Agricultural Marketing Service
Food and Nutrition Service
Food Safety and Inspection Service
Forest Service
Natural Resources Conservation Service
Industry and Security Bureau
Patent and Trademark Office
Air Force Department
Navy Department
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
U.S. Customs and Border Protection
Indian Affairs Bureau
Prisons Bureau
Federal Aviation Administration
Federal Motor Carrier Safety Administration
National Highway Traffic 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.
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Agricultural Marketing Service, USDA.
Direct final rule.
The Agricultural Marketing Service (AMS) is amending the Cotton Board Rules and Regulations, increasing the value assigned to imported cotton for the purposes of calculating supplemental assessments collected for use by the Cotton Research and Promotion Program. This amendment is required each year to ensure that assessments collected on imported cotton and the cotton content of imported products will be the same as those paid on domestically produced cotton. In addition, AMS is updating the Harmonized Tariff Schedule (HTS) statistical reporting numbers that were amended since the last assessment adjustment in 2021.
This direct rule is effective November 28, 2022, without further action or notice, unless significant adverse comment is received by October 28, 2022. If significant adverse comment is received, AMS will publish a timely withdrawal of the amendment in the
Interested persons are invited to submit written comments concerning this direct final rule. Comments may be submitted by mail or hand delivery to Cotton Research and Promotion, Cotton and Tobacco Program, AMS, USDA, 100 Riverside Parkway, Suite 101, Fredericksburg, Virginia 22406 or via the internet at:
Shethir M. Riva, Director, Research and Promotion, Cotton and Tobacco Program, AMS, USDA, 100 Riverside Parkway, Suite 101, Fredericksburg, Virginia 22406, telephone (540) 361-2726, facsimile (540) 361-1199, or email at
Amendments to the Cotton Research and Promotion Act (7 U.S.C. 2101-2118) (Act) were enacted by Congress under Subtitle G of Title XIX of the Food, Agriculture, Conservation, and Trade Act of 1990 (Pub. L. 101-624, 104 Stat. 3909, November 28, 1990). These amendments contained two provisions that authorized changes in the funding procedures for the Cotton Research and Promotion Program. These provisions provided for: (1) the assessment of imported cotton and cotton products; and (2) termination of refunds to cotton producers. (Prior to the 1990 amendments to the Act, producers could request assessment refunds.)
As amended, the Cotton Research and Promotion Order (7 CFR part 1205) (Order) was approved by producers and importers voting in a referendum held July 17-26, 1991, and the amended Order was published in the
This direct final rule would amend the value assigned to imported cotton in the Cotton Board Rules and Regulations (7 CFR 1205.510(b)(2)) that is used to determine the Cotton Research and Promotion assessment on imported cotton and cotton products. The total value of assessment levied on cotton imports is the sum of two parts. The first part of the assessment is based on the weight of cotton imported—levied at a rate of $1 per bale of cotton, which is equivalent to 500 pounds, or $1 per 226.8 kilograms of cotton. The second part of the import assessment (referred to as the supplemental assessment) is based on the value of imported cotton lint or the cotton contained in imported cotton products—levied at a rate of five-tenths of one percent of the value of domestically produced cotton.
Section 1205.510(b)(2) of the Cotton Board Rules and Regulations provides for assigning the calendar year weighted average price received by U.S. farmers for Upland cotton to represent the value of imported cotton. This is so that the assessment on domestically produced cotton and the assessment on imported cotton and the cotton content of imported products is the same. The source for the average price statistic is
The current value of imported cotton as published in 2021 in the
An example of the complete assessment formula and how the figures are obtained is as follows:
One bale is equal to 500 pounds.
One kilogram equals 2.2046 pounds.
One pound equals 0.453597 kilograms.
A 500-pound bale equals 226.8 kg. (500 × 0.453597).
$1 per bale assessment equals $0.002000 per pound or 0.2000 cents
The 2021 calendar year weighted average price received by producers for Upland cotton is $0.799 per pound or $1.761 per kg. (0.799 × 2.2046).
Five tenths of one percent of the average price equals $0.008806 per kg. (1.761 × 0.005).
The total assessment per kilogram of raw cotton is obtained by adding the $1 per bale equivalent assessment of $0.004409 per kg. and the supplemental assessment $0.008806 per kg., which equals $0.013215 per kg.
The current assessment on imported cotton is $0.011136 per kilogram of imported cotton. The revised assessment in this direct final rule is $0.013215, an increase of $0.002079 per kilogram. This reflects the increase in the average weighted price of Upland cotton received by U.S. farmers during the period January through December 2021.
The Import Assessment Table in section 1205.510(b)(3) of the Order indicates the total assessment rate ($ per kilogram) due for each Harmonized Tariff Schedule (HTS) number that is subject to assessment. This table must be revised each year to reflect changes in supplemental assessment rates and any changes to the HTS numbers. In this direct final rule, AMS is amending the Import Assessment Table.
AMS believes that these amendments are necessary to ensure that assessments collected on imported cotton and the cotton content of imported products are the same as those paid on domestically produced cotton. Accordingly, changes reflected in this rule should be adopted and implemented as soon as possible since it is required by regulation.
As described in this
Also, this direct-final rulemaking furthers the objectives of Executive Order 13563, which requires that the regulatory process “promote predictability and reduce uncertainty” and “identify and use the best, most innovative, and least burdensome tools for achieving regulatory ends.”
AMS has used the direct rule rulemaking process since 2013 and has not received any adverse comments; however, if AMS does receives significant adverse comments during the comment period, it will publish, in a timely manner, a document in the
This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation would not have substantial and direct effects on Tribal governments and would not have significant Tribal implications.
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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 12 of the Act, any person subject to an order may file with the Secretary of Agriculture (Secretary) a petition stating that the order, any provision of the plan, or any obligation imposed in connection with the order is not in accordance with law and requesting a modification of the order or to be exempted therefrom. Such person is afforded the opportunity for a hearing on the petition. After the hearing, the Secretary would rule on the petition. The Act provides that the District Court of the United States in any district in which the person is an inhabitant, or has his principal place of business, has jurisdiction to review the Secretary's ruling, provided a complaint is filed within 20 days from the date of the entry of the Secretary's ruling.
In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has examined the economic impact of this rule on small entities. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such action so that small businesses will not be unduly or disproportionately burdened. The Small Business Administration defines, in 13 CFR 121.201, a small cotton farming business as those having annual receipts of no more than $2,750,000 and small “Other Farm Product Raw Material Merchant Wholesalers” (cotton merchants/importers) as having no more than 100 employees. The Cotton Board estimates approximately 40,000 importers are subject to the rules and regulations issued pursuant to the Cotton Research and Promotion Order. According to the United States Census Bureau's “2019 Survey of SUSB Annual Data Tables by Establishment Industry,” most importers are considered small entities as defined by the Small Business Administration (13 CFR 121.201). This rule would only affect importers of cotton and cotton-containing products and would increase the assessments paid by the importers under the Cotton Research and Promotion Order. The current assessment on imported cotton is $0.011136 per kilogram of imported cotton. The amended assessment would be $0.013215, which was calculated based on the 12-month weighted average of price received by U.S. cotton farmers in 2021. Section 1205.510 of the Order, “Levy of assessments”, provides “The rate of the supplemental assessment on imported cotton will be the same as that levied on cotton produced within the United States.” In addition, section 1205.510 provides that the 12-month weighted average of prices received by U.S. farmers will be used as the value of imported cotton for the
Under the Cotton Research and Promotion Program, assessments are used by the Cotton Board to finance research and promotion programs designed to increase consumer demand for Upland cotton in the United States and international markets. In 2021, producer assessments totaled $40.1 million and importer assessments totaled $44.2 million. According to the Cotton Board, should the volume of cotton products imported into the U.S. remain at the same level in 2022, one could expect an increase of assessments by approximately $8,268,674.
Imported organic cotton and products may be exempt from assessment if eligible under section 1205.519 of the Order.
There are no Federal rules that duplicate, overlap, or conflict with this rule. In compliance with Office of Management and Budget (OMB) regulations (5 CFR part 1320) which implement the Paperwork Reduction Act (PRA) (44 U.S.C. Chapter 35) the information collection requirements contained in the regulation to be amended have been previously approved by OMB and were assigned control number 0581-0093, National Research, Promotion, and Consumer Information Programs. This rule does not result in a change to the information collection and recordkeeping requirements previously approved.
A 30-day comment period is provided to comment on the changes to the Cotton Board Rules and Regulations proposed herein. This period is deemed appropriate because an amendment is required to adjust the assessments collected on imported cotton and the cotton content of imported products to be the same as those paid on domestically produced cotton.
Advertising, Agricultural research, Cotton, Marketing agreements, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, AMS amends 7 CFR part 1205 as follows:
7 U.S.C. 2101-2118; 7 U.S.C. 7401.
(b) * * *
(2) The 12-month average of monthly weighted average prices received by U.S. farmers will be calculated annually. Such weighted average will be used as the value of imported cotton for the purpose of levying the supplemental assessment on imported cotton and will be expressed in kilograms. The value of imported cotton for the purpose of levying this supplemental assessment is $1.3215 cents per kilogram.
(3) * * *
7 U.S.C. 2101-2118.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Policy statement.
This document describes policy changes, clarification, or restatement to the FAA's International Aviation Safety Assessment (IASA) program to enhance engagement with civil aviation authorities (CAAs) through pre- and post-IASA assessment and to promote greater transparency. The FAA is making these changes to IASA policy to better meet the FAA's mission and safety expectations of the U.S. traveling public; better mitigate international civil aviation safety risks; strengthen international relationships with CAAs toward sustained success in maintaining or obtaining proper safety oversight; and improve effectiveness, integration, and efficiency in executing the IASA process. This docuent modifies the IASA policies previously announced by the FAA.
This policy modification is effective September 28, 2022.
Rolandos Lazaris, Division Manager, International Program Division (AFS-50), Flight Standards Service, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; (202) 267-3719,
The IASA program is the means by which the FAA determines whether another country's oversight of its air carriers that operate, or seek to operate, into the U.S., or code-share with a U.S. air carrier, complies with safety standards established by the International Civil Aviation Organization (ICAO). The published IASA results of Category 1 or Category 2 is notification to the U.S. traveling public of safety issues. Public notification of the IASA program was established by a
• August 24, 1992—established the FAA Procedures for Examining and Monitoring Foreign Air Carriers (57 FR 38342).
• September 8, 1994—established the Public Disclosure of the Results of Foreign Civil Aviation Authority Assessments, through a three-category numbered rating system. (59 FR 46332).
• October 31, 1995—DOT notice Clarification Concerning Examination of Foreign Carriers' Request for Expanded Economic Authority, clarified the Department's licensing policy regarding requests for expanded economic authority from foreign air carriers whose CAA's safety oversight capability has been assessed by the FAA as conditional (Category II) or unacceptable (Category III) (60 FR 55408).
• May 25, 2000—Changes to the International Aviation Safety Assessment Program removed the Category 3 rating and combined it with Category 2 (65 FR 33751).
• March 8, 2013—Changes to the International Aviation Safety Assessment Program removed inactive countries (countries with no air carrier operations to the United States or code-shares with U.S. operators for four years and no significant interaction between the country's CAA and the FAA) from the IASA Category list (78 FR 14912).
Through its IASA program, the FAA seeks continuous improvement to achieve even greater global aviation safety levels. As noted in the above-referenced
The following paragraphs describe policy changes, clarification, or restatement to the FAA's IASA program to enhance engagement with CAAs through pre- and post-IASA assessment and to promote greater transparency.
The FAA is clarifying the IASA Category definitions to align them with the types of operations that require an IASA Category rating and therefore demonstrate the need for FAA oversight. The notification, published on March 8, 2013,
•
•
The policy, established in the March 8, 2013
The removal criteria published in 2013 no longer meet the need for timeliness and accuracy of information on the IASA Category Rating list. The 2013 criteria leave Category 1 countries on the list for an extended period of time and may give the U.S. traveling public a false sense of safety. Also, leaving Category 2 countries on the list for an extended period of time can be perceived as unfairly penalizing those countries when there has been no activity since the Category 2 rating was issued. As a result, the FAA will reduce the removal benchmark from four years to two years absent the interaction described above.
The FAA will perform an IASA of countries with no IASA Category rating after an operator from that country files an economic authority application with the U.S. DOT for either direct U.S. service with its own aircraft and crew, or a code-share that involves the foreign operator displaying the code of a U.S. operator.In many requests for an IASA, the country either does not have an operator or its operator may not yet have the aircraft type needed to provide service to the United States. This clarification in policy is intended to ensure that an initial IASA is used for its intended purpose of ensuring that the CAA and its operator(s) have each taken the necessary measures to manage and oversee such operations in accordance with ICAO standards, and also to maintain the accuracy of the IASA Category Rating list by not listing countries with no operations that meet the IASA applicability criteria.
The FAA uses a risk analysis process to identify IASA Category 1 countries for reassessment. The risk analysis is performed, at least annually and whenever new safety information is obtained, on each country on the IASA Category Rating list to determine countries of highest risk to the U.S. National Airspace System (NAS) and the U.S. traveling public. The risk analysis was developed by FAA experts in this field, and is comprised of individual risk elements and grouped into the following five major IASA risk categories:
1. DOT Economic Authority—New or existing U.S. DOT economic authority; U.S. service under part 129; new or current code-share involving display of U.S. operator code on foreign operator flights; and any USDOT administrative emphasis items and initiatives.
2. Governance and Safety Culture—Areas of interest include: contracting of safety oversight functions; carrier wet lease to airlines of other countries; safety items identified by the CAA remain unresolved or not addressed; complaints received by FAA from other CAAs, operators, manufacturers, and the traveling public.
3. IASA Information—Time passed since the last IASA, and other factors that indicate the Category 1 rating may no longer be valid.
4. ICAO Requirements—Risk concerns include: negative ICAO Universal Safety Oversight Audit Program (USOAP) findings indicating noncompliance with one or more of the eight critical elements of safety oversight; ICAO reports indicating noncompliance with Standards and Recommended Practices (SARPs); inaction with respect to ICAO action plans; ICAO USOAP information over two years old thus limiting its value.
5. FAA Information—FAA has safety concerns about the oversight provided by the CAA, which include the areas of: FAA and foreign ramp inspections; safety-related complaints about carrier(s) from other CAAs; active technical assistance activities; compliance issues are present in FAA certificated or approved entities in the country; Congressional inquiries; and existing bilateral agreement implementation procedures.
In support of the FAA's objective of improving communications with CAAs of IASA Category 1 countries identified as priorities through the FAA's risk analysis, the FAA will exercise discretion to provide CAAs with informal notification of safety concerns and request discussions with CAAs prior to the initiation of the formal IASA process. If such safety concerns have not been satisfactorily addressed, the FAA will begin the formal IASA notification process. The FAA will retain its ability to initiate immediate IASA category changes or IASA assessments when justified based on available safety information. The discretion to engage informally is to make CAAs aware of potential defiencies in safety oversight to enable more efficient resolution.
This mitigation is twofold and involves limits to foreign operations to the United States and code-share arrangements with operators from countries for which the FAA has identified safety oversight concerns and limits on certain bilateral agreements. These changes will provide the U.S. traveling public and the U.S. air transportation system with an added measure of safety mitigation and freedom from external pressures to delay safety oversight responsibilities.
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The FAA currently requests that the CAA provide a completed IASA checklist (available on the FAA website) prior to the FAA conducting an IASA; however, the FAA has not explicitly identified this step in past IASA policy statements. While not mandatory, it is in the CAA's best interest to complete the checklist in preparation for safety oversight discussions. The CAA's provision of a completed IASA checklist in advance of the assessment, whether initial assessment or reassessment, will facilitate an efficient and effective assessment review.
This is a restatement of current policy. Once an IASA has been completed, the FAA will provide any findings of noncompliance with ICAO standards. Subsequently, the FAA will provide the results of the assessment to the CAA through an established cable process. If there are no findings of noncompliance with ICAO standards in the IASA report, the cable will reflect that the country will receive an IASA Category 1 rating. If there have been any findings of noncompliance with applicable ICAO standards, the FAA will provide the CAA with the opportunity to provide evidence to the FAA of the actions it has taken since the IASA to correct any findings of noncompliance.
This is a restatement of current policy. During the final discussions, the FAA will review each IASA finding of noncompliance with the CAA, the CAA's corrective action since the IASA, and the status of the finding as either open or closed. This will be documented in a Record of Discussions, and the record will be signed by both the FAA and the CAA. The final assignment of an IASA Category rating will be transmitted to the CAA through the cable process.
For additional communication and support for a country downgraded to an IASA Category 2 rating, the FAA will provide the CAA with a CAP to address its safety oversight deficiencies and will conduct a virtual meeting with the CAA to establish timelines for completion. This will allow the CAA to begin work on its safety oversight findings at the conclusion of the IASA process without delay. Should the CAA request FAA technical assistance implementation of its CAP, this would require a government-to-government agreement.
To restate current FAA policy, a country with an IASA Category 2 rating may request a reassessment in an attempt to obtain a Category 1 rating. A CAP, as discussed above, showing the CAA's action on resolving the identified safety oversight items is one way of providing evidence of CAA readiness for an IASA reassessment.
U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury.
Final rule.
This document amends the U.S. Customs and Border Protection
Effective September 29, 2022.
For legal aspects, W. Richmond Beevers, Chief, Cargo Security, Carriers and Restricted Merchandise Branch, Regulations and Rulings, Office of Trade, (202) 325-0084,
Pursuant to the Convention on Cultural Property Implementation Act, Public Law 97-446, 19 U.S.C. 2601
On October 3, 1997, the former U.S. Customs Service published T.D. 97-81 in the
Import restrictions listed at 19 CFR 12.104g(a) are effective for no more than five years beginning on the date on which an agreement enters into force with respect to the United States. This period may be extended for additional periods of no more than five years if it is determined that the factors which justified the agreement still pertain and no cause for suspension of the agreement exists.
Since the initial final rule was published on October 3, 1997, the import restrictions were subsequently extended and/or amended four (4) times. First, on September 30, 2002, the former U.S. Customs Service published a final rule (T.D. 02-56) in the
Second, on September 26, 2007, CBP published a final rule (CBP Dec. 07-79) in the
Third, on September 28, 2012, CBP published a final rule (CBP Dec. 12-17) in the
Fourth and lastly, on September 28, 2017, CBP published a final rule (CBP Dec. 17-14) in the
On January 6, 2022, the United States Department of State proposed in the
Accordingly, CBP is amending 19 CFR 12.104g(a) to reflect the extension of the import restrictions. The restrictions on the importation of archaeological and ecclesiastical ethnological material are to continue to be in effect through September 28, 2027. Importation of such material from Guatemala continues to be restricted through that date unless the conditions set forth in 19 U.S.C. 2606 and 19 CFR 12.104c are met.
The Designated List and additional information may also be found at the following website address:
This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure under 5 U.S.C. 553(a)(1). For the same reason, a delayed effective date is not required under 5 U.S.C. 553(d)(3).
Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601
CBP has determined that this document is not a regulation or rule subject to the provisions of Executive Order 12866 because it pertains to a foreign affairs function of the United States, as described above, and therefore is specifically exempted by section 3(d)(2) of Executive Order 12866.
This regulation is being issued in accordance with 19 CFR 0.1(a)(1), pertaining to the Secretary of the Treasury's authority (or that of his/her delegate) to approve regulations related to customs revenue functions.
Chris Magnus, the Commissioner of CBP, having reviewed and approved this document, has delegated the authority to electronically sign this document to Robert F. Altneu, who is the Director of the Regulations and Disclosure Law Division for CBP, for
Cultural property, Customs duties and inspection, Imports, Prohibited merchandise, and Reporting and recordkeeping requirements.
For the reasons set forth above, part 12 of title 19 of the Code of Federal Regulations (19 CFR part 12) is amended as set forth below:
5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States (HTSUS)), 1624.
Sections 12.104 through 12.104i also issued under 19 U.S.C. 2612;
(a) * * *
Approved:
Coast Guard, DHS.
Notification of enforcement of regulation.
The Coast Guard will enforce the Delaware River, Philadelphia, PA; Safety Zone from 8:30 p.m. through 9:15 p.m. on September 30, 2022, to provide for the safety of life on navigable waterways during the Cooper Foundation Gala fireworks display. Our regulation for fireworks displays in the Fifth Coast Guard District identifies the regulated area for this event in Philadelphia, PA. During the enforcement period, the operator of any vessel in the regulated area must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.
The regulation 33 CFR 165.506 will be enforced for the location identified in entry 10 of table 1 to paragraph (h)(1) from 8:30 p.m. through 9:15 p.m. on September 30, 2022.
If you have questions about this notification of enforcement, call or email Petty Officer Dylan Caikowski, U.S. Coast Guard, Sector Delaware Bay, Waterways Management Division, telephone: (215) 271-4814, Email:
The Coast Guard will enforce the safety zone in table 1 to paragraph (h)(1) to 33 CFR 165.506, entry 10 for the Cooper Foundation Gala fireworks display from 8:30 p.m. through 9:15 p.m. on September 30, 2022. This action is necessary to ensure safety of life on the navigable waters of the United States immediately prior to, during, and immediately after the fireworks display. Our regulation for safety zones of fireworks displays in the Fifth Coast Guard District, table 1 to paragraph (h)(1) to 33 CFR 165.506, entry 10 specifies the location of the regulated area as all waters of Delaware River, adjacent to Penn's Landing, Philadelphia, PA, within a 500-yard radius of the fireworks barge position. The approximate position for the fireworks barge is latitude 39°56′53″ N, longitude 075°08′03″ W. During the enforcement period, as reflected in § 165.506(d), vessels may not enter, remain in, or transit through the safety zone unless authorized by the Captain of the Port or designated Coast Guard patrol personnel on-scene.
In addition to this notice of enforcement in the
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve four permitting rules submitted as a revision to the San Diego County Air Pollution Control District (SDAPCD or “District”) portion of the California State Implementation Plan (SIP). These revisions concern the District's New Source Review (NSR) permitting program for new and modified sources of air pollution under section 110(a)(2)(C) and part D of title I of the Clean Air Act (CAA or “Act”). This action will update the District's applicable SIP with rules revised to address a deficiency identified in our September 16, 2020 limited disapproval
This rule is effective October 28, 2022.
The EPA has established a docket for this action under Docket No. EPA-R09-OAR-2022-0306. All documents in the docket are listed on the
Laura Yannayon, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105. By phone: (415) 972-3534 or by email at
Throughout this document, “we,” “us,” and “our” refer to the EPA.
On May 12, 2022, the EPA proposed to approve the following rules listed in Table 1 into the California SIP and simultaneously made an interim final determination that deferred sanctions triggered by the September 16, 2020 limited disapproval of Rule 20.1.
The SIP-approved versions of the submitted rules are identified below in Table 2.
The rules listed in Table 2 are being replaced in the SIP by the submitted set of rules listed in Table 1. Additionally, as described in our proposal, the EPA's final approval of Rule 20.1 addresses our September 16, 2020 limited disapproval.
The EPA's proposed action provided a 30-day public comment period. During this period, no comments were submitted on our proposal.
No comments were submitted on our proposal. Therefore, as authorized in sections 110(k)(3) and 301(a) of the Act, the EPA is approving the submitted rules. This action incorporates the
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the rules described in Section I of this preamble and set forth below in the amendments to 40 CFR part 52. The EPA has made, and will continue to make, these documents available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act.
The state did not evaluate environmental justice considerations as part of its SIP submittal. There is no information in the record inconsistent with the stated goals of E.O 12898 of achieving environmental justice for people of color, low-income populations, and indigenous peoples.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 28, 2022. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Administrative practice and procedure, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen oxides, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(c) * * *
(488) * * *
(i) * * *
(A) * * *
(
(508) * * *
(i) * * *
(A) * * *
(
(
(
(557) * * *
(i) * * *
(B) San Diego County Air Pollution Control District.
(
(
(587) [Reserved]
(588) The following regulations were submitted on February 2, 2022 by the Governor's designee as an attachment to a letter dated January 31, 2022.
(i)
(
(
(
(B) [Reserved]
(ii) [Reserved]
(d) The provisions of § 52.28 are hereby incorporated and made part of the applicable plan for the State of California, except for the air pollution control districts listed in paragraphs (d)(1) through (6) of this section. The provisions of § 52.28 remain the applicable plan for any Indian reservation lands, and any other area of Indian country where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, located within the State of California, including any such areas located in the air pollution control districts listed in paragraphs (d)(1) through (6) of this section.
(1) Monterey County air pollution control district;
(2) Sacramento County air pollution control district;
(3) Calaveras County air pollution control district;
(4) Mariposa County air pollution control district;
(5) Northern Sierra air quality management district; and
(6) San Diego County air pollution control district.
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations to modernize, simplify, and enhance the current system for oversight of FDA-regulated human subject research. This proposed rule, if finalized, would harmonize certain sections of FDA's regulations on human subject protection and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule), in accordance with the 21st Century Cures Act (Cures Act). We believe the proposed changes, if finalized, will reduce regulatory burden on IRBs, sponsors, and investigators. In addition, we propose related changes to the investigational device exemption (IDE) regulations to clarify and update the requirements for the submission of progress reports.
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The purpose of this proposed rule is to modernize, simplify, and enhance the current system for oversight of FDA-regulated human subject research. We propose to harmonize certain sections of FDA's regulations on human subject protection (part 50 (21 CFR part 50)) and IRBs (part 56 (21 CFR part 56)), to the extent practicable and consistent with other statutory provisions, with the revised Common Rule,
This proposed rule, if finalized, would amend parts 50 and 56 of FDA's regulations. Among other things, we are proposing to: (1) revise the content, organization, and presentation of information included in the informed consent form and process to facilitate a prospective subject's decision about whether to participate in the research; (2) add new basic and additional elements of informed consent; (3) add a provision that would allow IRBs to eliminate continuing review of research in certain circumstances; (4) revise the IRB recordkeeping requirements for certain determinations related to the need for continuing review; and (5) add or modify some definitions. We are also proposing to revise one section of part 812 regarding progress reports submitted by investigators and sponsors to a reviewing IRB for consistency with other revisions we are proposing to the continuing review process in part 56.
The provisions under which FDA is proposing to issue this rule include sections 403, 406, 409, 412, 413, 503, 505, 510, 513-515, 520, 531-539, 541-542, 701, and 721 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343, 346, 348, 350a, 350b, 353, 355, 360, 360c-360e, 360j, 360hh-360pp, 360rr-360ss, 371, and 379e) and section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262).
The primary quantifiable benefit of the proposed rule is a decreased time burden to IRBs, investigators, and sponsors of clinical trials from increased harmonization with the revised Common Rule. Quantifiable costs include the development of informed consent documents and additional recordkeeping burdens. The estimated annualized cost savings of the proposed rule range from approximately $22 to $103 million in 2018 dollars, with a central estimate of approximately $43 million, discounted at 7 percent over 10 years. At 3 percent, estimates of annualized cost savings range from approximately $22 to $103 million, with a central estimate of approximately $43 million. Estimated annualized costs of the proposed rule range from approximately $0.7 million to $2.3 million, with a central estimate of approximately $1.2 million, discounted at 7 percent. At 3 percent, estimates of annualized costs range from approximately $0.6 million to $2.0 million, with a central estimate of approximately $1.1 million. The impact of the proposed provisions is analyzed in the Preliminary Economic Analysis of Impacts for this proposed rule.
The Federal Policy for the Protection of Human Subjects, codified by the Department of Health and Human Services (HHS) at 45 CFR part 46, subpart A, and generally referred to as the Common Rule, sets forth requirements for the protection of human subjects involved in research that is conducted or supported by HHS. The Common Rule was issued in 1991
FDA's regulations for the protection of human subjects at parts 50 and 56 apply to clinical investigations, as defined at current §§ 50.3(c) and 56.102(c), regardless of the source of funding. These regulations, which include requirements for informed consent and IRBs, are intended to protect the rights, safety, and welfare of subjects involved in clinical investigations involving FDA-regulated products.
Prior to the most recent revision to the Common Rule, FDA's regulations regarding the protection of human subjects were largely consistent with the requirements in the Common Rule, with a few exceptions generally arising from differences in FDA's mission or statutory authority. FDA-regulated research that is HHS-conducted or HHS-supported is subject to both HHS's and FDA's regulations. Many IRBs review both types of research and must comply with both sets of regulations. FDA and the Office for Human Research Protections (OHRP) have been actively working together for many years to harmonize regulatory requirements and guidance.
On December 13, 2016, the Cures Act was signed into law with its purpose of accelerating the discovery, development, and delivery of 21st century cures.
As described above, FDA's regulations governing the protection of human subjects largely have been consistent with the requirements of the Common Rule, with a few exceptions generally due to differences in FDA's mission and statutory authority. The revised Common Rule includes provisions intended to strengthen the effectiveness of the human subject protection regulations, and FDA is proposing to harmonize with certain provisions in the revised Common Rule that are applicable to FDA-regulated clinical investigations. For example, proposed new basic and additional elements of informed consent, along with new requirements for the presentation of information in the consent form, would help facilitate a prospective subject's decision about whether to participate in the research and facilitate the enrollment process. In addition, FDA is proposing to harmonize with the revised Common Rule by adding provisions that reduce burden on IRBs and that are intended to allow IRBs to focus their resources on research that presents higher risk, thereby enhancing human subject protection. Harmonization will also reduce confusion and regulatory burden for the oversight of studies that are subject to both the revised Common Rule and FDA regulations.
This proposed rule does not address all of the provisions contained in the revised Common Rule. The Agency has addressed some of these provisions in a previously issued proposed rule
FDA is proposing to issue this rule under the Agency's authority to issue regulations regarding the investigational use of drugs under section 505(i) of the FD&C Act, the investigational use of devices under section 520(g) of the FD&C Act, and the investigational use of biological products under section 351(a) of the PHS Act. In addition, IRB review
These statutory provisions authorize FDA to issue the proposed revisions to its regulations to enhance protection of human subjects and the IRB review process for FDA-regulated clinical investigations.
We propose to revise part 50 by adding new requirements, including revised definitions intended to enhance human subject protections. These proposed revisions would require presentation of information in the informed consent document to be in an organized and understandable manner, and to include a concise and focused presentation of the key information most likely to assist a prospective subject in understanding the reasons why the subject might or might not want to participate in the research. The new proposed provisions also include a new basic element of informed consent and three new additional elements of informed consent. New proposed definitions include the definitions of private information, identifiable private information, and identifiable biospecimen. FDA is also proposing to make grammatical corrections or other editorial changes to provide clarity. Table 1 summarizes the proposed changes to part 50 that would harmonize with the revised Common Rule.
We propose to harmonize our definition of “legally authorized representative” at § 50.3(l) with the definition in the revised Common Rule at 45 CFR 46.102(i), by adding a sentence to address situations in which there is no applicable State or local law that authorizes a LAR to provide consent on behalf of a prospective research subject. We propose that in these circumstances, an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context may be considered a LAR for purposes of consenting to the subject's participation in the procedures involved in the research.
In addition, we propose to add several new definitions that are used in the revised Common Rule. At § 50.3(t), we propose to add the definition of “written or in writing,” which would harmonize with this definition in the revised Common Rule, at 45 CFR 46.102(m). The definition would include both paper and electronic
FDA is proposing to add three new definitions for the terms “private information,” “identifiable private information,” and “identifiable biospecimen.” The terms “identifiable private information,” and “identifiable biospecimen” and/or references to biospecimens are found in new proposed elements of informed consent at § 50.25(a)(9), (b)(7), and (b)(9), and in the proposed provisions regarding IRB continuing review at § 56.109(g)(1).
We propose to add, at § 50.3(u), a definition of “private information” that harmonizes with the definition of “private information” in the revised Common Rule, at 45 CFR 46.102(e)(4). Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (
We propose to add, at § 50.3(v), a definition of “identifiable private information” to harmonize with the revised Common Rule's definition of “identifiable private information” at 45 CFR 46.102(e)(5). We propose to define “identifiable private information” as private information for which the identity of the subject is or may readily be ascertained by the sponsor or investigator or associated with the information. This definition differs from the text of the revised Common Rule provision by including information for which a subject's identity is or may be readily ascertained by the “sponsor” in addition to information that is or may be readily ascertained by the investigator. FDA would consider information for which a subject's identity is or may be readily ascertained by members of the research team conducting the investigation under the supervision of the investigator to be “identifiable private information” under this proposed definition.
FDA's regulations define the terms “sponsor” and “investigator,” and they are used throughout our regulations to describe the responsibilities that apply to certain parties involved in FDA-regulated research. OHRP has stated in guidance that it considers the term “investigator” to include “anyone involved in conducting the research,”
We propose to add, at § 50.3(w), a definition of “identifiable biospecimen,” to harmonize with the revised Common Rule's definition of “identifiable biospecimen” at 45 CFR 46.102(e)(6). For the same reasons described above with respect to the definition of “identifiable private information”, we propose to define an identifiable biospecimen as a biospecimen for which the identity of the subject is or may readily be ascertained by the sponsor or investigator or associated with the biospecimen.
The revised Common Rule also includes a provision at 45 CFR 46.102(e)(7)(i) that requires the Federal Departments and Agencies implementing the revised Common Rule, upon consultation with appropriate experts, to reexamine the meaning of the terms “identifiable private information” and “identifiable biospecimen” within 1 year and regularly thereafter (at least every 4 years). That provision further provides that if appropriate and permitted by law, these Federal Departments and Agencies may alter the interpretation of these terms, including through the use of guidance. FDA intends to participate in this effort with HHS and the other Federal Departments and Agencies.
We propose to amend the general requirements for informed consent under § 50.20 to harmonize with the revised Common Rule at 45 CFR 46.116(a)(1) through (6). These requirements address the content, organization, and presentation of information included in the consent form and process to facilitate a prospective subject's decision about whether to participate in the research. To this end, we propose to redesignate our existing requirements as § 50.20(a), (b), (c), and (f) and add new paragraphs (d) and (e). New paragraph (d) would clarify that the prospective subject or the subject's legally authorized representative must be provided with the information that a reasonable person would want to have to make an informed decision about whether to participate and be given an opportunity to discuss that information.
In new § 50.20(e)(1) and (2), we propose to require that informed consent begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or LAR in understanding the reasons why the subject might or might not want to participate in the research, and that the information be organized and presented in a way that facilitates the subject's or LAR's comprehension.
We propose to add the phrase “or legally authorized representative” to § 50.25(a) and (b), to harmonize with the revised Common Rule at 45 CFR 46.116(b) and (c), and to clarify to whom informed consent information must be provided.
We propose to add a new basic element of informed consent at § 50.25(a)(9) to harmonize with the
The element of informed consent in the revised Common Rule at 45 CFR 46.116(b)(9) requires that subjects be provided with one of two statements that address research that involves the collection of identifiable private information or identifiable biospecimens.
FDA's proposed new element would require a description of how information or biospecimens may be used for future research or distributed to another investigator for future research. While FDA's proposed element is not limited to the two situations addressed by the statements required under the corresponding element of the revised Common Rule, the research community would be able to develop informed consent forms and processes that comply with both sets of regulations. For example, if appropriate, an investigator may use one of the statements provided in the revised Common Rule to satisfy FDA's proposed requirement. When applicable, an investigator would also be required to provide a description that conveys to subjects the possible future use of their identifiable biospecimens or information that may not be stripped of identifiers.
In addition, as noted above, Congress passed the Cures Act with a stated purpose of accelerating the discovery, development, and delivery of 21st century cures. FDA has been working to modernize its approach to evaluating innovative medical products as new technologies and sources of data create new options for generating and analyzing evidence regarding FDA-regulated products. Such technological advances may have the potential to, for example, streamline and improve the efficiency of clinical studies, but they may also raise new questions in the future about the applicability of certain FDA regulatory requirements, including requirements for informed consent. Therefore, we are concerned about the practicability of limiting this proposed element of informed consent to the two situations addressed by the statements required under the Common Rule at this time. FDA's proposal is intended to incorporate flexibility as to the description that an investigator would provide to each subject or the legally authorized representative to help ensure that subjects are informed regarding possible future uses of information and biospecimens collected from their participation in a clinical investigation as the ways in which information and biospecimens are used relevant to FDA-regulated products continue to evolve. We request public comment on whether FDA's proposed new basic element of informed consent at § 50.25(a)(9) would provide adequate notice to potential subjects regarding the possible future research use of their information and biospecimens or whether the Common Rule's provision at 45 CFR 46.116(b)(9) would better inform potential subjects about the possible future use of their information and biospecimens in research. We further request public comment on whether the research community anticipates challenges in implementing FDA's proposed new element and whether an alternative approach could lessen such challenges.
FDA is proposing to add three new additional elements of informed consent, § 50.25(b)(7), (8), and (9), to harmonize with the revised Common Rule at 45 CFR 46.116(c)(7), (8), and (9), respectively. Section 50.25(b)(7) would require a statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit. Section 50.25(b)(8) would require a statement on whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions. Section 50.25(b)(9) pertains to research involving biospecimens and would require that subjects be informed whether the research will (if known), or might, include whole genome sequencing (WGS). The preamble to the revised Common Rule noted that WGS generates an extremely large amount of information about people, including factors that will contribute to their future medical conditions. The Common Rule goes on to state “Given the unique implications of the information that can be developed through WGS, if it is either known that a specific research study will include this technique, or might include it, we believe that this aspect of the research must be disclosed to prospective subjects as part of the informed consent process.”
We propose to revise § 50.25(d) and (e) by adding a reference to tribal law passed by the official governing body of an American Indian or Alaska Native tribe, to clarify that references to Federal, State, or local law are intended to include tribal law. This proposed change would harmonize FDA regulations with the revised Common Rule at 45 CFR 46.116(i) and (j).
We propose to add a parenthetical to § 50.27(a), to clarify that consent forms in an electronic format are an acceptable format and add the term “informed consent” before the term “form” to harmonize the regulatory text with the revised Common Rule at 45 CFR 46.117(a).
We are proposing to revise § 50.27(b)(1) and (2) to include references to a subject's legally authorized representative. We are proposing to reorder sentences and make other changes in § 50.27(b)(1) to clarify that the subject or legally authorized representative shall have adequate opportunity to read the informed consent form. We are proposing to revise § 50.27(b)(2) to require that the key information required by § 50.20 be presented first when using a short form written informed consent. These changes are being proposed to better inform potential subjects about participation in a clinical investigation, and to
FDA is not proposing to add the new provision found in the revised Common Rule at 45 CFR 46.116(g) at this time. This provision allows IRBs to approve a research proposal for which investigators obtain information or biospecimens without an individual's informed consent for the purpose of screening, recruiting, or determining eligibility of the prospective human subject or LAR if either of the following conditions are met: (1) the investigator will obtain information through oral or written communication with the prospective subject or LAR or (2) the investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
FDA's longstanding policy on preparatory activities to a clinical investigation is that some specific activities are not considered to fall within the definition of a clinical investigation, and therefore do not require IRB review or informed consent under FDA's regulations. For example, we generally have not considered performing a survey of patient records at a site to determine whether the site has a sufficient number of patients with the condition of interest for the clinical investigation to be feasible to require informed consent and IRB review. However, IRB review and informed consent would need to be obtained prior to initiation of any clinical screening procedure that is performed solely for the purpose of determining eligibility for a clinical investigation.
We propose to modify § 50.1(a) to remove the list of statutory provisions in the final sentence because the scope of part 50 is already described in the provision. In addition, removing these provisions will delete certain out of date citations and eliminate the need to update statutory references in the future. Similarly, we propose to modify § 50.3(b)(20) and (j) to remove outdated references to certain provisions of the PHS Act. We propose to clarify that references in § 50.3(b)(16) through (19) and (23) are to sections of the FD&C Act.
We propose to add the following sentence, “The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects” to the definition of “institutional review board” at § 50.3(i), to be consistent with our current definition of IRB at § 56.102(g).
We propose to revise the citation in § 50.24(a)(6) from “§ 50.25” to “this part,” to simplify the regulatory text, and to clarify that both the informed consent procedures and documents for studies conducted under § 50.24 must be consistent with part 50.
We also propose to add a heading to § 50.25(c), “Required statement in informed consent documents for applicable clinical trials,” to conform to current
We propose to revise part 56 to modify provisions related to continuing review, add or modify definitions, and make clarifying editorial changes. FDA believes that these proposed changes will help modernize, clarify, and enhance both human subject protection and the IRB review process. Table 3 identifies sections in which FDA proposes to harmonize our regulatory requirements with language in the revised Common Rule.
We are proposing to add a new definition, “written or in writing”, at § 56.102(n), which would harmonize with the definition in the revised Common Rule at 45 CFR 46.102(m). The new definition would include both paper and electronic formats, the latter of which are increasingly used to fulfill many of the documentation requirements that appear throughout the IRB and human subject protection regulations. Adding this definition would provide clarity to the regulated community that IRB records may be maintained in electronic formats.
We are proposing to add a reference to tribal law passed by the official governing body of an American Indian or Alaska Native tribe to clarify that the reference to Federal, State, or local laws or regulations, is intended to include tribal law. This proposed revision would also harmonize § 56.103(c) with the revised Common Rule at 45 CFR 46.101(f).
We are proposing to amend § 56.107(a) to harmonize with the revised Common Rule's language at 45 CFR 46.107(a), which describes characteristics of IRB membership. We propose deleting § 56.107(b), which requires IRBs to ensure that their membership not consist entirely of a single gender and prohibits IRB membership from being composed entirely of members of one profession. Section 56.107(b) is no longer necessary because it would be subsumed into proposed § 56.107(a), which would require that an IRB's membership reflects diversity of professional qualifications, and other factors including race, gender, and cultural backgrounds.
We propose moving the details about IRB membership rosters from § 56.115(a)(5) to § 56.108(a)(2) and making editorial changes to harmonize the language with the revised Common Rule at 45 CFR 46.108(a)(2). We are also proposing editorial and technical revisions to § 56.108, including redesignating some sections, to harmonize with the revised Common Rule.
We propose adding “or legally authorized representative, when appropriate” to § 56.109(b), to clarify that subjects or legally authorized representatives must be given informed consent information in accordance with § 50.25, and to harmonize with the revised Common Rule at 45 CFR 46.109(b).
We propose adding new § 56.109(c)(3) to add an exception to the requirement for documentation of informed consent, to harmonize with the revised Common Rule at 45 CFR 46.117 (c)(1)(iii). The new provision would allow the IRB to waive documentation of informed consent for a study that presents no more than minimal risk of harm to the subjects, if the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, and there is an appropriate alternative mechanism for documenting that informed consent was obtained.
We note that the revised Common Rule also retains an exception to the requirement for documentation of informed consent at 45 CFR 46.117(c)(1)(i) for situations in which the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. FDA's regulations historically have not included this same exception, and we are not proposing to add it in this rulemaking because we do not believe it is relevant to FDA-regulated research. We are, however, requesting comment on whether this provision is relevant to FDA-regulated research and any examples of situations when it would be useful.
We propose adding “or legally authorized representatives” to § 56.109(d), to clarify that legally authorized representatives may also
We are proposing new § 56.109(g), which would eliminate the requirement for an IRB to conduct continuing review of research, unless an IRB determines otherwise, that has progressed to the point that it involves only data analysis, including analysis of identifiable private information or identifiable biospecimens, and/or accessing followup clinical data from procedures that subjects would undergo as part of clinical care, to harmonize with the revised Common Rule at 45 CFR 46.109(f)(1)(iii). In these circumstances, FDA believes that requiring continuing review would generally not provide added protection to human subjects, and therefore, would not be necessary. When the only remaining research activities are limited to analysis of data or biospecimens that are part of the IRB-approved study, there is little or no risk to human subjects that would be addressed by requiring continuing review. Furthermore, after all subjects have enrolled and completed the protocol-specified interventions and interactions (including required followup study visits) to support the study's objectives, a protocol may include a long-term followup phase during which subjects continue to be monitored as they undergo clinical care for their medical condition or disease by their healthcare provider. During this continued followup phase, information regarding long-term clinical outcomes may be obtained through accessing clinical data generated during the course of clinical care. This proposed rule would eliminate the requirement for continuing IRB review for this followup portion of the study, unless the IRB determines otherwise.
The revised Common Rule contains two other provisions identifying circumstances in which continuing review would not be necessary at 45 CFR 46.109(f)(1)(i) and (ii). We are not proposing to adopt the revised Common Rule provision at 45 CFR 46.109(f)(1)(i), which eliminates the requirement for an IRB to conduct continuing review of research that is eligible for expedited review in accordance with 45 CFR 46.110 unless the IRB determines otherwise. As described below, OHRP has clarified that, in order for research to qualify for expedited review under the current list of research eligible for expedited review referenced in 45 CFR 46.110(a), a determination must still be made by an IRB that the specific circumstances of the proposed research involve no more than minimal risk to human subjects. It is not practicable for FDA to adopt this provision because continuing review for minimal risk FDA-regulated clinical investigations would provide meaningful protections to human subjects participating in such investigations. For example, as a study progresses, the analysis of risks to subjects receiving a FDA-regulated product may change based on adverse events that occur during the course of the study and that do not rise to the level of unanticipated problems involving risks to human subjects or otherwise require reporting to the IRB. Continued IRB oversight of such studies would offer added human subject protection to those participating in such investigations by enabling the IRB to assess whether there are any additional risks that present more than minimal risk to participants and require discussion and/or action. Furthermore, for clinical investigations that are subject to both FDA's human subject regulations and the revised Common Rule, the Common Rule provision at 45 CFR 46.109(f)(1)(i) allows an IRB to determine that continuing review of research eligible for expedited review is required.
Finally, we are not proposing to adopt provisions from the revised Common Rule related to limited IRB review at this time, including 45 CFR 46.109(f)(1)(ii). As we continue to consider how other provisions of the revised Common Rule could be applied to FDA-regulated research, including the revised Common Rule's exemptions, we may take additional steps to harmonize with such provisions at a later time.
In addition, as described below, we are proposing changes to the IDE regulations at § 812.150(a)(3) and (b)(5) to align the IRB progress reporting requirements with these proposed changes to IRB continuing review requirements under part 56.
We propose reordering and redesignating the remaining language in § 56.109(f), and current § 56.109(g) and (h) as § 56.109(g), (h), and (i), respectively.
FDA's current regulations under § 56.110(a) state that FDA has established, and published in the
As described in the revised Common Rule, an IRB may use the expedited review procedure to review studies that involve activities appearing on the expedited review list, unless the IRB reviewer determines that the studies involve more than minimal risk (see 45 CFR 46.110(b)(1)(i)). OHRP has clarified that until a new list is finalized, the entire 1998 HHS Expedited Review List, including the “Applicability” section, remains in effect for studies subject to the revised Common Rule.
Under FDA's current regulations at § 56.110(b)(1), an IRB may use the expedited review procedure to review “[s]ome or all of the research appearing on the list
We also note that the current expedited review list (63 FR 60353, November 9, 1998) describes categories of research that include FDA-regulated clinical investigations that may involve more than minimal risk. For example, Category 1 from the current expedited review list describes clinical studies of drugs and medical devices that meet certain conditions, including those that do not require an IND or those for which an IDE application is not required. FDA does not believe that all drug and device studies that do not require an IND or an IDE application qualify as minimal risk. Given this, FDA does not presume all clinical investigations of drugs or medical devices that do not require an IND or an IDE application present no more than minimal risk to subjects. Category 4 also describes clinical studies using medical devices that may not qualify as minimal risk. Therefore, FDA is maintaining the requirement that the reviewer determine that the research involves no more than minimal risk and is only proposing a minor change to the regulatory text in current § 56.110(b) at this time. We propose to remove the parenthetical phrase “(of 1 year or less)” from § 56.110(b)(2) to harmonize with the revised Common Rule at 45 CFR 46.110(b)(1)(ii) because continuing review would not be required in certain circumstances unless the IRB determines otherwise (see § 56.109(g)).
