Agricultural Marketing Service
National Agricultural Statistics Service
Rural Utilities Service
The U.S. Codex Office
International Trade Administration
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Defense Acquisition Regulations System
Federal Energy Regulatory Commission
Agency for Healthcare Research and Quality
Centers for Medicare & Medicaid Services
Children and Families Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Fish and Wildlife Service
Indian Affairs Bureau
Drug Enforcement Administration
Federal Aviation Administration
National Highway Traffic Safety Administration
Pipeline and Hazardous Materials Safety Administration
Foreign Assets Control Office
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action revokes Colored Federal airways A-3, A-17, and G-16 in Alaska due to the pending decommissioning of the Put River, Evansville, Chandalar Lake, Nuiqsut Village, Browerville, and Wainwright Village Nondirectional Radio Beacons (NDB).
Effective date 0901 UTC, December 26, 2024. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11 and publication of conforming amendments.
A copy of the Notice of Proposed Rulemaking (NPRM), all comments received, this final rule, and all background material may be viewed online at
FAA Order JO 7400.11J, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Steven Roff, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 600 Independence Avenue SW, Washington, DC 20597; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the Air Traffic Service (ATS) route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System.
The FAA published a NPRM for Docket No. FAA 2022-2189 in the
The NPRM published for Docket No. FAA-2023-2189 in the
Colored Federal airways are published in paragraph 6009 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11J, dated July 31, 2024, and effective September 15, 2024. FAA Order JO 7400.11J is publicly available as listed in the
FAA Order JO 7400.11J lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
The FAA is finalizing an amendment to 14 CFR part 71 to revoke Colored Federal airways A-3, A-17, and G-16 in Alaska due to the pending decommissioning of their supporting Navigational Aids (NAVAID).
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this airspace action of revoking A-3, A-17, and G-16 in Alaska qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Internal Revenue Service (IRS), Treasury.
Final rule.
This document contains final regulations that terminate the continued application of certain tax provisions arising from a previous transfer of intangible property to a foreign corporation when the intangible property is repatriated to certain United States persons. The final regulations affect certain United States persons that previously transferred intangible property to a foreign corporation.
Concerning the final regulations other than § 1.904-4, Brittany N. Dobi (202) 317-6937; concerning § 1.904-4, Jeffrey L. Parry, (202) 317-6936 (not toll-free numbers).
This document contains final additions and amendments to 26 CFR part 1 (final regulations) under section 367(d) of the Internal Revenue Code (Code) regarding the termination of the continued application of certain tax provisions arising from a previous transfer of intangible property to a foreign corporation when the intangible property is repatriated to certain United States persons. The primary provisions of the final regulations are issued pursuant to the express delegations of authority to the Secretary of the Treasury (or her delegate) provided under sections 367(d) and 6038B. The provisions of the final regulations related to foreign branch income are issued pursuant to the express delegations of authority provided under sections 904(d)(2)(J) and (d)(7). The final regulations are also issued under the express delegation of authority under section 7805(a).
On May 3, 2023, the Department of the Treasury (Treasury Department) and the IRS published a notice of proposed rulemaking (REG-124064-19) in the
Five comments were submitted on the proposed regulations, which are available at
This Summary of Comments and Explanation of Revisions describes those comments and the revisions made in response to those comments. The comments also made various requests for future guidance, which the Treasury Department and the IRS will consider as part of a potential future rulemaking addressing, among other things, general issues under section 367(d).
To terminate the continued application of section 367(d) upon a
As the preamble to the proposed regulations explained in part I.C of the Explanation of Provisions, the definition of qualified domestic person was based on the principle that it is generally appropriate to terminate the continued application of section 367(d) only when all the income produced by the intangible property during its useful life, and all gain recognized on a disposition of the intangible property, will be subject to current tax in the United States as to the qualified domestic person while that person holds the property.
The proposed regulations neither treated a domestic partnership as a qualified domestic person, nor adopted an approach that would treat a partnership as an aggregate of its partners (aggregate approach) for purposes of determining qualified domestic person status. One comment suggested that the Treasury Department and the IRS modify the definition of qualified domestic person to include partnerships in which all of the partners in the partnership would themselves be qualified domestic persons, or partnerships that made the original outbound transfer of the intangible property subject to section 367(d) when there is substantial continuity of ownership of that partnership during the period beginning on the date of the initial section 367(d) transfer and ending on the date of the repatriation of the intangible property. As part of the modification, the comment also described various approaches for addressing the concerns identified in the proposed regulations regarding, for example, the potential for post-repatriation changes to partnership allocations or liquidation rights to frustrate the purposes of the proposed regulations if a partnership, or a partner in the partnership, were permitted as a qualified domestic person in certain cases.
The final regulations do not adopt this comment and therefore adopt the definition of qualified domestic person from the proposed regulations without change. The issues identified by the comment, along with potential solutions to those issues, were acknowledged in the preamble to the proposed regulations, and the Treasury Department and the IRS have determined that the approach outlined in the proposed regulations continues to strike the appropriate balance between implementing the general purpose and scope of the proposed regulations (ensuring that only appropriate repatriations terminate the continued application of section 367(d)) and concerns regarding administrability and compliance. The solutions described in the comment, like the alternatives described in the proposed regulations, would not achieve this balance because the solutions would either expand the scope of the proposed regulations in an inappropriate manner (that is, by expanding the basic principle upon which the proposed regulations rests), or the solutions would, given the relatively narrow scope of the proposed regulations, impose an undue burden on taxpayers and the IRS.
Another comment described general, long-standing issues under section 367(d) related to the treatment of partnerships. These issues were generally identified in the proposed regulations.
As described in part I.A of this Summary of Comments and Explanation of Revisions, the proposed regulations limited qualified domestic person status to “qualified corporations” in the case of a qualified successor or in the case of a U.S. person related to either the initial U.S. transferor or qualified successor.
One comment suggested that the final regulations allow S corporations as qualified corporations. The comment noted that the shareholders of an S corporation must generally be U.S. individuals subject to U.S. taxation, which ensures that income attributable to intangible property held by an S corporation would be subject to U.S. taxation (though the comment noted that the limitation is not absolute, as certain plans described in section 401(a) may be shareholders of an S corporation).
Section 512(e)(3) excludes a non-individual shareholder that is an employee stock ownership plan (ESOP) (as defined in section 4975(e)(7) from the scope of section 512(e)(1), which provides that, in the case of certain non-individual shareholders of the S corporation, any item of income, gain, loss, or deduction, and any gain or loss on the disposition of stock in the S corporation, is taken into account by such non-individual shareholders as unrelated business taxable income (UBTI). As a result, the pro rata share of an S corporation's items of income taken into account by an ESOP shareholder is not subject to current taxation as UBTI. As noted in part I.A of this Summary of Comments and Explanation of Revisions, a principle for the definition of qualified domestic person is that termination of the continued application of section 367(d)
The final regulations, therefore, do not adopt this comment and retain the definition of qualified domestic person from the proposed regulations without change. The Treasury Department and the IRS considered alternative approaches to address this comment—such as an aggregate approach, with prohibitions applicable to S corporation shareholders that are ESOPs—but determined that such approaches were effectively unworkable due to the compliance and administrative burden discussed in part II.B of this Summary of Comment and Explanation of Revisions in connection with the comment on partnerships.
Proposed § 1.367(d)-1(f)(4)(iv) provided rules regarding a qualified domestic person's adjusted basis in the intangible property it receives in a repatriation. The proposed regulations described how these rules were intended to achieve an appropriate result regarding a qualified domestic person's adjusted basis in intangible property upon a repatriation, but that general rules regarding adjusted basis under section 367(d) (and not in the context of a repatriation of intangible property to a qualified domestic person) would be addressed in future rulemaking.
One comment described how existing uncertainty regarding the treatment of adjusted basis of intangible property subject to section 367(d) may be implicated when that intangible property is repatriated. The comment noted that any solution would necessarily represent a broad solution to existing section 367(d) issues, instead of one limited to the proposed regulations, so the comment recommended the Treasury Department and the IRS address this issue in future rulemaking. Another comment suggested that, when a transferee foreign corporation incurs expenditures with respect to repatriated intangible property after the initial outbound transfer, proposed § 1.367(d)-1(f)(4)(iv) should be modified to allow a qualified domestic person's adjusted basis in repatriated intangible property to reflect those expenditures, reduced by any attributable amortization allowed or allowable to the transferee foreign corporation.
As noted in the proposed regulations, proposed § 1.367(d)-1(f)(4)(iv) operated “in a manner intended to reach an appropriate result regarding a qualified domestic person's basis in repatriated intangible property” until future rulemaking is issued that can address general basis rules under section 367(d).
The proposed regulations provided that the deemed annual payment under section 367(d) by the transferee foreign corporation is treated as an allowable deduction that must be allocated and apportioned to the transferee foreign corporation's classes of gross income in accordance with §§ 1.882-4(b)(1), 1.954-1(c), and 1.960-1(c) and (d) (as applicable).
One comment suggested that the proposed regulations were unclear as to whether the allowable deduction described in proposed § 1.367(d)-1(c)(2)(ii) and (e)(2)(ii) was limited to the listed provisions (§§ 1.882-4(b)(1), 1.954-1(c), and 1.960-1(c) and (d)) or whether such deduction was more generally available (for example, as a deduction under section 162). The comment posited that the latter approach was more appropriate and requested that the final regulations clarify that the allowable deduction may be allowed as a deduction under section 162. In support, the comment described how, in the case of certain transfers of intangible property to a U.S. person that is not a qualified domestic person, “excessive U.S. taxation” could result if the allowable deduction were limited to the listed provisions, which are provisions relevant to determinations with respect to foreign corporations.
The final regulations do not adopt this comment. The proposed regulations terminated the continued application of section 367(d) upon certain, rather than all, subsequent transfers of intangible property to a U.S. person (that is, upon a repatriation to a qualified domestic person if certain reporting requirements are met).
The comment also suggested that, when a subsequent transfer of intangible property results in treating the same entity as U.S. transferor and transferee foreign corporation under the section 367(d) regulations, the continued application of section 367(d) should terminate by reason of that convergence. As support, the comment cited to a case and guidance involving circumstances in which a taxpayer acquired its own debt. The Treasury Department and the IRS do not agree with this suggestion for the reasons described in the preceding paragraph, and references to cases or guidance involving a taxpayer acquiring its own debt are not instructive for, nor consistent with, the statutory and regulatory framework of section 367(d). Section 367(d) relies upon a statutory fiction that imposes a notional regime with a prescribed payor and payee, and the regulations describe cases in which a successor succeeds to the notional payment on both sides of the construct. For example, § 1.367(d)-1T(e)(1) provides that a related person can succeed an initial U.S. transferor for purposes of including income under section 367(d), and § 1.367(d)-1T(f)(3) provides that a related person can
One comment suggested changes to the proposed regulations to accommodate repatriations preceded by certain transfers of intangible property subject to section 367(d) between related foreign corporations. To illustrate this suggestion, the comment posited an example pursuant to which a repatriation was first preceded by a distribution under section 311 of the intangible property (first section 311 distribution) from one CFC (original transferee foreign corporation, or TFC) to another CFC (successor TFC). The successor TFC then distributes the intangible property under section 311 to a qualified domestic person (second 311 distribution) in a transaction with respect to which the successor TFC did not recognize gain or loss (under the theory that successor TFC's adjusted basis in the intangible property equaled the intangible property's fair market value).
On those modified facts, the comment described how the original TFC could recognize gain subject to U.S. taxation by reason of the first section 311 distribution (not under section 367(d), but rather under, for example, section 951A(a) as to a United States shareholder), and the qualified domestic person could recognize that same amount of gain upon the repatriation after the second 311 distribution under the proposed regulations (by reason of the application of the gain recognition rule in proposed § 1.367(d)-1(f)(4)(ii)(B), under which gain is determined by reference to the U.S. transferor's former adjusted basis in the property). And, because the successor TFC is the TFC at the time of the repatriation (that is, at the time of the second section 311 distribution), the required adjustments described in proposed § 1.367(d)-1(f)(2) would apply by reference to the successor TFC, which did not recognize gain or loss on the repatriation under the theory described above, rather than to the original TFC, which recognized gain on the first section 311 distribution. To address this concern, the comment suggested modifying the proposed regulations in a manner that would effectively negate a prior transfer that was subject to tax under a separate regime (for example, section 951A).
The example provided in the comment highlights significant potential interactions between the operation of section 367(d) and other generally operative provisions in the Code and regulations. For example, § 1.367(d)-1T(f)(3) explicitly provides that the ongoing annual royalty construct is unaffected by the taxable distribution of intangible property from the original TFC to the successor TFC in the first section 311 distribution, and § 1.367(d)-1T(d)(1) and (f)(1) are clear that the amount of income recognized by the U.S. transferor upon a later indirect or direct disposition of intangible property to an unrelated person is determined using the transferor's original basis in the property. However, the distribution of the intangible property from the original TFC to the successor TFC described in the comment's example might result in taxable gain to the original TFC that would be treated as tested income under section 951A, notwithstanding the lack of an acceleration of income under section 367(d). Similarly, the successor TFC might take the intangible property with a fair market value basis under section 301(d), even though that increased basis would not be available to reduce gain under section 367(d). Essentially, the example posited in the comment highlights that it may be possible to recognize income under both sections 951A and 367(d) with respect to the same property in some fact patterns where separate transactions occur in separate foreign corporations, notwithstanding that that result would not occur in cases where the property is not transferred among multiple foreign corporations. Coordinating potential disparities between income recognition under section 367(d) as compared to other generally applicable provisions of the Code, and potential disparities in tax basis for purposes of section 367(d) as compared to adjusted basis for other purposes, is beyond the scope of this rulemaking. The request for additional guidance addressing multiple related transfers, therefore, is not adopted.
As a condition for terminating the application of section 367(d) with respect to repatriated intangible property, proposed § 1.367(d)-1(f)(4)(i)(B) would have required a U.S. transferor to provide the information described in proposed § 1.6038B-1(d)(2)(iv). If a U.S. transferor failed to provide that information, the repatriation was subject to proposed § 1.367(d)-1(f)(3) such that the section 367(d) regulations, including the requirement to take an annual inclusion into account over the useful life of the intangible property, continued to apply. However, a U.S. transferor was eligible for relief under the proposed regulations if proposed § 1.367(d)-1(f)(4)(i)(B)(
One comment requested clarifications of the reporting and relief provisions. First, the comment requested that the final regulations clarify whether relief for a failure to comply is, in relevant part, also conditioned on the U.S. transferor timely filing one or more amended returns for the taxable year in which the subsequent transfer occurred and succeeding years, and, if the U.S. transferor is under examination when an amended return is filed, providing a copy of the amended return(s) to the IRS personnel conducting the examination. The Treasury Department and the IRS adopt this comment by revising of § 1.367(d)-1(f)(5) to clarify that the relief for a failure to comply is conditioned upon the requirements listed in the previous sentence (if applicable).
The comment also requested that the Treasury Department and the IRS consider prescribing in the future a particular form for filing the required information under proposed § 1.367(d)-1(f)(5). The Treasury Department and the IRS will consider prescribing a particular form as part of future improvements to reporting with respect to section 367(d) generally. However, to provide taxpayers with additional guidance on the manner for providing a U.S. transferor's explanation for its failure to comply to the IRS, the final regulations provide an eFax number for such purpose (and, if a taxable year of the U.S. transferor is under examination, that information should
Finally, the comment suggested clarifications or modifications to the requirements in proposed § 1.367(d)-1(f)(5) that a U.S. transferor “promptly” address its failure to file and to the way the U.S. transferor provides the remedial information (that is, to the Director of Field Operations, Cross Border Activities Practice Area of Large Business & International, or any successor to that role). The comment suggested that “promptly” does not provide sufficient guidance to taxpayers (the comment requested a prescribed period) and the comment asserted that it is unusual for regulations to require a taxpayer to provide information directly to a specified official within the IRS. The final regulations do not adopt these suggestions. The Treasury Department and the IRS believe that “promptly” requiring the U.S. transferor to address its failure to comply, rather than providing a specific period, allows flexibility so that the relief may apply as appropriate to a taxpayer's particular facts and circumstances. Additionally, proposed § 1.367(d)-1(f)(5) is modeled on similar relief provisions in other contexts (for example, §§ 1.367(a)-8(p) and 1.721(c)-6(f)).
The Treasury Department and the IRS clarify proposed § 1.367(d)-1(f)(5) by striking the last clause that appeared in the second sentence. That sentence described the consequences of a failure to comply, namely the continued application of the annual inclusion stream pursuant to proposed § 1.367(d)-1(f)(3) and application of the gain recognition rule of proposed § 1.367(d)-1(f)(4)(i)(A). If the failure to comply is remedied, the rules of the proposed regulations are treated as satisfied as of the date of the repatriation (so, the repatriation terminates the continued application of section 367(d) and the U.S. transferor, if applicable, would take a partial annual inclusion into account pursuant to proposed § 1.367(d)-1(f)(4)(i)(B)(
Proposed § 1.367(d)-1(f)(6)(ii)(C) (
One comment requested, in relevant part, that the final regulations clarify that TFC's earnings and profits and gross income arising by reason of the repatriation are reduced by the amount of gain recognized by USP under proposed § 1.367(d)-1(f)(4)(i)(A) ($50x). The Treasury and the IRS adopt the comment by clarifying in the facts of the example that, under § 1.367(d)-1(f)(2)(i), TFC will reduce its earnings and profits and gross income by $50x, the amount arising by reason of the repatriation and the amount of gain recognized by USP under § 1.367(d)-1(f)(4)(i)(A).
Proposed § 1.904-4(f)(2)(vi)(D)(
One comment requested that the Treasury Department and the IRS finalize the provisions of the proposed regulations without finalizing proposed § 1.904-4(f)(2)(vi)(D)(
A broader reconsideration of the application of section 367(d) principles in § 1.904-4(f)(2)(vi)(D) is beyond the scope of these final regulations. The Treasury Department and the IRS believe it is necessary to finalize proposed § 1.904-4(f)(2)(vi)(D)(
The proposed regulations were generally proposed to apply to subsequent dispositions of intangible property occurring on or after the date of publication of the Treasury decision adopting these rules as final regulations in the
The Treasury Department and the IRS generally consider several factors when evaluating whether a rule should apply retroactively on an elective basis. For example, and as relevant to the proposed regulations, retroactive application may be more compelling where the regulations are issued with respect to new legislation, or where retroactive application is necessary to achieve certain policy objectives. The Treasury Department and the IRS also evaluate the additional administrative burden likely to result from retroactive application. Finally, where the regulations represent a change in existing regulations, consideration is given to whether retroactive application could advantage certain taxpayers over similarly situated taxpayers, based on whether the relevant taxable year remains open for the taxpayer to amend
Pursuant to the Memorandum of Agreement, Review of Treasury Regulations under Executive Order 12866 (June 9, 2023), tax regulatory actions issued by the IRS are not subject to the requirements of section 6 of Executive Order 12866, as amended. Therefore, a regulatory impact assessment is not required.
The collection of information contained in these regulations has been reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) under control number 1545-0026. The collection of information in these final regulations is in § 1.6038B-1(d)(2)(iv). This information is necessary to ensure that proposed § 1.367(d)-1(f)(4) is appropriately applied to the subsequent transfer. The collection of information is required to comply with section 367(d). The likely respondents are domestic corporations. Burdens associated with these requirements will be reflected in the burden for Form 926,
Estimated total annual reporting burden is 1,601 hours.
Estimated average annual burden per respondent is 2.4 hours.
Estimated number of respondents is 667.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the Office of Management and Budget. Books or records relating to a collection of information must be retained if their contents may become material in the administration of any Internal Revenue law. Generally, tax returns and tax return information are confidential, as required by section 6103.
Pursuant to the Regulatory Flexibility Act (5 U.S.C. chapter 6), it is hereby certified that these final regulations will not have a significant economic impact on a substantial number of small entities.
The Treasury Department and the IRS do not have data readily available to assess the number of small entities potentially affected by the final regulations. However, entities potentially affected by these proposed regulations are generally not small entities, because of the resources and investment necessary to develop intangible property and, once so developed, transfer the intangible property to a foreign corporation. Therefore, the Treasury Department and the IRS have determined that there will not be a substantial number of domestic small entities affected by the final regulations. Consequently, the Treasury Department and the IRS certify that the final regulations will not have a significant economic impact on a substantial number of small entities.
Pursuant to section 7805(f) of the Code, the proposed regulations (REG-113839-22) preceding these final regulations were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business, and no comments were received.
Section 202 of the Unfunded Mandates Reform Act of 1995 requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a final rule that includes any Federal mandate that may result in expenditures in any one year by a State, local, or Tribal government, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. These final regulations do not include any Federal mandate that may result in expenditures by State, local, or Tribal governments, or by the private sector in excess of that threshold.
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial, direct compliance costs on State and local governments, and is not required by statute, or preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. These final regulations do not have federalism implications and do not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive order.
The principal author of these regulations is Brittany N. Dobi, of the Office of Associate Chief Counsel (International). However, other personnel from the Treasury Department and the IRS participated in their development.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, the Treasury Department and the IRS amend 26 CFR part 1 as follows:
26 U.S.C. 7805 * * *
Section 1.367(d)-1 also issued under 26 U.S.C. 367(d).
The additions and revision read as follows:
(c)
(2)
(i) [Reserved]
(ii) The deemed payment is treated as an allowable deduction (whether or not that amount is paid) of the transferee foreign corporation properly allocated and apportioned to the appropriate classes of gross income in accordance with §§ 1.882-4(b)(1), 1.951A-2(c)(3), 1.954-1(c), and 1.960-1(c) and(d), as applicable.
(4)
(d)
(e)
(2)
(i) [Reserved]
(ii) The deemed payment is treated as an allowable deduction (whether or not that amount is paid) of the transferee foreign corporation properly allocated and apportioned to the appropriate classes of gross income in accordance with §§ 1.882-4(b)(1), 1.951A-2(c)(3), 1.954-1(c), and 1.960-1(c) and(d), as applicable.
(iii) For further guidance,
(iv) [Reserved]
(3) through (4) [Reserved]
(f)
(2)
(i) For purposes of chapter 1 of the Code, the transferee foreign corporation reduces (but not below zero) the portion of its earnings and profits and gross income arising by reason of the subsequent disposition of the intangible property by the amount of gain recognized by the U.S. transferor under paragraph (f)(4)(i)(A) of this section or § 1.367(d)-1T(f)(1); and
(ii) The U.S. transferor may establish an account receivable from the transferee foreign corporation equal to the amount of gain recognized under paragraph (f)(4)(i)(A) of this section or § 1.367(d)-1T(f)(1) in accordance with § 1.367(d)-1T(g)(1).
(3)
(4)
(A) The U.S. transferor of the intangible property (or any person treated as such pursuant to § 1.367(d)-1T(e)(1)) is required to recognize gain, as applicable, equal to the amount described in paragraph (f)(4)(ii) of this section; and
(B) If the U.S. transferor provides the information described in § 1.6038B-1(d)(2)(iv), then—
(
(
(ii)
(A) If the intangible property is transferred basis property (as defined in section 7701(a)(43)) by reason of the subsequent disposition (determined without regard to section 367(d), this section, and § 1.367(d)-1T), the amount of gain, if any, the transferee foreign corporation would recognize if its adjusted basis in the intangible property were equal to the U.S. transferor's former adjusted basis in the property; or
(B) If the intangible property is not transferred basis property by reason of the subsequent disposition (determined without regard to section 367(d), this section, and § 1.367(d)-1T), the excess, if any, of the fair market value of the intangible property on the date of the subsequent disposition over the U.S. transferor's former adjusted basis in that property.
(iii)
(A) The U.S. transferor that initially transferred intangible property subject to section 367(d);
(B) A U.S. person treated as a U.S. transferor under § 1.367(d)-1T(e)(1), provided such person is an individual or a corporation other than a corporation exempt from tax under section 501(a), a regulated investment company (as defined in section 851(a)), a real estate investment trust (as defined in section 856(a)), a DISC (as defined in section 992(a)(1)), or an S corporation (as defined in section 1361(a));
(C) A U.S. person that is an individual related, within the meaning of paragraph (h)(2)(ii) of this section and § 1.367(d)-1T(h), to the person described in paragraph (f)(4)(iii)(A) or (B) of this section; or
(D) A U.S. person that is a corporation related, within the meaning of paragraph (h)(2)(ii) of this section and § 1.367(d)-1T(h), to the person described in paragraph (f)(4)(iii)(A) or (B) of this section, other than a corporation exempt from tax under section 501(a), a regulated investment company (as defined in section 851(a)), a real estate investment trust (as defined in section 856(a)), a DISC (as defined in section 992(a)(1)), or an S corporation (as defined in section 1361(a)).
(iv)
(A) In the case of a subsequent disposition of intangible property described in paragraph (f)(4)(ii)(A) of this section, and subject to any applicable limitations that may apply under the Code, the lesser of the U.S. transferor's former adjusted basis in the intangible property or the transferee foreign corporation's adjusted basis in the intangible property (as determined immediately before the subsequent disposition), in each case increased by the greater of the amount of gain (if any) described in paragraph (f)(4)(ii)(A) of this section and recognized by the U.S. transferor or the amount of gain (if any) recognized by the transferee foreign
(B) In the case of a subsequent disposition of intangible property described in paragraph (f)(4)(ii)(B) of this section, the fair market value of the intangible property (as determined on the date of the subsequent disposition).
(v)
(5)
(i) Promptly after the U.S. transferor becomes aware of the failure, the U.S. transferor provides such information and provides a reasonable explanation for its failure to comply to the Director of Field Operations, Cross Border Activities Practice Area of Large Business & International (or any successor to the roles and responsibilities of such position, as appropriate), by eFax at (855) 582-4842 (or as otherwise directed on
(ii) The U.S. transferor timely files an amended return for the taxable year in which the subsequent disposition occurred (and, if applicable, for each taxable year starting with the taxable year immediately after the taxable year in which the subsequent disposition occurred and ending with the taxable year in which the U.S. transferor seeks relief under this paragraph (f)(5)) that includes the information required by paragraph (f)(4)(i)(B) of this section; and
(iii) If any taxable year of the U.S. transferor is under examination when an amended return is filed, the U.S. transferor provides a copy of the amended return (or, if applicable, amended returns) to the Internal Revenue Service personnel conducting the examination.
(6)
(A) USP and USS are domestic corporations that each use a calendar taxable year.
(B) TFC is a foreign corporation whose functional currency is the U.S. dollar.
(C) In year 1, USP transfers intangible property, as defined in section 367(d)(4), with a $0 adjusted basis, to TFC in a section 351 exchange (the transferred IP), and such transfer is subject to section 367(d).
(D) Each annual inclusion (including any amount described in § 1.367(d)-1T(f)(1)(ii)) is taken into account under section 367(d)(2)(A)(ii)(I) and § 1.367(d)-1T(c)(1).
(E) Any subsequent transfer or disposition of stock of TFC or the transferred IP occurs within the useful life of the transferred IP.
(F) All transactions are respected under general principles of tax law.
(ii)
(A)
(
(
(B)
(
(C)
(
(D)
(
(E)
(
(g)
(2)
(i) The intangible property transferred constitutes an operating intangible, as defined in § 1.367(a)-1(d)(6).
(ii) For further guidance,
(iii)(A) through (D) [Reserved]
(E) The transferred intangible property will be used in the active conduct of a trade or business outside of the United States within the meaning of § 1.367(a)-2 and will not be used in connection with the manufacture or sale of products in or for use or consumption in the United States.
(F) For further guidance, see § 1.367(d)-1T(g)(2)(iii)(F).
(4)
(5)
(6)
(h)
(1) [Reserved]
(2) For further guidance,
(i) [Reserved]
(ii) Section 1563 applies (for purposes of section 267(f)) without regard to section 1563(b)(2).
(i)
(j)
(2)
The revisions read as follows:
(c) * * *
(2) * * *
(ii) For further guidance,
(e) * * *
(2) * * *
(ii) For further guidance,
(f) * * *
(2)
(3) through (6) [Reserved]
(h) * * *
(2) * * *
(ii) For further guidance,
(f) * * *
(2) * * *
(vi) * * *
(D) * * *
(
(q) * * *
(3) Except as provided in the following sentence, paragraph (f) of this section applies to taxable years that begin after December 31, 2019, and end on or after November 2, 2020. Paragraph (f)(2)(vi)(D)(
(c) * * *
(2)
(e)
The additions read as follows:
(d)
(i) through (iii) [Reserved]
(viii)
(2)
(i) through (ii) [Reserved]
(iii)
(A) For further guidance,
(B) through (C) [Reserved]
(iv)
(A) A statement providing that § 1.367(d)-1(f)(4)(i)(B) applies to the subsequent transfer;
(B) A general description of the subsequent transfer and any wider transaction of which it forms a part, including the U.S. transferor's former adjusted basis in the intangible property and the transferee foreign corporation's adjusted basis in the intangible property (as determined immediately before the subsequent transfer), the amount and computation of any gain recognized by the U.S. transferor under § 1.367(d)-1(f)(4)(i)(A), and a description of whether the intangible property was, or is expected to be, subsequently transferred to one or more other persons (as described in § 1.367(d)-1(f)(4)(v));
(C) A description of the intangible property;
(D) A copy of the Form 926 with respect to the original transfer of the intangible property and any attachments identifying the intangible property as within the scope of section 367(d);
(E) The name, address, and taxpayer identification number of the qualified domestic person that receives the intangible property, including a statement describing the relationship between the U.S. transferor and the qualified domestic person, and, if applicable, such information regarding any other persons described in § 1.367(d)-1(f)(4)(v); and
(F) Any other information as may be prescribed by the Commissioner in publications, forms, instructions, or other guidance.
(g) * * *
(8) Paragraphs (d)(2)(iii) introductory text and (d)(2)(iv) of this section apply to transfers occurring on or after October 10, 2024.
(d) * * *
(2) * * *
(iii)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing temporary, 500-yard radius, moving security zones within the navigable waters of the Corpus Christi Ship Channel and the La Quinta Channel. The security zone is needed to protect certain vessels carrying cargo which poses risks such that it requires an elevated level of security to protect the cargo itself and the surrounding waterway from terrorist acts, sabotage, or other subversive acts, accidents, or events of a similar nature. Entry of vessels or persons into these zones is prohibited unless specifically authorized by the Captain of the Port, Sector Corpus Christi or a designated representative.
This rule is effective from October 7, 2024 through October 17, 2024.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rule, call or email Lieutenant Tim Cardenas, Sector Corpus Christi Waterways Management Division, U.S. Coast Guard; telephone 361-939-5130, email
The Coast Guard is issuing this temporary rule under the authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The Coast Guard must establish this security zone by October 7, 2024, to ensure security of certain vessels and the surrounding area and lacks sufficient time to request public comments and respond to these comments before the safety zone must be established. As such, it is impracticable to publish an NPRM.
Additionally, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing these security zone regulation under the authority in 46 U.S.C. 70051 and 70124. The Captain of the Port, Sector Corpus Christi (COTP) has determined that potential hazards are associated with the transit of the Motor Vessels (M/V) MARAN GAS DELPHI, TRANIANO KNUTSEN, ADAMASTOS, and HELLAS ATHINA. There is a security concern within a 500-yard radius of these vessels when they are loaded. This rule is needed to provide for the safety and security of these vessels, their cargo, and the surrounding waterway from terrorist acts, sabotage, or other subversive acts, accidents, or other events of a similar nature while the vessels are transiting within Corpus Christi, TX.
The Coast Guard is establishing 500-yard radius, temporary, moving security zones around M/V MARAN GAS DELPHI, TRANIANO KNUTSEN, ADAMASTOS, and HELLAS ATHINA within the navigable waters of the Corpus Christi Ship Channel and the La Quinta Channel. The public will easily be able to identify these vessels because their names are clearly marked on the port and starboard bow and the stern of each vessel. The zones for these vessels will be effective from October 7, 2024, through October 17, 2024, to protect the vessels, their cargo, and the surrounding waterways from terrorist acts, sabotage, or other subversive acts, accidents, or other events of a similar nature while the vessels are traveling within the La Quinta and Corpus Christi Ship Channels. The zones will be enforced only during the time the vessels are transiting the Channels.
No vessel or person will be permitted to enter the security zone without obtaining permission from the COTP or a designated representative. As used in this section, “designated representative” means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel and a Federal, State, and local officer designated by or assisting the Captain of the Port, USCG Sector Corpus Christi (COTP) in the enforcement of the security zone. Persons or vessels desiring to enter or pass through each zone must request permission from the COTP or a designated representative on VHF-FM channel 16 or by telephone at 361-939-0450. If permission is granted, all persons and vessels must comply with the instructions of the COTP or designated representative. The COTP or a designated representative will inform the public through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs) as appropriate for the enforcement times and dates for the security zone.
We developed this 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, and we discuss First Amendment rights of protestors.
Executive Orders 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. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule is not subject to review by the Office of Management and Budget (OMB).
This regulatory action determination is based on the size, duration, and location of the security zone. This rule will impact a small, designated area of 500-yards around the moving vessels in the Corpus Christi Ship Channel and La Quinta Ship Channel as these vessels transit the channel over a ten-day period. Most vessels will be able to move around the security zone and therefore the impediment to the movement of other vessels will be minimal. Moreover, the rule allows other vessels to seek permission to enter or pass through each zone may request permission from the COTP or a designated representative on VHF-FM channel 16 or by telephone at 361-939-0450.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, 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. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the temporary security zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this 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
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or Tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this 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. 4321-4370f) 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 rule involves moving security zones lasting for the duration of time that the M/V MARAN GAS DELPHI, TRANIANO KNUTSEN, ADAMASTOS, HELLAS ATHINA are within the Corpus Christi Ship Channel and La Quinta Channel while loaded with cargo. It will prohibit entry within a 500-yard radius of the M/V MARAN GAS DELPHI, TRANIANO KNUTSEN, ADAMASTOS, and HELLAS ATHINA while the vessels are transiting loaded within Corpus Christi Ship Channel and La Quinta Channel. It is categorically excluded from further review under L60(a) in Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C 70034, 70051; 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
(a)
(b)
(c)
(d)
(2) Persons or vessels desiring to enter or pass through the zones must request permission from the COTP Sector Corpus Christi on VHF-FM channel 16 or by telephone at 361-939-0450.
(3) If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.
(d)
United States Patent and Trademark Office, Department of Commerce.
Final rule.
As part of its initiatives to expand access to practice before the U.S. Patent and Trademark Office (USPTO or Office), the USPTO modifies the rules regarding representation by counsel at the Patent Trial and Appeal Board (PTAB or Board) in proceedings under the Leahy-Smith America Invents Act (AIA proceedings) to: permit parties to proceed without back-up counsel upon a showing of good cause, such as a lack of resources to hire two counsel; establish a streamlined alternative procedure for recognizing counsel
This rule is effective November 12, 2024.
Scott C. Moore, Acting Senior Lead Administrative Patent Judge; or Michael P. Tierney, Vice Chief Administrative Patent Judge, both at 571-272-9797.
The USPTO is focused on expanding American innovation for and from all and has been examining the rules governing practice before the Office to ensure that they are properly aligned with the types of work performed by practitioners and the needs of clients. As part of this effort, the USPTO recently expanded the admission
The Director of the USPTO has statutory authority to require those seeking to practice before the Office to show that they possess “the necessary qualifications to render applicants or other persons valuable service, advice, and assistance in the presentation or prosecution of their applications or other business before the Office.” 35 U.S.C. 2(b)(2)(D). Thus, courts have determined that the USPTO Director bears the primary responsibility for protecting the public from unqualified practitioners. See
Pursuant to that authority and responsibility, the USPTO has promulgated regulations, administered by the Office of Enrollment and Discipline, that provide that registration to practice before the USPTO in patent matters or design patent matters requires a practitioner to demonstrate possession of “the legal, scientific, and technical qualifications necessary for [them] to render applicants valuable service.” 37 CFR 11.7(a)(2)(ii).
The rules that govern practice before the PTAB in AIA proceedings differ somewhat from the rules that govern other types of USPTO proceedings. In an AIA proceeding, 37 CFR 42.10(a) requires that each represented party designate a lead counsel and at least one back-up counsel. The regulation requires that lead counsel be a registered practitioner. The regulation allows non-registered practitioners to be back-up counsel upon a showing of good cause. For example, “where the lead counsel is a registered practitioner, a motion to appear
The Board typically requires that
a. Contain a statement of facts showing there is good cause for the Board to recognize counsel
b. Be accompanied by an affidavit or declaration of the individual seeking to appear attesting to the following:
i. Membership in good standing of the Bar of at least one State or the District of Columbia;
ii. No suspensions or disbarments from practice before any court or administrative body;
iii. No application for admission to practice before any court or administrative body ever denied;
iv. No sanctions or contempt citations imposed by any court or administrative body;
v. The individual seeking to appear has read and will comply with the Office Patent Trial Practice Guide and the Board's Rules of Practice for Trials set forth in 37 CFR part 42;
vi. The individual will be subject to the USPTO Rules of Professional Conduct set forth in 37 CFR 11.101
vii. All other proceedings before the Office for which the individual has applied to appear
viii. Familiarity with the subject matter at issue in the proceeding.
On October 18, 2022, the USPTO published a request for comments in which the Office sought feedback on potential ways to expand opportunities for non-registered practitioners to appear before the PTAB. Expanding Opportunities To Appear Before the Patent Trial and Appeal Board, 87 FR 63047. The request asked several questions, including: (1) whether the USPTO should permit non-registered practitioners to appear as lead counsel in AIA proceedings, and if so, whether they should be accompanied by a registered practitioner as back-up counsel; (2) whether the USPTO should establish a new procedure by which non-registered practitioners could be admitted to practice before the PTAB; (3) what impact various proposals would have on the cost of representation; and (4) whether any changes should be implemented initially as a pilot program.
The USPTO received nine comments in response to the request. Five comments were in favor of retaining existing limits on non-registered practitioners, while four comments generally supported expanding the ways in which non-registered practitioners can participate in AIA proceedings.
The comments were split on the issue of whether non-registered practitioners should be permitted to appear as lead counsel. However, some of the comments suggested that any potential issues with allowing non-registered practitioners to serve as lead counsel could be remedied by requiring that they be accompanied by a registered practitioner as back-up counsel. Most of the comments indicated that the Office should continue to require non-registered practitioners to meet fitness-to-practice standards, but several comments agreed that it might be more efficient and less costly to the parties to establish a separate registry or
Most of the comments expressed no opinion on whether any changes should be addressed as a pilot program. Of the three comments that discussed this issue, one favored implementing any changes as a pilot program, one indicated that a pilot program would be unnecessary, and one indicated a pilot program would be unnecessary if the Office were to permit non-registered practitioners to appear as lead counsel with a registered practitioner as back-up without making other substantive changes to admissions standards.
On February 21, 2024, after careful consideration of the public input received in response to the request for comments, the USPTO published a notice of proposed rulemaking (NPRM). See Expanding Opportunities To Appear Before the Patent Trial and Appeal Board, 89 FR 13017. The NPRM granted a 90-day comment period and proposed to amend § 42.10(a) to provide that, upon a showing of good cause, the Board may permit a party to proceed without separate back-up counsel so long as lead counsel is a registered practitioner. The NPRM also proposed to amend § 42.10(c) to provide that (1) a non-registered practitioner admitted
The USPTO received a total of seven comments from five organizations and two individuals. The Office appreciates the thoughtful comments representing views from various public stakeholder communities. The comments are publicly available at the Federal eRulemaking Portal at
Five comments supported the proposal to amend § 42.10(a) to provide that upon a showing of good cause, the Board may permit a party to proceed without separate back-up counsel so long as lead counsel is a registered practitioner. Three of these comments favored the requirement that parties without back-up counsel be represented by a registered practitioner, noting that this requirement is essential to ensure quality representation and protect represented parties. One comment noted that this proposal would allow parties with limited resources to consider participating in AIA trial proceedings, thereby increasing opportunities for attorneys from small law firms and solo practitioners. Another comment suggested that the Board should go further and retain flexibility to allow a party to proceed without a registered practitioner in special circumstances. Yet another commenter supported the proposed amendments to § 42.10(a) but suggested that the requirement to retain a registered practitioner might limit the proposed rule's impact.
One comment opposed the proposed amendment to § 42.10(a), arguing that no need has been shown for such a change, that this proposal might lead to situations in which a single counsel's limited availability frustrates the progress of proceedings, and that allowing parties to proceed without back-up counsel might limit opportunities for young attorneys and under-represented members of the legal profession.
After considering the input from the comments, the USPTO is moving forward with a final rule providing that, upon a showing of good cause, the Board may permit a party to proceed without separate back-up counsel. For example, good cause may be present if a party demonstrates that it lacks the financial resources to retain both lead and back-up counsel. However, the Office notes that it would likely be difficult for a party to demonstrate a lack of financial resources where that party has also elected to pursue litigation involving the challenged patents in other forums. The Office also notes that the good cause inquiry focuses on the needs of the party seeking relief, not the needs or preferences of counsel. Thus, for example, the fact that lead counsel is a solo practitioner who prefers to work alone would not constitute good cause for a party to proceed without separate back-up counsel.
Based on the comments and the Board's experience, the USPTO believes this rule will permit flexibility in situations in which good cause is shown, while ensuring that parties are represented by counsel having the requisite qualifications to engage in all matters before the PTAB, including in quasi-prosecution work such as claim amendments or reissue applications.
Three comments supported the proposal to amend § 42.10(c) to permit non-registered counsel admitted
Three comments opposed this proposal. These comments argued that it is important that lead counsel be qualified to discuss technical matters and quasi-prosecution matters such as claim amendments, that allowing non-
In addition, two comments noted that the proposed rule omitted language in the current rule pertaining to
Further, the USPTO notes that it is focused on issuing and maintaining robust and reliable intellectual property rights, including robust and reliable patents resulting from amendments made in PTAB proceedings or amendments made through reissue or reexamination before, during, or after an AIA proceeding.
Based on the input from commenters and the USPTO's experience and objectives, the Office believes that a cautious approach is appropriate and will not move forward at this time with a final rule permitting non-registered counsel admitted
The USPTO further notes that the language in § 42.10(c) pertaining to
Four comments supported the proposal to amend § 42.10(c) to establish a streamlined procedure for
One comment supported streamlining the
After considering the input from the commenters, the USPTO is moving forward with a final rule that establishes a streamlined procedure for
The proposed amendment to § 42.10(c) used the term “PTAB-recognized practitioners” to refer to non-registered counsel who were previously recognized
The USPTO notes that the observation in the above-referenced comment with respect to the use of the term “practitioner” in § 11.1 is incorrect in that “practitioner,” as defined by § 11.1, encompasses non-registered counsel
Four comments supported the proposed amendment to § 42.10(c) clarifying that non-registered counsel recognized
After considering the input from the commenters, the USPTO is moving forward with the provision clarifying that non-registered counsel recognized
In light of the comments received, this final rule makes revisions to the NPRM as follows.
In § 42.10(c)(1), the Office has dropped the proposed language that would have permitted non-registered counsel who are recognized
To conform § 42.10(c)(2) with the change discussed above, the Office has deleted language that would have permitted a non-registered attorney admitted
In § 42.10(c)(2) and (3), the term “PTAB-recognized practitioner” has been replaced with “provisionally recognized PTAB attorney.” This change was made in response to commenter concerns that the public might confuse “PTAB-recognized practitioners” with registered practitioners. Also, the term “non-registered practitioner” has been replaced with “counsel who is not a registered practitioner,” the term “non-registered practitioners recognized
The final rule contains two revisions to § 42.15(e) that were not contained in the NPRM but that commenters indicated were necessary to conform this section to the revised version of § 42.10 set forth in this final rule. First, for the same reasons discussed above, the term “non-registered practitioners” in § 42.15(e) has been replaced with “counsel who are not registered practitioners.” Second, § 42.15(e) has been revised to conform with § 42.10(c)(2) of this final rule, which provides for a new procedure for
Section 42.10(a) is amended to clarify that lead counsel must be a registered practitioner and to provide that, upon a showing of good cause, the Board may permit a party to proceed without separate back-up counsel.
Section 42.10(c) is amended to clarify that an established legal familiarity with the subject matter of a proceeding is sufficient to support a request for
Section 42.15(e) is amended to replace the term “non-registered practitioners” with the term “counsel who are not registered practitioners” and to conform with § 42.10(c)(2) of this final rule, which permits certain persons to seek
Nevertheless, the USPTO chose to seek public comment before implementing this rule to benefit from the public's input.
This rule permits parties to proceed without back-up counsel upon a showing of good cause, creates a new streamlined procedure for recognizing counsel
For the reasons discussed above, this rulemaking will not have a significant economic impact on a substantial number of small entities.
Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information has a currently valid OMB control number.
Administrative practice and procedure, Inventions and patents, Lawyers.
For the reasons set forth in the preamble, the USPTO amends 37 CFR part 42 as follows:
35 U.S.C. 2(b)(2), 3, 6, 21, 23, 41, 134, 135, 143, 153, 311, 312, 314, 316, 318, 321-326, 328; Pub. L. 112-29, 125 Stat. 284; and Pub. L. 112-274, 126 Stat. 2456.
(a) If a party is represented by counsel, the party must designate a lead counsel and at least one back-up counsel who can conduct business on behalf of the lead counsel. Lead counsel must be a registered practitioner. The Board may permit a party to proceed without back-up counsel upon a showing of good cause. A party may show good cause by demonstrating that it lacks the financial resources to retain both lead and back-up counsel.
(c)(1)
(2)
(ii) If a party seeks to be represented in a proceeding by a provisionally recognized PTAB attorney, that party may file a notice of intent to designate a provisionally recognized PTAB attorney as back-up counsel. No fee is required for such a notice. The notice shall:
(A) Identify a registered practitioner who will serve as lead counsel, and
(B) Be accompanied by a certification in the form of a declaration or affidavit in which the provisionally recognized PTAB attorney attests to satisfying all requirements set forth by the Board for
(iii) Any objection shall be filed by a party within five business days after the filing of the notice. If an objection is not filed within five business days, the provisionally recognized PTAB attorney shall be deemed admitted
(iv) If a provisionally recognized PTAB attorney is unable to satisfy any of the requirements set forth by the Board, or is unable to make any of the required attestations under oath, this procedure is not available, and
(3)
(i) The counsel who is not a registered practitioner is sanctioned, cited for contempt, suspended, disbarred, or denied admission by any court or administrative agency;
(ii) The counsel who is not a registered practitioner no longer qualifies as a member in good standing of the Bar of at least one State or the District of Columbia; or
(iii) Any other event occurs that renders materially inaccurate or incomplete any representation that was made to the Board in connection with the request for
(e) Fee for counsel who are not registered practitioners, and who are not seeking automatic recognition pursuant to § 42.10(c)(2), to appear
Department of Veterans Affairs.
Final rule.
The Department of Veterans Affairs (VA) is revising its regulation that governs the outer burial receptacle (OBR) monetary allowance for burials in a VA national cemetery when a privately purchased OBR is used in lieu of a Government-furnished graveliner. First, VA is expanding applicability of the monetary allowance to burials in VA grant-funded State and Tribal cemeteries when a privately purchased OBR was used, or where an OBR is placed at the time of interment, at the cost of the State or Tribal organization. Second, VA is adding a provision to reimburse States and Tribal organizations for OBRs that are pre-placed as part of a new construction or expansion grant project. In addition, VA is making minor conforming revisions to its regulations governing aid for the establishment, expansion, and improvement of veterans cemeteries to clarify that VA will reimburse the cost of pre-placed OBRs separately from the grant award. These changes implement new authorities provided in the Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act of 2020. VA also is removing retroactive provisions no longer needed because the relevant time period has passed.
This rule is effective November 12, 2024.
Michelle Myers, Management and Program Analyst, Policy and Regulatory Service, National Cemetery Administration, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420. Telephone: (720) 607-0364. (This is not a toll-free number.)
On February 6, 2024, VA published a proposed rule in the
During the final rule drafting process, VA noted an unintended outcome based on the proposed language of § 38.629(e)(2), which we have addressed in this final rule. In the proposed rule, the monetary allowance for OBRs placed at the time of interment would have only been payable if a State or Tribal organization submitted a request for payment within 1 year of interment. However, with the time that has elapsed while developing this rulemaking, the 1-year limitation on filing requests for payment would have created an unintended barrier to awarding the benefit from the earliest date authorized by statute, January 5, 2023. This provision would have unintentionally prohibited the payment of the allowance for burials that occurred more than 1 year prior to the final rule becoming effective. To ensure that the payment of the monetary allowance for OBRs placed at the time of interment is payable for all eligible burials, VA has revised the provision to read: “Requests for payment under this section for burials that occur from January 5, 2023, through December 31, 2024, must be submitted by December 31, 2025. Requests for payment under this section for burials that occur on or after January 1, 2025, must be submitted within 1 year of interment.” This change accommodates the lag in publishing this rulemaking and ensures VA can provide payment for claims that could not be submitted until such time as this final rule becomes effective.
VA has also made technical changes to note the heading change to § 38.629(c) in the amendatory instructions, which was inadvertently omitted in the proposed rule, and to conform to cross-reference conventions. We added the phrase “of this chapter” after cross-references to other regulatory sections in §§ 38.629(h), 39.50(e), and 39.122(a).
Because no comments were received during the public comment period, VA made no changes to the proposed regulatory text besides the technical changes described here.
Executive Order 12866 (Regulatory Planning and Review) directs agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 14094 (Modernizing Regulatory Review) supplements and reaffirms the principles, structures, and definitions governing contemporary regulatory review established in Executive Orders 12866 and 13563. The Office of Information and Regulatory Affairs has determined that this rulemaking is not a significant regulatory action under Executive Order 12866, as amended by Executive Order 14094. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at
The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). This final rule will generally be small business neutral as it applies only to State and Tribal entities that have received a grant for a cemetery under 38 U.S.C. 2408. The Secretary acknowledges that some Tribal governments may be considered small entities; however, the economic impact would be entirely beneficial. This final rule will impose no mandatory requirements or costs on Tribal governments as a whole and will only affect those that are recipients of veterans cemetery grants. To the extent that small entities are affected, the impact of this final rule will be entirely beneficial as it will provide reimbursement for costs of OBRs associated with casketed burials in grant-funded cemeteries. Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any 1 year. This final rule will have no such effect on State, local, and Tribal governments, or on the private sector.
This final rule includes a provision constituting a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The new collection of information requires approval by the Office of Management and Budget (OMB) and the assignment of an OMB Control Number. Accordingly, under 44 U.S.C. 3507(d), VA submitted a copy of this rulemaking to OMB for review and approval. VA received no comments on the new collection of information.
An OMB Control Number of 2900-0941 has been assigned to the new collection of information associated with this final rule. Assignment of this OMB control number is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. In accordance with 5 CFR part 1320, the new collection of information associated with this rulemaking is not approved by OMB at this time. OMB's approval of the new collection of information will occur within 30 days after the final rulemaking publishes. If OMB does not approve the new collection of information as requested, VA will immediately remove the provision containing a new collection of information or take such other action as is directed by OMB.
The new collection of information associated with this rulemaking contained in 38 CFR 38.629 is described immediately following this paragraph.
•
•
•
•
•
•
•
•
The Assistance Listing numbers and titles for the programs affected by this document are 64.201, National Cemeteries; 64.203, Veterans Cemetery Grants Program; and 64.206, VA OBR Allowance Program.
Pursuant to subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (known as the Congressional Review Act) (5 U.S.C. 801
Administrative practice and procedure, Cemeteries, Veterans.
Cemeteries, Grant programs—veterans, Veterans.
Denis McDonough, Secretary of Veterans Affairs, approved and signed this document on October 3, 2024, and
For the reasons stated in the preamble, VA amends 38 CFR parts 38 and 39 as set forth below:
38 U.S.C. 107, 501, 512, 531, 2306, 2400, 2402, 2403, 2404, 2407, 2408, 2411, 7105.
The revisions and additions read as follows:
(b)
(2) This section also provides for payment of a monetary allowance for outer burial receptacles placed at the time of interment, for burials on or after January 5, 2023, in a cemetery that is the subject of a grant awarded to a State or Tribal organization under 38 U.S.C. 2408.
(3) This section also provides for reimbursement of the cost of pre-placed outer burial receptacles that are installed as part of construction or expansion of a cemetery that is the subject of a grant awarded on or after January 5, 2023, to a State or Tribal organization under 38 U.S.C. 2408.
(c)
(d)
(2) VA will pay a monetary allowance for each casket burial in a cemetery that is the subject of a grant to a State or Tribal organization under 38 U.S.C. 2408, where a privately purchased outer burial receptacle was used on or after January 5, 2023. The person who paid for the outer burial receptacle must submit a request for payment of the allowance on the appropriate VA form. The request must be verified by the cemetery director where the burial occurred.
(e)
(2) VA will pay the allowance only if a State or Tribal organization submits a request for payment on the appropriate VA form. Requests may be submitted on a quarterly basis for the total number of burials that required an outer burial receptacle in that quarter and for which a fee for the outer burial receptacle was not charged to the decedent's family or other responsible party. Requests for payment under this section for burials that occur from January 5, 2023, through December 31, 2024, must be submitted by December 31, 2025. Requests for payment under this section for burials that occur on or after January 1, 2025, must be submitted within 1 year of interment.
(3) No payment may be made for burials where a fee for the outer burial receptacle was charged to the decedent's family or other responsible party.
(f)
(2) The amount of the allowance for each calendar year will be published in the “Notices” section of the
(g)
(2) States and Tribal organizations must submit a request for reimbursement of the cost of pre-placed outer burial receptacles using Standard Form 271, Outlay Report and Request for Reimbursement for Construction Programs, with supporting documentation. The Director of the Veterans Cemetery Grants Program must review and certify the request for payment. Funds paid under this section for pre-placed outer burial receptacles, as part of an approved establishment, expansion, and improvement project shall be used solely for payment of such outer burial receptacles. As a condition for payment, the representative of the State or Tribal organization must submit to VA an invoice reporting the cost for purchase and delivery of outer burial receptacles.
(h)
38 U.S.C. 101, 501, 2408, 2411, 3765.
The addition reads as follows:
(e) VA will reimburse the cost of preplaced outer burial receptacles separately in accordance with § 38.629 of this chapter.
(a) A State or Tribal organization will allow VA inspectors and auditors to conduct inspections as necessary to ensure compliance with the provisions of this part and with provisions of § 38.629 of this chapter regarding outer burial receptacles. The State or Tribal organization will provide to VA evidence that it has met its responsibilities under the Single Audit Act of 1984.
Federal Emergency Management Agency, Department of Homeland Security.
Final rule; correcting amendment.
On July 11, 2024, the Federal Emergency Management Agency (FEMA) published a final rule implementing the Federal Flood Risk Management Standard (FFRMS), updating the agency's 8-step decision-making process for floodplain reviews by changing how FEMA defines a floodplain with respect to certain actions and how FEMA uses natural systems, ecosystem processes, and nature-based approaches when developing alternatives to locating a proposed action in the floodplain. The rule contained two errors which this document corrects.
This rule is effective October 10, 2024 and is applicable beginning September 9, 2024.
Portia Ross, Policy and Integration Division Director, Office of Environmental Planning and Historic Preservation, Resilience, DHS/FEMA, 400 C St. SW, Suite 313, Washington, DC 20472-3020. Phone: (202) 709-0677; Email:
On July 11, 2024, at 89 FR 56929, FEMA published a final rule implementing the FFRMS. The rule contained two errors. The first error is typographical, capitalizing a word in a defined term in § 9.4 which should be lowercased. The second error is a procedural error in the instruction and text for the amendment to § 9.9. Paragraph (d) was instructed to be fully revised, but the full paragraph was not presented in the amendatory text. This document corrects both errors.
Floodplains, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Federal Emergency Management Agency (FEMA) is amending 44 CFR part 9 by making the following correcting amendments.
6 U.S.C. 101
The addition reads as follows:
(d)
(2) If no practicable alternative exists outside the floodplain or wetland, in order to carry out the action the floodplain or wetland must itself be a practicable location in light of the review required in this section.
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule; technical amendment.
DoD is amending the Defense Federal Acquisition Regulation Supplement (DFARS) to make needed editorial changes.
Effective October 10, 2024.
Ms. Jennifer D. Johnson, Defense Acquisition Regulations System, telephone 703-717-8226.
This final rule amends the DFARS to make needed editorial changes to add pointers to new text in DFARS Procedures, Guidance, and Information and to remove and reserve a section containing a pointer to DFARS Procedures, Guidance, and Information, which is no longer needed.
Government procurement.
Therefore, the Defense Acquisition Regulations System amends 48 CFR parts 205, 212, 214, 215, and 237 as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
See PGI 205.102-70 for policy and procedures related to the Solicitation Module within the Procurement Integrated Enterprise Environment.
(6) See the procedures at PGI 205.102-70 for use of the Solicitation Module within the Procurement Integrated Enterprise Environment.
See the procedures at PGI 205.102-70 for use of the Solicitation Module within the Procurement Integrated Enterprise Environment.
See the procedures at PGI 205.102-70 for use of the Solicitation Module within the Procurement Integrated Enterprise Environment.
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement sections of the National Defense Authorization Acts for Fiscal Year 2022 and Fiscal Year 2024 that authorize DoD to establish a pilot program that allows for the noncompetitive award of certain follow-on contracts to certain employee-owned businesses.
Effective November 25, 2024.
Ms. Jeanette Snyder, telephone 703-508-7524.
DoD published a proposed rule in the
DoD reviewed the public comments in the development of the final rule. A discussion of the comments and the changes made to the rule as a result of those comments is provided, as follows:
There are no significant changes from the proposed rule.
Additionally, the proposed rule text at DFARS Procedures, Guidance, and Information (PGI) 270.104, paragraph(d), specifies the reporting requirements for contracting officers, which include, but are not limited to, a summary of the contractor's performance and the benefits experienced from using the pilot program. This information will be used to assess the success of the pilot program and the need for adjustments and improvements over time. In reporting the contractor's performance pursuant to DFARS PGI 270.104, the contracting officer may use information from CPARS. To minimize the time required to collect and submit the data, the reporting requirements in the clause at DFARS 252.270-7002 are amended to clarify that data regarding challenges faced due to the contractor's corporate ownership structure is only required when applicable. In addition, contractors are only required to report data collected during the period of performance of the contract; therefore, the data should be readily available.
DFARS 270.102(b) is revised in the final rule to simplify the direction to contracting officers. The final rule revises the prescriptions for the solicitation provisions at DFARS 252.270-7000 and 252.270-7001 and the clause at DFARS 252.270-7002 to specify that they are not to be included in solicitations and contracts solely for the acquisition of commercially available off-the-shelf items. These provisions and this clause are added to the list of provisions and clauses that are not applicable to COTS items, located at DFARS 212.371. The reporting requirements are clarified in the clause at DFARS 252.270-7002.
The two provisions and the clause at DFARS 252.270-7000, Pilot Program to Incentivize Contracting with Employee-Owned Businesses-Representation; DFARS 252.270-7001, Pilot Program to Incentivize Contracting with Employee-Owned Businesses—Certification; and DFARS 252.270-7002, Pilot Program to Incentivize Contracting with Employee-Owned Businesses, are prescribed at DFARS 270.105 for use in solicitations and contracts for approved acquisitions under the Pilot Program to Incentivize Contracting with Employee-Owned Businesses. Consistent with the analysis that DoD provided in the proposed rule with regard to the application of the requirements of section 874 of the NDAA for FY 2022, as amended by
This final rule is expected to impact the Government and contractors that participate in the Pilot Program to Incentivize Contracting with Employee-Owned Businesses. This final rule is expected to incentivize and expedite the award of follow-on contracts to qualified businesses for the continued development, production, or provision of products or services previously procured by or for DoD. As a result, employee-owned businesses may benefit from additional opportunities to contract with DoD, which may benefit DoD by expanding the defense industrial base.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all 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 not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, as amended.
As required by the Congressional Review Act (5 U.S.C. 801-808) before an interim or final rule takes effect, DoD will submit a copy of the interim or final rule with the form, Submission of Federal Rules Under the Congressional Review Act, to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. A major rule under the Congressional Review Act cannot take effect until 60 days after it is published in the
A final regulatory flexibility analysis has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601,
This final rule is necessary to implement section 874 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2022 (Pub. L. 117-81; 10 U.S.C. 3204 note) and section 872 of the NDAA for FY 2024 (Pub. L. 118-31; 10 U.S.C. 3204 note). The objective of the rule is to implement sections 874 and 872, which authorize DoD to establish a pilot program to incentivize contracting with employee-owned businesses. The pilot program provides for the use of noncompetitive procedures for certain follow-on contracts to qualified businesses. A “qualified business” is defined as an S corporation (as defined in 26 U.S.C. 1361(a)(1)) for which 100 percent of the outstanding stock is held through an employee stock ownership plan as defined in 26 U.S.C. 4975(e)(7).
There were no significant issues raised by the public comments in response to the initial regulatory flexibility analysis. One respondent took exception to the number of hours DoD estimated it would take a contractor to comply with the reporting requirement. DoD reviewed the data to be collected and modified the reporting requirement to clarify that the contractor is required to only report challenges it faced, if any. Although not specified in the DFARS text, because this is a contract clause, contractors are only required to report data collected during the period of performance of the contract.
Data from the System for Award Management (SAM) revealed there were 384,145 small entities registered in SAM as of August 2024. Data on the number of small entities that are a qualified business, as defined in the final rule, is not available.
The pilot program was implemented on November 8, 2022. To date, eight businesses are participating in the pilot, six of which are small entities. DoD cannot estimate the number of contracting officers that will submit applications for participation in the pilot program, how many applications will be approved for participation, or how many of the subsequent awards will be made to small entities. However, based on current participation, DoD expects that the pilot program will grow to approximately 16 contractors per year, of which approximately 12 may be small entities.
This final rule imposes a new reporting requirement. Not later than 30 days after the end of the period of performance of the contract, contractors participating in the pilot program will be required to submit to the contracting officer the following information: (1) the number of years the contractor has been wholly-owned by its employee stock ownership plan; (2) the contractor's challenges, if any, in attracting and retaining a talented workforce due to its corporate ownership structure; (3) challenges, if any, the contractor experienced that hinder its ability to contract with DoD in order to scale its technologies and capabilities due to its corporate ownership structure; and (4) challenges, if any, the contractor experienced, due to its corporate ownership structure, in obtaining capital necessary to bridge funding gaps, for example, between prototype demonstration and full-scale development. The annual reporting burden is estimated as follows: 16 respondents, with 16 total annual responses (1 response per respondent), and a total annual burden of 16 hours.
There are no known significant alternative approaches that would accomplish the stated objectives.
This final rule contains information collection requirements that have been approved by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35). This information collection requirement has been assigned OMB Control Number 0750-0012, Defense Federal Acquisition Regulation Supplement Part 270, Defense Contracting Programs—Pilot Program to Incentivize Contracting with Employee-Owned Businesses, and Related Clause.
Government procurement.
Therefore, the Defense Acquisition Regulations System amends 48 CFR chapter 2 as follows as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
(b)
(i) Acquire supplies and services from military exchange stores outside the United States for use by the armed forces outside the United States in accordance with 10 U.S.C. 2424(a) and subject to the limitations of 10 U.S.C. 2424(b). The limitations of 10 U.S.C. 2424(b)(1) and (2) do not apply to the purchase of soft drinks that are manufactured in the United States. For the purposes of 10 U.S.C. 2424, soft drinks manufactured in the United States are brand name carbonated sodas, manufactured in the United States, as evidenced by product markings.
(ii) Acquire police, fire protection, airfield operation, or other community services from local governments at military installations to be closed under the circumstances in 237.7401 (section 2907 of Fiscal Year 1994 Defense Authorization Act (Pub. L. 103-160)).
(iii) Acquire products and services under the Pilot Program to Incentivize Contracting with Employee-Owned Businesses (see subpart 270.1).
(c)
(A) The statute authorizing or requiring award specifically—
(
(
(
(B) The Secretary of Defense provides Congress written notice of intent to award. The contract cannot be awarded until 180 days have elapsed since the date Congress received the notice of intent to award. Contracting activities must submit a draft notice of intent with supporting documentation through channels to the Principal Director, Defense Pricing, Contracting, and Acquisition Policy, Office of the Under Secretary of Defense (Acquisition and Sustainment).
(ii) The limitation in paragraph (c)(i) of this section applies only if the statute authorizing or requiring award was enacted after September 30, 1989.
(iii) Subsequent statutes may provide different or additional constraints on the award of contracts to specified colleges and universities. Contracting officers should consult legal counsel on a case-by-case basis.
41 U.S.C. 1303 and 48 CFR chapter 1.
(f) * * *
(xxii)
(B) Use the provision at 252.270-7001, Pilot Program to Incentivize Contracting with Employee-Owned Businesses—Subcontracting Certification, as prescribed at 270.105(b), to comply with section 874 of the NDAA for FY 2022 (Pub. L. 117-81; 10 U.S.C. 3204 note) and section 872 of the NDAA for FY 2024 (Pub. L. 118-31; 10 U.S.C. 3204 note).
(C) Use the clause at 252.270-7002, Pilot Program to Incentivize Contracting with Employee-Owned Businesses, as prescribed at 270.105(c), to comply with section 874 of the NDAA for FY 2022 (Pub. L. 117-81; 10 U.S.C. 3204 note) and section 872 of the NDAA for FY 2024 (Pub. L. 118-31; 10 U.S.C. 3204 note).
(b) 252.270-7000, Pilot Program to Incentivize Contracting with Employee-Owned Businesses—Representation.
(c) 252.270-7001, Pilot Program to Incentivize Contracting with Employee-Owned Businesses—Subcontracting Certification.
(d) 252.270-7002, Pilot Program to Incentivize Contracting with Employee-Owned Businesses.
41 U.S.C. 1303 and 48 CFR chapter 1.
As prescribed in 270.105(a), use the following provision:
(a)
(b)
As prescribed in 270.105(b), use the following provision:
Pilot Program To Incentivize Contracting With Employee-Owned Businesses—Subcontracting Certification (NOV 2024)
(a)
(b)
(1) The subcontract is awarded to a qualified business;
(2) The contract is for products and the subcontract is for materials not available from another qualified business; or
(3) A waiver is granted.
As prescribed in 270.105(c), use the following clause:
(a)
(b)
(1) The subcontract is awarded to a qualified business;
(2) The contract is for products and the subcontract is for materials not available from another qualified business; or
(3) A waiver is granted.
(c)
(1) The number of years the Contractor has been wholly-owned by its employee stock ownership plan.
(2) Challenges, if any, the Contractor experienced in attracting and retaining a talented workforce in a competitive market due to the Contractor's corporate ownership structure.
(3) Challenges, if any, the Contractor experienced that hinder its ability to contract with DoD to scale its technologies and capabilities due to the Contractor's corporate ownership structure.
(4) Challenges, if any, the Contractor experienced, due to its corporate ownership structure, in obtaining capital necessary to bridge funding gaps, for example, between prototype demonstration and full-scale development.
41 U.S.C. 1303 and 48 CFR chapter 1.
This part has been created to facilitate promulgation of additional DFARS coverage of defense-specific contracting programs that do not properly fall under DFARS subchapter D, Socioeconomic Programs, and neither implement nor supplement existing FAR part 19 or parts 22 through 25.
(a) This subpart implements section 874 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2022 (Pub. L. 117-81; 10 U.S.C. 3204 note) and section 872 of the NDAA for FY 2024 (Pub. L. 118-31; 10 U.S.C. 3204 note). Sections 874 and 872 authorize the establishment of a pilot program that allows for the noncompetitive award of certain follow-on contracts to contractors that meet the definition of a qualified business (see 270.101).
(b) The authority to award contracts under this subpart expires on December 27, 2029.
As used in this subpart,
(a) The contracting officer may only award one sole-source, follow-on contract to the incumbent contractor if—
(1) The contractor has represented that it is a qualified business; and
(2) The contract is for the continued development, production, or provision of products or services that are the same as or substantially similar to those procured under the prior contract awarded to the contractor by or for DoD.
(b) The contracting officer shall justify the use of a sole-source contract in accordance with FAR 6.303 and 6.304 and cite FAR 6.302-5 as the exception to full and open competition.
(a) Participation in the pilot program is subject to approval by the Under Secretary of Defense (Acquisition and Sustainment), Office of the Principal Director, Defense Pricing, Contracting, and Acquisition Policy (Contract Policy). Only a contracting officer may submit an application to participate in the pilot program. See PGI 270.104(a).
(b) Contracting officers shall only award—
(1) One sole-source, follow-on contract per predecessor contract to the incumbent contractor unless waived by the head of the contracting activity, delegable to a level no lower than one level above the contracting officer;
(2) Contracts to qualified businesses that have a minimum performance rating of satisfactory for the predecessor contract in the Contractor Performance Assessment Reporting System (see FAR subpart 42.15); and
(3) Contracts to qualified businesses that have certified they will not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not qualified businesses, except for subcontracts for materials not available from another qualified business when the contract is for products, unless waived by the head of the contracting activity, delegable to a level no lower than one level above the contracting officer.
See PGI 270.104 for procedures and information concerning the pilot program.
(a) Use the provision at 252.270-7000, Pilot Program to Incentivize Contracting with Employee-Owned Businesses—Representation, in solicitations, including solicitations using FAR part 12 procedures for the acquisition of commercial products and commercial services, except for solicitations solely for the acquisition of commercially available off-the-shelf (COTS) items, that include the clause at 252.270-7002, Pilot Program to Incentivize Contracting with Employee-Owned Businesses.
(b) Unless waived in accordance with 270.103(b)(3), use the provision at 252.270-7001, Pilot Program to
(c) Use the clause at 252.270-7002, Pilot Program to Incentivize Contracting with Employee-Owned Businesses, in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial products and commercial services, except for solicitations and contracts solely for the acquisition of COTS items, for approved pilot program acquisitions.
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2024 that modifies certain definitions associated with the Procurement Technical Assistance Program.
Effective October 10, 2024.
Jeanette Snyder, telephone 703-508-7524.
DoD published a proposed rule in the
DoD reviewed the public comments in the development of the final rule. A discussion of the comments is provided, as follows:
There are no significant changes from the proposed rule.
This final rule amends the clause at DFARS 252.205-7000, Provision of Information to Cooperative Agreement Holders. However, this final rule does not impose any new requirements on contracts at or below the SAT, for commercial products including COTS items, or for commercial services. The clause will continue to not apply to acquisitions at or below the SAT, and will continue to apply to acquisitions of commercial products excluding COTS items, and to acquisitions of commercial services.
This final rule is expected to impact DoD contractors whose contracts include the clause at DFARS 252.205-7000. The clause requires contractors to provide cooperative agreement holders under the PTAP, upon request, with a list of the contractor's employees or offices responsible for entering into subcontracts under defense contracts. As a result of this final rule, such contractors may be required to provide the list to different entities that are cooperative agreement holders under the PTAP.
The changes in section 853 allow any type of nonprofit organization to be a cooperative agreement holder under the PTAP. In addition, section 853 provides a definition of “business entities” to specify the entities that may receive assistance under the PTAP, including corporations, associations, partnerships, limited liability companies, limited liability partnerships, consortia, not-for-profit, or other legal entities. These changes are reflected in the revisions to the clause at DFARS 252.205-7000. As a result, there may be increases in the number of entities that become cooperative agreement holders and in the number of business entities that receive assistance under the PTAP.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all 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
As required by the Congressional Review Act (5 U.S.C. 801-808) before an interim or final rule takes effect, DoD will submit a copy of the interim or final rule with the form, Submission of Federal Rules under the Congressional Review Act, to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. A major rule under the Congressional Review Act cannot take effect until 60 days after it is published in the
A final regulatory flexibility analysis has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601,
This final rule is necessary to implement section 853 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2024 (Pub. L. 118-31; 10 U.S.C. 4951). Section 853 modifies the definitions of “nonprofit organization” and “business entities” at 10 U.S.C. 4951 for the Procurement Technical Assistance Program. The objective of this rule is to implement the revised definitions in the contract clause at DFARS 252.205-7000, Provision of Information to Cooperative Agreement Holders. The clause requires contractors to provide cooperative agreement holders under the Procurement Technical Assistance Program, upon request, with a list of the contractor's employees or offices responsible for entering into subcontracts under defense contracts.
There were no significant issues raised by the public comments in response to the initial regulatory flexibility analysis.
According to data from the Procurement Business Intelligence Service, in the last three fiscal years, DoD awarded contracts that included the clause at 252.205-7000 to unique small entities as follows: 5,652 in fiscal year 2021, 5,127 in fiscal year 2022, and 5,663 in fiscal year 2023. This averages out to approximately 5,480 per fiscal year. Therefore, DoD estimates that the number of small entities to which this rule will apply is approximately 5,480.
This rule does not include any new reporting, recordkeeping, or other compliance requirements for small entities.
There are no known significant alternative approaches that would accomplish the stated objectives.
The Paperwork Reduction Act (44 U.S.C. chapter 35) applies to this final rule. However, these changes to the DFARS do not impose additional information collection requirements to the paperwork burden previously approved by the Office of Management and Budget (OMB) under OMB Control Number 0704-0286, entitled Defense FAR Supplement (DFARS) Part 205, Publicizing Contract Actions, and DFARS 252.205-7000, Provision of Information to Cooperative Agreement Holders.
Government procurement.
Therefore, the Defense Acquisition Regulations System amends 48 CFR part 252 as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
As prescribed in 205.470, use the following clause:
(a)
(b) The Contractor shall provide cooperative agreement holders, upon their request, with a list of those appropriate employees or offices responsible for entering into subcontracts under defense contracts. The list shall include the business address, telephone number, and area of responsibility of each employee or office.
(c) The Contractor need not provide the listing to a particular cooperative agreement holder more frequently than once a year.
Agricultural Marketing Service, USDA.
Referendum order.
This document directs that a referendum be conducted among eligible Oregon and Washington hazelnut growers to determine whether they favor continuance of the marketing order regulating the handling of hazelnuts grown in Oregon and Washington.
