service presents the proposed updates to MODS-based labor productivities in its Proposal. Id. at 4-5, Table 1.

Rationale and Impact. The Postal Service states that “[t]he proposed [labor] productivities better reflect current mailflows, incorporate additional operation groups to facilitate future mailflow model refinements, and cease reporting of certain discontinued operations.” Id. at 1. The Proposal compares Fiscal Year (FY) 2025 labor productivities under the proposed methodology compared to current FY 2025 labor productivities. Id. at 21-22, Table 4. The Postal Service states that new labor productivities “will decrease the associated model costs if the new productivity is higher or increase them if the new productivity is lower, other things equal.” Id. at 23. The Postal Service describes the impacts of the Proposal on FY 2025 First-Class Mail and USPS Marketing Mail letter mail processing models, FY 2025 First-Class Mail and USPS Marketing Mail flat mail processing models, and FY 2025 Parcel Select cost models. Id. at 23-28.

The Commission establishes Docket No. RM2026-7 for consideration of matters raised by the Petition. More information on the Petition may be accessed via the Commission's website at https://www.prc.gov. Interested persons may submit comments on the Petition and Proposal no later than October 30, 2026. Pursuant to 39 U.S.C. 505, Jana Slovinska is designated as an officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding. The Public Representative does not represent any individual person, entity or particular point of view, and, when Commission attorneys are appointed, no attorney-client relationship is established.

It is ordered:

1. The Commission establishes Docket No. RM2026-7 for consideration of the matters raised by the Petition of the United States Postal Service to Initiate a Proceeding to Change Analytical Principles, filed September 16, 2026.

2. Comments by interested persons in this proceeding are no later than due October 30, 2026.

3. Pursuant to 39 U.S.C. 505, the Commission appoints Jana Slovinska to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this docket.

4. This order, or abstract thereof, will be published in the Federal Register .

This document, including a summary of the rule as required by 5 U.S.C. 553(b)(4), and all comments may be viewed online through the Federal eRulemaking portal at www.regulations.gov. An electronic copy of this document may also be downloaded by accessing the Office of the Federal Register's home page at: www.federalregister.gov.

Privacy Act: Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, or other entity). For information on DOT's compliance with the Privacy Act, please visit https://www.transportation.gov/privacy.

Improvement of regulations is a continuous focus for DOT and MARAD. For that reason, DOT and MARAD regularly and deliberately review their rules in accordance with Executive Order (E.O.) 12866, Regulatory Planning and Review (October 4, 1993), and section 610 of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. That process is summarized in Appendix D of DOT's semi-annual regulatory agenda. In addition, E.O. 14192, Unleashing Prosperity Through Deregulation (February 6, 2025), and E.O. 14219, Ensuring Lawful Governance and Implementing the President's “Department of Government Efficiency” Deregulatory Initiative (February 19, 2025), directed agencies to further scrutinize their regulations to reduce unnecessary costs, clear barriers to emerging technology, and alleviate unnecessary regulatory burdens.

Accordingly, MARAD has identified its CCF regulations governing applications and administrative procedures for consideration. In this proposed rule, MARAD seeks comment to ensure that the program remains current and is the least burdensome to the public. MARAD welcomes your comments to ensure that agency programs reflect current and comprehensive best practices.

This rule proposes revision of the CCF regulations found at 46 CFR part 390. The program was established by the Merchant Marine Act of 1936 (MMA) and is codified at 46 U.S.C. chapter 535.

The purpose of the program is to assist owners and operators of United States flagged vessels in accumulating the large amount of capital necessary for the modernization of their commercial fleets. The CCF Program was expanded significantly in December 2022 with the passage of the National Defense Authorization Act for Fiscal Year 2023 (2023 NDAA). Section 3544 of the 2023 NDAA extended the use of the program to all U.S. built vessels engaged in the domestic or foreign commerce of the United States, removing limitations on the availability of the CCF Program to certain geographic trades. The requirements in the current regulations have been superseded by these statutory updates.

The program encourages construction, reconstruction, or acquisition of vessels through deferment of Federal income taxes. Owners and operators of vessels deposit income from operations of eligible vessels into CCF accounts prior to paying income taxes. All deferred taxes are eventually recovered upon the sale of the vessel because the cost basis of the vessel is reduced by the dollar amount of CCF funds used for its acquisition or reconstruction.

To participate in the program, a vessel owner applies to MARAD's Office of Marine Financing in advance of the relevant Federal tax filing due date. The application identifies the income earning vessel(s), the type of project(s) anticipated, and the financial institution that will hold the CCF deposits. Once MARAD determines that an application complies with the CCF statute and regulations, a CCF Agreement is executed between the United States and the vessel owner or operator.

Currently, there are 129 CCF Agreements with a total of approximately $2.56 billion on deposit. Many of these CCF Agreements were established years ago and identify scheduled projects that are no longer viable. Consequently, CCF participants are faced with either having funds languish on deposit for nonviable scheduled projects or making non-qualified withdrawals of funds and paying deferred taxes at the highest marginal rate. The number of CCF Agreements has been increasing since the expansion of the program to all U.S. built vessels engaged in the domestic or foreign commerce of the United States. Without an update to the regulations to address this issue, it is expected to become more acute. MARAD's proposed regulatory revisions establish a mechanism to amend obsolete agreements to avoid non-qualified withdrawals or top-rate deferred tax penalties and to direct participants to invest idle capital into viable modern projects.

The authority to issue regulations to implement the program is granted under 46 U.S.C. 53502(a), which permits the Secretary of Transportation (delegated to MARAD) to prescribe regulations (except for the determination of tax liability) to carry out the program. Although the CCF Program regulations have been amended over the years, the current requirements and limitations remain substantially the same as when MARAD introduced them in 1976. The proposed rule would (i) conform the regulations to recent statutory amendments extending the application of the CCF Program to all U.S. built vessels engaged in the domestic or foreign commerce of the United States, (ii) eliminate certain geographic trade limitations, (iii) clarify the maximum allowable completion time for reconstruction projects, and (iv) provide for funds to be used for acquisitions under certain circumstances pursuant to 46 U.S.C. 53509. Revisions would also correct numerous citations in accordance with the codification of title 46 of the United States Code, improve accessibility by modernizing text, update agency contact information, remove obsolete references, and provide a mechanism to terminate inactive accounts, accounts with a zero balance, and accounts where a CCF Program objective has failed to commence within a 10-year period.

The proposed changes to the CCF regulations are deregulatory and intended to ease current restrictions on the allowable uses of CCF accounts while remaining consistent with current agency priorities of incentivizing private investment in the construction of commercial vessels. For example, currently, when establishing a CCF, unless there is new construction of at least one vessel as a program goal, there must be a reconstruction program goal of at least $1,000,000 for each vessel. This limitation is without regard for the number of vessels being reconstructed. This minimum threshold for reconstruction restricts the number of participants in the program. The intent of the revision to the reconstruction program goal is to allow for participation by applicants with smaller vessels that would otherwise be excluded by permitting the reconstruction costs of multiple vessels to be aggregated to meet minimum program requirements.

We are providing a 60-day comment period.

To ensure that your comments are correctly filed in the Docket, please include the Docket Number shown at the beginning of this document in your comments.

Comments may be submitted to the docket electronically by logging onto the Docket Management System website at http://www.regulations.gov. Search using the docket number and follow the online instructions for submitting comments. Please submit your comments, including the attachments, following the instructions provided under the above-entitled heading ADDRESSES .

Please note that pursuant to the Data Quality Act, for substantive data to be relied upon and used by the agency, it must meet the information quality standards set forth in the Office of Management and Budget (OMB) and DOT Data Quality Act guidelines. Accordingly, we encourage commenters to consult the guidelines in preparing your comments. OMB's guidelines may be accessed at https://www.opm.gov/information-management/information-quality-guidelines/. DOT's guidelines may be accessed at https://www.transportation.gov/sites/dot.gov/files/docs/regulations/513/dot-information-quality-guidelines-2019.pdf.

If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.

MARAD will consider all comments that the Docket Management Office receives before the close of business on the comment closing date indicated above under the DATES section of this proposed rule. To the extent possible, MARAD will also consider comments received after that date. If the Docket Management Office receives a comment too late for MARAD to consider in developing this action, MARAD will consider that comment as an informal suggestion in future rulemaking actions.

You may read the comments received by the Docket Management Office at the address given above under ADDRESSES . The hours of the Docket Management Office are indicated above in the same location. You may also see the comments on the internet. To read the comments on the internet, go to http://www.regulations.gov. Follow the online instructions for accessing the dockets.

Please note that, even after the comment closing date, MARAD will continue to file relevant information to the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically check the Docket for new material.

MARAD proposes to redesignate the sections and to amend the program regulations for purposes of clarity and brevity.

Section 390.1 Purpose (formerly Scope of the regulations).

Specifies clearly the purpose of the regulation.

Section 390.3 Definitions (formerly Application for an agreement).

Groups all definitions into one section to improve overall readability.

Section 390.5 Applying for a Capital Construction Fund Agreement (“Agreement”) (formerly Policy considerations).

Identifies the eligibility requirements and summarizes the application process in one section for clarity and improved accessibility.

Section 390.7 Acquisition, construction, or reconstruction (formerly Description of the agreement).

Highlights the acceptable objectives of the program to clarify the requirements of the statutory provision governing qualified withdrawals at 46 U.S.C. 53509.

Section 390.9 Non-qualified and permissible operations (formerly Agreement vessels).

Proposes edits to this section to reflect the updates to 46 U.S.C. 53501, which was amended by the 2023 NDAA to substitute “foreign or domestic trade of the United States” for “United States foreign, Great Lakes, noncontiguous domestic, or short sea transportation trade.”

Section 390.11 Constructive deposits, constructive withdrawals, and ratification of withdrawals without consent ( formerly Administration of the agreement).

Outlines the constructive deposit and withdrawal process and makes other non-substantive edits to this section for clarity.

Section 390.13 First Tax Year for which an agreement is effective (formerly Deposits into the fund).

Proposes minor, non-substantive edits to this section for clarity and improved accessibility.

Section 390.15 Annual reporting and modification of agreement (formerly Investment in the fund).

Clarifies the reporting requirements and process to modify the agreement.

