Title 34
SECTION 9.9
9.9 General rulemaking procedures.
§ 9.9 General rulemaking procedures.(a) Definitions. (1) Significant rulemaking means a regulatory action designated by OMB under Executive Order 12866 as likely to result in a rule that may -
(i) Have an annual effect on the U.S. economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities;
(ii) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(iii) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(iv) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in Executive Order 12866.
(2) Nonsignificant rulemaking means a regulatory action not designated as significant by OMB.
(b) Departmental review process. (1) Except as provided in this paragraph (b), all departmental rulemakings are to be reviewed and cleared by the Office of the Secretary prior to submission to OMB.
(2) Each POC head must -
(i) Ensure that all of the POC's rulemaking documents are written in plain language, technically sound, and generally of high quality;
(ii) Ensure that the division within OGC that is responsible for providing the POC with legal advice reviews all rulemaking documents for legal support and legal sufficiency, including compliance with all applicable legal authorities, including but not limited to those listed in § 9.1; and
(iii) Approve the submission of all rulemaking documents, including any regulatory impact analysis, to DRS for submission for departmental clearance.
(3) DRS transmits the rulemaking documents to POCs for review and comments in one or more rounds of departmental clearance, as appropriate, for a review period determined by DRS based on the length, complexity, and urgency of the particular rulemaking documents.
(4) Reviewing offices should provide comments or otherwise concur on rulemaking documents within 10 calendar days or as otherwise determined by DRS based on such factors as the length, complexity, and urgency of the documents.
(5) After each round of clearance, DRS sends reviewing offices' comments to the proposing POC for resolution. The POC resolves any comments and submits a revised draft to DRS for another round of clearance or for the next step following the completion of departmental clearance as determined by DRS.
(6) Following the completion of departmental clearance, DRS prepares a rulemaking package to request the Secretary's approval for the rulemaking to be submitted to OMB for review or to the Federal Register for publication. These rulemaking packages are submitted to the Office of the Executive Secretariat, with a copy to the RRO, who must approve the rulemaking prior to submission to the Secretary.
(7) DRS notifies the POC and the RRO when the Secretary approves or disapproves the submission of the rulemaking to OMB or to the Federal Register.
(8) DRS is responsible for coordination with OIRA staff on OIRA's designation of all rulemaking documents, submission and clearance of all significant rulemaking documents, and all discussions or meetings with OMB concerning these documents. Generally, POCs must not schedule their own meetings with OMB without DRS and RRO involvement. Each POC should coordinate with DRS and the RRO before holding any discussions with OMB concerning regulatory policy or agreements to modify significant regulatory documents.
(c) Petitions for rulemaking, exemptions, or retrospective review. (1) Any interested person may petition the Department to issue, amend, or repeal a rule, or for an exemption from a rule that authorizes a permanent or temporary exemption; or to perform a retrospective review of an existing rule.
(2) A petition must -
(i) Be submitted to the Department through its docket designated for petitions on regulations.gov;
(ii) Contain the petitioner's name and contact information, including, at a minimum, an email address or mailing address;
(iii) Describe the nature of the request, and identify the rule at issue, including the specific text or substance of the rule;
(iv) Explain the interest of the petitioner in the action requested, including, in the case of a petition for an exemption, the nature and extent of the relief sought and a description of the persons to be covered by the exemption; and
(v) Contain an adequate justification for the action sought.
(3)(i) Within 60 calendar days of the Department's receipt of the petition, the head of the POC with regulatory responsibility over the matter described in the petition, or their designee, must recommend whether to -
(A) Proceed with consideration of rulemaking, an exemption, or retrospective review; or
(B) Deny, in whole or in part, the petition.
(ii) The head of the POC, in consultation with the RRO and General Counsel, as needed, determines which petitions to deny. If the head of the POC determines that the petition contains adequate justification to issue, amend, or repeal a rule; to provide for a permanent or temporary exemption from any rule; or to perform a retrospective review of an existing rule, it refers the proposed action to the RRTF.
(4) After action by the RRTF, the POC responsible for the subject matter of the petition notifies the petitioner of any action on the petition. If the petition is denied, then the POC must provide an appropriately reasoned statement of the grounds for denial.
(d) Review of existing regulations. (1) All significant departmental regulations will be reviewed on a 10-year cycle.
(2) The POC that issued the regulation will review it for the following:
(i) Continued policy justification. Whether there is a policy justification for maintaining the regulation that is compelling and evidence-based.
(ii) Continued cost justification. Whether the regulation requires adjustment due to changed market conditions or is no longer net beneficial.
(iii) Regulatory flexibility. Whether the regulation has a significant economic impact on a substantial number of small entities and requires review under 5 U.S.C. 610 (commonly known as the Regulatory Flexibility Act).