The referendum will be conducted from October 28 through November 18, 2024. Only current hazelnut growers who have grown hazelnuts within the designated production area during the period July 1, 2023, through June 30, 2024, are eligible to vote in this referendum.
Copies of the marketing order may be obtained from the office of the referendum agents at 1220 SW 3rd Avenue, Suite 305, Portland, Oregon 97212; Telephone: (503) 326-2724; or the Market Development Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-8085; or on the internet
Virginia Tjemsland or Barry Broadbent, Northwest Region Branch, Market Development Division, Specialty Crops Program, AMS, USDA, 1220 SW 3rd Avenue, Suite 305, Portland, Oregon 97212; Telephone: (503) 326-2724, or Email:
Pursuant to Marketing Order No. 982, as amended (7 CFR part 982), hereinafter referred to as the “Order,” and the applicable provisions of the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act,” it is hereby directed that a referendum be conducted to ascertain whether continuance of the Order is favored by hazelnut growers. The referendum shall be conducted from October 28 to November 18, 2024, among hazelnut growers in the production area. Only current hazelnut growers that were also engaged in the production of hazelnuts during the period of July 1, 2023, through June 30, 2024, may participate in the continuance referendum.
USDA has determined that continuance referenda are an effective means for determining whether growers favor continuation of marketing order programs. USDA would consider termination of the Order if less than two-thirds of growers voting in the referendum, or growers of less than two-thirds of the volume represented in the referendum, favor continuance. In evaluating the merits of continuance versus termination, USDA will not exclusively consider the results of the continuance referendum. USDA will also consider all other relevant information concerning the operation of the Order and the relative benefits and costs to growers, handlers, and consumers to determine whether continued operation of the Order would tend to effectuate the declared policy of the Act.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the ballot materials used in the referendum have been approved by the Office of Management and Budget (OMB) and have been assigned OMB No. 0581-0178, Vegetable and Specialty Crops. It has been estimated that it will take an average of 20 minutes for each of the approximately 1,100 Oregon and Washington hazelnut growers to cast a ballot. Participation is voluntary. Ballots postmarked after November 18, 2024, will not be included in the vote tabulation.
Virginia Tjemsland and Barry Broadbent of the Northwest Region Branch, Market Development Division, Specialty Crops Program, AMS, USDA, are hereby designated as the referendum agents of the Secretary of Agriculture to conduct this referendum. The procedure applicable to the referendum shall be the “Procedure for the Conduct of Referenda in Connection with Marketing Orders for Fruits, Vegetables, and Nuts Pursuant to the Agricultural Marketing Agreement Act of 1937, as Amended” (7 CFR 900.400 through 900.407).
Ballots will be mailed to all hazelnut growers of record and may also be obtained from the referendum agents or their appointees.
Marketing agreements, Nuts, Reporting and recordkeeping requirements.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for all ATR—GIE Avions de Transport Régional Model ATR42 and ATR72 airplanes. This proposed AD was prompted by a report of a manufacturing defect identified in the lavatory fire extinguisher. This defect could potentially result in leakage at the eutectic tip, leading to a loss of pressure in the cylinder, making fire extinguishing capabilities ineffective. This proposed AD would require an inspection (
The FAA must receive comments on this proposed AD by November 25, 2024.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For EASA material identified in this proposed AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
• You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
Shahram Daneshmandi, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 206-231-3220; email
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
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
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 Shahram Daneshmandi, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 206-231-3220; email
EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2024-0132, dated July 9, 2024 (EASA AD 2024-0132) (also referred to as the MCAI), to correct an unsafe condition for all Model ATR42-200, ATR42-300, ATR42-320, ATR42-400, and ATR42-500 airplanes; and Model ATR72-101, ATR72-102, ATR72-201, ATR72-202, ATR72-211, ATR72-212, and ATR72-212A airplanes.
Model ATR42-400 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 a manufacturing defect was identified in the lavatory fire extinguisher. This defect could potentially result in leakage at the eutectic tip, leading to a loss of pressure in the cylinder, making fire extinguishing capabilities ineffective. This condition, if not detected and corrected, in combination with fire in the lavatory waste bin, could result in the propagation of an uncontrolled fire.
The FAA is proposing this AD to address the unsafe condition on these products.
You may examine the MCAI in the AD docket at
EASA AD 2024-0132 specifies procedures for the inspection (
This product has been approved by the aviation authority of another country and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it 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 2024-0132 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
The FAA estimates that this AD, if adopted as proposed, would affect 77 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
The FAA estimates the following costs to do any necessary on-condition action that would be required based on the results of any required actions. The FAA has no way of determining the number of aircraft that might need this on-condition action:
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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by November 25, 2024.
None.
This AD applies to all ATR—GIE Avions de Transport Régional Model ATR42-200, ATR42-300, ATR42-320, and ATR42-500 airplanes; and Model ATR72-101, ATR72-102, ATR72-201, ATR72-202, ATR72-211, ATR72-212, and ATR72-212A airplanes, certificated in any category, as identified in European Union Aviation Safety Agency (EASA) AD 2024-0132, dated July 9, 2024 (EASA AD 2024-0132).
Air Transport Association (ATA) of America Code 26, Fire protection.
This AD was prompted by a report of a manufacturing defect identified in the lavatory fire extinguisher. This defect could potentially result in leakage at the eutectic tip, leading to a loss of pressure in the cylinder, making fire extinguishing capabilities ineffective. The FAA is issuing this AD to address this condition, which if not detected and corrected, in combination with fire in the lavatory waste bin, could result in the propagation of an uncontrolled fire.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraphs (h) and (i) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, EASA AD 2024-0132.
(1) Where EASA AD 2024-0132 refers to its effective date, this AD requires using the effective date of this AD.
(2) Where EASA AD 2024-0132 defines a serviceable part as “Any lavatory (waste bin) compartment fire extinguishers, eligible for installation in accordance with ATR instructions, which is not an affected part,” for this AD replace that text with “Any lavatory (waste bin) compartment fire extinguishers, eligible for installation, which is not an affected part.”
(3) This AD does not adopt the “Remarks” section of EASA AD 2024-0132.
The following provisions also apply to this AD:
(1)
(2)
For more information about this AD, contact Shahram Daneshmandi, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 206-231-3220; email
(1) The Director of the Federal Register approved the incorporation by reference of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this material as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) European Union Aviation Safety Agency (EASA) AD 2024-0132, dated July 9, 2024.
(ii) Reserved
(3) For EASA material identified in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
(4) You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement statutory and other policy updates made to the cost and software data reporting requirements for major systems.
Comments on the proposed rule should be submitted in writing to the address shown below on or before December 9, 2024, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2021-D028, using either of the following methods:
○
○
Comments received generally will be posted without change to
Mr. Jon M. Snyder, telephone 703-945-5341.
DoD is proposing to revise the DFARS to implement 10 U.S.C. 3227(b) and (c) and updates to the DFARS cost and software data reporting requirements made in the Department of Defense Instruction (DoDI) 5000.73, Cost Analysis Guidance and Procedures, and Department of Defense Manual (DoDM) 5000.04, Cost and Software Data Reporting (CSDR). Paragraphs (b) and (c) of 10 U.S.C. 3227 require, unless waived, submission of cost data for contracts expected to exceed $20 million or $50 million for acquisition and sustainment programs expected to exceed $100 million. The data will facilitate cost estimation and comparison across acquisition programs. The changes to the DoDI and the DoDM implement DoDI 5000.02, Operation of the Adaptive Acquisition Framework, which restructured defense acquisition guidance to improve process effectiveness and implement the Adaptive Acquisition Framework.
This rule proposes to modify DFARS subpart 234.71 to implement 10 U.S.C. 3227(b) and (c) and the updates made to DoDI 5000.73 and DoDM 5000.04 resulting from implementation of the Adaptive Acquisition Framework. This proposed rule amends DFARS subpart 234.71 to establish policy and procedures necessary to implement the updates to DoDI 5000.73 and DoDM 5000.04.
The rule also proposes to modify the DFARS to revise cost and software data reporting requirements for contracts above certain thresholds when awarded in support of acquisition or sustainment programs expected to exceed $100 million. This proposed rule modifies DFARS 242.503 to remove cost and software data reporting from postaward conference procedures, because the cost and software data reporting is a separate process.
The solicitation provision at 252.234-7003, Notice of Cost and Software Data Reporting, is proposed for deletion. Revisions are proposed to the contract clause at 252.234-7004, Cost and Software Data Reporting.
This rule proposes to delete the solicitation provision and its Alternate I at DFARS 252.234-7003, Notice of Cost and Software Data Reporting, and proposes to rename and amend the clause and its Alternate I at DFARS 252.234-7004, Cost and Software Data Reporting. The basic clause at DFARS 252.234-7004 is prescribed at 234.7105(a) and the alternate I clause is prescribed at 234.7105(b). However, this proposed rule does not impose any new requirements on contracts at or below the SAT, for commercial products including COTS items, or for commercial services. The clause does not apply to acquisitions at or below the SAT, to acquisitions of commercial products (including COTS items), or to acquisitions of commercial services.
The proposed rule, if finalized, will impact the Government and large and small contractors. Contracting officers will be required to address CSDR requirements in acquisition plans and are now strongly encouraged to attend CSDR-readiness reviews for contracts meeting the updated thresholds.
Currently, contractors are required to comply with CSDR requirements for major defense acquisition programs. This proposed rule, if finalized, will require approximately 304 unique contractors (including about 112 small entities) per year to comply with CSDR reporting requirements for approximately 6,208 contracts (including about 358 awarded to small entities) per year expected to exceed $20 million and $50 million in support of acquisition and/or sustainment programs expected to exceed $100 million under certain acquisition pathways. Contractors will also be required to comply with CSDR requirements for any contract for a program that is expected to exceed $100 million, which the CSDR plan approval authority determines is high risk or of high technical interest.
DoD expects to benefit by having access to cost and software data for acquisition and sustainment programs in the various acquisition pathways. This data will allow DoD to accomplish more accurate cost estimation and comparison across acquisition programs.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all 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 not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, as amended.
DoD does not expect this proposed rule, when finalized, 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,
This proposed rule is required to implement 10 U.S.C. 3227(b) and (c) and updates made to DoDI 5000.73, Cost Analysis Guidance and Procedures, and DoDM 5000.04, Cost and Software Data Reporting. Unless waived, 10 U.S.C. 3227(b) and (c) require submission of cost data for contracts expected to exceed $20 million or $50 million for acquisition and sustainment programs expected to exceed $100 million. The data will facilitate cost estimation and comparison across acquisition programs. The updates to the DoDI and DoDM implement DoDI 5000.02, Operation of the Adaptive Acquisition Framework, which restructured defense acquisition guidance to improve process effectiveness and implement the Adaptive Acquisition Framework.
The objective of this proposed rule is to update the DFARS cost and software data reporting requirements to implement 10 U.S.C. 3227(b) and (c) and changes made to DoDI 5000.73, Cost Analysis Guidance and Procedures, and DoDM 5000.04, Cost and Software Data Reporting. The legal basis for this proposed rule is 41 U.S.C. 1303 and 10 U.S.C. 3227(b) and (c).
This proposed rule, when finalized, will require the clause at DFARS 252.234-7004, Cost and Software Data Reporting System, to be included in solicitations and contracts that are expected to exceed $50 million and that meet the requirements for cost and software data reporting. The proposed rule, when finalized, will require alternate I of the clause to be included in solicitations and contracts that are expected to be greater than $20 million, but less than or equal to $50 million, when required by the Cost and Software Data Reporting plan approval authority or when determined to be high-risk or of high-technical interest by the cost and software data reporting plan approval authority. Therefore, DoD considered contracts with this clause that were awarded during the last three fiscal years. According to data from the Procurement Business Intelligence Service, in the last three fiscal years, DoD awarded such contracts to unique small entities as follows: 130 in FY 2021, 99 in FY 2022, and 109 in FY 2023, which averages out to 112 per fiscal year. Therefore, the number of small entities to which this proposed rule may apply is approximately 112.
This proposed rule does not impose any new reporting, recordkeeping, or other compliance requirements for small entities.
This proposed rule does not duplicate, overlap, or conflict with any other Federal rules.
There are no known alternatives that would accomplish the stated objectives of the applicable statute.
DoD invites comments from small business concerns and other interested parties on the expected impact of this proposed rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this proposed rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2021-D028), in correspondence.
The Paperwork Reduction Act (44 U.S.C. chapter 35) applies to this proposed rule. However, these changes to the DFARS do not impose additional information collection requirements to the paperwork burden previously approved by the Office of Management and Budget (OMB) under OMB Control Number 0704-0671, entitled Cost and Software Data Reporting, and OMB Control Number 9000-0149, entitled
Government procurement.
Therefore, the Defense Acquisition Regulations System proposes to amend 48 CFR parts 234, 242, and 252 as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
This subpart implements 10 U.S.C. 3227(b) and (c).
(a) This subpart applies to contracts supporting any acquisition and/or sustainment program, if that program is expected to exceed $100 million in one or more of the following acquisition pathways and to meet the following program criteria, when the contract is expected to exceed either of the following amounts:
(1) $50 million.
(2) $20 million.
(b) This subpart also applies to contracts supporting any other program that is expected to exceed $100 million and is determined to be high-risk or of high-technical interest by the cost and software reporting (CSDR) plan approval authority.
The CSDR requirements are specified in DoD Instruction (DoDI) 5000.73, Cost Analysis Guidance and Procedures, and are mandatory for acquisitions as specified in DoDI 5000.02, Operation of the Adaptive Acquisition Framework. Additional requirements for CSDR reporting are specified in DoD Manual (DoDM) 5000.04, Cost and Software Data Reporting.
(a) The CSDR requirements identified in this subpart may be waived only by the Office of the Secretary of Defense, Director of Cost Assessment and Program Evaluation (see 10 U.S.C. 3227(c)).
(b) See PGI 234.7103 for contact information for the Cost Assessment and Program Evaluation office.
(a) If an indefinite-delivery contract is awarded, the contracting officer shall ensure the applicability of CSDR requirements is specified at the task order or delivery order level.
(b) Prior to the issuance of a solicitation, the contracting officer shall obtain from the program manager, or other official responsible for the program, written documentation that preaward requirements of DoDM 5000.04 have been met or include a signed CSDR waiver in the contract file.
(c) The contracting officer should attend the CSDR-readiness review for contracts that include the basic or alternate of the clause at 252.234-7004, Cost and Software Data Reporting (see DoDM 5000.04).
Use the basic or the alternate of the clause at 252.234-7004, Cost and Software Data Reporting, in solicitations and contracts for defense acquisition programs that are expected to exceed $100 million and meet the requirements for cost and software data reporting as follows:
(a) Use the basic clause in solicitations and contracts that exceed $50 million and meet the criteria at 234.7101(a) and (a)(1).
(b) Use the alternate clause in solicitations and contracts that exceed $20 million, but are less than or equal to $50 million, and that meet the criteria at 234.7101(a)(2) or (b).
DD Form 1484, Post-Award Conference Record, may be used in conducting the conference and in preparing the conference report.
As prescribed in 234.7105(a), use the following basic clause:
(a)
(b)
(1) Use cost and software data reporting (CSDR) processes and procedures that accomplish the requirements contained in the contract CSDR Plan (DD Form 2794) and applicable data item description(s);
(2) Establish, implement, and maintain processes and procedures that provide for the consistent collection and generation of reliable actual cost data required by the contract CSDR Plan (DD Form 2794) and applicable data item description(s); and
(3)(i) Within 60 days of contract award or the definitization of an undefinitized contract action, complete a CSDR-readiness review with the Cost Assessment and Program Evaluation, Deputy Director for Cost Assessment and the cost estimating component of the relevant military department or defense agency in order to review CSDR requirements.
(ii) During the CSDR-readiness review, the Contractor shall—
(A) Describe the processes and procedures the Contractor will use to—
(
(
(B) Identify any subcontractor whose contract is expected to exceed $50 million; and
(C) Identify any potential revisions to CSDR requirements that may better align data reporting to the Contractor's procedures.
(c)
(d)
(a)
(b)
(1) Use cost and software data reporting (CSDR) processes and procedures that accomplish the requirements contained in the contract CSDR Plan (DD Form 2794) and applicable data item description(s);
(2) Establish, implement, and maintain processes and procedures that provide for the consistent collection and generation of reliable actual cost data required by the contract CSDR Plan (DD Form 2794) and applicable data item description(s); and
(3)(i) Within 60 days of contract award or the definitization of an undefinitized contract action, complete a CSDR-readiness review with the Cost Assessment and Program Evaluation, Deputy Director for Cost Assessment and the cost estimating component of the relevant military department or defense agency in order to review CSDR requirements.
(ii) During the CSDR-readiness review, the Contractor shall—
(A) Describe the processes and procedures the Contractor will use to—
(
(
(B) Identify any subcontractor whose contract is expected to exceed $20 million; and
(C) Identify any potential revisions to CSDR requirements that may better align data reporting to the Contractor's procedures.
(c)
(d)
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to revise joint venture eligibility requirements and nonmanufacturer rule applicability to 8(a) contracts awarded pursuant to the 8(a) Partnership Agreement between DoD and the Small Business Administration. These changes are necessary to align the DFARS with the Federal Acquisition Regulation (FAR).
Comments on the proposed rule should be submitted in writing to the address shown below on or before December 9, 2024, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2024-D025, using either of the following methods:
○
○
Comments received generally will be posted without change to
Jeanette Snyder, telephone 703-508-7524.
DoD is proposing to revise the DFARS to align with changes made to the FAR via the final rules published in the
This rule is also proposing to revise the DFARS to align with the proposed rule for FAR Case 2021-020, Limitations on Subcontracting Revisions, published on January 17, 2024 (89 FR 2910). This FAR rule proposed to remove the nonmanufacturer rule requirements for 8(a) participants from FAR 19.809-2 as was intended to be accomplished via the final rule published on August 11, 2021, and to remove the kit assembler rule set from the nonmanufacturer rule. This DFARS rule proposes to make similar changes.
This rule proposes to modify the contract clause at DFARS 225.219-7010, Notification of Competition Limited to Eligible 8(a) Participants—Partnership Agreement, to add joint ventures to the list of concerns from whom offers are solicited for 8(a) Program acquisitions that are processed in accordance with the 8(a) Partnership Agreement between DoD and the Small Business Administration (SBA) (the Agreement). This proposed rule also includes the removal of the kit assembler rule set and the nonmanufacturer rule requirements addressed in paragraphs (d)(1), (d)(2), and (d)(3) of the clause at DFARS 252.219-7010 to align with the clause at FAR 52.219-33, Nonmanufacturer Rule, which specifies the nonmanufacturer rule requirements for all socioeconomic categories.
This proposed rule amends the clause at DFARS 225.219-7010, Notification of Competition Limited to Eligible 8(a) Participants—Partnership Agreement; however, this proposed rule does not impose any new requirements on contracts at or below the SAT, for commercial products including COTS items, or for commercial services. The clause will continue to not apply to acquisitions at or below the SAT and will continue to apply to acquisitions of commercial products including COTS items, and to acquisitions of commercial services.
This proposed rule, when finalized, is expected to impact 8(a) participants, including 8(a) joint ventures, who enter into contracts with DoD that are processed in accordance with the Agreement. These participants will be required to comply with the nonmanufacturer rule requirements in the clause at FAR 52.219-33. As a result, DoD may see an increase in the number of 8(a) participants that submit proposals for contracts processed in accordance with the Agreement, which may expand the defense industrial base.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all 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 not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, as amended.
DoD does not expect this proposed rule, when finalized, 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,
This proposed rule is necessary to revise the contract clause at DFARS 252.219-7010, Notification of Competition Limited to Eligible 8(a) Participants—Partnership Agreement, to align with changes made to the FAR regarding joint venture eligibility for 8(a) Program acquisitions processed in accordance with the 8(a) Partnership Agreement between DoD and the Small Business Administration (SBA). This proposed rule also removes the nonmanufacturer rule requirements from the clause to align with changes made to the FAR.
The objective of the rule is to revise the DFARS to align with amendments made to the FAR. The legal basis for the rule is 41 U.S.C. 1303.
According to data from the Procurement Business Intelligence Service, in the last three fiscal years DoD awarded contracts that included the clause at DFARS 252.219-7010 to unique small entities as follows: 848 in fiscal year 2021; 553 in fiscal year 2022; 600 in fiscal year 2023. This averages out to 667 per fiscal year. Therefore, DoD estimates that the number of small entities to which this rule will apply is approximately 667.
This proposed rule does not impose any new reporting, recordkeeping, or other compliance requirements for small entities.
This proposed rule does not duplicate, overlap, or conflict with any other Federal rules.
DoD did not identify any significant alternatives to the proposed rule. Any impact is expected to be beneficial.
DoD invites comments from small business concerns and other interested parties on the expected impact of this proposed rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this proposed rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2024-D025), in correspondence.
This proposed rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, the Defense Acquisition Regulations System proposes to amend 48 CFR part 252 as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
As prescribed in 219.811-3(2), use the following clause:
(a) Offers are solicited only from—
(1) Small business concerns expressly certified by the Small Business Administration (SBA) for participation in SBA's 8(a) Program and which meet the following criteria at the time of submission of offer:
(i) The Offeror is in conformance with the 8(a) support limitation set forth in its approved business plan.
(ii) The Offeror is in conformance with the Business Activity Targets set forth in its approved business plan or any remedial action directed by SBA.
(iii) If the competition is to be limited to 8(a) concerns within one or more specific SBA regions or districts, then the Offeror's approved business plan is on file and serviced by ___.
(2) A joint venture, in which at least one of the 8(a) program participants that is a party to the joint venture complies with the criteria set forth in paragraph (a)(1) of this clause, and that has a joint venture agreement that complies with 13 CFR 124.513(c); or
(3) A joint venture—
(i) That is comprised of a mentor and an 8(a) protégé with an approved mentor-protégé agreement under an SBA mentor-protégé program;
(ii) In which at least one of the 8(a) program participants that is a party to the joint venture complies with the criteria set forth in paragraph (a)(1) of this clause; and
(iii) With a joint venture agreement that complies with 13 CFR 124.513(c).
(b) By submission of its offer, the Offeror represents that it meets the applicable criteria set forth in paragraph (a) of this clause.
(c) Any award resulting from this solicitation will be made directly by the Contracting Officer to the successful 8(a) offeror selected through the evaluation criteria set forth in this solicitation.
(d) The ___
Agricultural Marketing Service, USDA.
Notice.
The Agricultural Marketing Service (AMS) is announcing the certification of the Alabama Department of Agriculture and Industries and the Washington State Department of Agriculture to provide official inspection services at the export port locations listed in table 1, below, under the delegated authority of the United States Grain Standards Act (USGSA or Act), as amended. AMS is also announcing the designation of official agencies to provide official services (at other than export port locations) in the geographic areas listed in table 2, below.
Jennifer Weiland, Grain Marketing Specialist, Telephone 202-989-5995; Email:
This notice announces AMS's certification that the Alabama Department of Agriculture and Industries and the Washington State Department of Agriculture are meeting the criteria required to perform official services at export port locations in the States of Alabama and Washington, respectively. Section 7(e) of the USGSA (7 U.S.C. 79(e)) requires the Secretary of Agriculture (Secretary) to certify, every five years, that each State agency with a delegation of authority is meeting the criteria described in section 7(f)(1)(A) of the Act for carrying out inspections on behalf of the Secretary. Under the certification process prescribed by the statute, the Secretary must: (1) publish in the
For more information about the delegation and certification processes, please see 7 CFR 800.195. Table 1 provides relevant information about the delegations of authority to the Alabama and Washington State agencies to perform official services at export port locations.
AMS published a notice of intent to certify the Alabama Department of Agriculture and Industries and requested comments on the quality of services the State agency provided at export port locations in Alabama in the March 9, 2023 edition of the
AMS also conducted an investigation to determine whether the Alabama State agency is qualified to perform inspections under section 7(e)(3) of the USGSA (7 U.S.C. 79(e)(3)). Pursuant to this section, AMS consulted with USDA's Office of Inspector General (OIG), the Department of Justice (DOJ), and the Government Accountability Office (GAO).
AMS published a notice of intent to certify the Washington State Department of Agriculture and requested comments on the quality of services the State agency provided at export port locations in Washington in the March 9, 2023 edition of the
AMS also conducted an investigation to determine whether the Washington State agency is qualified to perform inspections under section 7(e)(3) of the USGSA (7 U.S.C. 79(e)(3)). Pursuant to this section, AMS consulted with USDA's OIG, DOJ, and GAO. Neither the compliance review nor the consultations produced findings that would negatively impact the Washington State agency's ability to perform official inspections at export port locations. Accordingly, AMS certifies that the Washington State Department of Agriculture is meeting the criteria required to provide official services at export port locations in Washington.
This notice announces AMS's designation and/or renewal of the designation of the official agencies listed in table 2, below, to provide official services at locations other than export port locations. Section 7(f) of the USGSA (7 U.S.C. 79(f)) authorizes the Secretary to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services. A designated agency may provide official inspection services and/or Class X or Class Y weighing services at locations other than export port locations. Under section 7(g) of the USGSA, designations of official agencies are effective for no longer than five years but may be renewed according to the criteria and procedures prescribed in section 7(f) of the Act. For more information about the designation and renewal processes, please see 7 CFR 800.196. To view the applications for these areas, please contact
AMS
AMS
The official agencies listed in tables 2 and 3 for the designation areas of Decatur, Indiana; Helena, Montana; Aberdeen, South Dakota; Hastings, Nebraska; Jefferson City, Missouri; Montgomery, Alabama; Olympia, Washington; Essex, Illinois; Jamestown, North Dakota; Lincoln, Nebraska; Memphis, Tennessee; Topeka, Kansas; Cedar Rapids, Iowa; Minot, North Dakota; and Cincinnati, Ohio were the only applicants for designation in those geographic areas. The only designation area for which more than one application was received is the Texas Central area, which is discussed in the next section.
In the April 3, 2023,
In analyzing applications for the Texas Central geographic area, AMS evaluated applicants against the designation criteria in Section 7(f) of the USGSA (7 U.S.C. 79(f)), the recent audit report for Plainview detailing the applicant's performance of the designation criteria, customers' experience with the official service provider, public comments received related to the designation opportunity notice, current service agreements, and details provided in the application. Applications generally include information on an applicant's business plan to service the area, active licenses and service availability, fees, overall service costs, and proximity to customers and facilities. Plainview meets the designation criteria established under the USGSA and is operating with comparable costs for most service requests. GIST is a new entity and first-time applicant that demonstrates the ability to meet the designation criteria. In consideration of these factors, AMS determined that awarding eight counties to Plainview and the remaining 141 counties to GIST is the best manner in which to continue servicing the area. As such, the description of Plainview's designation area is amended. The new areas allow for an expansion of Plainview's geographic area without overlapping boundaries or isolating customers or areas within another official service provider's geographic area. GIST will be awarded a newly defined geographic area.
The Texas Central counties awarded to Plainview and GIST are listed below and will be reflected in their respective designation Appendix A documents:
Plainview—Coke, Coleman, Ector, Glasscock, Midland, Runnels, Sterling, and Winkler. GIST—Anderson,
In the November 15, 2023 edition of the
In Indiana:
Bounded on the north by the northern LaGrange and Steuben County lines; bounded on the east by the eastern Steuben, De Kalb, Allen, and Adams County lines; bounded on the south by the southern Adams and Wells County lines; and bounded on the west by the western Wells County line; the southern Huntington and Wabash County lines; the western Wabash County line north to State Route 114; State Route 114 northwest to State Route 19; State Route 19 north to Kosciusko County; the western and northern Kosciusko County lines; the western Noble and LaGrange County lines.
U.S. Codex Office, USDA.
Notice of public meeting and request for comments.
The U.S. Codex Office is sponsoring a public meeting on November 14, 2024. The objective of the public meeting is to provide information and receive public comments on agenda items and draft U.S. positions to be discussed at the 47th Session of the Codex Alimentarius Commission (CAC47), which will meet in Geneva, Switzerland from November 25, 2024 to November 30, 2024. The U.S. Manager for Codex Alimentarius and the Under Secretary for Trade and Foreign Agricultural Affairs recognize the importance of providing interested parties the opportunity to obtain background information on the 47th Session of the CAC and to address items on the agenda.
The public meeting is scheduled for November 14, 2024 from 1:00-4:00 p.m. ET.
The public meeting will take place via Video Teleconference only. Documents related to the 47th Session of the CAC will be accessible via the internet at the following address:
For further information about the 47th Session of the CAC, contact Kenneth Lowery, Senior International Issues Analyst, U.S. Codex Office, Office of the Under Secretary for Trade and Foreign Agricultural Affairs, by email at:
The Codex Alimentarius Commission was established in 1963 by two United Nations organizations: the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade; promotes coordination of all food standards work undertaken by international governmental and nongovernmental organizations; determines priorities, initiates, and guides the preparation of draft standards; finalizes the standards elaborated and publishes them in the Codex Alimentarius (food code) either as regional or worldwide standards, wherever this is practicable; and amends published standards, as appropriate, in the light of new developments.
The following items on the agenda for the 47th Session of CAC will be discussed during the public meeting:
Relevant documents are or will be available at the following address:
At the November 14, 2024, public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to
Public awareness of all segments of rulemaking and policy development is important. Consequently, the U.S. Codex Office will announce this
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
National Agricultural Statistics Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the National Agricultural Statistics Service (NASS) to seek approval to conduct a new information collection to gather data related to the use of agroforestry practices.
Comments on this notice must be received by December 9, 2024 to be assured of consideration.
You may submit comments, identified by docket number 0535-0273, by any of the following methods:
•
•
•
•
Joseph J. Prusacki, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, 202-720-2707. Copies of this information collection and related instructions can be obtained without charge from Richard Hopper, NASS—OMB Clearance Officer, at 202-720-2206 or at
All responses to this notice will become a matter of public record and be summarized in the request for OMB approval.
National Agricultural Statistics Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 this notice announces the intention of the National Agricultural Statistics Service (NASS) to request revision and extension of a currently approved information collection, the custom works surveys. This clearance allows NASS to conduct custom works surveys in a timely manner for the cooperating institutions providing funding for the surveys. There will be no revision to annual burden hours for the surveys.
Comments on this notice must be received by December 9, 2024 to be assured of consideration.
You may submit comments, identified by docket number 0535-0266, by any of the following methods:
•
•
•
•
Joseph J. Prusacki, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, 202-720-2707. Copies of this information collection and related instructions can be obtained without charge from Richard Hopper, NASS—OMB Clearance Officer, at 202-720-2206 or at
The Custom Works program will survey farmers who potentially paid for custom services during a specified reference period to collect information on how much they paid for those services. These services include land tillage, application of fertilizers and chemicals, planting, harvesting, hauling, various livestock tasks, and many more tasks. The program will provide farm operators with estimates of the average prices paid for different custom services in their state and/or local area. All questionnaires included in this information collection will be voluntary. This project is conducted as a cooperative effort between NASS and state agricultural departments and/or universities. Funding will be provided by the cooperating institutions under full cost recovery. The time between when funding for an individual survey is secured and the desired start of data collection is expected often to be too short to allow for a separate OMB approval for each survey. With this request, NASS will be able to provide services in a timelier manner.
All responses to this notice will become a matter of public record and be summarized in the request for OMB approval.
Rural Utilities Service, USDA.
Notice; request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Rural Utilities Service (RUS) intention to request a revision of a currently approved information collection and invites comments on this information collection.
Comments on this notice must be received by December 9, 2024, to be assured of consideration.
Comments may be submitted through the Federal eRulemaking Portal: Go to
Information on using
MaryPat Daskal, Chief, Branch 1, Rural Development Innovation Center—Regulations Management Division, U.S. Department of Agriculture, 1400 Independence Avenue SW, STOP 1522, South Building, Washington, DC 20250-1522. Telephone: (202) 720-7853. Email:
The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an existing information collection that the Agency is submitting to OMB for revision.
Copies of this information collection can be obtained from Kimble Brown, Rural Development Innovation Center, Regulations Management Division, at
Rural Utilities Service, USDA.
Notice; request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Rural Utilities Service (RUS) intention to request a revision of a currently approved information collection and invites comments on this information collection.
Comments on this notice must be received by December 9, 2024, to be assured of consideration.
Comments may be submitted through the Federal eRulemaking Portal: Go to
MaryPat Daskal, Chief, Branch 1, Rural Development Innovation Center—Regulations Management Division, U.S. Department of Agriculture, 1400 Independence Avenue SW, STOP 1522, South Building, Washington, DC 20250-1522. Telephone: (202) 720-7853. Email:
The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that RUS is submitting to OMB for revision.
1. RUS Form 168b, Contractor's Bond. This form is used to provide a surety bond for contracts on RUS Forms 200, 257, 786, 790, & 830.
2. RUS Form 168c, Contractor's Bond (less than $1 million). This form is used to provide a surety bond in lieu of RUS Form 168b, when contractor's surety has accepted a small business administration guarantee.
3. RUS Form 187, Certificate of Completion-Contract Construction. This form is used for the closeout of RUS Forms 200, 257, 786, and 830.
4. RUS Form 198, Equipment Contract. This form is used for equipment purchases.
5. RUS Form 200, Construction Contract-Generating. This form is used for generating plant construction or for the furnishing and installation of major items of equipment.
6. RUS Form 213, Certificate (“Buy American”). This form is used to document compliance with the “Buy American” requirement.
7. RUS Form 224, Waiver and Release of Lien. This form is used by subcontractors to provide a release of lien in connection with the closeout of RUS Forms 198, 200, 257, 786, 790, and 830.
8. RUS Form 231, Certificate of Contractor. This form is used for the closeout of RUS Forms 198, 200, 257, 786, and 830.
9. RUS Form 238, Construction or Equipment Contract Amendment. This form is used to amend contracts except for distribution line construction contracts.
10. RUS Form 254, Construction Inventory. This form is used to document the final construction in connection with the closeout of RUS Form 830.
11. RUS Form 257, Contract to Construct Buildings. This form is used to construct headquarter buildings, generating plant buildings, and other structure construction.
12. RUS Form 307, Bid Bond. This form is used to provide a bid bond in RUS Forms 200, 257, 786, 790 and 830.
13. RUS Form 786, Electric System Communications and Control Equipment Contract. This form is used for delivery and installation of equipment for system communications.
14. RUS Form 790, Electric System Construction Contract Non-Site Specific Construction (Notice and Instructions to Bidders). This form is used for limited distribution construction accounted for under work order procedure.
15. RUS Form 792b, Certificate of Contractor and Indemnity Agreement (Line Extensions). This form is used in the closeout of RUS Form 790.
16. RUS Form 830, Electric System Construction Contract (labor & material). This form is used for distribution and/or transmission project construction.
Copies of this information collection can be obtained from Kimble Brown, Rural Development Innovation Center,
Rural Utilities Service, USDA.
Notice; request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces Rural Development's (RD) intention to request a revision of a currently approved information collection and invites comments on this information collection.
Comments on this notice must be received by December 9, 2024, to be assured of consideration.
Comments may be submitted through the Federal eRulemaking Portal: Go to
MaryPat Daskal, Chief, Branch 1, Rural Development Innovation Center—Regulations Management Division, U.S. Department of Agriculture, 1400 Independence Avenue SW, STOP 1522, South Building, Washington, DC 20250-1522. Telephone: (202) 720-7853. Email:
The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an existing information collection that the Agency is submitting to OMB for revision.
Applicants seeking funding to finance the provision of retail broadband under the special broadband authority of this part are generally expected to comply with the rules related to broadband funding under Title VI of the Rural Electrification Act. To be considered for funding under special broadband authority, applicants must provide:
(1) A description of the proposed retail broadband project;
(2) a map, where applicable, of the proposed service area to be funded under smart utility authority of the applicant;
(3) the amount and type of support requested by the applicant;
(4) any other information required of similar applicants under Title VI of the Rural Electrification Act.
Fully Searchable Data Base—The applicant information provided will be made part of a fully searchable database which could disclose to the public the information above.
Public Notice Survey—The agency will post a public notice filing on the agency's website. Incumbent service providers in the area may respond to the public notice filing by providing a public notice response.
Copies of this information collection can be obtained from Kimble Brown, Rural Development Innovation Center, Regulations Management Division, at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily finds that narrow woven ribbons with woven selvedge (ribbons) from Taiwan were sold in the United States at less than normal value (NV) during the
Applicable October 10, 2024.
Paul Senoyuit, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-6106.
On September 1, 2010, Commerce published in the
The products subject to the
Commerce is conducting this review in accordance with sections 751(a)(1)(B) and (2) of the Tariff Act of 1930, as amended (the Act). Pursuant to sections 776(a) and (b) of the Act, Commerce preliminarily relied entirely upon facts otherwise available with adverse inferences for Hao Shyang and Lung Che. For a complete description of the methodology underlying our conclusions,
Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if a party who requested the review withdraws the request within 90 days of the date of publication of the notice of initiation of the requested review. On January 26, 2024, the petitioners timely withdrew their request for an administrative review with respect to all companies for which a review was requested other than Hao Shyang and Lung Che.
Commerce preliminarily determines that the following estimated weighted-average dumping margin exists for the period September 1, 2022, through August 31, 2023:
Normally, Commerce discloses to interested parties the calculations performed in connection with a preliminary results finding within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the notice of preliminary results in the
Interested parties may submit case briefs to Commerce no later than 30 days after the date of publication of this notice.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of issues to be discussed. If a request for a hearing is made, Commerce intends to hold a hearing at a time and date to be determined.
Pursuant to section 751(a)(2)(A) of the Act, upon completion of the final results of administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.
For the companies for which this review is being rescinded, in part, Commerce will instruct CBP to assess antidumping duties on all appropriate entries. Antidumping duties shall be assessed at rates equal to the cash deposit rate for estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). With respect to the recission of this review, in part, Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of this notice in the
For companies subject to this review, Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective upon publication in the
Unless the deadline is otherwise extended, Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised by interested parties in written briefs, within 120 days after the date of publication of this notice in the
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties, and/or an increase in the amount of antidumping duties by the amount of countervailing duties.
We are issuing and publishing these preliminary results in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.213(h) and 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that the sole respondent under review, Adisseo España S.A. (Adisseo España), sold subject merchandise at less than normal value during the period of review (POR) September 1, 2022, through August 31, 2023. We invite interested parties to comment on the preliminary results of this review.
Applicable October 10, 2024.
Elizabeth Bremer, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4987.
On September 14, 2021, Commerce published the antidumping duty (AD) order on methionine from Spain.
On November 15, 2023, based on timely requests for review,
The merchandise covered by the
Commerce is conducting this review in accordance with section 751(a) of the Act. We calculated constructed export price in accordance with section 772 of the Act and normal value in accordance with section 773 of the Act.
For a full description of the methodology underlying these preliminary results,
Commerce preliminarily finds that the following weighted-average dumping margin exists for the period September 1, 2022, through August 31, 2023:
Commerce intends to disclose under administrative protective order its calculations and analysis performed to interested parties for these preliminary results of review within five days of the date of publication of this notice in the
Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs to Commerce via ACCESS no later than 30 days after the date of publication of these preliminary results of review in the
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request for a hearing to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS, by no later than 5 p.m. Eastern Time within 30 days after the date of publication of this notice in the
Commerce intends to issue the final results of this administrative review, which will include the results of its analysis of issues raised in the case and rebuttal briefs, within 120 days of publication of these preliminary results of review in the
Pursuant to section 751(a)(2)(A) of the Act and 19 CFR 351.212(b)(1), upon completion of this administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise covered by this review.
In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Adisseo España for which it did not know was destined for the United States, we intend to instruct CBP to liquidate those entries at the all-others rate (
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be in effect for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the notice of the final results of this administrative review in the
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
We are issuing and publishing these preliminary results of review in accordance with sections 751(a)(1) and
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that countervailable subsidies were provided to Navneet Education Limited (Navneet), a producer/exporter of certain lined paper products (lined paper) from India. The period of review (POR) is January 1, 2022, through December 31, 2022. Interested parties are invited to comment on these preliminary results.
Applicable October 10, 2024.
Peter Zukowski, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0189.
On September 28, 2006, Commerce published the countervailing duty order on lined paper from India in the
For a complete description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum.
The product covered by the Order is lined paper from India. For a complete description of the scope of the
Commerce is conducting this administrative review in accordance with 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy,
As a result of this review, we preliminarily determine the following net countervailable subsidy rate exists for the POR, January 1, 2022, through December 31, 2022:
Commerce intends to disclose its calculations and analysis performed in connection with these preliminary results to interested parties within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
Because Commerce intends to address the new subsidy allegations following these preliminary results, interested parties will be notified of the deadline for the submission of case briefs at a later date.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their briefs that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Oral presentations at the hearing will be limited to issues raised in the briefs. If a request for a hearing is made, Commerce will inform parties of the scheduled date for the hearing.
Consistent with section 751(a)(1) of the Act and 19 CFR 351.212(b)(2), upon issuance of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries covered by this review. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
Pursuant to section 751(a)(2)(C) of the Act, upon publication of the final results, Commerce intends to instruct CBP to collect cash deposits of estimated countervailing duties in the amount indicated above with regard to shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this review, except where the rate calculated in the final results is zero or
Unless the deadline is extended pursuant to section 751(a)(3)(a) of the Act and 19 CFR 351.213(h)(2), Commerce intends to issue the final results of this administrative review, including the results of its analysis of issues by the parties in any written briefs, no later than 120 days after the date of publication of these preliminary results.
We are issuing and publishing these preliminary results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that the companies under review either sold certain steel racks and parts thereof (steel racks) from the People's Republic of China (China) in the United States at prices below normal value (NV) during the period of review (POR) September 1, 2022, through August 31, 2023, or do not qualify for a separate rate. Further, Commerce is rescinding this review with respect to six companies. Commerce invites interested parties to comment on the preliminary results of this review.
Applicable October 10, 2024.
Jonathan Hill, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3518.
On September 6, 2023, Commerce published in the
For a complete description of the events that followed the initiation of this review,
The merchandise covered by the
Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if all parties who requested a review withdraw their requests within 90 days of the date that the notice of initiation of the requested review was published in the
Further, pursuant to 19 CFR 351.213(d)(3), it is Commerce's practice to rescind an administrative review of an antidumping duty order where it concludes that there were no suspended entries of subject merchandise during the POR.
Based on record evidence in this review, Commerce preliminarily determines that mandatory respondent Jiangsu Nova Intelligent Logistics Equipment Co., Ltd. (Jiangsu Nova) and the following companies are affiliated, pursuant to section 771(33)(E) of the Tariff Act of 1930, as amended (the Act), and that they should be treated as a single entity, pursuant to 19 CFR 351.401(f)(1)-(2): (1) Nanjing Jinshidai Storage Equipment Co., Ltd., and (2) Hebei Nova Intelligent Logistics Equipment Co., Ltd. For additional information,
Commerce is conducting this review in accordance with section 751(a)(1)(B) of the Act. Commerce calculated constructed export price in accordance with section 772 of the Act. Further, because China is a non-market economy (NME) country within the meaning of section 771(18) of the Act, Commerce calculated NV in accordance with section 773(c) of the Act. For a full description of the methodology underlying our preliminary results,
In all proceedings involving an NME country, Commerce maintains a rebuttable presumption that all companies are subject to government control and, thus, should be assessed a single weighted-average dumping margin unless the company can affirmatively demonstrate an absence of government control, both in law (
However, Commerce has preliminarily determined that Jiangsu Starshine Industry Equipment Co., Ltd. (Starshine) has not demonstrated its eligibility for a separate rate because although it timely filed a separate rate application, it was selected as a mandatory respondent and failed to respond to Commerce's questionnaire. In the
Commerce's policy regarding conditional review of the China-wide entity applies to this administrative review.
Commerce preliminarily determines that the following weighted-average dumping margin exists for the period September 1, 2022, through August 31, 2023:
Commerce intends to disclose the calculations and analysis that it performed in these preliminary results of review to parties to the proceeding within five days of any public announcement of these preliminary results or, if there is no public announcement, within five days of the date of publication of this notice in the
Pursuant to 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs to Commerce no later than 30 days after the date of publication of these preliminary results of review in the
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their briefs that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide, at the beginning of their briefs, a public executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written hearing request to the Assistant Secretary for Enforcement and Compliance, filed electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). Requests should contain: (1) the requesting party's name, address, and telephone number; (2) the number of individuals from the requesting party that will attend the hearing and whether any of those individuals is a foreign national; and (3) a list of the issues the party intends to discuss at the hearing. Issues raised in the hearing by a party will be limited to those raised in the party's case and rebuttal briefs. An electronically filed hearing request must be received successfully in its entirety by Commerce's electronic records system, ACCESS, by 5 p.m. Eastern Time within 30 days after the date of publication of this notice.
In accordance with section 751(a)(2)(C) of the Act, the assessment of antidumping duties on entries of merchandise covered by the review shall be based on the final results of this review. Therefore, upon issuance of the final results of review, Commerce will determine, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise covered by this review.
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of these preliminary results in the
Commerce will calculate importer or customer-specific assessment rates for the individually examined respondent, in accordance with 19 CFR 351.212(b)(1).
Pursuant to a refinement to Commerce's assessment practice, where sales of subject merchandise exported by an individually examined respondent were not reported in the U.S. sales data submitted by the respondent, but the merchandise was entered into the United States during the POR, Commerce will instruct CBP to liquidate any entries of such merchandise at the antidumping duty assessment rate for the China-wide entity.
Commerce will instruct CBP to liquidate entries of subject merchandise exported by companies that are not eligible for a separate rate and which are therefore considered to be part of the China-wide entity, at the weighted-average dumping margin for the China-wide entity,
Pursuant to a refinement to Commerce's assessment practice, where sales of subject merchandise exported by an individually examined respondent were not reported in the U.S. sales data submitted by the respondent, but the merchandise was entered into the United States during the POR, Commerce will instruct CBP to liquidate any entries of such merchandise at the antidumping duty assessment rate for the China-wide entity.
The following cash deposit requirements will be in effect for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on, or after, the date of publication of the notice of the final results of this administrative review in the
These cash deposit requirements, when imposed, shall remain in effect until further notice.
Unless otherwise extended, Commerce intends to issue the final results of this administrative review, which will include the results of its analysis of issues raised in case and rebuttal briefs, within 120 days of publication of these preliminary results of review in the
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during the POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties, and/or an increase in the amount of antidumping duties by the amount of the countervailing duties.
We are issuing and publishing these preliminary results of review in accordance with sections 751(a)(l) and 777(i)(l) of the Act, and 19 CFR 351.213(h)(2) and 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily finds that certain oil country tubular goods (OCTG) from the Republic of Korea (Korea) were sold in the United States at prices below normal value. The period of review (POR) is September 1, 2022, through August 31, 2023. Interested parties are invited to comment on these preliminary results.
Applicable October 10, 2024.
Michael J. Heaney or Mark Flessner, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4475 or (202) 482-6312, respectively.
These preliminary results are made in accordance with section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this administrative review on November 15, 2023.
The product covered by the
Commerce is conducting this administrative review in accordance with section 751(a)(2) of the Act. Commerce has calculated export prices in accordance with section 772(a) of the Act. Constructed export prices have been calculated in accordance with section 772(b) of the Act. Normal value is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions,
The statute and Commerce's regulations do not address the rate to be applied to companies not selected for examination when Commerce limits its examination in an administrative review pursuant to section 777A(c)(2) of the Act. Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in a market economy investigation, for guidance when calculating the rate for companies which were not selected for individual examination in an administrative review. Under section 735(c)(5)(A) of the Act, the all-others rate is normally “an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero or
In this administrative review, Commerce preliminarily found a zero percent margin for NEXTEEL Co., Ltd. Therefore, the only rate that is not zero,
Commerce preliminarily finds that the following estimated weighted-average dumping margins exist:
Commerce intends to disclose the calculations and analysis performed for these preliminary results to interested parties within five days of public announcement of the preliminary results or, if there is no public announcement, within five days of the date of publication of this notice, in accordance with 19 CFR 351.224(b).
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 30 days after the date of publication of these preliminary results of review.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this administrative review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. Parties should confirm by telephone the date, time, and
Unless otherwise extended, Commerce intends to issue the final results of this administrative review, which will include the results of its analysis of issues raised in any briefs, within 120 days of publication of these preliminary results of review, pursuant to section 751(a)(3)(A) of the Act.
Upon issuance of the final results, Commerce shall determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.
For any individually examined respondents whose weighted-average dumping margin is above
For the companies which were not selected for individual review, we intend to assign an assessment rate based on the methodology described in the “Rates for Non-Examined Companies” section. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by this review where applicable.
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective upon publication of the notice of final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication, as provided by section 751(a)(2) of the Act: (1) the cash deposit rate for the companies listed in the final results of review will be equal to the weighted-average dumping margin established in the final results of this administrative review; (2) for merchandise exported by producers or exporters not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which they were reviewed; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation but the producer is, then the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the merchandise; (4) the cash deposit rate for all other producers or exporters will continue to be 5.24 percent, the all-others rate established in the less-than-fair-value investigation.
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
These preliminary results are issued and published in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that certain cold-rolled steel flat products (cold-rolled steel) from the Republic of Korea (Korea) were not made at less than normal value (NV) during the period of review (POR) September 1, 2022, through August 31, 2023. Interested parties are invited to comment on these preliminary results.
Applicable October 10, 2024.
Caroline Carroll, AD/CVD Operations, Office IX, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4948.
On September 20, 2016, Commerce published in the
The merchandise subject to the
Commerce is conducting this review in accordance with sections 751(a)(1)(B) and (2) of the Act. Export price and constructed export price are calculated in accordance with section 772 of the Act. NV is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions,
The Act and Commerce's regulations do not address the establishment of a weighted-average dumping margin to be determined for companies not selected for individual examination when Commerce limits its examination in an administrative review pursuant to section 777A(c)(2) of the Act. Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in a market economy less-than-fair-value (LTFV) investigation, for guidance when determining the weighted-average dumping margin for companies which were not selected for individual examination in an administrative review. Under section 735(c)(5)(A) of the Act, the all-others rate is normally “an amount equal to the weighted average of the estimated weighted average dumping margins established for exporters and producers individually investigated, excluding any zero or
In this review, we preliminarily calculated dumping margins of zero for both of the mandatory respondents. Consistent with the U.S. Court of Appeals for the Federal Circuit's decision in
As a result of this review, we preliminarily determine the following estimated weighted-average dumping margins for the period of September 1, 2022, through August 31, 2023:
Commerce intends to disclose the calculations performed for these preliminary results to interested parties within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in case briefs, may be filed no later than five days after the date for filing case briefs.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings, we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide, at the beginning of their briefs, a public executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS, within 30 days after the date of publication of this notice. Hearing requests should contain the party's name, address, and telephone number, and a list of issues to be discussed. Oral presentations at the hearing will be limited to issues raised in the briefs. If a request for a hearing is made, Commerce will inform parties of the time and date for the hearing.
Unless the deadline is extended, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(2), Commerce intends to issue the final results of this administrative review, including the results of our analysis of the issues raised by the parties in any written briefs, no later than 120 days after the date of publication of these preliminary results in the
Pursuant to section 751(a)(2)(A) of the Act and 19 CFR 351.212(b)(1), Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise covered by this review.
Commerce's “automatic assessment” practice will apply to entries of subject merchandise during the POR produced by Hyundai or POSCO for which the reviewed companies did not know that the merchandise they sold to the intermediary (
For KG Dongbu, the company that was not selected for individual examination, we intend to assign an assessment rate based on the review-specific rate determined as noted in the “Rate for Companies Not Selected for Individual Examination” section, above.
In accordance with section 751(a)(2)(C) of the Act, the final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future cash deposits of estimated antidumping duties, where applicable. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following deposit requirements will be effective upon publication in the
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties.
These preliminary results of review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of the determinations by the U.S. Department of Commerce (Commerce) and the U.S. International Trade Commission (ITC) that revocation of the antidumping duty (AD) order on sodium hexametaphosphate (SHMP) from the People's Republic of China (China) would likely lead to the continuation or recurrence of dumping and material injury to an industry in the United States, Commerce is publishing a notice of continuation of this AD order.
Applicable October 2, 2024.
Kabir Archuletta, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2593.
On March 19, 2008, Commerce published in the
On October 2, 2024, the ITC published its determination, pursuant to sections 751(c) and 752(a) of the Act, that revocation of the
The merchandise subject to the
The product covered by the
However, the product covered by the
As a result of the determinations by Commerce and the ITC that revocation of the
The effective date of the continuation of the
This notice also serves as the only reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceedings. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
This five-year (sunset) review and this notice are in accordance with sections 751(c) and 751(d)(2) of the Act, and published in accordance with section 777(i) of the Act and 19 CFR 351.218(f)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that Gujarat Fluorochemicals Limited (GFCL) made sales of subject merchandise in the United States at prices below normal value during the
Applicable October 10, 2024.
William Horn or Noah Wetzel, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4868 and (202) 482-7466 respectively.
On April 3, 2024, Commerce published the
The merchandise covered by the
We addressed all issues raised in the case and rebuttal briefs filed in this administrative review in the Issues and Decision Memorandum. A list of the issues addressed in the Issues and Decision Memorandum is in the appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Based on our evaluation of the comments received from interested parties regarding our
We determine that the following estimated weighted-average dumping margin exists for the period September 2, 2021, through February 28, 2023:
We intend to disclose the calculations performed for these final results of review to interested parties within five days of the date of publication of this notice in the
Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with section 751(a)(2)(C) of the Act and 19 CFR 351.212(b). Pursuant to 19 CFR 351.212(b)(1), because GFCL reported the entered value for its U.S. sales, we calculated importer-specific
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
Consistent with Commerce's clarification of its assessment practice, for entries of subject merchandise during the POR produced by GFCL where it did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate established in the original less-than-fair-value (LTFV) investigation of 10.01 percent
The following deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for GFCL will be equal to the weighted-average dumping margin established in the final results of this administrative review; (2) for merchandise exported by a producer or exporter not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which the producer or exporter participated; (3) if the exporter is not a firm covered in this review, a prior review, or the original less-than-fair-value (LTFV) investigation, but the producer is, the cash deposit rate will be the rate established for the most recently completed segment of the proceeding for the producer of the merchandise; and (4) the cash deposit rate for all other producers and exporters will continue to be 10.01 percent
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during the POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(5).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily finds that oil country tubular goods (OCTG) from India were not sold by Surya Roshni Limited (Surya) in the United States at less than normal value (NV) during the period of review (POR) September 1, 2022, through August 31, 2023. We invite interested parties to comment on these preliminary results.
Applicable October 10, 2024.
Brian Warnes, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0028.
On September 10, 2014, Commerce published the antidumping duty order on OCTG from India.
On May 20, 2024, we extended the deadline for these preliminary results until no later than September 27, 2024.
For a complete description of the events that followed the initiation of this review,
The merchandise subject to the
Commerce is conducting this review in accordance with section 751(a) of the Act. Export prices have been calculated in accordance with section 771 of the Act and NV was calculated in accordance with section 773 of the Act. For a full description of the methodology underlying these preliminary results,
Commerce preliminarily determines that the following estimated weighted-average dumping margin exists for the period September 1, 2022, through August 31, 2023:
Commerce intends to disclose the calculations used in our analysis to parties in this review within five days of the date of publication of this notice in the
Pursuant to 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs to Commerce no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs. An electronically filed hearing request must be received successfully in its entirety by Commerce's electronic records system, ACCESS, by 5 p.m. Eastern Time within 30 days after the date of publication of this notice.
Upon completion of the administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.
In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Surya for which the producer did not know its merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate (
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for Surya will be equal to the weighted-average dumping margin established in the final results of this administrative review, except if the rate is less than 0.50 percent and, therefore,
Unless otherwise extended, Commerce intends to issue the final results of this administrative review, including the results of our analysis of
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
These preliminary results of administrative review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(h)(2) and 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to a producer and exporter of oil country tubular goods (OCTG) from India. The period of review (POR) is January 1, 2022, through December 31, 2022. Interested parties are invited to comment on these preliminary results.
Applicable October 10, 2024.
Thomas Cloyd, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1246.
On September 10, 2024, Commerce published the countervailing duty (CVD) order on OCTG from India.
For a complete description of the events that followed the initiation of this investigation,
The merchandise covered by this
Commerce is conducting this CVD administrative review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (The Act). For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy,
As a result of this review, we preliminarily determine the following net countervailable subsidy rate for the period January 1, 2022, through December 31, 2022:
Commerce intends to disclose its calculations and analysis performed in connection with this preliminary determination to interested parties within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in the
Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs to Commerce no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date of filing case briefs.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS within 30 days after the date of publication of this notice. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants and whether any participant is a foreign national; and (3) a list of issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date of the hearing.
Consistent with section 751(a)(1) of the Act and 19 CFR 351.212(b)(2), upon issuance of the final results, Commerce will determine, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries covered by this review. We intend to issue instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
In accordance with section 751(a)(2)(C) of the Act, Commerce also intends, upon publication of the final results, to instruct CBP to collect cash deposits of estimated countervailing duties in the amount shown for the company listed above with regard to shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this review. For all non-reviewed firms, CBP will continue to collect cash deposits of estimated countervailing duties at the all-others rate or the most recent company-specific rate applicable to the company, as appropriate. These cash deposit requirements, when imposed, shall remain in effect until further notice.
Unless the deadline is extended pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(2), Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised by parties in their comments, within 120 days after the date of publication of these preliminary results.
We are issuing and publishing these preliminary results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The Gulf of Mexico Fishery Management Council (Council) will hold its first Recreational Initiative Working Group meeting in Tampa, FL.
The meeting will convene Tuesday, October 29, 2023, from 9 a.m. to 5 p.m. and Wednesday, October 30, 2024, from 9 a.m. to 4 p.m., EDT.
The meeting will take place at the Gulf Council Office. You may “listen in” by accessing the log-on information by visiting our website at
Dr. Carrie Simmons, Executive Director, Gulf of Mexico Fishery Management Council; telephone: (813) 348-1630.
The purpose of this meeting is to provide Working Group members with an opportunity to share their views on reef fish stock status and management, provide perspectives on what management “success” would look like, and offer initial thoughts on approaches that they would like to see the Council consider. The meeting agenda is as follows:
The meeting will begin with Welcome and Recreational Initiative Background, Introductions, Set the Stage and Review Meeting Purpose, History of Past and Current Goals and Objectives for Recreational Fisheries Management.
The group will review past challenges and successes of recreational reef fish management.
The Working Group will work on developing a vision, goals and objectives for Recreational Reef Fish Management. The Group will engage in a facilitated discussion and the meeting with end with closing remarks and logistics.
The full agenda and additional information will be posted on
This meeting is being held in-person at the Gulf Council office, Tampa, FL. You may register for the webinar to listen-in only by visiting
The timing and order in which agenda items are addressed may change as required to effectively address the issue, and the latest version along with other meeting materials will be posted on the website as they become available.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid or accommodations should be directed to Kathy Pereira, (813) 348-1630, at least 15 days prior to the meeting date.
National Oceanic & Atmospheric Administration (NOAA), Commerce.
Notice of Information Collection, request for comment.
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.
To ensure consideration, comments regarding this proposed information collection must be received on or before December 9, 2024.
Interested persons are invited to submit written comments to Adrienne Thomas, NOAA PRA Officer, at
Requests for additional information or specific questions related to collection activities should be directed to Colette Tweeddale, Fishery Management Specialist, Greater Atlantic Regional Fisheries Office, 55 Great Republic Dr., Gloucester, MA 01930, (978)-281-9335,
This is a request for a renewal of an approved information collection.
Under the Magnuson-Stevens Fishery Conservation and Management Act, the Secretary of Commerce has the responsibility for the conservation and management of marine fishery resources. Much of this responsibility has been delegated to NOAA's National Marine Fisheries Service (NMFS). NMFS manages the Atlantic sea scallop (scallop) fishery through a set of regulations that limit catch of scallops and fishing vessel activity. In addition, regulations limit catch of certain other species of fish in order to minimize bycatch and bycatch mortality (bycatch is the catch and discard of species that are not targeted in the scallop fishery). Finally, the regulations control vessel permitting and the exchange of effort and quota allocations between vessels. In order to effectively manage these resources, track fishing effort and catch, and to allow vessel owners to exchange fishing trips and quota, NMFS must collect information through the reporting requirements included in this renewal. This renewal contains the following information collections: Vessel Monitoring System (VMS) requirements; Access area trip exchange application procedures; Individual Fishing Quota (IFQ) transfers; Cost recovery; and IFQ sector program.
The one-for-one access area trip exchange program provides flexibility to scallop vessels about where they may fish. Participants need to send an access area trip exchange application to NMFS with the following information: Vessel name and permit number, owner name and signature, specification of the areas involved in the exchange. Both vessels involved in the exchange are required to submit forms for cross verification. This measure provides flexibility to vessels regarding which areas to fish, thereby reducing the possibility of revenue loss to those vessels that are unable to access some distant areas due to vessel capacity constraints.
IFQ permit holders can temporarily and/or permanently transfer individual fishing quota from one IFQ vessel to another. Quota transfers are requested through the submission of transfer applications. Required information includes vessel information, quota transfer information, and authorizing signatures from both parties. The IFQ transfer program is entirely optional, and provides greater flexibility for IFQ permit holders by enabling them to increase their vessel's IFQ or for individuals to lease or sell IFQ if they choose not to fish the allocation.
Section 304(d)(2) of the Magnuson-Stevens Act (MSA) requires an IFQ cost recovery plan to recover management and enforcement costs for IFQ fisheries. The FMP includes an IFQ cost recovery program, whereby NMFS will collect up to 3% of ex-vessel value of landed product to cover actual costs directly related to enforcement and management of the IFQ program. IFQ permit holders are required to submit a cost recovery payment annually via a pre-existing Federal payment system called
The FMP contains provisions that authorize allocation of a portion of the overall IFQ fishery total allowable catch (TAC) to a self-selected group of IFQ permit holders (sector), provided the sector provides adequate information describing the formation of the sector and its intended plan of operations. Individuals or other entities (corporations, cooperatives, etc.) proposing a sector are required to submit a Sector Allocation Proposal and
Participants will submit paper applications by mail, facsimile, or email.
We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this information collection request. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The New England Fishery Management Council (Council) is scheduling a public hybrid meeting of its Groundfish Recreational and Advisory Panels to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). This meeting will be held in-person with a webinar option. Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Monday, October 28, 2024, at 12:30 p.m.
This meeting will be held at the Hilton Garden Inn, 100 High Street, Portsmouth, NH 03801; telephone: (603) 431-1499.
Cate O'Keefe, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Groundfish Recreational and Advisory Panels will meet to receive an update on development of draft alternatives in Framework Adjustment 69/Specifications and Management Measures, including potential recommendations to the Groundfish Committee. They will receive an update on development of the Atlantic Cod Management Transition Plan. The Panel's will also make recommendations to the Groundfish Committee, as appropriate. Other business will be discussed, if necessary.
Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Cate O'Keefe, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The New England Fishery Management Council (Council) is scheduling a public hybrid meeting of its Groundfish Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). This meeting will be held in-person with a webinar option. Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Tuesday, October 29, 2024, at 9 a.m.
Cate O'Keefe, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Groundfish Committee will meet to discuss recommendations from the Recreational Advisory Panel, Groundfish Advisory Panel, and Groundfish Plan Development Team. They will receive an update on development of draft alternatives in Framework Adjustment 69/Specifications and Management Measures, including potential recommendations to the Council. The Committee will receive an update on development of the Atlantic Cod Management Transition Plan. Other business will be discussed, if necessary.
Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Cate O'Keefe, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
The Department of Commerce will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. We invite the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. Public comments were previously requested via the
National marine sanctuary regulations provide that the public can submit areas of the marine and Great Lakes environments for consideration by NOAA as a national marine sanctuary through the sanctuary nomination process (15 CFR 922.12). Persons wanting to submit nominations for consideration should submit information on the qualifying criteria and management considerations for the site to be nominated. The Office of National Marine Sanctuaries reviews the submissions, which could result in the nomination being added to an inventory of areas that NOAA may consider for sanctuary designation at some point in the future. Sanctuary designation is a separate public process that would be conducted pursuant to the requirements of the National Marine Sanctuaries Act, and all other applicable laws. This proposed information collection is for national marine sanctuary nominations received pursuant to NOAA regulations that provide that the public may nominate special places of the marine environment through the sanctuary nomination process at 15 CFR 922.12.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be submitted within 30 days of the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of letter of authorization.
In accordance with the Marine Mammal Protection Act (MMPA), as amended, its implementing regulations, and NMFS' MMPA Regulations for Taking Marine Mammals Incidental to Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico (GOM), notification is hereby given that NMFS has issued a Letter of Authorization (LOA) to WesternGeco for the take of marine mammals incidental to geophysical survey activity in the GOM.
This LOA is effective from October 3, 2024 through November 15, 2024.
The LOA, LOA request, and supporting documentation are available online at:
Rachel Wachtendonk, Office of Protected Resources, NMFS, (301) 427-8401.
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
On January 19, 2021, we issued a final rule with regulations to govern the unintentional taking of marine mammals incidental to geophysical survey activities conducted by oil and gas industry operators, and those persons authorized to conduct activities on their behalf (collectively “industry operators”), in U.S. waters of the GOM over the course of 5 years (86 FR 5322). The rule was based on our findings that the total taking from the specified activities over the 5-year period will have a negligible impact on the affected species or stock(s) of marine mammals and will not have an unmitigable adverse impact on the availability of those species or stocks for subsistence uses, and became effective on April 19, 2021.
The regulations at 50 CFR 217.180
NMFS subsequently discovered that the 2021 rule was based on erroneous take estimates. We conducted another rulemaking using correct take estimates and other newly available and pertinent information relevant to the analyses supporting some of the findings in the 2021 final rule and the taking allowable under the regulations. We issued a final rule in April 2024, effective May 24, 2024 (89 FR 31488).
The 2024 final rule made no changes to the specified activities or the specified geographical region in which those activities would be conducted, nor to the original 5-year period of effectiveness. In consideration of the new information, the 2024 rule presented new analyses supporting affirmance of the negligible impact determinations for all species, and affirmed that the existing regulations, which contain mitigation, monitoring, and reporting requirements, are consistent with the “least practicable adverse impact” standard of the MMPA.
NMFS issued a LOA to TGS on September 27, 2023, for the take of marine mammals incidental to a 3-dimensional ocean bottom node survey in the Green Canyon, Ewing Bank, and Atwater Valley protraction areas, including approximately 380 lease blocks, effective September 27, 2023, through September 28, 2024. Please see the
On December 20, 2023, TGS requested the transfer of the LOA to WesternGeco, its partner in the planned survey effort. WesternGeco confirmed to NMFS that it similarly requested transfer of the LOA. No other changes were requested. The revised LOA remained effective through
WesternGeco notified NMFS that due to survey delays it had not completed the survey plan described in the initial LOA request submitted by TGS and, because the original LOA has expired, has requested that an additional LOA be issued effective through November 15, 2024, to cover completion of the planned survey effort.
Although this is technically a new LOA, NMFS considers this to be functionally an extension of the original LOA, as the survey activity considered herein represents the conclusion of the originally planned survey. Of the originally planned 65 days of sound source operations, approximately 16 days of surveying remains, all in Zone 5. There are no other changes to WesternGeco's planned activity, as described in the original notice of issuance (88 FR 68106, October 3, 2023). On this basis, NMFS has updated take estimates based on information provided in the 2024 final rule (89 FR 31488, April 24, 2024), and corresponding with the estimated 16 days of remaining survey activity. As WesternGeco's is using conventional airgun sources consisting of 28 elements, with a total volume of 5,240 cubic inches (or the less-impactful Gemini source), we have used the 5,110 cu in airgun array proxy to estimate the take numbers.
Based on the results of our analysis, NMFS has determined that the level of taking expected for this survey and authorized through the LOA is consistent with the findings made for the total taking allowable under the regulations. See table 1 in this notice and table 6 of the rule (89 FR 31488, April 24, 2024).
Under the GOM rule, NMFS may not authorize incidental take of marine mammals in an LOA if it will exceed “small numbers.” In short, when an acceptable estimate of the individual marine mammals taken is available, if the estimated number of individual animals taken is up to, but not greater than, one-third of the best available abundance estimate, NMFS will determine that the numbers of marine mammals taken of a species or stock are small (89 FR 31535, May 24, 2024). For more information please see NMFS' discussion of small numbers in the 2021 final rule (86 FR 5438, January 19, 2021).
The take numbers for authorization are determined as described above in the Summary of Request and Analysis section. Subsequently, the total incidents of harassment for each species are multiplied by scalar ratios to produce a derived product that better reflects the number of individuals likely to be taken within a survey (as compared to the total number of instances of take), accounting for the likelihood that some individual marine mammals may be taken on more than 1 day (86 FR 5404, January 19, 2021; 89 FR 31535, May 24, 2024). The output of this scaling, where appropriate, is incorporated into adjusted total take estimates that are the basis for NMFS' small numbers determinations, as depicted in table 1. Normally, a survey with a duration of 16 days would not apply scalar ratios for the small numbers determination. However, scalar ratios were used in this instance since we consider this survey a continuation of the original 65 day survey.
This product is used by NMFS in making the necessary small numbers determinations through comparison with the best available abundance estimates (see discussion at 86 FR 5391, January 19, 2021). For this comparison, NMFS' approach is to use the maximum theoretical population, determined through review of current stock assessment reports (SAR
Based on the analysis contained herein of WesternGeco's modified survey activity described in its LOA modification requesr and the anticipated take of marine mammals, NMFS finds that small numbers of
NMFS has determined that the level of taking for this modified LOA request is consistent with the findings made for the total taking allowable under the incidental take regulations and that the amount of take authorized under the LOA is of no more than small numbers. Accordingly, we have issued an LOA to WesternGeco authorizing the take of marine mammals incidental to its geophysical survey activity, as described above.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The South Atlantic Fishery Management Council (Council) will hold a meeting of its Citizen Science Operations Committee October 30-31, 2024. The meeting will be held in Charleston, SC.
The Citizen Science Operations Committee meeting will be held Wednesday, October 30, 2024, from 1 p.m. until 5 p.m. and Thursday, October 31, 2024, from 8:30 a.m. until 12 p.m.
The meeting will be held at the South Atlantic Fishery Management Council office, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405. The meeting is open to the public and will also be available via webinar. Webinar registration, an online public comment form, and briefing book materials will be available two weeks prior to the meeting at:
Julia Byrd, Citizen Science Program Manager, SAFMC; phone: (843) 302-8439 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email:
The Citizen Science Operations Committee serves as advisors to the Council's Citizen Science Program. Committee members include representatives from the Council's Citizen Science Advisory Panel Pool, NOAA Fisheries' Southeast Regional Office, NOAA Fisheries' Southeast Fisheries Science Center, and the Council's Science and Statistical Committee. Their responsibilities include developing programmatic recommendations, reviewing policies, providing program direction/multi-partner support, identifying citizen science research needs, and providing general advice.
These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see
The times and sequence specified in this agenda are subject to change.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of SEDAR 84 Assessment Webinar IX for U.S Caribbean Yellowtail Snapper and Stoplight Parrotfish.
The SEDAR 84 assessment process of U.S. Caribbean yellowtail snapper and stoplight parrotfish will consist of a Data Workshop, and a series of assessment webinars, and a Review Workshop. See
The SEDAR 84 assessment webinar IX will be held Wednesday, October 30, 2024, from 1 p.m. to 4 p.m., Eastern Time.
The meeting will be held via webinar. The webinar is open to members of the public. Those interested in participating should contact Julie A. Neer at SEDAR (see
Julie A. Neer, SEDAR Coordinator; phone: (843) 571-4366; email:
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a multi-step process including: (1) Data Workshop, (2) a series of assessment webinars, and (3) A Review Workshop. The product of the Data Workshop is a report that compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The assessment webinars produce a report that describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The product of the Review Workshop is an Assessment Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office,
The items of discussion during the Assessment webinar IX are as follows:
Panelists will review and discuss and finalize the assessment modeling for stoplight parrotfish and yellowtail snapper.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see
The times and sequence specified in this agenda are subject to change.
Federal Energy Regulatory Commission.
Notice of information collection and request for comments.
In compliance with the requirements of the Paperwork Reduction Act of 1995 (PRA), the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC 725L (Mandatory Reliability Standards for the Bulk-Power System: MOD Reliability Standards). The 60-day notice comment period ended on September 27, 2024, and no comments were received.
Comments on the collection of information are due November 12, 2024.
Send written comments on FERC-725L to OMB through
Please submit copies of your comments to the Commission. You may submit copies of your comments (identified by Docket No. IC24-17-000) by one of the following methods:
Electronic filing through
•
• For those unable to file electronically, comments may be filed by USPS mail or by other delivery methods:
○
○
Kayla Williams may be reached by email at
On May 30, 2013, the North American Electric Reliability Corporation (NERC) filed a petition explaining that the reliability of the Bulk-Power System benefits from “good quality simulation models of power system equipment,” and that “model validation ensures the proper performance of the control systems and validates the computer models used for stability analysis.” NERC further stated that the Reliability Standards will enhance reliability because the tests performed to obtain model data may reveal latent defects that could cause “inappropriate unit response during system disturbances.”
On May 1, 2014,
MOD-025-2, MOD-026-1, MOD-027-1, MOD-031-3, MOD-032-1, and MOD-033-2 are all currently approved within the FERC-725L information collection. The reporting requirements associated with each standard will not change as a result of this extension request.
PA = Planning Authority, GO = Generator Owner, TP = Transmission Planner, BA = Balancing Authority, RP = Resource Planner, TSP = Transmission Service Provider, RC = Reliability Coordinator, TOP = Transmission Operator.
The total
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA or Agency) is announcing the availability of the final framework for expanding interagency collaboration to improve the communication and knowledge base within the federal family to fully consider potential adverse impact of pesticides on efficacy of human and animal drugs. In particular, the use of antifungal and antibacterial pesticides that can potentially lead to resistance in human and animal pathogens and may compromise the effectiveness of medically important antibacterial and antifungal drugs.