Section 390.17 Automatic termination of agreement (formerly Qualified withdrawals).

Proposes revisions to provide for termination of inactive CCF agreements and agreements with zero balances on deposit.

Section 390.19 Maximum deposit amounts and time to deposit (formerly Non-qualified withdrawals).

Sets forth the maximum annual ceiling established by 46 U.S.C. 53505 and other non-substantive edits to this section for clarity.

Section 390.21 CCF Accounts (formerly Sale or other disposition of agreement vessels).

MARAD is proposing to make minor, non-substantive edits to this section for clarity.

Section 390.23 Conditional consent to withdrawal qualification (formerly Liquidated damages).

Proposes to update the items needed for a withdrawal determination.

Section 390.25 Sale or other disposition of agreement vessels (formerly Failure to fulfill a substantial obligation under the agreement).

Updates the citations for accuracy.

Section 390.27 Failure to fulfill a substantial obligation under the agreement (formerly Departmental reports and certification).

MARAD is proposing to update contact information.

Section 390.29 Miscellaneous.

Section added to provide for confidentiality and timing of filings.

This NPRM is not a significant regulatory action under E.O. 12866; therefore, it was not reviewed by OMB. It is also not considered a major rule for purposes of congressional review under the Congressional Review Act. This NPRM is limited to (i) conforming the regulations to recent statutory amendments extending the application of the CCF Program to all U.S. built vessels engaged in the domestic or foreign commerce of the United States, (ii) eliminating limitations on the availability of the CCF Program to certain geographic trades, (iii) clarifying the maximum allowable completion time for reconstruction projects, and (iv) providing for funds to be used for acquisitions under certain circumstances as specified in section 53509.

A complete revision of the regulations is necessary to address the effects of time for an implementing regulation that has remained substantially unchanged for 40 years. Through this proposed revision, MARAD incorporates changes to reflect statutory changes from the National Defense Authorization Act for fiscal year 2022 (NDAA 2022). Specifically, the NDAA 2022 modified the definition of qualified vessels (46 U.S.C. 53501(5)) and removed trading restrictions on vessels eligible to participate in the program (46 U.S.C. 53503(b)) to expand the program to include almost any commercial vessel owner and operator in the U.S. registry. In addition, the proposed revision reorganizes the regulation and modernizes the language for clarity and ease of use.

Under this baseline, existing account holders in the CCF Program are assumed to comply with the statutory expansion enacted by Section 3544 of the NDAA 2022. This update extended CCF eligibility to all vessels operating in foreign and domestic commerce of the U.S. as long as they were built in the U.S. and are registered with the U.S. Coast Guard. Affected entities follow the statutory program, but face uncertainty and unnecessary delay because of the regulation, which does not conform to the statute. Vessel operators experience administrative burden and uncertainty regarding outdated criteria, such as the requirement to pay liquidated damages when operating in an unauthorized geographic trade. In addition, applicants may overlook the CCF Program as an option to assist with construction of new vessels or reconstruction of their existing vessels because the regulation would lead many to believe incorrectly that they are ineligible to participate in the program or that any vessels constructed or reconstructed utilizing the program are subject to geographic trading restrictions.

The revised rule does not impose any new or additional compliance requirements or costs. Many of the revisions are intended to conform with statutory updates, and others are simply incorporating current practices in evaluating eligibility. The revised rule will apply current policy practices and use modern regulatory language intended for simplicity, clarity, and brevity. Improvements are expected to result in administrative efficiencies and clarity in applicant and vessel eligibility requirements.

Improved administrative efficiency and clarification of practices will make the rule and the program more accessible and attractive to industry. As a result, the CCF Program should garner better prepared program participants that can best use the program for the benefit of the maritime sector. In addition, expanding the reconstruction threshold to $3,000,000 across multiple vessels provides access to smaller operators who were previously excluded by per-vessel minimums, deleting the geographic trading restrictions opens additional markets to owners for sale of vessels, and clarifying obligations of account holders to maintain accounts with active objectives. According to the latest available data from the U.S. Army Corps of Engineers, there were over 1,800 operators operating about 37,000 vessels (tugs, barges, push boats, etc.) on the inland waterways. Over 80 percent of these operators operate 10 or fewer vessels. provides a clear path for the deployment of capital into active and useful projects. Together, these updates should build applicant confidence in the program.

E.O. 14192 requires that for “each new [E.O. 14192 regulatory action] issued, at least ten prior regulations be identified for elimination.” Implementation guidance for E.O. 14192, issued by OMB (Memorandum M-25-20, March 26, 2025), defines an E.O. 14192 deregulatory action as “an action that has been finalized and has total costs less than zero.” This rule would, if adopted, have total costs less than zero and therefore be an E.O. 14192 deregulatory action.

MARAD analyzed this rulemaking in accordance with the principles and criteria contained in E.O. 13132, Federalism, and has determined that it has no substantial effect on the States, on the current Federal-State relationship, or on the current distribution of power and responsibilities among local officials. Nothing in this document preempts any State law or regulation. Therefore, MARAD did not consult with State and local officials on this rulemaking and did not prepare a Federalism summary impact statement.

Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601, et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), Public Law 104-121, whenever an agency is required to publish a notice of proposed rulemaking, the agency must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations and small governmental jurisdictions), unless the head of the agency certifies the rule will not have a significant economic impact on a substantial number of small entities. Agencies must also provide a statement of the factual basis for this certification.

For the following reasons, the MARAD Administrator certifies that this rulemaking action would not have a significant economic impact on a substantial number of small entities. The revisions to the regulations update administrative criteria, conform to statutory requirements, update citations and addresses, and modernize text. The revisions will also allow for easier submission of applications due to the elimination of obsolete requirements and clarifications in requirements for vessel owners and projects eligible to participate.

Section 522(a)(5) of the Transportation, Treasury, Independent Agencies, and General Government Appropriations Act, 2005 (Pub. L. 108-447, div. H, 118 Stat. 2809 at 3268) requires DOT and certain other Federal agencies to conduct a privacy impact assessment of each proposed rule that will affect the privacy of individuals. This rulemaking, which (i) conforms the regulations to statutory amendments extending the application of the CCF Program to all U.S. built vessels engaged in the domestic or foreign commerce of the United States, (ii) eliminates limitations on the availability of the CCF Program to certain geographic trades, (iii) clarifies the maximum allowable completion time for reconstruction projects, and (iv) provides for funds to be used for acquisitions under certain circumstances, does not result in personally identifiable information (PII) being collected or maintained in a Government-run website or IT system. Therefore, MARAD did not conduct a Privacy Impact Assessment.

The Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, requires agencies to evaluate whether an agency action would result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $212 million or more (as adjusted for inflation in 2026) in any one year, and if so, to take steps to minimize these unfunded mandates. This rulemaking will not impose unfunded mandates under the UMRA. It will not result in costs of $212 million or more to either State, local, or Tribal governments, in the aggregate, or to the private sector, so the analytical requirements of the UMRA do not apply. The rule is the least burdensome alternative that achieves MARAD's stated objectives for the rule.

Pursuant to 49 CFR 1.81, the Secretary has delegated the “functions” under NEPA to the DOT Administrators “as they relate to the matters within the primary responsibility of each Operating Administration.” MARAD has determined that this rule is categorically excluded pursuant to DOT Order 5610.1D, subpart C, section (e)(3). A categorical exclusion (CE) is an action identified in an agency's NEPA procedures that does not normally have a significant impact on the environment and therefore does not require either an environmental assessment (EA) or environmental impact statement (EIS). See DOT Order 5610.1D, section 9. In analyzing the applicability of a CE, the agency must also consider whether extraordinary circumstances are present that would warrant the preparation of an EA or EIS. Id. at section 9(b). MARAD may utilize its own CEs, in addition to CEs listed in DOT Order 5610.1D Appendix A or another Operating Administration's CEs, using the procedures described in DOT Order 5610.1D, section 9, and subpart C, section (e). This proposed rulemaking, Capital Construction Fund Revision, is categorically excluded pursuant to DOT Order 5610.1D, subpart C, section (e)(3): “Internal orders and procedures not required to be published in the Federal Register , promulgation of rules, regulations, directives, and amendments thereto that do not require a regulatory impact analysis under section 3 or do not have a potential to cause a significant impact on the environment . . .” MARAD does not anticipate any environmental impacts, and there are no extraordinary circumstances present in connection with this rulemaking.

A regulation identifier number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document can be used to cross-reference this action with the Unified Agenda.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et seq. ), a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid OMB control number. This proposed rule would establish a new requirement for the collection of information for all CCF applicants. MARAD has requested that OMB review and approve the information collection requirements under the PRA.

In accordance with the PRA, MARAD invites public comments regarding the collection of information arising under this proposed rule.

For the reasons described in the preamble, MARAD proposes to revise 46 CFR part 390 as set forth below:

Office of Federal Procurement Policy (OFPP), Office of Management and Budget (OMB); Department of Defense (DoD); General Services Administration (GSA); and National Aeronautics and Space Administration (NASA) (collectively referred to as the Federal Acquisition Regulatory Council or FAR Council) are working to amend the FAR to implement Executive Order (E.O.) 14275, Restoring Common Sense to Federal Procurement. The E.O. directs the elimination of excessive acquisition regulations to stop the inefficient use of American taxpayer dollars. In response to E.O. 14275, the Office of Management and Budget issued memorandum M-25-26, Overhauling the Federal Acquisition Regulation. The Memo directed the FAR Council to complete a “revolutionary overhaul” of the FAR (herein referred to as “Revolutionary FAR Overhaul” or “RFO”).

The FAR Council's RFO FAR case 2026-003 includes the complete revision to FAR part 8. FAR part 8, specifically FAR subpart 8.4, is where FSS ordering procedures are currently located. FAR case 2026-003 removes FSS ordering procedures and instead directs agencies to use the FSS ordering procedures provided by GSA. As a result, GSA is proposing to amend the GSAR to move FSS ordering procedures to GSAR part 538.

Currently, FAR part 8 contains requirements, guidance, and procedures for acquiring and using excess property and ordering products and/or services from Federal Prison Industries (FPI), AbilityOne participating nonprofit agencies, the Federal Supply Schedule (FSS) program, and the Government Publishing Office.