(iv) General updates. Whether the regulation may need technical corrections, updates, revisions, or repeal.
(v) Plain language. Whether the regulation needs revisions for plain language.
(vi) Other considerations. Whether there are other considerations under relevant Executive orders and laws.
(3) The results of each POC's review will be reported annually in the fall Unified Agenda.
(e) Regulatory impact analysis. (1) The Office of Budget Service has primary responsibility for conducting and approving regulatory impact analyses.
(2) Rules include, at a minimum -
(i) An assessment of the potential costs and benefits of the regulatory action (a regulatory impact analysis) or a reasoned determination that the expected economic impact is so minimal that a formal analysis of costs and benefits is not warranted; and
(ii) If the regulatory action is expected to impose costs, either a reasoned determination that the benefits outweigh the costs or, if the particular rulemaking is mandated by statute notwithstanding a negative cost-benefit assessment, a detailed discussion of the rationale supporting the specific regulatory action proposed and an explanation of why this approach maximizes net benefits.
(3) To the extent practicable, economic assessments will quantify the foreseeable annual economic costs and cost savings within the United States that would likely result from issuance of the rule and be conducted in accordance with section 1(b)(6) of Executive Order 12866 and OMB Circular A-4 (Regulatory Analysis), as specified by OMB in consultation with DRS. If the Office of Budget Service has estimated that the rule will likely impose economic costs on persons outside the United States, such costs should be reported separately.
(4) Deregulatory significant rulemakings will be evaluated for quantifiable as well as qualitative cost savings. If it is determined that quantification of cost savings is not possible or appropriate, then the proposing POC will provide a reasoned justification for the lack of quantification upon submission of the rulemaking to the Office of Budget Service.
(f) Regulatory flexibility analysis. All rulemakings subject to the requirements of 5 U.S.C. 603-604 (as enacted by the Regulatory Flexibility Act), and any amendment thereto, must include the required analysis regarding the potential impact of the rule on small entities.
(g) Notices of proposed rulemaking (NPRM) - (1) Timing. After obtaining approval from the RRTF under § 9.7, if applicable, the proposing POC proceeds with rulemaking, consistent with applicable statutory and regulatory procedures (such as negotiated rulemaking, public hearings, and notice-and-comment rulemaking) in consultation with DRS.
(2) Contents. The NPRM must include, at a minimum -
(i) A statement of the time and place for submission of public comments and the time, place, and nature of any related public rulemaking proceedings;
(ii) Reference to the legal authority under which the rule is proposed and consistency with applicable authorities cited in § 9.1 and with the policy set forth in § 9.4;
(iii) The terms of the proposed rule;
(iv) A description of material information known to the POC on the subject of the proposed rule, including but not limited to -
(A) The considerations specified in § 9.7(b);
(B) For economically significant rules or documents over 100 pages, a summary of any regulatory impact analysis performed by the Department; and
(C) Information specifically identifying material data, studies, models, and other evidence or information considered or used by the Department in connection with its determination to propose the rule;
(v) A reasoned preliminary analysis of the need for the proposed rule based on the information described in the preamble to the NPRM, and an additional statement of whether a rule is required by statute;
(vi) A reasoned preliminary analysis indicating whether the expected benefits of the proposed rule will meet the relevant statutory objectives and will outweigh the estimated costs of the proposed rule, in accordance with any applicable requirements;
(vii) When possible, and especially if the rulemaking is significant, a summary discussion of the alternatives to the proposed rule considered by the POC, the relative costs and benefits of those alternatives, whether the alternatives would meet relevant statutory objectives, and why the POC chose not to propose or pursue the alternatives;
(viii) A statement of whether existing rules have created or contributed to the issue the Department seeks to address with the proposed rule and, if so, whether the Department proposes to amend or rescind any such rules and why; and
(ix) All other statements and analyses required by law, including, without limitation, the Regulatory Flexibility Act.
(3) Information access and quality. (i) To inform public comment when the NPRM is published, the proposing POC will place in the docket for the proposed rule and make accessible to the public, including by electronic means, material information relied upon by the POC in the NPRM that is not provided in the NPRM, unless the information is exempt from disclosure under 5 U.S.C. 552(b), 5 U.S.C. 552a, or any other applicable law. Material provided electronically should be made available in accordance with the requirements of section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d).
(ii) The proposing POC will determine the most reliable and relevant scientific, technical, and economic information reasonably available to the Department as a basis for the proposal, identify the sources and availability of such information, and affirm such information complies with all applicable quality, objectivity, utility, and integrity provisions of OMB's “Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies” (Feb. 22, 2002) in the NPRM.
(h) Public comment. (1) Through the NPRM, or other applicable statutory procedures, the Department will provide the public a fair and sufficient opportunity to participate in the rulemaking through submission of written data, analysis, views, and recommendations.