The Framework is effective October 10, 2024.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2023-0445, is available online at
Susan Jennings, Immediate Office (7501M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (706) 355-8574; email address:
This action is directed to the public in general, although this action may be of particular interest to those persons who may be interested in assessments of potential risks to human and animal health where the use of certain pesticides could potentially result in antimicrobial resistance that compromises the effectiveness of medically important antibacterial and antifungal drugs. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
This action is being taken under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136
EPA is announcing the availability of a final Framework that outlines a process for EPA's collaboration with other federal agencies that recognizes the benefits of these pesticides to agriculture while minimizing their impact on public health and considers the goals of the One Health approach. While developing this Framework, EPA has coordinated with HHS and USDA, under the oversight of the White House Executive Office of the President. Each of these agencies is charged with protecting health in areas that are directly impacted by resistance resulting from pesticides or drug products used to protect humans, animals, or plants. This Framework clarifies that EPA intends to establish a process with those other federal agencies to consider their input when EPA evaluates antibacterial and antifungal pesticide products that may adversely impact the efficacy of human or animal drugs.
EPA is issuing this Framework to provide information and clarification to pesticide applicants, growers, the public health community, and the public about EPA's process for considering resistance issues related to regulatory decisions on antibacterial and antifungal pesticides with other federal agencies. While the requirements in FIFRA and the EPA regulations are binding on EPA and applicants, this Framework is not binding on EPA personnel, pesticide registrants and applicants, or the public. EPA may depart from the Framework where circumstances warrant and without prior notice. Likewise, pesticide applicants may assert that the Framework is not applicable to a specific pesticide or decision. Registrants and applicants may also propose alternative processes to the final Framework in any application to EPA.
Antimicrobial resistance in bacteria and fungi is a top threat to the public's health and a priority across the globe. The Centers for Disease Control and Prevention report that there are nearly 3 million antimicrobial-resistant infections and more than 35,000 associated deaths in the U.S. each year. According to USDA, plant diseases are also persistent threats to agricultural crops and global food security, having a significant impact on yields and quality. These diseases result in billions of dollars in economic losses and management inputs each year to crops, landscapes, and forests in the U.S. Plant diseases reduce yields, lower product quality or shelf-life, decrease aesthetic or nutritional value, and may contaminate food and feed with toxic compounds.
Determining a compound's potential to result in the development of antimicrobial resistance is complex. This Framework is intended to expand interagency collaboration to improve the
On September 26, 2023, EPA and the other federal agencies issued a document entitled “Concept Note: Soliciting Feedback from Stakeholders on the Structure of a Proposed Framework to Assess the Risk to the Effectiveness of Human and Animal Drugs Posed by Certain Antibacterial or Antifungal Pesticides” (88 FR 65998) (FRL-11370-01-OCSPP). The concept note was intended to be the first step in creating a process to improve assessments of potential risks to human and animal health where the use of certain pesticides could potentially result in antimicrobial resistance that compromises the effectiveness of medically important antibacterial and antifungal drugs. The concept note solicited stakeholder input on the proposed structure for the process and potential solutions, research, and mitigation approaches to reduce the spread of resistance. The concept note posed several questions about how resistance occurs and is spread. The Agency received many comments; however, very few directly responded to the specific charge questions asked by the concept paper. The agencies did not receive sufficient information to resolve the many scientific questions about assessing the potential risk of antifungal or antibacterial pesticides to adversely impact the efficacy of human or animal drugs.
On July 2, 2024, EPA announced the availability of and requested comment on the draft framework entitled “Pesticides; Final White Paper: Framework for Interagency Collaboration to Review Potential Antibacterial and Antifungal Resistance Risks Associated with Pesticide Use” (89 FR 54819) (FRL-11370-03-OCSPP). Fourteen comments were received. Commenters included grower groups (three), industry groups (four), consulting groups (one), public interest groups (one), human health groups (three), animal health group (one), and one private citizen.
These groups raised a number of issues. The industry and grower groups stressed the benefits of pesticides, the need for a transparent process, concerns about the research uncertainties, and several advocated for EPA to wait to take action until the scientific issues are more resolved. The health groups were concerned about the implications of resistance to humans and animals who need effective drugs to combat disease.
All public comments and EPA's responses to comments received, including those that do not raise significant issues or substantially change the proposed requirements, are included in Response to Comments document that is available in the docket for this action. After considering the public comments, EPA is issuing the Framework.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA or Agency) is announcing the availability of interim guidance to expand the availability of virucidal claims for antimicrobial pesticides and provide a framework for registrants who seek to make such claims. This interim guidance reiterates recommended test methods and guidance for the addition of virucidal claims to products that meet the criteria for hard surface disinfection claims and the addition of virucidal claims to products that meet the criteria for food/non-food contact sanitizer claims consistent with current test guidelines. This guidance specifically covers the addition of a virucidal claim to a product that has met the criteria for a bactericidal disinfectant and/or sanitizer. Pursuant to this guidance, the Agency intends to grant the addition of virucidal claims associated with sanitizer claims for a time-limited period of a maximum of ten years. Prior to the end of the ten-year period, the Agency will review the record and may terminate the policy, make suggestions for changes to the policy, as necessary, or decide to make the policy permanent. The methods and performance standards applicable to this expanded availability of virucidal claims are the same test methods and performance standards that are currently used to support existing virucidal claims and thus there are no expectations of a reduction of product performance against viruses.
This interim guidance is effective October 10, 2024.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2023-0288, is available online at
Tahirah Morris, Antimicrobial Division (7510M), Office of Pesticide Programs, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 566-0798; email address:
This action is directed to the general public and may be of specific interest to persons or entities that register antimicrobial pesticides. Since a potentially broad range of entities may be interested in this action, the Agency has not attempted to describe all the specific entities that may be interested. If you have any questions regarding the applicability of this interim guidance to a particular entity or registration action, contact the person listed under
EPA is issuing this guidance pursuant to its authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. 136
EPA is announcing the availability of interim guidance to expand the availability of virucidal claims for antimicrobial pesticides and provide a framework for registrants who seek to make such claims. The guidance document was revised based on the public comments received in 2023 (88 FR 45418, July 17, 2023 (FRL-11108-01-OCSPP). EPA received 5 comments, which are summarized and responded to in a response to comment document that is available in the docket.
This interim guidance reiterates recommended test methods and guidance for the addition of virucidal claims to products that meet the criteria for hard surface disinfection claims and
Pursuant to this guidance, the Agency intends to grant the addition of virucidal claims associated with sanitizer claims for a time-limited period of a maximum of ten years. Prior to the end of the ten-year period, the Agency will review the record and may terminate the policy, make suggestions for changes to the policy, as necessary, or decide to make the policy permanent. The methods and performance standards applicable to this expanded availability of virucidal claims are the same test methods and performance standards that are currently used to support existing virucidal claims and thus there are no expectations of a reduction of product performance against viruses.
Historically, EPA has approved claims for efficacy against viruses only as additional claims on certain antimicrobial products, such as those with sterilant and disinfectant claims, but not those that bear only sanitizer claims.
This guidance is intended to allow registrants to provide consumers with additional products that are effective against viruses including SARS-CoV-2. This guidance reiterates recommended test methods and guidance for the addition of virucidal claims to products that meet the criteria for hard surface disinfection claims in OCSPP 810.2200, Disinfectants for Use on Environmental Surfaces, Guidance for Efficacy Testing.
Products with only sanitizer claims should meet the test guidance requirements as described in OCSPP 810.2300 Sanitizers for Use on Hard Surfaces—Efficacy Data Recommendations (food or non-food contact sanitization) to treat hard, non-porous surfaces before a virucidal claim is added pursuant to this guidance.
Since there will be no changes to the test methods or performance standards recommended for virus claims, there is no concern about a reduced level of efficacy against viruses. Products that meet the basic criteria to allow for sanitizer claims and have data to support the addition of virucidal label claims pursuant to this guidance, may be used in non-healthcare use-sites in residential, commercial, and institutional settings (
Additional anticipated benefits include the availability of more products with reduced contact times (time the surface must remain wet) and/or more products on EPA's Design for the Environment list that are also effective against viruses. The expansion of the availability of virucidal claims under this guidance will facilitate the addition of virus claims to products bearing only sanitizer claims.
As guidance, these documents are not binding on the Agency or any outside parties, and the Agency may depart from it where circumstances warrant and without prior notice. While EPA has made every effort to ensure the accuracy of the discussion in the guidance, the obligations of EPA and the regulated community are determined by statutes, regulations, or other legally binding documents. In the event of a conflict between the discussion in the guidance documents and any statute, regulation, or other legally binding document, the guidance documents will not be controlling.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Publicly Owned Treatment Works (POTW) Influent Per- and Polyfluoroalkyl Substances (PFAS) Study and National Sewage Sludge Survey (NSSS) (EPA ICR Number 2799.01, OMB Control Number 2040-NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a request for approval of a new collection. Public comments were previously requested via the
Comments may be submitted on or before November 12, 2024.
Submit your comments, referencing Docket ID Number EPA-HQ-OW-2023-0580, to EPA online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Sean Dempsey, Engineering and Analysis Division, Office of Science and Technology, (4303T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-564-5088; email address:
This is a request for approval of a new collection. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Public comments were previously requested via the
The Clean Water Act directs the EPA to develop national regulations known as Effluent Limitations Guidelines and Standards (ELGs) to place limits on the pollutants that are discharged by categories of industry to surface waters and POTWs. Additionally, Section 405(d) of the Clean Water Act requires that the EPA establish requirements for the use or disposal of sewage sludge and review the regulations every two years to identify additional pollutants.
For many decades, industrial facilities have used and discharged PFAS into the environment. PFAS are a class of synthetic chemicals of concern to the EPA because of their widespread use and potential to accumulate in the environment. Certain PFAS are known to cause adverse ecological and human health effects.
The EPA will require, through an OMB-approved Information Collection Request, a subset of large POTWs across the United States to complete an electronic questionnaire and collect and analyze wastewater and sewage sludge samples. The data collection activities will produce a robust data set that will characterize the type and quantity of PFAS in wastewater discharges from industrial users (including industrial categories that the EPA has determined historically or currently use PFAS but for which there is insufficient PFAS monitoring data available), domestic wastewater or sewage, and POTW influent, effluent, and sewage sludge. The wastewater sampling data will primarily be used to identify and prioritize industrial point source categories where additional study or regulations may be warranted to control PFAS discharges. The sewage sludge sampling will fulfill the EPA's data needs for the upcoming NSSS by establishing a current national data set of sewage sludge characteristics which the EPA will subsequently use to inform upcoming risk assessments and the need for future regulations and guidance pertaining to the management of sewage sludge.
As part of the POTW Influent PFAS Study and NSSS, the EPA estimates that approximately 400 POTWs (individual wastewater or standalone wastewater treatment plans, as defined by Section 212 of the Clean Water Act, which is owned by a state or municipality) with a daily design flow rates greater than or equal to 10 million gallons per day (MGD) and a service population greater than or equal to 50,000 people will be required to complete an electronic questionnaire. The questionnaire will gather POTW-specific information and data on industrial users discharging to the POTW, known or suspected sources of PFAS discharges to the POTW, and wastewater and sewage sludge management practices of the POTW. The EPA will use the information and data collected in the questionnaire to select a subset of 200 to 300 of the 400 POTWs to participate in the POTW Influent PFAS Study and the NSSS's sampling programs.
Environmental Protection Agency (EPA).
Notice.
Notice is hereby given of the membership of the U.S. Environmental Protection Agency (EPA) Performance Review Board for 2024.
Lizabeth Engebretson, Acting Director, Strategic HR Insights Division, 3606R, Office of Human Resources Strategy, Office of Mission Support, U.S. Environmental Protection Agency, 1300 Pennsylvania Avenue NW, Washington, DC 20460, telephone number: (202) 564-0804, email address:
Section 4314(c)(1) through (5) of title 5, U.S.C., requires each agency to establish in accordance with regulations prescribed by the Office of Personnel Management, one or more SES performance review boards. This board shall review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any recommendations to the appointment authority relative to the performance of the senior executive. Members of the 2024 EPA Performance Review Board are:
Denise Benjamin-Sirmons, Director, Office of Small and Disadvantaged Business Utilization, Office of the Administrator.
Erica Canzler, Director, National Enforcement Investigations Center, Office of Enforcement and Compliance Assurance.
Louis D'Amico, Associate Director for Science, Office of Science Advisor, Policy and Engagement, Office of Research and Development.
Jeffrey Dawson, Senior Science Advisor, Office of Chemical Safety and Pollution Prevention.
Lizabeth Engebretson, (Ex-Officio) Deputy Director, Strategic HR Insights Division, Office of Human Resources Strategy, Office of Mission Support.
Caroline Freeman, Director, Superfund and Emergency Management Division, Region 4.
Alice Gilliland, Deputy Director for Management, Center for Environmental Measurement and Modeling, Office of Research and Development.
Michael Harris, Director, Enforcement and Compliance Division, Region 5.
JuanCarlos Hunt, (Ex-Officio) Director, Office of Civil Rights, Office of the Administrator.
Meshell Jones-Peeler, Controller, Office of the Chief Financial Officer.
Mara J. Kamen, (Ex-Officio) Director, Office of Human Resources Strategy, Office of Mission Support.
Wynne Miller, Deputy Director, Office of Wastewater Management, Office of Water.
Javier Laureano, Director, Water Division, Region 2.
Madison Le, Director, Biopesticides and Pollution Prevention Division, Office of Chemical Safety and Pollution Prevention.
Pamela Legare, Director, Office of Acquisition Solutions, Office of Mission Support.
David Lloyd, Director, Office of Brownfields and Land Revitalization, Office of Land and Emergency Management.
Vickie Richardson, Director, Office of Management and International Services, Office of International and Tribal Affairs.
Cheryl Seager, Director, Enforcement and Compliance Assurance Division, Region 6.
Helen Serassio, Associate General, Cross-Cutting Issues Law Office, Office of General Counsel.
Richard “Chet” Wayland, Director, Air Quality Assessment Division, Office of Air and Radiation.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Promoting Readiness and Enhancing Proficiency to Advance Reporting and Data (PREPARED) Program: Post-Award Reporting and Public Outreach Information Collections (EPA ICR Number 2804.01, OMB Control Number 2090-NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a request for approval of a new collection. Public comments were previously requested via the
Comments may be submitted on or before November 12, 2024.
Submit your comments, referencing Docket ID Number EPA-HQ- OCFO-2024-0048 to EPA online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Alex Valdez, Office of the Chief Financial Officer, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; email address:
This is a request for approval of a new collection. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Public comments were previously requested via the
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.” The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments and recommendations for the proposed information collection should be submitted on or before November 12, 2024.
Comments should be sent to
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) go to the web page
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, as part of its obligations under the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to take this opportunity to comment on the renewal of the existing information collections described below (OMB Control No. 3064-0165).
Comments must be submitted on or before December 9, 2024.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
•
•
•
•
All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Manny Cabeza, Regulatory Counsel, 202-898-3767,
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments received are subject to public disclosure. In general, comments received will be made available without change and will not be modified to remove personal or business information including confidential, contact, or other identifying information. Comments should not include any information such as confidential information that would not be appropriate for public disclosure.
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551-0001, not later than November 12, 2024.
A. Federal Reserve Bank of New York (Bank Applications Officer) 33 Liberty Street, New York, New York 10045-0001. Comments can also be sent electronically to
1.
B. Federal Reserve Bank of St. Louis (Holly A. Rieser, Senior Manager) P.O. Box 442, St. Louis, Missouri 63166-2034. Comments can also be sent electronically to
1.
C. Federal Reserve Bank of Minneapolis (Mark Rauzi, Vice President), 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291. Comments can also be sent electronically to
1.
Board of Governors of the Federal Reserve System.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the extension without change of the previously approved information collection project “Nursing Home Survey on Patient Safety Culture Database,” OMB No. 0935-0195. This information collection was previously published in the
Comments on this notice must be received by November 12, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email
In 1999, the Institute of Medicine called for healthcare organizations to develop a “culture of safety” such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999; To Err is Human: Building a Safer Health System). To respond to the need for tools to assess patient safety culture in healthcare, AHRQ developed and pilot tested the Surveys on Patient Safety Culture® (SOPS®) Nursing Home Survey with OMB approval (OMB No. 0935-0132). The survey is designed to enable nursing homes to assess provider and staff perspectives about patient safety issues, medical error, and error reporting and includes 42 items that measure 12 composites of patient safety culture. AHRQ made the survey publicly available along with a Survey User's Guide and other toolkit materials in November 2008 on the AHRQ website.
The AHRQ SOPS Nursing Home Database consists of data from the AHRQ Nursing Home Survey on Patient Safety Culture and may include
The SOPS Nursing Home Survey and the SOPS Nursing Home Database support AHRQ's goals of promoting improvements in the quality and safety of healthcare in nursing home settings. The survey, toolkit materials, and database results are all made publicly available on AHRQ's website. Technical assistance is provided by AHRQ through its contractor at no charge to nursing homes, to facilitate the use of these materials for nursing home patient safety and quality improvement.
• Promote improvements in the quality and safety of healthcare in nursing home settings,
• Present results from nursing homes that voluntarily submit their data,
• Provide data to nursing homes to facilitate internal assessment and learning in the patient safety improvement process, and
• Provide supplemental information to help nursing homes identify their strengths and areas with potential for improvement in patient safety culture.
This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services; quality measurement and improvement; and database development. 42 U.S.C 299a(a)(1), (2), and (8).
To achieve the goal of this project the following activities and data collections will be implemented:
(1)
(2)
(3)
(4)
Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. An estimated 50 POCs, each representing an average of 1 individual nursing home each, will complete the database submission steps and forms. Each POC will submit the following:
1. Eligibility and registration form (completion is estimated to take about 3 minutes).
2. Data Use Agreement (completion is estimated to take about 3 minutes).
3. Nursing Home Site Information Form (completion is estimated to take about 5 minutes).
4. Survey data submission will take an average of one hour.
The total annual burden hours are estimated to be 60 hours.
Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $2,903 annually.
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, comments on AHRQ's information collection are requested with regard to any of the following: (a) whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing the availability of CMS' final guidance for the second cycle of the Medicare Drug Price Negotiation Program and manufacturer effectuation of the maximum fair price in 2026 and 2027 for the implementation of the Inflation Reduction Act. This and other Inflation Reduction Act-related guidance can be viewed on the dedicated Inflation Reduction Act section of the CMS website at
Inquiries related to the final guidance should be sent to
The Inflation Reduction Act was signed into law on August 16, 2022. Sections 11001 and 11002 of the Inflation Reduction Act (IRA) (Pub. L. 117-169) established the Medicare Drug Price Negotiation Program (hereafter the “Negotiation Program”) to negotiate maximum fair prices (MFPs) for certain high expenditure, single source drugs and biological products. The requirements for this program are described in sections 1191 through 1198 of the Social Security Act (hereafter “the Act”) as added by sections 11001 and 11002 of the IRA. The final guidance summarizes and addresses comments received on the draft guidance issued on May 3, 2024 and describes how CMS intends to implement the Negotiation Program for Initial Price Applicability Year 2027 (January 1, 2027 to December 31, 2027), and specifies the requirements for manufacturer effectuation of the MFPs in 2026 and 2027. To obtain copies of the Negotiation Program final guidance and other Inflation Reduction Act-related documents, please access the CMS Inflation Reduction Act website by copying and pasting the following web address into your web browser:
Office of Planning, Research, and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.
Request for public comments.
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services seeks approval to collect information to deepen our understanding of Head Start programs' funding approaches, as well as how the use of multiple funding sources within a single Head Start program may be associated with the delivery of Head Start's comprehensive services and early care and education (ECE) funding landscapes within states. Interviews will be conducted with Head Start staff, as well as state and local/regional staff knowledgeable about and/or directly responsible for ECE financial decision making and/or funding source administration. Existing documents from Head Start programs and ECE agencies will also be reviewed to further contextualize interview data.
You can obtain copies of the proposed collection of information and submit comments by emailing
Studies 1 and 2 will both include semi-structured interviews with staff within Head Start programs and state government agencies, and Study 2 will also include interviews with staff within local/regional coordinating entities (LCEs). The interviews will probe on approaches to using multiple funding sources at state, local/regional, and Head Start program levels, including how Head Start programs use multiple funding sources to support high-quality programming, how Head Start program funding approaches are shaped by system-level approaches and structures, and the implications of using multiple funding sources for access, quality, and equity in ECE programming. Because of slight differences in the ECE funding landscape across states that do and do not combine funding at the state level, different interview protocols have been created within each study for state agency staff in states that do combine funding at the state level and staff in states that do not combine funding at the state level. Similarly, separate protocols were created for use in Head Start programs that do or do not use multiple funding sources. There is a single interview protocol for staff of LCEs with statutorily defined ECE financing authority.
Interviewers will also request and collect existing policy and/or budget-related documentation that may further contextualize respondent accounts and perspectives.
The resulting insights will inform ACF about the implementation of different funding models supporting Head Start programs, the facilitators that support and challenges that deter the use of multiple funding sources, and potential associations with program quality.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications. and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute on Drug Abuse. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute on Drug Abuse, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and
Comments must reach the Coast Guard on or before December 9, 2024.
You may submit comments identified by Coast Guard docket number [USCG-2024-0882] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the internet at
A.L. Craig, Office of Privacy Management, telephone 202-475-3528, fax 202-372-8405, or email
This notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. 3501
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) the practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology.
In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, USCG-2024-0882, and must be received by December 9, 2024.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. Comments we post to
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0014, Request for Designation and Exemption of Oceanographic Research Vessels; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before December 9, 2024.
You may submit comments identified by Coast Guard docket number [USCG-2024-0785] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the internet at
A.L. Craig, Office of Privacy Management, telephone 202-475-3528, fax 202-372-8405, or email
This notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. 3501
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) the practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology.
In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, USCG-2024-0785, and must be received by December 9, 2024.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. Comments we post to
Federal Emergency Management Agency, Department of Homeland Security.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
Comments are to be submitted on or before January 8, 2025.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-2461, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Federal Emergency Management Agency, Department of Homeland Security.
Notice of open Federal advisory committee meeting.
The Board of Visitors for the National Fire Academy (Board) will meet virtually on Monday, December 2, 2024. The meeting will be open to the public.
The meeting will take place on Monday, December 2, 2024, 1 p.m. to 3 p.m. Eastern Standard Time (EST). Please note that the meeting may close early if the Board has completed its business.
Members of the public who wish to participate in the virtual conference should contact Deborah Gartrell-Kemp as listed in the
To facilitate public participation, we are inviting public comment on the issues to be considered by the Board as listed in the
•
•
The Board will meet virtually on Monday, December 2, 2024. The meeting will be open to the public. Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. chapter 10.
The purpose of the Board is to review annually the programs of the National Fire Academy (Academy) and advise the Administrator of the Federal Emergency Management Agency (FEMA), through the United States Fire Administrator, on the operation of the Academy and any improvements therein that the Board deems appropriate. In carrying out its responsibilities, the Board examines Academy programs to determine whether these programs further the basic missions that are approved by the Administrator of FEMA, examines the physical plant of the Academy to determine the adequacy of the Academy's facilities, and examines the funding levels for Academy programs. The Board submits a written annual report through the United States Fire Administrator to the Administrator of FEMA. The report provides detailed comments and recommendations regarding the operation of the Academy.
On Monday, December 2, 2024, there will be four sessions, with deliberations and voting at the end of each session as necessary:
1. The Board will discuss United States Fire Administration Data, Emergency Medical Services (EMS), Research, Prevention and Response.
2. The Board will discuss deferred maintenance and capital improvements on the National Emergency Training Center campus and Fiscal Year 2025 and beyond Budget Request/Budget Planning.
3. The Board will deliberate and vote on recommendations on Academy program activities to include developments, deliveries, staffing, admissions, and strategic plan.
4. There will also be an update on the Board of Visitors Subcommittee Groups for the Professional Development Initiative Update and the National Fire Incident Report System.
There will be a 10-minute public comment period after each agenda item and each speaker will be given no more than 2 minutes to speak. Please note that the public comment period may end before the time indicated following the last call for comments. Contact Deborah Gartrell-Kemp to register as a speaker. Meeting materials will be posted by November 15, 2024, at
Fish and Wildlife Service, Interior.
Request for nominations.
The U.S. Department of the Interior and the Department of Agriculture are seeking nominations to the Hunting and Wildlife Conservation Council (Council) to fill one vacancy for a representative from a state fish and wildlife management agency. The Council provides recommendations to the Federal Government, through the Secretary of the Interior and the Secretary of Agriculture, regarding the establishment and implementation of existing and proposed policies and authorities with regard to wildlife and habitat conservation endeavors that benefit wildlife resources; encourage partnership among the public, sporting conservation organizations, wildlife-associated recreation interests, and Federal, State, Tribal, and territorial governments; and benefit fair-chase recreational hunting and safe recreational shooting sports.
Nominations for the Council must be submitted by November 12, 2024.
You may submit nominations via email to
Douglas Hobbs, Designated Federal Officer, by email at
The Council is established under the authority of the Secretaries of the Department of the Interior (DOI) and the Department of Agriculture (Secretaries) and is regulated by the Federal Advisory Committee Act, as amended (FACA; 5 U.S.C. ch. 10). The Council's duties are strictly advisory and consist of, but are not limited to, providing recommendations for implementation of Executive Order (E.O.) 13443, Facilitation of Hunting Heritage and Wildlife Conservation; E.O. 14008, Tackling the Climate Crisis at Home and Abroad; and Secretarial Order (S.O.) 3362, Improving Habitat Quality in Western Big Game Winter Range and Migration Corridors. Duties include, but are not limited to:
A. Assessing and quantifying implementation of E.O. 13443, E.O. 14008, and S.O. 3362 across relevant departments, agencies, and offices and making recommendations to enhance and expand their implementation as identified;
B. Making recommendations regarding policies and programs that accomplish the following objectives:
1. Conserve and restore wetlands, grasslands, forests, and other important wildlife habitats, and improve management of rangelands and agricultural lands to benefit wildlife;
2. Promote opportunities for fair-chase hunting and safe recreational shooting sports and wildlife-associated recreation on public and private lands;
3. Encourage hunting and recreational shooting sports safety, including by developing sighting-in ranges on public lands;
4. Recruit and retain hunters;
5. Increase public awareness of the importance of wildlife conservation and the social and economic benefits of fair-chase hunting, safe recreational shooting sports, and wildlife-associated recreation; and
6. Encourage coordination among the public; the hunting and shooting sports communities; wildlife conservation groups; wildlife-associated recreation interests; and Federal, State, Tribal, and territorial governments.
The Secretaries appoint members and their alternates to the Council to serve up to a 3-year term. The Council will not exceed 18 discretionary primary members, up to 18 alternate members, and 4 ex officio members. Ex officio members include:
• Secretary of the Interior or designated DOI representatives;
• Secretary of Agriculture or designated Department of Agriculture representatives; and
• Executive Director, Association of Fish and Wildlife Agencies.
The Secretaries select remaining members from among, but not limited to, the organization/interests listed below. These members must be senior-level representatives of their organization and/or have the ability to represent their designated constituencies.
• State fish and wildlife management agencies;
• Wildlife and habitat conservation/management organizations;
• Upland bird hunting organizations;
• Waterfowl hunting organizations;
• Big game hunting organizations;
• Shooting sports interests;
• Archery interests;
• Wildlife-associated recreation interests;
• Tourism, outfitter, and/or guide industries related to hunting and/or wildlife conservation;
• Tribal resource management organizations;
• Agriculture interests;
• Ranching interests; and
• Veterans' service organizations.
Nominations are sought to fill one primary member vacancy to represent State fish and wildlife management agencies.
Nominations should include a cover letter or email and a resume providing an adequate description of the nominee's qualifications, including information that would enable DOI to make an informed decision regarding meeting the membership requirements of the Council and to permit DOI to contact a potential member.
Members of the Council serve without compensation. However, while away from their homes or regular places of business, Council and subcommittee members engaged in Council or subcommittee business that the DFO approves may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by 5 U.S.C. 5703, in the same manner as persons employed intermittently in Federal Government service.
Bureau of Indian Affairs, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Affairs (BIA) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before November 12, 2024.
Written comments and recommendations for the proposed information collection request (ICR) should be sent within 30 days of publication of this notice to the Office of Information and Regulatory Affairs (OIRA) through
To request additional information about this ICR, contact Steven Mullen, Information Collection Clearance Officer, Office of Regulatory Affairs and Collaborative Action—Indian Affairs, U.S. Department of the Interior, 1001 Indian School Road NW, Suite 229, Albuquerque, New Mexico 87104;
In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
A
As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Office of the Secretary, Office of Environmental Policy and Compliance, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Office of the Secretary, Office of Environmental Policy and Compliance, Department of the Interior (we, OS-OEPC) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before November 12, 2024.
Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at
To request additional information about this ICR, contact Shawn Alam, National Environmental Policy Act and Environmental Review Coordination Division by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
On June 7, 2024, we published a
We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) is the collection necessary to the proper functions of the OS-OEPC; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the OS-OEPC enhance the quality, utility, and clarity of the information to be collected; and (5) how might the OS-OEPC minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
On November 23, 2016, the Departments of Agriculture, the Interior, and Commerce published a final rule on the March 31, 2015 revised interim final rule to the interim rule originally published in November 2005 at 7 CFR
Under FPA section 33, the Secretary of the Department involved must accept the proposed alternative if the Secretary determines, based on substantial evidence provided by a party to the license proceeding or otherwise available to the Secretary, (a) that the alternative condition provides for the adequate protection and utilization of the reservation, or that the alternative prescription will be no less protective than the fishway initially proposed by the Secretary, and (b) that the alternative will either cost significantly less to implement or result in improved operation of the project works for electricity production.
In order to make this determination, the regulations require that all of the following information be collected: (1) a description of the alternative, in an equivalent level of detail to the Department's preliminary condition or prescription; (2) an explanation of how the alternative: (i) if a condition, will provide for the adequate protection and utilization of the reservation; or (ii) if a prescription, will be no less protective than the fishway prescribed by the bureau; (3) an explanation of how the alternative, as compared to the preliminary condition or prescription, will: (i) cost significantly less to implement; or (ii) result in improved operation of the project works for electricity production; (4) an explanation of how the alternative or revised alternative will affect: (i) energy supply, distribution, cost, and use; (ii) flood control; (iii) navigation; (iv) water supply; (v) air quality; and (vi) other aspects of environmental quality; and (5) specific citations to any scientific studies, literature, and other documented information relied on to support the proposal.
This notice of proposed renewal of an existing information collection is being published by the Office of Environmental Policy and Compliance, Department of the Interior, on behalf of all three Departments, and the data provided below covers anticipated responses (alternative conditions/prescriptions and associated information) for all three Departments.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (“ALJ”) initial determination (“ID”) (Order No. 7) terminating the investigation based on a settlement agreement and withdrawal of the complaint.
Edward S. Jou, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-3316. Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission's electronic docket (EDIS) at
The Commission instituted this investigation on August 13, 2024, based on a complaint filed by MimirIP LLC of Dallas, Texas (“Mimir”). 89 FR 65931-32 (Aug. 13, 2024). The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain NAND memory devices and electronic devices containing same by reason of infringement of certain claims of U.S. Patent Nos. 8,637,919; 9,245,962; and 10,896,918. The notice of investigation named as respondents: Micron Technology, Inc. (“Micron”) of Boise, Idaho; Acer Inc. of New Taipei City, Taiwan; Acer America Corp. of San Jose, California; HP, Inc. of Palo Alto, California; Kingston Technology Company, Inc. of Fountain Valley, California; Lenovo Group Limited of Hong Kong, China; and Lenovo (United States) Inc. of Morrisville, North Carolina (collectively, “Respondents”). The Office of Unfair Import Investigations (“OUII”) is also a party in this investigation.
On August 28, 2024, Mimir and Respondents filed a joint motion to terminate the investigation based on a settlement between Mimir and Micron that resolves all issues as to all Respondents in this investigation. On September 5, 2024, OUII filed a response in support of the motion. On September 6, 2024, the ALJ issued Order No. 6 requesting additional clarification regarding the motion. On September 10, 2024, Mimir and Micron jointly filed a supplement to the motion stating that Mimir requests termination of the investigation based on withdrawal of
On September 12, 2024, the ALJ issued the subject ID granting the joint motion to terminate the investigation. The ALJ found that the motion complied with the requirements of Commission Rule 210.21(b)(1) (19 CFR 210.21(b)(1)) with respect to the termination of Micron based on a settlement agreement, and the motion complied with the requirements of Commission Rule 210.21(a)(1) (19 CFR 210.21(a)(1)) with respect to the termination of the remaining respondents by withdrawal of the complaint. No petitions for review of the ID were filed.
The Commission has determined not to review the subject ID. The investigation is hereby terminated in its entirety.
The Commission vote for this determination took place on October 4, 2024.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that on October 3, 2024, the presiding Chief Administrative Law Judge (“Chief ALJ”) issued an Initial Determination on Violation of Section 337. The Chief ALJ also issued a Recommended Determination on remedy and bonding should a violation be found in the above-captioned investigation. The Commission is soliciting submissions on public interest issues raised by the recommended relief should the Commission find a violation. This notice is soliciting comments from the public and interested government agencies only.
Houda Morad, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 708-4716. Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission's electronic docket (EDIS) at
Section 337 of the Tariff Act of 1930 provides that, if the Commission finds a violation, it shall exclude the articles concerned from the United States unless, after considering the effect of such exclusion upon the public health and welfare, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, and United States consumers, it finds that such articles should not be excluded from entry. (19 U.S.C. 1337(d)(1)). A similar provision applies to cease and desist orders. (19 U.S.C. 1337(f)(1)).
The Commission is soliciting submissions on public interest issues raised by the recommended relief should the Commission find a violation, specifically: a limited exclusion order directed to certain selective thyroid hormone receptor-beta agonists, processes for manufacturing or relating to same, and products containing same, imported, sold for importation, and/or sold after importation by respondents Ascletis Pharma Inc., Ascletis Pharmaceuticals Co. Ltd., Ascletis Bioscience Co., Ltd., Gannex Pharma Co., Ltd., and Jinzi Jason Wu (collectively, “Respondents”), and cease and desist orders against the Respondents. Parties are to file public interest submissions pursuant to 19 CFR 210.50(a)(4).
The Commission is interested in further development of the record on the public interest in this investigation. Accordingly, members of the public and interested government agencies are invited to file submissions of no more than five (5) pages, inclusive of attachments, concerning the public interest in light of the Chief ALJ's Recommended Determination on Remedy and Bonding issued in this investigation on October 3, 2024. Comments should address whether issuance of the recommended remedial orders in this investigation, should the Commission find a violation, would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the recommended remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the recommended orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third-party suppliers have the capacity to replace the volume of articles potentially subject to the recommended orders within a commercially reasonable time; and
(v) explain how the recommended orders would impact consumers in the United States.
Written submissions must be filed no later than by close of business on November 4, 2024.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above. The Commission's paper filing requirements in 19 CFR 210.4(f) are currently waived. 85 FR 15798 (Mar. 19, 2020). Submissions should refer to the investigation number (“Inv. No. 337-TA-1352”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment by marking each document with a header indicating that the document contains confidential information. This marking will be deemed to satisfy the request procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) &
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission (“Commission”) has determined not to review an initial determination (“ID”) (Order No. 10) of the presiding administrative law judge (“ALJ”) granting a joint motion to terminate the investigation based on a settlement agreement. The investigation is terminated.
Lynde Herzbach, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-3228. Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission's electronic docket (EDIS) at
The Commission instituted this investigation on July 9, 2024, based on a complaint filed by MimirIP LLC of Dallas, Texas (“Complainant” or “Mimir”). 89 FR 56406-407 (July 9, 2024). The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain memory devices and electronic devices containing the same by reason of the infringement of certain claims of U.S. Patent Nos. 7,468,928; 7,579,846; and 8,036,053.
The Commission previously terminated respondent Lenovo Group Limited from this investigation and amended the complaint and the notice of investigation to add Lenovo PC HK Limited of Hong Kong and Lenovo Global Technology (United States) Inc. of Morrisville, North Carolina as respondents. Order No. 8 (Aug. 8, 2024),
On August 27, 2024, Complainant and respondent Micron Technology, Inc. jointly moved for termination of this investigation in its entirety based on settlement agreements, which are “a [sublicense] agreement between Mimir and SK hynix Inc. and a patent license agreement between SK hynix and Micron.” ID at 1 n. 1 (citing Mot. at 2). The joint motion notes that it is “based on an agreement between Mimir and SK hynix and an agreement between SK hynix and Micron, which ‘collectively resolve all claims in the complaint asserted against all Respondents in this Investigation.’ ”
On September 12, 2024, the presiding ALJ issued the subject ID granting the joint motion to terminate the investigation. Order No. 10 (Sept. 12, 2024). The subject ID finds that the joint motion complies with Commission Rule 210.21(b)(1) (19 CFR 210.21(b)) and that no extraordinary circumstances prevent granting the motion. The ID also finds that termination of the investigation based on settlement would not be contrary to the public interest.
No petitions for review of the ID were filed.
The Commission has determined not to review the subject ID (Order No. 10). The investigation is terminated.
The Commission vote for this determination took place on October 4, 2024.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Cricut, Inc. on October 4, 2024. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain crafting machines and components thereof. The complaint names as respondents: Hunan Sijiu Technology, Co. Ltd. of China; Hunan Sijiu Electronic Technology Co., Ltd. of China; Guangdong Rongtu Technology Co., Ltd. of China; LiPing Zhan of China; SainStore Technology Co., Ltd of China; Shanghai Sishun E-commerce Co., Ltd. of China; Shanghai Sishun Co., Ltd. of China; Bozhou Wanxingyu Technology Co. Ltd. of China; Bozhou Zhongdaxiang Technology Co., Ltd. of China; and Wuyi Bohai Electric Tools Co., Ltd. of China. The complainant requests that the Commission issue a limited exclusion order, a general exclusion order, cease and desist orders, and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, members of the public, and interested government agencies are invited to file comments on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (“Docket No. 3774”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
On January 27, 2023, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Salman Akbar, M.D., of Richmond, Virginia (Applicant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, Attachment E, at 1, 4. The OSC proposed the denial of Applicant's application for a DEA Certificate of Registration (registration), Control No. W22109452C, alleging that Applicant has committed acts that would render his registration inconsistent with the public interest.
The OSC notified Applicant of his right to file with DEA a written request for hearing, and that if he failed to file such a request, he would be deemed to have waived his right to a hearing and be in default.
Further, “[i]n the event that a [registrant/applicant] . . . is deemed to be in default . . . DEA may then file a request for final agency action with the Administrator, along with a record to support its request. In such circumstances, the Administrator may enter a default final order pursuant to [21 CFR] § 1316.67.”
The Agency finds that, in light of Applicant's default, the factual allegations in the OSC are admitted. Applicant is deemed to have admitted that on March 2, 2020, DEA issued Applicant an Immediate Suspension Order and Order to Show Cause that suspended Applicant's previous DEA registration, Control No. BA5092856, and immediately rendered Applicant without authority to issue prescriptions for controlled substances. RFAAX 1, Attachment E, at 1-2;
Nonetheless, Applicant is deemed to have admitted, and the Agency finds, that between on or about January 15, 2021, and on or about January 6, 2022, Applicant issued at least 17 prescriptions for controlled substances, including four prescriptions for oxycodone (a Schedule II controlled substance), two prescriptions for hydrocodone (a Schedule II controlled substance), five prescriptions for lorazepam (a Schedule IV controlled substance), two prescriptions for zolpidem (a Schedule IV controlled substance), one prescription for clonazepam (a Schedule IV controlled substance), two prescriptions for pregabalin (a Schedule V controlled substance), and one prescription for diazepam (a Schedule IV controlled substance). RFAAX 1, Attachment E, at 2;
Pursuant to section 303(g)(1) of the CSA, “[t]he Attorney General shall register practitioners . . . to dispense . . . controlled substances . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.” 21 U.S.C. 823(g)(1). Section 303(g)(1) further provides that an application for a practitioner's registration may be denied upon a determination that “the issuance of such registration . . . would be inconsistent with the public interest.”
(A) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(B) The applicant's experience in dispensing, or conducting research with respect to controlled substances.
(C) The applicant's conviction record under Federal or State laws relating to the
(D) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(E) Such other conduct which may threaten the public health and safety.
The Agency considers these public interest factors in the disjunctive.
While the Agency has considered all of the public interest factors in 21 U.S.C. 823(g)(1),
Evidence is considered under Public Interest Factors B and D when it reflects compliance (or non-compliance) with laws related to controlled substances and experience dispensing controlled substances.
Here, Applicant has admitted that he repeatedly issued prescriptions for controlled substances while his DEA registration was suspended as well as after his DEA registration was revoked. As such, the Agency finds that Applicant violated 21 CFR 1306.03(a)(1-2) and Virginia Code section 54.1-3422(A).
Accordingly, the Agency finds that Factors B and D weigh in favor of denial of Applicant's application and thus finds Applicant's continued registration to be inconsistent with the public interest in balancing the factors of 21 U.S.C. 823(g)(1). The Agency further finds that Applicant failed to provide any evidence to rebut the Government's
Where, as here, the Government has established grounds to deny Applicant's application, the burden shifts to the registrant to show why he can be entrusted with the responsibility carried by a registration.
Here, although Applicant initially requested a hearing, he ultimately withdrew his hearing request and did not otherwise avail himself of the opportunity to refute the Government's case. As such, Applicant has made no representations as to his future compliance with the CSA nor demonstrated that he can be entrusted with registration. Moreover, the evidence presented by the Government shows that Applicant violated the CSA, further indicating that Applicant cannot be entrusted. Accordingly, the Agency will order the denial of Applicant's application.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1) and 21 U.S.C. 824(a), I hereby deny the pending application for a Certificate of Registration, Control No. W22109452C, submitted by Salman Akbar, M.D., as well as any other pending application of Salman Akbar, M.D., for additional registration in Virginia. This Order is effective November 12, 2024.
This document of the Drug Enforcement Administration was signed on October 4, 2024, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the
On January 25, 2023, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to Midtown Specialty RX (Respondent) of Houston, Texas. OSC/ISO, at 1. The OSC/ISO informed Respondent of the immediate suspension of its DEA Certificate of Registration, Control No. FM2396427, pursuant to 21 U.S.C. 824(d), alleging that Respondent's continued registration constitutes “ `an imminent danger to the public health or safety.' ”
A hearing was held before DEA Administrative Law Judge Paul E. Soeffing (the ALJ) who, on July 13, 2023, issued his Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision (Recommended Decision or RD), which recommended revocation of Respondent's registration. RD, at 67. Respondent did not file exceptions to the RD. Having reviewed the entire record, the Agency adopts and hereby incorporates by reference the entirety of the ALJ's rulings,
Katherine Salinas, R.Ph., who is currently employed full-time as a Compliance Officer for the Texas State Board of Pharmacy, credibly testified for the Government as an expert in the standard of care and the professional responsibility required of a Texas pharmacy in its dispensing practices. RD, at 7-8, 21; Tr. 128, 131, 133-134; Government Exhibit (GX) 4, at 8.
Ms. Salinas's testimony is consistent with Texas law which states that “[a] pharmacist may not . . . dispense or deliver a controlled substance . . . except under a valid prescription and in the course of professional practice.” Tex. Health & Safety Code section 481.074(a)(1). Texas law notes that “[a] pharmacist may not . . . dispense a controlled substance if the pharmacist knows or should have known that the prescription was issued without a valid patient-practitioner relationship.”
Ms. Salinas also testified that Texas pharmacists must check the Prescription Drug Monitoring Program (PDMP) and must attempt to resolve and document the resolution of any “red flags”—warning signs or problematic patterns that indicate a potential for diversion—prior to dispensing controlled substances. RD, at 9-10; Tr. 135-136, 270.
In discussing red flags, Ms. Salinas testified that some of the known red flags include: the same doctor or group of doctors repeatedly prescribing the same strength and dosage of medication over a long period of time and/or for multiple patients (also called “pattern prescribing”); prescriptions from a small group of doctors; patients traveling long distances to the pharmacy; multiple patients sharing the same address and receiving prescriptions for the same controlled substances from the same prescribers;
Similarly, the Texas Board of Pharmacy sets forth numerous operational standards for pharmacists filling prescriptions, requiring, firstly, that ” [f]or the purpose of promoting therapeutic appropriateness, a pharmacist shall, prior to or at the time of dispensing a prescription drug order, review the patient's medication record. Such review shall at a minimum identify clinically significant . . . (III) reasonable dose and route of administration; . . . (VI) drug-drug interactions; . . . and (X) proper utilization, including overutilization or underutilization.”
A Texas pharmacist must ensure that “[p]rior to dispensing, any questions regarding a prescription drug order [] be resolved with the prescriber and written documentation of these discussions [be] made and maintained.”
Finally, a Texas pharmacist must consider the various “red flag factors” in “preventing the non-therapeutic dispensing of controlled substances,” including, among others: pattern prescribing; prescriptions for controlled substances commonly known to be abused; prescriptions for controlled substances at the highest strength and/or in large quantities, indicating lack of individual drug therapy; multiple patients sharing the same address and obtaining similar controlled substance prescriptions from the same practitioner; and patients consistently paying for controlled substance prescriptions with cash rather than through insurance.
In reviewing the relevant PDMP data and patient profiles in the current matter, Ms. Salinas identified numerous instances and types of pattern prescribing. RD, at 10; Tr. 144-145. Specifically, Ms. Salinas noted that Respondent's most frequently dispensed controlled substances were oxycodone,
Moreover, Ms. Salinas testified regarding several examples of Respondent's dispensing that suggested a lack of individualization, another indicator of the pattern prescribing red flag. RD, at 47-48. For example, Patient M.B. always received a prescription for oxycodone along with a rotation of noncontrolled and over-the-counter substances such as a stool softener, ibuprofen, a muscle relaxant, vitamin D, and folic acid; meanwhile, Patient W.J. received prescriptions of oxycodone paired with a 300-day supply
In Ms. Salinas's unrebutted expert opinion, the red flag of pattern prescribing present in these prescriptions needed to be resolved before they were dispensed and such resolution needed to be documented; because there was no documented resolution of these red flags, Ms. Salinas found that Respondent failed to meet its corresponding responsibility. RD, at 11, 48; Tr. 146-147, 234, 239, 241-242. As such, the Agency agrees with the ALJ and finds that Respondent dispensed controlled substance prescriptions that presented the red flag of pattern prescribing and failed to properly document and resolve this red flag prior to dispensing; accordingly, Respondent filled these controlled substance prescriptions outside the usual course of professional practice in violation of the Texas standard of care. RD, at 49.
One of Texas' red flag factors is “multiple persons with the same address present[ing] substantially similar controlled substance prescriptions from the same practitioner.” 22 Tex. Admin. Code section 291.29(f)(11). Regarding the issue of shared addresses, Ms. Salinas provided many examples of Respondent's dispensing that raised the shared address red flag. RD, at 51-52. For example, Patients J.J. and S.B., who share an address, were both prescribed oxycodone 30 mg from Dr. L.S.; Respondent dispensed these prescriptions on January 6, 2022, and January 7, 2022, respectively. RD, at 51-52 n. 89; GX 44, at 20.
In Ms. Salinas's credible and unrebutted expert opinion, the red flag of shared addresses present in these prescriptions needed to be resolved before they were dispensed and such resolution needed to be documented; because there was no documented resolution of this red flag, Ms. Salinas found that Respondent failed to meet its corresponding responsibility. RD, at 14, 53; Tr. 162, 171-72, 279-280. As such, the Agency agrees with the ALJ and finds that Respondent dispensed controlled substances, issued less than two months apart, to patients who shared addresses and received prescriptions for the same controlled substances from the same prescriber. RD, at 54. Moreover, Respondent failed to properly resolve and document resolution of the shared address red flag prior to dispensing and, accordingly, filled these controlled substance prescriptions outside the usual course of professional practice in violation of the Texas standard of care.
One of Texas' red flag factors is “the geographical distance between the practitioner and the patient
Regarding the red flag of long distances, Ms. Salinas testified that she calculated the distances traveled in the current matter based on the home addresses listed on the patients' prescriptions filled at Respondent. RD, at 18; Tr. 216-218. Based on her calculations, Ms. Salinas found that multiple patients traveled far beyond the guideline of 30 miles of their home addresses to fill prescriptions at Respondent.
In Ms. Salinas's unrebutted expert opinion, the red flag of long distances present in these prescriptions needed to be resolved before they were dispensed and such resolution needed to be documented; because there was no documented resolution of this red flag, Ms. Salinas found that Respondent failed to meet its corresponding responsibility. RD, at 17, 20. Tr. 212-213, 241-242. As such, the Agency agrees with the ALJ and finds that Respondent dispensed controlled substances to patients who traveled long distances and failed to properly resolve and document resolution of the long-distance red flag prior to dispensing; accordingly, Respondent filled these controlled substance prescriptions outside the usual course of professional practice and in violation of the Texas standard of care. RD, at 59.
Regarding Respondent's case, E.W. was the pharmacist-in-charge at Respondent at the time of the relevant events. RD, at 22; Tr. 304, 307. E.W. testified credibly, but with little corroborating evidence, regarding Respondent's general dispensing practices; however, she did not testify specifically regarding the prescriptions at issue in this case. RD, at 23. With regard to Respondent's general practice, E.W. testified that before dispensing prescriptions, she would get a phone number from the patient, discuss insurance with the patient, and then make a copy of the patient's driver's license. RD, at 22; Tr. 304. Next, after reviewing the full PDMP drug history of the patient, if “everything check[ed] out,” E.W. would enter the prescription, pull the medication, and “go through the process.” RD, at 22; Tr. 304-305. E.W. explained that she would check to make sure that prescribers were “proper by law” and Houston-based, adding that the pharmacy only filled prescriptions from Houston doctors “in good standing.”
As for Respondent's owner, S.M., she testified that though she is not a licensed pharmacist, she works as a pharmacy technician at Respondent. RD, at 23; Tr. 313-314. S.M.'s testimony was generally credible, but there was little corroborating evidence and the ALJ noted that she has a significant personal interest in the outcome of the proceedings. RD, at 28. S.M. testified generally regarding Respondent's process, stating that the pharmacy only fills prescriptions written by doctors in the Houston area. RD, at 23; Tr. 315. When asked whether Respondent “check[ed] to make sure the prescriptions were legitimate,” S.M. testified that Respondent “hired a third party to go out to the doctors' offices to verify the doctors, check their licenses, [and] check to make sure that they were abiding by the red flag checklist.”
Regarding Respondent's procedure for addressing and resolving red flags, S.M. agreed that Texas pharmacies are to determine the legitimacy of prescriptions by resolving red flags and that resolution of red flags must be properly documented. RD, at 25; Tr. 370. S.M. testified that Respondent would “check the patient, contact the doctor, verify the prescription[,] . . . [and] verify any information that [it] could from the patient.” RD, at 24; Tr. 321. S.M. also testified that Respondent has refused to fill prescriptions in the past if, upon review of PDMP data, the pharmacist found that the patient was presenting for an early refill, the prescription was fraudulent, or the pharmacist did not think the prescription was legitimate. RD, at 24-25; Tr. 314. S.M. testified that if the pharmacist refuses to fill a prescription, the pharmacy keeps no record of that refusal and shreds the unfilled prescription; S.M. also asserted that “[the pharmacy does not] have to document that [it] didn't fill the prescription.” RD, at 25; Tr. 314-315.
S.M. testified that “patient counseled” written on prescriptions
Contrary to S.M.'s testimony, Ms. Salinas opined that the handwritten note to the effect of “patient counsel” present on the majority of the prescriptions at issue in the current matter does not constitute red flag resolution. First, she testified, patient counseling is a separate requirement under the Texas State Board of Pharmacy regulations, and “counseling usually entails talking about what the medication is, how to take it, what to do if you miss a dose, side effects to watch out for . . . that sort of thing.” RD, at 16, 18; Tr. 187-188, 209-210, 229-230. Second, even if Respondent writing “patient counsel” was meant to show red flag resolution, the notations in the current matter do not satisfy the requirement of documentation of red flag resolution because they “[do not] tell the story.” RD, at 16, 18; Tr. 187-188, 209-210, 229-230. The Agency credits Ms. Salinas's expert opinion that Respondent failed to adequately document resolution of the relevant red flags prior to dispensing each of the prescriptions at issue in this case.
Regarding the various red flags at issue in the current matter, S.M. testified that the patients who traveled to Respondent from non-Houston addresses did so because the pharmacies near their homes do not carry controlled substances prescribed to treat pain. RD, at 26; Tr. 325.
The CSA requires pharmacies to keep accurate and timely records of inventory and dispensing, including initial and biennial inventories. 21 CFR 1304.11(a)-(c). Texas law also requires pharmacies to keep and maintain records, including “a perpetual inventory of any controlled substance listed in Schedule II.” 22 Tex. Admin. Code section 291.75(a)(1), (c)(4)-(5).
Ms. Salinas testified that Texas pharmacies are required to keep and maintain accurate records of all prescriptions, invoices, signature logs for individuals participating in prescription processing, counseling documentation, and controlled substance inventories for at least two years. RD, at 10, 60; Tr. 138-139. Ms. Salinas also testified that Texas pharmacies are required by law to have inventories of all controlled substances available for inspection. RD, at 20-21; Tr. 243. Ms. Salinas noted that under the Texas standard of care, in the case of a disaster such as a flood, a pharmacy must notify the Texas State Board of Pharmacy within ten days and should immediately re-conduct an inventory. RD, at 21; Tr. 243-244.
The CSA requires that “[c]ontrolled substances listed in Schedules II, III, IV, and V . . . be stored in a securely locked, substantially constructed cabinet.” 21 CFR 1301.75(b); RD, at 60. Regarding storage, Ms. Salinas testified that Texas pharmacies must keep their controlled substances stored, locked, and secured at their registered location as well as have written security policies and procedures, motion sensors, and an alarm system with offsite monitoring. RD, at 10, 21, 61; Tr. 139, 245. Ms. Salinas testified that she was not aware
S.M. admitted that Respondent did not have initial, ending, or biennial inventories at the time of DEA's June 1, 2022 inspection and that the last annual inventory that Respondent had on file was for 2020. RD, at 26, 60; Tr. 339, 344, 352-353. S.M. testified that in late 2021, a pipe burst in a neighboring business causing a flood that damaged Respondent's inventories. RD, at 26; Tr. 340-341, 344, 351. S.M. admitted that she “should have immediately recreated” the inventory and that not doing so was a mistake in judgment. RD, at 26-27; Tr. 348-349. S.M. testified that she has since taken remedial action by updating Respondent's perpetual inventory on a daily basis. RD, at 27; Tr. 349. S.M. acknowledged that Respondent's current inventory was initially generated on June 1, 2022, during the DEA inspection when Respondent's pharmacist-in-charge and DEA Diversion Investigators conducted a pill count upon return of the controlled substances from S.M.'s residence to Respondent's registered location. RD, at 27; Tr. 353. S.M. also acknowledged that at least six months had passed between the date that she asserts Respondent's inventories were damaged by flooding and the June 1, 2022 inspection, with S.M. testifying that she tried to recreate the inventory during that time but that it “takes a lot to recreate an inventory.” RD, at 27; Tr. 353-354. S.M. asserted that Respondent has since corrected the situation and that on the date that the OSC/ISO was issued in the current matter, Respondent had current inventories. RD, at 26; Tr. 345.
S.M. also admitted that without permission from DEA or the Texas State Board of Pharmacy, she removed controlled substances from Respondent's registered location and transported them to her personal residence on a daily basis. RD, at 27, 61; Tr. 111, 338. S.M. acknowledged that while she was transporting drugs to and from her home, there was a working safe at the pharmacy. RD, at 28; Tr. 360.
Based on Respondent's admissions, the Agency agrees with the ALJ that Respondent did not take and/or keep initial or biennial inventories as of the date of DEA's June 2022 inspection and did not store its controlled substances in a securely locked and substantially constructed cabinet. RD, at 60, 61; ALJ Exhibit 7 (Respondent's Answer), at 2.
Under the CSA, “[a] registration . . . to . . . dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render [its] registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a). In making the public interest determination, the CSA requires consideration of the following factors:
(A) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(D) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(E) Such other conduct which may threaten the public health and safety.
The Agency considers these public interest factors in the disjunctive.
The Government has the burden of proof in this proceeding. 21 CFR 1301.44. While the Agency has considered all of the public interest factors in 21 U.S.C. 823(g)(1), the Government's evidence in support of its
Having reviewed the record and the RD, the Agency agrees with the ALJ, adopts the ALJ's analysis, and finds that the Government's evidence satisfies its
Evidence is considered under Public Interest Factors B and D when it reflects compliance (or non-compliance) with laws related to controlled substances and experience dispensing controlled substances.
As for State law, Texas regulations require that “[a] pharmacist may not . . . dispense or deliver a controlled substance . . . except under a valid prescription and in the course of professional practice.” Tex. Health & Safety Code section 481.074(a)(1).
In the current matter, the Agency agrees with the ALJ's analysis that Respondent's dispensing fell below the Texas standard of care—and thus was outside the usual course of professional practice—because, as detailed above, Respondent repeatedly filled prescriptions for controlled substances for multiple patients without adhering to Texas' operational standards for pharmacists filling prescriptions and without addressing or resolving numerous and blatant red flags of abuse and/or diversion;
Where, as here, the Government has established sufficient grounds to revoke Respondent's registration, the burden shifts to the registrant to show why it can be entrusted with the responsibility carried by a registration.
Here, and as noted by the ALJ, Respondent, through its owner, admitted fault for its failure to maintain adequate inventories and failure to properly store controlled substances at its registered location.
When a registrant fails to make the threshold showing of acceptance of responsibility, the Agency need not address the registrant's remedial measures.
In addition to acceptance of responsibility, the Agency considers both specific and general deterrence when determining an appropriate sanction.
Moreover, the Agency agrees with the ALJ that Respondent's actions were egregious.
In sum, Respondent has not offered any credible evidence on the record that rebuts the Government's case for revocation of its registration and Respondent has not demonstrated that it can be entrusted with the responsibility of registration.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. FM2396427 issued to Midtown Specialty RX. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I hereby deny any pending applications of Midtown Specialty RX to renew or modify this registration, as well as any other pending application of Midtown Specialty RX for additional registration in Texas. This Order is effective November 12, 2024.
This document of the Drug Enforcement Administration was signed on October 4, 2024, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the
On November 8, 2023, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to Halowells Pharmacy (Registrant) of Pearland, Texas. Request for Final Agency Action (RFAA), Exhibit (RFAAX) A, at 1. The OSC/ISO informed Registrant of the immediate suspension of its DEA Certificate of Registration, Control No.
The OSC/ISO notified Registrant of its right to file with DEA a written request for hearing, and that if it failed to file such a request, it would be deemed to have waived its right to a hearing and be in default.
Further, “[i]n the event that a registrant . . . is deemed to be in default . . . DEA may then file a request for final agency action with the Administrator, along with a record to support its request. In such circumstances, the Administrator may enter a default final order pursuant to [21 CFR] § 1316.67.”
The Agency finds that, in light of Registrant's default, the factual allegations in the OSC/ISO are admitted.
Texas regulations identify the following prescribing patterns as red flag factors: Dispensing to numerous persons substantially identical prescriptions by the same prescriber for the same controlled substances; a prescriber's prescriptions are routinely for controlled substances commonly known to be abused drugs, including opioids; and a prescriber's prescriptions for controlled substances are commonly for the highest strength of the drug and/or for large quantities (
Registrant is deemed to have admitted that it failed to identify and resolve the red flag that occurs when a practitioner prescribes the same controlled substance in identical or substantially similar quantities to multiple patients. RFAAX A, at 5. Specifically, between January 2022 and June 2023, Registrant filled over 90 prescriptions for oxycodone issued by Dr. V.M. to C.W., D.S.T., D.W., E.W., J.L., J.R., and L.T.
Further, between January 2022 and June 2023, Registrant filled over 30 prescriptions for hydrocodone-acetaminophen issued by Dr. V.M. to D.S.E., D.S.M., and J.J.
Accordingly, the Agency finds that Registrant filled over 120 controlled substance prescriptions without first resolving the pattern prescribing red flags.
Texas regulations identify the following prescribing pattern as a red flag factor: “[P]rescriptions for controlled substances by a prescriber presented to the pharmacy contain nonspecific or no diagnoses, or lack the intended use of the drug.” 22 Tex. Admin. Code section 291.29(f)(4); RFAAX A, at 3.
Registrant is deemed to have admitted that it failed to identify and resolve the red flag of prescriptions lacking a specific diagnosis. RFAAX A, at 5. Specifically, between January 2022 and June 2023, Registrant filled prescriptions lacking specific diagnoses for all ten individuals
Texas regulations identify the following prescribing pattern as a red flag factor: “[M]ultiple persons with the same address present substantially similar controlled substance prescriptions from the same practitioner.” 22 Tex. Admin. Code section 291.29(f)(11); RFAAX A, at 4.
Registrant is deemed to have admitted that it failed to identify and resolve the red flag of multiple persons with the same address presenting the same, or substantially similar, prescriptions from the same practitioner. RFAAX A, at 6. Specifically, between January 2022 and June 2023, Registrant filled prescriptions for oxycodone 30 mg for C.W. and D.W., who both share the same address and received their prescriptions from the same practitioner, Dr. V.M.
Accordingly, the Agency finds that Registrant filled controlled substance prescriptions without first resolving the red flag of shared addresses.
Texas regulations identify the following prescribing pattern as a red flag factor: “[T]he controlled substance(s) or the quantity of the controlled substance(s) prescribed are inconsistent with the practitioner's area of medical practice.” 22 Tex. Admin. Code section 291.29(f)(9); RFAAX A, at 6. Registrant is deemed to have admitted that between January 2022 and June 2023, Registrant repeatedly filled prescriptions for oxycodone and hydrocodone-acetaminophen issued by Dr. V.M., despite Dr. V.M. prescribing outside of her family and administrative medicine area of practice. RFAAX A, at 6.
Registrant is deemed to have admitted that individuals traveling long distances to obtain or fill controlled substance prescriptions is a well-known red flag of abuse or diversion. Registrant further admits that it repeatedly filled prescriptions without identifying and resolving the red flag of patients traveling long distances to obtain or fill controlled substance prescriptions.
Accordingly, the Agency finds that Registrant filled controlled substance prescriptions without first resolving the red flag arising from long distances traveled.
Texas regulations identify the following prescribing pattern as a red flag factor: “[P]ersons consistently pay for controlled substance prescriptions with cash or cash equivalents more often than through insurance.” 22 Tex. Admin. Code section 291.29(f)(12); RFAAX A, at 7-8.
Registrant is deemed to have admitted that it failed to identify and resolve the red flag of cash payments, which is a common red flag because it allows a patient to avoid the scrutiny associated with the use of insurance.
Accordingly, the Agency finds that Registrant filled controlled substance prescriptions without first resolving the red flag arising from cash payments.
DEA retained an independent pharmacy expert who concluded that the above prescription data presented multiple red flags that were highly indicative of abuse and diversion.
Under the Controlled Substances Act (CSA), “[a] registration . . . to . . . dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render [its] registration under [21 CFR 823] inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a). In making the public interest determination, the CSA requires consideration of the following factors:
(A) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(B) The [registrant]'s experience in dispensing, or conducting research with respect to controlled substances.
(C) The [registrant]'s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(D) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(E) Such other conduct which may threaten the public health and safety.
The Agency considers these public interest factors in the disjunctive.
While the Agency has considered all of the public interest factors in 21 U.S.C. 823(g)(1),
Here, the Agency finds that the Government's evidence satisfies its
Evidence is considered under Public Interest Factors B and D when it reflects compliance (or non-compliance) with laws related to controlled substances and experience dispensing controlled substances.
As for State law, under Texas regulations, “[a] pharmacist may not dispense . . . a controlled substance . . . except under a valid prescription and in the course of professional practice.” Tex. Health & Safety Code section 481.074(a). Regarding the specific standards for a pharmacist filing a new or refill prescription, “[f]or the purpose of promoting therapeutic appropriateness, a pharmacist shall, prior to or at the time of dispensing a prescription drug order, review the patient's medication record. Such review shall at a minimum identify clinically significant: . . . (III) reasonable dose and route of administration; . . . (VI) drug-drug interactions; . . . [and] (X) proper utilization, including overutilization or underutilization.” 22 Tex. Admin. Code section 291.33(c)(2)(A)(i). “Upon identifying any clinically significant conditions [or] situations . . . the pharmacist shall take appropriate steps to avoid or resolve the problem including consultation with the prescribing practitioner.”
Regarding “red flag factors” that are “relevant to preventing the non-therapeutic dispensing of controlled substances,” Texas regulations identify the following relevant circumstances as red flags:
(1) the pharmacy dispenses a reasonably discernible pattern of substantially identical prescriptions for the same controlled substances, potentially paired with other drugs, for numerous persons, indicating a lack of individual drug therapy in prescriptions issued by the practitioner; . . .
(3) prescriptions by a prescriber presented to the pharmacy are routinely for controlled substances commonly known to be abused drugs, including opioids, benzodiazepines, muscle relaxants, psychostimulants, and/or cough syrups containing codeine, or any combination of these drugs;
(4) prescriptions for controlled substances by a prescriber presented to the pharmacy contain nonspecific or no diagnoses, or lack the intended use of the drug;
(5) prescriptions for controlled substances are commonly for the highest strength of the drug and/or for large quantities (
(8) the practitioner's clinic is not registered as, and not exempted from registration as, a pain management clinic by the Texas Medical Board, despite prescriptions by the practitioner presented to the pharmacy indicating that the practitioner is mostly prescribing opioids . . . ;
(9) the controlled substance(s) or the quantity of the controlled substance(s) prescribed are inconsistent with the practitioner's area of medical practice; . . .
(11) multiple persons with the same address present substantially similar controlled substance prescriptions from the same practitioner; [and]
(12) persons consistently pay for controlled substance prescriptions with cash or cash equivalents more often than through insurance.”
Here, Registrant has admitted that it repeatedly filled prescriptions for controlled substances that contained multiple red flags of abuse and/or diversion without addressing or resolving those red flags. RFAAX A, at 5-8. DEA's pharmacy expert concluded that these red flags were highly indicative of abuse and diversion.
Accordingly, the Agency finds that Factors B and D weigh in favor of revocation of Registrant's registration and thus finds Registrant's continued registration to be inconsistent with the public interest in balancing the factors of 21 U.S.C. 823(g)(1). The Agency further finds that Registrant failed to provide any evidence to rebut the Government's
Where, as here, the Government has established grounds for revocation, the burden shifts to the registrant to show why it can be entrusted with the responsibility carried by a registration.
Here, Registrant failed to answer the allegations contained in the OSC/ISO
Accordingly, the Agency will order the revocation of Registrant's registration.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. FH9037830 issued to Halowells Pharmacy. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I hereby deny any pending applications of Halowells Pharmacy to renew or modify this registration, as well as any other pending application of Halowells Pharmacy for additional registration in Texas. This Order is effective November 12, 2024.
This document of the Drug Enforcement Administration was signed on October 4, 2024, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA
National Science Foundation (NSF).
Notice; withdrawal.
The National Science Foundation published a notice in the
Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314; telephone (703) 292-7556; or send email to
On September 23, 2024, the National Science Foundation published in the
From the
In accordance with the purposes of sections 29 and 182b of the Atomic Energy Act (42 U.S.C. 2039, 2232(b)), the Advisory Committee on Reactor Safeguards (ACRS) will hold meetings on November 6-8, 2024. The Committee will be conducting meetings that will include some Members being physically present at the NRC while other Members participate remotely. Interested members of the public are encouraged to participate remotely in any open sessions via MS Teams or via phone at 301-576-2978, passcode 887 935 620#. A more detailed agenda including the MSTeams link may be found at the ACRS public website at
Procedures for the conduct of and participation in ACRS meetings were published in the
An electronic copy of each presentation should be emailed to the cognizant ACRS staff at least one day before the meeting.
In accordance with subsection 10(d) of Public Law 92-463 and 5 U.S.C. 552b(c), certain portions of this meeting may be closed, as specifically noted above. Use of still, motion picture, and television cameras during the meeting may be limited to selected portions of the meeting as determined by the Chair. Electronic recordings will be permitted only during the open portions of the meeting.
ACRS meeting agendas, meeting transcripts, and letter reports are available through the NRC Public Document Room (PDR) at
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a Priority Mail Express International, Priority Mail International & First-Class Package International Service contract to the list of Negotiated Service Agreements in the Competitive Product List in the Mail Classification Schedule.
Date of notice: October 10, 2024.
Christopher C. Meyerson, (202) 268-7820.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 2, 2024, it filed with the Postal Regulatory Commission a
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the Connectivity Fee Schedule (“Fee Schedule”) to delete the currently-filed “Optic Low Latency Circuit—1 Gb” service as obsolete. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Connectivity Fee Schedule (“Fee Schedule”) to delete the currently-filed “Optic Low Latency Circuit—1 Gb” service as obsolete.
In 2023, the Exchange filed to amend the Fee Schedule to add several “FIDS Circuits” available at the Mahwah, New Jersey data center (“MDC”),
Since that time, no Users
The proposed changes would not apply differently to distinct types or sizes of market participants; rather, they would apply to all Users equally. As is currently the case, the Fee Schedule would be applied uniformly to all Users. The proposed changes are not intended to address any other issues and the Exchange is not aware of any problems that Users would have in complying with the proposed change.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that discontinuing offering the 1 Gb Optic Low Latency Circuit would perfect the mechanisms of a free and open market and a national market system and, in general, protect investors and the public interest. Demand for the 1 Gb Optic Low Latency Circuit is non-existent and there are currently no customers that subscribe to the service. The Exchange does not expect demand to rebound given customers' assessment that the 1 Gb-size of the circuit is too small for their needs. Removing references to the fees for this obsolete service from the Fee Schedule would make the Fee Schedule easier to read, understand, and administer.
The Exchange believes that the proposed rule change does not significantly affect the protection of investors or the public interest. The proposed rule change would delete an obsolete service from the Fee Schedule, which would enhance transparency and alleviate potential customer confusion.
The Exchange believes that removing this obsolete service from the Fee Schedule would not permit unfair discrimination between customers, issuers, brokers, or dealers. The proposed changes would apply equally to all Users: the obsolete 1 Gb Optic Low Latency Circuit would be removed for all customers.
For these reasons, the Exchange believes that the proposal is consistent with the Act.
The Exchange believes that the proposal will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of Section 6(b)(8) of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the Connectivity Fee Schedule (“Fee Schedule”) to delete the currently-filed “Optic Low Latency Circuit—1 Gb” service as obsolete. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Connectivity Fee Schedule (“Fee Schedule”) to delete the currently-filed “Optic Low Latency Circuit—1 Gb” service as obsolete.
In 2023, the Exchange filed to amend the Fee Schedule to add several “FIDS Circuits” available at the Mahwah, New Jersey data center (“MDC”),
Since that time, no Users
The proposed changes would not apply differently to distinct types or sizes of market participants; rather, they would apply to all Users equally. As is currently the case, the Fee Schedule would be applied uniformly to all Users. The proposed changes are not intended to address any other issues and the Exchange is not aware of any problems that Users would have in complying with the proposed change.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that discontinuing offering the 1 Gb Optic Low Latency Circuit would perfect the mechanisms of a free and open market and a national market system and, in general, protect investors and the public interest. Demand for the 1 Gb Optic Low Latency Circuit is non-existent and there are currently no customers that subscribe to the service. The Exchange does not expect demand to rebound given customers' assessment that the 1 Gb-size of the circuit is too small for their needs. Removing references to the fees for this obsolete service from the Fee Schedule would make the Fee Schedule easier to read, understand, and administer.
The Exchange believes that the proposed rule change does not significantly affect the protection of investors or the public interest. The proposed rule change would delete an obsolete service from the Fee Schedule, which would enhance transparency and alleviate potential customer confusion.
The Exchange believes that removing this obsolete service from the Fee Schedule would not permit unfair discrimination between customers, issuers, brokers, or dealers. The proposed changes would apply equally to all Users: the obsolete 1 Gb Optic Low Latency Circuit would be removed for all customers.
For these reasons, the Exchange believes that the proposal is consistent with the Act.
The Exchange believes that the proposal will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of Section 6(b)(8) of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the Connectivity Fee Schedule (“Fee Schedule”) to delete the currently-filed “Optic Low Latency Circuit—1 Gb” service as obsolete. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Connectivity Fee Schedule (“Fee Schedule”) to delete the currently-filed “Optic Low Latency Circuit—1 Gb” service as obsolete.
In 2023, the Exchange filed to amend the Fee Schedule to add several “FIDS Circuits” available at the Mahwah, New Jersey data center (“MDC”),
Since that time, no Users
The proposed changes would not apply differently to distinct types or sizes of market participants; rather, they would apply to all Users equally. As is currently the case, the Fee Schedule would be applied uniformly to all Users. The proposed changes are not intended to address any other issues and the Exchange is not aware of any problems that Users would have in complying with the proposed change.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that discontinuing offering the 1 Gb Optic Low Latency Circuit would perfect the mechanisms of a free and open market and a national market system and, in general, protect investors and the public interest. Demand for the 1 Gb Optic Low Latency Circuit is non-existent and there are currently no customers that subscribe to the service. The Exchange does not expect demand to rebound given customers' assessment that the 1 Gb-size of the circuit is too small for their needs. Removing references to the fees for this obsolete service from the Fee Schedule would make the Fee Schedule easier to read, understand, and administer.
The Exchange believes that the proposed rule change does not significantly affect the protection of investors or the public interest. The proposed rule change would delete an obsolete service from the Fee Schedule, which would enhance transparency and alleviate potential customer confusion.
The Exchange believes that removing this obsolete service from the Fee Schedule would not permit unfair discrimination between customers, issuers, brokers, or dealers. The proposed changes would apply equally to all Users: the obsolete 1 Gb Optic Low Latency Circuit would be removed for all customers.
For these reasons, the Exchange believes that the proposal is consistent with the Act.