FAR case 2026-003 removes duplicative requirements, guidance, and procedures currently found in the FAR part 8 and directs agencies to rely on the requirements, guidance, and procedures provided by these sources.

The FSS program pursuant to 41 U.S.C. 152(3) is directed and managed by GSA. GSA develops and oversees FSS ordering procedures. Currently, FSS ordering procedures are codified in Chapter 1 of Title 48 of the CFR (see FAR subpart 8.4). FSS ordering procedures would be moved under this proposed rule to Chapter 5 of title 48 of the CFR. At the same time, FSS ordering procedures are being reorganized to harmonize with RFO efforts and improve readability. The removal of FSS ordering procedures from FAR part 8 provides GSA with the flexibility necessary to better manage FSS ordering procedures and support customers' use of the FSS program. A summary of proposed changes to existing FSS ordering procedures follows:

The changes to FSS ordering procedures reflect the principles of the RFO and address only the essential requirements for placing orders and establishing blanket purchase agreements (BPAs) against FSS contracts. These changes-enhance the speed of acquisition and empower acquisition professionals to use innovative approaches to acquire products, services, and solutions under the FSS program.

The proposed rule retains GSA's statutory requirements and principles regarding the FSS program, including:

The proposed rule reorganizes requirements and simplifies the text into plain language. This aligns with the Federal plain language guidelines as directed by the Plain Writing Act of 2010 (Pub. L. 111-274; 5 U.S.C. 301 note). Plain language efforts include:

• Changes to active voice.

• Edits to improve readability and clarity.

• Reorganization to present information more logically.

• Replacing the use of the term “shall” with “must” or “will,” as appropriate to impose requirements.

The proposed rule harmonizes FSS ordering requirements with revisions being made by the FAR Council under their RFO FAR efforts. Revisions include updating cross-references and use of consistent language, where appropriate ( e.g., harmonization with language used in RFO part 12 and subpart 16.5).

The proposed rule improves clarity, organization, and usability while preserving existing statutory authorities and long-standing FSS program policy. Specifically, the proposed rule reorganizes existing text into a more direct and streamlined format that is easier to read and allows ordering activities to quickly and easily identify the requirements that apply to their specific acquisition. These efforts include:

• Creating a single unified approach to order placement based on dollar threshold vs. type of order. Currently, ordering requirements are spread across three different sections in FAR subpart 8.4 ( i.e., FAR 8.405-1 (for products/services not requiring a Statement of Work—non-Blanket Purchase Agreement (BPA) orders); FAR 8.405-2 (for services requiring an SOW—non-BPA order); and FAR 8.405-3 (for orders against BPAs)). This reorganization ensures ordering procedures are logically grouped and do not include unnecessary repetition, thereby simplifying the regulatory structure and enhancing clarity for ordering activities; and

• Relocating Order-level materials (OLM) requirements from GSAR clause 552.238-115 into GSAR subpart 538.71. This reorganization ensures OLM order-level requirements are located with FSS ordering procedures, thereby ensuring ordering activities have awareness of these requirements.

This proposed rule creates no significant new or additional costs. The rule moves the procedures from the FAR to GSA and reorganizes and improves the readability of the language. The revisions proposed by this rule will significantly benefit the FSS program as a whole ( i.e., GSA and VA, ordering activities, businesses interested in doing business with GSA, and existing FSS contractors).

The proposed rule streamlines the Federal Supply Ordering procedures at FAR 8.4 from over 10,000 words to approximately 2,600. Removing, reducing, and streamlining content ensures GSA, ordering activities, businesses interested in doing business with GSA, and existing FSS contractors don't:

• Waste time or effort navigating a maze of scattered instructions as currently required;

• Unnecessarily complete requirements not required by statute, executive order, or for sound procurement that don't support faster acquisitions or better results.

GSA anticipates that these revisions will result in qualitative benefits, such as:

• Increasing competition;

• Improving customer satisfaction and reduced customer costs ( e.g., time) associated with ordering products, services, and solutions under the FSS program);

• Encouraging businesses to consider seeking an FSS contract;

• Reducing administrative costs for ordering activities and existing FSS contractors;

• Clarifying burdensome procedures, like FAR part 15 source selection procedures that don't apply to FSS orders ( e.g., there is no requirement for evaluation plans, quotation scoring, or establishing a competitive range before communicating with quoters or soliciting revised quotations);

• Encouraging coordination between FSS contractors, such as through FSS contractor team arrangements and OLMs; and

• Encouraging an increase in the number and extent of offerings available under the FSS program.

GSA anticipates non-recurring costs associated with familiarization and training related to the rule. GSA anticipates these costs will apply to ordering activities and business concerns, including those interested in seeking a FSS contract and existing FSS contractors. These entities will likely need to take the time to familiarize themselves with the changes to FSS ordering procedures. Additionally, it is anticipated that GSA will need to update existing FSS program resources to reflect the revisions made under this proposed rule.

GSA calculates the estimated cost for ordering activities to familiarize themselves with the updates to FSS ordering procedures as $1,390,830. 1 GSA calculates the estimated cost for existing FSS contractors and potential interested business concerns seeking to obtain a FSS contract to familiarize themselves with the updates to FSS ordering procedures as $567,775. 2 GSA calculates the estimated cost for training and updating existing FSS program resources for purposes of reflecting these revisions as $33,115. 3

In whole, the movement of FSS ordering procedures from the FAR to the GSAR and the qualitative benefits outlined offset any new, de minimis non-recurring costs identified above.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is a significant regulatory action under section 3(f) of E.O. 12866 and, therefore, was subject to review under Section 6(b) of E.O. 12866.

This proposed rule, if finalized as proposed, is not an E.O. 14192 regulatory action because it does not impose any more than de minimis regulatory costs. See discussion in the “Expected Impact of the Rule” section of this preamble.

GSA does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because this rule is to move to the GSAR, reorganize, and improve readability of existing ordering procedures related to FSS program currently found in FAR subpart 8.4. The underlying purpose of the rule remains the same ( i.e., supporting the placement of orders and establishment of blanket purchase agreements against FSS contracts). However, an Initial Regulatory Flexibility Analysis (IRFA) has been prepared consistent with 5 U.S.C. 603.

The analysis is summarized as follows:

1. Reasons for the action.

OFPP, DoD, GSA, and NASA (collectively referred to as the Federal Acquisition Regulatory Council or FAR Council) are working to amend the Federal Acquisition Regulation (FAR) to implement Executive Order (E.O.) 14275, Restoring Common Sense to Federal Procurement, and Office of Management and Budget issued memorandum M-25-26, Overhauling the Federal Acquisition Regulation. This effort is collectively referred to as the Revolutionary FAR Overhaul (RFO).

One of the FAR Council's RFO efforts, specifically FAR case 2026-003, includes the complete revision to FAR part 8, which currently contains requirements, guidance, and procedures for ordering products and/or services from the following sources: Federal Prison Industries (FPI), AbilityOne participating nonprofit agencies, the Federal Supply Schedule (FSS) Program, and the Government Publishing Office. FAR case 2026-003 removes duplicative requirements, guidance, and procedures currently found in the FAR part 8 and has ordering activities rely on the requirements, guidance, and procedures provided by each source, instead. This approach simplifies the acquisition process for ordering activities when ordering from these sources and provides each of these sources with the flexibility to manage how customers use their programs ( e.g., the FSS Program).

As a result, GSA is proposing to amend the GSAR to move FSS ordering procedures to GSAR part 538.

2. Objective of, and legal basis for, the rule.

The rewrite of the FAR under the RFO represents a paradigm shift in federal acquisition. It emphasizes streamlining, clarity, and accessibility, while ensuring that the regulation focuses only on statutory mandates and foundational procurement principles. The RFO is designed to streamline compliance for contracting professionals, improve acquisition speed and agility, and reinforce mission outcomes over process formalities.

For purposes of moving FSS ordering procedures the GSAR, GSA is reorganizing and improving readability of existing requirements currently codified in FAR subpart 8.4. The proposed changes support the RFO objectives and do not create any new burden on the Government or industry. Instead, these changes simplify the requirements needed for customers to acquire products, services, and solutions from the FSS program, thereby making the acquisition process faster and more efficient.

The basis for the RFO, which encompasses the basis for this rule, is E.O. 14275, Restoring Common Sense to Federal Procurement. GSA's authority for promulgation of ordering procedures for the FSS Program is 10 U.S.C. 3012(3); 40 U.S.C. 121(c); 40 U.S.C. 501; 41 U.S.C. 152(3); and 41 U.S.C. 3302. These ordering procedures have been coordinated with The Administrator for Federal Procurement Policy in accordance with 41 U.S.C. 4104(c).

3. Description of, and estimate of, the number of small entities to which the rule will apply.

The proposed changes to the GSAR do not impose any new requirements or burdens on small business concerns. The proposed changes impact the internal procedures of the Government concerning the placement of orders and establishment of blanket purchase agreements under the FSS program. Therefore, the changes proposed by this rule are not expected to have a significant economic impact on a substantial number of small entities.

It is recognized that small business concerns seeking to do business with the Federal Government, specifically those seeking to obtain a FSS contract as well as existing FSS contractors will have to familiarize themselves with the updates to FSS ordering procedures. As of January 2026, there were 401,196 entities registered in the System for Award Management (SAM) that were small for at least one NAICS code they had selected. At the end of Fiscal Year 2025, there were approximately 14,000 active vendors holding a FSS contract (out of which approximately 12,400 (89 percent) were small business FSS contractors).

4. Description of projected reporting, recordkeeping, and other compliance requirements of the rule.

The proposed rule does not impose any new reporting, recording keeping, or compliance requirements.

5. Relevant Federal rules which may duplicate, overlap, or conflict with the rule.

The proposed rule, if finalized, would not duplicate, overlap, or conflict with other Federal rules.

6. Description of any significant alternatives to the rule which accomplish the stated objectives of applicable statutes and which minimize any significant economic impact of the rule on small entities.

There are no significant alternatives that would minimize the impact of the rule on small entities.

The Regulatory Secretariat Division has submitted a copy of the IRFA to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the IRFA may be obtained from the Regulatory Secretariat Division. The FAR Council invites comments from small business concerns and other interested parties on the expected impact of this proposed rule on small entities.