As HHS evaluates and amends, as appropriate, its current expedited review list as described above and as required under 45 CFR 46.110(a), FDA intends to participate in the process and will update our own expedited review list as appropriate and consider if any related changes to our regulations are necessary.
We are proposing to add, at § 56.111(a)(3) and (b), updated language consistent with the revised Common Rule, describing categories of subjects who are considered vulnerable to coercion or undue influence, specifically “. . . children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.” This proposal, if finalized, also would harmonize these sections with the language in the revised Common Rule at 45 CFR 46.111(a)(3) and (b). To simplify our regulatory text, FDA is also proposing to delete the phrase “to the extent required by” from § 56.111(a)(5), so that the requirement would read “Informed consent will be appropriately documented or appropriately waived, in accordance with § 50.27 of this chapter.” FDA's proposed revision differs slightly from the revised Common Rule at 45 CFR 46.111(a)(5), which states that informed consent will be appropriately documented or appropriately waived in accordance with 45 CFR 46.117. We are not proposing to include the reference to waiver of documentation as this is addressed under § 50.27.
We are proposing to add at § 56.115(a)(3), language that would require the IRB to maintain a record of the rationale for conducting continuing review, if the IRB determines that continuing review of research is necessary (when the research otherwise would not require continuing review under § 56.109(g)). This proposed change would also harmonize the regulations with the language in the revised Common Rule at 45 CFR 46.115(a)(3). The revised Common Rule includes a new recordkeeping requirement at 45 CFR 46.115(a)(8) related to changes made to the regulatory provision at 45 CFR 46.110(b)(1)(i) regarding review of research found on the HHS Expedited Review List. For the reasons described above, FDA is not proposing to make the same change to its expedited review provision at § 56.110(b)(1) and, accordingly, is not proposing to add the related recordkeeping requirement.
We are proposing to revise § 56.115(a)(5) by moving the details about IRB membership rosters from that section to § 56.108(a)(2), to harmonize the language with the revised Common Rule at 45 CFR 46.115(a)(5) and 46.108(a)(2).
Table 4 lists sections that will be moved, redesignated, or divided, with minor editorial changes to the regulatory text in some cases.
FDA also proposes to make minor changes to the current regulatory text and to delete outdated or unnecessary regulatory text from part 56 (see table 5). In addition, throughout part 56 a global change has been made to spell out references to “the act”, to conform to current
We are proposing to revise § 56.121(c) by deleting the phrase “in the
We are proposing to revise § 56.122 by modifying the section title to change “revocation” to “disqualification,” and clarify that FDA's determination of disqualification of an IRB, as well as an institution, is disclosable to the public under 21 CFR part 20.
We are proposing to revise § 812.150(a)(3), that requires investigators to submit progress reports on the investigation to the sponsor, the monitor, and the reviewing IRB at regular intervals, but in no event less often than yearly. The proposed revisions would provide that such progress reports must be submitted to the reviewing IRB to the extent that continuing review is required by part 56. Elsewhere in this document, FDA is proposing to revise part 56 to eliminate the requirement for IRB continuing review of research under certain circumstances, and FDA does not believe that submission of progress reports to the IRB remains necessary when continuing review of the research by the IRB is not required. This proposed revision to § 812.150(a)(3) is intended to provide consistency between the continuing review requirements under part 56 and the requirements for submission of IDE progress reports to the IRB.
We also propose revising § 812.150(b)(5), which currently provides, among other things, that sponsors must submit progress reports to all reviewing IRBs at regular intervals, and at least yearly. For the same reasons described above regarding § 812.150(a)(3), FDA is proposing to require sponsors to submit such progress reports to the reviewing IRB to the extent that continuing review is required by part 56. The sponsors of an IDE will continue to submit progress reports to FDA at regular intervals and at least yearly under § 812.150(b)(5), and as may be requested under § 812.150(b)(10), regardless of whether there is continuing IRB review. FDA is proposing to maintain this reporting requirement for continued oversight of investigations that require submission of an IDE application to ensure the Agency receives information regarding the IDE investigation. The proposed rule maintains the requirement that sponsors of treatment IDEs submit semi-annual and annual progress reports to all reviewing IRBs and FDA in accordance with §§ 812.36(f) and 812.150(b)(5).
FDA is not proposing to amend the requirements for treatment IDEs at § 812.36(f), which require semi-annual progress reports to both FDA and the IRB(s) until a marketing application is filed. After filing of a marketing application, § 812.36(f) requires progress reports to be submitted at least annually in accordance with the IDE regulations at § 812.150(b)(5). Our proposed changes to § 812.150(b)(5) would require progress reports to be submitted to reviewing IRBs to the extent that continuing review is required by part 56. As such, after filing of a marketing application, submission of annual progress reports for a treatment IDE to the reviewing IRB would be required only to the extent that continuing review is required under part 56.
FDA is proposing that the effective date of any final rule that issues based on this proposal would be 180 days from the date of publication of the final rule to allow the regulated community time to prepare to implement the proposed changes. FDA requests comment on this timeframe.
In addition, FDA's goal is to minimize disruption to FDA-regulated studies that are ongoing when the proposed new requirements would become effective, and we are proposing an implementation strategy to address research initially approved by an IRB before the proposed effective date. For these studies, FDA would not intend to enforce compliance with the following proposed provisions:
• proposed new § 50.20(d) through (e), which would, among other things, require informed consent to begin with a concise and focused presentation of “key information” and would require informed consent information to be organized and presented in certain ways;
• the proposed new basic and additional elements of informed consent at § 50.25(a)(9) and (b)(7) through (9); and
• the proposed revision to § 50.27(b)(2), which would require the key information required by § 50.20 to be presented first to the subject or the subject's legally authorized representative when informed consent information is provided orally and documented using a short form.
This approach reflects FDA's concern that, for research an IRB has approved before the proposed effective date, revising the already approved informed consent form and process to comply with the provisions identified above could cause unwarranted burden and, in some cases, delay research. However, nothing in this proposal would prevent sponsors and investigators from
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all 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, and other advantages; distributive impacts; and equity). This proposed rule has been designated an economically significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because estimated cost savings of the proposed rule are greater in magnitude than estimated costs, and because we do not expect the effects of the rule to affect entities by size, we propose to certify that the rule, if finalized, will not have a significant economic impact on a substantial number of small entities. However, as discussed in the Preliminary Economic Analysis of Impacts (Ref. 1), there is a lack of high quality, comprehensive data regarding the number of small and very small institutions associated with IRBs, as defined by revenue. We have prepared an initial regulatory flexibility analysis and are seeking comment on the data and assumptions used in that analysis.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $158 million, using the most current (2020) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.
If finalized, the proposed rule would: (1) revise content, organization, and presentation of the information included in the informed consent form and process to facilitate a prospective subject's decision about whether to participate in a clinical investigation; (2) add new basic and additional elements of informed consent; (3) add a provision allowing IRBs to eliminate continuing review of some research; (4) revise IRB recordkeeping requirements for certain determinations related to the need for continuing review; and (5) add or modify some definitions. The rule also proposes to revise FDA's regulations IDEs (part 812) to clarify and update the requirements for submission of progress reports for clinical investigations of devices.
The proposed rule would harmonize certain aspects of FDA's regulations on IRBs and informed consent processes, to the extent practicable and consistent with statutory provisions, with the requirements of the revised Common Rule in accordance with section 3023 of the Cures Act. The proposed rule should reduce the costs of conducting clinical investigations by harmonizing informed consent and certain continuing review processes for FDA-regulated research with the revised Common Rule. The proposed rule will also generate costs that we estimate will be relatively smaller than expected cost savings in the form of additional time spent learning the rule, developing new informed consent documents in line with the rule, and revised recordkeeping requirements related to continuing review. We also expect qualitative benefits that we do not estimate explicitly due to data limitations, including increased efficiency of clinical investigations and medical product development and improved human subject knowledge by providing subjects with clearer clinical investigation information. Table 6 summarizes our estimates of the annualized costs and annualized benefits (in the form of cost savings) of the proposed rule.
The benefits of the proposed rule take the form of quantified net cost savings (cost savings minus costs) and qualitative benefits. We estimate that the benefits of the proposed rule are approximately $68 million annually in 2018 dollars, with a lower bound of approximately $22 million and an upper bound of approximately $249 million, discounted at 7 percent over 10 years. When discounted at 3 percent, estimated benefits are approximately $68 million annually, with a lower bound of approximately $22 million and an upper bound of approximately $249 million. We also expect quantitative benefits in the form of cost savings from increased efficiency in medical product innovation and in the form of improved human subject knowledge. We estimate that the costs of the proposed rule are approximately $1.4 million annually in 2018 dollars, with a lower bound of approximately $0.7 million and an upper bound of approximately $3.0 million, discounted at 7 percent over 10 years. When discounted at 3 percent, estimated costs are approximately $1.3 million annually, with a lower bound of approximately $0.6 million and an upper bound of approximately $2.6 million. These estimates are summarized in table 6.
We have developed a comprehensive Preliminary Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full preliminary analysis of economic impacts is available in the docket for this proposed rule (Ref. 1) and at
We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This proposed rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). A description of these provisions is given in the
FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed 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) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Under FDA's existing regulations at part 50, investigators must obtain informed consent of subjects or their LARs before involving subjects in an FDA-regulated clinical investigation, typically through written consent forms reviewed and approved by an IRB and signed by the subject or LAR. FDA's current regulations at §§ 50.23 and 50.24 provide for exceptions from the requirement to obtain informed consent in certain narrow circumstances. The information collections associated with development, IRB approval, and documentation of informed consent in compliance with FDA's existing regulations at §§ 50.25 and 50.27 are currently approved under OMB control number 0910-0130.
The proposed rule, if finalized, would revise provisions at §§ 50.20, 50.25, and 50.27 regarding the content, organization, and presentation of information in the informed consent. Proposed § 50.20(e) would require informed consent to begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of informed consent would have to be organized and presented in a way that facilitates comprehension. The proposed rule would also add a new basic element of informed consent at proposed § 50.25(a)(9) and three new additional elements of informed consent at proposed § 50.25(b)(7) through (9). Finally, the proposed rule would revise § 50.27(b)(2) to clarify that when a short form is used to document that the required elements of informed consent have been presented orally to the subject or LAR, the key information required by proposed § 50.20 must be presented first to the subject or LAR. These proposed changes to FDA's informed consent requirements would help ensure that prospective subjects receive and understand information important to choosing whether to participate in a clinical investigation.
FDA's existing regulations at § 56.109(c) provide for an IRB to waive the requirements for documentation of informed consent in some circumstances. To harmonize with the revised Common Rule, proposed § 56.109(c)(3) would allow an IRB to waive documentation of informed consent in an additional circumstance: if the IRB finds that the research presents no more than minimal risk of harm to the subjects, the subjects or LARs are members of a distinct cultural group or community in which signing forms is not the norm, and there is an appropriate alternative mechanism for documenting that informed consent was obtained. IRBs are already required to maintain adequate documentation of their activities under FDA regulations at § 56.115, including minutes of IRB meetings and records of continuing review activities. Those existing recordkeeping requirements are part of the information collection currently approved under OMB control number 0910-0130. We believe that proposed § 56.109(c)(3) represents an unusual circumstance that would affect a limited number of IRBs and thus introduce minimal change in burden associated with IRB recordkeeping.
FDA is also proposing changes to its requirements for continuing review to harmonize with the revised Common Rule, which are intended to reduce burden on IRBs and allow them to focus their resources on research that presents higher risk. Under proposed § 56.109(g), unless an IRB determines otherwise, continuing review of research is not required for research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: (1) data analysis, including analysis of identifiable private information or identifiable biospecimens or (2) accessing followup clinical data from procedures that subjects would undergo as part of clinical care. In these circumstances, FDA believes that requiring continuing review would generally not provide added protection to human subjects, and, therefore, would not be necessary. If an IRB chooses to conduct continuing review for research that meets these criteria, the rationale for doing so must be documented according to proposed § 56.115(a)(3).
We estimate the burden of the information collection as follows:
Based on our review of information from ClinicalTrials.gov (
The information collection approved under OMB control number 0910-0130 pertains to developing and documenting informed consent in accordance with §§ 50.25 and 50.27 and includes burden attributable to development and approval by an IRB of a site-specific informed consent document, and the documentation of informed consent, but
We estimate that one percent of IRBs (25) will review one study annually to determine whether the subjects or their LARs are members of a distinct cultural group or community in which signing forms is not the norm, such that the IRB may waive documentation of informed consent under proposed § 56.109(c)(3). We believe these IRBs are likely to document the findings required to approve the waiver in IRB meeting minutes (§ 56.115(a)(2)), although they could be documented elsewhere in IRB records. We estimate that this recordkeeping will require 15 minutes to complete, as reflected in table 8, row 1.
We estimate that 500 IRBs will review one study annually that will be subject to the proposed requirement under § 56.115(a)(3) to document the IRB's rationale for conducting continuing review of research that otherwise would not require continuing review under proposed § 56.109(g). We estimate that the associated documentation will require 15 minutes to complete, as reflected in table 8, row 2.
We characterize burden associated with progress reports under § 812.150 that are submitted from clinical investigators and sponsors to reviewing IRBs as a disclosure burden. As noted above, the proposed changes to § 812.150(a)(3) and (b)(5) would eliminate the need to submit progress reports to reviewing IRBs for non-significant risk and significant risk devices studies when continuing review is no longer required under part 56. Therefore, there is no additional burden, and FDA believes these proposed changes may reduce the number of progress reports submitted to reviewing IRBs for device studies that progress to a point where continuing review is no longer required.
We maintain our current estimate of one report annually for non-significant risk device studies that do not require submission of an IDE application to FDA, and that preparing the report requires 6 hours, as approved under OMB control number 0910-0078. We note however, this is a longstanding estimate and invite comment specifically with regard to the number of progress reports sponsors and investigators anticipate submitting annually to reviewing IRBs and the burden associated with progress reports
To ensure that comments on information collection are received, OMB recommends that written comments be submitted through
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), we have submitted the information collection provisions of this proposed rule to OMB for review. These information collection requirements will not be effective until FDA publishes a final rule, OMB approves the information collection requirements, and the rule goes into effect. FDA will announce OMB approval of these requirements in the
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175. We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.
The following reference is on display at the Dockets Management Staff (see
Human research subjects, Prisoners, Reporting and recordkeeping requirements, Safety.
Human research subjects, Reporting and recordkeeping requirements, Safety.
Health records, Medical devices, Medical research, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR parts 50, 56, and 812 be amended as follows:
21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 360hh-360pp, 360rr-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262.
(a) * * * Compliance with these parts is intended to protect the rights and safety of human subjects involved in such investigations.
The revisions and additions read as follows:
(i)
(j)
(l)
(t)
(u)
(v)
(w)
Except as provided in §§ 50.23 and 50.24:
(a) Before involving a human subject in research covered by these regulations, the investigator shall obtain the legally effective informed consent of the subject or the subject's legally authorized representative.
(b) An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.
(c) The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative.
(d) The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
(e)(1) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
(2) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.
(f) No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
The additions and revisions read as follows:
(a)
(3) A description of any benefits to the subject or to others that may reasonably be expected from the research.
(9) A description of how information or biospecimens may be used for future research or distributed to another investigator for future research.
(b)
(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable.
(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or legally authorized representative's consent.
(5) A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject.
(7) A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
(8) A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
(9) For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (
(c)
(d)
(e)
(a) Except as provided in § 56.109(c) of this chapter, informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated (including in an electronic format) by the subject or the subject's legally authorized representative at the time of consent. A written copy shall be given to the person signing the informed consent form.
(b) Except as provided in § 56.109(c) of this chapter, the consent form may be either of the following:
(1) A written informed consent form that meets the requirements of this part. The investigator shall give either the subject or the subject's legally authorized representative adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally authorized representative.
(2) A short form written informed consent form stating that the elements of informed consent required by § 50.25 have been presented orally to the subject or the subject's legally authorized representative. The key information required by § 50.20 must be presented first to the subject or the subject's legally authorized
21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262.
The revisions and addition read as follows:
(b) * * *
(17) Data and information regarding an electronic product submitted as part of the procedures for establishing, amending, or repealing a standard for such products, described in section 534 of the Federal Food, Drug, and Cosmetic Act.
(l)
(n)
(a) Except as provided in §§ 56.104 and 56.105, any clinical investigation that must meet the requirements for prior submission (as required in parts 312 and 812 of this chapter) to the Food and Drug Administration shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB meeting the requirements of this part.
(c) Compliance with these regulations will in no way render inapplicable pertinent Federal, State, or local laws or regulations (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that may otherwise be applicable and that provide additional protections for human subjects.
(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects.
(b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
(c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
(d) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
(e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of complex issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
(a) In order to fulfill the requirements of these regulations, each IRB shall:
(1) [Reserved]
(2) Prepare and maintain a current list of the IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications or licenses sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution, for example, full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultant;
(3) Establish and follow written procedures for:
(i) Conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution;
(ii) Determining which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review;
(iii) Ensuring prompt reporting to the IRB of proposed changes in a research activity; and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject.
(4) Establish and follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Food and Drug Administration of:
(i) Any unanticipated problems involving risks to subjects or others, or any serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB; and
(ii) any suspension or termination of IRB approval.
(b) Except when an expedited review procedure is used (as described in § 56.110), an IRB must review proposed research at convened meetings at which
The revisions and additions read as follows:
(b) An IRB shall require that information given to subjects or legally authorized representatives, when appropriate, as part of informed consent is in accordance with § 50.25 of this chapter. The IRB may require that information, in addition to that specifically mentioned in § 50.25 of this chapter, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
(c) * * *
(3) The IRB may waive documentation of informed consent if it finds that the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects, and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
(d) In cases where the documentation requirement is waived under paragraph (c)(1) or (3) of this section, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.
(f) An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than once per year, except as described in paragraph (g) of this section.
(g) Unless an IRB determines otherwise, continuing review of research is not required for research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
(1) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
(2) Accessing followup clinical data from procedures that subjects would undergo as part of clinical care.
(h) An IRB shall have authority to observe or have a third party observe the consent process and the research.
(i) An IRB shall provide in writing to the sponsor of research involving an exception to informed consent under § 50.24 of this chapter a copy of information that has been publicly disclosed under § 50.24(a)(7)(ii) and (iii) of this chapter. The IRB shall provide this information to the sponsor promptly so that the sponsor is aware that such disclosure has occurred. Upon receipt, the sponsor shall provide copies of the information disclosed to FDA.
(j) When some or all of the subjects in a study are children, an IRB must determine that the research study is in compliance with part 50, subpart D of this chapter, at the time of its initial review of the research.
(b)(1) An IRB may use the expedited review procedure to review either or both of the following:
(i) Some or all of the research appearing on the list described in paragraph (a) of this section and found by the reviewer(s) to involve no more than minimal risk;
(ii) Minor changes in previously approved research during the period for which approval is authorized.
(2) Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the IRB chairperson from among the members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited review procedure set forth in § 56.108(b).
(c) Each IRB that uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals that have been approved under the procedure.
(a) * * *
(1) Risks to subjects are minimized:
(i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk and
(ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
(5) Informed consent will be appropriately documented or appropriately waived, in accordance with § 50.27 of this chapter.
(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
(a) * * *
(3) Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review as described in § 56.109(g).
(5) A list of IRB members in the same detail as § 56.108(a)(2).
(6) Written procedures for the IRB as required by § 56.108(a)(3) and (4).
(b) The records required by this regulation shall be retained for at least 3 years after completion of the research. The institution or IRB may maintain the records in printed form or electronically. All records shall be accessible for inspection and copying by authorized representatives of the Food and Drug Administration at reasonable times and in a reasonable manner.
(c) * * * In addition, the Agency may elect to publish a notice of its action.
A determination that FDA has disqualified an IRB or an institution and the administrative record regarding that determination are disclosable to the public under part 20 of this chapter.
21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360hh-360pp, 360rr-360ss, 360bbb-8b, 371, 372, 374, 379e, 381, 382; 42 U.S.C. 216, 241, 262.
(a) * * *
(3)
(b) * * *
(5)
Food and Drug Administration, Health and Human Services (HHS).
Proposed rule.
The Food and Drug Administration (FDA or we) is proposing to replace current requirements for FDA-regulated cooperative research with new requirements that would require any institution located in the United States participating in FDA-regulated cooperative research to rely on review and approval by a single institutional review board (IRB) for that portion of the research that is conducted in the United States, with some exceptions. FDA is also proposing an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution. FDA is proposing these revisions to streamline the IRB review process and decrease administrative burdens and inefficiencies for investigators and IRBs without compromising human subject protections. This proposed rule would harmonize FDA's requirements for cooperative research and IRB records, to the extent practicable and consistent with statutory provisions, with the “Federal Policy for the Protection of Human Subjects” (revised Common Rule) and is being issued in accordance with a provision of the 21st Century Cures Act (Cures Act).
Either electronic or written comments on the proposed rule must be submitted by November 28, 2022. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 (PRA) by October 28, 2022.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions.”)
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
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This proposed rule would harmonize, to the extent practicable and consistent with statutory provisions, FDA's cooperative research requirements with the cooperative research requirements in the revised Common Rule,
FDA is proposing to replace the current requirements under § 56.114 “Cooperative research” of part 56 (21 CFR part 56) with new regulatory text that would require any institution located in the United States participating in cooperative research to rely on approval by a single IRB for that portion of the research that is conducted in the United States, with some exceptions. FDA is also proposing an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution.
FDA is proposing to issue this rule under sections 403, 406, 409, 412, 413, 503, 505, 510, 513-515, 520, 531-539, 541-542, 701, and 721 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343, 346, 348, 350a, 350b, 353, 355, 360, 360c-360e, 360j, 360hh-360pp, 360rr-360ss, 371, and 379e) and section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262).
This proposed requirement for single IRB review for FDA-regulated cooperative research as well as harmonizing, to the extent practicable and consistent with statutory provisions, these FDA requirements
FDA is in the process of amending its regulations under 21 CFR parts 50 and 56 on protection of human subjects and IRBs to harmonize with the revised Common Rule, consistent with section 3023 of the Cures Act. This proposed rule only addresses single IRB review for cooperative research and a related IRB recordkeeping requirement. FDA intends to undertake additional rulemaking to harmonize our regulations with the revised Common Rule, to the extent practicable and consistent with statutory provisions.
The Common Rule was originally issued in 1991 (56 FR 28001, June 18, 1991). The Common Rule sets forth requirements for the protection of human subjects involved in research that is conducted or supported by the Department of Health and Human Services (HHS) (see 45 CFR part 46, subpart A) and other Federal Departments and Agencies. The purpose of the Common Rule is to promote uniformity, understanding, and compliance with human subject protections as well as to create a uniform body of regulations across the Federal Departments and Agencies (80 FR 53931 at 53935, September 8, 2015).
On January 19, 2017, HHS and the other Common Rule Departments and Agencies announced revisions to modernize, strengthen, and make the Common Rule more effective (82 FR 7149, January 19, 2017). The revised Common Rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators (82 FR 7149). One of the proposals adopted in the revised Common Rule is the requirement for institutions located in the United States that are engaged in cooperative research (also referred to as multi-institutional studies, multisite studies, or multicenter studies) to use single IRB review for that portion of the research that takes place within the United States, with certain exceptions.
In adopting a single IRB review requirement as part of the revised Common Rule, HHS and the other Common Rule Departments and Agencies agreed with those commenters on the proposed rule to revise the Common Rule who indicated that mandated single IRB review would ultimately decrease administrative burdens and inefficiencies for investigators and institutions without diminishing human subject protections, while also acknowledging that transition to the single IRB review model would require additional time and changes to institutional policies and structures. In addition, HHS and the other Common Rule Departments and Agencies stated in the preamble that “in many cases multiple IRB approvals increase burden and frequently delay the implementation of studies, increasing the costs of clinical trials and potentially stalling access to new therapies.” (82 FR 7149 at 7209.)
The revised Common Rule requires that all U.S. institutions engaged in cooperative research rely upon a single IRB review with two exceptions: (1) cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native (AI/AN) tribe) or (2) research for which any Federal Department or Agency supporting or conducting the research determines and documents that the use of single IRB review is not appropriate for the particular context (45 CFR 46.114(b)). Under the first exception, if applicable law (including when the official governing body of an AI/AN tribe passes a tribal law) requires more than single IRB review for certain cooperative research, then the revised Common Rule's requirement for single IRB review
On December 3, 2014, the NIH proposed a Draft NIH Policy, “Use of a Single Institutional Review Board of Record for Multisite Research,” which stated that NIH would generally expect all domestic sites of multisite NIH-funded studies to use a single IRB of record.
On December 13, 2016, the Cures Act was signed into law amending certain provisions of the FD&C Act. The Cures Act is designed to help accelerate the discovery, development, and delivery of 21st century cures. Section 3023 of the Cures Act directs the Secretary of HHS, to the extent practicable and consistent with other statutory provisions, to harmonize differences between the HHS Human Subject Regulations and FDA's Human Subject Regulations. Section 3023 requires modifications to the HHS and FDA Human Subject Regulations, as appropriate, to: (1) reduce regulatory duplication and unnecessary delays; (2) modernize such provisions in the context of multisite and cooperative research projects; and (3) protect vulnerable populations, incorporate local considerations, and support community engagement through mechanisms such as consultation with local researchers and human research protection programs. The Cures Act also requires the Secretary, as appropriate, to ensure that human subject research that is subject to the HHS Human Subject Regulations and to the FDA Human Subject Regulations may: (1) use joint or shared review; (2) rely upon the review of an independent IRB or an IRB of an entity other than the sponsor of the research; or (3) use similar arrangements to avoid duplication of effort (section 3023 of the Cures Act). FDA is working with the Office for Human Research Protections (OHRP) and others in HHS to carry out this statutory mandate.
In addition, section 3056 of the Cures Act amended section 520(g) of the FD&C Act to remove the requirement for IRBs overseeing clinical investigations of devices to be “local.”
FDA has historically supported efforts to reduce administrative burden in cooperative research. Since being issued in 1981, the IRB regulations at part 56 have provided for the voluntary use of cooperative review in multi-institutional studies (46 FR 8958, January 27, 1981). Under current FDA regulations, institutions involved in multi-institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoiding duplication of effort.
Although the use of a single IRB review process is already encouraged and consistent with our regulations at § 56.114, it is voluntary. Consistent with the purpose for including the single IRB review requirement for cooperative research in the revised Common Rule, as described above, FDA believes that requiring single IRB review for certain multi-institutional clinical investigations would streamline the review process without compromising human subject protections. In addition, as described in section II.A., FDA believes that the benefits of requiring
Institutions have been reluctant to voluntarily use single IRB review for a variety of reasons, most of which are unrelated to whether single IRB review is more efficient and less burdensome than multiple local IRB reviews. A study conducted by the Clinical Trials Transformation Initiative (CTTI)
Over the years, clinical investigations have become more complex, with increasing numbers of sites. For scientific reasons, multicenter clinical investigations generally share a common protocol that could be carried out at each site, or different aspects of the protocol (
Examples of administrative burdens and review inefficiencies that result from multiple IRB reviews as described above have also been cited in literature. For example, Greene and Geiger identified numerous related but distinct factors that contribute to research delays and unnecessary costs in multicenter studies that undergo review by multiple IRBs, including: added time for the initial review and approval of the clinical investigation; differing requirements across IRBs that included widely variable IRB approval processes and unique consent forms across sites even in a “standardized” environment; differing test subject recruitment procedures and participant incentives across sites, possibly affecting response rates; and, when additional review times and IRB requirements were involved, the additional approval requirements consumed significant amounts of fixed grant funds, reducing the scope of the research (Ref. 2). Several other empirical studies have also found inefficiencies and inconsistencies associated with multiple IRB reviews of multisite clinical investigations (Ref. 3).
In the preamble to the revised Common Rule, the Common Rule Departments and Agencies stated that they believed that merely encouraging single IRB review would “fail to yield substantive positive change in the system[,]” and, therefore, determined that requiring single IRB review was necessary in order to increase efficiencies in research (82 FR 7149 at 7209). FDA agrees with the Common Rule Departments and Agencies that the benefits of single IRB review—including a streamlined review process, reduced administrative burdens, and increased efficiencies—are unlikely to be realized if reliance on a single IRB for review of cooperative research remains purely voluntary. Therefore, FDA is proposing to require single IRB review for certain multi-institutional clinical investigations to streamline the review process, decrease administrative burden created by multiple IRB reviews, and reduce inefficiencies for investigators, sponsors, institutions, and IRBs. Increased efficiencies for the oversight of clinical investigations may facilitate faster initiation of clinical investigations for the development of new medical products to benefit the public health. For example, a study of the National Cancer Institute's (NCI) single IRB (Central Institutional Review Board or CIRB) found that the time required to reopen a trial after a temporary closure because of a major protocol amendment was significantly faster at CIRB-affiliated sites (less than 48 hours on average) than at sites that used their local IRBs to implement the same trial amendments (40.5 days on average) (Ref. 4).
Furthermore, a single IRB would provide FDA with a single focal point for an IRB inspection for a given investigation. Inspection of a single IRB could cover oversight of a larger number of clinical investigation sites during a single inspection, therefore providing FDA an opportunity to operate a more efficient IRB inspection program.
FDA recognizes, however, that there are likely to be some initial burdens associated with use of a single IRB, rather than a local IRB model, such as establishing reliance agreements to document responsibilities among the various institutions participating in the research and the reviewing IRB. While FDA agrees with the Common Rule Departments and Agencies that mandatory single IRB review will ultimately decrease administrative burdens and inefficiencies for much FDA-regulated research, for some types of research, we do not believe it is clear that the potential benefits of single IRB review outweigh the potential associated burdens in every circumstance. Therefore, as described below, we are proposing exceptions to the single IRB review requirement to account for these situations.
We note that the preamble to the revised Common Rule describes that some comments identified the importance of local IRB review as a reason for opposing the proposed requirement for use of single IRB review (82 FR 7149 at 7208). FDA believes that attention to local issues related to the communities where the research will take place is very important and has provided recommendations in an FDA guidance on addressing local aspects of IRB review when using a single IRB review process.
FDA notes that a substantial amount of the clinical research that FDA regulates is not subject to the revised Common Rule. Although the Common Rule Departments and Agencies conduct and support a significant number of multi-institutional clinical investigations involving FDA-regulated products, the majority of such investigations are conducted and supported by industry. FDA-regulated clinical investigations that are funded by a Common Rule Department or Agency would also be subject to the revised Common Rule, which requires single IRB review for cooperative research, with certain exceptions. Because FDA's proposed mandatory single IRB review provisions would harmonize with the corresponding requirements under the revised Common Rule, to the extent practicable and consistent with statutory provisions, FDA's proposal would reduce the need for sponsors, investigators, institutions, and IRBs to comply with differing requirements. Many institutions are already implementing the revised Common Rule's single IRB review requirement, which had a compliance date of January 20, 2020. In addition, clinical investigations funded by NIH are already subject to NIH's single IRB review policy. Thus, there should be minimal impact on sponsors of FDA-regulated clinical investigations that are also Federally funded.
FDA is proposing to issue this rule under our authority to issue regulations regarding the investigational use of drugs under section 505(i) of the FD&C Act, the investigational use of devices under section 520(g) of the FD&C Act, and the investigational use of biological products under section 351(a) of the PHS Act. In addition, IRB review helps assure the quality and integrity of data from clinical investigations relied upon in submissions to FDA regarding the safety, effectiveness, and/or marketing of FDA-regulated products, including submissions made pursuant to sections 403, 406, 409, 412, 413, 503, 505, 510, 513-515, 520, 531-539, 541-542, and 721 of the FD&C Act and section 351 of the PHS Act. IRB review also helps protect the rights and safety of human subjects involved in those clinical investigations. Section 701(a) of the FD&C Act authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act.
FDA believes that requiring single IRB review for multi-institutional clinical investigations as described in this proposed rule would streamline the IRB review process, decrease administrative burdens and inefficiencies for investigators and IRBs while maintaining adequate human subject protections, and provide FDA an opportunity to operate a more efficient IRB inspection program.
FDA is proposing to replace the current requirements under § 56.114, Cooperative research, with new regulations that would require any institution located in the United States participating in FDA-regulated cooperative research to rely on approval by a single IRB for that portion of the research that is conducted in the United States, with some exceptions. For research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution, FDA is also proposing a new IRB recordkeeping requirement at § 56.115, IRB records. This requirement would clarify the documentation needed to specify the institution's reliance on the IRB for oversight of the research and the responsibilities that the institution, and the organization operating the IRB, will undertake to ensure compliance with the requirements of part 56. These proposed changes address, in part, section 3023 of the Cures Act, which requires the Secretary of HHS to harmonize differences between the HHS Human Subject Regulations and FDA's Human Subject Regulations, to the extent practicable and consistent with other statutory provisions. This proposed rule is intended to fulfill that directive with respect to FDA's requirements for cooperative research and a related IRB recordkeeping requirement. The differences between FDA's proposal and the revised Common Rule are described in further detail below.
FDA is proposing new regulatory text at § 56.114(a) to describe cooperative research covered by these regulations as a clinical investigation that involves more than one institution and to explain that, in the conduct of cooperative research, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with these regulations. This proposed regulatory text differs from the revised Common Rule at 45 CFR 46.114(a) by using FDA's term “clinical investigations,” rather than “projects,” and the term “regulations,” rather than “policy.” This language better reflects the scope of FDA's authority and the terminology used throughout FDA's existing human subject protection regulations.
FDA is proposing new regulatory text at § 56.114(b)(1) to require that any institution located in the United States participating in FDA-regulated cooperative research rely on approval by a single IRB for that portion of the research that is conducted in the United States. This proposed regulatory text differs from the revised Common Rule at 45 CFR 46.114(b)(1) by using FDA's term “participating,” rather than “engaged.” This language better reflects the terminology used throughout FDA's existing human subject protection regulations.
The revised Common Rule provision at 45 CFR 46.114(b)(1) also requires the reviewing IRB to be identified by the Federal Department or Agency
The revised Common Rule, under 45 CFR 46.114(b)(2), provides two exceptions from the requirement under 45 CFR 46.114(b)(1) for reliance on approval by a single IRB. The following research is excepted: (1) cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an AI/AN tribe) or (2) research for which any Federal Department or Agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context. The preamble to the revised Common Rule noted that the second exception “allows a federal department or agency the flexibility to determine that the use of a single IRB is not appropriate for certain contexts, thereby permitting additional IRB review and consideration of local and regional variations in some circumstances” (82 FR 7149 at 7209).
FDA is proposing new regulatory text at § 56.114(b)(2) to provide exceptions to the requirement under § 56.114(b)(1) for reliance on approval by a single IRB. FDA is proposing the same exception as under 45 CFR 46.114(b)(2)(i) of the revised Common Rule for circumstances in which more than a single IRB review is required by law. However, we do not believe it is practicable for FDA to adopt the same regulatory text as the exception at 45 CFR 46.114(b)(2)(ii) because most of the research that FDA regulates is not conducted or supported by FDA or by any Federal Department or Agency. Therefore, this exception would have no applicability to the majority of FDA-regulated research.
We also believe it would be impracticable for FDA to adopt an analogous exception for situations in which FDA determines and documents that the use of a single IRB is not appropriate for the particular context. Unlike review of a research grant application that would be submitted to a Federal Department or Agency for approval, certain FDA-regulated research does not require a submission to FDA or other interaction with FDA before it begins (
After considering these issues, instead of proposing a broad exemption that would provide for FDA to make case-by-case determinations that use of single IRB review is not appropriate, FDA is proposing specific exceptions that we believe reflect circumstances for which requiring the use of a single IRB for oversight of multisite research may not be appropriate for FDA-regulated research. In these cases, use of single IRB review may not be adequate to provide important expertise for a particular FDA-regulated clinical investigation or may not increase efficiencies for the oversight of certain clinical investigations. The intent of these proposed exceptions is to facilitate FDA-regulated research, minimize administrative burden, and maintain appropriate human subject protections.
The first exception to the requirement for reliance on approval by a single IRB in the revised Common Rule at 45 CFR 46.114(b)(2)(i) includes cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an AI/AN tribe). FDA is proposing this same exception at § 56.114(b)(2)(i).
FDA is proposing, at § 56.114(b)(2)(ii), an exception from the use of single IRB review for research involving a highly specialized FDA-regulated medical product for which unique, localized expertise is required. For example, for certain highly specialized FDA-regulated medical products, expertise in the use of the product may be limited to only a few specialists at geographically dispersed locations. In such cases, the investigators, research staff, and IRBs associated with the investigational sites would have the critical knowledge and training relevant to the product, and therefore, these IRBs would have the capability to most efficiently conduct initial review and oversee the research, while maintaining appropriate human subject protections. We believe that mandating the use of single IRB review could be an obstacle to initiating important research when the localized expertise is readily available, but none of the IRBs associated with the investigational sites can serve as the single IRB of record. FDA believes that this proposed criterion for exception from use of single IRB review would be met in such a case, although we expect that such exceptions would be rare occurrences.
FDA is proposing, under § 56.114(b)(2)(iii), an exception from mandatory use of single IRB review for research on drugs that is exempt from the requirements for an IND application under § 312.2(b) (21 CFR 312.2(b)). FDA does not require submission of an IND application for certain clinical investigations of lawfully marketed drugs that meet the criteria under § 312.2(b) (see 52 FR 8797, March 19, 1987). Such studies are generally lower risk clinical investigations of products that are lawfully marketed. Unlike clinical investigations that are conducted under the IND requirements,
To facilitate research in accordance with the statutory purpose of section 520(g) of the FD&C Act and avoid unnecessary burden on regulated entities, when FDA issued the IDE regulations at part 812, FDA did not require submission of an IDE application for all categories of device investigations (45 FR 3731 at 3735-3736, January 18, 1980). A device investigation conducted under the abbreviated requirements at § 812.2(b) (21 CFR 812.2(b)) (a nonsignificant risk or “NSR” study) is deemed to have an approved IDE and, among other requirements, cannot be an investigation of a significant risk device, as defined at § 812.3(m) (21 CFR 812.3(m)). While IRB approval is required for an NSR study, FDA approval of an IDE application is not. Reducing the level of regulatory controls for these investigations based on the degree of risk was considered appropriate to avoid unnecessary burden and delay in the approval of research without sacrificing human subject protection (see 45 FR 3731 at 3735-3736). In accordance with § 812.2(c), certain device studies are also exempt from the requirements of part 812, with the exception of 21 CFR 812.119 (disqualification of a clinical investigator). The exempt categories outlined at § 812.2(c) include certain studies of legally marketed devices in which the device is used in accordance with its labeled indications (see § 812.2(c)(1) and (2)), and certain studies of diagnostic devices that present low risk to subjects (see § 812.2(c)(3)). The exempt categories also include studies of devices undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk (§ 812.2(c)(4)). In addition, § 812.2(c) clarifies that investigations of the following devices do not require an IDE: (1) a device intended solely for veterinary use; (2) a device shipped solely for research on or with laboratory animals and labeled in accordance with § 812.5(c); and (3) a custom device as defined in § 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution. (See § 812.2(c)(5)-(7).)
FDA is proposing an exception from the requirement for single IRB review under § 56.114(b)(2)(iv) for research on medical devices that meets the abbreviated requirements under § 812.2(b) or that meets the requirements for exempted investigations under § 812.2(c), to the extent the exempted investigation would be subject to part 56. This proposed exception would encompass research that presents a lower risk to subjects and, in certain instances, may not involve a therapeutic intervention or invasive procedure (
In developing this proposed rule, FDA also considered recommendations provided by the Secretary's Advisory Committee on Human Research Protections (SACHRP) to the Secretary of HHS regarding additional categories of research that would be potentially appropriate for exception from the requirement to use a single IRB.
First, FDA is requesting comment on whether it is appropriate to include an exception for cooperative research for which use of a single IRB is unable to meet the needs of specific populations. Such an exception might apply, for example, to research that involves recruiting members of a distinct patient population or community (
We request comment on whether a single IRB of record would generally be able to supplement its members' knowledge and experience with additional information or expertise to account for these situations, examples of FDA-regulated research for which these circumstances would apply, and any data on the frequency of how often this situation may occur.
FDA is also requesting comment on including an exception for cooperative research with a small number of investigational sites. SACHRP recommended that research involving five or fewer investigational sites should be considered as potentially appropriate for exception to the single IRB review requirement.
In addition, FDA recognizes that situations may arise in which a federally conducted or supported FDA-regulated
We also specifically request comment on whether there are unique challenges to use of a single IRB review model for FDA-regulated cooperative research that could not be addressed by FDA's proposed exceptions. For any challenges identified, we seek comment on whether additional exceptions should be included to address them. For example, should FDA consider including an exception analogous to the revised Common Rule's exception at 45 CFR 46.114(b)(2)(ii)? As explained above, we do not believe it is practicable to rely on a broad exemption that would provide for FDA to make case-by-case determinations that use of single IRB review is not appropriate for the particular context as the only means for excepting FDA-regulated cooperative research—other than research for which more than single IRB review is required by law—from the proposed new requirement. The Agency also believes that situations in which use of a single IRB might not be appropriate and in which none of FDA's proposed exceptions apply would be rare. However, we seek comment on whether including an exception that provides for FDA to determine and document that single IRB review is not appropriate for the particular context, in addition to the exceptions FDA has proposed, could help address any such situations and any negative impacts of differences between FDA's proposed exceptions and exceptions available under the revised Common Rule to a Common Rule Department or Agency supporting or conducting cooperative research.
Lastly, FDA is requesting comment on the proposed exceptions and any other criteria that should be considered when assessing whether an exception to the use of single IRB review might be warranted. We also encourage the public to provide examples of any additional types of FDA-regulated clinical investigations that they believe should qualify for such an exception. To help stakeholders comply with these proposed requirements, if finalized, FDA intends to update our guidance on using a centralized IRB review process in multicenter clinical trials.
FDA is proposing new regulatory text at § 56.114(c) to specify that an institution participating in cooperative research that is not subject to the requirement for single IRB review at § 56.114(b) may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort. This proposed regulatory text differs from the revised Common Rule at 45 CFR 46.114(c) by use of the term “research,” rather than “project.” We believe that the term “research” better reflects the terminology used throughout FDA's existing human subject protection regulations. In addition, we note that, even if one of the proposed exceptions under § 56.114(b)(2) applies to a study, use of single IRB review would still be permitted under this proposed provision.
In some cases, FDA-regulated clinical investigations are also Federally conducted or supported and, thus, subject to the revised Common Rule. It is possible that such studies could fit within a proposed exception from FDA's proposed requirement for use of single IRB review but may be required under the revised Common Rule to use single IRB review. In these instances, proposed § 56.114(c) would still permit use of a single IRB for review and approval of the cooperative research.
FDA is proposing new regulatory text at § 56.115(a)(8) to require documentation of an institution's reliance on an external IRB for oversight of research. FDA is proposing to require, for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution, the institution, or where appropriate the IRB, must retain documentation specifying the institution's reliance on the IRB for oversight of the research and the responsibilities that each entity will undertake to ensure compliance with the requirements of part 56 (
FDA is proposing that any final rule that may issue based on this proposal become effective 1 year after the final rule is published in the
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all 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, and other advantages; distributive impacts; and equity). This proposed rule has been designated an economically significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because small entities affected by this proposed rule would incur net cost savings, we propose to certify that the rule, if finalized, will not have a significant economic impact on a substantial number of small entities. However, as discussed in the Preliminary Economic Analysis of Impacts (Ref. 5), there is a lack of high quality, comprehensive data regarding the number of small and very small institutions associated with IRBs, as defined by revenue. We have prepared an initial regulatory flexibility analysis and are seeking comment on the data and assumptions used in that analysis.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $165 million, using the most current (2020) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would result in an expenditure in any year that meets or exceeds this amount.
The proposed rule, if finalized, would require any institution located in the United States participating in FDA-regulated cooperative research to rely on approval by a single IRB for that portion of the research that is conducted in the United States, with some exceptions. The proposed rule would harmonize, to the extent practicable and consistent with statutory provisions, FDA's requirements for cooperative research with the requirements of the revised Common Rule in accordance with section 3023 of the Cures Act. This proposed rule should reduce the administrative and coordination costs of conducting FDA-regulated cooperative research by: (1) reducing duplicative reviews; (2) facilitating an earlier start of cooperative research; and (3) reducing the need to reconcile variability in IRB review decisions for cooperative research conducted with a common protocol. Reducing the costs of conducting cooperative research should reduce the costs of FDA-regulated medical product development and facilitate an earlier start of cooperative research, which could contribute to a faster introduction of those products into commercial use. Table 1 summarizes our estimate of the annualized costs and the annualized benefits of the proposed rule, if finalized.
We have developed a comprehensive Preliminary Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full preliminary analysis of economic impacts is available in the docket for this proposed rule (Ref. 5) and at
We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This proposed rule contains information collection provisions that are subject to review by OMB under the PRA (44 U.S.C. 3501-3521). A description of these provisions is given in the
FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed 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) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
We estimate the burden of the information collection as follows:
There are approximately 2,520 IRBs that review FDA-regulated research. We estimate that most IRBs will need to set up 10 IRB reliance agreements and that each agreement will require an average of 15 hours to complete.
To ensure that comments on information collection are received, OMB recommends that written comments be submitted through
In compliance with the PRA (44 U.S.C. 3407(d)), FDA has submitted the information collection provisions of this proposed rule to OMB for review. These requirements will not be effective until FDA obtains OMB approval. FDA will publish a notice concerning OMB approval of these requirements in the
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175. We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. We solicit comments from tribal officials on any potential impact on Indian Tribes from this proposed action.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see
Human research subjects, Reporting and recordkeeping requirements, Safety.
Therefore, under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR part 56 be amended as follows:
21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360pp, 360rr-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262.
(a) Cooperative research covered by these regulations is a clinical investigation that involves more than one institution. In the conduct of cooperative research, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with these regulations.
(b)(1) Any institution located in the United States that is participating in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States.
(2) Research is not subject to paragraph (b)(1) of this section if at least one of the following criteria is met:
(i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe);
(ii) Cooperative research involving a highly specialized FDA-regulated medical product for which unique, localized expertise is required;
(iii) Cooperative research on drugs that meets the exemptions from an investigational new drug application under § 312.2(b) of this chapter; or
(iv) Cooperative research on medical devices that meets the abbreviated requirements under § 812.2(b) of this chapter, or that meets the requirements for exempted investigations under § 812.2(c) of this chapter.
(c) For research not subject to paragraph (b) of this section, an institution participating in cooperative research may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort.
(a) * * *
(8) For research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution, documentation specifying the institution's reliance on the IRB for oversight of the research and the responsibilities that each entity will undertake to ensure compliance with the requirements of this part (
Food Safety and Inspection Service (FSIS), U.S. Department of Agriculture (USDA).
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, FSIS is announcing its intention to renew an approved information collection regarding permits to transport domestic undenatured inedible meat products. The approval for this information collection will expire on February 28, 2023. FSIS is making no changes to the information collection.
Submit comments on or before November 28, 2022.
FSIS invites interested persons to submit comments on this
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Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Mailstop 3758, South Building, Washington, DC 20250-3700; (202) 720-5627.
FSIS is requesting a renewal of the approved information collection regarding permits to transport domestic undenatured inedible meat products. The approval for this information collection will expire on February 28, 2023. FSIS is making no changes to the information collection.
Under the regulations at 9 CFR 325.11(e), official establishments are to apply in writing to their District Office to obtain a permit for the transport of undenatured inedible meat products in commerce. The application is to indicate the name and address of the applicant, a description of the type of business operations, and the purpose of making such application. FSIS has made the following estimates based upon an information collection assessment:
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Mailstop 3758, South Building, Washington, DC 20250-3700; (202) 720-5627.
Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this
FSIS will also announce and provide a link to this
In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.
Persons with disabilities who require alternative means of communication for program information (
To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at
Submit your completed form or letter to USDA by: (1) mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3) email:
USDA is an equal opportunity provider, employer, and lender.
Food and Nutrition Service (FNS), USDA.
Notice.
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This is a revision of a currently approved collection and existing burden in use without a valid OMB control number in the Supplemental Nutrition Assistance Program (SNAP). This information collection is for the Performance Reporting System and management evaluation processes, which ensure that SNAP State agencies are operating the program in accordance with statute and regulations. The Food and Nutrition Service (FNS) and SNAP State agencies use this information to evaluate State agency operations and to collect information necessary to develop solutions to improve the State's administration of SNAP policy and procedures.
Written comments must be received on or before November 28, 2022.
Comments may be sent to: Program Design Branch, Program Development Division, Food and Nutrition Service, U.S. Department of Agriculture, 1320 Braddock Place, 5th Floor, Alexandria, VA 22314. Comments may also be submitted via phone to Jessica Luna at 703-305-2022 or via email to
All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record.
Requests for additional information or copies of this information collection should be directed to Jessica Luna at 703-305-2022.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall 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 that were 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 use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
In the process of renewing this information collection, FNS consulted with 7 State agencies to update, if necessary, estimates for the time that State agency staff spend preparing State ME schedules, conducting State ME reviews, and maintaining State ME records.
7 CFR 275.20 requires each State agency to submit State ME review schedules to FNS. The review schedules must ensure that all project areas will be reviewed every one, two or three years, depending on the project area size, unless the State receives approval for an alternative ME review schedule, per regulations at 7 CFR 275.5(b). FNS defines project areas as the county or similar political subdivision designated by a State as the administrative unit for program operations. Per definitions at 7 CFR 271.2, FNS defines project areas as large, medium or small depending on the number of households in their monthly active caseload. The number of hours required to prepare these review schedules is a function of the number and size of project areas in the State. FNS assumes that it takes approximately 4 hours for each State to generate and submit their yearly review schedule via email or other electronic means to their respective FNS Regional Office. The agency did not find adjustments necessary to this category following State agency consultation.
Because States do not review all project areas annually, FNS estimates that States will conduct reviews in half of the total number of project areas each year. Therefore, each of the 53 State agencies will conduct approximately 27 management evaluations annually (total of 1,431 State MEs nationally). It will take approximately 340 hours for States to conduct each of these reviews. The agency did not find adjustments necessary to this category following State agency consultation.
Each State agency must keep records of ME reviews and submit such reports and other information to their respective FNS Regional Office as required under 7 CFR 275.4. States generally submit these reports and other information via email, though in some cases the FNS Regional Office may facilitate submission via a web-based collaboration and document management platform. The State agency must retain all ME records for audit and review purposes for no less than three years from the month of record origin. Following State agency consultation, FNS adjusted the recordkeeping burden for State MEs to more accurately account for State time used, adding 5,968 burden hours as compared to the previous approval for this collection. FNS estimates that recordkeeping burden related to ME reviews requires one record keeper per each State agency. Each recordkeeper manages approximately 29 records each year and it takes 4 hours to complete each record.
Under 7 CFR 275.3, FNS also conducts monitoring reviews to ensure that State agencies are operating SNAP and their State management evaluation (ME) programs in accordance with SNAP requirements. Federal management evaluations, which the FNS Regional offices conduct, are very similar to those conducted by the States. States participating in Federal management evaluations incur burden related to preparing for and facilitating the Regional office's review during the Federal ME.
With this information collection request, FNS is seeking OMB approval for the burden hours associated with Federal management evaluation information that is currently being collected in violation of the PRA without a valid OMB control number. Therefore, the burden estimates for this requirement represent an additional 8,692 burden hours not included in the previous approval of this collection. To prepare the below estimate, FNS used the same State consultations mentioned above to estimate the time that State agency staff spend on Federal ME reviews.
According to FNS internal records from previous years, FNS Regional offices typically conduct management evaluations twice a year in each SNAP State for an average total of 106 Federal MEs each year. To prepare for a Federal ME, States must gather documentation and information for FNS' review. For example, documentation may include procedure manuals, example notifications, and case records. The information required for the ME is dependent on the type of ME being performed and most items are submitted electronically via email to FNS Regional offices prior to the ME to allow time for review. Once FNS begins the review, States host FNS Regional office employees at a designated location, participate in interviews, and facilitate SNAP case file reviews. FNS estimates that it takes a State approximately 82 hours total to prepare for, attend, and help facilitate each Federal ME.
There is no recordkeeping burden for the affected public associated with Federal MEs for this information collection since FNS is the recordholder.
Using the same 7 State agency consultations mentioned previously, FNS updated the reporting burden estimates related to corrective action plans resulting from State and Federal management evaluations. Due to the resulting updates, the burden hours for this requirement represent an additional 636 burden hours for Corrective Action Plans (CAPs) that was not included in the previous approval of this collection.
As required at 7 CFR 275, each State has an established system for analysis and evaluation of all data available to the State during both State and Federal MEs. Data analysis and evaluation are ongoing processes that facilitate the development of prompt corrective action. Through the ME process, States and FNS Regional offices often identify deficiencies (
Food and Nutrition Service (FNS), USDA.
Notice.
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other interested parties to comment on a proposed information collection. This collection is an extension of a currently approved collection. This information collection will conduct research in support of FNS' goal of delivering science-based nutrition education to targeted audiences. This information collection will also conduct research that will assist FNS in identifying effective design and implementation approaches to use to develop and assess grants. From development through testing of materials and tools with the target audience, FNS plans to conduct data collections that involve formative research including focus groups, interviews (dyad, triad, telephone,
Written comments must be received on or before November 28, 2022.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information has 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 use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments may be sent to Jamia Franklin and Maureen Lydon, Planning and Regulatory Affairs Office, Food and Nutrition Service, U.S. Department of Agriculture, 1320 Braddock Place, 5th floor, Alexandria, VA 22314. Comments may also be sent via email to
All responses to this notice will be summarized and included in the request for Office of Management and Budget (OMB) approval. All comments will be a matter of public record.
Requests for additional information or copies of this information collection should be directed to Jamia Franklin at (703) 305-2403 or via email at
FNS develops a variety of resources to support nutrition education and promotion activities. These resources are designed to convey science-based, behavior-focused nutrition messages about healthy eating and physical activity to children and adults eligible to participate in FNS nutrition assistance programs and to motivate them to consume more healthful foods as defined by the Dietary Guidelines for Americans (DGA). This includes education materials, messages, promotion tools and interventions for the diverse population served by the Federal nutrition programs as well as WIC, Team Nutrition, Food Distribution and other programs.
Obtaining formative input and feedback is fundamental to FNS' success in delivering science-based nutrition messages and reaching diverse segments of the population in ways that are meaningful and relevant. This includes conferring with the target audience, individuals who serve the target audience, and key stakeholders on the communication strategies and interventions that will be developed and on the delivery approaches that will be used to reach consumers. The formative research and testing activities described will help in the development of effective education and promotion tools and communication strategies. Collection of this information will increase FNS' ability to formulate nutrition education interventions that resonate with the intended target population, particularly low-income families.
FNS also uses formative input and feedback to determine how best to develop and assess grants so that grant recipients can successfully meet their goals under these grants. To do this, FNS confers with grant recipients to obtain input regarding their experiences, expectations, challenges, and lessons learned while implementing the grant.
Formative research methods and information collection will include focus groups, interviews (dyad, triad, telephone,
Findings from all data collection will be included in summary reports submitted to USDA-FNS. The reports will describe the data collection methods, findings, conclusions, implications, and recommendations for
FNS estimates the total annual burden hours are a total of 46,823 burden hours for 3 years. Additionally, the total annual responses are a total of 120,710 total responses for 3 year approval. See the 3 year approval estimates below.
Forest Service, Agriculture (USDA).
Notice of meeting.
The Land Between the Lakes Advisory Board will hold a public meeting according to the details shown below. The committee is authorized under the Charter for the Land Between the Lakes Advisory Board, established pursuant to Section 460 of the Land Between the Lakes Protection Act of 1998 and operates in compliance with the Federal Advisory Committee Act as amended. The purpose of the committee is to advise the Secretary of Agriculture on (1) means of promoting public participation for the Land and Resource Management Plan; and (2) environmental education. General information can be found at the following website:
The meeting will be held on October 19, 2022, from 9 a.m.- 4 p.m., Central Time. All committee meetings are subject to cancellation. For status of the meeting prior to attendance, please contact the person listed under
This meeting is open to the public and will be held at the Land Between the Lakes National Recreation Area Administration Building, 100 Van Morgan Drive, Golden Pond, Kentucky, 42211. The public may also join virtually via telephone and/or video conference. Virtual meeting participation details can be found on the website listed under
Written comments may be submitted as described under
Leisa Cook, Designated Federal Officer (DFO), by phone at 270-924-2001 or email at
The meeting agenda will include:
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should make a request in writing at least three days before the meeting to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Christine Bombard, 100 Van Morgan Drive, Golden Pond, Kentucky, 42211; or by email to
USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.
Persons with disabilities who require alternative means of communication for program information (
Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the Committee. To ensure that the recommendations of the Committee have taken into account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women, and person with disabilities. USDA is an equal opportunity provider, employer, and lender.
Natural Resources Conservation Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act, the Natural Resources Conservation Service (NRCS) is requesting comments from all interested individuals and organizations on an extension of a currently approved information collection associated with Volunteer Program—Earth Team. The Volunteer Interest and Placement Summary and the Timesheet forms are used by the respondents. The information NRCS collects on the forms is used to match the skills of individuals, who are 14 years of age or older and interested in volunteering for opportunities that will further NRCS's mission.
We will consider comments that we receive by November 28, 2022.
We invite you to submit comments on this notice. You may submit comments, identified by Docket ID: NRCS-2022-0010, in the Federal eRulemaking Portal: Go to
You may also send comments to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503.
For specific questions related to the collection activities or to request a copy of the information collection, contact Toni Flax, Legislative Affairs Specialist, 610 N Middle, Hill City KS, (785-421-8373), or
The timesheet is an optional form and provides the volunteer or volunteer's supervisor a simplified method for tracking the volunteer's time. The form is placed in a volunteer “case file” and will be destroyed 3 years after the volunteer has completed service. In the event the volunteer is injured while engaged in volunteer activities and claims workman's compensation, the “case file” will be transferred to an Official Personnel Folder.
The information collection burden estimates have been updated. There were no other revisions required.
We are requesting comments on all aspects of this information collection to help us to:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of NRCS, including whether the information will have practical utility;
(2) Evaluate the accuracy of the estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) 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 or other forms of information technology.
All responses received in response to this notice, including names and addresses when provided, will be a matter of public records. Comments will be summarized and included in the submission for Office of Management and Budget approval.
Commission on Civil Rights.
Notice; cancellation of meeting date.
The Commission on Civil Rights published a notice in the
Victoria Moreno, 434-515-0204,
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Nebraska Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a meeting on Tuesday, October 18, 2022 at 4:00 p.m.-5:00 p.m. Central Time. The purpose for the meeting is to discuss the proposal for their project on effects of the pandemic on education in the state.
The meeting will take place on Tuesday, October 18, 2022, from 4:00 p.m. -5:00 p.m. Central Time.
Victoria Moreno at
This meeting is available to the public through the Zoom link above. If joining only via phone, callers can expect to incur charges for calls they initiate over wireless lines and the Commission will not refund any incurred charges.
Individuals who are deaf, deafblind and hard of hearing may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Victoria Moreno at
Persons who desire additional information may contact the Regional Programs Unit at (202) 809-9618. Records and documents discussed during the meeting will be available for public viewing as they become available at
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
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 publication of this notice on the following website
United States Patent and Trademark Office, Department of Commerce.
Notice.
On June 29, 2016, the United States Patent and Trademark Office (USPTO) implemented the Cancer Immunotherapy Pilot Program in support of the White House's National Cancer Moonshot initiative, which sought to accelerate cancer research. The program permits patent applications pertaining to cancer
For questions regarding this pilot program in general, please contact Susy Tsang-Foster, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy, at 571-272-7711 or
On June 29, 2016, the USPTO published a notice for the implementation of the Cancer Immunotherapy Pilot Program.
The Cancer Immunotherapy Notice established that the pilot program would run for 12 months, beginning on June 29, 2016. Over the course of the pilot program, the USPTO has extended it four times through notices published in the
Various stakeholders from around the world—including independent inventors, universities, research institutions, hospitals, medical centers, government agencies, and large and small companies—have filed petitions to participate in the pilot program. To date, over 880 petitions requesting participation have been filed, and over 650 patents have been granted under the pilot program. In view of the continued interest in the pilot program, the USPTO is hereby extending it through January 31, 2023. The extension will enable the program to continue without lapse as the USPTO continues its ongoing evaluation of whether to expand the program and to what extent. The requirements of the pilot program will not be modified at this time.
Department of the Air Force, DoD Civilian/Military Service Review Board.
Notice.
Under the provisions of Section 401, Public Law 95-202 and DoD Directive 100.20, the Department of Defense Civilian/Military Service Review Board has accepted an application on behalf of a group known as “Former Members of the Free Iraq Forces and Free Iraq Civil Affairs Program Who Served Under Direct Command of U.S. Army and U.S. Marine Corps Units During Operation Iraqi Freedom Across the Iraqi Freedom Theater of Operations During the Period 2002 Through 2018.” Persons with information or documentation pertinent to the determination of whether service of this group should be considered active military service to the Armed Forces of the United States are encouraged to submit such information or documentation within 60 days to the DoD Civilian/Military Service Review Board (DoD C/MSRB), 1500 West Perimeter Road, Suite 3700, Joint Base Andrews, MD 20762.
Mr. John K. Vallario, President, DoD C/MSRB, at 240-612-5380,
Department of the Navy (DoN), Department of Defense (DoD).
Notice of issuance of certificate of alternate compliance.
The U.S. Navy hereby announces that a Certificate of Alternate Compliance has been issued for USS AUGUSTA (LCS 34). Due to the special construction and purpose of this vessel, the Admiralty Counsel of the Navy has determined it is a vessel of the Navy which, due to its special construction and purpose, cannot comply fully with the navigation lights provisions of the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS) without interfering with its special function as a naval ship. The intended effect of this notice is to warn mariners in waters where 72 COLREGS apply.
This Certificate of Alternate Compliance is effective September 28, 2022 and is applicable beginning September 21, 2022.
Lieutenant Commander Andrea Liou, JAGC, U.S. Navy, Admiralty Attorney, Office of the Judge Advocate General, Admiralty and Claims Division (Code
Executive Order 11964 of January 19, 1977 and 33 U.S.C. 1605 provide that the requirements of the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), as to the number, position, range, or arc of visibility of lights or shapes, as well as to the disposition and characteristics of sound-signaling appliances, shall not apply to a vessel or class of vessels of the Navy where the Secretary of the Navy shall find and certify that, by reason of special construction or purpose, it is not possible for such vessel(s) to comply fully with the provisions without interfering with the special function of the vessel(s). Notice of issuance of a Certificate of Alternate Compliance must be made in the
In accordance with 33 U.S.C. 1605, the Admiralty Counsel of the Navy, under authority delegated by the Secretary of the Navy, hereby finds and certifies that USS AUGUSTA (LCS 34) is a vessel of special construction or purpose, and that, with respect to the position of the following navigational lights, it is not possible to comply fully with the requirements of the provisions enumerated in the 72 COLREGS without interfering with the special function of the vessel:
Annex I, Paragraph 2(a)(i) pertaining to the height of the forward masthead light; Annex I, Paragraph (3)(a) pertaining to the location of the forward masthead light in relation to the forward quarter of the ship; Annex I, Paragraph 2(f)(i) pertaining to obstructions of the aft masthead light; Annex I, Paragraph (3)(a) pertaining to the horizontal separation of the masthead lights; Annex I, Paragraph 2(f)(ii), and Annex I, Paragraph 3(c) pertaining to the vertical and horizontal position of the task lights in relation to the masthead lights; Rule 27(b)(i) and Annex I, Paragraph 9(b) pertaining to the degree of obstruction of the task lights.
The Admiralty Counsel of the Navy further finds and certifies that these navigational lights are in closest possible compliance with the applicable provision of the 72 COLREGS.
Office of Postsecondary Education (OPE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension without change of a currently approved collection.
Interested persons are invited to submit comments on or before October 28, 2022.
Written comments and recommendations for proposed information collection requests should be sent within 30 days of publication of this notice to
For specific questions related to collection activities, please contact Jason Cottell, 202-453-7530.
The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed ICR that is described below. The Department is especially interested in public comments addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public record.
This collection of information is gathered electronically by the Department for the purpose of determining an institution's eligibility to participate in the Titles III, V, and VII grant programs based on its enrollment of needy students and low average Core Expenses per full-time equivalent student. This collection also allows an institution to request a waiver of certain non-Federal cost-share requirements under the Federal Work-Study Program, Federal Supplemental Educational Opportunity Grant, Student Support Services Program and the Undergraduate International Studies and Foreign Language Program.
The collection is paired with a computational exercise that results in the simultaneous publication of an Eligibility Matrix (EM), a listing of postsecondary institutions potentially eligible to apply for grants in Institutional Service. Criteria derived from applicable legislation and regulations are applied to enrollment and financial data from Department sources to determine the eligibility of each institution for each program. Only those institutions that either do not meet the financial criteria or do not appear in the eligibility matrix need to go through the application process.
The results of the application process are a determination of eligibility for grant application and waiver, and updated information on institutional eligibility which is added to the EM.
This collection is being submitted under the Streamlined Clearance Process for Discretionary Grant Information Collections (1894-0001). Therefore, the 30-day public comment period notice will be the only public comment notice published for this information collection.
Department of Energy, Office of Electricity.
Notice of open meeting.
This notice announces a meeting of the Electricity Advisory Committee (EAC). The Federal Advisory Committee Act (FACA) requires that public notice of these meetings be announced in the
The October meeting of the EAC will be held at the National Rural Electric Cooperative Association Headquarters in Arlington, VA, 4301 Wilson Blvd., Ste 1, Arlington, VA 22203. Members of the public are encouraged to participate virtually, however, limited physical space is available for members of the public to attend onsite. To register to attend either in-person or virtually, please visit the meeting website:
Jayne Faith, Designated Federal Officer, Office of Electricity, U.S. Department of Energy, Washington, DC 20585; Telephone: (202) 586-2983 or Email:
The meeting agenda and times may change to accommodate EAC business. For EAC agenda updates, see the EAC website at:
This document of the Department of Energy was signed on September 23, 2022, by Shena Kennerly, Acting Committee Management Officer, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been
Department of Energy.
Notice of open meeting.
The Department of Energy hereby publishes a notice of open meeting on October 25, 2022, of the Secretary of Energy Advisory Board (SEAB). This meeting will be held virtually for members of the public and in-person at Oak Ridge National Laboratory, 1 Bethel Valley Rd., Oak Ridge, TN 37830 for SEAB members only.
Tuesday, October 25, 2022; 9:00 a.m.-1:30 p.m. Eastern Time.
Virtual meeting for members of the public. Board members, Department of Energy (DOE) representatives, agency liaisons, and Board support staff will participate in-person, strictly following COVID-19 precautionary measures To track virtual attendees, registration is required by registering at the SEAB October 25 meeting page here:
David Borak, Acting Director, Office of Secretarial Boards and Councils, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585; Phone: (202) 586-5216; or email:
Individuals and representatives of organizations who would like to offer comments and suggestions may do so during the meeting. Approximately 15 minutes will be reserved for public comments. Time allotted per speaker will depend on the number who wish to speak but will not exceed three minutes. The Acting Director of the Office of Secretarial Boards and Councils is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Those wishing to speak should register to do so via email,
Those not able to attend the meeting or who have insufficient time to address the committee are invited to send a written statement to David Borak, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585, or email to:
This document of the Department of Energy was signed on September 23, 2022, by Shena Kennerly, Acting Committee Management Officer, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of availability of draft guidance.
The U.S. Department of Energy (DOE) announces the notice of availability (NOA) and invites public comment on its Clean Hydrogen Production Standard (CHPS) Draft Guidance. The draft guidance contains the initial proposal for the CHPS, as required by the Infrastructure Investment and Jobs Act (IIJA). Specifically, in the draft guidance, DOE establishes a target for the lifecycle (
Comments regarding this draft guidance must be received on or before October 20, 2022.
Comments on this draft guidance document must be provided in writing. Interested parties are to submit comments electronically to
Requests for additional information should be directed to Karen Dandridge at
In the Infrastructure Investment and Jobs Act (Pub. L. 117-58), Congress directed DOE to develop an initial standard for the carbon intensity of clean hydrogen production. Specifically, under section 40315(a) of the Infrastructure Investment and Jobs Act, the Secretary of Energy, in consultation with the Administrator of the Environmental Protection Agency and after taking into account input from industry and other
In response, DOE developed and is seeking comment on draft guidance for the clean hydrogen production standard. The draft guidance is available at:
Take notice that on September 19, 2022, WBI Energy Transmission, Inc. (WBI Energy), 1250 West Century Avenue, Bismarck, North Dakota 58503, filed a prior notice request pursuant to Sections 157.205 and 157.210 of the Federal Energy Regulatory Commission's (Commission) regulations, for authorization to construct and operate a new compressor station, tie-in facilities including pipeline, and associated measurement facilities on its Line Section 27 located in McKenzie County, North Dakota to provide 175,000 equivalent dekatherms per day incremental natural gas firm transportation service. WBI Energy proposes to construct and operate these facilities under authorities granted by its blanket certificate issued in Docket No. CP82-487-000, all as more fully set forth in the application which is on file with the Commission and open to public inspection.
In addition to publishing the full text of this document in the
Any questions concerning this application should be directed to Lori Myerchin, Director, Regulatory Affairs and Transportation Services, WBI Energy Transmission, Inc., 1250 West Century Avenue, Bismarck, North Dakota 58503, at (701) 530-1563 or
Pursuant to Section 157.9 of the Commission's Rules of Practice and Procedure,
There are three ways to become involved in the Commission's review of this project: you can file a protest to the project, you can file a motion to intervene in the proceeding, and you can file comments on the project. There is no fee or cost for filing protests, motions to intervene, or comments. The deadline for filing protests, motions to intervene, and comments is 5:00 p.m. Eastern Time on November 21, 2022. How to file protests, motions to intervene, and comments is explained below.
Pursuant to section 157.205 of the Commission's regulations under the NGA,
Protests must comply with the requirements specified in section 157.205(e) of the Commission's regulations,
Any person has the option to file a motion to intervene in this proceeding. Only intervenors have the right to request rehearing of Commission orders issued in this proceeding and to subsequently challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure
All timely, unopposed motions to intervene are automatically granted by operation of Rule 214(c)(1). Motions to intervene that are filed after the intervention deadline are untimely and may be denied. Any late-filed motion to intervene must show good cause for being late and must explain why the time limitation should be waived and provide justification by reference to factors set forth in Rule 214(d) of the Commission's Rules and Regulations. A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies (paper or electronic) of all documents filed by the applicant and by all other parties.
Any person wishing to comment on the project may do so. The Commission considers all comments received about the project in determining the appropriate action to be taken. To ensure that your comments are timely and properly recorded, please submit your comments on or before November 21, 2022. The filing of a comment alone will not serve to make the filer a party to the proceeding. To become a party, you must intervene in the proceeding.
There are two ways to submit protests, motions to intervene, and comments. In both instances, please reference the Project docket number CP22-512-000 in your submission.
(1) You may file your protest, motion to intervene, and comments by using the Commission's eFiling feature, which is located on the Commission's website (
(2) You can file a paper copy of your submission by mailing it to the address below. Your submission must reference the Project docket number CP22-512-000.
To mail via USPS, use the following address:
To mail via any other courier, use the following address:
The Commission encourages electronic filing of submissions (option 1 above) and has eFiling staff available to assist you at (202) 502-8258 or
Protests and motions to intervene must be served on the applicant either by mail or email (with a link to the document) at: Lori Myerchin, Director, Regulatory Affairs and Transportation Services, WBI Energy Transmission, Inc., 1250 West Century Avenue, Bismarck, North Dakota 58503 or
Any subsequent submissions by an intervenor must be served on the applicant and all other parties to the proceeding. Contact information for parties can be downloaded from the service list at the eService link on FERC Online.
Throughout the proceeding, additional information about the project will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. For more information and to register, go to
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
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The Commission strongly encourages electronic filing. Please file comments, motions to intervene, and protests using the Commission's eFiling system at
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
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m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
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On September 22, 2022, the Commission issued an order in Docket No. RP22-1118-000, pursuant to section 5 of the Natural Gas Act, 15 U.S.C. 717d, instituting an investigation into whether the rates currently charged by MountainWest Overthrust Pipeline, LLC are just and reasonable.
Any interested person desiring to be heard in Docket No. RP22-1118-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214 (2021), within 30 days of the date of issuance of the order.
In addition to publishing the full text of this document in the
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFile” link at
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380, the Office of Energy Projects has reviewed the relicense application for the Cocheco Falls Dam Hydroelectric Project No. 4718 (project), located on the Cocheco River in the City of Dover, Strafford County, New Hampshire, and has prepared an Environmental Assessment (EA) for the project. No federal land would be occupied by the project.
The EA contains staff's analysis of the potential environmental effects of the project and concludes that licensing the project, with appropriate environmental protection measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
The Commission provides all interested persons with an opportunity to view and/or print the EA via the internet through the Commission's Home Page (
You may register online at
Any comments should be filed within 45 days from the date of this notice. The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
For further information, contact Arash Barsari at (202) 502-6207, or by email at
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following Complaints and Compliance filings in EL Dockets:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
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-725J (Definition of the Bulk Electric System).
Comments on the collection of information are due November 28, 2022.
Send written comments on FERC-725J (IC22-35-000) to the Commission. You may submit copies of your comments by one of the following methods:
Electronic filing through
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• For those unable to file electronically, comments may be filed by USPS mail or by hand (including courier) delivery.
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Ellen Brown may be reached by email at
—Legal (code 23-0000), $145.35.
—File Clerks (code 43-4071), $34.38.
—Electrical Engineer (code 17-2071), $77.02.
The average hourly burden cost for this collection is $85.58 [($145.35 + $34.38 + $77.02)/3 = $85.58] and is rounded to $86.00 an hour.
1. Section 205 of the Federal Power Act (FPA), 16 U.S.C. 824d, and 18 CFR part 35 (2021), require, among other things, that all rates, terms, and conditions for jurisdictional services be filed with the Commission. In Order No. 697 and its progeny,
2. In Order No. 860,
3. In accordance with Order No. 860, as modified by Order No. 860-A, the Order Adopting Revisions to Information Collection,
4. To comply with the Commission's requirements, the above-captioned sellers must file their baseline submissions to the market-based rate relational database consistent with the procedures set forth in Order Nos. 860, 860-A, and the Order Adopting Revisions to Information Collection.
5. In the event any of the above-captioned sellers have already submitted their baseline submissions in compliance with the Commission's requirements, their inclusion herein is inadvertent. Such sellers are directed to make a filing with the Commission, within 15 days of the date of issuance of this order, to identify themselves and provide details about their prior submissions to establish that they complied with the Commission's market-based rate relational database filing requirements.
6. If any of the above-captioned sellers do not wish to continue having market-based rate authority, they may file a notice of cancellation of their market-based rate tariffs with the Commission pursuant to section 205 of the FPA.
(A) Within 15 days of the date of issuance of this order, each seller listed in the caption of this order shall file with the Commission its delinquent baseline submission to the market-based rate relational database. If a seller subject to this order fails to make the filings required in this order, the Commission intends to revoke that seller's market-based rate authorization and intends to terminate its electric market-based rate tariff. The Secretary is hereby directed, upon expiration of the filing deadline in this order, to promptly issue a notice, effective on the date of issuance, listing the sellers whose tariffs have been revoked for failure to comply with the requirements of this order and the Commission's market-based rate relational database requirements.
(B) The Secretary is hereby directed to publish this order in the
Federal Energy Regulatory Commission, DOE.
Notice of information collection and request for comments.
In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC-740 (Availability of E-Tag Information to Commission Staff), which will be submitted to the Office of Management and Budget (OMB) for a review of the information collection requirements.
Comments on the collection of information are due October 28, 2022.
Send written comments on FERC-740 to OMB through
Please submit copies of your comments (identified by Docket No. IC22-20-000) to the Commission as noted below. Electronic filing through
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• For those unable to file electronically, comments may be filed by USPS mail or by hand (including courier) delivery.
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FERC submissions must be formatted and filed in accordance with submission guidelines at
Ellen Brown may be reached by email at
Transmission system operators, which are among the addressees of e-Tags, use e-Tags to ascertain the transactions affecting their local systems, and to prevent damage to the power grid. Commission access to e-Tags helps the Commission detect and prevent market manipulation and anti-competitive behavior, and monitor the efficiency of markets. Both transmission system operators and the Commission need the e-Tag information to understand the use of the interconnected electricity grid, particularly transactions occurring at interchanges. Due to the nature of the electric grid, an individual transaction's impact on an interchange cannot be assessed adequately in all cases without information from all connected systems, which is included in the e-Tags. The inclusion of the Commission is completely automatic and is part of the normal business requirement. Thus, the time, effort, and financial resources necessary to comply with this collection of information are “usual and customary” within the meaning of the OMB regulation at 5 CFR 1320.3(b)(2) (excluding such activities from the definition of “burden”). In view of these circumstances, FERC is including only a “placeholder” burden of one hour to account for the rare event where a new BA qualifies for exemption under the Commission's regulations (
The estimated hourly cost (wages plus benefits) provided in this section is based on the figures for May 2021 posted by the Bureau of Labor Statistics for the Utilities sector (available at
The overall hourly cost is $36.90 (
Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following public utility holding company filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding of Huck Finn Solar, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is October 12, 2022.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
On August 11, 2022, The Chemical Market Analysis & Consulting Company, LLC, filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Fitler Bend Hydrokinetic Energy Project to be located on the Mississippi River in Issaquena County, Mississippi, and East Carroll Parish, Louisiana. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed Filter Bend Hydrokinetic Project would consist of: (1) 2,000, 10 to 13 foot diameter, 750 kilowatt hydrokinetic turbine units arranged in arrays, typically two units wide and three units high, and generating power from the flow of the Mississippi River; (2) approximately 333 stand-alone pilings, installed in the river bottom, one for mounting each array; and (3) 34.6 kilovolt substations, constructed of masonry above the high-water mark of the riverbank, receiving power from the arrays, and interconnecting with potential industrial consumers. The total project would occupy much of the bottom of the Issaquena County, Mississippi side of an approximately 15 mile reach of Mississippi River. The project would have a total installed capacity of 1,500 megawatts and an average annual generation of 1.56 million megawatt-hours.
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's website at
The license for the Pejepscot Hydroelectric Project No. 4784 was
Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee(s) under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.
If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 4784 is issued to the Topsham Hydro Partners Limited Partnership for a period effective September 1, 2022, through August 31, 2023, or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first. If issuance of a new license (or other disposition) does not take place on or before August 31, 2023, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise.
If the project is not subject to section 15 of the FPA, notice is hereby given that the Topsham Hydro Partners Limited Partnership is authorized to continue operation of the Pejepscot Hydroelectric Project under the terms and conditions of the prior license until the issuance of a new license for the project or other disposition under the FPA, whichever comes first.
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On September 22, 2022, the Commission issued an order in Docket No. RP22-1121-000, pursuant to section 5 of the Natural Gas Act, 15 U.S.C. 717d, instituting an investigation into whether the rates currently charged by Stagecoach Pipeline & Storage Company LLC are just and reasonable.
Any interested person desiring to be heard in Docket No. RP22-1121-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214 (2021), within 30 days of the date of issuance of the order.
In addition to publishing the full text of this document in the
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFile” link at
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for the Wood Building Products Surface Coating Industry (EPA ICR Number 2034.10, OMB Control Number 2060-0510) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through November 30, 2022. Public comments were previously requested via the
Additional comments may be submitted on or before October 28, 2022.
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2022-003, online using
The 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
Muntasir Ali, Sector Policies and Program Division (D243-05), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-0833; email address:
Supporting documents, which explain in detail the information that the EPA
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Stationary Combustion Turbines (EPA ICR Number 2177.08, OMB Control Number 2060-0582), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through November 30, 2022. Public comments were previously requested, via the
Additional comments may be submitted on or before October 28, 2022.
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2022-0037, online using
The 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
Muntasir Ali, Sector Policies and Program Division (D243-05), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-0833; email address:
Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at
The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Thursday, September 29, 2022, which is scheduled to commence at 10:30 a.m. in the Commission Meeting Room of the Federal Communications Commission, 45 L Street NE, Washington, DC. While attendance at the Open Meeting is available to the public, the FCC headquarters building is not open access, and all guests must check in with and be screened by FCC security at the main entrance on L Street. Attendees at the Open Meeting will not be required to have an appointment but must otherwise comply with protocols outlined at:
The meeting will be webcast at:
Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500. Audio/Video coverage of the meeting will be broadcast live with open captioning over the internet from the FCC Live web page at
Federal Deposit Insurance Corporation (FDIC).
Notice; correction; extension of comment period.
This document contains an extension of comment period and a correction to FDIC's Agency Information Collection Activities notice that published in the
Manny Cabeza, Regulatory Counsel, 202-898-3767,
In the
1. On page 56413, in the third column, correct the
Comments for information collection 3064-0092 (Community Reinvestment Act) and information collection 3064-0174 (Funding and Liquidity Risk Management) must be submitted on or before October 14, 2022.
2. Starting on page 56415, extending across three columns, correct the table labeled “Summary of Estimated Annual Burdens (OMB 3064-0113)” to read:
The Commission hereby gives notice of filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments, relevant information, or documents regarding the agreements to the Secretary by email at
The Commission gives notice that it intends to terminate the following agreement pursuant to 46 CFR 501.17(h)(2) thirty days from publication of this notice.
The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
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 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 October 13, 2022.
1.
Board of Governors of the Federal Reserve System.
Office of Government-wide Policy (OGP), General Services Administration (GSA).
Notice of GSA Bulletin FTR 23-02, marking, redacting, and segregating information when reporting travel data.
GSA Bulletin FTR 23-02 clarifies the Freedom of Information Act (FOIA) requirement of Federal agencies to reasonably segregate (
For clarification of content, contact Mr. LaMan Dantzler, Office of Government-wide Policy, Office of Asset and Transportation Management, at
FTR §§ 300-70.100 through 103 establish the requirements for agencies to report annually on the use of first class and business class transportation by Government travelers on official business. FTR § 300-70.103 specifies that agencies are required to submit protected data in the aggregate (
GSA Bulletin FTR 23-02 can be viewed in its entirety at
Office of Government-wide Policy (OGP), General Services Administration (GSA).
Notice of FMR Bulletin 2022-F1, database cost reporting.
FMR Bulletin 2022-F1. This bulletin clarifies, highlights, and reminds agencies of the importance of accurately reporting the cost of federal advisory committees to Congress and the public. It also adds the requirement to include financial reporting instructions in agency administrative procedures. This requirement will result in greater assurance that data reported in the FACA database is consistent with agencies' actual costs, and Congress will have greater assurance that it can rely on these data to inform decisions about funding for FACA committees.
For clarification of content, contact Ms. Lorelei Kowalski, Director of the Committee Management Secretariat, Office of Government-wide Policy by email at
The Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. App. 2, requires that:
• Each agency keep records of advisory committee funds that can be audited by the Comptroller General (§ 12(a))
• Congress and the public to be kept informed with respect to the cost of advisory committees (§ 2(b)(5))
• The GSA Administrator institute an annual comprehensive review (ACR) of the activities and responsibilities of advisory committees (§ 7(b))
• Each agency head must establish uniform administrative guidelines and management controls for the advisory committees established by that agency (§ 8(a))
During a recent evaluation of 11 selected committees covered under the Federal Advisory Committee Act (FACA) that serve the Departments of Commerce, Health and Human Services, and the Treasury, the Government Accountability Office determined that approximately 29 percent of selected committees' cost data reported in the GSA FACA database were inconsistent
FMR Bulletin 2022-F1 can be viewed in its entirety at
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of charter renewal.
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through September 18, 2024.
Gladys G. Lewellen, M.B.A., M.P.A., Designated Federal Officer, CDC, 1600 Clifton Road NE, Mailstop TW-2, Atlanta, Georgia 30329-4027; Telephone: (770) 488-4786; email:
The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign
Office of Early Childhood Development, Administration for Children and Families, Department of Health and Human Services (HHS).
Notice; Delegations of Authority.
The Administration for Children and Families (ACF) has redelegated the authorities for the Preschool Development Grants Birth Through Five (PDG B-5) and Tribal Maternal Infant and Early Childhood Home Visiting (MIECHV) Program from the Office of Child Care to the Office of Early Childhood Development.
Melissa Lim Brodowski, Deputy Director, Office of Early Childhood Development, 330 C Street SW, Washington, DC 20201, 202-401-9335.
I. By this notice, I rescind certain previously delegated authorities to the Director, Office of Child Care, and delegate authorities to the Deputy Assistant Secretary for Early Childhood Development.
The authority delegated to me by the Secretary of the Department of Health and Human Services to administer the provisions of the PDG B-5, authorized by Section 9212 of the Every Student Succeeds Act, 42 U.S.C. 9831 note, now and hereafter for the life of the program. I also rescind the delegation to the Director, Office of Child Care.
Section 9212 of Every Student Succeeds Act, 42 U.S.C. 9831 note, authorizes the Secretary of the Department of Health and Human Services to award initial and renewal grants to eligible entities for the purpose of carrying out the requirements of PDG B-5 grant program. This includes administering the grants funded under this program, as well as administrative services and contracts related to technical assistance to support the program. The initial PDG B-5 grants were designed to facilitate collaboration and coordination among existing programs within the state's early childhood care and education system. The PDG B-5 Renewal Grant Initiative will fund states to enhance, expand, and/or build upon activities described in their initial grant.
The authority delegated to me by the Secretary of the Department of Health and Human Services regarding implementation of the Tribal Maternal, Infant, and Early Childhood Home Visiting Program (Tribal MIECHV), authorized and funded by Section 511 of Title V of the Social Security Act, now and hereafter for the duration of the agreement with the Health Resources and Services Administration (HRSA) to administer the program. I also rescind the delegation to the Director, Office of Child Care, for the administration of the Tribal MIECHV grants.
Since FY 2010, HRSA and ACF have collaborated on the administration of the MIECHV program, which includes a set aside for the tribal home visiting program. Funding is provided by HRSA to ACF for administrative services and contracts related to research, evaluation, and associated technical assistance through an Intra-agency Agreement mechanism and for tribal grant program and technical assistance through an Intra-Departmental Delegation of Authority. The Office of Early Childhood Development manages the Tribal MIECHV grants and programmatic technical assistance for the grant program (listed below).
Tribal MIECHV Grants—Grants awarded on a competitive basis to eligible Indian tribes (including consortia of tribes), tribal organizations, and/or urban Indian organizations to enable the entities to deliver services under early childhood home visiting programs to at-risk families to improve the child and family outcomes listed above.
Contracts for Technical Assistance—Contracts to provide technical assistance to tribal entities administering home visiting programs, including support needed to collect MIECHV benchmark data, conduct evaluation and continuous quality improvement activities, and implement programs.
Tribal MIECHV Grantee Meeting—Contracts to support the planning and implementation of the Tribal MIECHV grantee meeting. This includes logistical support and coordination of meeting content.
II.
III.
IV.
This redelegation of authority supersedes all previous delegations for the PDG B-5 Program and Tribal MIECHV Program. This redelegation will be effective upon date of signature.
Office of Planning, Research, and Evaluation; Administration for Children and Families; Department of Health and Human Services.
Request for public comments.
The Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families (ACF) is proposing a new information collection for the Child Welfare Study to Enhance Equity with Data (CW-SEED). The project aims to understand how and to what extent data are used to explore equity in service delivery and child and family outcomes, to identify barriers or problematic data practices, and to explore efforts by child welfare agencies and their partners to use data to reduce barriers across the continuum of child welfare services.
You can obtain copies of the proposed collection of information and submit comments by emailing
Annual Burden Estimates
Office of Planning, Research, and Evaluation, Administration for Children and Families, Department of Health and Human Services.
Request for public comments.
The Administration for Children and Families (ACF), of the U.S. Department of Health and Human Services (HHS), is proposing to extend data collection activity for BEES. We are not proposing any changes to the currently approved materials. Data collected is being used to estimate the effects of the participating programs on employment, earnings, and other key outcomes for the purpose of assessing the effectiveness of the program.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Office of Planning, Research, and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.
Request for public comments.
The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), in collaboration with the Office on Trafficking in Persons (OTIP), is proposing a new data collection activity for the Human Trafficking Youth Prevention Education (HTYPE) Demonstration Grant Program Process Evaluation. The process evaluation will explore whether the program is being implemented as intended, describe the successes and barriers that have been encountered, and highlight the changes that may be needed to support program implementation.
Copies of the proposed collection of information can be obtained and comments may be forwarded by emailing
The purpose of the proposed information collection is to investigate and document how HTYPE projects approach and accomplish the goals of the HTYPE Demonstration Grant Program, inform ACF's efforts to support human trafficking prevention education in schools, and inform future evaluation efforts.
The proposed information collection activities include:
(1) One-time, semi-structured interviews or focus groups with trained LEA staff and implementers at select schools from each grant recipient site. Interviews/focus groups will include questions focused on implementation models, participant and implementer engagement, and implementation facilitators and barriers.
(2) One-time, semi-structured interviews with school staff related to the process and implementation of the HTSSP at select schools from each grant recipient site.
(3) One-time web survey with school administrators, which will include questions focused on school context and engagement, training mandates, implementation models, and implementation facilitators and barriers.
(4) One-time web survey with school staff tasked with implementing the HTYPE curriculum, which will include questions focused on educator training, student curriculum implementation models and quality, participant and implementer engagement, and implementation facilitators and barriers.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing a correction to the notice of meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the
James Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993-0002, 301-796-6313,
In the
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is requesting that any small business tobacco manufacturing industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to be included in a pool of individuals to represent the interests of the small business tobacco manufacturing industry on the Tobacco Products Scientific Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. This position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee. Nominations will be accepted for current vacancies effective with this notice.
Any small business tobacco manufacturing industry organization interested in participating in the selection of appropriate nonvoting members to represent industry interests must send a letter stating that interest to the FDA by October 28, 2022 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to *FDA by October 28, 2022.
All statements of interest from small business tobacco manufacturing industry organizations interested in participating in the selection process of nonvoting industry representative nominations should be sent to Serina Hunter-Thomas (see
Serina Hunter-Thomas, Office of Science, Center for Tobacco Products, Food and Drug Administration, Center for Tobacco Products Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,1-877-287-1373 (choose Option 5), or by email:
The Agency intends to add nonvoting industry representative(s) to the following advisory committee:
The Tobacco Products Scientific Advisory Committee (the Committee) advises the Commissioner of FDA (the Commissioner) or designee in discharging responsibilities related to the regulation of tobacco products. The Committee reviews and evaluates safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information, and recommendations to the Commissioner.
The Committee includes three nonvoting members who represent industry interests. These members include one representative of the interests of the tobacco manufacturing industry, one representative of the interests of tobacco growers, and one representative of the interests of the small business tobacco manufacturing industry, which may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee.
With this notice, nominations are sought for the following positions: a pool of individuals, with varying areas of expertise, to represent the interests of the small business tobacco manufacturing industry on a rotating, sequential basis.
Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see
Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Contact information, a current curriculum vitae, and the name of the committee of interest should be sent to the FDA Advisory Committee Membership Nomination Portal (see
FDA seeks to include the views of women, and men, members of all racial and ethnic groups and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Food and Drug Administration, Department of Health and Human Services (HHS).
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Providing Over-the-Counter Monograph Submissions in Electronic Format.” This guidance provides information on providing electronic submissions to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Submit either electronic or written comments on the draft guidance by November 28, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-
Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-7945.
FDA is announcing the availability of a draft guidance for industry entitled “Providing Over-the-Counter Monograph Submissions in Electronic Format.” This guidance provides information on providing electronic submissions to FDA under section 505G of the FD&C Act (21 U.S.C. 355h) (hereafter referred to as over-the-counter (OTC) monograph submissions). This guidance is intended to assist submitters by describing the electronic OTC monograph submissions requirement in section 505G(j) of the FD&C Act and providing recommendations and other information on how to send such OTC monograph submissions to FDA in electronic format.
Section 505G of the FD&C Act was added by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Public Law 116-136, which was enacted on March 27, 2020. Section 505G(j) of the FD&C Act requires that all OTC monograph submissions must be in electronic format. As required by section 505G(l)(3) of the FD&C Act, this draft guidance, when finalized, specifies the format of electronic submissions under section 505G of the FD&C Act.
In support of the CARES Act, FDA agreed to specific performance goals and procedures described in the document entitled “Over-the-Counter Monograph User Fee Program Performance Goals and Procedures—Fiscal Years 2018-2022,” commonly referred to as the OMUFA commitment letter (the document can be accessed at
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Providing Over-the-Counter Monograph Submissions in Electronic Format.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act of 1995 does not apply to collections of information made under section 505G of the FD&C Act. This guidance is being issued to implement the provisions of section 505G(l)(3) of the FD&C Act, which specifies the format of electronic submissions to FDA under section 505G of the FD&C Act. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
Persons with access to the internet may obtain the draft guidance at
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance document related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE) entitled “Policy for Coronavirus Disease—2019 Tests During the Public Health Emergency (Revised).” FDA is issuing this guidance to provide FDA's revised enforcement policies and review priorities regarding certain novel coronavirus (COVID-19) tests for the duration of the public health emergency. Rapid detection of COVID-19 cases in the United States requires wide availability of testing to control the spread of this highly contagious infection. This document supersedes “Policy for Coronavirus Disease—2019 Tests During the Public Health Emergency (Revised)” issued November 15, 2021. The guidance identified in this notice addresses issues related to the COVID-19 PHE and has been issued in accordance with the expedited process FDA announced in the
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see § 10.115(g)(5) (21 CFR 10.115(g)(5))).
Submit written requests for a single hard copy of the guidance document entitled “Policy for Coronavirus Disease—2019 Tests During the Public Health Emergency (Revised)” to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. See the
Toby Lowe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3416, Silver Spring, MD 20993-0002, 301-796-6512.
FDA is announcing the availability of a final guidance entitled “Policy for Coronavirus Disease—2019 Tests During the Public Health Emergency (Revised),” which supersedes the guidance of the same title issued November 15, 2021. FDA is issuing this guidance to provide FDA's updated enforcement policies and review priorities regarding certain novel coronavirus (COVID-19) tests for the duration of the public health emergency. Rapid detection of COVID-19 cases in the United States requires wide availability of testing to control the spread of this highly contagious infection.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3), the FDA Commissioner may authorize the use of unapproved medical products, or unapproved uses of approved medical products, in certain emergency circumstances, after the HHS Secretary has made a declaration of emergency or threat justifying authorization of emergency use, to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear threat agents when certain criteria are met (emergency use authorization (EUA)). As of August 15, 2022, FDA has authorized under EUA more than 439 tests for COVID-19, including more than 354 diagnostic and 85 serology or other immune response tests. Further, two molecular diagnostic COVID-19 tests have been granted marketing authorization through the traditional device premarket review pathways.