The Exchange believes that the proposal will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of Section 6(b)(8) of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On June 21, 2024, the New York Stock Exchange LLC (“NYSE” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act”)
Section 102.04 of the Manual sets forth listing requirements for closed-end
The Commission is instituting proceedings pursuant to Section 19(b)(2)(B) of the Exchange Act
Pursuant to Section 19(b)(2)(B) of the Exchange Act,
The development and enforcement of meaningful corporate governance exchange listing standards is of substantial importance to financial markets and the investing public, especially given investor expectations regarding the nature of companies that have achieved an exchange listing for their securities and the role of an exchange in overseeing its market and ensuring compliance with its listing standards.
In particular, the Commission has consistently recognized the importance of the annual shareholder meeting requirement to the protection of investors and the public interest.
The Exchange states in support of its current proposal that there are significant differences between listed CEFs and listed operating companies that justify also exempting listed CEFs from the Exchange's annual meeting requirement.
The Commission received comments supporting the proposal.
The Commission also received comments opposing the proposal.
The Commission has concerns about whether NYSE's proposal to exempt CEFs listed under Section 102.04A of the Manual from the annual shareholder meeting requirement set forth in Section 302.00 is designed to protect investors and the public interest, as required by Section 6(b)(5) of the Exchange Act.
Moreover, the Commission has concerns with the sufficiency of the Exchange's analysis and whether the Exchange has met its burden to demonstrate that its proposal is consistent with the Exchange Act.
As a result, the Commission believes there are questions as to whether the proposal is consistent with Section 6(b)(5) of the Exchange Act
The Commission requests that interested persons provide written submissions of their data, views, and arguments with respect to the issues identified above, as well as any other concerns they may have with the proposal. In particular, the Commission invites the written views of interested persons concerning whether the proposed rule change is consistent with Section 6(b)(5) of the Exchange Act
Interested persons are invited to submit written data, views, and arguments regarding whether the proposed rule change should be approved or disapproved by October 31, 2024. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal by November 14, 2024. The Commission asks that commenters address the sufficiency of the Exchange's statements in support of the proposal, in addition to any other comments they may wish to submit about the proposed rule change. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the Connectivity Fee Schedule (“Fee Schedule”) to delete the currently-filed “Optic Low Latency Circuit—1 Gb” service as obsolete. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Connectivity Fee Schedule (“Fee Schedule”) to delete the currently-filed “Optic Low Latency Circuit—1 Gb” service as obsolete.
In 2023, the Exchange filed to amend the Fee Schedule to add several “FIDS Circuits” available at the Mahwah, New Jersey data center (“MDC”),
Since that time, no Users
The proposed changes would not apply differently to distinct types or sizes of market participants; rather, they would apply to all Users equally. As is currently the case, the Fee Schedule would be applied uniformly to all Users. The proposed changes are not intended to address any other issues and the Exchange is not aware of any problems that Users would have in complying with the proposed change.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that discontinuing offering the 1 Gb Optic Low Latency Circuit would perfect the mechanisms of a free and open market and a national market system and, in general, protect investors and the public interest. Demand for the 1 Gb Optic Low Latency Circuit is non-existent and there are currently no customers that subscribe to the service. The Exchange does not expect demand to rebound given customers' assessment that the 1 Gb-size of the circuit is too small for their needs. Removing references to the fees for this obsolete service from the Fee Schedule would make the Fee Schedule easier to read, understand, and administer.
The Exchange believes that the proposed rule change does not significantly affect the protection of investors or the public interest. The proposed rule change would delete an obsolete service from the Fee Schedule,
The Exchange believes that removing this obsolete service from the Fee Schedule would not permit unfair discrimination between customers, issuers, brokers, or dealers. The proposed changes would apply equally to all Users: the obsolete 1 Gb Optic Low Latency Circuit would be removed for all customers.
For these reasons, the Exchange believes that the proposal is consistent with the Act.
The Exchange believes that the proposal will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of Section 6(b)(8) of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
SR-NYSE-2024-61 on the subject line.
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the Connectivity Fee Schedule (“Fee Schedule”) to delete the currently-filed “Optic Low Latency Circuit—1 Gb” service as obsolete. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Connectivity Fee Schedule (“Fee Schedule”) to delete the currently-filed “Optic Low Latency Circuit—1 Gb” service as obsolete.
In 2023, the Exchange filed to amend the Fee Schedule to add several “FIDS Circuits” available at the Mahwah, New Jersey data center (“MDC”),
Since that time, no Users
The proposed changes would not apply differently to distinct types or sizes of market participants; rather, they would apply to all Users equally. As is currently the case, the Fee Schedule would be applied uniformly to all Users. The proposed changes are not intended to address any other issues and the Exchange is not aware of any problems that Users would have in complying with the proposed change.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that discontinuing offering the 1 Gb Optic Low Latency Circuit would perfect the mechanisms of a free and open market and a national market system and, in general, protect investors and the public interest. Demand for the 1 Gb Optic Low Latency Circuit is non-existent and there are currently no customers that subscribe to the service. The Exchange does not expect demand to rebound given customers' assessment that the 1 Gb-size of the circuit is too small for their needs. Removing references to the fees for this obsolete service from the Fee Schedule would make the Fee Schedule easier to read, understand, and administer.
The Exchange believes that the proposed rule change does not significantly affect the protection of investors or the public interest. The proposed rule change would delete an obsolete service from the Fee Schedule, which would enhance transparency and alleviate potential customer confusion.
The Exchange believes that removing this obsolete service from the Fee Schedule would not permit unfair discrimination between customers, issuers, brokers, or dealers. The proposed changes would apply equally to all Users: the obsolete 1 Gb Optic Low Latency Circuit would be removed for all customers.
For these reasons, the Exchange believes that the proposal is consistent with the Act.
The Exchange believes that the proposal will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of Section 6(b)(8) of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative disaster declaration of a rural area for the State of Tennessee dated October 4, 2024.
Issued on October 4, 2024.
Vanessa Morgan, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the Administrator's disaster declaration of a rural area, applications for disaster loans may be submitted online using the MySBA Loan Portal
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 20709C and for economic injury is 207100.
The State which received an EIDL Declaration is Tennessee.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of South Carolina (FEMA-4829-DR), dated September 29, 2024.
Issued on October 2, 2024.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street
The notice of the President's major disaster declaration for the State of South Carolina, dated September 29, 2024, is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Vermont (FEMA-4826-DR), dated September 26, 2024.
Issued on September 26, 2024.
Vanessa Morgan, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on September 26, 2024, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications online using the MySBA Loan Portal
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 206966 and for economic injury is 206970.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative disaster declaration of a rural area for the State of Kansas dated October 4, 2024.
Issued on October 4, 2024.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the Administrator's disaster declaration of a rural area, applications for disaster loans may be submitted online using the MySBA Loan Portal
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 20627C and for economic injury is 206280.
The State which received an EIDL Declaration is Kansas.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of Vermont (FEMA-4826-DR), dated September 26, 2024.
Issued on September 26, 2024.
Vanessa Morgan, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on September 26, 2024, applications for disaster loans may be submitted online using the MySBA Loan Portal
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 205216 and for economic injury is 205220.
Closed meeting.
In accordance with section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. 1009(a)(2), the Department of State announces a meeting of the International Security Advisory Board (ISAB) to take place on October 30, 2024, at the Department of State, Washington, DC.
Pursuant to section 10(d) of the Federal Advisory Committee Act, 5 U.S.C. 1009(d), and 5 U.S.C. 552b(c)(1), it has been determined that this Board meeting will be closed to the public because the Board will be reviewing and discussing matters properly classified in accordance with Executive Order 13526. The purpose of the ISAB is to provide the Department with a continuing source of independent advice on all aspects of arms control, disarmament, nonproliferation, outer space, critical infrastructure, cybersecurity, the national security aspects of associated technologies, international security, and related aspects of public diplomacy. The agenda for this meeting will include classified discussions related to the Board's ongoing studies on current U.S. policy and issues regarding biotechnology and military-civil fusion strategy, multilateral disarmament structures, and security cooperation and arms transfers.
For more information, contact Michelle Dover, Executive Director of the International Security Advisory Board, Department of State, Washington, DC 20520, telephone: (202) 736-4930, email:
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, the FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The
Written comments should be submitted by November 12, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Scott Wessley by email at:
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The
Written comments should be submitted by November 12, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Sandra L. Ray by email at:
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The
Written comments should be submitted by November 12, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Tanya Glines by email at:
Response to this collection of information is required to obtain a benefit, specifically, to obtain a FAA designation as a representative of the FAA Administrator. Designee applicants come from private industry. They are experts in the aviation and medical communities who are familiar with the regulations and certification requirements necessary to issue an FAA certificate. Only highly experienced aviation professionals are expected to respond to the collection. The collection is for reporting of an individual's eligibility and qualifications and occurs on an as needed basis for initial applicants. However, if an individual is not selected as a designee, their application must be updated whenever information changes (as needed) and at least every 12 calendar months (annually). The FAA has now fully implemented the use of the Designee Management System (DMS) web-based application, located at
Additionally, designees must report any arrest, indictment, or conviction for violation of local, State, or Federal law to the FAA within 30 days of such arrest, indictment, or conviction.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Denial of petition.
Blue Bird Body Company (Blue Bird) has determined that certain model year (MY) 2019-2024 Blue Bird Vision and MY 2020-2024 Blue Bird All American school buses do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 217,
Daniel Lind, General Engineer, NHTSA, Office of Vehicle Safety Compliance, (202) 366-7235.
Blue Bird determined that certain MY 2019-2024 Blue Bird Vision and MY 2020-2024 Blue Bird All American school buses do not fully comply with paragraph S5.5.3(b) of FMVSS No. 217,
Blue Bird filed two noncompliance reports, both dated August 9, 2023, pursuant to 49 CFR part 573,
Notice of receipt of Blue Bird's petition was published with a 30-day public comment period, on December 6, 2023, in the
Approximately 28,765 MY 2019-2024 Blue Bird Vision and 403 MY 2020-2024 Blue Bird All American school buses, manufactured between July 1, 2019, and August 3, 2023, were reported by the manufacturer.
Blue Bird explains that the Emergency Exit Label in the subject vehicles contains lettering that does not meet the lettering height required by paragraph S5.5.3(b) of FMVSS No. 217. Specifically, the lettering height was 0.882 centimeters and therefore does not meet the minimum lettering height requirement of 1 centimeter.
Paragraph S5.5.3(b) of FMVSS No. 217 includes the requirements relevant
The following views and arguments presented in this section, “V. Summary of Blue Bird's Petition,” are the views and arguments provided by Blue Bird. They do not reflect the views of the Agency. Blue Bird describes the subject noncompliance and contends that the noncompliance is inconsequential as it relates to motor vehicle safety.
Blue Bird contends that the subject noncompliance is inconsequential to motor vehicle safety because the difference between 1 centimeter and 0.882 centimeters would be difficult to differentiate without the use of precise measuring equipment. A 0.118 centimeter difference is less than 3/64ths of an inch or 0.047 inches, which Blue Bird argues would be unrecognizable and would not cause the instructions to be unclear to passengers or impact their ability to open the door in an emergency.
In 2022, NHTSA denied a petition by Collins Bus Corporation (Collins) in which the lettering height on the affected buses was 2 millimeters less than 1 centimeter. Collins contended that some of the lettering in the labeled message exceeds the requirement by 1 millimeter. Therefore, the difference of the noncompliant lettering being 2 millimeters smaller than required should be deemed inconsequential. However, Blue Bird notes that NHTSA was not persuaded by Collins's assertion that a 2 millimeter measurement is any less significant than a 1 millimeter measurement. Blue Bird says that NHTSA's decision in this case implies that a 0.118 centimeter variation from the required lettering height at a single location can be considered inconsequential.
Moreover, Blue Bird believes that Vernier caliper jaws, when used for the official measurement of letter height can introduce inaccuracies, particularly in discerning small variations from the required height. Blue Bird says manual error in the repeatability of both the measurement device and the user could lead to discrepancies that exceed the difference between the Blue Bird text size from the requirement. Blue Bird contends that the photo provided of the measurement in this case illustrates the potential for human error in identifying a small variation. According to Blue Bird, “the caliper is not positioned flat against the decal, and only one location on the decal was measured.” Therefore, Blue Bird believes that a discrepancy of 0.118 centimeters could be attributed to a slight angle of the calipers or measurements conducted at various points on the signage.
According to Blue Bird, its lettering meets all other FMVSS No. 217 labeling requirements, specifically that (1) operating instructions must be “concise” and describe “the motions necessary to unlatch and open the emergency exit,” (2) operating instructions must “be located within 15 centimeters of the release mechanism on the inside surface of the bus,” and (3) operating instructions must be “of a color that contrasts with [their] background.”
Blue Bird asserts NHTSA has not put forth any claim or reasoning indicating that a 0.118 centimeter variation from the 1 centimeter lettering height requirement “compromises a passenger's ability to safely view or understand the lettering.” Furthermore, Blue Bird contends that NHTSA's prior determination on the Collins petition notes the substantial difference between a 1 millimeter and a 2 millimeter variation from the requirement. Additionally, Blue Bird believes it has effectively demonstrated that the manual use of Vernier calipers can introduce “discrepancies and variations when distinguishing variations as small as 0.118 cm.”
Blue Bird concludes by stating its belief that the subject noncompliance is inconsequential as it relates to motor vehicle safety and its petition to be exempted from providing notification of the noncompliance, as required by 49 U.S.C. 30118, and a remedy for the noncompliance, as required by 49 U.S.C. 30120, should be granted.
Congress passed the National Traffic and Motor Vehicle Safety Act of 1966 (the Safety Act) with the express purpose of reducing motor vehicle accidents, deaths, injuries, and property damage.
NHTSA adopts a FMVSS only after the Agency has determined that the requirements are objective and practicable and meet the need for motor vehicle safety.
Under the Safety Act and Part 556, inconsequentiality exemptions may be granted only in response to a petition from a manufacturer, and then only after notice in the
Neither the Safety Act nor part 556 define the term “inconsequential.” Rather, the Agency determines whether a particular noncompliance is inconsequential to motor vehicle safety based upon the specific facts before it in a particular petition. An important issue to consider in determining inconsequentiality based upon NHTSA's prior decisions on noncompliance issues was the safety risk to individuals who experience the type of event against which the recall would otherwise protect.
Further, because each inconsequential noncompliance petition must be evaluated on its own facts and determinations are highly fact-dependent, NHTSA does not consider prior determinations as binding precedent. Petitioners are reminded that they have the burden of persuading NHTSA that the noncompliance is inconsequential to safety.
NHTSA reviewed Blue Bird's arguments that the subject noncompliance is inconsequential to motor vehicle safety. Blue Bird contends that the lettering height of the operating instructions describing the motions necessary to unlatch and open the emergency window exit failing to meet the Emergency Exit Identification requirements, as specified in paragraph S5.5.3(b) of FMVSS No. 217, poses little, if any, risk to motor vehicle safety. NHTSA does not agree.
The purpose of FMVSS No. 217 is to minimize the likelihood of occupants being thrown from the bus and to provide a means of readily accessible emergency egress (
Regarding Blue Bird's argument that the letter height variation of 0.118 centimeters is inconsequential based on previous NHTSA decisions,
NHTSA is also not persuaded by Blue Bird's argument that “the jaws of a Vernier caliper when used for the official measurement of letter height can be inaccurate and inconsistent when used to differentiate such small variation from the standard.” Blue Bird states that “[m]anual error in repeatability of the measurement device and user could result in differences that exceed the difference the Blue Bird text size is from the requirement . . . A difference of .118 cm could easily be accounted for by a slight angle of the calipers or measurements taken in
Regarding the additional requirements at S5.5.3(b) of FMVSS No. 217 for the operating instructions, NHTSA agrees with Blue Bird that the operating instructions “lettering meets all other labeling requirements” at S5.5.3(b) of FMVSS No. 217, but NHTSA does not agree with Blue Bird that partial compliance with FMVSS No. 217 is sufficient to render the partial noncompliance inconsequential to safety. NHTSA is not persuaded by Blue Bird's argument that meeting the other requirements within S5.5.3(b) of FMVSS No. 217 for the operating instructions mitigates Blue Bird's noncompliance with the letter height requirement, as no evidence was provided in support of this claim.
In consideration of the foregoing, NHTSA has decided that Blue Bird has not met its burden of persuasion that the subject FMVSS No. 217 noncompliance is inconsequential to motor vehicle safety. Accordingly, Blue Bird's petition is hereby denied and Blue Bird is consequently obligated to provide notification of and free remedy for that noncompliance under 49 U.S.C. 30118 and 30120.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of applications for special permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.
Comments must be received on or before November 12, 2024.
Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Donald Burger, Chief, Office of Hazardous Materials Safety General Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington DC.
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice of actions on special permit applications.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.
Comments must be received on or before November 12, 2024.
Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Donald Burger, Chief, Office of Hazardous Materials Safety General Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC.
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, PHMSA invites public comments about PHMSA's intention to request Office of Management and Budget (OMB) approval to renew eight information collections that are scheduled to expire in 2025. PHMSA has reviewed each information collection and considers them vital to maintaining pipeline safety. As such, PHMSA will request renewal from OMB, without change, for each information collection.
Interested persons are invited to submit comments on or before December 9, 2024.
Comments may be submitted in the following ways:
Angela Hill by telephone at 202-366-1246 or by email at
Title 5, Code of Federal Regulations (CFR) section 1320.8(d), requires PHMSA to provide interested members of the public and affected agencies the opportunity to comment on information collection and recordkeeping requests before they are submitted to OMB for approval. This notice identifies eight information collection requests that PHMSA will submit to OMB for renewal and requests comment from interested parties. The information collections (including their expiration dates) are as follows: (1) OMB control number 2137-0627, OPID Assignment Request and Registry Notifications (03/31/2025); (2) OMB control number 2137-0600, Qualification of Pipeline Safety Training (04/30/2025); (3) OMB control number 2137-0605, Hazardous Liquid Integrity Management (04/30/2025); (4) OMB control number 2137-0622, Public Awareness Program (04/30/2025); (5) OMB control number 2137-0584, Gas and Liquid Pipeline Safety Program Certification (05/31/2025); (6) OMB control number 2137-0589, Response Plans for Onshore Oil Pipelines (9/30/2025); (7) OMB control number 2137-0610, Gas Transmission Integrity Management in HCAs (09/30/2025); and (8) OMB 2137-0624, Control Room Management/Human Factors (09/30/2025).
The following information is provided for these information collections: (1) Title of the information collection; (2) OMB control number; (3) Current expiration date; (4) Type of request; (5) Abstract of the information collection activity; (6) Description of affected public; (7) Estimate of total annual reporting and recordkeeping burden; and (8) Frequency of collection.
PHMSA will request a three-year term of approval for each of the following information collection activities. PHMSA requests comments on the following information:
1.
2.
3.
4.
5.
6.
7.
8.
(a) The need for the renewal and revision of these collections of information for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(b) The accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(d) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of applications for modification of special permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.
Comments must be received on or before October 25, 2024.
Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Donald Burger, Chief, Office of Hazardous Materials Safety General Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC or at
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Office of Foreign Assets Control, Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
This action was issued on October 7, 2024. See
OFAC: Associate Director for Global Targeting, 202-622-2420; Assistant Director for Licensing, 202-622-2480; or Assistant Director for Sanctions Compliance, 202-622-2490 or
The SDN List and additional information concerning OFAC sanctions programs are available on OFAC's website:
On October 7, 2024, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning the burden related to the failure of employers to make comparable health savings account contributions.
Written comments should be received on or before December 9, 2024 to be assured of consideration.
Direct all written comments to Andrés Garcia, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or by email to
Requests for additional information or copies of the form and instructions should be directed to Ronald J. Durbala, at (202) 317-5746, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet at
The following paragraph applies to all the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number.
Books or records relating to a collection of information must be retained if their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological
Comments submitted in response to this notice will be summarized and/or included in the ICR for OMB approval of the extension of the information collection; they will also become a matter of public record.
Internal Revenue Service, Treasury.
Notice.
A report summarizing the closed meeting activities of the Art Advisory Panel during fiscal year 2023 has been prepared. A copy of this report has been filed with the Assistant Secretary for Management of the Department of the Treasury.
The report is available at
Krista M. Floyd, AP:SPR:AREA 10:AAS, Internal Revenue Service/Independent Office of Appeals, 2203 N Lois Avenue, Tampa, FL 33607-2370, Telephone number (813) 367-8444 (not a toll free number).
It has been determined that this document is not a major rule as defined in Executive Order 12291 and that a regulatory impact analysis is, therefore, not required. Additionally, this document does not constitute a rule subject to the Regulatory Flexibility Act (5 U.S.C. chapter 6).
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning the burden for completing the form SS-4,
Written comments should be received on or before December 9, 2024 to be assured of consideration.
Direct all written comments to Andrés Garcia, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or by email to
Requests for additional information or copies of the form and instructions should be directed to Ronald J. Durbala, at (202) 317-5746, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet at
The following paragraph applies to all the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number.
Books or records relating to a collection of information must be retained if their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments submitted in response to this notice will be summarized and/or included in the ICR for OMB approval of the extension of the information collection; they will also become a matter of public record.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service (IRS), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning, Declarations and Authorizations for Electronic Filing.
Written comments should be received on or before December 9, 2024 to be assured of consideration.
Direct all written comments to Andres Garcia, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or by email to
Requests for additional information or copies of this collection should be directed to Martha R. Brinson, at (202) 317-5753, or at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
Veterans Benefits Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Comments must be received on or before December 9, 2024.
Comments must be submitted through
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
Proposed rule.
This proposed rule includes payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2026 benefit year user fee rates for issuers that participate in the HHS-operated risk adjustment program and the 2026 benefit year user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This proposed rule also includes proposed requirements related to modifications to the calculation of the Basic Health Program (BHP) payment; and changes to the Initial Validation Audit (IVA) sampling approach and Second Validation Audit (SVA) pairwise means test for HHS-RADV. It also addresses HHS' authority to engage in compliance reviews of and take enforcement action against lead agents of insurance agencies for violations of HHS' Exchange standards and requirements; HHS' system suspension authority to address noncompliance by agents and brokers; an optional fixed-dollar premium payment threshold; proposed reconsideration standards for certification denials; proposed changes to the approach for conducting Essential Community Provider (ECP) certification reviews; a proposal to publicly share aggregated, summary-level Quality Improvement Strategy (QIS) information on an annual basis; and proposed revisions to the medical loss ratio (MLR) reporting and rebate requirements for qualifying issuers that meet certain standards.
To be assured consideration, comments must be received at one of the addresses provided below, by November 12, 2024.
In commenting, please refer to file code CMS-9888-P.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
For information on viewing public comments, see the beginning of the
Jeff Wu, (301) 492-4305, Rogelyn McLean, (301) 492-4229, Grace Bristol, (410) 786-8437, for general information.
Ayesha Anwar, (301) 492-4000, Joshua Paul, (301) 492-4347, or Debbie Noymer, (301) 448-3755 for matters related to HHS-operated risk adjustment.
Leanne Scott, (410) 786-1045 or Ayesha Anwar, (301) 492-4000 for matters related to HHS-operated risk adjustment data validation.
Aaron Franz, (410) 786-8027, for matters related to user fees.
Brian Gubin, (410) 786-1659, for matters related to agent, broker, and web-broker guidelines.
Zarin Ahmed, (301) 492-4400, for matters related to enrollment of qualified individuals into QHPs and termination of Exchange enrollment or coverage for qualified individuals.
Christina Whitefield, (301) 492-4172, for matters related to the medical loss ratio program.
Preeti Hans, (301) 492-5144, for matters related to Quality Improvement Strategy.
Ken Buerger, (410) 786-1190, for matters related to certification standards for QHPs.
Nikolas Berkobien, (667) 290-9903, for matters related to standardized plan options, non-standardized plan option limits and exceptions, and financial requirements for issuers of QHPs on the FFEs.
Adelaide Balenger, (667) 414-0691, for matters related to the Actuarial Value Calculator.
Mary Evans, (470) 890-4113, for matters related to the Failure to File and Reconcile process.
Chris Truffer, (410) 786-1264, for matters related to the Basic Health Program (BHP) provision.
We are proposing changes to the provisions and parameters implemented through prior rulemaking to implement the ACA.
Title I of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) added a new title XXVII to the PHS Act to establish various reforms to the group and individual health insurance markets.
These provisions of the PHS Act were later augmented by other laws, including the ACA.
Subtitles A and C of title I of the ACA reorganized, amended, and added to the provisions of part A of title XXVII of the PHS Act relating to group health plans and health insurance issuers in the group and individual markets. The term “group health plan” includes both insured and self-insured group health plans.
Section 2718 of the PHS Act, as added by the ACA, generally requires health insurance issuers in the group and individual markets to submit an annual medical loss ratio (MLR) report to HHS and provide rebates to enrollees if the issuers do not achieve specified MLR thresholds.
Section 1301(a)(1)(B) of the ACA directs all issuers of qualified health plans (QHPs) to cover the EHB package described in section 1302(a) of the ACA, including coverage of the services described in section 1302(b) of the ACA, adherence to the cost-sharing limits described in section 1302(c) of the ACA, and meeting the Actuarial Value (AV) levels established in section 1302(d) of the ACA. Section 2707(a) of the PHS Act, which is effective for plan or policy years beginning on or after January 1, 2014, extends the requirement to cover the EHB package to non-grandfathered individual and small group health insurance coverage, irrespective of whether such coverage is offered through an Exchange. In addition, section 2707(b) of the PHS Act directs non-grandfathered group health plans to ensure that cost sharing under the plan does not exceed the limitations described in section 1302(c)(1) of the ACA.
Section 1302 of the ACA provides for the establishment of an EHB package that includes coverage of EHBs (as defined by the Secretary of HHS), cost-sharing limits, and AV requirements. The law directs that EHBs be equal in scope to the benefits provided under a typical employer plan, and that they cover at least the following 10 general categories: ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; and pediatric services, including oral and vision care.
Sections 1302(b)(4)(A) through (D) of the ACA establish that the Secretary must define EHB in a manner that: (1) reflects appropriate balance among the 10 categories; (2) is not designed in such a way as to discriminate based on age, disability, or expected length of life; (3) takes into account the health care needs of diverse segments of the population; and (4) does not allow denials of EHBs based on age, life expectancy, disability, degree of medical dependency, or quality of life.
Section 1302(d) of the ACA describes the various levels of coverage based on AV. Consistent with section 1302(d)(2)(A) of the ACA, AV is calculated based on the provision of EHB to a standard population. Section 1302(d)(3) of the ACA directs the Secretary of HHS to develop guidelines that allow for de minimis variation in AV calculations.
Section 1311(c) of the ACA provides the Secretary the authority to issue regulations to establish criteria for the certification of QHPs. Section 1311(c)(1)(B) of the ACA requires, among the criteria for certification that the Secretary must establish by regulation, that QHPs ensure a sufficient choice of providers. Section 1311(d)(4)(A) of the ACA requires the Exchange to implement procedures for the certification, recertification, and decertification of health plans as QHPs, consistent with guidelines developed by the Secretary under section 1311(c) of the ACA. Section 1311(e)(1) of the ACA grants the Exchange the authority to certify a health plan as a QHP if the health plan meets the Secretary's requirements for certification issued under section 1311(c) of the ACA, and the Exchange determines that making the plan available through the Exchange is in the interests of qualified individuals and qualified employers in the State. Section 1311(c)(6)(C) of the ACA directs the Secretary of HHS to
Section 1311(d)(3)(B) of the ACA permits a State, at its option, to require QHPs to cover benefits in addition to EHB. This section also requires a State to make payments, either to the individual enrollee or to the issuer on behalf of the enrollee, to defray the cost of these additional State-required benefits.
Section 1312(c) of the ACA generally requires a health insurance issuer to consider all enrollees in all health plans (except grandfathered health plans) offered by such issuer to be members of a single risk pool for each of its individual and small group markets. States have the option to merge the individual and small group market risk pools under section 1312(c)(3) of the ACA.
Section 1312(e) of the ACA provides the Secretary with the authority to establish procedures under which a State may allow agents or brokers to (1) enroll qualified individuals and qualified employers in QHPs offered through Exchanges and (2) assist individuals in applying for advance payments of the premium tax credit (APTC) and cost-sharing reductions (CSRs) for QHPs sold through an Exchange.
Section 1312(f)(1)(B) of the ACA provides that an individual shall not be treated as a qualified individual for enrollment in a QHP if, at the time of enrollment, the individual is incarcerated, other than incarceration pending the disposition of charges.
Sections 1313 and 1321 of the ACA provide the Secretary with the authority to oversee the financial integrity of State Exchanges, their compliance with HHS standards, and the efficient and non-discriminatory administration of State Exchange activities. Section 1313(a)(5)(A) of the ACA provides the Secretary with the authority to implement any measure or procedure that the Secretary determines is appropriate to reduce fraud and abuse in the administration of the Exchanges. Section 1321 of the ACA provides for State flexibility in the operation and enforcement of Exchanges and related requirements.
Section 1321(a) of the ACA provides broad authority for the Secretary to establish standards and regulations to implement the statutory requirements related to Exchanges, QHPs and other components of title I of the ACA, including such other requirements as the Secretary determines appropriate. When operating an FFE under section 1321(c)(1) of the ACA, HHS has the authority under sections 1321(c)(1) and 1311(d)(5)(A) of the ACA to collect and spend user fees. Office of Management and Budget (OMB) Circular A-25 Revised establishes Federal policy regarding user fees and specifies that a user charge will be assessed against each identifiable recipient for special benefits derived from Federal activities beyond those received by the public.
Section 1321(d) of the ACA provides that nothing in title I of the ACA must be construed to preempt any State law that does not prevent the application of title I of the ACA. Section 1311(k) of the ACA specifies that Exchanges may not establish rules that conflict with or prevent the application of regulations issued by the Secretary.
Section 1331 of the ACA provides States with an option to establish a Basic Health Program (BHP). In the States that elect to operate a BHP, the BHP makes affordable health benefits coverage available for individuals under age 65 with household incomes between 133 percent and 200 percent of the Federal poverty level (FPL) who are not otherwise eligible for Medicaid, the Children's Health Insurance Program (CHIP), or affordable employer-sponsored coverage, or for individuals whose income is equal to or below 200 percent of FPL but are lawfully present non-citizens ineligible for Medicaid. For those States that have expanded Medicaid coverage under section 1902(a)(10)(A)(i)(VIII) of the Social Security Act (the Act), the lower income threshold for BHP eligibility is effectively 138 percent of the FPL due to the application of a required 5 percent income disregard in determining the upper limits of Medicaid income eligibility (section 1902(e)(14)(I) of the Act).
Section 1343 of the ACA establishes a permanent risk adjustment program to provide payments to health insurance issuers that attract higher-than-average risk populations, such as those with chronic conditions, funded by charges collected from those issuers that attract lower-than-average risk populations, thereby reducing incentives for issuers to avoid higher-risk enrollees. Section 1343(b) of the ACA provides that the Secretary, in consultation with States, shall establish criteria and methods to be used in carrying out the risk adjustment activities under this section. Consistent with section 1321(c) of the ACA, the Secretary is responsible for operating the HHS risk adjustment program in any State that fails to do so.
Section 1401(a) of the ACA added section 36B to the Internal Revenue Code (the Code), which, among other things, requires that a taxpayer reconcile APTC for a year of coverage with the amount of the premium tax credit (PTC) the taxpayer is allowed for the year.
Section 1402 of the ACA provides for, among other things, reductions in cost sharing for EHB for qualified low- and moderate-income enrollees in silver level QHPs offered through the individual market Exchanges. This section also provides for reductions in cost sharing for Indians enrolled in QHPs at any metal level.
Section 1411(f) of the ACA requires the Secretary, in consultation with the Secretary of the Treasury and the Secretary of Homeland Security, and the Commissioner of Social Security, to establish procedures for hearing and making decisions governing appeals of Exchange eligibility determinations. Section 1411(f)(1)(B) of the ACA requires the Secretary to establish procedures to redetermine eligibility on a periodic basis, in appropriate circumstances, including eligibility to purchase a QHP through the Exchange and for APTC and CSRs.
Section 1411(g) of the ACA allows the use of applicant information only for the limited purpose of, and to the extent necessary for, ensuring the efficient operation of the Exchange, including by verifying eligibility to enroll through the Exchange and for APTC and CSRs, and limits the disclosure of such information.
Section 1413 of the ACA directs the Secretary to establish, subject to minimum requirements, a streamlined enrollment process for enrollment in QHPs and all insurance affordability programs.
Section 5000A of the Code, as added by section 1501(b) of the ACA, requires individuals to have minimum essential coverage (MEC) for each month, qualify for an exemption, or make an individual shared responsibility payment. Under the Tax Cuts and Jobs Act, which was enacted on December 22, 2017, the individual shared responsibility payment is reduced to $0, effective for months beginning after December 31, 2018. Notwithstanding that reduction, certain exemptions are still relevant to determine whether individuals aged 30 and above qualify to enroll in
Section 1902(r)(2)(A) of the Act permits States to apply less restrictive methodologies than cash assistance program methodologies in determining eligibility for certain eligibility groups.
The premium stabilization programs refer to the risk adjustment, risk corridors, and reinsurance programs established by the ACA.
• In the March 23, 2012
• In the March 11, 2013
• In the October 30, 2013
• In the November 6, 2013
• In the March 11, 2014
• In the May 27, 2014
• In the February 27, 2015
• In the March 8, 2016
• In the December 22, 2016
• In the April 17, 2018
• In the May 11, 2018
• On July 27, 2018, consistent with 45 CFR 153.320(b)(1)(i), we updated the 2019 benefit year final HHS risk adjustment model coefficients to reflect an additional recalibration related to an update to the 2016 enrollee-level EDGE data set.
• In the July 30, 2018
• In the December 10, 2018
• In the April 25, 2019
• On May 12, 2020, consistent with § 153.320(b)(1)(i), we issued the 2021 Benefit Year Final HHS Risk Adjustment Model Coefficients on the CCIIO website.
• In the May 14, 2020
• In the December 1, 2020
• In the September 2, 2020
• In the May 5, 2021
• On July 19, 2021, consistent with § 153.320(b)(1)(i), we released Updated 2022 Benefit Year Final HHS Risk Adjustment Model Coefficients on the CCIIO website, announcing some minor revisions to the 2022 benefit year final HHS risk adjustment adult model coefficients.
• In the May 6, 2022
• In the April 27, 2023
• In the April 15, 2024
We have finalized program integrity standards related to the Exchanges and premium stabilization programs in two rules: the “first Program Integrity Rule” issued in the August 30, 2013
In the April 27, 2023
In the February 27, 2013
We issued a request for comment relating to Exchanges in the August 3, 2010
In the August 17, 2011
In the 2014 Payment Notice and the Amendments to the HHS Notice of Benefit and Payment Parameters for 2014 interim final rule, issued in the March 11, 2013
In the 2016 Payment Notice, we also set forth the ECP certification standard at § 156.235, with revisions in the 2017 Payment Notice in the March 8, 2016
In the 2018 Payment Notice, issued in the December 22, 2016
In an interim final rule, issued in the May 11, 2016
In the Market Stabilization final rule, issued in the April 18, 2017
In the May 14, 2020
In the January 19, 2021
In the May 6, 2022
In the 2024 Payment Notice, issued in the April 27, 2023
In the 2025 Payment Notice, issued in the April 15, 2024
We established requirements relating to EHBs in the Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation Final Rule, which was issued in the February 25, 2013
In the 2025 Payment Notice, issued in the April 15, 2024
We issued a request for comment on section 2718 of the PHS Act in the April 14, 2010
We issued regulations in § 155.200(d) to direct Exchanges to evaluate quality improvement strategies, and § 156.200(b) to direct QHP issuers to implement and report on a quality improvement strategy or strategies consistent with section 1311(g) standards as QHP certification criteria for participation in an Exchange. In the 2016 Payment Notice, issued in the February 27, 2015
In the March 12, 2014,
On October 11, 2017, the Attorney General of the United States provided HHS and the Department of the Treasury (the Departments) with a legal opinion
In the November 5, 2019
In the December 20, 2022
The regulations outlined in this proposed rule would be codified in 42 CFR part 600 and 45 CFR parts 153, 155, 156, and 158.
We are proposing changes to the methodology regarding the premium adjustment factor (PAF), which is used to calculate the adjusted reference premium (ARP) for BHP payment. We propose maintaining the PAF value at 1.188 for States that have fully implemented BHP and are using Second Lowest Cost Silver Plan (SLCSP) premiums from a year in which BHP was fully implemented. As previously clarified, for States in their first year of implementing BHP and choosing to use prior year SLCSP premiums to determine BHP payment, the PAF value would be set to 1.00. We propose that if a State is using SLCSP premiums from a year in which BHP was not fully implemented, the PAF is calculated by determining the CSR adjustment that QHP issuers included in the SLCSP premiums, reporting the CSR adjustments for the SLCSP for each region in the State to CMS, and then CMS calculating the PAF as 1.20 divided by 1 plus the adjustment. Additionally, we are proposing a technical clarification for BHP payment rates in cases of multiple SLCSP premiums in an area.
In accordance with the OMB Report to Congress on the Joint Committee Reductions for Fiscal Year 2025, the HHS-operated risk adjustment program is subject to the fiscal year 2025 sequestration.
We propose to recalibrate the 2026 benefit year HHS risk adjustment models using the 2020, 2021, and 2022 benefit year enrollee-level EDGE data. Starting with the 2026 benefit year, we propose to begin phasing out the market pricing adjustment to the plan liability associated with Hepatitis C drugs in the HHS risk adjustment models (see, for example, 84 FR 17463 through 17466). We also are proposing to incorporate pre-exposure prophylaxis (PrEP) as a separate, new type of factor called an Affiliated Cost Factor (ACF) in the HHS risk adjustment adult and child models starting with the 2026 benefit year. We also request information on whether the HHS-operated risk adjustment program should take into account the time value of money for the collection and remittance of State transfers that occur 8 to 10 months after the conclusion of the benefit year. We also propose a risk adjustment user fee for the 2026 benefit year of $0.18 per member per month (PMPM).
Beginning with the 2025 benefit year of HHS-RADV, we propose to exclude enrollees without HCCs, which includes enrollees with only prescription drug categories (RXCs), from the IVA sample, remove the Finite Population Correction (FPC) from the IVA sampling methodology, and replace the source of the Neyman allocation data used for HHS-RADV sampling with the most recent 3 years of consecutive HHS-RADV data. In addition, beginning with the 2024 benefit year of HHS-RADV, we propose to modify the SVA pairwise means test, which tests for statistical differences between the IVA and SVA results, to use a bootstrapped 90 percent confidence interval methodology and to increase the initial SVA subsample size from 12 enrollees to 24 enrollees.
We seek comment on how assisters who perform their assister duties in a hospital and hospital system may, within the bounds of the statute, refer consumers to programs designed to reduce medical debt.
We address our authority to investigate and undertake compliance reviews and enforcement actions in response to misconduct or noncompliance with applicable agent, broker, and web-broker Exchange requirements or standards occurring at the insurance agency level and how we intend to hold lead agents of insurance agencies accountable for such misconduct or noncompliance.
We propose to revise § 155.220(k)(3) to reflect our authority to suspend an agent's or broker's ability to transact information with the Exchange in instances where HHS discovers circumstances that pose unacceptable risk to accuracy of Exchange eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems, including but not limited to risk related to noncompliance with the standards of conduct under § 155.220(j)(2)(i), (ii) or (iii) and the privacy and security standards under § 155.260, until the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction.
We propose to update the Model Consent Form that agents, brokers, and web-brokers can use to obtain and document consumer consent.
We propose to amend § 155.305(f)(4) to require Exchanges to provide notice to consumers and tax filers who have failed to file and reconcile their APTC for 2 consecutive years.
We propose to add § 155.400(d)(1) to codify HHS' guidance that requires that, within 60 calendar days after a State Exchange receives a data inaccuracy from an issuer operating in an State Exchange that includes a description of an inaccuracy that meets the requirements at § 156.1210(a)-(c) and all the information that the State Exchange requires or requests to properly assess the inaccuracy, State Exchanges must review and resolve the State Exchange issuer's enrollment data inaccuracies and submit to HHS a description of the resolution of any inaccuracies described by the State Exchange issuer that the State Exchange confirms to be inaccuracies in a format and manner specified by HHS.
We propose to revise § 155.400(g) to allow issuers to adopt a fixed-dollar payment threshold of $5 or less, adjusted for inflation, under which issuers would not be required to trigger a grace period or terminate enrollment for enrollees who fail to pay the full amount of their portion of premium owed. We propose to limit application of this fixed-dollar payment threshold to premium payments after coverage is effectuated. Issuers would be required to apply the fixed-dollar threshold uniformly to all enrollees and without regard to their health status. Issuers would be allowed to apply either the fixed-dollar payment threshold or one of two percentage-based thresholds (one of which is currently permitted under § 155.400(g), but which we propose to modify).
We propose revisions to § 155.505(b) to codify an option for application filers to file appeals on behalf of applicants and enrollees on the application filer's Exchange application, as this would streamline the appeals process and ensure operational consistency between the FFEs and the HHS appeals entity or State Exchange appeals entity.
We propose to amend § 155.1000 to state explicitly that an Exchange may deny certification to any plan that does not meet the general certification criteria at § 155.1000(c). We also propose to amend § 155.1090 with refinements to the standards for a request for the reconsideration of a denial of certification specific to the FFEs.
We propose that in addition to collecting the information and data currently provided by Exchanges under § 155.1200 to monitor performance and compliance, we would use the information and data that Exchanges submit to increase transparency into Exchange operations and to promote program improvements. We anticipate publicly releasing the Exchanges annual State-based Marketplace Annual Reporting Tools (SMARTs), programmatic and financial audits, Blueprint applications, and additional data points in the Open Enrollment (OE) Data Reports. We are seeking input on how to best display these data points and how to best develop a performance measurement tool to assess Exchange quality and consumer experience.
We solicit comments on reducing the risk of issuer insolvencies adversely impacting the integrity of the FFEs.
We propose 2026 benefit year FFE and SBE-FP user fee rates of 2.5 percent and 2.0 percent of total monthly premiums, respectively. However, if the enhanced PTC subsidies as currently enacted
We affirm that certain CSR loading practices that are permitted by State regulators are permissible under Federal law to the extent that they are reasonable and actuarially justified. We seek comment on whether we should codify this guidance at § 156.80(d).
We intend to revise the method for updating the AV Calculator, starting with the 2026 AV Calculator. Under this approach, for a plan year, we would only release a single, final version of the AV Calculator. We would also solicit public comments on the AV Calculator for a plan year generally but would only plan to incorporate this feedback into the development and release of the following plan year's AV Calculator.
We propose to make minor updates to the standardized plan option designs for PY 2026 to ensure these plans continue to have AVs within the permissible
We propose to amend § 156.202(b) and (d) to properly reflect the flexibility that issuers have been operationally permitted since these requirements were introduced to vary the inclusion of the distinct adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage categories under the non-standardized plan option limit in accordance with § 156.202(c)(1) through (3).
We propose to conduct ECP certification reviews of plans for which issuers submit QHP certification applications in FFEs in States performing plan management functions, beginning in PY 2026.
We propose to share aggregated, summary-level QIS information publicly on an annual basis beginning on January 1, 2026, with information QHP issuers submit during the PY 2025 QHP Application Period.
We propose to amend § 156.1220(a) to introduce a new materiality threshold for HHS-RADV appeals, such that HHS would rerun HHS-RADV results and adjust HHS-RADV adjustments to State transfers in response to a successful appeal when the impact of that appeal to the filer's HHS-RADV adjustments to State transfers is greater than or equal to $10,000.
We propose to amend § 158.140(b)(4)(ii) to allow qualifying issuers to not adjust incurred claims by the net payments or receipts related to
We also propose amendments to § 158.240(c) to add an illustrative example of how qualifying issuers would calculate the amount of rebate owed to each enrollee to accurately reflect how such issuers would incorporate the net risk adjustment transfer amounts into the MLR and rebate calculations differently from other issuers, as well as a conforming amendment to clarify that the current illustrative example in paragraph (c)(2) would apply to issuers that are not qualifying issuers.
Section 1331(d)(3) of the ACA directs the Secretary to consider several factors when determining the Federal BHP payment amount, which, as specified in the statute, must equal 95 percent of the value of the PTC under section 36B of the Code and CSRs under section 1402 of the ACA that would have been paid on behalf of BHP enrollees had they enrolled in a QHP through an Exchange. Thus, the BHP payment methodology is designed to calculate the PTC and CSRs as consistently as possible and in general alignment with the methodology used by Exchanges to calculate advance payments of the PTC (APTC) and CSRs, and the methodology used to reconcile APTC with the amount of the PTC allowed for the tax year under section 36B of the Code. In accordance with section 1331(d)(3)(A)(iii) of the ACA, the final payment methodology must be certified by the Chief Actuary of CMS, in consultation with the Office of Tax Analysis (OTA) of the Department of the Treasury, as having met the requirements of section 1331(d)(3)(A)(ii) of the ACA.
Section 1331(d)(3)(A)(ii) of the ACA specifies that the payment determination shall take into account all relevant factors necessary to determine the value of the PTC and CSRs that would have been paid on behalf of eligible individuals, including but not limited to, the age and income of the enrollee, whether the enrollment is for self-only or family coverage, geographic differences in average spending for health care across rating areas, the health status of the enrollee for purposes of determining risk adjustment payments and reinsurance payments that would have been made if the enrollee had enrolled in a QHP through an Exchange, and whether any reconciliation of APTC and CSR would have occurred if the enrollee had been enrolled. Under all previous payment methodologies, the total Federal BHP payment amount has been calculated using multiple rate cells in each BHP State. Each rate cell represents a unique combination of age range (if applicable), geographic area, coverage category (for example, self-only or two-adult coverage through the BHP), household size, and income range as a percentage of FPL, and there is a distinct rate cell for individuals in each coverage category within a particular age range who reside in a specific geographic area and are in households of the same size and income range. The BHP payment rates developed are also consistent with the State's rules on age rating. Thus, in the case of a State that does not use age as a rating factor on an Exchange, the BHP payment rates would not vary by age.
Under the methodology finalized in the July 2021 final BHP Payment Notice, the rate for each rate cell is calculated in 2 parts. The first part is equal to 95 percent of the estimated PTC that would have been allowed if a BHP enrollee in that rate cell had instead enrolled in a QHP in an Exchange. The second part is equal to 95 percent of the estimated CSR payment that would have been made if a BHP enrollee in that rate cell had instead enrolled in a QHP in an Exchange. These two parts are added together and the total rate for that rate cell would be equal to the sum of the PTC and CSR rates. As noted in the July 2021 final BHP Payment Notice, we currently assign a value of zero to the CSR portion of the BHP payment rate calculation, because there is presently no available appropriation from which we can make the CSR portion of any BHP payment.
The 2023 final BHP Payment Notice provides a detailed description of the structure of the BHP payments, including the equations, factors, and the values of the factors used to calculate the BHP payments. We are proposing one change to the methodology regarding the premium adjustment factor (PAF).
The PAF is used to calculate the adjusted reference premium (ARP) that is used to calculate the BHP payment. The adjusted reference premium (ARP) is used to calculate the estimated PTC that would be allowed if BHP-eligible individuals enrolled in QHPs through an Exchange and is based on the premiums for the applicable second lowest cost silver plan during the applicable plan year. The PAF considers the premium increases in other States that took effect after we discontinued payments to issuers for CSRs provided to enrollees in QHPs offered through Exchanges. Despite the discontinuance of Federal payments for CSRs, QHP issuers are required to provide CSRs to eligible enrollees. As a result, many QHP issuers increased the silver-level plan premiums to account for those additional costs; these premium adjustments and how they were applied (for example, to only silver-level plans or to all metal tier plans) varied across States. For the States operating BHPs in 2018, the increases in premiums were relatively minor, because the majority of enrollees eligible for CSRs (and all who were eligible for the largest CSRs) were enrolled in the BHP and not in QHPs on the Exchanges, and therefore issuers in BHP States did not significantly raise premiums to cover costs related to HHS not making CSR payments.
In the Final Administrative Order and the 2019 through 2023 final BHP Payment Notices, we incorporated the PAF into the BHP payment methodologies to capture the impact of how other States responded to HHS ceasing to make CSR payments.
Under the Final Administrative Order, we calculated the PAF by using information sought from QHP issuers in each State and the District of Columbia and determined the premium adjustment that the responding QHP issuers made to each silver level plan in 2018 to account for the discontinuation of CSR payments to QHP issuers. Based on the data collected, we estimated the median adjustment for silver level QHPs nationwide (excluding those in the two BHP States). To the extent that QHP issuers made no adjustment (or the adjustment was zero), this was counted as zero in determining the median
For each of the two BHP States, we determined the median premium adjustment for all silver level QHPs in that State, which we refer to as the State median adjustment. The PAF for each BHP State equaled one plus the nationwide median adjustment divided by one plus the State median adjustment for the BHP State. In other words,
To determine the PAF described above, we sought to collect QHP information from QHP issuers in each State and the District of Columbia to determine the premium adjustment those issuers made to each silver level plan offered through the Exchange in 2018 to account for the end of CSR payments. Specifically, we sought information showing the percentage change that QHP issuers made to the premium for each of their silver level plans to cover benefit expenditures associated with the CSRs, given the lack of CSR payments in 2018. This percentage change was a portion of the overall premium increase from 2017 to 2018.
According to our 2018 records, there were 1,233 silver-level QHPs operating on Exchanges in 2018. Of these 1,233 QHPs, 318 QHPs (25.8 percent) responded to our request for the percentage adjustment applied to silver-level QHP premiums in 2018 to account for the discontinuance of HHS making CSR payments. These 318 QHPs operated in 26 different States, with 10 of those States running State Exchanges (while we requested information only from QHP issuers in States serviced by an FFE, many of those issuers also had QHPs in State Exchanges and submitted information for those States as well). Thirteen of these 318 QHPs were in New York (and none were in Minnesota). Excluding these 13 QHPs from the analysis, the nationwide median adjustment was 20.0 percent. Of the 13 QHPs in New York that responded, the State median adjustment was 1.0 percent. We believed that this was an appropriate adjustment for QHPs in Minnesota, as well, based on the observed changes in New York's QHP premiums in response to the discontinuance of CSR payments (and the operation of the BHP in that State) and our analysis of expected QHP premium adjustments for States with BHPs. We calculated the proposed PAF as (1 + 20%) ÷ (1 + 1%) (or 1.20/1.01), which results in a value of 1.188.
We set the value of the PAF to 1.188 for all program years for 2018 through 2024, with limited exceptions.
Starting in 2023, we made one limited exception in setting the value of the PAF as part of the 2023 final BHP Payment Notice.
We propose to make a change to the calculation of the PAF starting in program year 2026. There are cases in which a State may not have fully implemented BHP for a full program year. For example, a State may operate BHP for only a portion of the year (in other words, less than 12 months); there may be other such cases in which a State would be deemed to have partially implemented BHP for a program year.
For a State that initially only partially implemented BHP, it is likely that, in the year (or years) when the BHP is only partially implemented, the percentage adjustment to the premiums for the program year to account for the discontinuation of CSR payments may be significantly higher than the 1 percent adjustment we determined for BHP States in 2018. In these cases, it is probable that QHP issuers would include a larger premium adjustment (that is, greater than 1 percent) because more individuals would be eligible for CSRs (and individuals eligible for relatively larger CSRs) would be enrolled in a QHP on the Exchange, for part or all of the initial implementation year. If premiums with a larger CSR adjustment are used as a basis for calculating the BHP payments and the current value of the PAF (1.188) is used, it is likely that this would “double count” a portion of the adjustment and lead to an effective CSR adjustment over 20 percent.
For example, assume a State implements BHP for only 6 months in a program year. As a result, QHP issuers may include a 10 percent adjustment to the premiums to account for the discontinuation of the CSR for the portion of the year when CSR eligible individuals would have QHP coverage. The issuers would be liable for roughly half of the CSR amounts they would have had to provide if there was no BHP in place. Under the previous BHP payment methodology, if these premiums that already partially account for CSRs are used to calculate the BHP payment, we would increase the reference premium by 18.8 percent for the PAF, leading to an effective increase of 30.68 percent (1.188 multiplied by 1.10 minus 1). This is significantly larger than the 20 percent adjustment we determined as the basis for the PAF for States that have operated their BHP for more than two full program years.
Under the Secretary's general authority to account for all relevant factors necessary to determine the value of the premium and cost-sharing reductions that would have been provided to eligible individuals now enrolled in BHP coverage
(1) If a State has fully implemented BHP and is using SLSCP premiums for a year in which the BHP was fully implemented, then the value of the PAF would remain 1.188, as described above.
(2) If a State is in the first year of implementing a BHP and the State chooses to use prior year SLCSP premiums to determine the BHP payment (for example, the 2025 premiums for the 2026 program year), we set the value of the PAF to 1.00. This is the same approach described in the 2023 final BHP Payment Notice.
(3) If a State is using SLCSP premiums from a year in which BHP was not fully implemented, then the PAF is calculated as follows:
This approach would apply based on the premium year, not necessarily the program year. If the State has fully implemented BHP but is using the prior year premiums and BHP was not fully implemented in that year, this modified approach would still apply. For example, if a State partially implemented BHP in 2026 and fully implemented BHP in 2027, when determining the BHP payments for 2027, we would then use 1.188 for the value of the PAF if the State elected to use 2027 QHP premiums to determine the payment; if the State elected to use the 2026 QHP premiums, then we would use the modified PAF calculation described in this section. CMS would make a determination of whether or not a BHP was fully implemented based on a review of the Blueprint and provide that determination to the State.
We considered other approaches to the modified PAF. We considered whether or not CMS would collect data on the underlying CSR adjustment in the SLCSP premiums; however, we believe that such activities fall within States roles as BHP administrators and States are better able to work with QHP issuers to administer this data collection process. We also considered if States should survey all QHP issuers (not just those with the SLSCP premium). We believe that only using the CSR adjustment from individual market Exchange plans with the SLCSPs would be a more reasonable approach and would minimize the burden on States and QHP issuers by only requiring the State to work with one issuer in each region, as opposed to all issuers in each region. We also considered whether or not we should make further changes to the PAF, but we believe that this approach balances maintaining accurate BHP payments with stability and limited burden for BHP States. We request comments on this approach or alternative approaches to calculating the PAF.
The BHP payment rates are based on the second lowest cost silver plan premium among individual market QHPs operating on the Exchanges in each rating area (or county) in a State. This is the basis for the reference premium (or RP) in the BHP payment methodology.
In general, we expect that each county would have a unique second lowest cost silver plan premium, which is used to calculate the payment rates for residents of that county for the BHP payment. However, in some cases, we have found that States may have more than one second lowest cost silver plan within a county. This may occur in cases where the State has allowed QHPs to operate in only a portion of the county instead of the entire county on the Exchange.
In our previous BHP payment methodologies, we do not describe how such a case would be handled for calculating BHP payments. In our technical guidance to States, we have instructed States to report the premiums for the second lowest cost silver plan operating in the largest part of the county as measured by total population.
Under the Secretary's general authority to account for all relevant factors necessary to determine the value of the premium and cost-sharing reductions that would have been provided to eligible individuals now enrolled in BHP coverage,
In subparts A, B, D, G, and H of part 153, we established standards for the administration of the risk adjustment program. The risk adjustment program is a permanent program created by section 1343 of the ACA that transfers funds from issuers of lower-than-average risk, risk adjustment covered plans to issuers of higher-than-average risk, risk adjustment covered plans in the individual, small group markets, or merged markets, inside and outside the Exchanges. In accordance with § 153.310(a), a State that is approved or conditionally approved by the Secretary to operate an Exchange may establish a risk adjustment program or have HHS do so on its behalf.
In accordance with the OMB Report to Congress on the Joint Committee Reductions for Fiscal Year 2025, the HHS-operated risk adjustment program is subject to the fiscal year 2025 sequestration.
HHS, in coordination with OMB, has determined that, under section 256(k)(6) of the Balanced Budget and Emergency Deficit Control Act of 1985 (BBEDCA),
Additionally, we note that the Infrastructure Investment and Jobs Act
The HHS risk adjustment models predict plan liability for an average enrollee based on that person's age, sex, and diagnoses (also referred to as hierarchical condition categories (HCCs)), producing a risk score. The State payment transfer formula
Infant risk scores are determined by inclusion in one of 25 mutually exclusive groups, based on the infant's maturity and the severity of diagnoses. If applicable, the risk score for adults, children, or infants is multiplied by a cost sharing reduction (CSR) adjustment factor. The enrollment-weighted average risk score of all enrollees in a particular risk adjustment covered plan (also referred to as the plan liability risk score (PLRS)) within a geographic rating area is one of the inputs into the State payment transfer formula, which determines the State transfer payment or charge that an issuer will receive or be required to pay for that plan for the applicable State market risk pool for a given benefit year. Thus, the HHS risk adjustment models predict average group costs to account for risk across plans, in keeping with the Actuarial Standards Board's Actuarial Standards of Practice for risk classification.
We are proposing to recalibrate the 2026 benefit year HHS risk adjustment models with the 2020, 2021, and 2022 enrollee-level EDGE data. Consistent with the approach outlined in the 2020 Payment Notice, we propose to recalibrate the HHS risk adjustment models for the 2026 benefit year using only enrollee-level EDGE data, and to continue to use blended, or averaged, coefficients from the 3 years of separately solved models for the 2026 benefit year model recalibration.
In the 2024 Payment Notice (88 FR 25740 through 25749), we finalized the use of 2018, 2019 and 2020 benefit year enrollee-level EDGE data for recalibration of the 2024 benefit year HHS risk adjustment models for all model coefficients. As explained in the 2024 Payment Notice proposed rule (87 FR 78215 through 78216) and final rule (88 FR 25749 through 25753), we analyzed the 2020 benefit year data to identify possible impacts of the COVID-19 Public Health Emergency (PHE). Our analysis generally found that the 2020 enrollee-level EDGE data were anomalous primarily in the volume and frequencies of certain types of claims, but that the relative costs of specific services, at least those associated with payment HCCs in the HHS risk adjustment models, were largely unaffected. Because the HHS risk adjustment models predict relative costs of care for specific conditions on an enrollee-level basis and tend not to rely on overall patterns of utilization, the minimal impacts to relative costs of care for payment HCCs likewise resulted in minimal impacts on the coefficients fitted by the 2020 enrollee-level EDGE recalibration data.
Then, in the 2025 Payment Notice (89 FR 26236 through 26238), we finalized the use of 2019, 2020 and 2021 benefit year enrollee-level EDGE data for recalibration of the 2025 benefit year HHS risk adjustment models for all model coefficients. As explained in the 2025 Payment Notice proposed rule (88 FR 82527 through 82529) and final rule (89 FR 26236 through 26238), we recognized that the COVID-19 PHE was still in effect throughout the 2021 benefit year.
Consistent with the approach for use of 2020 and 2021 benefit year enrollee-level EDGE data, we performed reviews of the 2022 benefit year enrollee-level EDGE data to identify potential anomalies prior to incorporating the 2022 benefit year enrollee-level EDGE data as part of the proposed recalibration of the HHS risk adjustment models for the 2026 benefit year. Our review did not identify systematic anomalies in the 2022 enrollee-level EDGE data. Therefore, after considering our analysis of the 2020, 2021 and 2022
We seek comment on the proposal to determine 2026 benefit year coefficients for the HHS risk adjustment models based on a blend of separately solved coefficients from the 2020, 2021, and 2022 enrollee-level EDGE data.
Beginning with the 2026 benefit year, we propose to begin phasing out the market pricing adjustment
As part of the 2026 benefit year model recalibration analysis, we reassessed the cost trend for Hepatitis C drugs using available enrollee-level EDGE data (including 2022 benefit year data) to consider whether the pricing adjustment was still needed and, if it is still needed, whether it should be modified. We found that projected costs for Hepatitis C drugs have begun to rise alongside the expected cost of other specialty drugs after many years of decline and stagnation due to the introduction of new and generic Hepatitis C drugs. Therefore, we believe that it is appropriate to begin phasing out the market pricing adjustment for Hepatitis C drugs and start trending the cost of these drugs consistent with other similar drugs in the HHS risk adjustment models to ensure that we continue to use the most appropriate estimates of the average cost of Hepatitis C treatments for recalibration of the HHS risk adjustment models for the 2026 benefit year and beyond.
To explain further, because the annual recalibration of our risk adjustment models use the most recent 3 years of enrollee-level EDGE data available at the time of the proposed rule (in the case of this proposed rule and the recalibration of the 2026 benefit year models: the 2020, 2021, and 2022 enrollee-level EDGE data) in our simulation of plan liability for the applicable benefit year, we apply trend factors to different categories of medical expenditures, including specialty drugs, for every calendar year between the applicable benefit year and each year of enrollee-level EDGE data.
In other words, we propose to adopt a phased approach (See table 1) to transition the Hepatitis C drugs' trending as part of the annual recalibration of the HHS risk adjustment models beginning with the 2026 benefit year to move away from the current unique market pricing adjustment for these drugs and align with the trending approach for specialty drugs as we expect that the current growth in Hepatitis C drug costs will continue to be similar to growth in specialty drug costs in future years. As described above, to begin this transition for the 2026 benefit year HHS risk adjustment models, we propose to apply the specialty drug trend to 1 year of trending Hepatitis C treatment costs (that is, the trend from 2025 to 2026) for all 3 years of enrollee-level EDGE data used in recalibration (that is, 2020, 2021, and 2022 enrollee-level EDGE data). These 3 years of enrollee-level EDGE data would otherwise be trended forward using the lower trend rate reflecting the market pricing adjustment for Hepatitis C treatments through the 2025 benefit year. As such, 2026 benefit year recalibration data for Hepatitis C would reflect 1 year of growth in the cost of treatment at the same rate as other specialty drugs. To continue the transition of phasing out the Hepatitis C drug pricing adjustment in future benefit years' annual model recalibration, under this proposal, we would annually increase the number of years for which we would use the specialty drug trend and decrease the number of years that would use the unique market pricing adjustment for Hepatitis C drugs. For example, as seen in table 1, for the recalibration of the 2027 benefit year HHS risk adjustment models, under this proposal, we would apply the specialty drug trend to 2 years of the trending used in the models to project growth in Hepatitis C drugs. Specifically, assuming that the 2027 benefit year would use 2021, 2022, and 2023 enrollee-level EDGE data for the annual model recalibration, we would project Hepatitis C treatment pricing changes reflecting the unique market pricing adjustment between 2021 and 2022 (for the 2021 EDGE data), between 2022 and 2023 (for the 2021 and 2022 EDGE data), and between 2023 and 2024 and between 2024 and 2025 for all three data years (2021, 2022, and 2023 EDGE data) used for the recalibration of the 2027 benefit year HHS risk adjustment models. Again, once we have trended Hepatitis C drug costs to reflect the unique market pricing adjustment from the 2021, 2022, and 2023 enrollee-level EDGE data to the 2025 benefit year, under the proposed transitional approach, for recalibration of the 2027 benefit year HHS risk adjustment models, we would complete the trending of these 3 years of data from the 2025 benefit year to the 2027 benefit year by applying the specialty drug trend factor between the 2025 and 2026 benefit years and between the 2026 and 2027 benefit years. This approach would continue until such time as all enrollee-level EDGE data years used for the recalibration of the HHS risk adjustment models are from benefit year 2025 or later (See table 1), at which time the specialty drug cost trend would be fully applied to Hepatitis C drug costs consistent with other specialty drugs in the HHS risk adjustment models and we would stop applying the separate market pricing adjustment for Hepatitis C drugs as part of the annual model recalibration.
We propose this transitional approach because we continue to believe a market pricing adjustment specific to Hepatitis C drugs in the simulation of plan liability as part of the annual recalibration of the HHS risk adjustment models for benefit years that involve the use of enrollee-level EDGE data prior to 2025 (for example, for 2026 recalibration, the 2020 through 2022 enrollee-level EDGE data, and the 2023 through 2025 intermediate years of trending) is necessary and appropriate to account for the lack of growth in Hepatitis C drug prices relative to other prescription drugs in the market between those data years and the 2025 benefit year.
We seek comment on our proposal to phase out the market pricing adjustment and trend Hepatitis C drugs consistent with other specialty drugs starting with the annual recalibration of the 2026 benefit year HHS risk adjustment models.
We are proposing to incorporate human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) as a separate, new type of factor called an Affiliated Cost Factor (ACF) in the HHS risk adjustment adult and child models starting with the 2026 benefit year. This proposed change would reflect an evolution in our approach to defining the factors used in the HHS risk adjustment models to include a factor that is not indicative of an active condition and would change our current policy that models the costs of PrEP alongside all other preventive services.
Starting with the 2021 benefit year HHS risk adjustment models, as finalized in the 2021 Payment Notice (85 FR 29185 through 29187), we incorporated PrEP in the simulation of plan liability in the HHS risk adjustment adult and child models as a preventive service with zero cost sharing after careful analysis of preventive drugs that are recommended at grade A or B by the United States Preventive Services Task Force (USPSTF), including analysis on when PrEP can used as a preventive service.
As a general principle, we currently incorporate preventive services into each of the HHS risk adjustment models to ensure that 100 percent of the cost of those services are reflected in the simulation of plan liability. In the simulation of plan liability, services are only counted as preventive when they occur in the recommended circumstances (for example, age) to the extent we can identify such circumstances from enrollee-level EDGE data. As with other preventive services, the incorporation of PrEP into the simulation of plan liability as a preventive service tends to impact the age-sex coefficients for the population that is most likely to utilize the given preventive service. For PrEP, this population is typically males between the ages of 25 and 39, because this group composes the most frequent utilizers of PrEP in the enrollee-level EDGE data. In addition to PrEP drugs, like other preventive services,
However, as a part of our commitment to consider ways to continually improve the HHS risk adjustment models, we continued to monitor and assess different ways to incorporate PrEP in the HHS risk adjustment models. In this regard, since the adoption of the current approach beginning with the 2021 benefit year HHS risk adjustment adult and child models, we have continued to assess the incorporation of PrEP into these models as we do other preventive services. We have also continued to receive recommendations from some interested parties that PrEP be incorporated into the HHS risk adjustment adult models differently than other preventive services in the calculation of plan liability due to the high cost of PrEP. We previously considered changing the treatment of PrEP to incorporate it in the HHS risk adjustment adult models as an RXC; however, we have always been concerned with this approach because RXCs are specifically incorporated as separate factors to impute a missing diagnosis or indicate severity of a diagnosis.
Additionally, when we initially incorporated PrEP as a preventive service in the simulation of plan liability in the HHS risk adjustment adult and child models, we expected that any risk of adverse selection regarding PrEP would decrease over time as we expected the costs of PrEP to decrease due to generics entering the market and gaining market share. We also expected minimal differences in issuers' populations of PrEP users because, under Section 2713 of the PHS Act and its implementing regulations at 45 CFR 147.130, all issuers of risk adjustment covered plans are required to cover PrEP and its ancillary services at zero cost sharing, consistent with the applicable USPSTF recommendation. Thus, we anticipated that the expected similarity across issuers' PrEP-associated cost sharing parameters would also mitigate the risk of adverse selection.
More recently, we have continued to analyze PrEP and its usage in the individual, small group, and merged markets as additional benefit years of enrollee-level EDGE data became available. Because of PrEP's high costs relative to other preventive services, and in contrast to our initial assumptions about pricing decreases, our analysis of 2022 benefit year enrollee-level data
We therefore tested incorporating a non-RXC and non-HCC model factor for PrEP in the HHS risk adjustment adult and child models to capture differences in costs for PrEP utilizers relative to the average enrollee. To signify that the potential new factor would not indicate the presence of a specific active medical condition, we refer to the potential new type of factor as an “affiliated cost factor” (ACF), thereby distinguishing this new type of potential factor from RXCs and HCCs.
Generally speaking, similar to our approach when determining the HCCs and RXCs to be included in the HHS risk adjustment models,
Principle 1—Like HCCs and RXCs, an ACF should be clinically meaningful, but in the case of ACFs, such variables
Principle 2—Like HCCs and RXCs, ACFs should meaningfully predict total medical and drug expenditures. Additionally, NDCs and procedure codes in an ACF should be reasonably homogeneous for their effect on current year costs, that is, the annual costs associated with NDCs or procedure codes triggering the ACF should fall within a reasonably limited range. Relative to the majority of NDCs or procedure codes in a given ACF, there should not be any extremely low or high cost NDCs or procedure codes included in the ACF.
Principle 3—Like HCCs and RXCs, because ACFs would affect State transfers, these factors should have adequate sample sizes to permit accurate and stable estimates of expenditures. For example, it is difficult to reliably determine the expected cost of extremely rare categories.
Principle 4—Like HCCs and RXCs, in creating an individual's clinical profile, hierarchies should be used to characterize the person's illness level within each disease process, where appropriate, while the effects of unrelated disease processes accumulate. Therefore, related HCCs, RXCs and ACFs should be treated hierarchically such that the most severe manifestation of a given specific potential disease process principally defines its impact on costs. As such, the presence of a relevant HCC or RXC in an enrollee's medical record, which would indicate the presence of a specific active medical condition, should preclude the application of a related ACF because ACFs do not indicate the presence of a specific active medical condition.
Principle 5—As with HCCs and RXCs, issuers should not be penalized for a provider prescribing additional NDCs or coding additional medical conditions (monotonicity). This principle has two consequences for modeling of ACFs: (1) Like HCCs and RXCs, ACFs should not carry a negative payment weight; and (2) an HCC or RXC, or a relevant combination of an HCC, RXC, and interaction factor(s), reflecting the presence of a potential disease process to which the ACF is directly related should have at least as large a payment weight as the ACF.
Principle 6—Like RXCs, we expect ACFs to primarily be composed of NDCs or service codes. As such, the classification for ACFs, like RXCs, should assign NDCs or service codes to only one ACF or RXC variable (mutually exclusive classification). Because each NDC can map to more than one RXC or ACF, the classification should map NDCs to the primary RXC or ACF variable based on considerations such as route of administration, intended application of the product, ingredient list identifier, label, dosage form, and strength of the drug.
Principle 7—As with HCCs and RXCs, in evaluating the inclusion of ACFs, discretionary and noncredible drug or diagnosis categories should be excluded from payment models. ACFs that are particularly subject to prescribing variation or inappropriate prescribing by health plans or providers or to intentional or unintentional discretionary coding, or that are not clinically or empirically credible as cost predictors, should not be included.
In developing an ACF variable reflecting PrEP, we are considering whether PrEP satisfies these principles and what approaches are necessary to appropriately balance all seven principles. A PrEP ACF would easily satisfy Principle 1 (clinically meaningful and specific), Principle 2 (meaningful and predictable costs
As mentioned above, we have found that PrEP overall satisfies Principle 2, having meaningful and predictable costs. In particular, our analyses found that the utilization patterns of PrEP medications have been fairly consistent year-over-year, with previously approved versions of PrEP medications maintaining substantial market share despite the availability of generic versions and new market entrants such as Apretude. If ACF medications and services that were commonly used in 1 year were largely supplanted by different medications or services in the following year, the cost predictions based on previous years of data may be inaccurate. Nevertheless, although we will continue to monitor the market for PrEP drugs, we generally do not anticipate substantial decrease in costs in the near future for enrollees taking brand name drugs due to the more convenient drugs and dose-forms (for example, long-acting injectable forms) coming to market
Despite the overall anticipation that PrEP costs are consistent and will remain high over the next several years, we have found that there exists a large disparity in the costs of generic PrEP medication and the costs of brand name PrEP medication.
As outlined by our discussion of Principles 1, 2, 3, and 7, our preliminary testing found minimal empirical concerns with a new PrEP ACF variable being added to the current HHS risk adjustment adult and child models, as the sample size for such a variable is reasonable for both the adult and child models, the clinical specifications are well defined, costs are generally predictable, and the resulting preliminary coefficient estimates for PrEP in the adult and child models are meaningful. However, in assessing Principles 4 (hierarchical factor definitions), 5 (monotonicity), and 6 (mutually exclusive classification), we found that the creation of a PrEP ACF variable would require further careful consideration.
To satisfy Principle 4 (hierarchical factor definitions), the most severe manifestation of a given specific potential disease process must principally define its impact on costs. Therefore, related HCCs and RXCs (in the case of a PrEP ACF, the related HCC 1 for HIV/AIDS, and RXC 1 for anti-HIV agents) should be treated hierarchically. As such, in considering PrEP as a potential ACF, the presence of HCC 1 or RXC 1 in an enrollee's medical record should preclude the application of the PrEP ACF, as the prevention of HIV infection clearly indicates a less severe manifestation of the specific potential disease process than treatment of an active HIV infection.
However, the coefficient for HIV/AIDS (HCC 1) in the adult models
Additionally, a PrEP ACF could pose issues for mutually exclusive classification (Principle 6). Specifically, the compounds used in PrEP medication are also used to treat HIV. As such, NDCs for medications used for PrEP or the individual compounds alone are not enough to distinguish between an enrollee receiving PrEP and an enrollee in treatment for an active HIV infection. However, due to the necessity of the additional anti-retroviral compounds for HIV infection treatment, with special considerations and data filtering, we are generally able to distinguish enrollees that are receiving antiretroviral therapy for PrEP and those receiving antiretroviral treatment as treatment for HIV/AIDS for the purposes of calculating plan liability with 100 percent cost sharing for PrEP and typical cost sharing treatment of HIV infection.
To address the HHS risk adjustment adult modeling concerns we identified regarding Principles 4, 5 and 6, we are considering two alternative approaches. First, we could modify the current definition of RXC 1 (Anti-HIV agents) by treating PrEP NDCs as RXC 1 NDCs in limited circumstances based on individual enrollee characteristics. Alternatively, we could place the PrEP ACF in a hierarchy with RXC 1 but define no hierarchical restrictions between PrEP and HCC 1 (HIV/AIDS). We discuss these alternatives in detail below.