GSA will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C 610 (GSAR Case 2026-G501), in correspondence.

The Paperwork Reduction Act does not apply because the changes to the GSAR do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget (OMB) under 44 U.S.C. 3501, et seq.

Therefore, GSA proposes to amend 48 CFR part 538 as set forth below:

On September 7, 2023, NHTSA published a Notice of Proposed Rulemaking (NPRM) to amend NHTSA's regulations to include an advanced crash test dummy, the Test Device for Human Occupant Restraint (THOR) 50th percentile adult male (THOR-50M). 1 The dummy represents an adult male of roughly average height and weight and is designed for use in frontal crash tests. The documentation for the dummy, including engineering drawings, qualification procedures and specifications, and procedures for assembly, disassembly, and inspection (PADI), would be incorporated by reference in 49 CFR part 572, Anthropomorphic Test Devices.

On July 9, 2024, NHTSA published a Supplemental Notice of Proposed Rulemaking (SNPRM)  2 to announce the availability of additional research reports and a Memorandum of Understanding (MOU) supplementing the September 2023 NPRM. The research reports described NHTSA's evaluation of alternative configurations of the THOR-50M, including an alternative shoulder design to the patented SD-3 shoulder and an alternative thoracic deflection measurement instrumentation, and presented further analysis of an in-dummy data acquisition system. Under the MOU, no restrictions will apply to copyrighted designs and drawings used as part of a NHTSA final rule issued under 49 CFR part 572 upon the effective date of the final rule. Similarly, no restrictions will apply to a patented design used as part of a NHTSA final rule issued under 49 CFR part 572 upon effective date of the final rule, if the final rule does not specify the use of another design as an alternative to the patented design. Based on the MOU, NHTSA tentatively concluded that it would be preferable if the final rule specifies only the SD-3 shoulder.

Since the NPRM, and in response to the NPRM comments, NHTSA has evaluated additional modifications to the dummy. The main modifications proposed in this notice are specifying the four-position spine as an alternative or replacement for the proposed spine and an updated face insert as an alternative to the proposed face foam. NHTSA is also proposing a minor modification to the upper arm to address a durability concern. These supplemental proposals are discussed below.

The NPRM version of the THOR-50M spine contains a posture adjustment joint known as the lumbar spine pitch change mechanism (original spine), which allows the posture of the THOR-50M to be adjusted into various seating configurations in three-degree increments, including, but not limited to, four designated positions (erect, neutral, slouched, and super slouched). The NPRM also proposed an alternate configuration that accommodates use of an in-dummy data acquisition system (DAS). 3

The original spine differs from the spine in THOR-50M units used in the European New Car Assessment Programme (Euro NCAP). Euro NCAP TB026 specifies a four-position lumbar spine box (four-position spine) that allows the spine to be set only in four distinct positions (erect, neutral, slouched, and super slouched). The four-position spine design accommodates the in-dummy installation of some DAS brands by providing a mounting surface for data loggers. Additional modifications to support cable routing and DAS attachments are made throughout the dummies. THOR-50M units utilized in Euro NCAP are configured with a four-position spine and an in-dummy DAS. 4

NHTSA is aware of two versions of the four-position spine, both of which are approved by Euro NCAP. 5 Humanetics Innovative Solutions (Humanetics) manufactures a version of the four-position spine which contains patented elements. 6 Kistler Group (Kistler) manufactures a different version of the four-position spine ( i.e., the specifications differ) for which Kistler does not hold a patent. NHTSA explained in the NPRM that it had tentatively decided not to specify the four-position spine because it had not tested with that spine, it was patented, and the original spine was more adjustable.

NHTSA received several comments on the proposed original spine specification in response to the NPRM. Several commenters (Automotive Safety Council [ASC], Partnership for Dummy Biomechanics [PDB], Mercedes-Benz Research and Development North America [Mercedes], General Motors [GM], Autoliv, Volkswagen [VW], the Alliance for Automotive Innovation [Auto Innovators], and Humanetics) requested that NHTSA align with Euro NCAP and allow use of the four-position spine. Commenters noted what they viewed as advantages of the four-position spine.

ASC, Auto Innovators, and GM commented that the four-position spine is easier to change with reduced risk of positioning errors. VW added that the four-position spine can be adjusted by a single user, whereas adjustment of the original spine requires an additional user. PDB, GM, and VW commented that incorrect adjustment of the original spine can result in damage. ASC, GM, and Autoliv commented that the positions available in the four-position spine are adequate for most applications, including qualification tests, a wide variety of crash test protocols, and global NCAP load cases.

ASC, PDB, Mercedes, VW, Autoliv, and Humanetics commented that the four-position spine allows integration of additional in-dummy DAS that are not possible with the original spine. Mercedes and VW commented further that the four-position spine is required for use of in-dummy DAS based on a central DAS device (recorder) such as the Kistler Digital Transducer Interface (DTI) system.

Mercedes stated that it has extensive experience testing with a four-position spine and found the design to be equivalent to the original spine. It noted that all its THOR-50M dummies use a four-position spine manufactured by Kistler, which differs from the four-position spine manufactured by Humanetics. Mercedes commented and provided supporting evidence that the Kistler four-position spine has the same weight and center of gravity (CG) as the original spine. VW also commented that the four-position spine has the same geometry and dynamic properties as the original spine.

Humanetics commented that the weight, CG location, and moment of inertia (MOI) in its four-position spine closely match the original spine, and ASC and Humanetics commented that the proposed and four-position spines should provide equivalent performance if set in the same position. Humanetics provided data from qualification tests showing that dummies in both the four-position spine and original spine configurations meet the qualification specifications for the head, upper thorax, lower thorax, and abdomen test modes.

In light of the NPRM comments, NHTSA has investigated whether the four-position spine is equivalent  7 to the original spine. NHTSA is docketing two documents related to this effort.

One is an additional research report that is being placed in the crashworthiness research docket. 8 The report provides an analysis of the Humanetics four-position spine and its equivalence to the original spine specified in the 2023 drawing package. NHTSA analyzed equivalence by comparing a dummy with the four-position spine to dummies with the original spine. This included comparison of the mass, CG, and MOI; responses in qualification tests; responses in Gold Standard 1 and 2 sled tests;  9 and responses in frontal vehicle crash tests. The testing showed equivalence between the original spine and the four-position spine within expected test-to-test variation. NHTSA also conducted some of these same tests on a dummy manufactured by Kistler and equipped with the Kistler four-position spine. However, NHTSA encountered issues with durability of the dummy during testing and was therefore unable to evaluate the Kistler four-position spine fully. Accordingly, the test report only includes information from testing the Humanetics four-position spine. However, information on the tests of the Kistler four-position spine can be found in NHTSA's crash test database. 10

The other document NHTSA is placing in the research docket contains updated dummy drawings reflecting the component changes necessary to incorporate the four-position spine, as well as additional minor modifications for an in-dummy DAS system. 11 These drawings show the overall assembly of the four-position spine and in-dummy DAS components. (The drawing package that is being docketed includes all the dummy drawings, not just those that have changes related to the four-position spine and in-dummy DAS.)

In light of the NPRM comments and the supplemental research described above and in the docketed documents, NHTSA is now proposing to specify the Humanetics four-position spine as a permitted optional configuration. 12 If NHTSA were to adopt this proposal, there would be two separate drawing packages: one for the original spine and one for the four-position spine. NHTSA could perform compliance tests using a dummy with either configuration. The four-position spine configuration contains modifications to incorporate an in-dummy DAS, as described in the research report. The specifications for the in-dummy DAS are generic, so that any conforming in-dummy DAS could be installed. Humanetics' four-position spine was designed to accommodate multiple DAS brands; it would accommodate the SLICE6 DAS, as well as other brands. The four-position spine configuration would not accommodate an external DAS. This is because NHTSA's understanding is that users, including the test labs that NHTSA utilizes, prefer an in-dummy DAS.

Should users desire to test with an external DAS, the originally proposed drawing package with the original spine—which accommodates an external DAS—would still be incorporated into part 572. However, under this supplemental proposal, the configuration consisting of the original spine with an in-dummy DAS that was proposed in the NPRM would not be incorporated into part 572; the four-position spine with an in-dummy DAS would take its place. Again, this is because NHTSA is unaware of demand from users to test with this configuration, and the agency would prefer to test with the four-position spine utilizing an in-dummy DAS, which also enables harmonization with Euro NCAP ATDs.

Under this supplemental proposal, Humanetics would not need to provide either a notice of abandonment or letter of non-enforcement with respect to patented spine elements because the original spine would also be specified as a permissible alternate configuration. 13 NHTSA has generally avoided specifying patented components or copyrighted designs in part 572 without securing agreement from the rights-holder for the free use of the item, licensing it on reasonable terms, or developing an alternative unencumbered by any rights claims. In this case, because there would be an alternative configuration (the original spine) free of any intellectual property claims, NHTSA tentatively believes that specifying a patented component would be acceptable.

Though NHTSA is now proposing to specify the original spine and the Humanetics four-position spine as permissible configurations, NHTSA is also considering two other regulatory options.

One regulatory alternative would be to specify only the Humanetics four-position spine. Under the Memorandum of Understanding (MOU), Humanetics would provide either a notice of abandonment or letter of non-enforcement. The advantage of this approach (in addition to the advantages of the four-position spine) would be that, even though the two configurations are believed to be equivalent, it would rule out any possible variation between the two configurations in the event that NHTSA compliance testing was conducted using a different configuration than an OEM used for self-certification. The disadvantages would be that NHTSA and other industry members may already have THOR-50M dummies configured with the original spine, and would need to perform costly updates to these dummies to use them for compliance or self-certification purposes.

The other regulatory alternative would be to specify only the original spine. The advantage of this approach would minimize the risk of disparate outcomes if different configurations were used in compliance and self-certification testing. It would also reduce risk in that NHTSA has more experience testing with the original spine configuration than the four-position spine configuration. The disadvantages would be that the benefits of the four-position spine would not be realized.

NHTSA seeks comment on all aspects of this supplemental proposal and regulatory alternatives. NHTSA also seeks comments and any additional data on the equivalency between the Humanetics four-position spine and the original spine.