In the context of a public health emergency involving pandemic infectious disease, it is critically important that tests are validated because false results not only can negatively impact the individual patient but also can have a broad public health impact. False positive results for diagnostic tests, for example, can lead to unnecessary quarantine and potential further spread when presumed positive individuals are quarantined together, wasted contact tracing and testing resources, and delay in accurate diagnosis and appropriate treatment for the individual. False negative results can lead to lack of appropriate treatment for the individual and further spread of the disease.
FDA has continued to closely monitor the COVID-19 testing landscape and believes it is appropriate to update its policies to reflect the current needs of the pandemic. As explained throughout this updated guidance, FDA intends to review the EUA requests for a smaller subset of tests. Traditional marketing pathways remain available to all developers and FDA encourages developers of tests that fall outside the scope of the priorities outlined in this updated guidance to pursue those routes. In sum, FDA has revised this guidance to update the types of COVID-19 tests for which the Agency intends to review EUA requests, to discuss the use of the traditional premarket review pathways for other types of COVID-19 tests for which the Agency does not intend to review EUA requests, and to make minor updates to the enforcement policies.
On January 31, 2020, as a result of confirmed cases of COVID-19, and after consultation with public health officials as necessary, the Secretary of Health and Human Services (HHS), pursuant to the authority under section 319 of the Public Health Service Act (42 U.S.C. 247d), determined that a PHE exists and has existed since January 27, 2020, nationwide.
In the
This guidance is being issued consistent with FDA's good guidance practices regulation (§ 10.115). The guidance represents the current thinking of FDA. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This guidance refers to previously approved FDA collections of information. These collections of information are subject to review by OMB under the Paperwork Reduction Act of 1995 (PRA). The collections of information in the following FDA regulations and guidances have been approved by OMB as listed in the table below. This guidance also contains a new collection of information not approved under a current collection. The new collection of information has been granted a public health emergency (PHE) waiver from the PRA by the Department of Health and Human Services (HHS) on March 19, 2020, under section 319(f) of the PHS Act. Information concerning the PHE PRA waiver can be found on the HHS website at
Persons with access to the internet may obtain the guidance at:
• FDA web page entitled “Guidance Documents (Medical Devices and Radiation-Emitting Products)” available at
• FDA web page entitled “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders,” available at
• FDA web page entitled “Search for FDA Guidance Documents” available at
•
Food and Drug Administration, Department of Health and Human Services (HHS).
Notice.
The Food and Drug Administration's (FDA), Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT) has modified its organizational structures.
These new organizational structures were approved by the Secretary of Health and Human Services on August 8, 2022, and effective on September 16, 2022.
Yashika Rahaman, Director, Office of Planning, Evaluation and Risk Management, Office of Finance, Budget, Acquisitions and Planning, FDA, 4041 Powder Mill Road, Beltsville, MD, 20705-4304, 301-796-3843.
Part D, Chapter D-B, (Food and Drug Administration), the Statement of Organization, Functions and Delegations of Authority for the Department of Health and Human Services (35 FR 3685, February 25, 1970, 60 FR 56606, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 50112, August 30, 2007, 74 FR 41713, August 18, 2009, 76 FR 45270, July 28, 2011, and 84 FR 22854, May 20, 2019) is revised to reflect the Food and Drug Administration's reorganization of CBER, Office of Tissues and Advanced Therapies (OTAT).
CBER's mission is to protect and enhance public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. With substantial growth in innovative, novel products, as well as a need to address an ever-changing landscape of potential public health threats, CBER is currently facing scientific, medical, and regulatory challenges that require changes to its structure.
Utilizing key tenets of CBER's modernization efforts, CBER will retitle OTAT to the Office of Therapeutic Products (OTP) and elevate OTP to a Super Office to manage its program at a macro level and to better position the Center to address an everchanging public health landscape. With the current and anticipated increase in workloads, the proposed structural changes will improve functional alignment, increase review capabilities, and enhance expertise on new cell and gene therapies. Additional supervisory positions will not only help to address this increased workload but will also provide advancement opportunities to facilitate recruitment and retention of highly qualified staff. The proposal creates flexibility and capacity for future growth in Full-Time Employees (FTEs) and workload, avoiding the need for continual reorganizations. The reorganization will position OTP to focus on commitments, including those negotiated with industry in the prescription drug user fee agreement (PDUFA) for FY 2023-2027, and other key priorities that protect public health. To advance the field and support the next generation of cell and gene therapies, OTP will continue to see growth in the Regenerative Medicine Advanced Therapy (RMAT) program, established in the 21st Century Cures Act.
The Food and Drug Administration's Center for Biologics Evaluation and Research, Office of Tissues and Advanced Therapies, has been restructured as follows:
DCB. ORGANIZATION. The Center for Biologics Evaluation and Research is headed by the Center Director, Center for Biologics Evaluation and Research.
Pending further delegation, directives, or orders by the Commissioner of Food and Drugs, all delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegations, provided they are consistent with this reorganization.
This reorganization is reflected in FDA's Staff Manual Guide (SMG). Persons interested in seeing the complete Staff Manual Guide can find it on FDA's website at:
Office of Regulatory Affairs, Food and Drug Administration, Department of Health and Human Services.
Notice.
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Headquarters (HQ) and Field Offices (RFO) have modified its structure.
This new organizational structure was approved by the Deputy Secretary of Health and Human Services on December 22, 2021, and became effective on February 9, 2022.
Glenda Barfell, Associate Commissioner for Regulatory Management Operations, Office of Regulatory Management Operations, Office of Regulatory Affairs, Food and Drug Administration, Element Building, Room 2002, 12420 Parklawn Drive, Rockville, MD 20857, Phone: 240-402-7562.
Part D, Chapter D-B, (Food and Drug Administration), the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (35 FR 3685, February 25, 1970, 60 FR 56606, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 50112, August 30, 2007, 74 FR 41713, August 18, 2009, 76 FR 45270, July 28, 2011, and 84 FR 22854, May 20, 2019) is amended to reflect the reorganization of the Office of Regulatory Affairs Headquarters Offices and Field Offices.
This reorganization is a continuation of the Program Alignment (PA) reorganization completed in 2017 to enhance organizational efficiencies identified after PA. The objective is to improve the Office of Regulatory Affairs (ORA) core functions, correct and enhance the structure with effective use of resources, and carry out the mission of protecting consumers by ensuring compliance of FDA-regulated products. As industry rapidly changes, the FDA must continue to evolve to ensure that public health is not negatively impacted by gaps in inspections and investigations of regulated firms.
The Food and Drug Administration, Office of Regulatory Affairs (ORA), has been restructured as follows:
DCI. ORGANIZATION. The Office of Regulatory Affairs is headed by the Associate Commissioner for Regulatory Affairs and includes the following organizational units:
Pending further delegation, directives, or orders by the Commissioner of Food and Drugs, all delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegations, provided they are consistent with this reorganization.
This reorganization is reflected in FDA's Staff Manual Guide (SMG). Persons interested in seeing the complete Staff Manual Guide can find it on FDA's website at:
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Clinical Decision Support Software.” This final guidance provides clarity on FDA's oversight of clinical decision support (CDS) software intended for health care professionals with the purpose of describing FDA's regulatory approach to CDS software functions. This guidance clarifies the types of CDS functions that do not meet the definition of a device as amended by the 21st Century Cures Act (Cures Act).
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
An electronic copy of the guidance document is available for download from the internet. See the
Brendan O'Leary, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5530, Silver Spring, MD 20993-0002, 301-796-6898; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911 or Kristina Lauritsen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6162, Silver Spring, MD 20993-0002, 301-796-8936.
FDA has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(h)), including software that is intended to provide decision support to health care professionals, patients, or caregivers for the diagnosis, treatment, prevention, cure, or mitigation of diseases or other conditions (often referred to as CDS software). Section 3060(a) of the Cures Act, enacted on December 13, 2016 (Pub. L. 114-255), amended section 520 of the FD&C Act (21 U.S.C. 360j) to exclude certain medical software functions, including certain decision support software, from the definition of device under section 201(h) of the FD&C Act.
This guidance describes CDS software functions that do not meet the definition of a device in the context of and based on the criteria from section 520(o) of the FD&C Act. This guidance also further clarifies that FDA's existing digital health policies continue to apply to software functions that meet the definition of a device, including those that are intended for use by patients or caregivers. For example, some decision support software functions may be identified in other guidance documents as software functions for which, based on our current understanding of the risks of these software functions, FDA does not intend at this time to enforce compliance with applicable device requirements of the FD&C Act, including, but not limited to, premarket clearance and approval requirements.
A notice of availability of the draft guidance appeared in the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on Clinical Decision Support Software. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations, guidance, and forms have been approved by OMB as listed in the following:
Office of the Secretary, HHS.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Comments on the ICR must be received on or before November 28, 2022.
Submit your comments to
When submitting comments or requesting information, please include the document identifier 4040-0010-60D and project title for reference, to Sagal Musa, email:
Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Notice is hereby given of a change in the meeting of the Instrumentation and Systems Development Study Section, October 4, 2022, 6:30 a.m. to October 5, 6:00 p.m., Doubletree Hotel Bethesda (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814, which was published in the
Pursuant to section 10(d) 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 10(d) 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the Motor Function, Speech and Rehabilitation Study Section, October 17, 2022, 9:00 a.m. to October 18, 2022, 8:00 p.m., National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the
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 December 27, 2022.
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-2270, to Rick Sacbibit, Chief, Engineering Services
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
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.
Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below. The FIRM and FIS report are the basis of the floodplain management measures that a 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 Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP).
The date of February 9, 2023 has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community.
The FIRM, and if applicable, the FIS report containing the final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the tables below and will be available online through the FEMA Map Service Center at
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.
This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at
The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.
Office of the Assistant Secretary for Public and Indian Housing, PIH, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, REE, Department of Housing and Urban Development, 451 7th Street SW, Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Leea J. Thornton, Office of Policy, Programs and Legislative Initiatives, PIH, Department of Housing and Urban Development, 451 7th Street SW, Room 3178, Washington, DC 20410; telephone 202-402-6455, (this is not a toll-free number). Persons with hearing or speech impairments may access this number via TTY by calling the Federal Relay Service at (800) 877-8339. Copies of available documents submitted to OMB may be obtained from Ms. Leea Thornton.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
HUD's Office of Native American Programs (ONAP) administers the IHBG program and offers contracted training and technical assistance to IHBG recipients on program requirements. ONAP's Notice of Funding Opportunity for training and technical assistance services includes the requirement for the contractor(s) to use an OMB-approved evaluation form at all ONAP-sponsored events. At the end of each training and technical assistance event, participants are invited to voluntarily complete the Training and Technical Assistance Evaluation Form (form HUD-5879) to assess training and technical assistance effectiveness and solicit ideas for improvement. Form HUD-5879 is a two-page survey instrument and does not collect any personally identifiable information, including a participant's name.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) 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;
(2) The accuracy of the agency'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 those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35.
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This notice governs Community Development Block Grant disaster recovery (CDBG-DR) funds awarded under the appropriations acts identified in the Table of Contents. Specifically, this notice provides waivers and establishes alternative requirements for certain CDBG-DR grantees that have submitted waiver requests for grants provided under the public laws cited in this notice.
Jessie Handforth Kome, Director, Office of Block Grant Assistance, U.S. Department of Housing and Urban Development, 451 7th Street SW, Room 7282, Washington, DC 20410, telephone number 202-708-3587. Individuals can dial 7-1-1 to access the Telecommunications Relay Service (TRS), which permits users to make text-based calls, including Text Telephone (TTY) and Speech to Speech (STS) calls. Individuals who require an alternative aid or service to communicate effectively with HUD should email the point of contact listed below and provide a brief description of their preferred method of communication. Facsimile inquiries may be sent to Ms. Kome at 202-708-0033. (Except for the “800” number, these telephone numbers are not toll-free.) Email inquiries may be sent to
Each of the appropriations acts cited in the Table of Contents authorize the Secretary to waive, or specify alternative requirements for, any provision of any statute or regulation that the Secretary administers in connection with the obligation by the Secretary or use by the recipient of grant funds, except for requirements related to fair housing, nondiscrimination, labor standards, and the environment. HUD may also exercise its regulatory waiver authority under 24 CFR 5.110, 91.600, and 570.5.
All waivers and alternative requirements authorized in this notice are based upon a determination by the Secretary that good cause exists, and that the waiver or alternative requirement is not inconsistent with the overall purposes of title I of the Housing and Community Development Act of 1974 (42 U.S.C. 5301
On August 14, 2018, HUD published a
The cap on the activity costs remains unchanged. The grantee can expend no more than $25,000,000 total on tourism and marketing activities authorized by this and previous waivers and alternative requirements.
In section IV.D.16. of the August 2018 Notice, the Department granted the USVI a waiver of 42 U.S.C. 5305(a) to the extent necessary to create a new eligible activity and use up to $5,000,000 of CDBG-DR funds to promote travel to disaster-impacted areas, which at the time was the amount included in the USVI's action plan and substantial amendments submitted to and approved by HUD. In section IV.5. of the
Tourism is a significant part of the USVI's economy and was severely impacted by Hurricanes Irma and Maria and further impacted by the COVID-19 pandemic. The expiration of the waiver and alternative requirements for tourism and marketing activities limits the ability of the USVI to use the CDBG-DR funds during its peak tourism season, interrupting economic development gains made by the USVI in its use of CDBG-DR funds for disaster recovery. As a result, the Secretary has determined that good cause exists to provide a replacement waiver and alternative requirements as requested. Accordingly, HUD hereby grants an additional waiver of 42 U.S.C. 5305(a) to the extent necessary to make eligible use of no more than $25,000,000 for assistance to promote the USVI in general and specific components of the islands, which amount shall include any funds expended in accordance with the waiver and alternative requirement in paragraph IV.D.16. of the August 2018 Notice, as amended, that expired May 19, 2022.
This additional waiver is subject to the following alternative requirements. The funding expended under this waiver and alternative requirement must be for assistance for tourism marketing, provided the assisted activities are designed to support tourism to the disaster-impacted areas related to the effects of Hurricanes Irma and Maria. Any CDBG-DR tourism expenditures may not supplant USVI or local government funds for tourism marketing. The USVI shall coordinate its tourism promotion and marketing activities with its designated Opportunity Zones. The grantee must use existing contracts already procured to carry out the activities allowed through this waiver and alternative requirement unless HUD approves the use of additional contracts in writing. Any additional procurement actions related to carrying out activities authorized by this waiver and alternative requirement must be submitted to HUD for approval to check for compliance with the waiver and alternative requirements provided herein. Additionally, no elected officials shall appear in tourism marketing materials financed with CDBG-DR funds. Given the importance of tourism to the overall economy, HUD is authorizing this use of funds without regard to unmet housing need. The waiver that expired May 19, 2022, required the grantee to develop metrics to demonstrate the impact of CDBG-DR expenditures on the tourism sector of the economy and to identify those metrics in the initial substantial amendment submitted. The metrics developed by the grantee also shall apply to the use of grant funds under this waiver and alternative requirement. HUD may further extend the waiver and alternative requirements administratively, if requested by the USVI and good cause for such an extension exists at that time.
In addition, although the grantee has not been authorized to draw grant funds for its tourism marketing activity since May 20, 2022, as of the applicability date of this notice, HUD is adopting a waiver and alternative requirement to modify 24 CFR 570.489(b) to the extent necessary to permit the grantee to reimburse its costs and the costs of its subrecipients from May 22, 2022 through the applicability date of this notice to the extent that they comply with the tourism and marketing waiver and alternative requirement authorized by this section II.A.
The Commonwealth of Puerto Rico (Commonwealth) has submitted a request for an extension of HUD's previously granted waiver and alternative requirement authorizing the expansion of the definition of public service at 42 U.S.C. 5305(a)(8) to include the “provision of rental assistance to disaster-impacted households for up to 24 months,” subject to the 15 percent cap on public services and to revise the expiration date for the waiver and alternative requirement by one year. The previously granted waiver and alternative requirement expires September 30, 2022. While the Commonwealth requested an extension for 36 months, HUD has reviewed the good cause justification and consulted with the Office of Community Planning and Development's (CPD) partners in Public and Indian Housing (PIH) and determined that extending this waiver for 12 months would allow enough time for any chosen projects to transition to Project-based Vouchers (PBVs), as described below. Accordingly, HUD hereby grants an extension of the waiver and alternative requirement described in this notice and establishes a revised expiration date of September 30, 2023.
In section VI.4. of the
In addition, declining economic conditions in the Commonwealth and the sustained decrease of Puerto Rico Department of Housing's (PRDOH) Law 173 funding, both exacerbated by Hurricanes Irma and Maria, leave CDBG-DR as the only available funding source to provide interim rental assistance to these low- and moderate-income (LMI) elderly households. PRDOH's Law 173 Program subsidizes the rent of thousands of low-income elderly tenants in 49 housing facilities for people over the age of 60 throughout the Commonwealth. The Puerto Rico Public Housing Administration (PRPHA) has been in negotiations with PRDOH to provide PBVs to address the existing need for rental assistance. A one-year extension of the waiver and alternative requirements would meet this need temporarily to permit PRPHA and PRDOH to confirm and conclude the transaction for PBVs without displacing applicants or program participants.
Based on the good cause summarized above, the Secretary hereby extends the waiver and alternative requirements in the February 2019 Notice for tenant-based rental assistance until September 30, 2023, subject to the following additional alternative requirements. The Commonwealth shall limit the application intake to properties and applicants of existing cases under PRDOH's Law 173. All existing and new contracts or award agreements granted under the tenant-based rental assistance must provide the benefit for no more than the overall period of 36 months (including the 24 months granted in the
In no case shall the tenant-based rental assistance under this waiver and alternative requirements extend beyond the expiration date of the waiver, even if a beneficiary has not yet received 36 months of assistance. This waiver and the alternative requirements shall remain in effect until September 30, 2023, after which the Commonwealth will no longer be able to use CDBG-DR funds for any tenant-based rental assistance.
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 renew an information collection with revisions.
Interested persons are invited to submit comments on or before October 28, 2022.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Steven Mullen, Information Collection Clearance Officer,
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.
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.
The proposed “Agreement for the Carriage of Water” (form number BIA-DWP-Irr-106) would allow BIA to determine whether BIA irrigation facility can support the third-party carriage or whether it is in the best interest of the BIA facility to convey our water through third-party facilities, under 25 CFR 171. 605.
An agency may not conduct or sponsor and a person is not required to
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 (“Commission”) has determined to review in part a final initial determination (“ID”) of the presiding administrative law judge (“ALJ”), finding a violation of section 337 as to two of the three asserted patents. The Commission requests written submissions from the parties on the issues under review and from the parties, interested government agencies, and other interested persons on the issues of remedy, the public interest, and bonding, under the schedule set forth below.
Panyin A. Hughes, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-3042. Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission's electronic docket (EDIS) at
On May 26, 2021, the Commission instituted this investigation based on a complaint filed by AliveCor, Inc. of Mountain View, California (“AliveCor”). 86 FR 28382 (May 26, 2021). The complaint alleged violations of section 337 based on the importation into the United States, the sale for importation, or the sale within the United States after importation of certain wearable electronic devices with ECG functionality and components thereof by reason of infringement of one or more of claims 1-30 of U.S. Patent No. 10,595,731 (“the '731 patent”); claims 1-23 of U.S. Patent No. 10,638,941 (“the '941 patent”); and claims 1-4, 6-14, 16-20 of U.S. Patent No. 9,572,499 (“the '499 patent”).
On February 23, 2022, the ALJ issued an initial determination granting AliveCor's motion to terminate the investigation as to (1) claims 1-4, 6-14, and 18-20 of the '499 patent; (2) claims 2, 4, 6, 7, 11, 13, 14, and 17-30 of the '731 patent; and (3) claims 1-11, 14, 15, 17, and 18 of the '941 patent based upon withdrawal of allegations from the complaint as to those claims. Order No. 16 (Feb. 23, 2022),
On June 27, 2022, the ALJ issued the final initial determination (“ID”) finding a violation of section 337 as to the '941 and '731 patents, and no violation of section 337 as to the '499 patent.
On July 11, 2022, Apple filed a petition for review of the ID, and AliveCor filed a combined petition and contingent petition for review of the ID. On July 19, 2022, the private parties and OUII's investigative attorney filed responses to the petitions.
Having reviewed the record of the investigation, including the final ID, the parties' submissions to the ALJ, the petitions for review, and the responses thereto, the Commission has determined to review the ID in part. Specifically, the Commission has determined to review the final ID's invalidity findings, including patent eligibility under 35 U.S.C. 101 and obviousness under 35 U.S.C. 103, and the economic prong of the domestic industry requirement.
In connection with its review, the Commission requests responses from the parties to the following questions. The parties are requested to brief their positions with reference to the applicable law and the existing evidentiary record.
(1) Discuss whether the record evidence of “industry praise” and “copying” is sufficient to establish the requisite objective indicia of non-obviousness.
(2) Please explain whether and how the Complainant's investments credited by the ID under subsection 337(a)(3)(B) are quantitatively and qualitatively significant.
(3) Please explain whether and how the Complainant's employment of labor in research and development in the exploitation of the patents under subsection 337(a)(3)(C) are quantitatively and qualitatively substantial. Please state whether the R&D contract labor amount credited by the ID under subsection 337(a)(3)(C) includes foreign contract labor and, if
(4) What is the factual and legal basis for crediting Complainant's investments in the KBP and PRD products toward satisfaction of the domestic industry requirement under subsection (C)?
The parties are invited to brief only these discrete questions. The parties are not to brief other issues on review, which are adequately presented in the parties' existing filings.
In connection with the final disposition of this investigation, the statute authorizes issuance of,
The statute requires the Commission to consider the effects of that remedy upon the public interest. The public interest factors the Commission will consider include the effect that an exclusion order and cease and desist orders would have on: (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation. In particular, the Commission requests that the parties, interested government agencies, and interested persons respond to the following:
(1) Please provide information and argument that responds to the statements on the public interest submitted on the public record by the parties and the various third parties.
(2) Please provide data and factual information that specifically addresses whether and to what extent each of the four public interest factors would be adversely impacted by the remedial orders recommended in the RD, including details regarding the extent to which alternatives to the infringing products would be available to replace the infringing products and address the public health and welfare concerns raised.
If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve, disapprove, or take no action on the Commission's determination.
In its initial submission, Complainant is also requested to identify the remedy sought and Complainant and OUII are requested to submit proposed remedial orders for the Commission's consideration. Complainant is further requested to provide the HTSUS subheadings under which the accused products are imported, and to supply the identification information for all known importers of the products at issue in this investigation. The initial written submissions and proposed remedial orders must be filed no later than close of business on October 6, 2022. Reply submissions must be filed no later than the close of business on October 13, 2022. No further submissions on these issues will be permitted unless otherwise ordered by the Commission. Opening submissions are limited to 75 pages. Reply submissions are limited to 50 pages. No further submissions on any of these issues will be permitted unless otherwise ordered by the Commission.
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 (March 19, 2020). Submissions should refer to the investigation number (Inv. No. 337-TA-1266) 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) & 210.5(e)(2)). Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. Any non-party wishing to submit comments containing confidential information must serve those comments on the parties to the investigation pursuant to the applicable Administrative Protective Order. A redacted non-confidential version of the document must also be filed with the Commission and served on any parties to the investigation within two business days of any confidential filing. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. All nonconfidential written submissions will be available for public inspection on EDIS.
The Commission has determined to extend the target date to December 12, 2022.
The Commission vote for this determination took place on September
By order of the Commission.
On the basis of the record
The Commission instituted these reviews on February 1, 2022 (87 FR 5511) and determined on May 9, 2022, that it would conduct expedited reviews (87 FR 53488, August 31, 2022).
The Commission made these determinations pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)). It completed and filed its determinations in these reviews on September 22, 2022. The views of the Commission are contained in USITC Publication 5368 (September 2022), entitled
By order of the Commission.
United States International Trade Commission.
Notice.
September 22, 2022.
Stamen Borisson (202-205-3125), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
On July 28, 2022, the Commission established a schedule for the conduct of the final phase of the subject investigations (87 FR 51701, August 23, 2022) as a result of affirmative preliminary determinations by the Department of Commerce (“Commerce”) regarding imports of lemon juice from Brazil and South Africa. Commerce had extended the date for its final determination with respect to Brazil but not for South Africa. Subsequently, Commerce extended the date for its final determination in the investigation of South Africa from October 11, 2022, to December 19, 2022 (87 FR 56631, September 15, 2022). The Commission, therefore, is revising its schedule to conform with Commerce's new schedule. The Commission also gives notice that the hearing in connection with the final phase of these investigations will not be held on October 11 but instead will be held in-person at the U.S. International Trade Commission Building beginning at 9:30 a.m. on December 15, 2022.
The Commission's revised dates in the schedule are as follows: the prehearing staff report will be placed in the nonpublic record on November 30, 2022; the deadline for filing prehearing briefs is December 7, 2022; requests to appear at the hearing must be filed with the Secretary to the Commission not later than December 9, 2022; the prehearing conference will be held at the U.S. International Trade Commission Building on December 9, 2022, if deemed necessary; the hearing will be held at the U.S. International Trade Commission Building at 9:30 a.m. on December 15, 2022; the deadline for filing posthearing briefs is December 22, 2022; the Commission will make its final release of information on January 13, 2023; and final party comments are due on January 18, 2023.
A nonparty who has testimony that may aid the Commission's deliberations may request permission to present a short statement at the hearing. All parties and nonparties desiring to appear at the hearing and make oral presentations should attend a prehearing conference to be held at 9:30 a.m. on December 9, 2022, if deemed necessary. Parties shall file and serve written testimony and presentation slides in connection with their presentation at the hearing by no later than 4:00 p.m. on December 14, 2022. Oral testimony and written materials to be submitted with respect for the public hearing are governed by sections 201.6(b)(2), 201.13(f), and 207.24 of the Commission's rules. Parties must submit any request to present a portion of their hearing testimony
Additional written submissions to the Commission, including requests pursuant to § 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.
In accordance with §§ 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
For further information concerning this proceeding see the Commission's notice cited above and the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).
By order of the Commission.
Federal Bureau of Prisons, U.S. Department of Justice.
Notice of intent to prepare a Draft Environmental Impact Statement for the Proposed Federal Correctional Institution and Federal Prison Camp in Letcher County, Kentucky.
Pursuant to the National Environmental Policy Act (NEPA) of 1969, as implemented by the Council on Environmental Quality and Federal Bureau of Prisons (Bureau) regulations, the Bureau announces its intent to prepare a Draft Environmental Impact Statement (DEIS) for the “Proposed Federal Correctional Institution and Federal Prison Camp Letcher County, Kentucky.”
The Bureau's mission is to protect society by confining offenders in the controlled environments of prisons and community-based facilities that are safe, humane, cost-efficient, appropriately secure, and provide work and other self-improvement opportunities to assist offenders in becoming law-abiding citizens. A growing challenge to successfully performing that mission is the increasing number of federal correctional facilities and supporting infrastructure that were constructed over 50 years ago (the approximate design life of such facilities), resulting in a continuous need to maintain existing facilities, and when necessary, develop new facilities and infrastructure.
To address the need for modern, efficient, and cost-effective institutions, the Bureau is proposing to construct and operate a new medium-security Federal Correctional Institution (FCI) and an adjoining minimum-security Federal Prison Camp (FPC) in Letcher County, Kentucky. The FCI and FPC would be designed to house approximately 1,152 adult males and 256 adult males, respectively, and serve the needs of the Bureau's Mid-Atlantic Region.
Development and operation of a new FCI and FPC is considered to be an action potentially significantly affecting the quality of the human environment. Therefore, the Bureau must comply with NEPA to ensure that the environmental consequences of such a federal action are adequately considered. This DEIS will be prepared to ensure that the potential environmental impacts associated with the proposed action are thoroughly documented and that compliance is achieved with NEPA as well as with other environmental statutes including but not limited to: the Coastal Zone Management Act of 1972; the Clean Air Act of 1974; the Clean Water Act and Amendments, the Endangered Species Act of 1973 (ESA); the National Historic Preservation Act (NHPA) of 1966; and the Farmland Protection Policy Act (FPPA), among other laws, regulations and Executive Orders.
Preparation of environmental documentation and its consideration by federal, state, and local officials, regulatory agencies, stakeholders, and the public will be carried out to demonstrate that the Bureau understands and fully considers the potential environmental impacts associated with the proposed action. This includes consideration to the potential impacts associated with correctional institution construction and operation and attainment of the project's objectives.
In 2006, Congress authorized and directed the Bureau to initiate various investigations for development of a new federal correctional facility in Letcher County. In accordance with Congress' directive, the Bureau conducted a wide range of technical investigations and studies and published multiple EISs in conformance with NEPA as summarized below.
While the Congressional directive to the Bureau to develop a new USP in Letcher County remains, the Bureau has been reevaluating the proposed project since the Record of Decision was withdrawn. During that time, the Bureau determined that the need to house medium-security inmates in a new FCI supersedes the need to house high-security inmates in a new USP. Design, construction, and operation of a high-security USP differs greatly from a medium-security FCI with the potential environmental impacts of its development and operation correspondingly different.
Consistent with the guidance provided in 40 CFR 1502.9, the DEIS will address “
Publication of the Notice of Intent to Prepare a DEIS for development of a new FCI and FPC in Letcher County, Kentucky initiates a scoping period lasting for 30 days from the date of publication of this Notice of Intent in the
The DEIS will analyze potential environmental impacts that may result from the proposed action including, but not limited to, land use and zoning; topography, geology, and soils; air quality; noise; cultural resources; water resources; and biological resources. The DEIS analysis will also evaluate direct, indirect, and cumulative impacts. Relevant and reasonable measures that could avoid or mitigate environmental impacts will also be analyzed. Additionally, the Bureau will undertake any consultations required by applicable laws or regulations.
The Bureau will issue the DEIS for a 45-day public comment period, during which time a public meeting will be held. A notice of availability of the DEIS and a notice of public meeting will be published in the
Following issuance of the DEIS and completion of the 45-day public comment period on the DEIS, the Bureau will issue a Final EIS (FEIS) that will include comments received during the public comment period on the DEIS. The FEIS will also include the Bureau's response to substantive comments received on the DEIS. Following publication of the FEIS, a 30-day review period will be provided. No action will be taken to implement any of the proposed alternatives until completion of the 30-day review period on the FEIS and issuance of a Record of Decision by the Director of the Bureau.
Questions concerning the proposed action and the DEIS may be directed to Kimberly S. Hudson, COR, Site Selection Specialist, Construction & Environmental Review Branch, U.S. Department of Justice, Federal Bureau of Prisons, 320 First Street NW, Room 901-5 West, Washington, DC 20534; email:
National Aeronautics and Space Administration.
Notice of intent to grant exclusive, co-exclusive or partially exclusive patent license.
NASA hereby gives notice of its intent to grant an Exclusive, Co-Exclusive or Partially Exclusive Patent License to practice the inventions described and claimed in the patents and/or patent applications listed in
The prospective Exclusive, Co-Exclusive or Partially Exclusive Patent License may be granted unless NASA receives written objections including evidence and argument, no later than October 13, 2022 that establish that the grant of the license would not be consistent with the requirements regarding the licensing of federally owned inventions as set forth in the Bayh-Dole Act and implementing regulations. Competing applications completed and received by NASA no later than October 13, 2022 will also be treated as objections to the grant of the contemplated Exclusive, Co-Exclusive or Partially Exclusive Patent License. Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act.
NASA intends to grant an Exclusive, Co-Exclusive or Partially Exclusive Patent License in the United States to practice the inventions described and claimed in: U.S. Patent No. 6,953,129 titled “Pressure Vessel With Impact and Fire Resistant Coating and Method of Making Same,” U.S. Patent No. 8,561,829 titled “Composite Pressure Vessel Including Crack Arresting Barrier,” U.S. Patent No. 8,297,468 titled “Fuel Tank for Liquefied Natural Gas,” U.S. Patent No. 7,867,589 titled “Hybrid Cryogenic Tank Construction and Method of Manufacture Therefor,” U.S. Patent No. 7,641,949 titled “Pressure Vessel With Improved Impact Resistance and Method of Making the Same,” to Hanwha Cimarron, having its principal place of business in Huntsville, AL. The fields of use may be limited. NASA has not yet made a final determination to grant the requested license and may deny the requested license even if no objections are submitted within the comment period.
This notice of intent to grant an Exclusive, Co-Exclusive or Partially Exclusive Patent License is issued in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). The patent rights in these inventions have been assigned to the United States of America as represented by the Administrator of the National Aeronautics and Space Administration. The prospective license will comply with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
Information about other NASA inventions available for licensing can be found online at
Office of National Drug Control Policy.
30-Day notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, the Office of National Drug Control Policy (ONDCP) announces it will submit to the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) an information collection request (ICR). The
ONDCP encourages and will accept public comments on or before 30 days after the date of this publication.
Address all comments in writing within 30 days to Helen Hernandez. Email is the most reliable means of communication. Ms. Hernandez's email address is
Under reauthorization legislation (
ONDCP's Drug-Free Communities office will continue to utilize the case study protocols previously approved by OMB to document coalition practices, successes and challenges. Approximately nine DFC grant award recipients are selected each year to highlight in the case studies. The information from the case studies will be used to illustrate not only what works to reduce drug use in a community setting, but also how and why it works.
The CARA Local Drug Crisis program evaluation makes use of a shortened version of the DFC progress report to support evaluation, monitoring and tracking of progress annually for grant award recipients and will provide information to ONDCP and the Administration's effort to address the opioid crisis.
ONDCP published a 60-day notice in the
National Science Foundation.
Submission for OMB review; comment request.
The National Science Foundation (NSF) has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995. This is the second notice for public comment; the first was published in the
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314, or send email to
NSF may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number, and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
The second is facilitation of the proposal review process. Since peer review is a key component of NSF's grant-making process, it is imperative that proposals are reviewed by scientists with appropriate expertise. The information collected helps ensure that the proposals are evaluated by specialists who are well versed in appropriate subject matter. This helps maintain a fair and equitable review process.
The third use of the information is program evaluation. The Directorate is committed to investing in a range of substantive areas. With data from this collection, the Directorate can calculate submission rates and funding rates in specific areas of research. Similarly, the information can be used to identify emerging areas of research, evaluate changing infrastructure needs in the research community, and track the amount of international research. As the National Science Foundation is committed to funding cutting-edge science, these factors all have implications for program management.
The Directorate of Biological Sciences has a continuing commitment to monitor its information collection in order to preserve its applicability and necessity. Through periodic updates and revisions, the Directorate ensures that only useful, non-redundant information is collected. These efforts will reduce excessive reporting burdens.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3030, and 39 CFR part 3040, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3040, subpart B. Comment deadline(s) for each request appear in section II.
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This Notice will be published in the
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on Sepember 19, 2022, it filed with the Postal Regulatory Commission a
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe EDGX Exchange, Inc. (“EDGX” or the “Exchange”) is filing with the Securities and Exchange Commission (the “Commission”) a proposed rule change to amend EDGX Rule 11.15, Clearly Erroneous Executions. The text
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange 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 these 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 aspects of such statements.
The purpose of the proposed rule change is to amend EDGX Rule 11.15, Clearly Erroneous Executions. Specifically, the Exchange proposes to: (1) make the current clearly erroneous pilot program permanent; and (2) limit the circumstances where clearly erroneous review would continue to be available during Regular Trading Hours,
On September 10, 2010, the Commission approved, on a pilot basis, changes to EDGX Rule 11.15 that, among other things: (i) provided for uniform treatment of clearly erroneous execution reviews in multi-stock events involving twenty or more securities; and (ii) reduced the ability of the Exchange to deviate from the objective standards set forth in the rule.
When it originally approved the clearly erroneous pilot, the Commission explained that the changes were “being implemented on a pilot basis so that the Commission and the Exchanges can monitor the effects of the pilot on the markets and investors, and consider appropriate adjustments, as necessary.”
The clearly erroneous pilot was implemented following a severe disruption in the U.S. equities markets on May 6, 2010 (“Flash Crash”) to “provide greater transparency and certainty to the process of breaking trades.”
When the Participants to the LULD Plan filed to introduce the Limit Up-Limit Down (“LULD”) mechanism, itself a response to the Flash Crash, a handful of commenters noted the potential discordance between the clearly erroneous rules and the Price Bands used to limit the price at which trades would be permitted to be executed pursuant to the LULD Plan. For example, two commenters requested that the clearly erroneous rules be amended so the presumption would be that trades executed within the Price Bands would not be not subject to review.
The Exchange believes that it is important for there to be some mechanism to ensure that investors' orders are either not executed at clearly erroneous prices or are subsequently busted as needed to maintain a fair and orderly market. At the same time, the Exchange believes that the LULD Plan, as amended, would provide sufficient protection for trades executed during Regular Trading Hours. Indeed, the LULD mechanism could be considered to offer superior protection as it prevents potentially erroneous trades from being executed in the first instance. After gaining experience with the LULD Plan, the Exchange now believes that it is appropriate to largely eliminate clearly erroneous review during Regular Trading Hours when Price Bands are in effect. Thus, as proposed, trades executed within the Price Bands would stand, barring one of a handful of identified scenarios where such review may still be necessary for the protection of investors. The Exchange believes that this change would be beneficial for the U.S. equities markets as it would ensure that trades executed within the Price Bands are subject to clearly erroneous review in only rare circumstances, resulting in greater certainty for Members and investors.
The current LULD mechanism for addressing extraordinary market volatility is available solely during Regular Trading Hours. Thus, trades during the Exchange's Early Trading,
On the other hand, there would be much more limited potential to request that a transaction be reviewed as potentially erroneous during Regular Trading Hours. With the introduction of the LULD mechanism in 2013, clearly erroneous trades are largely prevented by the requirement that trades be executed within the Price Bands. In addition, in 2019, Amendment Eighteen to the LULD Plan eliminated double-wide Price Bands: (1) at the Open, and (2) at the Close for Tier 2 NMS Stocks 2 with a Reference Price above $3.00.
At the same time, the Exchange is cognizant that there may be limited circumstances where clearly erroneous review may continue to be appropriate, even during Regular Trading Hours. Thus, the Exchange proposes to amend its clearly erroneous rules to enumerate the specific circumstances where such review would remain available during the course of Regular Trading Hours, as follows. All transactions that fall outside of these specific enumerated exceptions would be ineligible for clearly erroneous review.
First, pursuant to proposed paragraph (c)(1)(A), a transaction executed during Regular Trading Hours would continue to be eligible for clearly erroneous review if the transaction is not subject to the LULD Plan. In such case, the Numerical Guidelines set forth in paragraph (c)(2) of Rule 11.15 will be applicable to such NMS Stock. While the majority of securities traded on the Exchange would be subject to the LULD Plan, certain equity securities, such as rights and warrants, are explicitly excluded from the provisions of the LULD Plan and would therefore be eligible for clearly erroneous review instead.
Second, investors would also continue to be able to request review of transactions that resulted from certain systems issues pursuant to proposed paragraph (c)(1)(B). This limited exception would help to ensure that
Third, the Exchange proposes to narrowly allow for the review of transactions during Regular Trading Hours when the Reference Price, described in proposed paragraph (d), is determined to be erroneous by an Officer of the Exchange. Specifically, a transaction executed during Regular Trading Hours would be eligible for clearly erroneous review pursuant to proposed paragraph (c)(1)(C) if the transaction involved, in the case of (1) a corporate action or new issue or (2) a security that enters a Trading Pause pursuant to the LULD Plan and resumes trading without an auction,
In the context of a corporate action or a new issue, there may be instances where the security's Reference Price is later determined by the Exchange to be erroneous (
The following illustrate the proposed application of the rule in the context of a corporate action or new issue:
1. ABCD is subject to a corporate action, 1 for 10 reverse split, and the previous day close was $5, but the new theoretical price based on the terms of the corporate action is $50.
2. The security opens at $5, with LULD bands at $4.50 × $5.50.
3.The bands will be calculated correctly but the security is trading at an erroneous price based on the valuation of the remaining outstanding shares.
4.The theoretical price of $50 would be used as the new Reference Price when applying LULD bands to determine if executions would be cancelled as clearly erroneous.
1. ABCD is subject to a corporate action, the company is doing a spin off where a new issue will be listed, BCDE. ABCD trades at $50, and the spinoff company is worth
2. BCDE opens at $50 in the belief it is the same company as ABCD.
3.The theoretical values of the two companies are ABCD $40 and BCDE $10.
4. BCDE would be deemed to have had an incorrect Reference Price and the theoretical value of $10 would be used as the new Reference Price when applying the LULD Bands to determine if executions would be cancelled as clearly erroneous.
1. ABCD is an uplift from the OTC market, the prior days close on the OTC market was $20.
2. ABCD opens trading on the new listing exchange at $0.20 due to an erroneous order entry.
3. The new Reference Price to determine clearly erroneous executions would be $20, the theoretical value of the stock from where it was last traded.
In the context of the rare situation in which a security that enters a LULD Trading Pause and resumes trading without an auction (
The following example illustrates the proposed application of the rule in the context of a security that reopens without an auction:
1. ABCD stock is trading at $20, with LULD Bands at $18 × $22.
2. An incoming buy order causes the stock to enter a Limit State Trading Pause and then a Trading Pause at $22.
3. During the Trading Pause, the buy order causing the Trading Pause is cancelled.
4. At the end of the 5-minute halt, there is no crossed interest for an auction to occur, thus trading would resume on a quote.
5. Upon resumption, a quote that was available prior to the Trading Pause (
6. The Reference Price upon resumption is $50 (mid-point of BBO).
7. The SIP will use this Reference Price and publish LULD Bands of $45 × $55 (
8. The bands will be calculated correctly, but the $50 Reference Price is subsequently determined to be incorrect as the price clearly deviated from where it previously traded prior to the Trading Pause
9. The new Reference Price would be $22 (
In all of the foregoing situations, investors would be left with no remedy to request clearly erroneous review without the proposed carveouts in paragraph (c)(1)(C) because the trades occurred within the LULD Price Bands (albeit LULD Price Bands that were calculated from an erroneous Reference Price). The Exchange believes that removing the current ability for the Exchange to review in these narrow circumstances would lessen investor protections.
Today, paragraph (c)(1) defines the Numerical Guidelines that are used to determine if a transaction is deemed clearly erroneous during Regular Trading Hours, or during the Early Trading, Pre-Opening and After Hours Sessions. With respect to Regular Trading Hours, trades are generally deemed clearly erroneous if the execution price differs from the Reference Price (
Given the changes described in this proposed rule change, the Exchange proposes to amend the way that the Numerical Guidelines are calculated during Regular Trading Hours in the handful of instances where clearly erroneous review would continue to be available. Specifically, the Exchange would base these Numerical Guidelines, as applied to the circumstances described in paragraph (c)(1)(A), on the Percentage Parameters used to calculate Price Bands, as set forth in Appendix A to the LULD Plan. Without this change, a transaction that would otherwise stand if Price Bands were properly applied to the transaction may end up being subject to review and deemed clearly erroneous solely due to the fact that the Price Bands were not available due to a systems or other issue. The Exchange believes that it makes more sense to instead base the Price Bands on the same parameters as would otherwise determine whether the trade would have been allowed to execute within the Price Bands. The Exchange also proposes to modify the Numerical Guidelines applicable to leveraged ETF/ETN securities during Regular Trading Hours. As noted above, the Numerical Guidelines will only be applicable to transactions eligible for review pursuant paragraph (c)(1)(A) (
The Exchange also proposes to move existing paragraphs (c)(2), (c)(3), and (d) to proposed paragraph (c)(2)(B), (c)(2)(C), and (C)(2)(D), respectively, as Multi-Stock Events, Additional Factors, and Outlier Transactions will only be subject to review if those NMS Stocks are not subject to the LULD Plan or occur during the Early Trading, Pre-Opening and After Hours Sessions. Proposed paragraph (c)(2)(B) is substantially similar to existing paragraph (c)(2) except for a change in rule reference to paragraph (c)(1) has been updated to paragraph (c)(1)(A). Further, given the proposal to move existing paragraph (c)(2) to paragraph (c)(2)(B), the Exchange also proposes to amend applicable rule references throughout paragraph (c)(2)(A). Finally, the Exchange proposes to update applicable rule references in paragraph (c)(2)(D) based on the above-described structural changes to the Rule.
As proposed, the Reference Price used would continue to be based on last sale and would be memorialized in proposed paragraph (d). Continuing to use the last sale as the Reference Price is necessary for operational efficiency as it may not be possible to perform a timely clearly erroneous review if doing so required computing the arithmetic mean price of eligible reported transactions over the past five minutes, as contemplated by the LULD Plan. While this means that there would still be some differences between the Price Bands and the clearly erroneous parameters, the Exchange believes that this difference is reasonable in light of the need to ensure timely review if clearly erroneous rules are invoked. The Exchange also proposes to allow for an alternate Reference Price to be used as prescribed in proposed paragraphs (d)(1), (2), and (3). Specifically, the Reference Price may be a value other than the consolidated last sale immediately prior to the execution(s) under review (1) in the case of Multi-Stock Events involving twenty or more securities, as described in paragraph (c)(2)(B) above, (2) in the case of an erroneous Reference Price, as described in paragraph (c)(1)(C) above,
As described more fully below, the Exchange proposes to eliminate paragraph (f), System Disruption or Malfunction. Accordingly, the Exchange proposes to remove from paragraph (e)(2), Appeals, each reference to paragraph (f), and include language referencing proposed paragraph (g), Transactions Occurring Outside of the LULD Bands.
To conform with the structural changes described above, the Exchange now proposes to remove paragraph 11.15(f), System Disruption or Malfunction, and proposes new paragraph (c)(1)(B). Specifically, as described in paragraph (c)(1)(B), transactions occurring during Regular Trading Hours that are executed outside of the LULD Price Bands due to an Exchange technology or system issue, may be subject to clearly erroneous review pursuant to proposed paragraph
Current paragraph (h) of EDGX Rule 11.15 provides different procedures for conducting clearly erroneous review in initial public offering (“IPO”) securities that are traded pursuant to unlisted trading privileges (“UTP”) after the initial opening of such IPO securities on the listing market. Specifically, this paragraph provides that a clearly erroneous error may be deemed to have occurred in the opening transaction of the subject security if the execution price of the opening transaction on the Exchange is the lesser of $1.00 or 10% away from the opening price on the listing exchange or association. The Exchange no longer believes that this provision is necessary as opening transactions on the Exchange following an IPO are subject to Price Bands pursuant to the LULD Plan. The Exchange therefore proposes to eliminate this provision in connection with the broader changes to clearly erroneous review during Regular Trading Hours.
The Exchange proposes to renumber paragraph (i) to paragraph (h) based on the proposal to eliminate existing paragraph (h), and to rename the paragraph to provide for transactions occurring outside of LULD Price Bands. Given that proposed paragraph (c)(1) defines the LULD Plan, the Exchange also proposes to eliminate redundant language from proposed paragraph (h). Finally, the Exchange also proposes to update references to the LULD Plan and Price Bands so that they are uniform throughout the Rule and to update rule references throughout the paragraph to conform to the structural changes to the Rule described above.
The Exchange proposes to renumber paragraphs (j) and (k) to paragraphs (h) and (i), respectively, based on the proposal to eliminate existing paragraph (h). Additionally, the Exchange proposes to modify the text of both paragraphs to reference the Percentage Parameters as well as the Numerical Guidelines. Specifically, the existing text of proposed paragraphs (h) and (i) provides that any action taken in connection with this paragraph will be taken without regard to the Numerical Guidelines set forth in this Rule. The Exchange proposes to amend the rule text to provide that any action taken in connection with this paragraph will be taken without regard to the Percentage Parameters or Numerical Guidelines set forth in this Rule, with the Percentage Parameters being applicable to an NMS Stock subject to the LULD Plan and the Numerical Guidelines being applicable to an NMS Stock not subject to the LULD Plan. Finally, the Exchange proposes to make several ministerial changes to conform the Rule text to BZX Rule 11.17.