Under the first approach, modifying the current definition of RXC 1, we would add PrEP NDCs into RXC 1 (Anti-HIV agents) in limited circumstances to address situations where the adult enrollee has both a claim for PrEP and a claim for RXC 1 within the benefit year. Operationally, to capture these cases, the adult enrollees with a PrEP prescription claim would receive the RXC 1 flag instead of the ACF only in cases where the enrollee has both a PrEP prescription claim and an HIV diagnosis but does not have a typical RXC 1 prescription claim because the enrollee did not begin treatment for HIV, or because their treatment medication was provided at no cost to the issuer and therefore no claim was submitted to EDGE. As such, a PrEP NDC's classification as RXC 1 or the ACF would be contingent on the presence of HCC 1 (HIV/AIDS) on an adult enrollee's record. We estimate that less than 2 percent of adult enrollees with a PrEP prescription claim would meet these criteria, and that such enrollees would account for less than 1 percent of enrollees receiving RXC 1. As such, the sample size of the PrEP ACF would remain high and the impact on the RXC 1 coefficient would be minimal. This approach to defining the hierarchical relationship between HCC 1, RXC 1, and the PrEP ACF would ensure that an adult enrollee with a PrEP prescription claim who later tested positive for HIV would have an increase in their risk score as a result of the additional diagnosis, satisfying Principles 4 (hierarchical factor definitions) and 5 (monotonicity). Although this approach would not be strictly consistent with mutually exclusive classification of diagnosis codes and NDCs into only one variable (Principle 6), we find this to be acceptable in this limited circumstance because it would precisely dictate which model factor an adult enrollee would receive (which satisfies the intent of Principle 6, mutually exclusive classification) and because PrEP medications can be part of an approved HIV treatment protocol when additional anti-retroviral drugs are used. Thus, it is not unreasonable to assume that the few adult enrollees with PrEP prescription claims and an HIV diagnosis are also receiving the additional medications needed to meet treatment requirements.
Under the alternative approach, we would address the violation of monotonicity in the HHS risk adjustment adult models by placing the PrEP ACF below RXC 1 in a hierarchy but defining no hierarchical relationship between the PrEP ACF and HCC 1 (HIV/AIDS), allowing adult enrollees without RXC 1 to receive the PrEP ACF along with HCC 1 in cases where the enrollee has both a PrEP prescription claim and an HCC 1 diagnosis in their medical records for the benefit year. This approach would also ensure that an adult enrollee with a PrEP prescription claim who later tested positive for HIV would have an increase in their risk score as a result of the additional diagnosis, satisfying Principles 4 (hierarchical factor definitions) and 5 (monotonicity). This alternative PrEP ACF-RXC 1 hierarchy approach would likewise satisfy the intent of Principle 6 (mutually exclusive classification) by using similar considerations and filtering steps to those we currently use in our simulation of plan liability for PrEP. We solicit comments on addressing these hierarchy, monotonicity, and mutual exclusivity concerns, and both alternative approaches outlined above that are designed to address those concerns.
Table 2 below displays our testing of estimated values for the proposed PrEP ACF for the 2026 benefit year adult models using only 2021 benefit year enrollee-level EDGE data, but otherwise following the specifications of the 2025 benefit year HHS risk adjustment adult models.
Table 3 below displays estimated values for the proposed PrEP ACF for the 2026 benefit year HHS risk adjustment child models using only 2021 benefit year enrollee-level EDGE data, but otherwise following the specifications of the 2025 benefit year HHS risk adjustment child models.
Again, the above coefficient values in tables 2 and 3 have been calculated using the 2021 enrollee-level EDGE data only, with the 2025 benefit year HHS risk adjustment model specifications, and without our normal modeling constraints nor any of the constraints discussed in relation to Principles 4, 5 and 6. Although we anticipate that these values will change slightly when the modeling constraints and the 2026 benefit year risk adjustment model specifications are applied, if the proposed new PrEP ACF variable is added to the adult and child models, we believe these offer reliable estimates of the potential impact of the adoption of the proposed new PrEP ACF variable on other factors and approximate values for the proposed draft new PrEP ACF coefficients for the adult and child models. If this proposal is finalized, the final coefficients will be made available in the final rule or through subsequent notice-and-comment rulemaking or guidance, as appropriate.
We solicit comments on our proposal to create a new ACF category of model factors for incorporation into the HHS risk adjustment models to account for unique medical expenses or services (such as PrEP) that do not meet the criteria to qualify as HCC or RXC factors, but impact the actuarial risk presented to issuers of risk adjustment covered plans. In addition, we solicit comments on our proposal to modify the treatment of PrEP in the HHS risk adjustment adult and child models beginning with the 2026 benefit year, as well as how to methodologically define a potential ACF category of model factors that accounts for PrEP (or other unique medical expenses or services) and what other considerations should be part of the analysis and modeling for this proposed new category of model factors (such as the availability of drug rebates
The proposed 2026 benefit year HHS risk adjustment model factors resulting from the equally weighted (averaged) blended factors from separately solved models using the 2020, 2021, and 2022 enrollee-level EDGE data are shown in tables 4 through 9.
In the 2025 Payment Notice (89 FR 26252 through 26254), we finalized the updated CSR adjustment factors for American Indian/Alaska Native (AI/AN) zero-cost sharing and limited cost sharing CSR plan variant enrollees for the 2025 benefit year, and for all future benefit years, unless changed through notice-and-comment rulemaking. In the 2025 Payment Notice (89 FR 26252 through 26254), we also finalized maintaining the existing CSR adjustment factors for silver plan variant enrollees (70 percent, 73 percent, 87 percent, and 94 percent AV plan variants)
For the 2026 benefit year, we are not proposing to change the CSR adjustment factors as finalized in the 2025 Payment Notice and will maintain the existing CSR adjustment factors for the 2026 benefit year. Since we are not proposing any changes to the CSR adjustment factors for the 2026 benefit year, we are not republishing the CSR adjustment factors in this rule.
Each benefit year, to evaluate the HHS risk adjustment model performance, we examine each model's R-squared statistic and predictive ratios (PRs). The R-squared statistic, which calculates the percentage of individual variation explained by a model, measures the predictive accuracy of the model overall. The PR for each of the HHS risk adjustment models is the ratio of the weighted mean predicted plan liability for the model sample population to the weighted mean actual plan liability for the model sample population. The PR represents how well the model does on average at predicting plan liability for that subpopulation.
A subpopulation that is predicted perfectly would have a PR of 1.0. For each of the current and proposed HHS risk adjustment models, the R-squared statistic and the PRs are in the range of published estimates for concurrent HHS risk adjustment models.
In part 2 of the 2022 Payment Notice (86 FR 24183 through 24186), we finalized the proposal to continue to use the State payment transfer formula finalized in the 2021 Payment Notice for the 2022 benefit year and beyond, unless changed through notice-and-comment rulemaking. We explained that under this approach, we will no longer republish these formulas in future annual HHS notice of benefit and payment parameters rules unless changes are being proposed. We are not proposing any changes to the formula in this rule, and therefore, are not republishing the formulas in this rule. We therefore would continue to apply the formula as finalized in the 2021 Payment Notice (86 FR 24183 through 24186) in the States where HHS operates the risk adjustment program in the 2026 benefit year.
Additionally, as finalized in the 2020 Payment Notice (84 FR 17466 through 17468), we will maintain the high-cost risk pool parameters for the 2020 benefit year and beyond, unless amended through notice-and-comment rulemaking. We are not proposing any changes to the high-cost risk pool parameters for the 2025 benefit year; therefore, we would maintain the $1 million threshold and 60 percent coinsurance rate.
HHS received feedback from some interested parties that, for the 2023 benefit year, issuers of risk adjustment covered plans were impacted more by the time value of money, for the collection and remittance of State transfers that occurs 8 to 10 months after the conclusion of the benefit year,
Unlike Medicare Advantage's risk adjustment program, under which CMS makes risk-adjusted monthly payments to Medicare Advantage organizations during the coverage year (in advance of each month of coverage) using interim risk scores and then does a reconciliation to updated risk scores after the final deadline for submission of all risk adjustment data, the HHS-operated risk adjustment program for the individual, small group and merged markets uses a final data submission deadline 4 months after the end of the benefit year and calculates issuers' plan liability risk scores and the State transfer amounts 2 months after that, resulting in State transfers being made 8 to 10 months after the end of the benefit year.
To continue to ensure appropriate incentives exist in the individual, small group, and merged markets to cover both healthy and sick enrollees, we believe that this market dynamic, the time value of money, and its potential impact on actuarial risk and adverse selection should be discussed and considered. Consistent with section 1343 of the ACA, in States where HHS is responsible for operating the program,
The impact of the time value of money has increased to levels significantly higher than those seen in the initial years after the passage of the ACA. For example, in January 2016, the annual short-term Applicable Federal Rate (AFR) interest rate was 0.75 percent, whereas in January 2023 the AFR interest rate had increased to 4.50 percent.
For these reasons, we solicit comments on the impact of the time value of money on the HHS-operated risk adjustment program, including the impact of the time value of money on issuers' assessment of actuarial risk and the incentives for adverse selection, and what possible solutions or mitigating steps we should consider to address the impact of the time value of money on the HHS-operated risk adjustment program in future rulemaking.
We propose an HHS risk adjustment user fee for the 2026 benefit year of $0.18 PMPM. Under § 153.310, if a State is not approved to operate, or chooses to forgo operating, its own risk adjustment program, HHS will operate risk adjustment on its behalf. For the 2026 benefit year, HHS will operate risk adjustment in every State and the District of Columbia. As described in the 2014 Payment Notice (78 FR 15416 through 15417), HHS' operation of the risk adjustment program on behalf of States is funded through a risk adjustment user fee. Section 153.610(f)(2) provides that, where HHS operates a risk adjustment program on behalf of a State, an issuer of a risk adjustment covered plan must remit a user fee to HHS equal to the product of its monthly billable member enrollment in the plan and the PMPM risk adjustment user fee specified in the annual HHS notice of benefit and payment parameters for the applicable benefit year.
OMB Circular No. A-25 established Federal policy regarding user fees, and specifies that a user charge will be assessed against each identifiable recipient for special benefits derived from Federal activities beyond those received by the general public.
In the 2025 Payment Notice (89 FR 26218), we calculated the Federal administrative expenses of operating the HHS risk adjustment program for the 2025 benefit year to result in a risk adjustment user fee rate of $0.18 PMPM based on our estimated costs for HHS risk adjustment operations and estimated billable member months (BMM) for individuals enrolled in risk adjustment covered plans. For the 2026 benefit year, HHS proposes to use the same methodology to estimate our administrative expenses to operate the program. These costs cover development of the models and methodology, collections, payments, account management, data collection, data validation, program integrity and audit functions, operational and fraud analytics, interested parties training, operational support, and administrative and personnel costs dedicated to HHS-operated risk adjustment program activities. To calculate the risk adjustment user fee, we divided HHS' projected total costs for administering the program on behalf of States by the expected number of BMM in risk adjustment covered plans in States where the HHS-operated risk adjustment program will apply in the 2026 benefit year.
We estimate that the total cost for HHS to operate the risk adjustment program on behalf of States for the 2026 benefit year will be approximately $65 million, roughly the same as the amount estimated for the 2025 benefit year.
Similar to prior benefit years, we projected risk adjustment enrollment scenarios for the 2026 benefit year. For the 2021 through 2025 benefit years, we projected increased enrollment in the
We seek comment on the proposed HHS risk adjustment user fee for the 2026 benefit year.
HHS conducts risk adjustment data validation under §§ 153.350 and 153.630 in any State where HHS is responsible for operating the risk adjustment program.
To better align the IVA sampling methodology with the HHS-RADV error estimation methodology that estimates hierarchical condition categories (HCC) error rates and to improve overall sampling precision, we are proposing to exclude enrollees without HCCs
HHS-RADV IVA sampling policy was originally described in the 2014 Payment Notice (78 FR 15436) where we stated that HHS would choose a sample size of enrollees for HHS-RADV such that the estimated risk score errors would be statistically sound, and the enrollee-level risk score distributions would reflect enrollee characteristics for each issuer. To implement this approach, in the 2015 Payment Notice (79 FR 13756 through 13758), we finalized two key aspects of the IVA sampling methodology. First, HHS set the IVA sample size as 200 enrollees per issuer, as sample size precision analyses performed at the time with data available from Medicare Advantage RADV (MA-RADV) program, which utilizes a similar HCC-based methodology as the HHS-RADV methodology, indicated that a sample size of 200 enrollees would achieve the targeted precision for an average sized issuer and that there would be no meaningful improvement in the estimated level of precision with larger sample sizes. In particular, to establish this 200-enrollee sample, we set a 10 percent sampling precision target at a two-sided 95 percent confidence level. That is, we aimed to obtain a sample size such that 1.96 multiplied by the standard error, divided by the estimated adjusted risk score, equals 10 percent or less.
Under the current risk score stratification in IVA sampling, to align with the HHS-operated risk adjustment program's three separate models for adult, child, and infants, we group each issuer's enrollee population into 10 strata based on age group, risk level, and presence of HCCs and prescription drug factors (RXCs)
• Strata 1-3 includes low, medium, and high risk adults with the presence of at least one HCC or RXC.
• Strata 4-6 includes low, medium, and high risk children with the presence of at least one HCC.
• Strata 7-9 includes low, medium, and high risk infants with the presence of at least one HCC.
• Stratum 10 includes the No-HCC and No-RXC population, which is not further stratified by age group, because we assume this stratum has a uniformly low risk level.
The current IVA sampling methodology relies on MA-RADV proxy data to conduct the Neyman allocation, which optimizes stratum sample size by selecting the number of enrollees to be sampled from each of the 10 strata, listed above, that is proportional to each stratum's contribution to the total standard deviation of the population.
As described in the 2015 Payment Notice (79 FR 13756 through 13758), we use MA-RADV data to calculate the standard deviation of risk score error (
HHS-RADV error estimation has been modified over time without making corresponding changes to the IVA sampling methodology. For example, in the 2019 Payment Notice (83 FR 16961 through 16965), we finalized an HCC-failure rate error estimation methodology that adjusts an issuer's enrollees' risk scores when the issuer's failure rate for a group of HCCs is statistically different from a national benchmark.
After running the HHS-RADV program for several years, we now have several years of HHS-RADV data that could be evaluated and used to improve our IVA sampling methodology. When we finalized the IVA sampling methodology, we stated that we would reexamine our sampling assumptions and methodology over time using actual HHS-RADV enrollee data as it becomes available. As a result of these analyses and for the reasons explained in the sections below, we are proposing changes to the IVA sampling methodology.
We first propose to modify IVA sampling to exclude stratum 10 enrollees, which would exclude enrollees that do not have HCCs nor RXCs and adult enrollees in strata 1 through 3 that have RXCs only, from IVA sampling beginning with benefit year 2025 HHS-RADV. The purpose of this proposal to remove these enrollees (“enrollees without HCCs”) is to better align our IVA sampling methodology with the error estimation methodology that was established in the 2019 Payment Notice, which calculates issuer risk score error rates and applies these error rates to the HCC-related portion of issuers' plan liability risk scores,
Furthermore, RXC-only enrollees have been included in the HHS-RADV sampling of strata 1 through 3 to ensure an adequate number of enrollees with RXCs in issuers' samples to complete HHS-RADV RXC validation.
We propose to remove the FPC from the IVA sampling methodology such that, with the exclusion of enrollees without HCCs from IVA sampling, all issuers with at least 200 enrollees with HCCs in their enrollee population would have an IVA sample size of 200. Under this proposal, all issuers with fewer than 200 enrollees with HCCs would have an IVA sample size equal to their population of enrollees with HCCs. As previously explained, under the current IVA sampling methodology, issuers with between 51 and 3,999 enrollees in their total enrollee population are subject to the FPC and we calculate modified IVA sample sizes that are less than 200 enrollees using an FPC factor. Under the current approach, issuers with 50 or fewer enrollees have IVA sample sizes equal to their total enrollee population. We have found in recent years of HHS-RADV results that issuers with IVA sample sizes less than 200 enrollees are less likely to meet the 30 Super HCC constraint for outlier identification in a failure rate group.
Under this proposal, issuers with less than 200 enrollees with HCCs would have all enrollees with HCCs in their IVA sample. The issuer-specific sample size would be equal to the sum of all of their enrollees with HCCs in strata 1 through 9 in their EDGE population subject to HHS-RADV.
Based on an analysis of historical HHS-RADV data, we estimate that issuers with less than 1,200 enrollees or approximately 10,000 billable member months statewide would be likely to have insufficient enrollees with HCCs in strata 1 through 9 to create an IVA sample size with 200 enrollees. These issuers would therefore have an IVA sample size equal to their EDGE population of enrollees who have HCCs. In the absence of the FPC, small issuers may have IVA sample sizes that are larger or smaller than their IVA sample size would have been if subjected to the FPC under the current methodology. However, any increase in IVA sample size would only be realized in the years that a smaller issuer is selected for HHS-RADV, which is approximately once every 3 years (barring any risk-based triggers that would warrant more frequent audits) under the materiality threshold exemption at § 153.630(g)(2).
We also propose to change the current IVA sampling methodology to replace the source of the Neyman allocation data with HHS-RADV data now that we have accumulated sufficient HHS-RADV data to test and evaluate using it for IVA sampling purposes. As explained earlier in this preamble, relying on the MA-RADV in the Neyman allocation requires a simplifying assumption that the standard deviation of risk score error within a risk-score subgrouping (low, medium, and high) is the same for the three age groups (adult, child, and infant). However, we have found that the variance of net risk score error differs considerably, both between the MA-RADV data and the available HHS-RADV data and across strata. Because the Neyman allocation calculates the optimal allocation to each stratum such that strata with greater variance in net risk score error are sampled more intensely and strata with less variance in net risk score error are sampled less intensely, this implies that the MA-RADV data yields considerably different sample sizes for each stratum than the HHS-RADV data. For example, our analysis found that while the median sample proportion of stratum 3 (Adult—High risk) enrollees is 39 percent using the MA-RADV data, this could decrease to 19 percent of the sample being composed of stratum 3 enrollees if HHS-RADV data were used.
For these reasons, beginning with 2025 benefit year HHS-RADV, we are proposing to no longer use MA-RADV data to calculate the standard deviation of risk score error (
In addition, the proposal to use HHS-RADV data rather than the MA-RADV data as the source data for the Neyman allocation would decrease burden on issuers and IVA Entities. More specifically, our analysis found that the MA-RADV data yields considerably different sample sizes for each stratum than the HHS-RADV data, and that using the HHS-RADV data rather than the MA-RADV data is likely to increase the proportion of the sample in the lower-risk groups and decrease the proportion of the sample in the high-risk group. This proposed change in sampled enrollees means that under this proposal, issuers would have relatively fewer medical records to review because of the increase in the proportion of sampled enrollees in the lower-risk strata and the decrease in the proportion of enrollees in higher-risk strata. To further explain, this decrease in estimated medical record review would occur because higher-risk enrollees tend to have relatively more medical records to review than lower-risk enrollees. Issuers spend time and resources on retrieving, reviewing, and submitting medical records and documentation for HHS-RADV, so the estimated decrease in the average number of medical records reviewed per enrollee in the IVA sample from replacing MA-RADV data with HHS-RADV data is expected to lead to a decrease in issuer burden. We further address the estimated aggregate burden impact of all IVA sampling policies proposed in this rule in section 5 of this preamble and the ICR section of this rule.
In preparation for proposing changes to HHS-RADV IVA sampling, HHS conducted several analyses to evaluate the impact of these proposals. Our analysis revealed that the proposed modifications to switch data for the Neyman allocation to use the 3 most recent consecutive years of HHS-RADV data with results that have been released before HHS-RADV activities begin for the given benefit year, combined with the proposal to remove enrollees without HCCs from IVA sampling, and to remove the FPC would improve our ability to reach the 10 percent sampling precision target for net risk score error for a greater proportion of issuers in HHS-RADV.
Our analysis also focused on the impact of the proposed policies on group failure rate precision. Previously, in the 2019 HHS-RADV White Paper, we evaluated how precise the current IVA sampling methodology was in measuring group failure rates and estimated that approximately 60 percent of issuers with a sample size of 200 enrollees met 10 percent group failure rate precision in all three HCC groups.
In addition, we anticipate that the proposed changes to the IVA sampling methodology in this rule would result in an overall decrease in the number of medical records reviewed by IVA Entities. Issuers spend time and resources on retrieving, reviewing, and submitting medical records and documentation for IVA Entities to review, so the estimated decrease in medical records reviewed is expected to lead to a decrease in issuer burden. Although every enrollee sampled for the IVA would have HCCs, the proportion of enrollees sampled from strata 1 through 9 would change such that enrollees with more medical records are sampled less intensely due to the replacement of MA-RADV data with HHS-RADV data for the Neyman allocation. As mentioned earlier in this preamble, the median sample proportion of high-risk adult enrollees,
We also analyzed the impact of replacing the source data for the Neyman allocation with HHS-RADV data while continuing to include enrollees without HCCs in IVA sampling and retaining the FPC. However, this would result in sampling a greater proportion of enrollees without HCCs, who do not have risk scores to adjust when calculating issuers' error rates during HHS-RADV. In addition, keeping the FPC while excluding enrollees without HCCs from IVA sampling and replacing the source data for the Neyman allocation with available HHS-RADV data would lead to a dramatic increase in the number of issuers subject to the FPC and therefore decrease the total count of Super HCCs in issuers' IVA samples. For example, we estimate that the average Super HCC count for issuers currently subject to the FPC would decrease by 26 percent by keeping the FPC, which would increase the proportion of issuers that fail to meet the 30 Super HCC constraint in HHS-RADV. In contrast, removing the FPC would increase the average Super HCC count for these same issuers by 30 percent, which would improve these issuers' probability of meeting the 30 Super HCC constraint. Overall, we found that making all proposed modifications in unison led to the greatest improvements in sampling precision and group failure rate precision across all issuers and a decrease in aggregate issuer burden.
As explained above, removing enrollees without HCCs and the FPC, and updating the source of the IVA sampling Neyman allocation data to use HHS-RADV data, leads to an IVA sample that improves sampling precision while decreasing burden on issuers and IVA Entities on average. Therefore, we are proposing to exclude enrollees without HCCs from IVA sampling such that each enrollee in an issuer's IVA sample must have at least one HCC, remove the FPC, and discontinue use of MA-RADV data as the source for the Neyman allocation calculation and begin using the 3 most recent consecutive years of HHS-RADV data with results that have been released before HHS-RADV activities for the benefit year begin.
We solicit comments on these proposed changes to the IVA sampling methodology, the estimated impact of the changes, the timing of the implementation of the IVA sampling changes and feedback on whether there are other IVA sample changes that should be considered.
We seek comment on these proposals.
To improve the sensitivity of the SVA pairwise means test, we propose to modify the test, which currently uses a paired sample t-test methodology, to use a bootstrapping methodology, and to increase the initial SVA subsample size from 12 enrollees to 24 enrollees beginning with 2024 benefit year HHS-RADV.
In the 2014 Payment Notice (78 FR 15437), we established that an SVA will be conducted by an entity retained by HHS to verify the accuracy of the findings of the IVA. Consistent with § 153.630(c), HHS selects a subsample of the risk adjustment data validated by the IVA for the SVA. The HHS-RADV SVA sampling methodology was originally developed in the 2015 Payment Notice (79 FR 13761) and is designed to identify statistical differences between the IVA and SVA results. To do this, the SVA Entity currently starts by reviewing the medical records of an initial subsample of 12 enrollees from the IVA sample. The SVA subsample expands to include 24, 50, and 100 enrollees in the IVA sample
The pairwise means testing procedure promotes the integrity and effectiveness of HHS-RADV by ensuring that error estimation and the HHS-RADV adjustments to risk scores are based on the most reliable medical coder review data possible. As such, it is important that the pairwise means testing procedure can detect when issuers' IVA results significantly differ from their SVA results at the initial sample size. Based on our experience operating HHS-RADV for the past several benefit years, we have reassessed the sensitivity of our pairwise means testing procedure, meaning the ability of the statistical test to identify statistically significant differences between IVA and
To assess our current pairwise means testing procedure, we conducted a power analysis to investigate its sensitivity in detecting population-level differences. The analysis focused on “false negatives,” a detection error that occurs when there are significant differences between IVA and SVA results, but the statistical test does not identify a statistically significant difference between IVA and SVA enrollee risk scores. We are concerned about “false negatives” and therefore focused on them because they result in an atypical issuer passing the pairwise means test and the conclusion of the SVA review without further investigation at a higher subsample level. Our power analysis found that when using a subsample size of 12 enrollees the current paired sample t-test using a 95 percent confidence interval results in a false negative rate of over the target false negative rate of 20 percent at any of the simulated effect sizes.
As part of our examination of ways to address our concerns about false negatives in the current pairwise means testing procedure, we expanded our power analysis by investigating the use of a bootstrapping methodology as an alternative pairwise means testing procedure to identify statistically significant differences between IVA and SVA risk scores. A bootstrapping approach is a useful technique to construct confidence intervals when the underlying distribution is unknown, when sample size may be too small to assume a normal sampling distribution, or when no formula exists to describe the sampling distribution of a particular point estimate.
In particular, at a given SVA subsample level, the proposed pairwise bootstrapping methodology would perform 10,000 iterations of resampling with replacement from the enrollees in the issuer's SVA subsample at that level. The average difference between enrollees' IVA and SVA risk scores would be calculated for each resample to build an issuer-specific confidence interval for statistical testing of enrollee's IVA and SVA risk scores. Like the current pairwise means test, if the bootstrapped confidence interval contains zero, the bootstrapping procedure would show non-significant differences between IVA and SVA risk scores, and the issuer would pass pairwise means testing at that SVA subsample level and IVA results would be used in error estimation. If the bootstrapped confidence interval does not include zero, the differences between IVA and SVA risk scores identified would be statistically significant, and the issuer would fail pairwise means testing at that SVA subsample level. In these circumstances, the SVA subsample would be expanded and the pairwise means test conducted at that new SVA subsample level. If the issuer continues to fail the pairwise means test at the SVA 100-level, a precision analysis would be performed to determine whether the SVA audit results from the SVA 100 subsample can be used in error estimation or if the SVA sample needs to expand to the full IVA sample of 200 enrollees with the SVA 200 results used in error estimation.
We tested the bootstrapping methodology using a variety of confidence levels and found that using a bootstrapped confidence interval of 90 percent, rather than the current paired t-test with a 95 percent confidence interval, improves the pairwise means testing procedure's sensitivity and ability to detect when issuers' IVA results differ substantially from their SVA results. The proposed bootstrapping methodology with a 95 percent confidence interval achieves a lower rate of false negatives at smaller sample sizes for any given effect size compared to the current paired t-test methodology. Moreover, decreasing the size of the confidence interval from 95 percent to 90 percent under the bootstrapping methodology decreases the sample size required to achieve a targeted false negative rate of 20 percent, and therefore increases the probability of detecting significant differences when they exist. On the other hand, decreasing the confidence interval from 95 percent to 90 percent implies that the rate of false positives, or the rate at which an enrollee population with no major differences between IVA and SVA results would return a statistically significant finding at a given sample size, would increase from 5 percent to 10 percent. The reasonable increased false positive rate, in combination with the increased sensitivity of the bootstrapping methodology, would result in more issuers being expanded to larger SVA sample sizes during pairwise means testing. However, we believe that the increased false positive rate is necessary and appropriate to achieve an acceptable rate of false negatives and ensure that reliable audit results are used in error estimation. We also believe that in comparison to false negatives, false positives can be addressed through the expansion of the sample size and therefore, pose less of a concern than false negatives, which cannot be corrected for since a false negative would end the SVA review at the lower sample size. Therefore, we believe that the proposed changes to improve the sensitivity of the SVA pairwise means test achieve the right balance between false negatives and false positives.
Because the false negative rate decreases as sample size increases, the power analysis also showed the advantages of increasing the initial SVA subsample size beyond 12 enrollees. Specifically, under the proposed
We seek comment on the proposal to modify the SVA pairwise means testing procedure to use a bootstrapped 90 percent confidence interval and to increase the initial SVA subsample size from 12 enrollees to 24 enrollees beginning with 2024 benefit year HHS-RADV.
We propose to amend § 156.1220(a) to codify a new, second materiality threshold for HHS-RADV appeals, hereafter referred to as the materiality threshold for rerunning HHS-RADV results.
We are soliciting comment regarding how assisters who perform their assister duties in a hospital and hospital system may, within the bounds of the statute, refer consumers to programs designed to reduce medical debt.
Sections 1311(d)(4)(K) and 1311(i) of the ACA direct all Exchanges to establish a Navigator program. Navigator duties and requirements for all Exchanges are set forth in section 1311(i) of the ACA and § 155.210. Section 1321(a)(1) of the ACA directs the Secretary to issue regulations that set standards for meeting the requirements of title I of the ACA, for, among other things, the establishment and operation of Exchanges. Pursuant to section 1321(a)(1) of the ACA, the Secretary issued § 155.205(d) and (e), which requires Exchanges to perform certain consumer service functions in addition to the Navigator program. To satisfy these requirements, Exchanges may establish a non-Navigator assistance personnel program, as the FFEs have done, and must have a Certified Application Counselor (CAC) program. Existing regulations outlining duties and required activities for Navigators (§ 155.210(e)), non-Navigator assistance personnel (§ 155.215, through the cross-reference to § 155.210(e)), and CACs (§ 155.225(c)) were initially finalized in the 2015 Market Standards final rule (79 FR 30240).
The purpose of these assister programs is to ensure there are various ways consumers can receive help as they apply for and enroll in coverage through the Exchanges. In particular, Navigators (among other duties) help consumers make informed decisions during the health coverage selection process in a fair and impartial way, provide assistance in culturally and linguistically appropriate ways,
The Consumer Financial Protection Bureau estimates that $88 billion of outstanding medical bills are currently in collections, affecting one in five Americans.
We are interested in receiving comments about what we may do within the scope of our authority as it
We address our authority under § 155.220 to reach misconduct or noncompliance occurring at an agency-level,
Section 155.220 currently applies to an agent, broker, or web-broker that assists with or facilitates enrollment of qualified individuals, qualified employers, or qualified employees in a QHP in a manner that constitutes enrollment through the Exchange or assists individuals in applying for APTC and CSRs for coverage offered through an Exchange. “Web-broker” is defined in § 155.20 as an individual agent or broker, group of agents or brokers, or business entity registered with an Exchange under § 155.220(d)(1) that develops and hosts a non-Exchange website that interfaces with an Exchange to assist consumers with direct enrollment in QHPs offered through the Exchange as described in § 155.220(c)(3) or § 155.221.
We are not proposing amendments to our existing regulations to codify our approach to hold agencies accountable for misconduct or noncompliance with applicable standards and requirements in § 155.220 because they can reasonably be interpreted to apply to agencies that are involved in Exchange enrollment transactions, since agencies are entities licensed by the State as an agent, broker, or insurance producer. As such, agencies would fall under the current definitions of “agent or broker” and “web-broker” in § 155.20.
Many FFE or SBE-FP enrollments are conducted by individual agents, brokers, or web-brokers who work for an agency and provide the agency's business NPN on the consumer's eligibility application submitted to an FFE or SBE-FP. An agency's business NPN can be included on a consumer's eligibility application when individual agents, brokers, or web-brokers who work at the agency are assisting consumers with enrolling in QHPs or applying for APTC and CSRs and the person associated with the agency's business NPN completes the FFE registration process, takes the required training, and signs the applicable Exchange Agreements
The listing of a business NPN on the consumer's eligibility application or enrollment transaction submitted to an FFE or SBE-FP underscores the importance of holding agencies accountable for complying with the same standards and requirements as individual agents, brokers, or web-brokers. Applications and enrollments submitted to an FFE or SBE-FP that include a business NPN can impact Exchange operations, Exchange information technology systems, and Exchange enrollees or applicants, similar to situations where an individual agent, broker, or web-broker who does not work for an agency submits an application or enrollment to an FFE or SBE-FP. As such, we are addressing our authority to reach misconduct or noncompliance occurring at an agency-level and discussing how we intend to utilize this existing authority to hold agencies accountable for agency-level misconduct or noncompliance.
Section 1312(e) of the ACA directs the Secretary to establish procedures under which a State may permit agents and brokers to enroll individuals and employers in QHPs through an Exchange and to assist individuals in applying for financial assistance for QHPs sold through an Exchange. In addition, section 1313(a)(5)(A) of the ACA directs the Secretary to provide for the efficient and nondiscriminatory administration of Exchange activities and to implement any measure or procedure the Secretary determines is appropriate to reduce fraud and abuse. Section 1321(a) of the ACA provides broad authority to the Secretary to establish standards and issue regulations to implement the statutory requirements related to Exchanges, QHPs, and other components of title I of the ACA, which includes sections 1312 and 1313 of the ACA, and this statutory provision also provides the Secretary authority to implement other requirements as the Secretary determines appropriate. In prior rulemakings, we used these authorities to adopt § 155.220, which establishes standards and requirements applicable to agents, brokers, and web-brokers assisting individuals, employers, or employees with enrollment in QHPs offered through an Exchange.
We propose to utilize the same authorities against lead agents
Consistent with § 155.220(l), the FFE standards and requirements in § 155.220 also apply to agents, brokers, and web-brokers that assist with or facilitate enrollment in States with SBE-FPs.
The NPN is a unique identifier for an agent, broker, web-broker, or agency that the National Association of Insurance Commissioners assigns during the State licensing application process. The NPN can be recorded as part of the consumer's Exchange eligibility application and is used to track which individual agents, brokers, or web-brokers and agencies assisted Exchange consumers. QHP issuers use the NPN to identify the agent, broker, web-broker, or agency for compensation purposes. Either the NPN of the individual agent, broker, or web-broker assisting the consumer, or the business NPN of the agency, may be listed on the consumer's eligibility application submitted to an FFE or SBE-FP. In the most recent Open Enrollment survey, approximately 4 percent of respondents attested to using a business NPN for all their enrollments.
Under the approach described in this preamble, when information suggests there is agency-level misconduct or noncompliance, an investigation or compliance review would occur, and enforcement action may be taken. Any such compliance review, or enforcement action would be directed at the lead agent(s) and any other agent, broker, or web-broker who is discovered to be involved in the misconduct or noncompliant activity. When the misconduct or noncompliant activity is occurring at the agency-level, we believe it is appropriate for the lead agents to be subject to the compliance review, or enforcement action, in addition to the agents, brokers, or web-brokers working at or for an agency that may have been involved in the misconduct or noncompliant activity, as those lead agents are the individuals responsible for directing and/or overseeing their employees' and contractors' behavior and activity. Engaging in compliance reviews and taking enforcement actions against lead agents in these circumstances would ensure that the individuals who are directing and/or overseeing the misconduct or noncompliance are held accountable.
The first step (of two) we would take in determining if we would engage in a compliance review or enforcement action against the lead agents would be to determine if there appears to be agency-level endorsement of, or agency-level involvement in,
Agency-level endorsement would indicate the misconduct or noncompliant behavior or activities are not random, isolated occurrences undertaken by a singular agent, broker, or web-broker and that the agency, and its lead agent(s), may be complicit in such misconduct or noncompliant behavior or activities. Determining if there is agency-level endorsement or involvement would involve review of
Additionally, we would utilize system monitoring to identify potential misconduct or noncompliant behavior or activities. For example, we currently engage, and would continue to engage, in system monitoring by analyzing person searches on approved Classic DE and EDE partner sites to identify data trends that could indicate potential misconduct or noncompliant behavior or activities. Past investigations using system monitoring data have borne results that show a connection between potentially noncompliant, fraudulent, or abusive behavior and the trends we monitor. For example, we monitor the number of unsuccessful person searches on approved Classic DE and EDE partner sites because, in our experience, there is often a correlation between a high volume of unsuccessful person searches and noncompliant, fraudulent, or abusive behavior. The person search feature is intended to help agents, brokers, and web-brokers find consumer applications to prevent duplicate enrollments, but in our experience, bad actors use this feature to find applications and make plan changes or NPN changes without consumer knowledge or consent, negatively impacting the consumer and compliant agents, brokers, and web-brokers. However, because bad-acting agents, brokers, or web-brokers often do not have exact or complete consumer information, their person searches may not direct them to the consumer applications they are searching for, frequently leading them to run more unsuccessful searches using slightly different, yet incomplete or otherwise inaccurate, consumer information. Therefore, we monitor and would, under this proposal, continue to monitor, unsuccessful person searches on approved Classic DE and EDE partner websites to identify potential bad-actors.
Discovering agency-wide resources, such as company practices or directives, training manuals, or marketing material that suggests agency endorsement of or involvement in misconduct or noncompliant behavior or activities is another source of information we would use to determine whether to engage in a compliance review or take an enforcement action against the lead agents or other agents, brokers, or web-brokers who may be involved in the misconduct or noncompliant behavior or activities. We have seen agency-wide resources, such as training manuals or marketing documents, that contain information, promotions, or sales tactics suggestive of agency endorsement of or involvement in misconduct or noncompliant behavior or activities. For example, as part of compliance investigations and enforcement actions, we have seen agency documentation instructing agents and brokers who work at the agency to fabricate enrollee or applicant incomes on eligibility applications submitted to the FFEs or SBE-FPs to ensure the enrollee or applicant has a zero-dollar policy.
Once we determined there is information or evidence suggesting there may be agency-level endorsement of or involvement in misconduct or noncompliant behavior or activities, we would then determine if the agency was involved in or facilitated the submission of the consumer's eligibility application or enrollment to the FFEs or SBE-FPs. This would also inform our determination of whether to engage in a compliance review or take enforcement action against the lead agent(s) or other agents, brokers, or web-brokers who may be involved in the misconduct or
We seek comment on these proposals. In particular, we are interested in comments from States as to the specific or unique characteristics of their agency oversight policies and procedures, including how they define or describe the term “lead agent,” or whatever term of art each State uses to capture our definition of “lead agent” in this preamble, as well as suggestions from States for ways to enhance collaboration and alignment of our oversight and enforcement of agencies that assist consumers applying for and enrolling in QHPs through the FFEs and SBE-FPs. We are also interested in comments from Classic DE and EDE partners, issuers, and other interested parties regarding whether we should consider an agent, broker, or web-broker that allows their NPN to be used by other agents, brokers, or web-brokers to be a lead agent and potentially held responsible for misconduct or noncompliant behavior or activities committed by another agent, broker, or web-broker using their NPN.
We propose to amend § 155.220(k)(3), which outlines our authority to immediately suspend an agent's or broker's ability to transact information with the Exchange if we discover circumstances that pose unacceptable risk to Exchange operations or Exchange information technology systems until the incident or breach is sufficiently remedied or sufficiently mitigated to HHS' satisfaction. Specifically, we propose to add language to reflect that § 155.220(k)(3) system suspensions may be imposed in instances in which we discover circumstances that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems, including but not limited to risk related to noncompliance with the standards of conduct under § 155.220(j)(2)(i), (ii) or (iii) or the privacy and security standards at § 155.260,
Section 1312(e) of the ACA provides the Secretary with authority to establish procedures under which a State may allow agents or brokers to (1) enroll individuals and employers in any QHPs in the individual or small group market once the plan is offered through an Exchange in the State; and (2) assist individuals in applying for PTC and CSRs for plans sold through an Exchange. In addition, section 1313(a)(5)(A) of the ACA directs the Secretary to provide for the efficient and non-discriminatory administration of Exchange activities and to implement any measure or procedure the Secretary determines is appropriate to reduce fraud and abuse. Section 1321(a) of the ACA provides broad authority to the Secretary to establish standards and issue regulations to implement the statutory requirements related to Exchanges, QHPs, and other components of title I of the ACA, which includes sections 1312 and 1313. Section 1321(a) of the ACA also provides the Secretary with authority to implement other requirements as the Secretary determines appropriate. In prior rulemakings, we used these authorities to adopt § 155.220, which establishes standards and requirements applicable to agents, brokers, and web-brokers assisting individuals, employers, or employees with enrollment in QHPs offered through the FFEs, including the system suspension authority in § 155.220(k)(3). Consistent with § 155.220(l), the FFE standards and requirements in § 155.220 also apply to agents, brokers and web-brokers that assist with or facilitate enrollment in States with SBE-FPs.
As we explained in the 2020 Payment Notice,
We propose to amend § 155.220(k)(3) to reflect that HHS may immediately suspend the agent's or broker's ability to transact information with the Exchange if HHS discovers circumstances that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems, including but not limited to risk related to noncompliance with the standards of conduct under § 155.220(j)(2)(i), (ii) or (iii) and the privacy and security standards under § 155.260, until the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction.
We continuously monitor for behaviors or activities related to Exchange operations or access to Exchange systems and enrollee or applicant PII that we believe, based on our experience overseeing agents and brokers on the FFEs and SBE-FPs, may be indicative of misconduct or noncompliance with applicable HHS Exchange standards or requirements. Our experience overseeing agents and brokers on the FFEs and SBE-FPs includes past completed agent, broker, and web-broker investigations and enforcement actions, and observations of behavior by agents and brokers that may not comply with the standards of conduct at § 155.220(j)(2)(i), (ii) or (iii) or the privacy and security standards at § 155.260 and that could endanger the accuracy of Exchange eligibility determinations, applicant or enrollee PII, or Exchange operations or systems in a number of ways.
A non-exhaustive list of agent or broker data we monitor to identify behaviors or activities that may be indicative of misconduct or noncompliance with applicable HHS Exchange standards or requirements includes: (1) the number of Exchange transactions submitted to the FFEs or SBE-FPs to change enrollee or applicant eligibility application information or plan selections, (2) the volume of person search activities, (3) the number of submitted eligibility applications with missing Social Security Numbers (SSNs), (4) the number of enrollments submitted within a specified time-frame, and (5) the volume of submitted eligibility applications with NPN changes. We also review and consider complaints from enrollees, applicants, and other individuals or entities concerning agent and broker activities.
Once we receive a complaint or identify concerning or anomalous data, we review the complaint and/or data to determine if there is information that suggests the impacted enrollees or applicants may have authorized the agent or broker to submit an Exchange eligibility application, or an update to an existing enrollment, on their behalf. We then review the available documentation and application details and may contact the agent or broker and interview Exchange enrollees or applicants to gather more information. Depending on the results of this preliminary investigation, agents or brokers may be provided additional education and technical assistance, or we may implement a system suspension under § 155.220(k)(3) if we discover circumstances that pose unacceptable risk to Exchange operations or Exchange information technology systems.
There are different factors we consider when deciding whether to implement a system suspension under § 155.220(k)(3) or offer technical assistance. These factors include the number of times that our data, including complaints we receive, indicate that an agent or broker may have engaged in misconduct or noncompliance with applicable HHS Exchange standards or requirements, the number of consumers impacted by their suspected misconduct or noncompliant behavior or activities, and the severity of the alleged misconduct or noncompliant behavior or activities. We would continue these practices for system suspensions under the proposed updates in this rule to § 155.220(k)(3), which would expand the bases for imposing a system suspension to include situations that pose unacceptable risk to the accuracy of Exchange eligibility determinations, Exchange applicants, and Exchange enrollees. This proposed amendment to § 155.220(k)(3) aligns with the approach outlined in the 2020 Payment Notice (84 FR 17517) and is in response to misconduct and noncompliant behavior and activities by agents and brokers that we have observed in connection with our oversight of the FFEs and SBE-FPs. This proposal is designed to promote information technology system security in the FFEs and SBE-FPs, including the protection of consumer data, reduce fraud and abuse, and support the efficient administration of Exchange activities.
Consistent with the existing framework, in circumstances where we would impose a system suspension under the proposed amendments to § 155.220(k)(3), we would notify the agent or broker of the suspension and they would have an opportunity to submit evidence and information or to demonstrate that the circumstances of the incident, breach, or noncompliance are sufficiently remedied or mitigated to HHS' satisfaction to warrant lifting the suspension to reinstate their system access. We would review such evidence and information submitted by the agent or broker to determine if the circumstances of the incident, breach, or noncompliance are sufficiently remedied or mitigated to warrant lifting the suspension to reinstate their system access. For example, we anticipate receiving documentation of consumer consent and/or review and confirmation of the accuracy of the Exchange eligibility application information and assessing whether the documentation complies with § 155.220(j)(2)(ii) and (iii) for consumers cited in the suspension notice from agents and brokers we system suspend under § 155.220(k)(3). If such evidence or information sufficiently remedies or mitigates the incident, breach or noncompliance to our satisfaction, we would lift the
In cases where such evidence and information does not sufficiently remedy or mitigate the circumstances of the incident, breach or noncompliance to HHS' satisfaction (including situations where there is no response from the agent or broker), we would not lift the suspension under § 155.220(k)(3) to reinstate the agent's or broker's system access and would pursue a suspension or termination of the agent's or broker's Exchange Agreements under § 155.220(g). As previously noted, agents and brokers whose ability to transact information with the Exchange is suspended under § 155.220(k)(3) remain registered with the FFEs and are authorized to assist consumers using the Exchange (or side-by-side) pathway and the Marketplace Call Center, unless and until their Exchange Agreements are suspended or terminated under § 155.220(f) or (g).
We are pursuing these amendments at this time in light of recent increases in behavior by agents and brokers that indicate potential violations of § 155.220(j)(2)(i), (ii) or (iii) or the privacy and security standards at § 155.260 and endangers applicant or enrollee PII or Exchange program integrity in a manner that poses unacceptable risk to the accuracy of Exchange eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems.
Since the start of PY 2024 Open Enrollment, we have seen an increase in complaints from enrollees, applicants, and other individuals and entities to the Agent/Broker Help Desk regarding enrollments submitted without enrollee or applicant consent, enrollee or applicant eligibility applications submitted with incorrect information and without enrollee or applicant review or confirmation of the eligibility application information, and changes to enrollee or applicant eligibility applications made without enrollee or applicant consent.
Unauthorized plan changes may harm enrollees or applicants by removing them from their selected plan and placing them in another plan that may not provide coverage that meets their needs (for example, different plans can have different formularies and provider networks). Unauthorized enrollments can also involve situations where individuals are enrolled in an Exchange plan without having an existing Exchange plan. Being enrolled in an Exchange plan, including in the case of an unauthorized enrollment, may impact a consumer's future ability to enroll in health insurance through the Exchange or enroll in Medicare or Medicaid, as a consumer may not enroll in more than one plan simultaneously. Unauthorized enrollments may also create premium costs for the consumer if the unauthorized enrollment is in a non-zero-dollar premium plan. Unauthorized plan changes and enrollments cost the consumer time to learn about and resolve the discrepancy and either (1) unenroll from a plan they did not want, or (2) change the plan to one that better meets their needs.
Additionally, submission of eligibility applications with inaccurate enrollee or applicant data, such as an incorrect income, may cause harm by providing the enrollee or applicant with an incorrect APTC amount. An incorrect APTC amount can result in a consumer erroneously receiving a zero-dollar monthly premium. Because the consumer does not receive monthly billing notifications due to the zero-dollar premiums, they may not know they were enrolled or that their eligibility application information was incorrect. However, once the consumer files their taxes, a reconciliation may reveal that the consumer must repay the incorrect APTC amount they were receiving. By their nature, these unauthorized enrollments and plan changes involve the misuse of enrollee or applicant PII, and they threaten the efficient administration of the Exchange and the accuracy of Exchange eligibility determinations.
Our experience monitoring compliance with the new requirements in § 155.220(j)(2)(i), (ii), and (iii) has also shown that agents, brokers, and web-brokers are engaging in misconduct or noncompliant behavior or activities. For example, their consumer consent and eligibility application information review documentation often lacks the required content specified in § 155.220(j)(2)(ii) or (iii) that demonstrates the applicant or enrollee has taken an action to provide consent or confirm the accuracy of the eligibility application information prior to submission to the Exchange. For example, we have seen consent documentation that solely lists numbers that the agent, broker, or web-broker claims tie back to the consumer's IP address, which we cannot verify and does not meet the consent documentation requirements of § 155.220(j)(2)(iii). Additionally, we have received consent documentation that is merely a name, typed using a cursive script, with no indication the consumer took an action to confirm their consent to the assistance provided by the agent, broker, or web-broker, such as a text message response, email response, or signature.
Though we believe our current authority in § 155.220(k)(3) allows HHS to implement system suspensions broadly based on circumstances that pose unacceptable risk to Exchange operations or Exchange information technology systems, in light of the increasing complaints about unauthorized enrollments, we propose amendments to § 155.220(k)(3) to increase transparency concerning the reach and application of system suspensions and more accurately capture in regulation when HHS may invoke this authority. These proposed amendments would allow HHS to immediately respond to discovered risks to the accuracy of Exchange eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems. They would also provide agents and brokers with an increased understanding of our
We note that the types of misconduct or noncompliant behaviors or activities that could lead to a system suspension under § 155.220(k)(3) could also lead to an enforcement action under § 155.220(g). However, there are important distinctions between these authorities. For example, system suspensions under § 155.220(k)(3) allow HHS to immediately suspend an agent or broker's system access. These suspensions differ from suspensions or terminations under § 155.220(g) because they do not suspend or terminate the agent's or broker's Exchange Agreement(s).
In contrast, an enforcement action under § 155.220(g) to suspend or terminate an agent's, broker's, or web-broker's Exchange Agreement(s) results in the agent, broker, or web-broker no longer being registered with the FFEs.
Though we would only initiate enforcement action under § 155.220(k)(3) against agents and brokers based on data or other information that suggest noncompliance or misconduct, we recognize that data or other information could suggest there is noncompliance or misconduct by a compliant agent or broker. For example, in some instances, this could occur if an agent or broker works largely or exclusively with a specific group of consumers, including those who live in low-income communities, communities where life changes necessitating eligibility application changes may be more common, or communities where some consumers may not have SSNs but are nonetheless eligible for Exchange coverage. Consistent with the existing framework, when pursuing system suspensions under § 155.220(k)(3), as proposed to be amended, agents and brokers would be notified of the system suspension and would have an opportunity to submit evidence or other information (such as documentation of consumer consent and review of the eligibility application information that is compliant with § 155.220(j)(2)(ii) and (iii)), to demonstrate that the circumstances of the incident, breach, or noncompliance concerns are sufficiently remedied or mitigated to HHS' satisfaction to merit reinstatement of their system access. Where there is clear evidence of compliance, compliant agents and brokers would be able to quickly respond to or otherwise remediate the risks identified by HHS that led to the system suspension under § 155.220(k)(3) such that their system access could be reinstated more swiftly than the lifting of a suspension or reinstatement of an agent's or broker's Exchange Agreement(s) following an enforcement action under § 155.220(g).
We seek comment on this proposal.
We are proposing to modify the Model Consent Form that was created as part of the 2024 Payment Notice (88 FR 25809 through 25811).
Agents, brokers, and web-brokers are required to obtain consumer consent prior to assisting with and facilitating enrollment in coverage through FFEs and SBE-FPs or assisting an individual with applying for APTC and CSRs for QHPs. Until we finalized new requirements related to consumer consent in the 2024 Payment Notice, there was no mandate to document the receipt of consent of the consumer or their authorized representative, or to maintain such documentation. The absence of a consent documentation requirement led to disputes between consumers and agents, brokers, and web-brokers that were difficult for us to adjudicate because neither party had documentary proof of consent. In the 2024 Payment Notice (88 FR 25809 through 25811), we finalized regulations
We also finalized regulations in the 2024 Payment Notice (88 FR 25804 through 25809) requiring agents, brokers, and web-brokers assisting with and facilitating enrollment in coverage through FFEs and SBE-FPs or assisting an individual with applying for APTC and CSRs for QHPs to document that eligibility application information has been reviewed by and confirmed to be accurate by the consumer or their authorized representative prior to application submission.
The Model Consent Form
Because the requirements of § 155.220(j)(2)(ii)(A) and (j)(2)(iii) can be met via an audio recording, we are also proposing to create appendices to the Model Consent Form that would contain scripts agents, brokers, and web-brokers may use to document compliance with these requirements via an audio recording. Our goal is to provide agents, brokers, and web-brokers who assist consumers verbally with guidance on meeting the consent and eligibility application review documentation requirements contained in § 155.220(j)(2)(iii) and (j)(2)(ii)(A), respectively, similar to how the current Model Consent Form helps agents, brokers, and web-brokers documenting consent via a physical document with handwritten signatures demonstrate compliance with the new consent documentation requirements.
The proposed scripts, to the extent they are utilized by agents, brokers, and web-brokers, would help ensure agents, brokers, and web-brokers are following the regulatory requirements when enrolling consumers. We believe this would reduce consumer harm by reducing unauthorized enrollments, which can result in financial harm if a consumer receives an improper APTC amount upon enrollment. We also believe this proposal would clarify and simplify how regulated entities can meet regulatory requirements. This proposal does not involve any revisions to § 155.220(j)(2)(ii)(A) and (j)(2)(iii)(A)-(C). If finalized as proposed, it would not be mandatory for agents, brokers, or web-brokers to use the amended Model Consent Form or new scripts to comply with the requirements set forth in § 155.220(j)(2)(ii)(A) and (j)(2)(iii)(A)-(C).
We seek comment on these proposals.
As part of the 2024 Payment Notice, we changed the FTR process such that an Exchange may only determine enrollees ineligible for APTC due to their FTR status after a tax filer (or a tax filer's spouse, if married) has failed to file a Federal income tax return and reconcile their APTC for 2 consecutive years (specifically, years for which tax data will be utilized for verification of household income and family size). However, in that rule, we did not impose a requirement for Exchanges to notify enrollees or their tax filers that the applicable tax filer failed to file and reconcile. In the 2025 Payment Notice, we imposed a requirement for Exchanges to send direct or indirect notices for the first year in which the tax filer was determined to have failed to file and reconcile. We are now proposing to revise § 155.305(f)(4) to require Exchanges to send a direct or indirect notice (as defined below) to enrollees or their tax filers who have not filed their Federal income tax return and reconciled their APTC for two consecutive tax years.
To our knowledge, when FTR operations were conducted in prior years before the new two-year process that was implemented as part of the 2023 Payment Notice (87 FR 27208), it was the practice of Exchanges to send notices to enrollees or their tax filers (or both) who were at risk of being determined ineligible for APTC due to failing to file and reconcile APTC for the previous tax year. Enrollees or their tax filers would be sent notices after the initial identification of FTR status prior to Open Enrollment and/or during the FTR Re-check process, depending on the process of the Exchange. In addition, it has also been the practice of Exchanges to notify enrollees or their tax filers (or both) of their FTR status when they attest that they have filed their Federal income tax return and reconciled APTC, but IRS data has not been updated to reflect their compliance with the requirement to file and reconcile. FTR Re-check is the post
We are proposing to require, consistent with the notice requirement in § 155.305(f)(4)(i), that, for a consumer identified as having a two-tax year FTR status, Exchanges provide either a direct notification to the tax filer that the Exchange has determined that the tax filer or their spouse has failed to file and reconcile their APTC for two consecutive tax years (“direct notice”), or a notification to the consumer stating that they may be at risk of losing their APTC and educating them about the requirement to file their Federal income taxes and reconcile their APTC (“indirect notice or “combined notice”). The proposed revisions would require Exchanges to send a direct notice or a combined notice for consumers identified as having both a one tax-year, and a two tax-year, FTR status. In addition to these notices, consumers who lose their APTC after the FTR Recheck process will also receive the eligibility determination notice (EDN) under § 155.330(e)(1)(ii).
This proposed requirement represents the minimum requirement for Exchanges to provide sufficient notice to enrollees or their tax filer (or both) about the need to file their Federal income tax return and reconcile APTC, and the risks of failing to do so. Consistent with operations before the COVID-19 pandemic, Exchanges on the Federal platform provide enrollees or their tax filers (or both) with more notifications that go above and beyond the minimum requirement, and they will continue to do so. Specifically, Exchanges on the Federal platform send out combined notices prior to Open Enrollment, and then again after FTR Recheck for both the one-tax year and two-tax year FTR populations. Tax filers who are identified as being in either a one-tax year or two-tax year FTR status prior to Open Enrollment, and then again after FTR Recheck, also receive direct notices. HHS encourages State Exchanges to adopt these best practices as well to provide multiple points of contact to the enrollee or tax filer (or both) on the requirement to file and reconcile their APTC to remain eligible for APTC. However, due to the concerns of interested parties about the difficulty required to notify both enrollees and tax filers, we are choosing to propose requiring only notifying either the consumer or the tax filer for the second tax year FTR population, and we acknowledge that most State Exchanges' current practice already involves multiple notifications for consumers who are at risk of losing their APTC. As the proposal only requires one notification to consumers in a two-tax year FTR status, similarly to the current rules only requiring one notice for one-tax year FTR status consumers, it is possible that Exchanges could choose to send this notice with Open Enrollment prior to the plan year where the enrollee may lose APTC or during the plan year in which the Exchange would remove APTC.
Therefore, we are proposing to add a section to § 155.305(f)(4)(ii) stating that if HHS informs an Exchange that APTC payments were made on behalf of either the tax filer or the tax filer's spouse, if applicable, for two consecutive tax years and they did not comply with the requirement to file an income tax return for those years as required by 26 U.S.C. 6011, 6012 and applicable regulations, then the Exchange must send a notice as directed in proposed subparagraphs (f)(4)(ii)(A) or (B) (or both). In proposed subparagraph (f)(4)(ii)(A), we propose to require an Exchange to send a notice directly to the tax filer informing the tax filer that they have been identified as failing to file and reconcile for two consecutive tax years, educating them about the requirement to file and reconcile APTC, and warning them that they are at risk for losing APTC eligibility because they, or their spouse, if applicable, did not file their Federal income tax return for two consecutive tax years. Exchanges that choose to send these direct notices must comply with statutory requirements to protect Federal tax information (FTI) per 26 U.S.C. 6103. For Exchanges on the Federal platform, these direct notices are sent via U.S. postal mail only, and no electronic copy of the notice is retained to protect FTI. Finally, we propose to add new subparagraph (f)(4)(ii)(B), which requires an Exchange to send an indirect notice to either the tax filer or their enrollee that does not disclose FTI but educates the enrollee or their tax filer on the requirement to file their Federal income tax return and reconcile APTC.
These proposed changes would ensure that either all tax filers or, if applicable, their enrollees who are identified as having an FTR status for two consecutive tax years would receive educational notices detailing the requirement to file and reconcile their APTC at least twice before losing their APTC eligibility; they would receive a notice for the first year they were found to be in an FTR status, and then again the second consecutive tax year they were found to have failed to file and reconcile their APTC.
As discussed in 2025 Payment Notice (89 FR 26299), we want to continue to ensure tax filers and enrollees are provided appropriate education on the requirement to file and reconcile their ATPC before being determined ineligible for APTC for failing to file and reconcile for a second consecutive tax year. Sample notices would be available at
We seek comment on this proposal.
We propose to add § 155.400(d)(1) to codify HHS guidance
Section 156.1210 generally requires State Exchange issuers to submit a description of all enrollment data inaccuracies, including those that impact APTC payments, to HHS or the State Exchange, as indicated by State Exchange guidance, in a manner and format specified by HHS or the State Exchange, within 90 calendar days of the date of a payment and collections report from HHS. At the same time, § 156.1210(b) also acknowledges that, in limited circumstances, HHS may consider inaccuracies received from a State Exchange issuer to resolve an enrollment data inaccuracy that was submitted after 90 calendar days when: (1) the State Exchange issuer notifies the State Exchange or HHS, as applicable, within 15 calendar days after identifying the inaccuracy; and (2) the State Exchange issuer's failure to identify the inaccuracy and submit to HHS or the State Exchange within the required 90 calendar day period was reasonable and not due to the issuer's misconduct or negligence.
Most recently, in the 2024 Payment Notice (88 FR 25886), we amended § 156.1210 to add paragraph (c), which provides a final deadline for issuers to submit data inaccuracies identified in payment and collections reports. Section 156.1210(c) specifies that to be eligible for resolution under § 156.1210(b), an issuer must describe inaccuracies before the end of the 3-year period beginning at the end of the plan year to which the inaccuracy relates. Notwithstanding the above, and in alignment with obligations under the False Claims Act,
Because State Exchanges provide the enrollment data that HHS uses as the basis of APTC payments to State Exchange issuers in the automated Policy-Based Payment (PBP) system, State Exchanges must update their enrollment data before HHS makes any PBP APTC payment adjustments to a State Exchange issuer. Therefore, the State Exchange issuer must work with its State Exchange to ensure resolution of any inaccuracy impacting APTC payment. If a State Exchange issuer is directed by its State Exchange to submit inaccuracies directly to HHS, the State Exchange issuer should follow those submission instructions, but any information HHS shares in response to the submission is informational. If the inaccuracy remains unresolved, the State Exchange issuer must follow up with its State Exchange to identify and rectify the reason for non-resolution. In accordance with § 155.400(b), a State Exchange must submit all enrollment data that HHS then uses to calculate APTC payments to State Exchange issuers. Therefore, in instances when a State Exchange does not timely address State Exchange issuer data inaccuracies, HHS cannot directly assist the State Exchange issuer in addressing these data inaccuracies.
This proposal would codify guidance in the document titled, “Reporting and Reviewing Data Inaccuracy Reports in State-based Exchanges Frequently Asked Questions”.
We solicit comments on this proposal.
We propose to codify a provision related to the premium payment threshold policies under § 155.400(g) that would allow additional issuer flexibility to decide when amounts collected from an enrollee would be considered to satisfy their obligation to pay the enrollee-responsible portion of the premium for certain purposes. Specifically, this would provide issuers with additional flexibility to not place an enrollee in a grace period for failure to pay the full amount of their portion of premiums due, and to not terminate enrollment through the Exchange after the applicable grace period ends without outstanding premiums being paid in full. This proposal would reduce the number of coverage terminations for enrollees who owe only a small amount of premium within the threshold. Specifically, we propose that issuers be permitted to set a fixed-dollar threshold of $5 or less, which would be adjusted for inflation. We are also considering permitting issuers to adopt a threshold that is based on the gross premium owed by the enrollee, rather than net premium. We also propose to modify the threshold of the existing premium payment threshold policy at § 155.400(g) for clarity.
Currently, issuers have the option under § 155.400(g) to adopt a percentage-based premium payment threshold which allows issuers to effectuate coverage in accordance with binder payment rules at § 155.400(e) for enrollees who pay an amount of the enrollee-responsible portion of the premium that is less than 100 percent but within the threshold (we have historically recommended a percentage equal to or greater than 95 percent).
In the 2017 Payment Notice (81 FR 12271 through 12272), in which HHS established the option for issuers to implement a percentage-based premium payment threshold, we received a comment requesting that issuers be allowed to establish a flat dollar amount threshold. At that time, we stated that we did not consider implementing such a threshold because there may be cases in which even a low flat dollar amount may represent a large percentage of an enrollee's portion of the premium less APTC (81 FR 12272).
However, after implementation of the percentage-based threshold, we have realized that the percentage-based premium threshold policy does not always adequately enable enrollees who owe small amounts of premium to avoid triggering a grace period or termination of enrollment through the Exchange. For example, an enrollee whose enrollee-responsible portion of the premium was $1 after APTC, and who failed to make a premium payment, would be placed into a grace period even if the issuer had adopted a 95 percent payment threshold, despite being delinquent by only $1. In an analysis of Exchange data for the 2023 Plan Year, we found that there were 81,383 total policies terminated for non-payment in which $5 or less was owed by the enrollee, representing approximately 5.4 percent of the total number of policies terminated for non-payment that year. In addition, 102,728 policies in which enrollees owed premiums of $5.01 to $10 were terminated for non-payment, representing approximately 6.84 percent of the total number of policies terminated for non-payment. Even though $5 may represent a large percentage of an enrollee's portion of the premium less APTC, we believe that triggering a grace period or terminating enrollment through the Exchange is too severe a consequence for non-payment of such limited dollar amounts.
We are concerned about situations in which an issuer would be willing to avoid termination of enrollment through the Exchange if the enrollee owed only small amounts of premium but are prevented from doing so by the lack of flexibility in the current regulation. In addition, many of the enrollees who enter a grace period because they owe de minimis amounts of premium are likely low or moderate-income enrollees and thus might be especially hurt by disruptions in coverage. We recognize that issuers have historically implemented various premium payment thresholds, and we believe there is value in providing flexibility to issuers regarding whether to adopt a fixed-dollar payment threshold and the amount of the threshold.
We thus propose to modify § 155.400(g) to allow issuers to adopt a fixed-dollar premium payment threshold of $5 or less, adjusted for inflation, under which they could provide additional flexibility to enrollees who fail to pay the full amount of their portion of premium owed. We propose to limit the fixed-dollar premium threshold to $5 or less because, unlike the current percentage-based threshold, a fixed-dollar threshold would allow enrollees, in some cases, to pay $0 in premium without the issuer triggering a grace period or terminating enrollment through the Exchange. Such a limit would ensure that enrollees who owe large amounts of premium do not remain enrolled in coverage through the Exchange and would serve to limit the number of times an enrollee may fail to pay premium and avoid triggering a grace period or termination of enrollment through the Exchange. We believe that a limit of $5 is sufficiently large to enable issuers to allow enrollees who owe
Issuers that adopt such a policy could permit enrollees who owe less than the specified amount of premium to avoid triggering a grace period and termination of enrollment through the Exchange. However, we propose to limit application of this threshold to premium payments made after coverage is effectuated, so that it could not apply to the binder payment. Issuers have the option under the current percentage threshold policy at § 155.400(g)(1) of applying a percentage-based threshold to the binder payment, but under that policy, enrollees are required to pay some amount of premium, even if it less than the total. By contrast, under a fixed-dollar premium payment threshold, enrollees could have their coverage effectuated without making any payment if their portion of the binder payment is under the threshold amount. Due to concerns about program integrity, we believe it is important to ensure that, when a binder payment is required, enrollees must always pay some amount of premium to effectuate coverage as an important signal that the coverage is desired by the enrollee. In addition, as under the current policy (81 FR 12272), any amount that is unpaid but within the reasonable premium payment threshold established by an issuer remains an amount owed by the enrollee and cannot be forgiven by the issuer. This remains true whether the premium payment threshold is utilized for any of the following payments: binder payments, regularly billed payments, or amounts owed by an enrollee while in a grace period.
To illustrate how a fixed-dollar premium threshold will work under this proposal, we provide the following example:
During the annual Open Enrollment Period, a consumer selects a QHP with a total monthly premium amount of $300, and the consumer is determined eligible for $299 in APTC and elects to receive the entire amount. The consumer's enrollee-responsible portion of premium will thus be $1. The QHP issuer has adopted a fixed-dollar premium payment threshold policy under which it will not terminate enrollment of enrollees who owe $5 or less of the enrollee-responsible portion of premium. The issuer has set a binder payment deadline of January 30, and the consumer sends the binder payment of $1 ahead of the deadline and effectuates coverage effective January 1. Subsequently, the consumer does not make a payment for February, March, April, May, or June, and, as a result, the enrollee owes $5 in outstanding premiums. Because the issuer has adopted a $5 premium payment threshold, the issuer would not put the consumer into a grace period, since the total amount owed does not exceed $5. However, the issuer would not be permitted to write off the $5 owed, and if the consumer does not pay the premium for July in full, the issuer must put the consumer into a 3-month grace period since the total amount of premium owed would exceed the threshold set by the issuer. However, if within the grace period the consumer paid the full amount owed or a portion of the full amount owed that brings the amount owed under $5, the issuer could terminate the grace period without terminating enrollment through the Exchange.
Finally, under the current percentage-based threshold policy, the percentage is calculated based on the percentage paid of the enrollee's portion of the premium (that is, the total premium minus any APTC). We are considering whether to further amend § 155.400(g) to also permit issuers to set a reasonable threshold that is a percentage of the policy's total premium and not just the enrollee's portion of premium, thus allowing APTC paid on the consumer's behalf to count toward the threshold.
In the 2017 Payment Notice (81 FR 12271 through 12272), we established the option for issuers to adopt a premium payment threshold based on net premium owed by the enrollee. At that time, we did not consider establishing a threshold based on gross premium, nor have we done so since then. We now recognize that this option may provide issuers with an alternative method of keeping consumers enrolled in coverage that issuers may prefer, either because it is simpler to implement or because it is percentage-based and therefore more similar to the premium payment threshold that is currently allowed under § 155.400(g).
Establishing an option for issuers to adopt a percentage threshold based on gross premium owed by the enrollee with APTC counting toward the threshold would, in some cases, allow enrollees to remain enrolled in coverage or avoid triggering a grace period or termination of enrollment through the Exchange for owing small amounts of the enrollee-responsible portion of the premium. For example, an enrollee whose gross premium was $600, and was receiving $595 in APTC, could avoid triggering a grace period or termination of enrollment through the Exchange or termination of coverage even without paying the $5 enrollee-responsible portion of the premium if the issuer had adopted a 99 percent premium threshold based on gross premium because 99 percent of the gross premium would have been paid on the enrollee's behalf in the form of APTC. With the current 95 percent threshold based on net premium, by contrast, the enrollee would be required to pay at least $4.75 to avoid triggering a grace period or termination of enrollment through the Exchange. While historically we have not defined a specific threshold for the premium threshold based on net premium, we would implement a threshold for the premium threshold based on gross premium that is 99 percent or more of the gross premium. We believe the gross premium threshold should be higher than the net premium threshold to avoid the enrollee accumulating a much larger amount of premium debt, and to keep to a similar
A percentage threshold based on gross premium may be simpler to implement, since it is similar to the type of threshold issuers are already allowed to adopt. However, we recognize that there may also be drawbacks to this approach, including that enrollees could accumulate more than $5 in premium debt, which the enrollee would continue to owe even if coverage were eventually terminated due to non-payment of premiums. Based on our experience with the current, net premium-based payment threshold, we do not believe this would result in significant premium debts accumulated by enrollees, since we are limiting the gross percentage-based threshold to be 99 percent or more of the gross premium. We recognize that a gross premium amount higher than the average gross premium (which was $604.78 in February 2023)
To illustrate how a premium threshold based on gross premium would work under this proposal, we provide the following example:
During the annual Open Enrollment Period, a consumer selects a QHP with a total monthly premium amount of $500, and the consumer is determined eligible for $495 in APTC and elects to receive the entire amount. The consumer's enrollee-responsible portion of premium will thus be $5. The QHP issuer has adopted a percentage-based premium payment threshold policy under which it will not trigger a grace period or termination of enrollment through the Exchange for enrollees who pay at least 99 percent of gross premium (including payments of APTC made on the enrollee's behalf), which here would be $5. The issuer has set a binder payment deadline of January 30, and the consumer sends the binder payment of $5 ahead of the deadline and effectuates coverage effective January 1. Subsequently, the consumer pays $1 in February and owes $4 in past due premium; because the consumer's payment is within the 99 percent threshold established by the issuer, the issuer would not place the enrollee in a grace period. The following month, the consumer does not pay any premium, and now owes $9 in past due premium. Since the $9 now owed after application of the $495 APTC paid on the consumer's behalf for March represents more than 1 percent of the $500 gross premium, the issuer must put the consumer into a 3-month grace period starting March 1. The issuer would not be permitted to write off the $9 owed, and the consumer must pay all outstanding premium owed before the end of the grace period (May 31) to avoid exhaustion of the grace period and remain enrolled in coverage.
We seek comments on this proposal. Specifically, we request comment on whether a fixed-dollar threshold, as
We also propose changing the premium payment threshold based on net premium owed by the enrollee from being a “reasonable” standard to a specifically defined threshold of 95% or higher of the net premium. We believe this would provide clarity for issuers and Exchanges.
We also propose limiting issuers to utilize one premium payment threshold, such that a fixed-dollar threshold cannot be adopted and utilized in tandem with a percentage-based policy, either net or gross. We believe that limiting this flexibility would allow issuers to choose and apply the threshold that works best for their payment operations but prevents complex situations that may arise from allowing multiple thresholds to be used simultaneously. We seek comment on whether we should allow issuers to adopt both a fixed-dollar and percentage-based threshold, and request commenters to consider the administrative feasibility of applying both thresholds, and how such a policy could be applied uniformly and consistently across enrollees.
We propose revising § 155.505(b) to codify an option for application filers to file appeals on behalf of applicants and enrollees on the application filer's Exchange application.
The Exchanges on the Federal platform allow application filers as defined under § 155.20 to file applications on behalf of an applicant. However, the appeals regulation at § 155.505(b) states that only applicants and enrollees may submit appeal requests to the HHS appeals entity or a State Exchange appeals entity. Appeal requests submitted online to the HHS appeals entity are linked to a consumer's
This limitation under § 155.505(b) puts a burden on consumers, as appeals filed by application filers who are neither an applicant or enrollee are considered invalid based on lack of standing, requiring either that the applicant or enrollee resubmit their appeal or that they designate the application filer as an authorized representative in writing. These extra steps not only add unnecessary complications for the applicant or enrollee, but also serve to delay an appeal resolution that may grant or restore QHP coverage and financial assistance.
This proposed change would allow application filers to file appeals through the HHS appeals entity or a State Exchange appeals entity on behalf of applicants and enrollees on their Exchange application, streamlining the appeals process and ensuring operational consistency throughout the application and appeals processes. We do not anticipate that this would impose any additional substantial burden on any Exchanges, including State Exchanges that operate their own platform, as this should not materially increase the number of appeals filed, or add complexity to appeals processes.
We seek comment on this proposal.
We propose to amend § 155.1000 by adding a new paragraph (e) stating that an Exchange may deny certification of any health plan as a QHP that does not meet the general certification criteria at § 155.1000(c).
Section 1311(e)(1) of the ACA grants an Exchange the authority to certify a health plan as a QHP if the health plan meets the requirements for certification promulgated by the Secretary under section 1311(c)(1) of the ACA, and the Exchange determines that making the plan available through the Exchange is in the interests of qualified individuals and qualified employers in the State.
However, an Exchange's authority to deny certification is not explicitly referenced in 45 CFR part 155. Several regulations, including §§ 155.1000(c) and 155.1090, can be read to imply, but do not explicitly state, that an Exchange may deny certification of a health plan that does not meet the requirements of § 155.1000(c). Despite this omission from our regulations, a plain reading of section 1311(e)(1) of the ACA makes clear that an Exchange, as the entity statutorily responsible for determining whether a plan meets the minimum QHP certification standards, has the implied authority to deny certification of plans that do not meet these standards. Any contrary read of section 1311(e)(1) of the ACA would mean that an Exchange does not have any statutory authority to take any action for plans that do not meet minimum certification standards, which is not a reasonable result.