NHTSA is docketing an alternative dummy drawing package that specifies the four-position spine assembly and other modifications related to the in-dummy DAS. 14 Therefore, if NHTSA adopts the proposal, there would be two dummy drawing packages: one with the original spine and an external DAS, and one with the four-position spine and an in-dummy DAS.

After consideration of the comments that it receives in response to this SNPRM, NHTSA will make changes to the qualification procedures and PADI previously submitted as materials Incorporated by Reference. If NHTSA decides to include the four-position spine, NHTSA would also update the qualification procedures and PADI accordingly. For the qualification procedures, this would involve adding a section for setting the four-position spine, similar to the discussion currently in section 3, ATD Adjustment. For the PADI, this would include adding a section describing how to install the four-position spine in place of the original spine and a discussion of components which can be switched to incorporate in dummy DAS. If NHTSA decides not to include the original spine, references to the original spine will be removed from both documents. NHTSA intends to update the references to the material incorporated by reference in the final rule regulatory text, but make no other changes to the regulatory text proposed in the September 2023 NPRM.

The NPRM proposed use of a confor memory foam (confor face foam) between the head skin and the face load cells on the skull. As the NPRM explained, the confor face foam has a few characteristics that necessitate care in qualification and crash testing. In the face impact qualification test, a fully-assembled THOR-50M is seated on a table and impacted on the face with rigid impactor. The test assesses the head CG accelerometers  15 at a level of severity similar to that expected from vehicle crash tests. The qualification procedure specifies acceptance intervals (consisting of minimum and maximum values) for the peak probe force and peak head CG resultant acceleration. The foam progressively degrades after each impact so that the peak probe force and peak head resultant acceleration increases with each test. If the response of the confor face foam is initially below the lower bound of the acceptance interval, repeated tests can therefore bring it within the acceptance interval. A recovery period is needed after a dynamic impact to allow the foam to recover (partially). NHTSA's current protocol is to impact the confor face foam until it is within the acceptance interval, with a 24-hour wait period between qualification tests. After repeated impacts, the response of the foam will eventually exceed the upper bound of the acceptance interval, so that the foam must be replaced.

Euro NCAP does not use the face impact qualification test and instead visually checks the confor face foams for cracking or damage.

The following section discusses the comments received on the confor face foam; NHTSA testing to validate an alternative to the confor face foam; and NHTSA's supplemental proposal for the face insert.

NHTSA received a number of comments in response to the 2023 NPRM regarding the proposed confor face foam. Mercedes, GM, PDB and Auto Innovators commented on the face impact qualification procedure and expressed concerns regarding the 24-hour recovery period and presence of damage on the foam. Mercedes and Auto Innovators proposed to omit the face impact test and to add an inspection procedure for the confor face foam according to Euro NCAP (Euro NCAP TB026).

GM commented that the 24-hour recovery period is not practicable for an organization that may be conducting a high volume of tests every week. GM commented in support of the development of a more durable facial insert. PDB commented that the conditioning/recovering time of the confor face foam of 24 hours is too long and not practicable, especially as this test causes serious problems ( e.g., damage of the confor face foam). PDB commented that, if the confor face foam requires this time to recover, it should be replaced by another material. PDB also commented that the face impact qualification test could be removed because there is no available technical solution. PDB stated that, if there are no injury criteria required for the face, there is not a strong need for this test.

Since the publication of the NPRM, Humanetics has developed a new face insert as an alternative to the confor face foam. The alternative face insert is a 3D-printed component comprised of thermoplastic polyurethane. The design incorporates an outer shell with a patterned infill. The face insert is designed to fit in the cavity between the head skin and the skull of the dummy.

In response to the comments regarding concerns with recovery time and use of the confor face foam, NHTSA has evaluated this face insert for use in THOR-50M. NHTSA's testing demonstrated similar weight, CG, and MOI as compared to the confor face foam. Face impact qualification testing showed that the face insert has advantages over the confor face foam, including that the face insert does not need to be struck multiple times before the response is within the corridor, and does not experience drift within the corridor with each successive impact. The 24-hour recovery period also was not necessary. Qualification testing of three inserts also showed improved repeatability and reproducibility compared to the confor face foam, with limited variability between tests. Testing for durability at elevated energy did not cause damage to the face insert or change its response when re-tested at face impact qualification levels; the face insert therefore should not need frequent replacement. Results from this testing are provided in a research report NHTSA is placing in the crashworthiness research docket. 16 Based on this evaluation, NHTSA has tentatively concluded that the face insert is equivalent to the confor face foam, and leads to repeatable and reproducible measurements.

Because NHTSA has tentatively concluded that the face insert improves on the face foam in several respects while still leading to equivalent measurements, NHTSA is proposing to specify the face insert (drawing 472-1405, Face Insert, THOR-50M) as an alternative to the face foam (drawing 472-1401, Confor Foam, Face). Both the face insert and the confor face foam would be part of the drawing package, and the PADI would note the face insert as an alternate. The face insert drawing defines the overall shape, external dimensions across multiple cross sections, specifications with tolerances on mass, and performance specifications using a quasi-static compression test. This specification is intended to avoid over-specifying the face insert while allowing for technology-neutral solutions. The mass, CG, and MOI of the overall head assembly are also specified (drawing 472-0000, sheet 5). NHTSA anticipates conducting further testing on the face insert, including crash testing, in preparation for the final rule.

Although NHTSA has tentatively concluded that the face insert addresses the issues present with the confor face foam and is appropriate for inclusion in part 572, NHTSA recognizes that this is a new component with which dummy users other than NHTSA may not be familiar. NHTSA therefore tentatively believes it would be prudent to retain the confor face foam in the drawing package as a permissible optional configuration. As shown in a research report NHTSA is placing in the crashworthiness research docket, 17 the qualifications specifications can be met using either the confor face foam or the face insert, and the resulting Head Injury Criterion (HIC) values are in the same range for both configurations.

NHTSA has also tentatively decided to retain the face impact qualification test and not to follow Euro NCAP and specify a visual inspection procedure. Omitting the face impact test would mean that there is no objective method to check the system response of the head skin, confor face foam, and remainder of the head assembly during impact through the face. This is especially important because an impact to the face can influence the HIC injury metric, which is based on the resultant acceleration at the CG of the head.

NHTSA believes the Euro NCAP visual inspection procedure for the confor face foam is not sufficient. Besides potentially lacking objectivity, 18 it assumes that the foam must have damage to be out of tolerance; this ignores the situation where there is no visible damage to the foam but the response does not meet the qualification specifications for other reasons ( e.g., damage not visible on the exterior surface, or improper material specification).

Regarding commenters' concern with waiting 24 hours between qualification tests of the confor face foam, NHTSA notes that other qualification tests can be conducted during that 24-hour span; the 24-hour wait time is for the confor face foam, not using the ATD. In addition, the face foam could be swapped with another one. Regarding commenters' concerns about damage to the confor face foam, NHTSA tentatively believes that the approach for the confor face foam described in the NPRM (and summarized above) continues to be feasible, should users decide to use the confor face foam instead of the face insert.

NHTSA requests comment on all aspects of this proposal, including any information relating to users' experience with the face insert ( e.g., usability, durability, test data, etc.), and whether the confor face foam should be retained as an alternate specification.

In response to the 2023 NPRM, Humanetics commented that the specification for the arm clevis assembly (472-3831) does not match Humanetics' current production part. Humanetics commented that, in 2018, it implemented a design update to address a durability concern for the arm clevis. NHTSA conducted tests to assess the range of motion and the durability of the new upper arm clevis, finding both to be acceptable. NHTSA has tentatively decided to update the drawing package to include the current production upper arm clevis specified by Humanetics. NHTSA is not aware of a patent pertaining specifically to the new upper arm clevis design. However, the upper arm clevis is a component of the SD-3 shoulder, for which Humanetics has two patents. The SD-3 shoulder is subject to the MOU  19 as described in the July 2024 SNPRM. 20 If NHTSA adopts its tentative conclusion that it would be preferable to specify only the SD-3 shoulder in the final rule, under the MOU Humanetics would provide to NHTSA either a notice of abandonment of the patent to the United States Patent and Trademark Office or a letter stating that the patent will not be enforced against any third-party use.

NHTSA has considered the impact of this proposed rule under Executive Order (E.O.) 12866 and DOT's rulemaking procedures (49 CFR part 5). This rule does not meet the criteria of a “significant regulatory action” under E.O. 12866. Therefore, the Office of Management and Budget (OMB) has not reviewed this rule under that E.O. NHTSA has considered the qualitative costs and benefits of the proposed rule under the principles of E.O. 12866. For this discussion, the reader is referred to the NPRM preamble. 21 Although this rulemaking does not require the use of the THOR-50M in regulatory or consumer information crash testing, the amendments proposed in this SNPRM would not impose any costs on those who choose to purchase and use the dummy. For users that have already purchased a THOR-50M with the original spine, they would not need to upgrade or purchase a new THOR-50M. For users purchasing a new THOR-50M, the two spine options would expand the dummy options available to manufacturers, and the four-position spine would allow installation of an in-dummy DAS that manufacturers are already familiar with and may already own. Furthermore, the proposed optional face insert could reduce testing and part replacement costs should users choose to install the optional face insert in place of the confor foam insert. NHTSA requests comment on the costs and benefits of the amendments proposed in this SNPRM.

E.O. 14192, Unleashing Prosperity Through Deregulation (90 FR 9065 (Jan. 31, 2025)), requires that, for “each new [E.O. 14192 regulatory action] issued, at least ten prior regulations be identified for elimination.” Implementation guidance for E.O. 14192 issued by OMB (Memorandum M-25-20 (Mar. 26, 2025)) defines an E.O. 14192 deregulatory action as “an action that has been finalized and has total costs less than zero.” This rule would define the THOR-50M in part 572, but would not require its use, so it would not impose any regulatory burden. As this rule would not require its use, an entity would only choose to use and take on the costs associated with the THOR-50M if it was cost effective.

This regulatory action provides greater flexibility which can result in cost savings. In addition, Memorandum M-25-20 also states that “Regulatory activities associated with regulatory cooperation with foreign governments that reduce costs to entities or individuals within the United States, including at the border, or otherwise lower the cost of regulations on the United States economy, may qualify as E.O. 14192 deregulatory actions.” The THOR-50M defined by this rulemaking action, particularly as amended by this SNPRM, shares many similarities with the test device used in foreign consumer information programs such as Euro NCAP. Using a similar crash test dummy in the United States would allow manufacturers to realize cost efficiencies in vehicle design and testing. As such, NHTSA expects this rule to be an E.O. 14192 deregulatory action.