The Exchange believes the proposed rule change is consistent with the requirements of Section 6(b) of the Act,
As explained in the purpose section of this proposed rule change, the current pilot was implemented following the Flash Crash to bring greater transparency to the process for conducting clearly erroneous reviews, and to help assure that the review process is based on clear, objective, and consistent rules across the U.S. equities markets. The Exchange believes that the amended clearly erroneous rules have been successful in that regard and have thus furthered fair and orderly markets. Specifically, the Exchange believes that the pilot has successfully ensured that such reviews are conducted based on objective and consistent standards across SROs and has therefore afforded greater certainty to Members and investors. The Exchange therefore believes that making the current pilot a permanent program is appropriate so that equities market participants can continue to reap the benefits of a clear, objective, and transparent process for conducting clearly erroneous reviews. In addition, the proposal is substantially identical to a recent rule change to BZX Rule 11.17, and the Exchange understands that the other U.S. equities exchanges and FINRA will also file largely identical proposals to make their respective clearly erroneous pilots permanent. The Exchange therefore believes that the proposed rule change would promote transparency and uniformity across markets concerning review of transactions as clearly erroneous and would also help assure consistent results in handling erroneous trades across the U.S. equities markets, thus furthering fair and orderly markets, the protection of investors, and the public interest.
Similarly, the Exchange believes that it is consistent with just and equitable principles of trade to limit the availability of clearly erroneous review during Regular Trading Hours. The Plan was approved by the Commission to operate on a permanent rather than pilot basis. As a number of market participants have noted, the LULD Plan provides protections that ensure that investors' orders are not executed at prices that may be considered clearly erroneous. Further, amendments to the LULD Plan approved in Amendment Eighteen serve to ensure that the Price Bands established by the LULD Plan are “appropriately tailored to prevent trades that are so far from current market prices that they would be viewed as having been executed in error.”
Given the fact that clearly erroneous review would largely be limited to
The Exchange believes that it is consistent with the protection of investors and the public interest to remove the current provision of the clearly erroneous rule dealing with UTP securities that are the subject of IPOs. This provision applies specifically to opening transactions on a non-listing market following an IPO on the listing market. As such, review under this paragraph is limited to trades conducted during Regular Trading Hours. As previously addressed, trades executed during Regular Trading Hours would generally not be subject to clearly erroneous review but would instead be protected by the Price Bands. The Exchange therefore no longer believes that this paragraph is necessary, as all trades subject to this provision today would either be subject to the LULD Plan, or, in the event of some systems or other issue, would be subject to the provisions that apply to transactions that are not adequately protected by the LULD Plan.
Finally, the proposed rule changes make organizational updates to the Exchange's Clearly Erroneous Execution Rule as well as minor updates and corrections to the Rule to improve readability and clarity.
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposal would ensure the continued, uninterrupted operation of harmonized clearly erroneous execution rules across the U.S. equities markets while also amending those rules to provide greater certainty to Members and investors that trades will stand if executed during Regular Trading Hours where the LULD Plan provides adequate protection against trading at erroneous prices. The Exchange understands that the other national securities exchanges and FINRA will also file similar proposals, the substance of which are substantively identical to this proposal. Thus, the proposed rule change will help to ensure consistency across SROs without implicating any competitive issues.
The Exchange neither solicited nor received comments on the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the 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 to determine whether the proposed rule should be approved or disapproved.
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) of the Securities Exchange Act of 1934 (the “Act”),
Cboe EDGA Exchange, Inc. (the “Exchange” or “EDGA”) is filing with the Securities and Exchange Commission (“Commission”) a proposed amendment to eliminate the listings standards provided for in Chapter XIV of the Exchange Rulebook as the Exchange is not a listing venue.
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange 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 these 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 aspects of such statements.
As part of this proposal, the Exchange proposes to (1) adopt a new definition for Derivative Security, move the definition of unlisted trading privileges (“UTP”) Derivative Security
The Exchange proposes to define “Derivative Security” in proposed Rule 1.5(ff) and amend existing Rule 1.5(gg) to add the definition of “UTP Derivative Security”. “Derivative Security” would be a new definition and would mean a security that meets the definition of “new derivative securities product” in Rule 19b-4(e) under the Act. “UTP Derivative Security” would refer to any one of a list of Derivative Securities that trades on the Exchange pursuant to unlisted trading privileges. The list of proposed Derivative Securities that may meet the definition of UTP Derivative Security are as follows: Equity Linked Notes; Index Fund Shares listed pursuant to Cboe BZX Exchange, Inc. (“BZX”) Rule 14.11(c) or Nasdaq Stock Market LLC (“Nasdaq”) Rule 5705(b) and Investment Company Units listed pursuant to NYSE Arca, Inc. (“NYSE Arca”) Rule 5.2-E(j)(3); Index-Linked Exchangeable Notes; Equity Gold Shares; Equity Index-Linked Securities; Commodity-Linked Securities; Currency-Linked Securities; Fixed Income Index-Linked Securities; Futures-Linked Securities; Multifactor Index-Linked Securities; Trust Certificates; Currency and Index Warrants; Portfolio Depository Receipts; Trust Issued Receipts; Commodity-Based Trust Shares; Currency Trust Shares; Commodity Index Trust Shares; Commodity Futures Trust Shares; Partnership Units; Paired Trust Shares; Trust Units; Managed Fund Shares; Managed Trust Securities; Managed Portfolio Shares; Tracking Fund Shares listed pursuant to BZX Exchange Rule 14.11(m), Active Proxy Portfolio Shares listed pursuant to NYSE Arca Rule 8.601-E, and Proxy Portfolio Shares listed pursuant to Nasdaq Stock Market LLC Rule 5750; Selected Equity-linked Debt Securities (“SEEDS”); Exchange-Traded Fund Shares; and Contingent
The Exchange also proposes to re-letter existing Rules 1.5(ff) through (ii) to allow for the addition of proposed Rule 1.5(ff). Further, the Exchange proposes to amend Rule 3.21 to reference the proposed definition of UTP Derivative Securities in Rule 1.5(gg).
Unlike its affiliate exchange BZX, the Exchange is not a listing venue and thus trades securities on a UTP basis only. Nonetheless, currently Chapter XIV of the Exchange's Rulebook provides for listing standards for Derivative Securities that are generally based on BZX Rule 14.11. Exchange Rule 14.1 also provides that the Exchange will not list an equity security, and that the provisions of Rules 14.2 through 14.9,
Exchange Rule 14.1 establishes the Exchange's authority to trade securities on a UTP Basis. Based on the proposed amendment to eliminate Derivative Security listings standards, the Exchange also proposes to amend Rule 14.1(a) to eliminate any references to the listing of securities on the Exchange. Additionally, the Exchange proposes to eliminate the definition of Equity Security from Rule 14.1 and to instead reference NMS Stock, as defined in Rule 4.5(cc). Lastly, based on the above proposals, the Exchange proposes to eliminate any reference to products listed on the Exchange as provided in Rules 3.7, 11.2, and 13.6.
Existing Rule 14.1(c) defines UTP Derivative Security. However, as the Exchange proposes to redefine such term in Rule 1.5(gg), it proposes to eliminate the definition from Rule 14.1(c). Existing Rule 14.1(c) also provides that a UTP Derivative Security is subject to additional rules, as set forth in subparagraphs (1) through (6). Now, the Exchange proposes to modify certain of those subparagraphs.
First, the Exchange proposes to eliminate existing Rule 14.1(c)(1), which provides that the Exchange shall file with the Commission a Form 19b-4(e) with respect to each UTP Derivative Security. The Exchange believes that it should not be necessary to file a Form 19b-4(e) with the Commission if it begins trading a UTP Derivative Security because Rule 19b-4(e) under the Act refers to the “listing and trading” of a “new derivative securities product”. The Exchange believes that the requirements of Rule 19b-4(e) refer to when an exchange lists and trades a Derivative Security, and not when an exchange seeks only to trade such product on a UTP basis pursuant to Rule 12f-2 under the Act.
The Exchange also proposes to replace the term “new derivative securities product” with the term Derivative Security in order to provide for consistent nomenclature in Exchange Rules. The proposed change is not a substantive change as the proposed definition of Derivative Security is equivalent to the definition of “new derivative securities product” under Rule 19b-4(e) under the Exchange Act, as set forth in proposed Rule 1.5(ff).
The Exchange proposes to add additional explanatory language to paragraph (c)(4) that states nothing in the Rule will limit the power of the Exchange under the Rules or procedures of the Exchange with respect to the Exchange's ability to suspend trading in any securities if such suspension is necessary for the protection of investors or in the public interest. The proposed text is substantively identical to that included in NYSE National Rule 5.1(a)(2)(C) and BZX Rule 14.11(j)(3). Further, the proposed text reinforces existing Exchange Rule 11.16(d).
The Exchange proposes to modify paragraphs (c)(5) and (c)(6) to harmonize the text with the Exchange's affiliate, Cboe BYX Exchange, Inc. (“BYX”), Rules 14.1(c)(5) and (c)(6), respectively. Specifically, in Rule 14.1(c)(5) the Exchange proposes to make ministerial changes to the Rule to conform to BYX Rule 14.1(c)(5). In Rule 14.1(c)(6), the Exchange proposes to modify the language so that it states that the Exchange shall enter into a comprehensive surveillance sharing agreement with markets trading components of the index or portfolio on which the UTP Derivative Security is based to the same extent as the listing exchange's rules require the listing exchange to enter into a comprehensive surveillance sharing agreement with such markets, which will conform to BYX Rule 14.1(c)(6).
Lastly, based on the proposal to eliminate Rule 14.1(c)(1), the Exchange proposes to renumber existing paragraphs (c)(2) through (c)(6) accordingly.
Finally, the Exchange is proposing to renumber Rule 14.10 to Rule 14.2 in order to reflect the elimination of Rule 14.2 through Rule 14.9 that the Exchange is proposing to delete as part of this proposal.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of
In particular, the Exchange believes the proposed definitions of Derivative Security and UTP Derivative Security are reasonable as the proposed substantive changes are substantially similar to other exchanges' rules. Specifically, the proposed definition of Derivative Security in Rule 1.5(ff) is substantially similar to the definition of Exchange Traded Product provided for in NYSE National Rule 1.1(m), except that it better conforms to the defined term “new derivative securities product” of Rule 19b-4(e) under the Act. The proposed definition of UTP Derivative Security is substantially similar to BZX Rule 1.5(ee), except that the list of Derivative Securities that may be UTP Derivative Securities includes CVRs. Further, the proposal is substantially similar to NYSE National Rule 1.1(m), but the list of Derivative Securities that may be UTP Derivative Securities includes three additional Derivative Securities, SEEDS, Exchange-Traded Fund Shares, and CVRs. While SEEDS and Exchange-Traded Fund Shares are not included in NYSE National Rule 1.1(m), they are Derivative Securities set forth not only in BZX Exchange Rules 14.11(e)(12) and 14.11(l), respectively, but also in section 5700 of the Nasdaq Rules. Further, while CVRs are not currently provided for in NYSE National Rule 1.1(m) or BZX Rule 1.5(ee), CVRs meet the definition of “new derivative securities product” in Rule 19b-4(e) under the Act and also may currently be traded on the Exchange pursuant to existing EDGA Rule 14.1(a) on a UTP basis.
The Exchange believes that its proposal to remove listings standards from Chapter XIV of the Exchange's Rulebook and references elsewhere in the Exchange's Rulebook will eliminate potential investor confusion as the Exchange is not a listing venue. Given this, the Exchange believes the removal of such rules from Chapter XIV and reference to such listings standards in Rules 3.7, 11.2, and 13.6 will simplify and clarify the Exchange's Rulebook. Further, as proposed, Chapter XIV is substantially similar to Chapter 5 of the NYSE National rulebook.
The Exchange's proposal to eliminate the definition of Equity Security from Rule 14.1 and to instead reference NMS Stock as defined in Rule 4.5(cc) will add consistency and clarity to the Exchange's rulebook.
Eliminating the requirement to file a Form 19b-4(e) for each Derivative Security is consistent with the Act because the regulatory requirement was not intended to apply in the context of Derivative Securities trading on a UTP basis. Moreover, the proposal to eliminate Rule 14.1(c)(1) will provide for a more efficient process for adding Derivative Securities to trading on the Exchange on a UTP basis. The Exchange also notes that the proposal is substantially identical to other exchange rules.
The Exchange believes that its proposal to amend Rule 14.1(c)(2), which eliminates redundant language and uses the defined term Derivative Security in lieu of the term “new derivatives securities product”, to amend Rule 14.1(c)(3) to substantially conform to NYSE National Rule 5.1(a)(2)(C) (trading halts), to modify Rule 14.1(c)(5) and (c)(6) to conform to BYX Rule 14.1(c)(5) and (c)(6), respectively, and to renumber existing paragraphs 14.1(c)(2)-(c)(6) based on its proposal to eliminate Rule 14.1(c)(1), will clarify and simplify the Exchange's Rulebook as well as provide consistency in the Exchange's Rules.
Lastly, the Exchange believes its proposed changes to renumber Rule 14.10, to Rule 14.2 is appropriate in order to reflect the elimination of Rule 14.2 through Rule 14.9 that the Exchange is proposing to delete as part of this proposal.
In light of the above proposals, the Exchange has also proposed to make corresponding changes to Rules 1.5, 3.7, 3.21, 11.2, 13.6 to renumber or re-letter certain paragraphs or subparagraphs of the Rule, eliminate any reference to Exchange listing rules in Chapter XIV, and update applicable rule references.
The proposal is intended to simplify and clarify the Exchange's Rules as they relate to UTP Derivative Securities and to reflect that EDGA is not a listing venue which the Exchange believes will remove impediments to, and perfect the mechanism of, a free and open market and a national market system and, in general, to protect investors and the public interest. The Exchange believes that renumbering and re-lettering current Rules to correspond to the proposed changes will allow the Exchange to maintain a clear and organized rule structure, thus preventing investor confusion. For these reasons, the Exchange believes the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Allowing the Exchange to make the above proposed modifications will clarify that the Exchange is not a listing venue by eliminating listing standards and any references to Exchange listed securities Further, the proposed rule change will harmonize certain Exchange Rules with those of other exchanges, including the Exchange's affiliate BZX, which will simplify and clarify the Exchange's rulebook and promote consistency and transparency on both the Exchange and its affiliated exchanges, thus making the Exchange's rules easier to navigate.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section
A proposed rule change filed under Rule 19b-4(f)(6)
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 to determine whether the proposed rule should be approved or disapproved.
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.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CboeEDGA-2022-014 and should be submitted on or before October 19, 2022.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is filing a proposed rule change to amend Exchange Rule 2621, Clearly Erroneous Executions.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange 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 these 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 aspects of such statements.
The purpose of the proposed rule change is to amend Exchange Rule 2621, Clearly Erroneous Executions. Specifically, the Exchange proposes to
On August 14, 2020, the Commission approved the adoption of Exchange Rule 2621 that, among other things: (i) provided for uniform treatment of clearly erroneous execution reviews in multi-stock events involving twenty or more securities; (ii) reduced the ability of the Exchange to deviate from the objective standards set forth in the rule; adopted a provision designed to address the operation of the LULD Plan; (iii) adopted a provision providing that a series of transactions in a particular security on one or more trading days may be viewed as one event if all such transactions were effected based on the same fundamentally incorrect or grossly misinterpreted issuance information resulting in a severe valuation error for all such transactions; and (iv) adopted a provision that in the event of any disruption or malfunction in the operation of the electronic communications and trading facilities of an Exchange, another SRO, or responsible single plan processor in connection with the transmittal or receipt of a trading halt, an Officer, acting on his or her own motion, shall nullify any transaction that occurs after a trading halt has been declared by the primary listing market for a security and before such trading halt has officially ended according to the primary listing market.
The clearly erroneous rules were first implemented by other equity exchanges on a pilot basis following a severe disruption in the U.S. equities markets on May 6, 2010 (“Flash Crash”) to “provide greater transparency and certainty to the process of breaking trades.”
When the Participants to the LULD Plan filed to introduce the Limit Up-Limit Down (“LULD”) mechanism, itself a response to the Flash Crash, a handful of commenters noted the potential discordance between the clearly erroneous rules and the Price Bands used to limit the price at which trades would be permitted to be executed pursuant to the LULD Plan. For example, two commenters requested that the clearly erroneous rules be amended so the presumption would be that trades executed within the Price Bands would not be not subject to review.
The Exchange believes that it is important for there to be some mechanism to ensure that investors' orders are either not executed at clearly erroneous prices or are subsequently busted as needed to maintain a fair and orderly market. At the same time, the Exchange believes that the LULD Plan, as amended, would provide sufficient protection for trades executed during Regular Trading Hours. Indeed, the LULD mechanism could be considered to offer superior protection as it prevents potentially erroneous trades from being executed in the first instance. After gaining experience with the LULD Plan, the Exchange now believes that it is appropriate to largely eliminate clearly erroneous review during Regular Trading Hours when Price Bands are in effect. Thus, as proposed, trades executed within the Price Bands would stand, barring one of a handful of identified scenarios where such review may still be necessary for the protection of investors. The Exchange believes that this change would be beneficial for the U.S. equities markets as it would ensure that trades executed within the Price Bands are subject to clearly erroneous review in only rare circumstances, resulting in
There would be much more limited potential to request that a transaction be reviewed as potentially erroneous during Regular Trading Hours.
At the same time, the Exchange is cognizant that there may be limited circumstances where clearly erroneous review may continue to be appropriate. Thus, the Exchange proposes to amend its clearly erroneous rules to enumerate the specific circumstances where such review would remain available, as follows. All transactions that fall outside of these specific enumerated exceptions would be ineligible for clearly erroneous review.
First, pursuant to proposed paragraph (c)(1)(A), a transaction would continue to be eligible for clearly erroneous review if the transaction is not subject to the LULD Plan. In such case, the Numerical Guidelines set forth in paragraph (c)(2) of Rule 2621 will be applicable to such NMS Stock. While the majority of securities traded on the Exchange would be subject to the LULD Plan, certain equity securities, such as rights and warrants, are explicitly excluded from the provisions of the LULD Plan and would therefore be eligible for clearly erroneous review instead.
Second, investors would also continue to be able to request review of transactions that resulted from certain systems issues pursuant to proposed paragraph (c)(1)(B). This limited exception would help to ensure that trades that should not have been executed would continue to be subject to clearly erroneous review. Specifically, as proposed, transactions would be eligible for clearly erroneous review pursuant to proposed paragraph (c)(1)(B) if the transaction is the result of an Exchange technology or systems issue that results in the transaction occurring outside of the applicable LULD Price Bands pursuant to Exchange Rule 2621(g). A transaction subject to review pursuant to this paragraph shall be found to be clearly erroneous if the price of the transaction to buy (sell) that is the subject of the complaint is greater than (less than) the Reference Price, described in paragraph (d) of this Rule, by an amount that equals or exceeds the applicable Percentage Parameter defined in Appendix A to the LULD Plan (“Percentage Parameters”).
Third, the Exchange proposes to narrowly allow for the review of transactions when the Reference Price, described in proposed paragraph (d), is determined to be erroneous by an Officer of the Exchange. Specifically, a transaction would be eligible for clearly erroneous review pursuant to proposed paragraph (c)(1)(C) if the transaction involved, in the case of (1) a corporate action or new issue or (2) a security that enters a Trading Pause pursuant to the LULD Plan and resumes trading without an auction,
In the context of a corporate action or a new issue, there may be instances where the security's Reference Price is later determined by the Exchange to be erroneous (
The following illustrate the proposed application of the rule in the context of a corporate action or new issue:
In the context of the rare situation in which a security that enters a LULD Trading Pause and resumes trading without an auction (
The following example illustrates the proposed application of the rule in the context of a security that reopens without an auction:
In all of the foregoing situations, investors would be left with no remedy to request clearly erroneous review without the proposed carve outs in paragraph (c)(1)(C) because the trades occurred within the LULD Price Bands (albeit LULD Price Bands that were calculated from an erroneous Reference Price). The Exchange believes that removing the current ability for the Exchange to review in these narrow circumstances would lessen investor protections.
Today, paragraph (c)(1) defines the Numerical Guidelines that are used to determine if a transaction is deemed clearly erroneous during Regular Trading Hours. With respect to Regular Trading Hours, trades are generally deemed clearly erroneous if the execution price differs from the Reference Price (
Given the changes described in this proposed rule change, the Exchange proposes to amend the way that the Numerical Guidelines are calculated during Regular Trading Hours in the handful of instances where clearly erroneous review would continue to be available. Specifically, the Exchange would base these Numerical Guidelines, as applied to the circumstances described in paragraph (c)(1)(A), on the Percentage Parameters used to calculate Price Bands, as set forth in Appendix A to the LULD Plan. Without this change, a transaction that would otherwise stand if Price Bands were properly applied to the transaction may end up being subject to review and deemed clearly erroneous solely due to the fact that the Price Bands were not available due to a systems or other issue. The Exchange believes that it makes more sense to instead base the Price Bands on the same parameters as would otherwise determine whether the trade would have been allowed to execute within the Price Bands. The Exchange also proposes to modify the Numerical Guidelines applicable to leveraged ETF/ETN securities during Regular Trading Hours. As noted above, the Numerical Guidelines will only be applicable to transactions eligible for review pursuant paragraph (c)(1)(A) (
The Exchange also proposes to move existing paragraphs (c)(2), (c)(3), and (d) to proposed paragraph (c)(2)(B), (c)(2)(C), and (C)(2)(D), respectively, as
As proposed, the Reference Price used would continue to be based on last sale and would be memorialized in proposed paragraph (d). Continuing to use the last sale as the Reference Price is necessary for operational efficiency as it may not be possible to perform a timely clearly erroneous review if doing so required computing the arithmetic mean price of eligible reported transactions over the past five minutes, as contemplated by the LULD Plan. While this means that there would still be some differences between the Price Bands and the clearly erroneous parameters, the Exchange believes that this difference is reasonable in light of the need to ensure timely review if clearly erroneous rules are invoked. The Exchange also proposes to allow for an alternate Reference Price to be used as prescribed in proposed paragraphs (d)(1), (2), and (3). Specifically, the Reference Price may be a value other than the consolidated last sale immediately prior to the execution(s) under review (1) in the case of Multi-Stock Events involving twenty or more securities, as described in paragraph (c)(2)(B) above, (2) in the case of an erroneous Reference Price, as described in paragraph (c)(1)(C) above,
As described more fully below, the Exchange proposes to eliminate paragraph (f), System Disruption or Malfunction. Accordingly, the Exchange proposes to remove from paragraph (e)(2), Appeals, each reference to paragraph (f), and include language referencing proposed paragraph (g), Transactions Occurring Outside of the LULD Bands.
To conform with the structural changes descried above, the Exchange proposes to remove paragraph 2621(f), System Disruption or Malfunction, and propose new paragraph (c)(1)(B). Specifically, as described in proposed paragraph (c)(1)(B) above, transactions occurring during Regular Trading Hours that are executed outside of the LULD Price Bands due to an Exchange technology or system issue, may be subject to clearly erroneous review pursuant to proposed paragraphs 2621(g). Proposed paragraph 2621(c)(1)(B) further provides that a transaction subject to review pursuant to this paragraph shall be found to be clearly erroneous if the price of the transaction to buy (sell) that is the subject of the complaint is greater than (less than) the Reference Price, described in paragraph (d), by an amount that equals or exceeds the applicable Percentage Parameter defined in Appendix A to the LULD Plan.
Current paragraph (h) of BZX Rule 11.17 provides different procedures for conducting clearly erroneous review in initial public offering (“IPO”) securities that are traded pursuant to unlisted trading privileges (“UTP”) after the initial opening of such IPO securities on the listing market. Specifically, this paragraph provides that a clearly erroneous error may be deemed to have occurred in the opening transaction of the subject security if the execution price of the opening transaction on the Exchange is the lesser of $1.00 or 10% away from the opening price on the listing exchange or association. The Exchange no longer believes that this provision is necessary as opening transactions on the Exchange following an IPO are subject to Price Bands pursuant to the LULD Plan. The Exchange therefore proposes to eliminate this provision in connection with the broader changes to clearly erroneous review during Regular Trading Hours.
The Exchange proposes to renumber paragraph (i) to paragraph (h) based on the proposal to eliminate existing paragraph (h), and to rename the paragraph to provide for transactions occurring outside of LULD Price Bands. Given that proposed paragraph (c)(1) defines the LULD Plan, the Exchange also proposes to eliminate redundant language from proposed paragraph (h). Finally, the Exchange also proposes to update references to the LULD Plan and Price Bands so that they are uniform throughout the Rule and to update rule references throughout the paragraph to conform to the structural changes to the Rule described above.
The Exchange proposes to renumber paragraphs (j) and (k) to paragraphs (h) and (i), respectively, based on the proposal to eliminate existing paragraph (h). Additionally, the Exchange proposes to modify the text of both paragraphs to reference the Percentage Parameters as well as the Numerical Guidelines. Specifically, the existing text of proposed paragraphs (h) and (i) provides that any action taken in connection with this paragraph will be taken without regard to the Numerical Guidelines set forth in this Rule. The Exchange proposes to amend the rule text to provide that any action taken in connection with this paragraph will be taken without regard to the Percentage Parameters or Numerical Guidelines set forth in this Rule, with the Percentage Parameters being applicable to an NMS Stock subject to the LULD Plan and the Numerical Guidelines being applicable to an NMS Stock not subject to the LULD Plan.
The proposed rule change would be effective on October 1, 2022.
The Exchange believes the proposed rule change is consistent with the requirements of Section 6(b) of the Act,
As explained in the purpose section of this proposed rule change, the current program was implemented following the Flash Crash to bring greater transparency to the process for conducting clearly erroneous reviews, and to help assure that the review process is based on clear, objective, and consistent rules across the U.S. equities markets. The Exchange believes that the amended clearly erroneous rules have been successful in that regard and have thus furthered fair and orderly markets. Specifically, the Exchange believes that the program has successfully ensured that such reviews are conducted based on objective and consistent standards across SROs and has therefore afforded greater certainty to Members and investors. The Exchange therefore believes that equities market participants should continue to reap the benefits of a clear, objective, and transparent process for conducting clearly erroneous reviews. In addition, this proposed rule change present no new or novel issues because it is based on the rules of Cboe BZX Exchange, Inc. (“BZX”) which were recently approved by the Commission.
Similarly, the Exchange believes that it is consistent with just and equitable principles of trade to limit the availability of clearly erroneous review during Regular Trading Hours. The Plan was approved by the Commission to operate on a permanent rather than pilot basis. As a number of market participants have noted, the LULD Plan provides protections that ensure that investors' orders are not executed at prices that may be considered clearly erroneous. Further, amendments to the LULD Plan approved in Amendment Eighteen serve to ensure that the Price Bands established by the LULD Plan are “appropriately tailored to prevent trades that are so far from current market prices that they would be viewed as having been executed in error.”
Given the fact that clearly erroneous review would largely be limited to transactions that were not subject to the LULD Plan, the Exchange also believes that it is necessary to change the parameters used to determine whether a trade is clearly erroneous. Specifically, due to the different parameters currently used for clearly erroneous review and for determining Price Bands, it is possible that a trade that would have been permitted to execute within the Price Bands would later be deemed clearly erroneous, if, for example, a systems issue prevented the dissemination of the Price Bands. The Exchange believes that this result is contrary to the principle that trades within the Price Bands should stand, and has the potential to cause investor confusion if trades that are properly executed within the applicable parameters described in the LULD Plan are later deemed erroneous. By using consistent parameters for clearly erroneous reviews conducted during Regular Trading Hours and the calculation of the Price Bands, the Exchange believes that this change would also serve to promote greater certainty with regards to when trades may be deemed erroneous.
The Exchange believes that it is consistent with the protection of investors and the public interest to remove the current provision of the clearly erroneous rule dealing with UTP securities that are the subject of IPOs. This provision applies specifically to opening transactions on a non-listing market following an IPO on the listing market. As such, review under this paragraph is limited to trades conducted during Regular Trading Hours. As previously addressed, trades executed during Regular Trading Hours would generally not be subject to clearly erroneous review but would instead be protected by the Price Bands. The Exchange therefore no longer believes that this paragraph is necessary, as all trades subject to this provision today would either be subject to the LULD Plan, or, in the event of some systems or other issue, would be subject to the provisions that apply to transactions that are not adequately protected by the LULD Plan.
Finally, the proposed rule changes make organizational updates to the Exchange's Clearly Erroneous Execution Rule as well as minor updates and corrections to the Rule to improve readability and clarity.
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposal would ensure the continued, uninterrupted operation of harmonized clearly erroneous execution rules across the U.S. equities markets while also amending those rules to provide greater certainty to Members and investors that trades will stand if executed during Regular Trading Hours where the LULD Plan provides adequate protection against trading at erroneous prices. This proposed rule change is based on changes to BZX Rule 11.17, which were recently approved by the Commission.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the 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 to determine whether the proposed rule should be approved or disapproved.
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 the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is filing a proposal to amend the MIAX Pearl Options Fee Schedule (the “Fee Schedule”).
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange 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 these 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 Exchange proposes to amend the Add/Remove Tiered Rebates/Fees set forth in Section 1(a) of the Fee Schedule to: (1) modify the Maker rebates (defined below) in all Tiers for transactions in Penny Classes (defined below) for MIAX Pearl Market Makers,
The Exchange currently assesses transaction rebates and fees to all market participants which are based upon the total monthly volume executed by the Member
The Exchange proposes to amend the Fee Schedule for the Exchange's options market to modify the Maker rebates in all Tiers for options transactions in Penny Classes for Market Makers and Non-Priority Customer, Firm, BD and Non-MIAX Pearl Market Maker origins' respective rate tables. Currently, the Exchange provides different Maker rebates for options transactions in Penny Classes for Market Makers and Non-Priority Customer, Firm, BD and Non-MIAX Pearl Market Maker origins depending on whether the Member is trading against the Priority Customer
The Exchange now proposes to lower the Maker rebates by $0.01 in all Tiers for options transactions in Penny Classes for Market Makers and Non-Priority Customer, Firm, BD and Non-MIAX Pearl Market Maker origins, respectively, when trading against the Priority Customer origin. Accordingly, with the proposed changes, the Exchange will provide the following Maker rebates for Market Makers for options transactions in Penny Classes when trading against the Priority Customer origin: ($0.22) in Tier 1, ($0.37) in Tier 2, ($0.37) in Tier 3, ($0.44) in Tier 4, ($0.45) in Tier 5, and ($0.46) in Tier 6. The Exchange will provide the following Maker rebates for Non-Priority Customer, Firm, BD and Non-MIAX Pearl Market Maker origins for options transactions in Penny Classes when trading against the Priority Customer origin: ($0.22) in Tier 1, ($0.37) in Tier 2, ($0.37) in Tier 3, ($0.44) in Tier 4, ($0.45) in Tier 5, and ($0.45) in Tier 6.
The purpose of adjusting the specified Maker rebates is for business and competitive reasons. In order to attract order flow, the Exchange initially set its Maker rebates so that they were higher than other options exchanges that operate comparable maker/taker pricing models.
The Exchange proposes to amend the Fee Schedule for the Exchange's options market to adopt additional separate Maker rebates for Market Makers and Non-Priority Customer, Firm, BD and Non-MIAX Pearl Market Maker origins for options transactions in Non-Penny Classes in Tiers 1 through 4. Currently, the Exchange provides the following Maker rebates for Market Makers and Non-Priority Customer, Firm, BD and Non-MIAX Pearl Market Maker origins for options transactions in Non-Penny Classes: ($0.30) in Tier 1, ($0.30) in Tier 2, ($0.60) in Tier 3, ($0.65) in Tier 4, ($0.70) in Tier 5, and ($0.85) in Tier 6.
The Exchange now proposes to adopt additional, separate Maker rebates for Market Makers for options transactions in Non-Penny Classes in Tiers 1 through 4. In particular, the Exchange proposes that Market Makers may qualify for additional, separate rebates for options transactions in Non-Penny classes in Tiers 1 through 4 if the Market Maker increases their Non-Penny Class Maker TCV by 100% or more as compared to that Market Maker's Non-Penny Class TCV for the month of July 2022,
The Exchange also proposes to adopt an additional, separate Maker rebate for EEM Professional origins (which includes, collectively, Non-Priority Customer, Firm, BD and Non-MIAX Pearl Market Maker origins), for options transactions in Non-Penny Classes in Tiers 1 through 4. In particular, the Exchange proposes that EEMs may qualify for additional separate rebates for options transactions in Non-Penny classes in Tiers 1 through 4 if the EEM increases their Professional origin Non-Penny Class Maker TCV by 100% or more as compared to that EEM's Professional origin Non-Penny Class TCV for the month of July 2022,
The proposed changes are immediately effective.
The Exchange believes that its proposal to amend its Fee Schedule is consistent with Section 6(b) of the Act
The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
There are currently 16 registered options exchanges competing for order flow. Based on publicly-available information, and excluding index-based options, as of September 13, 2022, no single exchange has more than approximately 11-13% equity options market share for the month of September 2022.
The Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can discontinue or reduce use of certain categories of products and services, terminate an existing membership or determine to not become a new member, and/or shift order flow, in response to transaction fee changes. For example, on February 28, 2019, the Exchange filed with the Commission a proposal to increase Taker fees in certain Tiers for options transactions in certain Penny classes for Priority Customers and decrease Maker rebates in certain Tiers for options transactions in Penny classes for Priority Customers (which fee was to be effective March 1, 2019).
The Exchange believes its proposal to modify the Maker rebates in all Tiers for options transactions in Penny classes for Market Makers and Non-Priority Customer, Firm, BD and Non-MIAX Pearl Market Maker origins when trading against Priority Customer origin is reasonable, equitable and not unfairly discriminatory because all similarly situated market participants in the same origin type are subject to the same tiered Maker rebates and access to the Exchange is offered on terms that are not unfairly discriminatory. For competitive and business reasons, the Exchange initially set its Maker rebates for such orders generally higher than certain other options exchanges that operate comparable maker/taker pricing models. The Exchange now believes that it is appropriate to modify those specified Maker rebates so that they are more in line with other exchanges, and will remain highly competitive such that they should enable the Exchange to continue to attract order flow and maintain market share.
The Exchange believes its proposal is not unfairly discriminatory because, with the proposed changes, the Maker rebates for Market Makers and Non-Priority Customer, Firm, BD and Non-MIAX Pearl Market Maker origins will be nearly the same as the Maker rebates for all other origin types except for Priority Customer origin orders. The Exchange believes that it is equitable and not unfairly discriminatory to assess lower Maker rebates to Market Makers and EEM Professional origins than to Priority Customer origin orders. A Priority Customer is by definition not a broker or dealer in securities, and does not place more than 390 orders in listed options per day on average during a calendar month for its own beneficial account(s).
The Exchange believes its proposal to adopt additional, separate Maker rebates for options transactions in Non-Penny Classes in Tiers 1 through 4 for Market Makers and EEM Professional origins is reasonable, equitable and not unfairly discriminatory because all similarly situated market participants in the same origin type are subject to the same tiered Maker rebates and access to the Exchange is offered on terms that are not unfairly discriminatory. The Exchange believes its proposal to offer an additional Non-Penny Class Maker rebates in Tiers 1 through 4 for Market Makers and EEM Professional origins will incentivize Market Makers and EEMs to improve their posted liquidity to the benefit of the entire market, which will increase order flow sent to the Exchange, benefiting all market participants through increased liquidity, tighter markets and order interaction. The Exchange believes it is reasonable and not unfairly discriminatory to offer higher additional Non-Penny Class Maker rebates for Tiers 1 and 2, as compared to Tiers 3 and 4, because the Exchange believes that the prospect of obtaining the higher rebates for Tiers 1 and 2 will attract Non-Penny Class Maker volume from new market participants. This anticipated new Non-Penny Class Maker volume should benefit all Exchange participants by providing more trading opportunities and tighter spreads. Further, with the proposed additional rebates, the Exchange's Non-Penny Class Maker rebates in Tiers 1 through 4 for Market Makers and EEM Professional origins will be in line with, or higher than (for Tiers 1 and 2) similar rebates from competing options exchanges.
The Exchange believes it is reasonable, equitable and not unfairly discriminatory to consider any new Non-Penny Class Maker volume as added volume for Market Makers with no volume in the Non-Penny Class Maker segment for the month of July 2022 in order for those Market Makers to receive the proposed additional rebate because this should attract additional Non-Penny Class Maker volume from Market Makers. In turn, this additional volume should benefit all Exchange participants by providing more trading opportunities and tighter spreads. Similarly, the Exchange believes it is reasonable, equitable and not unfairly discriminatory to consider any new Non-Penny Class Maker volume as added volume for EEMs with no Professional origin volume in the Non-Penny Class Maker segment for the month of July 2022 in order for those EEMs to receive the proposed additional rebate because this should attract additional Non-Penny Class volume from EEMs, which should benefit all Exchange participants by providing more trading opportunities and tighter spreads.
The Exchange does not believe that the proposed rule changes will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the proposed changes in the Maker rebates for the applicable market participants should continue to encourage the provision of liquidity that enhances the quality of the Exchange's market and increases the number of trading opportunities on the Exchange for all participants who will be able to compete for such opportunities. The proposed rule changes should enable the Exchange to continue to attract and compete for order flow with other exchanges. However, this competition does not create an undue burden on competition but rather offers all market participants the opportunity to receive the benefit of competitive pricing.
The proposed Maker rebate adjustments are intended to keep the Exchange's rebates highly competitive with those of other exchanges, and to encourage liquidity and should enable the Exchange to continue to attract and compete for order flow with other exchanges. The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive. In such an environment, the Exchange must continually adjust its rebates and fees to remain competitive with other exchanges and to attract order flow. The Exchange believes that the proposed rule changes reflect this competitive environment because the proposal modifies the Exchange's fees in a manner that encourages market participants to continue to provide liquidity and to send order flow to the Exchange.
Written comments were neither solicited nor received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
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) of the Securities Exchange Act of 1934 (the “Act”),
Cboe EDGX Exchange, Inc. (the “Exchange” or “EDGX”) is filing with the Securities and Exchange Commission (“Commission”) a proposed amendment to eliminate the listings standards provided for in Chapter XIV of the Exchange Rulebook as the Exchange is not a listing venue.
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange 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 these 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 aspects of such statements.
As part of this proposal, the Exchange proposes to (1) adopt a new definition for Derivative Security, move the definition of unlisted trading privileges (“UTP”) Derivative Security
The Exchange proposes to define “Derivative Security” in proposed Rule 1.5(ff) and amend existing Rule 1.5(gg) to add the definition of “UTP Derivative Security”. “Derivative Security” would be a new definition and would mean a security that meets the definition of “new derivative securities product” in Rule 19b-4(e) under the Act. “UTP Derivative Security” would refer to any one of a list of Derivative Securities that trades on the Exchange pursuant to unlisted trading privileges. The list of proposed Derivative Securities that may meet the definition of UTP Derivative Security are as follows: Equity Linked Notes; Index Fund Shares listed pursuant to Cboe BZX Exchange, Inc. (“BZX”) Rule 14.11(c) or Nasdaq Stock Market LLC (“Nasdaq”) Rule 5705(b) and Investment Company Units listed pursuant to NYSE Arca, Inc. (“NYSE Arca”) Rule 5.2-E(j)(3); Index-Linked Exchangeable Notes; Equity Gold Shares; Equity Index-Linked Securities; Commodity-Linked Securities; Currency-Linked Securities; Fixed Income Index-Linked Securities; Futures-Linked Securities; Multifactor Index-Linked Securities; Trust Certificates; Currency and Index Warrants; Portfolio Depository Receipts; Trust Issued Receipts; Commodity-Based Trust Shares; Currency Trust Shares; Commodity Index Trust Shares; Commodity Futures Trust Shares; Partnership Units; Paired Trust Shares; Trust Units; Managed Fund Shares; Managed Trust Securities; Managed Portfolio Shares; Tracking Fund Shares listed pursuant to BZX Exchange Rule 14.11(m), Active Proxy Portfolio Shares listed pursuant to NYSE Arca Rule 8.601-E, and Proxy Portfolio Shares listed pursuant to Nasdaq Stock Market LLC Rule 5750; Selected Equity-linked Debt Securities (“SEEDS”); Exchange-Traded Fund Shares; and Contingent Value Rights (“CVRs”).
The Exchange also proposes to re-letter existing Rules 1.5(ff) through (ii) to allow for the addition of proposed Rule 1.5(ff). Further, the Exchange proposes to amend Rule 3.21 to reference the proposed definition of UTP Derivative Securities in Rule 1.5(gg).
Unlike its affiliate exchange BZX, the Exchange is not a listing venue and thus trades securities on a UTP basis only. Nonetheless, currently Chapter XIV of the Exchange's Rulebook provides for listing standards for Derivative Securities that are generally based on BZX Rule 14.11. Exchange Rule 14.1 also provides that the Exchange will not list an equity security, and that the provisions of Rules 14.2 through 14.9,
Exchange Rule 14.1 establishes the Exchange's authority to trade securities on a UTP Basis. Based on the proposed amendment to eliminate Derivative Security listings standards, the Exchange also proposes to amend Rule 14.1(a) to eliminate any references to the listing of securities on the Exchange. Additionally, the Exchange proposes to eliminate the definition of Equity Security from Rule 14.1 and to instead reference NMS Stock, as defined in Rule 4.5(cc). Lastly, based on the above proposals, the Exchange proposes to eliminate any reference to products listed on the Exchange as provided in Rules 3.7, 11.2, and 13.6.
Existing Rule 14.1(c) defines UTP Derivative Security. However, as the Exchange proposes to redefine such term in Rule 1.5(gg), it proposes to eliminate the definition from Rule 14.1(c). Existing Rule 14.1(c) also provides that a UTP Derivative Security is subject to additional rules, as set forth in subparagraphs (1) through (6). Now, the Exchange proposes to modify certain of those subparagraphs.
First, the Exchange proposes to eliminate existing Rule 14.1(c)(1), which provides that the Exchange shall file with the Commission a Form 19b-4(e) with respect to each UTP Derivative Security. The Exchange believes that it should not be necessary to file a Form 19b-4(e) with the Commission if it begins trading a UTP Derivative Security because Rule 19b-4(e) under the Act refers to the “listing and trading” of a “new derivative securities product”. The Exchange believes that the requirements of Rule 19b-4(e) refer to when an exchange lists and trades a Derivative Security, and not when an exchange seeks only to trade such product on a UTP basis pursuant to Rule 12f-2 under the Act.
The Exchange also proposes to replace the term “new derivative securities product” with the term Derivative Security in order to provide for consistent nomenclature in Exchange Rules. The proposed change is not a substantive change as the proposed definition of Derivative Security is equivalent to the definition of “new derivative securities product” under Rule 19b-4(e) under the Exchange Act, as set forth in proposed Rule 1.5(ff).
The Exchange proposes to add additional explanatory language to paragraph (c)(4) that states nothing in the Rule will limit the power of the Exchange under the Rules or procedures of the Exchange with respect to the Exchange's ability to suspend trading in any securities if such suspension is necessary for the protection of investors or in the public interest. The proposed text is substantively identical to that included in NYSE National Rule 5.1(a)(2)(C) and BZX Rule 14.11(j)(3). Further, the proposed text reinforces existing Exchange Rule 11.16(d).
The Exchange proposes to modify paragraphs (c)(5) and (c)(6) to harmonize the text with the Exchange's affiliate, Cboe BYX Exchange, Inc. (“BYX”), Rules 14.1(c)(5) and (c)(6), respectively. Specifically, in Rule 14.1(c)(5) the Exchange proposes to make ministerial changes to the Rule to conform to BYX Rule 14.1(c)(5). In Rule 14.1(c)(6), the Exchange proposes to modify the language so that it states that the Exchange shall enter into a comprehensive surveillance sharing agreement with markets trading components of the index or portfolio on which the UTP Derivative Security is based to the same extent as the listing exchange's rules require the listing exchange to enter into a comprehensive surveillance sharing agreement with such markets, which will conform to BYX Rule 14.1(c)(6).
Lastly, based on the proposal to eliminate Rule 14.1(c)(1), the Exchange proposes to renumber existing paragraphs (c)(2) through (c)(6) accordingly.
Finally, the Exchange is proposing to renumber Rule 14.10 to Rule 14.2 in order to reflect the elimination of Rule 14.2 through Rule 14.9 that the Exchange is proposing to delete as part of this proposal.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes the proposed definitions of Derivative Security and UTP Derivative Security are reasonable as the proposed substantive changes are substantially similar to other exchanges' rules. Specifically, the proposed definition of Derivative Security in Rule 1.5(ff) is substantially similar to the definition of Exchange Traded Product provided for in NYSE National Rule 1.1(m), except that it better conforms to the defined term “new derivative securities product” of Rule 19b-4(e) under the Act. The proposed definition of UTP Derivative Security is substantially similar to BZX Rule 1.5(ee), except that the list of Derivative Securities that may be UTP Derivative Securities includes CVRs. Further, the proposal is substantially similar to NYSE National Rule 1.1(m), but the list of Derivative Securities that may be UTP Derivative Securities includes three additional Derivative Securities, SEEDS, Exchange-Traded Fund Shares, and CVRs. While SEEDS and Exchange-Traded Fund Shares are not included in NYSE National Rule 1.1(m), they are Derivative Securities set forth not only in Exchange Rules 14.11(e)(12) and 14.11(l), respectively, but also in section 5700 of the Nasdaq Rules. Further, while CVRs are not currently provided for in NYSE National Rule 1.1(m) or BZX Rule 1.5(ee), CVRs meet the definition of “new derivative securities product” in Rule 19b-4(e) under the Act and also may currently be traded on the Exchange pursuant to existing EDGX Rule 14.1(a) on a UTP basis.
The Exchange believes that its proposal to remove listings standards from Chapter XIV of the Exchange's Rulebook and references elsewhere in the Exchange's Rulebook will eliminate potential investor confusion as the Exchange is not a listing venue. Given this, the Exchange believes the removal of such rules from Chapter XIV and reference to such listings standards in Rules 3.7, 11.2, and 13.6 will simplify and clarify the Exchange's Rulebook. Further, as proposed, Chapter XIV is substantially similar to Chapter 5 of the NYSE National rulebook.
The Exchange's proposal to eliminate the definition of Equity Security from Rule 14.1 and to instead reference NMS Stock as defined in Rule 4.5(cc) will add consistency and clarity to the Exchange's rulebook.
Eliminating the requirement to file a Form 19b-4(e) for each Derivative Security is consistent with the Act because the regulatory requirement was not intended to apply in the context of Derivative Securities trading on a UTP basis. Moreover, the proposal to eliminate Rule 14.1(c)(1) will provide for a more efficient process for adding Derivative Securities to trading on the Exchange on a UTP basis. The Exchange also notes that the proposal is substantially identical to other exchange rules.
The Exchange believes that its proposal to amend Rule 14.1(c)(2), which eliminates redundant language and uses the defined term Derivative Security in lieu of the term “new derivatives securities product”, to amend Rule 14.1(c)(3) to substantially conform to NYSE National Rule 5.1(a)(2)(C) (trading halts), to modify Rule 14.1(c)(5) and (c)(6) to conform to BYX Rule 14.1(c)(5) and (c)(6), respectively, and to renumber existing paragraphs 14.1(c)(2)-(c)(6) based on its proposal to eliminate Rule 14.1(c)(1), will clarify and simplify the Exchange's Rulebook as well as provide consistency in the Exchange's Rules.
Lastly, the Exchange believes its proposed renumber of Rule 14.10 to Rule 14.2 is appropriate in order to reflect the elimination of Rule 14.2 through Rule 14.9 that the Exchange is proposing to delete as part of this proposal.