We seek to revise our regulations so that they more fully and accurately reflect the discretion that Exchanges have to deny certification of any plan that does not meet the general certification criteria at § 155.1000(c). Accordingly, we propose to use the authorities under section 1311(c) of the ACA (which gives HHS the authority to establish criteria for the certification of health plans as QHPs), section 1311(d)(4)(A) (which provides that Exchanges shall implement procedures for the certification, recertification, and decertification of QHPs consistent with the guidelines HHS develops under section 1311(c)), and section 1321(a)(1)(B) (which provides HHS with broad rulemaking authority to issue regulations setting standards for meeting the requirements under title I of the ACA (which includes section 1311) for the establishment and operation of Exchanges and the offering of QHPs through the Exchanges) to add new paragraph (e) to § 155.1000 to formalize
To be clear, we are not proposing to require Exchanges, including State Exchanges and SBE-FPs, to implement any specific procedures or processes for the denial of a QHP certification application. This proposal is not intended to amend the existing, implied authority of an Exchange to deny certification. This proposal is only intended to make that authority more explicit in our regulations, which will provide greater certainty to Exchanges, issuers, and consumers on an Exchange's role, which we expect will only improve the efficiency of the Exchanges.
We seek comment on this proposal.
We propose to amend § 155.1090 to revise the standards for an issuer to request the reconsideration of denial of certification as a QHP specific to the FFEs.
Section 1311(e)(1) of the ACA grants an Exchange the authority to certify a health plan as a QHP if the health plan meets the requirements for certification promulgated by the Secretary under section 1311(c)(1) of the ACA, and the Exchange determines that making the plan available through the Exchange is in the interests of qualified individuals and qualified employers in the State.
HHS, as operator of the FFEs, is responsible for ensuring that health plans offered through the FFEs meet all Federal requirements for certification as QHPs under § 155.1000(c). Starting with the 2014 plan year, HHS has certified numerous health plans as QHPs on the FFEs. During this time, HHS has also determined that a small number of applications submitted by issuers for the certification of health plans as QHPs on the FFEs did not meet minimum certification criteria under § 155.1000(c), and HHS denied certification to these plans. Some of these issuers submitted reconsideration requests to HHS under § 155.1090(a)(1). HHS ultimately sustained its denial determinations for these issuers' certification applications upon reconsideration review.
Based on our experience reviewing these certification application reconsideration requests, we believe that it would be appropriate to amend § 155.1090 to codify more structure for the FFEs' process for conducting a reconsideration of denial of certification. Accordingly, we propose to use the authorities under section 1311(c) of the ACA (which gives HHS the authority to establish criteria for the certification of health plans as QHPs), section 1311(d)(4)(A) (which provides that Exchanges shall implement procedures for the certification, recertification, and decertification of QHPs consistent with the guidelines HHS develops under section 1311(c)), and section 1321(a)(1)(B) (which provides HHS with broad rulemaking authority to issue regulations setting standards for meeting the requirements under title I of the ACA (which includes section 1311) for the establishment and operation of Exchanges and the offering of QHPs through the Exchanges) to require that an issuer's reconsideration request meet a specified burden of proof. Specifically, we propose revising § 155.1090(a)(2) to state that the burden is on an issuer that is denied certification to provide evidence that HHS' determination that the plan does not meet the certification criteria at § 155.1000(c) was in error.
As we stated in the Exchange Establishment Rule (76 FR 41891), offering only QHPs through an Exchange assures consumers that the coverage options presented through the Exchange meet certain minimum Federal standards. Given the voluntary nature of QHP certification, the FFEs utilize a process for QHP certification whereby the burden of proof is on issuers to provide sufficient evidence that they comply with those minimum Federal standards to obtain certification.
We also propose to revise § 155.1090(a)(2) to require that, as part of a reconsideration request, an issuer would be required to submit clear and convincing evidence that HHS' determination that the plan does not meet the general certification criteria at § 155.1000(c) was in error. We explained in the 2017 Payment Notice (81 FR 12289) that HHS expects to certify the vast majority of plans that meet the certification standards. To maximize this amount of time for health plans to prepare, submit, and revise QHP applications to the FFEs, HHS provides as much time as it can for issuers to demonstrate that they comply with the certification standards. The FFE's QHP certification timeline provides at least three opportunities for issuers to submit application materials to demonstrate that it meets minimum certification standards for a given plan year (four opportunities, if the issuer avails itself of an optional early bird submission). As such, by the time it issues a denial of certification, HHS will have typically already received substantial factual information from the issuer over the period of several months upon which it will have based its denial determination. It is unlikely that any additional evidence that the issuer would seek to provide upon reconsideration request that they had not already provided during the three or four rounds of application submissions would meaningfully weigh in favor of certification unless it clearly and convincingly establishes that HHS' determination that the plan does not meet the general certification criteria at § 155.1000(c) was in error.
Under this proposal, we would expect evidence to be clear and convincing that HHS' determination was in error if the issuer demonstrates that HHS clearly misunderstood or misinterpreted facts or data already provided by the issuer in previously submitted application materials (such as network adequacy calculation errors). We would not
Finally, we propose to revise the title of § 155.1090 to state, “Request for the reconsideration of a denial of certification” and the subtitle of § 155.1090(a) to state, “Request for the reconsideration of a denial of certification specific to a Federally-facilitated Exchange.”
We seek comment on this proposal.
We currently collect certain information and data from State Exchanges and SBE-FPs under § 155.1200 to monitor their performance and compliance. Under our authority under section 1321(a)(1)((D) of the ACA to promulgate appropriate requirements related to Exchanges, we are proposing to also use this information and data to increase transparency into State Exchange operations and to promote program improvements.
Under § 155.1200, State Exchanges must report to HHS on certain Exchange-related activities and performance monitoring data. State Exchanges must also engage an independent qualified auditing entity which follows generally accepted government auditing standards (GAGAS) to annually compile a financial statement and conduct a financial audit and a programmatic audit.
To meet these requirements, under section 1313(a)(1) of the ACA, State Exchanges and SBE-FPs are required to submit a State Marketplace Annual Reporting Tool (SMART) to CMS, which CMS uses to monitor and evaluate State Exchange compliance with Exchange requirements under Title I of the ACA.
State Exchanges that operate their own eligibility and enrollment platform also report enrollment and Exchange activity data to CMS weekly during Open Enrollment and twice a year outside of Open Enrollment.
In the 2025 Payment Notice (89 FR 26218), we noted that in the interest of transparency, we are considering the development of new tools to provide further information to the public about the performance of Exchanges. We are now proposing that, in addition to collecting the information and data currently submitted to CMS by State Exchanges and SBE-FPs under § 155.1200 to monitor performance and compliance, we would use the information and data to increase transparency into State Exchange operations and to promote program improvements. We would value feedback on our proposed approaches to meeting this objective.
Specifically, we plan to publicly release the State Exchange and SBE-FP annual SMARTs and financial and programmatic audits in addition to any documentation of corrective actions or open findings. We believe that in addition to increasing the public's understanding of State Exchanges, the release of the SMARTs and related documents, including programmatic and financial audits, would help ensure that the SMART and State Exchange compliance activities are conducted in a more transparent manner. Our intention is to begin with publication of the Plan Year 2023 SMART (which was due from the State Exchanges and SBE-FPs to CMS on June 1, 2024, and are currently under compliance review) beginning Spring 2025.
We also intend to expand on current Open Enrollment data reporting by publishing, additional metrics on State Exchange operations and functionality that we currently collect from State Exchanges, but do not currently report to external audiences. This data includes State Exchange spending on outreach (including Navigators), eligibility and enrollment policies and processes, plan certification requirements, and operational performance data, including Open Enrollment call center metrics (call center volume, average wait time, average call abandonment rate) and website visits and visitors. We believe that increasing transparency would allow the public to better understand the performance of the Exchanges, and it is our intention that this public reporting of State Exchange operations and functionality would include public release of comparable metrics for the FFEs and SBE-FPs.
We are interested in comments as to what other Exchange metrics would be useful to disclose to the public.
Several instances of issuer insolvencies (each involving multi-State parent organizations with several subsidiaries) have in recent years destabilized certain State markets and caused significant disruption to consumers, including in the applicable Exchanges. The disruptive nature of these incidents prompted State Departments of Insurance (DOIs), trade organizations, and issuers to request that we intervene to restabilize affected markets and employ additional measures to reduce the risk of similar scenarios occurring in subsequent years. In response to this feedback, we are soliciting comments on methods that HHS, as operator of the FFEs, could potentially employ, in partnership with State regulators, to reduce the risk that
One example of a potential approach we are considering adopting, and therefore solicit comment on, could be to increase our coordination with State DOIs, individually and collectively in the case of multi-State issuers, and the National Association of Insurance Commissioners (NAIC). Under this approach, we could review QHP applications in FFE States to identify issuers that are at risk of experiencing solvency-related difficulties, both at the time of an issuer's application for QHP certification and on a rolling basis throughout the plan year. To assess issuer solvency, we could examine well-understood and industry-standard financial measures, such as the risk-based capital ratio and quick ratio, in partnership with State regulators.
The risk-based capital ratio is an industry-standard regulatory method used to determine the minimum amount of capital an issuer must maintain to cover its risk. The risk-based capital ratio an issuer must maintain (in accordance with State licensure requirements) is based on the inherent level of risk associated with its financial assets, insurance products, and business operations. The risk-based capital ratio is defined as the ratio of an issuer's total adjusted capital to its authorized control level risk-based capital. Total adjusted capital is typically cash or liquid assets being held or obtained for expenditures. Authorized control level risk-based capital, also referred to as risk-weighted assets, is the denominator in the risk-based capital ratio. Authorized control level risk-based capital is used to determine the minimum amount of capital an issuer must hold in relation to the risk profile of its activities and other assets.
A low risk-based capital ratio may indicate that an issuer is insufficiently capitalized and therefore may be unable to pay claims and risk adjustment charges in a longer time horizon. Thus, monitoring issuers' risk-based capital ratios enables regulators to identify potentially insufficiently capitalized issuers, which could facilitate necessary regulatory intervention to ensure enrollees receive benefits without relying on a guaranty association or taxpayer funds. In the context of the Exchanges, such regulatory intervention could include implementing plan suppressions, enrollment caps, denying QHP certification, or decertifying existing QHPs.
While the risk-based capital ratio provides a measure of an issuer's overall long-term financial viability, it does not so readily indicate whether an issuer is able to pay claims or risk adjustment charges in the more immediate term by quickly liquidating its assets. For example, an issuer could have a risk-based capital ratio indicating a sufficient degree of capitalization but may not be able to quickly liquidate its assets to cover its immediate liabilities, either in the form of claims or risk adjustment payments.
As such, we are interested in comments on whether we should consider also utilizing a second industry-standard measure of financial instability, the quick ratio, which is a type of liquidity ratio, to assess issuer solvency. The quick ratio measures an issuer's ability to use its near-cash or “quick” assets to extinguish or retire its current liabilities immediately. The quick ratio is defined as the ratio between quickly available or liquid assets and current liabilities.
The quick ratio is a more conservative estimate of how liquid a company is compared to other calculations that include potentially illiquid assets, such as the risk-based capital ratio. In particular, the quick ratio addresses an issuer's ability to pay outstanding debts. This financial metric alone does not provide any indication about a company's future cash flow activity. However, the utilization of the quick ratio, in conjunction with the risk-based capital ratio, could potentially facilitate the identification of issuers with potential financial viability concerns that may pose risk to the integrity of the FFEs.
Altogether, monitoring issuers' risk-based capital ratios could facilitate the assessment of an issuer's longer-term prospects for financial viability, while monitoring issuers' quick ratios could facilitate the assessment of issuers' more immediate term prospects for financial viability. Together, the utilization of these two complementary measures could potentially provide a more holistic view of issuers' financial viability and help HHS, as operator of the FFEs, in partnership with applicable State DOIs, take the action necessary to ensure the integrity of the FFEs (such as by suppressing QHPs under § 156.815, instituting enrollment caps—which have been previously operationalized by implementing QHP suppressions under § 156.815(b)(5) based on the guaranteed availability exceptions at § 147.104(c) and (d), denying QHP certification applications under § 155.1000(c), or decertifying QHPs under § 156.810).
Under this potential approach, HHS, in partnership with State regulators, could assess an issuer's financial stability based on its risk-based capital ratio and its quick ratio using data that is included in the statutory annual and quarterly financial statements that issuers are already required to file with the NAIC. Since these materials are already available to HHS, this approach would not require issuers to prepare and submit additional materials to HHS, which would minimize burden on QHP issuers.
In addition to monitoring issuers' risk-based capital ratios and quick ratios to identify issuers at risk of experiencing solvency-related difficulties, HHS could work in partnership with applicable State regulators to identify issuers that are experiencing levels of enrollment growth that risk exceeding their capitalization rates, which has historically tended to occur in large part due to the relative premium position of issuers' newly-offered plans (specifically, having the lowest-cost bronze or silver plan in the county).
Issuers experiencing enrollment growth disproportionately comprised of comparatively low-risk enrollees that exceeds their capitalization rates has been a primary contributing factor in each of the recent instances of issuer insolvencies. In particular, in these instances of issuer insolvencies, insufficiently capitalized issuers underpriced their QHPs, which attracted a high number of relatively low-risk enrollees. These issuers subsequently accrued significantly higher-than-anticipated risk adjustment charges due to the relatively low risk profiles of their enrollees, which in turn led to these issuers being unable to timely pay risk adjustment charges in full.
Upon identifying issuers with insufficient risk-based capital and quick ratios, and/or issuers with enrollment growth that risks exceeding their capitalization rates, HHS could engage applicable State regulators—including State regulators in the affected States, regulators of those issuers in their States of domicile, and regulators of affiliated
Under this potential approach, we could monitor issuers offering QHPs through the FFEs—but not issuers only offering QHPs through State Exchanges or SBE-FPs. This is because we believe that State Exchanges (including SBE-FPs) are best positioned to understand both the nuances of their respective markets and the specific needs of qualified individuals enrolling in QHPs. We also believe that States that have invested the necessary time and resources to establish State Exchanges have done so to implement policies that differ from those on the FFEs, and we do not wish to impede these efforts, so long as they comply with existing legal requirements. However, we believe that HHS can serve a useful role in identifying broader risks that span multiple markets by convening States that regulate multi-State issuers.
State regulators are the primary regulators of licensure requirements, including solvency. Indeed, we strongly believe that States are best positioned to exercise these responsibilities as a general matter. Since HHS, as the operator of the FFEs in many States and as the operator of risk adjustment in all States, has a more complete view of multi-State issuers, and, in FFE States, the ability to wield Exchange-specific tools (such as plan suppressions, enrollment caps, denial of QHP certification applications, and the decertification of existing QHPs), we believe HHS can serve a useful role in promoting thoughtful discussions with and among State regulators around the advisability of certifying plans where there may be concerns around capitalization and enrollment growth that risks exceeding capitalization rates. Regardless, we underscore that nothing in this or any other potential approach we are considering would preempt any State's licensing requirements with regard to solvency or financial matters.
We solicit comments on this and other potential approaches for reducing the risk that issuer insolvencies pose to the integrity of the FFEs.
For the 2026 benefit year, we propose an FFE user fee rate of 2.5 percent of total monthly premiums and an SBE-FP user fee rate of 2.0 percent of total monthly premiums. These significant increases in the FFE and SBE-FP user fee rates would be necessary if Congress does not act to extend enhanced PTC subsidies
However, Congressional action that extends the enhanced PTC subsidies under the IRA through the 2026 benefit year, prior to issuer rate-setting deadlines for the 2026 benefit year, would lead us to revise our enrollment projections and modify the FFE and SBE-FP user fee rates to rates closer to FFE and SBE-FP user fee rates for 2025 than the proposed rates. Specifically, if the enhanced PTC subsidies as currently enacted
HHS also notes that this same dynamic related to lower enrollment is present across numerous calculations HHS makes associated with operation of the Exchange, outside the context of this proposed rule. For example, a reduction in enhanced PTC subsidies may considerably impact pass-through funding to States for programs established under Section 1332 waivers. Similarly, the expiration of enhanced PTC subsidies may affect BHP States' ability to implement, sustain, and expand their BHP programs. Lastly, we note that increased enrollment due to enhanced PTC subsidies has increased overall projected enrollment. In the absence of Congressional action to extend enhanced PTC subsidies, those calculations and payments will assume lower enrollment and lower APTC and PTC levels.
We are proposing March 31, 2025 as the date by which enhanced PTC subsidies must be extended in order for HHS to apply the alternative FFE and SBE user rates, because we anticipate this date as the latest date we could select that would still provide issuers the opportunity to take enactment of the law into account in setting rates for the 2026 benefit year and for HHS or States, as applicable, to timely review and approve those rates. However, we seek comment on whether March 31, 2025 provides sufficient time and whether we should select an earlier or later date.
Section 1311(d)(5)(A) of the ACA permits an Exchange to charge assessments or user fees on participating health insurance issuers as a means of generating funding to support its operations. If a State does not elect to operate an Exchange or does not have an approved Exchange, section 1321(c)(1) of the ACA directs HHS to operate an Exchange within the State. Accordingly, in § 156.50(c), we state that a participating issuer offering a plan through an FFE or SBE-FP must remit a user fee to HHS each month that is equal to the product of the annual user fee rate specified in the annual HHS notice of benefit and payment parameters for FFEs and SBE-FPs for the applicable benefit year and the monthly premium charged by the issuer for each policy where enrollment is through an FFE or SBE-FP. OMB Circular A-25 established Federal policy regarding user fees and what the fees can be used for.
Section 156.50(c)(1) provides that, to support the functions of FFEs, an issuer
• Provision of consumer assistance tools;
• Consumer outreach and education;
• Management of a Navigator program;
• Regulation of agents and brokers;
• Eligibility determinations;
• Enrollment processes; and
• Certification processes for QHPs (including ongoing compliance verification, recertification, and decertification).
Activities performed by the Federal government that do not provide issuers participating in an FFE with a special benefit are not covered by the FFE user fee.
The proposed user fee rate reflects our estimates for the 2026 benefit year of costs for operating the FFEs, premiums, enrollment, and transitions in Exchange models from the FFE and SBE-FP models to either the SBE-FP or State Exchange models. The total enrollment in Exchanges in States anticipated to transition from operating an SBE-FP to a State Exchange model represents premiums for which we will no longer collect user fees, and the total enrollment in Exchanges in States anticipated to transition from an FFE to an SBE-FP model represents premiums for which we will assess user fees at the lower SBE-FP rate. Thus, these anticipated transitions impact our total projected collections and may affect the FFE and SBE-FP user fee rates and are considered as part of our calculation of our proposed user fee rates.
To develop the proposed 2026 benefit year FFE user fee rates, we considered a range of costs, premiums, and enrollment projections.
We took several factors into consideration in choosing which premium and enrollment projections would inform the proposed 2026 FFE user fee rates. First, for our estimated premium trend rate projections, we found based on our analysis of historical premium trend data that our actual average premium trend rate was lower than we had estimated in prior benefit years and therefore, for our projected 2026 benefit year user fee rates, we decreased our estimated premium trend rate projections. This change serves to better align with our historical premium trend experience, and to reflect that the total monthly premiums to which the proposed FFE and SBE-FP user fee rates would be applied are likely to be lower than previously expected.
For the 2021 through 2025 benefit years, we projected increased enrollment in the individual non-catastrophic market risk pool in most States, due to the enhanced PTC subsidies provided for in the ARP
We believe that the 2026 benefit year is uniquely uncertain due to the potential significant changes in enrollment expected if the enhanced PTC subsidies expire at the end of the 2025 benefit year under current law. We understand that many interested parties
For example, a reduction in enhanced PTC subsidies may considerably impact pass-through funding to States for programs established under Section 1332 waivers. In 2021, when the enhanced PTC subsidies first took effect, HHS and the Department of the Treasury awarded over $510 million in additional pass-through funding to 14 States in light of the enhanced subsidies through the ARP.
Furthermore, the expiration of enhanced PTC subsidies would impact funding available for States to operate BHP programs that enable enrollees that would otherwise be PTC-eligible to purchase healthcare coverage. This includes individuals under age 65 with household incomes between 133 percent and 200 percent of the FPL who are not otherwise eligible for Medicaid, CHIP, or other minimum essential coverage, or individuals whose income is equal to or below 133 percent of FPL but are lawfully present non-citizens ineligible for Medicaid, not otherwise eligible for minimum essential coverage. Expiration of enhanced PTC subsidies may affect BHP States' ability to implement, sustain, and expand their BHP programs, thereby impacting enrollment in these plans.
We also know that the enhanced PTC subsidies have resulted in major enrollment gains in the ACA markets over the last few years.
If enhanced PTC subsidies expire, we project that the total enrollment through FFEs and SBE-FPs would decrease at a similar rate as the Congressional Budget Office projections.
Lastly, we note that the expiration of enhanced PTC subsidies is not expected to decrease our FFE and SBE-FP budget estimates for operating the FFEs and SBE-FPs for the 2026 benefit year. This is because, while certain cost estimates would be expected to decrease with the expiration of enhanced PTC subsidies, such as printing and mailing of educational materials to enrollees and QHP certification, other costs and labor estimates would be expected to increase, such as the rate of eligibility appeal cases and inquiries to CMS Agent/Broker Marketplace Help Desks and Call Centers.
Despite the very high level of uncertainty discussed above, we maintain our interest in ensuring that we collect user fees at a rate that will allow us to sustain the operations of the FFEs. After considering the range of costs, premiums, and enrollment projections, and considering how enhanced PTC subsidies could have a notable impact on our FFE and SBE-FP user fee rates, we propose a 2026 user fee rate that will ensure adequate funding for FFE operations. The proposed 2026 benefit year FFE user fee rate, which is 2.5 percent of total monthly premiums, is greater than the 2025 benefit year fee rate of 1.5 percent of total monthly premiums. Based on our estimates, this proposed user fee rate would allow us to have sufficient funding available to fully fund user-fee-eligible FFE activities. We note that if any events occurring between this proposed rule and the final rule significantly change our estimated costs to operate the FFEs or the Federal platform, or our projections of premiums or enrollment, we may finalize FFE and SBE-FP user fee rates that differ from these proposed rates to reflect those changes.
We seek comment on the proposed 2026 benefit year FFE user fee rate and the alternative proposed 2026 benefit year FFE user fee rate range (with this range to be set at a single rate in the final rule) if the current or a higher level of enhanced PTC subsidies are extended through the 2026 benefit year by March 31, 2025, including whether March 31, 2025 provides issuers sufficient time to request rates and for States to review and approve rate requests.
In § 156.50(c)(2), we specify that an issuer offering a plan through an SBE-FP must remit a user fee to HHS, in the timeframe and manner established by HHS, equal to the product of the monthly user fee rate specified in the annual HHS notice of benefit and payment parameters for the applicable benefit year and the monthly premium charged by the issuer for each policy where enrollment is through an SBE-FP. SBE-FPs enter into a Federal platform agreement with HHS to leverage the systems established for the FFEs to perform certain Exchange functions and enhance efficiency and coordination between State and Federal programs. The benefits provided to issuers in SBE-FPs by the Federal government include use of the FFE information technology and call center infrastructure used in connection with eligibility determinations for enrollment in QHPs and other applicable State health subsidy programs, as defined at section 1413(e) of the ACA, and QHP enrollment functions under 45 CFR part 155, subpart E. The user fee rate for SBE-FPs is calculated based on the proportion of total FFE costs associated with Federal activities that provide SBE-FP issuers with special benefits, including costs that are associated with the FFE information technology infrastructure, the consumer call center
To calculate the proposed SBE-FP rates for the 2026 benefit year, we used the same assumptions related to contract costs, enrollment, and premiums as we used for the proposed FFE user fee rates. As we explained previously in this section, the user fee rate for SBE-FPs is calculated based on the proportion of the total FFE costs associated with Federal activities that provide SBE-FP issuers with special benefits, which we continue to estimate to be approximately 80 percent of total FFE costs. These FFE costs associated with Federal activities that provide SBE-FP issuers with special benefits include the costs associated with the FFE information technology infrastructure, the consumer call center infrastructure, and eligibility and enrollment services.
Based on this methodology, the proposed 2026 benefit year SBE-FP user fee rate of 2.0 percent of total monthly premiums is greater than the user fee rate of 1.2 percent of total monthly premiums that we established for the 2025 benefit year. The proposed user fee rate for SBE-FP issuers for the 2026 benefit year also includes assumptions about States transitioning from either the FFE model to an SBE-FP, or from an SBE-FP to a State Exchange for the 2026 benefit year, which impacts the SBE-FP enrollment projections.
As discussed in detail above, we believe that the 2026 benefit year is uniquely different due to the potential significant changes to our projections if enhanced PTC subsidies expire at the end of the 2025 benefit year as currently expected. Despite this uncertainty, we maintain our interest in ensuring that we collect user fees at a rate that will allow us to sustain the Federal platform operations for the SBE-FPs. For these reasons, we also propose an alternative SBE-FP user fee range between 1.4 percent and 1.8 percent of total monthly premiums if current or a higher level of enhanced PTC subsidies are extended through the 2026 benefit year by March 31, 2025, to be set at a single rate in the final rule.
We seek comment on the proposed 2026 benefit year SBE-FP user fee rate and the alternative proposed 2026 benefit year SBE-FP user fee rate range (with this range to be set at a single rate in the final rule) if the enhanced PTC subsidies are extended through the 2026 benefit year by March 31, 2025.
Section 1402 of the ACA requires issuers to provide CSRs to help make health care more affordable for eligible low- and moderate-income consumers who enroll in silver level QHPs offered through the individual market Exchanges, as well as eligible American Indian (AI)/Alaska Native (AN) consumers who enroll in QHPs at any metal level. Section 1402 further states that HHS will reimburse issuers for the cost of providing CSRs. Until October 2017, the Federal government relied on the permanent appropriation at 31 U.S.C. 1324 as the source of funds for Federal CSR payments to issuers. However, on October 11, 2017, the Attorney General of the United States provided HHS and the Department of the Treasury with a legal opinion indicating that the permanent appropriation at 31 U.S.C. 1324 cannot be used to fund CSR payments to issuers.
In response to the termination of CSR payments to issuers, State DOIs generally permitted or instructed their issuers to increase premiums only, or primarily, on silver-level QHPs, to compensate for the cost of offering CSRs, since the vast majority of eligible enrollees receiving CSRs are enrolled in silver plans. This rating practice is sometimes referred to as “silver loading” or “actuarial loading.” Our regulations permit certain plan-level adjustments to the index rate on which premiums are based that are actuarially justified pursuant to the single risk pool requirements at § 156.80, and many States, which are the traditional regulators of insurance and rating practices, have provided issuers with pricing guidance specific to unpaid CSRs. For enrollees in silver plans who receive PTCs, the increase in PTCs corresponding to the higher premium rates generally fully offsets the higher premiums that they would otherwise experience because of silver loading.
In the January 24, 2019
Since the cessation of CSR payments in 2017, States and issuers have asked us to clarify how the single risk pool rules at § 156.80 apply to actuarial loading. In guidance published in 2018, we stated that “[a] plan-level variation for the actuarial value and cost-sharing design of a plan is permitted under § 156.80(d)(2)(i). A health insurance issuer that offers a QHP may vary premium rates for the QHP based on the impact of the loss of anticipated Federal funding for CSR payments.”
Since we continue to receive questions about permissible actuarial loading practices, we affirm that silver-loading and broad-loading practices to increase premiums to offset amounts of unpaid CSRs that are permitted by State regulators are permissible under Federal law to the extent that they are reasonable and actuarially justified. We have long implemented section 1312(c) of the ACA by permitting issuers to vary premium rates for a particular plan from the market-wide adjusted index rate based on a limited set of actuarially justified plan-specific factors, including the actuarial value and cost-sharing design of the plan. For example, reasonable and actuarially justified silver loading practices reflect such a
As established in part 2 of the 2022 Payment Notice (86 FR 24238), for benefit years in which we are not making changes to the methodology to calculate the premium adjustment percentage, the required contribution percentage, and maximum annual limitations on cost sharing and reduced maximum annual limitation on cost sharing, we will publish these parameters in guidance annually starting with the 2023 benefit year. Therefore, because we are not proposing to change the methodology for calculating these parameters for the 2026 benefit year, these parameters are not included in this rulemaking, and we intend to publish these parameters in guidance no later than December 31, 2024.
We intend to revise the method for updating the AV Calculator, starting with the 2026 AV Calculator.
Section 2707(a) of the PHS Act and section 1302 of the ACA direct issuers of non-grandfathered individual and small group health insurance coverage, including QHPs, to ensure that plans meet a level of coverage, or metal tier, specified in section 1302(d)(1) of the ACA. Each level of coverage corresponds to an AV calculated based on the cost-sharing features of the plan. On February 25, 2013, HHS published the EHB Rule (78 FR 12834), implementing section 1302(d) of the ACA, which requires at subsection (d)(2)(A) that, to determine the level of coverage for a given metal tier, the calculation of AV be based upon the provision of EHB to a standard population. Section 156.135(a), as finalized in the EHB Rule, provides that an issuer must use the AV Calculator developed and made available by HHS for the given benefit year to calculate the AV of a health plan, subject to the exception in paragraph (b).
In the 2015 Payment Notice (79 FR 13744), we established at § 156.135(g) provisions for updating the AV Calculator in future plan years. We stated in the preamble of the 2015 Payment Notice that we intend to release a draft version of the AV Calculator and AV Calculator Methodology through guidance for public comment each plan year before releasing the final version. In that same rule, we noted that interested parties could submit feedback on changes to the AV Calculator, and that we would consult as needed with the American Academy of Actuaries and the National Association of Insurance Commissioners on changes to the AV Calculator.
In the 2017 Payment Notice (81 FR 12204), we reiterated this approach and amended § 156.135(g) to allow for additional flexibility in our approach and options for updating the AV Calculator each year, which include trend factor updates, algorithms changes, user interface changes, updates to the claims data and demographic distribution being used in the AV Calculator, and an update to the AV Calculator's annual limitation on cost sharing. We also stated that we intend to release the final AV Calculator for a respective plan year no later than the end of the first quarter of the preceding plan year.
Since this time, we have largely fulfilled this intention. However, we have received feedback that HHS should strive to release the final version of the AV Calculator even sooner, in anticipation of State filing deadlines. SBE-FPs have also provided feedback explaining that they could benefit from an earlier release of the final version of the AV Calculator to design standardized plan options that satisfy the AV de minimis ranges. We believe these requests are reasonable and that we can accommodate them in most years when there are no material changes between the draft and final versions of an AV Calculator for a respective plan year.
Therefore, we intend to revise the current method whereby HHS releases a draft version of the AV Calculator for a respective plan year through guidance for public comment and then releases the final version of the AV Calculator for that plan year no later than the end of the first quarter of the preceding plan year after considering any comments received. We intend to only release the single, final version of the AV Calculator for a respective plan year. Under this approach, we would still solicit public comments on the AV Calculator for a plan year generally, but we would only plan to incorporate this feedback into the development and release of the following plan year's AV Calculator, rather than to specifically inform the potential revision of the final version of the upcoming plan year's AV Calculator. This approach would allow HHS to release the final AV Calculator sooner. We anticipate that issuers would have the final version of the AV Calculator 3 to 6 months sooner than the end of the first quarter of the preceding plan year.
This approach would not sacrifice the quality of the AV Calculator. The stability and functionality of the AV Calculator has improved every year, and we believe there are diminishing returns to receiving public comments on specific versions of it at this time. This is particularly evident given that we receive fewer than 10 comments on average each year on the draft AV Calculator. In addition, since the first AV Calculator was released for PY 2014, we have never made substantive changes in a final version of the AV Calculator for a plan year based on comments received on the draft version for that plan year, though this feedback is valuable to HHS and informs our decisions to update the AV Calculator in subsequent plan years. This decision to not make substantive changes to the final version of the AV Calculator is also partly influenced by the limited timeframe HHS would have to make substantive changes to the final AV Calculator.
Thus, changes from the draft to the final version of the AV Calculator have historically only included non-substantive amendments to correct and clarify language in the AV Calculator Methodology or to add frequently asked questions to the AV Calculator User Guide. Since these changes have historically been so minor, we believe the time delay required to effectuate those changes and release the final AV Calculator by the end of the first quarter of the preceding plan year is less valuable to issuers than releasing the final version sooner. Under this approach, we would leave open the rare possibility that HHS could reissue another final version of the AV Calculator for a plan year if HHS discovers the AV Calculator contains an error that materially impacts the functionality or accuracy of that version of the AV Calculator. Although this has never happened to date, under the current framework of releasing both a
Under this approach, we would still seek public comment on the AV Calculator for a plan year generally and would still consult with the American Academy of Actuaries, as well as the National Association of Insurance Commissioners. We would consider this feedback for incorporation into the following year's AV Calculator.
In order to maximize the benefits of this approach, we intend to make this change effective starting with the release of the 2026 AV Calculator. We believe there will be minimal effect in effectuating this change with the 2026 AV Calculator because we intend to base the 2026 AV Calculator substantially on the final 2025 AV Calculator, and do not plan to make any material changes to it.
We seek comment on this approach.
HHS proposes to exercise its authority under sections 1311(c)(1) and 1321(a)(1)(B) of the ACA to make updates to its approach to standardized plan options for PY 2026. Specifically, we propose to make minor updates to the plan designs for PY 2026 to ensure these plans continue to have AVs within the permissible
Section 1311(c)(1) of the ACA directs the Secretary to establish criteria for the certification of health plans as QHPs. Section 1321(a)(1)(B) of the ACA directs the Secretary to issue regulations that set standards for meeting the requirements of title I of the ACA, which includes section 1311, for, among other matters, the offering of QHPs through such Exchanges.
Standardized options were first introduced in the 2017 Payment Notice (81 FR 12289 through 12293). These plan designs were updated in the 2018 Payment Notice (81 FR 94107 through 94112). The 2018 Payment Notice (81 FR 94118) also introduced the authority for HHS to differentially display these plans on
These plans were then discontinued in the 2019 Payment Notice (83 FR 16974 through 16975). However, the discontinuance was challenged in the United States District Court for the District of Maryland. On March 4, 2021, the court decided City of Columbus,
As a result, in part 3 of the 2022 Payment Notice (86 FR 24140, 24264), HHS announced its intent to engage in rulemaking under which it would propose to resume standardized plan options in PY 2023. President Biden's Executive Order on Promoting Competition in the American Economy (86 FR 36987) also directed HHS to implement standardized plan options to facilitate the plan selection process for consumers on the Exchanges. We thus reintroduced standardized plan option requirements in the 2023 Payment Notice (87 FR 27310 through 27322) to enhance the consumer experience, increase consumer understanding, simplify the plan selection process, combat discriminatory benefit designs that disproportionately impact disadvantaged populations, and advance health equity.
We made these requirements applicable to FFE and SBE-FP issuers offering QHPs in the individual market. We exempted FFE and SBE-FP issuers offering QHPs in the small group market as well as issuers in State Exchanges from these requirements. We also exempted issuers of QHPs in FFEs and SBE-FPs that were already required to offer standardized plan options under State action taking place on or before January 1, 2020, such as issuers in the State of Oregon,
In the 2023 Payment Notice (87 FR 27312), we finalized standardized plan options at the following metal levels: one bronze plan, one bronze plan that meets the requirement to have an AV up to 5 points above the 60 percent standard, as specified in § 156.140(c) (known as an expanded bronze plan), one standard silver plan, one version of each of the three income-based silver CSR plan variations, one gold plan, and one platinum plan. We did not finalize standardized plan options for the AI/AN CSR plan variations as provided for at § 156.420(b) given that the cost-sharing parameters for these plan variations are already largely specified.
In the 2023 Payment Notice (87 FR 27312), we finalized two sets of standardized plan options to accommodate different States' cost sharing laws. Specifically, the first set of standardized plan options applied to all FFE and SBE-FP issuers, except issuers in Delaware, Louisiana, and Oregon. The second set of standardized plan options applied only to issuers in Delaware and Louisiana to accommodate these two States' specialty prescription drug cost sharing laws.
We designed these standardized plan options to resemble the most popular QHP offerings that millions of consumers were already enrolled in by taking the following steps: selecting the most popular cost-sharing type for each benefit category; selecting enrollee-weighted median values for each of these benefit categories based on PY 2022 cost sharing and enrollment data; modifying these plans to ensure they were able to comply with State cost sharing laws; and decreasing the AVs for these plan designs to be at the floor of each AV
We also resumed the differential display of standardized plan options on
As such, web-brokers and QHP issuers have been required to differentially display standardized plan options in accordance with the requirements under § 155.205(b)(1) in a manner consistent with how standardized plan options were displayed on
In the 2024 Payment Notice (88 FR 25847 through 25855), we maintained a high degree of continuity with our approach to standardized plan options finalized in the 2023 Payment Notice. However, in contrast to the policy finalized in the 2023 Payment Notice, we finalized for PY 2024 and subsequent plan years to no longer include a standardized plan option for the non-expanded bronze metal level—primarily due to AV constraints and the infeasibility of designing such a plan. As such, we finalized standardized plan options for the following metal levels: one bronze plan that meets the requirement to have an AV up to 5 points above the 60 percent standard, as specified in § 156.140(c) (known as an expanded bronze plan), one standard silver plan, one version of each of the three income-based silver CSR plan variations, one gold plan, and one platinum plan.
We also removed the regulation text language stating that standardized plan options for the AI/AN CSR plan variations as provided for at § 156.420(b) were not required, to clarify that while issuers must, under § 156.420(b), continue to offer such plan variations based on standardized plan options, those plan variations would themselves not be standardized plan options based on designs specified in rulemaking.
In the 2025 Payment Notice (89 FR 26357 through 26362), we once more maintained a high degree of continuity with the approach to standardized plan options finalized in the 2024 Payment Notice. In particular, in accordance with § 156.201(b), we finalized standardized plan options for the same metal levels as in the 2024 Payment Notice. We again did not finalize standardized plan options for the AI/AN CSR plan variations as provided for at § 156.420(b) but continued requiring issuers to offer these plan variations for all standardized plan options offered. We once more finalized two sets of standardized plan options with the same sets of designs applying to issuers in the same sets of States as in the 2023 and 2024 Payment Notices.
We refer readers to the preambles to the 2023, 2024, and 2025 Payment Notices discussing § 156.201 (87 FR 27310 through 27322, 88 FR 25847 through 25855, and 89 FR 26357 through 26362, respectively) for more detailed discussions regarding our approaches to standardized plan options in previous plan years.
For PY 2026, we propose to continue following the approach finalized in the 2024 Payment Notice concerning standardized plan option metal levels, and to otherwise maintain a high degree of continuity with our approach to standardized plan options finalized in the 2023, 2024, and 2025 Payment Notices. We once more propose to make minor updates to the plan designs for PY 2026 to ensure these plans continue to have AVs within the permissible
We propose to maintain this high degree of continuity for several reasons. Primarily, we believe maintaining a high degree of continuity will reduce the risk of disruption for all involved interested parties, including issuers, agents, brokers, States, and enrollees. We continue to believe that making major departures from the standardized plan option designs finalized in the 2023, 2024, and 2025 Payment Notices could result in significant changes that may create undue burden for interested parties.
For example, we continue to believe that if the standardized plan options that we create vary significantly from year to year, those enrolled in these plans could experience unexpected financial harm if the cost sharing for services they rely upon differs substantially from the previous year. Ultimately, we continue to believe that consistency in standardized plan options is important to allow issuers and enrollees to become accustomed to these plan designs. As such, the proposed standardized plan options include only modifications to the deductibles and maximum out-of-pocket limits (MOOPs) for several metal levels, but do not otherwise include modifications to the cost sharing structures.
Although we propose to continue to maintain a high degree of continuity with our approach to standardized plan options in previous years, we propose to amend § 156.201 to add paragraph (c) to require an issuer that offers multiple standardized plan options within the same product network type, metal level, and service area to meaningfully differentiate these plans from one another in terms of included benefits, provider networks, and/or formularies.
This proposal is based in part on our experience with the meaningful difference standard, which was previously codified at § 156.298. The meaningful difference standard was introduced in the 2015 Payment Notice (79 FR 13813 through 13814), revised in the 2017 Payment Notice (81 FR 12312 and 12331), and subsequently discontinued and removed from the regulation in the 2019 Payment Notice (83 FR 17027). The meaningful difference standard was originally intended to enhance the consumer experience on
Under the original meaningful difference standard introduced in the 2015 Payment Notice (79 FR 13813 through 13814), a plan within a service area and metal tier would be considered meaningfully different from other plans if a reasonable consumer (the typical consumer buying health insurance coverage) would be able to identify at least one material difference among six key characteristics between the plan and other plans to be offered by the same issuer: (1) cost sharing; (2) provider networks; (3) covered benefits (including prescription drugs); (4) plan type (for example, HMO or PPO); (5) health savings account eligibility; and (6) self- only, non-self-only, or child-only plan offerings. Under the original standard, if HHS determined that the plan offerings at a particular metal level within a county were limited, plans submitted for certification at that metal level within that county were not subject to the meaningful difference requirement.
Under the meaningful difference standard revised in the 2017 Payment Notice (81 FR 12312 and 12331), a plan was considered to be “meaningfully different” from other plans in the same service area and metal level if the plan had at least one of the following characteristics: a difference in network ID; a difference in formulary ID; a
We propose a meaningful difference standard for PY 2026 and subsequent plan years at § 156.201(c) because several issuers in recent years have offered indistinguishable standardized plan options, and we believe issuers may continue to do so in future plan years partly because the number of non-standardized plan options that issuers can offer is limited in accordance with § 156.202(b). We do not believe it benefits consumers for issuers to offer identical standardized plan options, or standardized plan options that do not differ in meaningful ways, within the same product network type, metal level, and service area. In addition, permitting issuers to offer identical standardized plan options or standardized plan options that do not differ in meaningful ways runs counter to our goals of enhancing the consumer experience, increasing consumer understanding, and simplifying the plan selection process. Allowing issuers to offer duplicative standardized plan options could cause significant consumer confusion and unnecessary plan proliferation if the trend continues unabated.
As such, under this proposal, although issuers would continue to be permitted to offer multiple standardized plan options within the same product network type, metal level, and service area, these standardized plan options would be required to have meaningfully different benefit coverage, provider networks, and/or formularies. For the purposes of this proposed standard, for PY 2026 and subsequent plan years, we would consider a standardized plan option with a different product, provider network, and/or formulary ID to be meaningfully different, similar to the version of the standard from the 2017 Payment Notice.
In particular, in that rule, we explained that a plan within a service area and metal tier would be considered meaningfully different from other plans if a reasonable consumer (the typical consumer buying health insurance coverage) would be able to identify at least one material differences among several key characteristics between the plan and other plans to be offered by the same issuer. Provider networks and covered benefits (including prescription drugs) were included among the list of key characteristics that would result in a material difference between plans and a plan therefore being considered meaningfully different.
If an issuer submitted two standardized plan options within the same product network type, metal level, and service area both with the same products, provider networks, and formulary IDs, we would not certify both of these plans. For example, we anticipate that we would seek feedback from the issuer regarding which plan to certify, assuming the issuer meets all other certification requirements. We also note that for the purposes of this proposed standard, we would not consider differences in plan variant marketing names, the availability of different language access features, or the administration of the plan by different vendors in determining whether two or more standardized plan options are meaningfully different.
If this policy is finalized as proposed, we would monitor whether issuers are seeking certification of plans that technically meet this standard but are nearly identical. If we determined that issuers were attempting to circumvent this standard in this manner, we would consider proposing in future rulemaking a version of this meaningful difference standard that would require greater variation among plans beyond product, provider network, and/or formulary IDs. We note that we are not proposing such a standard for PY 2026 and subsequent plan years at this time because, assuming issuers do not attempt to circumvent this standard as explained above, we believe that that this proposed policy would likely be sufficient to ensure that issuers' standardized plan offerings support our goals of enhancing the consumer experience, increasing consumer understanding, and simplifying the plan selection process.
We seek comment on our proposed approach to standardized plan options for PY 2026, including amending § 156.201 to add paragraph (c).
We propose to exercise our authority under sections 1311(c)(1) and 1321(a)(1)(B) of the ACA to amend § 156.202(b) and (d) to properly reflect the flexibility that issuers have operationally been permitted since the introduction of non-standardized plan option limits to vary the inclusion of distinct adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage categories under the non-standardized plan option limit in accordance with § 156.202(c)(1) through (3).
Section 1311(c)(1) of the ACA directs the Secretary to establish criteria for the certification of health plans as QHPs. Section 1321(a)(1)(B) of the ACA directs the Secretary to issue regulations that set standards for meeting the requirements of title I of the ACA, which includes section 1311, for, among other things, the offering of QHPs through such Exchanges.
In the 2024 Payment Notice (88 FR 25855 through 25865), we finalized requirements under § 156.202(a) and (b) limiting the number of non-standardized plan options that issuers of QHPs can offer through Exchanges on the Federal platform (including SBE-FPs) to four non-standardized plan options per product network type (as described in the definition of “product” at § 144.103), metal level (excluding catastrophic plans), inclusion of dental and/or vision benefit coverage, and service area for PY 2024, and two for PY 2025 and subsequent years.
In the 2025 Payment Notice (89 FR 26362 through 26375), we finalized an exceptions process under § 156.202(d) and (e) permitting FFE and SBE-FP issuers to offer more than two non-standardized plan options per product network type, metal level, inclusion of dental and/or vision benefit coverage, and service area for PY 2025 and subsequent plan years, if issuers demonstrate that these additional non-standardized plans offered beyond the limit at § 156.202(b) have specific design features that would substantially benefit consumers with chronic and high-cost conditions and meet certain other requirements.
In the 2025 Payment Notice (88 FR 26365 through 26366), we also clarified that the example included in the 2024 Payment Notice that illustrated issuers' flexibility to vary the inclusion of dental and/or vision benefit coverage in accordance with § 156.202(c) under the non-standardized plan option limits at § 156.202(a) and (b) failed to properly distinguish between the adult and pediatric dental benefit coverage categories.
In particular, in the 2024 Payment Notice (88 FR 25858), we stated that for PY 2025, for example, an issuer would be permitted to offer two non-standardized gold HMOs with no additional dental or vision benefit coverage, two non-standardized gold HMOs with additional dental benefit coverage, two non-standardized gold HMOs with additional vision benefit coverage, and two non-standardized gold HMOs with additional dental and vision benefit coverage, as well as two non-standardized gold PPOs with no additional dental or vision benefit coverage, two non-standardized gold PPOs with additional dental benefit coverage, two non-standardized gold PPOs with additional vision benefit coverage, and two non-standardized gold PPOs with additional dental and vision benefit coverage, in the same service area.
However, in the 2025 Payment Notice, we clarified that in PY 2024, issuers had the ability to vary the inclusion of dental and/or vision benefit coverage (including varying the inclusion of the distinct adult and pediatric dental benefit coverage categories), such that issuers could offer plans in the manner reflected in table 13, below, instead of in the more limited manner reflected in the incomplete example in the 2024 Payment Notice.
In the 2025 Payment Notice, we affirmed that issuers continued to retain this flexibility for PY 2025 and subsequent years. We thus explained that under the non-standardized plan option limit of two for PY 2025 and subsequent years, if an issuer desired to offer the theoretical maximum number of non-standardized plans, and if that issuer varied the inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage in these plans in accordance with the flexibility provided for at § 156.202(c)(1) through (3), that issuer could offer a theoretical maximum of 16 plans in a given product network type, metal level, and service area in the manner demonstrated in table 13. Furthermore, we explained that if an issuer offered QHPs with two product network types (for example, HMO and PPO), that issuer could offer a theoretical maximum of 32 plans in a given metal level and service area in the manner demonstrated in table 13.
As such, we propose to amend the regulation text at § 156.202(b) and (d) to properly reflect the flexibility that issuers have been operationally permitted since we introduced non-standardized plan option limits to vary the inclusion of the distinct adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage under the non-standardized plan option limit at § 156.202(b) in accordance with § 156.202(c)(1) through (3) for PY 2025 and subsequent plan years.
In particular, we propose to amend § 156.202(b) to properly distinguish between adult dental benefit coverage at § 156.202(c)(1) and pediatric dental benefit coverage at § 156.202(c)(2), such that an issuer offering QHPs in an FFE or SBE-FP, for PY 2025 and subsequent plan years, is limited to offering two non-standardized plan options per product network type, as the term is described in the definition of “product” at § 144.103 of this subchapter, metal level (excluding catastrophic plans), and inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage (as defined in paragraphs (c)(1) through (3) of § 156.202), in any service area.
Consistent with our proposed amendment of § 156.202(b), we propose a conforming amendment to § 156.202(d) to provide that, for PY 2025 and subsequent plan years, an issuer may offer additional non-standardized plan options for each product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage (as defined in paragraphs (c)(1) through (3) of § 156.202), and service area if it demonstrates that these additional plans' cost sharing for benefits pertaining to the treatment of chronic and high-cost conditions (including benefits in the form of prescription drugs, if pertaining to the treatment of the condition(s)) is at least 25 percent lower, as applied without restriction in scope throughout the plan year, than the cost sharing for the same corresponding benefits in the issuer's other non-standardized plan option offerings in the same product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage, and service area.
We propose these modifications to align the regulation text of § 156.202(b) and (d) with the existing flexibility that issuers have been operationally permitted since the non-standardized plan option limit was introduced in the 2024 Payment Notice.
We seek comment on these proposed modifications.
Under § 156.235, we propose to conduct Essential Community Provider (ECP) certification reviews of plans for which issuers submit QHP certification applications in FFEs in States performing plan management functions effective beginning in PY 2026.
Section 1311(c)(1)(C) of the ACA directs HHS to establish by regulation certification criteria for QHPs, including criteria that require QHPs to include within health insurance plan networks those ECPs, where available, that serve predominately low-income, medically-underserved individuals. Federal ECP standards were first detailed in the Exchange Establishment Rule (77 FR 18310) and codified at § 156.235. ECP certification reviews under § 156.235 ensure medical QHP and stand-alone dental plan (SADP) issuers include in their provider networks a sufficient number and geographic distribution of ECPs, where available.
HHS has relied on State ECP certification reviews for the certification of QHPs in FFEs in States that perform plan management functions since PY 2015 due to system limitations in the Systems for Electronic Rates & Forms Filing (SERFF),
As a result of HHS' system design enhancements via MPMS, HHS is now able to collect ECP data directly from issuers in States performing plan management functions, enabling HHS to conduct ECP evaluations of each issuer's network. Starting with certification reviews for PY 2025, issuers seeking certification of plans as QHPs in FFEs, including in States performing plan management functions, can now enter their ECP data in the HIOS MPMS using the ECP user interface. Because ECP data can now be collected directly in MPMS from issuers applying for certification of plans as QHPs in FFEs in States performing plan management functions, HHS will now be able to independently review the ECP data for such issuers.
Now, the MPMS ECP user interface also allows issuers in FFEs, including in States performing plan management functions, to validate data before submission to their States, improving data submission to the State as well as providing HHS with each issuer's provider network. Therefore, HHS will now be able to assess validated ECP data, improving the accuracy and efficiency of the QHP certification process.
It was always HHS' intent to implement operational capabilities that would allow for more efficient and accurate ECP reviews. As a result, we propose to harness the flexibilities afforded by MPMS to conduct Federal ECP certification reviews of plans for which issuers submit QHP certification applications in FFEs in States that perform plan management functions beginning with certification reviews for PY 2026. This proposal would allow HHS to review, evaluate, analyze, and compare provider networks across various FFE States. HHS would also consider challenges FFE issuers face across various provider networks and ECP categories, such as provider shortages or facility closures. As proposed, issuers applying for certification of plans as QHPs in FFEs, including in States performing plan management functions, would be evaluated against the same requirements and standards. FFE issuers in States with limited plan management staff or resources would be given the same ECP support, guidance, and monitoring of ECP deficiencies as other FFE issuers.
This proposal would provide more consistent oversight of ECP data across all FFEs. Federal ECP reviews would help ensure all medical QHP and SADP issuers applying for certification of plans as QHPs in FFEs, including in States performing plan management functions, include sufficient provider networks. This proposal would allow HHS to strengthen ECP data integrity in the FFEs by validating all ECP data before they are submitted and displayed on the FFEs, thereby supporting consumer access to vitally important medical and dental services and health equity for low-income and medically underserved consumers.
We seek comment on this proposal.
We propose to share aggregated, summary-level Quality Improvement Strategy (QIS) information publicly on an annual basis beginning on January 1, 2026, with information QHP issuers submit during the PY 2025 QHP Application Period. We do not propose any revisions to the regulation text to codify this proposal.
Section 1311(c)(1)(E) of the ACA specifies that to be certified as a QHP for participation on an Exchange, each health plan must implement a QIS described in section 1311(g)(1) of the ACA. Section 1311(g)(1) of the ACA describes this strategy as a payment structure that provides increased reimbursement or other incentives for improving health outcomes of plan enrollees, and the implementation of activities to prevent hospital readmissions, improve patient safety and reduce medical errors, promote wellness and health, and reduce health and health care disparities. Section 1311(g)(2) of the ACA requires the Secretary to develop guidelines associated with the QIS in consultation with health care quality experts and interested parties, including periodic reporting to the applicable Exchange of the activities that the plan has conducted to implement the QIS, as described in section 1311(g)(3) of the ACA. In the 2016 Payment Notice (80 FR 10844 through 10845), we issued regulations at § 156.1130(a) and (c) to direct eligible QHP issuers to implement and report on their QIS for each QHP offered in an Exchange, and to submit data annually to evaluate compliance with the standards for a QIS in a manner and timeline specified by the Exchange, respectively.
The CMS National Quality Strategy,
Since 2017, we have been collecting QIS information from QHP issuers on the FFEs. Over the years, we have received feedback from issuers, States, and Technical Expert Panel representatives about the benefits of sharing QIS data more broadly to promote transparency, improve engagement of best practices across QHP issuers, and provide consumers with useful information about quality improvement efforts by QHP issuers on the FFEs. Therefore, recognizing the general interest in this information, and consistent with the general authority set forth in section 1701(a)(8) of the PHS Act,
We believe that this proposal would promote transparency of data and drive innovation and quality improvement across Exchanges. Sharing QIS data publicly would also strengthen alignment across CMS quality reporting and value-based incentive programs, including the MQI programs, and would encourage learning to inform best practices for quality improvement across Exchanges, QHP issuers, researchers, and health care quality communities. Additionally, we believe that this proposal would increase accountability for QHP issuers through transparency of quality improvement goals, encourage State Exchanges to share QIS information from their State Exchange issuers publicly, and support HHS' mission to achieve optimal health and well-being for all individuals.
We acknowledge there may be concerns related to the potential sharing of proprietary and/or confidential information. However, we do not intend to share confidential or proprietary information from a QHP issuer and would only share QIS data that is de-identified and in summary and aggregate form. We would maintain compliance with CMS privacy policies, and to address potential confidentiality concerns, we would carefully redact and omit confidential data when data are released aggregately and in a summary format.
We seek comment on this proposal. In particular, we seek comment on the types of QHP issuer QIS data to release in an annual report, on the proposed approach and timeline for release of a QIS summary report with aggregated QIS data, and other potential mechanisms to present QIS information publicly in a manner that is informative to issuers and consumers.
We propose to amend § 156.1220(a) to codify a second, new materiality threshold for HHS-RADV appeals,
An issuer has the opportunity to submit a request for reconsideration to contest its HHS-RADV second validation audit results (if applicable) or its error rate calculations in accordance with § 156.1220(a)(1)(vii) and (viii).
We believe the adoption of the proposed additional materiality threshold to codify a standard for when HHS would rerun HHS-RADV results is necessary and appropriate because HHS-RADV is unique in comparison to other ACA financial programs, such as APTC, where the outcome of a successful appeal only impacts the filing issuer because an issuer's amount of APTC does not impact other issuers.
To further explain the uniqueness of HHS-RADV, we want to compare the existing HHS-RADV appeal materiality threshold at § 156.1220(a)(2) to that of the EDGE data discrepancies in § 153.630(d)(2). Under § 153.630(d)(2), upon receipt of an EDGE data discrepancy, the impact is first analyzed by HHS, and the entirety of an impact must reach the materiality threshold in order for HHS to take further action. However, unlike HHS-RADV appeals that have the potential to impact the national HHS-RADV results, EDGE data discrepancies typically only impact the issuers at the State market risk pool level and therefore, they do not have the potential to trigger the same national level of adjustments that can be
Because an HHS-RADV appeal can impact national program benchmarks and the HHS-RADV results and HHS-RADV adjustments of issuers nationally, we believe that the adoption of this proposed additional materiality threshold to specify when HHS would rerun HHS-RADV results would help ensure stability of HHS-RADV results for all issuers. In particular, HHS-RADV adjustments to State transfers already occur 2 years after the end of the applicable benefit year. Rerunning HHS-RADV results in response to a successful appeal could occur years later depending on the complexity of the issues raised and whether the matter involves an informal hearing under § 156.1220(b) or a request for CMS Administrator review under § 156.1220(c). After the initial issuance of HHS-RADV adjustments, issuers generally have already closed their books for the applicable benefit year, and we are concerned that rerunning HHS-RADV results as a result of a successful HHS-RADV appeal that would not meet the proposed additional materiality threshold would require issuers to reopen their books years later, increasing burden and creating instability for issuers of risk adjustment covered plans to account for minor adjustments. In these situations, we are of the opinion that the benefit of the minor adjustment would be outweighed by the costs and burdens associated with rerunning HHS-RADV results to account for the additional minor adjustment to State transfers.
We also note that it is burdensome to HHS to rerun HHS-RADV results, especially in situations where there is a small financial impact. Because of the budget-neutral nature of the HHS-operated risk adjustment program, including HHS-RADV, the costs associated with rerunning HHS-RADV are passed onto the issuers in the form of the risk adjustment user fees. Therefore, we believe that creating an additional materiality threshold for rerunning HHS-RADV results recognizes that an appeal must have a meaningful financial impact to justify the costs and burdens to HHS and issuers of rerunning HHS-RADV results. This would balance the policy goals of ensuring that processing errors, the incorrect application of the relevant methodology, or mathematical errors in HHS-RADV that have a material impact are appropriately addressed, while minimizing burden on issuers and HHS and promoting the stability of State transfers by not rerunning HHS-RADV results when there would be minor adjustments. For all of these reasons, we propose to adopt an additional materiality threshold for HHS-RADV appeals to provide a standard for when HHS would rerun HHS-RADV results. To align with § 153.710(e), we propose to apply this materiality threshold for rerunning HHS-RADV results based on the financial impact on the filer as we believe that issuers submit HHS-RADV appeals with the expectation that their acceptance would meaningfully benefit them financially. Thus, we believe that structuring the threshold based on the financial impact on the filer would ensure that HHS-RADV results are being rerun in situations where the impact of the HHS-RADV appeal is meaningful to the issuer that triggered the process and would have a material impact on other issuers that participate in HHS-RADV in the applicable benefit year.
We also reaffirm under this proposed policy that if the impact of the appeal meets the proposed materiality threshold for rerunning HHS-RADV results (that is, greater than or equal to $10,000 to the filing issuer's HHS-RADV adjustments for the applicable benefit year), HHS would rerun the HHS-RADV results for that benefit year. However, if the impact of the appeal is less than proposed materiality threshold for rerunning HHS-RADV results (that is, less than $10,000 to the filing issuer's HHS-RADV adjustment), then HHS would take no further action. That is, HHS would not rerun HHS-RADV results or make any changes to the HHS-RADV adjustments for the filing issuer or other issuers that participated in HHS-RADV for that benefit year if the new proposed materiality threshold is not met.
We solicit comments on the proposed materiality threshold for rerunning HHS-RADV results, including the proposed dollar amount for the materiality threshold and whether that dollar amount should be a higher or lower dollar amount or subject to an annual inflation adjustment amount, as well as the proposed applicability of this threshold beginning with 2023 benefit year HHS-RADV.
We propose to amend § 158.103 by adding a definition of “qualifying issuer.” See subsection E.2 below for the discussion of this proposal.
We propose to amend § 158.140(b)(4)(ii) to allow qualifying issuers to not adjust incurred claims by the net payments or receipts related to the risk adjustment program for MLR reporting and rebate calculation purposes beginning with the 2026 MLR reporting year (MLR reports due in 2027). We also propose to amend § 158.240(c) to add an illustrative example of how qualifying issuers would calculate the amount of rebate owed to each enrollee to accurately reflect how such issuers would incorporate the net risk adjustment transfer amounts into the MLR and rebate calculations differently from other issuers, as well as to make a conforming amendment to clarify that the current illustrative example in paragraph (c)(2) would apply to issuers that are not qualifying issuers.
Section 2718 of the PHS Act and the implementing regulations at 45 CFR part 158 require health insurance issuers offering group or individual health insurance coverage to submit an annual report to the Secretary of HHS concerning their MLR and issue an annual rebate to enrollees if the issuer's MLR is less than the applicable MLR standard established in sections 2718(b)(1)(A)(i) and (ii) of the PHS Act. Under section 2718 of the PHS Act, an issuer's MLR is defined as the ratio of (a) incurred claims and quality improvement activity expenses, to (b) premium revenue after subtracting taxes and licensing and regulatory fees and accounting for payments or receipts for risk adjustment, risk corridors, and reinsurance under sections 1341 1342, and 1343 of the ACA. The statute also defines the total amount of an issuer's annual rebate as an amount equal to the product of the amount by which the applicable MLR standard exceeds the issuer's MLR, multiplied by the issuer's premium revenue after subtracting taxes and licensing and regulatory fees and accounting for payments or receipts for
In contrast, section 1342(c) of the ACA provides that allowable costs shall be reduced by any risk adjustment payments in the numerator of the risk corridors calculation.
While most commenters on the 2014 Payment Notice proposed rule (77 FR 73187) supported the proposal to treat premium stabilization program amounts as an adjustment to incurred claims in the numerator of the MLR calculation, some commenters noted that risk adjustment transfer amounts are calculated based on the statewide average premium in a market, and asserted that it would, therefore, be more appropriate to include risk adjustment transfer amounts as a net adjustment to earned premium in § 158.130, which is included in the denominator of the MLR calculation in § 158.221(c). We recognized the validity of both perspectives in the 2014 Payment Notice, noting that either approach could be implemented in accordance with the statutory requirements for the MLR calculation set forth in section 2718 of the PHS Act, and finalized the proposal to treat premium stabilization amounts as an adjustment to incurred claims in the numerator of the MLR calculation to ensure consistency between the MLR and the risk corridors programs.
We recognize that although we generally assume that plans are pricing for average risk, our experience has shown that some issuers with plans with especially high or low claims costs may not necessarily price their offerings commensurate to these costs. While treating risk adjustment transfer amounts as either an adjustment to incurred claims in the numerator of the MLR calculation or an adjustment to premiums in the denominator of the MLR calculation may not significantly impact issuers with claims costs and premiums ratios that approximate the MLR standard and that closely approximate average risk, if an issuer's plan offerings are significantly mispriced or if its earned premiums are influenced by external factors, such as State subsidies, such an issuer could be in a position of owing rebates that are a substantial portion of its premium under the current MLR calculation methodology, despite also incurring very high claims costs and receiving large risk adjustment payments. In rare cases, these high rebate amounts may result in solvency concerns for these types of issuers with very high-risk populations and high claims expenses.
While many complex factors influence an issuer's underwriting position, our internal analysis suggests that issuers with unusual business models characterized by ratios of risk adjustment payments to earned premium that are approximately 50 percent or higher may owe disproportionately large MLR rebates that could impact solvency. In these circumstances, we believe that the way the current MLR methodology functions is misaligned with one of the primary statutory goals of the program, which is to ensure that consumers receive value for their premium dollars, as issuers with especially high-risk populations spend a significant proportion of their revenue paying medical claims and may nonetheless also owe rebates that make continued operation in their current markets untenable. Consistent with section 2718(c) of the PHS Act, the standardized methodologies for calculating an issuer's MLR “shall be designed to take into account the special circumstances of smaller plans, different types of plans, and newer plans.” We believe that modifying the treatment of risk adjustment transfer amounts in the MLR and rebate calculations for these issuers such that these amounts have a net impact on the MLR denominator rather than on MLR numerator would mitigate the solvency and stability concerns for this small subset of issuers that offer different types of plans with unique business models. Specifically, this proposed change would support the viability of issuers that offer different types of plans with unique business models that focus on underserved communities with significant rates of serious health conditions and that may disproportionately rely on risk adjustment payments, as opposed to premiums, for revenue.
HHS has in the past exercised its authority under section 2718(c) of the PHS Act to take into account the special circumstances of different types of plans by providing adjustments to increase the MLR numerator for “mini-med” and “expatriate” plans,
Consistent with this approach, we propose to exercise our authority to account for the special circumstances of the small subset of issuers that offer different types of plans with unique business models that receive risk adjustment payments and that are unable to reduce premiums sufficiently to meet the MLR standard without risking insolvency (hereinafter referred to as “qualifying issuers”). We propose to exercise this authority to narrowly extend flexibility for the manner in which risk adjustment transfer amounts must be reported by these qualifying issuers. Specifically, we propose to amend § 158.103 to add a definition of “qualifying issuer” to mean an issuer whose ratio of net payments related to the risk adjustment program under section 1343 of the ACA to earned premiums prior to accounting for the net payments or receipts related to the risk adjustment, risk corridors, and reinsurance programs (as described in § 158.130(b)(5)) in a relevant State and market is greater than or equal to 50 percent. We also propose to modify § 158.140(b)(4)(ii) to no longer apply net risk adjustment receipts as an adjustment to the incurred claims amount that is used to calculate the MLR numerator defined in § 158.221(b) for such qualifying issuers. We do not propose to make any changes to the definition of premium revenue in § 158.130.
Under this proposal, we would modify the calculation of the MLR denominator and rebates as described in the 2014 Payment Notice such that for qualifying issuers, earned premium would account for net risk adjustment receipts by simply adding these net receipts to total premium, without subsequently subtracting them from adjusted earned premium. The effect of these proposed changes would be to remove these offsetting adjustments (the addition and the subtraction that offset each other) to earned premium in the MLR denominator and rebate calculations, such that these qualifying issuers' risk adjustment transfer amounts would have a net impact on the MLR denominator and rebate calculations in § 158.221(c) and § 158.240(c), respectively. We also propose to make a conforming amendment to § 158.240(c) to clarify that the existing illustrative example in paragraph (c)(2) would apply to issuers that are not qualifying issuers, and to add an illustrative example in a new paragraph (c)(3) of how qualifying issuers would determine the amount of rebate owed to each enrollee, to accurately reflect how qualifying issuers would incorporate the net risk adjustment transfer amounts into the MLR and rebate calculations differently from other issuers.
We note that we are not proposing any changes that would alter the current treatment of Federal transitional reinsurance amounts in the MLR formula. Section 2718 of the PHS Act specified that Federal transitional reinsurance amounts under section 1341 of the ACA be accounted for in the denominator of the MLR calculation, while the Federal transitional reinsurance program expired after the 2016 benefit year, audit activities continue
We additionally note that HHS no longer collects charges or makes payments to issuers for the temporary Federal risk corridors program established in section 1342 of the ACA, which expired after the 2016 benefit year, and that therefore, the policy goal of aligning similar components in the risk corridors and MLR calculation no longer exists.
In sum, we propose that for qualifying issuers, risk adjustment transfer amounts would be a net adjustment to the denominator, rather than the numerator, of the MLR calculation as follows:
For a qualifying issuer whose MLR falls below the minimum MLR standard in a State and market, we propose to calculate the MLR rebate in § 158.240(c) as follows:
We note that, under this proposal, the proposed alternate MLR and rebate methodologies would only apply to qualifying issuers. For all other issuers, the current MLR and rebate methodologies codified at § 158.140 and § 158.240 would continue to apply. We propose that these amendments would be applicable beginning with the 2026 MLR reporting year (MLR reports due in 2027), in order to enable issuers that are or may be able to meet the definition of qualifying issuer to reflect the amendments in their premium rates.
We request comment on all aspects of this proposal. Specifically, we request comment on the definition of “qualifying issuer,” and whether issuers should satisfy additional criteria to qualify for this flexibility. We also request comment on whether the proposed alternate MLR and rebate methodologies that would apply to qualifying issuers would create any inappropriate incentives for issuers that are unable to accurately price their products or reduce administrative costs. Finally, we request comment on impacts to other issuers that are not “qualifying issuers” and potential market distortions that may arise if the proposed flexibility for MLR and rebate calculations is not extended to all issuers in applicable markets.
We are also considering an alternative approach that would modify § 158.140(b)(4)(ii) to no longer apply net risk adjustment receipts as an adjustment to the incurred claims amount that is used to calculate the MLR numerator defined in § 158.221(b) for all issuers subject to MLR requirements, which, as noted above, we believe to be consistent with the construction of the MLR formula in section 2718 of the PHS Act. Under this alternative approach, we would not make any changes to the definition of premium revenue in § 158.130, or to the regulatory treatment of Federal reinsurance or risk corridors in the MLR formula. Similar to the proposal above, under this alternative approach, we would modify the calculation of the MLR denominator and rebates as described in the 2014 Payment Notice such that for all issuers, earned premium would account for net risk adjustment receipts by simply adding these net receipts to total premium, without subsequently subtracting them from adjusted earned premium. The effect of this alternative approach would be that risk adjustment transfer amounts would have a net impact on the MLR denominator and rebate calculations in § 158.221(c) and § 158.240(c), respectively. This alternative approach would allow us to streamline MLR reporting in light of the expiration of the risk corridors program after the 2016 benefit year. In addition, this alternative approach would align MLR with the accounting approach used for risk adjustment transfers in State financial reporting, which accounts for these amounts in premium.
Under this alternative approach, risk adjustment transfer amounts would be a net adjustment to the denominator, rather than the numerator, of the MLR calculation, for all issuers, as follows:
For an issuer whose MLR falls below the minimum MLR standard in a State and market, we would calculate the MLR rebate in § 158.240(c) as follows:
We believe that both the proposal and the alternative approach present a valid means of accounting for the impact of premium stabilization program amounts in the MLR and rebate calculations. Because most issuers are above the threshold for paying MLR rebates, we do not believe that the alternative approach would materially impact rebate payments for most issuers. However, for some issuers that are either below or close to the MLR standard, the alternative approach could result in larger rebate payments, particularly for issuers that owe risk adjustment charges and that have plan designs that result in premiums that are lower than the market average. We recognize the possibility that some of these issuers may further adjust premiums in response to this alternative approach if it were finalized. We are not proposing this alternative approach as we believe that the more narrow, tailored proposal to provide this flexibility only for qualifying issuers is sufficient to maximize availability of coverage options while remaining consistent with the statutory objective of section 2718 of the PHS Act, which is to ensure that consumers receive value for their premium dollars. The more narrow, tailored proposal would also produce a smaller reduction in rebate payments to consumers than the alternative approach and would cause less disruption to the industry.
We request comment on all aspects of this alternative approach, including on ways that this alternative approach could potentially influence issuers' rebate positions, plan composition, and pricing decisions. Finally, we request comment on potential impacts of this alternative approach on consumers.
As demonstrated by the number of distinct programs addressed in this rulemaking and the structure of this proposed rule in addressing them independently, HHS generally intends the rule's provisions as finalized to be severable from each other. For example, the proposed rule outlines proposed payment parameters and provisions for the HHS-operated risk adjustment and data validation programs, 2026 user fee rates for issuers in these programs, and changes to the BHP payment calculations. It includes proposed modifications to the initial and second validation audit processes and addresses HHS' authority to take enforcement action against lead agents at insurance agencies for violations of HHS' Exchange standards and requirements. The rule also addresses certification standards, ECP reviews, public sharing of aggregated, summary-level QIS information on an annual basis, and proposed revisions to the MLR reporting and rebate requirements for qualifying issuers that meet certain standards. It is HHS' intent that if any provision of these proposed rules, if finalized, is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, the rule shall be construed so as to continue to give maximum effect as permitted by law, unless the holding shall be one of utter invalidity or unenforceability. In the event a provision as finalized is found to be utterly invalid or unenforceable, HHS intends that that provision to be severable.
Under the Paperwork Reduction Act of 1995, we are required to provide a 60-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of the agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs).
To derive wage estimates, we generally use data from the Bureau of Labor Statistics to derive average labor costs (including a 100 percent increase for the cost of fringe benefits and overhead) for estimating the burden associated with the ICRs.
As indicated, employee hourly wage estimates have been adjusted by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly across employers, and because methods of estimating these costs vary widely across studies. Nonetheless, there is no practical alternative, and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.
Beginning with the 2025 benefit year of HHS-RADV, we propose to exclude enrollees without HCCs from the IVA sampling methodology, to remove the FPC from IVA sampling,
These proposals are intended to improve the validity of our IVA sampling assumptions and sampling precision and would decrease burden on issuers when implemented in combination. As noted in section III.B.6 of this rule, the proposed changes to the IVA sampling methodology would result in increased sample sizes for some smaller issuers that are subject to the FPC and assigned IVA sample sizes less than 200 enrollees under the current methodology. However, sample size is not necessarily indicative of issuer burden in HHS-RADV, as the driving factor of burden is the number of enrollee medical records that must be retrieved and reviewed for the IVA sample. Overall, the proposed IVA sampling methodology in this rule alters the allocation of strata sample sizes within the IVA sample, ultimately resulting in relatively fewer enrollees from medium or high-risk strata, who have more medical records to review, being selected for the IVA sample. Consequently, under these proposed changes, the average number of medical records reviewed per enrollee in the IVA sample and the total number of medical records reviewed per issuer would decrease.