(2) The Department - in coordination with OMB under Executive Order 12866 for significant rulemakings - will ensure that the public is given an adequate period for comment, taking into account the scope, complexity, and nature of the issues and considerations involved in the proposed regulatory action.
(3) Unless a longer comment period is required by statute, absent special considerations and after individualized determinations, the comment period for nonsignificant regulatory actions generally should be at least 30 calendar days, and the comment period for significant regulatory actions should be at least 60 calendar days.
(i) Exemptions from notice and comment. (1) Except when prior notice and an opportunity for public comment are required by statute or determined by the Secretary to be appropriate for policy or programmatic reasons, the responsible POC may, subject to the approval of the RRTF (in consultation with OMB, as appropriate), publish certain final rules in the Federal Register without prior notice and comment, provided the reasons to forgo public comment are explained in the preamble to the final rule. These may include, consistent with the Administrative Procedure Act (5 U.S.C. 553) -
(i) Interpretive rules and rules addressing only Department organization, procedure, or practice;
(ii) Rules for which notice and comment are unnecessary to inform the rulemaking, such as rules correcting minor technical or clerical errors or rules that merely update regulations to include new or revised statutory language; and
(iii) Rules that require finalization without delay, such as rules to address an urgent need, and other rules for which it would be impracticable or contrary to the public interest to accommodate a period of public comment, provided the responsible POC finds that good cause exists to forgo public comment pursuant to 5 U.S.C. 553(b)(B).
(2) Except when required by statute, issuing a substantive Department rule without completing notice and comment, including as an interim final rule (IFR) and direct final rule (DFR), must be the exception. In most cases in which a POC has issued an IFR, the responsible POC will proceed at the earliest opportunity to finalize the IFR.
(j) Final rules. The Department will adopt a final rule only after consulting with the RRTF. The final rule, which includes the text of the rule as adopted along with a supporting preamble, will be published in the Federal Register and must satisfy the following requirements:
(1) The preamble to the final rule will include -
(i) A concise, general statement of the rule's basis and purpose, including clear reference to the legal authority supporting the rule;
(ii) A reasoned determination by the adopting POC regarding each of the considerations required to be addressed in an NPRM under paragraph (g)(2) of this section;
(iii) A response to comments on the proposed rule;
(iv) If the final rule has changed in significant respects from the rule as proposed in the NPRM, an explanation of the changes and the reasons why the changes are needed or are more appropriate to advance the objectives identified in the rulemaking; and
(v) A reasoned discussion supporting a final determination that the information upon which the POC bases the rule complies with the Information Quality Act, 44 U.S.C. 3516, note, or any subsequent amendments thereto; the Foundations for Evidence-Based Policymaking Act of 2018, Public Law 115-435, 132 Stat. 5529; and OMB's “Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies” (Feb. 22, 2002).
(2) All final rules issued by the Department will -
(i) Be written in plain language;
(ii) Be based on data and evidence to the extent possible;
(iii) Be based on a reasonable and well-founded interpretation of relevant statutory text; and
(iv) Not be unnecessarily inconsistent or incompatible with, or unnecessarily duplicative of, other Federal regulations.
(k) Reports to Congress and GAO. For each final rule adopted by the Department, DRS will submit the reports to Congress and GAO and comply with the procedures specified by 5 U.S.C. 801 (commonly known as the Congressional Review Act).
(l) Negotiated rulemaking. (1) The Department will conduct negotiated rulemaking in accordance with section 492 of the Higher Education Act of 1965, 20 U.S.C. 1098a; 5 U.S.C. 561-571, commonly known as the Negotiated Rulemaking Act, as applicable; section 1601(b) of the Elementary and Secondary Education Act of 1965, 20 U.S.C. 6571(b); and any other applicable negotiated rulemaking requirements, as well as the Federal Advisory Committee Act, 5 U.S.C. App., as applicable.
(2) Before initiating a negotiated rulemaking not required by law, the POC considering the use of negotiated rulemaking should -
(i) Assess whether using negotiated rulemaking for the proposed rule is in the public interest, in accordance with 5 U.S.C. 563(a), and present these findings to the Leadership Council;
(ii) Consult with DRS on the appropriateness of negotiated rulemaking; and
(iii) Receive the approval of the Leadership Council for the use of negotiated rulemaking.
(3) Unless otherwise approved by the General Counsel, all Department negotiated rulemakings should involve the assistance of at least one facilitator, as provided in 5 U.S.C. 561-567, commonly known as the Negotiated Rulemaking Act, 5 U.S.C. 566.
(4) Any charters, membership, Federal Register notices, and operating procedures (or bylaws) for negotiated rulemaking committees must be approved by OGC.