In light of the above proposals, the Exchange has also proposed to make corresponding changes to Rules 1.5, 3.7, 3.21, 11.2, 13.6 to renumber or re-letter certain paragraphs or subparagraphs of the Rule, eliminate any reference to Exchange listing rules in Chapter XIV, and update applicable rule references.
The proposal is intended to simplify and clarify the Exchange's Rules as they relate to UTP Derivative Securities and to reflect that EDGX is not a listing venue which the Exchange believes will remove impediments to, and perfect the mechanism of, a free and open market and a national market system and, in general, to protect investors and the public interest. The Exchange believes that renumbering and re-lettering current Rules to correspond to the proposed changes will allow the Exchange to maintain a clear and organized rule structure, thus preventing investor confusion. For these reasons, the Exchange believes the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Allowing the Exchange to make the above proposed modifications will clarify that the Exchange is not a listing venue by eliminating listing standards and any references to Exchange listed securities Further, the proposed rule change will harmonize certain Exchange Rules with those of other exchanges, including the Exchange's affiliate BZX, which will simplify and clarify the Exchange's rulebook and promote consistency and transparency on both the Exchange and its affiliated exchanges, thus making the Exchange's rules easier to navigate.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
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 to determine whether the proposed rule should be approved or disapproved.
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.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly.
All submissions should refer to File Number SR-CboeEDGX-2022-040 and should be submitted on or before
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to amend its Schedule of Fees and Rebates (“Fee Schedule”) to modify the requirements to qualify for Adding Tier 1. The Exchange proposes to implement the rule change on September 14, 2022. 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 its Fee Schedule to modify the requirements to qualify for Adding Tier 1.
The proposed changes respond to the current competitive environment where order flow providers have a choice of where to direct liquidity-providing and liquidity-removing orders by offering further incentives for ETP Holders to send additional adding liquidity to the Exchange.
The Exchange proposes to implement the rule change on September 14, 2022.
The Exchange operates in a highly competitive market. The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. Specifically, in Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
While Regulation NMS has enhanced competition, it has also fostered a “fragmented” market structure where trading in a single stock can occur across multiple trading centers. When multiple trading centers compete for order flow in the same stock, the Commission has recognized that “such competition can lead to the fragmentation of order flow in that stock.”
The Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can move order flow, or discontinue or reduce use of certain products, in response to fee changes. While it is not possible to know a firm's reason for moving order flow, the Exchange believes that one such reason is because of fee changes at any of the registered exchanges or non-exchange trading venues to which a firm routes order flow. These fees can vary from month to month, and not all are publicly available. With respect to non-marketable order flow that would provide liquidity on an exchange, ETP Holders can choose from any one of the 16 currently operating registered exchanges to route such order flow. Accordingly, competitive forces constrain the Exchange's transaction fees, and market participants can readily trade on competing venues if they deem pricing levels at those other venues to be more favorable.
The Exchange utilizes a “taker-maker” or inverted fee model to attract orders that provide liquidity at the most competitive prices. Under the taker-maker model, offering rebates for taking (or removing) liquidity increases the likelihood that market participants will send orders to the Exchange to trade with liquidity providers' orders. This increased taker order flow provides an incentive for market participants to send orders that provide liquidity. The Exchange generally charges fees for order flow that provides liquidity. These fees are reasonable due to the additional marketable interest (in part attracted by the Exchange's rebate to remove liquidity) with which those order flow providers can trade.
To respond to this competitive environment, the Exchange proposes the following change to its Fee Schedule designed to provide order flow providers with additional incentives to route order flow to the Exchange. As described above, ETP Holders have a choice of where to send their order flow.
Under current Adding Tier 1, ETP Holders that add liquidity to the Exchange in securities with a per share price of $1.00 or more and that have at least 0.25% or more of Adding ADV as a percentage of US CADV or at least 30 million Adding ADV are charged a fee of $0.0020 per share for adding displayed orders and a fee of $0.0024 per share for adding non-displayed orders in Tape A, B, and C securities. The Exchange proposes to revise requirements to qualify for Adding Tier 1 as follows: ETP Holders would qualify for the current fee by having at least 0.20% or more Adding ADV as a percentage of US CADV or at least 30 million shares or more of Adding ADV. The Exchange does not propose any changes to the adding fees for Adding Tier 1.
The Exchange believes that lowering the ADV requirement to qualify for Adding Tier 1 as proposed above will allow greater numbers of ETP Holders to potentially qualify for the tier, and therefore will incentivize more ETP Holders to route their liquidity-providing order flow to the Exchange in order to qualify for the tier. This in turn would support the quality of price discovery on the Exchange and provide additional price improvement opportunities for incoming orders. The Exchange believes that by correlating the amount of the fee to the level of orders sent by an ETP Holder that add liquidity, the Exchange's fee structure would incentivize ETP Holders to submit more orders that add liquidity to the Exchange, thereby increasing the potential for price improvement to incoming marketable orders submitted to the Exchange.
As noted above, the Exchange operates in a competitive environment, particularly as relates to attracting non-marketable orders, which add liquidity to the Exchange. The Exchange does not know how much order flow ETP Holders choose to route to other exchanges or to off-exchange venues. Based on the profile of liquidity-adding firms generally, the Exchange believes that additional ETP Holders could qualify for Adding Tier 1 under the revised qualification criteria if they choose to direct order flow to the Exchange. However, without having a view of ETP Holders' activity on other exchanges and off-exchange venues, the Exchange has no way of knowing whether this proposed rule change would result in any additional ETP Holders directing orders to the Exchange in order to qualify for the Adding Tier 1 rate.
The proposed change is not otherwise intended to address any other issues, and the Exchange is not aware of any problems that ETP Holders 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,
As discussed above, the Exchange operates in a highly competitive market. The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Given the current competitive environment, the Exchange believes that the proposal represents a reasonable attempt to attract additional order flow to the Exchange. Specifically, the Exchange believes that the proposed change lowering the requirements to qualify for Adding Tier 1 is reasonable because it would promote execution opportunities for more ETP Holders routing order flow to the Exchange.
The Exchange believes that the proposal represents a reasonable effort to promote price discovery and enhanced order execution opportunities for ETP Holders. All ETP Holders would benefit from the greater amounts of liquidity on the Exchange, which would represent a wider range of execution opportunities.
The Exchange believes the proposed rule change equitably allocates its fees among its market participants. The proposed change would continue to encourage ETP Holders to both submit additional liquidity to the Exchange and execute orders on the Exchange, thereby contributing to robust levels of liquidity, to the benefit of all market participants.
The Exchange believes that modifying the requirements to qualify for Adding Tier 1 would encourage the submission of additional adding liquidity to the Exchange, thus enhancing order execution opportunities for ETP Holders from the additional amounts of liquidity present on the Exchange. All ETP Holders would benefit from the greater amounts of liquidity that would be present on the Exchange, which would provide greater execution opportunities.
The Exchange believes the proposed rule change would also improve market quality for all market participants seeking to remove liquidity on the Exchange and, as a consequence, attract more liquidity to the Exchange, thereby improving market-wide quality. The proposal neither targets nor will it have a disparate impact on any particular category of market participant.
Specifically, the Exchange believes that the proposal constitutes an equitable allocation of fees because all similarly situated ETP Holders and other market participants would be eligible for the same general and tiered rates and would be eligible for the same fees. Moreover, the proposed change is equitable because the revised fees would apply equally to all similarly situated ETP Holders.
The Exchange believes that the proposal is not unfairly discriminatory. In the prevailing competitive environment, ETP Holders are free to disfavor the Exchange's pricing if they believe that alternatives offer them better value.
Moreover, the proposal neither targets nor will it have a disparate impact on any particular category of market participant. The Exchange believes that the proposal does not permit unfair discrimination because the proposal would be applied to all similarly situated ETP Holders and all ETP Holders would be subject to the same modified requirements to qualify for Adding Tier 1. Accordingly, no ETP Holder already operating on the Exchange would be disadvantaged by the proposed allocation of fees.
The Exchange further believes that the proposed change would not permit unfair discrimination among ETP Holders because the tiered rates are available equally to all ETP Holders. As described above, in today's competitive marketplace, order flow providers have a choice of where to direct order flow, and the Exchange believes there are additional ETP Holders that could qualify if they chose to direct their order flow to the Exchange.
Finally, the Exchange believes that it is subject to significant competitive forces, as described below in the Exchange's statement regarding the burden on competition.
For the foregoing reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
The Exchange believes that the proposed change could promote competition between the Exchange and other execution venues, including those that currently offer similar order types and comparable transaction pricing, by encouraging additional orders to be sent to the Exchange for execution.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
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) of the Securities Exchange Act of 1934 (“Act” or “Exchange Act”)
FINRA is proposing to change references in the Codes of Arbitration Procedure (“Codes”) from the Neutral List Selection System to the list selection algorithm.
The text of the proposed rule change is available on FINRA's website at
In its filing with the Commission, FINRA 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 these statements may be examined at the places specified in Item IV below. FINRA has prepared summaries, set forth in sections A, B,
From November 1998 until October 2006, the Neutral List Selection System (“NLSS”) was the computer system that generated lists of arbitrators from FINRA Dispute Resolution Services' (“DRS”) rosters of arbitrators for the selected hearing location for each arbitration proceeding. In October 2006, DRS replaced the NLSS with the Mediation and Arbitration Tracking and Retrieval Interactive Case System (“MATRICS”).
FINRA is proposing to update the Codes by making technical, non-substantive changes to remove references to the NLSS from those rules describing arbitrator list selection and instead refer to the “list selection algorithm.”
In the proposed rule change, FINRA is not proposing any changes to the list selection algorithm, or any of DRS's existing practices, processes and systems related to arbitrator list selection.
FINRA has filed the proposed rule change for immediate effectiveness and has requested that the SEC waive the requirement that the proposed rule change not become operative for 30 days after the date of the filing, so FINRA can implement the proposed rule change immediately.
FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Exchange Act,
FINRA does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Exchange Act. The proposed rule change brings transparency and consistency to FINRA rules without adding any burden on member firms.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the 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 to determine whether the proposed rule should be approved or disapproved.
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.
All submissions should refer to File Number SR-FINRA-2022-026 and should be submitted on or before October 19, 2022.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is filing a proposal to amend the MIAX Emerald Fee Schedule (the “Fee Schedule”).
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange 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 these 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 aspects of such statements.
The Exchange proposes to amend Section 1)a)i) of the Fee Schedule to amend the rebates provided for Market Maker Origins for Simple
The Exchange currently assesses transaction rebates and fees to all market participants, which are based upon a threshold tier structure (“Tier”). Tiers are determined on a monthly basis and are based on three alternative calculation methods, as defined in Section 1)a)ii) of the Fee Schedule. The calculation method that results in the highest Tier achieved by the Member
The Exchange proposes to adopt note “!” to Market Maker in the Origin column to provide that, the rebate for Market Maker Origins for Simple Maker volume in Penny Classes will be reduced by $0.02 for each Tier when trading contra to a Priority Customer Origins. Currently, the Exchange provides a Simple Maker rebate for Market Maker Origins, for any contra Origin, in Tier 1 of $0.30; Tier 2 of $0.33; Tier 3 of $0.35; and Tier 4 of $0.45. Under the Exchange's proposal when a Market Maker Origin is contra to a Priority Customer in a Penny Class the Exchange will reduce the rebate for each Tier by $0.02. Therefore, the effective rebate for Market Maker Origins in Simple Maker volume when trading contra to a Priority Customer Origin in Tier 1 would be $0.28; Tier 2 would be $0.31; Tier 3 would be $0.33; and Tier 4 would be $0.43.
The purpose of adjusting the specified Simple Maker rebate is for business and competitive reasons. In order to attract order flow, the Exchange initially set its Maker rebates and Taker fees so that they were meaningfully higher/lower than other options exchanges that operate comparable maker/taker pricing models.
The proposed changes are immediately effective.
The Exchange believes that its proposal to amend its Fee Schedule is consistent with Section 6(b) of the Act
The Exchange operates in a competitive marketplace in which market participants can readily direct their order flow to competing venues if they deem fee levels at a particular venue to be excessive or incentives to be insufficient. There are currently 16 registered options exchanges competing for order flow. Based on publicly-available information, and excluding index-based options, no single exchange has a market share of more than approximately 11-12% of the equity options market.
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and also recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
The Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can discontinue or reduce use of certain categories of products and services, terminate an existing membership or determine to not become a new member, and/or shift order flow, in response to transaction fee changes. For example, on February 28, 2019, the Exchange's affiliate, MIAX PEARL, LLC (“MIAX Pearl”), filed with the Commission a proposal to increase Taker fees in certain Tiers for options transactions in certain Penny classes for Priority Customers and decrease Maker rebates in certain Tiers for options transactions in Penny classes for Priority Customers
The Exchange believes its proposal to amend the rebate provided to Market Maker Origins for Simple Maker volume in Penny Classes when contra to Priority Customer Origins is reasonable, equitable and not unfairly discriminatory because all similarly situated participants in the same Origin type and Tier are subject to the same tiered Maker rebates and Taker fees. The Exchange believes it is equitable and not unfairly discriminatory to reduce the rebates provided for executions of Simple Maker volume where the contra party is a Priority Customer Origin in Penny Classes.
The Exchange is making this change for business and competitive reasons as the Exchange initially set its Simple Maker rebates for such orders higher than certain other options exchanges that operate comparable pricing models.
The Exchange believes that it is equitable and not unfairly discriminatory that Priority Customer Origins be treated differently than other Origin types. The exchanges, in general, have historically aimed to improve markets for investors and develop various features within their market structure for customer benefit. Priority Customer liquidity benefits all market participants by providing more trading opportunities. An increase in the activity of these market participants in turn facilitates tighter spreads, which may cause an additional corresponding increase in order flow from other market participants.
Furthermore, the proposed amendment of Simple Maker rebates when the contra is a Priority Customer promotes just and equitable principles of trade, fosters cooperation and coordination with persons engaged in facilitating transactions in securities, and protects investors and the public interest, because even with the decrease, the Exchange's proposed rebates should enable the Exchange to continue to attract order flow and maintain market share.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange believes that the proposed changes to the specified Simple Maker rebates for the applicable market participants should continue to encourage the provision of liquidity that enhances the quality of the Exchange's market and increases the number of trading opportunities on the Exchange for all participants who will be able to compete for such opportunities. The proposed rule change should enable the Exchange to continue to attract and compete for Priority Customer order flow with other exchanges. The Exchange believes that even with the proposed changes, the rebates provided will continue to encourage Members to transact on the Exchange, which benefits all Exchange participants by providing more trading opportunities and tighter spreads. However, this competition does not create an undue burden on competition but rather offers all market participants the opportunity to receive the benefit of competitive pricing.
The Exchange believes that the pricing structure to provide different rebates to Market Maker Origins for Simple volume dependent upon whether the contra is a Priority Customer Origin will not impose any undue burden on intra-market competition because the applicable rebate applies equally to all similarly situated Market Makers on the Exchange.
The Exchange believes that it is equitable and not unfairly discriminatory that Priority Customer Origins be treated differently than other Origin types. The exchanges, in general, have historically aimed to improve markets for investors and develop various features within their market structure for customer benefit. Priority Customer liquidity benefits all market participants by providing more trading opportunities. An increase in the activity of these market participants in turn facilitates tighter spreads, which may cause an additional corresponding increase in order flow from other market participants.
The Exchange believes that it is equitable and not unfairly discriminatory to reduce the rebate provided to Market Maker Origins for Simple volume when the contra Origin is Priority Customer. A Priority Customer by definition is not a broker or dealer in securities, and does not place more than 390 orders in listed options per day on average during a calendar month for its own beneficial account(s).
The Exchange does not believe its proposal will have any effect on Priority Customer order flow to the Exchange as the proposal affects only Simple Maker volume in Penny Classes when contra to Priority Customer Origins.
The Exchange operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive. There are currently 16 registered options exchanges competing for order flow. Based on publicly-available
Additionally, the Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. Specifically, in Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Written comments were neither solicited nor received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
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) of the Securities Exchange Act of 1934 (the “Act”),
Cboe BYX Exchange, Inc. (“BYX” or the “Exchange”) is filing with the Securities and Exchange Commission (the “Commission”) a proposed rule change to amend BYX Rule 11.17, Clearly Erroneous Executions. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange 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 these 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 aspects of such statements.
The purpose of the proposed rule change is to amend BYX Rule 11.17, Clearly Erroneous Executions. Specifically, the Exchange proposes to: (1) make the current clearly erroneous pilot program permanent; and (2) limit the circumstances where clearly erroneous review would continue to be available during Regular Trading Hours,
On September 10, 2010, the Commission approved, on a pilot basis, changes to BYX Rule 11.17 that, among other things: (i) provided for uniform treatment of clearly erroneous execution reviews in multi-stock events involving twenty or more securities; and (ii) reduced the ability of the Exchange to deviate from the objective standards set forth in the rule.
When it originally approved the clearly erroneous pilot, the Commission explained that the changes were “being implemented on a pilot basis so that the Commission and the Exchanges can monitor the effects of the pilot on the markets and investors, and consider appropriate adjustments, as necessary.”
The clearly erroneous pilot was implemented following a severe disruption in the U.S. equities markets on May 6, 2010 (“Flash Crash”) to “provide greater transparency and certainty to the process of breaking trades.”
When the Participants to the LULD Plan filed to introduce the Limit Up-Limit Down (“LULD”) mechanism, itself a response to the Flash Crash, a handful of commenters noted the potential discordance between the clearly erroneous rules and the Price Bands
The Exchange believes that it is important for there to be some mechanism to ensure that investors' orders are either not executed at clearly erroneous prices or are subsequently busted as needed to maintain a fair and orderly market. At the same time, the Exchange believes that the LULD Plan, as amended, would provide sufficient protection for trades executed during Regular Trading Hours. Indeed, the LULD mechanism could be considered to offer superior protection as it prevents potentially erroneous trades from being executed in the first instance. After gaining experience with the LULD Plan, the Exchange now believes that it is appropriate to largely eliminate clearly erroneous review during Regular Trading Hours when Price Bands are in effect. Thus, as proposed, trades executed within the Price Bands would stand, barring one of a handful of identified scenarios where such review may still be necessary for the protection of investors. The Exchange believes that this change would be beneficial for the U.S. equities markets as it would ensure that trades executed within the Price Bands are subject to clearly erroneous review in only rare circumstances, resulting in greater certainty for Members and investors.
The current LULD mechanism for addressing extraordinary market volatility is available solely during Regular Trading Hours. Thus, trades during the Exchange's Early Trading,
On the other hand, there would be much more limited potential to request that a transaction be reviewed as potentially erroneous during Regular Trading Hours. With the introduction of the LULD mechanism in 2013, clearly erroneous trades are largely prevented by the requirement that trades be executed within the Price Bands. In addition, in 2019, Amendment Eighteen to the LULD Plan eliminated double-wide Price Bands: (1) at the Open, and (2) at the Close for Tier 2 NMS Stocks 2 with a Reference Price above $3.00.
At the same time, the Exchange is cognizant that there may be limited circumstances where clearly erroneous review may continue to be appropriate, even during Regular Trading Hours. Thus, the Exchange proposes to amend its clearly erroneous rules to enumerate the specific circumstances where such review would remain available during the course of Regular Trading Hours, as follows. All transactions that fall outside of these specific enumerated exceptions would be ineligible for clearly erroneous review.
First, pursuant to proposed paragraph (c)(1)(A), a transaction executed during Regular Trading Hours would continue to be eligible for clearly erroneous review if the transaction is not subject to the LULD Plan. In such case, the Numerical Guidelines set forth in paragraph (c)(2) of Rule 11.17 will be applicable to such NMS Stock. While the majority of securities traded on the Exchange would be subject to the LULD Plan, certain equity securities, such as rights and warrants, are explicitly excluded from the provisions of the LULD Plan and would therefore be eligible for clearly erroneous review instead.
Second, investors would also continue to be able to request review of transactions that resulted from certain systems issues pursuant to proposed paragraph (c)(1)(B). This limited exception would help to ensure that trades that should not have been executed would continue to be subject to clearly erroneous review. Specifically, as proposed, transactions executed during Regular Trading Hours would be eligible for clearly erroneous review pursuant to proposed paragraph (c)(1)(B) if the transaction is the result of an Exchange technology or systems issue that results in the transaction occurring outside of the applicable LULD Price Bands pursuant to BYX Rule 11.17(g). A transaction subject to review pursuant to this paragraph shall be found to be clearly erroneous if the price of the transaction to buy (sell) that is the subject of the complaint is greater than (less than) the Reference Price, described in paragraph (d) of this Rule, by an amount that equals or exceeds the applicable Percentage Parameter defined in Appendix A to the LULD Plan (“Percentage Parameters”).
Third, the Exchange proposes to narrowly allow for the review of transactions during Regular Trading Hours when the Reference Price, described in proposed paragraph (d), is determined to be erroneous by an Officer of the Exchange. Specifically, a transaction executed during Regular Trading Hours would be eligible for clearly erroneous review pursuant to proposed paragraph (c)(1)(C) if the transaction involved, in the case of (1) a corporate action or new issue or (2) a security that enters a Trading Pause pursuant to the LULD Plan and resumes trading without an auction,
In the context of a corporate action or a new issue, there may be instances where the security's Reference Price is later determined by the Exchange to be erroneous (
The following illustrate the proposed application of the rule in the context of a corporate action or new issue:
In the context of the rare situation in which a security that enters a LULD Trading Pause and resumes trading without an auction (
The following example illustrates the proposed application of the rule in the context of a security that reopens without an auction:
In all of the foregoing situations, investors would be left with no remedy to request clearly erroneous review without the proposed carveouts in paragraph (c)(1)(C) because the trades occurred within the LULD Price Bands (albeit LULD Price Bands that were calculated from an erroneous Reference Price). The Exchange believes that removing the current ability for the Exchange to review in these narrow circumstances would lessen investor protections.
Today, paragraph (c)(1) defines the Numerical Guidelines that are used to determine if a transaction is deemed clearly erroneous during Regular Trading Hours, or during the Early Trading, Pre-Opening and After Hours Sessions. With respect to Regular Trading Hours, trades are generally deemed clearly erroneous if the execution price differs from the Reference Price (
Given the changes described in this proposed rule change, the Exchange proposes to amend the way that the Numerical Guidelines are calculated during Regular Trading Hours in the handful of instances where clearly erroneous review would continue to be available. Specifically, the Exchange would base these Numerical Guidelines, as applied to the circumstances described in paragraph (c)(1)(A), on the Percentage Parameters used to calculate Price Bands, as set forth in Appendix A to the LULD Plan. Without this change, a transaction that would otherwise stand if Price Bands were properly applied to the transaction may end up being subject to review and deemed clearly erroneous solely due to the fact that the Price Bands were not available due to a systems or other issue. The Exchange believes that it makes more sense to instead base the Price Bands on the same parameters as would otherwise determine whether the trade would have been allowed to execute within the Price Bands. The Exchange also proposes to modify the Numerical Guidelines applicable to leveraged ETF/ETN securities during Regular Trading Hours. As noted above, the Numerical Guidelines will only be applicable to transactions eligible for review pursuant paragraph (c)(1)(A) (
The Exchange also proposes to move existing paragraphs (c)(2), (c)(3), and (d) to proposed paragraph (c)(2)(B), (c)(2)(C), and (C)(2)(D), respectively, as Multi-Stock Events, Additional Factors, and Outlier Transactions will only be subject to review if those NMS Stocks are not subject to the LULD Plan or occur during the Early Trading, Pre-Opening and After Hours Sessions. Proposed paragraph (c)(2)(B) is substantially similar to existing paragraph (c)(2) except for a change in rule reference to paragraph (c)(1) has been updated to paragraph (c)(1)(A). Further, given the proposal to move existing paragraph (c)(2) to paragraph (c)(2)(B), the Exchange also proposes to amend applicable rule references throughout paragraph (c)(2)(A). Finally, the Exchange proposes to update applicable rule references in paragraph (c)(2)(D) based on the above-described structural changes to the Rule.
As proposed, the Reference Price used would continue to be based on last sale and would be memorialized in proposed paragraph (d). Continuing to use the last sale as the Reference Price is necessary for operational efficiency as it may not be possible to perform a timely clearly erroneous review if doing so required computing the arithmetic mean price of eligible reported transactions over the past five minutes, as contemplated by the LULD Plan. While this means that there would still be some differences between the Price Bands and the clearly erroneous parameters, the Exchange believes that this difference is reasonable in light of the need to ensure timely review if clearly erroneous rules are invoked. The Exchange also proposes to allow for an alternate Reference Price to be used as prescribed in proposed paragraphs (d)(1), (2), and (3). Specifically, the Reference Price may be a value other than the consolidated last sale immediately prior to the execution(s) under review (1) in the case of Multi-Stock Events involving twenty or more securities, as described in paragraph (c)(2)(B) above, (2) in the case of an erroneous Reference Price, as described in paragraph (c)(1)(C) above,
As described more fully below, the Exchange proposes to eliminate paragraph (f), System Disruption or Malfunction. Accordingly, the Exchange
To conform with the structural changes described above, the Exchange now proposes to remove paragraph 11.17(f), System Disruption or Malfunction, and proposes new paragraph (c)(1)(B). Specifically, as described in paragraph (c)(1)(B), transactions occurring during Regular Trading Hours that are executed outside of the LULD Price Bands due to an Exchange technology or system issue, may be subject to clearly erroneous review pursuant to proposed paragraph 11.17(g). Proposed paragraph 1d1.17(c)(1)(B) further provides that a transaction subject to review pursuant to this paragraph shall be found to be clearly erroneous if the price of the transaction to buy (sell) that is the subject of the complaint is greater than (less than) the Reference Price, described in paragraph (d), by an amount that equals or exceeds the applicable Percentage Parameter defined in Appendix A to the LULD Plan.
Current paragraph (h) of BYX Rule 11.17 provides different procedures for conducting clearly erroneous review in initial public offering (“IPO”) securities that are traded pursuant to unlisted trading privileges (“UTP”) after the initial opening of such IPO securities on the listing market. Specifically, this paragraph provides that a clearly erroneous error may be deemed to have occurred in the opening transaction of the subject security if the execution price of the opening transaction on the Exchange is the lesser of $1.00 or 10% away from the opening price on the listing exchange or association. The Exchange no longer believes that this provision is necessary as opening transactions on the Exchange following an IPO are subject to Price Bands pursuant to the LULD Plan. The Exchange therefore proposes to eliminate this provision in connection with the broader changes to clearly erroneous review during Regular Trading Hours.
The Exchange proposes to renumber paragraph (i) to paragraph (h) based on the proposal to eliminate existing paragraph (h), and to rename the paragraph to provide for transactions occurring outside of LULD Price Bands. Given that proposed paragraph (c)(1) defines the LULD Plan, the Exchange also proposes to eliminate redundant language from proposed paragraph (h). Finally, the Exchange also proposes to update references to the LULD Plan and Price Bands so that they are uniform throughout the Rule and to update rule references throughout the paragraph to conform to the structural changes to the Rule described above.
The Exchange proposes to renumber paragraphs (j) and (k) to paragraphs (h) and (i), respectively, based on the proposal to eliminate existing paragraph (h). Additionally, the Exchange proposes to modify the text of both paragraphs to reference the Percentage Parameters as well as the Numerical Guidelines. Specifically, the existing text of proposed paragraphs (h) and (i) provides that any action taken in connection with this paragraph will be taken without regard to the Numerical Guidelines set forth in this Rule. The Exchange proposes to amend the rule text to provide that any action taken in connection with this paragraph will be taken without regard to the Percentage Parameters or Numerical Guidelines set forth in this Rule, with the Percentage Parameters being applicable to an NMS Stock subject to the LULD Plan and the Numerical Guidelines being applicable to an NMS Stock not subject to the LULD Plan.
The Exchange believes the proposed rule change is consistent with the requirements of Section 6(b) of the Act,
As explained in the purpose section of this proposed rule change, the current pilot was implemented following the Flash Crash to bring greater transparency to the process for conducting clearly erroneous reviews, and to help assure that the review process is based on clear, objective, and consistent rules across the U.S. equities markets. The Exchange believes that the amended clearly erroneous rules have been successful in that regard and have thus furthered fair and orderly markets. Specifically, the Exchange believes that the pilot has successfully ensured that such reviews are conducted based on objective and consistent standards across SROs and has therefore afforded greater certainty to Members and investors. The Exchange therefore believes that making the current pilot a permanent program is appropriate so that equities market participants can continue to reap the benefits of a clear, objective, and transparent process for conducting clearly erroneous reviews. In addition, the proposal is substantially identical to a recent rule change to BZX Rule 11.17, and the Exchange understands that the other U.S. equities exchanges and FINRA will also file largely identical proposals to make their respective clearly erroneous pilots permanent. The Exchange therefore believes that the proposed rule change would promote transparency and uniformity across markets concerning review of transactions as clearly erroneous and would also help assure consistent results in handling erroneous trades across the U.S. equities markets, thus furthering fair and orderly markets, the protection of investors, and the public interest.
Similarly, the Exchange believes that it is consistent with just and equitable principles of trade to limit the availability of clearly erroneous review during Regular Trading Hours. The Plan was approved by the Commission to operate on a permanent rather than pilot basis. As a number of market participants have noted, the LULD Plan provides protections that ensure that investors' orders are not executed at prices that may be considered clearly erroneous. Further, amendments to the LULD Plan approved in Amendment Eighteen serve to ensure that the Price Bands established by the LULD Plan are “appropriately tailored to prevent trades that are so far from current market prices that they would be viewed as having been executed in error.”
Given the fact that clearly erroneous review would largely be limited to transactions that were not subject to the LULD Plan, the Exchange also believes that it is necessary to change the parameters used to determine whether a trade is clearly erroneous. Specifically, due to the different parameters currently used for clearly erroneous review and for determining Price Bands, it is possible that a trade that would have been permitted to execute within the Price Bands would later be deemed clearly erroneous, if, for example, a systems issue prevented the dissemination of the Price Bands. The Exchange believes that this result is contrary to the principle that trades within the Price Bands should stand, and has the potential to cause investor confusion if trades that are properly executed within the applicable parameters described in the LULD Plan are later deemed erroneous. By using consistent parameters for clearly erroneous reviews conducted during Regular Trading Hours and the calculation of the Price Bands, the Exchange believes that this change would also serve to promote greater certainty with regards to when trades may be deemed erroneous.
The Exchange believes that it is consistent with the protection of investors and the public interest to remove the current provision of the clearly erroneous rule dealing with UTP securities that are the subject of IPOs. This provision applies specifically to opening transactions on a non-listing market following an IPO on the listing market. As such, review under this paragraph is limited to trades conducted during Regular Trading Hours. As previously addressed, trades executed during Regular Trading Hours would generally not be subject to clearly erroneous review but would instead be protected by the Price Bands. The Exchange therefore no longer believes that this paragraph is necessary, as all trades subject to this provision today would either be subject to the LULD Plan, or, in the event of some systems or other issue, would be subject to the provisions that apply to transactions that are not adequately protected by the LULD Plan.
Finally, the proposed rule changes make organizational updates to the Exchange's Clearly Erroneous Execution Rule as well as minor updates and corrections to the Rule to improve readability and clarity.
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposal would ensure the continued, uninterrupted operation of harmonized clearly erroneous execution rules across the U.S. equities markets while also amending those rules to provide greater certainty to Members and investors that trades will stand if executed during Regular Trading Hours where the LULD Plan provides adequate protection against trading at erroneous prices. The Exchange understands that the other national securities exchanges and FINRA will also file similar proposals, the substance of which are substantively identical to this proposal. Thus, the proposed rule change will help to ensure consistency across SROs without implicating any competitive issues.
The Exchange neither solicited nor received comments on the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the 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 to determine whether the proposed rule should be approved or disapproved.
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) of the Securities Exchange Act of 1934 (the “Act”),
Cboe EDGA Exchange, Inc. (“EDGA” or the “Exchange”) is filing with the Securities and Exchange Commission (the “Commission”) a proposed rule change to amend EDGA Rule 11.15, Clearly Erroneous Executions. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange 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 these 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 aspects of such statements.
The purpose of the proposed rule change is to amend EDGA Rule 11.15, Clearly Erroneous Executions. Specifically, the Exchange proposes to: (1) make the current clearly erroneous pilot program permanent; and (2) limit the circumstances where clearly erroneous review would continue to be available during Regular Trading Hours,
On September 10, 2010, the Commission approved, on a pilot basis, changes to EDGA Rule 11.15 that, among other things: (i) provided for uniform treatment of clearly erroneous execution reviews in multi-stock events involving twenty or more securities; and (ii) reduced the ability of the Exchange to deviate from the objective standards set forth in the
When it originally approved the clearly erroneous pilot, the Commission explained that the changes were “being implemented on a pilot basis so that the Commission and the Exchanges can monitor the effects of the pilot on the markets and investors, and consider appropriate adjustments, as necessary.”
The clearly erroneous pilot was implemented following a severe disruption in the U.S. equities markets on May 6, 2010 (“Flash Crash”) to “provide greater transparency and certainty to the process of breaking trades.”
When the Participants to the LULD Plan filed to introduce the Limit Up-Limit Down (“LULD”) mechanism, itself a response to the Flash Crash, a handful of commenters noted the potential discordance between the clearly erroneous rules and the Price Bands used to limit the price at which trades would be permitted to be executed pursuant to the LULD Plan. For example, two commenters requested that the clearly erroneous rules be amended so the presumption would be that trades executed within the Price Bands would not be not subject to review.
The Exchange believes that it is important for there to be some mechanism to ensure that investors' orders are either not executed at clearly erroneous prices or are subsequently busted as needed to maintain a fair and orderly market. At the same time, the Exchange believes that the LULD Plan, as amended, would provide sufficient protection for trades executed during Regular Trading Hours. Indeed, the LULD mechanism could be considered to offer superior protection as it prevents potentially erroneous trades from being executed in the first instance. After gaining experience with the LULD Plan, the Exchange now believes that it is appropriate to largely eliminate clearly erroneous review during Regular Trading Hours when Price Bands are in effect. Thus, as proposed, trades executed within the Price Bands would stand, barring one of a handful of identified scenarios where such review may still be necessary for the protection of investors. The Exchange believes that this change would be beneficial for the U.S. equities markets as it would ensure that trades executed within the Price Bands are subject to clearly erroneous review in only rare circumstances, resulting in greater certainty for Members and investors.
The current LULD mechanism for addressing extraordinary market volatility is available solely during Regular Trading Hours. Thus, trades during the Exchange's Early Trading,
On the other hand, there would be much more limited potential to request that a transaction be reviewed as potentially erroneous during Regular Trading Hours. With the introduction of the LULD mechanism in 2013, clearly erroneous trades are largely prevented by the requirement that trades be executed within the Price Bands. In addition, in 2019, Amendment Eighteen to the LULD Plan eliminated double-wide Price Bands: (1) at the Open, and (2) at the Close for Tier 2 NMS Stocks 2 with a Reference Price above $3.00.
At the same time, the Exchange is cognizant that there may be limited circumstances where clearly erroneous review may continue to be appropriate, even during Regular Trading Hours. Thus, the Exchange proposes to amend its clearly erroneous rules to enumerate the specific circumstances where such review would remain available during the course of Regular Trading Hours, as follows. All transactions that fall outside of these specific enumerated exceptions would be ineligible for clearly erroneous review.
First, pursuant to proposed paragraph (c)(1)(A), a transaction executed during Regular Trading Hours would continue to be eligible for clearly erroneous review if the transaction is not subject to the LULD Plan. In such case, the Numerical Guidelines set forth in paragraph (c)(2) of Rule 11.15 will be applicable to such NMS Stock. While the majority of securities traded on the Exchange would be subject to the LULD Plan, certain equity securities, such as rights and warrants, are explicitly excluded from the provisions of the LULD Plan and would therefore be eligible for clearly erroneous review instead.
Second, investors would also continue to be able to request review of transactions that resulted from certain systems issues pursuant to proposed paragraph (c)(1)(B). This limited exception would help to ensure that trades that should not have been executed would continue to be subject to clearly erroneous review. Specifically, as proposed, transactions executed during Regular Trading Hours would be eligible for clearly erroneous review pursuant to proposed paragraph (c)(1)(B) if the transaction is the result of an Exchange technology or systems issue that results in the transaction occurring outside of the applicable LULD Price Bands pursuant to EDGA Rule 11.15(g). A transaction subject to review pursuant to this paragraph shall be found to be clearly erroneous if the price of the transaction to buy (sell) that is the subject of the complaint is greater than (less than) the Reference Price, described in paragraph (d) of this Rule, by an amount that equals or exceeds the applicable Percentage Parameter defined in Appendix A to the LULD Plan (“Percentage Parameters”).
Third, the Exchange proposes to narrowly allow for the review of transactions during Regular Trading Hours when the Reference Price, described in proposed paragraph (d), is determined to be erroneous by an Officer of the Exchange. Specifically, a transaction executed during Regular Trading Hours would be eligible for clearly erroneous review pursuant to proposed paragraph (c)(1)(C) if the transaction involved, in the case of (1) a corporate action or new issue or (2) a security that enters a Trading Pause pursuant to the LULD Plan and resumes trading without an auction,
In the context of a corporate action or a new issue, there may be instances where the security's Reference Price is later determined by the Exchange to be erroneous (
The following illustrate the proposed application of the rule in the context of a corporate action or new issue:
1. ABCD is subject to a corporate action, 1 for 10 reverse split, and the previous day close was $5, but the new theoretical price based on the terms of the corporate action is $50.
2. The security opens at $5, with LULD bands at $4.50 × $5.50.
3. The bands will be calculated correctly but the security is trading at an erroneous price based on the valuation of the remaining outstanding shares.
4. The theoretical price of $50 would be used as the new Reference Price when applying LULD bands to determine if executions would be cancelled as clearly erroneous.
1. ABCD is subject to a corporate action, the company is doing a spin off where a new issue will be listed, BCDE. ABCD trades at $50, and the spinoff company is worth
2. BCDE opens at $50 in the belief it is the same company as ABCD.
3. The theoretical values of the two companies are ABCD $40 and BCDE $10.
4. BCDE would be deemed to have had an incorrect Reference Price and the theoretical value of $10 would be used as the new Reference Price when applying the LULD Bands to determine if executions would be cancelled as clearly erroneous.
1. ABCD is an uplift from the OTC market, the prior days close on the OTC market was $20.
2. ABCD opens trading on the new listing exchange at $0.20 due to an erroneous order entry.
3. The new Reference Price to determine clearly erroneous executions would be $20, the theoretical value of the stock from where it was last traded.
In the context of the rare situation in which a security that enters a LULD Trading Pause and resumes trading without an auction (
The following example illustrates the proposed application of the rule in the context of a security that reopens without an auction:
1. ABCD stock is trading at $20, with LULD Bands at $18 × $22.
2. An incoming buy order causes the stock to enter a Limit State Trading Pause and then a Trading Pause at $22.
3. During the Trading Pause, the buy order causing the Trading Pause is cancelled.
4. At the end of the 5-minute halt, there is no crossed interest for an auction to occur, thus trading would resume on a quote.
5. Upon resumption, a quote that was available prior to the Trading Pause (
6. The Reference Price upon resumption is $50 (mid-point of BBO).
7. The SIP will use this Reference Price and publish LULD Bands of $45 × $55 (
8. The bands will be calculated correctly, but the $50 Reference Price is subsequently determined to be incorrect as the price clearly deviated from where it previously traded prior to the Trading Pause.
9. The new Reference Price would be $22 (
In all of the foregoing situations, investors would be left with no remedy to request clearly erroneous review without the proposed carveouts in paragraph (c)(1)(C) because the trades occurred within the LULD Price Bands (albeit LULD Price Bands that were calculated from an erroneous Reference Price). The Exchange believes that removing the current ability for the Exchange to review in these narrow circumstances would lessen investor protections.
Today, paragraph (c)(1) defines the Numerical Guidelines that are used to determine if a transaction is deemed clearly erroneous during Regular Trading Hours, or during the Early Trading, Pre-Opening and After Hours Sessions. With respect to Regular Trading Hours, trades are generally deemed clearly erroneous if the execution price differs from the Reference Price (
Given the changes described in this proposed rule change, the Exchange proposes to amend the way that the Numerical Guidelines are calculated during Regular Trading Hours in the handful of instances where clearly erroneous review would continue to be available. Specifically, the Exchange would base these Numerical Guidelines, as applied to the circumstances described in paragraph (c)(1)(A), on the Percentage Parameters used to calculate Price Bands, as set forth in Appendix A to the LULD Plan. Without this change, a transaction that would otherwise stand if Price Bands were properly applied to the transaction may end up being subject to review and deemed clearly erroneous solely due to the fact that the Price Bands were not available due to a systems or other issue. The Exchange believes that it makes more sense to instead base the Price Bands on the same parameters as would otherwise determine whether the trade would have been allowed to execute within the Price Bands. The Exchange also proposes to modify the Numerical Guidelines applicable to leveraged ETF/ETN securities during Regular Trading Hours. As noted above, the Numerical Guidelines will only be applicable to transactions eligible for review pursuant paragraph (c)(1)(A) (
The Exchange also proposes to move existing paragraphs (c)(2), (c)(3), and (d) to proposed paragraph (c)(2)(B), (c)(2)(C), and (C)(2)(D), respectively, as Multi-Stock Events, Additional Factors, and Outlier Transactions will only be subject to review if those NMS Stocks are not subject to the LULD Plan or occur during the Early Trading, Pre-Opening and After Hours Sessions. Proposed paragraph (c)(2)(B) is substantially similar to existing paragraph (c)(2) except for a change in rule reference to paragraph (c)(1) has been updated to paragraph (c)(1)(A). Further, given the proposal to move existing paragraph (c)(2) to paragraph (c)(2)(B), the Exchange also proposes to amend applicable rule references throughout paragraph (c)(2)(A). Finally, the Exchange proposes to update applicable rule references in paragraph (c)(2)(D) based on the above-described structural changes to the Rule.
As proposed, the Reference Price used would continue to be based on last sale and would be memorialized in proposed paragraph (d). Continuing to use the last sale as the Reference Price is necessary for operational efficiency as it may not be possible to perform a timely clearly erroneous review if doing so required computing the arithmetic mean price of eligible reported transactions over the past five minutes, as contemplated by the LULD Plan. While this means that there would still be some differences between the Price Bands and the clearly erroneous parameters, the Exchange believes that this difference is reasonable in light of the need to ensure timely review if clearly erroneous rules are invoked. The Exchange also proposes to allow for an alternate Reference Price to be used as prescribed in proposed paragraphs (d)(1), (2), and (3). Specifically, the Reference Price may be a value other than the consolidated last sale immediately prior to the execution(s) under review (1) in the case of Multi-Stock Events involving twenty or more securities, as described in paragraph (c)(2)(B) above, (2) in the case of an erroneous Reference Price, as described in paragraph (c)(1)(C) above,
As described more fully below, the Exchange proposes to eliminate paragraph (f), System Disruption or Malfunction. Accordingly, the Exchange proposes to remove from paragraph (e)(2), Appeals, each reference to paragraph (f), and include language referencing proposed paragraph (g), Transactions Occurring Outside of the LULD Bands.
To conform with the structural changes described above, the Exchange now proposes to remove paragraph 11.15(f), System Disruption or Malfunction, and proposes new paragraph (c)(1)(B). Specifically, as described in paragraph (c)(1)(B), transactions occurring during Regular Trading Hours that are executed outside of the LULD Price Bands due to an Exchange technology or system issue, may be subject to clearly erroneous review pursuant to proposed paragraph 11.15(g). Proposed paragraph 11.17 (c)(1)(B) further provides that a transaction subject to review pursuant to this paragraph shall be found to be clearly erroneous if the price of the transaction to buy (sell) that is the subject of the complaint is greater than (less than) the Reference Price, described in paragraph (d), by an amount that equals or exceeds the applicable Percentage Parameter defined in Appendix A to the LULD Plan.
Current paragraph (h) of EDGA Rule 11.15 provides different procedures for conducting clearly erroneous review in initial public offering (“IPO”) securities that are traded pursuant to unlisted trading privileges (“UTP”) after the initial opening of such IPO securities on the listing market. Specifically, this paragraph provides that a clearly erroneous error may be deemed to have occurred in the opening transaction of the subject security if the execution price of the opening transaction on the Exchange is the lesser of $1.00 or 10% away from the opening price on the listing exchange or association. The Exchange no longer believes that this provision is necessary as opening transactions on the Exchange following an IPO are subject to Price Bands pursuant to the LULD Plan. The Exchange therefore proposes to eliminate this provision in connection with the broader changes to clearly erroneous review during Regular Trading Hours.
The Exchange proposes to renumber paragraph (i) to paragraph (h) based on the proposal to eliminate existing paragraph (h), and to rename the paragraph to provide for transactions occurring outside of LULD Price Bands. Given that proposed paragraph (c)(1) defines the LULD Plan, the Exchange also proposes to eliminate redundant language from proposed paragraph (h). Finally, the Exchange also proposes to update references to the LULD Plan and Price Bands so that they are uniform throughout the Rule and to update rule references throughout the paragraph to conform to the structural changes to the Rule described above.
The Exchange proposes to renumber paragraphs (j) and (k) to paragraphs (h) and (i), respectively, based on the proposal to eliminate existing paragraph (h). Additionally, the Exchange proposes to modify the text of both paragraphs to reference the Percentage Parameters as well as the Numerical Guidelines. Specifically, the existing text of proposed paragraphs (h) and (i) provides that any action taken in connection with this paragraph will be taken without regard to the Numerical Guidelines set forth in this Rule. The Exchange proposes to amend the rule text to provide that any action taken in connection with this paragraph will be taken without regard to the Percentage Parameters or Numerical Guidelines set forth in this Rule, with the Percentage Parameters being applicable to an NMS Stock subject to the LULD Plan and the Numerical Guidelines being applicable to an NMS Stock not subject to the
The Exchange believes the proposed rule change is consistent with the requirements of Section 6(b) of the Act,
As explained in the purpose section of this proposed rule change, the current pilot was implemented following the Flash Crash to bring greater transparency to the process for conducting clearly erroneous reviews, and to help assure that the review process is based on clear, objective, and consistent rules across the U.S. equities markets. The Exchange believes that the amended clearly erroneous rules have been successful in that regard and have thus furthered fair and orderly markets. Specifically, the Exchange believes that the pilot has successfully ensured that such reviews are conducted based on objective and consistent standards across SROs and has therefore afforded greater certainty to Members and investors. The Exchange therefore believes that making the current pilot a permanent program is appropriate so that equities market participants can continue to reap the benefits of a clear, objective, and transparent process for conducting clearly erroneous reviews. In addition, the proposal is substantially identical to a recent rule change to BZX Rule 11.17, and the Exchange understands that the other U.S. equities exchanges and FINRA will also file largely identical proposals to make their respective clearly erroneous pilots permanent. The Exchange therefore believes that the proposed rule change would promote transparency and uniformity across markets concerning review of transactions as clearly erroneous and would also help assure consistent results in handling erroneous trades across the U.S. equities markets, thus furthering fair and orderly markets, the protection of investors, and the public interest.
Similarly, the Exchange believes that it is consistent with just and equitable principles of trade to limit the availability of clearly erroneous review during Regular Trading Hours. The Plan was approved by the Commission to operate on a permanent rather than pilot basis. As a number of market participants have noted, the LULD Plan provides protections that ensure that investors' orders are not executed at prices that may be considered clearly erroneous. Further, amendments to the LULD Plan approved in Amendment Eighteen serve to ensure that the Price Bands established by the LULD Plan are “appropriately tailored to prevent trades that are so far from current market prices that they would be viewed as having been executed in error.”