The policy statement in section 1 of E.O. 13609 provides that the regulatory approaches taken by foreign governments may differ from those taken by the United States to address similar issues, and that, in some cases, the differences between them might not be necessary and might impair the ability of American businesses to export and compete internationally. It further recognizes that, in meeting shared challenges involving health, safety, and other issues, international regulatory cooperation can identify approaches that are at least as protective as those that are or would be adopted in the absence of such cooperation and can reduce, eliminate, or prevent unnecessary differences in regulatory requirements.

In addition, section 24211 of the Infrastructure Investment and Jobs Act (Pub. L. 117-58), Global Harmonization, provides that DOT “shall cooperate, to the maximum extent practicable, with foreign governments, nongovernmental stakeholder groups, the motor vehicle industry, and consumer groups with respect to global harmonization of vehicle regulations as a means for improving motor vehicle safety.”

This proposed change would align with some, but not all, of the specifications of the THOR-50M used internationally in NCAP programs. The proposed use of the four-position spine would align with the Euro NCAP THOR-50M specification. 22 However, NHTSA is not proposing to align with the confor face foam visual inspection procedure for reasons explained in the preamble. NHTSA is also not proposing to align with the use of the Hybrid III 50th lower leg and knee slider for reasons explained in the NPRM.

Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 601, et seq. ), for any rulemaking where publication of a proposed rule is required by 5 U.S.C. 553 or any other law, agencies must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations, and small government jurisdictions). No regulatory flexibility analysis is required, however, if the head of an agency or an appropriate designee certifies that the rule will not have a significant economic impact on a substantial number of small entities.

NHTSA has considered the effects of this rulemaking under the Regulatory Flexibility Act. I hereby certify that this rulemaking action would not have a significant economic impact on a substantial number of small entities. This action would not have a significant economic impact on a substantial number of small entities because the addition of the test dummy to part 572 would not impose any requirements on anyone. This rulemaking only proposes to include the dummy in NHTSA's regulation for crash test dummies; it does not propose NHTSA's use of the ATD in agency testing or to require anyone to manufacture the dummy or to test motor vehicles or motor vehicle equipment with it. Therefore, a regulatory flexibility analysis is not required.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) requires Federal agencies to assess the effects of regulatory actions that may result in the expenditure by a State, local, or Tribal government, in the aggregate, or by the private sector of $214 million (the value equivalent of $100 million in 1995, adjusted for inflation to 2026 dollars) or more in any one year. This proposed rule does not contain Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local and Tribal governments, or the private sector of $206 million or more in any one year. Thus, the analytical requirements of the UMRA do not apply to this action.

E.O. 13175 requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. NHTSA has assessed the impact of this proposed rule on Indian tribes and determined that this rule would not have Tribal implications that require consultation under E.O. 13175.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the collection displays a currently valid OMB control number. This proposed rule would not impose any additional information collection requirements.

NHTSA is committed to complying with the E-Government Act, 2002 to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. The E-Government Act of 2002 (Pub. L. 107-347, sec. 208, 116 Stat. 2899, 2921, Dec. 17, 2002), requires Federal agencies to conduct a privacy impact assessment for new or substantially changed technology that collects, maintains, or disseminates information in an identifiable form. No new or substantially changed technology would collect, maintain, or disseminate information as a result of this proposed rule. Accordingly, NHTSA has not conducted a privacy impact assessment.

NHTSA has examined this proposed rule pursuant to E.O. 13132 (64 FR 43255, August 10, 1999) and concluded that no additional consultation with States, local governments or their representatives is mandated beyond the rulemaking process. The agency has concluded that the proposed rule would not have federalism implications because the proposed rule would not have “substantial direct effects 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.” This proposed rule would not impose any requirements on anyone. Businesses will be affected only if they choose to manufacture or test with the dummy.

Further, no consultation is needed to discuss the preemptive effect of this proposed rule. Although NHTSA's safety standards can have preemptive effect, the proposed rule would amend 49 CFR part 572 and is not a safety standard. This part 572 proposed rule would not impose any requirements on anyone.

The Department has analyzed the environmental impacts of this final rule pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321, et seq. ). NHTSA has determined that this rule is categorically excluded pursuant to 23 CFR 771.118(c)(4). Categorical exclusions are categories of actions that the agency has determined normally do not significantly affect the quality of the human environment and therefore do not require either an environmental assessment (EA) or environmental impact statement (EIS). See DOT Order 5610.1D § 9. In analyzing the applicability of a categorical exclusion (CE), the agency must also consider whether extraordinary circumstances are present that would warrant the preparation of an EA or EIS. Id. § 9(b). Each Operating Administration (OA) of DOT may apply CEs established in another OA's procedures. Id. § 9(f). To do so, the OA “must evaluate the action for extraordinary circumstances identified in the OA procedures in which the CE is established to determine if a normally excluded action may have a significant impact and coordinate with the originating OA to ensure that the CE is being applied correctly.” Id. This rulemaking, which would add a new crash test dummy to NHTSA's regulations, is categorically excluded pursuant to 23 CFR 771.118(c)(4): “Planning and administrative activities not involving or leading directly to construction, such as: Training, technical assistance and research; promulgation of rules, regulations, directives, or program guidance; approval of project concepts; engineering; and operating assistance to transit authorities to continue existing service or increase service to meet routine demand.” NHTSA has coordinated with the Federal Transit Administration (FTA) to ensure that this CE is being applied correctly. NHTSA does not anticipate any environmental impacts, and there are no extraordinary circumstances present in connection with this rulemaking.

With respect to the review of the promulgation of a new regulation, section 3(b)(2) of E.O. 12988, “Civil Justice Reform” (61 FR 4729, February 7, 1996) requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) clearly specifies the preemptive effect; (2) clearly specifies the effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct, while promoting simplification and burden reduction; (4) clearly 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 Attorney General.

NHTSA has reviewed this rulemaking action and determined that it conforms to the applicable standards in section 3(b)(2) of E.O. 12988, Civil Justice Reform. The issue of preemption is discussed above in connection with E.O. 13132 (Federalism). NHTSA believes that this final rule specifies clearly the changes that would be made to part 572, defines any necessary key terms, and provides a clear legal standard for manufacturers to follow. The amendments do not take effect retroactively. NHTSA notes further that there is no requirement that an individual submit a petition for reconsideration or pursue other administrative proceedings before they may file suit in court.

Under the National Technology Transfer and Advancement Act of 1995 (NTTAA) (Pub. L. 104-113), “[A]ll Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.” Voluntary consensus standards are technical standards ( e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies, such as SAE (formerly, the Society of Automotive Engineers). The NTTAA directs this agency to provide Congress, through OMB, explanations when the agency decides not to use available and applicable voluntary consensus standards.

There are no technical standards with regard to the THOR-50M spine box.

E.O. 12866 requires each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:

• Have we organized the material to suit the public's needs?

• Are the requirements in the rule clearly stated?

• Does the rule contain technical language or jargon that is not clear?

• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?

• Would more (but shorter) sections be better?

• Could we improve clarity by adding tables, lists, or diagrams?

• What else could we do to make the rule easier to understand?

If you have any responses to these questions, please include them in your comments on this proposal.

DOT assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions. The Regulatory Information Service Center publishes the Unified Agenda. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.

In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to inform its rulemaking process better. DOT posts these comments, without edit, to www.regulations.gov, as described in the system of records notice, DOT/ALL-14 FDMS, accessible through www.dot.gov/privacy. In order to facilitate comment tracking and response, we encourage commenters to provide their name, or the name of their organization; however, submission of names is completely optional. Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, or other organizations). For information on DOT's compliance with the Privacy Act, see https://www.transportation.gov/privacy.

As required by 5 U.S.C. 553(b)(4), a summary of this rule can be found at regulations.gov, Docket No. NHTSA-2023-0031, in the SUMMARY section of this proposed rule.

How do I prepare and submit comments?

Your comments must be written and in English. To ensure that your comments are correctly filed in the docket, please include the docket number indicated in this document in your comments.

Your comments must not be more than 15 pages long. (49 CFR 553.21). NHTSA established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments.

If you are submitting comments electronically as a PDF (Adobe) file, NHTSA asks that the documents be submitted using the Optical Character Recognition (OCR) process, thus allowing NHTSA to search and copy certain portions of your submissions.

Please note that pursuant to the Data Quality Act, in order for substantive data to be relied upon and used by the agency, it must meet the information quality standards set forth in the OMB and DOT Data Quality Act guidelines. Accordingly, NHTSA encourages you to consult the guidelines in preparing your comments. OMB's guidelines may be accessed at https://www.transportation.gov/regulations/dot-information-dissemination-quality-guidelines.

If you wish the docket to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, the docket will return the postcard by mail.

You should submit a redacted “public version” of your comment (including redacted versions of any additional documents or attachments) to the docket using any of the methods identified under ADDRESSES . This “public version” of your comment should contain only the portions for which no claim of confidential treatment is made and from which those portions for which confidential treatment is claimed has been redacted. See below for further instructions on how to do this.

You also need to submit a request for confidential treatment directly to the Office of Chief Counsel. Requests for confidential treatment are governed by 49 CFR part 512. Your request must set forth the information specified in part 512. This includes the materials for which confidentiality is being requested (as explained in more detail below); supporting information, pursuant to § 512.8; and a certificate, pursuant to § 512.4(b) and part 512, appendix A.

You are required to submit to the Office of Chief Counsel one unredacted “confidential version” of the information for which you are seeking confidential treatment. Pursuant to § 512.6, the words “ENTIRE PAGE CONFIDENTIAL BUSINESS INFORMATION” or “CONFIDENTIAL BUSINESS INFORMATION CONTAINED WITHIN BRACKETS” (as applicable) must appear at the top of each page containing information claimed to be confidential. In the latter situation, where not all information on the page is claimed to be confidential, identify each item of information for which confidentiality is requested within brackets: “[ ].”