The currently approved information collection (OMB Control Number 0938-1155/Expiration April 30, 2025) for conducting the IVA takes into account that the issuer must review the IVA sample and determine which enrollees will require medical records to validate their HCCs and details the processes the issuer must undertake to obtain medical records for their enrollees selected for the IVA sample. In the currently approved information collection, we estimate an upper limit of 650 issuers submitting samples of 200 enrollees for HHS-RADV for any given benefit year, five medical record requests per enrollee in the IVA sample size and three HCCs to be reviewed by a certified medical coder per enrollees with HCCs, which leads to an aggregate burden of conducting IVAs of approximately 1,663,729 hours and $116,963,821.
For our monetary and hourly burden estimates, we are incorporating labor and wage costs from the most recent premium stabilization programs information collection, “Standards Related to Reinsurance, Risk Corridors, Risk Adjustment, and Payment Appeals” (OMB Control Number 0938-1155/Expiration April 30, 2025). Based on an analysis that applies the proposed changes to remove enrollees without HCCs from IVA sampling, remove the FPC, and use HHS-RADV data in the Neyman allocation beginning with 2025 benefit year HHS-RADV, approximately 200 enrollees in an issuer sample will require medical records to validate HCCs, with approximately two medical record requests per enrollee (approximately 400 medical record requests per issuer) if these policies are finalized as proposed.
Based on a review of enrollee-level EDGE data for the 2017-2021 benefit years and the proposed changes to the IVA sampling methodology in this rule, we have determined that for enrollee with HCCs, the average number of HCCs to be reviewed by a certified medical coder per enrollee would be approximately two HCCs if these policies are finalized as proposed. Additionally, based on HHS-RADV audit experience, we estimate that it may cost approximately $272.52 ($60.56 per hour for 4.5 hours on average) for a certified medical coder to review the medical record documentation for one enrollee with roughly two HCCs. For 200 enrollees with HCCs in an issuer's IVA sample, the total cost to each issuer would be $54,504 (for 900 hours). In some cases, a secondary review by a senior certified medical coder (occupation title “Health Information Technologists and Medical Registrars” at an hourly wage rate of $60.56 per hour) will be needed to re-review approximately one-third of the medical record documentation required during the first review. Thus, a senior certified medical coder would need to review medical documentation for the equivalent of approximately 66 enrollees with HCCs in an issuer sample. We estimate that the total cost to each issuer would be approximately $17,986.32 ($60.56 per hour for 4.5 hours per enrollee). For this review and secondary review, the total cost to each issuer would be approximately $72,490.32 (1,197 total hours).
These proposals will not affect the review of demographic and enrollment information, as we will continue to validate demographic and enrollment information for a subsample of up to 50 enrollees from the audit sample, or the RXC review, as the audit entity must review RXCs for all adult enrollees in the audit sample with at least one RXC, and we continue to assume that an IVA will be performed on approximately 50 RXCs per issuer. As such, we are only changing our burden estimates of demographic and enrollment or RXC review to update the most recent BLS' median hourly wage estimates. We estimate that it may cost approximately $20.19 per enrollee ($60.56 per hour for 20 minutes) to validate demographic information for 50 enrollees in each audit sample totaling $1,009.33 per issuer. Similarly, we estimate that RXC validation for 50 enrollees would cost approximately $20.19 per RXC ($60.56 per hour for 20 minutes), totaling $1,009.33 per issuer. In addition, for each issuer, we expect it would require a compliance officer working 40 hours at $72.76 per hour, and 2 operations managers working a total of 80 hours at $97.38 per hour to make available to external medical coders associated with the initial validation audit entity claims documents for review of demographic information and RXC review (120 hours at a combined cost of $10,701).
For each issuer submitting audit findings for HHS-RADV in a given benefit year, the total burden for reporting, coding, and administration would be approximately 1,750.33 hours at a cost of $115,817.79 per issuer. For an estimated 600 issuers required to submit audit findings for HHS-RADV for any given benefit year, we anticipate that the aggregate burden of conducting IVAs will be approximately 1,050,200 hours and $69,490,672 beginning in 2025. This reflects an aggregate burden decrease of 613,529 hours and $47,473,149 from the existing aggregate burden estimate of approximately 1,663,729 hours and $116,963,821.
We seek comment on this proposal and the estimated burdens discussed above.
This proposal addresses HHS' authority to engage in compliance reviews of and take enforcement action against lead agents of insurance agencies in both FFE and SBE-FP States for misconduct or noncompliant activity at the agency level. We are not proposing any changes to regulations as the current regulatory framework and definitions supports this approach. Furthermore, this proposal only envisions collecting agency-level documentation, including but not limited to, training manuals, onboarding material, and marketing materials, from lead agents, in addition to the existing documentation collection
We seek comment on these assumptions.
This proposal would expand HHS' authority to suspend Exchange system access for agents and brokers under § 155.220(k)(3) to also include situations that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations or Exchange applicants or enrollees, including but not limited to risk related to noncompliance with the standards of conduct under § 155.220(j)(2)(i), (ii) or (iii) or the privacy and security standards at § 155.260, until the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction. Since this proposal would entail providing an opportunity for agents and brokers to submit evidence and information to demonstrate that the circumstances of the incident, breach, or noncompliance has been remedied or sufficiently mitigated to HHS' satisfaction, it would involve collecting documents from agents and brokers whose system access has been suspended. Depending on the circumstances leading to the system suspension, we anticipate receiving documentation of consumer consent and/or review and confirmation of the accuracy of the Exchange eligibility application information and assessing whether the documentation complies with § 155.220(j)(2)(ii) and (iii) for consumers cited in the suspension notice from agents and brokers we system suspend under § 155.220(k)(3). The system suspension authority in § 155.220(k)(3) is part of HHS' oversight and enforcement framework applicable to agents and brokers who participate in the FFEs and SBE-FPs. Therefore, this collection would fall under 5 CFR 1320.4(a)(2), stating collections of information “. . . during the conduct of an [. . .] investigation” are exceptions to the ICR requirements.
We seek comment on these assumptions.
We are proposing amendments to the Model Consent Form created as part of the 2024 Payment Notice (88 FR 25809 through 25811). The existing Model Consent Form only provides a template for meeting the consent documentation and retention requirements of § 155.220(j)(2)(iii)(A)-(C). We are proposing to update that Model Consent Form to also include a template to meet the requirements under § 155.220(j)(2)(ii), which requires agents, brokers, and web-brokers to document that eligibility application information has been reviewed by and confirmed to be accurate by the consumer or their authorized representative prior to submission of the application to the FFE or SBE-FP. This proposal would only update the optional Model Consent Form that was created as part of the 2024 Payment Notice and adopted on June 30, 2023. The 2024 Payment Notice
The proposed Model Consent Form would also include scripts agents, brokers, or web-brokers could utilize to meet the consumer consent and eligibility application review requirements finalized in the 2024 Payment Notice requirements when assisting consumers via an audio recording. The scripts would ensure agents, brokers, or web-brokers having verbal, recorded conversations with consumers discuss all the regulatory requirements with consumers. We do not anticipate these scripts would increase burden on any assisting agent, broker, web-broker or consumer as no regulatory requirements have been changed. As agents, brokers, and web-brokers should already be complying with these requirements, no additional costs would be borne by the agent, broker, or web-broker if using the updated Model Consent Form scripts. The scripts are merely meant to provide agents, brokers, and web-brokers guidance and clarification on how the consent documentation and eligibility application review documentation requirements can be met when having a verbal, recorded conversation with a consumer. The proposed scripts in the updated Model Consent Form are not mandatory and are not intended to limit or otherwise impact the agent, broker, or web-broker's ability to answer consumer questions about plan selection or other matters.
Finally, there is no anticipated increase in documentation collection burden on HHS based on the updated model consent form. We currently request documentation of consumer consent and eligibility application review for compliance reviews and, assuming agents, brokers, and web-brokers used the updated model consent form, that would not meaningfully impact the documentation collection or review by HHS.
If this proposal is finalized, the updated Model Consent Form discussed in this section would be submitted for OMB review and approval in the amended PRA package (OMB Control Number 0938-1438/Expiration date: June 30, 2026). We seek comment on these assumptions.
We are proposing to amend current regulation at § 155.305(f)(4) under which an Exchange needs to provide notification to either an enrollee or their tax filer (or both) who have been identified as having failed to file their Federal income taxes and reconcile their APTC after two consecutive tax years. This provision is not associated with an ICR under 5 CFR 1320.3(c) and not subject to the requirements of the PRA. We anticipate that the proposed amendment will not impact the information collection (OMB Control Number 0938-1207) burden for Exchanges.
As discussed in the preamble of this rule, we intend to increase transparency into Exchange operations by publishing annual State Exchange and SBE-FP SMARTs, programmatic and financial audits, Blueprint applications, and additional data points in the Open Enrollment (OE) data reports. We estimate that there will be no additional costs or burdens on Exchanges associated with this proposal since this data is already collected through the Blueprint application (OMB Control Number: 0938-1172), SMART (OMB Control Number: 0938-1244), and Enrollment Metrics PRA (OMB Control Number: 0938-1119).
The proposal to conduct ECP certification reviews of plans for which issuers submit QHP certification applications in FFEs in States performing plan management functions effective beginning in PY 2026 continues our ECP data collection as permitted under the currently approved information collection (OMB Control Number: 0938-1187/Expiration date: June 30, 2025).
To satisfy the ECP requirement under § 156.235, medical QHP and SADP issuers must complete and submit ECP data as part of their QHP application, in which they must list the names and geographic locations of ECPs with whom they have contracted to provide health care services to low-income, medically underserved individuals in their service areas. These issuers must contract with a certain percentage, as determined by HHS, of the available ECPs in the plan's service area. This proposal, if finalized, would not significantly change the burden currently approved under OMB Control Number 0938-1415,
There is no information collection associated with this proposal and no changes are proposed to the QIS data collection requirements applicable to QHP issuers. QIS data collection from QHP issuers to the Exchange has been approved under OMB Control Number 0938-1286.
We propose to add a definition of “qualifying issuer” to § 158.103, amend § 158.140(b)(4)(ii) to no longer adjust incurred claims by the net payments or receipts related to the risk adjustment program for MLR reporting and rebate calculation purposes for qualifying issuers, make conforming amendments to the rebate calculation example in § 158.240(c)(2), and add § 158.240(c)(3) to provide a rebate calculation example for qualifying issuers. To the extent issuers currently report their risk adjustment transfer amounts on their Annual MLR Reporting Form(s), we do not expect there to be any impact on the reporting burden, as the affected issuers would continue to report the same risk adjustment transfer amounts but would include them on different lines of the MLR Annual Reporting Form. The burden related to this information collection is currently approved under OMB Control Number: 0938-1164.
We have submitted a copy of this proposed rule to OMB for its review of the rule's information collection and recordkeeping requirements. These requirements are not effective until they have been approved by the OMB.
To obtain copies of the supporting statement and any related forms for the proposed collections discussed above, please visit CMS' websit
We invite public comments on these potential information collection requirements. If you wish to comment, please submit your comments electronically as specified in the
ICR-related comments are due [
Because of the large number of public comments we normally receive on
This proposed rule includes payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation programs, as well as 2026 user fee rates for issuers offering QHPs through FFEs and SBE-FPs. This proposed rule also includes proposed requirements related to modifications to the calculation of the BHP payment, changes to the IVA sampling approach and SVA pairwise means test for HHS-RADV, as well as proposed compliance reviews of and enforcement action against lead agents, proposed updates to the Model Consent Form, the authority for HHS to suspend agent and broker access to Exchange systems, consumer notification requirements, and proposed standards for an issuer to request the reconsideration of denial of certification as a QHP specific to the FFEs, proposed changes to the approach for conducting ECP certification reviews of plans for which issuers submit QHP certification applications in FFEs in States performing plan management functions, and proposed revisions to the MLR reporting and rebate requirements for qualifying issuers.
We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), Executive Order 14094 entitled “Modernizing Regulatory Review” (April 6, 2023), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999).
Executive Orders 12866 and 13563 direct agencies to assess all 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). The April 6, 2023 Executive Order on Modernizing Regulatory Review
A regulatory impact analysis (RIA) must be prepared for significant rules. OMB's OIRA has determined that this rulemaking is “significant” as measured by the $200 million threshold under section 3(f)(1). We have prepared an RIA that to the best of our ability presents the costs and benefits of the rulemaking. OMB has reviewed these proposed regulations, and the Departments have provided the following assessment of their impact.
As required by OMB Circular A-4 (available at
This proposed rule implements standards for programs that would have numerous effects, including providing consumers with access to affordable health insurance coverage, reducing the impact of adverse selection, and stabilizing premiums in the individual and small group health insurance markets and in Exchanges. We are unable to quantify all the benefits and costs of this proposed rule. The effects in table 16 reflect qualitative assessment of impacts and estimated direct monetary costs and transfers resulting from the provisions of this proposed rule for health insurance issuers and consumers. The annual monetized transfers described in table 17 include changes to costs associated with the risk adjustment user fee paid to HHS by issuers.
The aggregate economic impact of these proposed changes to the BHP payment methodology is estimated to be $0 in transfers for calendar year 2026 and all subsequent years. For the purposes of this analysis, we have assumed that two States would operate BHPs in 2026 since currently only two States operate BHPs, and we do not assume any more States would do so.
For the States currently operating BHPs, we do not anticipate these proposed changes to the payment methodology would affect future payments. We expect that these States would have fully implemented programs by 2026, and thus these proposed changes would not change the value of the PAF used in the payment
We are proposing the incorporation of PrEP into the HHS risk adjustment adult and child models as part of a new proposed class of factors that reflect the costs associated with care that is not related to active medical conditions. This proposed class of factors, called the Affiliated Cost Factors (ACFs), which are detailed in the preamble discussion under 45 CFR part 153, will not result in any additional reporting burden for issuers. Because it will have some impact on risk adjustment State transfers, some issuers' State transfers will be impacted, either in a positive or in a negative manner, consistent with the budget-neutral nature of the HHS-operated risk adjustment program. As HHS is responsible for operating the risk adjustment program in all 50 States and the District of Columbia, we do not expect these policies to place any additional burden on State governments. The proposed model specifications in this rule result in limited changes to the number and type of risk adjustment model factors; therefore, we do not expect these changes to impact issuer burden beyond the current burden for the HHS-operated risk adjustment program. This proposal will help mitigate risk of adverse selection for coverage of PrEP users, resulting in increased health equity among this population.
Under § 153.630(b), we are proposing several changes to the IVA sampling methodology. Beginning with the 2025 benefit year of HHS-RADV, we propose to exclude enrollees without HCCs (enrollees in stratum 10 without HCCs nor RXCs and RXC-only enrollees in strata 1 through 3) from IVA sampling, remove the FPC such that issuers with 200 or more enrollees in strata 1 through 9 would have IVA sample sizes of 200 enrollees and issuers with less than 200 enrollees in strata 1 through 9 would have IVA sample sizes equal to their EDGE population of enrollees with HCCs, and change the source of the Neyman allocation data used to calculate the standard deviation of risk score error from MA-RADV data to the 3 most recent consecutive years of HHS-RADV data with results that have been released before that benefit year's HHS-RADV activities begin, beginning with benefit year 2025 HHS-RADV.
Although issuers are already required to provide the IVA Entities with all documentation necessary to complete HHS-RADV, the proposed changes to the IVA sample would ensure all enrollees in the IVA sample have at least one HCC on EDGE and therefore would have associated medical records that would need to be submitted. In the Collection of Information section of this proposed rule, we estimate the decrease in administrative burden that would result from the proposals to modify the IVA sample as the average number of medical records reviewed per enrollee in the IVA sample and the average number of medical records reviewed per issuer would decrease. We estimate that the aggregate burden of conducting IVAs would be approximately 1,050,200 hours and $69,490,672 beginning with 2025 benefit year HHS-RADV, which is an aggregate burden decrease of 613,529 hours and $47,473,149 from the existing aggregate burden estimate of approximately 1,663,729 hours and $116,963,821. We believe that these proposed changes to the IVA sampling methodology would result in more precise HHS-RADV results which are used to adjust risk scores and associated risk adjustment State transfers. While this could affect the adjustments to risk adjustment State transfers for an individual issuer, we do not expect an impact on aggregate risk adjustment State transfer adjustments because of the proposed modifications to the IVA sampling methodology.
We propose to modify the pairwise means test to use a 90 percent confidence interval bootstrapping methodology and to increase the initial SVA subsample size from 12 enrollees to 24 enrollees beginning with 2024 benefit year HHS-RADV. Because issuers are already required to provide the IVA and SVA Entities with all documentation necessary to complete the audits, the proposed changes to the pairwise means test that would increase the initial SVA subsample size to 24 enrollees and transition to a bootstrapping methodology using a 90 percent confidence interval would not directly increase burden on issuers. We believe that these proposed changes would increase the burden and costs to the Federal government of conducting the SVA. We estimate that increasing the initial SVA sample size from 12 to 24 enrollees would increase the annual costs of SVA medical review by approximately $1.5 million and that transitioning from the current t-test pairwise means testing procedure to a bootstrapped procedure would increase the annual cost of SVA medical review by approximately $500,000 as more issuers would be expanded to larger SVA sample sizes under a more sensitive pairwise means testing procedure. In addition, there would be a one-time cost of approximately $250,000 to code these modifications to the existing SVA pairwise means test in the Audit Tool. Any increase in SVA costs would increase the costs to the Federal government associated with HHS-RADV program activities, which are covered through the risk adjustment user fees that are charged to issuers. While issuers would indirectly cover these costs through the risk adjustment user fee, we do not anticipate that this policy alone would increase the risk adjustment user fee as the costs are relatively small compared to the entirety of the budget to operate the HHS-operated risk adjustment program. We believe that the benefits from improving the SVA process for validating the IVA results and determining the appropriate audit results to use in error estimation would outweigh the increased costs to the Federal government and better ensure the integrity of the risk adjustment program.
As discussed in the preamble to this proposed rule, we address our authority to investigate, engage in compliance reviews of, and take enforcement actions against lead agents of insurance agencies who are engaging in potential misconduct or noncompliant behavior or activities in FFE and SBE-FP States. This would better align our oversight and enforcement approach with how States regulate agencies. This would also ensure enhanced consumer protections from agency-level misconduct or noncompliance facilitated at the agency level, which similarly impacts consumers negatively as misconduct or noncompliance by individual agents, brokers, and web-brokers. This proposal is also designed to reduce consumer harm associated with unauthorized enrollments or bad-
This proposal is also designed to reduce consumer harm associated with unauthorized enrollments or unauthorized plan switches which can lead to the consumer receiving a DMI. Upon application submission, certain consumer data is checked against trusted data sources to ensure a match between what is in the application submission and the information HHS receives from the trusted data source(s). If the trusted data source does not have the consumer data or the data is inconsistent with the information provided on the application, a DMI is generated. A non-exhaustive list of DMIs include the Annual Income DMI, Citizenship/Immigration DMI, and American Indian/Alaskan Native Status DMI. Certain DMIs may lead to loss of Exchange coverage, including a Citizenship/Immigration DMI, which occurs when the consumer is unable to verify an eligible citizenship or lawful presence status.
We believe the impact related to the proposed changes to § 155.220(k)(3) would be positive. The proposed changes would allow HHS to take swift action for misconduct and noncompliance with existing standards and requirements by expanding the bases on which § 155.220(k)(3) system suspensions may be implemented. This proposal would enhance consumer protection and promote program integrity by allowing HHS to immediately suspend an agent's or broker's access to Exchange systems when HHS discovers circumstances that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems, including but not limited to risk related to noncompliance with the standards of conduct under § 155.220(j)(2)(i), (ii) or (iii) or the privacy and security standards at § 155.260, until the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction. This would help reduce future consumer harm by allowing HHS to quickly suspend system access for agents or brokers who are engaged in misconduct or noncompliant behavior that impacts Exchange consumers, operations, and systems. This proposal would also increase transparency by informing agents and brokers of the full suite of HHS enforcement actions that may be leveraged in response to noncompliance or misconduct, which may help curb such activities and behaviors. We do not anticipate negative feedback from the entities impacted by this, such as agents and brokers, as these changes are meant to more quickly system suspend bad-acting agents and brokers. This would help build consumer trust in compliant agents and brokers who work with consumers on the FFEs and SBE-FPs.
We are proposing to update the Model Consent Form to include a section that agents, brokers, and web-brokers assisting with and facilitating enrollment through FFEs and SBE-FPs or assisting an individual with applying for APTC and CSRs for QHPs can use to document that eligibility application information has been reviewed by and confirmed to be accurate by the consumer or their authorized representative prior to application submission in a manner that complies with § 155.220(j)(2)(ii)(A)(1)-(2). We are also proposing to update the Model Consent Form to include scripts agents, brokers, and web-brokers could use when meeting the requirements codified at § 155.220(j)(2)(ii)(A) and (j)(2)(iii)(A)-(C) via an audio recording.
These proposals would update the optional Model Consent Form that was created as part of the 2024 Payment Notice and adopted on June 18, 2023. The 2024 Payment Notice (88 FR 25890 through 25892) considered the additional time it would take to process and submit each consumer's eligibility application and those assumptions remain and are unchanged. We believe these assumptions remain because we are not changing the regulatory requirements established by the 2024 Payment Notice, and we are not adding requirements with this proposal. The time required to gather the documentation required by the 2024 Payment Notice requirements is already a part of every agent's, broker's, and web-broker's enrollment process. We do not believe the updated Model Consent Form would impose any additional burden on agents, brokers, web-brokers, or consumers; we do not anticipate that the updated Model Consent Form would take any longer to fill out than agent, broker, web-broker, or agency-created forms already being utilized. The use of the proposed Model Consent Form would not be mandatory. Therefore, the proposal would not impart extra time or costs to the assisting agent or broker.
This updated model consent form, if finalized, would provide agents, brokers, and web-brokers with clarity on how to meet the regulatory requirements under § 155.220(j)(2)(ii) and help them comply with this regulation by providing a standardized form they may use to do so. Furthermore, we believe providing a clearly written Model Consent Form would provide more consumer clarity and assurance that the agent, broker, or web-broker they are working with is complying with § 155.220(j)(2)(ii). The proposed scripts, to the extent they are utilized by agents, brokers, and web-brokers, would help ensure they are following the regulatory requirements when enrolling consumers. We believe this would reduce consumer harm by reducing unauthorized enrollments, which can result in financial harm if a consumer receives an improper APTC amount upon enrollment, and DMIs, which may lead to cancellation of coverage if the DMIs are not resolved in a timely manner. We also believe this proposal would clarify and simplify how regulated entities can meet regulatory requirements.
We seek comment on these assumptions.
We anticipate a small financial impact related to our proposed changes at § 155.305(f)(4)(i)(A)(1)-(2). Prior to pausing the FTR process during the COVID-19 public health emergency, Exchanges provided notice to enrollees or their tax filers (or both) who were identified as at risk of losing their APTC due to their failure to file their Federal income taxes and reconcile their APTC using Form 8962 prior to the FTR Recheck process. The 2025 Payment Notice codified the requirement to send notices in the first tax year a tax filer was identified as having FTR status. This proposal would require sending either direct or indirect notices to tax filers and their enrollees when the tax filer is identified as having FTR status for a second consecutive tax year, which
We seek comments on this proposal, including regarding additional costs, burdens, and benefits to issuers, consumers, and Exchanges as a result of this proposal.
We propose to add § 155.400(d)(1) to codify HHS' guidance document titled, “Reporting and Reviewing Data Inaccuracy Reports in State-based Exchanges Frequently Asked Questions,”
We do not believe that the proposed amendment would impose substantial additional costs to HHS, State Exchanges, or State Exchanges issuers beyond the costs that are already accounted for as part of the existing issuers' enrollment data inaccuracies description process and existing State Exchange enrollment data reconciliation requirements. The existing process already requires State Exchange issuers to submit enrollment inaccuracies and the State Exchanges to resolve those inaccuracies and reconcile enrollment information with both State Issuers and HHS no less than on a monthly basis. We have no reason to believe that codifying a timeliness standard would increase burden.
Furthermore, this proposal to codify a timeliness standard for resolution of enrollment data inaccuracies would clarify to issuers in State Exchanges the process for timely reviewing and resolving enrollment data inaccuracies and would ensure the accurate and timely payment of APTCs as this enrollment data is the basis of APTC payments to State Exchange issuers in the automated PBP system.
Therefore, we anticipate that this proposal would streamline the existing issuers' enrollment data inaccuracies process and benefit consumers by ensuring accurate payment of APTCs.
We seek comment on these impact estimates and assumptions.
We anticipate that the proposal to allow issuers to implement a fixed-dollar premium payment threshold, adjusted for inflation, would benefit enrollees who may otherwise have been unable to maintain enrollment due to owing
This proposed change would allow application filers to file appeals through the HHS appeals entity or a State Exchange appeals entity on behalf of applicants and enrollees on their Exchange application, streamlining the appeals process and ensuring operational consistency between the FFEs and appeals entities. We do not anticipate any financial impact related to our proposed change at § 155.505(b).
We propose to amend § 155.1000 by clarifying that an Exchange may deny certification to any plan that does not meet the general certification criteria at § 155.1000 and amend § 155.1090 with refinements to the standards for the request for the reconsideration of a denial of certification specific to the FFEs. We anticipate no appreciable changes in impact because of these proposals. We expect that the FFE would deny certification to one or fewer certification applications on average each year, so we expect the number of affected entities to be small. In addition, the proposed revisions to §§ 155.1000 and 155.1090 do not substantively alter the responsibilities of affected issuers or the content of reconsideration requests. As a result, there is no material impact on regulated entities because of these proposals.
As part of § 155.1200, we intend to increase transparency in Exchanges by publishing annual State Exchange and SBE-FP SMARTs, programmatic and financial audits, Blueprint applications, and additional data points in the Open Enrollment (OE) data reports. We anticipate no appreciable change in impact with this proposal since this data is already collected through the Blueprint application (OMB Control Number: 0938-1172), SMART (OMB Control Number: 0938-1244), and Enrollment Metrics PRA (OMB Control Number: 0938-1119). We expect that this proposal would increase the public's understanding of State Exchanges, promote program improvements, and better evaluate Exchange quality.
We propose an FFE user fee rate of 2.5 percent of monthly premiums for the 2026 benefit year, which is greater than the FFE user fee rate finalized in the 2025 Payment Notice (89 FR 26336 through 26338) of 1.5 percent of total monthly premiums. We also propose an SBE-FP user fee rate of 2.0 percent for the 2026 benefit year, which is greater than the SBE-FP user fee rate finalized in the 2025 Payment Notice of 1.2 percent of total monthly premiums. As a result, we estimate an increase in FFE and SBE-FP user fee transfers from issuers to the Federal government of $644 million for benefit year 2026 compared to if the user fee level from the prior benefit year were maintained in 2026. We estimate additional increases in FFE and SBE-FP user fee transfers from issuers to the Federal government of $849 million in 2027, $852 million in 2028, and $854 million in 2029 if the proposed 2026 benefit year user fee level were maintained in subsequent years.
We anticipate that these proposed user fee rates would have upward pressure on premiums compared to the 2025 benefit year. We believe that increasing the user fee rates from the 2025 Payment Notice would provide financial stability to the Exchanges on the Federal platform, ensure continuity of special benefits to issuers, and access to QHP plans for enrollees.
We also propose alternate user fee rate ranges if Congress extends the current or a higher level of enhanced PTC subsidies for the 2026 benefit year by March 31, 2025. We recognize that the expiration of the enhanced PTC subsidies at the end of the 2025 benefit year creates a significant amount of uncertainty in the ACA markets and despite this uncertainty, we maintain our interest in ensuring that we collect user fees at a rate that will allow us to sustain the operations of the FFEs. Therefore, if the enhanced PTC subsidies as currently enacted or higher are extended through the 2026 benefit year by March 31, 2025, we propose a 2026 benefit year FFE user fee rate range between 1.8 and 2.2 percent of total monthly premiums and a 2026 benefit year SBE-FP user fee rate range between 1.4 and 1.8 of total monthly premiums, with each of these ranges to be set at a single rate in the final rule. As a result, if we finalize user fee rates from these ranges, we estimate an increase in FFE and SBE-FP user fee transfers from issuers to the Federal government of between $425 million to $690 million for benefit year 2026 compared to if the user fee level from the prior benefit year were maintained in 2026. We estimate additional increases in FFE and SBE-FP user fee transfers from issuers to the Federal government of between $585 million to $950 million in 2027, $607 million to $985 million in 2028, and $629 million to $1.021 billion in 2029 if the alternate proposed 2026 benefit year user fee level were maintained in subsequent years. We seek comment on whether March 31, 2025, provides issuers sufficient time to request rates and for States to review rate requests.
This approach to revise the method for updating the AV Calculator, starting with the 2026 AV Calculator, resulting in an earlier release of the final AV Calculator for a given plan year, would benefit both issuers and States. Issuers have previously provided feedback that HHS should strive to release the final version of the AV Calculator sooner, and this approach addresses such requests. In addition, States could benefit from an earlier release of the final version of the AV Calculator to ensure their EHB-benchmark plans comply with EHB requirements, and States that design their own standardized plan options could benefit from an earlier release to ensure they satisfy the AV de minimis ranges. This approach would have no impact on consumers.
We seek comment on these impact estimates and assumptions.
We are proposing minor updates to the standardized plan options for PY 2026 to ensure these plans continue to have AVs within the permissible
Thus, like the approach taken in the 2023, 2024, and 2025 Payment Notices, we are proposing standardized plan options that continue to resemble the most popular QHP offerings that millions of consumers are already enrolled in. As such, these proposed standardized plan options are based on updated cost sharing and enrollment data to ensure that these plans continue to reflect the most popular offerings in the Exchanges. By proposing an approach to standardized plan options like that taken in the 2023, 2024, and 2025 Payment Notices, issuers would continue to be able to utilize many existing benefit packages, networks, and formularies, including those paired with standardized plan options for PY 2025. Further, issuers would continue to not be required to extend plan offerings beyond their existing service areas.
Furthermore, as discussed earlier in the preamble, we intend to continue to differentially display standardized plan options on
Finally, since we intend to continue to allow approved web-brokers and QHP issuers to submit requests to deviate from the manner in which standardized plan options are differentially displayed on
We do not anticipate that the proposed modification at § 156.201(c) that would require an issuer that offers multiple standardized plan options within the same product network type, metal level, and service area to meaningfully differentiate these plans from one another in terms of included benefits, networks, and/or formularies would have a significant impact on issuers. This is because most issuers have not offered multiple standardized plan options within the same product network type, metal level, and service area since these requirements were introduced in PY 2023. In fact, current QHP certification submission data indicates that only three issuers intend to offer multiple standardized plan options within the same product network type, metal level, and service area in PY 2025.
However, we acknowledge that those issuers that do offer multiple standardized plan options in the same product network type, metal level, and service area would either have to modify certain offerings (such as by modifying included benefits, provider networks, and/or formularies) or choose to discontinue certain plans to the extent they are not meaningfully different. That said, given that issuers would retain the discretion to choose between modifying or discontinuing plans, and given that making these modifications to plans are a routine part of the annual plan design process, we do not anticipate significant burden for affected issuers related to this proposed requirement.
We seek comment on these impact estimates and assumptions.
We propose to amend § 156.202(b) and (d) to properly reflect the flexibility that issuers have been operationally permitted since the introduction of these requirements to vary the inclusion of the distinct adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage categories under the non-standardized plan option limit at § 156.202(b) in accordance with § 156.202(c)(1) through (3).
In particular, we propose to amend § 156.202(b) to properly distinguish between adult dental benefit coverage at § 156.202(c)(1) and pediatric dental benefit coverage at § 156.202(c)(2), such that an issuer offering QHPs in an FFE or SBE-FP, for PY 2025 and subsequent plan years, is limited to offering two non-standardized plan options per product network type, as the term is described in the definition of “product” at § 144.103 of this subchapter, metal level (excluding catastrophic plans), and inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage (as defined in paragraphs (c)(1) through (3) of § 156.202), in any service area.
We propose a similar conforming amendment to § 156.202(d), such that for PY 2025 and subsequent plan years, an issuer may offer additional non-standardized plan options for each product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage (as defined in paragraphs (c)(1) through (3) of § 156.202), and service area if it demonstrates that these additional plans' cost sharing for benefits pertaining to the treatment of chronic and high-cost conditions (including benefits in the form of prescription drugs, if pertaining to the treatment of the condition(s)) is at least 25 percent lower, as applied without restriction in scope throughout the plan year, than the cost sharing for the same corresponding benefits in an issuer's other non-standardized plan option offerings in the same product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage, and service area.
We propose these modifications to align the regulation text with the existing flexibility that issuers have been operationally permitted since the non-standardized plan option limit was introduced in the 2024 Payment
We seek comment on these impact estimates and assumptions.
This proposal to conduct ECP certification reviews of plans for which issuers submit QHP certification applications in FFEs in States performing plan management functions beginning in PY 2026 would not have a significant financial impact on the Federal government. HHS continues to perform ECP certification reviews for plans in the FFEs, so the financial burden to conduct the certification reviews of plans for which issuers submit QHP certification applications in FFEs in States performing plan management functions using the existing data infrastructure is a marginal increase within the annual programming for QHP certifications. For PY 2025, HHS would use MPMS for ECP reviews for plans seeking QHP certification in FFEs, and HHS has all the necessary data infrastructure and operational processes to conduct reviews for States performing plan management functions for PY 2026 as proposed. While the Federal government would undertake additional administrative work to review the ECP data from QHP certification applications submitted by issuers seeking certification of their plans as QHPs in FFEs in States performing plan management functions, the transfer of administrative impact from the State that had been performing these reviews to the Federal government is marginal, as the Federal government already has in place processes and procedures to conduct the ECP certification reviews. HHS would continue ECP QHP certification reviews in all other FFE States.
This proposal would reduce the administrative burden for these States as they would no longer be responsible for ECP data review. We estimate a cost savings of $157,052.70 per State annually for each of the 12 FFE States performing plan management functions in PY 2026.
Further, this proposal should not lead to increased burden for issuers in the FFE in States performing plan management functions as they would still have to submit ECP data to HHS regardless of whether it is the State or HHS conducting the QHP certification review. In previous years, these issuers were required to submit ECP data to HHS via the SERFF binders, whereas these issuers are now required to submit their ECP data to HHS in MPMS beginning with the PY 2025 QHP application submission season, making it now possible for HHS to begin reviewing these ECP data going forward.
In addition, this proposal would not financially impact providers on the HHS ECP list.
We seek comment on these impact estimates and assumptions.
We propose to amend § 156.1220(a)(2) to codify a materiality threshold for when HHS would rerun HHS-RADV results in response to a successful HHS-RADV appeal. We believe that this proposal supports providing stability for issuers that participate in risk adjustment because it limits the potential for issuers to reopen their books for small changes to their State transfers because of a successful HHS-RADV appeal. This proposal would avoid situations where HHS is required to rerun HHS-RADV results, and for all issuers to reopen their books, when the impact for the filer of a successful HHS-RADV appeal is less than $10,000. Because this approach is limited to small dollar amounts, we do not believe that the proposal would materially impact issuers or their premiums and it would provide stability to issuers by limiting the situations where their books would need to be reopened. We believe that this proposal, when applicable, would reduce Federal costs by an estimated $75,000 due to the estimated 575 hours of contractor work. We also believe that this proposal, when applicable, would reduce Federal costs through a decrease in HHS staff work hours. These HHS staff are funded by the risk adjustment user fee, therefore there is no cost impact. Rerunning HHS-RADV results requires HHS to recalculate all national metrics, reissue all issuers' error rate results, and then apply all of those revised error rates to State transfers for the applicable benefit year before going through the process to net, invoice, collect, and redistribute the changes to the HHS-RADV adjustments to State transfers.
We propose to add a definition of “qualifying issuer” to § 158.103, amend § 158.140(b)(4)(ii) to allow qualifying issuers to not adjust incurred claims by the net payments or receipts related to the risk adjustment program for MLR reporting and rebate calculation purposes beginning with the 2026 MLR reporting year, amend § 158.240(c) to add an illustrative example of how qualifying issuers would determine the amount of rebate owed to each enrollee, and make a conforming amendment to § 158.240(c) to clarify that the current illustrative example in paragraph (c)(2)
Under the alternative approach we are considering, in which the proposed amendments to § 158.140(b)(4)(ii) and § 158.240(c) would extend to all issuers subject to the risk adjustment program, based on 2022 MLR data, these proposed amendments would reduce rebates paid by issuers to consumers or increase premiums collected by issuers from consumers by a net total of approximately $164 million per year.
We seek comment on these impact estimates and assumptions.
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this proposed rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that a range of between the total number of unique commenters on last year's proposed rule (251) and the total number of page views on last year's proposed rule (about 10,000) will include the actual number of reviewers of this proposed rule. We therefore use an average number of approximately 5,125 reviewers of this proposed rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters reviewed last year's rule in detail, and it is also possible that some page viewers did not actually read the proposed rule. For these reasons, we believe that the average of the number of commenters and number of page viewers on last year's proposed rule would be a fair estimate of the number of reviewers of this rule. We welcome any comments on the approach in estimating the number of entities which will review this proposed rule.
We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this proposed rule, and therefore, for the purposes of our estimate we assume that each reviewer reads approximately 55 percent of the rule (an average of the range from 10 percent to 100 percent of the rule). We seek comments on this assumption.
Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this rule is $106.42 per hour, including overhead and fringe benefits.
Under § 153.630(b), we propose to exclude enrollees without HCCs, remove the FPC, and change the source of the Neyman allocation data used to calculate the standard deviation of risk score error from MA-RADV data to HHS-RADV data beginning with the 2025 benefit year of HHS-RADV.
The proposed IVA sampling methodology would use the most recent 3 consecutive years of HHS-RADV data with results that have been released before that benefit year's HHS-RADV activities begin to calculate a national variance of net risk score error to calculate each issuer's standard deviation of risk score error used in the Neyman allocation formula, whereas the current IVA sampling methodology relies on MA-RADV data to calculate this national variance of net risk score error.
We considered proposing to replace the source of the Neyman allocation data while continuing to include enrollees without HCCs in IVA sampling and retaining the FPC.
We also considered only excluding stratum 10 enrollees from the IVA sampling methodology and retaining RXC-only enrollees in strata 1 through 3. However, we believe removing all enrollees without HCCs (both stratum 10 enrollees and RXC-only enrollees) is the preferred approach so issuers and IVA Entities are not spending resources on enrollees who do not have risk scores to adjust when calculating issuers' error rates during HHS-RADV. In addition, our analysis reveals the greatest improvements in precision and greatest decreases in the average medical records reviewed per enrollee, and therefore the greatest decreases in issuer and IVA Entity burden, when excluding RXC-only enrollees and stratum 10 enrollees from the IVA sampling methodology.
As an alternative respect to the SVA pairwise means test proposal we considered only changing the pairwise means testing procedure from the 95 percent confidence interval paired t-test to the 90 percent confidence interval bootstrapped test without increasing the initial SVA subsample size to 24. However, our analysis found that maintaining an initial SVA subsample size of 12 under the bootstrapping methodology did not achieve an optimal target false negative rate of approximately 20 percent at various effect sizes. Therefore, we are proposing to modify the pairwise means test to use a 90 percent confidence interval bootstrapping methodology and to increase the initial SVA subsample size from 12 enrollees to 24 enrollees beginning with 2024 benefit year HHS-RADV.
We considered taking no action regarding the proposed changes at § 155.305(f)(4)(ii) and instead relying on the guidance released by CMS to inform Exchanges of noticing best practices as was previously done, but instead decided to codify this as a requirement to ensure that tax filers or their enrollees receive multiple educational notices regarding the requirement to file their Federal income taxes and reconcile their APTC.
We considered taking no action regarding our proposal to modify § 155.400(g) to allow issuers to adopt a fixed-dollar premium payment threshold or a gross premium-based percentage payment threshold. However, the proposal would provide important flexibility to issuers that wish to allow enrollees who owe de minimis amounts of premium to maintain their enrollment. This flexibility is limited under current regulation, and as a result enrollees who owe small amounts of premium are sometimes unable to remain enrolled. We are soliciting feedback from interested parties on whether a fixed-dollar threshold, or a percentage threshold based on gross premium, would better meet our goal of providing flexibility to issuers to allow enrollees to avoid triggering a grace period and termination of enrollment through the Exchange for owing small amounts of premium. For the fixed-dollar premium payment threshold, we are also considering whether to implement a $5 or $10 cap on the fixed-dollar threshold because while we believe the $5 cap is sufficient to help many enrollees avoid termination, CMS data on non-payment terminations also indicate that there are a considerable number of policies that were terminated in PY2023 with a member responsibility amount of $10 or less. We are soliciting feedback from interested parties in order to determine what the appropriate cap should be on the fixed-dollar threshold. We also considered keeping the existing net premium-based threshold at a “reasonable” limit, which we recommended to be 95 percent or higher, but are proposing to specifically define the threshold at 95 percent or higher, in order to provide clarity for issuers and Exchanges. We also considered whether it would be administratively feasible to allow issuers to adopt both a fixed-dollar and percentage-based threshold but restricted issuers to choosing one threshold method. We are soliciting feedback from interested parties on whether we should allow this flexibility.
For the proposed 2026 benefit year FFE and SBE-FP user fees, we considered only proposing one FFE user fee rate and one SBE-FP user fee rate as we have done in previous years. However, we recognize that the expiration of the enhanced PTC subsidies at the end of the 2025 benefit year creates a significant amount of uncertainty in the ACA markets and despite this uncertainty, we maintain our interest in ensuring that we collect user fees at a rate that will allow us to sustain the operations of the FFEs. Therefore, we are proposing an FFE user fee rate of 2.5 percent of monthly premiums for the 2026 benefit year, which is greater than the FFE user fee rate finalized in the 2025 Payment Notice (89 FR 26336 through 26338) of 1.5 percent of total monthly premiums, and if the enhanced PTC subsidies as currently enacted or at a higher level are extended through the 2026 benefit year by March 31, 2025, we are also proposing a 2026 benefit year FFE user fee rate range between 1.8 and 2.2 percent of total monthly premiums and a 2026 benefit year SBE-FP user fee rate range between 1.4 and 1.8 of total monthly premiums, with each of these ranges to be set at a single rate in the final rule.
We considered taking no action regarding our proposal to conduct ECP certification reviews of plans for which issuers submit QHP certification applications in FFEs in States performing plan management functions under § 156.235. Not conducting reviews as proposed would maintain current certification operations for issuers in FFE States that perform plan management functions and continue to provide States with the ability to use a similar approach to Federal ECP certification reviews of plans for which issuers submit QHP certification applications in FFEs. However, due to the implementation of the MPMS and enhancement of the ECP user interface, issuers seeking QHP certification in FFEs, including States performing plan management functions, can now submit ECP data to HHS for data integrity of the Federal platform regardless of whether it is the State or HHS conducting the review.
We propose to amend § 156.1220(a)(2) to codify when HHS would take action in response to a successful HHS-RADV appeal. We considered several ways to design the new materiality threshold to rerun HHS-RADV results. For example, we considered setting the second materiality threshold to rerun HHS-RADV results to include a percentage of
The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, we estimate that small businesses, nonprofit organizations, and small governmental jurisdictions are small entities as that term is used in the RFA. The great majority of hospitals and most other health care providers and suppliers are small entities, either by being nonprofit organizations or by meeting the Small Business Administration (SBA) definition of a small business (having revenues of less than $8.0 million to $41.5 million in any 1 year). We do not anticipate that providers would be directly impacted by the proposals in this proposed rule. Individuals and States are not included in the definition of a small entity. The proposals in this proposed rule would affect Exchanges and QHP issuers.
For purposes of the RFA, we believe that health insurance issuers would be classified under the NAICS code 524114 (Direct Health and Medical Insurance Carriers). According to SBA size standards, entities with average annual receipts of $47 million or less would be considered small entities for these NAICS codes. Issuers could possibly be classified in 621491 (HMO Medical Centers) and, if this is the case, the SBA size standard will be $44.5 million or less.
The proposed policies that would result in an increased burden to small entities are described below.
We propose to update the IVA sampling methodology, including the proposed removal of enrollees without HCCs (including RXC-only enrollees), removing the FPC, and replacing the source of the Neyman allocation data with the most recent 3 years of consecutive HHS-RADV data with results that have been released before that benefit year's HHS-RADV activities begin, beginning with benefit year 2025 HHS-RADV. The total cost savings associated with this proposal would be approximately $79,121.92 per issuer audited per year. For more details, please refer to the Regulatory Impact Analysis section associated with this policy in this proposed rule.
We propose to add a definition of “qualifying issuer” and to no longer require such issuers to adjust incurred claims by the net payments or receipts related to the risk adjustment program for MLR reporting and rebate calculation purposes. This proposal would reduce rebates paid by these issuers to consumers or increase premiums collected by these issuers from consumers by approximately $20 million annually. The cost savings per issuer would therefore be approximately $41,067.76.
Thus, the per-entity estimated annual cost savings for small issuers is $120,189.68, and the total estimated annual cost savings for small issuers is $10,456,502.16. See tables 18 and 19.
We seek comment on this analysis and seek information on the number of small issuers that may be affected by the provisions in these proposed rules.
As its measure of significant economic impact on a substantial number of small entities, HHS uses a change in revenue of more than 3 to 5 percent. We do not believe that this threshold will be reached by the requirements in this proposed rule, given that the annual per-entity cost savings of $120,189.68 per small issuer represents approximately 0.06 percent of the average annual receipts for a small issuer.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For the purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. While this rule is not subject to section 1102 of the Act, we have determined that this rule will not affect small rural hospitals. Therefore, the Secretary has certified that this proposed rule will not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2024, that threshold is approximately $183 million. Although we have not been able to quantify all costs, we expect that the combined impact on State, local, or Tribal governments and the private sector does not meet the UMRA definition of unfunded mandate.
Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications.
In compliance with the requirement of Executive Order 13132 that agencies examine closely any policies that may have Federalism implications or limit the policy making discretion of the States, we have engaged in efforts to consult with and work cooperatively with affected States, including participating in conference calls with and attending conferences of the NAIC, and consulting with State insurance officials on an individual basis.
While developing this rule, we attempted to balance the States' interests in regulating health insurance issuers with the need to ensure market stability. By doing so, we complied with the requirements of Executive Order 13132.
Because States have flexibility in designing their Exchange and Exchange-related programs, State decisions will ultimately influence both administrative expenses and overall premiums. States are not required to establish an Exchange or risk adjustment program. For States that elected previously to operate an Exchange, those States had the opportunity to use funds under Exchange Planning and Establishment Grants to fund the development of data. Accordingly, some of the initial cost of creating programs was funded by Exchange Planning and Establishment Grants. After establishment, Exchanges must be financially self-sustaining, with revenue sources at the discretion of the State. Current State Exchanges charge user fees to issuers.
In our view, while this proposed rule will not impose substantial direct requirement costs on State and local governments, this regulation has Federalism implications due to potential direct effects on the distribution of power and responsibilities among the State and Federal governments relating to determining standards relating to health insurance that is offered in the individual and small group markets. For example, the proposal to conduct ECP certification reviews for States performing plan management functions effective beginning in plan year 2026 may have Federalism implications, given that HHS has not conducted Federal ECP certification reviews for States performing plan management functions since the 2015 plan year. However, these Federalism implications may be balanced by enabling HHS to align standards in these States with Federal review standards, and thereby increasing consumer access in these States and improving efficiency of the QHP certification process. Additionally, we do not believe that the proposed amendment to codify the timeliness guidance for State Exchanges to review and resolve the State Exchange issuers enrollment data inaccuracies within 60 calendar days would have significant Federalism implications because this proposal is merely codifying a timeline for an existing data submission requirement.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid Services, approved this document on September 30, 2024.
Administrative practice and procedure, Advertising, Brokers, Conflict of interests, Consumer protection, Grants administration, Grant programs—health, Health care, Health insurance, Health maintenance organizations (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Intergovernmental relations, Loan programs—health, Medicaid, Organization and functions (Government agencies), Public assistance programs, Reporting and recordkeeping requirements, Technical assistance, Women and youth.
Administrative practice and procedure, Advertising, Advisory committees, Brokers, Conflict of interests, Consumer protection, Grant programs—health, Grants
Administrative practice and procedure, Claims, Health care, Health insurance, Penalties, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, under the authority at 5 U.S.C. 301, the Department of Health and Human Services proposes to amend 45 CFR subtitle A, subchapter B, as set forth below.
42 U.S.C. 18021-18024, 18031-18033, 18041-18042, 18051, 18054, 18071, and 18081-18083.
(k) * * *
(3) HHS may immediately suspend the agent's or broker's ability to transact information with the Exchange if HHS discovers circumstances that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems, including but not limited to risk related to noncompliance with the standards of conduct under paragraph (j)(2)(i), (ii), or (iii) of this section and the privacy and security standards under § 155.260, until the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction.
(f) * * *
(4) * * *
(ii) If HHS notifies the Exchange as part of the process described in § 155.320(c)(3) that APTC payments were made on behalf of either the tax filer or their spouse, if the tax filer is a married couple, for 2 consecutive tax years for which tax data would be utilized for verification of household income and family size in accordance with § 155.320(c)(1)(i), and the tax filer or the tax filer's spouse did not comply with the requirement to file an income tax return for both years as required by 26 U.S.C. 6011, 6012, and their implementing regulations and reconcile APTC for that period (“file and reconcile”), the Exchange must:
(A) Send a direct notification to the tax filer, consistent with the standards applicable to the protection of Federal Tax Information, that explicitly informs the tax filer that the Exchange has determined that the tax filer or the tax filer's spouse, if the tax filer is married, has failed to file their Federal income taxes and reconcile APTC, and educate the tax filer of the need to file and reconcile or risk being determined ineligible for APTC after 2 consecutive years of failing to file and reconcile; or
(B) Send an indirect notification to either the tax filer or their enrollee, that informs the tax filer or enrollee that they may be at risk of being determined ineligible for APTC after 2 years of failing to file and reconcile. These notices must educate tax filers or their enrollees on the requirement to file and reconcile, while not directly stating that the Internal Revenue Service indicates the tax filer or the tax filer's spouse, if the tax filer is married, has failed to file and reconcile.
(d) * * *
(1)
(2) [Reserved]
(g)
(1) Under a net premium percentage-based premium payment threshold policy, issuers can consider applicants or enrollees to have paid all amounts due for the following purposes, if the applicants or enrollees pay an amount sufficient to maintain a percentage of total premium paid out of the total premium owed equal to or greater than 95 percent of the net monthly premium amount owed by the enrollees. If an applicant or enrollee satisfies the percentage-based premium payment threshold policy, the issuer may:
(i) Effectuate an enrollment based on payment of the binder payment under paragraph (e) of this section.
(ii) Avoid triggering a grace period for non-payment of premium, as described by § 156.270(d) of this subchapter or a grace period governed by State rules.
(iii) Avoid terminating the enrollment for non-payment of premium as, described by §§ 156.270(g) of this subchapter and 155.430(b)(2)(ii)(A) and (B).
(2) Under a gross premium percentage-based premium payment threshold policy, issuers can consider enrollees to have paid all amounts due for the following purposes, if the enrollees pay an amount sufficient to maintain a percentage of the gross premium of the policy before the application of advance payments of the premium tax credit that is equal to or greater than 99 percent of the gross monthly premium owed by the enrollees. If an enrollee satisfies the gross premium percentage-based premium payment threshold policy, the issuer may:
(i) Avoid triggering a grace period for non-payment of premium, as described by § 156.270(d) of this subchapter or a grace period governed by State rules.
(ii) Avoid terminating the enrollment for non-payment of premium as,
(3) Under a fixed-dollar premium payment threshold policy, issuers can consider enrollees to have paid all amounts due for the following purposes, if the enrollees pay an amount that is less than the total premium owed, the unpaid remainder of which is equal to or less than a fixed-dollar amount of $5 or less, adjusted for inflation, as prescribed by the issuer. If an enrollee satisfies the fixed-dollar premium payment threshold policy, the issuer may:
(i) Avoid triggering a grace period for non-payment of premium, as described by § 156.270(d) of this subchapter or a grace period governed by State rules.
(ii) Avoid terminating the enrollment for non-payment of premium as, described by §§ 156.270(g) of this subchapter and 155.430(b)(2)(ii)(A) and (B).
(b)
(e)
(a)
(2)
(3)
42 U.S.C. 18021-18024, 18031-18032, 18041-18042, 18044, 18054, 18061, 18063, 18071, 18082, and 26 U.S.C. 36B.
(c) For PY 2026 and subsequent plan years, an issuer that offers multiple standardized plan options within the same product network type, metal level, and service area must meaningfully differentiate these plans from one another in terms of included benefits, provider networks, and/or formularies. For the purposes of this standard, a standardized plan option with a different product, provider network, and/or formulary ID would be considered meaningfully different.
(b) For plan year 2025 and subsequent plan years, is limited to offering two non-standardized plan options per product network type, as the term is described in the definition of “product” at § 144.103 of this subchapter, metal level (excluding catastrophic plans), and inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage (as defined in paragraphs (c)(1) through (3) of this section), in any service area.
(d) For plan year 2025 and subsequent plan years, an issuer may offer additional non-standardized plan options for each product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage (as defined in paragraphs (c)(1) through (3) of this section), and service area if it demonstrates that these additional plans' cost sharing for benefits pertaining to the treatment of chronic and high-cost conditions (including benefits in the form of prescription drugs, if pertaining to the treatment of the condition(s)) is at least 25 percent lower, as applied without restriction in scope throughout the plan year, than the cost sharing for the same corresponding benefits in the issuer's other non-standardized plan option offerings in the same product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage, and service area.
(a) * * *
(2) * * *
(i) Notwithstanding paragraph (a)(1) and (2) of this section, for appeals related to HHS-RADV under paragraphs (a)(1)(vii) and (viii) of this section, HHS will only take action to adjust risk adjustment State payments and charges for an issuer in response to an appeal decision when the impact of the decision to the filer's HHS-RADV adjustments to risk adjustment State transfers is greater than or equal to $10,000.
(ii) [Reserved]
42 U.S.C. 300gg-18.
(b) * * *
(4) * * *
(ii) Beginning with the 2026 MLR reporting year, for qualifying issuers (as defined in § 158.103), receipts related to the transitional reinsurance program and net payments or receipts related to the risk corridors program (calculated using an adjustment percentage, as described in § 153.500 of this subchapter, equal to zero percent) under sections 1341 and 1342 of the Patient Protection and Affordable Care Act, 42 U.S.C. 18061, 18062. For all other issuers, receipts related to the transitional reinsurance program and net payments or receipts related to the risk adjustment and risk corridors programs (calculated using an adjustment percentage, as described in § 153.500 of this subchapter, equal to zero percent) under sections 1341, 1342, and 1343 of the Patient Protection and Affordable Care Act, 42 U.S.C. 18061, 18062, 18063.
(c) * * *
(2) For example, an issuer must rebate a pro rata portion of premium revenue if it does not meet an 80 percent MLR for the individual market in a State that has not set a higher MLR. If an issuer has a 75 percent MLR for the coverage it offers in the individual market in a State that has not set a higher MLR, the issuer must rebate 5 percent of the premium paid by or on behalf of the enrollee for the MLR reporting year after subtracting a pro rata portion of taxes and fees and accounting for payments or receipts related to the reinsurance, risk adjustment and risk corridors programs (calculated using an adjustment percentage, as described in § 153.500 of this subchapter, equal to zero percent). If the issuer is not a qualifying issuer (defined in § 158.103), the issuer's total earned premium for the MLR reporting year in the individual market in the State is $200,000, incurred claims are $121,250, the issuer received transitional reinsurance payments of $2,500, and made net payments related to risk adjustment and risk corridors of $20,000 (calculated using an adjustment percentage, as described in § 153.500 of this subchapter, equal to zero percent), then the issuer's gross earned premium in the individual market in the State would be $200,000 plus $2,500 minus $20,000, for a total of $182,500. If the issuer's Federal and State taxes and licensing and regulatory fees, including reinsurance contributions, that may be excluded from premium revenue as described in §§ 158.161(a), 158.162(a)(1), and 158.162(b)(1), allocated to the individual market in the State are $15,000, and the net payments related to risk adjustment and risk corridors, reduced by reinsurance receipts, that must be accounted for in premium revenue as described in §§ 158.130(b)(5), 158.221, and 158.240, are $17,500 ($20,000 reduced by $2,500), then the issuer would subtract $15,000 and add $17,500 to gross premium revenue of $182,500, for a base of $185,000 in adjusted premium. The issuer would owe rebates of 5 percent of $185,000, or $9,250 in the individual market in the State. In this example, if an enrollee of the issuer in the individual market in the State paid $2,000 in premiums for the MLR reporting year, or 1/100 of the issuer's total premium in that State market, then the enrollee would be entitled to 1/100 of the total rebates owed by the issuer, or $92.50.
(3) As another example, if an issuer is a qualifying issuer (defined in § 158.103), the issuer's total earned premium for the MLR reporting year in the individual market in the State is $90,000, incurred claims are $151,250, and the issuer received transitional reinsurance payments of $12,500 and net receipts related to risk adjustment of $110,000, then the issuer's gross earned premium in the individual market in the State would be $90,000 plus $12,500, for a total of $102,500. If the qualifying issuer's Federal and State taxes and licensing and regulatory fees, including reinsurance contributions, that may be excluded from premium revenue as described in §§ 158.161(a), 158.162(a)(1), and 158.162(b)(1), allocated to the individual market in the State are $15,000, and the reinsurance payments that must be accounted for in premium revenue as described in §§ 158.130(b)(5), 158.221, and 158.240 are $12,500, then the qualifying issuer would subtract $15,000 and $12,500 from gross premium revenue of $102,500, for a subtotal of $75,000. The qualifying issuer would then add $110,000 in net receipts related to risk adjustment, for a base of $185,000 in adjusted premium. The qualifying issuer would owe rebates of 5 percent of $185,000, or $9,250 in the individual market in the State. In this example, if an enrollee of the issuer in the individual market in the State paid $900 in premiums for the MLR reporting year, or 1/100 of the issuer's total premium in that State market, then the enrollee would be entitled to 1/100 of the total rebates owed by the issuer, or $92.50.
Environmental Protection Agency (EPA).
Final rule.
This action establishes recordkeeping and reporting requirements for uses of ozone-depleting substances as process agents and updates related definitions. Codified recordkeeping and reporting requirements will provide clear notice of information the U.S. Environmental Protection Agency collects, aggregates, and reports each year on behalf of the United States as a party to the Montreal Protocol on Substances that Deplete the Ozone Layer; effectively monitor these narrow uses in a more routine and consistent manner under the Clean Air Act; and enhance understanding of emissions of substances harmful to the stratospheric ozone layer.
This final rule is effective on November 12, 2024. The incorporation by reference (IBR) of certain publications listed in the rule is approved by the Director of the Federal Register as of November 12, 2024.
The U.S. Environmental Protection Agency (EPA) has established a docket for this action under Docket ID No. EPA-HQ-OAR-2022-0707. All documents in the docket are listed on the
John Feather, Stratospheric Protection Division, Office of Atmospheric Protection (Mail Code 6205A), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-564-1230; or email address:
Throughout this document, whenever “we,” “us,” “the Agency,” or “our” is used, we mean the EPA. Acronyms that are used in this rulemaking that may be helpful include:
You may be potentially affected by this action if you use ozone-depleting substances
This list is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this section could also be affected. If you have any questions regarding the applicability of this action to a particular entity,
This action is narrow in scope and primarily codifies reporting and recordkeeping requirements for a limited number of chemical manufacturing facilities. EPA annually
Several sections of the CAA provide authority for this action. In particular, section 603 provides authority to establish monitoring and reporting requirements for controlled substances. EPA also relies on its authority under section 114 of the CAA, which authorizes the EPA Administrator to establish recordkeeping and reporting requirements in carrying out any provision of the CAA (with certain exceptions that do not apply here). Sections 604 and 605 of the CAA provide the authority to phase out the production and consumption of class I and class II controlled substances, to restrict the use of class I and class II controlled substances, and to promulgate regulations associated with the production of class I and class II controlled substances. EPA's regulations implementing the production and consumption controls for class I and class II controlled substances, including provisions implementing exceptions to those controls, can be found at 40 CFR part 82, subpart A. Additional authority for electronic reporting, as required under provisions in 40 CFR 82.13(c) and 82.24(a)(1) comes from the Government Paperwork Elimination Act (44 U.S.C. 3504), which provides “(1) for the option of the electronic maintenance, submission, or disclosure of information, when practicable as a substitute for paper; and (2) for the use and acceptance of electronic signatures, when practicable.”
In 1987, the United States joined 23 other countries and the European Union to sign the
Process agents are generally understood to be used to create an environment for another process to occur, without themselves being transformed or destroyed during that process. The process agent is not consumed in the reaction, though trace quantities of the process agent may remain in the final product. Certain quantities may also be emitted. For the purposes of this rulemaking, EPA uses the terms “controlled substance used as a process agent”, “ODS process agent”, and “process agent” interchangeably. The Agency also uses the term “consumed” in this context to mean “used up” or transformed.
After initial use, process agents may be reused (with or without recycling), used in transformation reactions, or destroyed. While process agents are generally reused, additional process agents may need to be introduced to replenish losses due to transformation, destruction, emission, or being present in trace quantities in the chemical substance being manufactured. Emissions can be reduced through limiting process agent losses (
Some legacy uses of ODS as process agents continue, in particular where substitutes or alternative processes may not be currently viable, and the Agency annually requests, collects, and reviews information on these uses. This is in line with decisions under the Montreal Protocol to allow the continued use of ODS as process agents under specified situations. The parties to the Montreal Protocol agreed in decision X/14 to except quantities of ODS produced or imported for use as process agents from the general requirements to phase out production and consumption of controlled ODS.
EPA is establishing one-time, annual, and situational reporting for entities that use ODS as process agents, a
EPA understands that uses in the United States of ODS as process agents are primarily in legacy processes at existing facilities. Based on the information reported and reviewed by the Ozone Secretariat, as well as the discussions held at Montreal Protocol meetings, the United States is one of a few countries that continue to use controlled substances as process agents. The additional recordkeeping and reporting requirements established in this action will support EPA's efforts to assess use of controlled substances as process agents, prepare and report associated information supporting continued need for excepted uses where appropriate, and ensure there is clarity and consistency in reporting on emissions of ODS used as process agents.
This reporting will allow EPA to effectively monitor these narrow process agent uses in a more routine and consistent manner under CAA section 603, and ensure the Agency is accurately documenting production and consumption of class I and class II controlled substances consistent with the limits established under CAA sections 604 and 605.
To establish a baseline set of information from which EPA can monitor potential changes over time, EPA is generally finalizing as proposed the one-time reporting requirements, with the additional reported data element of the percentage of process agent consumed in the process agent application. The Agency proposed that any facility that uses a controlled substance as a process agent must submit a one-time report. This report must be submitted within 120 days of October 10, 2024, or within 120 days of the date that a facility first uses a controlled substance as a process agent, whichever is later, and is required regardless of whether an entity has provided this information to EPA previously.
EPA proposed that this one-time report include information concerning the controlled substance being used as a process agent; a mass balance describing where, how, and how much of the controlled substance is used and emitted; if relevant, where, how, and how much of the controlled substance is transformed, destroyed, or otherwise captured; data on how much controlled substance was used in the last year and what it was used to produce (
One commenter requested that EPA remove from the reporting requirements the data elements relating to the percentages of class I controlled substances used as a process agent and retained within the process agent application, recovered after the process agent application, and emitted or entrained in the final product. The commenter stated that this baseline information on process agent use is unnecessary because the information would already be provided in the use, volume, and emission data in the annual reports. The commenter further stated that it produces controlled substances for other uses in addition to use as a process agent, and that reporting this baseline information would require a facility to include information associated with all controlled substance production. The commenter stated that process agent use could be a small percentage of overall production, market conditions that drive overall production do not provide a reliable baseline, and reporting on overall production could compromise confidential information associated with manufacturing processes. Alternatively, the commenter requested that EPA consider this reporting to be confidential and that process knowledge be allowed to serve as the basis for the information requested.
In response, EPA does not agree that reporting elements concerning the percentages of process agent used are unnecessary and would disclose confidential information. Details of the percentages of process agents used will provide EPA information on how other reported information relate to typical chemical manufacturing pathways and may be relevant to future Agency considerations. It is not evident how EPA may identify these values from the aggregated quantities of use, volume, and emission data that entities will report. Considering the variety of internal processes, process cycles, and potential pathways, it is not feasible for EPA to reliably derive the information the Agency is seeking from the data otherwise provided in annual reports. EPA is also not requiring that facilities include in their annual reporting the amounts retained within the process or entrained in the product. The Agency is requiring that this information be included in the one-time reporting to ensure that this process information may be understood within the context of other reported data. Furthermore, these data elements provide useful information that will help address a recommendation from another commenter, discussed in section V of this preamble, concerning what quantities typically remain in a final product. As also discussed in section V of this preamble, EPA is further adding a requirement that the percentage of process agent consumed in the process agent application be included in this one-time report. Information on these data elements from the one-time reports will be relevant to Agency considerations of what may be appropriate thresholds for determining if a use meets the definition of “process agent” codified in this action at 40 CFR 82.3. EPA further understands that the commenter misunderstood this information as being intended to apply across overall production of the given controlled substances instead of the proportion used as process agents. The relevant data elements were, of the amount of controlled substance used as a process agent, what percentages were respectively retained, recovered, emitted, or entrained. These representative percentages of process agent use through a cycle of the process agent application are not relevant to the commenter's concerns that reporting on the overall production may not provide
As part of a continuing effort to monitor potential changes over time, EPA is generally finalizing as proposed the requirement that any facility that uses a controlled substance as a process agent must submit an annual report each year by February 14, with the addition of a process for entities to request extensions of reporting due dates. If there are facilities that employ more than one process agent use, any such facilities will need to report data individually for each process that uses an ODS process agent. This information will help enable the Agency to develop annual reports regarding uses of process agents in the United States and to effectively monitor production and consumption of ODS used for process agents consistent with domestic requirements.
EPA proposed to require that each entity with a facility that uses a controlled substance as a process agent must submit for each applicable facility an annual report by February 14 of each year concerning process agent uses for the previous calendar year (
One commenter supported the proposed reporting on process agent sourcing and on actions taken or under evaluation to phase out use of ODS as a process agent, stating that this information will allow EPA to assess the progress of developing alternatives and possibly end the need for the U.S. exemption for ODS process agents. EPA acknowledges the commenter's support for the proposed reporting requirements. The Agency notes that this action is limited to establishing reporting requirements, so the commenter's asserted support for actions to phase out use of ODS as process agents are beyond the scope of this action.
Another commenter requested that EPA revise the annual reporting timeline to provide consistency with prior practice, allow time for necessary information to become available, and avoid conflicting with other EPA deadlines. Specifically, the commenter requested that EPA revise the date by which annual reports must be submitted each year, from February 14 to July 31, or April 30 at the earliest. The commenter stated that previous requests for information from EPA on these process agent uses have been received in July and responses were due within 20 working days and that the proposal did not indicate a need or reason to vary this timeline. The commenter stated that information EPA proposed to require in the annual reports would not be available by February 14 and that this accelerated timeline would place an undue burden on the commenter. The commenter stated that manufacturing facilities that will be subject to the requirements being established in this rule will not have finalized emission calculations for the prior calendar year by February 14, and provided as examples that reporting under the Toxics Release Inventory (TRI) program is not due until July 1 and emission inventory reporting obligations for the commenter's facilities under State programs ranged from April 1 to April 30. The commenter stated that aligning the timing with other existing and established requirements would reduce burden associated with the proposed reporting obligations. The commenter cited identical rationales for asserting that data elements are confidential as it had for the proposed one-time reporting requirements.
EPA disagrees with the commenter's assertions that a February 14 deadline for annual reporting would be infeasible, unduly burdensome, or unjustified. The commenter did not explain why the information required to be included in the annual report would not be available by February 14. The commenter provided examples of later deadlines under different programs, but did not provide a reason that it would be infeasible for facilities to submit the required information for this program by February 14 of each year. Emissions of controlled substances from process agent uses are one component of overall emission inventories for subject facilities and EPA is unaware of any impact the requirements being finalized in this action may have on these facilities under other programs. As EPA stated at proposal, February 14 aligns with the fourth quarter and annual deadlines for existing ODS reporting requirements under 40 CFR part 82. February 14 also aligns with existing deadlines for regulated substances, including reporting requirements under 40 CFR part 84 for hydrofluorocarbon (HFC) production (which includes emissions), HFC-23 emissions, and HFC process agent emissions. The commenter noted that it was subject to existing reporting deadlines that ranged from April 1 to July 1, and it is unclear why the commenter requested the requirements being finalized in this action should be no later than July 31, or, at the earliest, April 30. Furthermore, in line with U.S. commitments through the Montreal Protocol, the earlier reporting deadline being finalized supports EPA efforts to thoroughly review submitted information for completeness, accuracy, and consistency prior to a timely submission of this information to the Montreal Protocol's Ozone Secretariat on behalf of the United States. However, EPA is finalizing that the Agency may grant a short extension in the unlikely event that an entity cannot comply with this reporting timeline. Entities may submit a request for an extension with supporting documentation and explanation of the reasons needed for an extension. The Agency will consider the circumstances of any such requests and act accordingly. EPA addresses comments concerning the confidentiality determinations in section IV.B of this preamble.
EPA is largely finalizing as proposed a requirement that entities provide advance notice of changes, with revisions to the conditions under which reporting would be necessary. This advance notice of changes is required at least 180 days before an entity expects to increase, as compared to the previous year and the average of the three previous years, the amount of process agent introduced into the application by more than 20 percent or emissions by at least one metric ton and 20 percent. EPA understands that facility operations change over time, and the Agency can monitor such changes through the annual reporting mechanism. However, large changes in facility operations over a short period of time can impact the environment, conformance with domestic regulatory requirements, and our commitment to international
EPA proposed to require that each facility with a significant process change, including an increase in the quantity of the final output manufactured using an ODS process agent, submit a report specifying changes at least 180 days prior to implementing the change. EPA proposed that this prior notification requirement apply to any process changes anticipated to result in increases by the next annual report of greater than 20 percent of the amount of controlled substance initially introduced for or emitted during use as a process agent by a facility, as compared to the corresponding data in the previous calendar year.
One commenter supported EPA's proposal to require reporting to specify changes at least 180 days before implementing a significant process change, including any increase in the quantity of manufacturing output using an ODS process agent. EPA acknowledges the commenter's support.
Another commenter requested that EPA not require the significant change report or, alternatively, that the reporting requirement exclude changes due to production variability and unexpected circumstances. The commenter offered examples of potential changes that may be difficult to predict with at least 180-day notice or where further revisions may occur after a notification is submitted, including plant outage(s), natural disasters, and market conditions. The commenter further stated that uses of process agents can be quite small and that a 20 percent change could be difficult to predict. The commenter suggested that, particularly for facilities that emit greater than one ton, EPA could require reporting of these changes in the annual report through which process agent use and emissions would already be reported.
EPA acknowledges the commenter's concerns about situations where the proposed requirements may be difficult to implement, but disagrees with the commenter's suggestion that the Agency not finalize the requirement to report significant changes in advance. It is unclear how the examples the commenter provided, namely plant outage(s), downtime due to natural disasters, other pauses in production, and drops in demand and production due to the covid epidemic, would result in unanticipated large increases in process agent use or emissions. These are cases where process agent use and emissions may decrease by large quantities, but these decreases would not necessitate an advance notice of changes. Subsequent increases in use or emissions in a year following such unexpected cases might necessitate reporting, but after such incidents it would be reasonable to anticipate a return to previous production levels.
EPA could also imagine that unexpected changes at one of a company's facilities might result in increased utilization of one or more of its other facilities. Shifting production between facilities to account for such cases might result in an individual facility increasing its process use or emissions by large amounts, but not result in an overall increase across the company or the United States. This scenario would be unlikely to result in large impacts on total use and emissions, conformance with domestic regulatory requirements, or U.S. commitments under the Montreal Protocol. Therefore, EPA is revising the advance notice of changes reporting requirement so that it applies to each entity rather than to an individual facility. Additionally, the Agency is revising the basis of the percentage change to apply only if the increase is greater than a 20 percent increase relative to values from both the immediately previous year and the average of the past three years. This accounts for situations where production may drop in a single year and then return to typical levels in the following year, which would result in an apparent year-on-year increase. In this case it would be reasonable to expect that production may return to previous levels after a disruption. This also addresses cases where production may moderately increase annually, which would result in a relatively large increase over several years. EPA would receive relevant information each year and there would not be a large increase in any given year. In both cases advance notice would not be necessary for EPA to understand the potential for large increases and impacts by the submission of the next annual report. Furthermore, the Agency would have had opportunities to assess the circumstances and request additional information as relevant. Advance notice reporting will only be required for anticipated changes that represent a large overall increase for the entity, as calculated across all the entity's applicable facilities. EPA expects that this mitigates the commenter's concern about production variability at the facility level or other unanticipated changes raised by the commenter. At the same time, the reports will provide EPA the information it needs to monitor uses and emissions of process agents. The Agency also recognizes that there may be instances where it is not feasible to provide EPA with the requisite 180 days of notice, but the possibility of those instances is not, in the Agency's view, a reason not to require the notice period. If that situation were to occur, EPA encourages the entity to contact the Agency as soon as practicable so that EPA can work with the entity.
EPA acknowledges the commenter's statement that a 20 percent change from a facility with relatively small emissions may be difficult to assess, but the Agency disagrees with the commenter's alternative recommendation that these changes instead be included in the annual report. Smaller changes at that level would pose lesser contributions to overall emissions in the United States, and advance notice would be less necessary. The annual report is submitted by February 14 of the year following actions taken, and is inherently retrospective. Only including this information in the annual report would defeat the purpose of providing advance notice. However, EPA recognizes that changes in emissions from process agents from facilities that have, on the whole, relatively small emissions, pose lesser contributions to overall emissions in the United States, and advance notice of these changes is therefore less critical.