Given the fact that clearly erroneous review would largely be limited to transactions that were not subject to the LULD Plan, the Exchange also believes that it is necessary to change the parameters used to determine whether a trade is clearly erroneous. Specifically, due to the different parameters currently used for clearly erroneous review and for determining Price Bands, it is possible that a trade that would have been permitted to execute within the Price Bands would later be deemed clearly erroneous, if, for example, a systems issue prevented the dissemination of the Price Bands. The Exchange believes that this result is contrary to the principle that trades within the Price Bands should stand, and has the potential to cause investor confusion if trades that are properly executed within the applicable parameters described in the LULD Plan are later deemed erroneous. By using consistent parameters for clearly erroneous reviews conducted during Regular Trading Hours and the calculation of the Price Bands, the Exchange believes that this change would also serve to promote greater certainty with regards to when trades may be deemed erroneous.
The Exchange believes that it is consistent with the protection of investors and the public interest to remove the current provision of the clearly erroneous rule dealing with UTP securities that are the subject of IPOs. This provision applies specifically to opening transactions on a non-listing market following an IPO on the listing market. As such, review under this paragraph is limited to trades conducted during Regular Trading Hours. As previously addressed, trades executed during Regular Trading Hours would generally not be subject to clearly erroneous review but would instead be protected by the Price Bands. The Exchange therefore no longer believes that this paragraph is necessary, as all trades subject to this provision today would either be subject to the LULD Plan, or, in the event of some systems or other issue, would be subject to the provisions that apply to transactions that are not adequately protected by the LULD Plan.
Finally, the proposed rule changes make organizational updates to the Exchange's Clearly Erroneous Execution Rule as well as minor updates and corrections to the Rule to improve readability and clarity.
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposal would ensure the continued, uninterrupted operation of harmonized clearly erroneous execution rules across the U.S. equities markets while also amending those rules to provide greater certainty to Members and investors that trades will stand if executed during Regular Trading Hours where the LULD Plan provides adequate protection against trading at erroneous prices. The Exchange understands that the other national securities exchanges and FINRA will also file similar proposals, the substance of which are substantively identical to this proposal. Thus, the proposed rule change will help to ensure consistency across SROs without implicating any competitive issues.
The Exchange neither solicited nor received comments on the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the 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 to determine whether the proposed rule should be approved or disapproved.
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) of the Securities Exchange Act of 1934 (“Act”),
Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to amend Rule 5.34. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange 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 these 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 aspects of such statements.
The Exchange proposes to amend Rule 5.34. Specifically, the Exchange proposes to amend its drill-through protection mechanism for both simple and complex orders and its limit order fat finger check.
The Exchange proposes to amend Rule 5.34(a)(4) and (b)(6) to update the drill-through protection mechanism for simple and complex orders, respectively, to provide orders with additional execution opportunities. Pursuant to the current simple drill-through protection, if a buy (sell) order enters the Book at the conclusion of the opening auction process or would execute or post to the Book at the time of order entry, the System executes the order up to a buffer amount (the Exchange determines the buffer amount on a class and premium basis) above (below) the offer (bid) limit of the opening collar
The proposed rule change amends Rule 5.34(a)(4)(C)(i) to eliminate the concept that there will be a maximum number of time periods and proposes that the order (or unexecuted portion) will rest in the Book at the drill-through price for the duration of consecutive time periods.
The proposed rule change makes a similar change to the drill-through protection mechanism for complex orders. Specifically, the proposed rule change eliminates the concept that, for complex orders for which the user does not establish a buffer amount (and instead the Exchange-determined default buffer amount applies),
The proposed rule change amends Rule 5.34(b)(6)(B)(i) and (ii) to eliminate the concept that there will be a maximum number of time periods and proposes that the order (or unexecuted portion) will rest in the COB at the drill-through price for the duration of consecutive time periods when a User does not establish its own buffer amount.
The proposed rule change also makes certain nonsubstantive changes to Rule 5.34(b)(6). Specifically, the proposed rule change moves all provisions specific to the application of the drill-through mechanism if the user establishes a buffer amount into Rule 5.34(b)(6)(B)(i) and moves all provisions specific to the application of the drill-through mechanism if the user does not establish a buffer amount into Rule 5.34(b)(6)(B)(ii). This includes incorporating into each of proposed subparagraphs (i) and (ii) how the System handles a complex order if its limit price equals or less than (if a buy order) or greater than (if a sell order) the drill-through price, as described in current subparagraph (iv). As a result, the proposed rule change deletes current subparagraph (iv). Additionally, the proposed rule change moves certain language regarding what happens if the SBBO changes during any period, which applies to all complex orders subject to the drill-through protection mechanism, regardless of whether the user input its own buffer amount, to proposed subparagraph (iii) from current subparagraph (ii) and correspondingly changes current subparagraph (iii) to proposed subparagraph (iv). The proposed rule change makes a nonsubstantive change to the beginning of proposed subparagraph (iii) by changing “However” to “Notwithstanding the above,” as the Exchange believes that phrase is more appropriate.
In addition, the Exchange proposes to amend Rule 5.34(c)(1)(D) to add Limit-on-Close orders
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes the proposed rule change to eliminate the maximum number of time periods for which a simple or complex order will rest in the Book or COB, respectively, during application of the drill-through protection mechanism will remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, protect investors, because it will provide simple and complex orders with additional execution opportunities. These orders may continue to be available on the Book or COB, as applicable, for execution, at a wider range of prices, as opposed to today when such orders are cancelled or routed to PAR for manual handling after a specified number of time periods (depending on the User's instructions and if the order does not reach its limit price prior to the end of those time periods). The Exchange believes these additional execution opportunities will benefit investors that submit such orders and believes such orders will continue to receive protection against potentially erroneous executions, as the limit order fat finger check will continue to apply to them.
The Exchange believes the proposed nonsubstantive rule changes to the complex order drill-through protection mechanism will protect investors and the public interest, because these changes improve the organization of this rule's provisions by grouping all provisions that apply when a User establishes its own buffer and all provisions that apply when a User does not establish its own buffer, eliminating potential confusion.
Finally, the Exchange believes excluding Limit-on-Close orders from the limit order fat finger check will remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, protect investors, because it may reduce inadvertent rejections of Limit-on-Close orders, which may be purposely priced further away from the NBBO or SNBBO, as applicable, at the time of entry, as their limit prices are intended to relate to price at the RTH market close. Therefore, this proposed rule change may increase execution opportunities for Users that submit Limit-on-Close orders.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that the proposed rule change will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act, because the amended drill-through protection mechanism (for both simple and complex orders) and limit order fat finger check will continue to apply in the same manner to orders of all Users and may lead to increased execution opportunities. The Exchange does not believe that the proposed rule change will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of purposes of the Act, because the proposed rule change relates solely to Exchange risk controls and how the Exchange handles orders subject to those risk controls.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not:
A. significantly affect the protection of investors or the public interest;
B. impose any significant burden on competition; and
C. become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
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 September 8, 2022, the Operating Committee for Consolidated Audit Trail, LLC (“CAT LLC”), on behalf of the following parties to the National Market System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan” or “Plan”):
Set forth in this Section II is the statement of the purpose and summary of the amendment, along with information required by Rule 608(a)(4) and (5) under the Exchange Act,
The Proposed Amendment would ensure that a dispute arising out of CAT reporting would be addressed by either the SDNY or the New York State Supreme Court. Designating an Article III court and a sophisticated state court as potential forums for dispute resolution is plainly consistent with the Exchange Act.
Courts offer important substantive expertise and procedural mechanisms that would facilitate the fair and efficient resolution of claims in relation to CAT reporting. As an example, because a CAT technical issue, system failure, or data breach may impact thousands of potential parties, the ability of courts to consolidate and join claims and certify class actions would minimize costs of litigation for all potential parties (including Industry Members), which, in turn, furthers the market efficiency and fair competition objectives of the Exchange Act.
The importance of a court resolving claims regarding CAT reporting is underscored by the regulatory nature of the CAT. The Participants are implementing the requirements of Rule 613 and the CAT NMS Plan in their regulatory capacities. While cyber litigation frequently presents complex questions, the CAT's regulatory nature adds a further layer of complexity to any potential dispute. Among other issues, a tribunal would have to evaluate the relationships between the Commission, the Participants, and Industry Members and determine the applicability of any immunity claims. In connection with the Participants' limitation of liability proposal, both the Commission and the Securities Industry and Financial Markets Association (“SIFMA”) recognized that regulatory immunity may be at issue in a dispute regarding CAT reporting. Utilizing courts to resolve such disputes will ensure that bedrock principles of the self-regulatory framework are adjudicated based on decades of binding precedent (often developed through the Commission's feedback via amicus briefs) and afford the parties critical appellate rights.
Notwithstanding the benefits of litigation, an arbitration provision was
The Participants' proposed federal forum and alternative state forum are well equipped to handle any dispute relating to CAT reporting. The United States Court of Appeals for the Second Circuit, and the SDNY, have significant experience resolving securities matters and cyber claims. Likewise, the New York State Supreme Court in the First Judicial Department, and in particular its Commercial Division in New York County (Manhattan), is comprised of experienced judges who regularly preside over complex disputes. Both forums routinely adjudicate matters involving the Participants, Industry Members, and the Commission, and given the locations of potential parties to a CAT Data breach, New York would constitute a convenient forum for dispute resolution.
On July 11, 2012, the Commission adopted Rule 613 of Regulation NMS to enhance regulatory oversight of the U.S. securities markets. The rule directed the Participants to create a “Consolidated Audit Trail” (also referred to herein as the “CAT”) that would strengthen the ability of regulators—including the Commission and the self-regulatory organizations—to surveil the securities markets.
In preparation for CAT reporting, the Operating Committee of CAT LLC approved a Reporter Agreement and Reporting Agent Agreement by unanimous written consent on August 29, 2019. Those agreements contained industry standard limitation of liability provisions that disclaimed all damages and capped the liability of CAT LLC, the Participants, and FINRA CAT to any CAT Reporter at $500 per calendar year. The agreements also contained a mandatory arbitration provision with respect to any disputes in connection with CAT reporting and authorized an arbitrator to grant remedies that “the arbitrator deems just and equitable within the scope of [the] Agreement.”
On April 22, 2020, SIFMA challenged the Reporter Agreement's limitation of liability and indemnification provisions by filing an application for review of actions taken by CAT LLC and the Participants pursuant to Sections 19(d) and 19(f) of the Exchange Act (the “Administrative Proceeding”). On May 13, 2020, SIFMA and the Participants reached a settlement of the Administrative Proceeding that permitted Industry Members to report data to the CAT pursuant to a revised Reporter Agreement that did not contain a limitation of liability provision, while the Participants prepared a filing with the Commission to resolve the parties' underlying disagreement regarding the proper allocation of liability.
On December 18, 2020, the Participants proposed to amend the CAT NMS Plan to authorize CAT LLC to revise the Reporter Agreement and the Reporting Agent Agreement to insert limitation of liability provisions (the “Limitation of Liability Proposal”).
On October 29, 2021, the Commission issued an order disapproving the Limitation of Liability Proposal (the “Disapproval Order”).
On May 20, 2022, the Participants filed with the Commission a proposed amendment (the “May 2022 Proposed Amendment”) to the CAT NMS Plan to revise the Reporter Agreement and the Reporting Agent Agreement by removing the arbitration provision from each agreement and replacing it with a
The Forum Selection Provision is contained in Appendix A to this Proposed Amendment. In sum, the Forum Selection Provision provides that any dispute concerning CAT reporting must be filed in the SDNY if there is any basis for federal subject matter jurisdiction.
The Forum Selection Provision also provides that the parties to any litigation agree to accept service of a complaint by U.S. registered mail and waive any objections based on venue. The Proposed Amendment would apply to any litigation commenced by any signatory to the CAT Reporter Agreement (or Reporting Agent Agreement).
The Participants believe that a court is the proper forum to resolve claims regarding CAT reporting, including claims in relation to potential technical issues, system failures, and data breaches. Although the specific claims asserted likely will depend on the nature of the incident, in the aftermath of high-profile data breaches (
In any dispute regarding CAT reporting, CAT LLC will likely have defenses based on the CAT's robust—and SEC-approved—cybersecurity, and the Participants' regulatory role in implementing the CAT NMS Plan.
The Proposed Amendment would lead to the fair and efficient resolution of potential disputes, ensure that issues implicating foundational principles of the self-regulatory framework are decided based on longstanding precedent, and provide the parties with important appellate rights. Litigating claims in an Article III court, or sophisticated state court, is plainly consistent with the Exchange Act.
Because certain potential claims arising out of CAT reporting—including technical issues, system failures, and data breaches—are likely to impact multiple parties, one important consideration is the extent to which a particular dispute resolution mechanism allows for consolidation of claims. Indeed, consolidating such claims would reduce costs of dispute resolution, enable CAT LLC to focus on its regulatory mandate, and decrease the risk of disparate outcomes in similar cases, all of which promote the efficiency and fair competition objectives of the Exchange Act.
In court, litigants can rely on the applicability of the rules of consolidation and joinder to increase the likelihood that all cases arising out of one incident are heard together. Both federal and New York State rules of civil procedure provide mechanisms to consolidate cases and join parties to actions.
By contrast, under the AAA Commercial Arbitration Rules (the “AAA Rules”), which govern arbitration under the current Reporter Agreement and Reporting Agent Agreement, consolidation is a “suggest[ion] . . . that the parties and the arbitrator should address at the preliminary hearing,” and the ultimate decision regarding whether consolidation is appropriate is “subject to the discretion of the arbitrator.”
For those reasons, if the arbitration provision remains in the Reporter Agreement and Reporting Agent Agreement, actions involving the same common questions of law or fact or arising out of the same “transaction or occurrence” may be brought piecemeal, with signatories to the agreements arbitrating their claims or defenses and non-signatories litigating those claims or defenses in court. This can lead to illogical or unworkable outcomes;
A dispute regarding CAT reporting is likely to present complex legal and factual issues inherent in cyber litigation generally as well as in relation to the Participants' regulatory roles in overseeing the CAT. Allowing the parties to litigate in court would ensure that the forum charged with resolving disputes is bound by the substantial body of precedent that has been developed to address these issues.
Relatedly, the doctrine of regulatory immunity may play an important role in any dispute concerning CAT reporting. In connection with the Limitation of Liability Proposal, multiple comment letters discussed the applicability of regulatory immunity to a CAT Data breach and demonstrated an assumption and understanding that such a determination was the province of courts.
The ability to rely on binding precedent is even more critical in the event of a claim arising out of CAT reporting. As discussed
Adjudicating claims in relation to CAT reporting in court provides all parties with critical appellate rights. While important for any high stakes dispute, appellate rights are particularly important in the event of a CAT system failure, technical issue, or data breach, considering the complicated legal and factual issues, the nature of the parties, and the potentially large amount in controversy. Regulatory immunity claims, for example, are often the subject of appellate review.
Direct appellate review is largely absent in arbitration.
Considering the magnitude of data transmitted to the CAT, a dispute is likely to involve a substantial volume of documents and information. Additionally, many documents that might be the subject of discovery requests are likely to be either commercially sensitive for Industry Members or involve nonpublic, sensitive information regarding the CAT's security.
Parties to litigation are afforded the benefits of rules governing the discovery process and admissibility of evidence. These rules promote predictability of litigation, efficiency of resolutions, and fairness of results,
The Proposed Amendment's Forum Selection Provision designates the SDNY, or, in the absence of federal subject matter jurisdiction, a New York State Supreme Court in New York County within the First Judicial Department as the venue for any dispute concerning CAT reporting. Both forums would provide the parties with a sophisticated tribunal that has experience adjudicating matters involving the federal securities laws, market structure, and cybersecurity.
As an initial mater, based on the potential parties to any lawsuit arising out of CAT reporting, New York is likely to be a convenient venue. As the reputed financial capital of the world, New York is home to the two largest securities exchanges and several other Participants. Additionally, many of the most prominent Industry Members by trading volume are located in New York.
The existing Reporter Agreement and Reporting Agent Agreement both provide that any claim must be commenced in New York (
In addition to being a convenient venue for potential parties, the Participants' proposed forum—and backup forum—have the requisite subject matter expertise to resolve claims in relation to CAT reporting fairly and efficiently. The Second Circuit has extensive experience with securities and financial regulation matters.
The Second Circuit—and the SDNY in particular—also has significant experience determining the rights and remedies of parties following data breaches, including in relation to critical issues such as standing and damages,
As the Commission noted in its Disapproval Order, in the absence of a limitation on liability, the Participants can assert regulatory immunity in response to a claim for damages. The Second Circuit has authored several seminal opinions regarding the scope of regulatory immunity,
New York State courts—particularly those within the Commercial Division of the First Judicial Department—are likewise well suited to address the complex issues that might arise during litigation regarding a CAT Data breach. The court's judges focus primarily on complex cases and have developed sophisticated procedural rules designed to foster the efficient and fair resolution of disputes.
The Proposed Amendment modifies the governing law provision contained in the existing Reporter Agreement and Reporting Agent Agreement to provide that the agreements, and any matters between CAT LLC and either a CAT Reporter or a CAT Reporting Agent, will be governed by federal law and the laws of the State of New York. The existing governing law provision refers only to New York state law and, because CAT LLC was created pursuant to federal law and is subject to a federal regulatory regime, claims by or against CAT LLC could involve issues of federal law. Therefore, the Proposed Amendment modifies the existing governing law provision to clarify that any disputes arising out of or related to the agreements will be governed by both federal law and by New York state law.
Not applicable.
The Participants propose to implement the Proposed Amendment by making the revised agreements effective upon Commission approval of this Proposed Amendment, without requiring CAT Reporters and CAT Reporting Agents to re-sign the agreements.
The Participants propose the revised agreements be effective upon Commission approval of this Proposed Amendment, without requiring CAT Reporters and CAT Reporting Agents to re-sign the agreements.
The Participants do not believe the Proposed Amendment will have any impact on competition. The Proposed Amendment would mandate that all CAT Reporters and CAT Reporting Agents are bound by revised agreements that contain the amended provisions. Moreover, the Forum Selection Provision would apply equally to all Industry Members, the Participants, and CAT LLC, and would not impact the relative competitive positions among different Industry Members. Additionally, as discussed above, adjudication of disputes relating to CAT reporting in courts promotes consistency of outcomes, which thereby promotes fair competition. Conversely, arbitration could lead to disparate and inconsistent outcomes of similar disputes, which would unfairly advantage certain parties over others.
Not applicable.
Section 12.3 of the CAT NMS Plan states that, subject to certain exceptions, the Plan may be amended from time to time only by a written amendment, authorized by the affirmative vote of not less than two-thirds of all of the Participants, that has been approved by the SEC pursuant to Rule 608 or has otherwise become effective under Rule 608. The Participants, by a vote of the Operating Committee obtained via written consent on September 6, 2022, have authorized the filing of this Proposed Amendment with the SEC in accordance with the Plan.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the amendment is consistent with the Exchange 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 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.
[proposed additions]
Section 12.15.
[proposed additions]
7.9.
7.11.
[proposed additions]
7.9.
7.11.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
Cboe EDGX Exchange, Inc. (the “Exchange” or “EDGX” or “EDGX Equities”) is filing with the Securities and Exchange Commission (“Commission”) a proposed rule change to amend its Fee Schedule. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange 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 these 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 aspects of such statements.
The Exchange proposes to amend its Fee Schedule to adopt monthly fees assessed to Users
On August 9, 2022, the Exchange introduced a new data product known as the Short Volume Report.
The Exchange proposes to adopt fees applicable to Users that subscribe to the Short Volume Report. As proposed, the Exchange would assess a monthly
The Exchange also proposes to adopt fees for the Short Volume Report provided on a historical basis. The Short Volume Report will be available for each calendar month dating back to January 2015, and Users of such data will be assessed a fee of $200 per month of data. Data provided via the historical Short Volume Report is for only display use redistribution (
The Exchange anticipates that a wide variety of market participants will purchase the proposed Short Volume Report, including, but not limited to, active equity trading firms and academic institutions. For example, the Exchange notes that academic institutions may utilize the Short Volume Report data and as a result promote research and studies of the equities industry to the benefit of all market participants. The Exchange further believes the proposed Short Volume Report may provide helpful trading information regarding investor sentiment that may allow market participants to make more informed trading decisions and may be used to create and test trading models and analytical strategies and provide comprehensive insight into trading on the Exchange.
The Exchange notes that the Short Volume Report is a completely voluntary product, in that the Exchange is not required by any rule or regulation to make the reports or services available and that potential subscribers may purchase it only if they voluntarily choose to do so. Further, the Exchange notes that other exchanges offer similar products for a fee.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In adopting Regulation NMS, the Commission granted self-regulatory organizations (“SROs”) and broker-dealers increased authority and flexibility to offer new and unique market data to the public. It was believed that this authority would expand the amount of data available to consumers, and also spur innovation and competition for the provision of market data. The Exchange believes that the Short Volume Report further broadens the availability of U.S. equity market data to investors consistent with the principles of Regulation NMS. The Short Volume Report also promotes increased transparency through the dissemination of short volume data. The Short Volume Report benefits investors by providing access to the Short Volume Report data, which may promote better informed trading, as well as research and studies of the equities industry.
The Exchange operates in a highly competitive environment. Indeed, there are currently 16 registered equities exchanges that trade equities. Based on publicly available information, no single equities exchange has more than 16% of the equity market share.
The Exchange believes that the proposed fee for the Short Volume Report is consistent with the Act in that it is reasonable, equitable, and not unfairly discriminatory. In particular, the Exchange believes that the proposed fee is reasonable because it is reasonably aligned with the value and benefits provided to Users that choose to subscribe to the Short Volume Report on the Exchange. As discussed above, the Short Volume Report may be beneficial to Members and non-Members as it may provide helpful trading information regarding investor sentiment that may allow market participants to make more informed trading decisions and may be used to create and test trading models and analytical strategies and provide comprehensive insight into trading on the Exchange. Therefore, the Exchange believes that it is reasonable to assess a modest fee to Users that subscribe to the Short Volume Report.
The Exchange further believes the proposed fee is reasonable because the amount assessed is less than the analogous fees charged by competitor exchanges. For example, the Nasdaq Stock Market LLC (“Nasdaq”) charges $750 to Internal Distributors and $1,250 to External Distributors of the Nasdaq Short Sale Volume Reports provided on both a daily and historical monthly basis. Additionally, the New York Stock Exchange LLC (“NYSE”) and its affiliated equity markets (the “NYSE Group”) also charge for the TAQ NYSE Group Short Sales (Monthly File) and TAQ NYSE Group Short Volume (Daily File). Specifically, NYSE Group charges an access fee of $1,000 per month for an ongoing subscription that includes 12 months of back history, then additional back history charged at $500 per data content month. NYSE Group also charges a back history fee, of $1,000 per data content month for the first 12 months of history, then additional back history charged at $500 per data content month. The Exchange therefore believes that the proposed fees are reasonable and set at a level to compete with other equity exchanges that offer similar reports. Indeed, proposing fees that are excessively higher than established fees for similar data products would simply serve to reduce demand for the Exchange's data product, which as noted, is entirely optional. Although each of these similar data products provide only proprietary trade data and not trade data from other exchanges, it's possible investors are still able to gauge overall investor sentiment across different equities based on the included data points on any one exchange. As such, if a market participant views another exchange's potential report as more attractive, then such market participant can merely choose not to purchase the Exchange's Short Volume Report and instead purchase another exchange's similar data product, which offers similar data points, albeit based on that other market's trading activity.
In addition, the Exchange believes that the proposed fees are equitable and not unfairly discriminatory because they will apply to all Members and non-Members that choose to subscribe to the Short Volume Report equally. As stated, the Short Volume Report is completely optional and not necessary for trading. Rather, the Exchange voluntarily makes the Short Volume Report available, and Users may choose to subscribe (and pay for) the report based on their own individual business needs. Potential subscribers may subscribe to the Short Volume Report at any time if they believe it to be valuable or may decline to purchase it.
The Exchange also believes it is reasonable, equitable and not unfairly discriminatory to charge an External Distributor of the Short Volume Report a higher fee than an Internal Distributor as an External Distributor will ordinarily charge a fee to its downstream customers for this service, and, even if the vendor is not charging a specific fee for this particular service, the Exchange expects products from the Short Volume Report to be part of a suite of offerings from distributors that generally promote sales. External distribution is also fundamentally different than internal use, in that the former generates revenue from external sales while the latter does not. Therefore, the Exchange believes it is reasonable, equitable and not unfairly discriminatory to charge a higher fee for a product that generates downstream revenue. Further, the proposed fee will apply equally to Internal and External
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act because the Short Volume Report will be available equally to all Members and non-Members that choose to subscribe to the report. As stated, the Short Volume Report is optional and Members and non-Members may choose to subscribe to such report, or not, based on their view of the additional benefits and added value provided by utilizing the Short Volume Report. As such, the Exchange believes the proposed rule change imposes no burden on intramarket competition. Next, the Exchange believes the proposed rule change does not impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. As previously discussed, similar products offered by Nasdaq and the NYSE Group are priced higher than the Short Volume Report. Moreover, the Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. Specifically, in Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.” The fact that this market is competitive has also long been recognized by the courts. In NetCoalition v. Securities and Exchange Commission, the D.C. Circuit stated as follows: “[n]o one disputes that competition for order flow is `fierce.' . . . As the SEC explained, `[i]n the U.S. national market system, buyers and sellers of securities, and the broker-dealers that act as their order-routing agents, have a wide range of choices of where to route orders for execution'; [and] `no exchange can afford to take its market share percentages for granted' because `no exchange possesses a monopoly, regulatory or otherwise, in the execution of order flow from broker dealers'. . . .”. Accordingly, the Exchange does not believe its proposal imposes any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
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) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to amend LTSE Rule 11.270, Clearly Erroneous Executions to limit the circumstances where clearly erroneous review would continue to be available during the Regular Market Session
The text of the proposed rule change is enclosed as Exhibit 5 and 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 these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements
The purpose of the proposed rule change is to amend LTSE Rule 11.270, Clearly Erroneous Executions. Specifically, the Exchange proposes to limit the circumstances where clearly erroneous review would continue to be available during the Regular Market Session,
On May 10, 2019, the Commission approved the Exchange's application for registration as a national securities exchange.
When the Participants to the LULD Plan filed to introduce the Limit Up-Limit Down (“LULD”) mechanism, itself a response to the Flash Crash, a handful of commenters noted the potential discordance between the clearly erroneous rules and the Price Bands used to limit the price at which trades would be permitted to be executed pursuant to the LULD Plan. For example, two commenters requested that the clearly erroneous rules be amended so the presumption would be that trades executed within the Price Bands would not be not subject to review.
The Exchange believes that it is important for there to be some mechanism to ensure that investors' orders are either not executed at clearly erroneous prices or are subsequently busted as needed to maintain a fair and orderly market. At the same time, the Exchange believes that the LULD Plan, as amended, would provide sufficient protection for trades executed during the Regular Market Session. Indeed, the LULD mechanism could be considered to offer superior protection as it prevents potentially erroneous trades from being executed in the first instance. After gaining experience with the LULD Plan, the Exchange now believes that it is appropriate to largely eliminate clearly erroneous review during the Regular Market Session when Price Bands are in effect. Thus, as proposed, trades executed within the Price Bands would stand, barring one of a handful of identified scenarios where such review may still be necessary for the protection of investors. The Exchange believes that this change would be beneficial for the U.S. equities markets as it would ensure that trades executed within the Price Bands are subject to clearly erroneous review in only rare circumstances, resulting in greater certainty for Members and investors.
The current LULD mechanism for addressing extraordinary market volatility is available solely during Regular Trading Hours. Thus, trades during the Exchange's Pre-Market Session or Post-Market Session
On the other hand, there would be much more limited potential to request that a transaction be reviewed as potentially erroneous during the Regular Market Session. With the introduction of the LULD mechanism in 2013, clearly erroneous trades are largely prevented by the requirement that trades be executed within the Price Bands. In addition, in 2019, Amendment Eighteen to the LULD Plan eliminated double-wide Price Bands: (1) at the Open, and (2) at the Close for Tier 2 NMS Stocks 2 with a Reference Price above $3.00.
At the same time, the Exchange is cognizant that there may be limited circumstances where clearly erroneous review may continue to be appropriate, even during the Regular Market Session. Thus, the Exchange proposes to amend its clearly erroneous rules to enumerate the specific circumstances where such review would remain available during the course of the Regular Market Session, as follows. All transactions that fall outside of these specific enumerated exceptions would be ineligible for clearly erroneous review.
First, proposed paragraph (b)(2) would adopt provisions contained in the clearly erroneous executions rules of other exchanges pertaining to routed executions.
Second, pursuant to proposed paragraph (c)(1)(A), a transaction executed during the Regular Market Session would continue to be eligible for clearly erroneous review if the transaction is not subject to the LULD Plan. In such case, the Numerical Guidelines set forth in paragraph (c)(2) of Rule 11.17 will be applicable to such NMS Stock. While the majority of securities traded on the Exchange would be subject to the LULD Plan, certain equity securities, such as rights and warrants, are explicitly excluded from the provisions of the LULD Plan and would therefore be eligible for clearly erroneous review instead.
Third, investors would also continue to be able to request review of transactions that resulted from certain systems issues pursuant to proposed paragraph (c)(1)(B). This limited exception would help to ensure that trades that should not have been executed would continue to be subject to clearly erroneous review. Specifically, as proposed, transactions executed during Regular Trading Hours would be eligible for clearly erroneous review pursuant to proposed paragraph (c)(1)(B) if the transaction is the result of an Exchange technology or systems issue that results in the transaction occurring outside of the applicable LULD Price Bands pursuant to LULD Rule 11.270(g). A transaction subject to review pursuant to this paragraph shall be found to be clearly erroneous if the price of the transaction to buy (sell) that is the subject of the complaint is greater than (less than) the Reference Price, described in paragraph (d) of this Rule, by an amount that equals or exceeds the applicable Percentage Parameter defined in Appendix A to the LULD Plan (“Percentage Parameters”).
Fourth, the Exchange proposes to narrowly allow for the review of transactions during the Regular Market Session when the Reference Price, described in proposed paragraph (d), is determined to be erroneous by an Officer of the Exchange. Specifically, a transaction executed during the Regular Market Session would be eligible for clearly erroneous review pursuant to proposed paragraph (c)(1)(C) if the transaction involved, in the case of (1) a corporate action or new issue or (2) a security that enters a Trading Pause pursuant to the LULD Plan and resumes trading without an auction,
In the context of a corporate action or a new issue, there may be instances where the security's Reference Price is later determined by the Exchange to be erroneous (
The following illustrate the proposed application of the rule in the context of a corporate action or new issue:
1. ABCD is subject to a corporate action, 1 for 10 reverse split, and the previous day close was $5, but the new theoretical price based on the terms of the corporate action is $50.
2. The security opens at $5, with LULD bands at $4.50 × $5.50.
3. The bands will be calculated correctly but the security is trading at an erroneous price based on the valuation of the remaining outstanding shares.
4. The theoretical price of $50 would be used as the new Reference Price when applying LULD bands to determine if executions would be cancelled as clearly erroneous.
1. ABCD is subject to a corporate action, the company is doing a spin off where a new issue will be listed, BCDE. ABCD trades at $50, and the spinoff company is worth
2. BCDE opens at $50 in the belief it is the same company as ABCD.
3. The theoretical values of the two companies are ABCD $40 and BCDE $10.
4. BCDE would be deemed to have had an incorrect Reference Price and the theoretical value of $10 would be used as the new Reference Price when applying the LULD Bands to determine if executions would be cancelled as clearly erroneous.
1. ABCD is an uplift from the OTC market, the prior days close on the OTC market was $20.
2. ABCD opens trading on the new listing exchange at $0.20 due to an erroneous order entry.
3. The new Reference Price to determine clearly erroneous executions would be $20, the theoretical value of the stock from where it was last traded.
In the context of the rare situation in which a security that enters a LULD Trading Pause and resumes trading without an auction (
The following example illustrates the proposed application of the rule in the context of a security that reopens without an auction:
1. ABCD stock is trading at $20, with LULD Bands at $18 × $22.
2. An incoming buy order causes the stock to enter a Limit State Trading Pause and then a Trading Pause at $22.
3. During the Trading Pause, the buy order causing the Trading Pause is cancelled.
4. At the end of the 5-minute halt, there is no crossed interest for an auction to occur, thus trading would resume on a quote.
5. Upon resumption, a quote that was available prior to the Trading Pause (
6. The Reference Price upon resumption is $50 (mid-point of BBO).
7. The SIP will use this Reference Price and publish LULD Bands of $45 × $55 (
8. The bands will be calculated correctly, but the $50 Reference Price is subsequently determined to be incorrect as the price clearly deviated from where it previously traded prior to the Trading Pause.
9. The new Reference Price would be $22 (
In all of the foregoing situations, investors would be left with no remedy to request clearly erroneous review without the proposed carveouts in paragraph (c)(1)(C) because the trades occurred within the LULD Price Bands (albeit LULD Price Bands that were calculated from an erroneous Reference Price). The Exchange believes that removing the current ability for the Exchange to review in these narrow circumstances would lessen investor protections.
Today, paragraph (c)(1) defines the Numerical Guidelines that are used to determine if a transaction is deemed clearly erroneous during the Regular Market Session, or during the Pre-Market and Post-Market Session. With respect to the Regular Market Session, trades are generally deemed clearly erroneous if the execution price differs from the Reference Price (
Given the changes described in this proposed rule change, the Exchange proposes to amend the way that the Numerical Guidelines are calculated during Regular Trading Hours in the handful of instances where clearly erroneous review would continue to be available. Specifically, the Exchange would base these Numerical Guidelines, as applied to the circumstances described in paragraph (c)(1)(A), on the Percentage Parameters used to calculate Price Bands, as set forth in Appendix A to the LULD Plan. Without this change, a transaction that would otherwise stand if Price Bands were properly
The Exchange also proposes to move existing paragraphs (c)(2), (c)(3), and (d) to proposed paragraph (c)(2)(B), (c)(2)(C), and (C)(2)(D), respectively, as Multi-Stock Events, Additional Factors, and Outlier Transactions will only be subject to review if those NMS Stocks are not subject to the LULD Plan or occur during the Early Trading, Pre-Opening and After Hours Sessions. Proposed paragraph (c)(2)(B) is substantially similar to existing paragraph (c)(2) except for a change in rule reference to paragraph (c)(1) has been updated to paragraph (c)(1)(A). Further, given the proposal to move existing paragraph (c)(2) to paragraph (c)(2)(B), the Exchange also proposes to amend applicable rule references throughout paragraph (c)(2)(A). Finally, the Exchange proposes to update applicable rule references in paragraph (c)(2)(D) based on the above-described structural changes to the Rule.
As proposed, the Reference Price used would continue to be based on last sale and would be memorialized in proposed paragraph (d). Continuing to use the last sale as the Reference Price is necessary for operational efficiency as it may not be possible to perform a timely clearly erroneous review if doing so required computing the arithmetic mean price of eligible reported transactions over the past five minutes, as contemplated by the LULD Plan. While this means that there would still be some differences between the Price Bands and the clearly erroneous parameters, the Exchange believes that this difference is reasonable in light of the need to ensure timely review if clearly erroneous rules are invoked. The Exchange also proposes to allow for an alternate Reference Price to be used as prescribed in proposed paragraphs (d)(1), (2), and (3). Specifically, the Reference Price may be a value other than the consolidated last sale immediately prior to the execution(s) under review (1) in the case of Multi-Stock Events involving twenty or more securities, as described in paragraph (c)(2)(B) above, (2) in the case of an erroneous Reference Price, as described in paragraph (c)(1)(C) above,
As described more fully below, the Exchange proposes to eliminate paragraph (f), System Disruption or Malfunction. Accordingly, the Exchange proposes to remove from paragraph (e)(2), Appeals, each reference to paragraph (f), and include language referencing proposed paragraph (g), Transactions Occurring Outside of the LULD Bands.
To conform with the structural changes described above, the Exchange proposes to remove paragraph 11.270(f), System Disruption or Malfunction, combine paragraph (c)(1)(C) with paragraph (c)(1)(B), and remove the reference to a trading halt in paragraph (c)(1)(C) to make clear that Trading Halts are subject to proposed paragraph (i). Specifically, as described in proposed paragraph (c)(1)(B) above, transactions occurring during the Regular Market Session that are executed outside of the LULD Price Bands due to an Exchange technology or system issue, may be subject to clearly erroneous review pursuant to proposed paragraphs 11.270(g). Proposed paragraph 11.270 (c)(1)(B) further provides that a transaction subject to review pursuant to this paragraph shall be found to be clearly erroneous if the price of the transaction to buy (sell) that is the subject of the complaint is greater than (less than) the Reference Price, described in paragraph (d), by an amount that equals or exceeds the applicable Percentage Parameter defined in Appendix A to the LULD Plan.
The Exchange proposes to renumber paragraph (g) to paragraph (f) based on the proposal to eliminate existing paragraph (f). The Exchange also proposes to update references throughout the paragraph to conform to the structural changes to the Rule.
The Exchange proposes to renumber paragraph (h) to paragraph (g) based on the proposal to eliminate existing paragraph (f), and to rename the paragraph to provide for transactions occurring outside of LULD Price Bands. Given that proposed paragraph (c)(1) defines the LULD Plan, the Exchange also proposes to eliminate redundant language from proposed paragraph (h). Finally, the Exchange also proposes to update references to the LULD Plan and Price Bands so that they are uniform throughout the Rule and to update rule references throughout the paragraph to conform to the structural changes to the Rule described above.
The Exchange proposes to renumber paragraphs (i) and (j) to paragraphs (h) and (i), respectively, based on the proposal to eliminate existing paragraph (f). Additionally, the Exchange proposes to modify the text of both paragraphs to reference the Percentage Parameters as well as the Numerical Guidelines. Specifically, the existing text of proposed paragraphs (h) and (i) provides that any action taken in connection with this paragraph will be taken without regard to the Numerical Guidelines set forth in this Rule. The Exchange proposes to amend the rule text to provide that any action taken in connection with this paragraph will be
The Exchange believes the proposed rule change is consistent with the requirements of Section 6(b) of the Act,
The Exchange believes that it is consistent with just and equitable principles of trade to limit the availability of clearly erroneous review during the Regular Market Session. The Plan was approved by the Commission to operate on a permanent rather than pilot basis. As a number of market participants have noted, the LULD Plan provides protections that ensure that investors' orders are not executed at prices that may be considered clearly erroneous. Further, amendments to the LULD Plan approved in Amendment Eighteen serve to ensure that the Price Bands established by the LULD Plan are “appropriately tailored to prevent trades that are so far from current market prices that they would be viewed as having been executed in error.”
Given the fact that clearly erroneous review would largely be limited to transactions that were not subject to the LULD Plan, the Exchange also believes that it is necessary to change the parameters used to determine whether a trade is clearly erroneous. Specifically, due to the different parameters currently used for clearly erroneous review and for determining Price Bands, it is possible that a trade that would have been permitted to execute within the Price Bands would later be deemed clearly erroneous, if, for example, a systems issue prevented the dissemination of the Price Bands. The Exchange believes that this result is contrary to the principle that trades within the Price Bands should stand, and has the potential to cause investor confusion if trades that are properly executed within the applicable parameters described in the LULD Plan are later deemed erroneous. By using consistent parameters for clearly erroneous reviews conducted during the Regular Market Session and the calculation of the Price Bands, the Exchange believes that this change would also serve to promote greater certainty with regards to when trades may be deemed erroneous.
Finally, the proposed rule changes make organizational updates to the Exchange's Clearly Erroneous Execution Rule as well as minor updates and corrections to the Rule to improve readability and clarity.
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposal would ensure the continued, uninterrupted operation of harmonized clearly erroneous execution rules across the U.S. equities markets while also amending those rules to provide greater certainty to Members and investors that trades will stand if executed during the Regular Market Session where the LULD Plan provides adequate protection against trading at erroneous prices. The Exchange understands that the other national securities exchanges and FINRA will also file similar proposals, the substance of which are identical to this proposal. Thus, the proposed rule change will help to ensure consistency across SROs without implicating any competitive issues.
No comments were solicited or received on the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the 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 to determine whether the proposed rule should be approved or disapproved.
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) of the Securities Exchange Act of 1934 (the “Act”),
Cboe BYX Exchange, Inc. (the “Exchange” or “BYX”) is filing with the Securities and Exchange Commission (“Commission”) a proposed amendment to eliminate the listings standards provided for in Chapter XIV of the Exchange Rulebook as the Exchange is not a listing venue.
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange 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 these 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 aspects of such statements.
As part of this proposal, the Exchange proposes to (1) adopt a new definition for Derivative Security, move the definition of unlisted trading privileges (“UTP”) Derivative Security
The Exchange proposes to define “Derivative Security” in proposed Rule 1.5(dd) and amend existing Rule 1.5(ee) to add the definition of “UTP Derivative Security”. “Derivative Security” would be a new definition and would mean a security that meets the definition of “new derivative securities product” in Rule 19b-4(e) under the Act. “UTP Derivative Security” would refer to any one of a list of Derivative Securities that trades on the Exchange pursuant to unlisted trading privileges. The list of proposed Derivative Securities that may meet the definition of UTP Derivative Security are as follows: Equity Linked Notes; Index Fund Shares listed pursuant to Cboe BZX Exchange, Inc. (“BZX”) Rule 14.11(c) or Nasdaq Stock Market LLC (“Nasdaq”) Rule 5705(b) and Investment Company Units listed pursuant to NYSE Arca, Inc. (“NYSE Arca”) Rule 5.2-E(j)(3); Index-Linked Exchangeable Notes; Equity Gold Shares; Equity Index-Linked Securities; Commodity-Linked Securities; Currency-Linked Securities; Fixed Income Index-Linked Securities; Futures-Linked Securities; Multifactor Index-Linked Securities; Trust Certificates; Currency and Index Warrants; Portfolio Depository Receipts; Trust Issued Receipts; Commodity-Based Trust Shares; Currency Trust Shares; Commodity Index Trust Shares; Commodity Futures Trust Shares; Partnership Units; Paired Trust Shares; Trust Units; Managed Fund Shares; Managed Trust Securities; Managed Portfolio Shares; Tracking Fund Shares listed pursuant to BZX Exchange Rule 14.11(m), Active Proxy Portfolio Shares listed pursuant to NYSE Arca Rule 8.601-E, and Proxy Portfolio Shares listed pursuant to Nasdaq Stock Market LLC Rule 5750; Selected Equity-linked Debt Securities (“SEEDS”); Exchange-Traded Fund Shares; and Contingent Value Rights (“CVRs”).
The Exchange also proposes to re-letter existing Rules 1.5(dd) through (ee) to allow for the addition of proposed Rule 1.5(dd). Further, the Exchange proposes to amend Rule 3.21 to reference the proposed definition of UTP Derivative Securities in Rule 1.5(ee).
Unlike its affiliate exchange BZX, the Exchange is not a listing venue and thus trades securities on a UTP basis only. Nonetheless, currently Chapter XIV of the Exchange's Rulebook provides for listing standards for Derivative Securities that are generally based on BZX Rule 14.11. Exchange Rule 14.1 also provides that the Exchange will not list an equity security, and that the provisions of Rules 14.2 through 14.9,
Exchange Rule 14.1 establishes the Exchange's authority to trade securities on a UTP Basis. Based on the proposed amendment to eliminate Derivative Security listings standards, the Exchange also proposes to amend Rule 14.1(a) to eliminate any references to the listing of securities on the Exchange. Additionally, the Exchange proposes to eliminate the definition of Equity Security from Rule 14.1 and to instead reference NMS Stock, as defined in Rule 4.5(cc). Lastly, based on the above proposals, the Exchange proposes to eliminate any reference to products listed on the Exchange as provided in Rules 3.7, 11.2, and 13.6.
Existing Rule 14.1(c) defines UTP Derivative Security. However, as the Exchange proposes to redefine such term in Rule 1.5(ee), it proposes to eliminate the definition from Rule 14.1(c). Existing Rule 14.1(c) also provides that a UTP Derivative Security is subject to additional rules, as set forth in subparagraphs (1) through (6). Now, the Exchange proposes to modify certain of those subparagraphs.
First, the Exchange proposes to eliminate existing Rule 14.1(c)(1), which provides that the Exchange shall file with the Commission a Form 19b-4(e) with respect to each UTP Derivative Security. The Exchange believes that it should not be necessary to file a Form 19b-4(e) with the Commission if it begins trading a UTP Derivative Security because Rule 19b-4(e) under the Act refers to the “listing and trading” of a “new derivative securities product”. The Exchange believes that the requirements of Rule 19b-4(e) refer to when an exchange lists and trades a Derivative Security, and not when an exchange seeks only to trade such product on a UTP basis pursuant to Rule 12f-2 under the Act.
The Exchange also proposes to replace the term “new derivative securities product” with the term Derivative Security in order to provide for consistent nomenclature in Exchange Rules. The proposed change is not a substantive change as the proposed definition of Derivative Security is equivalent to the definition of “new derivative securities product” under Rule 19b-4(e) under the Exchange Act, as set forth in proposed Rule 1.5(dd).
The Exchange proposes to add additional explanatory language to paragraph (c)(4) that states nothing in
Lastly, based on the proposal to eliminate Rule 14.1(c)(1), the Exchange proposes to renumber existing paragraphs (c)(2) through (c)(6) accordingly.
Finally, the Exchange is proposing to renumber Rule 14.10 to Rule 14.2 in order to reflect the elimination of Rule 14.2 through Rule 14.9 that the Exchange is proposing to delete as part of this proposal.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes the proposed definitions of Derivative Security and UTP Derivative Security are reasonable as the proposed substantive changes are substantially similar to other exchanges' rules. Specifically, the proposed definition of Derivative Security in Rule 1.5(dd) is substantially similar to the definition of Exchange Traded Product provided for in NYSE National Rule 1.1(m), except that it better conforms to the defined term “new derivative securities product” of Rule 19b-4(e) under the Act. The proposed definition of UTP Derivative Security is substantially similar to BZX Rule 1.5(ee), except that the list of Derivative Securities that may be UTP Derivative Securities includes CVRs. Further, the proposal is substantially similar to NYSE National Rule 1.1(m), but the list of Derivative Securities that may be UTP Derivative Securities includes three additional Derivative Securities, SEEDS, Exchange-Traded Fund Shares, and CVRs. While SEEDS and Exchange-Traded Fund Shares are not included in NYSE National Rule 1.1(m), they are Derivative Securities set forth not only in BZX Exchange Rules 14.11(e)(12) and 14.11(l), respectively, but also in section 5700 of the Nasdaq Rules. Further, while CVRs are not currently provided for in NYSE National Rule 1.1(m) or BZX Rule 1.5(ee), CVRs meet the definition of “new derivative securities product” in Rule 19b-4(e) under the Act and also may currently be traded on the Exchange pursuant to existing BYX Rule 14.1(a) on a UTP basis.
The Exchange believes that its proposal to remove listings standards from Chapter XIV of the Exchange's Rulebook and references elsewhere in the Exchange's Rulebook will eliminate potential investor confusion as the Exchange is not a listing venue. Given this, the Exchange believes the removal of such rules from Chapter XIV and reference to such listings standards in Rules 3.7, 11.2, and 13.6 will simplify and clarify the Exchange's Rulebook. Further, as proposed Chapter XIV is substantially similar to Chapter 5 of the NYSE National rulebook.
The Exchange's proposal to eliminate the definition of Equity Security from Rule 14.1 and to instead reference NMS Stock as defined in Rule 4.5(cc) will add consistency and clarity to the Exchange's rulebook.