You are also required to submit to the Office of Chief Counsel one redacted “public version” of the information for which you are seeking confidential treatment. Pursuant to § 512.5(a)(2), the redacted “public version” should include redactions of any information for which you are seeking confidential treatment ( i.e., the only information that should be unredacted is information for which you are not seeking confidential treatment).

NHTSA is currently treating electronic submission as an acceptable method for submitting confidential business information to the agency under part 512. Please do not send a hardcopy of a request for confidential treatment to NHTSA's headquarters. The request should be sent to Dan Rabinovitz in the Office of the Chief Counsel at Daniel.Rabinovitz@dot.gov. You may either submit your request via email or request a secure file transfer link. If you are submitting the request via email, please also email a courtesy copy of the request to John Piazza at john.piazza@dot.gov.

We will consider all comments received before the close of business on the comment closing date indicated above under DATES . To the extent possible, we will also consider comments that the docket receives after that date. If the docket receives a comment too late for us to consider in developing a final rule (assuming that one is issued), we will consider that comment as an informal suggestion for future rulemaking action.

You may read the comments received by the docket at the address given above under ADDRESSES . The hours of the docket are indicated above in the same location. You may also see the comments on the internet. To read the comments on the internet, go to https://www.regulations.gov. Follow the online instructions for accessing the dockets.

Please note that even after the comment closing date, NHTSA will continue to file relevant information in the docket as it becomes available. Further, some people may submit late comments. Accordingly, NHTSA recommends that you periodically check the docket for new material. You can arrange with the docket to be notified when others file comments in the docket. See www.regulations.gov for more information.

NMFS, in collaboration with the South Atlantic Fishery Management Council (Council), manages the South Atlantic snapper-grouper fishery, which includes black sea bass, in Federal waters under the FMP. The FMP was prepared by NMFS and the Council, and is implemented by NMFS through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

The Magnuson-Stevens Act requires that NMFS and the regional fishery management councils prevent overfishing and continually achieve the optimum yield from federally managed fish stocks. These mandates are intended to ensure that fishery resources are managed for the greatest overall benefit to the Nation, particularly with respect to providing food production and recreational opportunities, and protecting marine ecosystems. To further this goal, the Magnuson-Stevens Act also requires fishery managers to minimize bycatch and bycatch mortality to the extent practicable.

This action is proposed under the statutory authority of the Magnuson-Steven Act, section 303(a)(1)(A) as necessary and appropriate for the conservation and management of the fishery to prevent overfishing and rebuild overfished stocks, and to promote the long-term health and stability of the fishery.

All weights described in this proposed rule are in round weight. The metric conversion for the imperial measurement used in this document is 1 pound (lb) equals approximately 0.45 kilograms.

The snapper-grouper fishery includes the South Atlantic stock of black sea bass from 35°15.19′ N latitude, which is due east of Cape Hatteras Light, North Carolina, southward to the Council's jurisdictional boundary at the Florida Keys. Black sea bass occurring in Federal waters north of 35°15.19′ N latitude is a separate stock, which is managed under a different fishery management plan and regulations. Regulatory Amendment 37 and this proposed rule apply to South Atlantic black sea bass in Federal waters only and respond to declines in stock abundance and landings.

South Atlantic black sea bass was previously listed as overfished throughout the 2000s, a 10-year rebuilding plan was implemented in 2006, and the stock was rebuilt in 2013. Amendment 11 to the Snapper-Grouper FMP set the existing maximum sustainable yield (MSY) based proxies used to determine the overfishing and overfished status of black sea bass based on the fishing mortality rate and spawning stock biomass (SSB) that correspond with a reproductive capacity equal to 30 percent of the spawning potential ratio (SPR) of an unfished population (SSB30% SPR ). In 2018, NMFS determined, based on the stock assessment completed the same year for South Atlantic black sea bass, Southeast Data, Assessment, and Review (SEDAR 56), that the stock was not undergoing overfishing and not overfished but was below the threshold of the SSB that can produce long-term MSY. In 2023, SEDAR 76 was completed using data through 2021. SEDAR 76 concluded that the stock was subject to overfishing and was overfished. Following the assessment, NMFS recommended that the Council develop measures to improve stock health, as well as a plan to rebuild the black sea bass stock.

Due to concerns from the Council and its Scientific and Statistical Committee (SSC) over assumptions of catch level projections in SEDAR 76, the SEDAR 76 Update was developed between 2023 and 2025. During this time, in March 2024, the Council initiated development of Amendment 56 to the FMP in preparation for catch level recommendations from the SEDAR 76 Update. In 2025, the SEDAR 76 Update was completed using data through 2023 and some additional modeling changes from SEDAR 76. The March 2025 SEDAR 76 Update found that the stock was overfished and overfishing was occurring. The Council's SSC provided an acceptable biological catch (ABC) recommendation, based on that update assessment. After reviewing the assessment and related ABC recommendation, the Council asked NMFS' Southeast Fisheries Science Center (SEFSC) to further investigate and consider updating several data inputs, including recreational catch estimates, which are expected to be revised in 2026. In response, the SEFSC is revising the SEDAR 76 Update assessment and is scheduled to bring these revisions before the SSC in late 2026, after which the Council will receive ABC advice and updated projections for longer-term advice. The Council paused work on Amendment 56 pending completion of the assessment revisions.

While modifications to and subsequent review of the stock assessment are being conducted, NMFS recognizes the persistent, strong declines in biomass, abundance, fishery-independent indices, and landings, as reflected in the SEDAR 76 Update. To limit this decline in the short-term, the Council developed Regulatory Amendment 37 to: (1) reduce directed fishing mortality, and (2) increase spawning output and recruitment through a spawning season closure. NMFS has reviewed Regulatory Amendment 37 and pursuant to 304(b)(1)(A) of the Magnuson-Stevens Act now issues this proposed rule. To reduce directed fishing mortality, this proposed rule would establish annual catch targets (ACTs), revise AMs to limit commercial and recreational harvest to the new ACTs, and lower the recreational bag limit. Additionally, black sea bass and other winter spawning species in the South Atlantic such as gag and scamp are experiencing recruitment declines. Therefore, Regulatory Amendment 37 recommends that NMFS establish a seasonal spawning closure for both the commercial and recreational sectors during the months of February and March to protect spawning fish and increase stock recruitment.

NMFS seeks public comment on the following proposed management measures for black sea bass.

An ACL is the maximum amount of fish that can be harvested in a given year and is set at a level intended to ensure overfishing does not occur. An ACT is a management-focused target set below the ACL to create a buffer against overharvesting and account for management uncertainty. Currently, the South Atlantic black sea bass commercial ACL is 276,490 lb, and the recreational ACL is 366,510 lb. There are no sector ACTs currently in place for South Atlantic black sea bass. While landings have not reached or exceeded the current ACLs since the 2018 assessment, the stock's abundance estimates have continued to trend downward, indicating that fishing mortality needs to be lowered to increase the SSB of the black sea bass stock. Therefore, if implemented by NMFS, this proposed rule would establish commercial and recreational ACTs below the ACLs and recent harvest levels. ACTs for each sector would be set at 50 percent of the average annual landings for the 5 most recent years of available catch information as detailed in Regulatory Amendment 37. The commercial ACT would be 48,557 lb and the recreational ACT would be 63,143 lb.

The current in-season AM requires NMFS to close the commercial season if landings of black sea bass are projected to reach the commercial quota, which is equal to the commercial ACL, during a fishing year. This proposed rule would revise the commercial AMs so that the commercial season would close if NMFS projects that landings will reach the proposed commercial ACT during a fishing year. The current post-season AM to reduce the following year's commercial ACL by the amount of any overage would not change.

Under the proposed commercial ACT and AM, a commercial in-season closure could be triggered more frequently because the commercial ACT is likely to be met earlier during the season than the current commercial ACL. A commercial ACT set at 50 percent of recent landings could increase the occurrence of in-season commercial closures. In the short term, economic benefits would decrease. There could be long-term economic benefits to the commercial industry through improvements to the status of the black sea bass stock.

Under the current recreational AMs, NMFS sets the recreational season length based on when landings are projected to reach the recreational ACL and announces the end date for the recreational fishing season in the Federal Register before the recreational fishing year begins on April 1. This proposed rule would continue to require that NMFS project and announce the recreational season length; however, the projection would be based on when NMFS estimates recreational landings would reach the proposed recreational ACT.

Over the past 5 years, average recreational landings have only been about one-half of the recreational ACL. Since the recreational sector ACT is notably lower than the sector ACL currently in place, NMFS may announce shorter seasons in the future. This would reduce recreational landings relative to recent levels, which could be expected to reduce fishing mortality from harvest of black sea bass. The proposed ACTs would restrict landings which can result in decreased net economic benefits if harvest decreases. However, in the long term, the ACTs may contribute to improving the status of the black sea bass stock, which would allow for long-term economic benefits.

Currently, there are no commercial or recreational seasonal spawning closures for black sea bass in or from South Atlantic Federal waters south of Cape Hatteras, North Carolina. However, commercial black sea bass pots are prohibited in certain areas from November 1 through April 30 to minimize gear interactions with migrating whales. This proposed rule would establish a seasonal spawning closure for both the commercial and recreational sectors during the months of February and March. During the spawning closure, the commercial sale, purchase, harvest, or possession of black sea bass in or from South Atlantic Federal waters south of Cape Hatteras, North Carolina, would be prohibited and the commercial trip limit would be zero. During the closed months, the recreational harvest or possession of black sea bass in or from South Atlantic Federal waters south of Cape Hatteras, North Carolina, would be prohibited and the bag and possession limits would be zero.

Spawning season closures are intended to protect and increase the stock biomass by allowing fish to spawn without any fishing mortality from harvest (though there may still be some fishing mortality from fish that are caught and released). The months of February and March were chosen because they overlap with the peak spawning season for black sea bass (February-April), and closures for several other snapper grouper species, some of which are caught with black sea bass, also occur during these months. Including black sea bass in a closure with other snapper-grouper species could reduce discards.

The current recreational bag limit for black sea bass, which applies to each person per day, is seven fish. This proposed rule would reduce the recreational bag limit to three fish. The bag limit applies to all anglers who harvest black sea bass from Federal waters south of Cape Hatteras, North Carolina, and for anglers on federally permitted charter and headboat vessels, regardless of whether black sea bass are harvested from state or Federal waters. Constraining recreational harvest by means of bag limits could result in positive long-term biological benefits by reducing fishing mortality.