Accordingly, EPA is revising the qualifying criteria to require that this advance notice be provided only where changes that would result in annual increases greater than 20 percent of the amount initially introduced or, for emissions, increases of at least 20 percent and one metric ton. This will ensure the Agency has advance notice of changes that may have a large impact on overall use or emissions of process agents in the United States, while exempting from the advance notice requirements changes from smaller contributors. EPA addresses comments concerning the confidentiality determinations in section IV.B of this preamble.
In alignment with the one-time and annual reporting requirements being finalized in this action, EPA is establishing requirements that entities using controlled substances as process agents report emissions as specified in
These requirements prescribe emission estimation methodologies through vent-specific and mass balance compliance options. Associated reporting and recordkeeping requirements will support EPA's efforts to validate the reported information. For example, for facilities using an emission factor-based method, each process vent in the top quartile of its respective facility's emissions generally must use the process-vent-specific emission factor method, which requires emission tests with process activity parameters measured for either each operating scenario or the operating scenario with the largest overall emissions. All emissions test data and procedures used in developing emission factors must be documented. Process vents with less emissions may use the process-vent-specific emission calculation factor method, which prescribes certain procedures to calculate emissions for each operating scenario, but does not require testing. All data, assumptions, and procedures used in the calculations or engineering assessment must be documented. Each process using the mass balance method must demonstrate adherence to accuracy and precision requirements. In these cases, the reported information follow specified methodologies and EPA may request and assess detailed records to better understand the reported data. EPA is also listing and incorporating by reference certain American Society of Mechanical Engineers (ASME), ASTM International (ASTM), and EPA standards as acceptable options to calculate, measure, analyze, or measure parameters associated with emissions. Due to similarities in requirements, emitted chemicals, and regulated industries, these standards are the same standards listed in 40 CFR part 98, subpart L, and the same versions incorporated by reference in 40 CFR 98.7, except for ASTM D6348-03,
EPA proposed to require that entities using controlled substances as process agents report emissions using a methodology similar to the emissions reporting requirements for the Greenhouse Gas Reporting Program (GHGRP) codified at 40 CFR part 98, subpart L (40 CFR 98.120 through 98.128). EPA also sought comment on a description of procedures to implement the proposed emission reporting requirements (available in a memorandum to the docket for this action at Docket ID No. EPA-HQ-OAR-2022-0707-0002).
Specifically, EPA proposed that acceptable testing methods for measuring process vent emissions of controlled substances would include EPA Method 18 in appendix A-1 to 40 CFR part 60, EPA Method 320 in appendix A to 40 CFR part 63, EPA 430-R-10-003, ASTM D6348-03, or other analytical methods validated using EPA Method 301 in appendix A to 40 CFR part 63. EPA Method 301 provides a process to validate and approve other analytical methods as appropriate. In the memorandum to the docket, EPA included as compliance options these and other methods listed for existing requirements in 40 CFR part 98, subpart L, and incorporated by reference in 40 CFR 98.7.
In the proposal, EPA discussed advantages and disadvantages of potential approaches, requested comment on these assessments, and highlighted particular areas of consideration. The Agency noted the approach used by the TRI program at 40 CFR part 372, and explained its concerns with applying the general TRI reporting requirements to this limited set of ODS process agent pollutants, industry sectors, and types of operations for the purposes of this action.
Two commenters expressed their support for an emissions reporting approach similar to the GHGRP instead of TRI reporting requirements. There were no responses to EPA's request for comment on whether adjustments from the proposed methodology were necessary to account for distinctions between controlled substance emissions, process agent applications, or industry sectors. The Agency understands that the emission reporting methodology established in this rule is applicable to these process agent applications and their associated industry sectors.
The Agency requested comment on whether there are potential gaps in the proposed approaches to determining emissions from process agent applications and whether alternative approaches, such as a mass balance method as described in appendix A to 40 CFR part 98, subpart L, may be suitable in those particular cases. EPA also requested comment on the advantages and disadvantages of specifying one testing method instead of several options (
Two commenters supported EPA's proposal to use a methodology similar to the emissions reporting requirements at 40 CFR part 98, subpart L. These commenters stated that it would be reasonable to allow only one testing method for this small set of affected entities instead of several options and that this would ensure more consistency when evaluating emissions. One of these commenters recommended that EPA finalize the rule as proposed. The commenter stated that the GHGRP approach is more reasonable than the TRI approach because it would require entities to use a specific methodology and report more detailed information, which would result in data that are more consistent and manageable for EPA to validate. The commenter further stated that the approach EPA proposed is more likely to produce more reliable emission data than the mass balance approach the Agency took comment on. The other commenter stated that more frequent and involved testing was necessary to ensure accurate accounting of emissions. Further, the commenter referenced a report that it had previously issued and stated that the report had demonstrated that the GHGRP reporting requirements, which rely on emission factor estimates and/or limited and infrequent testing to support calculation methods, may be insufficient to accurately estimate and account for the controlled substances
EPA acknowledges the commenters' support for the proposed methodology and one commenter's support for the proposal as a whole. The Agency acknowledges the commenters' general support for specifying one testing method instead of allowing any of the several methods that were proposed. No commenters indicated potential disadvantages with specifying EPA Method 18 as the analytical method and EPA Method 21 monitoring procedures for leak detection. However, EPA remains unaware of whether these methods may be applicable in all situations for these operations and process agent emissions. At this time, EPA will allow entities to use any of the several methods being finalized in this action, as applicable. EPA will further assess available information and may consider in a future rulemaking whether it would be practicable and advisable to specify a more limited set of testing methods and monitoring procedures. To align with existing EPA emission reporting requirements for similar chemicals and processes, the Agency is incorporating by reference in 40 CFR part 82, subpart A, the same versions of the relevant methods listed at 40 CFR part 98, subpart L.
With respect to the commenter's request to require CEMS or some other form of continuous monitoring in order to verify the emission factor-based calculations underlying the proposed reporting requirements, EPA does not agree that these additional monitoring requirements and associated compliance burden are warranted for these circumstances. The Agency disagrees with the commenter's characterization of the report's findings as undermining the emission factor-based method or structure of the GHGRP reporting requirements in general as applied in this context for estimating emissions of controlled substances used as process agents. EPA's understanding is that the facility where the commenter detected CFCs does not use controlled substances as process agents and would not be subject to the requirements being established in this action. The commenter did not justify why the emissions it detected from that facility would indicate that the proposed methodology would be insufficient for the process agent uses addressed in this action. The fact that controlled substances were detected from the specific facility but not reported through the GHGRP does not indicate any inadequacies of the emission calculation, monitoring, or reporting requirements being established for process agent uses in this action. EPA explicitly excepted ODS controlled substances from the definition of “fluorinated greenhouse gas” under 40 CFR 98.6, and accordingly from the GHGRP emission reporting requirements under 40 CFR 98.122, because EPA already regulated controlled substances under 40 CFR part 82.
Another commenter stated that there are instances where a mass balance approach may be more accurate to estimate fugitive emissions than the proposed approach. The commenter provided information about its operations at one facility as an example, and requested EPA include a mass balance approach as an acceptable method for calculating fugitive ODS emissions. The commenter stated that, while the proposed emission factor-based methods have historically been used to quantify equipment leak emissions from various industrial processes, these approaches include factors that are based on general industry-wide data and do not necessarily reflect individual facility, site-specific process and equipment characteristics. The commenter explained that ODS enter into the
EPA understands that the proposed emission methodology requirements would be applicable to the commenter's operations and does not agree that these requirements lack adaptability to site-specific circumstances. The requirements being established in this action include a process to create site-specific process-vent-specific emission calculation factors and site-specific leak monitoring approaches. However, EPA acknowledges that a mass balance approach may also be an appropriate option for the situation described, which EPA understands to involve batch operations with no on-site production or transformation. Accordingly, EPA is adding a mass balance approach as a compliance option for batch operations with no on-site production or transformation of controlled substances, based on the GHGRP provisions listed in appendix A to subpart L of 40 CFR part 98. The GHGRP requirements were designed for situations where fluorine enters a process as part of a reactant and leaves as part of a product or byproduct. Controlled substances are not produced or transformed in these process agent applications. Accordingly, the mass balance approach established in this action for controlled substances used as process agents addresses the quantities of controlled substances entering and leaving the process agent application. Any entity that uses this compliance option must demonstrate that it can meet the error limits or measurement and operating criteria specified in the requirements. Each facility should use the methodology that most accurately estimates emissions from its processes.
More information on the standards being incorporated by reference in 40 CFR 82.27 is available in section VII.I of this preamble. Available ASME methods are ASME MFC-3M-2004, Measurement of Fluid Flow in Pipes Using Orifice, Nozzle, and Venturi; ASME MFC-4M-1986 (Reaffirmed 2016), Measurement of Gas Flow by Turbine Meters; ASME MFC-5M-1985 (Reaffirmed 1994), Measurement of Liquid Flow in Closed Conduits Using Transit-Time Ultrasonic Flowmeters; ASME MFC-6M-1998, Measurement of Fluid Flow in Pipes Using Vortex Flowmeters; ASME MFC-7M-1987 (Reaffirmed 1992), Measurement of Gas Flow by Means of Critical Flow Venturi Nozzles; ASME MFC-9M-1988 (Reaffirmed 2001), Measurement of Liquid Flow in Closed Conduits by Weighing Method; ASME MFC-11M-2006), Measurement of Fluid Flow by Means of Coriolis Mass Flowmeters; and ASME MFC-14M-2003, Measurement of Fluid Flow Using Small Bore Precision Orifice Meters.
The ASTM method is ASTM D6348-03, Standard Test Method for Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transform Infrared (FTIR) Spectroscopy. ASTM D2879-97 (Reapproved 2007), Standard Test Method for Vapor Pressure-Temperature Relationship and Initial Decomposition Temperature of Liquids by Isoteniscope may also be used to determine vapor pressures for purposes of the definition “in light liquid service.” ASTM D2879-97 is available for inspection at U.S. EPA's Air and Radiation Docket; EPA West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC 202-566-1742 and may be obtained at ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428; phone: 610.832.9500; email:
EPA methods are Approved Alternative Method 012: An Alternate Procedure for Stack Gas Volumetric Flow Rate Determination; Methods for Estimating Air Emissions from Chemical Manufacturing Facilities, Emissions Inventory Improvement Program, Volume II: Chapter 16, August 2007; EPA-453/R-95-017, November 1995; EPA-430-R-10-003, March 2010, Protocol for Equipment Leak Emission Estimates; and Other Test Method 24, September 2006, Tracer Gas Protocol for the Determination of Volumetric Flow Rate Through the Ring Pipe of the Xact Multi-Metals Monitoring System.
Entities are obligated under existing requirements to record information in accordance with 40 CFR 82.13 and 82.24, including information concerning ODS used as process agents. In this action EPA is finalizing as proposed recordkeeping requirements specifically for uses of ODS as process agents. Under 40 CFR 82.13(d), entities must retain the records and copies of reports required for at least three years. Under previously established requirements in 40 CFR 82.13 and 82.24, entities, including producers and importers, must record information that applies to controlled substances in general, including those used as process agents. In this action EPA is establishing specific requirements that differentiate controlled substances intended for process agent use from the wider uses. This additional information will provide further distinctions of information already required to be recorded.
EPA proposed to also require that entities using process agents record information that documents what would be reported to the Agency, which includes information concerning sourcing, production, recycling, reuse, transformation, and destruction for ODS intended to be used for process agent applications.
Specifically, the Agency proposed to add requirements that companies that use process agents maintain: dated records of the quantity of each process agent produced at each facility; records identifying the producer or importer of process agents received; copies of invoices or receipts documenting the sale or other transfer of ownership of process agents; dated records identifying the quantity of each product manufactured within each facility by using process agents; dated records of the quantity of process agent spills or releases greater than or equal to 100 pounds; dated records of information used to calculate emissions; dated records of the quantity of process agents which are subsequently transformed or destroyed; and a copy of the transformation or destruction verification in the case that a process agent is subsequently sold or distributed to another entity for transformation or destruction.
One commenter requested that EPA revise the proposed reference to recordkeeping responsibility in 40 CFR 82.13(ee)(3) from applying to a “person” to instead apply to an “entity,” in alignment with EPA's terminology for proposed reporting requirements under 40 CFR 82.13(ee)(1) and (2). The same commenter requested that EPA revise the recordkeeping requirements proposed in 40 CFR 82.13(ee)(3)(i) to reflect the amount of controlled substance used as process agent at each facility instead of the amount of controlled substance produced at each facility, as the commenter also produces the same controlled substance for other uses. The commenter stated that it would be difficult to predict or keep accurate numbers prospectively recording the amount of controlled substance that was produced and may be used as a process agent, and that
As EPA states in footnote 2 of this preamble, “person” and “entity” may be used interchangeably in certain circumstances. The instances referenced were not intended to carry a material distinction in interpretation or application. For clarity, EPA is finalizing terminology in 40 CFR 82.13(ee)(3) that refers to the recordkeeping obligations as applying to an “entity.” To be clear, each entity, including all commonly owned companies, is responsible for the regulatory obligations as applicable of all commonly owned facilities and plants subject to the requirements being finalized in this action. EPA acknowledges the commenter's explanation of its process agent production operations and understands that the same chemical may be used for multiple purposes and, after use as a process agent, may subsequently be transformed or destroyed. The Agency agrees that the amount of process agent used is a relevant recordkeeping element to track the use of controlled substances and is finalizing that additional data element for the recordkeeping requirements. However, under existing requirements in 40 CFR 82.13(f)(2)(ii) and 82.24(b)(1)(i) and (ii), entities must differentiate production records by whether the quantities of controlled substances were intended for use in processes resulting in their transformation or destruction. EPA understands that some quantities of controlled substances are produced solely for use by the same entity as a process agent and ultimately are not transformed or destroyed. The Agency understands that complete information on future use and disposition may not be known at the time of production, but sees value in documentation of the expected use. Therefore, in addition to requiring that entities maintain records of the quantities of each controlled substance initially introduced into the process agent application for use as a process agent, EPA is clarifying records of the quantity that was produced for use as a process agent refers to the expectation at the time of production. This requirement for entities that use process agents is separate from existing requirements for producers in 40 CFR 82.13(f)(2)(ii) and 82.24(b)(1)(i) and (ii) and may not necessarily correspond directly with the quantities actually used as a process agent.
Consistent with EPA's commitment to transparency in program implementation, as well as to proactively encourage compliance with EPA's general ODS phaseout and to meet the United States' reporting commitments under the Montreal Protocol, EPA is finalizing determinations for the treatment and release of data that will be collected.
EPA is finalizing certain categorical emission data and confidentiality determinations for individual reported data elements that EPA will be collecting through this rulemaking. This action identifies certain information categories that must be submitted to the Agency that will be subject to disclosure to the public without further notice because the information has been determined to be either “emission data” under 40 CFR 2.301(a), or EPA has found that the information does not meet the standard for confidential treatment under Exemption 4 of the FOIA. The Agency has also identified certain other categories of information that may be entitled to confidential treatment. The emission data and confidentiality determinations in this action are intended to encourage consistency among reported data, compliance with EPA's ODS phaseout, and to meet the United States' reporting commitments under the Montreal Protocol. Establishing these determinations through this rulemaking will provide predictability for both information requesters and submitters. Separately, for information reported on process agents that is not addressed in this rulemaking,
Regulated entities that must submit information to EPA frequently claim that some or all of that information is entitled to confidential treatment and therefore exempt from disclosure under Exemption 4 of the FOIA.
Generally, when EPA has information that the Agency intends to disclose publicly that is covered by a claim of confidentiality under FOIA Exemption 4, EPA has a process to make case-by-case or class determinations under 40 CFR part 2 to evaluate whether such information qualifies for confidential treatment under the exemption.
The U.S. Supreme Court decision in
Following the issuance of the Court's opinion in
As described further below, EPA is making categorical determinations that some of the data elements that will be submitted to EPA are not entitled to confidential treatment because either: it is not the type of information that submitters customarily keep private or closely held; it is already publicly available; or it is discernible information that is self-evident or readily observable through reverse engineering by a third party.
The CAA states that “[a]ny records, reports or information obtained under [section 114] shall be available to the public.”
The regulations at 40 CFR 2.301 define emission data to include the following:
• Information necessary to determine the identity, amount, frequency, concentration, or other characteristics (to the extent related to air quality) of any emission which has been emitted by the source (or of any pollutant resulting from any emission by the source), or any combination of the foregoing;
• Information necessary to determine the identity, amount, frequency, concentration, or other characteristics (to the extent related to air quality) of the emissions which, under an applicable standard or limitation, the source was authorized to emit (including, to the extent necessary for such purposes, a description of the manner or rate of operation of the source); and
• A general description of the location and/or nature of the source to the extent necessary to identify the source and to distinguish it from other sources (including, to the extent necessary for such purposes, a description of the device, installation, or operation constituting the source).
In this action, EPA is applying the regulatory definition of “emission data” in 40 CFR 2.301(a)(2)(i) to determine that certain categories of source certification and compliance information are not entitled to confidential treatment because they qualify as emission data. That information is subject to disclosure to the public without further notice. As relevant to this action, a “source” for purposes of the definition in 40 CFR 2.301 is generally the equipment covered by a regulatory requirement, such as process equipment in a plant or facility and any related emission units. EPA's definition of emission data also excludes certain information related to products still in the research and development phase or products not yet on the market except for limited purposes. Thus, for example, 40 CFR 2.301(a)(2)(ii) excludes information related to “any product, method, device, or installation (or any component thereof) designed and intended to be marketed or used commercially but not yet so marketed or used.” This specific exclusion from the definition of emission data is limited in time. EPA has concluded that no data related to this exclusion are implicated in this rulemaking because data required to be reported under this rule generally relate to equipment that EPA understands are primarily for purposes of maintaining legacy production processes at existing facilities.
Consistent with EPA's commitment to transparency in program implementation, EPA has reviewed the data reporting elements being finalized in this action to see if information under the umbrella of those data elements could be considered entitled to confidential treatment. EPA is finalizing as proposed its determinations to treat
Some of the data elements EPA is collecting may be similar to or the same as those required to be reported under the existing requirements associated with the GHGRP, particularly for entities subject to 40 CFR part 98, subpart L. Those reporting requirements are separate and the Agency is not making any changes to 40 CFR part 98 in this rulemaking. To the extent relevant, data elements submitted in accordance with requirements established through this rulemaking and determined to not be confidential under 40 CFR part 82, subpart A, will not be provided confidential treatment regardless of whether they have previously been determined to be confidential under the GHGRP.
Specifically, EPA proposed that the identity of byproducts manufactured in the process agent application; contact information for facilities that use controlled substances as process agents; emission data, including reported emission factors and the proposed ODS process agent monitoring plan; and technologies currently being used and actions taken to minimize use or emissions of controlled substances used as process agents would not be considered confidential. The Agency proposed in general, as described in more detail in a memorandum to the docket for this rulemaking, to determine the following information concerning ODS process agents as confidential: process agent sourcing; internal facility processes such as the quantity of process agent use, process agent recycling, process agent reuse, end products from the process agent application (
One commenter supported EPA's proposal that data reported by the United States in accordance with commitments under the Montreal Protocol would not be confidential and stated that publishing this data is a requirement to assess the success of current emissions abatement technologies. The same commenter urged EPA to transparently share data on process agent emissions by specific use.
EPA acknowledges the commenter's support for the Agency's determination of the confidentiality of information submitted under the Montreal Protocol on behalf of the United States. The Agency reiterates that EPA may release and publish both data that has been determined to not be confidential and aggregated data derived from information that has been determined to be confidential. The Agency will further consider how such data may be shared.
Another commenter stated that certain data reporting elements established in this action, as addressed in sections III.A, III.B, and III.C of this preamble, meet the criteria to be considered confidential and requested that other elements that also meet those criteria may also be treated as confidential. The commenter requested that EPA confirm that the Agency will extend confidential treatment to all information submitted in the one-time and annual reports that meet FOIA exemptions. The commenter further stated that EPA should not preclude entities from claiming information as confidential in the reports if the item or process is not on EPA's list of items that should be identified as confidential information, but that does meet a FOIA statutory exemption. The commenter statements generally aligned with EPA's proposed confidentiality determinations.
In accordance with the process established in this action at 40 CFR 82.26, EPA is making determinations by rulemaking on data elements discussed in this section, as well as in the addendum provided in the docket for this action titled
The commenter more specifically stated that percentages of class I controlled substances used as a process agent and retained, recovered, or entrained in the final product should be identified as confidential. The commenter noted that EPA had proposed to determine that information relating to internal process agent use, recycling, reuse, products, and byproducts would be confidential and requested that EPA clearly delineate that this information would be considered confidential. In support of its assertions, the commenter claimed that percentages and volumes, despite the few domestic manufacturers for some of the controlled substances, could reveal insights into a variety of sensitive considerations, including business decisions, production approaches, operational changes, and confidential manufacturing processes. The commenter specifically stated that percentages used as a process agent and then retained, recovered, or recycled, and the amounts of each product and byproduct manufactured during the prior control period, including the amounts destroyed or used as feedstock, are confidential. The commenter stated that there may be technologies or processes in place that reduce information (EPA understands the commenter as intending to refer to emissions) but are trade secrets or otherwise related to commercial information that qualify for exemptions as confidential under the Freedom of Information Act (FOIA).
As discussed in section III.A of the preamble, EPA disagrees that reported information on percentages of process agent used would disclose confidential information concerning overall production of the given controlled substances. The relevant data elements are, of the amount of controlled substance used as a process agent, what percentages in the process agent application were respectively retained, consumed, recovered, emitted, or entrained. These representative percentages of process agent use through a cycle of the process agent application would not compromise its manufacturing processes. With regard to the particular data elements, EPA acknowledges the commenter's support for its confidentiality determinations and determines, as proposed, that specific information related to internal processes,
The commenter referenced EPA's proposed determinations of data elements for annual reports, including examples for internal facility processes. The commenter stated that this confidential information includes, but may not be limited to, information proposed to be submitted under 40 CFR 82.13(ee)(2)(iv) for the amount used as a process agent that was ultimately transformed, recycled, or destroyed, and under 40 CFR 82.13(ee)(2)(vi) for the amount of product and byproduct manufactured in the process agent application. The commenter further stated that production variability due to market variability is confidential, supported the Agency's proposed confidentiality determination concerning the proposed advance notice of change, and, if the requirements were to be finalized, encouraged EPA to confirm that the determination applies to information submitted in advance of a change.
EPA discusses comments concerning the annual report and advance notice of changes in sections III.B and C. of this preamble. As specified above in this section of the preamble, the Agency will treat the confidentiality of submitted information in accordance with its determinations by rulemaking. Entities may claim other information as confidential, and EPA will follow the process described in this section of the preamble. EPA acknowledges the commenter's support in general on the proposed confidentiality determinations and notes that the Agency is finalizing in this action a determination that the fact that an advance notice of changes was submitted is not confidential, but the changes themselves are confidential.
EPA is finalizing a definition of “process agent” largely the same as the definition proposed, with the addition of a list explicitly including currently approved process agent uses, and is finalizing as proposed two definitions to better reflect current Agency and international practices. EPA is also adding definitions as part of the emission reporting requirements this action is establishing in 40 CFR 82.25.
EPA proposed to define the term “process agent” for the purposes of 40 CFR part 82 as “the use of a controlled substance to form the environment for a chemical reaction or inhibiting an unintended chemical reaction (
One commenter supported EPA's proposed definition of “process agent.” EPA acknowledges the first commenter's support for the proposed definition of “process agent.”
Another commenter suggested that specific measurable numerical thresholds for quantities retained in the final product or consumed during the reaction would provide regulatory clarity. The commenter recommended EPA define a residual concentration of process agent in a product as 0.01 percent by weight and to set a consumption rate of below one percent to distinguish a controlled substance used as a process agent from one use as a feedstock.
The Agency acknowledges the commenter's statement that including thresholds may provide additional clarity, but disagrees with the commenter's suggested changes. EPA did not propose numerical thresholds, the commenter did not provide supporting evidence to justify the particular suggested values, and it is not readily apparent what the appropriate thresholds for these process agent uses would be. In this action EPA is establishing reporting requirements for these process agent uses, including for information that would be relevant for further consideration of this issue. Specifically, as discussed in section III.A of this preamble, EPA is establishing requirements in the one-time report for companies to provide details of the amount of process agent used and of what percentages are subsequently retained within the process agent application, consumed during the process agent application, recovered after the process agent application, emitted, or entrained in the final product. EPA is not establishing numerical thresholds at this time, but will consider this information, as well as potential interactions with related
A commenter who uses a controlled substance in a manufacturing process expressed concern that the definition EPA proposed could unintentionally exclude certain existing uses, including the commenter's use. The commenter noted that EPA had previously acknowledged that its use of a controlled substance constituted a process agent use, the same process agent use is listed in table A to decision XXXI/6, and the commenter has annually submitted information to EPA on this process agent use. For clarity and to include existing approved uses, this commenter recommended that the Agency revise the definition to reference, in addition to chemical changes, uses that result in forming the environment for or inhibiting an unintended physical change, and to specify a physical spinning/extruding process as an example. Alternatively, the commenter recommended to expand the definition to include any uses identified in the Technology and Economic Assessment Panel (TEAP)'s list of process agent usages, and included in Table A from a TEAP report.
EPA acknowledges the commenter's concerns that the text of the proposed definition of “process agent” could be interpreted to exclude existing process agent uses. The Agency understands, based on another TEAP report included in the comments, that the controlled substance in question is used as an extraction solvent associated with a chemical reaction process. EPA sought clarification from the commenter and confirmed that it does not use the process agent for other purposes. EPA did not intend in this definition to exclude existing process agent uses that EPA has previously recognized, as listed in footnote 6 to the proposed rule (88 FR 72030). However, EPA disagrees that it is appropriate or necessary to include physical changes in the definition. As EPA discussed in a similar context for HFC process agents (86 FR 55135), EPA does not have sufficient information to support a change. It is unclear what other processes might be included within that wider scope or what the potential implications may be of including physical changes in the definition. Furthermore, EPA does not agree that any uses listed by the TEAP should be incorporated into the definition. Table A, first established in decision X/14 and most recently updated in decision XXXI/6, includes all uses that have been permitted among the Parties to the Montreal Protocol, including those that have not been approved for the United States. Table A may be subject to further updates by the Parties in the future, and EPA is aware that five of these uses continue in the United States. In this action EPA clarifies that the definition of “process agent” includes, but is not limited to, the use of the following controlled substances in the following process agent applications and therefore the existing use referenced by the commenter: the use of carbon tetrachloride in the elimination of nitrogen trichloride in chlor-alkali production, the use of carbon tetrachloride in the recovery of chlorine by tail gas absorption from chlor-alkali production, the use of CFC-11 in the production of synthetic fiber sheet, the use of bromochloromethane in bromination of a styrenic polymer, and the use of CFC-113 in the production of high modulus polyethylene fiber. This definition also includes any other uses of controlled substances that meet the functional criteria.
One commenter supported EPA's proposed definitions of “plant” and “facility.” Another commenter stated that the Agency should change the term “plant” to “unit” or “process unit” because “plant” may be used synonymously as EPA's proposed definition of “facility.” The commenter also stated that, in addition to process equipment, this definition should include a collection of process equipment.
EPA acknowledges the first commenter's support for the proposed definitions. In response to the second commenter, EPA recognizes that terminologies may vary between particular situations, the term “plant” may be used in similar contexts as “facility,” the reference to process equipment could be applied more narrowly to a process unit, and that a plant would typically contain a collection or group of process equipment. However, multiple plants may be collocated within what is commonly considered a facility. These terms have particular relevance within EPA's domestic requirements and the Montreal Protocol. For example, in decision X/14 the Parties agreed, with certain conditions, that no new plants using the listed process agents would be installed or commissioned. This context more closely aligns with equipment associated with a process agent application than an overall industrial site. Similarly, a plant contains any process equipment associated with the relevant industrial operations. The definition of “plant” is intended to broadly encompass any individual piece or collection of equipment. EPA further clarifies that this term includes any equipment that use controlled substances, such as process agents, related to industrial operations that convert raw materials, convert feedstock chemicals, or produce other chemicals. EPA is therefore not adopting the commenter's suggested changes to the definitions. Moreover, EPA expects the terminology, that is being finalized as proposed, will be clear for the limited set of entities subject to the requirements of 40 CFR part 82.
EPA is finalizing the definitions listed in the description of procedures to implement the proposed emission reporting requirements in 40 CFR part 82, subpart A. These definitions align with existing practice in 40 CFR part 98, subpart L, and the Agency did not receive comment on these definitions. The defined terms are: “batch emission episode,” “batch process or batch operation,” “byproduct,” “continuous process or operation,” “difficult-to-monitor,” “dual mechanical seal pump and dual mechanical seal agitator,” “equipment,” “in controlled substance service,” “in gas and vapor service,” “in heavy liquid service,” “in light liquid service,” “in vacuum service,” “isolated intermediate,” “no external shaft pump and no external shaft agitator,” “operating scenario,” “process,” “process condenser,” “process vent,” “typical batch,” “uncontrolled emissions of controlled substances,” and “unsafe-to-monitor.”
The recordkeeping and reporting requirements EPA is establishing in this rule for uses of ODS as process agents in general codify existing practices and do not represent substantive additional effort on the part of affected entities. EPA is aware of six potentially affected entities, and expects that these entities are already able to meet most of the requirements based on current practice. These requirements will support U.S. efforts to report information consistent with Montreal Protocol decisions and to better understand potential implications of uses of ODS as process agents under the CAA.
EPA expects that entities that will be affected by this action are already subject to recordkeeping and reporting requirements under 40 CFR part 82 and that the requirements established in this action will not result in significant increased burden. In 40 CFR 82.13 and 82.24 the Agency had already required producers of controlled substance to record and report related information, including requirements in 40 CFR 82.13(f)(2)(vii) and 82.24(b)(2)(vi) to maintain records of any controlled
This action will result in costs for each subject entity to prepare an initial one-time report, submit annual reports and notifications of significant changes as warranted, and recordkeeping. However, with regards to the annual reports, the Agency has historically solicited information from the affected entities via annual requests. Therefore, EPA expects any associated change in burden will be limited relative to past practice. The Agency conservatively estimates these requirements to result in costs of approximately $13,000 per facility for the first year, with the higher costs due to initial preparation of the one-time report, and $1,000 per facility in following years for continued compliance with the other recordkeeping and reporting requirements. As noted in section II.B. of this preamble, EPA does not anticipate the establishment of new processes or facilities using ODS as process agents. The Agency did not receive additional information on this assumption in response to a request for comment at proposal.
The Agency estimates that the annual emissions reporting requirements being finalized in this action, without accounting for past practice, will result in additional costs of approximately $190,000 per facility in the first year due to initial planning and additional sampling, analysis, monitoring, and calculations. EPA estimates compliance costs of approximately $17,000 in subsequent years for continued sampling, analysis, monitoring, and calculations. The total estimated costs for all requirements are approximately $1.8 million in the first year and $210,000 annually in subsequent years. The costs are discussed in the supporting statement for the information collection request (ICR).
This action is not a significant regulatory action as defined in Executive Order 12866, as amended by Executive Order 14094, and was therefore not subject to a requirement for Executive Order 12866 review.
The information collection activities in this rule will be submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR number 1432.40. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.
This ICR covers provisions under the Montreal Protocol and title VI of the CAA that establish limits on total U.S. production, import, and export of class I and class II ozone-depleting substances (or controlled substances). Production and import of class I controlled substances was phased out in the United States. The phaseout includes exceptions for essential uses, critical uses of methyl bromide, quarantine and pre-shipment uses of methyl bromide, previously used material, and material that will be transformed or destroyed. There are also regulations that restrict the use of class II controlled substances and require a gradual reduction in the production and consumption of these chemicals leading to their eventual phaseout. The class II controlled substance phaseout regulations include exceptions for previously used material and material that will be transformed or destroyed.
In this action, EPA is establishing requirements for one-time, annual, and situational reporting and for recordkeeping to provide relevant information to EPA concerning implications of process agent uses and emissions and support international agreements concerning the use of controlled substances as process agents. One-time reporting, annual reporting, and recordkeeping requirements are consistent with the existing requirements for importers and producers in 40 CFR 82.13 for class I controlled substances and 40 CFR 82.24 for class II controlled substances. These requirements are also consistent with existing practice of facilities subject to this rule who have provided similar information to EPA concerning these uses of controlled substances as process agents. The ICR includes these incremental changes in addition to the existing reporting and recordkeeping programs that are approved under OMB control number 2060-0170.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities because none of the identified affected entities are small entities.
This action does not contain an unfunded mandate of $100 million (in 1995 dollars, adjusted annually for inflation) or more or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. While this action creates an enforceable duty on the private sector, the cost is less than $100 million.
This action does not have federalism implications. It will 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 action does not have Tribal implications as specified in Executive Order 13175. EPA is not aware of Tribal businesses engaged in activities that would be directly affected by this action. Based on the Agency's assessments, as discussed in section VI of this preamble, EPA also does not believe that potential effects, even if direct, would be substantial. Accordingly, this action will not have substantial direct effects on one or more Indian Tribes, the relationship between the Federal Government and Indian Tribes, or the distribution of power and responsibilities between the Federal Government and Indian Tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action. The Agency has updated Tribal officials on this air regulation through a monthly meeting of the National Tribal Air Association.
EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. Therefore, this action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks. Since this action does not concern human health, EPA's Policy on Children's Health also does not apply.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This action involves technical standards. EPA has decided to allow the use of the following ASME, ASTM, and EPA standards as compliance options under the emission reporting requirements established in this action. These existing voluntary consensus standards were previously incorporated under the GHGRP in 40 CFR 98.7 to help facilities monitor, report, and keep records of GHG emissions. This version of ASTM D6348-03 was previously incorporated by reference in 40 CFR 60.17 and the remaining standard versions, except for ASME MFC-4M-1986 (Reaffirmed 2016), were previously incorporated by reference in 40 CFR 98.7. ASME MFC-3M-2004 specifies the geometry and method of use for pressure difference devices which give necessary information for calculating flow rates and associated uncertainties. ASME MFC-4M-1986 (Reaffirmed 2016) specifies procedures to evaluate flow rates using turbine meters. ASME MFC-5M-1985 (Reaffirmed 1994) specifies procedures to evaluate flow rates using ultrasonic flowmeters that base their operation on the measurement of transit times of acoustic signals. ASME MFC-6M-1998 describes the use of vortex flowmeters to measure volumetric flow rate and total flow. ASME MFC-7M-1987 (Reaffirmed 1992) specifies the geometry and method of use for critical flow venturi nozzles. ASME MFC-9M-1988 (Reaffirmed 2001) specifies a method to calculate liquid flow rate and uncertainties by measuring the mass of liquid delivered into a weighing tank in a known time interval. ASME MFC-11M-2006 gives guidelines for the selection, installation, calibration, and operation of Coriolis flow meters for the determination of mass flow, density, volume flow, and other related parameters of flowing fluids. ASME MFC-14M-2003 specifies the geometry and method of use for orifice meters. The ASME standards are available for purchase from Two Park Avenue, New York, NY 10016, phone: 800.843.2763, email:
ASTM D6348-03 specifies a test method to quantify gas phase concentrations of target analytes by using extractive direct interface FTIR spectroscopy. The ASTM International standard is available for purchase from ASTM International at 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428; tel.: 610.832.9500;
EPA's Approved Alternative Method 012 specifies procedures to use a tracer gas to determine the stack gas volumetric flow rate when low velocities and temporal variations complicate measurement. The Emissions Inventory Improvement Program, Volume II: Chapter 16 provides methods for estimating air emissions from chemical manufacturing facilities. EPA-453/R-95-017 provides a protocol to generic process unit-specific estimates for equipment leak emissions. EPA-430-R-10-003 provides a protocol for two specific methods for measuring abatement system inlet and outlet flows, and hence destruction or removal efficiencies, for process equipment. EPA's Other Test Method 24 specifies a tracer gas procedure with a gas chromatograph and flame ionizer detector to measure the volumetric flow rate. The EPA standards are freely available from U.S. Environmental Protection Agency at 1200 Pennsylvania Avenue NW, Washington, DC 20460, 202.272.0167,
EPA believes that this type of action does not concern human health or environmental conditions and therefore cannot be evaluated with respect to potentially disproportionate and adverse effects on communities with environmental justice concerns because it does not impact emissions from subject facilities. This regulatory action establishes reporting and recordkeeping requirements that do not impact human health or the environment, but provide additional insight into the uses and emissions of ODS used as process agents.
This action is subject to the CRA, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Environmental protection, Chemicals, Emissions, Incorporation by reference, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, 40 CFR part 82 is amended as follows:
42 U.S.C. 7414, 7601, 7671-7671q.
The additions and revisions read as follows:
(1) Each dual mechanical seal system is operated with the barrier fluid at a pressure that is at all times (except periods of startup, shutdown, or malfunction) greater than the pump or agitator stuffing box pressure; or
(2) Equipped with a barrier fluid degassing reservoir that is routed to a process or fuel gas system or connected by a closed-vent system to a control device; or
(3) Equipped with a closed-loop system that purges the barrier fluid into a process stream.
(1) The vapor pressure of one or more of the compounds is greater than 0.3 kilopascals at 20 °C;
(2) The total concentration of the pure compounds constituents having a vapor pressure greater than 0.3 kilopascals at 20 °C is equal to or greater than 20 percent by weight of the total process stream; and
(3) The fluid is a liquid at operating conditions.
Note 1 to definition of “in light liquid service”: Vapor pressures may be determined by standard reference texts or ASTM D-2879.
(1) A description of the process, the specific process equipment used, and the range of operating conditions for the process.
(2) An identification of related process vents, their associated emissions episodes and durations, and calculations and engineering analyses to show the annual uncontrolled emissions of controlled substances from the process vent.
(3) The control or destruction units used, as applicable, including a description of operating and/or testing conditions for any associated destruction unit.
(4) The process vents (including those from other processes) that are simultaneously routed to the control or destruction unit(s).
(5) The applicable monitoring requirements and any parametric level that assures destruction or removal for all emissions routed to the control or destruction unit.
The addition reads as follows:
(ee)
(1)
(i) The name and address of each facility and plant, and each responsible person's name, email address, and phone number;
(ii) The name, purpose, and final product manufactured of each process agent application that uses a class I controlled substance;
(iii) The start-up date of each facility and the start-up date of each plant that uses a class I controlled substance as a process agent;
(iv) For each facility, the names and amounts of each product and byproduct manufactured in the process agent application during the previous control period, including amounts destroyed or used as a feedstock;
(v) For each facility, the total air, fugitive air, and stack point air emissions of class I controlled substances used as a process agent during the previous control period;
(vi) For each facility, a description of technologies currently being used and actions taken or currently under evaluation to minimize use or emissions of class I controlled substances used as process agents (including estimated emissions reductions associated with each); and
(vii) For each facility, a description that includes details of the percentages of class I controlled substances used as a process agent and:
(A) Retained within the process agent application;
(B) Consumed in the process agent application;
(C) Recovered after the process agent application;
(D) Emitted; and
(E) Entrained in the final product.
(2)
(i) For each facility, contact information including email address and phone number for a primary and alternate contact person;
(ii) For each facility, the name and amount of each class I controlled substance initially introduced into the process agent application for use as a process agent, specified independently for paragraphs (ee)(2)(ii)(A) through (G) of this section by whether the class I controlled substance was:
(A) Obtained as virgin;
(B) Obtained as used;
(C) Produced by the entity;
(D) Purchased from a U.S. producer;
(E) Imported;
(F) Reclaimed by the entity from a different use; and
(G) Reclaimed by another entity;
(iii) For each facility, the name and amount of each class I controlled substance used as a process agent and reused or recycled for use by the entity for continued use in the same process agent application at the same facility;
(iv) For each facility, the name and amount of each class I controlled substance used as a process agent that was ultimately:
(A) Transformed;
(B) Reused or recycled for use in a different process agent application; or
(C) Destroyed by approved destruction technologies;
(v) For each facility, the total air, fugitive air, and stack point air emissions of each class I controlled substance used as a process agent;
(vi) For each facility, the names and amounts of each product and byproduct manufactured in the process agent application during the previous control period, including amounts destroyed or used as a feedstock;
(vii) For each facility, a description of emission reduction actions for class I controlled substances used as a process agent taken since the last one-time or annual report, planned, or currently under evaluation; and
(viii) For each entity, any process agent application changes anticipated to result in increases for the next annual report, as compared to the previous control period and the average of the three previous control periods, of the following magnitude must be specified in a report submitted to EPA at least 180 days prior to implementing the change:
(A) Greater than 20 percent of the amount of class I controlled substance initially introduced for use as a process agent; or
(B) At least one metric ton and 20 percent of the amount emitted during use as a process agent.
(3)
(i) Dated records of the quantity of each class I controlled substance initially introduced at each facility into the process application for use as a process agent;
(ii) Dated records of the quantity of each class I controlled substance produced at each facility for use as a process agent;
(iii) Records identifying the producer or importer of the class I controlled substance received at each facility for use as a process agent by the entity;
(iv) For each facility, copies of the invoices or receipts documenting the sale or other transfer of ownership of each class I controlled substance for use as a process agent to the entity;
(v) Dated records identifying the quantity of each product manufactured within each facility by using a class I controlled substance as a process agent;
(vi) For each facility, records of the date and the estimated quantity of any spill or release of each class I controlled substance used as a process agent that equals or exceeds 100 pounds;
(vii) For each facility, a description of the methodology used to measure and calculate emissions, and dated records of equipment parameters, measured data, supporting calculations, and other rationale used to validate reported emission quantities;
(viii) For each facility, dated records of the quantity of each class I controlled substance used as a process agent which is subsequently transformed or destroyed;
(ix) In the case where class I controlled substances used as a process agent were ultimately transformed by an entity other than the entity which last used the class I controlled substances as a process agent, a copy of the Internal Revenue Service Certificate showing that the purchaser or recipient of the controlled substance, in the United States or in another country that is a Party, certifies the intent to transform the controlled substance, or sell the controlled substance for transformation; and
(x) In the case where class I controlled substances used as a process agent were ultimately destroyed by an entity other than the entity which last used the class I controlled substances as a process agent, a copy of the destruction verification (as in paragraph (k) of this section), showing that the purchaser or recipient of a controlled substance, in the United States or in another country that is a Party, certifies the intent to destroy the controlled substance, or sell the controlled substance for destruction.
(4)
(i) This request must include the following information:
(A) Name of the facility submitting the request, contact information for a
(B) An explanation of the reasons that an extension is necessary and the timeline that would be practicable; and
(C) Supporting documentation of the circumstances.
(ii) The Administrator will review the request and, within five working days of receiving a complete request, provide notification of whether the request is granted and when the report is due.
(5)
The addition reads as follows:
(g)
(1)
(i) The name and address of each facility and plant, and each responsible person's name, email address, and phone number;
(ii) The name, purpose, and final product manufactured of each process agent application that uses a class II controlled substance;
(iii) The start-up date of each facility and the start-up date of each plant that uses a class II controlled substance as a process agent;
(iv) For each facility, the names and amounts of each product and byproduct manufactured in the process agent application during the previous control period, including amounts destroyed or used as a feedstock;
(v) For each facility, the total air, fugitive air, and stack point air emissions of class II controlled substances used as a process agent during the previous control period;
(vi) For each facility, a description of technologies currently being used and actions taken or currently under evaluation to minimize use or emissions of class II controlled substances used as process agents (including estimated emissions reductions associated with each); and
(vii) For each facility, a description that includes details of the percentages of class II controlled substances used as a process agent and:
(A) Retained within the process agent application;
(B) Consumed in the process agent application;
(C) Recovered after the process agent application;
(D) Emitted; and
(E) Entrained in the final product.
(2)
(i) For each facility, contact information including email address and phone number for a primary and alternate contact person;
(ii) For each facility, the name and amount of each class II controlled substance initially introduced into the process agent application for use as a process agent, specified independently for paragraphs (g)(2)(ii)(A) through (G) of this section by whether the class II controlled substance was:
(A) Obtained as virgin;
(B) Obtained as used;
(C) Produced by the entity;
(D) Purchased from a U.S. producer;
(E) Imported;
(F) Reclaimed by the entity from a different use; and
(G) Reclaimed by another entity;
(iii) For each facility, the name and amount of each class II controlled substance used as a process agent and reused or recycled for use by the entity for continued use in the same process agent application at the same facility;
(iv) For each facility, the name and amount of each class II controlled substance used as a process agent that was ultimately:
(A) Transformed;
(B) Reused or recycled for use in a different process agent application; or
(C) Destroyed by approved destruction technologies;
(v) For each facility, the total air, fugitive air, and stack point air emissions of each class II controlled substance used as a process agent;
(vi) For each facility, the names and amounts of each product and byproduct manufactured in the process agent application during the previous control period, including amounts destroyed or used as a feedstock;
(vii) For each facility, a description of emission reduction actions for class II controlled substances used as a process agent taken since the last one-time or annual report, planned, or currently under evaluation; and
(viii) For each entity, any process agent application changes anticipated to result in increases for the next annual report, as compared to the previous control period and the average of the three previous control periods, of the following magnitude must be specified in a report submitted to EPA at least 180 days prior to implementing the change:
(A) Greater than 20 percent of the amount of class II controlled substance initially introduced for use as a process agent; or
(B) At least one metric ton and 20 percent of the amount emitted during use as a process agent.
(3)
(i) Dated records of the quantity of each class II controlled substance initially introduced at each facility into the process application for use as a process agent;
(ii) Dated records of the quantity of each class II controlled substance produced at each facility for use as a process agent;
(iii) Records identifying the producer or importer of the class II controlled substance received at each facility for use as a process agent by the entity;
(iv) For each facility, copies of the invoices or receipts documenting the sale or other transfer of ownership of each class II controlled substance for use as a process agent to the entity;
(v) Dated records identifying the quantity of each product manufactured within each facility by using a class II controlled substance as a process agent;
(vi) For each facility, records of the date and the estimated quantity of any spill or release of each class II
(vii) For each facility, a description of the methodology used to measure and calculate emissions, and dated records of equipment parameters, measured data, supporting calculations, and other rationale used to validate reported emission quantities;
(viii) For each facility, dated records of the quantity of each class II controlled substance used as a process agent which is subsequently transformed or destroyed;
(ix) In the case where class II controlled substances used as a process agent were ultimately transformed by an entity other than the entity which last used the class II controlled substances as a process agent, a copy of the entity's transformation verification as provided under paragraph (e)(3) of this section; and
(x) In the case where class II controlled substances used as a process agent were ultimately destroyed by an entity other than the entity which last used the class II controlled substances as a process agent, a copy of the entity's destruction verification, as provided under paragraph (e)(5) of this section.
(4)
(i) This request must include the following information:
(A) Name of the facility submitting the request, contact information for a person at the facility, and the address of the facility;
(B) An explanation of the reasons that an extension is necessary and the timeline that would be practicable; and
(C) Supporting documentation of the circumstances.
(ii) The Administrator will review the request and, within five working days of receiving a complete request, provide notification of whether the request is granted and when the report is due.
(5)
(a)
(1) Use of a controlled substance as a process agent.
(2) [Reserved]
(b)
(1)
(i) Each controlled substance used as a process agent.
(ii) [Reserved]
(2)
(i) Each activity listed in paragraph (a) of this section;
(ii) Each separation process for the reuse or recycling of the controlled substance;
(iii) Each transformation process of the controlled substance, where the controlled substance is produced at the facility and used in processes resulting in its transformation at the same facility;
(iv) Each transformation process of the controlled substance at the facility, where one or more of the controlled substances transformed at the facility is produced at another facility; and
(v) Each destruction process of the controlled substance.
(c)
(1)
(i)
(A)
(
(
(
(
(
(
(
(B)
(
(
(
(
(C)
(
(
(D)
(ii)
(B) The remaining continuous process vents that comprise the bottom three quartiles of estimated annual emissions of controlled substances may use either the emission factor method specified in paragraph (c)(1)(iii) of this section (Emission Factor approach) or a method specified in paragraph (c)(1)(iv) of this section (Emission Calculation Factor approach).
(
(
(iii)
(A) Conduct a separate emissions test for operation under each operating scenario.
(B) Conduct an emissions test for the operating scenario that is expected to have the largest emissions of controlled substances (considering both activity
(C) Each entity must measure the process activity, such as the process feed rate, process production rate, or other process activity rate, as applicable, during the emissions test and calculate the rate for the test period, in kg (or another appropriate metric) per hour.
(D) For continuous processes, each entity must calculate the hourly emission rate of each controlled substance using equation 1 to this paragraph (c)(1)(iii)(D) and determine the hourly emission rate of each controlled substance per process vent (and per operating scenario, as applicable) for the test run.
(E) Each entity must calculate a site-specific, process-vent-specific emission factor for each controlled substance for each process vent and each operating scenario, in kg of controlled substance per process activity rate (
(F) If emissions testing is conducted upstream of the destruction unit, apply the destruction efficiencies of the device that have been demonstrated for the controlled substance in the vent stream to the controlled substance emissions for the process vent (and operating scenario, as applicable), using equation 3 to this paragraph (c)(1)(iii)(F). Each entity may apply the destruction efficiency only to the portion of the process activity during which emissions are vented to the properly functioning destruction unit (
(G) For process vents from processes with multiple operating scenarios, use equation 4 to this paragraph (c)(1)(iii)(G) to develop an adjusted process-vent-specific emission factor for each operating scenario whose emission calculation factor differs by less than 15 percent from the emission calculation factor of the operating scenario that is expected to have the largest emissions (or of another operating scenario for which emission testing is performed).
(H) Sum the emissions of each controlled substance from all process vents in each operating scenario and all operating scenarios in the process for the year to estimate the total process vent emissions of each controlled substance from the process, using equation 5 to this paragraph (c)(1)(iii)(H).
(iv)
(A) Each entity must calculate uncontrolled emissions of controlled substances by individual process vent, E
(B) Each entity must calculate a site-specific, process-vent-specific emission calculation factor for each process vent each operating scenario, and each controlled substance, in kg of controlled substance per activity rate (
(C) Each entity must calculate emissions of each controlled substance for the process vent (and for each operating scenario, as applicable) for the year by multiplying the process-vent-specific emission calculation factor by the total process activity, as applicable, for the year, using equation 7 to this paragraph (c)(1)(iv)(C).
(D) If the process vent is vented to a destruction unit, apply the demonstrated destruction efficiency of the device to the controlled substance emissions for the process vent (and operating scenario, as applicable), using equation 8 to this paragraph (c)(1)(iv)(D). Apply the destruction efficiency only to the portion of the process activity that is vented to the properly functioning destruction unit (
(E) Sum the emissions of each controlled substance from all process vents in each operating scenario and all operating scenarios in the process for the year to estimate the total process vent emissions of each controlled substance from the process, using equation 9 to this paragraph (c)(1)(iv)(E).
(2)
(i) The emissions from equipment leaks must be calculated using any of the procedures in paragraphs (c)(2)(i)(A), (B), (C), or (D) of this section.
(A)
(B)
(C)
(D)
(ii) Each entity must collect information on the number of each type of equipment, the service of each piece of equipment (gas, light liquid, heavy liquid), the concentration of each controlled substance in the stream, and the time period each piece of equipment was in service (
(iii) Calculate and sum the emissions of each controlled substance in kilograms per year for equipment pieces for each process, E
(3)
(ii) Estimate annually the total mass of each controlled substance emitted at the facility from each applicable process listed in paragraph (b)(2) of this section using equation 11 to this paragraph (c)(3)(ii). Develop separate totals for each applicable process listed in paragraph (b)(2) of this section.
(4)
(i) To perform the calculation, you must first calculate the absolute and relative errors associated with the quantities calculated using either equations 18 through 21 to this section
(A) Where the measured quantity is a mass, the error in the mass must be equated to the accuracy or precision (whichever is larger) of the flowmeter, scale, or combination of volumetric and density measurements at the flow rate or mass measured.
(B) Where the measured quantity is a concentration of a stream component, the error of the concentration must be equated to the accuracy or precision (whichever is larger) with which you estimate the mean concentration of that stream component, accounting for the variability of the process, the frequency of the measurements, and the accuracy or precision (whichever is larger) of the analytical technique used to measure the concentration at the concentration measured. If the variability of process measurements is used to estimate the error, this variability shall be assumed to account both for the variability of the process and the precision of the analytical technique. Use standard statistical techniques such as the student's t distribution to estimate the error of the mean of the concentration measurements as a function of process variability and frequency of measurement.
(C) Equation 12 to this paragraph (c)(4)(i)(C) provides the general formula for calculating the absolute errors of sums and differences where the sum, S, is the summation of variables measured, a, b, c, etc. (
(D) Equation 13 to this paragraph (c)(4)(i)(D) provides the general formula for calculating the relative errors of sums and differences.
(E) Equation 14 to this paragraph (c)(4)(i)(E) provides the general formula for calculating the absolute errors of products (
(F) Equation 15 to this paragraph (c)(4)(i)(F) provides the general formula for calculating the relative errors of products.
(G) Calculate the absolute error of the controlled substance emissions estimate by performing a preliminary estimate of the annual controlled substance emissions of the process using the method in paragraph (c)(4)(i)(H) of this section. Multiply this result by the relative error calculated for the mass of halogen emitted from the process in equation 15 to paragraph (c)(4)(i)(F) of this section.
(H) To estimate the annual controlled substance emissions of the process for use in the error estimate, apply the methods set forth in paragraphs (c)(4)(ii) through (vii) and (ix) through (xvi) of this section to representative process measurements. If these process measurements represent less than one year of typical process activity, adjust the estimated emissions to account for one year of typical process activity. To estimate the terms FERd, FEP, and FEBk for use in the error estimate for equations 22, 23, and 24 to this section, you must either use emission testing, monitoring of emitted streams, and/or engineering calculations or assessments.
(ii) The total mass of each controlled substance emitted annually from each controlled substance process must be estimated by using equation 16 to this paragraph (c)(4)(ii).
(iii) The total mass of halogen emitted from process i over the period t must be estimated at least monthly by calculating the difference between the total mass of halogen in the reactant(s) (or inputs, for processes that do not involve a chemical reaction) and the total mass of halogen in the product (or outputs, for processes that do not involve a chemical reaction), accounting for the total mass of halogen in any destroyed or recaptured streams that contain reactants, products, or byproducts (or inputs or outputs). This calculation must be performed using equation 17 to this paragraph (c)(4)(iii). An element other than a halogen may be used in the mass-balance equation, provided the element occurs in all of the controlled substances fed into or generated by the process. In this case, the mass fractions of the element in the
(iv) The mass of total halogen in destroyed or recaptured streams containing halogen-containing reactants, products, and byproducts must be estimated at least monthly using equation 18 to this paragraph (c)(4)(iv) unless you use the alternative approach provided in paragraph (c)(4)(xv) of this section.
(v) The mass of each controlled substance removed from process i in stream j and destroyed over the period t (
(vi) The mass of each halogen-containing compound that is not a controlled substance and that is removed from process i in stream j and destroyed over the period t (
(vii) The mass of halogen-containing byproduct k removed from process i in stream l and recaptured over the period t must be estimated using equation 21 to this paragraph (c)(4)(vii).
(viii) To estimate the terms FERd, FEP, and FEBk for equations 22, 23, and 24 to this section, you must account for the total mass of halogen emitted, EF, estimated in equation 17 to paragraph (c)(4)(iii) of this section. These emission characterization measurements must meet the requirements in paragraph
(A) If the calculations under paragraph (b)(1)(viii) of this section, or any subsequent measurements and calculations under this subpart, indicate that the process emits 0.1 metric tons controlled substance or more, estimate the emissions from each process vent, considering controls, using the methods in paragraph (c)(1)(i) of this section. You must characterize the emissions of any process vent that emits 0.1 metric tons controlled substance or more as specified in paragraph (d)(4)(iv) of this section.
(B) For other vents, including vents from processes that emit less than 0.1 metric tons of controlled substance, you must characterize emissions as specified in paragraph (d)(4)(v) of this section.
(C) For halogen emissions that are not accounted for by vent estimates, you must characterize emissions as specified in paragraph (d)(4)(vi) of this section.
(ix) The total mass of halogen-containing reactant d emitted must be estimated at least monthly based on the total halogen emitted and the fraction that consists of halogen-containing reactants using equation 22 to this paragraph (c)(4)(ix). If the halogen-containing reactant d is not a controlled substance, you may assume that FER
(x) The total mass of halogen-containing product emitted must be estimated at least monthly based on the total halogen emitted and the fraction that consists of halogen-containing products using equation 23 to this paragraph (c)(4)(x). If the halogen-containing product is not a controlled substance, you may assume that FEP is zero.
(xi) The total mass of halogen-containing byproduct k emitted must be estimated at least monthly based on the total halogen emitted and the fraction that consists of halogen-containing byproducts using equation 24 to this paragraph (c)(4)(xi). If halogen-containing byproduct k is not a controlled substance, you may assume that FEB
(xii) The mass fraction of halogen in reactant d must be estimated using equation 25 to this paragraph (c)(4)(xii).
(xiii) The mass fraction of halogen in the product must be estimated using equation 26 to this paragraph (c)(4)(xiii).
(xiv) The mass fraction of each applicable halogen in byproduct k must be estimated using equation 27 to this paragraph (c)(4)(xiv).
(xv) As an alternative to using equation 18 to paragraph (c)(4)(iv) of this section as provided in paragraph (b)(4) of this section, you may estimate at least monthly the total mass of halogen in destroyed or recaptured streams containing halogen-containing compounds (including all halogen-containing reactants, products, and byproducts) using equation 28 to this paragraph (c)(4)(xv).
(xvi) For purposes of equation 28 to paragraph (c)(4)(xv) of this section, calculate the weighted average destruction efficiency applicable to a destroyed stream using equation 29 to this paragraph (c)(4)(xvi).
(5)
(6)
(d)
(i)
(ii)
(2)
(i)
(ii)
(iii)
(iv)
(A) Each entity may sample emissions from each process in the ducts upstream from the point where the emissions are combined.
(B) Each entity may sample in the common duct or at the outlet of the destruction unit when only one process is operating.
(C) Each entity may sample the combined emissions and use engineering calculations and assessments as specified in paragraph (c)(1)(iv) of this section to allocate the emissions to each manifolded process vent, provided the sum of the calculated controlled substance emissions across the individual process vents is within 20 percent of the total controlled substance emissions measured during the manifolded testing.
(v)
(vi)
(A)
(B)
(vii)
(3)
(i)
(ii)
(iii)
(iv)
(v)
(4)
(i)
(A) Total mass of each halogen-containing product produced. Account for any used halogen-containing product added into the production process upstream of the output measurement as directed at §§ 98.413(b) and 98.414(b) of this chapter.
(B) Total mass of each halogen-containing reactant fed into the process.
(C) The mass removed from the process in each stream fed into the destruction device.
(D) The mass removed from the process in each recaptured stream.
(ii)
(A) The concentration (mass fraction) of the halogen-containing product in each stream that is fed into the destruction device.
(B) The concentration (mass fraction) of each halogen-containing byproduct in each stream that is fed into the destruction device.
(C) The concentration (mass fraction) of each halogen-containing reactant in each stream that is fed into the destruction device.
(D) The concentration (mass fraction) of each halogen-containing byproduct in each stream that is recaptured (c
(iii)
(A) The concentration (mass fraction) of total halogen in each stream that is fed into the destruction device.
(B) The concentration (mass fraction) of total halogen in each stream that is recaptured.
(iv)
(A)
(B)
(C)
(D)
(
(
(E)
(v)
(A)
(B)
(C)
(vi)
(vii)
(viii)
(A)
(B)
(C)
(5)
(i)
(A)
(B)
(C)
(D)
(ii)
(iii)
(6)
(i)
(ii)
(iii)
(7)
(i)
(A) For all other controlled substances that are vented to the destruction unit in any stream in more than trace concentrations, each entity must test and determine the destruction efficiency achieved for the most-difficult-to-destroy controlled substance or surrogate vented to the destruction unit. Examples of acceptable surrogates include the Class 1 compounds (ranked 1 through 34) in Appendix D, Table D-
(B) [Reserved]
(ii)
(A)
(B)
(iii)
(iv)
(8)
(9)
(10)
(11)
(12)
(i) ASME MFC-3M-2004 Measurement of Fluid Flow in Pipes Using Orifice, Nozzle, and Venturi (incorporated by reference, see § 82.27).
(ii) ASME MFC-4M-1986 (Reaffirmed 2016) Measurement of Gas Flow by Turbine Meters (incorporated by reference, see § 82.27).
(iii) ASME-MFC-5M-1985, (Reaffirmed1994) Measurement of Liquid Flow in Closed Conduits Using Transit-Time Ultrasonic Flowmeters (incorporated by reference, see § 82.27).
(iv) ASME MFC-6M-1998 Measurement of Fluid Flow in Pipes Using Vortex Flowmeters (incorporated by reference, see § 82.27).
(v) ASME MFC-7M-1987 (Reaffirmed 1992) Measurement of Gas Flow by Means of Critical Flow Venturi Nozzles (incorporated by reference, see § 82.27).
(vi) ASME MFC-9M-1988 (Reaffirmed 2001) Measurement of Liquid Flow in Closed Conduits by Weighing Method (incorporated by reference, see § 82.27).
(vii) ASME MFC-11M-2006 Measurement of Fluid Flow by Means of Coriolis Mass Flowmeters (incorporated by reference, see § 82.27).
(viii) ASME MFC-14M-2003 Measurement of Fluid Flow Using Small Bore Precision Orifice Meters (incorporated by reference, see § 82.27).
(13)
(e)
(i)
(ii)
(A) A description and identification of the process listed in paragraph (b)(2) of this section.
(B) A description and number, letter, or other identifier for each process vent associated with the process. This identifier must be a consistent name reported from year to year.
(C) The type of method(s) (
(D) The type of method(s) (
(iii)
(iv)
(v)
(2)
(i) The identity and quantity of the process activity used to estimate emissions (
(ii) The site-specific, process-vent-specific emission factor(s) or emission calculation factor for each process vent associated with the process.
(iii) For each controlled substance, the mass emitted from each process vent associated with the process, in kilograms.
(iv) For each controlled substance, the total mass emitted from equipment leaks, in kilograms.
(3)
(i) If you calculate the relative and absolute errors under paragraph (c)(4)(i) of this section, the absolute and relative errors calculated under paragraph (c)(4)(i) of this section, as well as the data (including quantities and their accuracies and precisions) used in these calculations.
(ii) The balanced chemical equation that describes the reaction used to manufacture the controlled substance product and each controlled substance transformation product.
(iii) The mass and chemical formula of each controlled substance reactant emitted from the process in metric tons.
(iv) The mass and chemical formula of the controlled substance product emitted from the process in metric tons.
(v) The mass and chemical formula of each controlled substance byproduct emitted from the process in metric tons.
(vi) The mass and chemical formula of each controlled substance reactant that is fed into the process (metric tons).
(vii) The mass and chemical formula of each halogen-containing product produced by the process (metric tons).
(viii) If you use paragraph (c)(4)(iv) of this section to estimate the total mass of halogen in destroyed or recaptured streams, report the following.
(A) The mass and chemical formula of each halogen-containing product that is removed from the process and fed into the destruction device (metric tons).
(B) The mass and chemical formula of each halogen-containing byproduct that is removed from the process and fed into the destruction device (metric tons).
(C) The mass and chemical formula of each halogen-containing reactant that is removed from the process and fed into the destruction device (metric tons).
(D) The mass and chemical formula of each halogen-containing byproduct that is removed from the process and recaptured (metric tons).
(E) The demonstrated destruction efficiency of the destruction device for each controlled substance fed into the device from the process in greater than trace concentrations (fraction).
(ix) If you use paragraph (c)(4)(xv) of this section to estimate the total mass of halogen in destroyed or recaptured streams, report the following.
(A) The mass of halogen in each stream that is fed into the destruction device (metric tons).
(B) The mass of halogen that is recaptured (metric tons).
(C) The weighted average destruction efficiency of the destruction device calculated for each stream under paragraph (c)(4)(xvi) of this section.
(x) The fraction of the mass emitted that consists of each halogen-containing reactant.
(xi) The fraction of the mass emitted that consists of the halogen-containing product.
(xii) The fraction of the mass emitted that consists of each halogen-containing byproduct.
(xiii) The method used to estimate the total mass of halogen in destroyed or recaptured streams (specify paragraph (c)(4)(iv) or (xv) of this section).
(4)
(5)
(i) Chemical identity of the controlled substance(s) used in the performance test conducted to determine destruction efficiency, including surrogates, and information on why the surrogate is sufficient to demonstrate the destruction efficiency for each controlled substance, consistent with requirements in paragraph (d)(7)(i) of this section, vented to the destruction unit.
(ii) Date of the most recent destruction unit test.
(iii) Name of all applicable Federal or State regulations that may apply to the destruction process.
(6)
(i) The mass of the controlled substance emitted from the destruction unit (kilograms).
(ii) [Reserved]
(7)
(f)
(1)
(ii) Monthly and annual records, as applicable, of all analyses and calculations conducted as required under paragraph (c) of this section, including the data monitored under paragraph (d) of this section, and all information reported as required under paragraph (e) of this section.
(2)
(3)
(i) Identify all continuous process vents with emissions of controlled substances that are included in the top 25 percent of continuous process vents, and all continuous process vents in the remaining group (
(ii) Identify all batch process vents.
(iii) For each vent, identify the method used to develop the factor (
(iv) The emissions test data and reports (see paragraph (d)(2)(v) of this section) and the calculations used to determine the process-vent-specific emission factor, including the actual process-vent-specific emission factor, the average hourly emission rate of each controlled substance from the process vent during the test and the process feed rate, process production rate, or other process activity rate during the test.
(v) The process-vent-specific emission calculation factor and the calculations used to determine the process-vent-specific emission calculation factor.
(vi) The annual process production quantity or other process activity information in the appropriate units, along with the dates and time period during which the process was operating and dates and time periods the process vents are vented to the destruction unit. As an alternative to date and time periods when process vents are vented to the destruction unit, a facility may track dates and time periods that process vents by-pass the destruction unit.
(vii) Calculations used to determine annual emissions of each controlled substance for each process and the total controlled substance emissions for all processes,
(4)
(i) The data and calculations used to estimate the absolute and relative errors associated with use of the mass-balance approach.
(ii) The data and calculations used to estimate the mass of halogen emitted from the process.
(iii) The data and calculations used to determine the fractions of the mass emitted consisting of each reactant (FERd), product (FEP), and byproduct (FEBk), including the preliminary calculations in paragraph (c)(4)(viii)(A) of this section.
(5)
(i) Destruction efficiency (DE) determined for each controlled substance whose destruction the facility reflects in paragraph (c) of this section, in accordance with paragraph (d)(7)(i)(A) of this section.
(ii) Chemical identity of the controlled substance(s) used in the performance test conducted to determine destruction efficiency,
(iii) Mass flow rate of the stream containing the controlled substance or surrogate into the device during the test.
(iv) Concentration (mass fraction) of each controlled substance or surrogate in the stream flowing into the device during the test.
(v) Concentration (mass fraction) of each controlled substance or surrogate at the outlet of the destruction unit during the test.
(vi) Mass flow rate at the outlet of the destruction unit during the test.
(vii) Test methods and analytical methods used to determine the mass flow rates and controlled substance (or surrogate) concentrations of the streams flowing into and out of the destruction unit during the test.
(viii) Destruction unit conditions that are normally monitored for device control, such as temperature, total mass flow rates into the device, and CO or O
(ix) Name of all applicable Federal or State regulations that may apply to the destruction process.
(6)
(7)
(8)
(i) At a minimum, the monitoring plan shall include the elements listed in this paragraph (f)(8)(i) of this section.
(A) Identification of positions of responsibility (
(B) Explanation of the processes and methods used to collect the necessary data for calculations under this section.
(C) Description of the procedures and methods that are used for quality assurance, maintenance, and repair of all continuous monitoring systems, flow meters, and other instrumentation used to provide data for the controlled substances reported under this part.
(ii) The monitoring plan may rely on references to existing corporate documents (
(iii) The owner or operator shall revise the monitoring as needed to reflect changes in production processes, monitoring instrumentation, and quality assurance procedures; or to improve procedures for the maintenance and repair of monitoring systems to reduce the frequency of monitoring equipment downtime.
(a) Sections 2.201 through 2.215 and 2.301 of this chapter do not apply to data submitted under this subpart that EPA has determined through rulemaking to be either of the following:
(1) Emission data, as defined in § 2.301(a)(2) of this chapter, determined in accordance with section 114(c) and 307(d) of the Clean Air Act; or
(2) Data not otherwise entitled to confidential treatment.
(b) Except as otherwise provided in paragraph (d) of this section and §§ 2.201 through 2.208 and 2.301(c) and (d) of this chapter do not apply to data submitted under this part that EPA has determined through rulemaking to be entitled to confidential treatment. EPA shall treat that information as confidential in accordance with the provisions of § 2.211 of this chapter, subject to paragraph (d) of this section and § 2.209 of this chapter.
(c) Upon receiving a request under 5 U.S.C. 552 for data submitted under this part that EPA has determined through rulemaking to be entitled to confidential treatment, the relevant Agency official shall furnish the requestor a notice that the information has been determined to be entitled to confidential treatment and that the request is therefore denied. The notice shall include or cite to the appropriate EPA determination.
(d) A determination made through rulemaking that information submitted under this part is entitled to confidential treatment shall continue in effect unless, subsequent to the confidentiality determination through rulemaking, EPA takes one of the following actions:
(1) EPA determines through a subsequent rulemaking that the information is emission data or data not otherwise entitled to confidential treatment; or
(2) The Office of General Counsel issues a final determination, based on the requirements of 5 U.S.C. 552(b)(4), stating that the information is no longer entitled to confidential treatment because of change in the applicable law or newly discovered or changed facts. Prior to making such final determination, EPA shall afford the business an opportunity to submit comments on pertinent issues in the manner described by §§ 2.204(e) and 2.205(b) of this chapter. If, after consideration of any timely comments submitted by the business, the Office of General Counsel makes a revised final determination that the information is not entitled to confidential treatment, the relevant agency official will notify the business in accordance with the procedures described in § 2.205(f)(2) of this chapter.
(a)(1) Certain material is incorporated by reference into this subpart with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available
(2) The IBR material may be obtained from the sources in the following paragraphs of this section or from one or more private resellers listed in this paragraph (a)(2). For material that is no longer commercially available, contact: U.S. EPA's Air and Radiation Docket; EPA West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC 20460;
(i) Accuris Standards Store, 321 Inverness Drive, South Englewood, CO 80112; phone: (800) 332-6077; website:
(ii) American National Standards Institute (ANSI), 25 West 43rd Street, Fourth Floor, New York, NY 10036-7417; phone: (212) 642-4980; email:
(iii) GlobalSpec, 257 Fuller Road, Suite NFE 1100, Albany, NY 12203-3621; phone: (800) 261-2052; website:
(iv) Nimonik Document Center, 401 Roland Way, Suite 224, Oakland, CA 94624; phone (650) 591-7600; email:
(b) American Society of Mechanical Engineers (ASME), Two Park Avenue, New York, NY 10016, phone: 800.843.2763, email:
(1) ASME MFC-3M-2004, Measurement of Fluid Flow in Pipes Using Orifice, Nozzle, and Venturi, issued August 15, 2005; IBR approved for § 82.25(d).
(2) ASME MFC-4M-1986 (Reaffirmed 2016), Measurement of Gas Flow by Turbine Meters, reaffirmed 2016, IBR approved for § 82.25(d).
(3) ASME MFC-5M-1985 (Reaffirmed 1994), Measurement of Liquid Flow in Closed Conduits Using Transit-Time Ultrasonic Flow Meters, copyright 1985; IBR approved for § 82.25(d).
(4) ASME MFC-6M-1998, Measurement of Fluid Flow in Pipes Using Vortex Flowmeters, July 4, 1998; IBR approved for § 82.25(d).
(5) ASME MFC-7M-1987 (Reaffirmed 1992), Measurement of Gas Flow by Means of Critical Flow Venturi Nozzles, copyright 1987; IBR approved for § 82.25(d).
(6) ASME MFC-9M-1988 (Reaffirmed 2001), Measurement of Liquid Flow in Closed Conduits by Weighing Method, reaffirmed 2001; IBR approved for § 82.25(d).
(7) ASME MFC-11M-2006, Measurement of Fluid Flow by Means of Coriolis Mass Flowmeters, issued March 30, 2007; IBR approved for § 82.25(d).
(8) ASME MFC-14M-2003, Measurement of Fluid Flow Using Small Bore Precision Orifice Meters, issued April 17, 2003; IBR approved for § 82.25(d).
(c) ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428; phone: 610.832.9500; email:
(1) ASTM D6348-03 Standard Test Method for Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transform Infrared (FTIR) Spectroscopy, approved October 1, 2003, IBR approved for § 82.25(d).
(2) [Reserved]
(d) U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; phone: 202.272.0167; website:
(1) Approved Alternative Method 012: An Alternate Procedure for Stack Gas Volumetric Flow Rate Determination (Tracer Gas) (ALT-012), U.S. Environmental Protection Agency Emission Measurement Center, May 23, 1994, IBR approved for § 82.25(d).
(2) Emissions Inventory Improvement Program, Volume II: Chapter 16, Methods for Estimating Air Emissions from Chemical Manufacturing Facilities, August 2007, Final, IBR approved for § 82.25(c).
(3) Protocol for Equipment Leak Emission Estimates, EPA-453/R-95-017, November 1995 (EPA-453/R-95-017), IBR approved for § 82.25(c) and (d).
(4) Protocol for Measuring Destruction or Removal Efficiency (DRE) of Fluorinated Greenhouse Gas Abatement Equipment in Electronics Manufacturing, Version 1, EPA-430-R-10-003, March 2010 (EPA 430-R-10-003), IBR approved for § 82.25 (d).
(5) Tracer Gas Protocol for the Determination of Volumetric Flow Rate Through the Ring Pipe of the Xact Multi-Metals Monitoring System, also known as Other Test Method 24 (Tracer Gas Protocol), Eli Lilly and Company Tippecanoe Laboratories, September 2006, IBR approved for § 82.25(d).