Eliminating the requirement to file a Form 19b-4(e) for each Derivative Security is consistent with the Act because the regulatory requirement was not intended to apply in the context of Derivative Securities trading on a UTP basis. Moreover, the proposal to eliminate Rule 14.1(c)(1) will provide for a more efficient process for adding Derivative Securities to trading on the Exchange on a UTP basis. The Exchange also notes that the proposal is substantially identical to other exchange rules.
The Exchange believes that its proposal to amend Rule 14.1(c)(2), which eliminates redundant language and uses the defined term Derivative Security in lieu of the term “new derivatives securities product”, to amend Rule 14.1(c)(3) to substantially conform to NYSE National Rule 5.1(a)(2)(C) (trading halts), and to renumber existing paragraphs 14.1(c)(2)-(c)(6) based on its proposal to eliminate Rule 14.1(c)(1), will clarify and simplify the Exchange's Rulebook as well as provide consistency in the Exchange's Rules.
Lastly, the Exchange believes its proposed renumber of Rule 14.10 to Rule 14.2, is appropriate in order to reflect the elimination of Rule 14.2 through Rule 14.9 that the Exchange is proposing to delete as part of this proposal.
In light of the above proposals, the Exchange has also proposed to make corresponding changes to Rules 1.5, 3.7, 3.21, 11.2, 13.6 to renumber or re-letter certain paragraphs or subparagraphs of the Rule, eliminate any reference to Exchange listing rules in Chapter XIV, and update applicable rule references.
The proposal is intended to simplify and clarify the Exchange's Rules as they relate to UTP Derivative Securities and to reflect that BYX is not a listing venue which the Exchange believes will remove impediments to, and perfect the mechanism of, a free and open market and a national market system and, in general, to protect investors and the public interest. The Exchange believes that renumbering and re-lettering current Rules to correspond to the proposed changes will allow the Exchange to maintain a clear and organized rule structure, thus preventing investor confusion. For these reasons, the Exchange believes the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Allowing the Exchange to make the above proposed modifications will clarify that the Exchange is not a listing venue by eliminating listing standards and any references to Exchange listed securities Further, the proposed rule change will harmonize certain Exchange Rules with
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
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 to determine whether the proposed rule should be approved or disapproved.
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.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CboeBYX-2022-022 and should be submitted on or before October 19, 2022.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition “Metal of Honor: Gold from Simone Martini to Contemporary Art” at the Isabella Stewart Gardner Museum, Boston, Massachusetts, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the
Elliot Chiu, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made by the Deputy Assistant Secretary for Professional and Cultural Exchanges in the Bureau of Educational and Cultural Affairs in the U.S. Department of State,
Department of State.
Notice of request for public comment.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
The Department will accept comments from the public up to November 28, 2022.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent by any of the following methods:
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You must include the subject (PRA 60 Day Comment), information collection title (Request to Change End-User, End-Use and/or Destination of Hardware and Open General Licenses), and OMB control number (1405-0173) in any correspondence.
Mr. Dilan Wickrema, Office of Defense Trade Controls Policy, Department of State, telephone (202) 634-4981; email
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information is necessary for the proper functions of the Department.
• 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.
• Enhance the quality, utility, and clarity of the information to be collection.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note, comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware your comments as submitted, including your personal information, will be available for public review.
This information collection is used for two main purposes: (1) the collection and submission of information required for DDTC approval of a reexport or retransfer; and (2) the collection and retention of certain information for authorizations and other approvals, including for reexports and retransfers under an Open General License (OGL) program. Under § 123.9(a) of the International Traffic in Arms Regulations (ITAR), unless an exemption applies, DDTC's written approval must be obtained before reselling, transferring, reexporting, retransferring, transshipping, or disposing of a defense article to any end-user, end-use, or destination other than as stated on the export license or in the Electronic Export Information filing in cases where an exemption was claimed. Such approval is normally granted through case-by-case review of requests to authorize specific transfers. In addition, ITAR § 126.9(b) allows DDTC to provide export authorization for DDTC's own initiatives, including pilot programs and other specifically anticipated circumstances for which DDTC considers special authorizations appropriate. DDTC has launched a pilot program pursuant to its authorities in ITAR § 126.9(b) in order to assess the concept of an OGL mechanism by which it may authorize certain transfers of defense articles to predetermined parties. OGLs eliminate the need for the Department to individually review and approve certain lower-risk transactions involving certain recipients. DDTC believes the OGL pilot program will provide unprecedented flexibility for the U.S. defense industry and U.S. allies to operate consistent with the ITAR and will enhance their ability to maintain, repair, and store defense articles.Under ITAR § 123.1(c), DDTC may require pertinent documentation regarding the proposed transaction and proper completion of the application form, including information about the quantity and value of the defense article proposed for export and information on the proposed end-user, end-use, and ultimate destination. Under ITAR § 123.9(c), foreign persons who seek approval from DDTC to reexport or retransfer defense articles are required to submit a description, quantity, and value of the defense article; a description and identification of the new end-user, end-use, and destination. Under ITAR § 123.26 any foreign person engaging in any reexport or retransfer of a defense article pursuant to an exemption must maintain records of each such transfer including the
Respondents will submit information as attachments to relevant license applications or requests for other approval. Applicants are referred to ITAR § 123.9 for guidance on what information to submit regarding the request to change end-user, end-use and/or destination of hardware. This information may be submitted electronically via a DS-6004, Reexport/Retransfer Application, through DDTC's case management system, the Defense Export Control and Compliance System (DECCS).
Separately, under the OGL program, as described in each OGL, and as also described in ITAR § 123.26, respondents will be required to retain certain information in their own records for a period of five years from the date of the reexport or retransfer.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35.
Federal Aviation Administration (FAA), Department of Transportation (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 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 allow renewal of the currently approved information collection via the FAA's deployed Web-based Frequency Coordination system (WebFCR), which collects certain broadcast and transmitter frequency information under OMB control number 2120-0786. The information collected is needed to perform the aeronautical studies, technical evaluations required and to meet the specified requirements for the radio frequency engineering pursuant to the FAA Order. The Federal Aviation Administration (FAA) Order 6050.32.B, Chapter 3, Section 302 outlines the US National Organizations, and the role of the National Telecommunications and Information Administration (NTIA) is assigning the Aviation Assignment Group (AAG) of the radio spectrum to FAA which support aeronautical services. Hence, FAA must “authorize” aeronautical frequencies of broadcast applications which impact the AAG bands.
Written comments should be submitted by November 28, 2022.
Please send written comments:
Christopher S. Jones by email or phone at:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of intent to designate Caldwell Commercial, Inc., supplemental type certificate as abandoned; request for comments.
This notice announces the FAA's intent to designate Caldwell Commercial, Inc., Supplemental Type Certificate (STC) No. SB2236NM as abandoned and make the related engineering data available upon request. The FAA has received a request to provide engineering data concerning this STC. The FAA has been unsuccessful in contacting Caldwell Commercial, Inc., concerning the STC. This action is intended to enhance aviation safety.
The FAA must receive all comments by March 27, 2023.
You may send comments on this notice by any of the following methods:
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Calvin Hang, Aerospace Engineer, Federal Aviation Administration, Los Angeles ACO Branch, 3960 Paramount Boulevard, Suite 100, Lakewood, CA 90712-4137; telephone (562) 627-5254; email
The FAA invites interested parties to provide comments, written data, views, or arguments relating to this notice. Send your comments to an address listed under
The FAA is posting this notice to inform the public that the FAA intends to designate Caldwell Commercial, Inc., STC No. SB2236NM, for the removal of Balloon Works FireFly 7 envelope and installation of Caldwell Commercial CC-7 envelope, as abandoned and subsequently release the related engineering data.
The FAA has received a third-party request for the release of data for the modification of the balloon envelope under the provisions of the Freedom of Information Act (FOIA), 5 U.S.C. 552. The FAA cannot release commercial or financial information, such as the requested data, under FOIA without the permission of the data owner. However, in accordance with title 49 of the United States Code § 44704(a)(5), the FAA can make STC “engineering data” in possession of the FAA available upon request if the FAA determines that the STC has been inactive for 3 or more years and, using due diligence, the FAA is unable to locate the owner of record or the owner of record's heir. There has been no activity on this STC for more than 3 years.
On March 31, 2022, the FAA sent a registered letter to Caldwell Commercial, Inc., to its last-known address: c/o 20215 Fortuna Del Este Elfin Forest, Escondido, CA 92025. The letter informed Caldwell Commercial, Inc., that the FAA had received a request for engineering data related to STC No. SB2236NM and was conducting a due diligence search to determine whether the STC was inactive and may be considered abandoned. The letter further requested that the company respond in writing within 60 days and state whether it is the holder of the STC. The FAA has also attempted to make contact with Caldwell Commercial, Inc., by other means, including telephone communication and emails, but without success.
If you are the owner or heir or a transferee of STC No. SB2236NM, or have any knowledge regarding who may now hold STC No. SB2236NM, please contact Calvin Hang using a method described in this notice under
If the FAA does not receive any response by March 27, 2023, the FAA will consider STC No. SB2236NM abandoned, and the FAA will proceed with the release of the requested data. This action is for the purpose of maintaining the airworthiness of an aircraft and enhancing aviation safety.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of funding opportunity.
The Department of Transportation (DOT), Federal Aviation Administration (FAA) announces the opportunity to apply for approximately $1 billion in FY 2023 discretionary funds for the Airport Terminal Program (ATP), made available under the Infrastructure Investment and Jobs Act of 2021 (IIJA), Public Law 117-58, herein referred to as the Bipartisan Infrastructure Law (BIL). The purpose of the ATP is to make annual grants available to eligible airports for airport terminal development projects that address the aging infrastructure of the nation's airports. In addition, ATP grants will align with DOT's Strategic Framework FY2022-2026 at
Airport sponsors that wish to be considered for FY 2023 ATP discretionary funding should submit an application that meets the requirements of this NOFO as soon as possible, but no later than 5:00 p.m. Eastern time, October 24, 2022.
Submit applications electronically at
Robin K. Hunt, Manager, BIL Implementation Team, FAA Office of Airports, at (202) 267-3263 or our FAA BIL email address:
BIL established the ATP, a competitive discretionary grant program, which provides approximately $1 billion in grant funding annually for five years (Fiscal Years 2022-2026) to upgrade, modernize, and rebuild our nation's airport terminals and airport-owned Airport Traffic Control Towers (ATCTs). This includes bringing airport facilities into conformity with current standards; constructing, modifying, or expanding facilities as necessary to meet demonstrated aeronautical demand; enhancing environmental sustainability; encouraging actual and potential competition; and providing a balanced system of airports to meet the roles and functions necessary to support civil aeronautical demand. This program also supports the President's goals to mobilize American ingenuity to build modern infrastructure and an equitable, clean energy future. In support of Executive Order 13985,
The ATP falls under the project grant authority for the Airport Improvement Program (AIP) in 49 United States Code (U.S.C.) § 47104. Per 2 Code of Federal Regulations (CFR) Part 200—
Consistent with statutory criteria and Executive Order 14008,
The FAA will also consider projects that advance the goals of the Executive Orders listed under Section E.2.
This NOFO announces up to $1,000,000,000, subject to availability of funds, for the Fiscal Year 2023 ATP. The ATP is a $5 billion grant program, distributed as approximately $1 billion annually for five years (Fiscal Years 2022, 2023, 2024, 2025, and 2026), subject to annual allocations limitations based on airport roles found in the published National Plan of Integrated Airport Systems (NPIAS). In general, the $5 billion in ATP grant funding is subject to the following annual award allocation limitations: not more than 55 percent shall be for large hub airports, not more than 15 percent shall be for medium hub airports, not more than 20 percent shall be for small hub airports, and not less than 10 percent shall be for nonhub and nonprimary airports.
The FAA will consider projects that increase capacity and passenger access; projects that replace aging infrastructure; projects that achieve compliance with the Americans with Disabilities Act (42 U.S.C. 12101,
Projects for relocating, reconstructing, repairing, or improving an airport-owned ATCT will also be considered. In addition to the considerations above, these projects will also be evaluated based on overall impact on the National Airspace System, including age of facility, operational constraints, and nonstandard facilities.
The FAA will publish a NOFO annually to announce additional funding made available, approximately $1 billion per year, for Fiscal Years 2024-2026.
Eligible applicants are those airport sponsors normally eligible for Airport Improvement Program (AIP) discretionary grants as defined in 49 U.S.C. 47115. This includes a public agency, private entity, state agency, Indian Tribe or Pueblo owning a public-use NPIAS airport, the Secretary of the Interior for Midway Island airport, the Republic of the Marshall Islands, Federated States of Micronesia, Republic of Palau.
The Federal cost share of ATP grants is 80 percent for large and medium hub
All projects funded from the ATP must be:
i. Airport terminal development, defined in 49 U.S.C. 47102(28) as development of an airport passenger terminal building, including terminal gates; access roads servicing exclusively airport traffic that leads directly to or from an airport passenger terminal building; and walkways that lead directly to or from an airport passenger terminal building. Under the ATP, the FAA may consider projects that qualify as “terminal development” (including multimodal terminal development), as that term is defined in 49 U.S.C. 47102(28); or
ii. On-airport rail access projects as set forth in Passenger Facility Charge (PFC) Update 75-21 (86 FR 48793, August 31, 2021); or
iii. Airport-owned ATCT that includes relocating, reconstructing, repairing, or improving the ATCT; and
iv. Justified based on civil aeronautical demand.
An application for ATP terminal or ATCT projects, FAA Form 5100-144,
Direct all inquiries regarding applications to the appropriate Regional Office (RO) or Airports District Office (ADO). RO/ADO contact information is available at:
Applicants are required to submit information contained in FAA Form 5100-144,
All applications must be submitted electronically following the instruction on the form. Once the form is complete, save a copy of the form electronically to your files for future reference. Next, scroll to the bottom of the form and press the “submit” button. This will generate an email for you to send to the FAA BIL Team for review and evaluation. If the submit button did not automatically generate an email, you can also manually email your saved open field form to:
Applicants selected to receive an ATP grant will then be required to follow AIP grant application procedures prior to award, which include meeting all prerequisites for funding, and submission of Standard Form SF-424,
Airports covered under the FAA's State Block Grant Program or airports in a channeling act state should coordinate with their associated state agency on the process for who should submit an application, via the procedures noted above.
Applicants must comply with 2 CFR part 25—
Once awarded, the FAA grant recipient must maintain the currency of its information in SAM until the grantee submits the final financial report required under the grant or receives the final payment, whichever is later. A grant recipient must review and update the information at least annually after the initial registration and more frequently if required by changes in information or another award term.
The FAA may not make an award until the applicant has complied with all applicable UEI and SAM requirements. If an applicant has not fully complied with the requirements by the time the FAA is ready to make an award, the FAA may determine that the applicant is not qualified to receive an award and use that determination as a basis for making a federal award to another applicant.
Non-federal entities that have received a federal award are required to report certain civil, criminal, or administrative proceedings to SAM (currently the Federal Awardee Performance and Integrity Information System (FAPIIS)
Airports that wish to be considered for FY 2023 ATP discretionary funding should submit an application that meets the requirements of this NOFO as soon as possible, but no later than 5:00 p.m. Eastern time on October 24, 2022. Submit applications electronically to
All projects funded from the ATP must be airport terminal development, defined under Section 3 Project Eligibility.
ATP funds may not be used to support or oppose union organizing.
Once Form 5100-144 is complete, save a copy of the form electronically to your files for future reference. Next, scroll to the bottom of the form and choose the “Submit” button. That creates a new email message with the PDF attached. Or, as a backup method, you can manually email the form to:
Applications for FY 2023 ATP will be rated using the following criteria:
i. Projects must meet eligibility requirements under the ATP, which includes terminal development (including multimodal terminal development) as defined in 49 U.S.C. 47102(28), on-airport rail access projects, or airport-owned ATCT relocation, reconstruction, repair, or improvements.
ii. FAA will consider timeliness of implementation, with priority given to those projects, including “design only” projects, that can satisfy all statutory and administrative requirements for grant award by July 2023.
iii. Favorable consideration will be given to eligible and justified terminal development (including multimodal terminal development), on-airport rail access projects, and ATCT projects that:
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iv. ATCT projects that relocate, reconstruct, repair, or improve an airport-owned ATCT will also be evaluated based on overall impact on the National Airspace System, including age of facility, operational constraints, and nonstandard facility conditions.
v. FAA will provide a preference to projects that achieve a complete development objective, even if awards for the project must be phased, and prioritize projects that have received partial awards.
vi. The applicant should describe whether and how project delivery and implementation create good-paying jobs with the free and fair choice to join a union to the greatest extent possible, the use of demonstrated strong labor standards, practices and policies (including for direct employees, contractors, sub-contractors, and service workers on airport property); use of project labor agreements; distribution of workplace rights notices; union neutrality agreements; wage and/or
Applications will be evaluated on the above criteria in E.1 to ensure responsiveness to this NOFO and the intent of the ATP. Applicants are encouraged to submit projects that meet as many of the above criteria as possible, but do not need to meet all criteria to be considered. Federal awarding agency personnel will evaluate applications based on how well the projects meet the criteria in E.1, including project eligibility, justification, readiness, impact on the National Airspace System, and the availability of matching funds. The FAA will also consider how well projects advance the goals of the following Executive Orders: the President's January 20, 2021, Executive Order 13990,
Prior to making a Federal award with a total amount of Federal share greater than the simplified acquisition threshold, FAA is required to review and consider any information about the applicant that is in the designated integrity and performance system accessible through SAM (currently FAPIIS) (see 41 U.S.C. 2313). An applicant, at its option, may review information in the designated integrity and performance systems accessible through SAM and comment on any information about itself that a Federal awarding agency previously entered. FAA will consider any comments by the applicant, in addition to the other information in the designated integrity and performance system, in making a judgment about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR 200.206.
BIL awards are announced through a Congressional notification process and a DOT Secretary's Notice of Intent to Fund. The FAA RO/ADO representative will contact the airport with further information and instructions. Once all pre-grant actions are complete, the FAA RO/ADO will offer the airport sponsor a grant for the announced project. This offer may be provided through postal mail or by electronic means. Once this offer is signed by the airport sponsor, it becomes a grant agreement. Awards made under this program are subject to conditions and assurances in the grant agreement.
All project costs must be incurred after the grant execution date unless specifically permitted under 49 U.S.C. 47110(c). Certain airport development costs incurred before execution of the grant agreement, but after November 15, 2021, are allowable, only if certain conditions under 49 U.S.C. 47110(c) are met [see Table 3-60 of the AIP Handbook, FAA Order 5100.38 D Change 1, for a specific list of the guidance regarding when project costs can be incurred in relation to section 47110(c)].
All grant recipients are subject to the grant requirements of the AIP, found in 49 U.S.C. Chapter 471. Grant recipients are subject to requirements in the FAA's
Each grant recipient must assure that it will comply with all applicable federal statutes, regulations, executive orders, directives, FAA circulars, and other federal administrative requirements in carrying out any project supported by the ATP grant. The grant recipient must acknowledge that it is under a continuing obligation to comply with the terms and conditions of the grant agreement issued for its project with the FAA. The grant recipient understands that federal laws, regulations, policies, and administrative practices might be modified from time to time and may affect the implementation of the project. The grant recipient must agree that the most recent Federal requirements will apply to the project unless the FAA issues a written determination otherwise.
The grant recipient must submit the Certifications at the time of grant application and Assurances must be accepted as part of the grant agreement at the time of accepting a grant offer. Grant recipients must also comply with the requirements of 2 CFR part 200, which “are applicable to all costs related to Federal awards,” and which are cited in the grant assurances of the grant agreements. The Airport Sponsor Assurances are available on the FAA website at:
Grant recipients are subject to financial reporting per 2 CFR 200.328 and performance reporting per 2 CFR 200.329. Under the ATP, the grant recipient is required to comply with all Federal financial reporting requirements and payment requirements, including the submittal of timely and accurate reports. Financial and performance reporting requirements are available in the FAA October 2020 Financial Reporting Policy, which is available at
The grant recipient must comply with annual audit reporting requirements. The grant recipient and sub-recipients, if applicable, must comply with 2 CFR part 200, subpart F,
For further information concerning this notice, please contact the FAA BIL Implementation Team via email at
All applicants, including those requesting full federal share of eligible projects costs, should have a plan to address potential cost overruns as part of an overall funding plan.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of final disposition; grant of exemption.
FMCSA announces its decision to grant United Parcel Service, Inc.'s (UPS) application for an exemption from certain provisions of the Agency's commercial driver's license (CDL) regulations. The exemption allows UPS to conduct behind-the-wheel training for commercial learner's permit (CLP) holders in twin 28-foot trailers, rather than waiting to conduct the training after the individuals receive their Class A CDLs and pass the required knowledge test to obtain the double/triple trailer endorsement on their CDLs. FMCSA has analyzed the exemption application and the public comments and has determined that the exemptions, subject to the terms and conditions imposed, will likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption.
This exemption is effective September 28, 2022 and expires September 28, 2027.
Ms. Pearlie Robinson, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: (202) 366-4225; Email:
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain parts of the Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the
The Agency reviews safety analyses and public comments submitted and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the
When the Agency denies a request for an exemption, the applicant may be allowed to resubmit the application if the applicant can reasonably address the basis for denial. 49 U.S.C. 31315(b)(3).
FMCSA's CDL regulations prohibit employers from allowing an individual to operate a CMV during any period in which the driver does not have a CLP or CDL with the proper class or endorsements (49 CFR 383.37(a)), and the regulations prohibit the State driver licensing agencies (SDLAs) from issuing a double/triple trailer endorsement to CLP holders (49 CFR 383.25(a)(5)(iv) and 383.93(a)(2)). The regulations do not specify a minimum amount of time an individual must hold a Class A CDL prior to seeking the double/triple endorsement and do not require training or passing a double/triple trailer skills test prior to receiving the double/triple trailer endorsement. Individuals seeking such an endorsement need only pass a knowledge test.
UPS requests exemptions from 49 CFR 383.37(a) and 49 CFR 383.93(b)(1) to permit its CDL instructors to conduct behind-the-wheel training of CLP holders using twin 28-foot trailers. UPS uses single and double trailers in its fleet and requires that all its Class A CDL drivers be qualified to operate twin 28-foot trailers. UPS wants to ensure that its driver-trainees know how to safely operate the vehicles they will be driving in normal operations and plans to train its Class A CLP holders to operate double trailers prior to the individuals receiving their CDLs and taking the double/triple trailer knowledge test.
Because of the regulations cited above, UPS states that it is unable to include on-the-road doubles training in its initial driver training because double/triple trailer endorsements are not allowed on CLPs. Instead, a driver must receive a CDL before the driver can obtain a double/triple trailer endorsement. After the driver obtains the endorsement, the employer may conduct training on public roads.
UPS explained that it has a “hire from within” culture. Typically, its long-haul driver candidates come from the ranks of UPS associates who are experienced drivers of CMVs that do not require a CDL. Once a candidate obtains a CLP, UPS provides 80 hours of combined classroom and behind-the-wheel skills instruction training. UPS noted that a driver must wait 14 days after receiving a CLP before he or she can take the skills test required to obtain a CDL (49 CFR 383.25(e)). Depending on the State, it may take longer to secure an appointment for the CDL skills test. Therefore, weeks could pass between the time the driver receives primary training and the time the driver can obtain on-the-road training in doubles.
UPS notes that the regulations allow any Class A CDL holder to take the double/triple trailer endorsement knowledge test and obtain the endorsement without completing specialized training or passing a skills test. By contrast, under the requested exemptions, the UPS driver-trainee with a CLP would be permitted to operate doubles only under direct supervision of an experienced instructor and be required to successfully complete the training prior to obtaining the Class A CDL and applying for the double/triple trailer endorsement.
After the close of the comment period to UPS's application for exemptions, UPS submitted additional materials to FMCSA detailing UPS's training program. UPS identified the additional materials as Confidential Business Information (CBI). Because the information is CBI, there is no way for the public to comment on it. For this reason, the additional materials were not placed in the docket for this notice.
According to UPS, the requested exemption would achieve a level of safety equivalent to, or greater than, that which would be obtained by complying with current regulations and cites the following measures in support of this conclusion:
• Each driver with a CLP will receive a minimum of 80 hours of training;
• Drivers must successfully pass a UPS knowledge test similar to one that would be administered by the SDLA before beginning on-road skills training in doubles;
• Doubles skills training for drivers with CLPs will start in a closed yard;
• During all phases of behind-the-wheel training (BTW) (
• UPS will maintain a “satisfactory” safety rating with FMCSA.
Upon completion of the formal training, UPS asserts that the driver-trainees continue to improve their skills by operating UPS vehicles under the close supervision of certified instructors until they are ready to obtain their CDL. UPS believes these controls should address any safety concerns FMCSA or the motoring public might have regarding the requested exemptions. A copy of UPS's application for exemptions is available for review in the docket for this notice.
On February 25, 2020, FMCSA published notice of UPS's application for exemptions and requested public comment (85 FR 10810). The Agency received 38 comments. Twenty respondents supported the exemptions. Ms. Carolyn Carter said, for example, that “[a]llowing UPS to train with doubles during the initial training period gives the new drivers more experience and training prior to getting on the road by themselves. Providing UPS receives this exemption, it allows for safer new drivers to be prepared for the conditions of the roadways while hauling sets.” An anonymous commenter stated that, “All of the trainers at UPS go through extensive training in order to drive and operate doubles (Tractor and two 28' trailers)
Eighteen individuals opposed the exemption. Commenters who opposed the exemption stated that new drivers do not have sufficient experience to operate double trailers and that those drivers would not operate safely. Mr. Michael Millard wrote: “Based on the verbiage of UPS' application that did not request an exception from [§ 380.203] that requires a driver to possess a CDL for six months or [§ 383.25] which prohibits CLP holders from obtaining a double/triple trailer endorsement and the safety issues associated with double/triple trailers. I strongly suggest UPS's application be denied.” Another individual, MJ Thorne, said, “Please do not give UPS this exemption! New drivers need experience before they start handling things like doubles. If UPS is experiencing a hardship because they are training drivers but can't have them pull doubles, then they should not be training people new to this industry.”
The premise of some comments opposing the exemptions is that CLP holders lack experience driving a single trailer and should not be able to operate double/triple trailers until they receive their CDL. The CDL regulations, however, do not specify a minimum amount of time an individual must hold a Class A CDL prior to seeking the double/triple trailer endorsement and do not require training or passing a double/triple trailer skills test prior to receiving the double/triple trailer endorsement. Individuals with a valid Class A CDL seeking such an endorsement need only pass a knowledge test. The measures proposed by UPS would ensure that drivers receive on-road skills training prior to receiving the double/triple trailer endorsement.
In response to the comment stating that UPS did not seek an exemption from 49 CFR 380.23, FMCSA notes that section 380.23 applies only to operators of longer combination vehicles (LCVs), which have a gross vehicle weight greater than 80,000 pounds. The training requirements in 49 CFR part 380, subpart A, continue to apply to UPS drivers operating LCVs.
FMCSA has evaluated UPS's application and the public comments and decided to grant the exemptions. The Agency believes that UPS's training procedures will likely enable UPS and its drivers to achieve a level of safety that is equivalent to, or greater than, the level of safety achieved without the exemption (49 CFR 381.305(a)). The exemption is restricted to UPS's driver-trainee CLP holders operating vehicles with a gross vehicle weight of 80,000 pounds or less. The exemption will enable UPS drivers to obtain on-the-road training in doubles only under direct supervision of a certified driver instructor who has completed UPS's 8 week UPS Driver Trainer and Instructor Program and is recertified every 90 days before obtaining a CDL and the required endorsement for operating such CMVs.
Prior to making its decision, the Agency conducted a comprehensive review of UPS's safety performance, which included a review of the Motor Carrier Management Information System safety records, and inspection and accident reports submitted to FMCSA by State agencies. UPS possesses an active USDOT registration, maintains minimum required levels of financial responsibility, is not subject to an “imminent hazard” or other out-of-service (OOS) order, and has a “satisfactory” safety rating with FMCSA. FMCSA has therefore decided to grant the exemptions, subject to the terms and conditions outlined below.
The exemptions from 49 CFR 383.37(a) and 49 CFR 383.93(b)(1) will allow UPS driver-trainee CLP holders who have completed yard skills training and passed a company administered knowledge test in all of the areas required to obtain a double/triple trailer endorsement on a CDL under 49 CFR 383.115 to operate doubles under direct supervision of a certified training instructor who has a CDL with the double/triple trailer endorsement. Driver-trainees covered by these exemptions will not be required to possess a CDL or a double/triple trailer endorsement while performing on-the-road training in doubles. However, drivers will be required to present proof to law enforcement, upon request, that they have completed yard skills training and passed a company-administered knowledge test.
• Each driver covered by the exemption must maintain a valid CLP and not be subject to an OOS order or loss of driving privileges;
• Each driver must meet all of FMCSA's physical qualifications requirements under 49 CFR part 391;
• Each driver with a CLP must receive a minimum of 80 hours of training administered by UPS. The training must include at least 15 hours of classroom instruction, 18 hours of one-on-one field instruction focused on coupling and uncoupling doubles equipment, and 45 hours of individual on-road instruction operating doubles equipment on a public roadway;
• Drivers must successfully achieve a score of at least 80% on a UPS-administered written knowledge test similar in content to that which would be administered by the State pursuant to 49 CFR 383.115, before beginning BTW skills training in doubles;
• Doubles skills training for CLP holders will start in empty vehicles in a closed yard before moving to a public roadway;
• During all BTW training, driver-trainees will be under the direct supervision of a Class A CDL holder with a double/triple endorsement who has been certified as an instructor by UPS through an 8 week training program and is recertified every 90 days and who meets the qualifications in the definition of “BTW instructor” in 49 CFR 380.605;
• UPS will maintain a “satisfactory” safety rating assigned by FMCSA under the procedures in 49 CFR part 385; and
• Each driver must have a copy of this notice in his or her possession while operating under the terms of the exemptions. This notice serves as the exemption document and must be presented to law enforcement officials upon request.
During the period these exemptions are in effect; no State may enforce any law or regulation that conflicts with or is inconsistent with the exemptions with respect to a person or entity operating under the exemptions (49 U.S.C. 31315(d)).
UPS must notify FMCSA immediately of any accidents (as defined by 49 CFR 390.5) involving the operation of any of its CMVs while utilizing these exemptions. The notification must be by email to
a. Exemption Identifier: “UPS”;
b. Date of the accident;
c. City or town, and State, in which the accident occurred, or which is closest to the scene of the accident;
d. Driver's name and driver's license number;
e. Co-driver's name and driver's license State, number, and class;
f. Vehicle company number and power unit license plate State and number;
g. Number of individuals suffering physical injury;
h. Number of fatalities;
i. The police-reported cause of the accident;
j. Whether the driver was cited for violation of any traffic laws, or motor carrier safety regulations; and
k. The total driving time and the total on-duty time of the CMV driver at the time of the accident.
The FMCSA does not believe the CLP holders covered by the exemptions will experience any deterioration of their safety record. However, should this occur, FMCSA will take all steps necessary to protect the public interest, including revocation of these exemptions. The FMCSA will immediately revoke these exemptions for failure to comply with the terms and conditions set forth above.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice and request for comments on a request for extension with modification of a currently approved information collection.
NHTSA invites public comments about our intention to request the Office of Management and Budget (OMB) for an extension with modification of a currently approved information collection. Before a federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections. This document describes collections of information for which NHTSA intends to seek OMB approval that collect for NHTSA's Crash Report Sampling System (CRSS), Non-Traffic Surveillance (NTS), and special studies.
Written comments should be submitted by November 28, 2022.
You may submit comments [identified by Docket No. DOT-NHTSA-20XX-XXXX] through one of the following methods:
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For additional information or access to background documents, contact Jonae S. Anderson, Office of Data Acquisition (NSA-120), Room W53-470. (202) 366-1028, 1200 New Jersey Avenue SE, Washington, DC 20590, Please identify the relevant collection of information by referring to its OMB Control Number.
Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
In compliance with these requirements, NHTSA asks for public comments on the following proposed collections of information for which the agency is seeking approval from OMB.
Since late 1970s, NHTSA's National Center for Statistics and Analysis (NCSA) has utilized a multidisciplinary approach to meet the data needs of our end users that leverages an efficient combination of census, sample-based, and existing State files to provide information on traffic crashes on a timely basis. Beginning in 2016, the CRSS has been used to identify highway safety problem areas and provide general data trends. The Non-Traffic Surveillance System (NTS) provides data regarding fatalities and injuries that occur in non-traffic crashes and non-crash incidents.
CRSS obtains data from a nationally representative probability sample selected from police reported motor vehicle traffic crashes. Specifically, CRSS collects data on crashes involving at least one motor vehicle in transport on a trafficway that resulted in property damage, injury or a fatality will be included in the CRSS sample. The crash reports sampled will be chosen from selected areas that reflect the geography, population, miles driven, and the number of crashes in the United States. No additional data beyond the selected crash reports will be collected. Once the crash reports are received, they will be coded and the data will be entered into the CRSS Records Based Information Solution (RBIS), the repository for CRSS cases and reporting tools.
CRSS will acquire nationally representative information on fatalities, injuries and property damage directly from existing State police crash reports. The user population includes Federal and State agencies, automobile manufacturers, insurance companies, and the private sector. Annual changes in the sample parameters are minor in terms of operation and method of data collection, and do not affect the reporting burden on respondents.
The Non-Traffic Surveillance (NTS) is a data collection effort for collecting information about counts and details regarding fatalities and injuries that occur in non-traffic crashes and non-crash incidents. Non-traffic crashes are crashes that occur off a public trafficway (
For the NTS data collection this notice only discusses for the non-traffic crash portion that is collected using methods for the CRSS data collection. The non-traffic crash data that feed into NTS from the FARS and CISS data collection efforts are covered under information collection clearances for those data collection efforts. This is done because the data is collected differently under each of NHTSA's three data collection efforts. During the CRSS and CISS sampling process, NTS applicable crashes will be chosen from the same sample sites. The FARS data collection effort uncovers NTS applicable reports received from the State during their normal data collection activities for FARS. Therefore, the burden for NTS is included in each study's calculation. No additional data will be collected beyond the NTS applicable reports. Once the crash reports are received, each case will be coded and entered into the NTS RBIS application. NHTSA uses NTS data to estimate fatalities and injuries in non-traffic crashes, which are crashes which occur off the trafficways such as nonpublic roads, driveways, and parking lots.
In addition to CRSS data collection, NHTSA may require special studies to further analyze motor vehicle crashes in the CRSS jurisdictions. One type of special study is the collection of data from the non-sampled crashes from CRSS Police Jurisdictions (PJs) by the crash report Strata, NTS applicable, or out of scope, to help assess the accuracy of the PJ frame. Non-sample PJs are defined as PJs that investigate motor vehicle crashes within the CRSS PSU boundaries but are not sampled through the CRSS study.
Another special study NHTSA may require is the CRSS PJ frame evaluation. The PJ frame is constantly changing: new PJs start operating, existing PJs are closed, multiple PJs are merged into one PJ, or one PJ splits into multiple PJs. The current CRSS PJ sample was selected from the 2016 PJ frame and the PJ weights were calculated accordingly. If the PJ frame has changed dramatically from the 2016 PJ frame, the CRSS PJ weights are no longer correct and the CRSS estimates may be biased. To prevent this, NHTSA needs to evaluate the current PJ frame to identify all PJs that currently generate PCRs for the sampled non-Electronic Data Transfer (EDT) PSUs and collect 6 crash counts (total crashes, fatal crashes, injury crashes, pedestrian crashes, motorcycle crashes, and commercial motor vehicle crashes). The EDT is the nightly transfer of crash data. EDT PSUs have been collapsed into one PJ and sample crash reports throughout the county. Thus, the concern of completeness of the PJ frame in EDT PSUs, isn't an issue. Additionally, this study is different from the non-sample count special study, because the six crash counts are unrelated to CRSS or NTS applicability. These crash counts will be used as PJ measurement of size for PJ sample selection or PJ weight adjustment if needed.
NHTSA is seeking approval to modify the existing information collection to (a) reduce the burden hour estimates for CRSS information collection to account for previous inflated estimates and current efficiencies and (b) add the non-sampled Special Study into this package. The combined impact is an increase of 7,000 burden hours to NHTSA's overall total.
NHTSA's mission is to save lives, prevent injuries, and reduce economic losses resulting from motor vehicle crashes. In order to accomplish this mission, NHTSA needs high-quality data on motor vehicle crashes. The CRSS supports this mission by providing the agency with vital information about a nationally representative sample involving motor vehicle traffic crashes that occur on our nation's roadways.
CRSS data is used extensively by all the NHTSA program and research offices, other DOT modes, States, and local jurisdictions. The highway research community uses the CRSS data for trend analysis, problem identification, and program evaluation. Congress uses the CRSS data for making
The NTS is a Congressionally mandated data collection effort, which provides counts and details regarding injuries and fatalities that occur in non-traffic crashes and in non-crash incidents. NTS annual data is used to produce estimates for injuries and fatalities in non-traffic crashes. The NTS data is also made publicly available for highway safety research purposes.
The special studies such as the non-sample count and PJ frame evaluation are critical to assessing the quality of the PJ frame of the CRSS PSUs to determine PJ weights and measure of size for the CRSS PJ sample selection. Without the special studies, NHTSA may fail to accurately assess the national crash picture by missing pertinent crash data.
Local police jurisdictions (PJs) and State agencies that collect and maintain central databases of motor vehicle crashes partner with NHTSA to provide access to crash reports for the CRSS sample sites on a routine basis. CRSS collects data from sampled police jurisdictions in order to collect a nationally representative sample. However, because CRSS only collects information from police crash reports for many jurisdictions, NHTSA is able to collect the data directly from the States. This is because States have been moving toward more electronic and centralized data collection systems.
Within the 30 States or 60 CRSS Primary Sampling Units (PSUs) there are Police Jurisdictions (PJs), from which a CRSS sampler must obtain crash reports for listing, categorization, and sampling. Currently, 50 PSUs provide NHTSA data electronically—through EDT, State website access, or web service portal. For one State, the crash reports are obtained through EDT and manually since not all crashes are reported through EDT. Therefore, NHTSA counted that state more than once due to the crash report acquisition method. However, there is a total of 10 PSUs, or 21 local PJs, where crash reports collection is conducted in the field using a combination of electronic and manual methods as dictated by the sample PJ's crash report collection methods. These PJs required field samplers which incur an increased burden due to the labor-intensive administrative practices and privacy protections associated with manually accessing the crash reports. The total respondents doesn't equal to 30 States or 60 PSUs, due to the variation in accessing crash reports throughout the sample.
The annual burden estimate detailed in Table 1 is produced by identifying the crash report access method for each PSU and PJ and assigning the appropriate burden hours for that method as outlined below.
• EDT Maintenance—For PSUs providing crash report through EDT, the burden is estimated at 5 hours annually. This accounts for yearly updates to programming needed to successfully transmit data, such as updating data structures if new data elements are added or any changes to the state made to their crash report and/or databases.
• State Website—User Access Only: For PSUs providing crash reports via a state repository/website or database, the burden is estimated at 10 hours annually. This represents time to process user account requests, establish credentials, and routine maintenance of the State's data repositories.
• State Website—User Access and Additional Administrative Functions: For PSUs providing crash reports directly to NHTSA via web service or where the State employees provide user access accounts in addition to regularly searches for crash reports, compiles the lists of crashes to send to NHTSA monthly, the burden is estimated at 60 hours annually. This represents implementation, data transfer monitoring, and communications with NHTSA and its contractors.
• For PSUs providing crash reports to NHTSA via manual crash report access methods (
On an ad-hoc basis, NHTSA requests a non-sample count special study to assess the Police Jurisdiction (PJ) frame. The non-sample count and the PJ Frame evaluation studies are critical to assessing the quality of the PJ frame of the CRSS PSUs to determine PJ weights and measure of size for the CRSS PJ sample selection. Without the special studies, NHTSA may fail to accurately assess the national crash picture by missing pertinent crash data.
The burden calculation for the non-sample count special study is difficult to determine. Each burden calculation is associated with the agreed upon crash report access method for sample sites. For non-sample PJs we have no established relationship nor is it known which type of access to crash report is feasible. Most importantly, non-sample count special studies are conducted on an ad-hoc basis and not implemented every year. Table 2 illustrates non-sample counts by access method in the state for sample sites.
EDT has been removed from the table because CRSS samples from the entire county, there is no distinction between the non-sample and sample PJs. This is an added benefit to EDT implementation as we get an accurate assessment of the PSU frame by CRSS strata. State websites with user access have non-sample PJs however, there is no added burden because the initial access granted is at the state level. State website with user access and additional administrative functions provide NHTSA data at the county level, which includes both sample and non-sample PJs, thus there is no additional burden to the state. Webservice agreements also provide data at the county level, thus there is no additional burden to the state. States noted as having manual methods only account for the sample PJs. Without established cooperation, NHTSA can't forecast individual PJs access methods for the purposes of the burden calculation. Thus, the maximum burden for the non-sample count special study's estimated burden is 21,307 with the possibility of reduction with cooperative agreements finalized.
The activities associated with PJ frame evaluation special study include identifying the in-scope PJs and contacting the in-scope PJs for the 6 crash counts. NHTSA estimates there are total 40 non-EDT PSUs and about 1,248 PJs in those non-EDT PSUs. NHTSA estimates it would about 1 minute per PJ to confirm if any changes to the PJ since the 2016. NHTSA anticipates approximately 15 minutes (0.25 hours) for each PJ to prepare the 6 crash counts. NHTSA estimates the total number of hours of response burden is about 333 hours.
This hourly burden was calculated using the Bureau of Labor Statistics' mean hourly wage estimate for Court, Municipal, and License Clerks (Standard Occupational Classification
The total burden hours are presented in the table below but described for each study.
NHTSA estimates that there are no costs associated with this information collection other than labor costs associated with burden hours. This is a drastic decrease from the $1.7 M from when NHTSA last sought approval for this information collection. The decrease in costs is a result of removing labor costs associated with labor hours that were included in response to question 12, but unfortunately were incorrect.
Office of Foreign Assets Control, Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing an update to the identifying information of one vessel currently included on the Specially Designated Nationals and Blocked Persons List. The vessel remains the blocked property of a person who has an interest under the relevant sanctions authority listed below.
See
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On September 15, 2022, OFAC updated the Specially Designated Nationals and Blocked Persons List entry for the following vessel, in which a blocked person has an interest and continues to be blocked pursuant to the prohibitions in Executive Order 13726.
1. BONU 5 Malta flag; Vessel Registration Identification 15411 (Malta) (vessel) [LIBYA3] (Linked To: ANDREA MARTINA LIMITED).
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. Additionally, OFAC is publishing updates to the identifying information of one person currently included on the SDN List. OFAC is further publishing the name of one person that has been removed from the SDN List.
See
OFAC: Andrea Gacki, Director, tel.: 202-622-2490; Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel.: 202-622-4855; or the Assistant Director for Sanctions
The SDN List and additional information concerning OFAC sanctions programs are available on OFAC's website (
A. On September 15, 2022, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authority 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 associated with the U.S. Income Tax Return Forms for Individual Taxpayers.
Written comments should be received on or before November 28, 2022 to be assured of consideration.
Written comments and recommendations for the proposed information collection should be sent within 60 days of publication of this notice to
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
• 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, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning forms used by tax-exempt organizations. See Appendix A for a list of forms, schedules, and related attachments.
Written comments should be received on or before November 28, 2022 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 the form and instructions should be directed to Jon Callahan, (737) 800-7639, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet at
Today, 93 percent of all tax-exempt organization returns are prepared using software by the taxpayer or with preparer assistance. Section 3101 of the Taxpayer First Act, Public Law 116-25, requires all tax-exempt organizations to electronically file statements or returns in the Form 990 series or Form 8872, with a temporary waiver for small organizations.
These are forms used by tax-exempt organizations. These include Forms 990, 990-BL, 990-EZ, 990-N, 990-PF, 990-T, 990-W, and related forms and schedules tax-exempt organizations attach to their tax returns (see Appendix-A to this notice). In addition, there are numerous regulations, notices and Treasury Decisions that are covered by the burden estimate provided in this notice. See Appendix-B for a list.
Tax compliance burden is defined as the time and money taxpayers spend to comply with their tax filing responsibilities. Time-related activities include recordkeeping, tax planning, gathering tax materials, learning about the law and what you need to do, and completing and submitting the return. Out-of-pocket costs include expenses such as purchasing tax software, paying a third-party preparer, and printing and postage. Tax compliance burden does not include a taxpayer's tax liability, economic inefficiencies caused by sub-optimal choices related to tax deductions or credits, or psychological costs.
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.
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 general 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 (PRA). The IRS is soliciting comments on forms used by business entity taxpayers. (See Appendix-A of this notice for a list of forms, schedules, and related attachments).
Written comments should be received on or before November 28, 2022 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 the form and instructions should be directed to Sara Covington, at (202)-317-5744, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet, at
Today, over 90 percent of all business entity tax returns are prepared using software by the taxpayer or with preparer assistance.
These are forms used by business taxpayers. These include Forms
Tax compliance burden is defined as the time and money taxpayers spend to comply with their tax filing responsibilities. Time-related activities include recordkeeping, tax planning, gathering tax materials, learning about the law and what you need to do, and completing and submitting the return.
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.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary 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 collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
OMB numbers that will no longer be separately reported in order to eliminate duplicate burden reporting. For business filers, the following OMB numbers are or will be retired.
Department of the Treasury.
Notice of appointments to Performance Review Boards (PRBs).
This notice announces the appointment of members to the Department of the Treasury's Performance Review Boards (PRBs). The purpose of these Boards are to review and make recommendations concerning proposed performance appraisals, ratings, bonuses and other appropriate personnel actions for incumbents of SES positions in the Department.
Membership is effective on the date of this notice.
Julia J. Markham or Kimberly Jackson, Office of Executive Resources, 1500 Pennsylvania Avenue NW, ATTN: 1722 Eye Street, 9th Floor, Washington, DC 20220, Telephone: 202-622-0774.
Human Resources and Administration/Operations, Security, and Preparedness (HRA/OSP), Department of Veterans Affairs.
Notice.
Human Resources and Administration/Operations, Security, and Preparedness, 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
Written comments and recommendations on the proposed collection of information should be received on or before November 28, 2022.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Please refer to “OMB Control No. 2900-0662” in any correspondence. During the comment period, comments may be viewed online through FDMS.
Maribel Aponte, Office of Enterprise and Integration, Data Governance Analytics (008), 810 Vermont Ave. NW, Washington, DC 20006, (202) 266-4688 or email
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, HRA/OSP invites comments on: (1) whether the proposed collection of information is necessary for the proper performance of HRA/OSP's functions, including whether the information will have practical utility; (2) the accuracy of HRA/OSP'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.
With respect to the following collection of information, HRA/OSP invites comments on: (1) whether the proposed collection of information is necessary for the proper performance of ORMDI's functions, including whether the information will have practical utility; (2) the accuracy of HRA/OSP'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
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Maribel Aponte, Office of Enterprise and Integration, Data Governance Analytics (008), 810 Vermont Ave. NW, Washington, DC 20006, (202) 266-4688 or email
The respondent burden for VA Form 21-526EZ has increased due to: the number of receivables averaged over the past year, general program changes—such as regulatory changes, and the continuing improvement of VA's electronic claims processing systems.
VA Form 21-526EZ has been updated, to include: new instructions associated with `The Sergeant First Class (SFC) Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act'; the GENDER question has been removed; a new Section IV: Exposure Information, including new PACT Act questions that identify toxic exposures the claimant may have been exposed to during service; and an `Addendum' has been added to provide additional space for disabilities if the claimant has more than the space provided in Section V: Claim Information.
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
By direction of the Secretary.