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with Regulatory Amendment 37, the FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.

This proposed rule has been determined to be not significant for purposes of Executive Order (E.O.) 12866.

An initial regulatory flexibility analysis (IRFA) was prepared, as required by section 603 of the RFA. The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. A description of the action, why it is being considered, and the legal basis for this action is contained in this SUPPLEMENTARY INFORMATION section of the preamble. A summary of the IRFA follows. All monetary estimates in the following analysis are in 2024 dollars. A copy of this analysis is available from NMFS (see ADDRESSES ).

The Magnuson-Stevens Act provides the statutory basis for this proposed rule. No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, record-keeping, or other compliance requirements are introduced by this proposed rule.

This proposed rule would implement the following measures for South Atlantic black sea bass: (1) establish a commercial ACT of 48,557 lb and a recreational ACT of 63,143 lb; (2) revise the in-season AM for the commercial sector, such that if NMFS estimates that commercial landings will reach the commercial quota, set at the proposed commercial ACT, during a fishing year NMFS will close the commercial harvest for the remainder of the fishing year; (3) revise the in-season AM for the recreational sector, such that NMFS will project the length of the recreational fishing season based on when NMFS estimates the proposed recreational ACT will be met and announce the recreational fishing season end date in the Federal Register prior to the start of the recreational fishing year begins on April 1; (4) establish a commercial seasonal closure from February 1 through March 31 during which commercial sale, purchase, harvest, or possession of black sea bass in or from South Atlantic Federal waters south of Cape Hatteras, North Carolina, is prohibited and the commercial trip limit is zero; (5) establish a recreational seasonal closure from February 1 through March 31 during which recreational harvest or possession of black sea bass in or from South Atlantic Federal waters south of Cape Hatteras is prohibited and the bag limit is zero; and (6) reduce the recreational bag limit from seven to three fish per person per day.

Action 1 would apply to all commercial fishing businesses, for-hire fishing businesses, and recreational anglers that fish for black sea bass in Federal waters of the South Atlantic. Actions 2 and 4 would only apply to commercial fishing businesses. Finally, actions 3, 5, and 6 would only apply to for-hire fishing businesses and recreational anglers. None of the proposed changes would directly apply to federally permitted dealers. Any change in the supply of black sea bass available for purchase by dealers as a result of the proposed rule, and associated economic effects, would be an indirect effect of the proposed rule and would therefore fall outside the scope of the RFA.

The RFA requires NMFS to describe the impact of the proposed rule on small entities (5 U.S.C. 603). Small entities include small businesses, small organizations, and small governmental jurisdictions (5 U.S.C. 601(3)-(6)). Recreational anglers are not businesses, organizations, or governmental jurisdictions, so they are outside the scope of this analysis.

Any fishing vessel that harvests and sells any of the snapper-grouper species from South Atlantic Federal waters must have a valid South Atlantic commercial snapper-grouper permit, which is a limited access permit. In 2024, there were 508 valid or renewable South Atlantic snapper-grouper unlimited permits and 86 valid or renewable 225-lb (102-kg) trip-limited permits. On average from 2019 through 2023, there were 148 federally permitted commercial vessels with reported landings of South Atlantic black sea bass. Ex-vessel revenue from landings of black sea bass averaged $291,690 during this period, representing 2.9 percent of total ex-vessel revenue for the vessels that harvested black sea bass. The average total revenue per vessel from 2019 through 2023 was $67,329. For commercial vessels that harvest black sea bass in the South Atlantic, NMFS estimates that economic profits are −$1,279 or −1.9 percent of annual gross revenue, on average. However, a negative economic profit does not automatically mean a vessel is losing money, running a negative cash flow, or operating at an accounting loss. Standard accounting tracks real cash coming in and going out. Economic profit goes a step further by including implicit costs, such as the unpaid value of the owner's time compared to what they could earn in their next best alternative. A negative economic profit simply means the business owner is earning less than they theoretically might in a different job or investment. The maximum annual revenue from all species reported by a single vessel that harvested black sea bass from 2019 through 2023 was $445,119.

Although this proposed rule would apply to for-hire vessels, it would not be expected to have any direct effects on these entities. From 2019 through 2023, there were an average of 3,918 charter vessels that targeted black sea bass in the South Atlantic, which accounts for just under 3 percent of all recreational target trips for black sea bass. In contrast, an average of 45,952 charter vessel trips had landings of black sea bass from 2019 through 2023 (almost 12 times the number of target trips). This indicates that black sea bass are an incidentally harvested species and for-hire vessels do not typically sell targeted trips for these fish. Therefore, NMFS does not expect the proposed changes to the black sea bass management measures to directly alter the services sold by these vessels. Any change in demand for these fishing services, and associated economic effects, as a result of this proposed rule would be a consequence of a change in anglers' behavior, secondary to any direct effect on anglers and, therefore, an indirect effect of the proposed rule. This indirect effect would fall outside the scope of the RFA. In summary, only the impacts on commercial fishing businesses will be discussed.

For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (North American Industry Classification System code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide. All of the commercial fishing businesses directly regulated by this proposed rule are believed to be small entities based on the NMFS size standard.

As stated earlier, this proposed rule would establish a commercial ACT of 48,557 lb and would revise the in-season AM for the commercial sector, such that if NMFS estimates that commercial landings will reach the commercial quota, set at the proposed commercial ACT, during a fishing year NMFS will close the commercial harvest of black sea bass for the remainder of the fishing year. Currently, the commercial AMs are triggered if NMFS estimates that landings during a fishing year will reach the commercial ACL of 276,490 lb. When taken together, the proposed commercial ACT and revisions to the commercial AM would result in a reduction in landings of 41,150 lb and a reduction in ex-vessel revenue of $155,959 annually relative to the status quo, as based on average commercial landings from 2019 through 2023. Divided by the average number of vessels that harvested black sea bass from 2019 through 2023, this results in an annual decrease in ex-vessel revenue of $1,054 per vessel (approximately 1.6 percent of average annual per vessel gross revenue). Based on the assumed −1.9 percent economic profit rate for black sea bass vessels, average annual economic profits per vessel would increase by $20. In practical terms, because harvesting less fish reduces operating expenses (including implicit costs), the resulting cost savings would slightly outweigh the lost sales revenue. Individual fishing businesses, however, may experience varying levels of economic effects, depending on their fishing practices, operating characteristics, and profit maximization strategies.

Additionally, the proposed rule would establish a commercial seasonal closure from February 1 through March 31 during which the commercial sale, purchase, harvest, or possession of black sea bass in or from South Atlantic Federal waters south of Cape Hatteras, North Carolina, would be prohibited and the commercial trip limit would be zero. Although this closure would reduce commercial fishing opportunities during the year, overall landings would still be expected to achieve the proposed ACT and thus no additional negative economic effects are estimated.

The following discussion describes the significant alternatives to the proposed rule that were not selected by NMFS.

One alternative, the no action alternative, was considered for the proposed action to establish a commercial ACT of 48,557 lb and a recreational ACT of 63,143 lb for South Atlantic black sea bass. This alternative would not establish ACTs and the harvest of black sea bass would continue to be managed under the existing total and sector ACLs, which have not been fully harvested by either sector for several years and presumably would continue to not be fully utilized. Thus, there would be no change in economic benefits to commercial fishing businesses under this alternative. This alternative was not selected because the benefits of reducing fishing mortality and increasing black sea bass population levels through implementation of the proposed ACTs would outweigh the costs of the associated reduction in harvest.

One alternative, the no action alternative, was considered for the proposed action to revise the commercial AMs such that if NMFS estimates that commercial landings of South Atlantic black sea bass will reach the commercial quota, set at the proposed commercial ACT, NMFS will close the commercial harvest of black sea bass for the remainder of the fishing year. This alternative would not revise the AMs and therefore an in-season closure would be triggered when landings are estimated to reach the ACL during a fishing year, as opposed to the proposed ACT. Because this alternative would not modify existing management measures, it would not be expected to alter current harvest levels or result in economic effects relative to the status quo. This alternative was not selected because the proposed revisions to the commercial AMs are required for the proposed ACT to be effective at reducing fishing mortality of black sea bass. Absent the revisions to the AMs, the proposed ACT would be unenforceable.

Finally, one alternative and two sub-alternatives were considered for the proposed action to establish a commercial seasonal closure for black sea bass in or from South Atlantic Federal waters south of Cape Hatteras, North Carolina during February 1 through March 31. The first alternative, the no action alternative, would not implement a seasonal spawning closure for black sea bass and would therefore not affect commercial harvest or result in direct economic effects. This alternative was not selected because it forgoes the benefits of a spawning closure, specifically, increased reproduction and recruitment necessary to restore the black sea bass stock biomass to a level that would allow for MSY.

The first sub-alternative to the proposed action to implement a February 1 through March 31 commercial seasonal closure for black sea bass in or from South Atlantic Federal waters south of Cape Hatteras would establish a commercial seasonal closure from January 1 through January 31 in the same area as the proposed spawning closure. The second sub-alternative would establish a commercial seasonal closure from April 1 through April 30 in the same area as the proposed spawning closure. These sub-alternatives were considered both individually and in combination with the proposed seasonal closure, such that the closure could occur during any combination of the months from January through April. Considered individually, each sub-alternative would not be expected to result in economic effects because total harvest would be the same as under the proposed seasonal closure and capped at the proposed ACT. If these sub-alternatives were combined with the proposed seasonal closure, they could result in a reduction in landings, ex-vessel revenue, and economic profits relative to the status quo, should a portion of the commercial ACT go unharvested. However, even if all of January through April were closed, effort could still shift to open harvest months, which would eliminate or reduce such losses. Quantified effects estimates for such combinations of closed months are not available. Neither of the two sub-alternatives were selected because the proposed February 1 through March 31 seasonal closure would best balance the benefits of spawning protection with the needs of the commercial sector to maintain access to the fishery during critical times of the year, especially January.

This proposed rule contains no information collection requirements under the Paperwork Reduction Act of 1995.

For the reasons set out in the preamble, NMFS proposes to amend 50 CFR part 622 as follows: